```

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 34 Enrolled Bill (ENR)]

        H.R.34

                     One Hundred Fourteenth Congress

                                 of the

                        United States of America

                          AT THE SECOND SESSION

           Begun and held at the City of Washington on Monday,
           the fourth day of January, two thousand and sixteen

                                 An Act

 
 To accelerate the discovery, development, and delivery of 21st century 
                     cures, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
    (a) Short Title.--This Act may be cited as the ``21st Century Cures 
Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.

                     DIVISION A--21ST CENTURY CURES

Sec. 1000. Short title.

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

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

                           TITLE II--DISCOVERY

        Subtitle A--National Institutes of Health Reauthorization

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

                Subtitle B--Advancing Precision Medicine

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

            Subtitle C--Supporting Young Emerging Scientists

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

  Subtitle D--National Institutes of Health Planning and Administration

Sec. 2031. National Institutes of Health strategic plan.
Sec. 2032. Triennial reports.
Sec. 2033. Increasing accountability at the National Institutes of 
          Health.
Sec. 2034. Reducing administrative burden for researchers.
Sec. 2035. Exemption for the National Institutes of Health from the 
          Paperwork Reduction Act requirements.
Sec. 2036. High-risk, high-reward research.
Sec. 2037. National Center for Advancing Translational Sciences.
Sec. 2038. Collaboration and coordination to enhance research.
Sec. 2039. Enhancing the rigor and reproducibility of scientific 
          research.
Sec. 2040. Improving medical rehabilitation research at the National 
          Institutes of Health.
Sec. 2041. Task force on research specific to pregnant women and 
          lactating women.
Sec. 2042. Streamlining National Institutes of Health reporting 
          requirements.
Sec. 2043. Reimbursement for research substances and living organisms.
Sec. 2044. Sense of Congress on increased inclusion of underrepresented 
          populations in clinical trials.

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

Sec. 2051. Technical updates to clinical trials database.
Sec. 2052. Compliance activities reports.
Sec. 2053. Updates to policies to improve data.
Sec. 2054. Consultation.

             Subtitle F--Facilitating Collaborative Research

Sec. 2061. National neurological conditions surveillance system.
Sec. 2062. Tick-borne diseases.
Sec. 2063. Accessing, sharing, and using health data for research 
          purposes.

                Subtitle G--Promoting Pediatric Research

Sec. 2071. National pediatric research network.
Sec. 2072. Global pediatric clinical study network.

                         TITLE III--DEVELOPMENT

              Subtitle A--Patient-Focused Drug Development

Sec. 3001. Patient experience data.
Sec. 3002. Patient-focused drug development guidance.
Sec. 3003. Streamlining patient input.
Sec. 3004. Report on patient experience drug development.

                Subtitle B--Advancing New Drug Therapies

Sec. 3011. Qualification of drug development tools.
Sec. 3012. Targeted drugs for rare diseases.
Sec. 3013. Reauthorization of program to encourage treatments for rare 
          pediatric diseases.
Sec. 3014. GAO study of priority review voucher programs.
Sec. 3015. Amendments to the Orphan Drug grants.
Sec. 3016. Grants for studying continuous drug manufacturing.

        Subtitle C--Modern Trial Design and Evidence Development

Sec. 3021. Novel clinical trial designs.
Sec. 3022. Real world evidence.
Sec. 3023. Protection of human research subjects.
Sec. 3024. Informed consent waiver or alteration for clinical 
          investigations.

         Subtitle D--Patient Access to Therapies and Information

Sec. 3031. Summary level review.
Sec. 3032. Expanded access policy.
Sec. 3033. Accelerated approval for regenerative advanced therapies.
Sec. 3034. Guidance regarding devices used in the recovery, isolation, 
          or delivery of regenerative advanced therapies.
Sec. 3035. Report on regenerative advanced therapies.
Sec. 3036. Standards for regenerative medicine and regenerative advanced 
          therapies.
Sec. 3037. Health care economic information.
Sec. 3038. Combination product innovation.

          Subtitle E--Antimicrobial Innovation and Stewardship

Sec. 3041. Antimicrobial resistance monitoring.
Sec. 3042. Limited population pathway.
Sec. 3043. Prescribing authority.
Sec. 3044. Susceptibility test interpretive criteria for microorganisms; 
          antimicrobial susceptibility testing devices.

                 Subtitle F--Medical Device Innovations

Sec. 3051. Breakthrough devices.
Sec. 3052. Humanitarian device exemption.
Sec. 3053. Recognition of standards.
Sec. 3054. Certain class I and class II devices.
Sec. 3055. Classification panels.
Sec. 3056. Institutional review board flexibility.
Sec. 3057. CLIA waiver improvements.
Sec. 3058. Least burdensome device review.
Sec. 3059. Cleaning instructions and validation data requirement.
Sec. 3060. Clarifying medical software regulation.

     Subtitle G--Improving Scientific Expertise and Outreach at FDA

Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical 
          Product Assessment Service.
Sec. 3072. Hiring authority for scientific, technical, and professional 
          personnel.
Sec. 3073. Establishment of Food and Drug Administration Intercenter 
          Institutes.
Sec. 3074. Scientific engagement.
Sec. 3075. Drug surveillance.
Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration.

             Subtitle H--Medical Countermeasures Innovation

Sec. 3081. Medical countermeasure guidelines.
Sec. 3082. Clarifying BARDA contracting authority.
Sec. 3083. Countermeasure budget plan.
Sec. 3084. Medical countermeasures innovation.
Sec. 3085. Streamlining Project BioShield procurement.
Sec. 3086. Encouraging treatments for agents that present a national 
          security threat.
Sec. 3087. Paperwork Reduction Act waiver during a public health 
          emergency.
Sec. 3088. Clarifying Food and Drug Administration emergency use 
          authorization.

          Subtitle I--Vaccine Access, Certainty, and Innovation

Sec. 3091. Predictable review timelines of vaccines by the Advisory 
          Committee on Immunization Practices.
Sec. 3092. Review of processes and consistency of Advisory Committee on 
          Immunization Practices recommendations.
Sec. 3093. Encouraging vaccine innovation.

                    Subtitle J--Technical Corrections

Sec. 3101. Technical corrections.
Sec. 3102. Completed studies.

                           TITLE IV--DELIVERY

Sec. 4001. Assisting doctors and hospitals in improving quality of care 
          for patients.
Sec. 4002. Transparent reporting on usability, security, and 
          functionality.
Sec. 4003. Interoperability.
Sec. 4004. Information blocking.
Sec. 4005. Leveraging electronic health records to improve patient care.
Sec. 4006. Empowering patients and improving patient access to their 
          electronic health information.
Sec. 4007. GAO study on patient matching.
Sec. 4008. GAO study on patient access to health information.
Sec. 4009. Improving Medicare local coverage determinations.
Sec. 4010. Medicare pharmaceutical and technology ombudsman.
Sec. 4011. Medicare site-of-service price transparency.
Sec. 4012. Telehealth services in Medicare.

                            TITLE V--SAVINGS

Sec. 5001. Savings in the Medicare Improvement Fund.
Sec. 5002. Medicaid reimbursement to States for durable medical 
          equipment.
Sec. 5003. Penalties for violations of grants, contracts, and other 
          agreements.
Sec. 5004. Reducing overpayments of infusion drugs.
Sec. 5005. Increasing oversight of termination of Medicaid providers.
Sec. 5006. Requiring publication of fee-for-service provider directory.
Sec. 5007. Fairness in Medicaid supplemental needs trusts.
Sec. 5008. Eliminating Federal financial participation with respect to 
          expenditures under Medicaid for agents used for cosmetic 
          purposes or hair growth.
Sec. 5009. Amendment to the Prevention and Public Health Fund.
Sec. 5010. Strategic Petroleum Reserve drawdown.
Sec. 5011. Rescission of portion of ACA territory funding.
Sec. 5012. Medicare coverage of home infusion therapy.

          DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS

Sec. 6000. Short title.

          TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY

                         Subtitle A--Leadership

Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
Sec. 6002. Strengthening the leadership of the Substance Abuse and 
          Mental Health Services Administration.
Sec. 6003. Chief Medical Officer.
Sec. 6004. Improving the quality of behavioral health programs.
Sec. 6005. Strategic plan.
Sec. 6006. Biennial report concerning activities and progress.
Sec. 6007. Authorities of centers for mental health services, substance 
          abuse prevention, and substance abuse treatment.
Sec. 6008. Advisory councils.
Sec. 6009. Peer review.

                Subtitle B--Oversight and Accountability

Sec. 6021. Improving oversight of mental and substance use disorders 
          programs through the Assistant Secretary for Planning and 
          Evaluation.
Sec. 6022. Reporting for protection and advocacy organizations.
Sec. 6023. GAO study.

   Subtitle C--Interdepartmental Serious Mental Illness Coordinating 
                                Committee

Sec. 6031. Interdepartmental Serious Mental Illness Coordinating 
          Committee.

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

Sec. 7001. Encouraging innovation and evidence-based programs.
Sec. 7002. Promoting access to information on evidence-based programs 
          and practices.
Sec. 7003. Priority mental health needs of regional and national 
          significance.
Sec. 7004. Priority substance use disorder treatment needs of regional 
          and national significance.
Sec. 7005. Priority substance use disorder prevention needs of regional 
          and national significance.

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

Sec. 8001. Community mental health services block grant.
Sec. 8002. Substance abuse prevention and treatment block grant.
Sec. 8003. Additional provisions related to the block grants.
Sec. 8004. Study of distribution of funds under the substance abuse 
          prevention and treatment block grant and the community mental 
          health services block grant.

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

              Subtitle A--Helping Individuals and Families

Sec. 9001. Grants for treatment and recovery for homeless individuals.
Sec. 9002. Grants for jail diversion programs.
Sec. 9003. Promoting integration of primary and behavioral health care.
Sec. 9004. Projects for assistance in transition from homelessness.
Sec. 9005. National Suicide Prevention Lifeline Program.
Sec. 9006. Connecting individuals and families with care.
Sec. 9007. Strengthening community crisis response systems.
Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
Sec. 9009. Adult suicide prevention.
Sec. 9010. Mental health awareness training grants.
Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska 
          Native youth within suicide prevention programs.
Sec. 9012. Evidence-based practices for older adults.
Sec. 9013. National violent death reporting system.
Sec. 9014. Assisted outpatient treatment.
Sec. 9015. Assertive community treatment grant program.
Sec. 9016. Sober truth on preventing underage drinking reauthorization.
Sec. 9017. Center and program repeals.

           Subtitle B--Strengthening the Health Care Workforce

Sec. 9021. Mental and behavioral health education and training grants.
Sec. 9022. Strengthening the mental and substance use disorders 
          workforce.
Sec. 9023. Clarification on current eligibility for loan repayment 
          programs.
Sec. 9024. Minority fellowship program.
Sec. 9025. Liability protections for health professional volunteers at 
          community health centers.
Sec. 9026. Reports.

             Subtitle C--Mental Health on Campus Improvement

Sec. 9031. Mental health and substance use disorder services on campus.
Sec. 9032. Interagency Working Group on College Mental Health.
Sec. 9033. Improving mental health on college campuses.

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

Sec. 10001. Programs for children with a serious emotional disturbance.
Sec. 10002. Increasing access to pediatric mental health care.
Sec. 10003. Substance use disorder treatment and early intervention 
          services for children and adolescents.
Sec. 10004. Children's recovery from trauma.
Sec. 10005. Screening and treatment for maternal depression.
Sec. 10006. Infant and early childhood mental health promotion, 
          intervention, and treatment.

             TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA

Sec. 11001. Sense of Congress.
Sec. 11002. Confidentiality of records.
Sec. 11003. Clarification on permitted uses and disclosures of protected 
          health information.
Sec. 11004. Development and dissemination of model training programs.

               TITLE XII--MEDICAID MENTAL HEALTH COVERAGE

Sec. 12001. Rule of construction related to Medicaid coverage of mental 
          health services and primary care services furnished on the 
          same day.
Sec. 12002. Study and report related to Medicaid managed care 
          regulation.
Sec. 12003. Guidance on opportunities for innovation.
Sec. 12004. Study and report on Medicaid emergency psychiatric 
          demonstration project.
Sec. 12005. Providing EPSDT services to children in IMDs.
Sec. 12006. Electronic visit verification system required for personal 
          care services and home health care services under Medicaid.

                    TITLE XIII--MENTAL HEALTH PARITY

Sec. 13001. Enhanced compliance with mental health and substance use 
          disorder coverage requirements.
Sec. 13002. Action plan for enhanced enforcement of mental health and 
          substance use disorder coverage.
Sec. 13003. Report on investigations regarding parity in mental health 
          and substance use disorder benefits.
Sec. 13004. GAO study on parity in mental health and substance use 
          disorder benefits.
Sec. 13005. Information and awareness on eating disorders.
Sec. 13006. Education and training on eating disorders.
Sec. 13007. Clarification of existing parity rules.

              TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES

             Subtitle A--Mental Health and Safe Communities

Sec. 14001. Law enforcement grants for crisis intervention teams, mental 
          health purposes.
Sec. 14002. Assisted outpatient treatment programs.
Sec. 14003. Federal drug and mental health courts.
Sec. 14004. Mental health in the judicial system.
Sec. 14005. Forensic assertive community treatment initiatives.
Sec. 14006. Assistance for individuals transitioning out of systems.
Sec. 14007. Co-occurring substance abuse and mental health challenges in 
          drug courts.
Sec. 14008. Mental health training for Federal uniformed services.
Sec. 14009. Advancing mental health as part of offender reentry.
Sec. 14010. School mental health crisis intervention teams.
Sec. 14011. Active-shooter training for law enforcement.
Sec. 14012. Co-occurring substance abuse and mental health challenges in 
          residential substance abuse treatment programs.
Sec. 14013. Mental health and drug treatment alternatives to 
          incarceration programs.
Sec. 14014. National criminal justice and mental health training and 
          technical assistance.
Sec. 14015. Improving Department of Justice data collection on mental 
          illness involved in crime.
Sec. 14016. Reports on the number of mentally ill offenders in prison.
Sec. 14017. Codification of due process for determinations by secretary 
          of veterans affairs of mental capacity of beneficiaries.
Sec. 14018. Reauthorization of appropriations.

           Subtitle B--Comprehensive Justice and Mental Health

Sec. 14021. Sequential intercept model.
Sec. 14022. Prison and jails.
Sec. 14023. Allowable uses.
Sec. 14024. Law enforcement training.
Sec. 14025. Federal law enforcement training.
Sec. 14026. GAO report.
Sec. 14027. Evidence based practices.
Sec. 14028. Transparency, program accountability, and enhancement of 
          local authority.
Sec. 14029. Grant accountability.

 DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR 
                                AMERICANS

Sec. 15000. Short title.

            TITLE XV--PROVISIONS RELATING TO MEDICARE PART A

Sec. 15001. Development of Medicare HCPCS version of MS-DRG codes for 
          similar hospital services.
Sec. 15002. Establishing beneficiary equity in the Medicare hospital 
          readmission program.
Sec. 15003. Five-year extension of the rural community hospital 
          demonstration program.
Sec. 15004. Regulatory relief for LTCHs.
Sec. 15005. Savings from IPPS MACRA pay-for through not applying 
          documentation and coding adjustments.
Sec. 15006. Extension of certain LTCH Medicare payment rules.
Sec. 15007. Application of rules on the calculation of hospital length 
          of stay to all LTCHs.
Sec. 15008. Change in Medicare classification for certain hospitals.
Sec. 15009. Temporary exception to the application of the Medicare LTCH 
          site neutral provisions for certain spinal cord specialty 
          hospitals.
Sec. 15010. Temporary extension to the application of the Medicare LTCH 
          site neutral provisions for certain discharges with severe 
          wounds.

            TITLE XVI--PROVISIONS RELATING TO MEDICARE PART B

Sec. 16001. Continuing Medicare payment under HOPD prospective payment 
          system for services furnished by mid-build off-campus 
          outpatient departments of providers.
Sec. 16002. Treatment of cancer hospitals in off-campus outpatient 
          department of a provider policy.
Sec. 16003. Treatment of eligible professionals in ambulatory surgical 
          centers for meaningful use and MIPS.
Sec. 16004. Continuing Access to Hospitals Act of 2016.
Sec. 16005. Delay of implementation of Medicare fee schedule adjustments 
          for wheelchair accessories and seating systems when used in 
          conjunction with complex rehabilitation technology (CRT) 
          wheelchairs.
Sec. 16006. Allowing physical therapists to utilize locum tenens 
          arrangements under Medicare.
Sec. 16007. Extension of the transition to new payment rates for durable 
          medical equipment under the Medicare program.
Sec. 16008. Requirements in determining adjustments using information 
          from competitive bidding programs.

                  TITLE XVII--OTHER MEDICARE PROVISIONS

Sec. 17001. Delay in authority to terminate contracts for Medicare 
          Advantage plans failing to achieve minimum quality ratings.
Sec. 17002. Requirement for enrollment data reporting for Medicare.
Sec. 17003. Updating the Welcome to Medicare package.
Sec. 17004. No payment for items and services furnished by newly 
          enrolled providers or suppliers within a temporary moratorium 
          area.
Sec. 17005. Preservation of Medicare beneficiary choice under Medicare 
          Advantage.
Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a 
          Medicare Advantage plan.
Sec. 17007. Improvements to the assignment of beneficiaries under the 
          Medicare Shared Savings Program.

                      TITLE XVIII--OTHER PROVISIONS

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

                     DIVISION A--21ST CENTURY CURES

SEC. 1000. SHORT TITLE.
    This Division may be cited as the ``21st Century Cures Act''.

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

SEC. 1001. BEAU BIDEN CANCER MOONSHOT AND NIH INNOVATION PROJECTS.
    (a) In General.--The Director of the National Institutes of Health 
(referred to in this section as the ``Director of NIH'') shall use any 
funds appropriated pursuant to the authorization of appropriations in 
subsection (b)(3) to carry out the National Institutes of Health 
innovation projects described in subsection (b)(4) (referred to in this 
section as the ``NIH Innovation Projects'').
    (b) National Institutes of Health Innovation Account.--
        (1) Establishment of nih innovation account.--There is 
    established in the Treasury an account, to be known as the ``NIH 
    Innovation Account'' (referred to in this subsection as the 
    ``Account''), for purposes of carrying out the NIH Innovation 
    Projects described in paragraph (4).
        (2) Transfer of direct spending savings.--
            (A) In general.--The following amounts shall be transferred 
        to the Account from the general fund of the Treasury:
                (i) For fiscal year 2017, $352,000,000.
                (ii) For fiscal year 2018, $496,000,000.
                (iii) For fiscal year 2019, $711,000,000.
                (iv) For fiscal year 2020, $492,000,000.
                (v) For fiscal year 2021, $404,000,000.
                (vi) For fiscal year 2022, $496,000,000.
                (vii) For fiscal year 2023, $1,085,000,000.
                (viii) For fiscal year 2024, $407,000,000.
                (ix) For fiscal year 2025, $127,000,000.
                (x) For fiscal year 2026, $226,000,000.
            (B) Amounts deposited.--Any amounts transferred under 
        subparagraph (A) shall remain unavailable in the Account until 
        such amounts are appropriated pursuant to paragraph (3).
        (3) Appropriations.--
            (A) Authorization of appropriations.--For each of the 
        fiscal years 2017 through 2026, there is authorized to be 
        appropriated from the Account to the Director of NIH, for the 
        purpose of carrying out the NIH Innovation Projects, an amount 
        not to exceed the total amount transferred to the Account under 
        paragraph (2)(A), to remain available until expended.
            (B) Offsetting future appropriations.--For any of fiscal 
        years 2017 through 2026, for any discretionary appropriation 
        under the heading ``NIH Innovation Account'' provided to the 
        Director of NIH pursuant to the authorization of appropriations 
        under subparagraph (A) for the purpose of carrying out the NIH 
        Innovation Projects, the total amount of such appropriations 
        for the applicable fiscal year (not to exceed the total amount 
        remaining in the Account) shall be subtracted from the estimate 
        of discretionary budget authority and the resulting outlays for 
        any estimate under the Congressional Budget and Impoundment 
        Control Act of 1974 or the Balanced Budget and Emergency 
        Deficit Control Act of 1985, and the amount transferred to the 
        Account shall be reduced by the same amount.
        (4) NIH innovation projects.--NIH Innovation Projects 
    authorized to be funded under this section shall consist of the 
    following and, of the total amounts authorized to be appropriated 
    under paragraph (3), there are authorized to be appropriated to 
    each such project a total amount not to exceed the following, over 
    the period of fiscal years 2017 through 2026:
            (A) For the Precision Medicine Initiative, including for 
        the advancement of a cohort of individuals to support the goals 
        of the Precision Medicine Initiative, not to exceed a total of 
        $1,455,000,000, as follows:
                (i) For fiscal year 2017, $40,000,000.
                (ii) For fiscal year 2018, $100,000,000.
                (iii) For fiscal year 2019, $186,000,000.
                (iv) For fiscal year 2020, $149,000,000.
                (v) For fiscal year 2021, $109,000,000.
                (vi) For fiscal year 2022, $150,000,000.
                (vii) For fiscal year 2023, $419,000,000.
                (viii) For fiscal year 2024, $235,000,000.
                (ix) For fiscal year 2025, $36,000,000.
                (x) For fiscal year 2026, $31,000,000.
            (B) For the Brain Research through Advancing Innovative 
        Neurotechnologies Initiative (known as the ``BRAIN 
        Initiative''), not to exceed a total of $1,511,000,000, as 
        follows:
                (i) For fiscal year 2017, $10,000,000.
                (ii) For fiscal year 2018, $86,000,000.
                (iii) For fiscal year 2019, $115,000,000.
                (iv) For fiscal year 2020, $140,000,000.
                (v) For fiscal year 2021, $100,000,000.
                (vi) For fiscal year 2022, $152,000,000.
                (vii) For fiscal year 2023, $450,000,000.
                (viii) For fiscal year 2024, $172,000,000.
                (ix) For fiscal year 2025, $91,000,000.
                (x) For fiscal year 2026, $195,000,000.
            (C) To support cancer research, such as the development of 
        cancer vaccines, the development of more sensitive diagnostic 
        tests for cancer, immunotherapy and the development of 
        combination therapies, and research that has the potential to 
        transform the scientific field, that has inherently higher 
        risk, and that seeks to address major challenges related to 
        cancer, not to exceed a total of $1,800,000,000, as follows:
                (i) For fiscal year 2017, $300,000,000.
                (ii) For fiscal year 2018, $300,000,000.
                (iii) For fiscal year 2019, $400,000,000.
                (iv) For fiscal year 2020, $195,000,000.
                (v) For fiscal year 2021, $195,000,000.
                (vi) For fiscal year 2022, $194,000,000.
                (vii) For fiscal year 2023, $216,000,000.
            (D) For the National Institutes of Health, in coordination 
        with the Food and Drug Administration, to award grants and 
        contracts for clinical research to further the field of 
        regenerative medicine using adult stem cells, including 
        autologous stem cells, for which grants and contracts shall be 
        contingent upon the recipient making available non-Federal 
        contributions toward the costs of such research in an amount 
        not less than $1 for each $1 of Federal funds provided in the 
        award, not to exceed a total of $30,000,000, as follows:
                (i) For fiscal year 2017, $2,000,000.
                (ii) For each of fiscal years 2018 and 2019, 
            $10,000,000.
                (iii) For fiscal year 2020, $8,000,000.
                (iv) For each of fiscal years 2021 through 2026, $0.
    (c) Accountability and Oversight.--
        (1) Work plan.--
            (A) In general.--Not later than 180 days after the date of 
        enactment of this Act, the Director of NIH shall submit to the 
        Committee on Health, Education, Labor, and Pensions and the 
        Committee on Appropriations of the Senate and the Committee on 
        Energy and Commerce and the Committee on Appropriations of the 
        House of Representatives, a work plan including the proposed 
        allocation of funds authorized to be appropriated pursuant to 
        subsection (b)(3) for each of fiscal years 2017 through 2026 
        for the NIH Innovation Projects and the contents described in 
        subparagraph (B).
            (B) Contents.--The work plan submitted under subparagraph 
        (A) shall include--
                (i) recommendations from the Advisory Committee 
            described in subparagraph (C);
                (ii) the amount of money to be obligated or expended in 
            each fiscal year for each NIH Innovation Project;
                (iii) a description and justification of each such 
            project; and
                (iv) a description of how each such project supports 
            the strategic research priorities identified in the NIH 
            Strategic Plan under subsection (m) of section 402 of the 
            Public Health Service Act (42 U.S.C. 282), as added by 
            section 2031.
            (C) Recommendations.--Prior to submitting the work plan 
        under this paragraph, the Director of NIH shall seek 
        recommendations from the Advisory Committee to the Director of 
        NIH appointed under section 222 of the Public Health Service 
        Act (42 U.S.C. 217a) on--
                (i) the allocations of funds appropriated pursuant to 
            the authorization of appropriations under subsection (b)(3) 
            for each of fiscal years 2017 through 2026; and
                (ii) on the contents of the proposed work plan.
        (2) Reports.--
            (A) Annual reports.--Not later than October 1 of each of 
        fiscal years 2018 through 2027, the Director of NIH shall 
        submit to the Committee on Health, Education, Labor, and 
        Pensions and the Committee on Appropriations of the Senate and 
        the Committee on Energy and Commerce and the Committee on 
        Appropriations of the House of Representatives, a report 
        including--
                (i) the amount of money obligated or expended in the 
            prior fiscal year for each NIH Innovation Project;
                (ii) a description of any such project using funds 
            provided pursuant to the authorization of appropriations 
            under subsection (b)(3); and
                (iii) whether such projects are advancing the strategic 
            research priorities identified in the NIH Strategic Plan 
            under subsection (m) of section 402 of the Public Health 
            Service Act (42 U.S.C. 282), as added by section 2031.
            (B) Additional reports.--At the request of the Committee on 
        Health, Education, Labor, and Pensions or the Committee on 
        Appropriations of the Senate, or the Committee on Energy and 
        Commerce or the Committee on Appropriations of the House of 
        Representatives, the Director of NIH shall provide an update in 
        the form of testimony and any additional reports to the 
        respective congressional committee regarding the allocation of 
        funding under this section or the description of the NIH 
        Innovation Projects.
    (d) Limitations.--Notwithstanding any transfer authority authorized 
by this Act or any appropriations Act, any funds made available 
pursuant to the authorization of appropriations under subsection (b)(3) 
may not be used for any purpose other than a NIH Innovation Project.
    (e) Sunset.--This section shall expire on September 30, 2026.
SEC. 1002. FDA INNOVATION PROJECTS.
    (a) In General.--The Commissioner of Food and Drugs (referred to in 
this section as the ``Commissioner'') shall use any funds appropriated 
pursuant to the authorization of appropriations under subsection (b)(3) 
to carry out the activities described in subsection (b)(4).
    (b) FDA Innovation Account.--
        (1) Establishment of fda innovation account.--There is 
    established in the Treasury an account, to be known as the ``FDA 
    Innovation Account'' (referred to in this subsection as the 
    ``Account''), for purposes of carrying out the activities described 
    in paragraph (4).
        (2) Transfer of direct spending savings.--
            (A) In general.--For each of fiscal years 2017 through 
        2025, the following amounts shall be transferred to the Account 
        from the general fund of the Treasury:
                (i) For fiscal year 2017, $20,000,000.
                (ii) For fiscal year 2018, $60,000,000.
                (iii) For fiscal year 2019, $70,000,000.
                (iv) For fiscal year 2020, $75,000,000.
                (v) For fiscal year 2021, $70,000,000.
                (vi) For fiscal year 2022, $50,000,000.
                (vii) For fiscal year 2023, $50,000,000.
                (viii) For fiscal year 2024, $50,000,000.
                (ix) For fiscal year 2025, $55,000,000.
            (B) Amounts deposited.--Any amounts transferred under 
        subparagraph (A) shall remain unavailable in the Account until 
        such amounts are appropriated pursuant to paragraph (3).
        (3) Appropriations.--
            (A) Authorization of appropriations.--For each of the 
        fiscal years 2017 through 2025, there is authorized to be 
        appropriated from the Account to the Commissioner, for the 
        purpose of carrying out the activities described in paragraph 
        (5), an amount not to exceed the total amount transferred to 
        the Account under paragraph (2)(A), to remain available until 
        expended.
            (B) Offsetting future appropriations.--For any of fiscal 
        years 2017 through 2025, for any discretionary appropriation 
        under the heading ``FDA Innovation Account'' provided to the 
        Commissioner pursuant to the authorization of appropriations 
        under subparagraph (A) for the purpose of carrying out the 
        projects activities described in paragraph (4), the total 
        amount of such appropriations in the applicable fiscal year 
        (not to exceed the total amount remaining in the Account) shall 
        be subtracted from the estimate of discretionary budget 
        authority and the resulting outlays for any estimate under the 
        Congressional Budget and Impoundment Control Act of 1974 or the 
        Balanced Budget and Emergency Deficit Control Act of 1985, and 
        the amount transferred to the Account shall be reduced by the 
        same amount.
        (4) FDA activities.--The activities authorized to be funded 
    under this section are the activities under subtitles A through F 
    (including the amendments made by such subtitles) of title III of 
    this Act and section 1014 of the Federal Food, Drug, and Cosmetic 
    Act, as added by section 3073 of this Act.
    (c) Accountability and Oversight.--
        (1) Work plan.--
            (A) In general.--Not later than 180 days after the date of 
        enactment of this Act, the Commissioner shall submit to the 
        Committee on Health, Education, Labor, and Pensions and the 
        Committee on Appropriations of the Senate and the Committee on 
        Energy and Commerce and the Committee on Appropriations of the 
        House of Representatives, a work plan including the proposed 
        allocation of funds appropriated pursuant to the authorization 
        of appropriations under subsection (b)(3) for each of fiscal 
        years 2017 through 2025 and the contents described in 
        subparagraph (B).
            (B) Contents.--The work plan submitted under subparagraph 
        (A) shall include--
                (i) recommendations from the Advisory Committee 
            described in subparagraph (C);
                (ii) the amount of money to be obligated or expended in 
            each fiscal year for each activity described in subsection 
            (b)(4); and
                (iii) a description and justification of each such 
            project activity.
            (C) Recommendations.--Prior to submitting the work plan 
        under this paragraph, the Commissioner shall seek 
        recommendations from the Science Board to the Food and Drug 
        Administration, on the proposed allocation of funds 
        appropriated pursuant to the authorization of appropriations 
        under subsection (b)(3) for each of fiscal years 2017 through 
        2025 and on the contents of the proposed work plan.
        (2) Reports.--
            (A) Annual reports.--Not later than October 1 of each of 
        fiscal years 2018 through 2026, the Commissioner shall submit 
        to the Committee on Health, Education, Labor, and Pensions and 
        the Committee on Appropriations of the Senate and the Committee 
        on Energy and Commerce and the Committee on Appropriations of 
        the House of Representatives, a report including--
                (i) the amount of money obligated or expended in the 
            prior fiscal year for each activity described in subsection 
            (b)(4);
                (ii) a description of all such activities using funds 
            provided pursuant to the authorization of appropriations 
            under subsection (b)(3); and
                (iii) how the activities are advancing public health.
            (B) Additional reports.--At the request of the Committee on 
        Health, Education, Labor, and Pensions or the Committee on 
        Appropriations of the Senate, or the Committee on Energy and 
        Commerce or the Committee on Appropriations of the House of 
        Representatives, the Commissioner shall provide an update in 
        the form of testimony and any additional reports to the 
        respective congressional committee regarding the allocation of 
        funding under this section or the description of the activities 
        undertaken with such funding.
    (d) Limitations.--Notwithstanding any transfer authority authorized 
by this Act or any appropriations Act, any funds made available 
pursuant to the authorization of appropriations in subsection (b)(3) 
shall not be used for any purpose other than an activity described in 
subsection (b)(4).
    (e) Sunset.--This section shall expire on September 30, 2025.
SEC. 1003. ACCOUNT FOR THE STATE RESPONSE TO THE OPIOID ABUSE CRISIS.
    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall use any funds 
appropriated pursuant to the authorization of appropriations under 
subsection (b) to carry out the grant program described in subsection 
(c) for purposes of addressing the opioid abuse crisis within the 
States.
    (b) Account for the State Response to the Opioid Abuse Crisis.--
        (1) Establishment.--There is established in the Treasury an 
    account, to be known as the ``Account For the State Response to the 
    Opioid Abuse Crisis'' (referred to in this subsection as the 
    ``Account''), to carry out the opioid grant program described in 
    subsection (c).
        (2) Transfer of direct spending savings.--
            (A) In general.--The following amounts shall be transferred 
        to the Account from the general fund of the Treasury:
                (i) For fiscal year 2017, $500,000,000.
                (ii) For fiscal year 2018, $500,000,000.
            (B) Amounts deposited.--Any amounts transferred under 
        subparagraph (A) shall remain unavailable in the Account until 
        such amounts are appropriated pursuant to paragraph (3).
        (3) Appropriations.--
            (A) Authorization of appropriations.--In each of the fiscal 
        years 2017 and 2018, there is authorized to be appropriated 
        from the Account to the Secretary, for the grant program 
        described in subsection (c), an amount not to exceed the total 
        amount transferred to the Account under paragraph (2)(A), to 
        remain available until expended.
            (B) Offsetting future appropriations.--In each of fiscal 
        years 2017 and 2018, for any discretionary appropriation under 
        the heading ``Account For the State Response to the Opioid 
        Abuse Crisis'' for the grant program described in subsection 
        (c), the total amount of such appropriations in the applicable 
        fiscal year (not to exceed the total amount remaining in the 
        Account) shall be subtracted from the estimate of discretionary 
        budget authority and the resulting outlays for any estimate 
        under the Congressional Budget and Impoundment Control Act of 
        1974 or the Balanced Budget and Emergency Deficit Control Act 
        of 1985, and the amount transferred to the Account shall be 
        reduced by the same amount.
    (c) Opioid Grant Program.--
        (1) State response to the opioid abuse crisis.--Subject to the 
    availability of appropriations, the Secretary shall award grants to 
    States for the purpose of addressing the opioid abuse crisis within 
    such States, in accordance with subparagraph (B). In awarding such 
    grants, the Secretary shall give preference to States with an 
    incidence or prevalence of opioid use disorders that is 
    substantially higher relative to other States.
        (2) Opioid grants.--Grants awarded to a State under this 
    subsection shall be used for carrying out activities that 
    supplement activities pertaining to opioids undertaken by the State 
    agency responsible for administering the substance abuse prevention 
    and treatment block grant under subpart II of part B of title XIX 
    of the Public Health Service Act (42 U.S.C. 300x-21 et seq.), which 
    may include public health-related activities such as the following:
            (A) Improving State prescription drug monitoring programs.
            (B) Implementing prevention activities, and evaluating such 
        activities to identify effective strategies to prevent opioid 
        abuse.
            (C) Training for health care practitioners, such as best 
        practices for prescribing opioids, pain management, recognizing 
        potential cases of substance abuse, referral of patients to 
        treatment programs, and overdose prevention.
            (D) Supporting access to health care services, including 
        those services provided by Federally certified opioid treatment 
        programs or other appropriate health care providers to treat 
        substance use disorders.
            (E) Other public health-related activities, as the State 
        determines appropriate, related to addressing the opioid abuse 
        crisis within the State.
    (d) Accountability and Oversight.--A State receiving a grant under 
subsection (c) shall include in a report related to substance abuse 
submitted to the Secretary pursuant to section 1942 of the Public 
Health Service Act (42 U.S.C. 300x-52), a description of--
        (1) the purposes for which the grant funds received by the 
    State under such subsection for the preceding fiscal year were 
    expended and a description of the activities of the State under the 
    program; and
        (2) the ultimate recipients of amounts provided to the State in 
    the grant.
    (e) Limitations.--Any funds made available pursuant to the 
authorization of appropriations under subsection (b)--
        (1) notwithstanding any transfer authority in any 
    appropriations Act, shall not be used for any purpose other than 
    the grant program in subsection (c); and
        (2) shall be subject to the same requirements as substance 
    abuse prevention and treatment programs under titles V and XIX of 
    the Public Health Service Act (42 U.S.C. 290aa et seq., 300w et 
    seq.).
    (f) Sunset.--This section shall expire on September 30, 2026.
SEC. 1004. BUDGETARY TREATMENT.
    (a) Statutory Paygo Scorecards.--The budgetary effects of division 
A of this Act shall not be entered on either PAYGO scorecard maintained 
pursuant to section 4(d) of the Statutory Pay-As-You-Go Act of 2010.
    (b) Senate Paygo Scorecards.--The budgetary effects of division A 
of this Act shall not be entered on any PAYGO scorecard maintained for 
purposes of section 201 of S. Con. Res. 21 (110th Congress).
    (c) Reservation of Savings.--None of the funds in the NIH 
Innovation Account, the FDA Innovation Account, or the Account For the 
State Response to the Opioid Abuse Crisis established by this title 
shall be made available except to the extent provided in advance in 
appropriations Acts, and legislation or an Act that rescinds or reduces 
amounts in such accounts shall not be estimated as a reduction in 
direct spending under the Congressional Budget and Impoundment Control 
Act of 1974 or the Balanced Budget and Emergency Deficit Control Act of 
1985.

                          TITLE II--DISCOVERY
       Subtitle A--National Institutes of Health Reauthorization

SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION.
    Section 402A(a)(1) of the Public Health Service Act (42 U.S.C. 
282a(a)(1)) is amended--
        (1) in subparagraph (B), by striking ``and'' at the end;
        (2) in subparagraph (C), by striking the period at the end and 
    inserting a semicolon; and
        (3) by adding at the end the following new subparagraphs:
            ``(D) $34,851,000,000 for fiscal year 2018;
            ``(E) $35,585,871,000 for fiscal year 2019; and
            ``(F) $36,472,442,775 for fiscal year 2020.''.
SEC. 2002. EUREKA PRIZE COMPETITIONS.
    (a) In General.--Pursuant to the authorities and processes 
established under section 24 of the Stevenson-Wydler Technology 
Innovation Act of 1980 (15 U.S.C. 3719), the Director of the National 
Institutes of Health shall support prize competitions for one or both 
of the following goals:
        (1) Identifying and funding areas of biomedical science that 
    could realize significant advancements through a prize competition.
        (2) Improving health outcomes, particularly with respect to 
    human diseases and conditions--
            (A) for which public and private investment in research is 
        disproportionately small relative to Federal Government 
        expenditures on prevention and treatment activities with 
        respect to such diseases and conditions, such that Federal 
        expenditures on health programs would be reduced;
            (B) that are serious and represent a significant disease 
        burden in the United States; or
            (C) for which there is potential for significant return on 
        investment to the United States.
    (b) Tracking; Reporting.--The Director of the National Institutes 
of Health shall--
        (1) collect information on--
            (A) the effect of innovations funded through the prize 
        competitions under this section in advancing biomedical science 
        or improving health outcomes pursuant to subsection (a); and
            (B) the effect of the innovations on Federal expenditures; 
        and
        (2) include the information collected under paragraph (1) in 
    the triennial report under section 403 of the Public Health Service 
    Act (42 U.S.C. 283) (as amended by section 2032).

                Subtitle B--Advancing Precision Medicine

SEC. 2011. PRECISION MEDICINE INITIATIVE.
    Part H of title IV of the Public Health Service Act (42 U.S.C. 289 
et seq.) is amended by adding at the end the following:
``SEC. 498E. PRECISION MEDICINE INITIATIVE.
    ``(a) In General.--The Secretary is encouraged to establish and 
carry out an initiative, to be known as the `Precision Medicine 
Initiative' (in this section referred to as the `Initiative'), to 
augment efforts to address disease prevention, diagnosis, and 
treatment.
    ``(b) Components.--The Initiative described under subsection (a) 
may include--
        ``(1) developing a network of scientists to assist in carrying 
    out the purposes of the Initiative;
        ``(2) developing new approaches for addressing scientific, 
    medical, public health, and regulatory science issues;
        ``(3) applying genomic technologies, such as whole genomic 
    sequencing, to provide data on the molecular basis of disease;
        ``(4) collecting information voluntarily provided by a diverse 
    cohort of individuals that can be used to better understand health 
    and disease; and
        ``(5) other activities to advance the goals of the Initiative, 
    as the Secretary determines appropriate.
    ``(c) Authority of the Secretary.--In carrying out this section, 
the Secretary may--
        ``(1) coordinate with the Secretary of Energy, private 
    industry, and others, as the Secretary determines appropriate, to 
    identify and address the advanced supercomputing and other advanced 
    technology needs for the Initiative;
        ``(2) develop and utilize public-private partnerships; and
        ``(3) leverage existing data sources.
    ``(d) Requirements.--In the implementation of the Initiative under 
subsection (a), the Secretary shall--
        ``(1) ensure the collaboration of the National Institutes of 
    Health, the Food and Drug Administration, the Office of the 
    National Coordinator for Health Information Technology, and the 
    Office for Civil Rights of the Department of Health and Human 
    Services;
        ``(2) comply with existing laws and regulations for the 
    protection of human subjects involved in research, including the 
    protection of participant privacy;
        ``(3) implement policies and mechanisms for appropriate secure 
    data sharing across systems that include protections for privacy 
    and security of data;
        ``(4) consider the diversity of the cohort to ensure inclusion 
    of a broad range of participants, including consideration of 
    biological, social, and other determinants of health that 
    contribute to health disparities;
        ``(5) ensure that only authorized individuals may access 
    controlled or sensitive, identifiable biological material and 
    associated information collected or stored in connection with the 
    Initiative; and
        ``(6) on the appropriate Internet website of the Department of 
    Health and Human Services, identify any entities with access to 
    such information and provide information with respect to the 
    purpose of such access, a summary of the research project for which 
    such access is granted, as applicable, and a description of the 
    biological material and associated information to which the entity 
    has access.
    ``(e) Report.--Not later than 1 year after the date of enactment of 
the 21st Century Cures Act, the Secretary shall submit a report on the 
relevant data access policies and procedures to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives. Such report 
shall include steps the Secretary has taken to consult with experts or 
other heads of departments or agencies of the Federal Government in the 
development of such policies.''.
SEC. 2012. PRIVACY PROTECTION FOR HUMAN RESEARCH SUBJECTS.
    (a) In General.--Subsection (d) of section 301 of the Public Health 
Service Act (42 U.S.C. 241) is amended to read as follows:
    ``(d)(1)(A) If a person is engaged in biomedical, behavioral, 
clinical, or other research, in which identifiable, sensitive 
information is collected (including research on mental health and 
research on the use and effect of alcohol and other psychoactive 
drugs), the Secretary, in coordination with other agencies, as 
applicable--
        ``(i) shall issue to such person a certificate of 
    confidentiality to protect the privacy of individuals who are the 
    subjects of such research if the research is funded wholly or in 
    part by the Federal Government; and
        ``(ii) may, upon application by a person engaged in research, 
    issue to such person a certificate of confidentiality to protect 
    the privacy of such individuals if the research is not so funded.
    ``(B) Except as provided in subparagraph (C), any person to whom a 
certificate is issued under subparagraph (A) to protect the privacy of 
individuals described in such subparagraph shall not disclose or 
provide to any other person not connected with the research the name of 
such an individual or any information, document, or biospecimen that 
contains identifiable, sensitive information about such an individual 
and that was created or compiled for purposes of the research.
    ``(C) The disclosure prohibition in subparagraph (B) shall not 
apply to disclosure or use that is--
        ``(i) required by Federal, State, or local laws, excluding 
    instances described in subparagraph (D);
        ``(ii) necessary for the medical treatment of the individual to 
    whom the information, document, or biospecimen pertains and made 
    with the consent of such individual;
        ``(iii) made with the consent of the individual to whom the 
    information, document, or biospecimen pertains; or
        ``(iv) made for the purposes of other scientific research that 
    is in compliance with applicable Federal regulations governing the 
    protection of human subjects in research.
    ``(D) Any person to whom a certificate is issued under subparagraph 
(A) to protect the privacy of an individual described in such 
subparagraph shall not, in any Federal, State, or local civil, 
criminal, administrative, legislative, or other proceeding, disclose or 
provide the name of such individual or any such information, document, 
or biospecimen that contains identifiable, sensitive information about 
the individual and that was created or compiled for purposes of the 
research, except in the circumstance described in subparagraph 
(C)(iii).
    ``(E) Identifiable, sensitive information protected under 
subparagraph (A), and all copies thereof, shall be immune from the 
legal process, and shall not, without the consent of the individual to 
whom the information pertains, be admissible as evidence or used for 
any purpose in any action, suit, or other judicial, legislative, or 
administrative proceeding.
    ``(F) Identifiable, sensitive information collected by a person to 
whom a certificate has been issued under subparagraph (A), and all 
copies thereof, shall be subject to the protections afforded by this 
section for perpetuity.
    ``(G) The Secretary shall take steps to minimize the burden to 
researchers, streamline the process, and reduce the time it takes to 
comply with the requirements of this subsection.
    ``(2) The Secretary shall coordinate with the heads of other 
applicable Federal agencies to ensure that such departments have 
policies in place with respect to the issuance of a certificate of 
confidentiality pursuant to paragraph (1) and other requirements of 
this subsection.
    ``(3) Nothing in this subsection shall be construed to limit the 
access of an individual who is a subject of research to information 
about himself or herself collected during such individual's 
participation in the research.
    ``(4) For purposes of this subsection, the term `identifiable, 
sensitive information' means information that is about an individual 
and that is gathered or used during the course of research described in 
paragraph (1)(A) and--
        ``(A) through which an individual is identified; or
        ``(B) for which there is at least a very small risk, as 
    determined by current scientific practices or statistical methods, 
    that some combination of the information, a request for the 
    information, and other available data sources could be used to 
    deduce the identity of an individual.''.
    (b) Applicability.--Beginning 180 days after the date of enactment 
of this Act, all persons engaged in research and authorized by the 
Secretary of Health and Human Services to protect information under 
section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)) 
prior to the date of enactment of this Act shall be subject to the 
requirements of such section (as amended by this Act).
SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMATION.
    Section 301 of the Public Health Service Act (42 U.S.C. 241) is 
amended by adding at the end the following:
    ``(f)(1) The Secretary may exempt from disclosure under section 
552(b)(3) of title 5, United States Code, biomedical information that 
is about an individual and that is gathered or used during the course 
of biomedical research if--
        ``(A) an individual is identified; or
        ``(B) there is at least a very small risk, as determined by 
    current scientific practices or statistical methods, that some 
    combination of the information, the request, and other available 
    data sources could be used to deduce the identity of an individual.
    ``(2)(A) Each determination of the Secretary under paragraph (1) to 
exempt information from disclosure shall be made in writing and 
accompanied by a statement of the basis for the determination.
    ``(B) Each such determination and statement of basis shall be 
available to the public, upon request, through the Office of the Chief 
FOIA Officer of the Department of Health and Human Services.
    ``(3) Nothing in this subsection shall be construed to limit a 
research participant's access to information about such participant 
collected during the participant's participation in the research.''.
SEC. 2014. DATA SHARING.
    (a) In General.--Section 402(b) of the Public Health Service Act 
(42 U.S.C. 282(b)) is amended--
        (1) in paragraph (23), by striking ``and'' at the end;
        (2) in paragraph (24), by striking the period and inserting ``; 
    and''; and
        (3) by inserting after paragraph (24) the following:
        ``(25) may require recipients of National Institutes of Health 
    awards to share scientific data, to the extent feasible, generated 
    from such National Institutes of Health awards in a manner that is 
    consistent with all applicable Federal laws and regulations, 
    including such laws and regulations for the protection of--
            ``(A) human research participants, including with respect 
        to privacy, security, informed consent, and protected health 
        information; and
            ``(B) proprietary interests, confidential commercial 
        information, and the intellectual property rights of the 
        funding recipient.''.
    (b) Confidentiality.--Nothing in the amendments made by subsection 
(a) authorizes the Secretary of Health and Human Services to disclose 
any information that is a trade secret, or other privileged or 
confidential information, described in section 552(b)(4) of title 5, 
United States Code, or section 1905 of title 18, United States Code, or 
be construed to require recipients of grants or cooperative agreements 
through the National Institutes of Health to share such information.

            Subtitle C--Supporting Young Emerging Scientists

SEC. 2021. INVESTING IN THE NEXT GENERATION OF RESEARCHERS.
    (a) In General.--Part A of title IV of the Public Health Service 
Act (42 U.S.C. 281 et seq.) is amended by adding at the end the 
following:
``SEC. 404M. NEXT GENERATION OF RESEARCHERS.
    ``(a) Next Generation of Researchers Initiative.--There shall be 
established within the Office of the Director of the National 
Institutes of Health, the Next Generation of Researchers Initiative 
(referred to in this section as the `Initiative'), through which the 
Director shall coordinate all policies and programs within the National 
Institutes of Health that are focused on promoting and providing 
opportunities for new researchers and earlier research independence.
    ``(b) Activities.--The Director of the National Institutes of 
Health, through the Initiative shall--
        ``(1) promote policies and programs within the National 
    Institutes of Health that are focused on improving opportunities 
    for new researchers and promoting earlier research independence, 
    including existing policies and programs, as appropriate;
        ``(2) develop, modify, or prioritize policies, as needed, 
    within the National Institutes of Health to promote opportunities 
    for new researchers and earlier research independence, such as 
    policies to increase opportunities for new researchers to receive 
    funding, enhance training and mentorship programs for researchers, 
    and enhance workforce diversity;
        ``(3) coordinate, as appropriate, with relevant agencies, 
    professional and academic associations, academic institutions, and 
    others, to improve and update existing information on the 
    biomedical research workforce in order to inform programs related 
    to the training, recruitment, and retention of biomedical 
    researchers; and
        ``(4) carry out other activities, including evaluation and 
    oversight of existing programs, as appropriate, to promote the 
    development of the next generation of researchers and earlier 
    research independence.''.
    (b) Consideration of Recommendations.--In carrying out activities 
under section 404M(b) of the Public Health Service Act, the Director of 
the National Institutes of Health shall take into consideration the 
recommendations made by the National Academies of Sciences, 
Engineering, and Medicine as part of the comprehensive study on 
policies affecting the next generation of researchers under the 
Department of Health and Human Services Appropriations Act, 2016 
(Public Law 114-113), and submit a report to the Committee on Health, 
Education, Labor, and Pensions and the Committee on Appropriations of 
the Senate, and the Committee on Energy and Commerce and the Committee 
on Appropriations of the House of Representatives, with respect to any 
actions taken by the National Institutes of Health based on the 
recommendations not later than 2 years after the completion of the 
study required pursuant to the Department of Health and Human Services 
Appropriations Act, 2016.
SEC. 2022. IMPROVEMENT OF LOAN REPAYMENT PROGRAM.
    (a) Intramural Loan Repayment Program.--Section 487A of the Public 
Health Service Act (42 U.S.C. 288-1) is amended--
        (1) by amending the section heading to read as follows: 
    ``intramural loan repayment program'';
        (2) in subsection (a)--
            (A) by striking ``The Secretary shall carry out a program'' 
        and inserting ``The Director of the National Institutes of 
        Health shall, as appropriate and based on workforce and 
        scientific priorities, carry out a program through the 
        subcategories listed in subsection (b)(1) (or modified 
        subcategories as provided for in subsection (b)(2))'';
            (B) by striking ``conduct'' and inserting ``conduct 
        research'';
            (C) by striking ``research with respect to acquired immune 
        deficiency syndrome''; and
            (D) by striking ``$35,000'' and inserting ``$50,000'';
        (3) by redesignating subsection (b) as subsection (d);
        (4) by inserting after subsection (a), the following:
    ``(b) Subcategories of Research.--
        ``(1) In general.--In carrying out the program under subsection 
    (a), the Director of the National Institutes of Health--
            ``(A) shall continue to focus on--
                ``(i) general research;
                ``(ii) research on acquired immune deficiency syndrome; 
            and
                ``(iii) clinical research conducted by appropriately 
            qualified health professional who are from disadvantaged 
            backgrounds; and
            ``(B) may focus on an area of emerging scientific or 
        workforce need.
        ``(2) Elimination or establishment of subcategories.--The 
    Director of the National Institutes of Health may eliminate one or 
    more subcategories provided for in paragraph (1) due to changes in 
    workforce or scientific needs related to biomedical research. The 
    Director may establish other subcategory areas based on workforce 
    and scientific priorities if the total number of subcategories does 
    not exceed the number of subcategories listed in paragraph (1).
    ``(c) Limitation.--The Director of the National Institutes of 
Health may not enter into a contract with a health professional 
pursuant to subsection (a) unless such professional has a substantial 
amount of education loans relative to income (as determined pursuant to 
guidelines issued by the Director).''; and
        (5) by adding at the end the following:
    ``(e) Availability of Appropriations.--Amounts available for 
carrying out this section shall remain available until the expiration 
of the second fiscal year beginning after the fiscal year for which 
such amounts are made available.''.
    (b) Extramural Loan Repayment Program.--Section 487B of the Public 
Health Service Act (42 U.S.C. 288-2) is amended--
        (1) by amending the section heading to read as follows: 
    ``extramural loan repayment program'';
        (2) in subsection (a)--
            (A) by striking ``The Secretary, in consultation with the 
        Director of the Eunice Kennedy Shriver National Institute of 
        Child Health and Human Development, shall establish a program'' 
        and inserting ``In General.--The Director of the National 
        Institutes of Health shall, as appropriate and based on 
        workforce and scientific priorities, carry out a program 
        through the subcategories listed in subsection (b)(1) (or 
        modified subcategories as provided for in subsection 
        (b)(2)),'';
            (B) by striking ``(including graduate students)'';
            (C) by striking ``with respect to contraception, or with 
        respect to infertility,''; and
            (D) by striking ``service, not more than $35,000'' and 
        inserting ``research, not more than $50,000'';
        (3) by redesignating subsections (b) and (c) as subsections (d) 
    and (e), respectively;
        (4) by inserting after subsection (a), the following:
    ``(b) Subcategories of Research.--
        ``(1) In general.--In carrying out the program under subsection 
    (a), the Director of the National Institutes of Health--
            ``(A) shall continue to focus on--
                ``(i) contraception or infertility research;
                ``(ii) pediatric research, including pediatric 
            pharmacological research;
                ``(iii) minority health disparities research;
                ``(iv) clinical research; and
                ``(v) clinical research conducted by appropriately 
            qualified health professional who are from disadvantaged 
            backgrounds; and
            ``(B) may focus on an area of emerging scientific or 
        workforce need.
        ``(2) Elimination or establishment of subcategories.--The 
    Director of the National Institutes of Health may eliminate one or 
    more subcategories provided for in paragraph (1) due to changes in 
    workforce or scientific needs related to biomedical research. The 
    Director may establish other subcategory areas based on workforce 
    and scientific priorities if the total number of subcategories does 
    not exceed the number of subcategories listed in paragraph (1).
    ``(c) Limitation.--The Director of the National Institutes of 
Health may not enter into a contract with a health professional 
pursuant to subsection (a) unless such professional has a substantial 
amount of education loans relative to income (as determined pursuant to 
guidelines issued by the Director).'';
        (5) in subsection (d) (as so redesignated), by striking ``The 
    provisions'' and inserting ``Applicability of Certain Provisions 
    Regarding Obligated Service.--The provisions''; and
        (6) in subsection (e) (as so redesignated), by striking 
    ``Amounts'' and inserting ``Availability of Appropriations.--
    Amounts''.
    (c) Technical and Conforming Amendments.--Title IV of the Public 
Health Service Act is amended--
        (1) by striking section 464z-5 (42 U.S.C. 285t-2);
        (2) by striking section 487C (42 U.S.C. 288-3);
        (3) by striking section 487E (42 U.S.C. 288-5);
        (4) by striking section 487F (42 U.S.C. 288-5a), as added by 
    section 205 of Public Law 106-505, relating to loan repayment for 
    clinical researchers; and
        (5) by striking section 487F (42 U.S.C. 288-6), as added by 
    section 1002(b) of Public Law 106-310 relating to pediatric 
    research loan repayment.
    (d) GAO Report.--Not later than 18 months after the date of 
enactment of this Act, the Comptroller General of the United States 
shall submit to Congress a report on the efforts of the National 
Institutes of Health to attract, retain, and develop emerging 
scientists, including underrepresented individuals in the sciences, 
such as women, racial and ethnic minorities, and other groups. Such 
report shall include an analysis of the impact of the additional 
authority provided to the Secretary of Health and Human Services under 
this Act to address workforce shortages and gaps in priority research 
areas, including which centers and research areas offered loan 
repayment program participants the increased award amount.

 Subtitle D--National Institutes of Health Planning and Administration

SEC. 2031. NATIONAL INSTITUTES OF HEALTH STRATEGIC PLAN.
    (a) Strategic Plan.--Section 402 of the Public Health Service Act 
(42 U.S.C. 282) is amended--
        (1) in subsection (b)(5), by inserting before the semicolon the 
    following: ``, and through the development, implementation, and 
    updating of the strategic plan developed under subsection (m)''; 
    and
        (2) by adding at the end the following:
    ``(m) National Institutes of Health Strategic Plan.--
        ``(1) In general.--Not later than 2 years after the date of 
    enactment of the 21st Century Cures Act, and at least every 6 years 
    thereafter, the Director of the National Institutes of Health shall 
    develop and submit to the appropriate committees of Congress and 
    post on the Internet website of the National Institutes of Health, 
    a coordinated strategy (to be known as the `National Institutes of 
    Health Strategic Plan') to provide direction to the biomedical 
    research investments made by the National Institutes of Health, to 
    facilitate collaboration across the institutes and centers, to 
    leverage scientific opportunity, and to advance biomedicine.
        ``(2) Requirements.--The strategy under paragraph (1) shall--
            ``(A) identify strategic research priorities and objectives 
        across biomedical research, including--
                ``(i) an assessment of the state of biomedical and 
            behavioral research, including areas of opportunity with 
            respect to basic, clinical, and translational research;
                ``(ii) priorities and objectives to advance the 
            treatment, cure, and prevention of health conditions;
                ``(iii) emerging scientific opportunities, rising 
            public health challenges, and scientific knowledge gaps; 
            and
                ``(iv) the identification of near-, mid-, and long-term 
            scientific needs;
            ``(B) consider, in carrying out subparagraph (A)--
                ``(i) disease burden in the United States and the 
            potential for return on investment to the United States;
                ``(ii) rare diseases and conditions;
                ``(iii) biological, social, and other determinants of 
            health that contribute to health disparities; and
                ``(iv) other factors the Director of National 
            Institutes of Health determines appropriate;
            ``(C) include multi-institute priorities, including 
        coordination of research among institutes and centers;
            ``(D) include strategic priorities for funding research 
        through the Common Fund, in accordance with section 
        402A(c)(1)(C);
            ``(E) address the National Institutes of Health's proposed 
        and ongoing activities related to training and the biomedical 
        workforce; and
            ``(F) describe opportunities for collaboration with other 
        agencies and departments, as appropriate.
        ``(3) Use of plans.--Strategic plans developed and updated by 
    the national research institutes and national centers of the 
    National Institutes of Health shall be prepared regularly and in 
    such a manner that such plans will be informed by the strategic 
    plans developed and updated under this subsection. Such plans 
    developed by and updated by the national research institutes and 
    national centers shall have a common template.
        ``(4) Consultation.--The Director of National Institutes of 
    Health shall develop the strategic plan under paragraph (1) in 
    consultation with the directors of the national research institutes 
    and national centers, researchers, patient advocacy groups, and 
    industry leaders.''.
    (b) Conforming Amendment.--Section 402A(c)(1)(C) of the Public 
Health Service Act (42 U.S.C. 282a(c)(1)(C)) is amended by striking 
``Not later than June 1, 2007, and every 2 years thereafter,'' and 
inserting ``As part of the National Institutes of Health Strategic Plan 
required under section 402(m),''.
    (c) Strategic Plan.--Section 492B(a) of the Public Health Service 
Act (42 U.S.C. 289a-2(a)) is amended by adding at the end the 
following:
        ``(3) Strategic planning.--
            ``(A) In general.--The directors of the national institutes 
        and national centers shall consult at least once annually with 
        the Director of the National Institute on Minority Health and 
        Health Disparities and the Director of the Office of Research 
        on Women's Health regarding objectives of the national 
        institutes and national centers to ensure that future 
        activities by such institutes and centers take into account 
        women and minorities and are focused on reducing health 
        disparities.
            ``(B) Strategic plans.--Any strategic plan issued by a 
        national institute or national center shall include details on 
        the objectives described in subparagraph (A).''.
SEC. 2032. TRIENNIAL REPORTS.
    Section 403 of the Public Health Service Act (42 U.S.C. 283) is 
amended--
        (1) in the section heading, by striking ``biennial'' and 
    inserting ``triennial'' ; and
        (2) in subsection (a)--
            (A) in the matter preceding paragraph (1), by striking 
        ``biennial'' and inserting ``triennial'';
            (B) by amending paragraph (3) to read as follows:
        ``(3) A description of intra-National Institutes of Health 
    activities, including--
            ``(A) identification of the percentage of funds made 
        available by each national research institute and national 
        center with respect to each applicable fiscal year for 
        conducting or supporting research that involves collaboration 
        between the institute or center and 1 or more other national 
        research institutes or national centers; and
            ``(B) recommendations for promoting coordination of 
        information among the centers of excellence.'';
            (C) in paragraph (4)--
                (i) in subparagraph (B), by striking ``demographic 
            variables and other variables'' and inserting ``demographic 
            variables, including biological and social variables and 
            relevant age categories (such as pediatric subgroups), and 
            determinants of health,''; and
                (ii) in subparagraph (C)(v)--

                    (I) by striking ``demographic variables and such'' 
                and inserting ``demographic variables, including 
                relevant age categories (such as pediatric subgroups), 
                information submitted by each national research 
                institute and national center to the Director of 
                National Institutes of Health under section 492B(f), 
                and such''; and
                    (II) by striking ``(regarding inclusion of women 
                and minorities in clinical research)'' and inserting 
                ``and other applicable requirements regarding inclusion 
                of demographic groups''; and

            (D) in paragraph (6)--
                (i) in the matter preceding subparagraph (A), by 
            striking ``the following:'' and inserting ``the following--
            '';
                (ii) in subparagraph (A)--

                    (I) by striking ``An evaluation'' and inserting 
                ``an evaluation''; and
                    (II) by striking the period and inserting ``; 
                and'';

                (iii) by striking subparagraphs (B) and (D);
                (iv) by redesignating subparagraph (C) as subparagraph 
            (B); and
                (v) in subparagraph (B), as redesignated by clause 
            (iv), by striking ``Recommendations'' and inserting 
            ``recommendations''.
SEC. 2033. INCREASING ACCOUNTABILITY AT THE NATIONAL INSTITUTES OF 
HEALTH.
    (a) Appointment and Terms of Directors of National Research 
Institutes and National Centers.--Subsection (a) of section 405 of the 
Public Health Service Act (42 U.S.C. 284) is amended to read as 
follows:
    ``(a) Appointment.--
        ``(1) In general.--The Director of the National Cancer 
    Institute shall be appointed by the President, and the Directors of 
    the other national research institutes and national centers shall 
    be appointed by the Secretary, acting through the Director of 
    National Institutes of Health. Each Director of a national research 
    institute or national center shall report directly to the Director 
    of National Institutes of Health.
        ``(2) Appointment.--
            ``(A) Term.--A Director of a national research institute or 
        national center who is appointed by the Secretary, acting 
        through the Director of National Institutes of Health, shall be 
        appointed for 5 years.
            ``(B) Reappointment.--At the end of the term of a Director 
        of a national research institute or national center, the 
        Director may be reappointed in accordance with standards 
        applicable to the relevant appointment mechanism. There shall 
        be no limit on the number of terms that a Director may serve.
            ``(C) Vacancies.--If the office of a Director of a national 
        research institute or national center becomes vacant before the 
        end of such Director's term, the Director appointed to fill the 
        vacancy shall be appointed for a 5-year term starting on the 
        date of such appointment.
            ``(D) Current directors.--Each Director of a national 
        research institute or national center who is serving on the 
        date of enactment of the 21st Century Cures Act shall be deemed 
        to be appointed for a 5-year term under this subsection 
        beginning on such date of enactment.
            ``(E) Rule of construction.--Nothing in this subsection 
        shall be construed to limit the authority of the Secretary or 
        the Director of National Institutes of Health to terminate the 
        appointment of a director referred to in subparagraph (A) 
        before the expiration of such director's 5-year term.
            ``(F) Nature of appointment.--Appointments and 
        reappointments under this subsection shall be made on the basis 
        of ability and experience as it relates to the mission of the 
        National Institutes of Health and its components, including 
        compliance with any legal requirement that the Secretary or 
        Director of National Institutes of Health determines relevant.
        ``(3) Nonapplication of certain provision.--The restrictions 
    contained in section 202 of the Departments of Labor, Health and 
    Human Services, and Education, and Related Agencies Appropriations 
    Act, 1993 (Public Law 102-394; 42 U.S.C. 238f note) related to 
    consultants and individual scientists appointed for limited periods 
    of time shall not apply to Directors appointed under this 
    subsection.''.
    (b) Review of Certain Awards by Directors.--Section 405(b) of the 
Public Health Service Act (42 U.S.C. 284(b)) is amended by adding at 
the end the following:
    ``(3) Before an award is made by a national research institute or 
by a national center for a grant for a research program or project 
(commonly referred to as an `R-series grant'), other than an award 
constituting a noncompetitive renewal of such a grant, or a 
noncompetitive administrative supplement to such a grant, the Director 
of such national research institute or national center shall, 
consistent with the peer review process--
        ``(A) review and make the final decision with respect to making 
    the award; and
        ``(B) take into consideration, as appropriate--
            ``(i) the mission of the national research institute or 
        national center and the scientific priorities identified in the 
        strategic plan under section 402(m);
            ``(ii) programs or projects funded by other agencies on 
        similar research topics; and
            ``(iii) advice by staff and the advisory council or board 
        of such national research institute or national center.''.
    (c) Report on Duplication in Federal Biomedical Research.--The 
Secretary of Health and Human Services (referred to in this subsection 
as the ``Secretary''), shall, not later than 2 years after the date of 
enactment of this Act, submit a report to Congress on efforts to 
prevent and eliminate duplicative biomedical research that is not 
necessary for scientific purposes. Such report shall--
        (1) describe the procedures in place to identify such 
    duplicative research, including procedures for monitoring research 
    applications and funded research awards to prevent unnecessary 
    duplication;
        (2) describe the steps taken to improve the procedures 
    described in paragraph (1), in response to relevant recommendations 
    made by the Comptroller General of the United States;
        (3) describe how the Secretary operationally distinguishes 
    necessary and appropriate scientific replication from unnecessary 
    duplication; and
        (4) provide examples of instances where the Secretary has 
    identified unnecessarily duplicative research and the steps taken 
    to eliminate the unnecessary duplication.
SEC. 2034. REDUCING ADMINISTRATIVE BURDEN FOR RESEARCHERS.
    (a) Plan Preparation and Implementation of Measures To Reduce 
Administrative Burdens.--
        (1) In general.--Not later than 2 years after the date of 
    enactment of this Act, the Secretary of Health and Human Services 
    (referred to in this section as the ``Secretary'') shall--
            (A) lead a review by research funding agencies of all 
        regulations and policies related to the disclosure of financial 
        conflicts of interest, including the minimum threshold for 
        reporting financial conflicts of interest;
            (B) make revisions, as appropriate, to harmonize existing 
        policies and reduce administrative burden on researchers while 
        maintaining the integrity and credibility of research findings 
        and protections of human participants; and
            (C) confer with the Office of the Inspector General about 
        the activities of such office related to financial conflicts of 
        interest involving research funding agencies.
        (2) Considerations.--In updating policies under paragraph 
    (1)(B), the Secretary shall consider--
            (A) modifying the timelines for the reporting of financial 
        conflicts of interest to just-in-time information by 
        institutions receiving grant or cooperative agreement funding 
        from the National Institutes of Health;
            (B) ensuring that financial interest disclosure reporting 
        requirements are appropriate for, and relevant to, awards that 
        will directly fund research, which may include modification of 
        the definition of the term ``investigator'' for purposes of the 
        regulations and policies described in subparagraphs (A) and (B) 
        of paragraph (1); and
            (C) updating any applicable training modules of the 
        National Institutes of Health related to Federal financial 
        interest disclosure.
    (b) Monitoring of Subrecipients of Funding From the National 
Institutes of Health.--The Director of the National Institutes of 
Health (referred to in this section as the ``Director of National 
Institutes of Health'') shall implement measures to reduce the 
administrative burdens related to monitoring of subrecipients of grants 
by primary awardees of funding from the National Institutes of Health, 
which may incorporate findings and recommendations from existing and 
ongoing activities. Such measures may include, as appropriate--
        (1) an exemption from subrecipient monitoring requirements, 
    upon request from the primary awardees, provided that--
            (A) the subrecipient is subject to Federal audit 
        requirements pursuant to the Uniform Guidance of the Office of 
        Management and Budget;
            (B) the primary awardee conducts, pursuant to guidance of 
        the National Institutes of Health, a pre-award evaluation of 
        each subrecipient's risk of noncompliance with Federal statutes 
        and regulations, the conditions of the subaward, and any 
        recurring audit findings; and
            (C) such exemption does not absolve the primary awardee of 
        liability for misconduct by subrecipients; and
        (2) the implementation of alternative grant structures that 
    obviate the need for subrecipient monitoring, which may include 
    collaborative grant models allowing for multiple primary awardees.
    (c) Reporting of Financial Expenditures.--The Secretary, in 
consultation with the Director of National Institutes of Health, shall 
evaluate financial expenditure reporting procedures and requirements 
for recipients of funding from the National Institutes of Health and 
take action, as appropriate, to avoid duplication between department 
and agency procedures and requirements and minimize burden to funding 
recipients.
    (d) Animal Care and Use in Research.--Not later than 2 years after 
the date of enactment of this Act, the Director of National Institutes 
of Health, in collaboration with the Secretary of Agriculture and the 
Commissioner of Food and Drugs, shall complete a review of applicable 
regulations and policies for the care and use of laboratory animals and 
make revisions, as appropriate, to reduce administrative burden on 
investigators while maintaining the integrity and credibility of 
research findings and protection of research animals. In carrying out 
this effort, the Director of the National Institutes of Health shall 
seek the input of experts, as appropriate. The Director of the National 
Institutes of Health shall--
        (1) identify ways to ensure such regulations and policies are 
    not inconsistent, overlapping, or unnecessarily duplicative, 
    including with respect to inspection and review requirements by 
    Federal agencies and accrediting associations;
        (2) take steps to eliminate or reduce identified 
    inconsistencies, overlap, or duplication among such regulations and 
    policies; and
        (3) take other actions, as appropriate, to improve the 
    coordination of regulations and policies with respect to research 
    with laboratory animals.
    (e) Documentation of Personnel Expenses.--The Secretary shall 
clarify the applicability of the requirements under the Office of 
Management and Budget Uniform Guidance for management and certification 
systems adopted by entities receiving Federal research grants through 
the Department of Health and Human Services regarding documentation of 
personnel expenses, including clarification of the extent to which any 
flexibility to such requirements specified in such Uniform Guidance 
applies to entities receiving grants through the Department of Health 
and Human Services.
    (f) Research Policy Board.--
        (1) Establishment.--Not later than 1 year after the date of 
    enactment of this Act, the Director of the Office of Management and 
    Budget shall establish an advisory committee, to be known as the 
    ``Research Policy Board'' (referred to in this subsection as the 
    ``Board''), to provide Federal Government officials with 
    information on the effects of regulations related to Federal 
    research requirements.
        (2) Membership.--
            (A) In general.--The Board shall include not more than 10 
        Federal members, including each of the following Federal 
        members or their designees:
                (i) The Administrator of the Office of Information and 
            Regulatory Affairs of the Office of Management and Budget.
                (ii) The Director of the Office of Science and 
            Technology Policy.
                (iii) The Secretary of Health and Human Services.
                (iv) The Director of the National Science Foundation.
                (v) The secretaries and directors of other departments 
            and agencies that support or regulate scientific research, 
            as determined by the Director of the Office of Management 
            and Budget.
            (B) Non-federal members.--The Board shall be comprised of 
        not less than 9 and not more than 12 representatives of 
        academic research institutions, other private, nonprofit 
        research institutions, or other nonprofit organizations with 
        relevant expertise. Such members shall be appointed by a formal 
        process, to be established by the Director of the Office of 
        Management and Budget, in consultation with the Federal 
        membership, and that incorporates--
                (i) nomination by members of the nonprofit scientific 
            research community, including academic research 
            institutions; and
                (ii) procedures to fill membership positions vacated 
            before the end of a member's term.
        (3) Purpose and responsibilities.--The Board shall make 
    recommendations regarding the modification and harmonization of 
    regulations and policies having similar purposes across research 
    funding agencies to ensure that the administrative burden of such 
    research policy and regulation is minimized to the greatest extent 
    possible and consistent with maintaining responsible oversight of 
    federally funded research. Activities of the Board may include--
            (A) providing thorough and informed analysis of regulations 
        and policies;
            (B) identifying negative or adverse consequences of 
        existing policies and making actionable recommendations 
        regarding possible improvement of such policies;
            (C) making recommendations with respect to efforts within 
        the Federal Government to improve coordination of regulation 
        and policy related to research;
            (D) creating a forum for the discussion of research policy 
        or regulatory gaps, challenges, clarification, or harmonization 
        of such policies or regulation, and best practices; and
            (E) conducting ongoing assessment and evaluation of 
        regulatory burden, including development of metrics, periodic 
        measurement, and identification of process improvements and 
        policy changes.
        (4) Expert subcommittees.--The Board may form temporary expert 
    subcommittees, as appropriate, to develop timely analysis on 
    pressing issues and assist the Board in anticipating future 
    regulatory challenges, including challenges emerging from new 
    scientific advances.
        (5) Reporting requirements.--Not later than 2 years after the 
    date of enactment of this Act, and once thereafter, the Board shall 
    submit a report to the Director of the Office of Management and 
    Budget, the Administrator of the Office of Information and 
    Regulatory Affairs of the Office of Management and Budget, the 
    Director of the Office of Science and Technology Policy, the heads 
    of relevant Federal departments and agencies, the Committee on 
    Health, Education, Labor, and Pensions of the Senate, and the 
    Committee on Energy and Commerce of the House of Representatives 
    containing formal recommendations on the conceptualization, 
    development, harmonization, and reconsideration of scientific 
    research policy, including the regulatory benefits and burdens.
        (6) Sunset.--The Board shall terminate on September 30, 2021.
        (7) GAO report.--Not later than 4 years after the date of 
    enactment of this Act, the Comptroller General of the United States 
    shall conduct an independent evaluation of the activities carried 
    out by the Board pursuant to this subsection and submit to the 
    appropriate committees of Congress a report regarding the results 
    of the independent evaluation. Such report shall review and assess 
    the Board's activities with respect to the responsibilities 
    described in paragraph (3).
SEC. 2035. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH FROM THE 
PAPERWORK REDUCTION ACT REQUIREMENTS.
    Section 301 of the Public Health Service Act (42 U.S.C. 241), as 
amended by section 2013, is further amended by adding at the end the 
following:
    ``(g) Subchapter I of chapter 35 of title 44, United States Code, 
shall not apply to the voluntary collection of information during the 
conduct of research by the National Institutes of Health.''.
SEC. 2036. HIGH-RISK, HIGH-REWARD RESEARCH.
    (a) In General.--Section 402 of the Public Health Service Act (42 
U.S.C. 282), as amended by section 2031, is further amended by adding 
at the end the following:
    ``(n) Unique Research Initiatives.--
        ``(1) In general.--The Director of NIH may approve, after 
    consideration of a proposal under paragraph (2)(A), requests by the 
    national research institutes and centers, or program officers 
    within the Office of the Director to engage in transactions other 
    than a contract, grant, or cooperative agreement with respect to 
    projects that carry out--
            ``(A) the Precision Medicine Initiative under section 498E; 
        or
            ``(B) section 402(b)(7), except that not more than 50 
        percent of the funds available for a fiscal year through the 
        Common Fund under section 402A(c)(1) for purposes of carrying 
        out such section 402(b)(7) may be used to engage in such other 
        transactions.
        ``(2) Requirements.--The authority provided under this 
    subsection may be used to conduct or support high impact cutting-
    edge research described in paragraph (1) using the other 
    transactions authority described in such paragraph if the 
    institute, center, or office--
            ``(A) submits a proposal to the Director of NIH for the use 
        of such authority before conducting or supporting the research, 
        including why the use of such authority is essential to 
        promoting the success of the project;
            ``(B) receives approval for the use of such authority from 
        the Director of NIH; and
            ``(C) for each year in which the institute, center, or 
        office has used such authority in accordance with this 
        subsection, submits a report to the Director of NIH on the 
        activities of the institute, center, or office relating to such 
        research.''.
    (b) Report to Congress.--Not later than September 30, 2020, the 
Secretary of Health and Human Services, acting through the Director of 
the National Institutes of Health, shall conduct an evaluation of the 
activities under subsection (n) of section 402 of the Public Health 
Service Act (42 U.S.C. 282), as added by subsection (a), and submit a 
report to the Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce of the House of 
Representatives on the results of such evaluation.
    (c) Duties of Directors of Institutes.--Section 405(b)(1) of the 
Public Health Service Act (42 U.S.C. 284(b)(1)) is amended--
        (1) by redesignating subparagraphs (C) through (L) as 
    subparagraphs (D) through (M), respectively; and
        (2) by inserting after subparagraph (B), the following:
        ``(C) shall, as appropriate, conduct and support research that 
    has the potential to transform the scientific field, has inherently 
    higher risk, and that seeks to address major current challenges;''.
SEC. 2037. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES.
    (a) In General.--Section 479(b) of the Public Health Service Act 
(42 U.S.C. 287(b)) is amended--
        (1) in paragraph (1), by striking ``phase IIA'' and inserting 
    ``phase IIB''; and
        (2) in paragraph (2)--
            (A) in the matter preceding subparagraph (A), by striking 
        ``phase IIB'' and inserting ``phase III'';
            (B) in subparagraph (A), by striking ``phase IIB'' and 
        inserting ``phase III'';
            (C) in subparagraph (B), by striking ``phase IIA'' and 
        inserting ``phase IIB''; and
            (D) in subparagraph (C), by striking ``phase IIB'' and 
        inserting ``phase III''.
    (b) Increased Transparency.--Section 479 of the Public Health 
Service Act (42 U.S.C. 287) is amended--
        (1) in subsection (c)--
            (A) in paragraph (4)(D), by striking ``and'' at the end;
            (B) in paragraph (5), by striking the period and inserting 
        a semicolon; and
            (C) by adding at the end the following:
        ``(6) the methods and tools, if any, that have been developed 
    since the last biennial report was prepared; and
        ``(7) the methods and tools, if any, that have been developed 
    and are being utilized by the Food and Drug Administration to 
    support medical product reviews.''; and
        (2) by adding at the end the following:
    ``(d) Inclusion of List.--The first biennial report submitted under 
this section after the date of enactment of the 21st Century Cures Act 
shall include a complete list of all of the methods and tools, if any, 
which have been developed by research supported by the Center.
    ``(e) Rule of Construction.--Nothing in this section shall be 
construed as authorizing the Secretary to disclose any information that 
is a trade secret, or other privileged or confidential information 
subject to section 552(b)(4) of title 5, United States Code, or section 
1905 of title 18, United States Code.''.
SEC. 2038. COLLABORATION AND COORDINATION TO ENHANCE RESEARCH.
    (a) Research Priorities; Collaborative Research Projects.--Section 
402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended--
        (1) by amending paragraph (4) to read as follows:
        ``(4) shall assemble accurate data to be used to assess 
    research priorities, including--
            ``(A) information to better evaluate scientific 
        opportunity, public health burdens, and progress in reducing 
        health disparities; and
            ``(B) data on study populations of clinical research, 
        funded by or conducted at each national research institute and 
        national center, which--
                ``(i) specifies the inclusion of--

                    ``(I) women;
                    ``(II) members of minority groups;
                    ``(III) relevant age categories, including 
                pediatric subgroups; and
                    ``(IV) other demographic variables as the Director 
                of the National Institutes of Health determines 
                appropriate;

                ``(ii) is disaggregated by research area, condition, 
            and disease categories; and
                ``(iii) is to be made publicly available on the 
            Internet website of the National Institutes of Health;''; 
            and
        (2) in paragraph (8)--
            (A) in subparagraph (A), by striking ``and'' at the end; 
        and
            (B) by adding at the end the following:
            ``(C) foster collaboration between clinical research 
        projects funded by the respective national research institutes 
        and national centers that--
                ``(i) conduct research involving human subjects; and
                ``(ii) collect similar data; and
            ``(D) encourage the collaboration described in subparagraph 
        (C) to--
                ``(i) allow for an increase in the number of subjects 
            studied; and
                ``(ii) utilize diverse study populations, with special 
            consideration to biological, social, and other determinants 
            of health that contribute to health disparities;''.
    (b) Reporting.--Section 492B(f) of the Public Health Service Act 
(42 U.S.C. 289a-2(f)) is amended--
        (1) by striking ``biennial'' each place such term appears and 
    inserting ``triennial'';
        (2) by striking ``The advisory council'' and inserting the 
    following:
        ``(1) In general.--The advisory council''; and
        (3) by adding at the end the following:
        ``(2) Contents.--Each triennial report prepared by an advisory 
    council of each national research institute as described in 
    paragraph (1) shall include each of the following:
            ``(A) The number of women included as subjects, and the 
        proportion of subjects that are women, in any project of 
        clinical research conducted during the applicable reporting 
        period, disaggregated by categories of research area, 
        condition, or disease, and accounting for single-sex studies.
            ``(B) The number of members of minority groups included as 
        subjects, and the proportion of subjects that are members of 
        minority groups, in any project of clinical research conducted 
        during the applicable reporting period, disaggregated by 
        categories of research area, condition, or disease and 
        accounting for single-race and single-ethnicity studies.
            ``(C) For the applicable reporting period, the number of 
        projects of clinical research that include women and members of 
        minority groups and that--
                ``(i) have been completed during such reporting period; 
            and
                ``(ii) are being carried out during such reporting 
            period and have not been completed.
            ``(D) The number of studies completed during the applicable 
        reporting period for which reporting has been submitted in 
        accordance with subsection (c)(2)(A).''.
    (c) Coordination.--Section 486(c)(2) of the Public Health Service 
Act (42 U.S.C. 287d(c)(2)) is amended by striking ``designees'' and 
inserting ``senior-level staff designees''.
    (d) In General.--Part A of title IV of the Public Health Service 
Act (42 U.S.C. 281 et seq.), as amended by section 2021, is further 
amended by adding at the end the following:
``SEC. 404N. POPULATION FOCUSED RESEARCH.
    ``The Director of the National Institutes of Health shall, as 
appropriate, encourage efforts to improve research related to the 
health of sexual and gender minority populations, including by--
        ``(1) facilitating increased participation of sexual and gender 
    minority populations in clinical research supported by the National 
    Institutes of Health, and reporting on such participation, as 
    applicable;
        ``(2) facilitating the development of valid and reliable 
    methods for research relevant to sexual and gender minority 
    populations; and
        ``(3) addressing methodological challenges.''.
    (e) Reporting.--
        (1) In general.--The Secretary, in collaboration with the 
    Director of the National Institutes of Health, shall as 
    appropriate--
            (A) continue to support research for the development of 
        appropriate measures related to reporting health information 
        about sexual and gender minority populations; and
            (B) not later than 2 years after the date of enactment of 
        this Act, disseminate and make public such measures.
        (2) National academy of medicine recommendations.--In 
    developing the measures described in paragraph (1)(A), the 
    Secretary shall take into account recommendations made by the 
    National Academy of Medicine.
    (f) Improving Coordination Related to Minority Health and Health 
Disparities.--Section 464z-3 of the Public Health Service Act (42 
U.S.C. 285t) is amended--
        (1) by redesignating subsection (h), relating to interagency 
    coordination, that follows subsection (j) as subsection (k); and
        (2) in subsection (k) (as so redesignated)--
            (A) in the subsection heading, by striking ``Interagency'' 
        and inserting ``Intra-National Institutes of Health'';
            (B) by striking ``as the primary Federal officials'' and 
        inserting ``as the primary Federal official'';
            (C) by inserting a comma after ``review'';
            (D) by striking ``Institutes and Centers of the National 
        Institutes of Health'' and inserting ``national research 
        institutes and national centers''; and
            (E) by adding at the end the following: ``The Director of 
        the Institute may foster partnerships between the national 
        research institutes and national centers and may encourage the 
        funding of collaborative research projects to achieve the goals 
        of the National Institutes of Health that are related to 
        minority health and health disparities.''.
    (g) Basic Research.--
        (1) Developing policies.--Not later than 2 years after the date 
    of enactment of this Act, the Director of the National Institutes 
    of Health (referred to in this section as the ``Director of the 
    National Institutes of Health''), taking into consideration the 
    recommendations developed under section 2039, shall develop 
    policies for projects of basic research funded by National 
    Institutes of Health to assess--
            (A) relevant biological variables including sex, as 
        appropriate; and
            (B) how differences between male and female cells, tissues, 
        or animals may be examined and analyzed.
        (2) Revising policies.--The Director of the National Institutes 
    of Health may update or revise the policies developed under 
    paragraph (1) as appropriate.
        (3) Consultation and outreach.--In developing, updating, or 
    revising the policies under this section, the Director of the 
    National Institutes of Health shall--
            (A) consult with--
                (i) the Office of Research on Women's Health;
                (ii) the Office of Laboratory Animal Welfare; and
                (iii) appropriate members of the scientific and 
            academic communities; and
            (B) conduct outreach to solicit feedback from members of 
        the scientific and academic communities on the influence of sex 
        as a variable in basic research, including feedback on when it 
        is appropriate for projects of basic research involving cells, 
        tissues, or animals to include both male and female cells, 
        tissues, or animals.
        (4) Additional requirements.--The Director of the National 
    Institutes of Health shall--
            (A) ensure that projects of basic research funded by the 
        National Institutes of Health are conducted in accordance with 
        the policies developed, updated, or revised under this section, 
        as applicable; and
            (B) encourage that the results of such research, when 
        published or reported, be disaggregated as appropriate with 
        respect to the analysis of any sex differences.
    (h) Clinical Research.--
        (1) In general.--Not later than 1 year after the date of 
    enactment of this Act, the Director of the National Institutes of 
    Health, in consultation with the Director of the Office of Research 
    on Women's Health and the Director of the National Institute on 
    Minority Health and Health Disparities, shall update the guidelines 
    established under section 492B(d) of Public Health Service Act (42 
    U.S.C. 289a-2(d)) in accordance with paragraph (2).
        (2) Requirements.--The updated guidelines described in 
    paragraph (1) shall--
            (A) reflect the science regarding sex differences;
            (B) improve adherence to the requirements under section 
        492B of the Public Health Service Act (42 U.S.C. 289a-2), 
        including the reporting requirements under subsection (f) of 
        such section; and
            (C) clarify the circumstances under which studies should be 
        designed to support the conduct of analyses to detect 
        significant differences in the intervention effect due to 
        demographic factors related to section 492B of the Public 
        Health Service Act, including in the absence of prior studies 
        that demonstrate a difference in study outcomes on the basis of 
        such factors and considering the effects of the absence of such 
        analyses on the availability of data related to demographic 
        differences.
    (i) Appropriate Age Groupings in Clinical Research.--
        (1) Input from experts.--Not later than 180 days after the date 
    of enactment of this Act, the Director of the National Institutes 
    of Health shall convene a workshop of experts on pediatric and 
    older populations to provide input on--
            (A) appropriate age groups to be included in research 
        studies involving human subjects; and
            (B) acceptable justifications for excluding participants 
        from a range of age groups from human subjects research 
        studies.
        (2) Policy updates.--Not later than 180 days after the 
    conclusion of the workshop under paragraph (1), the Director of the 
    National Institutes of Health shall make a determination with 
    respect to whether the policies of the National Institutes of 
    Health on the inclusion of relevant age groups in clinical studies 
    need to be updated, and shall update such policies as appropriate. 
    In making the determination, the Director of the National 
    Institutes of Health shall take into consideration whether such 
    policies--
            (A) address the consideration of age as an inclusion 
        variable in research involving human subjects; and
            (B) identify the criteria for justification for any age-
        related exclusions in such research.
        (3) Public availability of findings and conclusions.--The 
    Director of the National Institutes of Health shall--
            (A) make the findings and conclusions resulting from the 
        workshop under paragraph (1) and updates to policies in 
        accordance with paragraph (2), as applicable, available to the 
        public on the Internet website of the National Institutes of 
        Health; and
            (B) ensure that age-related data reported in the triennial 
        report under section 403 of the Public Health Service Act (42 
        U.S.C. 283) (as amended by section 2032) are made available to 
        the public on the Internet website of the National Institutes 
        of Health.
SEC. 2039. ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCIENTIFIC 
RESEARCH.
    (a) Establishment.--Not later than 1 year after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Director of the National Institutes of Health, shall 
convene a working group under the Advisory Committee to the Director of 
the National Institutes of Health (referred to in this section as the 
``Advisory Committee''), appointed under section 222 of the Public 
Health Service Act (42 U.S.C. 217a), to develop and issue 
recommendations through the Advisory Committee for a formal policy, 
which may incorporate or be informed by relevant existing and ongoing 
activities, to enhance rigor and reproducibility of scientific research 
funded by the National Institutes of Health.
    (b) Considerations.--In developing and issuing recommendations 
through the Advisory Committee under subsection (a), the working group 
established under such subsection shall consider, as appropriate--
        (1) preclinical experiment design, including analysis of sex as 
    a biological variable;
        (2) clinical experiment design, including--
            (A) the diversity of populations studied for clinical 
        research, with respect to biological, social, and other 
        determinants of health that contribute to health disparities;
            (B) the circumstances under which summary information 
        regarding biological, social, and other factors that contribute 
        to health disparities should be reported; and
            (C) the circumstances under which clinical studies, 
        including clinical trials, should conduct an analysis of the 
        data collected during the study on the basis of biological, 
        social, and other factors that contribute to health 
        disparities;
        (3) applicable levels of rigor in statistical methods, 
    methodology, and analysis;
        (4) data and information sharing in accordance with applicable 
    privacy laws and regulations; and
        (5) any other matter the working group determines relevant.
    (c) Policies.--Not later than 18 months after the date of enactment 
of this Act, the Director of the National Institutes of Health shall 
consider the recommendations developed by the working group and issued 
by the Advisory Committee under subsection (a) and develop or update 
policies as appropriate.
    (d) Report.--Not later than 2 years after the date of enactment of 
this Act, the Director of the National Institutes of Health shall issue 
a report to the Secretary of Health and Human Services, the Committee 
on Health, Education, Labor, and Pensions of the Senate, and the 
Committee on Energy and Commerce of the House of Representatives 
regarding recommendations developed under subsection (a) and any 
subsequent policy changes implemented, to enhance rigor and 
reproducibility in scientific research funded by the National 
Institutes of Health.
    (e) Confidentiality.--Nothing in this section authorizes the 
Secretary of Health and Human Services to disclose any information that 
is a trade secret, or other privileged or confidential information, 
described in section 552(b)(4) of title 5, United States Code, or 
section 1905 of title 18, United States Code.
SEC. 2040. IMPROVING MEDICAL REHABILITATION RESEARCH AT THE NATIONAL 
INSTITUTES OF HEALTH.
    (a) In General.--Section 452 of the Public Health Service Act (42 
U.S.C. 285g-4) is amended--
        (1) in subsection (b), by striking ``conduct and support'' and 
    inserting ``conduct, support, and coordination'';
        (2) in subsection (c)(1)(C), by striking ``of the Center'' and 
    inserting ``within the Center'';
        (3) in subsection (d)--
            (A) by striking ``(d)(1) In consultation'' and all that 
        follows through the end of paragraph (1) and inserting the 
        following:
    ``(d)(1) The Director of the Center, in consultation with the 
Director of the Institute, the coordinating committee established under 
subsection (e), and the advisory board established under subsection 
(f), shall develop a comprehensive plan (referred to in this section as 
the `Research Plan') for the conduct, support, and coordination of 
medical rehabilitation research.'';
            (B) in paragraph (2)--
                (i) in subparagraph (A), by striking ``; and'' and 
            inserting a semicolon;
                (ii) in subparagraph (B), by striking the period and 
            inserting ``; and''; and
                (iii) by adding at the end the following:
        ``(C) include goals and objectives for conducting, supporting, 
    and coordinating medical rehabilitation research, consistent with 
    the purpose described in subsection (b).'';
            (C) by striking paragraph (4) and inserting the following:
    ``(4) The Director of the Center, in consultation with the Director 
of the Institute, the coordinating committee established under 
subsection (e), and the advisory board established under subsection 
(f), shall revise and update the Research Plan periodically, as 
appropriate, or not less than every 5 years. Not later than 30 days 
after the Research Plan is so revised and updated, the Director of the 
Center shall transmit the revised and updated Research Plan to the 
President, the Committee on Health, Education, Labor, and Pensions of 
the Senate, and the Committee on Energy and Commerce of the House of 
Representatives.''; and
            (D) by adding at the end the following:
    ``(5) The Director of the Center, in consultation with the Director 
of the Institute, shall, prior to revising and updating the Research 
Plan, prepare a report for the coordinating committee established under 
subsection (e) and the advisory board established under subsection (f) 
that describes and analyzes the progress during the preceding fiscal 
year in achieving the goals and objectives described in paragraph 
(2)(C) and includes expenditures for rehabilitation research at the 
National Institutes of Health. The report shall include recommendations 
for revising and updating the Research Plan, and such initiatives as 
the Director of the Center and the Director of the Institute determine 
appropriate. In preparing the report, the Director of the Center and 
the Director of the Institute shall consult with the Director of the 
National Institutes of Health.'';
        (4) in subsection (e)--
            (A) in paragraph (2), by inserting ``periodically host a 
        scientific conference or workshop on medical rehabilitation 
        research and'' after ``The Coordinating Committee shall''; and
            (B) in paragraph (3), by inserting ``the Director of the 
        Division of Program Coordination, Planning, and Strategic 
        Initiatives within the Office of the Director of the National 
        Institutes of Health,'' after ``shall be composed of'';
        (5) in subsection (f)(3)(B)--
            (A) by redesignating clauses (ix) through (xi) as clauses 
        (x) through (xii), respectively; and
            (B) by inserting after clause (viii) the following:
        ``(ix) The Director of the Division of Program Coordination, 
    Planning, and Strategic Initiatives.''; and
        (6) by adding at the end the following:
    ``(g)(1) The Secretary and the heads of other Federal agencies 
shall jointly review the programs carried out (or proposed to be 
carried out) by each such official with respect to medical 
rehabilitation research and, as appropriate, enter into agreements 
preventing duplication among such programs.
    ``(2) The Secretary shall, as appropriate, enter into interagency 
agreements relating to the coordination of medical rehabilitation 
research conducted by agencies of the National Institutes of Health and 
other agencies of the Federal Government.
    ``(h) For purposes of this section, the term `medical 
rehabilitation research' means the science of mechanisms and 
interventions that prevent, improve, restore, or replace lost, 
underdeveloped, or deteriorating function.''.
    (b) Conforming Amendment.--Section 3 of the National Institutes of 
Health Amendments of 1990 (42 U.S.C. 285g-4 note) is amended--
        (1) in subsection (a), by striking ``In General.--''; and
        (2) by striking subsection (b).
SEC. 2041. TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN AND 
LACTATING WOMEN.
    (a) Task Force on Research Specific to Pregnant Women and Lactating 
Women.--
        (1) Establishment.--Not later than 90 days after the date of 
    enactment of this Act, the Secretary of Health and Human Services 
    (referred to in this section as the ``Secretary'') shall establish 
    a task force, in accordance with the Federal Advisory Committee Act 
    (5 U.S.C. App.), to be known as the ``Task Force on Research 
    Specific to Pregnant Women and Lactating Women'' (in this section 
    referred to as the ``Task Force'').
        (2) Duties.--The Task Force shall provide advice and guidance 
    to the Secretary regarding Federal activities related to 
    identifying and addressing gaps in knowledge and research regarding 
    safe and effective therapies for pregnant women and lactating 
    women, including the development of such therapies and the 
    collaboration on and coordination of such activities.
        (3) Membership.--
            (A) Federal members.--The Task Force shall be composed of 
        each of the following Federal members, or the designees of such 
        members:
                (i) The Director of the Centers for Disease Control and 
            Prevention.
                (ii) The Director of the National Institutes of Health, 
            the Director of the Eunice Kennedy Shriver National 
            Institute of Child Health and Human Development, and the 
            directors of such other appropriate national research 
            institutes.
                (iii) The Commissioner of Food and Drugs.
                (iv) The Director of the Office on Women's Health.
                (v) The Director of the National Vaccine Program 
            Office.
                (vi) The head of any other research-related agency or 
            department not described in clauses (i) through (v) that 
            the Secretary determines appropriate, which may include the 
            Department of Veterans Affairs and the Department of 
            Defense.
            (B) Non-federal members.--The Task Force shall be composed 
        of each of the following non-Federal members, including--
                (i) representatives from relevant medical societies 
            with subject matter expertise on pregnant women, lactating 
            women, or children;
                (ii) nonprofit organizations with expertise related to 
            the health of women and children;
                (iii) relevant industry representatives; and
                (iv) other representatives, as appropriate.
            (C) Limitations.--The non-Federal members described in 
        subparagraph (B) shall--
                (i) compose not more than one-half, and not less than 
            one-third, of the total membership of the Task Force; and
                (ii) be appointed by the Secretary.
        (4) Termination.--
            (A) In general.--Subject to subparagraph (B), the Task 
        Force shall terminate on the date that is 2 years after the 
        date on which the Task Force is established under paragraph 
        (1).
            (B) Extension.--The Secretary may extend the operation of 
        the Task Force for one additional 2-year period following the 
        2-year period described in subparagraph (A), if the Secretary 
        determines that the extension is appropriate for carrying out 
        the purpose of this section.
        (5) Meetings.--The Task Force shall meet not less than 2 times 
    each year and shall convene public meetings, as appropriate, to 
    fulfill its duties under paragraph (2).
        (6) Task force report to congress.--Not later than 18 months 
    after the date on which the Task Force is established under 
    paragraph (1), the Task Force shall prepare and submit to the 
    Secretary, the Committee on Health, Education, Labor, and Pensions 
    of the Senate, and the Committee on Energy and Commerce of the 
    House of Representatives a report that includes each of the 
    following:
            (A) A plan to identify and address gaps in knowledge and 
        research regarding safe and effective therapies for pregnant 
        women and lactating women, including the development of such 
        therapies.
            (B) Ethical issues surrounding the inclusion of pregnant 
        women and lactating women in clinical research.
            (C) Effective communication strategies with health care 
        providers and the public on information relevant to pregnant 
        women and lactating women.
            (D) Identification of Federal activities, including--
                (i) the state of research on pregnancy and lactation;
                (ii) recommendations for the coordination of, and 
            collaboration on research related to pregnant women and 
            lactating women;
                (iii) dissemination of research findings and 
            information relevant to pregnant women and lactating women 
            to providers and the public; and
                (iv) existing Federal efforts and programs to improve 
            the scientific understanding of the health impacts on 
            pregnant women, lactating women, and related birth and 
            pediatric outcomes, including with respect to 
            pharmacokinetics, pharmacodynamics, and toxicities.
            (E) Recommendations to improve the development of safe and 
        effective therapies for pregnant women and lactating women.
    (b) Confidentiality.--Nothing in this section shall authorize the 
Secretary of Health and Human Services to disclose any information that 
is a trade secret, or other privileged or confidential information, 
described in section 552(b)(4) of title 5, United States Code, or 
section 1905 of title 18, United States Code.
    (c) Updating Protections for Pregnant Women and Lactating Women in 
Research.--
        (1) In general.--Not later than 2 years after the date of 
    enactment of this Act, the Secretary, considering any 
    recommendations of the Task Force available at such time and in 
    consultation with the heads of relevant agencies of the Department 
    of Health and Human Services, shall, as appropriate, update 
    regulations and guidance, as applicable, regarding the inclusion of 
    pregnant women and lactating women in clinical research.
        (2) Criteria for excluding pregnant or lactating women.--In 
    updating any regulations or guidance described in paragraph (1), 
    the Secretary shall consider any appropriate criteria to be used by 
    institutional review boards and individuals reviewing grant 
    proposals for excluding pregnant women or lactating women as a 
    study population requiring additional protections from 
    participating in human subject research.
SEC. 2042. STREAMLINING NATIONAL INSTITUTES OF HEALTH REPORTING 
REQUIREMENTS.
    (a) Trans-National Institutes of Health Research Reporting.--
Section 402A(c)(2) of the Public Health Service Act (42 U.S.C. 
282a(c)(2)) is amended--
        (1) by amending subparagraph (B) to read as follows:
            ``(B) Reporting.--Not later than 2 years after the date of 
        enactment of 21st Century Cures Act, the head of each national 
        research institute or national center shall submit to the 
        Director of the National Institutes of Health a report, to be 
        included in the triennial report under section 403, on the 
        amount made available by the institute or center for conducting 
        or supporting research that involves collaboration between the 
        institute or center and 1 or more other national research 
        institutes or national centers.''; and
        (2) in subparagraphs (D) and (E) by striking ``(B)(i)'' each 
    place it appears and inserting ``(B)''.
    (b) Fraud and Abuse Reporting.--Section 403B of the Public Health 
Service Act (42 U.S.C. 283a-1) is amended--
        (1) by striking subsection (b);
        (2) by redesignating subsection (c) as subsection (b); and
        (3) in subsection (b) (as so redesignated), by striking 
    ``subsections (a) and (b)'' and inserting ``subsection (a)''.
    (c) Doctoral Degrees Reporting.--Section 403C(a)(2) of the Public 
Health Service Act (42 U.S.C. 283a-2(a)(2)) is amended by striking 
``(not including any leaves of absence)''.
    (d) Vaccine Reporting.--Section 404B of the Public Health Service 
Act (42 U.S.C. 283d) is amended--
        (1) by striking subsection (b); and
        (2) by striking ``(a) Development of New Vaccines.--The 
    Secretary'' and inserting ``The Secretary''.
    (e) National Center for Advancing Translational Sciences.--Section 
479(c) of the Public Health Service Act (42 U.S.C. 287(c)) is amended--
        (1) in the subsection heading, by striking ``Annual'' and 
    inserting ``Biennial''; and
        (2) in the matter preceding paragraph (1), by striking ``an 
    annual report'' and inserting ``a report on a biennial basis''.
    (f) Review of Centers of Excellence.--
        (1) Repeal.--Section 404H of the Public Health Service Act (42 
    U.S.C. 283j) is repealed.
        (2) Conforming amendment.--Section 399EE(c) of the Public 
    Health Service Act (42 U.S.C. 280-4(c)) is amended by striking 
    ``399CC, 404H,'' and inserting ``399CC''.
    (g) Rapid HIV Test Report.--Section 502(a) of the Ryan White CARE 
Act Amendments of 2000 (42 U.S.C. 300cc note) is amended--
        (1) by striking paragraph (2); and
        (2) by redesignating paragraph (3) as paragraph (2).
    (h) National Institute of Nursing Research.--
        (1) Repeal.--Section 464Y of the Public Health Service Act (42 
    U.S.C. 285q-3) is repealed.
        (2) Conforming amendment.--Section 464X(g) of the Public Health 
    Service Act (42 U.S.C. 285q-2(g)) is amended by striking ``biennial 
    report made under section 464Y,'' and inserting ``triennial report 
    made under section 403''.
SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING ORGANISMS.
    Section 301 of the Public Health Service Act (42 U.S.C. 241), as 
amended by section 2035, is further amended--
        (1) in the flush matter at the end of subsection (a)--
            (A) by redesignating such matter as subsection (h)(1); and
            (B) by moving such matter so as to appear at the end of 
        such section; and
        (2) in subsection (h) (as so redesignated), by adding at the 
    end the following:
    ``(2) Where research substances and living organisms are made 
available under paragraph (1) through contractors, the Secretary may 
direct such contractors to collect payments on behalf of the Secretary 
for the costs incurred to make available such substances and organisms 
and to forward amounts so collected to the Secretary, in the time and 
manner specified by the Secretary.
    ``(3) Amounts collected under paragraph (2) shall be credited to 
the appropriations accounts that incurred the costs to make available 
the research substances and living organisms involved, and shall remain 
available until expended for carrying out activities under such 
accounts.''.
SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION OF UNDERREPRESENTED 
POPULATIONS IN CLINICAL TRIALS.
    It is the sense of Congress that the National Institute on Minority 
Health and Health Disparities should include within its strategic plan 
under section 402(m) of the Public Health Service Act (42 U.S.C. 
282(m)) ways to increase representation of underrepresented populations 
in clinical trials.

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

SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.
    Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(D)) is amended--
        (1) in clause (ii)(I), by inserting before the semicolon ``, 
    unless the responsible party affirmatively requests that the 
    Director of the National Institutes of Health publicly post such 
    clinical trial information for an applicable device clinical trial 
    prior to such date of clearance or approval''; and
        (2) by adding at the end the following:
                ``(iii) Option to make certain clinical trial 
            information available earlier.--The Director of the 
            National Institutes of Health shall inform responsible 
            parties of the option to request that clinical trial 
            information for an applicable device clinical trial be 
            publicly posted prior to the date of clearance or approval, 
            in accordance with clause (ii)(I).
                ``(iv) Combination products.--An applicable clinical 
            trial for a product that is a combination of drug, device, 
            or biological product shall be considered--

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

SEC. 2052. COMPLIANCE ACTIVITIES REPORTS.
    (a) Definitions.--In this section:
        (1) Applicable clinical trial.--The term ``applicable clinical 
    trial'' has the meaning given the term in section 402(j) of the 
    Public Health Service Act (42 U.S.C. 282(j)).
        (2) Secretary.--The term ``Secretary'' means the Secretary of 
    Health and Human Services.
    (b) Report on Activities To Encourage Compliance.--Not later than 2 
years after the date of enactment of this Act, the Secretary, acting 
through the Director of the National Institutes of Health and in 
collaboration with the Commissioner of Food and Drugs, shall submit to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives, a report that describes education and outreach, 
guidance, enforcement, and other activities undertaken to encourage 
compliance with section 402(j) of the Public Health Service Act (42 
U.S.C. 282(j)).
    (c) Reports on Clinical Trials.--
        (1) In general.--Not later than 2 years after the final 
    compliance date under the final rule implementing section 402(j) of 
    the Public Health Service Act, and every 2 years thereafter for the 
    next 4 years, the Secretary, acting through the Director of the 
    National Institutes of Health and in collaboration with the 
    Commissioner of Food and Drugs, shall submit to the Committee on 
    Health, Education, Labor, and Pensions of the Senate and the 
    Committee on Energy and Commerce of the House of Representatives, a 
    report describing--
            (A) the total number of applicable clinical trials with 
        complete data bank registration information registered during 
        the period for which the report is being prepared (broken down 
        by each year of such reporting period);
            (B) the total number of applicable clinical trials 
        registered during the period for which the report is being 
        prepared for which results have been submitted to the data bank 
        (broken down by each year of such reporting period);
            (C) the activities undertaken by the Secretary to educate 
        responsible persons about data bank registration and results 
        submission requirements, including through issuance of guidance 
        documents, informational meetings, and training sessions; and
            (D) the activities described in the report submitted under 
        subsection (b).
        (2) Actions to enforce compliance.--After the Secretary has 
    undertaken the educational activities described in paragraph 
    (1)(C), the Secretary shall include in subsequent reports submitted 
    under paragraph (1) the number of actions taken by the Secretary 
    during the period for which the report is being prepared to enforce 
    compliance with data bank registration and results submission 
    requirements.
SEC. 2053. UPDATES TO POLICIES TO IMPROVE DATA.
    Section 492B(c) of the Public Health Service Act (42 U.S.C. 289a-
2(c)) is amended--
        (1) by striking ``In the case'' and inserting the following:
        ``(1) In general.--In the case''; and
        (2) by adding at the end the following:
        ``(2) Reporting requirements.--For any new and competing 
    project of clinical research subject to the requirements under this 
    section that receives a grant award 1 year after the date of 
    enactment of the 21st Century Cures Act, or any date thereafter, 
    for which a valid analysis is provided under paragraph (1)--
            ``(A) and which is an applicable clinical trial as defined 
        in section 402(j), the entity conducting such clinical research 
        shall submit the results of such valid analysis to the clinical 
        trial registry data bank expanded under section 402(j)(3), and 
        the Director of the National Institutes of Health shall, as 
        appropriate, consider whether such entity has complied with the 
        reporting requirement described in this subparagraph in 
        awarding any future grant to such entity, including pursuant to 
        section 402(j)(5)(A)(ii) when applicable; and
            ``(B) the Director of the National Institutes of Health 
        shall encourage the reporting of the results of such valid 
        analysis described in paragraph (1) through any additional 
        means determined appropriate by the Director.''.
SEC. 2054. CONSULTATION.
    Not later than 90 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall consult with relevant 
Federal agencies, including the Food and Drug Administration, the 
Office of the National Coordinator for Health Information Technology, 
and the National Institutes of Health, as well as other stakeholders 
(including patients, researchers, physicians, industry representatives, 
and developers of health information technology) to receive 
recommendations with respect to enhancements to the clinical trial 
registry data bank under section 402(j) of the Public Health Service 
Act (42 U.S.C. 282(j)), including with respect to usability, 
functionality, and search capability.

            Subtitle F--Facilitating Collaborative Research

SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SURVEILLANCE SYSTEM.
    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by inserting after section 399S the following:
``SEC. 399S-1. SURVEILLANCE OF NEUROLOGICAL DISEASES.
    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention and in coordination with 
other agencies as the Secretary determines, shall, as appropriate--
        ``(1) enhance and expand infrastructure and activities to track 
    the epidemiology of neurological diseases; and
        ``(2) incorporate information obtained through such activities 
    into an integrated surveillance system, which may consist of or 
    include a registry, to be known as the National Neurological 
    Conditions Surveillance System.
    ``(b) Research.--The Secretary shall ensure that the National 
Neurological Conditions Surveillance System is designed in a manner 
that facilitates further research on neurological diseases.
    ``(c) Content.--In carrying out subsection (a), the Secretary--
        ``(1) shall provide for the collection and storage of 
    information on the incidence and prevalence of neurological 
    diseases in the United States;
        ``(2) to the extent practicable, shall provide for the 
    collection and storage of other available information on 
    neurological diseases, including information related to persons 
    living with neurological diseases who choose to participate, such 
    as--
            ``(A) demographics, such as age, race, ethnicity, sex, 
        geographic location, family history, and other information, as 
        appropriate;
            ``(B) risk factors that may be associated with neurological 
        diseases, such as genetic and environmental risk factors and 
        other information, as appropriate; and
            ``(C) diagnosis and progression markers;
        ``(3) may provide for the collection and storage of information 
    relevant to analysis on neurological diseases, such as information 
    concerning--
            ``(A) the natural history of the diseases;
            ``(B) the prevention of the diseases;
            ``(C) the detection, management, and treatment approaches 
        for the diseases; and
            ``(D) the development of outcomes measures;
        ``(4) may address issues identified during the consultation 
    process under subsection (d); and
        ``(5) initially may address a limited number of neurological 
    diseases.
    ``(d) Consultation.--In carrying out this section, the Secretary 
shall consult with individuals with appropriate expertise, which may 
include--
        ``(1) epidemiologists with experience in disease surveillance 
    or registries;
        ``(2) representatives of national voluntary health associations 
    that--
            ``(A) focus on neurological diseases; and
            ``(B) have demonstrated experience in research, care, or 
        patient services;
        ``(3) health information technology experts or other 
    information management specialists;
        ``(4) clinicians with expertise in neurological diseases; and
        ``(5) research scientists with experience conducting 
    translational research or utilizing surveillance systems for 
    scientific research purposes.
    ``(e) Grants.--The Secretary may award grants to, or enter into 
contracts or cooperative agreements with, public or private nonprofit 
entities to carry out activities under this section.
    ``(f) Coordination With Other Federal, State, and Local Agencies.--
Subject to subsection (h), the Secretary shall--
        ``(1) make information and analysis in the National 
    Neurological Conditions Surveillance System available, as 
    appropriate--
            ``(A) to Federal departments and agencies, such as the 
        National Institutes of Health and the Department of Veterans 
        Affairs; and
            ``(B) to State and local agencies; and
        ``(2) identify, build upon, leverage, and coordinate among 
    existing data and surveillance systems, surveys, registries, and 
    other Federal public health infrastructure, wherever practicable.
    ``(g) Public Access.--Subject to subsection (h), the Secretary 
shall ensure that information and analysis in the National Neurological 
Conditions Surveillance System are available, as appropriate, to the 
public, including researchers.
    ``(h) Privacy.--The Secretary shall ensure that information and 
analysis in the National Neurological Conditions Surveillance System 
are made available only to the extent permitted by applicable Federal 
and State law, and in a manner that protects personal privacy, to the 
extent required by applicable Federal and State privacy law, at a 
minimum.
    ``(i) Reports.--
        ``(1) Report on information and analyses.--Not later than 1 
    year after the date on which any system is established under this 
    section, the Secretary shall submit an interim report to the 
    Committee on Health, Education, Labor, and Pensions of the Senate 
    and the Committee on Energy and Commerce of the House of 
    Representatives regarding aggregate information collected pursuant 
    to this section and epidemiological analyses, as appropriate. Such 
    report shall be posted on the Internet website of the Department of 
    Health and Human Services and shall be updated biennially.
        ``(2) Implementation report.--Not later than 4 years after the 
    date of the enactment of this section, the Secretary shall submit a 
    report to the Congress concerning the implementation of this 
    section. Such report shall include information on--
            ``(A) the development and maintenance of the National 
        Neurological Conditions Surveillance System;
            ``(B) the type of information collected and stored in the 
        surveillance system;
            ``(C) the use and availability of such information, 
        including guidelines for such use; and
            ``(D) the use and coordination of databases that collect or 
        maintain information on neurological diseases.
    ``(j) Definition.--In this section, the term `national voluntary 
health association' means a national nonprofit organization with 
chapters, other affiliated organizations, or networks in States 
throughout the United States with experience serving the population of 
individuals with neurological disease and have demonstrated experience 
in neurological disease research, care, and patient services.
    ``(k) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $5,000,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 2062. TICK-BORNE DISEASES.
    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as ``the Secretary'') shall continue to 
conduct or support epidemiological, basic, translational, and clinical 
research related to vector-borne diseases, including tick-borne 
diseases.
    (b) Reports.--The Secretary shall ensure that each triennial report 
under section 403 of the Public Health Service Act (42 U.S.C. 283) (as 
amended by section 2032) includes information on actions undertaken by 
the National Institutes of Health to carry out subsection (a) with 
respect to tick-borne diseases.
    (c) Tick-borne Diseases Working Group.--
        (1) Establishment.--The Secretary shall establish a working 
    group, to be known as the Tick-Borne Disease Working Group 
    (referred to in this section as the ``Working Group''), comprised 
    of representatives of appropriate Federal agencies and other non-
    Federal entities, to provide expertise and to review all efforts 
    within the Department of Health and Human Services related to all 
    tick-borne diseases, to help ensure interagency coordination and 
    minimize overlap, and to examine research priorities.
        (2) Responsibilities.--The working group shall--
            (A) not later than 2 years after the date of enactment of 
        this Act, develop or update a summary of--
                (i) ongoing tick-borne disease research, including 
            research related to causes, prevention, treatment, 
            surveillance, diagnosis, diagnostics, duration of illness, 
            and intervention for individuals with tick-borne diseases;
                (ii) advances made pursuant to such research;
                (iii) Federal activities related to tick-borne 
            diseases, including--

                    (I) epidemiological activities related to tick-
                borne diseases; and
                    (II) basic, clinical, and translational tick-borne 
                disease research related to the pathogenesis, 
                prevention, diagnosis, and treatment of tick-borne 
                diseases;

                (iv) gaps in tick-borne disease research described in 
            clause (iii)(II);
                (v) the Working Group's meetings required under 
            paragraph (4); and
                (vi) the comments received by the Working Group;
            (B) make recommendations to the Secretary regarding any 
        appropriate changes or improvements to such activities and 
        research; and
            (C) solicit input from States, localities, and 
        nongovernmental entities, including organizations representing 
        patients, health care providers, researchers, and industry 
        regarding scientific advances, research questions, surveillance 
        activities, and emerging strains in species of pathogenic 
        organisms.
        (3) Membership.--The members of the working group shall 
    represent a diversity of scientific disciplines and views and shall 
    be composed of the following members:
            (A) Federal members.--Seven Federal members, consisting of 
        one or more representatives of each of the following:
                (i) The Office of the Assistant Secretary for Health.
                (ii) The Food and Drug Administration.
                (iii) The Centers for Disease Control and Prevention.
                (iv) The National Institutes of Health.
                (v) Such other agencies and offices of the Department 
            of Health and Human Services as the Secretary determines 
            appropriate.
            (B) Non-Federal public members.--Seven non-Federal public 
        members, consisting of representatives of the following 
        categories:
                (i) Physicians and other medical providers with 
            experience in diagnosing and treating tick-borne diseases.
                (ii) Scientists or researchers with expertise.
                (iii) Patients and their family members.
                (iv) Nonprofit organizations that advocate for patients 
            with respect to tick-borne diseases.
                (v) Other individuals whose expertise is determined by 
            the Secretary to be beneficial to the functioning of the 
            Working Group.
        (4) Meetings.--The Working Group shall meet not less than twice 
    each year.
        (5) Reporting.--Not later than 2 years after the date of 
    enactment of this Act, and every 2 years thereafter until 
    termination of the Working Group pursuant to paragraph (7), the 
    Working Group shall--
            (A) submit a report on its activities under paragraph 
        (2)(A) and any recommendations under paragraph (2)(B) to the 
        Secretary, the Committee on Energy and Commerce of the House of 
        Representatives, and the Committee on Health, Education, Labor, 
        and Pensions of the Senate; and
            (B) make such report publicly available on the Internet 
        website of the Department of Health and Human Services.
        (6) Applicability of faca.--The Working Group shall be treated 
    as an advisory committee subject to the Federal Advisory Committee 
    Act (5 U.S.C. App.).
        (7) Sunset.--The Working Group under this section shall 
    terminate 6 years after the date of enactment of this Act.
SEC. 2063. ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH 
PURPOSES.
    (a) Guidance Related to Remote Access.--Not later than 1 year after 
the date of enactment of this Act, the Secretary of Health and Human 
Services (referred to in this section as the ``Secretary'') shall issue 
guidance clarifying that subparagraph (B) of section 164.512(i)(1)(ii) 
of part 164 of the Rule (prohibiting the removal of protected health 
information by a researcher) does not prohibit remote access to health 
information by a researcher for such purposes as described in section 
164.512(i)(1)(ii) of part 164 of the Rule so long as--
        (1) at a minimum, security and privacy safeguards, consistent 
    with the requirements of the Rule, are maintained by the covered 
    entity and the researcher; and
        (2) the protected health information is not copied or otherwise 
    retained by the researcher.
    (b) Guidance Related to Streamlining Authorization.--Not later than 
1 year after the date of enactment of this Act, the Secretary shall 
issue guidance on the following:
        (1) Authorization for use and disclosure of health 
    information.--Clarification of the circumstances under which the 
    authorization for the use or disclosure of protected health 
    information, with respect to an individual, for future research 
    purposes contains a sufficient description of the purpose of the 
    use or disclosure, such as if the authorization--
            (A) sufficiently describes the purposes such that it would 
        be reasonable for the individual to expect that the protected 
        health information could be used or disclosed for such future 
        research;
            (B) either--
                (i) states that the authorization will expire on a 
            particular date or on the occurrence of a particular event; 
            or
                (ii) states that the authorization will remain valid 
            unless and until it is revoked by the individual; and
            (C) provides instruction to the individual on how to revoke 
        such authorization at any time.
        (2) Reminder of the right to revoke.--Clarification of the 
    circumstances under which it is appropriate to provide an 
    individual with an annual notice or reminder that the individual 
    has the right to revoke such authorization.
        (3) Revocation of authorization.--Clarification of appropriate 
    mechanisms by which an individual may revoke an authorization for 
    future research purposes, such as described in paragraph (1)(C).
    (c) Working Group on Protected Health Information for Research.--
        (1) Establishment.--Not later than 1 year after the date of 
    enactment of this Act, the Secretary shall convene a working group 
    to study and report on the uses and disclosures of protected health 
    information for research purposes, under the Health Insurance 
    Portability and Accountability Act of 1996 (Public Law 104-191).
        (2) Members.--The working group shall include representatives 
    of--
            (A) relevant Federal agencies, including the National 
        Institutes of Health, the Centers for Disease Control and 
        Prevention, the Food and Drug Administration, and the Office 
        for Civil Rights;
            (B) the research community;
            (C) patients;
            (D) experts in civil rights, such as privacy rights;
            (E) developers of health information technology;
            (F) experts in data privacy and security;
            (G) health care providers;
            (H) bioethicists; and
            (I) other experts and entities, as the Secretary determines 
        appropriate.
        (3) Report.--Not later than 1 year after the date on which the 
    working group is convened under paragraph (1), the working group 
    shall conduct a review and submit a report to the Secretary 
    containing recommendations on whether the uses and disclosures of 
    protected health information for research purposes should be 
    modified to allow protected health information to be available, as 
    appropriate, for research purposes, including studies to obtain 
    generalizable knowledge, while protecting individuals' privacy 
    rights. In conducting the review and making recommendations, the 
    working group shall--
            (A) address, at a minimum--
                (i) the appropriate manner and timing of authorization, 
            including whether additional notification to the individual 
            should be required when the individual's protected health 
            information will be used or disclosed for such research;
                (ii) opportunities for individuals to set preferences 
            on the manner in which their protected health information 
            is used in research;
                (iii) opportunities for patients to revoke 
            authorization;
                (iv) notification to individuals of a breach in 
            privacy;
                (v) existing gaps in statute, regulation, or policy 
            related to protecting the privacy of individuals, and
                (vi) existing barriers to research related to the 
            current restrictions on the uses and disclosures of 
            protected health information; and
            (B) consider, at a minimum--
                (i) expectations and preferences on how an individual's 
            protected health information is shared and used;
                (ii) issues related to specific subgroups of people, 
            such as children, incarcerated individuals, and individuals 
            with a cognitive or intellectual disability impacting 
            capacity to consent;
                (iii) relevant Federal and State laws;
                (iv) models of facilitating data access and levels of 
            data access, including data segmentation, where applicable;
                (v) potential impacts of disclosure and non-disclosure 
            of protected health information on access to health care 
            services; and
                (vi) the potential uses of such data.
        (4) Report submission.--The Secretary shall submit the report 
    under paragraph (3) to the Committee on Health, Education, Labor, 
    and Pensions of the Senate and the Committee on Energy and Commerce 
    of the House of Representatives, and shall post such report on the 
    appropriate Internet website of the Department of Health and Human 
    Services.
        (5) Termination.--The working group convened under paragraph 
    (1) shall terminate the day after the report under paragraph (3) is 
    submitted to Congress and made public in accordance with paragraph 
    (4).
    (d) Definitions.--In this section:
        (1) The rule.--References to ``the Rule'' refer to part 160 or 
    part 164, as appropriate, of title 45, Code of Federal Regulations 
    (or any successor regulation).
        (2) Part 164.--References to a specified section of ``part 
    164'', refer to such specified section of part 164 of title 45, 
    Code of Federal Regulations (or any successor section).

                Subtitle G--Promoting Pediatric Research

SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK.
    Section 409D(d) of the Public Health Service Act (42 U.S.C. 
284h(d)) is amended--
        (1) in paragraph (1), by striking ``in consultation with the 
    Director of the Eunice Kennedy Shriver National Institute of Child 
    Health and Human Development and in collaboration with other 
    appropriate national research institutes and national centers that 
    carry out activities involving pediatric research, may provide for 
    the establishment of'' and inserting ``in collaboration with the 
    national research institutes and national centers that carry out 
    activities involving pediatric research, shall support''; and
        (2) in paragraph (2)(A) and the first sentence of paragraph 
    (2)(E), by striking ``may'' each place such term appears and 
    inserting ``shall''.
SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK.
    It is the sense of Congress that--
        (1) the National Institutes of Health should encourage a global 
    pediatric clinical study network by providing grants, contracts, or 
    cooperative agreements to support new and early stage investigators 
    who participate in the global pediatric clinical study network;
        (2) the Secretary of Health and Human Services (referred to in 
    this section as the ``Secretary'') should engage with clinical 
    investigators and appropriate authorities outside of the United 
    States, including authorities in the European Union, during the 
    formation of the global pediatric clinical study network to 
    encourage the participation of such investigator and authorities; 
    and
        (3) once a global pediatric clinical study network is 
    established and becomes operational, the Secretary should continue 
    to encourage and facilitate the participation of clinical 
    investigators and appropriate authorities outside of the United 
    States, including in the European Union, to participate in the 
    network with the goal of enhancing the global reach of the network.

                         TITLE III--DEVELOPMENT
              Subtitle A--Patient-Focused Drug Development

SEC. 3001. PATIENT EXPERIENCE DATA.
    Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-8c) is amended--
        (1) in subsection (a)--
            (A) in the subsection heading, by striking ``In General'' 
        and inserting ``Patient Engagement in Drugs and Devices'';
            (B) by redesignating paragraphs (1) and (2) as 
        subparagraphs (A) and (B), respectively, and moving such 
        subparagraphs 2 ems to the right; and
            (C) by striking ``The Secretary'' and inserting the 
        following:
        ``(1) In general.--The Secretary'';
        (2) by redesignating subsections (b) through (e) as paragraphs 
    (2) through (5), respectively, and moving such paragraphs 2 ems to 
    the right; and
        (3) by adding at the end the following:
    ``(b) Statement of Patient Experience.--
        ``(1) In general.--Following the approval of an application 
    that was submitted under section 505(b) of this Act or section 
    351(a) of the Public Health Service Act at least 180 days after the 
    date of enactment of the 21st Century Cures Act, the Secretary 
    shall make public a brief statement regarding the patient 
    experience data and related information, if any, submitted and 
    reviewed as part of such application.
        ``(2) Data and information.--The data and information referred 
    to in paragraph (1) are--
            ``(A) patient experience data;
            ``(B) information on patient-focused drug development 
        tools; and
            ``(C) other relevant information, as determined by the 
        Secretary.
    ``(c) Patient Experience Data.--For purposes of this section, the 
term `patient experience data' includes data that--
        ``(1) are collected by any persons (including patients, family 
    members and caregivers of patients, patient advocacy organizations, 
    disease research foundations, researchers, and drug manufacturers); 
    and
        ``(2) are intended to provide information about patients' 
    experiences with a disease or condition, including--
            ``(A) the impact of such disease or condition, or a related 
        therapy, on patients' lives; and
            ``(B) patient preferences with respect to treatment of such 
        disease or condition.''.
SEC. 3002. PATIENT-FOCUSED DRUG DEVELOPMENT GUIDANCE.
    (a) Publication of Guidance Documents.--Not later than 180 days 
after the date of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this section as the ``Secretary''), 
acting through the Commissioner of Food and Drugs, shall develop a plan 
to issue draft and final versions of one or more guidance documents, 
over a period of 5 years, regarding the collection of patient 
experience data, and the use of such data and related information in 
drug development. Not later than 18 months after the date of enactment 
of this Act, the Secretary shall issue a draft version of at least one 
such guidance document. Not later than 18 months after the public 
comment period on the draft guidance ends, the Secretary shall issue a 
revised draft guidance or final guidance.
    (b) Patient Experience Data.--For purposes of this section, the 
term ``patient experience data'' has the meaning given such term in 
section 569C of the Federal Food, Drug, and Cosmetic Act (as added by 
section 3001).
    (c) Contents.--The guidance documents described in subsection (a) 
shall address--
        (1) methodological approaches that a person seeking to collect 
    patient experience data for submission to, and proposed use by, the 
    Secretary in regulatory decisionmaking may use, that are relevant 
    and objective and ensure that such data are accurate and 
    representative of the intended population, including methods to 
    collect meaningful patient input throughout the drug development 
    process and methodological considerations for data collection, 
    reporting, management, and analysis;
        (2) methodological approaches that may be used to develop and 
    identify what is most important to patients with respect to burden 
    of disease, burden of treatment, and the benefits and risks in the 
    management of the patient's disease;
        (3) approaches to identifying and developing methods to measure 
    impacts to patients that will help facilitate collection of patient 
    experience data in clinical trials;
        (4) methodologies, standards, and technologies to collect and 
    analyze clinical outcome assessments for purposes of regulatory 
    decisionmaking;
        (5) how a person seeking to develop and submit proposed draft 
    guidance relating to patient experience data for consideration by 
    the Secretary may submit such proposed draft guidance to the 
    Secretary;
        (6) the format and content required for submissions under this 
    section to the Secretary, including with respect to the information 
    described in paragraph (1);
        (7) how the Secretary intends to respond to submissions of 
    information described in paragraph (1), if applicable, including 
    any timeframe for response when such submission is not part of a 
    regulatory application or other submission that has an associated 
    timeframe for response; and
        (8) how the Secretary, if appropriate, anticipates using 
    relevant patient experience data and related information, including 
    with respect to the structured risk-benefit assessment framework 
    described in section 505(d) of the Federal Food, Drug, and Cosmetic 
    Act (21 U.S.C. 355(d)), to inform regulatory decisionmaking.
SEC. 3003. STREAMLINING PATIENT INPUT.
    Chapter 35 of title 44, United States Code, shall not apply to the 
collection of information to which a response is voluntary, that is 
initiated by the Secretary under section 569C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb-8c) (as amended by section 
3001) or section 3002.
SEC. 3004. REPORT ON PATIENT EXPERIENCE DRUG DEVELOPMENT.
    Not later than June 1 of 2021, 2026, and 2031, the Secretary of 
Health and Human Services, acting through the Commissioner of Food and 
Drugs, shall prepare and publish on the Internet website of the Food 
and Drug Administration a report assessing the use of patient 
experience data in regulatory decisionmaking, in particular with 
respect to the review of patient experience data and information on 
patient-focused drug development tools as part of applications approved 
under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(c)) or section 351(a) of the Public Health Service Act (42 
U.S.C. 262(a)).

                Subtitle B--Advancing New Drug Therapies

SEC. 3011. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F 
the following new section:
    ``SEC. 507. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
    ``(a) Process for Qualification.--
        ``(1) In general.--The Secretary shall establish a process for 
    the qualification of drug development tools for a proposed context 
    of use under which--
            ``(A)(i) a requestor initiates such process by submitting a 
        letter of intent to the Secretary; and
            ``(ii) the Secretary accepts or declines to accept such 
        letter of intent;
            ``(B)(i) if the Secretary accepts the letter of intent, a 
        requestor submits a qualification plan to the Secretary; and
            ``(ii) the Secretary accepts or declines to accept the 
        qualification plan; and
            ``(C)(i) if the Secretary accepts the qualification plan, 
        the requestor submits to the Secretary a full qualification 
        package;
            ``(ii) the Secretary determines whether to accept such 
        qualification package for review; and
            ``(iii) if the Secretary accepts such qualification package 
        for review, the Secretary conducts such review in accordance 
        with this section.
        ``(2) Acceptance and review of submissions.--
            ``(A) In general.--Subparagraphs (B), (C), and (D) shall 
        apply with respect to the treatment of a letter of intent, a 
        qualification plan, or a full qualification package submitted 
        under paragraph (1) (referred to in this paragraph as 
        `qualification submissions').
            ``(B) Acceptance factors; nonacceptance.--The Secretary 
        shall determine whether to accept a qualification submission 
        based on factors which may include the scientific merit of the 
        qualification submission. A determination not to accept a 
        submission under paragraph (1) shall not be construed as a 
        final determination by the Secretary under this section 
        regarding the qualification of a drug development tool for its 
        proposed context of use.
            ``(C) Prioritization of qualification review.--The 
        Secretary may prioritize the review of a full qualification 
        package submitted under paragraph (1) with respect to a drug 
        development tool, based on factors determined appropriate by 
        the Secretary, including--
                ``(i) as applicable, the severity, rarity, or 
            prevalence of the disease or condition targeted by the drug 
            development tool and the availability or lack of 
            alternative treatments for such disease or condition; and
                ``(ii) the identification, by the Secretary or by 
            biomedical research consortia and other expert 
            stakeholders, of such a drug development tool and its 
            proposed context of use as a public health priority.
            ``(D) Engagement of external experts.--The Secretary may, 
        for purposes of the review of qualification submissions, 
        through the use of cooperative agreements, grants, or other 
        appropriate mechanisms, consult with biomedical research 
        consortia and may consider the recommendations of such 
        consortia with respect to the review of any qualification plan 
        submitted under paragraph (1) or the review of any full 
        qualification package under paragraph (3).
        ``(3) Review of full qualification package.--The Secretary 
    shall--
            ``(A) conduct a comprehensive review of a full 
        qualification package accepted under paragraph (1)(C); and
            ``(B) determine whether the drug development tool at issue 
        is qualified for its proposed context of use.
        ``(4) Qualification.--The Secretary shall determine whether a 
    drug development tool is qualified for a proposed context of use 
    based on the scientific merit of a full qualification package 
    reviewed under paragraph (3).
    ``(b) Effect of Qualification.--
        ``(1) In general.--A drug development tool determined to be 
    qualified under subsection (a)(4) for a proposed context of use 
    specified by the requestor may be used by any person in such 
    context of use for the purposes described in paragraph (2).
        ``(2) Use of a drug development tool.--Subject to paragraph 
    (3), a drug development tool qualified under this section may be 
    used for--
            ``(A) supporting or obtaining approval or licensure (as 
        applicable) of a drug or biological product (including in 
        accordance with section 506(c)) under section 505 of this Act 
        or section 351 of the Public Health Service Act; or
            ``(B) supporting the investigational use of a drug or 
        biological product under section 505(i) of this Act or section 
        351(a)(3) of the Public Health Service Act.
        ``(3) Rescission or modification.--
            ``(A) In general.--The Secretary may rescind or modify a 
        determination under this section to qualify a drug development 
        tool if the Secretary determines that the drug development tool 
        is not appropriate for the proposed context of use specified by 
        the requestor. Such a determination may be based on new 
        information that calls into question the basis for such 
        qualification.
            ``(B) Meeting for review.--If the Secretary rescinds or 
        modifies under subparagraph (A) a determination to qualify a 
        drug development tool, the requestor involved shall, on 
        request, be granted a meeting with the Secretary to discuss the 
        basis of the Secretary's decision to rescind or modify the 
        determination before the effective date of the rescission or 
        modification.
    ``(c) Transparency.--
        ``(1) In general.--Subject to paragraph (3), the Secretary 
    shall make publicly available, and update on at least a biannual 
    basis, on the Internet website of the Food and Drug Administration 
    the following:
            ``(A) Information with respect to each qualification 
        submission under the qualification process under subsection 
        (a), including--
                ``(i) the stage of the review process applicable to the 
            submission;
                ``(ii) the date of the most recent change in stage 
            status;
                ``(iii) whether external scientific experts were 
            utilized in the development of a qualification plan or the 
            review of a full qualification package; and
                ``(iv) submissions from requestors under the 
            qualification process under subsection (a), including any 
            data and evidence contained in such submissions, and any 
            updates to such submissions.
            ``(B) The Secretary's formal written determinations in 
        response to such qualification submissions.
            ``(C) Any rescissions or modifications under subsection 
        (b)(3) of a determination to qualify a drug development tool.
            ``(D) Summary reviews that document conclusions and 
        recommendations for determinations to qualify drug development 
        tools under subsection (a).
            ``(E) A comprehensive list of--
                ``(i) all drug development tools qualified under 
            subsection (a); and
                ``(ii) all surrogate endpoints which were the basis of 
            approval or licensure (as applicable) of a drug or 
            biological product (including in accordance with section 
            506(c)) under section 505 of this Act or section 351 of the 
            Public Health Service Act.
        ``(2) Relation to trade secrets act.--Information made publicly 
    available by the Secretary under paragraph (1) shall be considered 
    a disclosure authorized by law for purposes of section 1905 of 
    title 18, United States Code.
        ``(3) Applicability.--Nothing in this section shall be 
    construed as authorizing the Secretary to disclose any information 
    contained in an application submitted under section 505 of this Act 
    or section 351 of the Public Health Service Act that is 
    confidential commercial or trade secret information subject to 
    section 552(b)(4) of title 5, United States Code, or section 1905 
    of title 18, United States Code.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed--
        ``(1) to alter the standards of evidence under subsection (c) 
    or (d) of section 505, including the substantial evidence standard 
    in such subsection (d), or under section 351 of the Public Health 
    Service Act (as applicable); or
        ``(2) to limit the authority of the Secretary to approve or 
    license products under this Act or the Public Health Service Act, 
    as applicable (as in effect before the date of the enactment of the 
    21st Century Cures Act).
    ``(e) Definitions.--In this section:
        ``(1) Biomarker.--The term `biomarker'--
            ``(A) means a characteristic (such as a physiologic, 
        pathologic, or anatomic characteristic or measurement) that is 
        objectively measured and evaluated as an indicator of normal 
        biologic processes, pathologic processes, or biological 
        responses to a therapeutic intervention; and
            ``(B) includes a surrogate endpoint.
        ``(2) Biomedical research consortia.--The term `biomedical 
    research consortia' means collaborative groups that may take the 
    form of public-private partnerships and may include government 
    agencies, institutions of higher education (as defined in section 
    101(a) of the Higher Education Act of 1965), patient advocacy 
    groups, industry representatives, clinical and scientific experts, 
    and other relevant entities and individuals.
        ``(3) Clinical outcome assessment.--The term `clinical outcome 
    assessment' means--
            ``(A) a measurement of a patient's symptoms, overall mental 
        state, or the effects of a disease or condition on how the 
        patient functions; and
            ``(B) includes a patient-reported outcome.
        ``(4) Context of use.--The term `context of use' means, with 
    respect to a drug development tool, the circumstances under which 
    the drug development tool is to be used in drug development and 
    regulatory review.
        ``(5) Drug development tool.--The term `drug development tool' 
    includes--
            ``(A) a biomarker;
            ``(B) a clinical outcome assessment; and
            ``(C) any other method, material, or measure that the 
        Secretary determines aids drug development and regulatory 
        review for purposes of this section.
        ``(6) Patient-reported outcome.--The term `patient-reported 
    outcome' means a measurement based on a report from a patient 
    regarding the status of the patient's health condition without 
    amendment or interpretation of the patient's report by a clinician 
    or any other person.
        ``(7) Qualification.--The terms `qualification' and `qualified' 
    mean a determination by the Secretary that a drug development tool 
    and its proposed context of use can be relied upon to have a 
    specific interpretation and application in drug development and 
    regulatory review under this Act.
        ``(8) Requestor.--The term `requestor' means an entity or 
    entities, including a drug sponsor or a biomedical research 
    consortia, seeking to qualify a drug development tool for a 
    proposed context of use under this section.
        ``(9) Surrogate endpoint.--The term `surrogate endpoint' means 
    a marker, such as a laboratory measurement, radiographic image, 
    physical sign, or other measure, that is not itself a direct 
    measurement of clinical benefit, and--
            ``(A) is known to predict clinical benefit and could be 
        used to support traditional approval of a drug or biological 
        product; or
            ``(B) is reasonably likely to predict clinical benefit and 
        could be used to support the accelerated approval of a drug or 
        biological product in accordance with section 506(c).''.
    (b) Guidance.--
        (1) In general.--The Secretary of Health and Human Services 
    (referred to in this section as the ``Secretary'') shall, in 
    consultation with biomedical research consortia (as defined in 
    subsection (e) of section 507 of the Federal Food, Drug, and 
    Cosmetic Act (as added by subsection (a)) and other interested 
    parties through a collaborative public process, issue guidance to 
    implement such section 507 that--
            (A) provides a conceptual framework describing appropriate 
        standards and scientific approaches to support the development 
        of biomarkers delineated under the taxonomy established under 
        paragraph (3);
            (B) with respect to the qualification process under such 
        section 507--
                (i) describes the requirements that entities seeking to 
            qualify a drug development tool under such section shall 
            observe when engaging in such process;
                (ii) outlines reasonable timeframes for the Secretary's 
            review of letters, qualification plans, or full 
            qualification packages submitted under such process; and
                (iii) establishes a process by which such entities or 
            the Secretary may consult with biomedical research 
            consortia and other individuals and entities with expert 
            knowledge and insights that may assist the Secretary in the 
            review of qualification plans and full qualification 
            submissions under such section; and
            (C) includes such other information as the Secretary 
        determines appropriate.
        (2) Timing.--Not later than 3 years after the date of the 
    enactment of this Act, the Secretary shall issue draft guidance 
    under paragraph (1) on the implementation of section 507 of the 
    Federal Food, Drug, and Cosmetic Act (as added by subsection (a)). 
    The Secretary shall issue final guidance on the implementation of 
    such section not later than 6 months after the date on which the 
    comment period for the draft guidance closes.
        (3) Taxonomy.--
            (A) In general.--For purposes of informing guidance under 
        this subsection, the Secretary shall, in consultation with 
        biomedical research consortia and other interested parties 
        through a collaborative public process, establish a taxonomy 
        for the classification of biomarkers (and related scientific 
        concepts) for use in drug development.
            (B) Public availability.--Not later than 2 years after the 
        date of the enactment of this Act, the Secretary shall make 
        such taxonomy publicly available in draft form for public 
        comment. The Secretary shall finalize the taxonomy not later 
        than 1 year after the close of the public comment period.
    (c) Meeting and Report.--
        (1) Meeting.--Not later than 2 years after the date of the 
    enactment of this Act, the Secretary shall convene a public meeting 
    to describe and solicit public input regarding the qualification 
    process under section 507 of the Federal Food, Drug, and Cosmetic 
    Act, as added by subsection (a).
        (2) Report.--Not later than 5 years after the date of the 
    enactment of this Act, the Secretary shall make publicly available 
    on the Internet website of the Food and Drug Administration a 
    report. Such report shall include, with respect to the 
    qualification process under section 507 of the Federal Food, Drug, 
    and Cosmetic Act, as added by subsection (a), information on--
            (A) the number of requests submitted, as a letter of 
        intent, for qualification of a drug development tool (as 
        defined in subsection (e) of such section 507);
            (B) the number of such requests accepted and determined to 
        be eligible for submission of a qualification plan or full 
        qualification package (as such terms are defined in subsection 
        (e) of such section 507), respectively;
            (C) the number of such requests for which external 
        scientific experts were utilized in the development of a 
        qualification plan or review of a full qualification package;
            (D) the number of qualification plans and full 
        qualification packages, respectively, submitted to the 
        Secretary; and
            (E) the drug development tools qualified through such 
        qualification process, specified by type of tool, such as a 
        biomarker or clinical outcome assessment (as such terms are 
        defined in subsection (e) of such section 507).
SEC. 3012. TARGETED DRUGS FOR RARE DISEASES.
    Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360aa et seq.) is amended by inserting after section 529 
the following:
``SEC. 529A. TARGETED DRUGS FOR RARE DISEASES.
    ``(a) Purpose.--The purpose of this section, through the approach 
provided for in subsection (b), is to--
        ``(1) facilitate the development, review, and approval of 
    genetically targeted drugs and variant protein targeted drugs to 
    address an unmet medical need in one or more patient subgroups, 
    including subgroups of patients with different mutations of a gene, 
    with respect to rare diseases or conditions that are serious or 
    life-threatening; and
        ``(2) maximize the use of scientific tools or methods, 
    including surrogate endpoints and other biomarkers, for such 
    purposes.
    ``(b) Leveraging of Data From Previously Approved Drug Application 
or Applications.--The Secretary may, consistent with applicable 
standards for approval under this Act or section 351(a) of the Public 
Health Service Act, allow the sponsor of an application under section 
505(b)(1) of this Act or section 351(a) of the Public Health Service 
Act for a genetically targeted drug or a variant protein targeted drug 
to rely upon data and information--
        ``(1) previously developed by the same sponsor (or another 
    sponsor that has provided the sponsor with a contractual right of 
    reference to such data and information); and
        ``(2) submitted by a sponsor described in paragraph (1) in 
    support of one or more previously approved applications that were 
    submitted under section 505(b)(1) of this Act or section 351(a) of 
    the Public Health Service Act,
for a drug that incorporates or utilizes the same or similar 
genetically targeted technology as the drug or drugs that are the 
subject of an application or applications described in paragraph (2) or 
for a variant protein targeted drug that is the same or incorporates or 
utilizes the same variant protein targeted drug, as the drug or drugs 
that are the subject of an application or applications described in 
paragraph (2).
    ``(c) Definitions.--For purposes of this section--
        ``(1) the term `genetically targeted drug' means a drug that--
            ``(A) is the subject of an application under section 
        505(b)(1) of this Act or section 351(a) of the Public Health 
        Service Act for the treatment of a rare disease or condition 
        (as such term is defined in section 526) that is serious or 
        life-threatening;
            ``(B) may result in the modulation (including suppression, 
        up-regulation, or activation) of the function of a gene or its 
        associated gene product; and
            ``(C) incorporates or utilizes a genetically targeted 
        technology;
        ``(2) the term `genetically targeted technology' means a 
    technology comprising non-replicating nucleic acid or analogous 
    compounds with a common or similar chemistry that is intended to 
    treat one or more patient subgroups, including subgroups of 
    patients with different mutations of a gene, with the same disease 
    or condition, including a disease or condition due to other 
    variants in the same gene; and
        ``(3) the term `variant protein targeted drug' means a drug 
    that--
            ``(A) is the subject of an application under section 
        505(b)(1) of this Act or section 351(a) of the Public Health 
        Service Act for the treatment of a rare disease or condition 
        (as such term is defined in section 526) that is serious or 
        life-threatening;
            ``(B) modulates the function of a product of a mutated gene 
        where such mutation is responsible in whole or in part for a 
        given disease or condition; and
            ``(C) is intended to treat one or more patient subgroups, 
        including subgroups of patients with different mutations of a 
        gene, with the same disease or condition.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to--
        ``(1) alter the authority of the Secretary to approve drugs 
    pursuant to this Act or section 351 of the Public Health Service 
    Act (as authorized prior to the date of enactment of the 21st 
    Century Cures Act), including the standards of evidence, and 
    applicable conditions, for approval under such applicable Act; or
        ``(2) confer any new rights, beyond those authorized under this 
    Act or the Public Health Service Act prior to enactment of this 
    section, with respect to the permissibility of a sponsor 
    referencing information contained in another application submitted 
    under section 505(b)(1) of this Act or section 351(a) of the Public 
    Health Service Act.''.
SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS FOR RARE 
PEDIATRIC DISEASES.
    (a) In General.--Section 529(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking paragraph (5) 
and inserting the following:
        ``(5) Termination of authority.--The Secretary may not award 
    any priority review vouchers under paragraph (1) after September 
    30, 2020, unless the rare pediatric disease product application--
            ``(A) is for a drug that, not later than September 30, 
        2020, is designated under subsection (d) as a drug for a rare 
        pediatric disease; and
            ``(B) is, not later than September 30, 2022, approved under 
        section 505(b)(1) of this Act or section 351(a) of the Public 
        Health Service Act.''.
    (b) Report.--The Advancing Hope Act of 2016 (Public Law 114-229) is 
amended by striking section 3.
SEC. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS.
    (a) Study.--The Comptroller General of the United States (referred 
to in this section as the ``Comptroller General'') shall conduct a 
study addressing the effectiveness and overall impact of the following 
priority review voucher programs, including any such programs amended 
or established by this Act:
        (1) The neglected tropical disease priority review voucher 
    program under section 524 of the Federal Food, Drug, and Cosmetic 
    Act (21 U.S.C. 360n).
        (2) The rare pediatric disease priority review voucher program 
    under section 529 of the Federal Food, Drug, and Cosmetic Act (21 
    U.S.C. 360ff).
        (3) The medical countermeasure priority review voucher program 
    under section 565A of the Federal Food, Drug, and Cosmetic Act, as 
    added by section 3086.
    (b) Issuance of Report.--Not later than January 31, 2020, the 
Comptroller General shall submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report containing the 
results of the study under subsection (a).
    (c) Contents of Reports.--The report submitted under subsection (b) 
shall address--
        (1) for each drug for which a priority review voucher has been 
    awarded as of initiation of the study--
            (A) the indications for which the drug is approved under 
        section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(c)), pursuant to an application under section 
        505(b)(1) of such Act, or licensed under section 351(a) of the 
        Public Health Service Act (42 U.S.C. 262(a));
            (B) whether, and to what extent, the voucher impacted the 
        sponsor's decision to develop the drug; and
            (C) whether, and to what extent, the approval or licensure 
        of the drug, as applicable and appropriate--
                (i) addressed a global unmet need related to the 
            treatment or prevention of a neglected tropical disease, 
            including whether the sponsor of a drug coordinated with 
            international development organizations;
                (ii) addressed an unmet need related to the treatment 
            of a rare pediatric disease; or
                (iii) affected the Nation's preparedness against a 
            chemical, biological, radiological, or nuclear threat, 
            including naturally occurring threats;
        (2) for each drug for which a priority review voucher has been 
    used--
            (A) the indications for which such drug is approved under 
        section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(c)), pursuant to an application under section 
        505(b)(1) of such Act, or licensed under section 351(a) of the 
        Public Health Service Act (42 U.S.C. 262);
            (B) the value of the voucher, if transferred; and
            (C) the length of time between the date on which the 
        voucher was awarded and the date on which the voucher was used; 
        and
        (3) an analysis of the priority review voucher programs 
    described in subsection (a), including--
            (A) the resources used by the Food and Drug Administration 
        in reviewing drugs for which vouchers were used, including the 
        effect of the programs on the Food and Drug Administration's 
        review of drugs for which priority review vouchers were not 
        awarded or used;
            (B) whether any improvements to such programs are necessary 
        to appropriately target incentives for the development of drugs 
        that would likely not otherwise be developed, or developed in 
        as timely a manner, and, as applicable and appropriate--
                (i) address global unmet needs related to the treatment 
            or prevention of neglected tropical diseases, including in 
            countries in which neglected tropical diseases are endemic; 
            or
                (ii) address unmet needs related to the treatment of 
            rare pediatric diseases; and
            (C) whether the sunset of the rare pediatric disease 
        program and medical countermeasure program has had an impact on 
        the program, including any potential unintended consequences.
    (d) Protection of National Security.--The Comptroller General shall 
conduct the study and issue reports under this section in a manner that 
does not compromise national security.
SEC. 3015. AMENDMENTS TO THE ORPHAN DRUG GRANTS.
    Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended--
        (1) in subsection (a), by striking paragraph (1) and inserting 
    the following: ``(1) defraying the costs of developing drugs for 
    rare diseases or conditions, including qualified testing 
    expenses,''; and
        (2) in subsection (b)(1)--
            (A) in subparagraph (A)(ii), by striking ``and'' after the 
        semicolon;
            (B) in subparagraph (B), by striking the period and 
        inserting ``; and''; and
            (C) by adding at the end the following:
            ``(C) prospectively planned and designed observational 
        studies and other analyses conducted to assist in the 
        understanding of the natural history of a rare disease or 
        condition and in the development of a therapy, including 
        studies and analyses to--
                ``(i) develop or validate a drug development tool 
            related to a rare disease or condition; or
                ``(ii) understand the full spectrum of the disease 
            manifestations, including describing genotypic and 
            phenotypic variability and identifying and defining 
            distinct subpopulations affected by a rare disease or 
            condition.''.
SEC. 3016. GRANTS FOR STUDYING CONTINUOUS DRUG MANUFACTURING.
    (a) In General.--The Secretary of Health and Human Services may 
award grants to institutions of higher education and nonprofit 
organizations for the purpose of studying and recommending improvements 
to the process of continuous manufacturing of drugs and biological 
products and similar innovative monitoring and control techniques.
    (b) Definitions.--In this section--
        (1) the term ``drug'' has the meaning given such term in 
    section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
    321);
        (2) the term ``biological product'' has the meaning given such 
    term in section 351(i) of the Public Health Service Act (42 U.S.C. 
    262(i)); and
        (3) the term ``institution of higher education'' has the 
    meaning given such term in section 101(a) of the Higher Education 
    Act of 1965 (20 U.S.C. 1001(a)).

        Subtitle C--Modern Trial Design and Evidence Development

SEC. 3021. NOVEL CLINICAL TRIAL DESIGNS.
    (a) Proposals for Use of Novel Clinical Trial Designs for Drugs and 
Biological Products.--For purposes of assisting sponsors in 
incorporating complex adaptive and other novel trial designs into 
proposed clinical protocols and applications for new drugs under 
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
and biological products under section 351 of the Public Health Service 
Act (42 U.S.C. 262), the Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall conduct a 
public meeting and issue guidance in accordance with subsection (b).
    (b) Guidance Addressing Use of Novel Clinical Trial Designs.--
        (1) In general.--The Secretary, acting through the Commissioner 
    of Food and Drugs, shall update or issue guidance addressing the 
    use of complex adaptive and other novel trial design in the 
    development and regulatory review and approval or licensure for 
    drugs and biological products.
        (2) Contents.--The guidance under paragraph (1) shall address--
            (A) the use of complex adaptive and other novel trial 
        designs, including how such clinical trials proposed or 
        submitted help to satisfy the substantial evidence standard 
        under section 505(d) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355(d));
            (B) how sponsors may obtain feedback from the Secretary on 
        technical issues related to modeling and simulations prior to--
                (i) completion of such modeling or simulations; or
                (ii) the submission of resulting information to the 
            Secretary;
            (C) the types of quantitative and qualitative information 
        that should be submitted for review; and
            (D) recommended analysis methodologies.
        (3) Public meeting.--Prior to updating or issuing the guidance 
    required by paragraph (1), the Secretary shall consult with 
    stakeholders, including representatives of regulated industry, 
    academia, patient advocacy organizations, consumer groups, and 
    disease research foundations, through a public meeting to be held 
    not later than 18 months after the date of enactment of this Act.
        (4) Timing.--The Secretary shall update or issue a draft 
    version of the guidance required by paragraph (1) not later than 18 
    months after the date of the public meeting required by paragraph 
    (3) and finalize such guidance not later than 1 year after the date 
    on which the public comment period for the draft guidance closes.
SEC. 3022. REAL WORLD EVIDENCE.
    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 505E (21 U.S.C. 355f) the following:
``SEC. 505F. UTILIZING REAL WORLD EVIDENCE.
    ``(a) In General.--The Secretary shall establish a program to 
evaluate the potential use of real world evidence--
        ``(1) to help to support the approval of a new indication for a 
    drug approved under section 505(c); and
        ``(2) to help to support or satisfy postapproval study 
    requirements.
    ``(b) Real World Evidence Defined.--In this section, the term `real 
world evidence' means data regarding the usage, or the potential 
benefits or risks, of a drug derived from sources other than randomized 
clinical trials.
    ``(c) Program Framework.--
        ``(1) In general.--Not later than 2 years after the date of 
    enactment of the 21st Century Cures Act, the Secretary shall 
    establish a draft framework for implementation of the program under 
    this section.
        ``(2) Contents of framework.--The framework shall include 
    information describing--
            ``(A) the sources of real world evidence, including ongoing 
        safety surveillance, observational studies, registries, claims, 
        and patient-centered outcomes research activities;
            ``(B) the gaps in data collection activities;
            ``(C) the standards and methodologies for collection and 
        analysis of real world evidence; and
            ``(D) the priority areas, remaining challenges, and 
        potential pilot opportunities that the program established 
        under this section will address.
        ``(3) Consultation.--
            ``(A) In general.--In developing the program framework 
        under this subsection, the Secretary shall consult with 
        regulated industry, academia, medical professional 
        organizations, representatives of patient advocacy 
        organizations, consumer organizations, disease research 
        foundations, and other interested parties.
            ``(B) Process.--The consultation under subparagraph (A) may 
        be carried out through approaches such as--
                ``(i) a public-private partnership with the entities 
            described in such subparagraph in which the Secretary may 
            participate;
                ``(ii) a contract, grant, or other arrangement, as the 
            Secretary determines appropriate, with such a partnership 
            or an independent research organization; or
                ``(iii) public workshops with the entities described in 
            such subparagraph.
    ``(d) Program Implementation.--The Secretary shall, not later than 
2 years after the date of enactment of the 21st Century Cures Act and 
in accordance with the framework established under subsection (c), 
implement the program to evaluate the potential use of real world 
evidence.
    ``(e) Guidance for Industry.--The Secretary shall--
        ``(1) utilize the program established under subsection (a), its 
    activities, and any subsequent pilots or written reports, to inform 
    a guidance for industry on--
            ``(A) the circumstances under which sponsors of drugs and 
        the Secretary may rely on real world evidence for the purposes 
        described in paragraphs (1) and (2) of subsection (a); and
            ``(B) the appropriate standards and methodologies for 
        collection and analysis of real world evidence submitted for 
        such purposes;
        ``(2) not later than 5 years after the date of enactment of the 
    21st Century Cures Act, issue draft guidance for industry as 
    described in paragraph (1); and
        ``(3) not later than 18 months after the close of the public 
    comment period for the draft guidance described in paragraph (2), 
    issue revised draft guidance or final guidance.
    ``(f) Rule of Construction.--
        ``(1) In general.--Subject to paragraph (2), nothing in this 
    section prohibits the Secretary from using real world evidence for 
    purposes not specified in this section, provided the Secretary 
    determines that sufficient basis exists for any such nonspecified 
    use.
        ``(2) Standards of evidence and secretary's authority.--This 
    section shall not be construed to alter--
            ``(A) the standards of evidence under--
                ``(i) subsection (c) or (d) of section 505, including 
            the substantial evidence standard in such subsection (d); 
            or
                ``(ii) section 351(a) of the Public Health Service Act; 
            or
            ``(B) the Secretary's authority to require postapproval 
        studies or clinical trials, or the standards of evidence under 
        which studies or trials are evaluated.''.
SEC. 3023. PROTECTION OF HUMAN RESEARCH SUBJECTS.
    (a) In General.--In order to simplify and facilitate compliance by 
researchers with applicable regulations for the protection of human 
subjects in research, the Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall, to the extent 
practicable and consistent with other statutory provisions, harmonize 
differences between the HHS Human Subject Regulations and the FDA Human 
Subject Regulations in accordance with subsection (b).
    (b) Avoiding Regulatory Duplication and Unnecessary Delays.--The 
Secretary shall, as appropriate--
        (1) make such modifications to the provisions of the HHS Human 
    Subject Regulations, the FDA Human Subject Regulations, and the 
    vulnerable populations rules as may be necessary--
            (A) to reduce regulatory duplication and unnecessary 
        delays;
            (B) to modernize such provisions in the context of 
        multisite and cooperative research projects; and
            (C) to protect vulnerable populations, incorporate local 
        considerations, and support community engagement through 
        mechanisms such as consultation with local researchers and 
        human research protection programs, in a manner consistent with 
        subparagraph (B); and
        (2) ensure that human subject research that is subject to the 
    HHS Human Subject Regulations and to the FDA Human Subject 
    Regulations may--
            (A) use joint or shared review;
            (B) rely upon the review of--
                (i) an independent institutional review board; or
                (ii) an institutional review board of an entity other 
            than the sponsor of the research; or
            (C) use similar arrangements to avoid duplication of 
        effort.
    (c) Consultation.--In harmonizing or modifying regulations or 
guidance under this section, the Secretary shall consult with 
stakeholders (including researchers, academic organizations, hospitals, 
institutional research boards, pharmaceutical, biotechnology, and 
medical device developers, clinical research organizations, patient 
groups, and others).
    (d) Timing.--The Secretary shall complete the harmonization 
described in subsection (a) not later than 3 years after the date of 
enactment of this Act.
    (e) Progress Report.--Not later than 2 years after the date of 
enactment of this Act, the Secretary shall submit to Congress a report 
on the progress made toward completing such harmonization.
    (f) Definitions.--
        (1) Human subject regulations.--In this section:
            (A) FDA human subject regulations.--The term ``FDA Human 
        Subject Regulations'' means the provisions of parts 50, 56, 
        312, and 812 of title 21, Code of Federal Regulations (or any 
        successor regulations).
            (B) HHS human subject regulations.--The term ``HHS Human 
        Subject Regulations'' means the provisions of subpart A of part 
        46 of title 45, Code of Federal Regulations (or any successor 
        regulations).
            (C) Vulnerable population rules.--The term ``vulnerable 
        population rules'' means--
                (i) except in the case of research described in clause 
            (ii), the provisions of subparts B through D of part 46, 
            Code of Federal Regulations (or any successor regulations); 
            and
                (ii) in the case of research that is subject to FDA 
            Human Subject Regulations, the provisions applicable to 
            vulnerable populations under part 56 of title 21, Code of 
            Federal Regulations (or any successor regulations) and 
            subpart D of part 50 of such title 21 (or any successor 
            regulations).
        (2) Institutional review board defined.--In this section, the 
    term ``institutional review board'' has the meaning that applies to 
    the term ``institutional review board'' under the HHS Human Subject 
    Regulations.
SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL 
INVESTIGATIONS.
    (a) Devices.--Section 520(g)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended--
        (1) in subparagraph (D), by striking ``except where subject to 
    such conditions as the Secretary may prescribe, the investigator'' 
    and inserting the following: ``except where, subject to such 
    conditions as the Secretary may prescribe--
            ``(i) the proposed clinical testing poses no more than 
        minimal risk to the human subject and includes appropriate 
        safeguards to protect the rights, safety, and welfare of the 
        human subject; or
            ``(ii) the investigator''; and
        (2) in the matter following subparagraph (D), by striking 
    ``subparagraph (D)'' and inserting ``subparagraph (D)(ii)''.
    (b) Drugs.--Section 505(i)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ``except 
where it is not feasible or it is contrary to the best interests of 
such human beings'' and inserting ``except where it is not feasible, it 
is contrary to the best interests of such human beings, or the proposed 
clinical testing poses no more than minimal risk to such human beings 
and includes appropriate safeguards as prescribed to protect the 
rights, safety, and welfare of such human beings''.

        Subtitle D--Patient Access to Therapies and Information

SEC. 3031. SUMMARY LEVEL REVIEW.
    (a) FFDCA.--Section 505(c) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(c)) is amended by adding at the end the following:
    ``(5)(A) The Secretary may rely upon qualified data summaries to 
support the approval of a supplemental application, with respect to a 
qualified indication for a drug, submitted under subsection (b), if 
such supplemental application complies with subparagraph (B).
    ``(B) A supplemental application is eligible for review as 
described in subparagraph (A) only if--
        ``(i) there is existing data available and acceptable to the 
    Secretary demonstrating the safety of the drug; and
        ``(ii) all data used to develop the qualified data summaries 
    are submitted to the Secretary as part of the supplemental 
    application.
    ``(C) The Secretary shall post on the Internet website of the Food 
and Drug Administration and update annually--
        ``(i) the number of applications reviewed solely under 
    subparagraph (A) or section 351(a)(2)(E) of the Public Health 
    Service Act;
        ``(ii) the average time for completion of review under 
    subparagraph (A) or section 351(a)(2)(E) of the Public Health 
    Service Act;
        ``(iii) the average time for review of supplemental 
    applications where the Secretary did not use review flexibility 
    under subparagraph (A) or section 351(a)(2)(E) of the Public Health 
    Service Act; and
        ``(iv) the number of applications reviewed under subparagraph 
    (A) or section 351(a)(2)(E) of the Public Health Service Act for 
    which the Secretary made use of full data sets in addition to the 
    qualified data summary.
    ``(D) In this paragraph--
        ``(i) the term `qualified indication' means an indication for a 
    drug that the Secretary determines to be appropriate for summary 
    level review under this paragraph; and
        ``(ii) the term `qualified data summary' means a summary of 
    clinical data that demonstrates the safety and effectiveness of a 
    drug with respect to a qualified indication.''.
    (b) PHSA.--Section 351(a)(2) of the Public Health Service Act (42 
U.S.C. 262(a)(2)) is amended by adding at the end the following:
    ``(E)(i) The Secretary may rely upon qualified data summaries to 
support the approval of a supplemental application, with respect to a 
qualified indication for a drug, submitted under this subsection, if 
such supplemental application complies with the requirements of 
subparagraph (B) of section 505(c)(5) of the Federal Food, Drug, and 
Cosmetic Act.
    ``(ii) In this subparagraph, the terms `qualified indication' and 
`qualified data summary' have the meanings given such terms in section 
505(c)(5) of the Federal Food, Drug, and Cosmetic Act.''.
SEC. 3032. EXPANDED ACCESS POLICY.
    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 561 (21 U.S.C. 360bbb) the following:
``SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR INVESTIGATIONAL DRUGS.
    ``(a) In General.--The manufacturer or distributor of one or more 
investigational drugs for the diagnosis, monitoring, or treatment of 
one or more serious diseases or conditions shall make available the 
policy of the manufacturer or distributor on evaluating and responding 
to requests submitted under section 561(b) for provision of such a 
drug.
    ``(b) Public Availability of Expanded Access Policy.--The policies 
under subsection (a) shall be made public and readily available, such 
as by posting such policies on a publicly available Internet website. 
Such policies may be generally applicable to all investigational drugs 
of such manufacturer or distributor.
    ``(c) Content of Policy.--A policy described in subsection (a) 
shall include--
        ``(1) contact information for the manufacturer or distributor 
    to facilitate communication about requests described in subsection 
    (a);
        ``(2) procedures for making such requests;
        ``(3) the general criteria the manufacturer or distributor will 
    use to evaluate such requests for individual patients, and for 
    responses to such requests;
        ``(4) the length of time the manufacturer or distributor 
    anticipates will be necessary to acknowledge receipt of such 
    requests; and
        ``(5) a hyperlink or other reference to the clinical trial 
    record containing information about the expanded access for such 
    drug that is required under section 402(j)(2)(A)(ii)(II)(gg) of the 
    Public Health Service Act.
    ``(d) No Guarantee of Access.--The posting of policies by 
manufacturers and distributors under subsection (a) shall not serve as 
a guarantee of access to any specific investigational drug by any 
individual patient.
    ``(e) Revised Policy.--Nothing in this section shall prevent a 
manufacturer or distributor from revising a policy required under this 
section at any time.
    ``(f) Application.--This section shall apply to a manufacturer or 
distributor with respect to an investigational drug beginning on the 
later of--
        ``(1) the date that is 60 calendar days after the date of 
    enactment of the 21st Century Cures Act; or
        ``(2) the first initiation of a phase 2 or phase 3 study (as 
    such terms are defined in section 312.21(b) and (c) of title 21, 
    Code of Federal Regulations (or any successor regulations)) with 
    respect to such investigational drug.''.
SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED THERAPIES.
    (a) In General.--Section 506 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356) is amended--
        (1) by transferring subsection (e) (relating to construction) 
    so that it appears before subsection (f) (relating to awareness 
    efforts); and
        (2) by adding at the end the following:
    ``(g) Regenerative Advanced Therapy.--
        ``(1) In general.--The Secretary, at the request of the sponsor 
    of a drug, shall facilitate an efficient development program for, 
    and expedite review of, such drug if the drug qualifies as a 
    regenerative advanced therapy under the criteria described in 
    paragraph (2).
        ``(2) Criteria.--A drug is eligible for designation as a 
    regenerative advanced therapy under this subsection if--
            ``(A) the drug is a regenerative medicine therapy (as 
        defined in paragraph (8));
            ``(B) the drug is intended to treat, modify, reverse, or 
        cure a serious or life-threatening disease or condition; and
            ``(C) preliminary clinical evidence indicates that the drug 
        has the potential to address unmet medical needs for such a 
        disease or condition.
        ``(3) Request for designation.--The sponsor of a drug may 
    request the Secretary to designate the drug as a regenerative 
    advanced therapy concurrently with, or at any time after, 
    submission of an application for the investigation of the drug 
    under section 505(i) of this Act or section 351(a)(3) of the Public 
    Health Service Act.
        ``(4) Designation.--Not later than 60 calendar days after the 
    receipt of a request under paragraph (3), the Secretary shall 
    determine whether the drug that is the subject of the request meets 
    the criteria described in paragraph (2). If the Secretary 
    determines that the drug meets the criteria, the Secretary shall 
    designate the drug as a regenerative advanced therapy and shall 
    take such actions as are appropriate under paragraph (1). If the 
    Secretary determines that a drug does not meet the criteria for 
    such designation, the Secretary shall include with the 
    determination a written description of the rationale for such 
    determination.
        ``(5) Actions.--The sponsor of a regenerative advanced therapy 
    shall be eligible for the actions to expedite development and 
    review of such therapy under subsection (a)(3)(B), including early 
    interactions to discuss any potential surrogate or intermediate 
    endpoint to be used to support the accelerated approval of an 
    application for the product under subsection (c).
        ``(6) Access to expedited approval pathways.--An application 
    for a regenerative advanced therapy under section 505(b)(1) of this 
    Act or section 351(a) of the Public Health Service Act may be--
            ``(A) eligible for priority review, as described in the 
        Manual of Policies and Procedures of the Food and Drug 
        Administration and goals identified in the letters described in 
        section 101(b) of the Prescription Drug User Fee Amendments of 
        2012; and
            ``(B) eligible for accelerated approval under subsection 
        (c), as agreed upon pursuant to subsection (a)(3)(B), through, 
        as appropriate--
                ``(i) surrogate or intermediate endpoints reasonably 
            likely to predict long-term clinical benefit; or
                ``(ii) reliance upon data obtained from a meaningful 
            number of sites, including through expansion to additional 
            sites, as appropriate.
        ``(7) Postapproval requirements.--The sponsor of a regenerative 
    advanced therapy that is granted accelerated approval and is 
    subject to the postapproval requirements under subsection (c) may, 
    as appropriate, fulfill such requirements, as the Secretary may 
    require, through--
            ``(A) the submission of clinical evidence, clinical 
        studies, patient registries, or other sources of real world 
        evidence, such as electronic health records;
            ``(B) the collection of larger confirmatory data sets, as 
        agreed upon pursuant to subsection (a)(3)(B); or
            ``(C) postapproval monitoring of all patients treated with 
        such therapy prior to approval of the therapy.
        ``(8) Definition.--For purposes of this section, the term 
    `regenerative medicine therapy' includes cell therapy, therapeutic 
    tissue engineering products, human cell and tissue products, and 
    combination products using any such therapies or products, except 
    for those regulated solely under section 361 of the Public Health 
    Service Act and part 1271 of title 21, Code of Federal 
    Regulations.''.
    (b) Rule of Construction.--Nothing in this section and the 
amendments made by this section shall be construed to alter the 
authority of the Secretary of Health and Human Services--
        (1) to approve drugs pursuant to the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 of the Public 
    Health Service Act (42 U.S.C. 262) as authorized prior to the date 
    of enactment of the 21st Century Cures Act, including the standards 
    of evidence, and applicable conditions, for approval under such 
    Acts; or
        (2) to alter the authority of the Secretary to require 
    postapproval studies pursuant to such Acts, as authorized prior to 
    the date of enactment of the 21st Century Cures Act.
    (c) Conforming Amendment.--Section 506(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356(e)(1)) is amended by inserting 
``and the 21st Century Cures Act'' after ``Food and Drug Administration 
Safety and Innovation Act''.
SEC. 3034. GUIDANCE REGARDING DEVICES USED IN THE RECOVERY, ISOLATION, 
OR DELIVERY OF REGENERATIVE ADVANCED THERAPIES.
    (a) Draft Guidance.--Not later than 1 year after the date of 
enactment of the 21st Century Cures Act, the Secretary of Health and 
Human Services, acting through the Commissioner of Food and Drugs, 
shall issue draft guidance clarifying how, in the context of 
regenerative advanced therapies, the Secretary will evaluate devices 
used in the recovery, isolation, or delivery of regenerative advanced 
therapies. In doing so, the Secretary shall specifically address--
        (1) how the Food and Drug Administration intends to simplify 
    and streamline regulatory requirements for combination device and 
    cell or tissue products;
        (2) what, if any, intended uses or specific attributes would 
    result in a device used with a regenerative therapy product to be 
    classified as a class III device;
        (3) when the Food and Drug Administration considers it is 
    necessary, if ever, for the intended use of a device to be limited 
    to a specific intended use with only one particular type of cell; 
    and
        (4) application of the least burdensome approach to demonstrate 
    how a device may be used with more than one cell type.
    (b) Final Guidance.--Not later than 12 months after the close of 
the period for public comment on the draft guidance under subsection 
(a), the Secretary of Health and Human Services shall finalize such 
guidance.
SEC. 3035. REPORT ON REGENERATIVE ADVANCED THERAPIES.
    (a) Report to Congress.--Before March 1 of each calendar year, the 
Secretary of Health and Human Services shall, with respect to the 
previous calendar year, submit a report to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives on--
        (1) the number and type of applications for approval of 
    regenerative advanced therapies filed, approved or licensed as 
    applicable, withdrawn, or denied; and
        (2) how many of such applications or therapies, as applicable, 
    were granted accelerated approval or priority review.
    (b) Regenerative Advanced Therapy.--In this section, the term 
``regenerative advanced therapy'' has the meaning given such term in 
section 506(g) of the Federal Food, Drug, and Cosmetic Act, as added by 
section 3033 of this Act.
SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE 
ADVANCED THERAPIES.
    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F 
the following:
``SEC. 506G. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE 
ADVANCED THERAPIES.
    ``(a) In General.--Not later than 2 years after the date of 
enactment of the 21st Century Cures Act, the Secretary, in consultation 
with the National Institute of Standards and Technology and 
stakeholders (including regenerative medicine and advanced therapies 
manufacturers and clinical trial sponsors, contract manufacturers, 
academic institutions, practicing clinicians, regenerative medicine and 
advanced therapies industry organizations, and standard setting 
organizations), shall facilitate an effort to coordinate and prioritize 
the development of standards and consensus definition of terms, through 
a public process, to support, through regulatory predictability, the 
development, evaluation, and review of regenerative medicine therapies 
and regenerative advanced therapies, including with respect to the 
manufacturing processes and controls of such products.
    ``(b) Activities.--
        ``(1) In general.--In carrying out this section, the Secretary 
    shall continue to--
            ``(A) identity opportunities to help advance the 
        development of regenerative medicine therapies and regenerative 
        advanced therapies;
            ``(B) identify opportunities for the development of 
        laboratory regulatory science research and documentary 
        standards that the Secretary determines would help support the 
        development, evaluation, and review of regenerative medicine 
        therapies and regenerative advanced therapies through 
        regulatory predictability; and
            ``(C) work with stakeholders, such as those described in 
        subsection (a), as appropriate, in the development of such 
        standards.
        ``(2) Regulations and guidance.--Not later than 1 year after 
    the development of standards as described in subsection (a), the 
    Secretary shall review relevant regulations and guidance and, 
    through a public process, update such regulations and guidance as 
    the Secretary determines appropriate.
    ``(c) Definitions.--For purposes of this section, the terms 
`regenerative medicine therapy' and `regenerative advanced therapy' 
have the meanings given such terms in section 506(g).''.
SEC. 3037. HEALTH CARE ECONOMIC INFORMATION.
    Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(a)) is amended--
        (1) by striking ``(a) If its'' and inserting ``(a)(1) If its'';
        (2) by striking ``a formulary committee, or other similar 
    entity, in the course of the committee or the entity carrying out 
    its responsibilities for the selection of drugs for managed care or 
    other similar organizations'' and inserting ``a payor, formulary 
    committee, or other similar entity with knowledge and expertise in 
    the area of health care economic analysis, carrying out its 
    responsibilities for the selection of drugs for coverage or 
    reimbursement'';
        (3) by striking ``directly relates'' and inserting ``relates'';
        (4) by striking ``and is based on competent and reliable 
    scientific evidence. The requirements set forth in section 505(a) 
    or in section 351(a) of the Public Health Service Act shall not 
    apply to health care economic information provided to such a 
    committee or entity in accordance with this paragraph'' and 
    inserting ``, is based on competent and reliable scientific 
    evidence, and includes, where applicable, a conspicuous and 
    prominent statement describing any material differences between the 
    health care economic information and the labeling approved for the 
    drug under section 505 or under section 351 of the Public Health 
    Service Act. The requirements set forth in section 505(a) or in 
    subsections (a) and (k) of section 351 of the Public Health Service 
    Act shall not apply to health care economic information provided to 
    such a payor, committee, or entity in accordance with this 
    paragraph''; and
        (5) by striking ``In this paragraph, the term'' and all that 
    follows and inserting the following:
    ``(2)(A) For purposes of this paragraph, the term `health care 
economic information' means any analysis (including the clinical data, 
inputs, clinical or other assumptions, methods, results, and other 
components underlying or comprising the analysis) that identifies, 
measures, or describes the economic consequences, which may be based on 
the separate or aggregated clinical consequences of the represented 
health outcomes, of the use of a drug. Such analysis may be comparative 
to the use of another drug, to another health care intervention, or to 
no intervention.
    ``(B) Such term does not include any analysis that relates only to 
an indication that is not approved under section 505 or under section 
351 of the Public Health Service Act for such drug.''.
SEC. 3038. COMBINATION PRODUCT INNOVATION.
    (a) In General.--Section 503(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(g)) is amended--
        (1) by striking paragraph (3);
        (2) by redesignating paragraph (2) as paragraph (7);
        (3) by redesignating paragraphs (4) and (5) as paragraphs (8) 
    and (9), respectively;
        (4) by striking ``(g)(1)'' and all that follows through the end 
    of paragraph (1) and inserting the following:
    ``(g)(1)(A) The Secretary shall, in accordance with this 
subsection, assign a primary agency center to regulate products that 
constitute a combination of a drug, device, or biological product.
    ``(B) The Secretary shall conduct the premarket review of any 
combination product under a single application, whenever appropriate.
    ``(C) For purposes of this subsection, the term `primary mode of 
action' means the single mode of action of a combination product 
expected to make the greatest contribution to the overall intended 
therapeutic effects of the combination product.
    ``(D) The Secretary shall determine the primary mode of action of 
the combination product. If the Secretary determines that the primary 
mode of action is that of--
        ``(i) a drug (other than a biological product), the agency 
    center charged with premarket review of drugs shall have primary 
    jurisdiction;
        ``(ii) a device, the agency center charged with premarket 
    review of devices shall have primary jurisdiction; or
        ``(iii) a biological product, the agency center charged with 
    premarket review of biological products shall have primary 
    jurisdiction.
    ``(E) In determining the primary mode of action of a combination 
product, the Secretary shall not determine that the primary mode of 
action is that of a drug or biological product solely because the 
combination product has any chemical action within or on the human 
body.
    ``(F) If a sponsor of a combination product disagrees with the 
determination under subparagraph (D)--
        ``(i) such sponsor may request, and the Secretary shall 
    provide, a substantive rationale to such sponsor that references 
    scientific evidence provided by the sponsor and any other 
    scientific evidence relied upon by the Secretary to support such 
    determination; and
        ``(ii)(I) the sponsor of the combination product may propose 
    one or more studies (which may be nonclinical, clinical, or both) 
    to establish the relevance, if any, of the chemical action in 
    achieving the primary mode of action of such product;
        ``(II) if the sponsor proposes any such studies, the Secretary 
    and the sponsor of such product shall collaborate and seek to reach 
    agreement, within a reasonable time of such proposal, not to exceed 
    90 calendar days, on the design of such studies; and
        ``(III) if an agreement is reached under subclause (II) and the 
    sponsor conducts one or more of such studies, the Secretary shall 
    consider the data resulting from any such study when reevaluating 
    the determination of the primary mode of action of such product, 
    and unless and until such reevaluation has occurred and the 
    Secretary issues a new determination, the determination of the 
    Secretary under subparagraph (D) shall remain in effect.
    ``(2)(A)(i) To establish clarity and certainty for the sponsor, the 
sponsor of a combination product may request a meeting on such 
combination product. If the Secretary concludes that a determination of 
the primary mode of action pursuant to paragraph (1)(D) is necessary, 
the sponsor may request such meeting only after the Secretary makes 
such determination. If the sponsor submits a written meeting request, 
the Secretary shall, not later than 75 calendar days after receiving 
such request, meet with the sponsor of such combination product.
    ``(ii) A meeting under clause (i) may--
        ``(I) address the standards and requirements for market 
    approval or clearance of the combination product;
        ``(II) address other issues relevant to such combination 
    product, such as requirements related to postmarket modification of 
    such combination product and good manufacturing practices 
    applicable to such combination product; and
        ``(III) identify elements under subclauses (I) and (II) that 
    may be more appropriate for discussion and agreement with the 
    Secretary at a later date given that scientific or other 
    information is not available, or agreement is otherwise not 
    feasible regarding such elements, at the time a request for such 
    meeting is made.
    ``(iii) Any agreement under this subparagraph shall be in writing 
and made part of the administrative record by the Secretary.
    ``(iv) Any such agreement shall remain in effect, except--
        ``(I) upon the written agreement of the Secretary and the 
    sponsor or applicant; or
        ``(II) pursuant to a decision by the director of the reviewing 
    division of the primary agency center, or a person more senior than 
    such director, in consultation with consulting centers and the 
    Office, as appropriate, that an issue essential to determining 
    whether the standard for market clearance or other applicable 
    standard under this Act or the Public Health Service Act applicable 
    to the combination product has been identified since the agreement 
    was reached, or that deviating from the agreement is otherwise 
    justifiable based on scientific evidence, for public health 
    reasons.
    ``(3) For purposes of conducting the premarket review of a 
combination product that contains an approved constituent part 
described in paragraph (4), the Secretary may require that the sponsor 
of such combination product submit to the Secretary only data or 
information that the Secretary determines is necessary to meet the 
standard for clearance or approval, as applicable, under this Act or 
the Public Health Service Act, including any incremental risks and 
benefits posed by such combination product, using a risk-based approach 
and taking into account any prior finding of safety and effectiveness 
or substantial equivalence for the approved constituent part relied 
upon by the applicant in accordance with paragraph (5).
    ``(4) For purposes of paragraph (3), an approved constituent part 
is--
        ``(A) a drug constituent part of a combination product being 
    reviewed in a single application or request under section 515, 
    510(k), or 513(f)(2) (submitted in accordance with paragraph (5)), 
    that is an approved drug, provided such application or request 
    complies with paragraph (5);
        ``(B) a device constituent part approved under section 515 that 
    is referenced by the sponsor and that is available for use by the 
    Secretary under section 520(h)(4); or
        ``(C) any constituent part that was previously approved, 
    cleared, or classified under section 505, 510(k), 513(f)(2), or 515 
    of this Act for which the sponsor has a right of reference or any 
    constituent part that is a nonprescription drug, as defined in 
    section 760(a)(2).
    ``(5)(A) If an application is submitted under section 515 or 510(k) 
or a request is submitted under section 513(f)(2), consistent with any 
determination made under paragraph (1)(D), for a combination product 
containing as a constituent part an approved drug--
        ``(i) the application or request shall include the 
    certification or statement described in section 505(b)(2); and
        ``(ii) the applicant or requester shall provide notice as 
    described in section 505(b)(3).
    ``(B) For purposes of this paragraph and paragraph (4), the term 
`approved drug' means an active ingredient--
        ``(i) that was in an application previously approved under 
    section 505(c);
        ``(ii) where such application is relied upon by the applicant 
    submitting the application or request described in subparagraph 
    (A);
        ``(iii) for which full reports of investigations that have been 
    made to show whether such drug is safe for use and whether such 
    drug is effective in use were not conducted by or for the applicant 
    submitting the application or request described in subparagraph 
    (A); and
        ``(iv) for which the applicant submitting the application or 
    request described in subparagraph (A) has not obtained a right of 
    reference or use from the person by or for whom the investigations 
    described in clause (iii) were conducted.
    ``(C) The following provisions shall apply with respect to an 
application or request described in subparagraph (A) to the same extent 
and in the same manner as if such application or request were an 
application described in section 505(b)(2) that referenced the approved 
drug:
        ``(i) Subparagraphs (A), (B), (C), and (D) of section 
    505(c)(3).
        ``(ii) Clauses (ii), (iii), and (iv) of section 505(c)(3)(E).
        ``(iii) Subsections (b) and (c) of section 505A.
        ``(iv) Section 505E(a).
        ``(v) Section 527(a).
    ``(D) Notwithstanding any other provision of this subsection, an 
application or request for classification for a combination product 
described in subparagraph (A) shall be considered an application 
submitted under section 505(b)(2) for purposes of section 271(e)(2)(A) 
of title 35, United States Code.
    ``(6) Nothing in this subsection shall be construed as prohibiting 
a sponsor from submitting separate applications for the constituent 
parts of a combination product, unless the Secretary determines that a 
single application is necessary.'';
        (5) in paragraph (8) (as redesignated by paragraph (3))--
            (A) in subparagraph (C)--
                (i) by amending clause (i) to read as follows:
    ``(i) In carrying out this subsection, the Office shall help to 
ensure timely and effective premarket review that involves more than 
one agency center by coordinating such reviews, overseeing the 
timeliness of such reviews, and overseeing the alignment of feedback 
regarding such reviews.'';
                (ii) in clause (ii), by inserting ``and alignment'' 
            after ``the timeliness'' each place it appears; and
                (iii) by adding at the end the following new clauses:
    ``(iii) The Office shall ensure that, with respect to a combination 
product, a designated person or persons in the primary agency center is 
the primary point or points of contact for the sponsor of such 
combination product. The Office shall also coordinate communications to 
and from any consulting center involved in such premarket review, if 
requested by such primary agency center or any such consulting center. 
Agency communications and commitments, to the extent consistent with 
other provisions of law and the requirements of all affected agency 
centers, from the primary agency center shall be considered as 
communication from the Secretary on behalf of all agency centers 
involved in the review.
    ``(iv) The Office shall, with respect to the premarket review of a 
combination product--
        ``(I) ensure that any meeting between the Secretary and the 
    sponsor of such product is attended by each agency center involved 
    in the review, as appropriate;
        ``(II) ensure that each consulting agency center has completed 
    its premarket review and provided the results of such review to the 
    primary agency center in a timely manner; and
        ``(III) ensure that each consulting center follows the guidance 
    described in clause (vi) and advises, as appropriate, on other 
    relevant regulations, guidances, and policies.
    ``(v) In seeking agency action with respect to a combination 
product, the sponsor of such product--
        ``(I) shall identify the product as a combination product; and
        ``(II) may request in writing the participation of 
    representatives of the Office in meetings related to such 
    combination product, or to have the Office otherwise engage on such 
    regulatory matters concerning the combination product.
    ``(vi) Not later than 4 years after the date of enactment of the 
21st Century Cures Act, and after a public comment period of not less 
than 60 calendar days, the Secretary shall issue a final guidance that 
describes--
        ``(I) the structured process for managing pre-submission 
    interactions with sponsors developing combination products;
        ``(II) the best practices for ensuring that the feedback in 
    such pre-submission interactions represents the Agency's best 
    advice based on the information provided during such pre-submission 
    interactions;
        ``(III) the information that is required to be submitted with a 
    meeting request under paragraph (2), how such meetings relate to 
    other types of meetings in the Food and Drug Administration, and 
    the form and content of any agreement reached through a meeting 
    under such paragraph (2);''; and
            (B) in subparagraph (G)--
                (i) in the matter preceding clause (i), by inserting 
            ``(except with respect to clause (iv), beginning not later 
            than one year after the date of the enactment of the 21st 
            Century Cures Act)'' after ``enactment of this paragraph'';
                (ii) in clause (ii), by striking ``and'' at the end;
                (iii) in clause (iii), by striking the period at the 
            end and inserting ``; and''; and
                (iv) by adding at the end the following new clause:
        ``(iv) identifying the percentage of combination products for 
    which a dispute resolution, with respect to premarket review, was 
    requested by the combination product's sponsor.''; and
        (6) in paragraph (9) (as redesignated by paragraph (3))--
            (A) in subparagraph (C)--
                (i) in clause (i), by striking the comma at the end and 
            inserting a semicolon;
                (ii) in clause (ii), by striking ``, and'' at the end 
            and inserting a semicolon;
                (iii) in clause (iii), by striking the period at the 
            end and inserting ``; and''; and
                (iv) by adding at the end the following:
                ``(iv) de novo classification under section 
            513(a)(1).''; and
            (B) by adding at the end the following:
        ``(D) The terms `premarket review' and `reviews' include all 
    activities of the Food and Drug Administration conducted prior to 
    approval or clearance of an application, notification, or request 
    for classification submitted under section 505, 510(k), 513(f)(2), 
    515, or 520 of this Act or under section 351 of the Public Health 
    Service Act, including with respect to investigational use of the 
    product.''.
    (b) Information for Approval of Combination Products.--Section 
520(h)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(h)(4)) is amended--
        (1) in subparagraph (A), by striking ``Any information'' and 
    inserting ``Subject to subparagraph (C), any information''; and
        (2) by adding at the end the following new subparagraph:
    ``(C) No information contained in an application for premarket 
approval filed with the Secretary pursuant to section 515(c) may be 
used to approve or clear any application submitted under section 515 or 
510(k) or to classify a product under section 513(f)(2) for a 
combination product containing as a constituent part an approved drug 
(as defined in section 503(g)(5)(B)) unless--
        ``(i) the application includes the certification or statement 
    referenced in section 503(g)(5)(A);
        ``(ii) the applicant provides notice as described in section 
    503(g)(5)(A); and
        ``(iii) the Secretary's approval of such application is subject 
    to the provisions in section 503(g)(5)(C).''.
    (c) Variations From CGMP Streamlined Approach.--Not later than 18 
months after the date of enactment of this Act, the Secretary of Health 
and Human Services (referred to in this subsection as the 
``Secretary'') shall identify types of combination products and 
manufacturing processes with respect to which the Secretary proposes 
that good manufacturing processes may be adopted that vary from the 
requirements set forth in section 4.4 of title 21, Code of Federal 
Regulations (or any successor regulations) or that the Secretary 
proposes can satisfy the requirements in section 4.4 through 
alternative or streamlined mechanisms. The Secretary shall identify 
such types, variations from such requirements, and such mechanisms, in 
a proposed list published in the Federal Register. After a public 
comment period regarding the appropriate good manufacturing practices 
for such types, the Secretary shall publish a final list in the Federal 
Register, notwithstanding section 553 of title 5, United States Code. 
The Secretary shall evaluate such types, variations, and mechanisms 
using a risk-based approach. The Secretary shall periodically review 
such final list.

          Subtitle E--Antimicrobial Innovation and Stewardship

SEC. 3041. ANTIMICROBIAL RESISTANCE MONITORING.
    (a) In General.--Section 319E of the Public Health Service Act (42 
U.S.C. 247d-5) is amended--
        (1) by redesignating subsections (f) and (g) as subsections (l) 
    and (m), respectively; and
        (2) by inserting after subsection (e), the following:
    ``(f) Monitoring at Federal Health Care Facilities.--The Secretary 
shall encourage reporting on aggregate antimicrobial drug use and 
antimicrobial resistance to antimicrobial drugs and the implementation 
of antimicrobial stewardship programs by health care facilities of the 
Department of Defense, the Department of Veterans Affairs, and the 
Indian Health Service and shall provide technical assistance to the 
Secretary of Defense and the Secretary of Veterans Affairs, as 
appropriate and upon request.
    ``(g) Report on Antimicrobial Resistance in Humans and Use of 
Antimicrobial Drugs.--Not later than 1 year after the date of enactment 
of the 21st Century Cures Act, and annually thereafter, the Secretary 
shall prepare and make publicly available data and information 
concerning--
        ``(1) aggregate national and regional trends of antimicrobial 
    resistance in humans to antimicrobial drugs, including such drugs 
    approved under section 506(h) of the Federal Food, Drug, and 
    Cosmetic Act;
        ``(2) antimicrobial stewardship, which may include summaries of 
    State efforts to address antimicrobial resistance in humans to 
    antimicrobial drugs and antimicrobial stewardship; and
        ``(3) coordination between the Director of the Centers for 
    Disease Control and Prevention and the Commissioner of Food and 
    Drugs with respect to the monitoring of--
            ``(A) any applicable resistance under paragraph (1); and
            ``(B) drugs approved under section 506(h) of the Federal 
        Food, Drug, and Cosmetic Act.
    ``(h) Information Related to Antimicrobial Stewardship Programs.--
The Secretary shall, as appropriate, disseminate guidance, educational 
materials, or other appropriate materials related to the development 
and implementation of evidence-based antimicrobial stewardship programs 
or practices at health care facilities, such as nursing homes and other 
long-term care facilities, ambulatory surgical centers, dialysis 
centers, outpatient clinics, and hospitals, including community and 
rural hospitals.
    ``(i) Supporting State-Based Activities To Combat Antimicrobial 
Resistance.--The Secretary shall continue to work with State and local 
public health departments on statewide or regional programs related to 
antimicrobial resistance. Such efforts may include activities to 
related to--
        ``(1) identifying patterns of bacterial and fungal resistance 
    in humans to antimicrobial drugs;
        ``(2) preventing the spread of bacterial and fungal infections 
    that are resistant to antimicrobial drugs; and
        ``(3) promoting antimicrobial stewardship.
    ``(j) Antimicrobial Resistance and Stewardship Activities.--
        ``(1) In general.--For the purposes of supporting stewardship 
    activities, examining changes in antimicrobial resistance, and 
    evaluating the effectiveness of section 506(h) of the Federal Food, 
    Drug, and Cosmetic Act, the Secretary shall--
            ``(A) provide a mechanism for facilities to report data 
        related to their antimicrobial stewardship activities 
        (including analyzing the outcomes of such activities); and
            ``(B) evaluate--
                ``(i) antimicrobial resistance data using a 
            standardized approach; and
                ``(ii) trends in the utilization of drugs approved 
            under such section 506(h) with respect to patient 
            populations.
        ``(2) Use of systems.--The Secretary shall use available 
    systems, including the National Healthcare Safety Network or other 
    systems identified by the Secretary, to fulfill the requirements or 
    conduct activities under this section.
    ``(k) Antimicrobial.--For purposes of subsections (f) through (j), 
the term `antimicrobial' includes any antibacterial or antifungal 
drugs, and may include drugs that eliminate or inhibit the growth of 
other microorganisms, as appropriate.''.
    (b) Availability of Data.--The Secretary shall make the data 
collected pursuant to this subsection public. Nothing in this 
subsection shall be construed as authorizing the Secretary to disclose 
any information that is a trade secret or confidential information 
subject to section 552(b)(4) of title 5, United States Code, or section 
1905 of title 18, United States Code.
SEC. 3042. LIMITED POPULATION PATHWAY.
    Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356), as amended by section 3033, is further amended by adding at the 
end the following:
    ``(h) Limited Population Pathway for Antibacterial and Antifungal 
Drugs.--
        ``(1) In general.--The Secretary may approve an antibacterial 
    or antifungal drug, alone or in combination with one or more other 
    drugs, as a limited population drug pursuant to this subsection 
    only if--
            ``(A) the drug is intended to treat a serious or life-
        threatening infection in a limited population of patients with 
        unmet needs;
            ``(B) the standards for approval under section 505(c) and 
        (d), or the standards for licensure under section 351 of the 
        Public Health Service Act, as applicable, are met; and
            ``(C) the Secretary receives a written request from the 
        sponsor to approve the drug as a limited population drug 
        pursuant to this subsection.
        ``(2) Benefit-risk consideration.--The Secretary's 
    determination of safety and effectiveness of an antibacterial or 
    antifungal drug shall reflect the benefit-risk profile of such drug 
    in the intended limited population, taking into account the 
    severity, rarity, or prevalence of the infection the drug is 
    intended to treat and the availability or lack of alternative 
    treatment in such limited population. Such drug may be approved 
    under this subsection notwithstanding a lack of evidence to fully 
    establish a favorable benefit-risk profile in a population that is 
    broader than the intended limited population.
        ``(3) Additional requirements.--A drug approved under this 
    subsection shall be subject to the following requirements, in 
    addition to any other applicable requirements of this Act:
            ``(A) Labeling.--To indicate that the safety and 
        effectiveness of a drug approved under this subsection has been 
        demonstrated only with respect to a limited population--
                ``(i) all labeling and advertising of an antibacterial 
            or antifungal drug approved under this subsection shall 
            contain the statement `Limited Population' in a prominent 
            manner and adjacent to, and not more prominent than--

                    ``(I) the proprietary name of such drug, if any; or
                    ``(II) if there is no proprietary name, the 
                established name of the drug, if any, as defined in 
                section 503(e)(3), or, in the case of a drug that is a 
                biological product, the proper name, as defined by 
                regulation; and

                ``(ii) the prescribing information for the drug 
            required by section 201.57 of title 21, Code of Federal 
            Regulations (or any successor regulation) shall also 
            include the following statement: `This drug is indicated 
            for use in a limited and specific population of patients.'.
            ``(B) Promotional material.--The sponsor of an 
        antibacterial or antifungal drug subject to this subsection 
        shall submit to the Secretary copies of all promotional 
        materials related to such drug at least 30 calendar days prior 
        to dissemination of the materials.
        ``(4) Other programs.--A sponsor of a drug that seeks approval 
    of a drug under this subsection may also seek designation or 
    approval, as applicable, of such drug under other applicable 
    sections or subsections of this Act or the Public Health Service 
    Act.
        ``(5) Guidance.--Not later than 18 months after the date of 
    enactment of the 21st Century Cures Act, the Secretary shall issue 
    draft guidance describing criteria, processes, and other general 
    considerations for demonstrating the safety and effectiveness of 
    limited population antibacterial and antifungal drugs. The 
    Secretary shall publish final guidance within 18 months of the 
    close of the public comment period on such draft guidance. The 
    Secretary may approve antibacterial and antifungal drugs under this 
    subsection prior to issuing guidance under this paragraph.
        ``(6) Advice.--The Secretary shall provide prompt advice to the 
    sponsor of a drug for which the sponsor seeks approval under this 
    subsection to enable the sponsor to plan a development program to 
    obtain the necessary data for such approval, and to conduct any 
    additional studies that would be required to gain approval of such 
    drug for use in a broader population.
        ``(7) Termination of limitations.--If, after approval of a drug 
    under this subsection, the Secretary approves a broader indication 
    for such drug under section 505(b) or section 351(a) of the Public 
    Health Service Act, the Secretary may remove any postmarketing 
    conditions, including requirements with respect to labeling and 
    review of promotional materials under paragraph (3), applicable to 
    the approval of the drug under this subsection.
        ``(8) Rules of construction.--Nothing in this subsection shall 
    be construed to alter the authority of the Secretary to approve 
    drugs pursuant to this Act or section 351 of the Public Health 
    Service Act, including the standards of evidence and applicable 
    conditions for approval under such Acts, the standards of approval 
    of a drug under such Acts, or to alter the authority of the 
    Secretary to monitor drugs pursuant to such Acts.
        ``(9) Reporting and accountability.--
            ``(A) Biennial reporting.--The Secretary shall report to 
        Congress not less often than once every 2 years on the number 
        of requests for approval, and the number of approvals, of an 
        antibacterial or antifungal drug under this subsection.
            ``(B) GAO report.--Not later than December 2021, the 
        Comptroller General of the United States shall submit to the 
        Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor 
        and Pensions of the Senate a report on the coordination of 
        activities required under section 319E of the Public Health 
        Service Act. Such report shall include a review of such 
        activities, and the extent to which the use of the pathway 
        established under this subsection has streamlined premarket 
        approval for antibacterial or antifungal drugs for limited 
        populations, if such pathway has functioned as intended, if 
        such pathway has helped provide for safe and effective 
        treatment for patients, if such premarket approval would be 
        appropriate for other categories of drugs, and if the 
        authorities under this subsection have affected antibacterial 
        or antifungal resistance.''.
SEC. 3043. PRESCRIBING AUTHORITY.
    Nothing in this subtitle, or an amendment made by this subtitle, 
shall be construed to restrict the prescribing of antimicrobial drugs 
or other products, including drugs approved under subsection (h) of 
section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) 
(as added by section 3042), by health care professionals, or to limit 
the practice of health care.
SEC. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR 
MICROORGANISMS; ANTIMICROBIAL SUSCEPTIBILITY TESTING DEVICES.
    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
after section 511 the following:
``SEC. 511A. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR 
MICROORGANISMS.
    ``(a) Purpose; Identification of Criteria.--
        ``(1) Purpose.--The purpose of this section is to clarify the 
    Secretary's authority to--
            ``(A) efficiently update susceptibility test interpretive 
        criteria for antimicrobial drugs when necessary for public 
        health, due to, among other things, the constant evolution of 
        microorganisms that leads to the development of resistance to 
        drugs that have been effective in decreasing morbidity and 
        mortality for patients, which warrants unique management of 
        antimicrobial drugs that is inappropriate for most other drugs 
        in order to delay or prevent the development of further 
        resistance to existing therapies;
            ``(B) provide for public notice of the availability of 
        recognized interpretive criteria and interpretive criteria 
        standards; and
            ``(C) clear under section 510(k), classify under section 
        513(f)(2), or approve under section 515, antimicrobial 
        susceptibility testing devices utilizing updated, recognized 
        susceptibility test interpretive criteria to characterize the 
        in vitro susceptibility of particular bacteria, fungi, or other 
        microorganisms, as applicable, to antimicrobial drugs.
        ``(2) Identification of criteria.--The Secretary shall identify 
    appropriate susceptibility test interpretive criteria with respect 
    to antimicrobial drugs--
            ``(A) if such criteria are available on the date of 
        approval of the drug under section 505 of this Act or licensure 
        of the drug under section 351 of the Public Health Service Act 
        (as applicable), upon such approval or licensure; or
            ``(B) if such criteria are unavailable on such date, on the 
        date on which such criteria are available for such drug.
        ``(3) Bases for initial identification.--The Secretary shall 
    identify appropriate susceptibility test interpretive criteria 
    under paragraph (2), based on the Secretary's review of, to the 
    extent available and relevant--
            ``(A) preclinical and clinical data, including 
        pharmacokinetic, pharmacodynamic, and epidemiological data;
            ``(B) the relationship of susceptibility test interpretive 
        criteria to morbidity and mortality associated with the disease 
        or condition for which such drug is used; and
            ``(C) such other evidence and information as the Secretary 
        considers appropriate.
    ``(b) Susceptibility Test Interpretive Criteria Website.--
        ``(1) In general.--Not later than 1 year after the date of the 
    enactment of the 21st Century Cures Act, the Secretary shall 
    establish, and maintain thereafter, on the website of the Food and 
    Drug Administration, a dedicated website that contains a list of 
    any appropriate new or updated susceptibility test interpretive 
    criteria standards and interpretive criteria in accordance with 
    paragraph (2) (referred to in this section as the `Interpretive 
    Criteria Website').
        ``(2) Listing of susceptibility test interpretive criteria 
    standards and interpretive criteria.--
            ``(A) In general.--The list described in paragraph (1) 
        shall consist of any new or updated susceptibility test 
        interpretive criteria standards that are--
                ``(i) established by a nationally or internationally 
            recognized standard development organization that--

                    ``(I) establishes and maintains procedures to 
                address potential conflicts of interest and ensure 
                transparent decisionmaking;
                    ``(II) holds open meetings to ensure that there is 
                an opportunity for public input by interested parties, 
                and establishes and maintains processes to ensure that 
                such input is considered in decisionmaking; and
                    ``(III) permits its standards to be made publicly 
                available, through the National Library of Medicine or 
                another similar source acceptable to the Secretary; and

                ``(ii) recognized in whole, or in part, by the 
            Secretary under subsection (c).
            ``(B) Other list.--The Interpretive Criteria Website shall, 
        in addition to the list described in subparagraph (A), include 
        a list of interpretive criteria, if any, that the Secretary has 
        determined to be appropriate with respect to legally marketed 
        antimicrobial drugs, where--
                ``(i) the Secretary does not recognize, in whole or in 
            part, an interpretive criteria standard described under 
            subparagraph (A) otherwise applicable to such a drug;
                ``(ii) the Secretary withdraws under subsection 
            (c)(1)(A) recognition of a standard, in whole or in part, 
            otherwise applicable to such a drug;
                ``(iii) the Secretary approves an application under 
            section 505 of this Act or section 351 of the Public Health 
            Service Act, as applicable, with respect to marketing of 
            such a drug for which there are no relevant interpretive 
            criteria included in a standard recognized by the Secretary 
            under subsection (c); or
                ``(iv) because the characteristics of such a drug 
            differ from other drugs with the same active ingredient, 
            the interpretive criteria with respect to such drug--

                    ``(I) differ from otherwise applicable interpretive 
                criteria included in a standard listed under 
                subparagraph (A) or interpretive criteria otherwise 
                listed under this subparagraph; and
                    ``(II) are determined by the Secretary to be 
                appropriate for the drug.

            ``(C) Required statements.--The Interpretive Criteria 
        Website shall include statements conveying--
                ``(i) that the website provides information about the 
            in vitro susceptibility of bacteria, fungi, or other 
            microorganisms, as applicable to a certain drug (or drugs);
                ``(ii) that--

                    ``(I) the safety and efficacy of such drugs in 
                treating clinical infections due to such bacteria, 
                fungi, or other microorganisms, as applicable, may or 
                may not have been established in adequate and well-
                controlled clinical trials in order for the 
                susceptibility information described in clause (i) to 
                be included on the website; and
                    ``(II) the clinical significance of such 
                susceptibility information in such instances is 
                unknown;

                ``(iii) that the approved product labeling for specific 
            drugs provides the uses for which the Secretary has 
            approved the product; and
                ``(iv) any other information that the Secretary 
            determines appropriate to adequately convey the meaning of 
            the data supporting the recognition or listing of 
            susceptibility test interpretive criteria standards or 
            susceptibility test interpretive criteria included on the 
            website.
        ``(3) Notice.--Not later than the date on which the 
    Interpretive Criteria Website is established, the Secretary shall 
    publish a notice of that establishment in the Federal Register.
        ``(4) Inapplicability of misbranding provision.--The inclusion 
    in the approved labeling of an antimicrobial drug of a reference or 
    hyperlink to the Interpretive Criteria Website, in and of itself, 
    shall not cause the drug to be misbranded in violation of section 
    502.
        ``(5) Trade secrets and confidential information.--Nothing in 
    this section shall be construed as authorizing the Secretary to 
    disclose any information that is a trade secret or confidential 
    information subject to section 552(b)(4) of title 5, United States 
    Code.
    ``(c) Recognition of Susceptibility Test Interpretive Criteria.--
        ``(1) Evaluation and publication.--
            ``(A) In general.--Beginning on the date of the 
        establishment of the Interpretive Criteria Website, and at 
        least every 6 months thereafter, the Secretary shall--
                ``(i) evaluate any appropriate new or updated 
            susceptibility test interpretive criteria standards 
            established by a nationally or internationally recognized 
            standard development organization described in subsection 
            (b)(2)(A)(i); and
                ``(ii) publish on the public website of the Food and 
            Drug Administration a notice--

                    ``(I) withdrawing recognition of any different 
                susceptibility test interpretive criteria standard, in 
                whole or in part;
                    ``(II) recognizing the new or updated standards;
                    ``(III) recognizing one or more parts of the new or 
                updated interpretive criteria specified in such a 
                standard and declining to recognize the remainder of 
                such standard; and
                    ``(IV) making any necessary updates to the lists 
                under subsection (b)(2).

            ``(B) Upon approval of a drug.--Upon the approval of an 
        initial or supplemental application for an antimicrobial drug 
        under section 505 of this Act or section 351 of the Public 
        Health Service Act, as applicable, where such approval is based 
        on susceptibility test interpretive criteria which differ from 
        those contained in a standard recognized, or from those 
        otherwise listed, by the Secretary pursuant to this subsection, 
        or for which there are no relevant interpretive criteria 
        standards recognized, or interpretive criteria otherwise 
        listed, by the Secretary pursuant to this subsection, the 
        Secretary shall update the lists under subparagraphs (A) and 
        (B) of subsection (b)(2) to include the susceptibility test 
        interpretive criteria upon which such approval was based.
        ``(2) Bases for updating interpretive criteria standards.--In 
    evaluating new or updated susceptibility test interpretive criteria 
    standards under paragraph (1)(A), the Secretary may consider--
            ``(A) the Secretary's determination that such a standard is 
        not applicable to a particular drug because the characteristics 
        of the drug differ from other drugs with the same active 
        ingredient;
            ``(B) information provided by interested third parties, 
        including public comment on the annual compilation of notices 
        published under paragraph (3);
            ``(C) any bases used to identify susceptibility test 
        interpretive criteria under subsection (a)(2); and
            ``(D) such other information or factors as the Secretary 
        determines appropriate.
        ``(3) Annual compilation of notices.--Each year, the Secretary 
    shall compile the notices published under paragraph (1)(A) and 
    publish such compilation in the Federal Register and provide for 
    public comment. If the Secretary receives comments, the Secretary 
    shall review such comments and, if the Secretary determines 
    appropriate, update pursuant to this subsection susceptibility test 
    interpretive criteria standards or criteria--
            ``(A) recognized by the Secretary under this subsection; or
            ``(B) otherwise listed on the Interpretive Criteria Website 
        under subsection (b)(2).
        ``(4) Relation to section 514(c).--Any susceptibility test 
    interpretive standard recognized under this subsection or any 
    criteria otherwise listed under subsection (b)(2)(B) shall be 
    deemed to be recognized as a standard by the Secretary under 
    section 514(c)(1).
        ``(5) Voluntary use of interpretive criteria.--Nothing in this 
    section prohibits a person from seeking approval or clearance of a 
    drug or device, or changes to the drug or the device, on the basis 
    of susceptibility test interpretive criteria which differ from 
    those contained in a standard recognized, or from those otherwise 
    listed, by the Secretary pursuant to subsection (b)(2).
    ``(d) Antimicrobial Drug Labeling.--
        ``(1) Drugs marketed prior to establishment of interpretive 
    criteria website.--
            ``(A) In general.--With respect to an antimicrobial drug 
        lawfully introduced or delivered for introduction into 
        interstate commerce for commercial distribution before the 
        establishment of the Interpretive Criteria Website, a holder of 
        an approved application under section 505 of this Act or 
        section 351 of the Public Health Service Act, as applicable, 
        for each such drug, not later than 1 year after establishment 
        of the Interpretive Criteria Website described in subsection 
        (b)(1), shall remove susceptibility test interpretive criteria, 
        if any, and related information from the approved drug labeling 
        and replace it with a reference to the Interpretive Criteria 
        Website.
            ``(B) Labeling changes.--The labeling changes required by 
        this section shall be considered a minor change under section 
        314.70 of title 21, Code of Federal Regulations (or any 
        successor regulations) that may be implemented through 
        documentation in the next applicable annual report.
        ``(2) Drugs marketed subsequent to establishment of 
    interpretive criteria website.--With respect to antimicrobial drugs 
    approved on or after the date of the establishment of the 
    Interpretive Criteria Website described in subsection (b)(1), the 
    labeling for such a drug shall include, in lieu of susceptibility 
    test interpretive criteria and related information, a reference to 
    such Website.
    ``(e) Special Condition for Marketing of Antimicrobial 
Susceptibility Testing Devices.--
        ``(1) In general.--Notwithstanding sections 501, 502, 505, 510, 
    513, and 515, if the conditions specified in paragraph (2) are met 
    (in addition to other applicable provisions under this chapter) 
    with respect to an antimicrobial susceptibility testing device 
    described in subsection (f)(1), the Secretary may authorize the 
    marketing of such device for a use described in such subsection.
        ``(2) Conditions applicable to antimicrobial susceptibility 
    testing devices.--The conditions specified in this paragraph are 
    the following:
            ``(A) The device is used to make a determination of 
        susceptibility using susceptibility test interpretive criteria 
        that are--
                ``(i) included in a standard recognized by the 
            Secretary under subsection (c); or
                ``(ii) otherwise listed on the Interpretive Criteria 
            Website under subsection (b)(2).
            ``(B) The labeling of such device includes statements 
        conveying--
                ``(i) that the device provides information about the in 
            vitro susceptibility of bacteria, fungi, or other 
            microorganisms, as applicable to antimicrobial drugs;
                ``(ii) that--

                    ``(I) the safety and efficacy of such drugs in 
                treating clinical infections due to such bacteria, 
                fungi, or other microorganisms, as applicable, may or 
                may not have been established in adequate and well-
                controlled clinical trials in order for the device to 
                report the susceptibility of such bacteria, fungi, or 
                other microorganisms, as applicable, to such drugs; and
                    ``(II) the clinical significance of such 
                susceptibility information in those instances is 
                unknown;

                ``(iii) that the approved labeling for drugs tested 
            using such a device provides the uses for which the 
            Secretary has approved such drugs; and
                ``(iv) any other information the Secretary determines 
            appropriate to adequately convey the meaning of the data 
            supporting the recognition or listing of susceptibility 
            test interpretive criteria standards or susceptibility test 
            interpretive criteria described in subparagraph (A).
            ``(C) The antimicrobial susceptibility testing device meets 
        all other requirements to be cleared under section 510(k), 
        classified under section 513(f)(2), or approved under section 
        515.
    ``(f) Definitions.--In this section:
        ``(1) The term `antimicrobial susceptibility testing device' 
    means a device that utilizes susceptibility test interpretive 
    criteria to determine and report the in vitro susceptibility of 
    certain microorganisms to a drug (or drugs).
        ``(2) The term `qualified infectious disease product' means a 
    qualified infectious disease product designated under section 
    505E(d).
        ``(3) The term `susceptibility test interpretive criteria' 
    means--
            ``(A) one or more specific numerical values which 
        characterize the susceptibility of bacteria or other 
        microorganisms to the drug tested; and
            ``(B) related categorizations of such susceptibility, 
        including categorization of the drug as susceptible, 
        intermediate, resistant, or such other term as the Secretary 
        determines appropriate.
        ``(4)(A) The term `antimicrobial drug' means, subject to 
    subparagraph (B), a systemic antibacterial or antifungal drug 
    that--
            ``(i) is intended for human use in the treatment of a 
        disease or condition caused by a bacterium or fungus;
            ``(ii) may include a qualified infectious disease product 
        designated under section 505E(d); and
            ``(iii) is subject to section 503(b)(1).
        ``(B) If provided by the Secretary through regulations, such 
    term may include--
            ``(i) drugs other than systemic antibacterial and 
        antifungal drugs; and
            ``(ii) biological products (as such term is defined in 
        section 351 of the Public Health Service Act) to the extent 
        such products exhibit antimicrobial activity. 
        ``(5) The term `interpretive criteria standard' means a 
    compilation of susceptibility test interpretive criteria developed 
    by a standard development organization that meets the criteria set 
    forth in subsection (b)(2)(A)(i).
    ``(g) Rule of Construction.--Nothing in this section shall be 
construed to--
        ``(1) alter the standards of evidence under subsection (c) or 
    (d) of section 505 (including the substantial evidence standard 
    under section 505(d)) or under section 351 of the Public Health 
    Service Act (as applicable); or
        ``(2) with respect to clearing devices under section 510(k), 
    classifying devices under section 513(f)(2), or approving devices 
    under section 515--
            ``(A) apply with respect to any drug, device, or biological 
        product, in any context other than an antimicrobial drug and an 
        antimicrobial susceptibility testing device that uses 
        susceptibility test interpretive criteria to characterize and 
        report the susceptibility of certain bacteria, fungi, or other 
        microorganisms, as applicable, to such drug to reflect patient 
        morbidity and mortality in accordance with this section; or
            ``(B) unless specifically stated, have any effect on 
        authorities provided under other sections of this Act, 
        including any regulations issued under such sections.''.
    (b) Conforming Amendments.--
        (1) Repeal of prior related authority.--Section 1111 of the 
    Food and Drug Administration Amendments Act of 2007 (42 U.S.C. 
    247d-5a), relating to identification of clinically susceptible 
    concentrations of antimicrobials, is repealed.
        (2) Addition to categories of misbranded drugs.--Section 502 of 
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended 
    by adding at the end the following:
    ``(dd) If it is an antimicrobial drug, as defined in section 
511A(f), and its labeling fails to conform with the requirements under 
section 511A(d).''.
        (3) Recognition of interpretive criteria standard as device 
    standard.--Section 514(c)(1)(A) of the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by inserting 
    after ``the Secretary shall, by publication in the Federal 
    Register'' the following: ``(or, with respect to a susceptibility 
    test interpretive criteria standard under section 511A, by posting 
    on the Interpretive Criteria Website in accordance with such 
    section)''.
    (c) Report to Congress.--Not later than 2 years after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
submit to the Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce of the House of 
Representatives a report on the progress made in implementing section 
511A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as 
added by subsection (a).
    (d) Requests for Updates to Interpretive Criteria Website.--Chapter 
35 of title 44, United States Code, shall not apply to the collection 
of information from interested parties regarding updating the lists 
established under section 511A(b) of the Federal Food, Drug, and 
Cosmetic Act and posted on the Interpretive Criteria Website 
established under section 511A(c) of such Act.

                 Subtitle F--Medical Device Innovations

SEC. 3051. BREAKTHROUGH DEVICES.
    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 515B, 
as added by section 3034(b), the following:
``SEC. 515C. BREAKTHROUGH DEVICES.
    ``(a) Purpose.--The purpose of this section is to encourage the 
Secretary, and provide the Secretary with sufficient authority, to 
apply efficient and flexible approaches to expedite the development of, 
and prioritize the Food and Drug Administration's review of, devices 
that represent breakthrough technologies.
    ``(b) Establishment of Program.--The Secretary shall establish a 
program to expedite the development of, and provide for the priority 
review for, devices, as determined by the Secretary--
        ``(1) that provide for more effective treatment or diagnosis of 
    life-threatening or irreversibly debilitating human disease or 
    conditions; and
        ``(2)(A) that represent breakthrough technologies;
        ``(B) for which no approved or cleared alternatives exist;
        ``(C) that offer significant advantages over existing approved 
    or cleared alternatives, including the potential, compared to 
    existing approved alternatives, to reduce or eliminate the need for 
    hospitalization, improve patient quality of life, facilitate 
    patients' ability to manage their own care (such as through self-
    directed personal assistance), or establish long-term clinical 
    efficiencies; or
        ``(D) the availability of which is in the best interest of 
    patients.
    ``(c) Request for Designation.--A sponsor of a device may request 
that the Secretary designate such device for expedited development and 
priority review under this section. Any such request for designation 
may be made at any time prior to the submission of an application under 
section 515(c), a notification under section 510(k), or a petition for 
classification under section 513(f)(2).
    ``(d) Designation Process.--
        ``(1) In general.--Not later than 60 calendar days after the 
    receipt of a request under subsection (c), the Secretary shall 
    determine whether the device that is the subject of the request 
    meets the criteria described in subsection (b). If the Secretary 
    determines that the device meets the criteria, the Secretary shall 
    designate the device for expedited development and priority review.
        ``(2) Review.--Review of a request under subsection (c) shall 
    be undertaken by a team that is composed of experienced staff and 
    senior managers of the Food and Drug Administration.
        ``(3) Withdrawal.--The Secretary may not withdraw a designation 
    granted under this section on the basis of the criteria under 
    subsection (b) no longer applying because of the subsequent 
    clearance or approval of another device that--
            ``(A) was designated under this section; or
            ``(B) was given priority review under section 515(d)(5), as 
        in effect prior to the date of enactment of the 21st Century 
        Cures Act.
    ``(e) Expedited Development and Priority Review.--
        ``(1) Actions.--For purposes of expediting the development and 
    review of devices designated under subsection (d) the Secretary 
    shall--
            ``(A) assign a team of staff, including a team leader with 
        appropriate subject matter expertise and experience, for each 
        device for which a request is submitted under subsection (c);
            ``(B) provide for oversight of the team by senior agency 
        personnel to facilitate the efficient development of the device 
        and the efficient review of any submission described in 
        subsection (c) for the device;
            ``(C) adopt an efficient process for timely dispute 
        resolution;
            ``(D) provide for interactive and timely communication with 
        the sponsor of the device during the development program and 
        review process;
            ``(E) expedite the Secretary's review of manufacturing and 
        quality systems compliance, as applicable;
            ``(F) disclose to the sponsor, not less than 5 business 
        days in advance, the topics of any consultation the Secretary 
        intends to undertake with external experts or an advisory 
        committee concerning the sponsor's device and provide the 
        sponsor the opportunity to recommend such external experts;
            ``(G) provide for advisory committee input, as the 
        Secretary determines appropriate (including in response to the 
        request of the sponsor) for applications submitted under 
        section 515(c); and
            ``(H) assign staff to be available within a reasonable time 
        to address questions by institutional review committees 
        concerning the conditions and clinical testing requirements 
        applicable to the investigational use of the device pursuant to 
        an exemption under section 520(g).
        ``(2) Additional actions.--In addition to the actions described 
    in paragraph (1), for purposes of expediting the development and 
    review of devices designated under subsection (d), the Secretary, 
    in collaboration with the device sponsor, may, as appropriate--
            ``(A) coordinate with the sponsor regarding early agreement 
        on a data development plan;
            ``(B) take steps to ensure that the design of clinical 
        trials is as efficient and flexible as practicable, when 
        scientifically appropriate;
            ``(C) facilitate, when scientifically appropriate, 
        expedited and efficient development and review of the device 
        through utilization of timely postmarket data collection with 
        regard to application for approval under section 515(c); and
            ``(D) agree in writing to clinical protocols that the 
        Secretary will consider binding on the Secretary and the 
        sponsor, subject to--
                ``(i) changes to such protocols agreed to in writing by 
            the sponsor and the Secretary; or
                ``(ii) a decision, made by the director of the office 
            responsible for reviewing the device submission, that a 
            substantial scientific issue essential to determining the 
            safety or effectiveness of such device exists, provided 
            that such decision is in writing, and is made only after 
            the Secretary provides to the device sponsor or applicant 
            an opportunity for a meeting at which the director and the 
            sponsor or applicant are present and at which the director 
            documents the substantial scientific issue.
    ``(f) Priority Review Guidance.--
        ``(1) Content.--Not later than 1 year after the date of 
    enactment of the 21st Century Cures Act, the Secretary shall issue 
    guidance on the implementation of this section. Such guidance 
    shall--
            ``(A) set forth the process by which a person may seek a 
        designation under subsection (d);
            ``(B) provide a template for requests under subsection (c);
            ``(C) identify the criteria the Secretary will use in 
        evaluating a request for designation under this section; and
            ``(D) identify the criteria and processes the Secretary 
        will use to assign a team of staff, including team leaders, to 
        review devices designated for expedited development and 
        priority review, including any training required for such 
        personnel to ensure effective and efficient review.
        ``(2) Process.--Prior to finalizing the guidance under 
    paragraph (1), the Secretary shall seek public comment on a 
    proposed guidance.
    ``(g) Rule of Construction.--Nothing in this section shall be 
construed to affect--
        ``(1) the criteria and standards for evaluating an application 
    pursuant to section 515(c), a report and request for classification 
    under section 513(f)(2), or a report under section 510(k), 
    including the recognition of valid scientific evidence as described 
    in section 513(a)(3)(B) and consideration and application of the 
    least burdensome means of evaluating device effectiveness or 
    demonstrating substantial equivalence between devices with 
    differing technological characteristics, as applicable;
        ``(2) the authority of the Secretary with respect to clinical 
    holds under section 520(g)(8)(A);
        ``(3) the authority of the Secretary to act on an application 
    pursuant to section 515(d) before completion of an establishment 
    inspection, as the Secretary determines appropriate; or
        ``(4) the authority of the Secretary with respect to postmarket 
    surveillance under sections 519(h) and 522.''.
    (b) Documentation and Review of Significant Decisions.--Section 
517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g-
1(a)(1)) is amended by inserting ``a request for designation under 
section 515C,'' after ``application under section 515,''.
    (c) Termination of Previous Program.--
        (1) In general.--Section 515(d) of the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 360e(d)) is amended--
            (A) by striking paragraph (5); and
            (B) by redesignating paragraph (6) as paragraph (5).
        (2) Conforming amendment.--Section 737(5) of the Federal Food, 
    Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is amended by striking 
    ``515(d)(6)'' and inserting ``515(d)(5)''.
    (d) Report.--On January 1, 2019, the Secretary of Health and Human 
Services shall issue a report to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives--
        (1) on the program under section 515C of the Federal Food, 
    Drug, and Cosmetic Act, as added by subsection (a), in bringing 
    safe and effective devices included in such program to patients as 
    soon as possible; and
        (2) that includes recommendations, if any, to strengthen the 
    program to better meet patient device needs in a manner as timely 
    as possible.
SEC. 3052. HUMANITARIAN DEVICE EXEMPTION.
    (a) In General.--Section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j) is amended--
        (1) in paragraph (1) by striking ``fewer than 4,000'' and 
    inserting ``not more than 8,000'';
        (2) in paragraph (2)(A) by striking ``fewer than 4,000'' and 
    inserting ``not more than 8,000''; and
        (3) in paragraph (6)(A)(ii), by striking ``4,000'' and 
    inserting ``8,000''.
    (b) Guidance Document on Probable Benefit.--Not later than 18 
months after the date of enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commissioner of Food and Drugs, 
shall publish a draft guidance that defines the criteria for 
establishing ``probable benefit'' as that term is used in section 
520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)(2)(C)).
SEC. 3053. RECOGNITION OF STANDARDS.
    (a) In General.--Section 514(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360d(c)) is amended--
        (1) in paragraph (1), by inserting after subparagraph (B) the 
    following new subparagraphs:
    ``(C)(i) Any person may submit a request for recognition under 
subparagraph (A) of all or part of an appropriate standard established 
by a nationally or internationally recognized standard organization.
    ``(ii) Not later than 60 calendar days after the Secretary receives 
such a request, the Secretary shall--
        ``(I) make a determination to recognize all, part, or none of 
    the standard that is the subject of the request; and
        ``(II) issue to the person who submitted such request a 
    response in writing that states the Secretary's rationale for that 
    determination, including the scientific, technical, regulatory, or 
    other basis for such determination.
    ``(iii) The Secretary shall make a response issued under clause 
(ii)(II) publicly available, in such a manner as the Secretary 
determines appropriate.
    ``(iv) The Secretary shall take such actions as may be necessary to 
implement all or part of a standard recognized under clause (ii)(I), in 
accordance with subparagraph (A).
    ``(D) The Secretary shall make publicly available, in such manner 
as the Secretary determines appropriate, the rationale for recognition 
under subparagraph (A) of all, part, or none of a standard, including 
the scientific, technical, regulatory, or other basis for the decision 
regarding such recognition.''; and
        (2) by adding at the end the following:
    ``(4) The Secretary shall provide to all employees of the Food and 
Drug Administration who review premarket submissions for devices 
periodic training on the concept and use of recognized standards for 
purposes of meeting a premarket submission requirement or other 
applicable requirement under this Act, including standards relevant to 
an employee's area of device review.''.
    (b) Guidance.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall review and update, if 
necessary, previously published guidance and standard operating 
procedures identifying the principles for recognizing standards, and 
for withdrawing the recognition of standards, under section 514(c) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking 
into account the experience with and reliance on a standard by foreign 
regulatory authorities and the device industry, and whether recognition 
of a standard will promote harmonization among regulatory authorities 
in the regulation of devices.
SEC. 3054. CERTAIN CLASS I AND CLASS II DEVICES.
    (a) Class I Devices.--Section 510(l) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(l)) is amended--
        (1) by striking ``A report under subsection (k)'' and inserting 
    ``(1) A report under subsection (k)''; and
        (2) by adding at the end the following new paragraph:
    ``(2) Not later than 120 calendar days after the date of enactment 
of the 21st Century Cures Act and at least once every 5 years 
thereafter, as the Secretary determines appropriate, the Secretary 
shall identify, through publication in the Federal Register, any type 
of class I device that the Secretary determines no longer requires a 
report under subsection (k) to provide reasonable assurance of safety 
and effectiveness. Upon such publication--
        ``(A) each type of class I device so identified shall be exempt 
    from the requirement for a report under subsection (k); and
        ``(B) the classification regulation applicable to each such 
    type of device shall be deemed amended to incorporate such 
    exemption.''.
    (b) Class II Devices.--Section 510(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360(m)) is amended--
        (1) by striking ``(m)(1)'' and all that follows through ``by 
    the Secretary.'' and inserting the following:
    ``(m)(1) The Secretary shall--
        ``(A) not later than 90 days after the date of enactment of the 
    21st Century Cures Act and at least once every 5 years thereafter, 
    as the Secretary determines appropriate--
            ``(i) publish in the Federal Register a notice that 
        contains a list of each type of class II device that the 
        Secretary determines no longer requires a report under 
        subsection (k) to provide reasonable assurance of safety and 
        effectiveness; and
            ``(ii) provide for a period of not less than 60 calendar 
        days for public comment beginning on the date of the 
        publication of such notice; and
        ``(B) not later than 210 calendar days after the date of 
    enactment of the 21st Century Cures Act, publish in the Federal 
    Register a list representing the Secretary's final determination 
    with respect to the devices contained in the list published under 
    subparagraph (A).''; and
        (2) in paragraph (2)--
            (A) by striking ``1 day after the date of publication of a 
        list under this subsection,'' and inserting ``1 calendar day 
        after the date of publication of the final list under paragraph 
        (1)(B),''; and
            (B) by striking ``30-day period'' and inserting ``60-
        calendar-day period''; and
            (C) by adding at the end the following new paragraph:
    ``(3) Upon the publication of the final list under paragraph 
(1)(B)--
        ``(A) each type of class II device so listed shall be exempt 
    from the requirement for a report under subsection (k); and
        ``(B) the classification regulation applicable to each such 
    type of device shall be deemed amended to incorporate such 
    exemption.''.
SEC. 3055. CLASSIFICATION PANELS.
    (a) Classification Panels.--Paragraph (5) of section 513(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended--
        (1) by striking ``(5)'' and inserting ``(5)(A)''; and
        (2) by adding at the end the following:
    ``(B) When a device is specifically the subject of review by a 
classification panel, the Secretary shall--
        ``(i) ensure that adequate expertise is represented on the 
    classification panel to assess--
            ``(I) the disease or condition which the device is intended 
        to cure, treat, mitigate, prevent, or diagnose; and
            ``(II) the technology of the device; and
        ``(ii) provide an opportunity for the person whose device is 
    specifically the subject of panel review to provide recommendations 
    on the expertise needed among the voting members of the panel.
    ``(C) For purposes of subparagraph (B)(i), the term `adequate 
expertise' means that the membership of the classification panel 
includes--
        ``(i) two or more voting members, with a specialty or other 
    expertise clinically relevant to the device under review; and
        ``(ii) at least one voting member who is knowledgeable about 
    the technology of the device.
    ``(D) The Secretary shall provide an annual opportunity for 
patients, representatives of patients, and sponsors of medical device 
submissions to provide recommendations for individuals with appropriate 
expertise to fill voting member positions on classification panels.''.
    (b) Panel Review Process.--Section 513(b)(6) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended--
        (1) in subparagraph (A)(iii), by inserting before the period at 
    the end ``, including, subject to the discretion of the panel 
    chairperson, by designating a representative who will be provided a 
    time during the panel meeting to address the panel for the purpose 
    of correcting misstatements of fact or providing clarifying 
    information, and permitting the person or representative to call on 
    experts within the person's organization to address such specific 
    issues in the time provided''; and
        (2) by striking subparagraph (B) and inserting the following 
    new subparagraph:
    ``(B)(i) Any meeting of a classification panel with respect to the 
review of a device shall--
        ``(I) provide adequate time for initial presentations by the 
    person whose device is specifically the subject of such review and 
    by the Secretary; and
        ``(II) encourage free and open participation by all interested 
    persons.
    ``(ii) Following the initial presentations described in clause (i), 
the panel may--
        ``(I) pose questions to a designated representative described 
    in subparagraph (A)(iii); and
        ``(II) consider the responses to such questions in the panel's 
    review of the device.''.
SEC. 3056. INSTITUTIONAL REVIEW BOARD FLEXIBILITY.
    Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j) is amended--
        (1) in subsection (g)(3)--
            (A) in subparagraph (A)(i)--
                (i) by striking ``local''; and
                (ii) by striking ``which has been''; and
            (B) in subparagraph (B), by striking ``a local 
        institutional'' and inserting ``an institutional''; and
        (2) in subsection (m)(4)--
            (A) by striking subparagraph (A) and inserting the 
        following:
        ``(A) in facilities in which clinical testing of devices is 
    supervised by an institutional review committee established in 
    accordance with the regulations of the Secretary; and'';
            (B) in subparagraph (B), by striking ``a local 
        institutional'' and inserting ``an institutional''; and
            (C) in the matter following subparagraph (B), by striking 
        ``local''.
SEC. 3057. CLIA WAIVER IMPROVEMENTS.
    (a) Draft Revised Guidance.--Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and Human 
Services, acting through the Commissioner of Food and Drugs, shall 
publish a draft guidance that--
        (1) revises ``Section V. Demonstrating Insignificant Risk of an 
    Erroneous Result - Accuracy'' of the guidance entitled 
    ``Recommendations for Clinical Laboratory Improvement Amendments of 
    1988 (CLIA) Waiver Applications for Manufacturers of In Vitro 
    Diagnostic Devices'' and dated January 30, 2008; and
        (2) includes the appropriate use of comparable performance 
    between a waived user and a moderately complex laboratory user to 
    demonstrate accuracy.
    (b) Final Revised Guidance.--The Secretary of Health and Human 
Services, acting through the Commissioner of Food and Drugs, shall 
finalize the draft guidance published under subsection (a) not later 
than 1 year after the comment period for such draft guidance closes.
SEC. 3058. LEAST BURDENSOME DEVICE REVIEW.
    (a) In General.--Section 513 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end the 
following:
    ``(j) Training and Oversight of Least Burdensome Requirements.--
        ``(1) The Secretary shall--
            ``(A) ensure that each employee of the Food and Drug 
        Administration who is involved in the review of premarket 
        submissions, including supervisors, receives training regarding 
        the meaning and implementation of the least burdensome 
        requirements under subsections (a)(3)(D) and (i)(1)(D) of this 
        section and section 515(c)(5); and
            ``(B) periodically assess the implementation of the least 
        burdensome requirements, including the employee training under 
        subparagraph (A), to ensure that the least burdensome 
        requirements are fully and consistently applied.
        ``(2) Not later than 18 months after the date of enactment of 
    the 21st Century Cures Act, the ombudsman for any organizational 
    unit of the Food and Drug Administration responsible for the 
    premarket review of devices shall--
            ``(A) conduct an audit of the training described in 
        paragraph (1)(A), including the effectiveness of such training 
        in implementing the least burdensome requirements;
            ``(B) include in such audit interviews of persons who are 
        representatives of the device industry regarding their 
        experiences in the device premarket review process, including 
        with respect to the application of least burdensome concepts to 
        premarket review and decisionmaking;
            ``(C) include in such audit a list of the measurement tools 
        the Secretary uses to assess the implementation of the least 
        burdensome requirements, including under paragraph (1)(B) and 
        section 517A(a)(3), and may also provide feedback on the 
        effectiveness of such tools in the implementation of the least 
        burdensome requirements;
            ``(D) summarize the findings of such audit in a final audit 
        report; and
            ``(E) within 30 calendar days of completion of such final 
        audit report, make such final audit report available--
                ``(i) to the Committee on Health, Education, Labor, and 
            Pensions of the Senate and the Committee on Energy and 
            Commerce of the House of Representatives; and
                ``(ii) on the Internet website of the Food and Drug 
            Administration.''.
    (b) Premarket Applications.--Section 515(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended by adding at the 
end the following:
    ``(5)(A) In requesting additional information with respect to an 
application under this section, the Secretary shall consider the least 
burdensome appropriate means necessary to demonstrate a reasonable 
assurance of device safety and effectiveness.
    ``(B) For purposes of subparagraph (A), the term `necessary' means 
the minimum required information that would support a determination by 
the Secretary that an application provides a reasonable assurance of 
the safety and effectiveness of the device.
    ``(C) For purposes of this paragraph, the Secretary shall consider 
the role of postmarket information in determining the least burdensome 
means of demonstrating a reasonable assurance of device safety and 
effectiveness.
    ``(D) Nothing in this paragraph alters the standards for premarket 
approval of a device.''.
    (c) Rationale for Significant Decisions Regarding Devices.--Section 
517A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g-
1(a)) is amended by adding at the end the following:
        ``(3) Application of least burdensome requirements.--The 
    substantive summary required under this subsection shall include a 
    brief statement regarding how the least burdensome requirements 
    were considered and applied consistent with section 513(i)(1)(D), 
    section 513(a)(3)(D), and section 515(c)(5), as applicable.''.
SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION DATA REQUIREMENT.
    (a) In General.--Section 510 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360) is amended by adding at the end the 
following:
    ``(q) Reusable Medical Devices.--
        ``(1) In general.--Not later than 180 days after the date of 
    enactment of the 21st Century Cures Act, the Secretary shall 
    identify and publish a list of reusable device types for which 
    reports under subsection (k) are required to include--
            ``(A) instructions for use, which have been validated in a 
        manner specified by the Secretary; and
            ``(B) validation data, the types of which shall be 
        specified by the Secretary;
    regarding cleaning, disinfection, and sterilization, and for which 
    a substantial equivalence determination may be based.
        ``(2) Revision of list.--The Secretary shall revise the list 
    under paragraph (2), as the Secretary determines appropriate, with 
    notice in the Federal Register.
        ``(3) Content of reports.--Reports under subsection (k) that 
    are submitted after the publication of the list described in 
    paragraph (1), for devices or types of devices included on such 
    list, shall include such instructions for use and validation 
    data.''.
    (b) Device Modifications.--The Secretary of Health and Human 
Services, acting through the Commissioner of Food and Drugs, shall 
issue final guidance regarding when a premarket notification under 
section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360(k)) is required to be submitted for a modification or change to a 
legally marketed device. Such final guidance shall be issued not later 
than 1 year after the date on which the comment period closes for the 
draft guidance on such subject.
SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION.
    (a) In General.--Section 520 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end the 
following:
    ``(o) Regulation of Medical and Certain Decisions Support 
Software.--
        ``(1) The term device, as defined in section 201(h), shall not 
    include a software function that is intended--
            ``(A) for administrative support of a health care facility, 
        including the processing and maintenance of financial records, 
        claims or billing information, appointment schedules, business 
        analytics, information about patient populations, admissions, 
        practice and inventory management, analysis of historical 
        claims data to predict future utilization or cost-
        effectiveness, determination of health benefit eligibility, 
        population health management, and laboratory workflow;
            ``(B) for maintaining or encouraging a healthy lifestyle 
        and is unrelated to the diagnosis, cure, mitigation, 
        prevention, or treatment of a disease or condition;
            ``(C) to serve as electronic patient records, including 
        patient-provided information, to the extent that such records 
        are intended to transfer, store, convert formats, or display 
        the equivalent of a paper medical chart, so long as--
                ``(i) such records were created, stored, transferred, 
            or reviewed by health care professionals, or by individuals 
            working under supervision of such professionals;
                ``(ii) such records are part of health information 
            technology that is certified under section 3001(c)(5) of 
            the Public Health Service Act; and
                ``(iii) such function is not intended to interpret or 
            analyze patient records, including medical image data, for 
            the purpose of the diagnosis, cure, mitigation, prevention, 
            or treatment of a disease or condition;
            ``(D) for transferring, storing, converting formats, or 
        displaying clinical laboratory test or other device data and 
        results, findings by a health care professional with respect to 
        such data and results, general information about such findings, 
        and general background information about such laboratory test 
        or other device, unless such function is intended to interpret 
        or analyze clinical laboratory test or other device data, 
        results, and findings; or
            ``(E) unless the function is intended to acquire, process, 
        or analyze a medical image or a signal from an in vitro 
        diagnostic device or a pattern or signal from a signal 
        acquisition system, for the purpose of--
                ``(i) displaying, analyzing, or printing medical 
            information about a patient or other medical information 
            (such as peer-reviewed clinical studies and clinical 
            practice guidelines);
                ``(ii) supporting or providing recommendations to a 
            health care professional about prevention, diagnosis, or 
            treatment of a disease or condition; and
                ``(iii) enabling such health care professional to 
            independently review the basis for such recommendations 
            that such software presents so that it is not the intent 
            that such health care professional rely primarily on any of 
            such recommendations to make a clinical diagnosis or 
            treatment decision regarding an individual patient.
        ``(2) In the case of a product with multiple functions that 
    contains--
            ``(A) at least one software function that meets the 
        criteria under paragraph (1) or that otherwise does not meet 
        the definition of device under section 201(h); and
            ``(B) at least one function that does not meet the criteria 
        under paragraph (1) and that otherwise meets the definition of 
        a device under section 201(h),
    the Secretary shall not regulate the software function of such 
    product described in subparagraph (A) as a device. Notwithstanding 
    the preceding sentence, when assessing the safety and effectiveness 
    of the device function or functions of such product described in 
    subparagraph (B), the Secretary may assess the impact that the 
    software function or functions described in subparagraph (A) have 
    on such device function or functions.
        ``(3)(A) Notwithstanding paragraph (1), a software function 
    described in subparagraph (C), (D), or (E) of paragraph (1) shall 
    not be excluded from the definition of device under section 201(h) 
    if--
            ``(i) the Secretary makes a finding that use of such 
        software function would be reasonably likely to have serious 
        adverse health consequences; and
            ``(ii) the software function has been identified in a final 
        order issued by the Secretary under subparagraph (B).
        ``(B) Subparagraph (A) shall apply only if the Secretary--
            ``(i) publishes a notification and proposed order in the 
        Federal Register;
            ``(ii) includes in such notification the Secretary's 
        finding, including the rationale and identification of the 
        evidence on which such finding was based, as described in 
        subparagraph (A)(i); and
            ``(iii) provides for a period of not less than 30 calendar 
        days for public comment before issuing a final order or 
        withdrawing such proposed order.
        ``(C) In making a finding under subparagraph (A)(i) with 
    respect to a software function, the Secretary shall consider--
            ``(i) the likelihood and severity of patient harm if the 
        software function were to not perform as intended;
            ``(ii) the extent to which the software function is 
        intended to support the clinical judgment of a health care 
        professional;
            ``(iii) whether there is a reasonable opportunity for a 
        health care professional to review the basis of the information 
        or treatment recommendation provided by the software function; 
        and
            ``(iv) the intended user and user environment, such as 
        whether a health care professional will use a software function 
        of a type described in subparagraph (E) of paragraph (1).
        ``(4) Nothing in this subsection shall be construed as limiting 
    the authority of the Secretary to--
            ``(A) exercise enforcement discretion as to any device 
        subject to regulation under this Act;
            ``(B) regulate software used in the manufacture and 
        transfusion of blood and blood components to assist in the 
        prevention of disease in humans; or
            ``(C) regulate software as a device under this Act if such 
        software meets the criteria under section 513(a)(1)(C).''.
    (b) Reports.--The Secretary of Health and Human Services (referred 
to in this subsection as the ``Secretary''), after consultation with 
agencies and offices of the Department of Health and Human Services 
involved in health information technology, shall publish a report, not 
later than 2 years after the date of enactment of this Act and every 2 
years thereafter, that--
        (1) includes input from outside experts, such as 
    representatives of patients, consumers, health care providers, 
    startup companies, health plans or other third-party payers, 
    venture capital investors, information technology vendors, health 
    information technology vendors, small businesses, purchasers, 
    employers, and other stakeholders with relevant expertise, as 
    determined by the Secretary;
        (2) examines information available to the Secretary on any 
    risks and benefits to health associated with software functions 
    described in section 520(o)(1) of the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 360j) (as amended by subsection (a)); and
        (3) summarizes findings regarding the impact of such software 
    functions on patient safety, including best practices to promote 
    safety, education, and competency related to such functions.
    (c) Classification of Accessories.--Section 513(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by adding 
at the end the following:
    ``(9) The Secretary shall classify an accessory under this section 
based on the intended use of the accessory, notwithstanding the 
classification of any other device with which such accessory is 
intended to be used.''.
    (d) Conforming Amendment.--Section 201(h) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended by adding at the 
end the following: ``The term `device' does not include software 
functions excluded pursuant to section 520(o).''.

     Subtitle G--Improving Scientific Expertise and Outreach at FDA

SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND BIOMEDICAL 
PRODUCT ASSESSMENT SERVICE.
    (a) Hiring and Retention Authority.--Section 228 of the Public 
Health Service Act (42 U.S.C. 237) is amended--
        (1) in the section heading, by inserting ``and biomedical 
    product assessment'' after ``research'';
        (2) in subsection (a)--
            (A) in paragraph (1), by striking ``Silvio O. Conte Senior 
        Biomedical Research Service, not to exceed 500 members'' and 
        inserting ``Silvio O. Conte Senior Biomedical Research and 
        Biomedical Product Assessment Service (in this section referred 
        to as the `Service'), not to exceed 2,000 members, the purpose 
        of which is to recruit and retain outstanding and qualified 
        scientific and technical experts in the fields of biomedical 
        research, clinical research evaluation, and biomedical product 
        assessment'';
            (B) by amending paragraph (2) to read as follows:
    ``(2) The authority established in paragraph (1) may not be 
construed to require the Secretary to reduce the number of employees 
serving under any other employment system in order to offset the number 
of members serving in the Service.''; and
            (C) by adding at the end the following:
    ``(3) The Secretary shall assign experts under this section to 
agencies within the Department of Health and Human Services taking into 
account the need for the expertise of such expert.'';
        (3) in subsection (b)--
            (A) in the matter preceding paragraph (1), by striking ``or 
        clinical research evaluation'' and inserting ``, clinical 
        research evaluation, or biomedical product assessment''; and
            (B) in paragraph (1), by inserting ``or a doctoral or 
        master's level degree in engineering, bioinformatics, or a 
        related or emerging field,'' after the comma;
        (4) in subsection (d)(2), by striking ``and shall not exceed 
    the rate payable for level I of the Executive Schedule unless 
    approved by the President under section 5377(d)(2) of title 5, 
    United States Code'' and inserting ``and shall not exceed the 
    amount of annual compensation (excluding expenses) specified in 
    section 102 of title 3, United States Code'';
        (5) by striking subsection (e); and
        (6) by redesignating subsections (f) and (g) as subsections (e) 
    and (f), respectively.
    (b) GAO Study.--
        (1) In general.--The Comptroller General of the United States 
    shall conduct a study of the effectiveness of the amendments to 
    section 228 of the Public Health Service Act (42 U.S.C. 237) made 
    by subsection (a) and the impact of such amendments, if any, on all 
    agencies or departments of the Department of Health and Human 
    Services, and, not later than 4 years after the date of enactment 
    of this Act, shall submit a report based on such study to the 
    Committee on Health, Education, Labor, and Pensions of the Senate 
    and the Committee on Energy and Commerce of the House of 
    Representatives.
        (2) Content of study and report.--The study and report under 
    paragraph (1) shall include an examination of the extent to which 
    recruitment and retention of outstanding and qualified scientific, 
    medical, or technical experts in the fields of biomedical research, 
    clinical research evaluation, and biomedical product assessment 
    have improved or otherwise have been affected by the amendments to 
    section 228 of the Public Health Service Act (42 U.S.C. 237) made 
    by subsection (a), including by determining, during the period 
    between the date of enactment of this Act and the completion of the 
    study--
            (A) the total number of members recruited and retained 
        under the Senior Biomedical Research and Biomedical Product 
        Assessment Service under such section 228, and the effect of 
        increasing the number of members eligible for such Service;
            (B) the number of members of such Senior Biomedical 
        Research and Biomedical Product Assessment Service hired with a 
        doctoral level degree in biomedicine or a related field, and 
        the number of such members hired with a doctoral or master's 
        level degree in engineering, bioinformatics, or a related or 
        emerging field; and
            (C) the number of Senior Biomedical Research and Biomedical 
        Product Assessment Service members that have been hired by each 
        agency or department of the Department of Health and Human 
        Services, and how such Department assigns such members to each 
        agency or department.
SEC. 3072. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND PROFESSIONAL 
PERSONNEL.
    (a) In General.--The Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 714 (21 U.S.C. 379d-3) the 
following:
``SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 
PROFESSIONAL PERSONNEL.
    ``(a) In General.--The Secretary may, notwithstanding title 5, 
United States Code, governing appointments in the competitive service, 
appoint outstanding and qualified candidates to scientific, technical, 
or professional positions that support the development, review, and 
regulation of medical products. Such positions shall be within the 
competitive service.
    ``(b) Compensation.--
        ``(1) In general.--Notwithstanding any other provision of law, 
    including any requirement with respect to General Schedule pay 
    rates under subchapter III of chapter 53 of title 5, United States 
    Code, and consistent with the requirements of paragraph (2), the 
    Commissioner of Food and Drugs may determine and set--
            ``(A) the annual rate of pay of any individual appointed 
        under subsection (a); and
            ``(B) for purposes of retaining qualified employees, the 
        annual rate of pay for any qualified scientific, technical, or 
        professional personnel appointed to a position described in 
        subsection (a) before the date of enactment of the 21st Century 
        Cures Act.
        ``(2) Limitation.--The annual rate of pay established pursuant 
    to paragraph (1) may not exceed the amount of annual compensation 
    (excluding expenses) specified in section 102 of title 3, United 
    States Code.
        ``(3) Public availability.--The annual rate of pay provided to 
    an individual in accordance with this section shall be publicly 
    available information.
    ``(c) Rule of Construction.--The authorities under this section 
shall not be construed to affect the authority provided under section 
714.
    ``(d) Report on Workforce Planning.--
        ``(1) In general.--Not later than 18 months after the date of 
    enactment of the 21st Century Cures Act, the Secretary shall submit 
    a report on workforce planning to the Committee on Health, 
    Education, Labor, and Pensions of the Senate and the Committee on 
    Energy and Commerce of the House of Representatives that examines 
    the extent to which the Food and Drug Administration has a critical 
    need for qualified individuals for scientific, technical, or 
    professional positions, including--
            ``(A) an analysis of the workforce needs at the Food and 
        Drug Administration and the Secretary's strategic plan for 
        addressing such needs, including through use of the authority 
        under this section; and
            ``(B) a recruitment and retention plan for hiring qualified 
        scientific, technical, and professional candidates, which may 
        include the use of--
                ``(i) recruitment through nongovernmental recruitment 
            or placement agencies;
                ``(ii) recruitment through academic institutions;
                ``(iii) recruitment or hiring bonuses, if applicable;
                ``(iv) recruitment using targeted direct hiring 
            authorities; and
                ``(v) retention of qualified scientific, technical, and 
            professional employees using the authority under this 
            section, or other applicable authorities of the Secretary.
        ``(2) Recommendations.--The report under paragraph (1) may 
    include the recommendations of the Commissioner of Food and Drugs 
    that would help the Food and Drug Administration to better recruit 
    and retain qualified individuals for scientific, technical, or 
    professional positions at the agency.''.
    (b) GAO Study and Report.--
        (1) In general.--The Comptroller General of the United States 
    shall conduct a study of the ability of the Food and Drug 
    Administration to hire, train, and retain qualified scientific, 
    technical, and professional staff, not including contractors, 
    necessary to fulfill the mission of the Food and Drug 
    Administration to protect and promote public health. Not later than 
    January 1, 2022, the Comptroller General shall submit a report on 
    such study to the Committee on Health, Education, Labor, and 
    Pensions of the Senate and the Committee on Energy and Commerce of 
    the House of Representatives.
        (2) Contents of study.--The Comptroller General shall include 
    in the study and report under paragraph (1)--
            (A) information about the progress of the Food and Drug 
        Administration in recruiting and retaining qualified 
        scientific, technical, and professional staff outstanding in 
        the field of biomedical research, clinical research evaluation, 
        and biomedical product assessment;
            (B) the extent to which critical staffing needs exist at 
        the Food and Drug Administration, and barriers to hiring, 
        training, and retaining qualified staff, if any;
            (C) an examination of the recruitment and retention 
        strategies of the Food and Drug Administration, including 
        examining any strategic workforce plan, focused on improving 
        scientific, technical, and professional staff recruitment and 
        retention; and
            (D) recommendations for potential improvements that would 
        address staffing needs of the Food and Drug Administration.
SEC. 3073. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRATION INTERCENTER 
INSTITUTES.
    (a) In General.--Chapter X of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.) is amended by adding at the end the 
following:
``SEC. 1014. FOOD AND DRUG ADMINISTRATION INTERCENTER INSTITUTES.
    ``(a) In General.--The Secretary shall establish one or more 
Intercenter Institutes within the Food and Drug Administration 
(referred to in this section as an `Institute') for a major disease 
area or areas. With respect to the major disease area of focus of an 
Institute, such Institute shall develop and implement processes for 
coordination of activities, as applicable to such major disease area or 
areas, among the Center for Drug Evaluation and Research, the Center 
for Biologics Evaluation and Research, and the Center for Devices and 
Radiological Health (for the purposes of this section, referred to as 
the `Centers'). Such activities may include--
        ``(1) coordination of staff from the Centers with diverse 
    product expertise in the diagnosis, cure, mitigation, treatment, or 
    prevention of the specific diseases relevant to the major disease 
    area of focus of the Institute;
        ``(2) streamlining, where appropriate, the review of medical 
    products to diagnose, cure, mitigate, treat, or prevent the 
    specific diseases relevant to the major disease area of focus of 
    the Institute, applying relevant standards under sections 505, 
    510(k), 513(f)(2), and 515 of this Act and section 351 of the 
    Public Health Service Act, and other applicable authorities;
        ``(3) promotion of scientific programs within the Centers 
    related to the major disease area of focus of the Institute;
        ``(4) development of programs and enhancement of strategies to 
    recruit, train, and provide continuing education opportunities for 
    the personnel of the Centers with expertise related to the major 
    disease area of focus of the Institute;
        ``(5) enhancement of the interactions of the Centers with 
    patients, sponsors, and the external biomedical community regarding 
    the major disease area of focus of the Institute; and
        ``(6) facilitation of the collaborative relationships of the 
    Centers with other agencies within the Department of Health and 
    Human Services regarding the major disease area of focus of the 
    Institute.
    ``(b) Public Process.--The Secretary shall provide a period for 
public comment during the time that each Institute is being 
implemented.
    ``(c) Timing.--The Secretary shall establish at least one Institute 
under subsection (a) before the date that is 1 year after the date of 
enactment of the 21st Century Cures Act.
    ``(d) Termination of Institutes.--The Secretary may terminate any 
Institute established pursuant to this section if the Secretary 
determines such Institute is no longer benefitting the public health. 
Not less than 60 days prior to so terminating an Institute, the 
Secretary shall provide public notice, including the rationale for such 
termination.''.
    (b) Technical Amendments.--Chapter X of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 391 et seq.) is amended--
        (1) by redesignating section 1012 as section 1013; and
        (2) by redesignating the second section 1011 (with respect to 
    improving the training of State, local, territorial, and tribal 
    food safety officials), as added by section 209(a) of the FDA Food 
    Safety Modernization Act (Public Law 111-353), as section 1012.
SEC. 3074. SCIENTIFIC ENGAGEMENT.
    (a) In General.--Scientific meetings that are attended by 
scientific or medical personnel, or other professionals, of the 
Department of Health and Human Services for whom attendance at such 
meeting is directly related to their professional duties and the 
mission of the Department--
        (1) shall not be considered conferences for the purposes of 
    complying with Federal reporting requirements contained in annual 
    appropriations Acts or in this section; and
        (2) shall not be considered conferences for purposes of a 
    restriction contained in an annual appropriations Act, based on 
    Office of Management and Budget Memorandum M-12-12 or any other 
    regulation restricting travel to such meeting.
    (b) Limitation.--Nothing in this section shall be construed to 
exempt travel for scientific meetings from Federal regulations relating 
to travel.
    (c) Reports.--Not later than 90 days after the end of the fiscal 
year, each operating division of the Department of Health and Human 
Services shall prepare, and post on an Internet website of the 
operating division, an annual report on scientific meeting attendance 
and related travel spending for each fiscal year. Such report shall 
include--
        (1) general information concerning the scientific meeting 
    activities involved;
        (2) information concerning the total amount expended for such 
    meetings;
        (3) a description of all such meetings that were attended by 
    scientific or medical personnel, or other professionals, of each 
    such operating division where the total amount expended by the 
    operating division associated with each such meeting were in excess 
    of $30,000, including--
            (A) the total amount of meeting expenses incurred by the 
        operating division for such meeting;
            (B) the location of such meeting;
            (C) the date of such meeting;
            (D) a brief explanation on how such meeting advanced the 
        mission of the operating division; and
            (E) the total number of individuals whose travel expenses 
        or other scientific meeting expenses were paid by the operating 
        division; and
        (4) with respect to any such meeting where the total expenses 
    to the operating division exceeded $150,000, a description of the 
    exceptional circumstances that necessitated the expenditure of such 
    amounts.
SEC. 3075. DRUG SURVEILLANCE.
    (a) New Drugs.--Section 505(k)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by section 2074, is 
further amended--
        (1) in subparagraph (A), by striking ``, bi-weekly screening'' 
    and inserting ``screenings'';
        (2) in subparagraph (B), as redesignated by section 2074(1)(C), 
    by striking the period at the end and inserting ``; and''; and
        (3) by adding at the end the following:
        ``(C) make available on the Internet website of the Food and 
    Drug Administration--
            ``(i) guidelines, developed with input from experts 
        qualified by scientific training and experience to evaluate the 
        safety and effectiveness of drugs, that detail best practices 
        for drug safety surveillance using the Adverse Event Reporting 
        System; and
            ``(ii) criteria for public posting of adverse event 
        signals.''.
    (b) FAERS Revision.--Section 505(r)(2)(D) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is amended by striking 
``, by 18 months'' and all that follows through the semicolon at the 
end of the subparagraph and inserting ``and making publicly available 
on the Internet website established under paragraph (1) best practices 
for drug safety surveillance activities for drugs approved under this 
section or section 351 of the Public Health Service Act;''.
    (c) Risk Evaluation and Mitigation Strategies.--Section 505-1(f)(5) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f)(5)) is 
amended--
        (1) in the matter preceding subparagraph (A), by inserting ``or 
    other advisory committee'' after ``(or successor committee)''; and
        (2) in subparagraph (B), by striking ``at least annually,'' and 
    inserting ``periodically''.
SEC. 3076. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
ADMINISTRATION.
    (a) Board of Directors.--
        (1) Composition and size.--Section 770(d)(1)(C) of the Federal 
    Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)) is 
    amended--
            (A) by redesignating clause (ii) as clause (iii);
            (B) by inserting after clause (i) the following:
                ``(ii) Additional members.--The Board, through 
            amendments to the bylaws of the Foundation, may provide 
            that the number of voting members of the Board shall be a 
            number (to be specified in such amendment) greater than 14. 
            Any Board positions that are established by any such 
            amendment shall be appointed (by majority vote) by the 
            individuals who, as of the date of such amendment, are 
            voting members of the Board and persons so appointed may 
            represent any of the categories specified in subclauses (I) 
            through (V) of clause (i), so long as no more than 30 
            percent of the total voting members of the Board (including 
            members whose positions are established by such amendment) 
            are representatives of the general pharmaceutical, device, 
            food, cosmetic, and biotechnology industries.''; and
            (C) in clause (iii)(I), as redesignated by subparagraph 
        (A), by striking ``The ex officio members shall ensure'' and 
        inserting ``The ex officio members, acting pursuant to clause 
        (i), and the Board, acting pursuant to clause (ii), shall 
        ensure''.
        (2) Federal employees allowed to serve on board.--Clause 
    (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated by 
    paragraph (1)(A), is amended by adding at the end the following: 
    ``For purposes of this section, the term `employee of the Federal 
    Government' does not include a special Government employee, as that 
    term is defined in section 202(a) of title 18, United States 
    Code.''.
        (3) Staggered terms.--Subparagraph (A) of section 770(d)(3) of 
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(3)) is 
    amended to read as follows:
            ``(A) Term.--The term of office of each member of the Board 
        appointed under paragraph (1)(C)(i), and the term of office of 
        any member of the Board whose position is established pursuant 
        to paragraph (1)(C)(ii), shall be 4 years, except that--
                ``(i) the terms of offices for the members of the Board 
            initially appointed under paragraph (1)(C)(i) shall expire 
            on a staggered basis as determined by the ex officio 
            members; and
                ``(ii) the terms of office for the persons initially 
            appointed to positions established pursuant to paragraph 
            (1)(C)(ii) may be made to expire on a staggered basis, as 
            determined by the individuals who, as of the date of the 
            amendment establishing such positions, are members of the 
            Board.''.
    (b) Executive Director Compensation.--Section 770(g)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(g)(2)) is amended 
by striking ``but shall not be greater than the compensation of the 
Commissioner''.
    (c) Separation of Funds.--Section 770(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379dd(m)) is amended by striking ``are held 
in separate accounts from funds received from entities under subsection 
(i)'' and inserting ``are managed as individual programmatic funds 
under subsection (i), according to best accounting practices''.

             Subtitle H--Medical Countermeasures Innovation

SEC. 3081. MEDICAL COUNTERMEASURE GUIDELINES.
    Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
is amended--
        (1) in subsection (a), by adding at the end the following:
        ``(3) Utilization guidelines.--The Secretary shall ensure 
    timely and accurate recommended utilization guidelines for 
    qualified countermeasures (as defined in section 319F-1), qualified 
    pandemic and epidemic products (as defined in section 319F-3), and 
    security countermeasures (as defined in subsection (c)), including 
    for such products in the stockpile.''; and
        (2) in subsection (g)--
            (A) by amending paragraph (4) to read as follows:
        ``(4) Report on security countermeasure procurement.--Not later 
    than March 1 of each year in which the Secretary determines that 
    the amount of funds available for procurement of security 
    countermeasures is less than $1,500,000,000, the Secretary shall 
    submit to the Committee on Appropriations and the Committee on 
    Health, Education, Labor, and Pensions of the Senate and the 
    Committee on Appropriations and the Committee on Energy and 
    Commerce of the House of Representatives a report detailing the 
    amount of such funds available for procurement and the impact such 
    amount of funding will have--
            ``(A) in meeting the security countermeasure needs 
        identified under this section; and
            ``(B) on the annual Public Health Emergency Medical 
        Countermeasures Enterprise and Strategy Implementation Plan 
        (pursuant to section 2811(d)).''.
SEC. 3082. CLARIFYING BARDA CONTRACTING AUTHORITY.
    (a) In General.--Section 319F-2(g) of the Public Health Service Act 
(42 U.S.C. 247d-6b(g)) is amended by adding at the end the following:
        ``(5) Clarification on contracting authority.--The Secretary, 
    acting through the Director of the Biomedical Advanced Research and 
    Development Authority, shall carry out the programs funded by the 
    special reserve fund (for the procurement of security 
    countermeasures under subsection (c) and for carrying out section 
    319L), including the execution of procurement contracts, grants, 
    and cooperative agreements pursuant to this section and section 
    319L.''.
    (b) BARDA Contracting Authority.--Section 319L(c)(3) of the Public 
Health Service Act (42 U.S.C. 247d-7c) is amended by inserting ``, 
including the execution of procurement contracts, grants, and 
cooperative agreements pursuant to this section'' before the period.
SEC. 3083. COUNTERMEASURE BUDGET PLAN.
    Section 2811(b)(7) of the Public Health Service Act (42 U.S.C. 
300hh-10(b)(7)) is amended--
        (1) in the matter preceding subparagraph (A), by striking the 
    first sentence and inserting ``Develop, and update not later than 
    March 1 of each year, a coordinated 5-year budget plan based on the 
    medical countermeasure priorities described in subsection (d), 
    including with respect to chemical, biological, radiological, and 
    nuclear agent or agents that may present a threat to the Nation, 
    including such agents that are novel or emerging infectious 
    diseases, and the corresponding efforts to develop qualified 
    countermeasures (as defined in section 319F-1), security 
    countermeasures (as defined in section 319F-2), and qualified 
    pandemic or epidemic products (as defined in section 319F-3) for 
    each such threat.'';
        (2) in subparagraph (C), by striking ``; and'' and inserting a 
    semicolon;
        (3) in subparagraph (D), by striking ``to the appropriate 
    committees of Congress upon request.'' and inserting ``, not later 
    than March 15 of each year, to the Committee on Appropriations and 
    the Committee on Health, Education, Labor, and Pensions of the 
    Senate and the Committee on Appropriations and the Committee on 
    Energy and Commerce of the House of Representatives; and''; and
        (4) by adding at the end the following:
            ``(E) not later than March 15 of each year, be made 
        publicly available in a manner that does not compromise 
        national security.''.
SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION.
    Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 
247d-7e(c)(4)) is amended by adding at the end the following:
            ``(E) Medical countermeasures innovation partner.--
                ``(i) In general.--To support the purposes described in 
            paragraph (2), the Secretary, acting through the Director 
            of BARDA, may enter into an agreement (including through 
            the use of grants, contracts, cooperative agreements, or 
            other transactions as described in paragraph (5)) with an 
            independent, nonprofit entity to--

                    ``(I) foster and accelerate the development and 
                innovation of medical countermeasures and technologies 
                that may assist advanced research and the development 
                of qualified countermeasures and qualified pandemic or 
                epidemic products, including through the use of 
                strategic venture capital practices and methods;
                    ``(II) promote the development of new and promising 
                technologies that address urgent medical countermeasure 
                needs, as identified by the Secretary;
                    ``(III) address unmet public health needs that are 
                directly related to medical countermeasure 
                requirements, such as novel antimicrobials for 
                multidrug resistant organisms and multiuse platform 
                technologies for diagnostics, prophylaxis, vaccines, 
                and therapeutics; and
                    ``(IV) provide expert consultation and advice to 
                foster viable medical countermeasure innovators, 
                including helping qualified countermeasure innovators 
                navigate unique industry challenges with respect to 
                developing chemical, biological, radiological, and 
                nuclear countermeasure products.

                ``(ii) Eligibility.--

                    ``(I) In general.--To be eligible to enter into an 
                agreement under clause (i) an entity shall--

                        ``(aa) be an independent, nonprofit entity;
                        ``(bb) have a demonstrated record of being able 
                    to create linkages between innovators and investors 
                    and leverage such partnerships and resources for 
                    the purpose of addressing identified strategic 
                    needs of the Federal Government;
                        ``(cc) have experience in promoting novel 
                    technology innovation;
                        ``(dd) be problem-driven and solution-focused 
                    based on the needs, requirements, and problems 
                    identified by the Secretary under clause (iv);
                        ``(ee) demonstrate the ability, or the 
                    potential ability, to promote the development of 
                    medical countermeasure products;
                        ``(ff) demonstrate expertise, or the capacity 
                    to develop or acquire expertise, related to 
                    technical and regulatory considerations with 
                    respect to medical countermeasures; and
                        ``(gg) not be within the Department of Health 
                    and Human Services.

                    ``(II) Partnering experience.--In selecting an 
                entity with which to enter into an agreement under 
                clause (i), the Secretary shall place a high value on 
                the demonstrated experience of the entity in partnering 
                with the Federal Government to meet identified 
                strategic needs.

                ``(iii) Not agency.--An entity that enters into an 
            agreement under clause (i) shall not be deemed to be a 
            Federal agency for any purpose, including for any purpose 
            under title 5, United States Code.
                ``(iv) Direction.--Pursuant to an agreement entered 
            into under this subparagraph, the Secretary, acting through 
            the Director of BARDA, shall provide direction to the 
            entity that enters into an agreement under clause (i). As 
            part of this agreement the Director of BARDA shall--

                    ``(I) communicate the medical countermeasure needs, 
                requirements, and problems to be addressed by the 
                entity under the agreement;
                    ``(II) develop a description of work to be 
                performed by the entity under the agreement;
                    ``(III) provide technical feedback and appropriate 
                oversight over work carried out by the entity under the 
                agreement, including subsequent development and 
                partnerships consistent with the needs and requirements 
                set forth in this subparagraph;
                    ``(IV) ensure fair consideration of products 
                developed under the agreement in order to maintain 
                competition to the maximum practical extent, as 
                applicable and appropriate under applicable provisions 
                of this section; and
                    ``(V) ensure, as a condition of the agreement that 
                the entity--

                        ``(aa) has in place a comprehensive set of 
                    policies that demonstrate a commitment to 
                    transparency and accountability;
                        ``(bb) protects against conflicts of interest 
                    through a comprehensive set of policies that 
                    address potential conflicts of interest, ethics, 
                    disclosure, and reporting requirements;
                        ``(cc) provides monthly accounting on the use 
                    of funds provided under such agreement; and
                        ``(dd) provides on a quarterly basis, reports 
                    regarding the progress made toward meeting the 
                    identified needs set forth in the agreement.
                ``(v) Supplement not supplant.--Activities carried out 
            under this subparagraph shall supplement, and not supplant, 
            other activities carried out under this section.
                ``(vi) No establishment of entity.--To prevent 
            unnecessary duplication and target resources effectively, 
            nothing in this subparagraph shall be construed to 
            authorize the Secretary to establish within the Department 
            of Health and Human Services an entity for the purposes of 
            carrying out this subparagraph.
                ``(vii) Transparency and oversight.--Upon request, the 
            Secretary shall provide to Congress the information 
            provided to the Secretary under clause (iv)(V)(dd).
                ``(viii) Independent evaluation.--Not later than 4 
            years after the date of enactment of the 21st Century Cures 
            Act, the Comptroller General of the United States shall 
            conduct an independent evaluation, and submit to the 
            Secretary and the appropriate committees of Congress a 
            report, concerning the activities conducted under this 
            subparagraph. Such report shall include recommendations 
            with respect to any agreement or activities carried out 
            pursuant to this subparagraph.
                ``(ix) Sunset.--This subparagraph shall have no force 
            or effect after September 30, 2022.''.
SEC. 3085. STREAMLINING PROJECT BIOSHIELD PROCUREMENT.
    Section 319F-2(c) of the Public Health Service Act (42 U.S.C. 247d-
6b(c)) is amended--
        (1) in paragraph (4)(A)(ii), by striking ``make a 
    recommendation under paragraph (6) that the special reserve fund as 
    defined in subsection (h) be made available for the procurement of 
    such countermeasure'' and inserting ``and subject to the 
    availability of appropriations, make available the special reserve 
    fund as defined in subsection (h) for procurement of such 
    countermeasure, as applicable'';
        (2) in paragraph (6)--
            (A) by striking subparagraphs (A), (B), and (E);
            (B) by redesignating subparagraphs (C) and (D) as 
        subparagraphs (A) and (B), respectively;
            (C) by amending subparagraph (A), as so redesignated, to 
        read as follows:
            ``(A) Notice to appropriate congressional committees.--The 
        Secretary shall notify the Committee on Appropriations and the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Appropriations and the Committee on 
        Energy and Commerce of the House of Representatives of each 
        decision to make available the special reserve fund as defined 
        in subsection (h) for procurement of a security countermeasure, 
        including, where available, the number of, the nature of, and 
        other information concerning potential suppliers of such 
        countermeasure, and whether other potential suppliers of the 
        same or similar countermeasures were considered and rejected 
        for procurement under this section and the reasons for each 
        such rejection.''; and
            (D) in the heading, by striking ``Recommendation for 
        president's approval'' and inserting ``Recommendations for 
        procurement''; and
        (3) in paragraph (7)--
            (A) by striking subparagraphs (A) and (B) and inserting the 
        following:
            ``(A) Payments from special reserve fund.--The special 
        reserve fund as defined in subsection (h) shall be available 
        for payments made by the Secretary to a vendor for procurement 
        of a security countermeasure in accordance with the provisions 
        of this paragraph.''; and
            (B) by redesignating subparagraph (C) as subparagraph (B).
SEC. 3086. ENCOURAGING TREATMENTS FOR AGENTS THAT PRESENT A NATIONAL 
SECURITY THREAT.
    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 
565 the following:
``SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR AGENTS THAT 
PRESENT NATIONAL SECURITY THREATS.
    ``(a) Definitions.--In this section:
        ``(1) Human drug application.--The term `human drug 
    application' has the meaning given such term in section 735(1).
        ``(2) Priority review.--The term `priority review', with 
    respect to a human drug application, means review and action by the 
    Secretary on such application not later than 6 months after receipt 
    by the Secretary of such application, as described in the Manual of 
    Policies and Procedures in the Food and Drug Administration and 
    goals identified in the letters described in section 101(b) of the 
    Food and Drug Administration Safety and Innovation Act.
        ``(3) Priority review voucher.--The term `priority review 
    voucher' means a voucher issued by the Secretary to the sponsor of 
    a material threat medical countermeasure application that entitles 
    the holder of such voucher to priority review of a single human 
    drug application submitted under section 505(b)(1) or section 
    351(a) of the Public Health Service Act after the date of approval 
    of the material threat medical countermeasure application.
        ``(4) Material threat medical countermeasure application.--The 
    term `material threat medical countermeasure application' means an 
    application that--
            ``(A) is a human drug application for a drug intended for 
        use--
                ``(i) to prevent, or treat harm from a biological, 
            chemical, radiological, or nuclear agent identified as a 
            material threat under section 319F-2(c)(2)(A)(ii) of the 
            Public Health Service Act; or
                ``(ii) to mitigate, prevent, or treat harm from a 
            condition that may result in adverse health consequences or 
            death and may be caused by administering a drug, or 
            biological product against such agent; and
            ``(B) the Secretary determines eligible for priority 
        review;
            ``(C) is approved after the date of enactment of the 21st 
        Century Cures Act; and
            ``(D) is for a human drug, no active ingredient (including 
        any ester or salt of the active ingredient) of which has been 
        approved in any other application under section 505(b)(1) or 
        section 351(a) of the Public Health Service Act.
    ``(b) Priority Review Voucher.--
        ``(1) In general.--The Secretary shall award a priority review 
    voucher to the sponsor of a material threat medical countermeasure 
    application upon approval by the Secretary of such material threat 
    medical countermeasure application.
        ``(2) Transferability.--The sponsor of a material threat 
    medical countermeasure application that receives a priority review 
    voucher under this section may transfer (including by sale) the 
    entitlement to such voucher to a sponsor of a human drug for which 
    an application under section 505(b)(1) or section 351(a) of the 
    Public Health Service Act will be submitted after the date of the 
    approval of the material threat medical countermeasure application. 
    There is no limit on the number of times a priority review voucher 
    may be transferred before such voucher is used.
        ``(3) Notification.--
            ``(A) In general.--The sponsor of a human drug application 
        shall notify the Secretary not later than 90 calendar days 
        prior to submission of the human drug application that is the 
        subject of a priority review voucher of an intent to submit the 
        human drug application, including the date on which the sponsor 
        intends to submit the application. Such notification shall be a 
        legally binding commitment to pay for the user fee to be 
        assessed in accordance with this section.
            ``(B) Transfer after notice.--The sponsor of a human drug 
        application that provides notification of the intent of such 
        sponsor to use the voucher for the human drug application under 
        subparagraph (A) may transfer the voucher after such 
        notification is provided, if such sponsor has not yet submitted 
        the human drug application described in the notification.
    ``(c) Priority Review User Fee.--
        ``(1) In general.--The Secretary shall establish a user fee 
    program under which a sponsor of a human drug application that is 
    the subject of a priority review voucher shall pay to the Secretary 
    a fee determined under paragraph (2). Such fee shall be in addition 
    to any fee required to be submitted by the sponsor under chapter 
    VII.
        ``(2) Fee amount.--The amount of the priority review user fee 
    shall be determined each fiscal year by the Secretary and based on 
    the average cost incurred by the agency in the review of a human 
    drug application subject to priority review in the previous fiscal 
    year.
        ``(3) Annual fee setting.--The Secretary shall establish, 
    before the beginning of each fiscal year beginning after September 
    30, 2016, for that fiscal year, the amount of the priority review 
    user fee.
        ``(4) Payment.--
            ``(A) In general.--The priority review user fee required by 
        this subsection shall be due upon the submission of a human 
        drug application under section 505(b)(1) or section 351(a) of 
        the Public Health Service Act for which the priority review 
        voucher is used.
            ``(B) Complete application.--An application described under 
        subparagraph (A) for which the sponsor requests the use of a 
        priority review voucher shall be considered incomplete if the 
        fee required by this subsection and all other applicable user 
        fees are not paid in accordance with the Secretary's procedures 
        for paying such fees.
            ``(C) No waivers, exemptions, reductions, or refunds.--The 
        Secretary may not grant a waiver, exemption, reduction, or 
        refund of any fees due and payable under this section.
        ``(5) Offsetting collections.--Fees collected pursuant to this 
    subsection for any fiscal year--
            ``(A) shall be deposited and credited as offsetting 
        collections to the account providing appropriations to the Food 
        and Drug Administration; and
        ``(6) shall not be collected for any fiscal year except to the 
    extent provided in advance in appropriation Acts.
    ``(d) Notice of Issuance of Voucher and Approval of Products Under 
Voucher.--The Secretary shall publish a notice in the Federal Register 
and on the Internet website of the Food and Drug Administration not 
later than 30 calendar days after the occurrence of each of the 
following:
        ``(1) The Secretary issues a priority review voucher under this 
    section.
        ``(2) The Secretary approves a drug pursuant to an application 
    submitted under section 505(b) of this Act or section 351(a) of the 
    Public Health Service Act for which the sponsor of the application 
    used a priority review voucher issued under this section.
    ``(e) Eligibility for Other Programs.--Nothing in this section 
precludes a sponsor who seeks a priority review voucher under this 
section from participating in any other incentive program, including 
under this Act, except that no sponsor of a material threat medical 
countermeasure application may receive more than one priority review 
voucher issued under any section of this Act with respect to such drug.
    ``(f) Relation to Other Provisions.--The provisions of this section 
shall supplement, not supplant, any other provisions of this Act or the 
Public Health Service Act that encourage the development of medical 
countermeasures.
    ``(g) Sunset.--The Secretary may not award any priority review 
vouchers under subsection (b) after October 1, 2023.''.
SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC HEALTH 
EMERGENCY.
    Section 319 of the Public Health Service Act (42 U.S.C. 247d) is 
amended by adding at the end the following:
    ``(f) Determination With Respect to Paperwork Reduction Act Waiver 
During a Public Health Emergency.--
        ``(1) Determination.--If the Secretary determines, after 
    consultation with such public health officials as may be necessary, 
    that--
            ``(A)(i) the criteria set forth for a public health 
        emergency under paragraph (1) or (2) of subsection (a) has been 
        met; or
            ``(ii) a disease or disorder, including a novel and 
        emerging public health threat, is significantly likely to 
        become a public health emergency; and
            ``(B) the circumstances of such public health emergency, or 
        potential for such significantly likely public health 
        emergency, including the specific preparation for and response 
        to such public health emergency or threat, necessitate a waiver 
        from the requirements of subchapter I of chapter 35 of title 
        44, United States Code (commonly referred to as the Paperwork 
        Reduction Act),
    then the requirements of such subchapter I with respect to 
    voluntary collection of information shall not be applicable during 
    the immediate investigation of, and response to, such public health 
    emergency during the period of such public health emergency or the 
    period of time necessary to determine if a disease or disorder, 
    including a novel and emerging public health threat, will become a 
    public health emergency as provided for in this paragraph. The 
    requirements of such subchapter I with respect to voluntary 
    collection of information shall not be applicable during the 
    immediate postresponse review regarding such public health 
    emergency if such immediate postresponse review does not exceed a 
    reasonable length of time.
        ``(2) Transparency.--If the Secretary determines that a waiver 
    is necessary under paragraph (1), the Secretary shall promptly post 
    on the Internet website of the Department of Health and Human 
    Services a brief justification for such waiver, the anticipated 
    period of time such waiver will be in effect, and the agencies and 
    offices within the Department of Health and Human Services to which 
    such waiver shall apply, and update such information posted on the 
    Internet website of the Department of Health and Human Services, as 
    applicable.
        ``(3) Effectiveness of waiver.--Any waiver under this 
    subsection shall take effect on the date on which the Secretary 
    posts information on the Internet website as provided for in this 
    subsection.
        ``(4) Termination of waiver.--Upon determining that the 
    circumstances necessitating a waiver under paragraph (1) no longer 
    exist, the Secretary shall promptly update the Internet website of 
    the Department of Health and Human Services to reflect the 
    termination of such waiver.
        ``(5) Limitations.--
            ``(A) Period of waiver.--The period of a waiver under 
        paragraph (1) shall not exceed the period of time for the 
        related public health emergency, including a public health 
        emergency declared pursuant to subsection (a), and any 
        immediate postresponse review regarding the public health 
        emergency consistent with the requirements of this subsection.
            ``(B) Subsequent compliance.--An initiative subject to a 
        waiver under paragraph (1) that is ongoing after the date on 
        which the waiver expires, shall be subject to the requirements 
        of subchapter I of chapter 35 of title 44, United States Code, 
        and the Secretary shall ensure that compliance with such 
        requirements occurs in as timely a manner as possible based on 
        the applicable circumstances, but not to exceed 30 calendar 
        days after the expiration of the applicable waiver.''.
SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY USE 
AUTHORIZATION.
    (a) Authorization for Medical Products for Use in Emergencies.--
Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-3) is amended--
        (1) in subsection (a)(2)--
            (A) in subparagraph (A)--
                (i) by striking ``or 515'' and inserting ``512, or 
            515''; and
                (ii) by inserting ``or conditionally approved under 
            section 571 of this Act'' after ``Public Health Service 
            Act''; and
            (B) in subparagraph (B), by inserting ``conditionally 
        approved under section 571,'' after ``approved,'' each place 
        the term appears;
        (2) in subsection (b)(4), by striking the second comma after 
    ``determination'';
        (3) in subsection (e)(3)(B), by striking ``section 503(b)'' and 
    inserting ``subsection (b) or (f) of section 503 or under section 
    504'';
        (4) in subsection (f)(2)--
            (A) by inserting ``, or an animal to which,'' after ``to a 
        patient to whom''; and
            (B) by inserting ``or by the veterinarian caring for such 
        animal, as applicable'' after ``attending physician'';
        (5) in subsection (g)(1), by inserting ``conditional approval 
    under section 571,'' after ``approval,'';
        (6) in subsection (h)(1), by striking ``or section 520(g)''and 
    inserting ``512(j), or 520(g)''; and
        (7) in subsection (k), by striking ``section 520(g),''and 
    inserting ``512(j), or 520(g)''.
    (b) New Animal Drugs.--Section 512(a)(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended--
        (1) in subparagraph (B), by striking ``or'' at the end;
        (2) in subparagraph (C), by striking the period and inserting 
    ``; or''; and
        (3) by inserting after subparagraph (C) the following:
        ``(D) there is in effect an authorization pursuant to section 
    564 with respect to such use or intended use of such drug, and such 
    drug, its labeling, and such use conform to any conditions of such 
    authorization.''.
    (c) Emergency Use of Medical Products.--Section 564A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a) is amended--
        (1) in subsection (a)(1)(A), by inserting ``, conditionally 
    approved under section 571,'' after ``chapter''; and
        (2) in subsection (d), by striking ``sections 503(b) and 
    520(e)'' and inserting ``subsections (b) and (f) of section 503, 
    section 504, and section 520(e)''.
    (d) Products Held for Emergency Use.--Section 564B(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b(2)) is 
amended--
        (1) in subparagraph (A)--
            (A) by inserting ``or conditionally approved under section 
        571 of this Act'' after ``Public Health Service Act''; and
            (B) by striking ``or 515'' and inserting ``512, or 515''; 
        and
        (2) in subparagraph (B), by striking ``or 520'' and inserting 
    ``512, or 520''.

         Subtitle I--Vaccine Access, Certainty, and Innovation

SEC. 3091. PREDICTABLE REVIEW TIMELINES OF VACCINES BY THE ADVISORY 
COMMITTEE ON IMMUNIZATION PRACTICES.
    (a) Consideration of New Vaccines.--Upon the licensure of any 
vaccine or any new indication for a vaccine, the Advisory Committee on 
Immunization Practices (in this section referred to as the ``Advisory 
Committee'') shall, as appropriate, consider the use of the vaccine at 
its next regularly scheduled meeting.
    (b) Additional Information.--If the Advisory Committee does not 
make a recommendation with respect to the use of a vaccine at the 
Advisory Committee's first regularly scheduled meeting after the 
licensure of the vaccine or any new indication for the vaccine, the 
Advisory Committee shall provide an update on the status of such 
committee's review.
    (c) Consideration for Breakthrough Therapies and for Potential Use 
During Public Health Emergency.--The Advisory Committee shall make 
recommendations with respect to the use of certain vaccines in a timely 
manner, as appropriate, including vaccines that--
        (1) are designated as a breakthrough therapy under section 506 
    of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) and 
    licensed under section 351 of the Public Health Service Act (42 
    U.S.C. 262); or
        (2) could be used in a public health emergency.
    (d) Definition.--In this section, the terms ``Advisory Committee on 
Immunization Practices'' and ``Advisory Committee'' mean the Advisory 
Committee on Immunization Practices established by the Secretary 
pursuant to section 222 of the Public Health Service Act (42 U.S.C. 
217a), acting through the Director of the Centers for Disease Control 
and Prevention.''.
SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF ADVISORY COMMITTEE ON 
IMMUNIZATION PRACTICES RECOMMENDATIONS.
    (a) Review.--The Director of the Centers for Disease Control and 
Prevention shall conduct a review of the processes used by the Advisory 
Committee on Immunization Practices in formulating and issuing 
recommendations pertaining to vaccines, including with respect to 
consistency.
    (b) Considerations.--The review under subsection (a) shall include 
an assessment of--
        (1) the criteria used to evaluate new and existing vaccines, 
    including the identification of any areas for which flexibility in 
    evaluating such criteria is necessary and the reason for such 
    flexibility;
        (2) the Grading of Recommendations, Assessment, Development, 
    and Evaluation (GRADE) approach to the review and analysis of 
    scientific and economic data, including the scientific basis for 
    such approach; and
        (3) the extent to which the processes used by the work groups 
    of the Advisory Committee on Immunization Practices are consistent 
    among such groups, including the identification of reasons for any 
    variation.
    (c) Stakeholders.--In carrying out the review under subsection (a), 
the Director of the Centers for Disease Control and Prevention shall 
solicit input from vaccine stakeholders.
    (d) Report.--Not later than 18 months after the date of enactment 
of this Act, the Director of the Centers for Disease Control and 
Prevention shall submit to the appropriate committees of the Congress, 
and make publicly available, a report on the results of the review 
under subsection (a), including any recommendations on improving the 
consistency of the processes described in such subsection.
    (e) Definition.--In this section, the term ``Advisory Committee on 
Immunization Practices'' means the Advisory Committee on Immunization 
Practices established by the Secretary of Health and Human Services 
pursuant to section 222 of the Public Health Service Act (42 U.S.C. 
217a), acting through the Director of the Centers for Disease Control 
and Prevention.
SEC. 3093. ENCOURAGING VACCINE INNOVATION.
    (a) Vaccine Meetings.--The Director of the Centers for Disease 
Control and Prevention shall ensure that appropriate staff within the 
relevant centers and divisions of the Office of Infectious Diseases, 
and others, as appropriate, coordinate with respect to the public 
health needs, epidemiology, and program planning and implementation 
considerations related to immunization, including with regard to 
meetings with stakeholders related to such topics.
    (b) Report on Vaccine Innovation.--
        (1) In general.--Not later than 1 year after the date of 
    enactment of this Act, the Secretary of Health and Human Services 
    (referred to in this section as the ``Secretary''), in 
    collaboration with appropriate agencies or offices within the 
    Department of Health and Human Services, including the National 
    Institutes of Health, the Centers for Disease Control and 
    Prevention, the Food and Drug Administration, and the Biomedical 
    Advanced Research and Development Authority, shall submit to the 
    Committee on Health, Education, Labor, and Pensions of the Senate 
    and the Committee on Energy and Commerce of the House of 
    Representatives, and post publicly on the Internet website of the 
    Department of Health and Human Services, a report on ways to 
    promote innovation in the development of vaccines that minimize the 
    burden of infectious disease.
        (2) Contents.--The report described in paragraph (1) shall 
    review the current status of vaccine development and, as 
    appropriate--
            (A) consider the optimal process to determine which 
        vaccines would be beneficial to public health and how 
        information on such vaccines is disseminated to key 
        stakeholders;
            (B) examine and identify whether obstacles exist that 
        inhibit the development of beneficial vaccines; and
            (C) make recommendations about how best to remove any 
        obstacles identified under subparagraph (B) in order to promote 
        and incentivize vaccine innovation and development.
        (3) Consultation.--In preparing the report under this 
    subsection, the Secretary may consult with--
            (A) representatives of relevant Federal agencies and 
        departments, including the Department of Defense and the 
        Department of Veterans Affairs;
            (B) academic researchers;
            (C) developers and manufacturers of vaccines;
            (D) medical and public health practitioners;
            (E) representatives of patient, policy, and advocacy 
        organizations; and
            (F) representatives of other entities, as the Secretary 
        determines appropriate.
    (c) Updates Related to Maternal Immunization.--
        (1) Additional vaccines.--Section 2114(e) of the Public Health 
    Service Act (42 U.S.C. 300aa-14(e)) is amended by adding at the end 
    the following:
        ``(3) Vaccines recommended for use in pregnant women.--The 
    Secretary shall revise the Vaccine Injury Table included in 
    subsection (a), through the process described in subsection (c), to 
    include vaccines recommended by the Centers for Disease Control and 
    Prevention for routine administration in pregnant women and the 
    information described in subparagraphs (B) and (C) of paragraph (2) 
    with respect to such vaccines.''.
        (2) Petition content.--Section 2111 of the Public Health 
    Service Act (42 U.S.C. 300aa-11) is amended by adding at the end 
    the following:
    ``(f) Maternal Immunization.--
        ``(1) In general.--Notwithstanding any other provision of law, 
    for purposes of this subtitle, both a woman who received a covered 
    vaccine while pregnant and any child who was in utero at the time 
    such woman received the vaccine shall be considered persons to whom 
    the covered vaccine was administered and persons who received the 
    covered vaccine.
        ``(2) Definition.--As used in this subsection, the term `child' 
    shall have the meaning given that term by subsections (a) and (b) 
    of section 8 of title 1, United States Code, except that, for 
    purposes of this subsection, such section 8 shall be applied as if 
    the term `include' in subsection (a) of such section were replaced 
    with the term `mean'.''.
        (3) Petitioners.--Section 2111(b)(2) of the Public Health 
    Service Act (42 U.S.C. 300aa-11(b)(2)) is amended by adding ``A 
    covered vaccine administered to a pregnant woman shall constitute 
    more than one administration, one to the mother and one to each 
    child (as such term is defined in subsection (f)(2)) who was in 
    utero at the time such woman was administered the vaccine.'' at the 
    end.

                   Subtitle J--Technical Corrections

SEC. 3101. TECHNICAL CORRECTIONS.
    (a) FFDCA.--
        (1) References.--Except as otherwise expressly provided, 
    whenever in this subsection an amendment is expressed in terms of 
    an amendment to a section or other provision, the reference shall 
    be considered to be made to that section or other provision of the 
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
        (2) Amendments.--
            (A) Prohibited acts.--Section 301(r) (21 U.S.C. 331(r)) is 
        amended by inserting ``, drug,'' after ``device'' each place 
        the term appears.
            (B) New drugs.--Section 505 (21 U.S.C. 355) is amended--
                (i) in subsection (d), in the last sentence, by 
            striking ``premarket approval'' and inserting ``marketing 
            approval''; and
                (ii) in subsection (q)(5)(A), by striking ``subsection 
            (b)(2) or (j) of the Act or 351(k)'' and inserting 
            ``subsection (b)(2) or (j) of this section or section 
            351(k)''.
            (C) Risk evaluation and mitigation strategies.--Section 
        505-1(h)(21 U.S.C. 355-1(h)) is amended--
                (i) in paragraph (2)(A)(iii)--

                    (I) in the clause heading, by striking ``label'' 
                and inserting ``labeling'';
                    (II) by striking ``label'' each place the term 
                appears and inserting ``labeling''; and
                    (III) by striking ``sponsor'' and inserting 
                ``responsible person''; and

                (ii) in paragraph (8), by striking ``and (7).'' and 
            inserting ``and (7)''.
            (D) Pediatric study plans.--Section 505B (21 U.S.C. 355c) 
        is amended--
                (i) in subsection (e)--

                    (I) in paragraph (2)--

                        (aa) in subparagraph (A), by inserting 
                    ``study'' after ``initial pediatric'' each place 
                    the term appears; and
                        (bb) in subparagraph (B), in the subparagraph 
                    heading, by striking ``initial plan'' and inserting 
                    ``initial pediatric study plan'';

                    (II) in paragraph (5), in the paragraph heading, by 
                inserting ``agreed initial pediatric study'' before 
                ``plan''; and
                    (III) in paragraph (6), by striking ``agreed 
                initial pediatric plan'' and inserting ``agreed initial 
                pediatric study plan''; and

                (ii) in subsection (f)(1), by inserting ``and any 
            significant amendments to such plans,'' after ``agreed 
            initial pediatric study plans,''.
            (E) Discontinuance or interruption in the production of 
        live-saving drugs.--Section 506C (21 U.S.C. 356c) is amended--
                (i) in subsection (c), by striking ``discontinuation'' 
            and inserting ``discontinuance''; and
                (ii) in subsection (g)(1), by striking ``section 505(j) 
            that could help'' and inserting ``section 505(j), that 
            could help''.
            (F) Annual reporting on drug shortages.--Section 506C-1(a) 
        (21 U.S.C. 331(a)) is amended, in the matter before paragraph 
        (1)--
                (i) by striking ``Not later than the end of calendar 
            year 2013, and not later than the end of each calendar year 
            thereafter,'' and inserting ``Not later than March 31 of 
            each calendar year,''; and
                (ii) by inserting ``, with respect to the preceding 
            calendar year,'' after ``a report''.
            (G) Drug shortage list.--Section 506E(b)(3)(E) (21 U.S.C. 
        356e(b)(3)(E)) is amended by striking ``discontinuation'' and 
        inserting ``discontinuance''.
            (H) Inspections of establishments.--Section 510(h) (21 
        U.S.C. 360(h)) is amended--
                (i) in paragraph (4), in the matter preceding 
            subparagraph (A), by striking ``establishing the risk-based 
            scheduled'' and inserting ``establishing a risk-based 
            schedule''; and
                (ii) in paragraph (6)--

                    (I) in subparagraph (A), by striking ``fiscal'' and 
                inserting ``calendar'' each place the term appears; and
                    (II) in subparagraph (B), by striking ``an active 
                ingredient of a drug, a finished drug product, or an 
                excipient of a drug'' and inserting ``an active 
                ingredient of a drug or a finished drug product''.

            (I) Classification of devices intended for human use.--
        Section 513(f)(2)(A) (21 U.S.C. 360c(f)(2)(A)) is amended--
                (i) in clause (i), by striking ``within 30 days''; and
                (ii) in clause (iv), by striking ``low-moderate'' and 
            inserting ``low to moderate''.
            (J) Premarket approval.--Section 515(a)(1) (21 U.S.C. 
        360e(a)(1)) is amended by striking ``subject to a an order'' 
        and inserting ``subject to an order''.
            (K) Program to improve the device recall system.--Section 
        518A (21 U.S.C. 360h-1) is amended--
                (i) by striking subsection (c); and
                (ii) by redesignating subsection (d) as subsection (c).
            (L) Unique device identifier.--Section 519(f) (21 U.S.C. 
        360i(f)) is amended by striking ``and life sustaining'' and 
        inserting ``or life sustaining''.
            (M) Priority review to encourage treatments for tropical 
        diseases.--Section 524(c)(4)(A) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360n(c)(4)(A)) is amended by striking 
        ``Services Act'' and inserting ``Service Act''.
            (N) Priority review for qualified infectious disease 
        products.--Section 524A (21 U.S.C. 360n-1) is amended--
                (i) by striking ``If the Secretary'' and inserting the 
            following:
    ``(a) In General.--If the Secretary'';
                (ii) by striking ``any'' and inserting ``the first''; 
            and
                (iii) by adding at the end the following:
    ``(b) Construction.--Nothing in this section shall prohibit the 
Secretary from giving priority review to a human drug application or 
efficacy supplement submitted for approval under section 505(b) that 
otherwise meets the criteria for the Secretary to grant priority 
review.''.
            (O) Consultation with external experts on rare diseases, 
        targeted therapies, and genetic targeting of treatments.--
        Section 569(a)(2)(A) (21 U.S.C. 360bbb-8(a)(2)(A)) is amended, 
        in the first sentence, by striking ``subsection (c)'' and 
        inserting ``subsection (b)''.
            (P) Optimizing global clinical trials.--Section 569A(c) (21 
        U.S.C. 360bbb-8a(c)) is amended by inserting ``or under the 
        Public Health Service Act'' after ``this Act''.
            (Q) Use of clinical investigation data from outside the 
        united states.--Section 569B (21 U.S.C. 360bbb-8b) is amended 
        by striking ``drug or device'' and inserting ``drug, biological 
        product, or device'' each place the term appears.
            (R) Medical gases definitions.--Section 575(1)(H) (21 
        U.S.C. 360ddd(1)(H)) is amended--
                (i) by inserting ``for a new drug'' after ``any period 
            of exclusivity''; and
                (ii) by inserting ``or any period of exclusivity for a 
            new animal drug under section 512(c)(2)(F),'' after 
            ``section 505A,''.
            (S) Regulation of medical gases.--Section 576(a) (21 U.S.C. 
        360ddd-1(a)) is amended--
                (i) in the matter preceding subparagraph (A) of 
            paragraph (1), by inserting ``who seeks to initially 
            introduce or deliver for introduction a designated medical 
            gas into interstate commerce'' after ``any person''; and
                (ii) in paragraph (3)--

                    (I) in subparagraph (A)--

                        (aa) in clause (i)(VIII), by inserting ``for a 
                    new drug'' after ``any period of exclusivity''; and
                        (bb) in clause (ii), in the matter preceding 
                    subclause (I), by inserting ``the'' before ``final 
                    use''; and

                    (II) in subparagraph (B)--

                        (aa) in clause (i), by inserting ``for a new 
                    drug'' after ``any period of exclusivity''; and
                        (bb) in clause (ii), by inserting a comma after 
                    ``drug product''.
            (T) Inapplicability of drug fees to designated medical 
        gases.--Section 577 (21 U.S.C. 360ddd-2) is amended by 
        inserting ``or 740(a)'' after ``section 736(a)''.
            (U) Conflicts of interest.--Section 712(e)(1)(B) (21 U.S.C. 
        379d-1(e)(1)(B)) is amended by striking ``services'' and 
        inserting ``service''.
            (V) Authority to assess and use biosimilar biological 
        product fees.--Section 744H(a) (21 U.S.C. 379j-52(a)) is 
        amended--
                (i) in paragraph (1)(A)(v), by striking ``Biosimilars 
            User Fee Act of 2012'' and inserting ``Biosimilar User Fee 
            Act of 2012''; and
                (ii) in paragraph (2)(B), by striking ``Biosimilars 
            User Fee Act of 2012'' and inserting ``Biosimilar User Fee 
            Act of 2012''.
            (W) Registration of commercial importers.--
                (i) Amendment.--Section 801(s)(2) (21 U.S.C. 381(s)(2)) 
            is amended by adding at the end the following:
            ``(D) Effective date.--In establishing the effective date 
        of the regulations under subparagraph (A), the Secretary shall, 
        in consultation with the Secretary of Homeland Security acting 
        through U.S. Customs and Border Protection, as determined 
        appropriate by the Secretary of Health and Human Services, 
        provide a reasonable period of time for an importer of a drug 
        to comply with good importer practices, taking into account 
        differences among importers and types of imports, including 
        based on the level of risk posed by the imported product.''.
                (ii) Conforming amendment.--Section 714 of the Food and 
            Drug Administration Safety and Innovation Act (Public Law 
            112-144; 126 Stat. 1074) is amended by striking subsection 
            (d).
            (X) Recognition of foreign government inspections.--Section 
        809(a)(2) (21 U.S.C. 384e(a)(2)) is amended by striking 
        ``conduction'' and inserting ``conducting''.
    (b) FDASIA.--
        (1) Findings relating to drug approval.--Section 901(a)(1)(A) 
    of the Food and Drug Administration Safety and Innovation Act 
    (Public Law 112-144; 21 U.S.C. 356 note) is amended by striking 
    ``serious and life-threatening diseases'' and inserting ``serious 
    or life-threatening diseases''.
        (2) Reporting of inclusion of demographic subgroups.--Section 
    907 of the Food and Drug Administration Safety and Innovation Act 
    (Public Law 112-144; 126 Stat. 1092, 1093) is amended--
            (A) in the section heading, by striking ``biologics'' in 
        the heading and inserting ``biological products''; and
            (B) in subsection (a)(2)(B), by striking ``applications for 
        new drug applications'' and inserting ``new drug 
        applications''.
        (3) Combating prescription drug abuse.--Section 1122 of the 
    Food and Drug Administration Safety and Innovation Act (Public Law 
    112-144; 126 Stat. 1112, 1113) is amended--
            (A) in subsection (a)(2), by striking ``dependance'' and 
        inserting ``dependence''; and
            (B) in subsection (c), by striking ``promulgate'' and 
        inserting ``issue''.
SEC. 3102. COMPLETED STUDIES.
    The Federal Food, Drug, and Cosmetic Act is amended--
        (1) in section 505(k)(5) (21 U.S.C. 355(k)(5))--
            (A) in subparagraph (A), by inserting ``and'' after the 
        semicolon;
            (B) by striking subparagraph (B); and
            (C) by redesignating subparagraph (C) as subparagraph (B);
        (2) in section 505A (21 U.S.C. 355a), by striking subsection 
    (p);
        (3) in section 505B (21 U.S.C. 355c)--
            (A) by striking subsection (l); and
            (B) by redesignating subsection (m) as subsection (l); and
        (4) in section 523 (21 U.S.C. 360m), by striking subsection 
    (d).

                           TITLE IV--DELIVERY

SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING QUALITY OF CARE 
FOR PATIENTS.
    (a) In General.--The Health Information Technology for Economic and 
Clinical Health Act (title XIII of division A of Public Law 111-5) is 
amended--
        (1) by adding at the end of part 1 of subtitle A the following:
``SEC. 13103. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING QUALITY OF 
CARE FOR PATIENTS.
    ``(a) Reduction in Burdens Goal.--The Secretary of Health and Human 
Services (referred to in this section as the `Secretary'), in 
consultation with providers of health services, health care suppliers 
of services, health care payers, health professional societies, health 
information technology developers, health care quality organizations, 
health care accreditation organizations, public health entities, 
States, and other appropriate entities, shall, in accordance with 
subsection (b)--
        ``(1) establish a goal with respect to the reduction of 
    regulatory or administrative burdens (such as documentation 
    requirements) relating to the use of electronic health records;
        ``(2) develop a strategy for meeting the goal established under 
    paragraph (1); and
        ``(3) develop recommendations for meeting the goal established 
    under paragraph (1).
    ``(b) Strategy and Recommendations.--
        ``(1) In general.--To achieve the goal established under 
    subsection (a)(1), the Secretary, in consultation with the entities 
    described in such subsection, shall, not later than 1 year after 
    the date of enactment of the 21st Century Cures Act, develop a 
    strategy and recommendations to meet the goal in accordance with 
    this subsection.
        ``(2) Strategy.--The strategy developed under paragraph (1) 
    shall address the regulatory and administrative burdens (such as 
    documentation requirements) relating to the use of electronic 
    health records. Such strategy shall include broad public comment 
    and shall prioritize--
            ``(A)(i) incentives for meaningful use of certified EHR 
        technology for eligible professionals and hospitals under 
        sections 1848(a)(7) and 1886(b)(3)(B)(ix), respectively, of the 
        Social Security Act (42 U.S.C. 1395w-4(a)(7), 
        1395ww(b)(3)(B)(ix));
            ``(ii) the program for making payments under section 
        1903(a)(3)(F) of the Social Security Act (42 U.S.C. 
        1396b(a)(3)(F)) to encourage the adoption and use of certified 
        EHR technology by Medicaid providers;
            ``(iii) the Merit-based Incentive Payment System under 
        section 1848(q) of the Social Security Act (42 U.S.C. 1395w-
        4(q));
            ``(iv) alternative payment models (as defined in section 
        1833(z)(3)(C) of the Social Security Act (42 U.S.C. 
        1395l(z)(3)(C));
            ``(v) the Hospital Value-Based Purchasing Program under 
        section 1886(o) of the Social Security Act (42 U.S.C. 
        1395ww(o)); and
            ``(vi) other value-based payment programs, as the Secretary 
        determines appropriate;
            ``(B) health information technology certification;
            ``(C) standards and implementation specifications, as 
        appropriate;
            ``(D) activities that provide individuals access to their 
        electronic health information;
            ``(E) activities related to protecting the privacy of 
        electronic health information;
            ``(F) activities related to protecting the security of 
        electronic health information;
            ``(G) activities related to facilitating health and 
        clinical research;
            ``(H) activities related to public health;
            ``(I) activities related to aligning and simplifying 
        quality measures across Federal programs and other payers;
            ``(J) activities related to reporting clinical data for 
        administrative purposes; and
            ``(K) other areas, as the Secretary determines appropriate.
        ``(3) Recommendations.--The recommendations developed under 
    paragraph (1) shall address--
            ``(A) actions that improve the clinical documentation 
        experience;
            ``(B) actions that improve patient care;
            ``(C) actions to be taken by the Secretary and by other 
        entities; and
            ``(D) other areas, as the Secretary determines appropriate, 
        to reduce the reporting burden required of health care 
        providers.
        ``(4) FACA.--The Federal Advisory Committee Act (5 U.S.C. App.) 
    shall not apply to the development of the goal, strategies, or 
    recommendations described in this section.
    ``(c) Application of Certain Regulatory Requirements.--A physician 
(as defined in section 1861(r)(1) of the Social Security Act), to the 
extent consistent with applicable State law, may delegate electronic 
medical record documentation requirements specified in regulations 
promulgated by the Centers for Medicare & Medicaid Services to a person 
performing a scribe function who is not such physician if such 
physician has signed and verified the documentation.''; and
        (2) in the table of contents in section 13001(b), by inserting 
    after the item relating to section 13102 the following:

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

    (b) Certification of Health Information Technology for Medical 
Specialties and Sites of Service.--Section 3001(c)(5) of the Public 
Health Service Act (42 U.S.C. 300jj-11(c)(5)) is amended by adding at 
the end the following:
            ``(C) Health information technology for medical specialties 
        and sites of service.--
                ``(i) In general.--The National Coordinator shall 
            encourage, keep, or recognize, through existing 
            authorities, the voluntary certification of health 
            information technology under the program developed under 
            subparagraph (A) for use in medical specialties and sites 
            of service for which no such technology is available or 
            where more technological advancement or integration is 
            needed.
                ``(ii) Specific medical specialties.--The Secretary 
            shall accept public comment on specific medical specialties 
            and sites of service, in addition to those described in 
            clause (i), for the purpose of selecting additional 
            specialties and sites of service as necessary.
                ``(iii) Health information technology for pediatrics.--
            Not later than 18 months after the date of enactment of the 
            21st Century Cures Act, the Secretary, in consultation with 
            relevant stakeholders, shall make recommendations for the 
            voluntary certification of health information technology 
            for use by pediatric health providers to support the health 
            care of children. Not later than 2 years after the date of 
            enactment of the 21st Century Cures Act, the Secretary 
            shall adopt certification criteria under section 3004 to 
            support the voluntary certification of health information 
            technology for use by pediatric health providers to support 
            the health care of children.''.
    (c) Meaningful Use Statistics.--
        (1) In general.--Not later than 6 months after the date of 
    enactment of this Act, the Secretary of Health and Human Services 
    shall submit to the HIT Advisory Committee of the Office of the 
    National Coordinator for Health Information Technology, a report 
    concerning attestation statistics for the Medicare and Medicaid EHR 
    Meaningful Use Incentive programs to assist in informing standards 
    adoption and related practices. Such statistics shall include 
    attestation information delineated by State, including, to the 
    extent practicable, the number of providers who did not meet the 
    minimum criteria necessary to attest for the Medicare and Medicaid 
    EHR Meaningful Use Incentive programs for a calendar year, and 
    shall be made publicly available on the Internet website of the 
    Secretary on at least a quarterly basis.
        (2) Authority to alter format.--The Secretary of Health and 
    Human Services may alter the format of the reports on the 
    attestation of eligible health care professionals following the 
    first performance year of the Merit-based Incentive Payment System 
    to account for changes arising from the implementation of such 
    payment system.
SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECURITY, AND 
FUNCTIONALITY.
    (a) Enhancements to Certification.--Section 3001(c)(5) of the 
Public Health Service Act (42 U.S.C. 300jj-11), as amended by section 
4001(b), is further amended by adding at the end the following:
            ``(D) Conditions of certification.--Not later than 1 year 
        after the date of enactment of the 21st Century Cures Act, the 
        Secretary, through notice and comment rulemaking, shall 
        require, as a condition of certification and maintenance of 
        certification for programs maintained or recognized under this 
        paragraph, consistent with other conditions and requirements 
        under this title, that the health information technology 
        developer or entity--
                ``(i) does not take any action that constitutes 
            information blocking as defined in section 3022(a);
                ``(ii) provides assurances satisfactory to the 
            Secretary that such developer or entity, unless for 
            legitimate purposes specified by the Secretary, will not 
            take any action described in clause (i) or any other action 
            that may inhibit the appropriate exchange, access, and use 
            of electronic health information;
                ``(iii) does not prohibit or restrict communication 
            regarding--

                    ``(I) the usability of the health information 
                technology;
                    ``(II) the interoperability of the health 
                information technology;
                    ``(III) the security of the health information 
                technology;
                    ``(IV) relevant information regarding users' 
                experiences when using the health information 
                technology;
                    ``(V) the business practices of developers of 
                health information technology related to exchanging 
                electronic health information; and
                    ``(VI) the manner in which a user of the health 
                information technology has used such technology;

                ``(iv) has published application programming interfaces 
            and allows health information from such technology to be 
            accessed, exchanged, and used without special effort 
            through the use of application programming interfaces or 
            successor technology or standards, as provided for under 
            applicable law, including providing access to all data 
            elements of a patient's electronic health record to the 
            extent permissible under applicable privacy laws;
                ``(v) has successfully tested the real world use of the 
            technology for interoperability (as defined in section 
            3000) in the type of setting in which such technology would 
            be marketed;
                ``(vi) provides to the Secretary an attestation that 
            the developer or entity--

                    ``(I) has not engaged in any of the conduct 
                described in clause (i);
                    ``(II) has provided assurances satisfactory to the 
                Secretary in accordance with clause (ii);
                    ``(III) does not prohibit or restrict communication 
                as described in clause (iii);
                    ``(IV) has published information in accordance with 
                clause (iv);
                    ``(V) ensures that its technology allows for health 
                information to be exchanged, accessed, and used, in the 
                manner described in clause (iv); and
                    ``(VI) has undertaken real world testing as 
                described in clause (v); and

                ``(vii) submits reporting criteria in accordance with 
            section 3009A(b).''.
            ``(E) Compliance with conditions of certification.--The 
        Secretary may encourage compliance with the conditions of 
        certification described in subparagraph (D) and take action to 
        discourage noncompliance, as appropriate.''.
    (b) EHR Significant Hardship Exception.--
        (1) Application to eligible professionals.--
            (A) In case of decertification.--Section 1848(a)(7)(B) of 
        the Social Security Act (42 U.S.C. 1395w-4(a)(7)(B)) is amended 
        by inserting after the first sentence the following new 
        sentence: ``The Secretary shall exempt an eligible professional 
        from the application of the payment adjustment under 
        subparagraph (A) with respect to a year, subject to annual 
        renewal, if the Secretary determines that compliance with the 
        requirement for being a meaningful EHR user is not possible 
        because the certified EHR technology used by such professional 
        has been decertified under a program kept or recognized 
        pursuant to section 3001(c)(5) of the Public Health Service 
        Act.''.
            (B) Continued application under mips.--Section 
        1848(o)(2)(D) of the Social Security Act (42 U.S.C. 1395w-
        4(o)(2)(D)) is amended by adding at the end the following new 
        sentence: ``The provisions of subparagraphs (B) and (D) of 
        subsection (a)(7), shall apply to assessments of MIPS eligible 
        professionals under subsection (q) with respect to the 
        performance category described in subsection (q)(2)(A)(iv) in 
        an appropriate manner which may be similar to the manner in 
        which such provisions apply with respect to payment adjustments 
        made under subsection (a)(7)(A).''.
        (2) Application to eligible hospitals.--Section 
    1886(b)(3)(B)(ix)(II) of the Social Security Act (42 U.S.C. 
    1395ww(b)(3)(B)(ix)(II)) is amended by inserting after the first 
    sentence the following new sentence: ``The Secretary shall exempt 
    an eligible hospital from the application of the payment adjustment 
    under subclause (I) with respect to a fiscal year, subject to 
    annual renewal, if the Secretary determines that compliance with 
    the requirement for being a meaningful EHR user is not possible 
    because the certified EHR technology used by such hospital is 
    decertified under a program kept or recognized pursuant to section 
    3001(c)(5) of the Public Health Service Act.''.
    (c) Electronic Health Record Reporting Program.--Subtitle A of 
title XXX of the Public Health Service Act (42 U.S.C. 300jj-11 et seq.) 
is amended by adding at the end the following:
``SEC. 3009A. ELECTRONIC HEALTH RECORD REPORTING PROGRAM.
    ``(a) Reporting Criteria.--
        ``(1) Convening of stakeholders.--Not later than 1 year after 
    the date of enactment of the 21st Century Cures Act, the Secretary 
    shall convene stakeholders, as described in paragraph (2), for the 
    purpose of developing the reporting criteria in accordance with 
    paragraph (3).
        ``(2) Development of reporting criteria.--The reporting 
    criteria under this subsection shall be developed through a public, 
    transparent process that reflects input from relevant stakeholders, 
    including--
            ``(A) health care providers, including primary care and 
        specialty care health care professionals;
            ``(B) hospitals and hospital systems;
            ``(C) health information technology developers;
            ``(D) patients, consumers, and their advocates;
            ``(E) data sharing networks, such as health information 
        exchanges;
            ``(F) authorized certification bodies and testing 
        laboratories;
            ``(G) security experts;
            ``(H) relevant manufacturers of medical devices;
            ``(I) experts in health information technology market 
        economics;
            ``(J) public and private entities engaged in the evaluation 
        of health information technology performance;
            ``(K) quality organizations, including the consensus based 
        entity described in section 1890 of the Social Security Act;
            ``(L) experts in human factors engineering and the 
        measurement of user-centered design; and
            ``(M) other entities or individuals, as the Secretary 
        determines appropriate.
        ``(3) Considerations for reporting criteria.--The reporting 
    criteria developed under this subsection--
            ``(A) shall include measures that reflect categories 
        including--
                ``(i) security;
                ``(ii) usability and user-centered design;
                ``(iii) interoperability;
                ``(iv) conformance to certification testing; and
                ``(v) other categories, as appropriate to measure the 
            performance of electronic health record technology;
            ``(B) may include categories such as--
                ``(i) enabling the user to order and view the results 
            of laboratory tests, imaging tests, and other diagnostic 
            tests;
                ``(ii) submitting, editing, and retrieving data from 
            registries such as clinician-led clinical data registries;
                ``(iii) accessing and exchanging information and data 
            from and through health information exchanges;
                ``(iv) accessing and exchanging information and data 
            from medical devices;
                ``(v) accessing and exchanging information and data 
            held by Federal, State, and local agencies and other 
            applicable entities useful to a health care provider or 
            other applicable user in the furtherance of patient care;
                ``(vi) accessing and exchanging information from other 
            health care providers or applicable users;
                ``(vii) accessing and exchanging patient generated 
            information;
                ``(viii) providing the patient or an authorized 
            designee with a complete copy of their health information 
            from an electronic record in a computable format;
                ``(ix) providing accurate patient information for the 
            correct patient, including exchanging such information, and 
            avoiding the duplication of patients records; and
                ``(x) other categories regarding performance, 
            accessibility, as the Secretary determines appropriate; and
            ``(C) shall be designed to ensure that small and startup 
        health information technology developers are not unduly 
        disadvantaged by the reporting criteria.
        ``(4) Modifications.--After the reporting criteria have been 
    developed under paragraph (3), the Secretary may convene 
    stakeholders and conduct a public comment period for the purpose of 
    modifying the reporting criteria developed under such paragraph.
    ``(b) Participation.--As a condition of maintaining certification 
under section 3001(c)(5)(D), a developer of certified electronic health 
records shall submit to an appropriate recipient of a grant, contract, 
or agreement under subsection (c)(1) responses to the criteria 
developed under subsection (a), with respect to all certified 
technology offered by such developer.
    ``(c) Reporting Program.--
        ``(1) In general.--Not later than 1 year after the date of 
    enactment of the 21st Century Cures Act, the Secretary shall award 
    grants, contracts, or agreements to independent entities on a 
    competitive basis to support the convening of stakeholders as 
    described in subsection (a)(2), collect the information required to 
    be reported in accordance with the criteria established as 
    described subsection (a)(3), and develop and implement a process in 
    accordance with paragraph (5) and report such information to the 
    Secretary.
        ``(2) Applications.--An independent entity that seeks a grant, 
    contract, or agreement under this subsection shall submit an 
    application to the Secretary at such time, in such manner, and 
    containing such information as the Secretary may reasonably 
    require, including a description of--
            ``(A) the proposed method for reviewing and summarizing 
        information gathered based on reporting criteria established 
        under subsection (a);
            ``(B) if applicable, the intended focus on a specific 
        subset of certified electronic health record technology users, 
        such as health care providers, including primary care, 
        specialty care, and care provided in rural settings; hospitals 
        and hospital systems; and patients, consumers, and patients and 
        consumer advocates;
            ``(C) the plan for widely distributing reports described in 
        paragraph (6);
            ``(D) the period for which the grant, contract, or 
        agreement is requested, which may be up to 2 years; and
            ``(E) the budget for reporting program participation, and 
        whether the eligible independent entity intends to continue 
        participation after the period of the grant, contract, or 
        agreement.
        ``(3) Considerations for independent entities.--In awarding 
    grants, contracts, and agreements under paragraph (1), the 
    Secretary shall give priority to independent entities with 
    appropriate expertise in health information technology usability, 
    interoperability, and security (especially entities with such 
    expertise in electronic health records) with respect to--
            ``(A) health care providers, including primary care, 
        specialty care, and care provided in rural settings;
            ``(B) hospitals and hospital systems; and
            ``(C) patients, consumers, and patient and consumer 
        advocates.
        ``(4) Limitations.--
            ``(A) Assessment and redetermination.--Not later than 4 
        years after the date of enactment of the 21st Century Cures Act 
        and every 2 years thereafter, the Secretary, in consultation 
        with stakeholders, shall--
                ``(i) assess performance of the recipients of the 
            grants, contracts, and agreements under paragraph (1) based 
            on quality and usability of reports described in paragraph 
            (6); and
                ``(ii) re-determine grants, contracts, and agreements 
            as necessary.
            ``(B) Prohibitions on participation.--The Secretary may not 
        award a grant, contract, or cooperative agreement under 
        paragraph (1) to--
                ``(i) a proprietor of certified health information 
            technology or a business affiliate of such a proprietor;
                ``(ii) a developer of certified health information 
            technology; or
                ``(iii) a State or local government agency.
        ``(5) Feedback.--Based on reporting criteria established under 
    subsection (a), the recipients of grants, contracts, and agreements 
    under paragraph (1) shall develop and implement a process to 
    collect and verify confidential feedback on such criteria from--
            ``(A) health care providers, patients, and other users of 
        certified electronic health record technology; and
            ``(B) developers of certified electronic health record 
        technology.
        ``(6) Reports.--
            ``(A) Development of reports.--Each recipient of a grant, 
        contract, or agreement under paragraph (1) shall report on the 
        information reported to such recipient pursuant to subsection 
        (a) and the user feedback collected under paragraph (5) by 
        preparing summary reports and detailed reports of such 
        information.
            ``(B) Distribution of reports.--Each recipient of a grant, 
        contract, or agreement under paragraph (1) shall submit the 
        reports prepared under subparagraph (A) to the Secretary for 
        public distribution in accordance with subsection (d).
    ``(d) Publication.--The Secretary shall distribute widely, as 
appropriate, and publish, on the Internet website of the Office of the 
National Coordinator--
        ``(1) the reporting criteria developed under subsection (a); 
    and
        ``(2) the summary and detailed reports under subsection (c)(6).
    ``(e) Review.--Each recipient of a grant, contract, or agreement 
under paragraph (1) shall develop and implement a process through which 
participating electronic health record technology developers may review 
and recommend changes to the reports created under subsection (c)(6) 
for products developed by such developer prior to the publication of 
such report under subsection (d).
    ``(f) Additional Resources.--The Secretary may provide additional 
resources on the Internet website of the Office of the National 
Coordinator to better inform consumers of health information 
technology. Such reports may be carried out through partnerships with 
private organizations with appropriate expertise.''.
    (d) Authorization of Appropriations.--There is authorized to be 
appropriated $15,000,000 for purposes of carrying out subparagraph (D) 
of section 3001(c)(5) of the Public Health Service Act (42 U.S.C. 
300jj-11) (as added by subsection (a)) and section 3009A of the Public 
Health Service Act (as added by subsection (b)), including for purposes 
of administering any contracts, grants, or agreements, to remain 
available until expended.
SEC. 4003. INTEROPERABILITY.
    (a) Definition.--Section 3000 of the Public Health Service Act (42 
U.S.C. 300jj) is amended--
        (1) by redesignating paragraphs (10) through (14), as 
    paragraphs (11) through (15), respectively; and
        (2) by inserting after paragraph (9) the following:
        ``(10) Interoperability.--The term `interoperability', with 
    respect to health information technology, means such health 
    information technology that--
            ``(A) enables the secure exchange of electronic health 
        information with, and use of electronic health information 
        from, other health information technology without special 
        effort on the part of the user;
            ``(B) allows for complete access, exchange, and use of all 
        electronically accessible health information for authorized use 
        under applicable State or Federal law; and
            ``(C) does not constitute information blocking as defined 
        in section 3022(a).''.
    (b) Support for Interoperable Network Exchange.--Section 3001(c) of 
the Public Health Service Act (42 U.S.C. 300jj-11(c)) is amended by 
adding at the end the following:
        ``(9) Support for interoperable networks exchange.--
            ``(A) In general.--The National Coordinator shall, in 
        collaboration with the National Institute of Standards and 
        Technology and other relevant agencies within the Department of 
        Health and Human Services, for the purpose of ensuring full 
        network-to-network exchange of health information, convene 
        public-private and public-public partnerships to build 
        consensus and develop or support a trusted exchange framework, 
        including a common agreement among health information networks 
        nationally. Such convention may occur at a frequency determined 
        appropriate by the Secretary.
            ``(B) Establishing a trusted exchange framework.--
                ``(i) In general.--Not later than 6 months after the 
            date of enactment of the 21st Century Cures Act, the 
            National Coordinator shall convene appropriate public and 
            private stakeholders to develop or support a trusted 
            exchange framework for trust policies and practices and for 
            a common agreement for exchange between health information 
            networks. The common agreement may include--

                    ``(I) a common method for authenticating trusted 
                health information network participants;
                    ``(II) a common set of rules for trusted exchange;
                    ``(III) organizational and operational policies to 
                enable the exchange of health information among 
                networks, including minimum conditions for such 
                exchange to occur; and
                    ``(IV) a process for filing and adjudicating 
                noncompliance with the terms of the common agreement.

                ``(ii) Technical assistance.--The National Coordinator, 
            in collaboration with the National Institute of Standards 
            and Technology, shall provide technical assistance on how 
            to implement the trusted exchange framework and common 
            agreement under this paragraph.
                ``(iii) Pilot testing.--The National Coordinator, in 
            consultation with the National Institute of Standards and 
            Technology, shall provide for the pilot testing of the 
            trusted exchange framework and common agreement established 
            or supported under this subsection (as authorized under 
            section 13201 of the Health Information Technology for 
            Economic and Clinical Health Act). The National 
            Coordinator, in consultation with the National Institute of 
            Standards and Technology, may delegate pilot testing 
            activities under this clause to independent entities with 
            appropriate expertise.
            ``(C) Publication of a trusted exchange framework and 
        common agreement.--Not later than 1 year after convening 
        stakeholders under subparagraph (A), the National Coordinator 
        shall publish on its public Internet website, and in the 
        Federal register, the trusted exchange framework and common 
        agreement developed or supported under subparagraph (B). Such 
        trusted exchange framework and common agreement shall be 
        published in a manner that protects proprietary and security 
        information, including trade secrets and any other protected 
        intellectual property.
            ``(D) Directory of participating health information 
        networks.--
                ``(i) In general.--Not later than 2 years after 
            convening stakeholders under subparagraph (A), and annually 
            thereafter, the National Coordinator shall publish on its 
            public Internet website a list of the health information 
            networks that have adopted the common agreement and are 
            capable of trusted exchange pursuant to the common 
            agreement developed or supported under paragraph (B).
                ``(ii) Process.--The Secretary shall, through notice 
            and comment rulemaking, establish a process for health 
            information networks that voluntarily elect to adopt the 
            trusted exchange framework and common agreement to attest 
            to such adoption of the framework and agreement.
            ``(E) Application of the trusted exchange framework and 
        common agreement.--As appropriate, Federal agencies contracting 
        or entering into agreements with health information exchange 
        networks may require that as each such network upgrades health 
        information technology or trust and operational practices, such 
        network may adopt, where available, the trusted exchange 
        framework and common agreement published under subparagraph 
        (C).
            ``(F) Rule of construction.--
                ``(i) General adoption.--Nothing in this paragraph 
            shall be construed to require a health information network 
            to adopt the trusted exchange framework or common 
            agreement.
                ``(ii) Adoption when exchange of information is within 
            network.--Nothing in this paragraph shall be construed to 
            require a health information network to adopt the trusted 
            exchange framework or common agreement for the exchange of 
            electronic health information between participants of the 
            same network.
                ``(iii) Existing frameworks and agreements.--The 
            trusted exchange framework and common agreement published 
            under subparagraph (C) shall take into account existing 
            trusted exchange frameworks and agreements used by health 
            information networks to avoid the disruption of existing 
            exchanges between participants of health information 
            networks.
                ``(iv) Application by federal agencies.--
            Notwithstanding clauses (i), (ii), and (iii), Federal 
            agencies may require the adoption of the trusted exchange 
            framework and common agreement published under subparagraph 
            (C) for health information exchanges contracting with or 
            entering into agreements pursuant to subparagraph (E).
                ``(v) Consideration of ongoing work.--In carrying out 
            this paragraph, the Secretary shall ensure the 
            consideration of activities carried out by public and 
            private organizations related to exchange between health 
            information exchanges to avoid duplication of efforts.''.
    (c) Provider Digital Contact Information Index.--
        (1) In general.--Not later than 3 years after the date of 
    enactment of this Act, the Secretary of Health and Human Services 
    (referred to in this subsection as the ``Secretary'') shall, 
    directly or through a partnership with a private entity, establish 
    a provider digital contact information index to provide digital 
    contact information for health professionals and health facilities.
        (2) Use of existing index.--In establishing the initial index 
    under paragraph (1), the Secretary may utilize an existing provider 
    directory to make such digital contact information available.
        (3) Contact information.--An index established under this 
    subsection shall ensure that contact information is available at 
    the individual health care provider level and at the health 
    facility or practice level.
        (4) Rule of construction.--
            (A) In general.--The purpose of this subsection is to 
        encourage the exchange of electronic health information by 
        providing the most useful, reliable, and comprehensive index of 
        providers possible. In furthering such purpose, the Secretary 
        shall include all health professionals and health facilities 
        applicable to provide a useful, reliable, and comprehensive 
        index for use in the exchange of health information.
            (B) Limitation.--In no case shall exclusion from the index 
        of providers be used as a measure to achieve objectives other 
        the objectives described in subparagraph (A).
    (d) Standards Development Organizations.--Section 3004 of the 
Public Health Service Act (42 U.S.C. 300jj-14) is amended by adding at 
the end the following:
    ``(c) Deference to Standards Development Organizations.--In 
adopting and implementing standards under this section, the Secretary 
shall give deference to standards published by standards development 
organizations and voluntary consensus-based standards bodies.''.
    (e) Health Information Technology Advisory Committee.--
        (1) In general.--Title XXX of the Public Health Service Act (42 
    U.S.C. 300jj et seq.) is amended by striking sections 3002 (42 
    U.S.C. 300jj-12) and 3003 (42 U.S.C. 300jj-13) and inserting the 
    following:
``SEC. 3002. HEALTH INFORMATION TECHNOLOGY ADVISORY COMMITTEE.
    ``(a) Establishment.--There is established a Health Information 
Technology Advisory Committee (referred to in this section as the `HIT 
Advisory Committee') to recommend to the National Coordinator, 
consistent with the implementation of the strategic plan described in 
section 3001(c)(3), policies, and, for purposes of adoption under 
section 3004, standards, implementation specifications, and 
certification criteria, relating to the implementation of a health 
information technology infrastructure, nationally and locally, that 
advances the electronic access, exchange, and use of health 
information. Such Committee shall serve to unify the roles of, and 
replace, the HIT Policy Committee and the HIT Standards Committee, as 
in existence before the date of the enactment of the 21st Century Cures 
Act.
    ``(b) Duties.--
        ``(1) Recommendations on policy framework to advance an 
    interoperable health information technology infrastructure.--
            ``(A) In general.--The HIT Advisory Committee shall 
        recommend to the National Coordinator a policy framework for 
        adoption by the Secretary consistent with the strategic plan 
        under section 3001(c)(3) for advancing the target areas 
        described in this subsection. Such policy framework shall seek 
        to prioritize achieving advancements in the target areas 
        specified in subparagraph (B) of paragraph (2) and may, to the 
        extent consistent with this section, incorporate policy 
        recommendations made by the HIT Policy Committee, as in 
        existence before the date of the enactment of the 21st Century 
        Cures Act.
            ``(B) Updates.--The HIT Advisory Committee shall propose 
        updates to such recommendations to the policy framework and 
        make new recommendations, as appropriate.
        ``(2) General duties and target areas.--
            ``(A) In general.--The HIT Advisory Committee shall 
        recommend to the National Coordinator for purposes of adoption 
        under section 3004, standards, implementation specifications, 
        and certification criteria and an order of priority for the 
        development, harmonization, and recognition of such standards, 
        specifications, and certification criteria. Such 
        recommendations shall include recommended standards, 
        architectures, and software schemes for access to electronic 
        individually identifiable health information across disparate 
        systems including user vetting, authentication, privilege 
        management, and access control.
            ``(B) Priority target areas.--For purposes of this section, 
        the HIT Advisory Committee shall make recommendations under 
        subparagraph (A) with respect to at least each of the following 
        target areas:
                ``(i) Achieving a health information technology 
            infrastructure, nationally and locally, that allows for the 
            electronic access, exchange, and use of health information, 
            including through technology that provides accurate patient 
            information for the correct patient, including exchanging 
            such information, and avoids the duplication of patient 
            records.
                ``(ii) The promotion and protection of privacy and 
            security of health information in health information 
            technology, including technologies that allow for an 
            accounting of disclosures and protections against 
            disclosures of individually identifiable health information 
            made by a covered entity for purposes of treatment, 
            payment, and health care operations (as such terms are 
            defined for purposes of the regulation promulgated under 
            section 264(c) of the Health Insurance Portability and 
            Accountability Act of 1996), including for the segmentation 
            and protection from disclosure of specific and sensitive 
            individually identifiable health information with the goal 
            of minimizing the reluctance of patients to seek care.
                ``(iii) The facilitation of secure access by an 
            individual to such individual's protected health 
            information and access to such information by a family 
            member, caregiver, or guardian acting on behalf of a 
            patient, including due to age-related and other disability, 
            cognitive impairment, or dementia.
                ``(iv) Subject to subparagraph (D), any other target 
            area that the HIT Advisory Committee identifies as an 
            appropriate target area to be considered under this 
            subparagraph.
            ``(C) Additional target areas.--For purposes of this 
        section, the HIT Advisory Committee may make recommendations 
        under subparagraph (A), in addition to areas described in 
        subparagraph (B), with respect to any of the following areas:
                ``(i) The use of health information technology to 
            improve the quality of health care, such as by promoting 
            the coordination of health care and improving continuity of 
            health care among health care providers, reducing medical 
            errors, improving population health, reducing chronic 
            disease, and advancing research and education.
                ``(ii) The use of technologies that address the needs 
            of children and other vulnerable populations.
                ``(iii) The use of electronic systems to ensure the 
            comprehensive collection of patient demographic data, 
            including at a minimum, race, ethnicity, primary language, 
            and gender information.
                ``(iv) The use of self-service, telemedicine, home 
            health care, and remote monitoring technologies.
                ``(v) The use of technologies that meet the needs of 
            diverse populations.
                ``(vi) The use of technologies that support--

                    ``(I) data for use in quality and public reporting 
                programs;
                    ``(II) public health; or
                    ``(III) drug safety.

                ``(vii) The use of technologies that allow individually 
            identifiable health information to be rendered unusable, 
            unreadable, or indecipherable to unauthorized individuals 
            when such information is transmitted in a health 
            information network or transported outside of the secure 
            facilities or systems where the disclosing covered entity 
            is responsible for security conditions.
                ``(viii) The use of a certified health information 
            technology for each individual in the United States.
            ``(D) Authority for temporary additional priority target 
        areas.--For purposes of subparagraph (B)(iv), the HIT Advisory 
        Committee may identify an area to be considered for purposes of 
        recommendations under this subsection as a target area 
        described in subparagraph (B) if--
                ``(i) the area is so identified for purposes of 
            responding to new circumstances that have arisen in the 
            health information technology community that affect the 
            interoperability, privacy, or security of health 
            information, or affect patient safety; and
                ``(ii) at least 30 days prior to treating such area as 
            if it were a target area described in subparagraph (B), the 
            National Coordinator provides adequate notice to Congress 
            of the intent to treat such area as so described.
            ``(E) Focus of committee work.--It is the sense of Congress 
        that the HIT Advisory Committee shall focus its work on the 
        priority areas described in subparagraph (B) before proceeding 
        to other work under subparagraph (C).
        ``(3) Rules relating to recommendations for standards, 
    implementation specifications, and certification criteria.--
            ``(A) In general.--The HIT Advisory Committee shall 
        recommend to the National Coordinator standards, implementation 
        specifications, and certification criteria described in 
        subsection (a), which may include standards, implementation 
        specifications, and certification criteria that have been 
        developed, harmonized, or recognized by the HIT Advisory 
        Committee or predecessor committee. The HIT Advisory Committee 
        shall update such recommendations and make new recommendations 
        as appropriate, including in response to a notification sent 
        under section 3004(a)(2)(B). Such recommendations shall be 
        consistent with the latest recommendations made by the 
        Committee.
            ``(B) Harmonization.--The HIT Advisory Committee may 
        recognize harmonized or updated standards from an entity or 
        entities for the purpose of harmonizing or updating standards 
        and implementation specifications in order to achieve uniform 
        and consistent implementation of the standards and 
        implementation specification.
            ``(C) Pilot testing of standards and implementation 
        specifications.--In the development, harmonization, or 
        recognition of standards and implementation specifications, the 
        HIT Advisory Committee for purposes of recommendations under 
        paragraph (2)(B), shall, as appropriate, provide for the 
        testing of such standards and specifications by the National 
        Institute for Standards and Technology under section 13201(a) 
        of the Health Information Technology for Economic and Clinical 
        Health Act.
            ``(D) Consistency.--The standards, implementation 
        specifications, and certification criteria recommended under 
        paragraph (2)(B) shall be consistent with the standards for 
        information transactions and data elements adopted pursuant to 
        section 1173 of the Social Security Act.
            ``(E) Special rule related to interoperability.--Any 
        recommendation made by the HIT Advisory Committee after the 
        date of the enactment of this subparagraph with respect to 
        interoperability of health information technology shall be 
        consistent with interoperability as described in section 3000.
        ``(4) Forum.--The HIT Advisory Committee shall serve as a forum 
    for the participation of a broad range of stakeholders with 
    specific expertise in policies, including technical expertise, 
    relating to the matters described in paragraphs (1), (2), and (3) 
    to provide input on the development, harmonization, and recognition 
    of standards, implementation specifications, and certification 
    criteria necessary for the development and adoption of health 
    information technology infrastructure nationally and locally that 
    allows for the electronic access, exchange, and use of health 
    information.
        ``(5) Schedule.--Not later than 30 days after the date on which 
    the HIT Advisory Committee first meets, such HIT Advisory Committee 
    shall develop a schedule for the assessment of policy 
    recommendations developed under paragraph (1). The HIT Advisory 
    Committee shall update such schedule annually. The Secretary shall 
    publish such schedule in the Federal Register.
        ``(6) Public input.--The HIT Advisory Committee shall conduct 
    open public meetings and develop a process to allow for public 
    comment on the schedule described in paragraph (5) and 
    recommendations described in this subsection. Under such process 
    comments shall be submitted in a timely manner after the date of 
    publication of a recommendation under this subsection.
    ``(c) Measured Progress in Advancing Priority Areas.--
        ``(1) In general.--For purposes of this section, the National 
    Coordinator, in collaboration with the Secretary, shall establish, 
    and update as appropriate, objectives and benchmarks for advancing 
    and measuring the advancement of the priority target areas 
    described in subsection (b)(2)(B).
        ``(2) Annual progress reports on advancing interoperability.--
            ``(A) In general.--The HIT Advisory Committee, in 
        consultation with the National Coordinator, shall annually 
        submit to the Secretary and Congress a report on the progress 
        made during the preceding fiscal year in--
                ``(i) achieving a health information technology 
            infrastructure, nationally and locally, that allows for the 
            electronic access, exchange, and use of health information; 
            and
                ``(ii) meeting the objectives and benchmarks described 
            in paragraph (1).
            ``(B) Content.--Each such report shall include, for a 
        fiscal year--
                ``(i) a description of the work conducted by the HIT 
            Advisory Committee during the preceding fiscal year with 
            respect to the areas described in subsection (b)(2)(B);
                ``(ii) an assessment of the status of the 
            infrastructure described in subparagraph (A), including the 
            extent to which electronic health information is 
            appropriately and readily available to enhance the access, 
            exchange, and the use of electronic health information 
            between users and across technology offered by different 
            developers;
                ``(iii) the extent to which advancements have been 
            achieved with respect to areas described in subsection 
            (b)(2)(B);
                ``(iv) an analysis identifying existing gaps in 
            policies and resources for--

                    ``(I) achieving the objectives and benchmarks 
                established under paragraph (1); and
                    ``(II) furthering interoperability throughout the 
                health information technology infrastructure;

                ``(v) recommendations for addressing the gaps 
            identified in clause (iii); and
                ``(vi) a description of additional initiatives as the 
            HIT Advisory Committee and National Coordinator determine 
            appropriate.
        ``(3) Significant advancement determination.--The Secretary 
    shall periodically, based on the reports submitted under this 
    subsection, review the target areas described in subsection 
    (b)(2)(B), and, based on the objectives and benchmarks established 
    under paragraph (1), the Secretary shall determine if significant 
    advancement has been achieved with respect to such an area. Such 
    determination shall be taken into consideration by the HIT Advisory 
    Committee when determining to what extent the Committee makes 
    recommendations for an area other than an area described in 
    subsection (b)(2)(B).
    ``(d) Membership and Operations.--
        ``(1) In general.--The National Coordinator shall take a 
    leading position in the establishment and operations of the HIT 
    Advisory Committee.
        ``(2) Membership.--The membership of the HIT Advisory Committee 
    shall--
            ``(A) include at least 25 members, of which--
                ``(i) no fewer than 2 members are advocates for 
            patients or consumers of health information technology;
                ``(ii) 3 members are appointed by the Secretary, 1 of 
            whom shall be appointed to represent the Department of 
            Health and Human Services and 1 of whom shall be a public 
            health official;
                ``(iii) 2 members are appointed by the majority leader 
            of the Senate;
                ``(iv) 2 members are appointed by the minority leader 
            of the Senate;
                ``(v) 2 members are appointed by the Speaker of the 
            House of Representatives;
                ``(vi) 2 members are appointed by the minority leader 
            of the House of Representatives; and
                ``(vii) such other members are appointed by the 
            Comptroller General of the United States; and
            ``(B) at least reflect providers, ancillary health care 
        workers, consumers, purchasers, health plans, health 
        information technology developers, researchers, patients, 
        relevant Federal agencies, and individuals with technical 
        expertise on health care quality, system functions, privacy, 
        security, and on the electronic exchange and use of health 
        information, including the use standards for such activity.
        ``(3) Participation.--The members of the HIT Advisory Committee 
    shall represent a balance among various sectors of the health care 
    system so that no single sector unduly influences the 
    recommendations of the Committee.
        ``(4) Terms.--
            ``(A) In general.--The terms of the members of the HIT 
        Advisory Committee shall be for 3 years, except that the 
        Secretary shall designate staggered terms of the members first 
        appointed.
            ``(B) Vacancies.--Any member appointed to fill a vacancy in 
        the membership of the HIT Advisory Committee that occurs prior 
        to the expiration of the term for which the member's 
        predecessor was appointed shall be appointed only for the 
        remainder of that term. A member may serve after the expiration 
        of that member's term until a successor has been appointed. A 
        vacancy in the HIT Advisory Committee shall be filled in the 
        manner in which the original appointment was made.
            ``(C) Limits.--Members of the HIT Advisory Committee shall 
        be limited to two 3-year terms, for a total of not to exceed 6 
        years of service on the Committee.
        ``(5) Outside involvement.--The HIT Advisory Committee shall 
    ensure an opportunity for the participation in activities of the 
    Committee of outside advisors, including individuals with expertise 
    in the development of policies and standards for the electronic 
    exchange and use of health information, including in the areas of 
    health information privacy and security.
        ``(6) Quorum.--A majority of the members of the HIT Advisory 
    Committee shall constitute a quorum for purposes of voting, but a 
    lesser number of members may meet and hold hearings.
        ``(7) Consideration.--The National Coordinator shall ensure 
    that the relevant and available recommendations and comments from 
    the National Committee on Vital and Health Statistics are 
    considered in the development of policies.
        ``(8) Assistance.--For the purposes of carrying out this 
    section, the Secretary may provide or ensure that financial 
    assistance is provided by the HIT Advisory Committee to defray in 
    whole or in part any membership fees or dues charged by such 
    Committee to those consumer advocacy groups and not-for-profit 
    entities that work in the public interest as a party of their 
    mission.
    ``(e) Application of FACA.--The Federal Advisory Committee Act (5 
U.S.C. App.), other than section 14 of such Act, shall apply to the HIT 
Advisory Committee.
    ``(f) Publication.--The Secretary shall provide for publication in 
the Federal Register and the posting on the Internet website of the 
Office of the National Coordinator for Health Information Technology of 
all policy recommendations made by the HIT Advisory Committee under 
this section.''.
        (2) Technical and conforming amendments.--Title XXX of the 
    Public Health Service Act (42 U.S.C. 300jj et seq.) is amended--
            (A) by striking--
                (i) ``HIT Policy Committee'' and ``HIT Standards 
            Committee'' each place that such terms appear (other than 
            within the term ``HIT Policy Committee and the HIT 
            Standards Committee'' or within the term ``HIT Policy 
            Committee or the HIT Standards Committee'') and inserting 
            ``HIT Advisory Committee'';
                (ii) ``HIT Policy Committee and the HIT Standards 
            Committee'' each place that such term appears and inserting 
            ``HIT Advisory Committee''; and
                (iii) ``HIT Policy Committee or the HIT Standards 
            Committee'' each place that such term appears and inserting 
            ``HIT Advisory Committee'';
            (B) in section 3000 (42 U.S.C. 300jj)--
                (i) by striking paragraphs (7) and (8) and 
            redesignating paragraphs (9) through (14) as paragraphs (8) 
            through (13), respectively; and
                (ii) by inserting after paragraph (6) the following 
            paragraph:
        ``(7) Hit advisory committee.--The term `HIT Advisory 
    Committee' means such Committee established under section 
    3002(a).'';
            (C) in section 3001(c) (42 U.S.C. 300jj-11(c))--
                (i) in paragraph (1)(A), by striking ``under section 
            3003'' and inserting ``under section 3002'';
                (ii) in paragraph (2), by striking subparagraph (B) and 
            inserting the following:
            ``(B) Hit advisory committee.--The National Coordinator 
        shall be a leading member in the establishment and operations 
        of the HIT Advisory Committee and shall serve as a liaison 
        between that Committee and the Federal Government.'';
            (D) in section 3004(b)(3) (42 U.S.C. 300jj-14(b)(3)), by 
        striking ``3003(b)(2)'' and inserting ``3002(b)(4)'';
            (E) in section 3007(b) (42 U.S.C. 300jj-17(b)), by striking 
        ``3003(a)'' and inserting ``3002(a)(2)''; and
            (F) in section 3008 (42 U.S.C. 300jj-18)--
                (i) in subsection (b), by striking ``or 3003''; and
                (ii) in subsection (c), by striking ``3003(b)(1)(A)'' 
            and inserting ``3002(b)(2)''.
        (3) Transition to the hit advisory committee.--The Secretary of 
    Health and Human Services shall provide for an orderly and timely 
    transition to the HIT Advisory Committee established under 
    amendments made by this section.
    (f) Priorities for Adoption of Standards, Implementation 
Specifications, and Certification Criteria.--Title XXX of the Public 
Health Service Act (42 U.S.C. 300jj et seq.), as amended by subsection 
(e), is further amended by inserting after section 3002 the following:
``SEC. 3003. SETTING PRIORITIES FOR STANDARDS ADOPTION.
    ``(a) Identifying Priorities.--
        ``(1) In general.--Not later than 6 months after the date on 
    which the HIT Advisory Committee first meets, the National 
    Coordinator shall periodically convene the HIT Advisory Committee 
    to--
            ``(A) identify priority uses of health information 
        technology, focusing on priorities--
                ``(i) arising from the implementation of the incentive 
            programs for the meaningful use of certified EHR 
            technology, the Merit-based Incentive Payment System, 
            Alternative Payment Models, the Hospital Value-Based 
            Purchasing Program, and any other value-based payment 
            program determined appropriate by the Secretary;
                ``(ii) related to the quality of patient care;
                ``(iii) related to public health;
                ``(iv) related to clinical research;
                ``(v) related to the privacy and security of electronic 
            health information;
                ``(vi) related to innovation in the field of health 
            information technology;
                ``(vii) related to patient safety;
                ``(viii) related to the usability of health information 
            technology;
                ``(ix) related to individuals' access to electronic 
            health information; and
                ``(x) other priorities determined appropriate by the 
            Secretary;
            ``(B) identify existing standards and implementation 
        specifications that support the use and exchange of electronic 
        health information needed to meet the priorities identified in 
        subparagraph (A); and
            ``(C) publish a report summarizing the findings of the 
        analysis conducted under subparagraphs (A) and (B) and make 
        appropriate recommendations.
        ``(2) Prioritization.--In identifying such standards and 
    implementation specifications under paragraph (1)(B), the HIT 
    Advisory Committee shall prioritize standards and implementation 
    specifications developed by consensus-based standards development 
    organizations.
        ``(3) Guidelines for review of existing standards and 
    specifications.--In consultation with the consensus-based entity 
    described in section 1890 of the Social Security Act and other 
    appropriate Federal agencies, the analysis of existing standards 
    under paragraph (1)(B) shall include an evaluation of the need for 
    a core set of common data elements and associated value sets to 
    enhance the ability of certified health information technology to 
    capture, use, and exchange structured electronic health 
    information.
    ``(b) Review of Adopted Standards.--
        ``(1) In general.--Beginning 5 years after the date of 
    enactment of the 21st Century Cures Act and every 3 years 
    thereafter, the National Coordinator shall convene stakeholders to 
    review the existing set of adopted standards and implementation 
    specifications and make recommendations with respect to whether 
    to--
            ``(A) maintain the use of such standards and implementation 
        specifications; or
            ``(B) phase out such standards and implementation 
        specifications.
        ``(2) Priorities.--The HIT Advisory Committee, in collaboration 
    with the National Institute for Standards and Technology, shall 
    annually and through the use of public input, review and publish 
    priorities for the use of health information technology, standards, 
    and implementation specifications to support those priorities.
    ``(c) Rule of Construction.--Nothing in this section shall be 
construed to prevent the use or adoption of novel standards that 
improve upon the existing health information technology infrastructure 
and facilitate the secure exchange of health information.''.
SEC. 4004. INFORMATION BLOCKING.
    Subtitle C of title XXX of the Public Health Service Act (42 U.S.C. 
300jj-51 et seq.) is amended by adding at the end the following:
``SEC. 3022. INFORMATION BLOCKING.
    ``(a) Definition.--
        ``(1) In general.--In this section, the term `information 
    blocking' means a practice that--
            ``(A) except as required by law or specified by the 
        Secretary pursuant to rulemaking under paragraph (3), is likely 
        to interfere with, prevent, or materially discourage access, 
        exchange, or use of electronic health information; and
            ``(B)(i) if conducted by a health information technology 
        developer, exchange, or network, such developer, exchange, or 
        network knows, or should know, that such practice is likely to 
        interfere with, prevent, or materially discourage the access, 
        exchange, or use of electronic health information; or
            ``(ii) if conducted by a health care provider, such 
        provider knows that such practice is unreasonable and is likely 
        to interfere with, prevent, or materially discourage access, 
        exchange, or use of electronic health information.
        ``(2) Practices described.--The information blocking practices 
    described in paragraph (1) may include--
            ``(A) practices that restrict authorized access, exchange, 
        or use under applicable State or Federal law of such 
        information for treatment and other permitted purposes under 
        such applicable law, including transitions between certified 
        health information technologies;
            ``(B) implementing health information technology in 
        nonstandard ways that are likely to substantially increase the 
        complexity or burden of accessing, exchanging, or using 
        electronic health information; and
            ``(C) implementing health information technology in ways 
        that are likely to--
                ``(i) restrict the access, exchange, or use of 
            electronic health information with respect to exporting 
            complete information sets or in transitioning between 
            health information technology systems; or
                ``(ii) lead to fraud, waste, or abuse, or impede 
            innovations and advancements in health information access, 
            exchange, and use, including care delivery enabled by 
            health information technology.
        ``(3) Rulemaking.--The Secretary, through rulemaking, shall 
    identify reasonable and necessary activities that do not constitute 
    information blocking for purposes of paragraph (1).
        ``(4) No enforcement before exception identified.--The term 
    `information blocking' does not include any practice or conduct 
    occurring prior to the date that is 30 days after the date of 
    enactment of the 21st Century Cures Act.
        ``(5) Consultation.--The Secretary may consult with the Federal 
    Trade Commission in promulgating regulations under this subsection, 
    to the extent that such regulations define practices that are 
    necessary to promote competition and consumer welfare.
        ``(6) Application.--The term `information blocking', with 
    respect to an individual or entity, shall not include an act or 
    practice other than an act or practice committed by such individual 
    or entity.
        ``(7) Clarification.--In carrying out this section, the 
    Secretary shall ensure that health care providers are not penalized 
    for the failure of developers of health information technology or 
    other entities offering health information technology to such 
    providers to ensure that such technology meets the requirements to 
    be certified under this title.
    ``(b) Inspector General Authority.--
        ``(1) In general.--The inspector general of the Department of 
    Health and Human Services (referred to in this section as the 
    `Inspector General') may investigate any claim that--
            ``(A) a health information technology developer of 
        certified health information technology or other entity 
        offering certified health information technology--
                ``(i) submitted a false attestation under section 
            3001(c)(5)(D)(vii); or
                ``(ii) engaged in information blocking;
            ``(B) a health care provider engaged in information 
        blocking; or
            ``(C) a health information exchange or network engaged in 
        information blocking.
        ``(2) Penalties.--
            ``(A) Developers, networks, and exchanges.--Any individual 
        or entity described in subparagraph (A) or (C) of paragraph (1) 
        that the Inspector General, following an investigation 
        conducted under this subsection, determines to have committed 
        information blocking shall be subject to a civil monetary 
        penalty determined by the Secretary for all such violations 
        identified through such investigation, which may not exceed 
        $1,000,000 per violation. Such determination shall take into 
        account factors such as the nature and extent of the 
        information blocking and harm resulting from such information 
        blocking, including, where applicable, the number of patients 
        affected, the number of providers affected, and the number of 
        days the information blocking persisted.
            ``(B) Providers.--Any individual or entity described in 
        subparagraph (B) of paragraph (1) determined by the Inspector 
        General to have committed information blocking shall be 
        referred to the appropriate agency to be subject to appropriate 
        disincentives using authorities under applicable Federal law, 
        as the Secretary sets forth through notice and comment 
        rulemaking.
            ``(C) Procedure.--The provisions of section 1128A of the 
        Social Security Act (other than subsections (a) and (b) of such 
        section) shall apply to a civil money penalty applied under 
        this paragraph in the same manner as such provisions apply to a 
        civil money penalty or proceeding under such section 1128A(a).
            ``(D) Recovered penalty funds.--The amounts recovered under 
        this paragraph shall be allocated as follows:
                ``(i) Annual operating expenses.--Each year following 
            the establishment of the authority under this subsection, 
            the Office of the Inspector General shall provide to the 
            Secretary an estimate of the costs to carry out 
            investigations under this section. Such estimate may 
            include reasonable reserves to account for variance in 
            annual amounts recovered under this paragraph. There is 
            authorized to be appropriated for purposes of carrying out 
            this section an amount equal to the amount specified in 
            such estimate for the fiscal year.
                ``(ii) Application to other programs.--The amounts 
            recovered under this paragraph and remaining after amounts 
            are made available under clause (i) shall be transferred to 
            the Federal Hospital Insurance Trust Fund under section 
            1817 of the Social Security Act and the Federal 
            Supplementary Medical Insurance Trust Fund under section 
            1841 of such Act, in such proportion as the Secretary 
            determines appropriate.
            ``(E) Authorization of appropriations.--There is authorized 
        to be appropriated to the Office of the Inspector General to 
        carry out this section $10,000,000, to remain available until 
        expended.
        ``(3) Resolution of claims.--
            ``(A) In general.--The Office of the Inspector General, if 
        such Office determines that a consultation regarding the health 
        privacy and security rules promulgated under section 264(c) of 
        the Health Insurance Portability and Accountability Act of 1996 
        (42 U.S.C. 1320d-2 note) will resolve an information blocking 
        claim, may refer such instances of information blocking to the 
        Office for Civil Rights of the Department of Health and Human 
        Services for resolution.
            ``(B) Limitation on liability.--If a health care provider 
        or health information technology developer makes information 
        available based on a good faith reliance on consultations with 
        the Office for Civil Rights of the Department of Health and 
        Human Services pursuant to a referral under subparagraph (A), 
        with respect to such information, the health care provider or 
        developer shall not be liable for such disclosure or 
        disclosures made pursuant to subparagraph (A).
    ``(c) Identifying Barriers To Exchange of Certified Health 
Information Technology.--
        ``(1) Trusted exchange defined.--In this section, the term 
    `trusted exchange' with respect to certified electronic health 
    records means that the certified electronic health record 
    technology has the technical capability to enable secure health 
    information exchange between users and multiple certified 
    electronic health record technology systems.
        ``(2) Guidance.--The National Coordinator, in consultation with 
    the Office for Civil Rights of the Department of Health and Human 
    Services, shall issue guidance on common legal, governance, and 
    security barriers that prevent the trusted exchange of electronic 
    health information.
        ``(3) Referral.--The National Coordinator and the Office for 
    Civil Rights of the Department of Health and Human Services may 
    refer to the Inspector General instances or patterns of refusal to 
    exchange health information with an individual or entity using 
    certified electronic health record technology that is technically 
    capable of trusted exchange and under conditions when exchange is 
    legally permissible.
    ``(d) Additional Provisions.--
        ``(1) Information sharing provisions.--The National Coordinator 
    may serve as a technical consultant to the Inspector General and 
    the Federal Trade Commission for purposes of carrying out this 
    section. The National Coordinator may, notwithstanding any other 
    provision of law, share information related to claims or 
    investigations under subsection (b) with the Federal Trade 
    Commission for purposes of such investigations and shall share 
    information with the Inspector General, as required by law.
        ``(2) Protection from disclosure of information.--Any 
    information that is received by the National Coordinator in 
    connection with a claim or suggestion of possible information 
    blocking and that could reasonably be expected to facilitate 
    identification of the source of the information--
            ``(A) shall not be disclosed by the National Coordinator 
        except as may be necessary to carry out the purpose of this 
        section;
            ``(B) shall be exempt from mandatory disclosure under 
        section 552 of title 5, United States Code, as provided by 
        subsection (b)(3) of such section; and
            ``(C) may be used by the Inspector General or Federal Trade 
        Commission for reporting purposes to the extent that such 
        information could not reasonably be expected to facilitate 
        identification of the source of such information.
        ``(3) Standardized process.--
            ``(A) In general.--The National Coordinator shall implement 
        a standardized process for the public to submit reports on 
        claims of--
                ``(i) health information technology products or 
            developers of such products (or other entities offering 
            such products to health care providers) not being 
            interoperable or resulting in information blocking;
                ``(ii) actions described in subsection (b)(1) that 
            result in information blocking as described in subsection 
            (a); and
                ``(iii) any other act described in subsection (a).
            ``(B) Collection of information.--The standardized process 
        implemented under subparagraph (A) shall provide for the 
        collection of such information as the originating institution, 
        location, type of transaction, system and version, timestamp, 
        terminating institution, locations, system and version, failure 
        notice, and other related information.
        ``(4) Nonduplication of penalty structures.--In carrying out 
    this subsection, the Secretary shall, to the extent possible, 
    ensure that penalties do not duplicate penalty structures that 
    would otherwise apply with respect to information blocking and the 
    type of individual or entity involved as of the day before the date 
    of the enactment of this section.''.
SEC. 4005. LEVERAGING ELECTRONIC HEALTH RECORDS TO IMPROVE PATIENT 
CARE.
    (a) Requirement Relating to Registries.--
        (1) In general.--To be certified in accordance with title XXX 
    of the Public Health Service Act (42 U.S.C. 300jj et seq.), 
    electronic health records shall be capable of transmitting to, and 
    where applicable, receiving and accepting data from, registries in 
    accordance with standards recognized by the Office of the National 
    Coordinator for Health Information Technology, including clinician-
    led clinical data registries, that are also certified to be 
    technically capable of receiving and accepting from, and where 
    applicable, transmitting data to certified electronic health record 
    technology in accordance with such standards.
        (2) Rule of construction.--Nothing in this subsection shall be 
    construed to require the certification of registries beyond the 
    technical capability to exchange data in accordance with applicable 
    recognized standards.
    (b) Definition.--For purposes of this Act, the term ``clinician-led 
clinical data registry'' means a clinical data repository--
        (1) that is established and operated by a clinician-led or 
    controlled, tax-exempt (pursuant to section 501(c) of the Internal 
    Revenue Code of 1986), professional society or other similar 
    clinician-led or -controlled organization, or such organization's 
    controlled affiliate, devoted to the care of a population defined 
    by a particular disease, condition, exposure or therapy;
        (2) that is designed to collect detailed, standardized data on 
    an ongoing basis for medical procedures, services, or therapies for 
    particular diseases, conditions, or exposures;
        (3) that provides feedback to participants who submit reports 
    to the repository;
        (4) that meets standards for data quality including--
            (A) systematically collecting clinical and other health 
        care data, using standardized data elements and having 
        procedures in place to verify the completeness and validity of 
        those data; and
            (B) being subject to regular data checks or audits to 
        verify completeness and validity; and
        (5) that provides ongoing participant training and support.
    (c) Treatment of Health Information Technology Developers With 
Respect to Patient Safety Organizations.--
        (1) In general.--In applying part C of title IX of the Public 
    Health Service Act (42 U.S.C. 299b-21 et seq.), a health 
    information technology developer shall be treated as a provider (as 
    defined in section 921 of such Act) for purposes of reporting and 
    conducting patient safety activities concerning improving clinical 
    care through the use of health information technology that could 
    result in improved patient safety, health care quality, or health 
    care outcomes.
        (2) Report.--Not later than 4 years after the date of enactment 
    of this Act, the Secretary of Health and Human Services shall 
    submit to the Committee on Health, Education, Labor, and Pensions 
    of the Senate and the Committee on Energy and Commerce of the House 
    of Representatives, a report concerning best practices and current 
    trends voluntarily provided, without identifying individual 
    providers or disclosing or using protected health information or 
    individually identifiable information, by patient safety 
    organizations to improve the integration of health information 
    technology into clinical practice.
SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PATIENT ACCESS TO THEIR 
ELECTRONIC HEALTH INFORMATION.
    (a) Use of Health Information Exchanges for Patient Access.--
Section 3009 of the Public Health Service Act (42 U.S.C. 300jj-19) is 
amended by adding at the end the following:
    ``(c) Promoting Patient Access to Electronic Health Information 
Through Health Information Exchanges .--
        ``(1) In general.--The Secretary shall use existing authorities 
    to encourage partnerships between health information exchange 
    organizations and networks and health care providers, health plans, 
    and other appropriate entities with the goal of offering patients 
    access to their electronic health information in a single, 
    longitudinal format that is easy to understand, secure, and may be 
    updated automatically.
        ``(2) Education of providers.--The Secretary, in coordination 
    with the Office for Civil Rights of the Department of Health and 
    Human Services, shall--
            ``(A) educate health care providers on ways of leveraging 
        the capabilities of health information exchanges (or other 
        relevant platforms) to provide patients with access to their 
        electronic health information;
            ``(B) clarify misunderstandings by health care providers 
        about using health information exchanges (or other relevant 
        platforms) for patient access to electronic health information; 
        and
            ``(C) to the extent practicable, educate providers about 
        health information exchanges (or other relevant platforms) that 
        employ some or all of the capabilities described in paragraph 
        (1).
        ``(3) Requirements.--In carrying out paragraph (1), the 
    Secretary, in coordination with the Office for Civil Rights, shall 
    issue guidance to health information exchanges related to best 
    practices to ensure that the electronic health information provided 
    to patients is--
            ``(A) private and secure;
            ``(B) accurate;
            ``(C) verifiable; and
            ``(D) where a patient's authorization to exchange 
        information is required by law, easily exchanged pursuant to 
        such authorization.
        ``(4) Rule of construction.--Nothing in this subsection shall 
    be construed to preempt State laws applicable to patient consent 
    for the access of information through a health information exchange 
    (or other relevant platform) that provide protections to patients 
    that are greater than the protections otherwise provided for under 
    applicable Federal law.
    ``(d) Efforts To Promote Access to Health Information.--The 
National Coordinator and the Office for Civil Rights of the Department 
of Health and Human Services shall jointly promote patient access to 
health information in a manner that would ensure that such information 
is available in a form convenient for the patient, in a reasonable 
manner, without burdening the health care provider involved.
    ``(e) Accessibility of Patient Records.--
        ``(1) Accessibility and updating of information.--
            ``(A) In general.--The Secretary, in consultation with the 
        National Coordinator, shall promote policies that ensure that a 
        patient's electronic health information is accessible to that 
        patient and the patient's designees, in a manner that 
        facilitates communication with the patient's health care 
        providers and other individuals, including researchers, 
        consistent with such patient's consent.
            ``(B) Updating education on accessing and exchanging 
        personal health information.--To promote awareness that an 
        individual has a right of access to inspect, obtain a copy of, 
        and transmit to a third party a copy of such individual's 
        protected health information pursuant to the Health Information 
        Portability and Accountability Act, Privacy Rule (subpart E of 
        part 164 of title 45, Code of Federal Regulations), the 
        Director of the Office for Civil Rights, in consultation with 
        the National Coordinator, shall assist individuals and health 
        care providers in understanding a patient's rights to access 
        and protect personal health information under the Health 
        Insurance Portability and Accountability Act of 1996 (Public 
        Law 104-191), including providing best practices for requesting 
        personal health information in a computable format, including 
        using patient portals or third-party applications and common 
        cases when a provider is permitted to exchange and provide 
        access to health information.''.
        ``(2) Certifying usability for patients.--In carrying out 
    certification programs under section 3001(c)(5), the National 
    Coordinator may require that--
            ``(A) the certification criteria support--
                ``(i) patient access to their electronic health 
            information, including in a single longitudinal format that 
            is easy to understand, secure, and may be updated 
            automatically;
                ``(ii) the patient's ability to electronically 
            communicate patient-reported information (such as family 
            history and medical history); and
                ``(iii) patient access to their personal electronic 
            health information for research at the option of the 
            patient; and
            ``(B) the HIT Advisory Committee develop and prioritize 
        standards, implementation specifications, and certification 
        criteria required to help support patient access to electronic 
        health information, patient usability, and support for 
        technologies that offer patients access to their electronic 
        health information in a single, longitudinal format that is 
        easy to understand, secure, and may be updated 
        automatically.''.
    (b) Access to Information in an Electronic Format.--Section 
13405(e) of the Health Information Technology for Economic and Clinical 
Health Act (42 U.S.C. 17935) is amended--
        (1) in paragraph (1), by striking ``and'' at the end;
        (2) by redesignating paragraph (2) as paragraph (3); and
        (3) by inserting after paragraph (1), the following:
        ``(2) if the individual makes a request to a business associate 
    for access to, or a copy of, protected health information about the 
    individual, or if an individual makes a request to a business 
    associate to grant such access to, or transmit such copy directly 
    to, a person or entity designated by the individual, a business 
    associate may provide the individual with such access or copy, 
    which may be in an electronic form, or grant or transmit such 
    access or copy to such person or entity designated by the 
    individual; and''.
SEC. 4007. GAO STUDY ON PATIENT MATCHING.
    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Comptroller General of the United States shall conduct 
a study to--
        (1) review the policies and activities of the Office of the 
    National Coordinator for Health Information Technology and other 
    relevant stakeholders, which may include standards development 
    organizations, experts in the technical aspects of health 
    information technology, health information technology developers, 
    providers of health services, health care suppliers, health care 
    payers, health care quality organizations, States, health 
    information technology policy experts, and other appropriate 
    entities, to ensure appropriate patient matching to protect patient 
    privacy and security with respect to electronic health records and 
    the exchange of electronic health information; and
        (2) survey ongoing efforts related to the policies and 
    activities described in paragraph (1) and the effectiveness of such 
    efforts occurring in the private sector.
    (b) Areas of Concentration.--In conducting the study under 
subsection (a), the Comptroller General shall--
        (1) evaluate current methods used in certified electronic 
    health records for patient matching based on performance related to 
    factors such as--
            (A) the privacy of patient information;
            (B) the security of patient information;
            (C) improving matching rates;
            (D) reducing matching errors; and
            (E) reducing duplicate records; and
        (2) determine whether the Office of the National Coordinator 
    for Health Information Technology could improve patient matching by 
    taking steps including--
            (A) defining additional data elements to assist in patient 
        data matching;
            (B) agreeing on a required minimum set of elements that 
        need to be collected and exchanged;
            (C) requiring electronic health records to have the ability 
        to make certain fields required and use specific standards; and
            (D) other options recommended by the relevant stakeholders 
        consulted pursuant to subsection (a).
    (c) Report.--Not later than 2 years after the date of enactment of 
this Act, the Comptroller General shall submit to the appropriate 
committees of Congress a report concerning the findings of the study 
conducted under subsection (a).
SEC. 4008. GAO STUDY ON PATIENT ACCESS TO HEALTH INFORMATION.
    (a) Study.--
        (1) In general.--The Comptroller General of the United States 
    (referred to in this section as the ``Comptroller General'') shall 
    build on prior Government Accountability Office studies and other 
    literature review and conduct a study to review patient access to 
    their own protected health information, including barriers to such 
    patient access and complications or difficulties providers 
    experience in providing access to patients. In conducting such 
    study, the Comptroller General shall consider the increase in 
    adoption of health information technology and the increasing 
    prevalence of protected health information that is maintained 
    electronically.
        (2) Areas of concentration.--In conducting the review under 
    paragraph (1), the Comptroller General shall consider--
            (A) instances when covered entities charge individuals, 
        including patients, third parties, and health care providers, 
        for record requests, including records that are requested in an 
        electronic format;
            (B) examples of the amounts and types of fees charged to 
        individuals for record requests, including instances when the 
        record is requested to be transmitted to a third party;
            (C) the extent to which covered entities are unable to 
        provide the access requested by individuals in the form and 
        format requested by the individual, including examples of such 
        instances;
            (D) instances in which third parties may request protected 
        health information through patients' individual right of 
        access, including instances where such requests may be used to 
        circumvent appropriate fees that may be charged to third 
        parties;
            (E) opportunities that permit covered entities to charge 
        appropriate fees to third parties for patient records while 
        providing patients with access to their protected health 
        information at low or no cost;
            (F) the ability of providers to distinguish between 
        requests originating from an individual that require limitation 
        to a cost-based fee and requests originating from third parties 
        that may not be limited to cost-based fees; and
            (G) other circumstances that may inhibit the ability of 
        providers to provide patients with access to their records, and 
        the ability of patients to gain access to their records.
    (b) Report.--Not later than 18 months after the date of enactment 
of this Act, the Comptroller General shall submit a report to Congress 
on the findings of the study conducted under subsection (a).
SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINATIONS.
    (a) In General.--Section 1862(l)(5) of the Social Security Act (42 
U.S.C. 1395y(l)(5)) is amended by adding at the end the following new 
subparagraph:
            ``(D) Local coverage determinations.--The Secretary shall 
        require each Medicare administrative contractor that develops a 
        local coverage determination to make available on the Internet 
        website of such contractor and on the Medicare Internet 
        website, at least 45 days before the effective date of such 
        determination, the following information:
                ``(i) Such determination in its entirety.
                ``(ii) Where and when the proposed determination was 
            first made public.
                ``(iii) Hyperlinks to the proposed determination and a 
            response to comments submitted to the contractor with 
            respect to such proposed determination.
                ``(iv) A summary of evidence that was considered by the 
            contractor during the development of such determination and 
            a list of the sources of such evidence.
                ``(v) An explanation of the rationale that supports 
            such determination.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply with respect to local coverage determinations that are proposed 
or revised on or after the date that is 180 days after the date of 
enactment of this Act.
SEC. 4010. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.
    Section 1808 of the Social Security Act (42 U.S.C. 1395b-9) is 
amended by adding at the end the following new subsection:
    ``(d) Pharmaceutical and Technology Ombudsman.--
        ``(1) In general.--Not later than 12 months after the date of 
    enactment of this paragraph, the Secretary shall provide for a 
    pharmaceutical and technology ombudsman within the Centers for 
    Medicare & Medicaid Services who shall receive and respond to 
    complaints, grievances, and requests that--
            ``(A) are from entities that manufacture pharmaceutical, 
        biotechnology, medical device, or diagnostic products that are 
        covered or for which coverage is being sought under this title; 
        and
            ``(B) are with respect to coverage, coding, or payment 
        under this title for such products.
        ``(2) Application.--The second sentence of subsection (c)(2) 
    shall apply to the ombudsman under subparagraph (A) in the same 
    manner as such sentence applies to the Medicare Beneficiary 
    Ombudsman under subsection (c).''.
SEC. 4011. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY.
    Section 1834 of the Social Security Act (42 U.S.C. 1395m) is 
amended by adding at the end the following new subsection:
    ``(t) Site-of-Service Price Transparency.--
        ``(1) In general.--In order to facilitate price transparency 
    with respect to items and services for which payment may be made 
    either to a hospital outpatient department or to an ambulatory 
    surgical center under this title, the Secretary shall, for 2018 and 
    each year thereafter, make available to the public via a searchable 
    Internet website, with respect to an appropriate number of such 
    items and services--
            ``(A) the estimated payment amount for the item or service 
        under the outpatient department fee schedule under subsection 
        (t) of section 1833 and the ambulatory surgical center payment 
        system under subsection (i) of such section; and
            ``(B) the estimated amount of beneficiary liability 
        applicable to the item or service.
        ``(2) Calculation of estimated beneficiary liability.--For 
    purposes of paragraph (1)(B), the estimated amount of beneficiary 
    liability, with respect to an item or service, is the amount for 
    such item or service for which an individual who does not have 
    coverage under a Medicare supplemental policy certified under 
    section 1882 or any other supplemental insurance coverage is 
    responsible.
        ``(3) Implementation.--In carrying out this subsection, the 
    Secretary--
            ``(A) shall include in the notice described in section 
        1804(a) a notification of the availability of the estimated 
        amounts made available under paragraph (1); and
            ``(B) may utilize mechanisms in existence on the date of 
        enactment of this subsection, such as the portion of the 
        Internet website of the Centers for Medicare & Medicaid 
        Services on which information comparing physician performance 
        is posted (commonly referred to as the Physician Compare 
        Internet website), to make available such estimated amounts 
        under such paragraph.
        ``(4) Funding.--For purposes of implementing this subsection, 
    the Secretary shall provide for the transfer, from the Federal 
    Supplementary Medical Insurance Trust Fund under section 1841 to 
    the Centers for Medicare & Medicaid Services Program Management 
    Account, of $6,000,000 for fiscal year 2017, to remain available 
    until expended.''.
SEC. 4012. TELEHEALTH SERVICES IN MEDICARE.
    (a) Provision of Information by Centers for Medicare & Medicaid 
Services.--Not later than 1 year after the date of enactment of this 
Act, the Administrator of the Centers for Medicare & Medicaid Services 
shall provide to the committees of jurisdiction of the House of 
Representatives and the Senate information on the following:
        (1) The populations of Medicare beneficiaries, such as those 
    who are dually eligible for the Medicare program under title XVIII 
    of the Social Security Act (42 U.S.C. 1395 et seq.) and the 
    Medicaid program under title XIX of such Act (42 U.S.C. 1396 et 
    seq.) and those with chronic conditions, whose care may be improved 
    most in terms of quality and efficiency by the expansion, in a 
    manner that meets or exceeds the existing in-person standard of 
    care under the Medicare program under such title XVIII, of 
    telehealth services under section 1834(m)(4) of such Act (42 U.S.C. 
    1395m(m)(4)).
        (2) Activities by the Center for Medicare and Medicaid 
    Innovation which examine the use of telehealth services in models, 
    projects, or initiatives funded through section 1115A of such Act 
    (42 U.S.C. 1315a).
        (3) The types of high-volume services (and related diagnoses) 
    under such title XVIII which might be suitable to be furnished 
    using telehealth.
        (4) Barriers that might prevent the expansion of telehealth 
    services under section 1834(m)(4) of the Social Security Act (42 
    U.S.C. 1395m(m)(4)) beyond such services that are in effect as of 
    the date of enactment of this Act.
    (b) Provision of Information by MedPAC.--Not later than March 15, 
2018, the Medicare Payment Advisory Commission established under 
section 1805 of the Social Security Act (42 U.S.C. 1395b-6) shall, 
using quantitative and qualitative research methods, provide 
information to the committees of jurisdiction of the House of 
Representatives and the Senate that identifies--
        (1) the telehealth services for which payment can be made, as 
    of the date of enactment of this Act, under the fee-for-service 
    program under parts A and B of title XVIII of such Act;
        (2) the telehealth services for which payment can be made, as 
    of such date, under private health insurance plans; and
        (3) with respect to services identified under paragraph (2) but 
    not under paragraph (1), ways in which payment for such services 
    might be incorporated into such fee-for-service program (including 
    any recommendations for ways to accomplish this incorporation).
    (c) Sense of Congress.--It is the sense of Congress that--
        (1) eligible originating sites should be expanded beyond those 
    originating sites described in section 1834(m)(4)(C) of the Social 
    Security Act (42 U.S.C. 1395m(m)(4)(C)); and
        (2) any expansion of telehealth services under the Medicare 
    program under title XVIII of such Act should--
            (A) recognize that telemedicine is the delivery of safe, 
        effective, quality health care services, by a health care 
        provider, using technology as the mode of care delivery;
            (B) meet or exceed the conditions of coverage and payment 
        with respect to the Medicare program if the service was 
        furnished in person, including standards of care, unless 
        specifically addressed in subsequent legislation; and
            (C) involve clinically appropriate means to furnish such 
        services.

                            TITLE V--SAVINGS

SEC. 5001. SAVINGS IN THE MEDICARE IMPROVEMENT FUND.
    Section 1898(b)(1) of the Social Security Act (42 U.S.C. 
1395iii(b)(1)), as amended by section 704(h) of the Comprehensive 
Addiction and Recovery Act of 2016, is amended by striking 
``$140,000,000'' and inserting ``$270,000,000''.
SEC. 5002. MEDICAID REIMBURSEMENT TO STATES FOR DURABLE MEDICAL 
EQUIPMENT.
    Section 1903(i)(27) of the Social Security Act (42 U.S.C. 
1396b(i)(27)) is amended by striking ``January 1, 2019'' and inserting 
``January 1, 2018''.
SEC. 5003. PENALTIES FOR VIOLATIONS OF GRANTS, CONTRACTS, AND OTHER 
AGREEMENTS.
    (a) In General.--Section 1128A of the Social Security Act (42 
U.S.C. 1320a-7a) is amended by adding at the end the following new 
subsections:
    ``(o) Any person (including an organization, agency, or other 
entity, but excluding a program beneficiary, as defined in subsection 
(q)(4)) that, with respect to a grant, contract, or other agreement for 
which the Secretary provides funding--
        ``(1) knowingly presents or causes to be presented a specified 
    claim (as defined in subsection (r)) under such grant, contract, or 
    other agreement that the person knows or should know is false or 
    fraudulent;
        ``(2) knowingly makes, uses, or causes to be made or used any 
    false statement, omission, or misrepresentation of a material fact 
    in any application, proposal, bid, progress report, or other 
    document that is required to be submitted in order to directly or 
    indirectly receive or retain funds provided in whole or in part by 
    such Secretary pursuant to such grant, contract, or other 
    agreement;
        ``(3) knowingly makes, uses, or causes to be made or used, a 
    false record or statement material to a false or fraudulent 
    specified claim under such grant, contract, or other agreement;
        ``(4) knowingly makes, uses, or causes to be made or used, a 
    false record or statement material to an obligation (as defined in 
    subsection (s)) to pay or transmit funds or property to such 
    Secretary with respect to such grant, contract, or other agreement, 
    or knowingly conceals or knowingly and improperly avoids or 
    decreases an obligation to pay or transmit funds or property to 
    such Secretary with respect to such grant, contract, or other 
    agreement; or
        ``(5) fails to grant timely access, upon reasonable request (as 
    defined by such Secretary in regulations), to the Inspector General 
    of the Department, for the purpose of audits, investigations, 
    evaluations, or other statutory functions of such Inspector General 
    in matters involving such grants, contracts, or other agreements;
shall be subject, in addition to any other penalties that may be 
prescribed by law, to a civil money penalty in cases under paragraph 
(1), of not more than $10,000 for each specified claim; in cases under 
paragraph (2), not more than $50,000 for each false statement, 
omission, or misrepresentation of a material fact; in cases under 
paragraph (3), not more than $50,000 for each false record or 
statement; in cases under paragraph (4), not more than $50,000 for each 
false record or statement or $10,000 for each day that the person 
knowingly conceals or knowingly and improperly avoids or decreases an 
obligation to pay; or in cases under paragraph (5), not more than 
$15,000 for each day of the failure described in such paragraph. In 
addition, in cases under paragraphs (1) and (3), such a person shall be 
subject to an assessment of not more than 3 times the amount claimed in 
the specified claim described in such paragraph in lieu of damages 
sustained by the United States or a specified State agency because of 
such specified claim, and in cases under paragraphs (2) and (4), such a 
person shall be subject to an assessment of not more than 3 times the 
total amount of the funds described in paragraph (2) or (4), 
respectively (or, in the case of an obligation to transmit property to 
the Secretary described in paragraph (4), of the value of the property 
described in such paragraph) in lieu of damages sustained by the United 
States or a specified State agency because of such case. In addition, 
the Secretary may make a determination in the same proceeding to 
exclude the person from participation in the Federal health care 
programs (as defined in section 1128B(f)(1)) and to direct the 
appropriate State agency to exclude the person from participation in 
any State health care program.
    ``(p) The provisions of subsections (c), (d), (g), and (h) shall 
apply to a civil money penalty or assessment under subsection (o) in 
the same manner as such provisions apply to a penalty, assessment, or 
proceeding under subsection (a). In applying subsection (d), each 
reference to a claim under such subsection shall be treated as 
including a reference to a specified claim (as defined in subsection 
(r)).
    ``(q) For purposes of this subsection and subsections (o) and (p):
        ``(1) The term `Department' means the Department of Health and 
    Human Services.
        ``(2) The term `material' means having a natural tendency to 
    influence, or be capable of influencing, the payment or receipt of 
    money or property.
        ``(3) The term `other agreement' includes a cooperative 
    agreement, scholarship, fellowship, loan, subsidy, payment for a 
    specified use, donation agreement, award, or subaward (regardless 
    of whether one or more of the persons entering into the agreement 
    is a contractor or subcontractor).
        ``(4) The term `program beneficiary' means, in the case of a 
    grant, contract, or other agreement designed to accomplish the 
    objective of awarding or otherwise furnishing benefits or 
    assistance to individuals and for which the Secretary provides 
    funding, an individual who applies for, or who receives, such 
    benefits or assistance from such grant, contract, or other 
    agreement. Such term does not include, with respect to such grant, 
    contract, or other agreement, an officer, employee, or agent of a 
    person or entity that receives such grant or that enters into such 
    contract or other agreement.
        ``(5) The term `recipient' includes a subrecipient or 
    subcontractor.
        ``(6) The term `specified State agency' means an agency of a 
    State government established or designated to administer or 
    supervise the administration of a grant, contract, or other 
    agreement funded in whole or in part by the Secretary.
    ``(r) For purposes of this section, the term `specified claim' 
means any application, request, or demand under a grant, contract, or 
other agreement for money or property, whether or not the United States 
or a specified State agency has title to the money or property, that is 
not a claim (as defined in subsection (i)(2)) and that--
        ``(1) is presented or caused to be presented to an officer, 
    employee, or agent of the Department or agency thereof, or of any 
    specified State agency; or
        ``(2) is made to a contractor, grantee, or any other recipient 
    if the money or property is to be spent or used on the Department's 
    behalf or to advance a Department program or interest, and if the 
    Department--
            ``(A) provides or has provided any portion of the money or 
        property requested or demanded; or
            ``(B) will reimburse such contractor, grantee, or other 
        recipient for any portion of the money or property which is 
        requested or demanded.
    ``(s) For purposes of subsection (o), the term `obligation' means 
an established duty, whether or not fixed, arising from an express or 
implied contractual, grantor-grantee, or licensor-licensee 
relationship, for a fee-based or similar relationship, from statute or 
regulation, or from the retention of any overpayment.''.
    (b) Conforming Amendments.--Section 1128A of the Social Security 
Act (42 U.S.C. 1320a-7a) is amended--
        (1) in subsection (e), by inserting ``or specified claim'' 
    after ``claim'' in the first sentence; and
        (2) in subsection (f)--
            (A) in the matter preceding paragraph (1)--
                (i) by inserting ``or specified claim (as defined in 
            subsection (r))'' after ``district where the claim''; and
                (ii) by inserting ``(or, with respect to a person 
            described in subsection (o), the person)'' after 
            ``claimant''; and
            (B) in the matter following paragraph (4), by inserting 
        ``(or, in the case of a penalty or assessment under subsection 
        (o), by a specified State agency (as defined in subsection 
        (q)(6)),'' after ``or a State agency''.
SEC. 5004. REDUCING OVERPAYMENTS OF INFUSION DRUGS.
    (a) Treatment of Infusion Drugs Furnished Through Durable Medical 
Equipment.--Section 1842(o)(1) of the Social Security Act (42 U.S.C. 
1395u(o)(1)) is amended--
        (1) in subparagraph (C), by inserting ``(and including a drug 
    or biological described in subparagraph (D)(i) furnished on or 
    after January 1, 2017)'' after ``2005''; and
        (2) in subparagraph (D)--
            (A) by striking ``infusion drugs'' and inserting ``infusion 
        drugs or biologicals'' each place it appears; and
            (B) in clause (i)--
                (i) by striking ``2004'' and inserting ``2004, and 
            before January 1, 2017''; and
                (ii) by striking ``for such drug''.
    (b) Noninclusion of DME Infusion Drugs Under DME Competitive 
Acquisition Programs.--
        (1) In general.--Section 1847(a)(2)(A) of the Social Security 
    Act (42 U.S.C. 1395w-3(a)(2)(A)) is amended--
            (A) by striking ``and excluding'' and inserting ``, 
        excluding''; and
            (B) by inserting before the period at the end the 
        following: ``, and excluding drugs and biologicals described in 
        section 1842(o)(1)(D)''.
        (2) Conforming amendment.--Section 1842(o)(1)(D)(ii) of the 
    Social Security Act (42 U.S.C. 1395u(o)(1)(D)(ii)) is amended by 
    striking ``2007'' and inserting ``2007, and before the date of the 
    enactment of the 21st Century Cures Act.''.
SEC. 5005. INCREASING OVERSIGHT OF TERMINATION OF MEDICAID PROVIDERS.
    (a) Increased Oversight and Reporting.--
        (1) State reporting requirements.--Section 1902(kk) of the 
    Social Security Act (42 U.S.C. 1396a(kk)) is amended--
            (A) by redesignating paragraph (8) as paragraph (9); and
            (B) by inserting after paragraph (7) the following new 
        paragraph:
        ``(8) Provider terminations.--
            ``(A) In general.--Beginning on July 1, 2018, in the case 
        of a notification under subsection (a)(41) with respect to a 
        termination for a reason specified in section 455.101 of title 
        42, Code of Federal Regulations (as in effect on November 1, 
        2015) or for any other reason specified by the Secretary, of 
        the participation of a provider of services or any other person 
        under the State plan (or under a waiver of the plan), the 
        State, not later than 30 days after the effective date of such 
        termination, submits to the Secretary with respect to any such 
        provider or person, as appropriate--
                ``(i) the name of such provider or person;
                ``(ii) the provider type of such provider or person;
                ``(iii) the specialty of such provider's or person's 
            practice;
                ``(iv) the date of birth, Social Security number, 
            national provider identifier (if applicable), Federal 
            taxpayer identification number, and the State license or 
            certification number of such provider or person (if 
            applicable);
                ``(v) the reason for the termination;
                ``(vi) a copy of the notice of termination sent to the 
            provider or person;
                ``(vii) the date on which such termination is 
            effective, as specified in the notice; and
                ``(viii) any other information required by the 
            Secretary.
            ``(B) Effective date defined.--For purposes of this 
        paragraph, the term `effective date' means, with respect to a 
        termination described in subparagraph (A), the later of--
                ``(i) the date on which such termination is effective, 
            as specified in the notice of such termination; or
                ``(ii) the date on which all appeal rights applicable 
            to such termination have been exhausted or the timeline for 
            any such appeal has expired.''.
        (2) Contract requirement for managed care entities.--Section 
    1932(d) of the Social Security Act (42 U.S.C. 1396u-2(d)) is 
    amended by adding at the end the following new paragraph:
        ``(5) Contract requirement for managed care entities.--With 
    respect to any contract with a managed care entity under section 
    1903(m) or 1905(t)(3) (as applicable), no later than July 1, 2018, 
    such contract shall include a provision that providers of services 
    or persons terminated (as described in section 1902(kk)(8)) from 
    participation under this title, title XVIII, or title XXI shall be 
    terminated from participating under this title as a provider in any 
    network of such entity that serves individuals eligible to receive 
    medical assistance under this title.''.
        (3) Termination notification database.--Section 1902 of the 
    Social Security Act (42 U.S.C. 1396a) is amended by adding at the 
    end the following new subsection:
    ``(ll) Termination Notification Database.--In the case of a 
provider of services or any other person whose participation under this 
title or title XXI is terminated (as described in subsection (kk)(8)), 
the Secretary shall, not later than 30 days after the date on which the 
Secretary is notified of such termination under subsection (a)(41) (as 
applicable), review such termination and, if the Secretary determines 
appropriate, include such termination in any database or similar system 
developed pursuant to section 6401(b)(2) of the Patient Protection and 
Affordable Care Act (42 U.S.C. 1395cc note; Public Law 111-148).''.
        (4) No federal funds for items and services furnished by 
    terminated providers.--Section 1903 of the Social Security Act (42 
    U.S.C. 1396b) is amended--
            (A) in subsection (i)(2)--
                (i) in subparagraph (A), by striking the comma at the 
            end and inserting a semicolon;
                (ii) in subparagraph (B), by striking ``or'' at the 
            end; and
                (iii) by adding at the end the following new 
            subparagraph:
            ``(D) beginning on July 1, 2018, under the plan by any 
        provider of services or person whose participation in the State 
        plan is terminated (as described in section 1902(kk)(8)) after 
        the date that is 60 days after the date on which such 
        termination is included in the database or other system under 
        section 1902(ll); or''; and
            (B) in subsection (m), by inserting after paragraph (2) the 
        following new paragraph:
    ``(3) No payment shall be made under this title to a State with 
respect to expenditures incurred by the State for payment for services 
provided by a managed care entity (as defined under section 1932(a)(1)) 
under the State plan under this title (or under a waiver of the plan) 
unless the State--
        ``(A) beginning on July 1, 2018, has a contract with such 
    entity that complies with the requirement specified in section 
    1932(d)(5); and
        ``(B) beginning on January 1, 2018, complies with the 
    requirement specified in section 1932(d)(6)(A).''.
        (5) Development of uniform terminology for reasons for provider 
    termination.--Not later than July 1, 2017, the Secretary of Health 
    and Human Services shall, in consultation with the heads of State 
    agencies administering State Medicaid plans (or waivers of such 
    plans), issue regulations establishing uniform terminology to be 
    used with respect to specifying reasons under subparagraph (A)(v) 
    of paragraph (8) of section 1902(kk) of the Social Security Act (42 
    U.S.C. 1396a(kk)), as added by paragraph (1), for the termination 
    (as described in such paragraph (8)) of the participation of 
    certain providers in the Medicaid program under title XIX of such 
    Act or the Children's Health Insurance Program under title XXI of 
    such Act.
        (6) Conforming amendment.--Section 1902(a)(41) of the Social 
    Security Act (42 U.S.C. 1396a(a)(41)) is amended by striking 
    ``provide that whenever'' and inserting ``provide, in accordance 
    with subsection (kk)(8) (as applicable), that whenever''.
    (b) Increasing Availability of Medicaid Provider Information.--
        (1) FFS provider enrollment.--Section 1902(a) of the Social 
    Security Act (42 U.S.C. 1396a(a)) is amended by inserting after 
    paragraph (77) the following new paragraph:
        ``(78) provide that, not later than January 1, 2017, in the 
    case of a State that pursuant to its State plan or waiver of the 
    plan for medical assistance pays for medical assistance on a fee-
    for-service basis, the State shall require each provider furnishing 
    items and services to, or ordering, prescribing, referring, or 
    certifying eligibility for, services for individuals eligible to 
    receive medical assistance under such plan to enroll with the State 
    agency and provide to the State agency the provider's identifying 
    information, including the name, specialty, date of birth, Social 
    Security number, national provider identifier (if applicable), 
    Federal taxpayer identification number, and the State license or 
    certification number of the provider (if applicable);''.
        (2) Managed care provider enrollment.--Section 1932(d) of the 
    Social Security Act (42 U.S.C. 1396u-2(d)), as amended by 
    subsection (a)(2), is amended by adding at the end the following 
    new paragraph:
        ``(6) Enrollment of participating providers.--
            ``(A) In general.--Beginning not later than January 1, 
        2018, a State shall require that, in order to participate as a 
        provider in the network of a managed care entity that provides 
        services to, or orders, prescribes, refers, or certifies 
        eligibility for services for, individuals who are eligible for 
        medical assistance under the State plan under this title (or 
        under a waiver of the plan) and who are enrolled with the 
        entity, the provider is enrolled consistent with section 
        1902(kk) with the State agency administering the State plan 
        under this title. Such enrollment shall include providing to 
        the State agency the provider's identifying information, 
        including the name, specialty, date of birth, Social Security 
        number, national provider identifier, Federal taxpayer 
        identification number, and the State license or certification 
        number of the provider.
            ``(B) Rule of construction.--Nothing in subparagraph (A) 
        shall be construed as requiring a provider described in such 
        subparagraph to provide services to individuals who are not 
        enrolled with a managed care entity under this title.''.
    (c) Coordination With CHIP.--
        (1) In general.--Section 2107(e)(1) of the Social Security Act 
    (42 U.S.C. 1397gg(e)(1)) is amended--
            (A) by redesignating subparagraphs (B), (C), (D), (E), (F), 
        (G), (H), (I), (J), (K), (L), (M), (N), and (O) as 
        subparagraphs (D), (E), (F), (G), (H), (I), (J), (K), (M), (N), 
        (O), (P), (Q), and (R), respectively;
            (B) by inserting after subparagraph (A) the following new 
        subparagraphs:
            ``(B) Section 1902(a)(39) (relating to termination of 
        participation of certain providers).
            ``(C) Section 1902(a)(78) (relating to enrollment of 
        providers participating in State plans providing medical 
        assistance on a fee-for-service basis).'';
            (C) by inserting after subparagraph (K) (as redesignated by 
        subparagraph (A)) the following new subparagraph:
            ``(L) Section 1903(m)(3) (relating to limitation on payment 
        with respect to managed care).''; and
            (D) in subparagraph (P) (as redesignated by subparagraph 
        (A)), by striking ``(a)(2)(C) and (h)'' and inserting 
        ``(a)(2)(C) (relating to Indian enrollment), (d)(5) (relating 
        to contract requirement for managed care entities), (d)(6) 
        (relating to enrollment of providers participating with a 
        managed care entity), and (h) (relating to special rules with 
        respect to Indian enrollees, Indian health care providers, and 
        Indian managed care entities)''.
        (2) Excluding from medicaid providers excluded from chip.--
    Section 1902(a)(39) of the Social Security Act (42 U.S.C. 
    1396a(a)(39)) is amended by striking ``title XVIII or any other 
    State plan under this title'' and inserting ``title XVIII, any 
    other State plan under this title (or waiver of the plan), or any 
    State child health plan under title XXI (or waiver of the plan) and 
    such termination is included by the Secretary in any database or 
    similar system developed pursuant to section 6401(b)(2) of the 
    Patient Protection and Affordable Care Act''.
    (d) Rule of Construction.--Nothing in this section shall be 
construed as changing or limiting the appeal rights of providers or the 
process for appeals of States under the Social Security Act.
    (e) OIG Report.--Not later than March 31, 2020, the Inspector 
General of the Department of Health and Human Services shall submit to 
Congress a report on the implementation of the amendments made by this 
section. Such report shall include the following:
        (1) An assessment of the extent to which providers who are 
    included under subsection (ll) of section 1902 of the Social 
    Security Act (42 U.S.C. 1396a) (as added by subsection (a)(3)) in 
    the database or similar system referred to in such subsection are 
    terminated (as described in paragraph (8) of subsection (kk) of 
    such section, as added by subsection (a)(1)) from participation in 
    all State plans under title XIX of such Act (or waivers of such 
    plans).
        (2) Information on the amount of Federal financial 
    participation paid to States under section 1903 of such Act in 
    violation of the limitation on such payment specified in 
    subparagraph (D) of subsection (i)(2) of such section and paragraph 
    (3) of subsection (m) of such section, as added by subsection 
    (a)(4).
        (3) An assessment of the extent to which contracts with managed 
    care entities under title XIX of such Act comply with the 
    requirement specified in paragraph (5) of section 1932(d) of such 
    Act, as added by subsection (a)(2).
        (4) An assessment of the extent to which providers have been 
    enrolled under section 1902(a)(78) or 1932(d)(6)(A) of such Act (42 
    U.S.C. 1396a(a)(78), 1396u-2(d)(6)(A)) with State agencies 
    administering State plans under title XIX of such Act (or waivers 
    of such plans).
SEC. 5006. REQUIRING PUBLICATION OF FEE-FOR-SERVICE PROVIDER DIRECTORY.
    (a) In General.--Section 1902(a) of the Social Security Act (42 
U.S.C. 1396a(a)) is amended--
        (1) in paragraph (81), by striking ``and'' at the end;
        (2) in paragraph (82), by striking the period at the end and 
    inserting ``; and''; and
        (3) by inserting after paragraph (82) the following new 
    paragraph:
        ``(83) provide that, not later than January 1, 2017, in the 
    case of a State plan (or waiver of the plan) that provides medical 
    assistance on a fee-for-service basis or through a primary care 
    case-management system described in section 1915(b)(1) (other than 
    a primary care case management entity (as defined by the 
    Secretary)), the State shall publish (and update on at least an 
    annual basis) on the public website of the State agency 
    administering the State plan, a directory of the physicians 
    described in subsection (mm) and, at State option, other providers 
    described in such subsection that--
            ``(A) includes--
                ``(i) with respect to each such physician or provider--

                    ``(I) the name of the physician or provider;
                    ``(II) the specialty of the physician or provider;
                    ``(III) the address at which the physician or 
                provider provides services; and
                    ``(IV) the telephone number of the physician or 
                provider; and

                ``(ii) with respect to any such physician or provider 
            participating in such a primary care case-management 
            system, information regarding--

                    ``(I) whether the physician or provider is 
                accepting as new patients individuals who receive 
                medical assistance under this title; and
                    ``(II) the physician's or provider's cultural and 
                linguistic capabilities, including the languages spoken 
                by the physician or provider or by the skilled medical 
                interpreter providing interpretation services at the 
                physician's or provider's office; and

            ``(B) may include, at State option, with respect to each 
        such physician or provider--
                ``(i) the Internet website of such physician or 
            provider; or
                ``(ii) whether the physician or provider is accepting 
            as new patients individuals who receive medical assistance 
            under this title.''.
    (b) Directory Physician or Provider Described.--Section 1902 of the 
Social Security Act (42 U.S.C. 1396a), as amended by section 
5005(a)(3), is further amended by adding at the end the following new 
subsection:
    ``(mm) Directory Physician or Provider Described.--A physician or 
provider described in this subsection is--
        ``(1) in the case of a physician or provider of a provider type 
    for which the State agency, as a condition on receiving payment for 
    items and services furnished by the physician or provider to 
    individuals eligible to receive medical assistance under the State 
    plan, requires the enrollment of the physician or provider with the 
    State agency, a physician or a provider that--
            ``(A) is enrolled with the agency as of the date on which 
        the directory is published or updated (as applicable) under 
        subsection (a)(83); and
            ``(B) received payment under the State plan in the 12-month 
        period preceding such date; and
        ``(2) in the case of a physician or provider of a provider type 
    for which the State agency does not require such enrollment, a 
    physician or provider that received payment under the State plan 
    (or a waiver of the plan) in the 12-month period preceding the date 
    on which the directory is published or updated (as applicable) 
    under subsection (a)(83).''.
    (c) Rule of Construction.--
        (1) In general.--The amendment made by subsection (a) shall not 
    be construed to apply in the case of a State (as defined for 
    purposes of title XIX of the Social Security Act) in which all the 
    individuals enrolled in the State plan under such title (or under a 
    waiver of such plan), other than individuals described in paragraph 
    (2), are enrolled with a medicaid managed care organization (as 
    defined in section 1903(m)(1)(A) of such Act (42 U.S.C. 
    1396b(m)(1)(A))), including prepaid inpatient health plans and 
    prepaid ambulatory health plans (as defined by the Secretary of 
    Health and Human Services).
        (2) Individuals described.--An individual described in this 
    paragraph is an individual who is an Indian (as defined in section 
    4 of the Indian Health Care Improvement Act (25 U.S.C. 1603)) or an 
    Alaska Native.
    (d) Exception for State Legislation.--In the case of a State plan 
under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), 
which the Secretary of Health and Human Services determines requires 
State legislation in order for the respective plan to meet one or more 
additional requirements imposed by amendments made by this section, the 
respective plan shall not be regarded as failing to comply with the 
requirements of such title solely on the basis of its failure to meet 
such an additional requirement before the first day of the first 
calendar quarter beginning after the close of the first regular session 
of the State legislature that begins after the date of enactment of 
this Act. For purposes of the previous sentence, in the case of a State 
that has a 2-year legislative session, each year of the session shall 
be considered to be a separate regular session of the State 
legislature.
SEC. 5007. FAIRNESS IN MEDICAID SUPPLEMENTAL NEEDS TRUSTS.
    (a) In General.--Section 1917(d)(4)(A) of the Social Security Act 
(42 U.S.C. 1396p(d)(4)(A)) is amended by inserting ``the individual,'' 
after ``for the benefit of such individual by''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply to trusts established on or after the date of the enactment of 
this Act.
SEC. 5008. ELIMINATING FEDERAL FINANCIAL PARTICIPATION WITH RESPECT TO 
EXPENDITURES UNDER MEDICAID FOR AGENTS USED FOR COSMETIC PURPOSES OR 
HAIR GROWTH.
    (a) In General.--Section 1903(i)(21) of the Social Security Act (42 
U.S.C. 1396b(i)(21)) is amended by inserting ``section 1927(d)(2)(C) 
(relating to drugs when used for cosmetic purposes or hair growth), 
except where medically necessary, and'' after ``drugs described in''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply with respect to calendar quarters beginning on or after the date 
of the enactment of this Act.
SEC. 5009. AMENDMENT TO THE PREVENTION AND PUBLIC HEALTH FUND.
    Section 4002(b) of the Patient Protection and Affordable Care Act 
(42 U.S.C. 300u-11(b)) is amended--
        (1) in paragraph (3), by striking ``$1,250,000,000'' and 
    inserting ``$900,000,000'';
        (2) in paragraph (4), by striking ``$1,500,000,000'' and 
    inserting ``$1,000,000,000''; and
        (3) by striking paragraph (5) and inserting the following:
        ``(5) for fiscal year 2022, $1,500,000,000;
        ``(6) for fiscal year 2023, $1,000,000,000;
        ``(7) for fiscal year 2024, $1,700,000,000; and
        ``(8) for fiscal year 2025 and each fiscal year thereafter, 
    $2,000,000,000.''.
SEC. 5010. STRATEGIC PETROLEUM RESERVE DRAWDOWN.
    (a) Drawdown and Sale.--
        (1) In general.--Notwithstanding section 161 of the Energy 
    Policy and Conservation Act (42 U.S.C. 6241), except as provided in 
    subsections (b) and (c), the Secretary of Energy shall drawdown and 
    sell from the Strategic Petroleum Reserve--
            (A) 10,000,000 barrels of crude oil during fiscal year 
        2017;
            (B) 9,000,000 barrels of crude oil during fiscal year 2018; 
        and
            (C) 6,000,000 barrels of crude oil during fiscal year 2019.
        (2) Deposit of amounts received from sale.--Amounts received 
    from a sale under paragraph (1) shall be deposited in the general 
    fund of the Treasury during the fiscal year in which the sale 
    occurs.
    (b) Emergency Protection.--The Secretary shall not draw down and 
sell crude oil under this section in quantities that would limit the 
authority to sell petroleum products under section 161(h) of the Energy 
Policy and Conservation Act (42 U.S.C. 6241(h)) in the full quantity 
authorized by that subsection.
    (c) Strategic Petroleum Drawdown Limitations.--Subparagraphs (C) 
and (D) of section 161(h)(2) of the Energy Policy and Conservation Act 
(42 U.S.C. 6241(h)(2)(C) and (D)) are both amended by striking 
``500,000,000'' and inserting ``450,000,000''.
SEC. 5011. RESCISSION OF PORTION OF ACA TERRITORY FUNDING.
    Of the unobligated amounts available under section 1323(c)(1) of 
the Patient Protection and Affordable Care Act (42 U.S.C. 18043(c)(1)), 
$464,000,000 is rescinded immediately upon the date of the enactment of 
this Act.
SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THERAPY.
    (a) In General.--Section 1861 of the Social Security Act (42 U.S.C. 
1395x) is amended--
        (1) in subsection (s)(2)--
            (A) by striking ``and'' at the end of subparagraph (EE);
            (B) by inserting ``and'' at the end of subparagraph (FF); 
        and
            (C) by inserting at the end the following new subparagraph:
        ``(GG) home infusion therapy (as defined in subsection 
    (iii)(1));''; and
        (2) by adding at the end the following new subsection:
    ``(iii) Home Infusion Therapy.--(1) The term `home infusion 
therapy' means the items and services described in paragraph (2) 
furnished by a qualified home infusion therapy supplier (as defined in 
paragraph (3)(D)) which are furnished in the individual's home (as 
defined in paragraph (3)(B)) to an individual--
        ``(A) who is under the care of an applicable provider (as 
    defined in paragraph (3)(A)); and
        ``(B) with respect to whom a plan prescribing the type, amount, 
    and duration of infusion therapy services that are to be furnished 
    such individual has been established by a physician (as defined in 
    subsection (r)(1)) and is periodically reviewed by a physician (as 
    so defined) in coordination with the furnishing of home infusion 
    drugs (as defined in paragraph (3)(C)) under part B.
    ``(2) The items and services described in this paragraph are the 
following:
        ``(A) Professional services, including nursing services, 
    furnished in accordance with the plan.
        ``(B) Training and education (not otherwise paid for as durable 
    medical equipment (as defined in subsection (n)), remote 
    monitoring, and monitoring services for the provision of home 
    infusion therapy and home infusion drugs furnished by a qualified 
    home infusion therapy supplier.
    ``(3) For purposes of this subsection:
        ``(A) The term `applicable provider' means--
            ``(i) a physician;
            ``(ii) a nurse practitioner; and
            ``(iii) a physician assistant.
        ``(B) The term `home' means a place of residence used as the 
    home of an individual (as defined for purposes of subsection (n)).
        ``(C) The term `home infusion drug' means a parenteral drug or 
    biological administered intravenously, or subcutaneously for an 
    administration period of 15 minutes or more, in the home of an 
    individual through a pump that is an item of durable medical 
    equipment (as defined in subsection (n)). Such term does not 
    include the following:
            ``(i) Insulin pump systems.
            ``(ii) A self-administered drug or biological on a self-
        administered drug exclusion list.
        ``(D)(i) The term `qualified home infusion therapy supplier' 
    means a pharmacy, physician, or other provider of services or 
    supplier licensed by the State in which the pharmacy, physician, or 
    provider or services or supplier furnishes items or services and 
    that--
            ``(I) furnishes infusion therapy to individuals with acute 
        or chronic conditions requiring administration of home infusion 
        drugs;
            ``(II) ensures the safe and effective provision and 
        administration of home infusion therapy on a 7-day-a-week, 24-
        hour-a-day basis;
            ``(III) is accredited by an organization designated by the 
        Secretary pursuant to section 1834(u)(5); and
            ``(IV) meets such other requirements as the Secretary 
        determines appropriate, taking into account the standards of 
        care for home infusion therapy established by Medicare 
        Advantage plans under part C and in the private sector.
        ``(ii) A qualified home infusion therapy supplier may 
    subcontract with a pharmacy, physician, provider of services, or 
    supplier to meet the requirements of this subparagraph.''.
    (b) Payment and Related Requirements for Home Infusion Therapy.--
Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended 
by section 4011, is further amended by adding at the end the following 
new subsection:
    ``(u) Payment and Related Requirements for Home Infusion Therapy.--
        ``(1) Payment.--
            ``(A) Single payment.--
                ``(i) In general.--Subject to clause (iii) and 
            subparagraphs (B) and (C), the Secretary shall implement a 
            payment system under which a single payment is made under 
            this title to a qualified home infusion therapy supplier 
            for items and services described in subparagraphs (A) and 
            (B) of section 1861(iii)(2)) furnished by a qualified home 
            infusion therapy supplier (as defined in section 
            1861(iii)(3)(D)) in coordination with the furnishing of 
            home infusion drugs (as defined in section 1861(iii)(3)(C)) 
            under this part.
                ``(ii) Unit of single payment.--A unit of single 
            payment under the payment system implemented under this 
            subparagraph is for each infusion drug administration 
            calendar day in the individual's home. The Secretary shall, 
            as appropriate, establish single payment amounts for types 
            of infusion therapy, including to take into account 
            variation in utilization of nursing services by therapy 
            type.
                ``(iii) Limitation.--The single payment amount 
            determined under this subparagraph after application of 
            subparagraph (B) and paragraph (3) shall not exceed the 
            amount determined under the fee schedule under section 1848 
            for infusion therapy services furnished in a calendar day 
            if furnished in a physician office setting, except such 
            single payment shall not reflect more than 5 hours of 
            infusion for a particular therapy in a calendar day.
            ``(B) Required adjustments.--The Secretary shall adjust the 
        single payment amount determined under subparagraph (A) for 
        home infusion therapy services under section 1861(iii)(1) to 
        reflect other factors such as--
                ``(i) a geographic wage index and other costs that may 
            vary by region; and
                ``(ii) patient acuity and complexity of drug 
            administration.
            ``(C) Discretionary adjustments.--
                ``(i) In general.--Subject to clause (ii), the 
            Secretary may adjust the single payment amount determined 
            under subparagraph (A) (after application of subparagraph 
            (B)) to reflect outlier situations and other factors as the 
            Secretary determines appropriate.
                ``(ii) Requirement of budget neutrality.--Any 
            adjustment under this subparagraph shall be made in a 
            budget neutral manner.
        ``(2) Considerations.--In developing the payment system under 
    this subsection, the Secretary may consider the costs of furnishing 
    infusion therapy in the home, consult with home infusion therapy 
    suppliers, consider payment amounts for similar items and services 
    under this part and part A, and consider payment amounts 
    established by Medicare Advantage plans under part C and in the 
    private insurance market for home infusion therapy (including 
    average per treatment day payment amounts by type of home infusion 
    therapy).
        ``(3) Annual updates.--
            ``(A) In general.--Subject to subparagraph (B), the 
        Secretary shall update the single payment amount under this 
        subsection from year to year beginning in 2022 by increasing 
        the single payment amount from the prior year by the percentage 
        increase in the Consumer Price Index for all urban consumers 
        (United States city average) for the 12-month period ending 
        with June of the preceding year.
            ``(B) Adjustment.--For each year, the Secretary shall 
        reduce the percentage increase described in subparagraph (A) by 
        the productivity adjustment described in section 
        1886(b)(3)(B)(xi)(II). The application of the preceding 
        sentence may result in a percentage being less than 0.0 for a 
        year, and may result in payment being less than such payment 
        rates for the preceding year.
        ``(4) Authority to apply prior authorization.--The Secretary 
    may, as determined appropriate by the Secretary, apply prior 
    authorization for home infusion therapy services under section 
    1861(iii)(1).
        ``(5) Accreditation of qualified home infusion therapy 
    suppliers.--
            ``(A) Factors for designation of accreditation 
        organizations.--The Secretary shall consider the following 
        factors in designating accreditation organizations under 
        subparagraph (B) and in reviewing and modifying the list of 
        accreditation organizations designated pursuant to subparagraph 
        (C):
                ``(i) The ability of the organization to conduct timely 
            reviews of accreditation applications.
                ``(ii) The ability of the organization to take into 
            account the capacities of suppliers located in a rural area 
            (as defined in section 1886(d)(2)(D)).
                ``(iii) Whether the organization has established 
            reasonable fees to be charged to suppliers applying for 
            accreditation.
                ``(iv) Such other factors as the Secretary determines 
            appropriate.
            ``(B) Designation.--Not later than January 1, 2021, the 
        Secretary shall designate organizations to accredit suppliers 
        furnishing home infusion therapy. The list of accreditation 
        organizations so designated may be modified pursuant to 
        subparagraph (C).
            ``(C) Review and modification of list of accreditation 
        organizations.--
                ``(i) In general.--The Secretary shall review the list 
            of accreditation organizations designated under 
            subparagraph (B) taking into account the factors under 
            subparagraph (A). Taking into account the results of such 
            review, the Secretary may, by regulation, modify the list 
            of accreditation organizations designated under 
            subparagraph (B).
                ``(ii) Special rule for accreditations done prior to 
            removal from list of designated accreditation 
            organizations.--In the case where the Secretary removes an 
            organization from the list of accreditation organizations 
            designated under subparagraph (B), any supplier that is 
            accredited by the organization during the period beginning 
            on the date on which the organization is designated as an 
            accreditation organization under subparagraph (B) and 
            ending on the date on which the organization is removed 
            from such list shall be considered to have been accredited 
            by an organization designated by the Secretary under 
            subparagraph (B) for the remaining period such 
            accreditation is in effect.
            ``(D) Rule for accreditations made prior to designation.--
        In the case of a supplier that is accredited before January 1, 
        2021, by an accreditation organization designated by the 
        Secretary under subparagraph (B) as of January 1, 2019, such 
        supplier shall be considered to have been accredited by an 
        organization designated by the Secretary under such paragraph 
        as of January 1, 2023, for the remaining period such 
        accreditation is in effect.
        ``(6) Notification of infusion therapy options available prior 
    to furnishing home infusion therapy.--Prior to the furnishing of 
    home infusion therapy to an individual, the physician who 
    establishes the plan described in section 1861(iii)(1) for the 
    individual shall provide notification (in a form, manner, and 
    frequency determined appropriate by the Secretary) of the options 
    available (such as home, physician's office, hospital outpatient 
    department) for the furnishing of infusion therapy under this 
    part.''.
    (c) Conforming Amendments.--
        (1) Payment reference.--Section 1833(a)(1) of the Social 
    Security Act (42 U.S.C. 1395l(a)(1)) is amended--
            (A) by striking ``and'' before ``(AA)''; and
            (B) by inserting before the semicolon at the end the 
        following: ``, and (BB) with respect to home infusion therapy, 
        the amount paid shall be an amount equal to 80 percent of the 
        lesser of the actual charge for the services or the amount 
        determined under section 1834(u)''.
        (2) Direct payment.--The first sentence of section 1842(b)(6) 
    of the Social Security Act (42 U.S.C. 1395u(b)(6)) is amended--
            (A) by striking ``and'' before ``(H)''; and
            (B) by inserting before the period at the end the 
        following: ``, and (I) in the case of home infusion therapy, 
        payment shall be made to the qualified home infusion therapy 
        supplier''.
        (3) Exclusion from home health services.--Section 1861(m) of 
    the Social Security Act (42 U.S.C. 1395x(m)) is amended, in the 
    first sentence, by inserting the following before the period at the 
    end: ``and home infusion therapy (as defined in subsection 
    (iii)(i))''.
    (d) Effective Date.--The amendments made by this section shall 
apply to items and services furnished on or after January 1, 2021.

          DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS

SEC. 6000. SHORT TITLE.
    This division may be cited as the ``Helping Families in Mental 
Health Crisis Reform Act of 2016''.

         TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
                         Subtitle A--Leadership

SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH AND SUBSTANCE USE.
    (a) Assistant Secretary.--Section 501(c) of the Public Health 
Service Act (42 U.S.C. 290aa(c)) is amended to read as follows:
    ``(c) Assistant Secretary and Deputy Assistant Secretary.--
        ``(1) Assistant secretary.--The Administration shall be headed 
    by an official to be known as the Assistant Secretary for Mental 
    Health and Substance Use (hereinafter in this title referred to as 
    the `Assistant Secretary') who shall be appointed by the President, 
    by and with the advice and consent of the Senate.
        ``(2) Deputy assistant secretary.--The Assistant Secretary, 
    with the approval of the Secretary, may appoint a Deputy Assistant 
    Secretary and may employ and prescribe the functions of such 
    officers and employees, including attorneys, as are necessary to 
    administer the activities to be carried out through the 
    Administration.''.
    (b) Transfer of Authorities.--The Secretary of Health and Human 
Services shall delegate to the Assistant Secretary for Mental Health 
and Substance Use all duties and authorities that--
        (1) as of the day before the date of enactment of this Act, 
    were vested in the Administrator of the Substance Abuse and Mental 
    Health Services Administration; and
        (2) are not terminated by this Act.
    (c) Conforming Amendments.--Title V of the Public Health Service 
Act (42 U.S.C. 290aa et seq.), as amended by the previous provisions of 
this section, is further amended--
        (1) by striking ``Administrator of the Substance Abuse and 
    Mental Health Services Administration'' each place it appears and 
    inserting ``Assistant Secretary for Mental Health and Substance 
    Use''; and
        (2) by striking ``Administrator'' or ``Administrator'' each 
    place it appears (including in any headings) and inserting 
    ``Assistant Secretary'' or ``Assistant Secretary'', respectively, 
    except where the term ``Administrator'' appears--
            (A) in each of subsections (e) and (f) of section 501 of 
        such Act (42 U.S.C. 290aa), including the headings of such 
        subsections, within the term ``Associate Administrator'';
            (B) in section 507(b)(6) of such Act (42 U.S.C. 
        290bb(b)(6)), within the term ``Administrator of the Health 
        Resources and Services Administration'';
            (C) in section 507(b)(6) of such Act (42 U.S.C. 
        290bb(b)(6)), within the term ``Administrator of the Centers 
        for Medicare & Medicaid Services'';
            (D) in section 519B(c)(1)(B) of such Act (42 U.S.C. 290bb-
        25b(c)(1)(B)), within the term ``Administrator of the National 
        Highway Traffic Safety Administration''; or
            (E) in each of sections 519B(c)(1)(B), 520C(a), and 520D(a) 
        of such Act (42 U.S.C. 290bb-25b(c)(1)(B), 290bb-34(a), 290bb-
        35(a)), within the term ``Administrator of the Office of 
        Juvenile Justice and Delinquency Prevention''.
    (d) References.--After executing subsections (a), (b), and (c), any 
reference in statute, regulation, or guidance to the Administrator of 
the Substance Abuse and Mental Health Services Administration shall be 
construed to be a reference to the Assistant Secretary for Mental 
Health and Substance Use.
SEC. 6002. STRENGTHENING THE LEADERSHIP OF THE SUBSTANCE ABUSE AND 
MENTAL HEALTH SERVICES ADMINISTRATION.
    Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as 
amended by section 6001, is further amended--
        (1) in subsection (b)--
            (A) in the subsection heading, by striking ``Agencies'' and 
        inserting ``Centers''; and
            (B) in the matter preceding paragraph (1), by striking 
        ``entities'' and inserting ``Centers'';
        (2) in subsection (d)--
            (A) in paragraph (1)--
                (i) by striking ``agencies'' each place the term 
            appears and inserting ``Centers''; and
                (ii) by striking ``such agency'' and inserting ``such 
            Center'';
            (B) in paragraph (2)--
                (i) by striking ``agencies'' and inserting ``Centers'';
                (ii) by striking ``with respect to substance abuse'' 
            and inserting ``with respect to substance use disorders''; 
            and
                (iii) by striking ``and individuals who are substance 
            abusers'' and inserting ``and individuals with substance 
            use disorders'';
            (C) in paragraph (5), by striking ``substance abuse'' and 
        inserting ``substance use disorder'';
            (D) in paragraph (6)--
                (i) by striking ``the Centers for Disease Control'' and 
            inserting ``the Centers for Disease Control and 
            Prevention,'';
                (ii) by striking ``Administration develop'' and 
            inserting ``Administration, develop'';
                (iii) by striking ``HIV or tuberculosis among substance 
            abusers and individuals with mental illness'' and inserting 
            ``HIV, hepatitis, tuberculosis, and other communicable 
            diseases among individuals with mental or substance use 
            disorders,''; and
                (iv) by striking ``illnesses'' at the end and inserting 
            ``diseases or disorders'';
            (E) in paragraph (7), by striking ``abuse utilizing anti-
        addiction medications, including methadone'' and inserting 
        ``use disorders, including services that utilize drugs or 
        devices approved or cleared by the Food and Drug Administration 
        for the treatment of substance use disorders'';
            (F) in paragraph (8)--
                (i) by striking ``Agency for Health Care Policy 
            Research'' and inserting ``Agency for Healthcare Research 
            and Quality''; and
                (ii) by striking ``treatment and prevention'' and 
            inserting ``prevention and treatment'';
            (G) in paragraph (9)--
                (i) by inserting ``and maintenance'' after 
            ``development'';
                (ii) by striking ``Agency for Health Care Policy 
            Research'' and inserting ``Agency for Healthcare Research 
            and Quality''; and
                (iii) by striking ``treatment and prevention services'' 
            and inserting ``prevention, treatment, and recovery support 
            services and are appropriately incorporated into programs 
            carried out by the Administration'';
            (H) in paragraph (10), by striking ``abuse'' and inserting 
        ``use disorder'';
            (I) by striking paragraph (11) and inserting the following:
        ``(11) work with relevant agencies of the Department of Health 
    and Human Services on integrating mental health promotion and 
    substance use disorder prevention with general health promotion and 
    disease prevention and integrating mental and substance use 
    disorders treatment services with physical health treatment 
    services;'';
            (J) in paragraph (13)--
                (i) in the matter preceding subparagraph (A), by 
            striking ``this title, assure that'' and inserting ``this 
            title or part B of title XIX, or grant programs otherwise 
            funded by the Administration'';
                (ii) in subparagraph (A)--

                    (I) by inserting ``require that'' before ``all 
                grants''; and
                    (II) by striking ``and'' at the end;

                (iii) by redesignating subparagraph (B) as subparagraph 
            (C);
                (iv) by inserting after subparagraph (A) the following:
            ``(B) ensure that the director of each Center of the 
        Administration consistently documents the application of 
        criteria when awarding grants and the ongoing oversight of 
        grantees after such grants are awarded;'';
                (v) in subparagraph (C), as so redesignated--

                    (I) by inserting ``require that'' before ``all 
                grants''; and
                    (II) in clause (ii), by inserting ``and'' after the 
                semicolon at the end; and

                (vi) by adding at the end the following:
            ``(D) inform a State when any funds are awarded through 
        such a grant to any entity within such State;'';
            (K) in paragraph (16), by striking ``abuse and mental 
        health information'' and inserting ``use disorder information, 
        including evidence-based and promising best practices for 
        prevention, treatment, and recovery support services for 
        individuals with mental and substance use disorders,'';
            (L) in paragraph (17)--
                (i) by striking ``substance abuse'' and inserting 
            ``substance use disorder''; and
                (ii) by striking ``and'' at the end;
            (M) in paragraph (18), by striking the period and inserting 
        a semicolon; and
            (N) by adding at the end the following:
        ``(19) consult with State, local, and tribal governments, 
    nongovernmental entities, and individuals with mental illness, 
    particularly adults with a serious mental illness, children with a 
    serious emotional disturbance, and the family members of such 
    adults and children, with respect to improving community-based and 
    other mental health services;
        ``(20) collaborate with the Secretary of Defense and the 
    Secretary of Veterans Affairs to improve the provision of mental 
    and substance use disorder services provided by the Department of 
    Defense and the Department of Veterans Affairs to members of the 
    Armed Forces, veterans, and the family members of such members and 
    veterans, including through the provision of services using the 
    telehealth capabilities of the Department of Defense and the 
    Department of Veterans Affairs;
        ``(21) collaborate with the heads of relevant Federal agencies 
    and departments, States, communities, and nongovernmental experts 
    to improve mental and substance use disorders services for 
    chronically homeless individuals, including by designing strategies 
    to provide such services in supportive housing;
        ``(22) work with States and other stakeholders to develop and 
    support activities to recruit and retain a workforce addressing 
    mental and substance use disorders;
        ``(23) collaborate with the Attorney General and 
    representatives of the criminal justice system to improve mental 
    and substance use disorders services for individuals who have been 
    arrested or incarcerated;
        ``(24) after providing an opportunity for public input, set 
    standards for grant programs under this title for mental and 
    substance use disorders services and prevention programs, which 
    standards may address--
            ``(A) the capacity of the grantee to implement the award;
            ``(B) requirements for the description of the program 
        implementation approach;
            ``(C) the extent to which the grant plan submitted by the 
        grantee as part of its application must explain how the grantee 
        will reach the population of focus and provide a statement of 
        need, which may include information on how the grantee will 
        increase access to services and a description of measurable 
        objectives for improving outcomes;
            ``(D) the extent to which the grantee must collect and 
        report on required performance measures; and
            ``(E) the extent to which the grantee is proposing to use 
        evidence-based practices; and
        ``(25) advance, through existing programs, the use of 
    performance metrics, including those based on the recommendations 
    on performance metrics from the Assistant Secretary for Planning 
    and Evaluation under section 6021(d) of the Helping Families in 
    Mental Health Crisis Reform Act of 2016.''; and
        (3) in subsection (m), by adding at the end the following:
        ``(4) Emergency response.--Amounts made available for carrying 
    out this subsection shall remain available through the end of the 
    fiscal year following the fiscal year for which such amounts are 
    appropriated.''.
SEC. 6003. CHIEF MEDICAL OFFICER.
    Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as 
amended by sections 6001 and 6002, is further amended--
        (1) by redesignating subsections (g) through (j) and 
    subsections (k) through (o) as subsections (h) through (k) and 
    subsections (m) through (q), respectively;
        (2) in subsection (e)(3)(C), by striking ``subsection (k)'' and 
    inserting ``subsection (m)'';
        (3) in subsection (f)(2)(C)(iii), by striking ``subsection 
    (k)'' and inserting ``subsection (m)''; and
        (4) by inserting after subsection (f) the following:
    ``(g) Chief Medical Officer.--
        ``(1) In general.--The Assistant Secretary, with the approval 
    of the Secretary, shall appoint a Chief Medical Officer to serve 
    within the Administration.
        ``(2) Eligible candidates.--The Assistant Secretary shall 
    select the Chief Medical Officer from among individuals who--
            ``(A) have a doctoral degree in medicine or osteopathic 
        medicine;
            ``(B) have experience in the provision of mental or 
        substance use disorder services;
            ``(C) have experience working with mental or substance use 
        disorder programs;
            ``(D) have an understanding of biological, psychosocial, 
        and pharmaceutical treatments of mental or substance use 
        disorders; and
            ``(E) are licensed to practice medicine in one or more 
        States.
        ``(3) Duties.--The Chief Medical Officer shall--
            ``(A) serve as a liaison between the Administration and 
        providers of mental and substance use disorders prevention, 
        treatment, and recovery services;
            ``(B) assist the Assistant Secretary in the evaluation, 
        organization, integration, and coordination of programs 
        operated by the Administration;
            ``(C) promote evidence-based and promising best practices, 
        including culturally and linguistically appropriate practices, 
        as appropriate, for the prevention and treatment of, and 
        recovery from, mental and substance use disorders, including 
        serious mental illness and serious emotional disturbances;
            ``(D) participate in regular strategic planning with the 
        Administration;
            ``(E) coordinate with the Assistant Secretary for Planning 
        and Evaluation to assess the use of performance metrics to 
        evaluate activities within the Administration related to mental 
        and substance use disorders; and
            ``(F) coordinate with the Assistant Secretary to ensure 
        mental and substance use disorders grant programs within the 
        Administration consistently utilize appropriate performance 
        metrics and evaluation designs.''.
SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL HEALTH PROGRAMS.
    Section 505 of the Public Health Service Act (42 U.S.C. 290aa-4), 
as amended by section 6001(c), is amended--
        (1) by striking the section designation and heading and 
    inserting the following:
    ``SEC. 505. CENTER FOR BEHAVIORAL HEALTH STATISTICS AND QUALITY.'';
        (2) by redesignating subsections (a) through (d) as subsections 
    (b) through (e), respectively;
        (3) before subsection (b), as redesignated by paragraph (2), by 
    inserting the following:
    ``(a) In General.--The Assistant Secretary shall maintain within 
the Administration a Center for Behavioral Health Statistics and 
Quality (in this section referred to as the `Center'). The Center shall 
be headed by a Director (in this section referred to as the `Director') 
appointed by the Secretary from among individuals with extensive 
experience and academic qualifications in research and analysis in 
behavioral health care or related fields.'';
        (4) in subsection (b), as redesignated by paragraph (2)--
            (A) by redesignating paragraphs (1) and (2) as 
        subparagraphs (A) and (B), respectively;
            (B) by striking ``The Secretary, acting'' and all that 
        follows through ``year on--'' and inserting ``The Director 
        shall--
        ``(1) coordinate the Administration's integrated data strategy, 
    including by collecting data each year on--'';
            (C) in the subparagraph (B), as redesignated by 
        subparagraph (A), by striking ``Assistant Secretary'' and 
        inserting ``Director''; and
            (D) by adding at the end the following new paragraphs:
        ``(2) provide statistical and analytical support for activities 
    of the Administration;
        ``(3) recommend a core set of performance metrics to evaluate 
    activities supported by the Administration; and
        ``(4) coordinate with the Assistant Secretary, the Assistant 
    Secretary for Planning and Evaluation, and the Chief Medical 
    Officer appointed under section 501(g), as appropriate, to improve 
    the quality of services provided by programs of the Administration 
    and the evaluation of activities carried out by the 
    Administration.''.
        (5) in subsection (c), as so redesignated--
            (A) by striking ``With respect to the activities'' and 
        inserting ``Mental Health.--With respect to the activities'';
            (B) by striking ``Assistant Secretary'' each place it 
        appears and inserting ``Director''; and
            (C) by striking ``subsection (a)'' and inserting 
        ``subsection (b)(1)'';
        (6) in subsection (d), as so redesignated--
            (A) by striking the subsection designation and all that 
        follows through ``With respect to the activities'' and 
        inserting the following:
    ``(d) Substance Abuse.--
        ``(1) In general.--With respect to the activities'';
            (B) in paragraph (1)--
                (i) in the matter before subparagraph (A)--

                    (I) by striking ``subsection (a)'' and inserting 
                ``subsection (b)(1)''; and
                    (II) by striking ``Assistant Secretary'' each place 
                it appears and inserting ``Director''; and

                (ii) in subparagraph (B), by inserting ``in 
            coordination with the Centers for Disease Control and 
            Prevention'' before the semicolon at the end; and
            (C) in paragraph (2), by striking ``Annual surveys'' and 
        inserting ``Annual surveys; public availability of data.--
        Annual surveys''; and
        (7) in subsection (e), as so redesignated--
            (A) by striking ``After consultation'' and inserting 
        ``Consultation.--After consultation''; and
            (B) by striking ``Assistant Secretary shall develop'' and 
        inserting ``Assistant Secretary shall use existing standards 
        and best practices to develop''.
SEC. 6005. STRATEGIC PLAN.
    Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as 
amended by sections 6001 through 6003, is further amended by inserting 
after subsection (k), as redesignated by section 6003, the following:
    ``(l) Strategic Plan.--
        ``(1) In general.--Not later than September 30, 2018, and every 
    4 years thereafter, the Assistant Secretary shall develop and carry 
    out a strategic plan in accordance with this subsection for the 
    planning and operation of activities carried out by the 
    Administration, including evidence-based programs.
        ``(2) Coordination.--In developing and carrying out the 
    strategic plan under this subsection, the Assistant Secretary shall 
    take into consideration the findings and recommendations of the 
    Assistant Secretary for Planning and Evaluation under section 
    6021(d) of the Helping Families in Mental Health Crisis Reform Act 
    of 2016 and the report of the Interdepartmental Serious Mental 
    Illness Coordinating Committee under section 6031 of such Act.
        ``(3) Publication of plan.--Not later than September 30, 2018, 
    and every 4 years thereafter, the Assistant Secretary shall--
            ``(A) submit the strategic plan developed under paragraph 
        (1) to the Committee on Energy and Commerce and the Committee 
        on Appropriations of the House of Representatives and the 
        Committee on Health, Education, Labor, and Pensions and the 
        Committee on Appropriations of the Senate; and
            ``(B) post such plan on the Internet website of the 
        Administration.
        ``(4) Contents.--The strategic plan developed under paragraph 
    (1) shall--
            ``(A) identify strategic priorities, goals, and measurable 
        objectives for mental and substance use disorders activities 
        and programs operated and supported by the Administration, 
        including priorities to prevent or eliminate the burden of 
        mental and substance use disorders;
            ``(B) identify ways to improve the quality of services for 
        individuals with mental and substance use disorders, and to 
        reduce homelessness, arrest, incarceration, violence, including 
        self-directed violence, and unnecessary hospitalization of 
        individuals with a mental or substance use disorder, including 
        adults with a serious mental illness or children with a serious 
        emotional disturbance;
            ``(C) ensure that programs provide, as appropriate, access 
        to effective and evidence-based prevention, diagnosis, 
        intervention, treatment, and recovery services, including 
        culturally and linguistically appropriate services, as 
        appropriate, for individuals with a mental or substance use 
        disorder;
            ``(D) identify opportunities to collaborate with the Health 
        Resources and Services Administration to develop or improve--
                ``(i) initiatives to encourage individuals to pursue 
            careers (especially in rural and underserved areas and with 
            rural and underserved populations) as psychiatrists, 
            including child and adolescent psychiatrists, 
            psychologists, psychiatric nurse practitioners, physician 
            assistants, clinical social workers, certified peer support 
            specialists, licensed professional counselors, or other 
            licensed or certified mental health or substance use 
            disorder professionals, including such professionals 
            specializing in the diagnosis, evaluation, or treatment of 
            adults with a serious mental illness or children with a 
            serious emotional disturbance; and
                ``(ii) a strategy to improve the recruitment, training, 
            and retention of a workforce for the treatment of 
            individuals with mental or substance use disorders, or co-
            occurring disorders;
            ``(E) identify opportunities to improve collaboration with 
        States, local governments, communities, and Indian tribes and 
        tribal organizations (as such terms are defined in section 4 of 
        the Indian Self-Determination and Education Assistance Act); 
        and
            ``(F) specify a strategy to disseminate evidence-based and 
        promising best practices related to prevention, diagnosis, 
        early intervention, treatment, and recovery services related to 
        mental illness, particularly for adults with a serious mental 
        illness and children with a serious emotional disturbance, and 
        for individuals with a substance use disorder.''.
SEC. 6006. BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.
    (a) In General.--Section 501 of the Public Health Service Act (42 
U.S.C. 290aa), as so amended, is further amended by amending subsection 
(m), as redesignated by section 6003, to read as follows:
    ``(m) Biennial Report Concerning Activities and Progress.--Not 
later than September 30, 2020, and every 2 years thereafter, the 
Assistant Secretary shall prepare and submit to the Committee on Energy 
and Commerce and the Committee on Appropriations of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions and the Committee on Appropriations of the Senate, and post on 
the Internet website of the Administration, a report containing at a 
minimum--
        ``(1) a review of activities conducted or supported by the 
    Administration, including progress toward strategic priorities, 
    goals, and objectives identified in the strategic plan developed 
    under subsection (l);
        ``(2) an assessment of programs and activities carried out by 
    the Assistant Secretary, including the extent to which programs and 
    activities under this title and part B of title XIX meet identified 
    goals and performance measures developed for the respective 
    programs and activities;
        ``(3) a description of the progress made in addressing gaps in 
    mental and substance use disorders prevention, treatment, and 
    recovery services and improving outcomes by the Administration, 
    including with respect to serious mental illnesses, serious 
    emotional disturbances, and co-occurring disorders;
        ``(4) a description of the manner in which the Administration 
    coordinates and partners with other Federal agencies and 
    departments related to mental and substance use disorders, 
    including activities related to--
            ``(A) the implementation and dissemination of research 
        findings into improved programs, including with respect to how 
        advances in serious mental illness and serious emotional 
        disturbance research have been incorporated into programs;
            ``(B) the recruitment, training, and retention of a mental 
        and substance use disorders workforce;
            ``(C) the integration of mental disorder services, 
        substance use disorder services, and physical health services;
            ``(D) homelessness; and
            ``(E) veterans;
        ``(5) a description of the manner in which the Administration 
    promotes coordination by grantees under this title, and part B of 
    title XIX, with State or local agencies; and
        ``(6) a description of the activities carried out under section 
    501A(e), with respect to mental and substance use disorders, 
    including--
            ``(A) the number and a description of grants awarded;
            ``(B) the total amount of funding for grants awarded;
            ``(C) a description of the activities supported through 
        such grants, including outcomes of programs supported; and
            ``(D) information on how the National Mental Health and 
        Substance Use Policy Laboratory is consulting with the 
        Assistant Secretary for Planning and Evaluation and 
        collaborating with the Center for Substance Abuse Treatment, 
        the Center for Substance Abuse Prevention, the Center for 
        Behavioral Health Statistics and Quality, and the Center for 
        Mental Health Services to carry out such activities; and
        ``(7) recommendations made by the Assistant Secretary for 
    Planning and Evaluation under section 6021 of the Helping Families 
    in Mental Health Crisis Reform Act of 2016 to improve programs 
    within the Administration, and actions taken in response to such 
    recommendations to improve programs within the Administration.
The Assistant Secretary may meet reporting requirements established 
under this title by providing the contents of such reports as an 
addendum to the biennial report established under this subsection, 
notwithstanding the timeline of other reporting requirements in this 
title. Nothing in this subsection shall be construed to alter the 
content requirements of such reports or authorize the Assistant 
Secretary to alter the timeline of any such reports to be less frequent 
than biennially, unless as specified in this title.''.
    (b) Conforming Amendment.--Section 508(p) of the Public Health 
Service Act (42 U.S.C. 290bb-1(p)) is amended by striking ``section 
501(k)'' and inserting ``section 501(m)''.
SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL HEALTH SERVICES, SUBSTANCE 
ABUSE PREVENTION, AND SUBSTANCE ABUSE TREATMENT.
    (a) Center for Mental Health Services.--Section 520(b) of the 
Public Health Service Act (42 U.S.C. 290bb-31(b)) is amended--
        (1) by redesignating paragraphs (3) through (15) as paragraphs 
    (4) through (16), respectively;
        (2) by inserting after paragraph (2) the following:
        ``(3) collaborate with the Director of the National Institute 
    of Mental Health and the Chief Medical Officer, appointed under 
    section 501(g), to ensure that, as appropriate, programs related to 
    the prevention and treatment of mental illness and the promotion of 
    mental health and recovery support are carried out in a manner that 
    reflects the best available science and evidence-based practices, 
    including culturally and linguistically appropriate services, as 
    appropriate;'';
        (3) in paragraph (5), as so redesignated, by inserting ``, 
    including through programs that reduce risk and promote 
    resiliency'' before the semicolon;
        (4) in paragraph (6), as so redesignated, by inserting ``in 
    collaboration with the Director of the National Institute of Mental 
    Health,'' before ``develop'';
        (5) in paragraph (8), as so redesignated, by inserting ``, 
    increase meaningful participation of individuals with mental 
    illness in programs and activities of the Administration,'' before 
    ``and protect the legal'';
        (6) in paragraph (10), as so redesignated, by striking 
    ``professional and paraprofessional personnel pursuant to section 
    303'' and inserting ``health paraprofessional personnel and health 
    professionals'';
        (7) in paragraph (11), as so redesignated, by inserting ``and 
    tele-mental health'' after ``rural mental health'';
        (8) in paragraph (12), as so redesignated, by striking 
    ``establish a clearinghouse for mental health information to assure 
    the widespread dissemination of such information'' and inserting 
    ``disseminate mental health information, including evidence-based 
    practices,'';
        (9) in paragraph (15), as so redesignated, by striking ``and'' 
    at the end;
        (10) in paragraph (16), as so redesignated, by striking the 
    period and inserting ``; and''; and
        (11) by adding at the end the following:
        ``(17) ensure the consistent documentation of the application 
    of criteria when awarding grants and the ongoing oversight of 
    grantees after such grants are awarded.''.
    (b) Director of the Center for Substance Abuse Prevention.--Section 
515 of the Public Health Service Act (42 U.S.C. 290bb-21) is amended--
        (1) in the section heading, by striking ``office'' and 
    inserting ``center'';
        (2) in subsection (a)--
            (A) by striking ``an Office'' and inserting ``a Center''; 
        and
            (B) by striking ``The Office'' and inserting ``The 
        Prevention Center''; and
        (3) in subsection (b)--
            (A) in paragraph (1), by inserting ``through the reduction 
        of risk and the promotion of resiliency'' before the semicolon;
            (B) by redesignating paragraphs (3) through (11) as 
        paragraphs (4) through (12), respectively;
            (C) by inserting after paragraph (2) the following:
        ``(3) collaborate with the Director of the National Institute 
    on Drug Abuse, the Director of the National Institute on Alcohol 
    Abuse and Alcoholism, and States to promote the study of substance 
    abuse prevention and the dissemination and implementation of 
    research findings that will improve the delivery and effectiveness 
    of substance abuse prevention activities;'';
            (D) in paragraph (4), as so redesignated, by striking 
        ``literature on the adverse effects of cocaine free base (known 
        as crack)'' and inserting ``educational information on the 
        effects of drugs abused by individuals, including drugs that 
        are emerging as abused drugs'';
            (E) in paragraph (6), as so redesignated--
                (i) by striking ``substance abuse counselors'' and 
            inserting ``health professionals who provide substance use 
            and misuse prevention and treatment services''; and
                (ii) by striking ``drug abuse education, prevention,'' 
            and inserting ``illicit drug use education and 
            prevention'';
            (F) by amending paragraph (7), as so redesignated, to read 
        as follows:
        ``(7) in cooperation with the Director of the Centers for 
    Disease Control and Prevention, develop and disseminate educational 
    materials to increase awareness for individuals at greatest risk 
    for substance use disorders to prevent the transmission of 
    communicable diseases, such as HIV, hepatitis, tuberculosis, and 
    other communicable diseases;'';
            (G) in paragraph (9), as so redesignated--
                (i) by striking ``to discourage'' and inserting ``that 
            reduce the risk of''; and
                (ii) by inserting before the semicolon ``and promote 
            resiliency'';
            (H) in paragraph (11), as so redesignated, by striking 
        ``and'' after the semicolon;
            (I) in paragraph (12), as so redesignated, by striking the 
        period and inserting a semicolon; and
            (J) by adding at the end the following:
        ``(13) ensure the consistent documentation of the application 
    of criteria when awarding grants and the ongoing oversight of 
    grantees after such grants are awarded; and
        ``(14) assist and support States in preventing illicit drug 
    use, including emerging illicit drug use issues.''.
    (c) Director of the Center for Substance Abuse Treatment.--Section 
507 of the Public Health Service Act (42 U.S.C. 290bb) is amended--
        (1) in subsection (a)--
            (A) by striking ``treatment of substance abuse'' and 
        inserting ``treatment of substance use disorders''; and
            (B) by striking ``abuse treatment systems'' and inserting 
        ``use disorder treatment systems''; and
        (2) in subsection (b)--
            (A) in paragraph (1), by striking ``abuse'' and inserting 
        ``use disorder'';
            (B) in paragraph (3), by striking ``abuse'' and inserting 
        ``use disorder'';
            (C) in paragraph (4), by striking ``individuals who abuse 
        drugs'' and inserting ``individuals who illicitly use drugs'';
            (D) in paragraph (9), by striking ``carried out by the 
        Director'';
            (E) by striking paragraph (10);
            (F) by redesignating paragraphs (11) through (14) as 
        paragraphs (10) through (13), respectively;
            (G) in paragraph (12), as so redesignated, by striking ``; 
        and'' and inserting a semicolon; and
            (H) by striking paragraph (13), as so redesignated, and 
        inserting the following:
        ``(13) ensure the consistent documentation of the application 
    of criteria when awarding grants and the ongoing oversight of 
    grantees after such grants are awarded; and
        ``(14) work with States, providers, and individuals in 
    recovery, and their families, to promote the expansion of recovery 
    support services and systems of care oriented toward recovery.''.
SEC. 6008. ADVISORY COUNCILS.
    Section 502(b) of the Public Health Service Act (42 U.S.C. 290aa-
1(b)) is amended--
        (1) in paragraph (2)--
            (A) in subparagraph (E), by striking ``and'' after the 
        semicolon;
            (B) by redesignating subparagraph (F) as subparagraph (J); 
        and
            (C) by inserting after subparagraph (E), the following:
            ``(F) the Chief Medical Officer, appointed under section 
        501(g);
            ``(G) the Director of the National Institute of Mental 
        Health for the advisory councils appointed under subsections 
        (a)(1)(A) and (a)(1)(D);
            ``(H) the Director of the National Institute on Drug Abuse 
        for the advisory councils appointed under subsections 
        (a)(1)(A), (a)(1)(B), and (a)(1)(C);
            ``(I) the Director of the National Institute on Alcohol 
        Abuse and Alcoholism for the advisory councils appointed under 
        subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C); and''; and
        (2) in paragraph (3), by adding at the end the following:
            ``(C) Not less than half of the members of the advisory 
        council appointed under subsection (a)(1)(D)--
                ``(i) shall--

                    ``(I) have a medical degree;
                    ``(II) have a doctoral degree in psychology; or
                    ``(III) have an advanced degree in nursing or 
                social work from an accredited graduate school or be a 
                certified physician assistant; and

                ``(ii) shall specialize in the mental health field.
            ``(D) Not less than half of the members of the advisory 
        councils appointed under subsections (a)(1)(B) and (a)(1)(C)--
                ``(i) shall--

                    ``(I) have a medical degree;
                    ``(II) have a doctoral degree; or
                    ``(III) have an advanced degree in nursing, public 
                health, behavioral or social sciences, or social work 
                from an accredited graduate school or be a certified 
                physician assistant; and

                ``(ii) shall have experience in the provision of 
            substance use disorder services or the development and 
            implementation of programs to prevent substance misuse.''.
SEC. 6009. PEER REVIEW.
    Section 504(b) of the Public Health Service Act (42 U.S.C. 290aa-
3(b)) is amended by adding at the end the following: ``In the case of 
any such peer review group that is reviewing a grant, cooperative 
agreement, or contract related to mental illness treatment, not less 
than half of the members of such peer review group shall be licensed 
and experienced professionals in the prevention, diagnosis, or 
treatment of, or recovery from, mental illness or co-occurring mental 
illness and substance use disorders and have a medical degree, a 
doctoral degree in psychology, or an advanced degree in nursing or 
social work from an accredited program, and the Secretary, in 
consultation with the Assistant Secretary, shall, to the extent 
possible, ensure such peer review groups include broad geographic 
representation, including both urban and rural representatives.''.

                Subtitle B--Oversight and Accountability

SEC. 6021. IMPROVING OVERSIGHT OF MENTAL AND SUBSTANCE USE DISORDERS 
PROGRAMS THROUGH THE ASSISTANT SECRETARY FOR PLANNING AND EVALUATION.
    (a) In General.--The Secretary of Health and Human Services, acting 
through the Assistant Secretary for Planning and Evaluation, shall 
ensure efficient and effective planning and evaluation of mental and 
substance use disorders prevention and treatment programs and related 
activities.
    (b) Evaluation Strategy.--In carrying out subsection (a), the 
Assistant Secretary for Planning and Evaluation shall, not later than 
180 days after the date of enactment of this Act, develop a strategy 
for conducting ongoing evaluations that identifies priority programs to 
be evaluated by the Assistant Secretary for Planning and Evaluation and 
priority programs to be evaluated by other relevant offices and 
agencies within the Department of Health and Human Services. The 
strategy shall--
        (1) include a plan for evaluating programs related to mental 
    and substance use disorders, including co-occurring disorders, 
    across agencies, as appropriate, including programs related to--
            (A) prevention, intervention, treatment, and recovery 
        support services, including such services for adults with a 
        serious mental illness or children with a serious emotional 
        disturbance;
            (B) the reduction of homelessness and incarceration among 
        individuals with a mental or substance use disorder; and
            (C) public health and health services; and
        (2) include a plan for assessing the use of performance metrics 
    to evaluate activities carried out by entities receiving grants, 
    contracts, or cooperative agreements related to mental and 
    substance use disorders prevention and treatment services under 
    title V or title XIX of the Public Health Service Act (42 U.S.C. 
    290aa et seq.; 42 U.S.C. 300w et seq.).
    (c) Consultation.--In carrying out this section, the Assistant 
Secretary for Planning and Evaluation shall consult, as appropriate, 
with the Assistant Secretary for Mental Health and Substance Use, the 
Chief Medical Officer of the Substance Abuse and Mental Health Services 
Administration appointed under section 501(g) of the Public Health 
Service Act (42 U.S.C. 290aa(g)), as amended by section 6003, the 
Behavioral Health Coordinating Council of the Department of Health and 
Human Services, other agencies within the Department of Health and 
Human Services, and other relevant Federal departments and agencies.
    (d) Recommendations.--In carrying out this section, the Assistant 
Secretary for Planning and Evaluation shall provide recommendations to 
the Secretary of Health and Human Services, the Assistant Secretary for 
Mental Health and Substance Use, and the Congress on improving the 
quality of prevention and treatment programs and activities related to 
mental and substance use disorders, including recommendations for the 
use of performance metrics. The Assistant Secretary for Mental Health 
and Substance Use shall include such recommendations in the biennial 
report required by subsection 501(m) of the Public Health Service Act, 
as redesignated by section 6003 of this Act.
SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY ORGANIZATIONS.
    (a) Public Availability of Reports.--Section 105(a)(7) of the 
Protection and Advocacy for Individuals with Mental Illness Act (42 
U.S.C. 10805(a)(7)) is amended by striking ``is located a report'' and 
inserting ``is located, and make publicly available, a report''.
    (b) Detailed Accounting.--Section 114(a) of the Protection and 
Advocacy for Individuals with Mental Illness Act (42 U.S.C. 10824(a)) 
is amended--
        (1) in paragraph (3), by striking ``and'' at the end;
        (2) in paragraph (4), by striking the period at the end and 
    inserting ``; and''; and
        (3) by adding at the end the following:
        ``(5) using data from the existing required annual program 
    progress reports submitted by each system funded under this title, 
    a detailed accounting for each such system of how funds are spent, 
    disaggregated according to whether the funds were received from the 
    Federal Government, the State government, a local government, or a 
    private entity.''.
SEC. 6023. GAO STUDY.
    (a) In General.--Not later than 18 months after the date of 
enactment of this Act, the Comptroller General of the United States, in 
consultation with the Secretary of Health and Human Services and the 
Assistant Secretary for Mental Health and Substance Use, shall conduct 
an independent evaluation, and submit a report, to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives, on programs 
funded by allotments made under title I of the Protection and Advocacy 
for Individuals with Mental Illness Act (42 U.S.C. 10801 et seq.).
    (b) Contents.--The report and evaluation required under subsection 
(a) shall include--
        (1) a review of the programs described in such subsection that 
    are carried out by State agencies and such programs that are 
    carried out by private, nonprofit organizations; and
        (2) a review of the compliance of the programs described in 
    subsection (a) with statutory and regulatory responsibilities, such 
    as--
            (A) responsibilities relating to family engagement;
            (B) responsibilities relating to the grievance procedure 
        for clients or prospective clients of the system to assure that 
        individuals with mental illness have full access to the 
        services of the system, for individuals who have received or 
        are receiving mental health services, and for family members of 
        such individuals with mental illness, or representatives of 
        such individuals or family members, to assure that the eligible 
        system is operating in compliance with the provisions of the 
        Protection and Advocacy for Individuals with Mental Illness 
        Act, as required to be established by section 105(a)(9) of such 
        Act (42 U.S.C. 10805(a)(9));
            (C) investigation of alleged abuse and neglect of persons 
        with mental illness;
            (D) availability of adequate medical and behavioral health 
        treatment;
            (E) denial of rights for persons with mental illness; and
            (F) compliance with the Federal prohibition on lobbying.

   Subtitle C--Interdepartmental Serious Mental Illness Coordinating 
                               Committee

SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING 
COMMITTEE.
    (a) Establishment.--
        (1) In general.--Not later than 3 months after the date of 
    enactment of this Act, the Secretary of Health and Human Services, 
    or the designee of the Secretary, shall establish a committee to be 
    known as the Interdepartmental Serious Mental Illness Coordinating 
    Committee (in this section referred to as the ``Committee'').
        (2) Federal advisory committee act.--Except as provided in this 
    section, the provisions of the Federal Advisory Committee Act (5 
    U.S.C. App.) shall apply to the Committee.
    (b) Meetings.--The Committee shall meet not fewer than 2 times each 
year.
    (c) Responsibilities.--Not later than 1 year after the date of 
enactment of this Act, and 5 years after such date of enactment, the 
Committee shall submit to Congress and any other relevant Federal 
department or agency a report including--
        (1) a summary of advances in serious mental illness and serious 
    emotional disturbance research related to the prevention of, 
    diagnosis of, intervention in, and treatment and recovery of 
    serious mental illnesses, serious emotional disturbances, and 
    advances in access to services and support for adults with a 
    serious mental illness or children with a serious emotional 
    disturbance;
        (2) an evaluation of the effect Federal programs related to 
    serious mental illness have on public health, including public 
    health outcomes such as--
            (A) rates of suicide, suicide attempts, incidence and 
        prevalence of serious mental illnesses, serious emotional 
        disturbances, and substance use disorders, overdose, overdose 
        deaths, emergency hospitalizations, emergency room boarding, 
        preventable emergency room visits, interaction with the 
        criminal justice system, homelessness, and unemployment;
            (B) increased rates of employment and enrollment in 
        educational and vocational programs;
            (C) quality of mental and substance use disorders treatment 
        services; or
            (D) any other criteria as may be determined by the 
        Secretary; and
        (3) specific recommendations for actions that agencies can take 
    to better coordinate the administration of mental health services 
    for adults with a serious mental illness or children with a serious 
    emotional disturbance.
    (d) Committee Extension.--Upon the submission of the second report 
under subsection (c), the Secretary shall submit a recommendation to 
Congress on whether to extend the operation of the Committee.
    (e) Membership.--
        (1) Federal members.--The Committee shall be composed of the 
    following Federal representatives, or the designees of such 
    representatives--
            (A) the Secretary of Health and Human Services, who shall 
        serve as the Chair of the Committee;
            (B) the Assistant Secretary for Mental Health and Substance 
        Use;
            (C) the Attorney General;
            (D) the Secretary of Veterans Affairs;
            (E) the Secretary of Defense;
            (F) the Secretary of Housing and Urban Development;
            (G) the Secretary of Education;
            (H) the Secretary of Labor;
            (I) the Administrator of the Centers for Medicare & 
        Medicaid Services; and
            (J) the Commissioner of Social Security.
        (2) Non-federal members.--The Committee shall also include not 
    less than 14 non-Federal public members appointed by the Secretary 
    of Health and Human Services, of which--
            (A) at least 2 members shall be an individual who has 
        received treatment for a diagnosis of a serious mental illness;
            (B) at least 1 member shall be a parent or legal guardian 
        of an adult with a history of a serious mental illness or a 
        child with a history of a serious emotional disturbance;
            (C) at least 1 member shall be a representative of a 
        leading research, advocacy, or service organization for adults 
        with a serious mental illness;
            (D) at least 2 members shall be--
                (i) a licensed psychiatrist with experience in treating 
            serious mental illnesses;
                (ii) a licensed psychologist with experience in 
            treating serious mental illnesses or serious emotional 
            disturbances;
                (iii) a licensed clinical social worker with experience 
            treating serious mental illnesses or serious emotional 
            disturbances; or
                (iv) a licensed psychiatric nurse, nurse practitioner, 
            or physician assistant with experience in treating serious 
            mental illnesses or serious emotional disturbances;
            (E) at least 1 member shall be a licensed mental health 
        professional with a specialty in treating children and 
        adolescents with a serious emotional disturbance;
            (F) at least 1 member shall be a mental health professional 
        who has research or clinical mental health experience in 
        working with minorities;
            (G) at least 1 member shall be a mental health professional 
        who has research or clinical mental health experience in 
        working with medically underserved populations;
            (H) at least 1 member shall be a State certified mental 
        health peer support specialist;
            (I) at least 1 member shall be a judge with experience in 
        adjudicating cases related to criminal justice or serious 
        mental illness;
            (J) at least 1 member shall be a law enforcement officer or 
        corrections officer with extensive experience in interfacing 
        with adults with a serious mental illness, children with a 
        serious emotional disturbance, or individuals in a mental 
        health crisis; and
            (K) at least 1 member shall have experience providing 
        services for homeless individuals and working with adults with 
        a serious mental illness, children with a serious emotional 
        disturbance, or individuals in a mental health crisis.
        (3) Terms.--A member of the Committee appointed under 
    subsection (e)(2) shall serve for a term of 3 years, and may be 
    reappointed for 1 or more additional 3-year terms. Any member 
    appointed to fill a vacancy for an unexpired term shall be 
    appointed for the remainder of such term. A member may serve after 
    the expiration of the member's term until a successor has been 
    appointed.
    (f) Working Groups.--In carrying out its functions, the Committee 
may establish working groups. Such working groups shall be composed of 
Committee members, or their designees, and may hold such meetings as 
are necessary.
    (g) Sunset.--The Committee shall terminate on the date that is 6 
years after the date on which the Committee is established under 
subsection (a)(1).

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

SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED PROGRAMS.
    Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) 
is amended by inserting after section 501 (42 U.S.C. 290aa) the 
following:
``SEC. 501A. NATIONAL MENTAL HEALTH AND SUBSTANCE USE POLICY 
LABORATORY.
    ``(a) In General.--There shall be established within the 
Administration a National Mental Health and Substance Use Policy 
Laboratory (referred to in this section as the `Laboratory').
    ``(b) Responsibilities.--The Laboratory shall--
        ``(1) continue to carry out the authorities and activities that 
    were in effect for the Office of Policy, Planning, and Innovation 
    as such Office existed prior to the date of enactment of the 
    Helping Families in Mental Health Crisis Reform Act of 2016;
        ``(2) identify, coordinate, and facilitate the implementation 
    of policy changes likely to have a significant effect on mental 
    health, mental illness, recovery supports, and the prevention and 
    treatment of substance use disorder services;
        ``(3) work with the Center for Behavioral Health Statistics and 
    Quality to collect, as appropriate, information from grantees under 
    programs operated by the Administration in order to evaluate and 
    disseminate information on evidence-based practices, including 
    culturally and linguistically appropriate services, as appropriate, 
    and service delivery models;
        ``(4) provide leadership in identifying and coordinating 
    policies and programs, including evidence-based programs, related 
    to mental and substance use disorders;
        ``(5) periodically review programs and activities operated by 
    the Administration relating to the diagnosis or prevention of, 
    treatment for, and recovery from, mental and substance use 
    disorders to--
            ``(A) identify any such programs or activities that are 
        duplicative;
            ``(B) identify any such programs or activities that are not 
        evidence-based, effective, or efficient; and
            ``(C) formulate recommendations for coordinating, 
        eliminating, or improving programs or activities identified 
        under subparagraph (A) or (B) and merging such programs or 
        activities into other successful programs or activities; and
        ``(6) carry out other activities as deemed necessary to 
    continue to encourage innovation and disseminate evidence-based 
    programs and practices.
    ``(c) Evidence-Based Practices and Service Delivery Models.--
        ``(1) In general.--In carrying out subsection (b)(3), the 
    Laboratory--
            ``(A) may give preference to models that improve--
                ``(i) the coordination between mental health and 
            physical health providers;
                ``(ii) the coordination among such providers and the 
            justice and corrections system; and
                ``(iii) the cost effectiveness, quality, effectiveness, 
            and efficiency of health care services furnished to adults 
            with a serious mental illness, children with a serious 
            emotional disturbance, or individuals in a mental health 
            crisis; and
            ``(B) may include clinical protocols and practices that 
        address the needs of individuals with early serious mental 
        illness.
        ``(2) Consultation.--In carrying out this section, the 
    Laboratory shall consult with--
            ``(A) the Chief Medical Officer appointed under section 
        501(g);
            ``(B) representatives of the National Institute of Mental 
        Health, the National Institute on Drug Abuse, and the National 
        Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
            ``(C) other appropriate Federal agencies;
            ``(D) clinical and analytical experts with expertise in 
        psychiatric medical care and clinical psychological care, 
        health care management, education, corrections health care, and 
        mental health court systems, as appropriate; and
            ``(E) other individuals and agencies as determined 
        appropriate by the Assistant Secretary.
    ``(d) Deadline for Beginning Implementation.--The Laboratory shall 
begin implementation of this section not later than January 1, 2018.
    ``(e) Promoting Innovation.--
        ``(1) In general.--The Assistant Secretary, in coordination 
    with the Laboratory, may award grants to States, local governments, 
    Indian tribes or tribal organizations (as such terms are defined in 
    section 4 of the Indian Self-Determination and Education Assistance 
    Act), educational institutions, and nonprofit organizations to 
    develop evidence-based interventions, including culturally and 
    linguistically appropriate services, as appropriate, for--
            ``(A) evaluating a model that has been scientifically 
        demonstrated to show promise, but would benefit from further 
        applied development, for--
                ``(i) enhancing the prevention, diagnosis, 
            intervention, and treatment of, and recovery from, mental 
            illness, serious emotional disturbances, substance use 
            disorders, and co-occurring illness or disorders; or
                ``(ii) integrating or coordinating physical health 
            services and mental and substance use disorders services; 
            and
            ``(B) expanding, replicating, or scaling evidence-based 
        programs across a wider area to enhance effective screening, 
        early diagnosis, intervention, and treatment with respect to 
        mental illness, serious mental illness, serious emotional 
        disturbances, and substance use disorders, primarily by--
                ``(i) applying such evidence-based programs to the 
            delivery of care, including by training staff in effective 
            evidence-based treatments; or
                ``(ii) integrating such evidence-based programs into 
            models of care across specialties and jurisdictions.
        ``(2) Consultation.--In awarding grants under this subsection, 
    the Assistant Secretary shall, as appropriate, consult with the 
    Chief Medical Officer, appointed under section 501(g), the advisory 
    councils described in section 502, the National Institute of Mental 
    Health, the National Institute on Drug Abuse, and the National 
    Institute on Alcohol Abuse and Alcoholism, as appropriate.
        ``(3) Authorization of appropriations.--There are authorized to 
    be appropriated--
            ``(A) to carry out paragraph (1)(A), $7,000,000 for the 
        period of fiscal years 2018 through 2020; and
            ``(B) to carry out paragraph (1)(B), $7,000,000 for the 
        period of fiscal years 2018 through 2020.''.
SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED PROGRAMS 
AND PRACTICES.
    Part D of title V of the Public Health Service Act (42 U.S.C. 290dd 
et seq.) is amended by inserting after section 543 of such Act (42 
U.S.C. 290dd-2) the following:
``SEC. 543A. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED PROGRAMS 
AND PRACTICES.
    ``(a) In General.--The Assistant Secretary shall, as appropriate, 
improve access to reliable and valid information on evidence-based 
programs and practices, including information on the strength of 
evidence associated with such programs and practices, related to mental 
and substance use disorders for States, local communities, nonprofit 
entities, and other stakeholders, by posting on the Internet website of 
the Administration information on evidence-based programs and practices 
that have been reviewed by the Assistant Secretary in accordance with 
the requirements of this section.
    ``(b) Applications.--
        ``(1) Application period.--In carrying out subsection (a), the 
    Assistant Secretary may establish a period for the submission of 
    applications for evidence-based programs and practices to be posted 
    publicly in accordance with subsection (a).
        ``(2) Notice.--In establishing the application period under 
    paragraph (1), the Assistant Secretary shall provide for the public 
    notice of such application period in the Federal Register. Such 
    notice may solicit applications for evidence-based programs and 
    practices to address gaps in information identified by the 
    Assistant Secretary, the National Mental Health and Substance Use 
    Policy Laboratory established under section 501A, or the Assistant 
    Secretary for Planning and Evaluation, including pursuant to the 
    evaluation and recommendations under section 6021 of the Helping 
    Families in Mental Health Crisis Reform Act of 2016 or priorities 
    identified in the strategic plan under section 501(l).
    ``(c) Requirements.--The Assistant Secretary may establish minimum 
requirements for the applications submitted under subsection (b), 
including applications related to the submission of research and 
evaluation.
    ``(d) Review and Rating.--
        ``(1) In general.--The Assistant Secretary shall review 
    applications prior to public posting in accordance with subsection 
    (a), and may prioritize the review of applications for evidence-
    based programs and practices that are related to topics included in 
    the notice provided under subsection (b)(2).
        ``(2) System.--In carrying out paragraph (1), the Assistant 
    Secretary may utilize a rating and review system, which may include 
    information on the strength of evidence associated with the 
    evidence-based programs and practices and a rating of the 
    methodological rigor of the research supporting the applications.
        ``(3) Public access to metrics and rating.--The Assistant 
    Secretary shall make the metrics used to evaluate applications 
    under this section, and any resulting ratings of such applications, 
    publicly available.''.
SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND NATIONAL 
SIGNIFICANCE.
    Section 520A of the Public Health Service Act (42 U.S.C. 290bb-32) 
is amended--
        (1) in subsection (a)--
            (A) in paragraph (4), by inserting before the period ``, 
        which may include technical assistance centers''; and
            (B) in the flush sentence following paragraph (4)--
                (i) by inserting ``, contracts,'' before ``or 
            cooperative agreements''; and
                (ii) by striking ``Indian tribes and tribal 
            organizations'' and inserting ``Indian tribes or tribal 
            organizations (as such terms are defined in section 4 of 
            the Indian Self-Determination and Education Assistance 
            Act), health facilities, or programs operated by or in 
            accordance with a contract or grant with the Indian Health 
            Service, or''; and
        (2) by amending subsection (f) to read as follows:
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $394,550,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREATMENT NEEDS OF REGIONAL 
AND NATIONAL SIGNIFICANCE.
    Section 509 of the Public Health Service Act (42 U.S.C. 290bb-2) is 
amended--
        (1) in subsection (a)--
            (A) in the matter preceding paragraph (1), by striking 
        ``abuse'' and inserting ``use disorder'';
            (B) in paragraph (3), by inserting before the period ``that 
        permit States, local governments, communities, and Indian 
        tribes and tribal organizations (as the terms `Indian tribes' 
        and `tribal organizations' are defined in section 4 of the 
        Indian Self-Determination and Education Assistance Act) to 
        focus on emerging trends in substance abuse and co-occurrence 
        of substance use disorders with mental illness or other 
        conditions''; and
            (C) in the flush sentence following paragraph (3)--
                (i) by inserting ``, contracts,'' before ``or 
            cooperative agreements''; and
                (ii) by striking ``Indian tribes and tribal 
            organizations,'' and inserting ``Indian tribes or tribal 
            organizations (as such terms are defined in section 4 of 
            the Indian Self-Determination and Education Assistance 
            Act), health facilities, or programs operated by or in 
            accordance with a contract or grant with the Indian Health 
            Service, or'';
        (2) in subsection (b)--
            (A) in paragraph (1), by striking ``abuse'' and inserting 
        ``use disorder''; and
            (B) in paragraph (2), by striking ``abuse'' and inserting 
        ``use disorder'';
        (3) in subsection (e), by striking ``abuse'' and inserting 
    ``use disorder''; and
        (4) in subsection (f), by striking ``$300,000,000'' and all 
    that follows through the period and inserting ``$333,806,000 for 
    each of fiscal years 2018 through 2022.''.
SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS OF REGIONAL 
AND NATIONAL SIGNIFICANCE.
    Section 516 of the Public Health Service Act (42 U.S.C. 290bb-22) 
is amended--
        (1) in the section heading, by striking ``abuse'' and inserting 
    ``use disorder'';
        (2) in subsection (a)--
            (A) in the matter preceding paragraph (1), by striking 
        ``abuse'' and inserting ``use disorder'';
            (B) in paragraph (3), by inserting before the period ``, 
        including such programs that focus on emerging drug abuse 
        issues''; and
            (C) in the flush sentence following paragraph (3)--
                (i) by inserting ``, contracts,'' before ``or 
            cooperative agreements''; and
                (ii) by striking ``Indian tribes and tribal 
            organizations,'' and inserting ``Indian tribes or tribal 
            organizations (as such terms are defined in section 4 of 
            the Indian Self-Determination and Education Assistance 
            Act), health facilities, or programs operated by or in 
            accordance with a contract or grant with the Indian Health 
            Service,'';
        (3) in subsection (b)--
            (A) in paragraph (1), by striking ``abuse'' and inserting 
        ``use disorder''; and
            (B) in paragraph (2)--
                (i) in subparagraph (A), by striking ``; and'' at the 
            end and inserting ``;'';
                (ii) in subparagraph (B)--

                    (I) by striking ``abuse'' and inserting ``use 
                disorder''; and
                    (II) by striking the period and inserting ``; 
                and''; and

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

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

SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT.
    (a) Formula Grants.--Section 1911(b) of the Public Health Service 
Act (42 U.S.C. 300x(b)) is amended--
        (1) by redesignating paragraphs (1) through (3) as paragraphs 
    (2) through (4), respectively; and
        (2) by inserting before paragraph (2) (as so redesignated) the 
    following:
        ``(1) providing community mental health services for adults 
    with a serious mental illness and children with a serious emotional 
    disturbance as defined in accordance with section 1912(c);''.
    (b) State Plan.--Section 1912(b) of the Public Health Service Act 
(42 U.S.C. 300x-1(b)) is amended--
        (1) in paragraph (3), by redesignating subparagraphs (A) 
    through (C) as clauses (i) through (iii), respectively, and 
    realigning the margins accordingly;
        (2) by redesignating paragraphs (1) through (5) as 
    subparagraphs (A) through (E), respectively, and realigning the 
    margins accordingly;
        (3) in the matter preceding subparagraph (A) (as so 
    redesignated), by striking ``With respect to'' and all that follows 
    through ``are as follows:'' and inserting ``In accordance with 
    subsection (a), a State shall submit to the Secretary a plan every 
    two years that, at a minimum, includes each of the following:'';
        (4) by inserting before subparagraph (A) (as so redesignated) 
    the following:
        ``(1) System of care.--A description of the State's system of 
    care that contains the following:'';
        (5) by striking subparagraph (A) (as so redesignated) and 
    inserting the following:
            ``(A) Comprehensive community-based health systems.--The 
        plan shall--
                ``(i) identify the single State agency to be 
            responsible for the administration of the program under the 
            grant, including any third party who administers mental 
            health services and is responsible for complying with the 
            requirements of this part with respect to the grant;
                ``(ii) provide for an organized community-based system 
            of care for individuals with mental illness, and describe 
            available services and resources in a comprehensive system 
            of care, including services for individuals with co-
            occurring disorders;
                ``(iii) include a description of the manner in which 
            the State and local entities will coordinate services to 
            maximize the efficiency, effectiveness, quality, and cost-
            effectiveness of services and programs to produce the best 
            possible outcomes (including health services, 
            rehabilitation services, employment services, housing 
            services, educational services, substance use disorder 
            services, legal services, law enforcement services, social 
            services, child welfare services, medical and dental care 
            services, and other support services to be provided with 
            Federal, State, and local public and private resources) 
            with other agencies to enable individuals receiving 
            services to function outside of inpatient or residential 
            institutions, to the maximum extent of their capabilities, 
            including services to be provided by local school systems 
            under the Individuals with Disabilities Education Act;
                ``(iv) include a description of how the State promotes 
            evidence-based practices, including those evidence-based 
            programs that address the needs of individuals with early 
            serious mental illness regardless of the age of the 
            individual at onset, provide comprehensive individualized 
            treatment, or integrate mental and physical health 
            services;
                ``(v) include a description of case management 
            services;
                ``(vi) include a description of activities that seek to 
            engage adults with a serious mental illness or children 
            with a serious emotional disturbance and their caregivers 
            where appropriate in making health care decisions, 
            including activities that enhance communication among 
            individuals, families, caregivers, and treatment providers; 
            and
                ``(vii) as appropriate to, and reflective of, the uses 
            the State proposes for the block grant funds, include--

                    ``(I) a description of the activities intended to 
                reduce hospitalizations and hospital stays using the 
                block grant funds;
                    ``(II) a description of the activities intended to 
                reduce incidents of suicide using the block grant 
                funds;
                    ``(III) a description of how the State integrates 
                mental health and primary care using the block grant 
                funds, which may include providing, in the case of 
                individuals with co-occurring mental and substance use 
                disorders, both mental and substance use disorders 
                services in primary care settings or arrangements to 
                provide primary and specialty care services in 
                community-based mental and substance use disorders 
                settings; and
                    ``(IV) a description of recovery and recovery 
                support services for adults with a serious mental 
                illness and children with a serious emotional 
                disturbance.'';

        (6) in subparagraph (B) (as so redesignated)--
            (A) by striking ``The plan contains'' and inserting ``The 
        plan shall contain''; and
            (B) by striking ``presents quantitative targets to be 
        achieved in the implementation of the system described in 
        paragraph (1)'' and inserting ``present quantitative targets 
        and outcome measures for programs and services provided under 
        this subpart'';
        (7) in subparagraph (C) (as so redesignated)--
            (A) by striking ``serious emotional disturbance'' in the 
        matter preceding clause (i) (as so redesignated) and all that 
        follows through ``substance abuse services'' in clause (i) (as 
        so redesignated) and inserting the following: ``a serious 
        emotional disturbance (as defined pursuant to subsection (c)), 
        the plan shall provide for a system of integrated social 
        services, educational services, child welfare services, 
        juvenile justice services, law enforcement services, and 
        substance use disorder services'';
            (B) by striking ``Education Act);'' and inserting 
        ``Education Act).''; and
            (C) by striking clauses (ii) and (iii) (as so 
        redesignated);
        (8) in subparagraph (D) (as so redesignated), by striking 
    ``plan describes'' and inserting ``plan shall describe'';
        (9) in subparagraph (E) (as so redesignated)--
            (A) in the subparagraph heading by striking ``systems'' and 
        inserting ``services'';
            (B) in the first sentence, by striking ``plan describes'' 
        and all that follows through ``and provides for'' and inserting 
        ``plan shall describe the financial resources available, the 
        existing mental health workforce, and the workforce trained in 
        treating individuals with co-occurring mental and substance use 
        disorders, and shall provide for''; and
            (C) in the second sentence--
                (i) by striking ``further describes'' and inserting 
            ``shall further describe''; and
                (ii) by striking ``involved.'' and inserting 
            ``involved, and the manner in which the State intends to 
            comply with each of the funding agreements in this subpart 
            and subpart III.'';
        (10) by striking the flush matter at the end; and
        (11) by adding at the end the following:
        ``(2) Goals and objectives.--The establishment of goals and 
    objectives for the period of the plan, including targets and 
    milestones that are intended to be met, and the activities that 
    will be undertaken to achieve those targets.''.
    (c) Early Serious Mental Illness.--Section 1920 of the Public 
Health Service Act (42 U.S.C. 300x-9) is amended by adding at the end 
the following:
    ``(c) Early Serious Mental Illness.--
        ``(1) In general.--Except as provided in paragraph (2), a State 
    shall expend not less than 10 percent of the amount the State 
    receives for carrying out this section for each fiscal year to 
    support evidence-based programs that address the needs of 
    individuals with early serious mental illness, including psychotic 
    disorders, regardless of the age of the individual at onset.
        ``(2) State flexibility.--In lieu of expending 10 percent of 
    the amount the State receives under this section for a fiscal year 
    as required under paragraph (1), a State may elect to expend not 
    less than 20 percent of such amount by the end of such succeeding 
    fiscal year.''.
    (d) Additional Provisions.--Section 1915(b) of the Public Health 
Service Act (42 U.S.C. 300x-4(b)) is amended--
        (1) in paragraph (3)--
            (A) by striking ``The Secretary'' and inserting the 
        following:
            ``(A) In general.--The Secretary'';
            (B) by striking ``paragraph (1) if'' and inserting 
        ``paragraph (1) in whole or in part if'';
            (C) by striking ``State justify the waiver.'' and inserting 
        ``State in the fiscal year involved or in the previous fiscal 
        year justify the waiver''; and
            (D) by adding at the end the following:
            ``(B) Date certain for action upon request.--The Secretary 
        shall approve or deny a request for a waiver under this 
        paragraph not later than 120 days after the date on which the 
        request is made.
            ``(C) Applicability of waiver.--A waiver provided by the 
        Secretary under this paragraph shall be applicable only to the 
        fiscal year involved.''; and
        (2) in paragraph (4)--
            (A) in subparagraph (A)--
                (i) by inserting after the subparagraph designation the 
            following: ``In general.--'';
                (ii) by striking ``In making a grant'' and inserting 
            the following:
                ``(i) Determination.--In making a grant''; and
                (iii) by inserting at the end the following:
                ``(ii) Alternative.--A State that has failed to comply 
            with paragraph (1) and would otherwise be subject to a 
            reduction in the State's allotment under section 1911 may, 
            upon request by the State, in lieu of having the amount of 
            the allotment under section 1911 for the State reduced for 
            the fiscal year of the grant, agree to comply with a 
            negotiated agreement that is approved by the Secretary and 
            carried out in accordance with guidelines issued by the 
            Secretary. If a State fails to enter into or comply with a 
            negotiated agreement, the Secretary may take action under 
            this paragraph or the terms of the negotiated agreement.''; 
            and
            (B) in subparagraph (B)--
                (i) by inserting after the subparagraph designation the 
            following: ``Submission of information to the secretary.--
            ''; and
                (ii) by striking ``subparagraph (A)'' and inserting 
            ``subparagraph (A)(i)''.
    (e) Application for Grant.--Section 1917(a) of the Public Health 
Service Act (42 U.S.C. 300x-6(a)) is amended--
        (1) in paragraph (1), by striking ``1941'' and inserting 
    ``1942(a)''; and
        (2) in paragraph (5), by striking ``1915(b)(3)(B)'' and 
    inserting ``1915(b)''.
    (f) Funding.--Section 1920 of the Public Health Service Act (42 
U.S.C. 300x-9) is amended--
        (1) in subsection (a)--
            (A) by striking ``section 505'' and inserting ``section 
        505(c)''; and
            (B) by striking ``$450,000,000'' and all that follows 
        through the period and inserting ``$532,571,000 for each of 
        fiscal years 2018 through 2022.''; and
        (2) in subsection (b)(2) by striking ``sections 505 and'' and 
    inserting ``sections 505(c) and''.
SEC. 8002. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT.
    (a) Formula Grants.--Section 1921(b) of the Public Health Service 
Act (42 U.S.C. 300x-21(b)) is amended--
        (1) by inserting ``carrying out the plan developed in 
    accordance with section 1932(b) and for'' after ``for the purpose 
    of''; and
        (2) by striking ``abuse'' and inserting ``use disorders''.
    (b) Outreach to Persons Who Inject Drugs.--Section 1923(b) of the 
Public Health Service Act (42 U.S.C. 300x-23(b)) is amended--
        (1) in the subsection heading, by striking ``Regarding 
    Intravenous Substance Abuse'' and inserting ``to Persons Who Inject 
    Drugs''; and
        (2) by striking ``for intravenous drug abuse'' and inserting 
    ``for persons who inject drugs''.
    (c) Requirements Regarding Tuberculosis and Human Immunodeficiency 
Virus.--Section 1924 of the Public Health Service Act (42 U.S.C. 300x-
24) is amended--
        (1) in subsection (a)(1)--
            (A) in the matter preceding subparagraph (A), by striking 
        ``substance abuse'' and inserting ``substance use disorders''; 
        and
            (B) in subparagraph (A), by striking ``such abuse'' and 
        inserting ``such disorders'';
        (2) in subsection (b)--
            (A) in paragraph (1)(A), by striking ``substance abuse'' 
        and inserting ``substance use disorders'';
            (B) in paragraph (2), by inserting ``and Prevention'' after 
        ``Disease Control'';
            (C) in paragraph (3)--
                (i) in the paragraph heading, by striking ``abuse'' and 
            inserting ``use disorders''; and
                (ii) by striking ``substance abuse'' and inserting 
            ``substance use disorders''; and
            (D) in paragraph (6)(B), by striking ``substance abuse'' 
        and inserting ``substance use disorders'';
        (3) by striking subsection (d); and
        (4) by redesignating subsection (e) as subsection (d).
    (d) Group Homes.--Section 1925 of the Public Health Service Act (42 
U.S.C. 300x-25) is amended--
        (1) in the section heading, by striking ``recovering substance 
    abusers'' and inserting ``persons in recovery from substance use 
    disorders''; and
        (2) in subsection (a), in the matter preceding paragraph (1), 
    by striking ``recovering substance abusers'' and inserting 
    ``persons in recovery from substance use disorders''.
    (e) Additional Agreements.--Section 1928 of the Public Health 
Service Act (42 U.S.C. 300x-28) is amended--
        (1) in subsection (a), by striking ``(relative to fiscal year 
    1992)'';
        (2) by striking subsection (b) and inserting the following:
    ``(b) Professional Development.--A funding agreement for a grant 
under section 1921 is that the State involved will ensure that 
prevention, treatment, and recovery personnel operating in the State's 
substance use disorder prevention, treatment, and recovery systems have 
an opportunity to receive training, on an ongoing basis, concerning--
        ``(1) recent trends in substance use disorders in the State;
        ``(2) improved methods and evidence-based practices for 
    providing substance use disorder prevention and treatment services;
        ``(3) performance-based accountability;
        ``(4) data collection and reporting requirements; and
        ``(5) any other matters that would serve to further improve the 
    delivery of substance use disorder prevention and treatment 
    services within the State.''; and
        (3) in subsection (d)(1), by striking ``substance abuse'' and 
    inserting ``substance use disorders''.
    (f) Repeal.--Section 1929 of the Public Health Service Act (42 
U.S.C. 300x-29) is repealed.
    (g) Maintenance of Effort.--Section 1930 of the Public Health 
Service Act (42 U.S.C. 300x-30) is amended--
        (1) in subsection (c)(1), by striking ``in the State justify 
    the waiver'' and inserting ``exist in the State, or any part of the 
    State, to justify the waiver''; and
        (2) in subsection (d), by inserting at the end the following:
        ``(3) Alternative.--A State that has failed to comply with this 
    section and would otherwise be subject to a reduction in the 
    State's allotment under section 1921, may, upon request by the 
    State, in lieu of having the State's allotment under section 1921 
    reduced, agree to comply with a negotiated agreement that is 
    approved by the Secretary and carried out in accordance with 
    guidelines issued by the Secretary. If a State fails to enter into 
    or comply with a negotiated agreement, the Secretary may take 
    action under this paragraph or the terms of the negotiated 
    agreement.''.
    (h) Restrictions on Expenditures.--Section 1931(b)(1) of the Public 
Health Service Act (42 U.S.C. 300x-31(b)(1)) is amended by striking 
``substance abuse'' and inserting ``substance use disorders''.
    (i) Application.--Section 1932 of the Public Health Service Act (42 
U.S.C. 300x-32) is amended--
        (1) in subsection (a)--
            (A) in the matter preceding paragraph (1), by striking 
        ``subsections (c) and (d)(2)'' and inserting ``subsection 
        (c)''; and
            (B) in paragraph (5), by striking ``the information 
        required in section 1929, the information required in section 
        1930(c)(2), and'';
        (2) in subsection (b)--
            (A) by striking paragraph (1) and inserting the following:
        ``(1) In general.--In order for a State to be in compliance 
    with subsection (a)(6), the State shall submit to the Secretary a 
    plan that, at a minimum, includes the following:
            ``(A) A description of the State's system of care that--
                ``(i) identifies the single State agency responsible 
            for the administration of the program, including any third 
            party who administers substance use disorder services and 
            is responsible for complying with the requirements of the 
            grant;
                ``(ii) provides information on the need for substance 
            use disorder prevention and treatment services in the 
            State, including estimates on the number of individuals who 
            need treatment, who are pregnant women, women with 
            dependent children, individuals with a co-occurring mental 
            health and substance use disorder, persons who inject 
            drugs, and persons who are experiencing homelessness;
                ``(iii) provides aggregate information on the number of 
            individuals in treatment within the State, including the 
            number of such individuals who are pregnant women, women 
            with dependent children, individuals with a co-occurring 
            mental health and substance use disorder, persons who 
            inject drugs, and persons who are experiencing 
            homelessness;
                ``(iv) provides a description of the system that is 
            available to provide services by modality, including the 
            provision of recovery support services;
                ``(v) provides a description of the State's 
            comprehensive statewide prevention efforts, including the 
            number of individuals being served in the system, target 
            populations, and priority needs, and provides a description 
            of the amount of funds from the prevention set-aside 
            expended on primary prevention;
                ``(vi) provides a description of the financial 
            resources available;
                ``(vii) describes the existing substance use disorders 
            workforce and workforce trained in treating co-occurring 
            substance use and mental disorders;
                ``(viii) includes a description of how the State 
            promotes evidence-based practices; and
                ``(ix) describes how the State integrates substance use 
            disorder services and primary health care, which in the 
            case of those individuals with co-occurring mental health 
            and substance use disorders may include providing both 
            mental health and substance use disorder services in 
            primary care settings or providing primary and specialty 
            care services in community-based mental health and 
            substance use disorder service settings.
            ``(B) The establishment of goals and objectives for the 
        period of the plan, including targets and milestones that are 
        intended to be met, and the activities that will be undertaken 
        to achieve those targets.
            ``(C) A description of how the State will comply with each 
        funding agreement for a grant under section 1921 that is 
        applicable to the State, including a description of the manner 
        in which the State intends to expend grant funds.''; and
            (B) in paragraph (2)--
                (i) in the paragraph heading, by striking ``authority 
            of secretary regarding modifications'' and inserting 
            ``modifications'';
                (ii) by striking ``As a condition'' and inserting the 
            following:
            ``(A) Authority of secretary.--As a condition;''; and
                (iii) by adding at the end the following:
            ``(B) State request for modification.--If the State 
        determines that a modification to such plan is necessary, the 
        State may request the Secretary to approve the modification. 
        Any such modification shall be in accordance with paragraph (1) 
        and section 1941.''; and
            (C) in paragraph (3), by inserting, ``, including any 
        modification under paragraph (2)'' after ``subsection (a)(6)''; 
        and
        (3) in subsection (e)(2), by striking ``section 1922(c)'' and 
    inserting ``section 1922(b)''.
    (j) Definitions.--Section 1934 of the Public Health Service Act (42 
U.S.C. 300x-34) is amended--
        (1) in paragraph (3), by striking ``substance abuse'' and 
    inserting ``substance use disorders''; and
        (2) in paragraph (7), by striking ``substance abuse'' and 
    inserting ``substance use disorders''.
    (k) Funding.--Section 1935 of the Public Health Service Act (42 
U.S.C. 300x-35) is amended--
        (1) in subsection (a)--
            (A) by striking ``section 505'' and inserting ``section 
        505(d)''; and
            (B) by striking ``$2,000,000,000 for fiscal year 2001, and 
        such sums as may be necessary for each of the fiscal years 2002 
        and 2003'' and inserting ``$1,858,079,000 for each of fiscal 
        years 2018 through 2022.''; and
        (2) in subsection (b)(1)(B) by striking ``sections 505 and'' 
    and inserting ``sections 505(d) and''.
SEC. 8003. ADDITIONAL PROVISIONS RELATED TO THE BLOCK GRANTS.
    Subpart III of part B of title XIX of the Public Health Service Act 
(42 U.S.C. 300x-51 et seq.) is amended--
        (1) in section 1943(a)(3) (42 U.S.C. 300x-53(a)(3)), by 
    striking ``section 505'' and inserting ``subsections (c) and (d) of 
    section 505'';
        (2) in section 1953(b) (42 U.S.C. 300x-63(b)), by striking 
    ``substance abuse'' and inserting ``substance use disorder''; and
        (3) by adding at the end the following:
``SEC. 1957. PUBLIC HEALTH EMERGENCIES.
    ``In the case of a public health emergency (as determined under 
section 319), the Secretary, on a State by State basis, may, as the 
circumstances of the emergency reasonably require and for the period of 
the emergency, grant an extension, or waive application deadlines or 
compliance with any other requirement, of a grant authorized under 
section 521, 1911, or 1921 or an allotment authorized under Public Law 
99-319 (42 U.S.C. 10801 et seq.).
``SEC. 1958. JOINT APPLICATIONS.
    ``The Secretary, acting through the Assistant Secretary for Mental 
Health and Substance Use, shall permit a joint application to be 
submitted for grants under subpart I and subpart II upon the request of 
a State. Such application may be jointly reviewed and approved by the 
Secretary with respect to such subparts, consistent with the purposes 
and authorized activities of each such grant program. A State 
submitting such a joint application shall otherwise meet the 
requirements with respect to each such subpart.''.
SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE ABUSE 
PREVENTION AND TREATMENT BLOCK GRANT AND THE COMMUNITY MENTAL HEALTH 
SERVICES BLOCK GRANT.
    (a) In General.--The Secretary of Health and Human Services, acting 
through the Assistant Secretary for Mental Health and Substance Use, 
shall through a grant or contract, or through an agreement with a third 
party, conduct a study on the formulas for distribution of funds under 
the substance abuse prevention and treatment block grant, and the 
community mental health services block grant, under part B of title XIX 
of the Public Health Service Act (42 U.S.C. 300x et seq.) and recommend 
changes if necessary. Such study shall include--
        (1) an analysis of whether the distributions under such block 
    grants accurately reflect the need for the services under the 
    grants in the States;
        (2) an examination of whether the indices used under the 
    formulas for distribution of funds under such block grants are 
    appropriate, and if not, alternatives recommended by the Secretary;
        (3) where recommendations are included under paragraph (2) for 
    the use of different indices, a description of the variables and 
    data sources that should be used to determine the indices;
        (4) an evaluation of the variables and data sources that are 
    being used for each of the indices involved, and whether such 
    variables and data sources accurately represent the need for 
    services, the cost of providing services, and the ability of the 
    States to pay for such services;
        (5) the effect that the minimum allotment requirements for each 
    such block grant have on each State's final allotment and the 
    effect of such requirements, if any, on each State's formula-based 
    allotment;
        (6) recommendations for modifications to the minimum allotment 
    provisions to ensure an appropriate distribution of funds; and
        (7) any other information that the Secretary determines 
    appropriate.
    (b) Report.--Not later than 2 years after the date of enactment of 
this Act, the Secretary of Health and Human Services shall submit to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives, a report containing the findings and recommendations 
of the study conducted under subsection (a) and the study conducted 
under section 9004(g).

TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER 
                                  CARE
              Subtitle A--Helping Individuals and Families

SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR HOMELESS INDIVIDUALS.
    Section 506 of the Public Health Service Act (42 U.S.C. 290aa-5) is 
amended--
        (1) in subsection (a), by striking ``substance abuse'' and 
    inserting ``substance use disorder'';
        (2) in subsection (b)--
            (A) in paragraphs (1) and (3), by striking ``substance 
        abuse'' each place the term appears and inserting ``substance 
        use disorder''; and
            (B) in paragraph (4), by striking ``substance abuse'' and 
        inserting ``a substance use disorder'';
        (3) in subsection (c)--
            (A) in paragraph (1), by striking ``substance abuse 
        disorder'' and inserting ``substance use disorder''; and
            (B) in paragraph (2)--
                (i) in subparagraph (A), by striking ``substance 
            abuse'' and inserting ``a substance use disorder''; and
                (ii) in subparagraph (B), by striking ``substance 
            abuse'' and inserting ``substance use disorder''; and
        (4) in subsection (e), by striking ``, $50,000,000 for fiscal 
    year 2001, and such sums as may be necessary for each of the fiscal 
    years 2002 and 2003'' and inserting ``$41,304,000 for each of 
    fiscal years 2018 through 2022''.
SEC. 9002. GRANTS FOR JAIL DIVERSION PROGRAMS.
    Section 520G of the Public Health Service Act (42 U.S.C. 290bb-38) 
is amended--
        (1) by striking ``substance abuse'' each place such term 
    appears and inserting ``substance use disorder'';
        (2) in subsection (a)--
            (A) by striking ``Indian tribes, and tribal organizations'' 
        and inserting ``and Indian tribes and tribal organizations (as 
        the terms `Indian tribes' and `tribal organizations' are 
        defined in section 4 of the Indian Self-Determination and 
        Education Assistance Act)''; and
            (B) by inserting ``or a health facility or program operated 
        by or in accordance with a contract or grant with the Indian 
        Health Service,'' after ``entities,'';
        (3) in subsection (c)(2)(A)(i), by striking ``the best known'' 
    and inserting ``evidence-based'';
        (4) by redesignating subsections (d) through (i) as subsections 
    (e) through (j), respectively;
        (5) by inserting after subsection (c) the following:
    ``(d) Special Consideration Regarding Veterans.--In awarding grants 
under subsection (a), the Secretary shall, as appropriate, give special 
consideration to entities proposing to use grant funding to support 
jail diversion services for veterans.'';
        (6) in subsection (e), as so redesignated--
            (A) in paragraph (3), by striking ``; and'' and inserting a 
        semicolon;
            (B) in paragraph (4), by striking the period and inserting 
        ``; and''; and
            (C) by adding at the end the following:
        ``(5) develop programs to divert individuals prior to booking 
    or arrest.''; and
        (7) in subsection (j), as so redesignated, by striking 
    ``$10,000,000 for fiscal year 2001, and such sums as may be 
    necessary for fiscal years 2002 through 2003'' and inserting 
    ``$4,269,000 for each of fiscal years 2018 through 2022''.
SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BEHAVIORAL HEALTH CARE.
    Section 520K of the Public Health Service Act (42 U.S.C. 290bb-42) 
is amended to read as follows:
``SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE AGREEMENTS.
    ``(a) Definitions.--In this section:
        ``(1) Eligible entity.--The term `eligible entity' means a 
    State, or other appropriate State agency, in collaboration with 1 
    or more qualified community programs as described in section 
    1913(b)(1) or 1 or more community health centers as described in 
    section 330.
        ``(2) Integrated care.--The term `integrated care' means 
    collaborative models or practices offering mental and physical 
    health services, which may include practices that share the same 
    space in the same facility.
        ``(3) Special population.--The term `special population' 
    means--
            ``(A) adults with a mental illness who have co-occurring 
        physical health conditions or chronic diseases;
            ``(B) adults with a serious mental illness who have co-
        occurring physical health conditions or chronic diseases;
            ``(C) children and adolescents with a serious emotional 
        disturbance with co-occurring physical health conditions or 
        chronic diseases; or
            ``(D) individuals with a substance use disorder.
    ``(b) Grants and Cooperative Agreements.--
        ``(1) In general.--The Secretary may award grants and 
    cooperative agreements to eligible entities to support the 
    improvement of integrated care for primary care and behavioral 
    health care in accordance with paragraph (2).
        ``(2) Purposes.--A grant or cooperative agreement awarded under 
    this section shall be designed to--
            ``(A) promote full integration and collaboration in 
        clinical practices between primary and behavioral health care;
            ``(B) support the improvement of integrated care models for 
        primary care and behavioral health care to improve the overall 
        wellness and physical health status of adults with a serious 
        mental illness or children with a serious emotional 
        disturbance; and
            ``(C) promote integrated care services related to 
        screening, diagnosis, prevention, and treatment of mental and 
        substance use disorders, and co-occurring physical health 
        conditions and chronic diseases.
    ``(c) Applications.--
        ``(1) In general.--An eligible entity seeking a grant or 
    cooperative agreement under this section shall submit an 
    application to the Secretary at such time, in such manner, and 
    accompanied by such information as the Secretary may require, 
    including the contents described in paragraph (2).
        ``(2) Contents.--The contents described in this paragraph are--
            ``(A) a description of a plan to achieve fully 
        collaborative agreements to provide services to special 
        populations;
            ``(B) a document that summarizes the policies, if any, that 
        serve as barriers to the provision of integrated care, and the 
        specific steps, if applicable, that will be taken to address 
        such barriers;
            ``(C) a description of partnerships or other arrangements 
        with local health care providers to provide services to special 
        populations;
            ``(D) an agreement and plan to report to the Secretary 
        performance measures necessary to evaluate patient outcomes and 
        facilitate evaluations across participating projects; and
            ``(E) a plan for sustainability beyond the grant or 
        cooperative agreement period under subsection (e).
    ``(d) Grant and Cooperative Agreement Amounts.--
        ``(1) Target amount.--The target amount that an eligible entity 
    may receive for a year through a grant or cooperative agreement 
    under this section shall be $2,000,000.
        ``(2) Adjustment permitted.--The Secretary, taking into 
    consideration the quality of the application and the number of 
    eligible entities that received grants under this section prior to 
    the date of enactment of the Helping Families in Mental Health 
    Crisis Reform Act of 2016, may adjust the target amount that an 
    eligible entity may receive for a year through a grant or 
    cooperative agreement under this section.
        ``(3) Limitation.--An eligible entity receiving funding under 
    this section may not allocate more than 10 percent of funds awarded 
    under this section to administrative functions, and the remaining 
    amounts shall be allocated to health facilities that provide 
    integrated care.
    ``(e) Duration.--A grant or cooperative agreement under this 
section shall be for a period not to exceed 5 years.
    ``(f) Report on Program Outcomes.--An eligible entity receiving a 
grant or cooperative agreement under this section shall submit an 
annual report to the Secretary that includes--
        ``(1) the progress made to reduce barriers to integrated care 
    as described in the entity's application under subsection (c); and
        ``(2) a description of functional outcomes of special 
    populations, including--
            ``(A) with respect to adults with a serious mental illness, 
        participation in supportive housing or independent living 
        programs, attendance in social and rehabilitative programs, 
        participation in job training opportunities, satisfactory 
        performance in work settings, attendance at scheduled medical 
        and mental health appointments, and compliance with prescribed 
        medication regimes;
            ``(B) with respect to individuals with co-occurring mental 
        illness and physical health conditions and chronic diseases, 
        attendance at scheduled medical and mental health appointments, 
        compliance with prescribed medication regimes, and 
        participation in learning opportunities related to improved 
        health and lifestyle practices; and
            ``(C) with respect to children and adolescents with a 
        serious emotional disturbance who have co-occurring physical 
        health conditions and chronic diseases, attendance at scheduled 
        medical and mental health appointments, compliance with 
        prescribed medication regimes, and participation in learning 
        opportunities at school and extracurricular activities.
    ``(g) Technical Assistance for Primary-Behavioral Health Care 
Integration.--
        ``(1) In general.--The Secretary may provide appropriate 
    information, training, and technical assistance to eligible 
    entities that receive a grant or cooperative agreement under this 
    section, in order to help such entities meet the requirements of 
    this section, including assistance with--
            ``(A) development and selection of integrated care models;
            ``(B) dissemination of evidence-based interventions in 
        integrated care;
            ``(C) establishment of organizational practices to support 
        operational and administrative success; and
            ``(D) other activities, as the Secretary determines 
        appropriate.
        ``(2) Additional dissemination of technical information.--The 
    information and resources provided by the Secretary under paragraph 
    (1) shall, as appropriate, be made available to States, political 
    subdivisions of States, Indian tribes or tribal organizations (as 
    defined in section 4 of the Indian Self-Determination and Education 
    Assistance Act), outpatient mental health and addiction treatment 
    centers, community mental health centers that meet the criteria 
    under section 1913(c), certified community behavioral health 
    clinics described in section 223 of the Protecting Access to 
    Medicare Act of 2014, primary care organizations such as Federally 
    qualified health centers or rural health clinics as defined in 
    section 1861(aa) of the Social Security Act, other community-based 
    organizations, or other entities engaging in integrated care 
    activities, as the Secretary determines appropriate.
    ``(h) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $51,878,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 9004. PROJECTS FOR ASSISTANCE IN TRANSITION FROM HOMELESSNESS.
    (a) Formula Grants to States.--Section 521 of the Public Health 
Service Act (42 U.S.C. 290cc-21) is amended by striking ``1991 through 
1994'' and inserting ``2018 through 2022''.
    (b) Purpose of Grants.--Section 522 of the Public Health Service 
Act (42 U.S.C. 290cc-22) is amended--
        (1) in subsection (a)(1)(B), by striking ``substance abuse'' 
    and inserting ``a substance use disorder'';
        (2) in subsection (b)(6), by striking ``substance abuse'' and 
    inserting ``substance use disorder'';
        (3) in subsection (c), by striking ``substance abuse'' and 
    inserting ``a substance use disorder'';
        (4) in subsection (e)--
            (A) in paragraph (1), by striking ``substance abuse'' and 
        inserting ``a substance use disorder''; and
            (B) in paragraph (2), by striking ``substance abuse'' and 
        inserting ``substance use disorder'';
        (5) by striking subsection (g) and redesignating subsections 
    (h) and (i) as (g) and (h), accordingly; and
        (6) in subsection (g), as redesignated by paragraph (5), by 
    striking ``substance abuse'' each place such term appears and 
    inserting ``substance use disorder''.
    (c) Description of Intended Expenditures of Grant.--Section 527 of 
the Public Health Service Act (42 U.S.C. 290cc-27) is amended by 
striking ``substance abuse'' each place such term appears and inserting 
``substance use disorder''.
    (d) Technical Assistance.--Section 530 of the Public Health Service 
Act (42 U.S.C. 290cc-30) is amended by striking ``through the National 
Institute of Mental Health, the National Institute of Alcohol Abuse and 
Alcoholism, and the National Institute on Drug Abuse'' and inserting 
``acting through the Assistant Secretary''.
    (e) Definitions.--Section 534(4) of the Public Health Service Act 
(42 U.S.C. 290cc-34(4)) is amended to read as follows:
        ``(4) Substance use disorder services.--The term `substance use 
    disorder services' has the meaning given the term `substance abuse 
    services' in section 330(h)(5)(C).''.
    (f) Funding.--Section 535(a) of the Public Health Service Act (42 
U.S.C. 290cc-35(a)) is amended by striking ``$75,000,000 for each of 
the fiscal years 2001 through 2003'' and inserting ``$64,635,000 for 
each of fiscal years 2018 through 2022''.
    (g) Study Concerning Formula.--
        (1) In general.--Not later than 2 years after the date of 
    enactment of this Act, the Assistant Secretary for Mental Health 
    and Substance Use (referred to in this section as the ``Assistant 
    Secretary'') shall conduct a study concerning the formula used 
    under section 524 of the Public Health Service Act (42 U.S.C. 
    290cc-24) for making allotments to States under section 521 of such 
    Act (42 U.S.C. 290cc-21). Such study shall include an evaluation of 
    quality indicators of need for purposes of revising the formula for 
    determining the amount of each allotment for the fiscal years 
    following the submission of the study.
        (2) Report.--In accordance with section 8004(b), the Assistant 
    Secretary shall submit to the committees of Congress described in 
    such section a report concerning the results of the study conducted 
    under paragraph (1).
SEC. 9005. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
    Subpart 3 of part B of title V of the Public Health Service Act (42 
U.S.C. 290bb-31 et seq.) is amended by inserting after section 520E-2 
(42 U.S.C. 290bb-36b) the following:
``SEC. 520E-3. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
    ``(a) In General.--The Secretary, acting through the Assistant 
Secretary, shall maintain the National Suicide Prevention Lifeline 
program (referred to in this section as the `program'), authorized 
under section 520A and in effect prior to the date of enactment of the 
Helping Families in Mental Health Crisis Reform Act of 2016.
    ``(b) Activities.--In maintaining the program, the activities of 
the Secretary shall include--
        ``(1) coordinating a network of crisis centers across the 
    United States for providing suicide prevention and crisis 
    intervention services to individuals seeking help at any time, day 
    or night;
        ``(2) maintaining a suicide prevention hotline to link callers 
    to local emergency, mental health, and social services resources; 
    and
        ``(3) consulting with the Secretary of Veterans Affairs to 
    ensure that veterans calling the suicide prevention hotline have 
    access to a specialized veterans' suicide prevention hotline.
    ``(c) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $7,198,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 9006. CONNECTING INDIVIDUALS AND FAMILIES WITH CARE.
    Subpart 3 of part B of title V of the Public Health Service Act (42 
U.S.C. 290bb-31 et seq.), as amended by section 9005, is further 
amended by inserting after section 520E-3 the following:
``SEC. 520E-4. TREATMENT REFERRAL ROUTING SERVICE.
    ``(a) In General.--The Secretary, acting through the Assistant 
Secretary, shall maintain the National Treatment Referral Routing 
Service (referred to in this section as the `Routing Service') to 
assist individuals and families in locating mental and substance use 
disorders treatment providers.
    ``(b) Activities of the Secretary.--To maintain the Routing 
Service, the activities of the Assistant Secretary shall include 
administering--
        ``(1) a nationwide, telephone number providing year-round 
    access to information that is updated on a regular basis regarding 
    local behavioral health providers and community-based organizations 
    in a manner that is confidential, without requiring individuals to 
    identify themselves, is in languages that include at least English 
    and Spanish, and is at no cost to the individual using the Routing 
    Service; and
        ``(2) an Internet website to provide a searchable, online 
    treatment services locator of behavioral health treatment providers 
    and community-based organizations, which shall include information 
    on the name, location, contact information, and basic services 
    provided by such providers and organizations.
    ``(c) Removing Practitioner Contact Information.--In the event that 
the Internet website described in subsection (b)(2) contains 
information on any qualified practitioner that is certified to 
prescribe medication for opioid dependency under section 303(g)(2)(B) 
of the Controlled Substances Act, the Assistant Secretary--
        ``(1) shall provide an opportunity to such practitioner to have 
    the contact information of the practitioner removed from the 
    website at the request of the practitioner; and
        ``(2) may evaluate other methods to periodically update the 
    information displayed on such website.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to prevent the Assistant Secretary from using any unobligated 
amounts otherwise made available to the Administration to maintain the 
Routing Service.''.
SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
    Section 520F of the Public Health Service Act (42 U.S.C. 290bb-37) 
is amended to read as follows:
``SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
    ``(a) In General.--The Secretary shall award competitive grants 
to--
        ``(1) State and local governments and Indian tribes and tribal 
    organizations, to enhance community-based crisis response systems; 
    or
        ``(2) States to develop, maintain, or enhance a database of 
    beds at inpatient psychiatric facilities, crisis stabilization 
    units, and residential community mental health and residential 
    substance use disorder treatment facilities, for adults with a 
    serious mental illness, children with a serious emotional 
    disturbance, or individuals with a substance use disorder.
    ``(b) Applications.--
        ``(1) In general.--To receive a grant under subsection (a), an 
    entity shall submit to the Secretary an application, at such time, 
    in such manner, and containing such information as the Secretary 
    may require.
        ``(2) Community-based crisis response plan.--An application for 
    a grant under subsection (a)(1) shall include a plan for--
            ``(A) promoting integration and coordination between local 
        public and private entities engaged in crisis response, 
        including first responders, emergency health care providers, 
        primary care providers, law enforcement, court systems, health 
        care payers, social service providers, and behavioral health 
        providers;
            ``(B) developing memoranda of understanding with public and 
        private entities to implement crisis response services;
            ``(C) addressing gaps in community resources for crisis 
        intervention and prevention; and
            ``(D) developing models for minimizing hospital 
        readmissions, including through appropriate discharge planning.
        ``(3) Beds database plan.--An application for a grant under 
    subsection (a)(2) shall include a plan for developing, maintaining, 
    or enhancing a real-time, Internet-based bed database to collect, 
    aggregate, and display information about beds in inpatient 
    psychiatric facilities and crisis stabilization units, and 
    residential community mental health and residential substance use 
    disorder treatment facilities to facilitate the identification and 
    designation of facilities for the temporary treatment of 
    individuals in mental or substance use disorder crisis.
    ``(c) Database Requirements.--A bed database described in this 
section is a database that--
        ``(1) includes information on inpatient psychiatric facilities, 
    crisis stabilization units, and residential community mental health 
    and residential substance use disorder facilities in the State 
    involved, including contact information for the facility or unit;
        ``(2) provides real-time information about the number of beds 
    available at each facility or unit and, for each available bed, the 
    type of patient that may be admitted, the level of security 
    provided, and any other information that may be necessary to allow 
    for the proper identification of appropriate facilities for 
    treatment of individuals in mental or substance use disorder 
    crisis; and
        ``(3) enables searches of the database to identify available 
    beds that are appropriate for the treatment of individuals in 
    mental or substance use disorder crisis.
    ``(d) Evaluation.--An entity receiving a grant under subsection 
(a)(1) shall submit to the Secretary, at such time, in such manner, and 
containing such information as the Secretary may reasonably require, a 
report, including an evaluation of the effect of such grant on--
        ``(1) local crisis response services and measures for 
    individuals receiving crisis planning and early intervention 
    supports;
        ``(2) individuals reporting improved functional outcomes; and
        ``(3) individuals receiving regular followup care following a 
    crisis.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, $12,500,000 for the period of 
fiscal years 2018 through 2022.''.
SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHORIZATION.
    (a) Suicide Prevention Technical Assistance Center.--Section 520C 
of the Public Health Service Act (42 U.S.C. 290bb-34), as amended by 
section 6001, is further amended--
        (1) in the section heading, by striking ``youth interagency 
    research, training, and technical assistance centers'' and 
    inserting ``suicide prevention technical assistance center'';
        (2) in subsection (a), by striking ``acting through the 
    Assistant Secretary for Mental Health and Substance Use'' and all 
    that follows through the period at the end of paragraph (2) and 
    inserting ``acting through the Assistant Secretary, shall establish 
    a research, training, and technical assistance resource center to 
    provide appropriate information, training, and technical assistance 
    to States, political subdivisions of States, federally recognized 
    Indian tribes, tribal organizations, institutions of higher 
    education, public organizations, or private nonprofit organizations 
    regarding the prevention of suicide among all ages, particularly 
    among groups that are at a high risk for suicide.'';
        (3) by striking subsections (b) and (c);
        (4) by redesignating subsection (d) as subsection (b);
        (5) in subsection (b), as so redesignated--
            (A) in the subsection heading, by striking ``Additional 
        Center'' and inserting ``Responsibilities of the Center'';
            (B) in the matter preceding paragraph (1), by striking 
        ``The additional research'' and all that follows through 
        ``nonprofit organizations for'' and inserting ``The center 
        established under subsection (a) shall conduct activities for 
        the purpose of'';
            (C) by striking ``youth suicide'' each place such term 
        appears and inserting ``suicide'';
            (D) in paragraph (1)--
                (i) by striking ``the development or continuation of'' 
            and inserting ``developing and continuing''; and
                (ii) by inserting ``for all ages, particularly among 
            groups that are at a high risk for suicide'' before the 
            semicolon at the end;
            (E) in paragraph (2), by inserting ``for all ages, 
        particularly among groups that are at a high risk for suicide'' 
        before the semicolon at the end;
            (F) in paragraph (3), by inserting ``and tribal'' after 
        ``statewide'';
            (G) in paragraph (5), by inserting ``and prevention'' after 
        ``intervention'';
            (H) in paragraph (8), by striking ``in youth'';
            (I) in paragraph (9), by striking ``and behavioral health'' 
        and inserting ``health and substance use disorder''; and
            (J) in paragraph (10), by inserting ``conducting'' before 
        ``other''; and
        (6) by striking subsection (e) and inserting the following:
    ``(c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $5,988,000 
for each of fiscal years 2018 through 2022.
    ``(d) Annual Report.--Not later than 2 years after the date of 
enactment of this subsection, the Secretary shall submit to Congress a 
report on the activities carried out by the center established under 
subsection (a) during the year involved, including the potential 
effects of such activities, and the States, organizations, and 
institutions that have worked with the center.''.
    (b) Youth Suicide Early Intervention and Prevention Strategies.--
Section 520E of the Public Health Service Act (42 U.S.C. 290bb-36) is 
amended--
        (1) in paragraph (1) of subsection (a) and in subsection (c), 
    by striking ``substance abuse'' each place such term appears and 
    inserting ``substance use disorder'';
        (2) in subsection (b)--
            (A) in paragraph (2)--
                (i) by striking ``ensure that each State is awarded 
            only 1 grant or cooperative agreement under this section'' 
            and inserting ``ensure that a State does not receive more 
            than 1 grant or cooperative agreement under this section at 
            any 1 time''; and
                (ii) by striking ``been awarded'' and inserting 
            ``received''; and
            (B) by adding after paragraph (2) the following:
        ``(3) Consideration.--In awarding grants under this section, 
    the Secretary shall take into consideration the extent of the need 
    of the applicant, including the incidence and prevalence of suicide 
    in the State and among the populations of focus, including rates of 
    suicide determined by the Centers for Disease Control and 
    Prevention for the State or population of focus.'';
        (3) in subsection (g)(2), by striking ``2 years after the date 
    of enactment of this section,'' and insert ``2 years after the date 
    of enactment of Helping Families in Mental Health Crisis Reform Act 
    of 2016,''; and
        (4) by striking subsection (m) and inserting the following:
    ``(m) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $30,000,000 
for each of fiscal years 2018 through 2022.''.
SEC. 9009. ADULT SUICIDE PREVENTION.
    Subpart 3 of part B of title V of the Public Health Service Act (42 
U.S.C. 290bb-31 et seq.) is amended by adding at the end the following:
``SEC. 520L. ADULT SUICIDE PREVENTION.
    ``(a) Grants.--
        ``(1) In general.--The Assistant Secretary shall award grants 
    to eligible entities described in paragraph (2) to implement 
    suicide prevention and intervention programs, for individuals who 
    are 25 years of age or older, that are designed to raise awareness 
    of suicide, establish referral processes, and improve care and 
    outcomes for such individuals who are at risk of suicide.
        ``(2) Eligible entities.--To be eligible to receive a grant 
    under this section, an entity shall be a community-based primary 
    care or behavioral health care setting, an emergency department, a 
    State mental health agency (or State health agency with mental or 
    behavioral health functions), public health agency, a territory of 
    the United States, or an Indian tribe or tribal organization (as 
    the terms `Indian tribe' and `tribal organization' are defined in 
    section 4 of the Indian Self-Determination and Education Assistance 
    Act).
        ``(3) Use of funds.--The grants awarded under paragraph (1) 
    shall be used to implement programs, in accordance with such 
    paragraph, that include one or more of the following components:
            ``(A) Screening for suicide risk, suicide intervention 
        services, and services for referral for treatment for 
        individuals at risk for suicide.
            ``(B) Implementing evidence-based practices to provide 
        treatment for individuals at risk for suicide, including 
        appropriate followup services.
            ``(C) Raising awareness and reducing stigma of suicide.
    ``(b) Evaluations and Technical Assistance.--The Assistant 
Secretary shall--
        ``(1) evaluate the activities supported by grants awarded under 
    subsection (a), and disseminate, as appropriate, the findings from 
    the evaluation; and
        ``(2) provide appropriate information, training, and technical 
    assistance, as appropriate, to eligible entities that receive a 
    grant under this section, in order to help such entities to meet 
    the requirements of this section, including assistance with 
    selection and implementation of evidence-based interventions and 
    frameworks to prevent suicide.
    ``(c) Duration.--A grant under this section shall be for a period 
of not more than 5 years.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $30,000,000 for the period of 
fiscal years 2018 through 2022.''.
SEC. 9010. MENTAL HEALTH AWARENESS TRAINING GRANTS.
    Section 520J of the Public Health Service Act (42 U.S.C. 290bb-41) 
is amended--
        (1) in the section heading, by inserting ``mental health 
    awareness'' before ``training''; and
        (2) in subsection (b)--
            (A) in the subsection heading, by striking ``Illness'' and 
        inserting ``Health'';
            (B) in paragraph (1), by inserting ``veterans, law 
        enforcement, and other categories of individuals, as determined 
        by the Secretary,'' after ``emergency services personnel'';
            (C) in paragraph (5)--
                (i) in the matter preceding subparagraph (A), by 
            striking ``to'' and inserting ``for evidence-based programs 
            that provide training and education in accordance with 
            paragraph (1) on matters including''; and
                (ii) by striking subparagraphs (A) through (C) and 
            inserting the following:
            ``(A) recognizing the signs and symptoms of mental illness; 
        and
            ``(B)(i) resources available in the community for 
        individuals with a mental illness and other relevant resources; 
        or
            ``(ii) safely de-escalating crisis situations involving 
        individuals with a mental illness.''; and
            (D) in paragraph (7), by striking ``, $25,000,000'' and all 
        that follows through the period at the end and inserting 
        ``$14,693,000 for each of fiscal years 2018 through 2022.''.
SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMERICAN INDIANS AND 
ALASKA NATIVE YOUTH WITHIN SUICIDE PREVENTION PROGRAMS.
    (a) Findings.--The Congress finds as follows:
        (1) Suicide is the eighth leading cause of death among American 
    Indians and Alaska Natives across all ages.
        (2) Among American Indians and Alaska Natives who are 10 to 34 
    years of age, suicide is the second leading cause of death.
        (3) The suicide rate among American Indian and Alaska Native 
    adolescents and young adults ages 15 to 34 (17.9 per 100,000) is 
    approximately 1.3 times higher than the national average for that 
    age group (13.3 per 100,000).
    (b) Sense of Congress.--It is the sense of Congress that the 
Secretary of Health and Human Services, in carrying out suicide 
prevention and intervention programs, should prioritize programs and 
activities for populations with disproportionately high rates of 
suicide, such as American Indians and Alaska Natives.
SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS.
    Section 520A(e) of the Public Health Service Act (42 U.S.C. 290bb-
32(e)) is amended by adding at the end the following:
        ``(3) Geriatric mental disorders.--The Secretary shall, as 
    appropriate, provide technical assistance to grantees regarding 
    evidence-based practices for the prevention and treatment of 
    geriatric mental disorders and co-occurring mental health and 
    substance use disorders among geriatric populations, as well as 
    disseminate information about such evidence-based practices to 
    States and nongrantees throughout the United States.''.
SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM.
    The Secretary of Health and Human Services, acting through the 
Director of the Centers for Disease Control and Prevention, is 
encouraged to improve, particularly through the inclusion of additional 
States, the National Violent Death Reporting System as authorized by 
title III of the Public Health Service Act (42 U.S.C. 241 et seq.). 
Participation in the system by the States shall be voluntary.
SEC. 9014. ASSISTED OUTPATIENT TREATMENT.
    Section 224 of the Protecting Access to Medicare Act of 2014 (42 
U.S.C. 290aa note) is amended--
        (1) in subsection (e), by striking ``and 2018,'' and inserting 
    ``2018, 2019, 2020, 2021, and 2022,''; and
        (2) in subsection (g)--
            (A) in paragraph (1), by striking ``2018'' and inserting 
        ``2022''; and
            (B) in paragraph (2), by striking ``is authorized to be 
        appropriated to carry out this section $15,000,000 for each of 
        fiscal years 2015 through 2018'' and inserting ``are authorized 
        to be appropriated to carry out this section $15,000,000 for 
        each of fiscal years 2015 through 2017, $20,000,000 for fiscal 
        year 2018, $19,000,000 for each of fiscal years 2019 and 2020, 
        and $18,000,000 for each of fiscal years 2021 and 2022''.
SEC. 9015. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
    Part B of title V of the Public Health Service Act (42 U.S.C. 290bb 
et seq.), as amended by section 9009, is further amended by adding at 
the end the following:
``SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
    ``(a) In General.--The Assistant Secretary shall award grants to 
eligible entities--
        ``(1) to establish assertive community treatment programs for 
    adults with a serious mental illness; or
        ``(2) to maintain or expand such programs.
    ``(b) Eligible Entities.--To be eligible to receive a grant under 
this section, an entity shall be a State, political subdivision of a 
State, Indian tribe or tribal organization (as such terms are defined 
in section 4 of the Indian Self-Determination and Education Assistance 
Act), mental health system, health care facility, or any other entity 
the Assistant Secretary deems appropriate.
    ``(c) Special Consideration.--In selecting among applicants for a 
grant under this section, the Assistant Secretary may give special 
consideration to the potential of the applicant's program to reduce 
hospitalization, homelessness, and involvement with the criminal 
justice system while improving the health and social outcomes of the 
patient.
    ``(d) Additional Activities.--The Assistant Secretary shall--
        ``(1) not later than the end of fiscal year 2021, submit a 
    report to the appropriate congressional committees on the grant 
    program under this section, including an evaluation of--
            ``(A) any cost savings and public health outcomes such as 
        mortality, suicide, substance use disorders, hospitalization, 
        and use of services;
            ``(B) rates of involvement with the criminal justice system 
        of patients;
            ``(C) rates of homelessness among patients; and
            ``(D) patient and family satisfaction with program 
        participation; and
        ``(2) provide appropriate information, training, and technical 
    assistance to grant recipients under this section to help such 
    recipients to establish, maintain, or expand their assertive 
    community treatment programs.
    ``(e) Authorization of Appropriations.--
        ``(1) In general.--To carry out this section, there is 
    authorized to be appropriated $5,000,000 for the period of fiscal 
    years 2018 through 2022.
        ``(2) Use of certain funds.--Of the funds appropriated to carry 
    out this section in any fiscal year, not more than 5 percent shall 
    be available to the Assistant Secretary for carrying out subsection 
    (d).''.
SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE DRINKING REAUTHORIZATION.
    Section 519B of the Public Health Service Act (42 U.S.C. 290bb-25b) 
is amended--
        (1) in subsection (c)(3), by striking ``fiscal year 2007'' and 
    all that follows through the period at the end and inserting ``each 
    of the fiscal years 2018 through 2022.'';
        (2) in subsection (d)(4), by striking ``fiscal year 2007'' and 
    all that follows through the period at the end and inserting ``each 
    of the fiscal years 2018 through 2022.'';
        (3) in subsection (e)(1)(I), by striking ``fiscal year 2007'' 
    and all that follows through the period at the end and inserting 
    ``each of the fiscal years 2018 through 2022.'';
        (4) in subsection (f)(2), by striking ``$6,000,000 for fiscal 
    year 2007'' and all that follows through the period at the end and 
    inserting ``$3,000,000 for each of the fiscal years 2018 through 
    2022''; and
        (5) by adding at the end the following new subsection:
    ``(g) Reducing Underage Drinking Through Screening and Brief 
Intervention.--
        ``(1) Grants to pediatric health care providers to reduce 
    underage drinking.--The Assistant Secretary may make grants to 
    eligible entities to increase implementation of practices for 
    reducing the prevalence of alcohol use among individuals under the 
    age of 21, including college students.
        ``(2) Purposes.--Grants under this subsection shall be made to 
    improve--
            ``(A) screening children and adolescents for alcohol use;
            ``(B) offering brief interventions to children and 
        adolescents to discourage such use;
            ``(C) educating parents about the dangers of, and methods 
        of discouraging, such use;
            ``(D) diagnosing and treating alcohol use disorders; and
            ``(E) referring patients, when necessary, to other 
        appropriate care.
        ``(3) Use of funds.--An entity receiving a grant under this 
    subsection may use such funding for the purposes identified in 
    paragraph (2) by--
            ``(A) providing training to health care providers;
            ``(B) disseminating best practices, including culturally 
        and linguistically appropriate best practices, as appropriate, 
        and developing and distributing materials; and
            ``(C) supporting other activities, as determined 
        appropriate by the Assistant Secretary.
        ``(4) Application.--To be eligible to receive a grant under 
    this subsection, an entity shall submit an application to the 
    Assistant Secretary at such time, and in such manner, and 
    accompanied by such information as the Assistant Secretary may 
    require. Each application shall include--
            ``(A) a description of the entity;
            ``(B) a description of activities to be completed;
            ``(C) a description of how the services specified in 
        paragraphs (2) and (3) will be carried out and the 
        qualifications for providing such services; and
            ``(D) a timeline for the completion of such activities.
        ``(5) Definitions.--For the purpose of this subsection:
            ``(A) Brief intervention.--The term `brief intervention' 
        means, after screening a patient, providing the patient with 
        brief advice and other brief motivational enhancement 
        techniques designed to increase the insight of the patient 
        regarding the patient's alcohol use, and any realized or 
        potential consequences of such use, to effect the desired 
        related behavioral change.
            ``(B) Children and adolescents.--The term `children and 
        adolescents' means any person under 21 years of age.
            ``(C) Eligible entity.--The term `eligible entity' means an 
        entity consisting of pediatric health care providers and that 
        is qualified to support or provide the activities identified in 
        paragraph (2).
            ``(D) Pediatric health care provider.--The term `pediatric 
        health care provider' means a provider of primary health care 
        to individuals under the age of 21 years.
            ``(E) Screening.--The term `screening' means using 
        validated patient interview techniques to identify and assess 
        the existence and extent of alcohol use in a patient.''.
SEC. 9017. CENTER AND PROGRAM REPEALS.
    Part B of title V of the Public Health Service Act (42 U.S.C. 290bb 
et seq.) is amended by striking section 506B (42 U.S.C. 290aa-5b), the 
second section 514 (42 U.S.C. 290bb-9) relating to methamphetamine and 
amphetamine treatment initiatives, and each of sections 514A, 517, 
519A, 519C, 519E, 520B, 520D, and 520H (42 U.S.C. 290bb-8, 290bb-23, 
290bb-25a, 290bb-25c, 290bb-25e, 290bb-33, 290bb-35, and 290bb-39).

          Subtitle B--Strengthening the Health Care Workforce

SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
    Section 756 of the Public Health Service Act (42 U.S.C. 294e-1) is 
amended--
        (1) in subsection (a)--
            (A) in the matter preceding paragraph (1), by striking ``of 
        higher education''; and
            (B) by striking paragraphs (1) through (4) and inserting 
        the following:
        ``(1) accredited institutions of higher education or accredited 
    professional training programs that are establishing or expanding 
    internships or other field placement programs in mental health in 
    psychiatry, psychology, school psychology, behavioral pediatrics, 
    psychiatric nursing (which may include master's and doctoral level 
    programs), social work, school social work, substance use disorder 
    prevention and treatment, marriage and family therapy, occupational 
    therapy, school counseling, or professional counseling, including 
    such programs with a focus on child and adolescent mental health 
    and transitional-age youth;
        ``(2) accredited doctoral, internship, and post-doctoral 
    residency programs of health service psychology (including clinical 
    psychology, counseling, and school psychology) for the development 
    and implementation of interdisciplinary training of psychology 
    graduate students for providing behavioral health services, 
    including substance use disorder prevention and treatment services, 
    as well as the development of faculty in health service psychology;
        ``(3) accredited master's and doctoral degree programs of 
    social work for the development and implementation of 
    interdisciplinary training of social work graduate students for 
    providing behavioral health services, including substance use 
    disorder prevention and treatment services, and the development of 
    faculty in social work; and
        ``(4) State-licensed mental health nonprofit and for-profit 
    organizations to enable such organizations to pay for programs for 
    preservice or in-service training in a behavioral health-related 
    paraprofessional field with preference for preservice or in-service 
    training of paraprofessional child and adolescent mental health 
    workers.'';
        (2) in subsection (b)--
            (A) by striking paragraph (5);
            (B) by redesignating paragraphs (1) through (4) as 
        paragraphs (2) through (5), respectively;
            (C) by inserting before paragraph (2), as so redesignated, 
        the following:
        ``(1) an ability to recruit and place the students described in 
    subsection (a) in areas with a high need and high demand 
    population;'';
            (D) in paragraph (3), as so redesignated, by striking 
        ``subsection (a)'' and inserting ``paragraph (2), especially 
        individuals with mental disorder symptoms or diagnoses, 
        particularly children and adolescents, and transitional-age 
        youth'';
            (E) in paragraph (4), as so redesignated, by striking ``;'' 
        and inserting ``; and''; and
            (F) in paragraph (5), as so redesignated, by striking ``; 
        and'' and inserting a period;
        (3) in subsection (c), by striking ``authorized under 
    subsection (a)(1)'' and inserting ``awarded under paragraphs (2) 
    and (3) of subsection (a)'';
        (4) by amending subsection (d) to read as follows:
    ``(d) Priority.--In selecting grant recipients under this section, 
the Secretary shall give priority to--
        ``(1) programs that have demonstrated the ability to train 
    psychology, psychiatry, and social work professionals to work in 
    integrated care settings for purposes of recipients under 
    paragraphs (1), (2), and (3) of subsection (a); and
        ``(2) programs for paraprofessionals that emphasize the role of 
    the family and the lived experience of the consumer and family-
    paraprofessional partnerships for purposes of recipients under 
    subsection (a)(4).''; and
        (5) by striking subsection (e) and inserting the following:
    ``(e) Report to Congress.--Not later than 4 years after the date of 
enactment of the Helping Families in Mental Health Crisis Reform Act of 
2016, the Secretary shall include in the biennial report submitted to 
Congress under section 501(m) an assessment on the effectiveness of the 
grants under this section in--
        ``(1) providing graduate students support for experiential 
    training (internship or field placement);
        ``(2) recruiting students interested in behavioral health 
    practice;
        ``(3) recruiting students in accordance with subsection (b)(1);
        ``(4) developing and implementing interprofessional training 
    and integration within primary care;
        ``(5) developing and implementing accredited field placements 
    and internships; and
        ``(6) collecting data on the number of students trained in 
    behavioral health care and the number of available accredited 
    internships and field placements.
    ``(f) Authorization of Appropriations.--For each of fiscal years 
2018 through 2022, there are authorized to be appropriated to carry out 
this section $50,000,000, to be allocated as follows:
        ``(1) For grants described in subsection (a)(1), $15,000,000.
        ``(2) For grants described in subsection (a)(2), $15,000,000.
        ``(3) For grants described in subsection (a)(3), $10,000,000.
        ``(4) For grants described in subsection (a)(4), 
    $10,000,000.''.
SEC. 9022. STRENGTHENING THE MENTAL AND SUBSTANCE USE DISORDERS 
WORKFORCE.
    Part D of title VII of the Public Health Service Act (42 U.S.C. 294 
et seq.) is amended by adding at the end the following:
    ``SEC. 760. TRAINING DEMONSTRATION PROGRAM.
    ``(a) In General.--The Secretary shall establish a training 
demonstration program to award grants to eligible entities to support--
        ``(1) training for medical residents and fellows to practice 
    psychiatry and addiction medicine in underserved, community-based 
    settings that integrate primary care with mental and substance use 
    disorders prevention and treatment services;
        ``(2) training for nurse practitioners, physician assistants, 
    health service psychologists, and social workers to provide mental 
    and substance use disorders services in underserved community-based 
    settings that integrate primary care and mental and substance use 
    disorders services; and
        ``(3) establishing, maintaining, or improving academic units or 
    programs that--
            ``(A) provide training for students or faculty, including 
        through clinical experiences and research, to improve the 
        ability to be able to recognize, diagnose, and treat mental and 
        substance use disorders, with a special focus on addiction; or
            ``(B) develop evidence-based practices or recommendations 
        for the design of the units or programs described in 
        subparagraph (A), including curriculum content standards.
    ``(b) Activities.--
        ``(1) Training for residents and fellows.--A recipient of a 
    grant under subsection (a)(1)--
            ``(A) shall use the grant funds--
                ``(i)(I) to plan, develop, and operate a training 
            program for medical psychiatry residents and fellows in 
            addiction medicine practicing in eligible entities 
            described in subsection (c)(1); or
                ``(II) to train new psychiatric residents and fellows 
            in addiction medicine to provide and expand access to 
            integrated mental and substance use disorders services; and
                ``(ii) to provide at least 1 training track that is--

                    ``(I) a virtual training track that includes an in-
                person rotation at a teaching health center or in a 
                community-based setting, followed by a virtual rotation 
                in which the resident or fellow continues to support 
                the care of patients at the teaching health center or 
                in the community-based setting through the use of 
                health information technology and, as appropriate, 
                telehealth services;
                    ``(II) an in-person training track that includes a 
                rotation, during which the resident or fellow practices 
                at a teaching health center or in a community-based 
                setting; or
                    ``(III) an in-person training track that includes a 
                rotation during which the resident practices in a 
                community-based setting that specializes in the 
                treatment of infants, children, adolescents, or 
                pregnant or postpartum women; and

            ``(B) may use the grant funds to provide additional support 
        for the administration of the program or to meet the costs of 
        projects to establish, maintain, or improve faculty 
        development, or departments, divisions, or other units 
        necessary to implement such training.
        ``(2) Training for other providers.--A recipient of a grant 
    under subsection (a)(2)--
            ``(A) shall use the grant funds to plan, develop, or 
        operate a training program to provide mental and substance use 
        disorders services in underserved, community-based settings, as 
        appropriate, that integrate primary care and mental and 
        substance use disorders prevention and treatment services; and
            ``(B) may use the grant funds to provide additional support 
        for the administration of the program or to meet the costs of 
        projects to establish, maintain, or improve faculty 
        development, or departments, divisions, or other units 
        necessary to implement such program.
        ``(3) Academic units or programs.--A recipient of a grant under 
    subsection (a)(3) shall enter into a partnership with organizations 
    such as an education accrediting organization (such as the Liaison 
    Committee on Medical Education, the Accreditation Council for 
    Graduate Medical Education, the Commission on Osteopathic College 
    Accreditation, the Accreditation Commission for Education in 
    Nursing, the Commission on Collegiate Nursing Education, the 
    Accreditation Council for Pharmacy Education, the Council on Social 
    Work Education, American Psychological Association Commission on 
    Accreditation, or the Accreditation Review Commission on Education 
    for the Physician Assistant) to carry out activities under 
    subsection (a)(3).
    ``(c) Eligible Entities.--
        ``(1) Training for residents and fellows.--To be eligible to 
    receive a grant under subsection (a)(1), an entity shall--
            ``(A) be a consortium consisting of--
                ``(i) at least one teaching health center; and
                ``(ii) the sponsoring institution (or parent 
            institution of the sponsoring institution) of--

                    ``(I) a psychiatry residency program that is 
                accredited by the Accreditation Council of Graduate 
                Medical Education (or the parent institution of such a 
                program); or
                    ``(II) a fellowship in addiction medicine, as 
                determined appropriate by the Secretary; or

            ``(B) be an entity described in subparagraph (A)(ii) that 
        provides opportunities for residents or fellows to train in 
        community-based settings that integrate primary care with 
        mental and substance use disorders prevention and treatment 
        services.
        ``(2) Training for other providers.--To be eligible to receive 
    a grant under subsection (a)(2), an entity shall be--
            ``(A) a teaching health center (as defined in section 
        749A(f));
            ``(B) a Federally qualified health center (as defined in 
        section 1905(l)(2)(B) of the Social Security Act);
            ``(C) a community mental health center (as defined in 
        section 1861(ff)(3)(B) of the Social Security Act);
            ``(D) a rural health clinic (as defined in section 1861(aa) 
        of the Social Security Act);
            ``(E) a health center operated by the Indian Health 
        Service, an Indian tribe, a tribal organization, or an urban 
        Indian organization (as defined in section 4 of the Indian 
        Health Care Improvement Act); or
            ``(F) an entity with a demonstrated record of success in 
        providing training for nurse practitioners, physician 
        assistants, health service psychologists, and social workers.
        ``(3) Academic units or programs.--To be eligible to receive a 
    grant under subsection (a)(3), an entity shall be a school of 
    medicine or osteopathic medicine, a nursing school, a physician 
    assistant training program, a school of pharmacy, a school of 
    social work, an accredited public or nonprofit private hospital, an 
    accredited medical residency program, or a public or private 
    nonprofit entity which the Secretary has determined is capable of 
    carrying out such grant.
    ``(d) Priority.--
        ``(1) In general.--In awarding grants under subsection (a)(1) 
    or (a)(2), the Secretary shall give priority to eligible entities 
    that--
            ``(A) demonstrate sufficient size, scope, and capacity to 
        undertake the requisite training of an appropriate number of 
        psychiatric residents, fellows, nurse practitioners, physician 
        assistants, or social workers in addiction medicine per year to 
        meet the needs of the area served;
            ``(B) demonstrate experience in training providers to 
        practice team-based care that integrates mental and substance 
        use disorder prevention and treatment services with primary 
        care in community-based settings;
            ``(C) demonstrate experience in using health information 
        technology and, as appropriate, telehealth to support--
                ``(i) the delivery of mental and substance use 
            disorders services at the eligible entities described in 
            subsections (c)(1) and (c)(2); and
                ``(ii) community health centers in integrating primary 
            care and mental and substance use disorders treatment; or
            ``(D) have the capacity to expand access to mental and 
        substance use disorders services in areas with demonstrated 
        need, as determined by the Secretary, such as tribal, rural, or 
        other underserved communities.
        ``(2) Academic units or programs.--In awarding grants under 
    subsection (a)(3), the Secretary shall give priority to eligible 
    entities that--
            ``(A) have a record of training the greatest percentage of 
        mental and substance use disorders providers who enter and 
        remain in these fields or who enter and remain in settings with 
        integrated primary care and mental and substance use disorder 
        prevention and treatment services;
            ``(B) have a record of training individuals who are from 
        underrepresented minority groups, including native populations, 
        or from a rural or disadvantaged background;
            ``(C) provide training in the care of vulnerable 
        populations such as infants, children, adolescents, pregnant 
        and postpartum women, older adults, homeless individuals, 
        victims of abuse or trauma, individuals with disabilities, and 
        other groups as defined by the Secretary;
            ``(D) teach trainees the skills to provide 
        interprofessional, integrated care through collaboration among 
        health professionals; or
            ``(E) provide training in cultural competency and health 
        literacy.
    ``(e) Duration.--Grants awarded under this section shall be for a 
minimum of 5 years.
    ``(f) Study and Report.--
        ``(1) Study.--
            ``(A) In general.--The Secretary, acting through the 
        Administrator of the Health Resources and Services 
        Administration, shall conduct a study on the results of the 
        demonstration program under this section.
            ``(B) Data submission.--Not later than 90 days after the 
        completion of the first year of the training program and each 
        subsequent year that the program is in effect, each recipient 
        of a grant under subsection (a) shall submit to the Secretary 
        such data as the Secretary may require for analysis for the 
        report described in paragraph (2).
        ``(2) Report to congress.--Not later than 1 year after receipt 
    of the data described in paragraph (1)(B), the Secretary shall 
    submit to Congress a report that includes--
            ``(A) an analysis of the effect of the demonstration 
        program under this section on the quality, quantity, and 
        distribution of mental and substance use disorders services;
            ``(B) an analysis of the effect of the demonstration 
        program on the prevalence of untreated mental and substance use 
        disorders in the surrounding communities of health centers 
        participating in the demonstration; and
            ``(C) recommendations on whether the demonstration program 
        should be expanded.
    ``(g) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $10,000,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 9023. CLARIFICATION ON CURRENT ELIGIBILITY FOR LOAN REPAYMENT 
PROGRAMS.
    The Administrator of the Health Resources and Services 
Administration shall clarify the eligibility pursuant to section 
338B(b)(1)(B) of the Public Health Service Act (42 U.S.C. 254l-
1(b)(1)(B)) of child and adolescent psychiatrists for the National 
Health Service Corps Loan Repayment Program under subpart III of part D 
of title III of such Act (42 U.S.C. 254l et seq.).
SEC. 9024. MINORITY FELLOWSHIP PROGRAM.
    Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) 
is amended by adding at the end the following:

                 ``PART K--MINORITY FELLOWSHIP PROGRAM

    ``SEC. 597. FELLOWSHIPS.
    ``(a) In General.--The Secretary shall maintain a program, to be 
known as the Minority Fellowship Program, under which the Secretary 
shall award fellowships, which may include stipends, for the purposes 
of--
        ``(1) increasing the knowledge of mental and substance use 
    disorders practitioners on issues related to prevention, treatment, 
    and recovery support for individuals who are from racial and ethnic 
    minority populations and who have a mental or substance use 
    disorder;
        ``(2) improving the quality of mental and substance use 
    disorder prevention and treatment services delivered to racial and 
    ethnic minority populations; and
        ``(3) increasing the number of culturally competent mental and 
    substance use disorders professionals who teach, administer 
    services, conduct research, and provide direct mental or substance 
    use disorder services to racial and ethnic minority populations.
    ``(b) Training Covered.--The fellowships awarded under subsection 
(a) shall be for postbaccalaureate training (including for master's and 
doctoral degrees) for mental and substance use disorder treatment 
professionals, including in the fields of psychiatry, nursing, social 
work, psychology, marriage and family therapy, mental health 
counseling, and substance use disorder and addiction counseling.
    ``(c) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $12,669,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL VOLUNTEERS AT 
COMMUNITY HEALTH CENTERS.
    Section 224 of the Public Health Service Act (42 U.S.C. 233) is 
amended by adding at the end the following:
    ``(q)(1) For purposes of this section, a health professional 
volunteer at a deemed entity described in subsection (g)(4) shall, in 
providing a health professional service eligible for funding under 
section 330 to an individual, be deemed to be an employee of the Public 
Health Service for a calendar year that begins during a fiscal year for 
which a transfer was made under paragraph (4)(C). The preceding 
sentence is subject to the provisions of this subsection.
    ``(2) In providing a health service to an individual, a health care 
practitioner shall for purposes of this subsection be considered to be 
a health professional volunteer at an entity described in subsection 
(g)(4) if the following conditions are met:
        ``(A) The service is provided to the individual at the 
    facilities of an entity described in subsection (g)(4), or through 
    offsite programs or events carried out by the entity.
        ``(B) The entity is sponsoring the health care practitioner 
    pursuant to paragraph (3)(B).
        ``(C) The health care practitioner does not receive any 
    compensation for the service from the individual, the entity 
    described in subsection (g)(4), or any third-party payer (including 
    reimbursement under any insurance policy or health plan, or under 
    any Federal or State health benefits program), except that the 
    health care practitioner may receive repayment from the entity 
    described in subsection (g)(4) for reasonable expenses incurred by 
    the health care practitioner in the provision of the service to the 
    individual, which may include travel expenses to or from the site 
    of services.
        ``(D) Before the service is provided, the health care 
    practitioner or the entity described in subsection (g)(4) posts a 
    clear and conspicuous notice at the site where the service is 
    provided of the extent to which the legal liability of the health 
    care practitioner is limited pursuant to this subsection.
        ``(E) At the time the service is provided, the health care 
    practitioner is licensed or certified in accordance with applicable 
    Federal and State laws regarding the provision of the service.
        ``(F) At the time the service is provided, the entity described 
    in subsection (g)(4) maintains relevant documentation certifying 
    that the health care practitioner meets the requirements of this 
    subsection.
    ``(3) Subsection (g) (other than paragraphs (3) and (5)) and 
subsections (h), (i), and (l) apply to a health care practitioner for 
purposes of this subsection to the same extent and in the same manner 
as such subsections apply to an officer, governing board member, 
employee, or contractor of an entity described in subsection (g)(4), 
subject to paragraph (4), and subject to the following:
        ``(A) The first sentence of paragraph (1) applies in lieu of 
    the first sentence of subsection (g)(1)(A).
        ``(B) With respect to an entity described in subsection (g)(4), 
    a health care practitioner is not a health professional volunteer 
    at such entity unless the entity sponsors the health care 
    practitioner. For purposes of this subsection, the entity shall be 
    considered to be sponsoring the health care practitioner if--
            ``(i) with respect to the health care practitioner, the 
        entity submits to the Secretary an application meeting the 
        requirements of subsection (g)(1)(D); and
            ``(ii) the Secretary, pursuant to subsection (g)(1)(E), 
        determines that the health care practitioner is deemed to be an 
        employee of the Public Health Service.
        ``(C) In the case of a health care practitioner who is 
    determined by the Secretary pursuant to subsection (g)(1)(E) to be 
    a health professional volunteer at such entity, this subsection 
    applies to the health care practitioner (with respect to services 
    performed on behalf of the entity sponsoring the health care 
    practitioner pursuant to subparagraph (B)) for any cause of action 
    arising from an act or omission of the health care practitioner 
    occurring on or after the date on which the Secretary makes such 
    determination.
        ``(D) Subsection (g)(1)(F) applies to a health care 
    practitioner for purposes of this subsection only to the extent 
    that, in providing health services to an individual, each of the 
    conditions specified in paragraph (2) is met.
    ``(4)(A) Amounts in the fund established under subsection (k)(2) 
shall be available for transfer under subparagraph (C) for purposes of 
carrying out this subsection.
    ``(B)(i) Not later than May 1 of each fiscal year, the Attorney 
General, in consultation with the Secretary, shall submit to the 
Congress a report providing an estimate of the amount of claims 
(together with related fees and expenses of witnesses) that, by reason 
of the acts or omissions of health professional volunteers, will be 
paid pursuant to this section during the calendar year that begins in 
the following fiscal year.
    ``(ii) Subsection (k)(1)(B) applies to the estimate under clause 
(i) regarding health professional volunteers to the same extent and in 
the same manner as such subsection applies to the estimate under such 
subsection regarding officers, governing board members, employees, and 
contractors of entities described in subsection (g)(4).
    ``(iii) The report shall include a summary of the data relied upon 
for the estimate in clause (i), including the number of claims filed 
and paid from the previous calendar year.
    ``(C) Not later than December 31 of each fiscal year, the Secretary 
shall transfer from the fund under subsection (k)(2) to the appropriate 
accounts in the Treasury an amount equal to the estimate made under 
subparagraph (B) for the calendar year beginning in such fiscal year, 
subject to the extent of amounts in the fund.
    ``(5)(A) This subsection shall take effect on October 1, 2017, 
except as provided in subparagraph (B) and paragraph (6).
    ``(B) Effective on the date of the enactment of this subsection--
        ``(i) the Secretary may issue regulations for carrying out this 
    subsection, and the Secretary may accept and consider applications 
    submitted pursuant to paragraph (3)(B); and
        ``(ii) reports under paragraph (4)(B) may be submitted to 
    Congress.
    ``(6) Beginning on October 1, 2022, this subsection shall cease to 
have any force or effect.''.
SEC. 9026. REPORTS.
    (a) Workforce Development Report.--
        (1) In general.--Not later than 2 years after the date of 
    enactment of this Act, the Administrator of the Health Resources 
    and Services Administration, in consultation with the Assistant 
    Secretary for Mental Health and Substance Use, shall conduct a 
    study and publicly post on the appropriate Internet website of the 
    Department of Health and Human Services a report on the adult and 
    pediatric mental health and substance use disorder workforce in 
    order to inform Federal, State, and local efforts related to 
    workforce enhancement.
        (2) Contents.--The report under this subsection shall contain--
            (A) national and State-level projections of the supply and 
        demand of the mental health and substance use disorder health 
        workforce, disaggregated by profession;
            (B) an assessment of the mental health and substance use 
        disorder workforce capacity, strengths, and weaknesses as of 
        the date of the report, including the extent to which primary 
        care providers are preventing, screening, or referring for 
        mental and substance use disorder services;
            (C) information on trends within the mental health and 
        substance use disorder provider workforce, including the number 
        of individuals expected to enter the mental health workforce 
        over the next 5 years; and
            (D) any additional information determined by the 
        Administrator of the Health Resources and Services 
        Administration, in consultation with the Assistant Secretary 
        for Mental Health and Substance Use, to be relevant to the 
        mental health and substance use disorder provider workforce.
    (b) Peer-Support Specialist Programs.--
        (1) In general.--The Comptroller General of the United States 
    shall conduct a study on peer-support specialist programs in up to 
    10 States that receive funding from the Substance Abuse and Mental 
    Health Services Administration.
        (2) Contents of study.--In conducting the study under paragraph 
    (1), the Comptroller General of the United States shall examine and 
    identify best practices, in the States selected pursuant to such 
    paragraph, related to training and credential requirements for 
    peer-support specialist programs, such as--
            (A) hours of formal work or volunteer experience related to 
        mental and substance use disorders conducted through such 
        programs;
            (B) types of peer-support specialist exams required for 
        such programs in the selected States;
            (C) codes of ethics used by such programs in the selected 
        States;
            (D) required or recommended skill sets for such programs in 
        the selected States; and
            (E) requirements for continuing education.
        (3) Report.--Not later than 2 years after the date of enactment 
    of this Act, the Comptroller General of the United States shall 
    submit to the Committee on Health, Education, Labor, and Pensions 
    of the Senate and the Committee on Energy and Commerce of the House 
    of Representatives a report on the study conducted under paragraph 
    (1).

            Subtitle C--Mental Health on Campus Improvement

SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES ON CAMPUS.
    Section 520E-2 of the Public Health Service Act (42 U.S.C. 290bb-
36b) is amended--
        (1) in the section heading, by striking ``and behavioral 
    health'' and inserting ``health and substance use disorder'';
        (2) in subsection (a)--
            (A) by striking ``Services,'' and inserting ``Services 
        and'';
            (B) by striking ``and behavioral health problems'' and 
        inserting ``health or substance use disorders'';
            (C) by striking ``substance abuse'' and inserting 
        ``substance use disorders''; and
            (D) by adding after, ``suicide attempts,'' the following: 
        ``prevent mental and substance use disorders, reduce stigma, 
        and improve the identification and treatment for students at 
        risk,'';
        (3) in subsection (b)--
            (A) in the matter preceding paragraph (1), by striking 
        ``for--'' and inserting ``for one or more of the following:''; 
        and
            (B) by striking paragraphs (1) through (6) and inserting 
        the following:
        ``(1) Educating students, families, faculty, and staff to 
    increase awareness of mental and substance use disorders.
        ``(2) The operation of hotlines.
        ``(3) Preparing informational material.
        ``(4) Providing outreach services to notify students about 
    available mental and substance use disorder services.
        ``(5) Administering voluntary mental and substance use disorder 
    screenings and assessments.
        ``(6) Supporting the training of students, faculty, and staff 
    to respond effectively to students with mental and substance use 
    disorders.
        ``(7) Creating a network infrastructure to link institutions of 
    higher education with health care providers who treat mental and 
    substance use disorders.
        ``(8) Providing mental and substance use disorders prevention 
    and treatment services to students, which may include recovery 
    support services and programming and early intervention, treatment, 
    and management, including through the use of telehealth services.
        ``(9) Conducting research through a counseling or health center 
    at the institution of higher education involved regarding improving 
    the behavioral health of students through clinical services, 
    outreach, prevention, or academic success, in a manner that is in 
    compliance with all applicable personal privacy laws.
        ``(10) Supporting student groups on campus, including athletic 
    teams, that engage in activities to educate students, including 
    activities to reduce stigma surrounding mental and behavioral 
    disorders, and promote mental health.
        ``(11) Employing appropriately trained staff.
        ``(12) Developing and supporting evidence-based and emerging 
    best practices, including a focus on culturally and linguistically 
    appropriate best practices.'';
        (4) in subsection (c)(5), by striking ``substance abuse'' and 
    inserting ``substance use disorder'';
        (5) in subsection (d)--
            (A) in the matter preceding paragraph (1), by striking ``An 
        institution of higher education desiring a grant under this 
        section'' and inserting ``To be eligible to receive a grant 
        under this section, an institution of higher education'';
            (B) by striking paragraph (1) and inserting--
        ``(1) A description of the population to be targeted by the 
    program carried out under the grant, including veterans whenever 
    possible and appropriate, and of identified mental and substance 
    use disorder needs of students at the institution of higher 
    education.'';
            (C) in paragraph (2), by inserting ``, which may include, 
        as appropriate and in accordance with subsection (b)(7), a plan 
        to seek input from relevant stakeholders in the community, 
        including appropriate public and private entities, in order to 
        carry out the program under the grant'' before the period at 
        the end; and
            (D) by adding after paragraph (5) the following new 
        paragraphs:
        ``(6) An outline of the objectives of the program carried out 
    under the grant.
        ``(7) For an institution of higher education proposing to use 
    the grant for an activity described in paragraph (8) or (9) of 
    subsection (b), a description of the policies and procedures of the 
    institution of higher education that are related to applicable laws 
    regarding access to, and sharing of, treatment records of students 
    at any campus-based mental health center or partner organization, 
    including the policies and State laws governing when such records 
    can be accessed and shared for non-treatment purposes and a 
    description of the process used by the institution of higher 
    education to notify students of these policies and procedures, 
    including the extent to which written consent is required.
        ``(8) An assurance that grant funds will be used to supplement 
    and not supplant any other Federal, State, or local funds available 
    to carry out activities of the type carried out under the grant.'';
        (6) in subsection (e)(1), by striking ``and behavioral health 
    problems'' and inserting ``health and substance use disorders'';
        (7) in subsection (f)(2)--
            (A) by striking ``and behavioral health'' and inserting 
        ``health and substance use disorder''; and
            (B) by striking ``suicide and substance abuse'' and 
        inserting ``suicide and substance use disorders'';
        (8) by redesignating subsection (h) as subsection (i);
        (9) by inserting after subsection (g) the following new 
    subsection:
    ``(h) Technical Assistance.--The Secretary may provide technical 
assistance to grantees in carrying out this section.''; and
        (10) in subsection (i), as redesignated by paragraph (8), by 
    striking ``$5,000,000 for fiscal year 2005'' and all that follows 
    through the period at the end and inserting ``$7,000,000 for each 
    of fiscal years 2018 through 2022.''.
SEC. 9032. INTERAGENCY WORKING GROUP ON COLLEGE MENTAL HEALTH.
    (a) Purpose.--It is the purpose of this section to provide for the 
establishment of a College Campus Task Force to discuss mental and 
behavioral health concerns on campuses of institutions of higher 
education.
    (b) Establishment.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall establish a 
College Campus Task Force (referred to in this section as the ``Task 
Force'') to discuss mental and behavioral health concerns on campuses 
of institutions of higher education.
    (c) Membership.--The Task Force shall be composed of a 
representative from each Federal agency (as appointed by the head of 
the agency) that has jurisdiction over, or is affected by, mental 
health and education policies and projects, including--
        (1) the Department of Education;
        (2) the Department of Health and Human Services;
        (3) the Department of Veterans Affairs; and
        (4) such other Federal agencies as the Assistant Secretary for 
    Mental Health and Substance Use, in consultation with the 
    Secretary, determines to be appropriate.
    (d) Duties.--The Task Force shall--
        (1) serve as a centralized mechanism to coordinate a national 
    effort to--
            (A) discuss and evaluate evidence and knowledge on mental 
        and behavioral health services available to, and the prevalence 
        of mental illness among, the age population of students 
        attending institutions of higher education in the United 
        States;
            (B) determine the range of effective, feasible, and 
        comprehensive actions to improve mental and behavioral health 
        on campuses of institutions of higher education;
            (C) examine and better address the needs of the age 
        population of students attending institutions of higher 
        education dealing with mental illness;
            (D) survey Federal agencies to determine which policies are 
        effective in encouraging, and how best to facilitate outreach 
        without duplicating, efforts relating to mental and behavioral 
        health promotion;
            (E) establish specific goals within and across Federal 
        agencies for mental health promotion, including determinations 
        of accountability for reaching those goals;
            (F) develop a strategy for allocating responsibilities and 
        ensuring participation in mental and behavioral health 
        promotion, particularly in the case of competing agency 
        priorities;
            (G) coordinate plans to communicate research results 
        relating to mental and behavioral health amongst the age 
        population of students attending institutions of higher 
        education to enable reporting and outreach activities to 
        produce more useful and timely information;
            (H) provide a description of evidence-based practices, 
        model programs, effective guidelines, and other strategies for 
        promoting mental and behavioral health on campuses of 
        institutions of higher education;
            (I) make recommendations to improve Federal efforts 
        relating to mental and behavioral health promotion on campuses 
        of institutions of higher education and to ensure Federal 
        efforts are consistent with available standards, evidence, and 
        other programs in existence as of the date of enactment of this 
        Act;
            (J) monitor Federal progress in meeting specific mental and 
        behavioral health promotion goals as they relate to settings of 
        institutions of higher education; and
            (K) examine and disseminate best practices related to 
        intracampus sharing of treatment records;
        (2) consult with national organizations with expertise in 
    mental and behavioral health, especially those organizations 
    working with the age population of students attending institutions 
    of higher education; and
        (3) consult with and seek input from mental health 
    professionals working on campuses of institutions of higher 
    education as appropriate.
    (e) Meetings.--
        (1) In general.--The Task Force shall meet not fewer than three 
    times each year.
        (2) Annual conference.--The Secretary shall sponsor an annual 
    conference on mental and behavioral health in settings of 
    institutions of higher education to enhance coordination, build 
    partnerships, and share best practices in mental and behavioral 
    health promotion, data collection, analysis, and services.
    (f) Definition.--In this section, the term ``institution of higher 
education'' has the meaning given such term in section 101 of the 
Higher Education Act of 1965 (20 U.S.C. 1001).
    (g) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $1,000,000 for the period of 
fiscal years 2018 through 2022.
SEC. 9033. IMPROVING MENTAL HEALTH ON COLLEGE CAMPUSES.
    Part D of title V of the Public Health Service Act (42 U.S.C. 290dd 
et seq.) is amended by adding at the end the following:
    ``SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION ON 
      COLLEGE CAMPUSES.
    ``(a) Purpose.--It is the purpose of this section to increase 
access to, and reduce the stigma associated with, mental health 
services to ensure that students at institutions of higher education 
have the support necessary to successfully complete their studies.
    ``(b) National Public Education Campaign.--The Secretary, acting 
through the Assistant Secretary and in collaboration with the Director 
of the Centers for Disease Control and Prevention, shall convene an 
interagency, public-private sector working group to plan, establish, 
and begin coordinating and evaluating a targeted public education 
campaign that is designed to focus on mental and behavioral health on 
the campuses of institutions of higher education. Such campaign shall 
be designed to--
        ``(1) improve the general understanding of mental health and 
    mental disorders;
        ``(2) encourage help-seeking behaviors relating to the 
    promotion of mental health, prevention of mental disorders, and 
    treatment of such disorders;
        ``(3) make the connection between mental and behavioral health 
    and academic success; and
        ``(4) assist the general public in identifying the early 
    warning signs and reducing the stigma of mental illness.
    ``(c) Composition.--The working group convened under subsection (b) 
shall include--
        ``(1) mental health consumers, including students and family 
    members;
        ``(2) representatives of institutions of higher education;
        ``(3) representatives of national mental and behavioral health 
    associations and associations of institutions of higher education;
        ``(4) representatives of health promotion and prevention 
    organizations at institutions of higher education;
        ``(5) representatives of mental health providers, including 
    community mental health centers; and
        ``(6) representatives of private-sector and public-sector 
    groups with experience in the development of effective public 
    health education campaigns.
    ``(d) Plan.--The working group under subsection (b) shall develop a 
plan that--
        ``(1) targets promotional and educational efforts to the age 
    population of students at institutions of higher education and 
    individuals who are employed in settings of institutions of higher 
    education, including through the use of roundtables;
        ``(2) develops and proposes the implementation of research-
    based public health messages and activities;
        ``(3) provides support for local efforts to reduce stigma by 
    using the National Health Information Center as a primary point of 
    contact for information, publications, and service program 
    referrals; and
        ``(4) develops and proposes the implementation of a social 
    marketing campaign that is targeted at the population of students 
    attending institutions of higher education and individuals who are 
    employed in settings of institutions of higher education.
    ``(e) Definition.--In this section, the term `institution of higher 
education' has the meaning given such term in section 101 of the Higher 
Education Act of 1965 (20 U.S.C. 1001).
    ``(f) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $1,000,000 for the period of 
fiscal years 2018 through 2022.''.

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

SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL DISTURBANCE.
    (a) Comprehensive Community Mental Health Services for Children 
With a Serious Emotional Disturbance.--Section 561(a)(1) of the Public 
Health Service Act (42 U.S.C. 290ff(a)(1)) is amended by inserting ``, 
which may include efforts to identify and serve children at risk'' 
before the period.
    (b) Requirements With Respect to Carrying Out Purpose of Grants.--
Section 562(b) of the Public Health Service Act (42 U.S.C. 290ff-1(b)) 
is amended by striking ``will not provide an individual with access to 
the system if the individual is more than 21 years of age'' and 
inserting ``will provide an individual with access to the system 
through the age of 21 years''.
    (c) Additional Provisions.--Section 564(f) of the Public Health 
Service Act (42 U.S.C. 290ff-3(f)) is amended by inserting ``(and 
provide a copy to the State involved)'' after ``to the Secretary''.
    (d) General Provisions.--Section 565 of the Public Health Service 
Act (42 U.S.C. 290ff-4) is amended--
        (1) in subsection (b)(1)--
            (A) in the matter preceding subparagraph (A), by striking 
        ``receiving a grant under section 561(a)'' and inserting ``, 
        regardless of whether such public entity is receiving a grant 
        under section 561(a)''; and
            (B) in subparagraph (B), by striking ``pursuant to'' and 
        inserting ``described in'';
        (2) in subsection (d)(1), by striking ``not more than 21 years 
    of age'' and inserting ``through the age of 21 years''; and
        (3) in subsection (f)(1), by striking ``$100,000,000 for fiscal 
    year 2001, and such sums as may be necessary for each of the fiscal 
    years 2002 and 2003'' and inserting ``$119,026,000 for each of 
    fiscal years 2018 through 2022''.
SEC. 10002. INCREASING ACCESS TO PEDIATRIC MENTAL HEALTH CARE.
    Title III of the Public Health Service Act is amended by inserting 
after section 330L of such Act (42 U.S.C. 254c-18) the following new 
section:
``SEC. 330M PEDIATRIC MENTAL HEALTH CARE ACCESS GRANTS.
    ``(a) In General.--The Secretary, acting through the Administrator 
of the Health Resources and Services Administration and in coordination 
with other relevant Federal agencies, shall award grants to States, 
political subdivisions of States, and Indian tribes and tribal 
organizations (for purposes of this section, as such terms are defined 
in section 4 of the Indian Self-Determination and Education Assistance 
Act (25 U.S.C. 450b)) to promote behavioral health integration in 
pediatric primary care by--
        ``(1) supporting the development of statewide or regional 
    pediatric mental health care telehealth access programs; and
        ``(2) supporting the improvement of existing statewide or 
    regional pediatric mental health care telehealth access programs.
    ``(b) Program Requirements.--
        ``(1) In general.--A pediatric mental health care telehealth 
    access program referred to in subsection (a), with respect to which 
    a grant under such subsection may be used, shall--
            ``(A) be a statewide or regional network of pediatric 
        mental health teams that provide support to pediatric primary 
        care sites as an integrated team;
            ``(B) support and further develop organized State or 
        regional networks of pediatric mental health teams to provide 
        consultative support to pediatric primary care sites;
            ``(C) conduct an assessment of critical behavioral 
        consultation needs among pediatric providers and such 
        providers' preferred mechanisms for receiving consultation, 
        training, and technical assistance;
            ``(D) develop an online database and communication 
        mechanisms, including telehealth, to facilitate consultation 
        support to pediatric practices;
            ``(E) provide rapid statewide or regional clinical 
        telephone or telehealth consultations when requested between 
        the pediatric mental health teams and pediatric primary care 
        providers;
            ``(F) conduct training and provide technical assistance to 
        pediatric primary care providers to support the early 
        identification, diagnosis, treatment, and referral of children 
        with behavioral health conditions;
            ``(G) provide information to pediatric providers about, and 
        assist pediatric providers in accessing, pediatric mental 
        health care providers, including child and adolescent 
        psychiatrists, and licensed mental health professionals, such 
        as psychologists, social workers, or mental health counselors 
        and in scheduling and conducting technical assistance;
            ``(H) assist with referrals to specialty care and community 
        or behavioral health resources; and
            ``(I) establish mechanisms for measuring and monitoring 
        increased access to pediatric mental health care services by 
        pediatric primary care providers and expanded capacity of 
        pediatric primary care providers to identify, treat, and refer 
        children with mental health problems.
        ``(2) Pediatric mental health teams.--In this subsection, the 
    term `pediatric mental health team' means a team consisting of at 
    least one case coordinator, at least one child and adolescent 
    psychiatrist, and at least one licensed clinical mental health 
    professional, such as a psychologist, social worker, or mental 
    health counselor. Such a team may be regionally based.
    ``(c) Application.--A State, political subdivision of a State, 
Indian tribe, or tribal organization seeking a grant under this section 
shall submit an application to the Secretary at such time, in such 
manner, and containing such information as the Secretary may require, 
including a plan for the comprehensive evaluation of activities that 
are carried out with funds received under such grant.
    ``(d) Evaluation.--A State, political subdivision of a State, 
Indian tribe, or tribal organization that receives a grant under this 
section shall prepare and submit an evaluation of activities that are 
carried out with funds received under such grant to the Secretary at 
such time, in such manner, and containing such information as the 
Secretary may reasonably require, including a process and outcome 
evaluation.
    ``(e) Access to Broadband.--In administering grants under this 
section, the Secretary may coordinate with other agencies to ensure 
that funding opportunities are available to support access to reliable, 
high-speed Internet for providers.
    ``(f) Matching Requirement.--The Secretary may not award a grant 
under this section unless the State, political subdivision of a State, 
Indian tribe, or tribal organization involved agrees, with respect to 
the costs to be incurred by the State, political subdivision of a 
State, Indian tribe, or tribal organization in carrying out the purpose 
described in this section, to make available non-Federal contributions 
(in cash or in kind) toward such costs in an amount that is not less 
than 20 percent of Federal funds provided in the grant.
    ``(g) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated, $9,000,000 for the period of 
fiscal years 2018 through 2022.''.
SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY INTERVENTION 
SERVICES FOR CHILDREN AND ADOLESCENTS.
    The first section 514 of the Public Health Service Act (42 U.S.C. 
290bb-7), relating to substance abuse treatment services for children 
and adolescents, is amended--
        (1) in the section heading, by striking ``abuse treatment'' and 
    inserting ``use disorder treatment and early intervention'';
        (2) by striking subsection (a) and inserting the following:
    ``(a) In General.--The Secretary shall award grants, contracts, or 
cooperative agreements to public and private nonprofit entities, 
including Indian tribes or tribal organizations (as such terms are 
defined in section 4 of the Indian Self-Determination and Education 
Assistance Act), or health facilities or programs operated by or in 
accordance with a contract or grant with the Indian Health Service, for 
the purpose of--
        ``(1) providing early identification and services to meet the 
    needs of children and adolescents who are at risk of substance use 
    disorders;
        ``(2) providing substance use disorder treatment services for 
    children, including children and adolescents with co-occurring 
    mental illness and substance use disorders; and
        ``(3) providing assistance to pregnant women, and parenting 
    women, with substance use disorders, in obtaining treatment 
    services, linking mothers to community resources to support 
    independent family lives, and staying in recovery so that children 
    are in safe, stable home environments and receive appropriate 
    health care services.'';
        (3) in subsection (b)--
            (A) by striking paragraph (1) and inserting the following:
        ``(1) apply evidence-based and cost-effective methods;'';
            (B) in paragraph (2)--
                (i) by striking ``treatment''; and
                (ii) by inserting ``substance abuse,'' after ``child 
            welfare,'';
            (C) in paragraph (3), by striking ``substance abuse 
        disorders'' and inserting ``substance use disorders, including 
        children and adolescents with co-occurring mental illness and 
        substance use disorders,'';
            (D) in paragraph (5), by striking ``treatment;'' and 
        inserting ``services; and'';
            (E) in paragraph (6), by striking ``substance abuse 
        treatment; and'' and inserting ``treatment.''; and
            (F) by striking paragraph (7); and
        (4) in subsection (f), by striking ``$40,000,000'' and all that 
    follows through the period and inserting ``$29,605,000 for each of 
    fiscal years 2018 through 2022.''.
SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.
    The first section 582 of the Public Health Service Act (42 U.S.C. 
290hh-1; relating to grants to address the problems of persons who 
experience violence related stress) is amended--
        (1) in subsection (a), by striking ``developing programs'' and 
    all that follows through the period at the end and inserting the 
    following: ``developing and maintaining programs that provide for--
        ``(1) the continued operation of the National Child Traumatic 
    Stress Initiative (referred to in this section as the `NCTSI'), 
    which includes a cooperative agreement with a coordinating center, 
    that focuses on the mental, behavioral, and biological aspects of 
    psychological trauma response, prevention of the long-term 
    consequences of child trauma, and early intervention services and 
    treatment to address the long-term consequences of child trauma; 
    and
        ``(2) the development of knowledge with regard to evidence-
    based practices for identifying and treating mental, behavioral, 
    and biological disorders of children and youth resulting from 
    witnessing or experiencing a traumatic event.'';
        (2) in subsection (b)--
            (A) by striking ``subsection (a) related'' and inserting 
        ``subsection (a)(2) (related'';
            (B) by striking ``treating disorders associated with 
        psychological trauma'' and inserting ``treating mental, 
        behavioral, and biological disorders associated with 
        psychological trauma)''; and
            (C) by striking ``mental health agencies and programs that 
        have established clinical and basic research'' and inserting 
        ``universities, hospitals, mental health agencies, and other 
        programs that have established clinical expertise and 
        research'';
        (3) by redesignating subsections (c) through (g) as subsections 
    (g) through (k), respectively;
        (4) by inserting after subsection (b), the following:
    ``(c) Child Outcome Data.--The NCTSI coordinating center described 
in subsection (a)(1) shall collect, analyze, report, and make publicly 
available, as appropriate, NCTSI-wide child treatment process and 
outcome data regarding the early identification and delivery of 
evidence-based treatment and services for children and families served 
by the NCTSI grantees.
    ``(d) Training.--The NCTSI coordinating center shall facilitate the 
coordination of training initiatives in evidence-based and trauma-
informed treatments, interventions, and practices offered to NCTSI 
grantees, providers, and partners.
    ``(e) Dissemination and Collaboration.--The NCTSI coordinating 
center shall, as appropriate, collaborate with--
        ``(1) the Secretary, in the dissemination of evidence-based and 
    trauma-informed interventions, treatments, products, and other 
    resources to appropriate stakeholders; and
        ``(2) appropriate agencies that conduct or fund research within 
    the Department of Health and Human Services, for purposes of 
    sharing NCTSI expertise, evaluation data, and other activities, as 
    appropriate.
    ``(f) Review.--The Secretary shall, consistent with the peer-review 
process, ensure that NCTSI applications are reviewed by appropriate 
experts in the field as part of a consensus-review process. The 
Secretary shall include review criteria related to expertise and 
experience in child trauma and evidence-based practices.'';
        (5) in subsection (g) (as so redesignated), by striking ``with 
    respect to centers of excellence are distributed equitably among 
    the regions of the country'' and inserting ``are distributed 
    equitably among the regions of the United States'';
        (6) in subsection (i) (as so redesignated), by striking 
    ``recipient may not exceed 5 years'' and inserting ``recipient 
    shall not be less than 4 years, but shall not exceed 5 years''; and
        (7) in subsection (j) (as so redesignated), by striking 
    ``$50,000,000'' and all that follows through ``2006'' and inserting 
    ``$46,887,000 for each of fiscal years 2018 through 2022''.
SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 317L (42 U.S.C. 247b-13) 
the following:
``SEC. 317L-1. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
    ``(a) Grants.--The Secretary shall make grants to States to 
establish, improve, or maintain programs for screening, assessment, and 
treatment services, including culturally and linguistically appropriate 
services, as appropriate, for women who are pregnant, or who have given 
birth within the preceding 12 months, for maternal depression.
    ``(b) Application.--To seek a grant under this section, a State 
shall submit an application to the Secretary at such time, in such 
manner, and containing such information as the Secretary may require. 
At a minimum, any such application shall include explanations of--
        ``(1) how a program, or programs, will increase the percentage 
    of women screened and treated, as appropriate, for maternal 
    depression in 1 or more communities; and
        ``(2) how a program, or programs, if expanded, would increase 
    access to screening and treatment services for maternal depression.
    ``(c) Priority.--In awarding grants under this section, the 
Secretary may give priority to States proposing to improve or enhance 
access to screening services for maternal depression in primary care 
settings.
    ``(d) Use of Funds.--The activities eligible for funding through a 
grant under subsection (a)--
        ``(1) shall include--
            ``(A) providing appropriate training to health care 
        providers; and
            ``(B) providing information to health care providers, 
        including information on maternal depression screening, 
        treatment, and followup support services, and linkages to 
        community-based resources; and
        ``(2) may include--
            ``(A) enabling health care providers (including 
        obstetrician-gynecologists, pediatricians, psychiatrists, 
        mental health care providers, and adult primary care 
        clinicians) to provide or receive real-time psychiatric 
        consultation (in-person or remotely) to aid in the treatment of 
        pregnant and parenting women;
            ``(B) establishing linkages with and among community-based 
        resources, including mental health resources, primary care 
        resources, and support groups; and
            ``(C) utilizing telehealth services for rural areas and 
        medically underserved areas (as defined in section 330I(a)).
    ``(e) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $5,000,000 for each of fiscal 
years 2018 through 2022.''.
SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, 
INTERVENTION, AND TREATMENT.
    Part Q of title III of the Public Health Service Act (42 U.S.C. 
280h et seq.) is amended by adding at the end the following:
``SEC. 399Z-2. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, 
INTERVENTION, AND TREATMENT.
    ``(a) Grants.--The Secretary shall--
        ``(1) award grants to eligible entities to develop, maintain, 
    or enhance infant and early childhood mental health promotion, 
    intervention, and treatment programs, including--
            ``(A) programs for infants and children at significant risk 
        of developing, showing early signs of, or having been diagnosed 
        with mental illness, including a serious emotional disturbance; 
        and
            ``(B) multigenerational therapy and other services that 
        support the caregiving relationship; and
        ``(2) ensure that programs funded through grants under this 
    section are evidence-informed or evidence-based models, practices, 
    and methods that are, as appropriate, culturally and linguistically 
    appropriate, and can be replicated in other appropriate settings.
    ``(b) Eligible Children and Entities.--In this section:
        ``(1) Eligible child.--The term `eligible child' means a child 
    from birth to not more than 12 years of age who--
            ``(A) is at risk for, shows early signs of, or has been 
        diagnosed with a mental illness, including a serious emotional 
        disturbance; and
            ``(B) may benefit from infant and early childhood 
        intervention or treatment programs or specialized preschool or 
        elementary school programs that are evidence-based or that have 
        been scientifically demonstrated to show promise but would 
        benefit from further applied development.
        ``(2) Eligible entity.--The term `eligible entity' means a 
    human services agency or nonprofit institution that--
            ``(A) employs licensed mental health professionals who have 
        specialized training and experience in infant and early 
        childhood mental health assessment, diagnosis, and treatment, 
        or is accredited or approved by the appropriate State agency, 
        as applicable, to provide for children from infancy to 12 years 
        of age mental health promotion, intervention, or treatment 
        services; and
            ``(B) provides services or programs described in subsection 
        (a) that are evidence-based or that have been scientifically 
        demonstrated to show promise but would benefit from further 
        applied development.
    ``(c) Application.--An eligible entity seeking a grant under 
subsection (a) shall submit to the Secretary an application at such 
time, in such manner, and containing such information as the Secretary 
may require.
    ``(d) Use of Funds for Early Intervention and Treatment Programs.--
An eligible entity may use amounts awarded under a grant under 
subsection (a)(1) to carry out the following:
        ``(1) Provide age-appropriate mental health promotion and early 
    intervention services or mental illness treatment services, which 
    may include specialized programs, for eligible children at 
    significant risk of developing, showing early signs of, or having 
    been diagnosed with a mental illness, including a serious emotional 
    disturbance. Such services may include social and behavioral 
    services as well as multigenerational therapy and other services 
    that support the caregiving relationship.
        ``(2) Provide training for health care professionals with 
    expertise in infant and early childhood mental health care with 
    respect to appropriate and relevant integration with other 
    disciplines such as primary care clinicians, early intervention 
    specialists, child welfare staff, home visitors, early care and 
    education providers, and others who work with young children and 
    families.
        ``(3) Provide mental health consultation to personnel of early 
    care and education programs (including licensed or regulated 
    center-based and home-based child care, home visiting, preschool 
    special education, and early intervention programs) who work with 
    children and families.
        ``(4) Provide training for mental health clinicians in infant 
    and early childhood in promising and evidence-based practices and 
    models for infant and early childhood mental health treatment and 
    early intervention, including with regard to practices for 
    identifying and treating mental illness and behavioral disorders of 
    infants and children resulting from exposure or repeated exposure 
    to adverse childhood experiences or childhood trauma.
        ``(5) Provide age-appropriate assessment, diagnostic, and 
    intervention services for eligible children, including early mental 
    health promotion, intervention, and treatment services.
    ``(e) Matching Funds.--The Secretary may not award a grant under 
this section to an eligible entity unless the eligible entity agrees, 
with respect to the costs to be incurred by the eligible entity in 
carrying out the activities described in subsection (d), to make 
available non-Federal contributions (in cash or in kind) toward such 
costs in an amount that is not less than 10 percent of the total amount 
of Federal funds provided in the grant.
    ``(f) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $20,000,000 for the period of 
fiscal years 2018 through 2022.''.

             TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA

SEC. 11001. SENSE OF CONGRESS.
    (a) Findings.--Congress finds the following:
        (1) According to the National Survey on Drug Use and Health, in 
    2015, there were approximately 9,800,000 adults in the United 
    States with serious mental illness.
        (2) The Substance Abuse and Mental Health Services 
    Administration defines the term ``serious mental illness'' as an 
    illness affecting individuals 18 years of age or older as having, 
    at any time in the past year, a diagnosable mental, behavioral, or 
    emotional disorder that results in serious functional impairment 
    and substantially interferes with or limits one or more major life 
    activities.
        (3) In reporting on the incidence of serious mental illness, 
    the Substance Abuse and Mental Health Services Administration 
    includes major depression, schizophrenia, bipolar disorder, and 
    other mental disorders that cause serious impairment.
        (4) Adults with a serious mental illness are at a higher risk 
    for chronic physical illnesses and premature death.
        (5) According to the World Health Organization, adults with a 
    serious mental illness have lifespans that are 10 to 25 years 
    shorter than those without serious mental illness. The vast 
    majority of these deaths are due to chronic physical medical 
    conditions, such as cardiovascular, respiratory, and infectious 
    diseases, as well as diabetes and hypertension.
        (6) According to the World Health Organization, the majority of 
    deaths of adults with a serious mental illness that are due to 
    physical medical conditions are preventable.
        (7) Supported decision making can facilitate care decisions in 
    areas where serious mental illness may impact the capacity of an 
    individual to determine a course of treatment while still allowing 
    the individual to make decisions independently.
        (8) Help should be provided to adults with a serious mental 
    illness to address their acute or chronic physical illnesses, make 
    informed choices about treatment, and understand and follow through 
    with appropriate treatment.
        (9) There is confusion in the health care community regarding 
    permissible practices under the regulations promulgated under the 
    Health Insurance Portability and Accountability Act of 1996 
    (commonly known as ``HIPAA''). This confusion may hinder 
    appropriate communication of health care information or treatment 
    preferences with appropriate caregivers.
    (b) Sense of Congress.--It is the sense of Congress that 
clarification is needed regarding the privacy rule promulgated under 
section 264(c) of the Health Insurance Portability and Accountability 
Act of 1996 (42 U.S.C. 1320d-2 note) regarding existing permitted uses 
and disclosures of health information by health care professionals to 
communicate with caregivers of adults with a serious mental illness to 
facilitate treatment.
SEC. 11002. CONFIDENTIALITY OF RECORDS.
    Not later than 1 year after the date on which the Secretary of 
Health and Human Services (in this title referred to as the 
``Secretary'') first finalizes regulations updating part 2 of title 42, 
Code of Federal Regulations, relating to confidentiality of alcohol and 
drug abuse patient records, after the date of enactment of this Act, 
the Secretary shall convene relevant stakeholders to determine the 
effect of such regulations on patient care, health outcomes, and 
patient privacy.
SEC. 11003. CLARIFICATION ON PERMITTED USES AND DISCLOSURES OF 
PROTECTED HEALTH INFORMATION.
    (a) In General.--The Secretary, acting through the Director of the 
Office for Civil Rights, shall ensure that health care providers, 
professionals, patients and their families, and others involved in 
mental or substance use disorder treatment have adequate, accessible, 
and easily comprehensible resources relating to appropriate uses and 
disclosures of protected health information under the regulations 
promulgated under section 264(c) of the Health Insurance Portability 
and Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
    (b) Guidance.--
        (1) Issuance.--In carrying out subsection (a), not later than 1 
    year after the date of enactment of this section, the Secretary 
    shall issue guidance clarifying the circumstances under which, 
    consistent with regulations promulgated under section 264(c) of the 
    Health Insurance Portability and Accountability Act of 1996, a 
    health care provider or covered entity may use or disclose 
    protected health information.
        (2) Circumstances addressed.--The guidance issued under this 
    section shall address circumstances including those that--
            (A) require the consent of the patient;
            (B) require providing the patient with an opportunity to 
        object;
            (C) are based on the exercise of professional judgment 
        regarding whether the patient would object when the opportunity 
        to object cannot practicably be provided because of the 
        incapacity of the patient or an emergency treatment 
        circumstance; and
            (D) are determined, based on the exercise of professional 
        judgment, to be in the best interest of the patient when the 
        patient is not present or otherwise incapacitated.
        (3) Communication with family members and caregivers.--In 
    addressing the circumstances described in paragraph (2), the 
    guidance issued under this section shall clarify permitted uses or 
    disclosures of protected health information for purposes of--
            (A) communicating with a family member of the patient, 
        caregiver of the patient, or other individual, to the extent 
        that such family member, caregiver, or individual is involved 
        in the care of the patient;
            (B) in the case that the patient is an adult, communicating 
        with a family member of the patient, caregiver of the patient, 
        or other individual involved in the care of the patient;
            (C) in the case that the patient is a minor, communicating 
        with the parent or caregiver of the patient;
            (D) involving the family members or caregivers of the 
        patient, or others involved in the patient's care or care plan, 
        including facilitating treatment and medication adherence;
            (E) listening to the patient, or receiving information with 
        respect to the patient from the family or caregiver of the 
        patient;
            (F) communicating with family members of the patient, 
        caregivers of the patient, law enforcement, or others when the 
        patient presents a serious and imminent threat of harm to self 
        or others; and
            (G) communicating to law enforcement and family members or 
        caregivers of the patient about the admission of the patient to 
        receive care at, or the release of a patient from, a facility 
        for an emergency psychiatric hold or involuntary treatment.
SEC. 11004. DEVELOPMENT AND DISSEMINATION OF MODEL TRAINING PROGRAMS.
    (a) Initial Programs and Materials.--Not later than 1 year after 
the date of the enactment of this Act, the Secretary, in consultation 
with appropriate experts, shall identify the following model programs 
and materials, or (in the case that no such programs or materials 
exist) recognize private or public entities to develop and disseminate 
each of the following:
        (1) Model programs and materials for training health care 
    providers (including physicians, emergency medical personnel, 
    psychiatrists, including child and adolescent psychiatrists, 
    psychologists, counselors, therapists, nurse practitioners, 
    physician assistants, behavioral health facilities and clinics, 
    care managers, and hospitals, including individuals such as general 
    counsels or regulatory compliance staff who are responsible for 
    establishing provider privacy policies) regarding the permitted 
    uses and disclosures, consistent with the standards governing the 
    privacy and security of individually identifiable health 
    information promulgated by the Secretary under part C of title XI 
    of the Social Security Act (42 U.S.C. 1320d et seq.) and 
    regulations promulgated under section 264(c) of the Health 
    Insurance Portability and Accountability Act of 1996 (42 U.S.C. 
    1320d-2 note) and such part C, of the protected health information 
    of patients seeking or undergoing mental or substance use disorder 
    treatment.
        (2) A model program and materials for training patients and 
    their families regarding their rights to protect and obtain 
    information under the standards and regulations specified in 
    paragraph (1).
    (b) Periodic Updates.--The Secretary shall--
        (1) periodically review and update the model programs and 
    materials identified or developed under subsection (a); and
        (2) disseminate the updated model programs and materials to the 
    individuals described in subsection (a).
    (c) Coordination.--The Secretary shall carry out this section in 
coordination with the Director of the Office for Civil Rights within 
the Department of Health and Human Services, the Assistant Secretary 
for Mental Health and Substance Use, the Administrator of the Health 
Resources and Services Administration, and the heads of other relevant 
agencies within the Department of Health and Human Services.
    (d) Input of Certain Entities.--In identifying, reviewing, or 
updating the model programs and materials under subsections (a) and 
(b), the Secretary shall solicit the input of relevant national, State, 
and local associations; medical societies; licensing boards; providers 
of mental and substance use disorder treatment; organizations with 
expertise on domestic violence, sexual assault, elder abuse, and child 
abuse; and organizations representing patients and consumers and the 
families of patients and consumers.
    (e) Funding.--There are authorized to be appropriated to carry out 
this section--
        (1) $4,000,000 for fiscal year 2018;
        (2) $2,000,000 for each of fiscal years 2019 and 2020; and
        (3) $1,000,000 for each of fiscal years 2021 and 2022.

               TITLE XII--MEDICAID MENTAL HEALTH COVERAGE

SEC. 12001. RULE OF CONSTRUCTION RELATED TO MEDICAID COVERAGE OF MENTAL 
HEALTH SERVICES AND PRIMARY CARE SERVICES FURNISHED ON THE SAME DAY.
    Nothing in title XIX of the Social Security Act (42 U.S.C. 1396 et 
seq.) shall be construed as prohibiting separate payment under the 
State plan under such title (or under a waiver of the plan) for the 
provision of a mental health service or primary care service under such 
plan, with respect to an individual, because such service is--
        (1) a primary care service furnished to the individual by a 
    provider at a facility on the same day a mental health service is 
    furnished to such individual by such provider (or another provider) 
    at the facility; or
        (2) a mental health service furnished to the individual by a 
    provider at a facility on the same day a primary care service is 
    furnished to such individual by such provider (or another provider) 
    at the facility.
SEC. 12002. STUDY AND REPORT RELATED TO MEDICAID MANAGED CARE 
REGULATION.
    (a) Study.--The Secretary of Health and Human Services, acting 
through the Administrator of the Centers for Medicare & Medicaid 
Services, shall conduct a study on coverage under the Medicaid program 
under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) of 
services provided through a medicaid managed care organization (as 
defined in section 1903(m) of such Act (42 U.S.C. 1396b(m)) or a 
prepaid inpatient health plan (as defined in section 438.2 of title 42, 
Code of Federal Regulations (or any successor regulation)) with respect 
to individuals over the age of 21 and under the age of 65 for the 
treatment of a mental health disorder in institutions for mental 
diseases (as defined in section 1905(i) of such Act (42 U.S.C. 
1396d(i))). Such study shall include information on the following:
        (1) The extent to which States, including the District of 
    Columbia and each territory or possession of the United States, are 
    providing capitated payments to such organizations or plans for 
    enrollees who are receiving services in institutions for mental 
    diseases.
        (2) The number of individuals receiving medical assistance 
    under a State plan under such title XIX, or a waiver of such plan, 
    who receive services in institutions for mental diseases through 
    such organizations and plans.
        (3) The range of and average number of months, and the length 
    of stay during such months, that such individuals are receiving 
    such services in such institutions.
        (4) How such organizations or plans determine when to provide 
    for the furnishing of such services through an institution for 
    mental diseases in lieu of other benefits (including the full range 
    of community-based services) under their contract with the State 
    agency administering the State plan under such title XIX, or a 
    waiver of such plan, to address psychiatric or substance use 
    disorder treatment.
        (5) The extent to which the provision of services within such 
    institutions has affected the capitated payments for such 
    organizations or plans.
    (b) Report.--Not later than 3 years after the date of the enactment 
of this Act, the Secretary shall submit to Congress a report on the 
study conducted under subsection (a).
SEC. 12003. GUIDANCE ON OPPORTUNITIES FOR INNOVATION.
    Not later than 1 year after the date of the enactment of this Act, 
the Administrator of the Centers for Medicare & Medicaid Services shall 
issue a State Medicaid Director letter regarding opportunities to 
design innovative service delivery systems, including systems for 
providing community-based services, for adults with a serious mental 
illness or children with a serious emotional disturbance who are 
receiving medical assistance under title XIX of the Social Security Act 
(42 U.S.C. 1396 et seq.). The letter shall include opportunities for 
demonstration projects under section 1115 of such Act (42 U.S.C. 1315) 
to improve care for such adults and children.
SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY PSYCHIATRIC 
DEMONSTRATION PROJECT.
    (a) Collection of Information.--The Secretary of Health and Human 
Services, acting through the Administrator of the Centers for Medicare 
& Medicaid Services, shall, to the extent practical and data is 
available, with respect to each State that has participated in the 
demonstration project established under section 2707 of the Patient 
Protection and Affordable Care Act (42 U.S.C. 1396a note), collect from 
each such State information on the following:
        (1) The number of institutions for mental diseases (as defined 
    in section 1905(i) of the Social Security Act (42 U.S.C. 1396d(i))) 
    and beds in such institutions that received payment for the 
    provision of services to individuals who receive medical assistance 
    under a State plan under the Medicaid program under title XIX of 
    the Social Security Act (42 U.S.C. 1396 et seq.) (or under a waiver 
    of such plan) through the demonstration project in each such State 
    as compared to the total number of institutions for mental diseases 
    and beds in the State.
        (2) The extent to which there is a reduction in expenditures 
    under the Medicaid program under title XIX of the Social Security 
    Act (42 U.S.C. 1396 et seq.) or other spending on the full 
    continuum of physical or mental health care for individuals who 
    receive treatment in an institution for mental diseases under the 
    demonstration project, including outpatient, inpatient, emergency, 
    and ambulatory care, that is attributable to such individuals 
    receiving treatment in institutions for mental diseases under the 
    demonstration project.
        (3) The number of forensic psychiatric hospitals, the number of 
    beds in such hospitals, and the number of forensic psychiatric beds 
    in other hospitals in such State, based on the most recent data 
    available, to the extent practical, as determined by such 
    Administrator.
        (4) The amount of any disproportionate share hospital payments 
    under section 1923 of the Social Security Act (42 U.S.C. 1396r-4) 
    that institutions for mental diseases in the State received during 
    the period beginning on July 1, 2012, and ending on June 30, 2015, 
    and the extent to which the demonstration project reduced the 
    amount of such payments.
        (5) The most recent data regarding all facilities or sites in 
    the State in which any adults with a serious mental illness who are 
    receiving medical assistance under a State plan under the Medicaid 
    program under title XIX of the Social Security Act (42 U.S.C. 1396 
    et seq.) (or under a waiver of such plan) are treated during the 
    period referred to in paragraph (4), to the extent practical, as 
    determined by the Administrator, including--
            (A) the types of such facilities or sites (such as an 
        institution for mental diseases, a hospital emergency 
        department, or other inpatient hospital);
            (B) the average length of stay in such a facility or site 
        by such an individual, disaggregated by facility type; and
            (C) the payment rate under the State plan (or a waivers of 
        such plan) for services furnished to such an individual for 
        that treatment, disaggregated by facility type, during the 
        period in which the demonstration project is in operation.
        (6) The extent to which the utilization of hospital emergency 
    departments during the period in which the demonstration project 
    was is in operation differed, with respect to individuals who are 
    receiving medical assistance under a State plan under the Medicaid 
    program under title XIX of the Social Security Act (42 U.S.C. 1396 
    et seq.) (or under a waiver of such plan), between--
            (A) those individuals who received treatment in an 
        institution for mental diseases under the demonstration 
        project;
            (B) those individuals who met the eligibility requirements 
        for the demonstration project but who did not receive treatment 
        in an institution for mental diseases under the demonstration 
        project; and
            (C) those adults with a serious mental illness who did not 
        meet such eligibility requirements and did not receive 
        treatment for such illness in an institution for mental 
        diseases.
    (b) Report.--Not later than 2 years after the date of the enactment 
of this Act, the Secretary of Health and Human Services shall submit to 
Congress a report that summarizes and analyzes the information 
collected under subsection (a). Such report may be submitted as part of 
the report required under section 2707(f) of the Patient Protection and 
Affordable Care Act (42 U.S.C. 1396a note) or separately.
SEC. 12005. PROVIDING EPSDT SERVICES TO CHILDREN IN IMDS.
    (a) In General.--Section 1905(a)(16) of the Social Security Act (42 
U.S.C. 1396d(a)(16)) is amended--
        (1) by striking ``effective January 1, 1973'' and inserting 
    ``(A) effective January 1, 1973''; and
        (2) by inserting before the semicolon at the end the following: 
    ``, and, (B) for individuals receiving services described in 
    subparagraph (A), early and periodic screening, diagnostic, and 
    treatment services (as defined in subsection (r)), whether or not 
    such screening, diagnostic, and treatment services are furnished by 
    the provider of the services described in such subparagraph''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
apply with respect to items and services furnished in calendar quarters 
beginning on or after January 1, 2019.
SEC. 12006. ELECTRONIC VISIT VERIFICATION SYSTEM REQUIRED FOR PERSONAL 
CARE SERVICES AND HOME HEALTH CARE SERVICES UNDER MEDICAID.
    (a) In General.--Section 1903 of the Social Security Act (42 U.S.C. 
1396b) is amended by inserting after subsection (k) the following new 
subsection:
    ``(l)(1) Subject to paragraphs (3) and (4), with respect to any 
amount expended for personal care services or home health care services 
requiring an in-home visit by a provider that are provided under a 
State plan under this title (or under a waiver of the plan) and 
furnished in a calendar quarter beginning on or after January 1, 2019 
(or, in the case of home health care services, on or after January 1, 
2023), unless a State requires the use of an electronic visit 
verification system for such services furnished in such quarter under 
the plan or such waiver, the Federal medical assistance percentage 
shall be reduced--
        ``(A) in the case of personal care services--
            ``(i) for calendar quarters in 2019 and 2020, by .25 
        percentage points;
            ``(ii) for calendar quarters in 2021, by .5 percentage 
        points;
            ``(iii) for calendar quarters in 2022, by .75 percentage 
        points; and
            ``(iv) for calendar quarters in 2023 and each year 
        thereafter, by 1 percentage point; and
        ``(B) in the case of home health care services--
            ``(i) for calendar quarters in 2023 and 2024, by .25 
        percentage points;
            ``(ii) for calendar quarters in 2025, by .5 percentage 
        points;
            ``(iii) for calendar quarters in 2026, by .75 percentage 
        points; and
            ``(iv) for calendar quarters in 2027 and each year 
        thereafter, by 1 percentage point.
    ``(2) Subject to paragraphs (3) and (4), in implementing the 
requirement for the use of an electronic visit verification system 
under paragraph (1), a State shall--
        ``(A) consult with agencies and entities that provide personal 
    care services, home health care services, or both under the State 
    plan (or under a waiver of the plan) to ensure that such system--
            ``(i) is minimally burdensome;
            ``(ii) takes into account existing best practices and 
        electronic visit verification systems in use in the State; and
            ``(iii) is conducted in accordance with the requirements of 
        HIPAA privacy and security law (as defined in section 3009 of 
        the Public Health Service Act);
        ``(B) take into account a stakeholder process that includes 
    input from beneficiaries, family caregivers, individuals who 
    furnish personal care services or home health care services, and 
    other stakeholders, as determined by the State in accordance with 
    guidance from the Secretary; and
        ``(C) ensure that individuals who furnish personal care 
    services, home health care services, or both under the State plan 
    (or under a waiver of the plan) are provided the opportunity for 
    training on the use of such system.
    ``(3) Paragraphs (1) and (2) shall not apply in the case of a State 
that, as of the date of the enactment of this subsection, requires the 
use of any system for the electronic verification of visits conducted 
as part of both personal care services and home health care services, 
so long as the State continues to require the use of such system with 
respect to the electronic verification of such visits.
    ``(4)(A) In the case of a State described in subparagraph (B), the 
reduction under paragraph (1) shall not apply--
        ``(i) in the case of personal care services, for calendar 
    quarters in 2019; and
        ``(ii) in the case of home health care services, for calendar 
    quarters in 2023.
    ``(B) For purposes of subparagraph (A), a State described in this 
subparagraph is a State that demonstrates to the Secretary that the 
State--
        ``(i) has made a good faith effort to comply with the 
    requirements of paragraphs (1) and (2) (including by taking steps 
    to adopt the technology used for an electronic visit verification 
    system); and
        ``(ii) in implementing such a system, has encountered 
    unavoidable system delays.
    ``(5) In this subsection:
        ``(A) The term `electronic visit verification system' means, 
    with respect to personal care services or home health care 
    services, a system under which visits conducted as part of such 
    services are electronically verified with respect to--
            ``(i) the type of service performed;
            ``(ii) the individual receiving the service;
            ``(iii) the date of the service;
            ``(iv) the location of service delivery;
            ``(v) the individual providing the service; and
            ``(vi) the time the service begins and ends.
        ``(B) The term `home health care services' means services 
    described in section 1905(a)(7) provided under a State plan under 
    this title (or under a waiver of the plan).
        ``(C) The term `personal care services' means personal care 
    services provided under a State plan under this title (or under a 
    waiver of the plan), including services provided under section 
    1905(a)(24), 1915(c), 1915(i), 1915(j), or 1915(k) or under a 
    wavier under section 1115.
    ``(6)(A) In the case in which a State requires personal care 
service and home health care service providers to utilize an electronic 
visit verification system operated by the State or a contractor on 
behalf of the State, the Secretary shall pay to the State, for each 
quarter, an amount equal to 90 per centum of so much of the sums 
expended during such quarter as are attributable to the design, 
development, or installation of such system, and 75 per centum of so 
much of the sums for the operation and maintenance of such system.
    ``(B) Subparagraph (A) shall not apply in the case in which a State 
requires personal care service and home health care service providers 
to utilize an electronic visit verification system that is not operated 
by the State or a contractor on behalf of the State.''.
    (b) Collection and Dissemination of Best Practices.--Not later than 
January 1, 2018, the Secretary of Health and Human Services shall, with 
respect to electronic visit verification systems (as defined in 
subsection (l)(5) of section 1903 of the Social Security Act (42 U.S.C. 
1396b), as inserted by subsection (a)), collect and disseminate best 
practices to State Medicaid Directors with respect to--
        (1) training individuals who furnish personal care services, 
    home health care services, or both under the State plan under title 
    XIX of such Act (or under a waiver of the plan) on such systems and 
    the operation of such systems and the prevention of fraud with 
    respect to the provision of personal care services or home health 
    care services (as defined in such subsection (l)(5)); and
        (2) the provision of notice and educational materials to family 
    caregivers and beneficiaries with respect to the use of such 
    electronic visit verification systems and other means to prevent 
    such fraud.
    (c) Rules of Construction.--
        (1) No employer-employee relationship established.--Nothing in 
    the amendment made by this section may be construed as establishing 
    an employer-employee relationship between the agency or entity that 
    provides for personal care services or home health care services 
    and the individuals who, under a contract with such an agency or 
    entity, furnish such services for purposes of part 552 of title 29, 
    Code of Federal Regulations (or any successor regulations).
        (2) No particular or uniform electronic visit verification 
    system required.--Nothing in the amendment made by this section 
    shall be construed to require the use of a particular or uniform 
    electronic visit verification system (as defined in subsection 
    (l)(5) of section 1903 of the Social Security Act (42 U.S.C. 
    1396b), as inserted by subsection (a)) by all agencies or entities 
    that provide personal care services or home health care under a 
    State plan under title XIX of the Social Security Act (or under a 
    waiver of the plan) (42 U.S.C. 1396 et seq.).
        (3) No limits on provision of care.--Nothing in the amendment 
    made by this section may be construed to limit, with respect to 
    personal care services or home health care services provided under 
    a State plan under title XIX of the Social Security Act (or under a 
    waiver of the plan) (42 U.S.C. 1396 et seq.), provider selection, 
    constrain beneficiaries' selection of a caregiver, or impede the 
    manner in which care is delivered.
        (4) No prohibition on state quality measures requirements.--
    Nothing in the amendment made by this section shall be construed as 
    prohibiting a State, in implementing an electronic visit 
    verification system (as defined in subsection (l)(5) of section 
    1903 of the Social Security Act (42 U.S.C. 1396b), as inserted by 
    subsection (a)), from establishing requirements related to quality 
    measures for such system.

                    TITLE XIII--MENTAL HEALTH PARITY

SEC. 13001. ENHANCED COMPLIANCE WITH MENTAL HEALTH AND SUBSTANCE USE 
DISORDER COVERAGE REQUIREMENTS.
    (a) Compliance Program Guidance Document.--Section 2726(a) of the 
Public Health Service Act (42 U.S.C. 300gg-26(a)) is amended by adding 
at the end the following:
        ``(6) Compliance program guidance document.--
            ``(A) In general.--Not later than 12 months after the date 
        of enactment of the Helping Families in Mental Health Crisis 
        Reform Act of 2016, the Secretary, the Secretary of Labor, and 
        the Secretary of the Treasury, in consultation with the 
        Inspector General of the Department of Health and Human 
        Services, the Inspector General of the Department of Labor, and 
        the Inspector General of the Department of the Treasury, shall 
        issue a compliance program guidance document to help improve 
        compliance with this section, section 712 of the Employee 
        Retirement Income Security Act of 1974, and section 9812 of the 
        Internal Revenue Code of 1986, as applicable. In carrying out 
        this paragraph, the Secretaries may take into consideration the 
        2016 publication of the Department of Health and Human Services 
        and the Department of Labor, entitled `Warning Signs - Plan or 
        Policy Non-Quantitative Treatment Limitations (NQTLs) that 
        Require Additional Analysis to Determine Mental Health Parity 
        Compliance'.
            ``(B) Examples illustrating compliance and noncompliance.--
                ``(i) In general.--The compliance program guidance 
            document required under this paragraph shall provide 
            illustrative, de-identified examples (that do not disclose 
            any protected health information or individually 
            identifiable information) of previous findings of 
            compliance and noncompliance with this section, section 712 
            of the Employee Retirement Income Security Act of 1974, or 
            section 9812 of the Internal Revenue Code of 1986, as 
            applicable, based on investigations of violations of such 
            sections, including--

                    ``(I) examples illustrating requirements for 
                information disclosures and nonquantitative treatment 
                limitations; and
                    ``(II) descriptions of the violations uncovered 
                during the course of such investigations.

                ``(ii) Nonquantitative treatment limitations.--To the 
            extent that any example described in clause (i) involves a 
            finding of compliance or noncompliance with regard to any 
            requirement for nonquantitative treatment limitations, the 
            example shall provide sufficient detail to fully explain 
            such finding, including a full description of the criteria 
            involved for approving medical and surgical benefits and 
            the criteria involved for approving mental health and 
            substance use disorder benefits.
                ``(iii) Access to additional information regarding 
            compliance.--In developing and issuing the compliance 
            program guidance document required under this paragraph, 
            the Secretaries specified in subparagraph (A)--

                    ``(I) shall enter into interagency agreements with 
                the Inspector General of the Department of Health and 
                Human Services, the Inspector General of the Department 
                of Labor, and the Inspector General of the Department 
                of the Treasury to share findings of compliance and 
                noncompliance with this section, section 712 of the 
                Employee Retirement Income Security Act of 1974, or 
                section 9812 of the Internal Revenue Code of 1986, as 
                applicable; and
                    ``(II) shall seek to enter into an agreement with a 
                State to share information on findings of compliance 
                and noncompliance with this section, section 712 of the 
                Employee Retirement Income Security Act of 1974, or 
                section 9812 of the Internal Revenue Code of 1986, as 
                applicable.

            ``(C) Recommendations.--The compliance program guidance 
        document shall include recommendations to advance compliance 
        with this section, section 712 of the Employee Retirement 
        Income Security Act of 1974, or section 9812 of the Internal 
        Revenue Code of 1986, as applicable, and encourage the 
        development and use of internal controls to monitor adherence 
        to applicable statutes, regulations, and program requirements. 
        Such internal controls may include illustrative examples of 
        nonquantitative treatment limitations on mental health and 
        substance use disorder benefits, which may fail to comply with 
        this section, section 712 of the Employee Retirement Income 
        Security Act of 1974, or section 9812 of the Internal Revenue 
        Code of 1986, as applicable, in relation to nonquantitative 
        treatment limitations on medical and surgical benefits.
            ``(D) Updating the compliance program guidance document.--
        The Secretary, the Secretary of Labor, and the Secretary of the 
        Treasury, in consultation with the Inspector General of the 
        Department of Health and Human Services, the Inspector General 
        of the Department of Labor, and the Inspector General of the 
        Department of the Treasury, shall update the compliance program 
        guidance document every 2 years to include illustrative, de-
        identified examples (that do not disclose any protected health 
        information or individually identifiable information) of 
        previous findings of compliance and noncompliance with this 
        section, section 712 of the Employee Retirement Income Security 
        Act of 1974, or section 9812 of the Internal Revenue Code of 
        1986, as applicable.''.
    (b) Additional Guidance.--Section 2726(a) of the Public Health 
Service Act (42 U.S.C. 300gg-26(a)), as amended by subsection (a), is 
further amended by adding at the end the following:
        ``(7) Additional guidance.--
            ``(A) In general.--Not later than 12 months after the date 
        of enactment of the Helping Families in Mental Health Crisis 
        Reform Act of 2016, the Secretary, the Secretary of Labor, and 
        the Secretary of the Treasury shall issue guidance to group 
        health plans and health insurance issuers offering group or 
        individual health insurance coverage to assist such plans and 
        issuers in satisfying the requirements of this section, section 
        712 of the Employee Retirement Income Security Act of 1974, or 
        section 9812 of the Internal Revenue Code of 1986, as 
        applicable.
            ``(B) Disclosure.--
                ``(i) Guidance for plans and issuers.--The guidance 
            issued under this paragraph shall include clarifying 
            information and illustrative examples of methods that group 
            health plans and health insurance issuers offering group or 
            individual health insurance coverage may use for disclosing 
            information to ensure compliance with the requirements 
            under this section, section 712 of the Employee Retirement 
            Income Security Act of 1974, or section 9812 of the 
            Internal Revenue Code of 1986, as applicable, (and any 
            regulations promulgated pursuant to such sections, as 
            applicable).
                ``(ii) Documents for participants, beneficiaries, 
            contracting providers, or authorized representatives.--The 
            guidance issued under this paragraph shall include 
            clarifying information and illustrative examples of methods 
            that group health plans and health insurance issuers 
            offering group or individual health insurance coverage may 
            use to provide any participant, beneficiary, contracting 
            provider, or authorized representative, as applicable, with 
            documents containing information that the health plans or 
            issuers are required to disclose to participants, 
            beneficiaries, contracting providers, or authorized 
            representatives to ensure compliance with this section, 
            section 712 of the Employee Retirement Income Security Act 
            of 1974, or section 9812 of the Internal Revenue Code of 
            1986, as applicable, compliance with any regulation issued 
            pursuant to such respective section, or compliance with any 
            other applicable law or regulation. Such guidance shall 
            include information that is comparative in nature with 
            respect to--

                    ``(I) nonquantitative treatment limitations for 
                both medical and surgical benefits and mental health 
                and substance use disorder benefits;
                    ``(II) the processes, strategies, evidentiary 
                standards, and other factors used to apply the 
                limitations described in subclause (I); and
                    ``(III) the application of the limitations 
                described in subclause (I) to ensure that such 
                limitations are applied in parity with respect to both 
                medical and surgical benefits and mental health and 
                substance use disorder benefits.

            ``(C) Nonquantitative treatment limitations.--The guidance 
        issued under this paragraph shall include clarifying 
        information and illustrative examples of methods, processes, 
        strategies, evidentiary standards, and other factors that group 
        health plans and health insurance issuers offering group or 
        individual health insurance coverage may use regarding the 
        development and application of nonquantitative treatment 
        limitations to ensure compliance with this section, section 712 
        of the Employee Retirement Income Security Act of 1974, or 
        section 9812 of the Internal Revenue Code of 1986, as 
        applicable, (and any regulations promulgated pursuant to such 
        respective section), including--
                ``(i) examples of methods of determining appropriate 
            types of nonquantitative treatment limitations with respect 
            to both medical and surgical benefits and mental health and 
            substance use disorder benefits, including nonquantitative 
            treatment limitations pertaining to--

                    ``(I) medical management standards based on medical 
                necessity or appropriateness, or whether a treatment is 
                experimental or investigative;
                    ``(II) limitations with respect to prescription 
                drug formulary design; and
                    ``(III) use of fail-first or step therapy 
                protocols;

                ``(ii) examples of methods of determining--

                    ``(I) network admission standards (such as 
                credentialing); and
                    ``(II) factors used in provider reimbursement 
                methodologies (such as service type, geographic market, 
                demand for services, and provider supply, practice 
                size, training, experience, and licensure) as such 
                factors apply to network adequacy;

                ``(iii) examples of sources of information that may 
            serve as evidentiary standards for the purposes of making 
            determinations regarding the development and application of 
            nonquantitative treatment limitations;
                ``(iv) examples of specific factors, and the 
            evidentiary standards used to evaluate such factors, used 
            by such plans or issuers in performing a nonquantitative 
            treatment limitation analysis;
                ``(v) examples of how specific evidentiary standards 
            may be used to determine whether treatments are considered 
            experimental or investigative;
                ``(vi) examples of how specific evidentiary standards 
            may be applied to each service category or classification 
            of benefits;
                ``(vii) examples of methods of reaching appropriate 
            coverage determinations for new mental health or substance 
            use disorder treatments, such as evidence-based early 
            intervention programs for individuals with a serious mental 
            illness and types of medical management techniques;
                ``(viii) examples of methods of reaching appropriate 
            coverage determinations for which there is an indirect 
            relationship between the covered mental health or substance 
            use disorder benefit and a traditional covered medical and 
            surgical benefit, such as residential treatment or 
            hospitalizations involving voluntary or involuntary 
            commitment; and
                ``(ix) additional illustrative examples of methods, 
            processes, strategies, evidentiary standards, and other 
            factors for which the Secretary determines that additional 
            guidance is necessary to improve compliance with this 
            section, section 712 of the Employee Retirement Income 
            Security Act of 1974, or section 9812 of the Internal 
            Revenue Code of 1986, as applicable.
            ``(D) Public comment.--Prior to issuing any final guidance 
        under this paragraph, the Secretary shall provide a public 
        comment period of not less than 60 days during which any member 
        of the public may provide comments on a draft of the 
        guidance.''.
    (c) Availability of Plan Information.--
        (1) Solicitation of public feedback.--Not later than 6 months 
    after the date of enactment of this Act, the Secretary of Health 
    and Human Services, the Secretary of Labor, and the Secretary of 
    the Treasury shall solicit feedback from the public on how the 
    disclosure request process for documents containing information 
    that health plans or health insurance issuers are required under 
    Federal or State law to disclose to participants, beneficiaries, 
    contracting providers, or authorized representatives to ensure 
    compliance with existing mental health parity and addiction equity 
    requirements can be improved while continuing to ensure consumers' 
    rights to access all information required by Federal or State law 
    to be disclosed.
        (2) Public availability.--Not later than 12 months after the 
    date of the enactment of this Act, the Secretary of Health and 
    Human Services, the Secretary of Labor, and the Secretary of the 
    Treasury shall make such feedback publicly available.
        (3) NAIC.--The Secretary of Health and Human Services, the 
    Secretary of Labor, and the Secretary of the Treasury shall share 
    feedback obtained pursuant to paragraph (1) directly with the 
    National Association of Insurance Commissioners to the extent such 
    feedback includes recommendations for the development of simplified 
    information disclosure tools to provide consistent information for 
    consumers. Such feedback may be taken into consideration by the 
    National Association of Insurance Commissioners and other 
    appropriate entities for the voluntary development and voluntary 
    use of common templates and other sample standardized forms to 
    improve consumer access to plan information.
    (d) Improving Compliance.--
        (1) In general.--In the case that the Secretary of Health and 
    Human Services, the Secretary of Labor, or the Secretary of the 
    Treasury determines that a group health plan or health insurance 
    issuer offering group or individual health insurance coverage has 
    violated, at least 5 times, section 2726 of the Public Health 
    Service Act (42 U.S.C. 300gg-26), section 712 of the Employee 
    Retirement Income Security Act of 1974 (29 U.S.C. 1185a), or 
    section 9812 of the Internal Revenue Code of 1986, respectively, 
    the appropriate Secretary shall audit plan documents for such 
    health plan or issuer in the plan year following the Secretary's 
    determination in order to help improve compliance with such 
    section.
        (2) Rule of construction.--Nothing in this subsection shall be 
    construed to limit the authority, as in effect on the day before 
    the date of enactment of this Act, of the Secretary of Health and 
    Human Services, the Secretary of Labor, or the Secretary of the 
    Treasury to audit documents of health plans or health insurance 
    issuers.
SEC. 13002. ACTION PLAN FOR ENHANCED ENFORCEMENT OF MENTAL HEALTH AND 
SUBSTANCE USE DISORDER COVERAGE.
    (a) Public Meeting.--
        (1) In general.--Not later than 6 months after the date of 
    enactment of this Act, the Secretary of Health and Human Services 
    shall convene a public meeting of stakeholders described in 
    paragraph (2) to produce an action plan for improved Federal and 
    State coordination related to the enforcement of section 2726 of 
    the Public Health Service Act (42 U.S.C. 300gg-26), section 712 of 
    the Employee Retirement Income Security Act of 1974 (29 U.S.C. 
    1185a), and section 9812 of the Internal Revenue Code of 1986, and 
    any comparable provisions of State law (in this section such 
    sections and provisions are collectively referred to as ``mental 
    health parity and addiction equity requirements'').
        (2) Stakeholders.--The stakeholders described in this paragraph 
    shall include each of the following:
            (A) The Federal Government, including representatives 
        from--
                (i) the Department of Health and Human Services;
                (ii) the Department of the Treasury;
                (iii) the Department of Labor; and
                (iv) the Department of Justice.
            (B) State governments, including--
                (i) State health insurance commissioners;
                (ii) appropriate State agencies, including agencies on 
            public health or mental health; and
                (iii) State attorneys general or other representatives 
            of State entities involved in the enforcement of mental 
            health parity and addiction equity requirements.
            (C) Representatives from key stakeholder groups, 
        including--
                (i) the National Association of Insurance 
            Commissioners;
                (ii) health insurance issuers;
                (iii) providers of mental health and substance use 
            disorder treatment;
                (iv) employers; and
                (v) patients or their advocates.
    (b) Action Plan.--Not later than 6 months after the conclusion of 
the public meeting under subsection (a), the Secretary of Health and 
Human Services shall finalize the action plan described in such 
subsection and make it plainly available on the Internet website of the 
Department of Health and Human Services.
    (c) Content.--The action plan under this section shall--
        (1) take into consideration the recommendations of the Mental 
    Health and Substance Use Disorder Parity Task Force in its final 
    report issued in October of 2016, and any subsequent Federal and 
    State actions in relation to such recommendations;
        (2) reflect the input of the stakeholders participating in the 
    public meeting under subsection (a);
        (3) identify specific strategic objectives regarding how the 
    various Federal and State agencies charged with enforcement of 
    mental health parity and addiction equity requirements will 
    collaborate to improve enforcement of such requirements;
        (4) provide a timeline for implementing the action plan; and
        (5) provide specific examples of how such objectives may be 
    met, which may include--
            (A) providing common educational information and documents, 
        such as the Consumer Guide to Disclosure Rights, to patients 
        about their rights under mental health parity and addiction 
        equity requirements;
            (B) facilitating the centralized collection of, monitoring 
        of, and response to patient complaints or inquiries relating to 
        mental health parity and addiction equity requirements, which 
        may be through the development and administration of--
                (i) a single, toll-free telephone number; and
                (ii) a new parity website--

                    (I) to help consumers find the appropriate Federal 
                or State agency to assist with their parity complaints, 
                appeals, and other actions; and
                    (II) that takes into consideration, but is not 
                duplicative of, the parity beta site being tested, and 
                released for public comment, by the Department of 
                Health and Human Services as of the date of the 
                enactment of this Act;

            (C) Federal and State law enforcement agencies entering 
        into memoranda of understanding to better coordinate 
        enforcement responsibilities and information sharing--
                (i) including whether such agencies should make the 
            results of enforcement actions related to mental health 
            parity and addiction equity requirements publicly 
            available; and
                (ii) which may include State Policy Academies on Parity 
            Implementation for State Officials and other forums to 
            bring together national experts to provide technical 
            assistance to teams of State officials on strategies to 
            advance compliance with mental health parity and addiction 
            equity requirements in both the commercial market, and in 
            the Medicaid program under title XIX of the Social Security 
            Act and the State Children's Health Insurance Program under 
            title XXI of such Act; and
            (D) recommendations to the Congress regarding the need for 
        additional legal authority to improve enforcement of mental 
        health parity and addiction equity requirements, including the 
        need for additional legal authority to ensure that 
        nonquantitative treatment limitations are applied, and the 
        extent and frequency of the applications of such limitations, 
        both to medical and surgical benefits and to mental health and 
        substance use disorder benefits in a comparable manner.
SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PARITY IN MENTAL HEALTH 
AND SUBSTANCE USE DISORDER BENEFITS.
    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, and annually thereafter for the subsequent 5 years, the 
Assistant Secretary of Labor of the Employee Benefits Security 
Administration, in collaboration with the Administrator of the Centers 
for Medicare & Medicaid Services and the Secretary of the Treasury, 
shall submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report summarizing the results of all closed 
Federal investigations completed during the preceding 12-month period 
with findings of any serious violation regarding compliance with mental 
health and substance use disorder coverage requirements under section 
2726 of the Public Health Service Act (42 U.S.C. 300gg-26), section 712 
of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 
1185a), and section 9812 of the Internal Revenue Code of 1986.
    (b) Contents.--Subject to subsection (c), a report under subsection 
(a) shall, with respect to investigations described in such subsection, 
include each of the following:
        (1) The number of closed Federal investigations conducted 
    during the covered reporting period.
        (2) Each benefit classification examined by any such 
    investigation conducted during the covered reporting period.
        (3) Each subject matter, including compliance with requirements 
    for quantitative and nonquantitative treatment limitations, of any 
    such investigation conducted during the covered reporting period.
        (4) A summary of the basis of the final decision rendered for 
    each closed investigation conducted during the covered reporting 
    period that resulted in a finding of a serious violation.
    (c) Limitation.--Any individually identifiable information shall be 
excluded from reports under subsection (a) consistent with protections 
under the health privacy and security rules promulgated under section 
264(c) of the Health Insurance Portability and Accountability Act of 
1996 (42 U.S.C. 1320d-2 note).
SEC. 13004. GAO STUDY ON PARITY IN MENTAL HEALTH AND SUBSTANCE USE 
DISORDER BENEFITS.
    Not later than 3 years after the date of enactment of this Act, the 
Comptroller General of the United States, in consultation with the 
Secretary of Health and Human Services, the Secretary of Labor, and the 
Secretary of the Treasury, shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report detailing the 
extent to which group health plans or health insurance issuers offering 
group or individual health insurance coverage that provides both 
medical and surgical benefits and mental health or substance use 
disorder benefits, medicaid managed care organizations with a contract 
under section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), 
and health plans provided under the State Children's Health Insurance 
Program under title XXI of the Social Security Act (42 U.S.C. 1397aa et 
seq.) comply with section 2726 of the Public Health Service Act (42 
U.S.C. 300gg-26), section 712 of the Employee Retirement Income 
Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of the 
Internal Revenue Code of 1986, including--
        (1) how nonquantitative treatment limitations, including 
    medical necessity criteria, of such plans or issuers comply with 
    such sections;
        (2) how the responsible Federal departments and agencies ensure 
    that such plans or issuers comply with such sections, including an 
    assessment of how the Secretary of Health and Human Services has 
    used its authority to conduct audits of such plans to ensure 
    compliance;
        (3) a review of how the various Federal and State agencies 
    responsible for enforcing mental health parity requirements have 
    improved enforcement of such requirements in accordance with the 
    objectives and timeline described in the action plan under section 
    13002; and
        (4) recommendations for how additional enforcement, education, 
    and coordination activities by responsible Federal and State 
    departments and agencies could better ensure compliance with such 
    sections, including recommendations regarding the need for 
    additional legal authority.
SEC. 13005. INFORMATION AND AWARENESS ON EATING DISORDERS.
    (a) Information.--The Secretary of Health and Human Services, 
acting through the Director of the Office on Women's Health, may--
        (1) update information, related fact sheets, and resource lists 
    related to eating disorders that are available on the public 
    Internet website of the National Women's Health Information Center 
    sponsored by the Office on Women's Health, to include--
            (A) updated findings and current research related to eating 
        disorders, as appropriate; and
            (B) information about eating disorders, including 
        information related to males and females;
        (2) incorporate, as appropriate, and in coordination with the 
    Secretary of Education, information from publicly available 
    resources into appropriate obesity prevention programs developed by 
    the Office on Women's Health; and
        (3) make publicly available (through a public Internet website 
    or other method) information, related fact sheets, and resource 
    lists, as updated under paragraph (1), and the information 
    incorporated into appropriate obesity prevention programs under 
    paragraph (2).
    (b) Awareness.--The Secretary of Health and Human Services may 
advance public awareness on--
        (1) the types of eating disorders;
        (2) the seriousness of eating disorders, including prevalence, 
    comorbidities, and physical and mental health consequences;
        (3) methods to identify, intervene, refer for treatment, and 
    prevent behaviors that may lead to the development of eating 
    disorders;
        (4) discrimination and bullying based on body size;
        (5) the effects of media on self-esteem and body image; and
        (6) the signs and symptoms of eating disorders.
SEC. 13006. EDUCATION AND TRAINING ON EATING DISORDERS.
    The Secretary of Health and Human Services may facilitate the 
identification of model programs and materials for educating and 
training health professionals in effective strategies to--
        (1) identify individuals with eating disorders;
        (2) provide early intervention services for individuals with 
    eating disorders;
        (3) refer patients with eating disorders for appropriate 
    treatment;
        (4) prevent the development of eating disorders; and
        (5) provide appropriate treatment services for individuals with 
    eating disorders.
SEC. 13007. CLARIFICATION OF EXISTING PARITY RULES.
    If a group health plan or a health insurance issuer offering group 
or individual health insurance coverage provides coverage for eating 
disorder benefits, including residential treatment, such group health 
plan or health insurance issuer shall provide such benefits consistent 
with the requirements of section 2726 of the Public Health Service Act 
(42 U.S.C. 300gg-26), section 712 of the Employee Retirement Income 
Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of the 
Internal Revenue Code of 1986.

             TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES
             Subtitle A--Mental Health and Safe Communities

SEC. 14001. LAW ENFORCEMENT GRANTS FOR CRISIS INTERVENTION TEAMS, 
MENTAL HEALTH PURPOSES.
    (a) Edward Byrne Memorial Justice Assistance Grant Program.--
Section 501(a)(1) of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3751(a)(1)) is amended by adding at the 
end the following:
            ``(H) Mental health programs and related law enforcement 
        and corrections programs, including behavioral programs and 
        crisis intervention teams.''.
    (b) Community Oriented Policing Services Program.--Section 1701(b) 
of title I of the Omnibus Crime Control and Safe Streets Act of 1968 
(42 U.S.C. 3796dd(b)) is amended--
        (1) in paragraph (17), by striking ``and'' at the end;
        (2) by redesignating paragraph (18) as paragraph (22);
        (3) by inserting after paragraph (17) the following:
        ``(18) to provide specialized training to law enforcement 
    officers to--
            ``(A) recognize individuals who have a mental illness; and
            ``(B) properly interact with individuals who have a mental 
        illness, including strategies for verbal de-escalation of 
        crises;
        ``(19) to establish collaborative programs that enhance the 
    ability of law enforcement agencies to address the mental health, 
    behavioral, and substance abuse problems of individuals encountered 
    by law enforcement officers in the line of duty;
        ``(20) to provide specialized training to corrections officers 
    to recognize individuals who have a mental illness;
        ``(21) to enhance the ability of corrections officers to 
    address the mental health of individuals under the care and custody 
    of jails and prisons, including specialized training and strategies 
    for verbal de-escalation of crises; and''; and
        (4) in paragraph (22), as redesignated, by striking ``through 
    (17)'' and inserting ``through (21)''.
    (c) Modifications to the Staffing for Adequate Fire and Emergency 
Response Grants.--Section 34(a)(1)(B) of the Federal Fire Prevention 
and Control Act of 1974 (15 U.S.C. 2229a(a)(1)(B)) is amended by 
inserting before the period at the end the following: ``and to provide 
specialized training to paramedics, emergency medical services workers, 
and other first responders to recognize individuals who have mental 
illness and how to properly intervene with individuals with mental 
illness, including strategies for verbal de-escalation of crises''.
SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS.
    (a) In General.--Section 2201 of title I of the Omnibus Crime 
Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) is amended in 
paragraph (2)(B), by inserting before the semicolon the following: ``, 
or court-ordered assisted outpatient treatment when the court has 
determined such treatment to be necessary''.
    (b) Definitions.--Section 2202 of title I of the Omnibus Crime 
Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii--1) is amended--
        (1) in paragraph (1), by striking ``and'' at the end;
        (2) in paragraph (2), by striking the period at the end and 
    inserting a semicolon; and
        (3) by adding at the end the following:
        ``(3) the term `court-ordered assisted outpatient treatment' 
    means a program through which a court may order a treatment plan 
    for an eligible patient that--
            ``(A) requires such patient to obtain outpatient mental 
        health treatment while the patient is not currently residing in 
        a correctional facility or inpatient treatment facility; and
            ``(B) is designed to improve access and adherence by such 
        patient to intensive behavioral health services in order to--
                ``(i) avert relapse, repeated hospitalizations, arrest, 
            incarceration, suicide, property destruction, and violent 
            behavior; and
                ``(ii) provide such patient with the opportunity to 
            live in a less restrictive alternative to incarceration or 
            involuntary hospitalization; and
        ``(4) the term `eligible patient' means an adult, mentally ill 
    person who, as determined by a court--
            ``(A) has a history of violence, incarceration, or 
        medically unnecessary hospitalizations;
            ``(B) without supervision and treatment, may be a danger to 
        self or others in the community;
            ``(C) is substantially unlikely to voluntarily participate 
        in treatment;
            ``(D) may be unable, for reasons other than indigence, to 
        provide for any of his or her basic needs, such as food, 
        clothing, shelter, health, or safety;
            ``(E) has a history of mental illness or a condition that 
        is likely to substantially deteriorate if the person is not 
        provided with timely treatment; or
            ``(F) due to mental illness, lacks capacity to fully 
        understand or lacks judgment to make informed decisions 
        regarding his or her need for treatment, care, or 
        supervision.''.
SEC. 14003. FEDERAL DRUG AND MENTAL HEALTH COURTS.
    (a) Definitions.--In this section--
        (1) the term ``eligible offender'' means a person who--
            (A)(i) previously or currently has been diagnosed by a 
        qualified mental health professional as having a mental 
        illness, mental retardation, or co-occurring mental illness and 
        substance abuse disorders; or
            (ii) manifests obvious signs of mental illness, mental 
        retardation, or co-occurring mental illness and substance abuse 
        disorders during arrest or confinement or before any court;
            (B) comes into contact with the criminal justice system or 
        is arrested or charged with an offense that is not--
                (i) a crime of violence, as defined under applicable 
            State law or in section 3156 of title 18, United States 
            Code; or
                (ii) a serious drug offense, as defined in section 
            924(e)(2)(A) of title 18, United States Code; and
            (C) is determined by a judge to be eligible; and
        (2) the term ``mental illness'' means a diagnosable mental, 
    behavioral, or emotional disorder--
            (A) of sufficient duration to meet diagnostic criteria 
        within the most recent edition of the Diagnostic and 
        Statistical Manual of Mental Disorders published by the 
        American Psychiatric Association; and
            (B) that has resulted in functional impairment that 
        substantially interferes with or limits 1 or more major life 
        activities.
    (b) Establishment of Program.--Not later than 1 year after the date 
of enactment of this Act, the Attorney General shall establish a pilot 
program to determine the effectiveness of diverting eligible offenders 
from Federal prosecution, Federal probation, or a Bureau of Prisons 
facility, and placing such eligible offenders in drug or mental health 
courts.
    (c) Program Specifications.--The pilot program established under 
subsection (b) shall involve--
        (1) continuing judicial supervision, including periodic review, 
    of program participants who have a substance abuse problem or 
    mental illness; and
        (2) the integrated administration of services and sanctions, 
    which shall include--
            (A) mandatory periodic testing, as appropriate, for the use 
        of controlled substances or other addictive substances during 
        any period of supervised release or probation for each program 
        participant;
            (B) substance abuse treatment for each program participant 
        who requires such services;
            (C) diversion, probation, or other supervised release with 
        the possibility of prosecution, confinement, or incarceration 
        based on noncompliance with program requirements or failure to 
        show satisfactory progress toward completing program 
        requirements;
            (D) programmatic offender management, including case 
        management, and aftercare services, such as relapse prevention, 
        health care, education, vocational training, job placement, 
        housing placement, and child care or other family support 
        services for each program participant who requires such 
        services;
            (E) outpatient or inpatient mental health treatment, as 
        ordered by the court, that carries with it the possibility of 
        dismissal of charges or reduced sentencing upon successful 
        completion of such treatment;
            (F) centralized case management, including--
                (i) the consolidation of all cases, including 
            violations of probations, of the program participant; and
                (ii) coordination of all mental health treatment plans 
            and social services, including life skills and vocational 
            training, housing and job placement, education, health 
            care, and relapse prevention for each program participant 
            who requires such services; and
            (G) continuing supervision of treatment plan compliance by 
        the program participant for a term not to exceed the maximum 
        allowable sentence or probation period for the charged or 
        relevant offense and, to the extent practicable, continuity of 
        psychiatric care at the end of the supervised period.
    (d) Implementation; Duration.--The pilot program established under 
subsection (b) shall be conducted--
        (1) in not less than 1 United States judicial district, 
    designated by the Attorney General in consultation with the 
    Director of the Administrative Office of the United States Courts, 
    as appropriate for the pilot program; and
        (2) during fiscal year 2017 through fiscal year 2021.
    (e) Criteria for Designation.--Before making a designation under 
subsection (d)(1), the Attorney General shall--
        (1) obtain the approval, in writing, of the United States 
    Attorney for the United States judicial district being designated;
        (2) obtain the approval, in writing, of the chief judge for the 
    United States judicial district being designated; and
        (3) determine that the United States judicial district being 
    designated has adequate behavioral health systems for treatment, 
    including substance abuse and mental health treatment.
    (f) Assistance From Other Federal Entities.--The Administrative 
Office of the United States Courts and the United States Probation 
Offices shall provide such assistance and carry out such functions as 
the Attorney General may request in monitoring, supervising, providing 
services to, and evaluating eligible offenders placed in a drug or 
mental health court under this section.
    (g) Reports.--The Attorney General, in consultation with the 
Director of the Administrative Office of the United States Courts, 
shall monitor the drug and mental health courts under this section, and 
shall submit a report to Congress on the outcomes of the program at the 
end of the period described in subsection (d)(2).
SEC. 14004. MENTAL HEALTH IN THE JUDICIAL SYSTEM.
    Part V of title I of the Omnibus Crime Control and Safe Streets Act 
of 1968 (42 U.S.C. 3796ii et seq.) is amended by inserting at the end 
the following:
``SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL SYSTEM.
    ``(a) Pretrial Screening and Supervision.--
        ``(1) In general.--The Attorney General may award grants to 
    States, units of local government, territories, Indian Tribes, 
    nonprofit agencies, or any combination thereof, to develop, 
    implement, or expand pretrial services programs to improve the 
    identification and outcomes of individuals with mental illness.
        ``(2) Allowable uses.--Grants awarded under this subsection may 
    be may be used for--
            ``(A) behavioral health needs and risk screening of 
        defendants, including verification of interview information, 
        mental health evaluation, and criminal history screening;
            ``(B) assessment of risk of pretrial misconduct through 
        objective, statistically validated means, and presentation to 
        the court of recommendations based on such assessment, 
        including services that will reduce the risk of pre-trial 
        misconduct;
            ``(C) followup review of defendants unable to meet the 
        conditions of pretrial release;
            ``(D) evaluation of process and results of pre-trial 
        service programs;
            ``(E) supervision of defendants who are on pretrial 
        release, including reminders to defendants of scheduled court 
        dates;
            ``(F) reporting on process and results of pretrial services 
        programs to relevant public and private mental health 
        stakeholders; and
            ``(G) data collection and analysis necessary to make 
        available information required for assessment of risk.
    ``(b) Behavioral Health Assessments and Intervention.--
        ``(1) In general.--The Attorney General may award grants to 
    States, units of local government, territories, Indian Tribes, 
    nonprofit agencies, or any combination thereof, to develop, 
    implement, or expand a behavioral health screening and assessment 
    program framework for State or local criminal justice systems.
        ``(2) Allowable uses.--Grants awarded under this subsection may 
    be used for--
            ``(A) promotion of the use of validated assessment tools to 
        gauge the criminogenic risk, substance abuse needs, and mental 
        health needs of individuals;
            ``(B) initiatives to match the risk factors and needs of 
        individuals to programs and practices associated with research-
        based, positive outcomes;
            ``(C) implementing methods for identifying and treating 
        individuals who are most likely to benefit from coordinated 
        supervision and treatment strategies, and identifying 
        individuals who can do well with fewer interventions; and
            ``(D) collaborative decision-making among the heads of 
        criminal justice agencies, mental health systems, judicial 
        systems, substance abuse systems, and other relevant systems or 
        agencies for determining how treatment and intensive 
        supervision services should be allocated in order to maximize 
        benefits, and developing and utilizing capacity accordingly.
    ``(c) Use of Grant Funds.--A State, unit of local government, 
territory, Indian Tribe, or nonprofit agency that receives a grant 
under this section shall, in accordance with subsection (b)(2), use 
grant funds for the expenses of a treatment program, including--
        ``(1) salaries, personnel costs, equipment costs, and other 
    costs directly related to the operation of the program, including 
    costs relating to enforcement;
        ``(2) payments for treatment providers that are approved by the 
    State or Indian Tribe and licensed, if necessary, to provide needed 
    treatment to program participants, including aftercare supervision, 
    vocational training, education, and job placement; and
        ``(3) payments to public and nonprofit private entities that 
    are approved by the State or Indian Tribe and licensed, if 
    necessary, to provide alcohol and drug addiction treatment to 
    offenders participating in the program.
    ``(d) Supplement of Non-Federal Funds.--
        ``(1) In general.--Grants awarded under this section shall be 
    used to supplement, and not supplant, non-Federal funds that would 
    otherwise be available for programs described in this section.
        ``(2) Federal share.--The Federal share of a grant made under 
    this section may not exceed 50 percent of the total costs of the 
    program described in an application under subsection (e).
    ``(e) Applications.--To request a grant under this section, a 
State, unit of local government, territory, Indian Tribe, or nonprofit 
agency shall submit an application to the Attorney General in such form 
and containing such information as the Attorney General may reasonably 
require.
    ``(f) Geographic Distribution.--The Attorney General shall ensure 
that, to the extent practicable, the distribution of grants under this 
section is equitable and includes--
        ``(1) each State; and
        ``(2) a unit of local government, territory, Indian Tribe, or 
    nonprofit agency--
            ``(A) in each State; and
            ``(B) in rural, suburban, Tribal, and urban jurisdictions.
    ``(g) Reports and Evaluations.--For each fiscal year, each grantee 
under this section during that fiscal year shall submit to the Attorney 
General a report on the effectiveness of activities carried out using 
such grant. Each report shall include an evaluation in such form and 
containing such information as the Attorney General may reasonably 
require. The Attorney General shall specify the dates on which such 
reports shall be submitted.
    ``(h) Accountability.--Grants awarded under this section shall be 
subject to the following accountability provisions:
        ``(1) Audit requirement.--
            ``(A) Definition.--In this paragraph, the term `unresolved 
        audit finding' means a finding in the final audit report of the 
        Inspector General of the Department of Justice under 
        subparagraph (C) that the audited grantee has used grant funds 
        for an unauthorized expenditure or otherwise unallowable cost 
        that is not closed or resolved within 1 year after the date on 
        which final audit report is issued.
            ``(B) Audits.--Beginning in the first fiscal year beginning 
        after the date of enactment of this section, and in each fiscal 
        year thereafter, the Inspector General of the Department of 
        Justice shall conduct audits of grantees under this section to 
        prevent waste, fraud, and abuse of funds by grantees. The 
        Inspector General shall determine the appropriate number of 
        grantees to be audited each year.
            ``(C) Final audit report.--The Inspector General of the 
        Department of Justice shall submit to the Attorney General a 
        final report on each audit conducted under subparagraph (B).
            ``(D) Mandatory exclusion.--Grantees under this section 
        about which there is an unresolved audit finding shall not be 
        eligible to receive a grant under this section during the 2 
        fiscal years beginning after the end of the 1-year period 
        described in subparagraph (A).
            ``(E) Priority.--In making grants under this section, the 
        Attorney General shall give priority to applicants that did not 
        have an unresolved audit finding during the 3 fiscal years 
        before submitting an application for a grant under this 
        section.
            ``(F) Reimbursement.--If an entity receives a grant under 
        this section during the 2-fiscal-year period during which the 
        entity is prohibited from receiving grants under subparagraph 
        (D), the Attorney General shall--
                ``(i) deposit an amount equal to the amount of the 
            grant that was improperly awarded to the grantee into the 
            General Fund of the Treasury; and
                ``(ii) seek to recoup the costs of the repayment under 
            clause (i) from the grantee that was erroneously awarded 
            grant funds.
        ``(2) Nonprofit agency requirements.--
            ``(A) Definition.--For purposes of this paragraph and the 
        grant program under this section, the term `nonprofit agency' 
        means an organization that is described in section 501(c)(3) of 
        the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3)) and is 
        exempt from taxation under section 501(a) of the Internal 
        Revenue Code of 1986 (26 U.S.C. 501(a)).
            ``(B) Prohibition.--The Attorney General may not award a 
        grant under this section to a nonprofit agency that holds money 
        in an offshore account for the purpose of avoiding paying the 
        tax described in section 511(a) of the Internal Revenue Code of 
        1986 (26 U.S.C. 511(a)).
            ``(C) Disclosure.--Each nonprofit agency that is awarded a 
        grant under this section and uses the procedures prescribed in 
        regulations to create a rebuttable presumption of 
        reasonableness for the compensation of its officers, directors, 
        trustees, and key employees, shall disclose to the Attorney 
        General, in the application for the grant, the process for 
        determining such compensation, including the independent 
        persons involved in reviewing and approving such compensation, 
        the comparability data used, and contemporaneous substantiation 
        of the deliberation and decision. Upon request, the Attorney 
        General shall make the information disclosed under this 
        subparagraph available for public inspection.
        ``(3) Conference expenditures.--
            ``(A) Limitation.--Not more than $20,000 of the amounts 
        made available to the Department of Justice to carry out this 
        section may be used by the Attorney General, or by any 
        individual or entity awarded a grant under this section to 
        host, or make any expenditures relating to, a conference unless 
        the Deputy Attorney General provides prior written 
        authorization that the funds may be expended to host the 
        conference or make such expenditure.
            ``(B) Written approval.--Written approval under 
        subparagraph (A) shall include a written estimate of all costs 
        associated with the conference, including the cost of all food, 
        beverages, audio-visual equipment, honoraria for speakers, and 
        entertainment.
            ``(C) Report.--The Deputy Attorney General shall submit an 
        annual report to the Committee on the Judiciary of the Senate 
        and the Committee on the Judiciary of the House of 
        Representatives on all conference expenditures approved under 
        this paragraph.
        ``(4) Annual certification.--Beginning in the first fiscal year 
    beginning after the date of enactment of this subsection, the 
    Attorney General shall submit to the Committee on the Judiciary and 
    the Committee on Appropriations of the Senate and the Committee on 
    the Judiciary and the Committee on Appropriations of the House of 
    Representatives an annual certification--
            ``(A) indicating whether--
                ``(i) all final audit reports issued by the Office of 
            the Inspector General under paragraph (1) have been 
            completed and reviewed by the appropriate Assistant 
            Attorney General or Director;
                ``(ii) all mandatory exclusions required under 
            paragraph (1)(D) have been issued; and
                ``(iii) any reimbursements required under paragraph 
            (1)(F) have been made; and
            ``(B) that includes a list of any grantees excluded under 
        paragraph (1)(D) from the previous year.
    ``(i) Preventing Duplicative Grants.--
        ``(1) In general.--Before the Attorney General awards a grant 
    to an applicant under this section, the Attorney General shall 
    compare the possible grant with any other grants awarded to the 
    applicant under this Act to determine whether the grants are for 
    the same purpose.
        ``(2) Report.--If the Attorney General awards multiple grants 
    to the same applicant for the same purpose, the Attorney General 
    shall submit to the Committee on the Judiciary of the Senate and 
    the Committee on the Judiciary of the House of Representatives a 
    report that includes--
            ``(A) a list of all duplicate grants awarded, including the 
        total dollar amount of any such grants awarded; and
            ``(B) the reason the Attorney General awarded the duplicate 
        grants.''.
SEC. 14005. FORENSIC ASSERTIVE COMMUNITY TREATMENT INITIATIVES.
    Section 2991 of the Omnibus Crime Control and Safe Streets Act of 
1968 (42 U.S.C. 3797aa) is amended by--
        (1) redesignating subsection (j) as subsection (o); and
        (2) inserting after subsection (i) the following:
    ``(j) Forensic Assertive Community Treatment (FACT) Initiative 
Program.--
        ``(1) In general.--The Attorney General may make grants to 
    States, units of local government, territories, Indian Tribes, 
    nonprofit agencies, or any combination thereof, to develop, 
    implement, or expand Assertive Community Treatment initiatives to 
    develop forensic assertive community treatment (referred to in this 
    subsection as `FACT') programs that provide high intensity services 
    in the community for individuals with mental illness with 
    involvement in the criminal justice system to prevent future 
    incarcerations.
        ``(2) Allowable uses.--Grant funds awarded under this 
    subsection may be used for--
            ``(A) multidisciplinary team initiatives for individuals 
        with mental illnesses with criminal justice involvement that 
        address criminal justice involvement as part of treatment 
        protocols;
            ``(B) FACT programs that involve mental health 
        professionals, criminal justice agencies, chemical dependency 
        specialists, nurses, psychiatrists, vocational specialists, 
        forensic peer specialists, forensic specialists, and dedicated 
        administrative support staff who work together to provide 
        recovery oriented, 24/7 wraparound services;
            ``(C) services such as integrated evidence-based practices 
        for the treatment of co-occurring mental health and substance-
        related disorders, assertive outreach and engagement, 
        community-based service provision at participants' residence or 
        in the community, psychiatric rehabilitation, recovery oriented 
        services, services to address criminogenic risk factors, and 
        community tenure;
            ``(D) payments for treatment providers that are approved by 
        the State or Indian Tribe and licensed, if necessary, to 
        provide needed treatment to eligible offenders participating in 
        the program, including behavioral health services and aftercare 
        supervision; and
            ``(E) training for all FACT teams to promote high-fidelity 
        practice principles and technical assistance to support 
        effective and continuing integration with criminal justice 
        agency partners.
        ``(3) Supplement and not supplant.--Grants made under this 
    subsection shall be used to supplement, and not supplant, non-
    Federal funds that would otherwise be available for programs 
    described in this subsection.
        ``(4) Applications.--To request a grant under this subsection, 
    a State, unit of local government, territory, Indian Tribe, or 
    nonprofit agency shall submit an application to the Attorney 
    General in such form and containing such information as the 
    Attorney General may reasonably require.''.
SEC. 14006. ASSISTANCE FOR INDIVIDUALS TRANSITIONING OUT OF SYSTEMS.
    Section 2976(f) of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797w(f)) is amended--
        (1) in paragraph (5), by striking ``and'' at the end;
        (2) in paragraph (6), by striking the period at the end and 
    inserting a semicolon; and
        (3) by adding at the end the following:
        ``(7) provide mental health treatment and transitional services 
    for those with mental illnesses or with co-occurring disorders, 
    including housing placement or assistance; and''.
SEC. 14007. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH CHALLENGES 
IN DRUG COURTS.
    Part EE of title I of the Omnibus Crime Control and Safe Streets 
Act of 1968 (42 U.S.C. 3797u et seq.) is amended--
        (1) in section 2951(a)(1) (42 U.S.C. 3797u(a)(1)), by inserting 
    ``, including co-occurring substance abuse and mental health 
    problems,'' after ``problems''; and
        (2) in section 2959(a) (42 U.S.C. 3797u-8(a)), by inserting ``, 
    including training for drug court personnel and officials on 
    identifying and addressing co-occurring substance abuse and mental 
    health problems'' after ``part''.
SEC. 14008. MENTAL HEALTH TRAINING FOR FEDERAL UNIFORMED SERVICES.
    (a) In General.--Not later than 180 days after the date of 
enactment of this Act, the Secretary of Defense, the Secretary of 
Homeland Security, the Secretary of Health and Human Services, and the 
Secretary of Commerce shall provide the following to each of the 
uniformed services (as that term is defined in section 101 of title 10, 
United States Code) under their direction:
        (1) Training programs.--Programs that offer specialized and 
    comprehensive training in procedures to identify and respond 
    appropriately to incidents in which the unique needs of individuals 
    with mental illnesses are involved.
        (2) Improved technology.--Computerized information systems or 
    technological improvements to provide timely information to Federal 
    law enforcement personnel, other branches of the uniformed 
    services, and criminal justice system personnel to improve the 
    Federal response to mentally ill individuals.
        (3) Cooperative programs.--The establishment and expansion of 
    cooperative efforts to promote public safety through the use of 
    effective intervention with respect to mentally ill individuals 
    encountered by members of the uniformed services.
SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER REENTRY.
    (a) Reentry Demonstration Projects.--Section 2976(f) of title I of 
the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 
3797w(f)), as amended by section 14006, is amended--
        (1) in paragraph (3)(C), by inserting ``mental health 
    services,'' before ``drug treatment''; and
        (2) by adding at the end the following:
        ``(8) target offenders with histories of homelessness, 
    substance abuse, or mental illness, including a prerelease 
    assessment of the housing status of the offender and behavioral 
    health needs of the offender with clear coordination with mental 
    health, substance abuse, and homelessness services systems to 
    achieve stable and permanent housing outcomes with appropriate 
    support service.''.
    (b) Mentoring Grants.--Section 211(b)(2) of the Second Chance Act 
of 2007 (42 U.S.C. 17531(b)(2)) is amended by inserting ``, including 
mental health care'' after ``community''.
SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
    Section 2701(b) of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended--
        (1) by redesignating paragraphs (4) and (5) as paragraphs (5) 
    and (6), respectively; and
        (2) by inserting after paragraph (3) the following:
        ``(4) The development and operation of crisis intervention 
    teams that may include coordination with law enforcement agencies 
    and specialized training for school officials in responding to 
    mental health crises.''.
SEC. 14011. ACTIVE-SHOOTER TRAINING FOR LAW ENFORCEMENT.
    The Attorney General, as part of the Preventing Violence Against 
Law Enforcement and Ensuring Officer Resilience and Survivability 
Initiative (VALOR) of the Department of Justice, may provide safety 
training and technical assistance to local law enforcement agencies, 
including active-shooter response training.
SEC. 14012. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH CHALLENGES 
IN RESIDENTIAL SUBSTANCE ABUSE TREATMENT PROGRAMS.
    Section 1901(a) of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3796ff(a)) is amended--
        (1) in paragraph (1), by striking ``and'' at the end;
        (2) in paragraph (2), by striking the period at the end and 
    inserting ``; and''; and
        (3) by adding at the end the following:
        ``(3) developing and implementing specialized residential 
    substance abuse treatment programs that identify and provide 
    appropriate treatment to inmates with co-occurring mental health 
    and substance abuse disorders or challenges.''.
SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO 
INCARCERATION PROGRAMS.
    Title I of the Omnibus Crime Control and Safe Streets Act of 1968 
(42 U.S.C. 3711 et seq.) is amended by striking part CC and inserting 
the following:

      ``PART CC--MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO 
                         INCARCERATION PROGRAMS

``SEC. 2901. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES TO 
INCARCERATION PROGRAMS.
    ``(a) Definitions.--In this section--
        ``(1) the term `eligible entity' means a State, unit of local 
    government, Indian tribe, or nonprofit organization; and
        ``(2) the term `eligible participant' means an individual who--
            ``(A) comes into contact with the criminal justice system 
        or is arrested or charged with an offense that is not--
                ``(i) a crime of violence, as defined under applicable 
            State law or in section 3156 of title 18, United States 
            Code; or
                ``(ii) a serious drug offense, as defined in section 
            924(e)(2)(A) of title 18, United States Code;
            ``(B) has a history of, or a current--
                ``(i) substance use disorder;
                ``(ii) mental illness; or
                ``(iii) co-occurring mental illness and substance use 
            disorder; and
            ``(C) has been approved for participation in a program 
        funded under this section by the relevant law enforcement 
        agency, prosecuting attorney, defense attorney, probation 
        official, corrections official, judge, representative of a 
        mental health agency, or representative of a substance abuse 
        agency, as required by law.
    ``(b) Program Authorized.--The Attorney General may make grants to 
eligible entities to develop, implement, or expand a treatment 
alternative to incarceration program for eligible participants, 
including--
        ``(1) pre-booking treatment alternative to incarceration 
    programs, including--
            ``(A) law enforcement training on substance use disorders, 
        mental illness, and co-occurring mental illness and substance 
        use disorders;
            ``(B) receiving centers as alternatives to incarceration of 
        eligible participants;
            ``(C) specialized response units for calls related to 
        substance use disorders, mental illness, or co-occurring mental 
        illness and substance use disorders; and
            ``(D) other arrest and pre-booking treatment alternatives 
        to incarceration models; or
        ``(2) post-booking treatment alternative to incarceration 
    programs, including--
            ``(A) specialized clinical case management;
            ``(B) pre-trial services related to substances use 
        disorders, mental illness, and co-occurring mental illness and 
        substance use disorders;
            ``(C) prosecutor and defender based programs;
            ``(D) specialized probation;
            ``(E) treatment and rehabilitation programs; and
            ``(F) problem-solving courts, including mental health 
        courts, drug courts, co-occurring mental health and substance 
        abuse courts, DWI courts, and veterans treatment courts.
    ``(c) Application.--
        ``(1) In general.--An eligible entity desiring a grant under 
    this section shall submit an application to the Attorney General--
            ``(A) that meets the criteria under paragraph (2); and
            ``(B) at such time, in such manner, and accompanied by such 
        information as the Attorney General may require.
        ``(2) Criteria.--An eligible entity, in submitting an 
    application under paragraph (1), shall--
            ``(A) provide extensive evidence of collaboration with 
        State and local government agencies overseeing health, 
        community corrections, courts, prosecution, substance abuse, 
        mental health, victims services, and employment services, and 
        with local law enforcement agencies;
            ``(B) demonstrate consultation with the Single State 
        Authority for Substance Abuse of the State (as that term is 
        defined in section 201(e) of the Second Chance Act of 2007);
            ``(C) demonstrate that evidence-based treatment practices 
        will be utilized; and
            ``(D) demonstrate that evidence-based screening and 
        assessment tools will be used to place participants in the 
        treatment alternative to incarceration program.
    ``(d) Requirements.--Each eligible entity awarded a grant for a 
treatment alternative to incarceration program under this section 
shall--
        ``(1) determine the terms and conditions of participation in 
    the program by eligible participants, taking into consideration the 
    collateral consequences of an arrest, prosecution or criminal 
    conviction;
        ``(2) ensure that each substance abuse and mental health 
    treatment component is licensed and qualified by the relevant 
    jurisdiction;
        ``(3) for programs described in subsection (b)(2), organize an 
    enforcement unit comprised of appropriately trained law enforcement 
    professionals under the supervision of the State, Tribal, or local 
    criminal justice agency involved, the duties of which shall 
    include--
            ``(A) the verification of addresses and other contact 
        information of each eligible participant who participates or 
        desires to participate in the program; and
            ``(B) if necessary, the location, apprehension, arrest, and 
        return to custody of an eligible participant in the program who 
        has absconded from the facility of a treatment provider or has 
        otherwise significantly violated the terms and conditions of 
        the program, consistent with Federal and State confidentiality 
        requirements;
        ``(4) notify the relevant criminal justice entity if any 
    eligible participant in the program absconds from the facility of 
    the treatment provider or otherwise violates the terms and 
    conditions of the program, consistent with Federal and State 
    confidentiality requirements;
        ``(5) submit periodic reports on the progress of treatment or 
    other measured outcomes from participation in the program of each 
    eligible participant in the program to the relevant State, Tribal, 
    or local criminal justice agency, including mental health courts, 
    drug courts, co-occurring mental health and substance abuse courts, 
    DWI courts, and veterans treatment courts;
        ``(6) describe the evidence-based methodology and outcome 
    measurements that will be used to evaluate the program, and 
    specifically explain how such measurements will provide valid 
    measures of the impact of the program; and
        ``(7) describe how the program could be broadly replicated if 
    demonstrated to be effective.
    ``(e) Use of Funds.--An eligible entity shall use a grant received 
under this section for expenses of a treatment alternative to 
incarceration program, including--
        ``(1) salaries, personnel costs, equipment costs, and other 
    costs directly related to the operation of the program, including 
    the enforcement unit;
        ``(2) payments for treatment providers that are approved by the 
    relevant State or Tribal jurisdiction and licensed, if necessary, 
    to provide needed treatment to eligible offenders participating in 
    the program, including aftercare supervision, vocational training, 
    education, and job placement; and
        ``(3) payments to public and nonprofit private entities that 
    are approved by the State or Tribal jurisdiction and licensed, if 
    necessary, to provide alcohol and drug addiction treatment to 
    eligible offenders participating in the program.
    ``(f) Supplement Not Supplant.--An eligible entity shall use 
Federal funds received under this section only to supplement the funds 
that would, in the absence of those Federal funds, be made available 
from other Federal and non-Federal sources for the activities described 
in this section, and not to supplant those funds. The Federal share of 
a grant made under this section may not exceed 50 percent of the total 
costs of the program described in an application under subsection (d).
    ``(g) Geographic Distribution.--The Attorney General shall ensure 
that, to the extent practicable, the geographical distribution of 
grants under this section is equitable and includes a grant to an 
eligible entity in--
        ``(1) each State;
        ``(2) rural, suburban, and urban areas; and
        ``(3) Tribal jurisdictions.
    ``(h) Reports and Evaluations.--Each fiscal year, each recipient of 
a grant under this section during that fiscal year shall submit to the 
Attorney General a report on the outcomes of activities carried out 
using that grant in such form, containing such information, and on such 
dates as the Attorney General shall specify.
    ``(i) Accountability.--All grants awarded by the Attorney General 
under this section shall be subject to the following accountability 
provisions:
        ``(1) Audit requirement.--
            ``(A) Definition.--In this paragraph, the term `unresolved 
        audit finding' means a finding in the final audit report of the 
        Inspector General of the Department of Justice that the audited 
        grantee has utilized grant funds for an unauthorized 
        expenditure or otherwise unallowable cost that is not closed or 
        resolved within 12 months from the date on which the final 
        audit report is issued.
            ``(B) Audits.--Beginning in the first fiscal year beginning 
        after the date of enactment of this subsection, and in each 
        fiscal year thereafter, the Inspector General of the Department 
        of Justice shall conduct audits of recipients of grants under 
        this section to prevent waste, fraud, and abuse of funds by 
        grantees. The Inspector General shall determine the appropriate 
        number of grantees to be audited each year.
            ``(C) Mandatory exclusion.--A recipient of grant funds 
        under this section that is found to have an unresolved audit 
        finding shall not be eligible to receive grant funds under this 
        section during the first 2 fiscal years beginning after the end 
        of the 12-month period described in subparagraph (A).
            ``(D) Priority.--In awarding grants under this section, the 
        Attorney General shall give priority to eligible applicants 
        that did not have an unresolved audit finding during the 3 
        fiscal years before submitting an application for a grant under 
        this section.
            ``(E) Reimbursement.--If an entity is awarded grant funds 
        under this section during the 2-fiscal-year period during which 
        the entity is barred from receiving grants under subparagraph 
        (C), the Attorney General shall--
                ``(i) deposit an amount equal to the amount of the 
            grant funds that were improperly awarded to the grantee 
            into the General Fund of the Treasury; and
                ``(ii) seek to recoup the costs of the repayment to the 
            fund from the grant recipient that was erroneously awarded 
            grant funds.
        ``(2) Nonprofit organization requirements.--
            ``(A) Definition.--For purposes of this paragraph and the 
        grant programs under this part, the term `nonprofit 
        organization' means an organization that is described in 
        section 501(c)(3) of the Internal Revenue Code of 1986 and is 
        exempt from taxation under section 501(a) of such Code.
            ``(B) Prohibition.--The Attorney General may not award a 
        grant under this part to a nonprofit organization that holds 
        money in offshore accounts for the purpose of avoiding paying 
        the tax described in section 511(a) of the Internal Revenue 
        Code of 1986.
            ``(C) Disclosure.--Each nonprofit organization that is 
        awarded a grant under this section and uses the procedures 
        prescribed in regulations to create a rebuttable presumption of 
        reasonableness for the compensation of its officers, directors, 
        trustees, and key employees, shall disclose to the Attorney 
        General, in the application for the grant, the process for 
        determining such compensation, including the independent 
        persons involved in reviewing and approving such compensation, 
        the comparability data used, and contemporaneous substantiation 
        of the deliberation and decision. Upon request, the Attorney 
        General shall make the information disclosed under this 
        subparagraph available for public inspection.
        ``(3) Conference expenditures.--
            ``(A) Limitation.--No amounts made available to the 
        Department of Justice under this section may be used by the 
        Attorney General, or by any individual or entity awarded 
        discretionary funds through a cooperative agreement under this 
        section, to host or support any expenditure for conferences 
        that uses more than $20,000 in funds made available by the 
        Department of Justice, unless the head of the relevant agency 
        or department, provides prior written authorization that the 
        funds may be expended to host the conference.
            ``(B) Written approval.--Written approval under 
        subparagraph (A) shall include a written estimate of all costs 
        associated with the conference, including the cost of all food, 
        beverages, audio-visual equipment, honoraria for speakers, and 
        entertainment.
            ``(C) Report.--The Deputy Attorney General shall submit an 
        annual report to the Committee on the Judiciary of the Senate 
        and the Committee on the Judiciary of the House of 
        Representatives on all conference expenditures approved under 
        this paragraph.
        ``(4) Annual certification.--Beginning in the first fiscal year 
    beginning after the date of enactment of this subsection, the 
    Attorney General shall submit, to the Committee on the Judiciary 
    and the Committee on Appropriations of the Senate and the Committee 
    on the Judiciary and the Committee on Appropriations of the House 
    of Representatives, an annual certification--
            ``(A) indicating whether--
                ``(i) all audits issued by the Office of the Inspector 
            General under paragraph (1) have been completed and 
            reviewed by the appropriate Assistant Attorney General or 
            Director;
                ``(ii) all mandatory exclusions required under 
            paragraph (1)(C) have been issued; and
                ``(iii) all reimbursements required under paragraph 
            (1)(E) have been made; and
            ``(B) that includes a list of any grant recipients excluded 
        under paragraph (1) from the previous year.
        ``(5) Preventing duplicative grants.--
            ``(A) In general.--Before the Attorney General awards a 
        grant to an applicant under this section, the Attorney General 
        shall compare potential grant awards with other grants awarded 
        under this Act to determine if duplicate grant awards are 
        awarded for the same purpose.
            ``(B) Report.--If the Attorney General awards duplicate 
        grants to the same applicant for the same purpose the Attorney 
        General shall submit to the Committee on the Judiciary of the 
        Senate and the Committee on the Judiciary of the House of 
        Representatives a report that includes--
                ``(i) a list of all duplicate grants awarded, including 
            the total dollar amount of any duplicate grants awarded; 
            and
                ``(ii) the reason the Attorney General awarded the 
            duplicate grants.''.
SEC. 14014. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH TRAINING AND 
TECHNICAL ASSISTANCE.
    Part HH of title I of the Omnibus Crime Control and Safe Streets 
Act of 1968 (42 U.S.C. 3797aa et seq.) is amended by adding at the end 
the following:
``SEC. 2992. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH TRAINING AND 
TECHNICAL ASSISTANCE.
    ``(a) Authority.--The Attorney General may make grants to eligible 
organizations to provide for the establishment of a National Criminal 
Justice and Mental Health Training and Technical Assistance Center.
    ``(b) Eligible Organization.--For purposes of subsection (a), the 
term `eligible organization' means a national nonprofit organization 
that provides technical assistance and training to, and has special 
expertise and broad, national-level experience in, mental health, 
crisis intervention, criminal justice systems, law enforcement, 
translating evidence into practice, training, and research, and 
education and support of people with mental illness and the families of 
such individuals.
    ``(c) Use of Funds.--Any organization that receives a grant under 
subsection (a) shall collaborate with other grant recipients to 
establish and operate a National Criminal Justice and Mental Health 
Training and Technical Assistance Center to--
        ``(1) provide law enforcement officer training regarding mental 
    health and working with individuals with mental illnesses, with an 
    emphasis on de-escalation of encounters between law enforcement 
    officers and those with mental disorders or in crisis, which shall 
    include support the development of in-person and technical 
    information exchanges between systems and the individuals working 
    in those systems in support of the concepts identified in the 
    training;
        ``(2) provide education, training, and technical assistance for 
    States, Indian tribes, territories, units of local government, 
    service providers, nonprofit organizations, probation or parole 
    officers, prosecutors, defense attorneys, emergency response 
    providers, and corrections institutions to advance practice and 
    knowledge relating to mental health crisis and approaches to mental 
    health and criminal justice across systems;
        ``(3) provide training and best practices to mental health 
    providers and criminal justice agencies relating to diversion 
    initiatives, jail and prison strategies, reentry of individuals 
    with mental illnesses into the community, and dispatch protocols 
    and triage capabilities, including the establishment of learning 
    sites;
        ``(4) develop suicide prevention and crisis intervention 
    training and technical assistance for criminal justice agencies;
        ``(5) develop a receiving center system and pilot strategy that 
    provides, for a jurisdiction, a single point of entry into the 
    mental health and substance abuse system for assessments and 
    appropriate placement of individuals experiencing a crisis;
        ``(6) collect data and best practices in mental health and 
    criminal health and criminal justice initiatives and policies from 
    grantees under this part, other recipients of grants under this 
    section, Federal, State, and local agencies involved in the 
    provision of mental health services, and nongovernmental 
    organizations involved in the provision of mental health services;
        ``(7) develop and disseminate to mental health providers and 
    criminal justice agencies evaluation tools, mechanisms, and 
    measures to better assess and document performance measures and 
    outcomes relating to the provision of mental health services;
        ``(8) disseminate information to States, units of local 
    government, criminal justice agencies, law enforcement agencies, 
    and other relevant entities about best practices, policy standards, 
    and research findings relating to the provision of mental health 
    services; and
        ``(9) provide education and support to individuals with mental 
    illness involved with, or at risk of involvement with, the criminal 
    justice system, including the families of such individuals.
    ``(d) Accountability.--Grants awarded under this section shall be 
subject to the following accountability provisions:
        ``(1) Audit requirement.--
            ``(A) Definition.--In this paragraph, the term `unresolved 
        audit finding' means a finding in the final audit report of the 
        Inspector General of the Department of Justice under 
        subparagraph (C) that the audited grantee has used grant funds 
        for an unauthorized expenditure or otherwise unallowable cost 
        that is not closed or resolved within 1 year after the date on 
        which the final audit report is issued.
            ``(B) Audits.--Beginning in the first fiscal year beginning 
        after the date of enactment of this section, and in each fiscal 
        year thereafter, the Inspector General of the Department of 
        Justice shall conduct audits of grantees under this section to 
        prevent waste, fraud, and abuse of funds by grantees. The 
        Inspector General shall determine the appropriate number of 
        grantees to be audited each year.
            ``(C) Final audit report.--The Inspector General of the 
        Department of Justice shall submit to the Attorney General a 
        final report on each audit conducted under subparagraph (B).
            ``(D) Mandatory exclusion.--Grantees under this section 
        about which there is an unresolved audit finding shall not be 
        eligible to receive a grant under this section during the 2 
        fiscal years beginning after the end of the 1-year period 
        described in subparagraph (A).
            ``(E) Priority.--In making grants under this section, the 
        Attorney General shall give priority to applicants that did not 
        have an unresolved audit finding during the 3 fiscal years 
        before submitting an application for a grant under this 
        section.
            ``(F) Reimbursement.--If an entity receives a grant under 
        this section during the 2-fiscal-year period during which the 
        entity is prohibited from receiving grants under subparagraph 
        (D), the Attorney General shall--
                ``(i) deposit an amount equal to the amount of the 
            grant that was improperly awarded to the grantee into the 
            General Fund of the Treasury; and
                ``(ii) seek to recoup the costs of the repayment under 
            clause (i) from the grantee that was erroneously awarded 
            grant funds.
        ``(2) Nonprofit agency requirements.--
            ``(A) Definition.--For purposes of this paragraph and the 
        grant program under this section, the term `nonprofit agency' 
        means an organization that is described in section 501(c)(3) of 
        the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3)) and is 
        exempt from taxation under section 501(a) of the Internal 
        Revenue Code of 1986 (26 U.S.C. 501(a)).
            ``(B) Prohibition.--The Attorney General may not award a 
        grant under this section to a nonprofit agency that holds money 
        in an offshore account for the purpose of avoiding paying the 
        tax described in section 511(a) of the Internal Revenue Code of 
        1986 (26 U.S.C. 511(a)).
            ``(C) Disclosure.--Each nonprofit agency that is awarded a 
        grant under this section and uses the procedures prescribed in 
        regulations to create a rebuttable presumption of 
        reasonableness for the compensation of its officers, directors, 
        trustees, and key employees, shall disclose to the Attorney 
        General, in the application for the grant, the process for 
        determining such compensation, including the independent 
        persons involved in reviewing and approving such compensation, 
        the comparability data used, and contemporaneous substantiation 
        of the deliberation and decision. Upon request, the Attorney 
        General shall make the information disclosed under this 
        subparagraph available for public inspection.
        ``(3) Conference expenditures.--
            ``(A) Limitation.--No amounts made available to the 
        Department of Justice under this section may be used by the 
        Attorney General, or by any individual or entity awarded 
        discretionary funds through a cooperative agreement under this 
        section, to host or support any expenditure for conferences 
        that uses more than $20,000 in funds made available by the 
        Department of Justice, unless the head of the relevant agency 
        or department, provides prior written authorization that the 
        funds may be expended to host the conference.
            ``(B) Written approval.--Written approval under 
        subparagraph (A) shall include a written estimate of all costs 
        associated with the conference, including the cost of all food, 
        beverages, audio-visual equipment, honoraria for speakers, and 
        entertainment.
            ``(C) Report.--The Deputy Attorney General shall submit an 
        annual report to the Committee on the Judiciary of the Senate 
        and the Committee on the Judiciary of the House of 
        Representatives on all conference expenditures approved under 
        this paragraph.
        ``(4) Annual certification.--Beginning in the first fiscal year 
    beginning after the date of enactment of this subsection, the 
    Attorney General shall submit to the Committee on the Judiciary and 
    the Committee on Appropriations of the Senate and the Committee on 
    the Judiciary and the Committee on Appropriations of the House of 
    Representatives an annual certification--
            ``(A) indicating whether--
                ``(i) all final audit reports issued by the Office of 
            the Inspector General under paragraph (1) have been 
            completed and reviewed by the appropriate Assistant 
            Attorney General or Director;
                ``(ii) all mandatory exclusions required under 
            paragraph (1)(D) have been issued; and
                ``(iii) any reimbursements required under paragraph 
            (1)(F) have been made; and
            ``(B) that includes a list of any grantees excluded under 
        paragraph (1)(D) from the previous year.
        ``(5) Preventing duplicative grants.--
            ``(A) In general.--Before the Attorney General awards a 
        grant to an applicant under this section, the Attorney General 
        shall compare potential grant awards with other grants awarded 
        under this Act to determine if duplicate grant awards are 
        awarded for the same purpose.
            ``(B) Report.--If the Attorney General awards duplicate 
        grants to the same applicant for the same purpose the Attorney 
        General shall submit to the Committee on the Judiciary of the 
        Senate and the Committee on the Judiciary of the House of 
        Representatives a report that includes--
                ``(i) a list of all duplicate grants awarded, including 
            the total dollar amount of any duplicate grants awarded; 
            and
                ``(ii) the reason the Attorney General awarded the 
            duplicate grants.''.
SEC. 14015. IMPROVING DEPARTMENT OF JUSTICE DATA COLLECTION ON MENTAL 
ILLNESS INVOLVED IN CRIME.
    (a) In General.--Notwithstanding any other provision of law, on or 
after the date that is 90 days after the date on which the Attorney 
General promulgates regulations under subsection (b), any data prepared 
by, or submitted to, the Attorney General or the Director of the 
Federal Bureau of Investigation with respect to the incidences of 
homicides, law enforcement officers killed, seriously injured, and 
assaulted, or individuals killed or seriously injured by law 
enforcement officers shall include data with respect to the involvement 
of mental illness in such incidences, if any.
    (b) Regulations.--Not later than 90 days after the date of the 
enactment of this Act, the Attorney General shall promulgate or revise 
regulations as necessary to carry out subsection (a).
SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS IN PRISON.
    (a) Report on the Cost of Treating the Mentally Ill in the Criminal 
Justice System.--Not later than 12 months after the date of enactment 
of this Act, the Comptroller General of the United States shall submit 
to Congress a report detailing the cost of imprisonment for individuals 
who have serious mental illness by the Federal Government or a State or 
unit of local government, which shall include--
        (1) the number and type of crimes committed by individuals with 
    serious mental illness each year; and
        (2) detail strategies or ideas for preventing crimes by those 
    individuals with serious mental illness from occurring.
    (b) Definition.--For purposes of this section, the Attorney 
General, in consultation with the Assistant Secretary of Mental Health 
and Substance Use Disorders, shall define ``serious mental illness'' 
based on the ``Health Care Reform for Americans with Severe Mental 
Illnesses: Report'' of the National Advisory Mental Health Council, 
American Journal of Psychiatry 1993; 150:1447-1465.
SEC. 14017. CODIFICATION OF DUE PROCESS FOR DETERMINATIONS BY SECRETARY 
OF VETERANS AFFAIRS OF MENTAL CAPACITY OF BENEFICIARIES.
    (a) In General.--Chapter 55 of title 38, United States Code, is 
amended by inserting after section 5501 the following new section:
``Sec. 5501A. Beneficiaries' rights in mental competence determinations
    ``The Secretary may not make an adverse determination concerning 
the mental capacity of a beneficiary to manage monetary benefits paid 
to or for the beneficiary by the Secretary under this title unless such 
beneficiary has been provided all of the following, subject to the 
procedures and timelines prescribed by the Secretary for determinations 
of incompetency:
        ``(1) Notice of the proposed adverse determination and the 
    supporting evidence.
        ``(2) An opportunity to request a hearing.
        ``(3) An opportunity to present evidence, including an opinion 
    from a medical professional or other person, on the capacity of the 
    beneficiary to manage monetary benefits paid to or for the 
    beneficiary by the Secretary under this title.
        ``(4) An opportunity to be represented at no expense to the 
    Government (including by counsel) at any such hearing and to bring 
    a medical professional or other person to provide relevant 
    testimony at any such hearing.''.
    (b) Clerical Amendment.--The table of sections at the beginning of 
such chapter 55 is amended by inserting after the item relating to 
section 5501 the following new item:

``5501A. Beneficiaries' rights in mental competence determinations''.

    (c) Effective Date.--Section 5501A of title 38, United States Code, 
as added by subsection (a), shall apply to determinations made by the 
Secretary of Veterans Affairs on or after the date of the enactment of 
this Act.
SEC. 14018. REAUTHORIZATION OF APPROPRIATIONS.
    Subsection (o) of section 2991 of the Omnibus Crime Control and 
Safe Streets Act of 1968 (42 U.S.C. 3797aa), as redesignated by section 
14006, is amended--
        (1) in paragraph (1)(C), by striking ``2009 through 2014'' and 
    inserting ``2017 through 2021''; and
        (2) by adding at the end the following:
    ``(3) Limitation.--Not more than 20 percent of the funds authorized 
to be appropriated under this section may be used for purposes 
described in subsection (i) (relating to veterans).''.

          Subtitle B--Comprehensive Justice and Mental Health

SEC. 14021. SEQUENTIAL INTERCEPT MODEL.
    Section 2991 of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797aa), as amended by section 14005, is 
amended by inserting after subsection (j), the following:
    ``(k) Sequential Intercept Grants.--
        ``(1) Definition.--In this subsection, the term `eligible 
    entity' means a State, unit of local government, Indian tribe, or 
    tribal organization.
        ``(2) Authorization.--The Attorney General may make grants 
    under this subsection to an eligible entity for sequential 
    intercept mapping and implementation in accordance with paragraph 
    (3).
        ``(3) Sequential intercept mapping; implementation.--An 
    eligible entity that receives a grant under this subsection may use 
    funds for--
            ``(A) sequential intercept mapping, which--
                ``(i) shall consist of--

                    ``(I) convening mental health and criminal justice 
                stakeholders to--

                        ``(aa) develop a shared understanding of the 
                    flow of justice-involved individuals with mental 
                    illnesses through the criminal justice system; and
                        ``(bb) identify opportunities for improved 
                    collaborative responses to the risks and needs of 
                    individuals described in item (aa); and

                    ``(II) developing strategies to address gaps in 
                services and bring innovative and effective programs to 
                scale along multiple intercepts, including--

                        ``(aa) emergency and crisis services;
                        ``(bb) specialized police-based responses;
                        ``(cc) court hearings and disposition 
                    alternatives;
                        ``(dd) reentry from jails and prisons; and
                        ``(ee) community supervision, treatment and 
                    support services; and
                ``(ii) may serve as a starting point for the 
            development of strategic plans to achieve positive public 
            health and safety outcomes; and
            ``(B) implementation, which shall--
                ``(i) be derived from the strategic plans described in 
            subparagraph (A)(ii); and
                ``(ii) consist of--

                    ``(I) hiring and training personnel;
                    ``(II) identifying the eligible entity's target 
                population;
                    ``(III) providing services and supports to reduce 
                unnecessary penetration into the criminal justice 
                system;
                    ``(IV) reducing recidivism;
                    ``(V) evaluating the impact of the eligible 
                entity's approach; and
                    ``(VI) planning for the sustainability of effective 
                interventions.''.

SEC. 14022. PRISON AND JAILS.
    Section 2991 of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after 
subsection (k), as added by section 14021, the following:
    ``(l) Correctional Facilities.--
        ``(1) Definitions.--
            ``(A) Correctional facility.--The term `correctional 
        facility' means a jail, prison, or other detention facility 
        used to house people who have been arrested, detained, held, or 
        convicted by a criminal justice agency or a court.
            ``(B) Eligible inmate.--The term `eligible inmate' means an 
        individual who--
                ``(i) is being held, detained, or incarcerated in a 
            correctional facility; and
                ``(ii) manifests obvious signs of a mental illness or 
            has been diagnosed by a qualified mental health 
            professional as having a mental illness.
        ``(2) Correctional facility grants.--The Attorney General may 
    award grants to applicants to enhance the capabilities of a 
    correctional facility--
            ``(A) to identify and screen for eligible inmates;
            ``(B) to plan and provide--
                ``(i) initial and periodic assessments of the clinical, 
            medical, and social needs of inmates; and
                ``(ii) appropriate treatment and services that address 
            the mental health and substance abuse needs of inmates;
            ``(C) to develop, implement, and enhance--
                ``(i) post-release transition plans for eligible 
            inmates that, in a comprehensive manner, coordinate health, 
            housing, medical, employment, and other appropriate 
            services and public benefits;
                ``(ii) the availability of mental health care services 
            and substance abuse treatment services; and
                ``(iii) alternatives to solitary confinement and 
            segregated housing and mental health screening and 
            treatment for inmates placed in solitary confinement or 
            segregated housing; and
            ``(D) to train each employee of the correctional facility 
        to identify and appropriately respond to incidents involving 
        inmates with mental health or co-occurring mental health and 
        substance abuse disorders.''.
SEC. 14023. ALLOWABLE USES.
    Section 2991(b)(5)(I) of title I of the Omnibus Crime Control and 
Safe Streets Act of 1968 (42 U.S.C. 3797aa(b)(5)(I)) is amended by 
adding at the end the following:
                ``(v) Teams addressing frequent users of crisis 
            services.--Multidisciplinary teams that--

                    ``(I) coordinate, implement, and administer 
                community-based crisis responses and long-term plans 
                for frequent users of crisis services;
                    ``(II) provide training on how to respond 
                appropriately to the unique issues involving frequent 
                users of crisis services for public service personnel, 
                including criminal justice, mental health, substance 
                abuse, emergency room, healthcare, law enforcement, 
                corrections, and housing personnel;
                    ``(III) develop or support alternatives to hospital 
                and jail admissions for frequent users of crisis 
                services that provide treatment, stabilization, and 
                other appropriate supports in the least restrictive, 
                yet appropriate, environment; and
                    ``(IV) develop protocols and systems among law 
                enforcement, mental health, substance abuse, housing, 
                corrections, and emergency medical service operations 
                to provide coordinated assistance to frequent users of 
                crisis services.''.

SEC. 14024. LAW ENFORCEMENT TRAINING.
    Section 2991(h) of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended--
        (1) in paragraph (1), by adding at the end the following:
            ``(F) Academy training.--To provide support for academy 
        curricula, law enforcement officer orientation programs, 
        continuing education training, and other programs that teach 
        law enforcement personnel how to identify and respond to 
        incidents involving persons with mental health disorders or co-
        occurring mental health and substance abuse disorders.''; and
        (2) by adding at the end the following:
        ``(4) Priority consideration.--The Attorney General, in 
    awarding grants under this subsection, shall give priority to 
    programs that law enforcement personnel and members of the mental 
    health and substance abuse professions develop and administer 
    cooperatively.''.
SEC. 14025. FEDERAL LAW ENFORCEMENT TRAINING.
    Not later than 1 year after the date of enactment of this Act, the 
Attorney General shall provide direction and guidance for the 
following:
        (1) Training programs.--Programs that offer specialized and 
    comprehensive training, in procedures to identify and appropriately 
    respond to incidents in which the unique needs of individuals who 
    have a mental illness are involved, to first responders and 
    tactical units of--
            (A) Federal law enforcement agencies; and
            (B) other Federal criminal justice agencies such as the 
        Bureau of Prisons, the Administrative Office of the United 
        States Courts, and other agencies that the Attorney General 
        determines appropriate.
        (2) Improved technology.--The establishment of, or improvement 
    of existing, computerized information systems to provide timely 
    information to employees of Federal law enforcement agencies, and 
    Federal criminal justice agencies to improve the response of such 
    employees to situations involving individuals who have a mental 
    illness.
SEC. 14026. GAO REPORT.
    No later than 1 year after the date of enactment of this Act, the 
Comptroller General of the United States, in coordination with the 
Attorney General, shall submit to Congress a report on--
        (1) the practices that Federal first responders, tactical 
    units, and corrections officers are trained to use in responding to 
    individuals with mental illness;
        (2) procedures to identify and appropriately respond to 
    incidents in which the unique needs of individuals who have a 
    mental illness are involved, to Federal first responders and 
    tactical units;
        (3) the application of evidence-based practices in criminal 
    justice settings to better address individuals with mental 
    illnesses; and
        (4) recommendations on how the Department of Justice can expand 
    and improve information sharing and dissemination of best 
    practices.
SEC. 14027. EVIDENCE BASED PRACTICES.
    Section 2991(c) of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797aa(c)) is amended--
        (1) in paragraph (3), by striking ``or'' at the end;
        (2) by redesignating paragraph (4) as paragraph (6); and
        (3) by inserting after paragraph (3), the following:
        ``(4) propose interventions that have been shown by empirical 
    evidence to reduce recidivism;
        ``(5) when appropriate, use validated assessment tools to 
    target preliminarily qualified offenders with a moderate or high 
    risk of recidivism and a need for treatment and services; or''.
SEC. 14028. TRANSPARENCY, PROGRAM ACCOUNTABILITY, AND ENHANCEMENT OF 
LOCAL AUTHORITY.
    (a) In General.--Section 2991(a) of title I of the Omnibus Crime 
Control and Safe Streets Act of 1968 (42 U.S.C. 3797aa(a)) is amended--
        (1) in paragraph (7)--
            (A) in the heading, by striking ``Mental illness'' and 
        inserting ``Mental illness; mental health disorder''; and
            (B) by striking ``term `mental illness' means'' and 
        inserting ``terms `mental illness' and `mental health disorder' 
        mean''; and
        (2) by striking paragraph (9) and inserting the following:
        ``(9) Preliminarily qualified offender.--
            ``(A) In general.--The term `preliminarily qualified 
        offender' means an adult or juvenile accused of an offense 
        who--
                ``(i)(I) previously or currently has been diagnosed by 
            a qualified mental health professional as having a mental 
            illness or co-occurring mental illness and substance abuse 
            disorders;
                ``(II) manifests obvious signs of mental illness or co-
            occurring mental illness and substance abuse disorders 
            during arrest or confinement or before any court; or
                ``(III) in the case of a veterans treatment court 
            provided under subsection (i), has been diagnosed with, or 
            manifests obvious signs of, mental illness or a substance 
            abuse disorder or co-occurring mental illness and substance 
            abuse disorder;
                ``(ii) has been unanimously approved for participation 
            in a program funded under this section by, when 
            appropriate--

                    ``(I) the relevant--

                        ``(aa) prosecuting attorney;
                        ``(bb) defense attorney;
                        ``(cc) probation or corrections official; and
                        ``(dd) judge; and

                    ``(II) a representative from the relevant mental 
                health agency described in subsection (b)(5)(B)(i);

                ``(iii) has been determined, by each person described 
            in clause (ii) who is involved in approving the adult or 
            juvenile for participation in a program funded under this 
            section, to not pose a risk of violence to any person in 
            the program, or the public, if selected to participate in 
            the program; and
                ``(iv) has not been charged with or convicted of--

                    ``(I) any sex offense (as defined in section 111 of 
                the Sex Offender Registration and Notification Act (42 
                U.S.C. 16911)) or any offense relating to the sexual 
                exploitation of children; or
                    ``(II) murder or assault with intent to commit 
                murder.

            ``(B) Determination.--In determining whether to designate a 
        defendant as a preliminarily qualified offender, the relevant 
        prosecuting attorney, defense attorney, probation or 
        corrections official, judge, and mental health or substance 
        abuse agency representative shall take into account--
                ``(i) whether the participation of the defendant in the 
            program would pose a substantial risk of violence to the 
            community;
                ``(ii) the criminal history of the defendant and the 
            nature and severity of the offense for which the defendant 
            is charged;
                ``(iii) the views of any relevant victims to the 
            offense;
                ``(iv) the extent to which the defendant would benefit 
            from participation in the program;
                ``(v) the extent to which the community would realize 
            cost savings because of the defendant's participation in 
            the program; and
                ``(vi) whether the defendant satisfies the eligibility 
            criteria for program participation unanimously established 
            by the relevant prosecuting attorney, defense attorney, 
            probation or corrections official, judge and mental health 
            or substance abuse agency representative.''.
    (b) Technical and Conforming Amendment.--Section 2927(2) of title I 
of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 
3797s-6(2)) is amended by striking ``has the meaning given that term in 
section 2991(a).'' and inserting ``means an offense that--
            ``(A) does not have as an element the use, attempted use, 
        or threatened use of physical force against the person or 
        property of another; or
            ``(B) is not a felony that by its nature involves a 
        substantial risk that physical force against the person or 
        property of another may be used in the course of committing the 
        offense.''.
SEC. 14029. GRANT ACCOUNTABILITY.
    Section 2991 of title I of the Omnibus Crime Control and Safe 
Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting after 
subsection (l), as added by section 14022, the following:
    ``(m) Accountability.--All grants awarded by the Attorney General 
under this section shall be subject to the following accountability 
provisions:
        ``(1) Audit requirement.--
            ``(A) Definition.--In this paragraph, the term `unresolved 
        audit finding' means a finding in the final audit report of the 
        Inspector General of the Department of Justice that the audited 
        grantee has utilized grant funds for an unauthorized 
        expenditure or otherwise unallowable cost that is not closed or 
        resolved within 12 months from the date when the final audit 
        report is issued.
            ``(B) Audits.--Beginning in the first fiscal year beginning 
        after the date of enactment of this subsection, and in each 
        fiscal year thereafter, the Inspector General of the Department 
        of Justice shall conduct audits of recipients of grants under 
        this section to prevent waste, fraud, and abuse of funds by 
        grantees. The Inspector General shall determine the appropriate 
        number of grantees to be audited each year.
            ``(C) Mandatory exclusion.--A recipient of grant funds 
        under this section that is found to have an unresolved audit 
        finding shall not be eligible to receive grant funds under this 
        section during the first 2 fiscal years beginning after the end 
        of the 12-month period described in subparagraph (A).
            ``(D) Priority.--In awarding grants under this section, the 
        Attorney General shall give priority to eligible applicants 
        that did not have an unresolved audit finding during the 3 
        fiscal years before submitting an application for a grant under 
        this section.
            ``(E) Reimbursement.--If an entity is awarded grant funds 
        under this section during the 2-fiscal-year period during which 
        the entity is barred from receiving grants under subparagraph 
        (C), the Attorney General shall--
                ``(i) deposit an amount equal to the amount of the 
            grant funds that were improperly awarded to the grantee 
            into the General Fund of the Treasury; and
                ``(ii) seek to recoup the costs of the repayment to the 
            fund from the grant recipient that was erroneously awarded 
            grant funds.
        ``(2) Nonprofit organization requirements.--
            ``(A) Definition.--For purposes of this paragraph and the 
        grant programs under this part, the term `nonprofit 
        organization' means an organization that is described in 
        section 501(c)(3) of the Internal Revenue Code of 1986 and is 
        exempt from taxation under section 501(a) of such Code.
            ``(B) Prohibition.--The Attorney General may not award a 
        grant under this part to a nonprofit organization that holds 
        money in offshore accounts for the purpose of avoiding paying 
        the tax described in section 511(a) of the Internal Revenue 
        Code of 1986.
            ``(C) Disclosure.--Each nonprofit organization that is 
        awarded a grant under this section and uses the procedures 
        prescribed in regulations to create a rebuttable presumption of 
        reasonableness for the compensation of its officers, directors, 
        trustees, and key employees, shall disclose to the Attorney 
        General, in the application for the grant, the process for 
        determining such compensation, including the independent 
        persons involved in reviewing and approving such compensation, 
        the comparability data used, and contemporaneous substantiation 
        of the deliberation and decision. Upon request, the Attorney 
        General shall make the information disclosed under this 
        subparagraph available for public inspection.
        ``(3) Conference expenditures.--
            ``(A) Limitation.--No amounts made available to the 
        Department of Justice under this section may be used by the 
        Attorney General, or by any individual or entity awarded 
        discretionary funds through a cooperative agreement under this 
        section, to host or support any expenditure for conferences 
        that uses more than $20,000 in funds made available by the 
        Department of Justice, unless the head of the relevant agency 
        or department, provides prior written authorization that the 
        funds may be expended to host the conference.
            ``(B) Written approval.--Written approval under 
        subparagraph (A) shall include a written estimate of all costs 
        associated with the conference, including the cost of all food, 
        beverages, audio-visual equipment, honoraria for speakers, and 
        entertainment.
            ``(C) Report.--The Deputy Attorney General shall submit an 
        annual report to the Committee on the Judiciary of the Senate 
        and the Committee on the Judiciary of the House of 
        Representatives on all conference expenditures approved under 
        this paragraph.
        ``(4) Annual certification.--Beginning in the first fiscal year 
    beginning after the date of enactment of this subsection, the 
    Attorney General shall submit, to the Committee on the Judiciary 
    and the Committee on Appropriations of the Senate and the Committee 
    on the Judiciary and the Committee on Appropriations of the House 
    of Representatives, an annual certification--
            ``(A) indicating whether--
                ``(i) all audits issued by the Office of the Inspector 
            General under paragraph (1) have been completed and 
            reviewed by the appropriate Assistant Attorney General or 
            Director;
                ``(ii) all mandatory exclusions required under 
            paragraph (1)(C) have been issued; and
                ``(iii) all reimbursements required under paragraph 
            (1)(E) have been made; and
            ``(B) that includes a list of any grant recipients excluded 
        under paragraph (1) from the previous year.
    ``(n) Preventing Duplicative Grants.--
        ``(1) In general.--Before the Attorney General awards a grant 
    to an applicant under this section, the Attorney General shall 
    compare potential grant awards with other grants awarded under this 
    Act to determine if duplicate grant awards are awarded for the same 
    purpose.
        ``(2) Report.--If the Attorney General awards duplicate grants 
    to the same applicant for the same purpose the Attorney General 
    shall submit to the Committee on the Judiciary of the Senate and 
    the Committee on the Judiciary of the House of Representatives a 
    report that includes--
            ``(A) a list of all duplicate grants awarded, including the 
        total dollar amount of any duplicate grants awarded; and
            ``(B) the reason the Attorney General awarded the duplicate 
        grants.''.

 DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR 
                               AMERICANS

SEC. 15000. SHORT TITLE.
    This division may be cited as the ``Increasing Choice, Access, and 
Quality in Health Care for Americans Act''.

            TITLE XV--PROVISIONS RELATING TO MEDICARE PART A

SEC. 15001. DEVELOPMENT OF MEDICARE HCPCS VERSION OF MS-DRG CODES FOR 
SIMILAR HOSPITAL SERVICES.
    Section 1886 of the Social Security Act (42 U.S.C. 1395ww) is 
amended by adding at the end the following new subsection:
    ``(t) Relating Similar Inpatient and Outpatient Hospital 
Services.--
        ``(1) Development of hcpcs version of ms-drg codes.--Not later 
    than January 1, 2018, the Secretary shall develop HCPCS versions 
    for MS-DRGs that are similar to the ICD-10-PCS for such MS-DRGs 
    such that, to the extent possible, the MS-DRG assignment shall be 
    similar for a claim coded with the HCPCS version as an identical 
    claim coded with a ICD-10-PCS code.
        ``(2) Coverage of surgical ms-drgs.--In carrying out paragraph 
    (1), the Secretary shall develop HCPCS versions of MS-DRG codes for 
    not fewer than 10 surgical MS-DRGs.
        ``(3) Publication and dissemination of the hcpcs versions of 
    ms-drgs.--
            ``(A) In general.--The Secretary shall develop a HCPCS MS-
        DRG definitions manual and software that is similar to the 
        definitions manual and software for ICD-10-PCS codes for such 
        MS-DRGs. The Secretary shall post the HCPCS MS-DRG definitions 
        manual and software on the Internet website of the Centers for 
        Medicare & Medicaid Services. The HCPCS MS-DRG definitions 
        manual and software shall be in the public domain and available 
        for use and redistribution without charge.
            ``(B) Use of previous analysis done by medpac.--In 
        developing the HCPCS MS-DRG definitions manual and software 
        under subparagraph (A), the Secretary shall consult with the 
        Medicare Payment Advisory Commission and shall consider the 
        analysis done by such Commission in translating outpatient 
        surgical claims into inpatient surgical MS-DRGs in preparing 
        chapter 7 (relating to hospital short-stay policy issues) of 
        its `Medicare and the Health Care Delivery System' report 
        submitted to Congress in June 2015.
        ``(4) Definition and reference.--In this subsection:
            ``(A) HCPCS.--The term `HCPCS' means, with respect to 
        hospital items and services, the code under the Healthcare 
        Common Procedure Coding System (HCPCS) (or a successor code) 
        for such items and services.
            ``(B) ICD-10-PCS.--The term `ICD-10-PCS' means the 
        International Classification of Diseases, 10th Revision, 
        Procedure Coding System, and includes any subsequent revision 
        of such International Classification of Diseases, Procedure 
        Coding System.''.
SEC. 15002. ESTABLISHING BENEFICIARY EQUITY IN THE MEDICARE HOSPITAL 
READMISSION PROGRAM.
    (a) Transitional Adjustment for Dual Eligible Population.--Section 
1886(q)(3) of the Social Security Act (42 U.S.C. 1395ww(q)(3)) is 
amended--
        (1) in subparagraph (A), by inserting ``subject to subparagraph 
    (D),'' after ``purposes of paragraph (1),''; and
        (2) by adding at the end the following new subparagraph:
            ``(D) Transitional adjustment for dual eligibles.--
                ``(i) In general.--In determining a hospital's 
            adjustment factor under this paragraph for purposes of 
            making payments for discharges occurring during and after 
            fiscal year 2019, and before the application of clause (i) 
            of subparagraph (E), the Secretary shall assign hospitals 
            to groups (as defined by the Secretary under clause (ii)) 
            and apply the applicable provisions of this subsection 
            using a methodology in a manner that allows for separate 
            comparison of hospitals within each such group, as 
            determined by the Secretary.
                ``(ii) Defining groups.--For purposes of this 
            subparagraph, the Secretary shall define groups of 
            hospitals, based on their overall proportion, of the 
            inpatients who are entitled to, or enrolled for, benefits 
            under part A, and who are full-benefit dual eligible 
            individuals (as defined in section 1935(c)(6)). In defining 
            groups, the Secretary shall consult the Medicare Payment 
            Advisory Commission and may consider the analysis done by 
            such Commission in preparing the portion of its report 
            submitted to Congress in June 2013 relating to 
            readmissions.
                ``(iii) Minimizing reporting burden on hospitals.--In 
            carrying out this subparagraph, the Secretary shall not 
            impose any additional reporting requirements on hospitals.
                ``(iv) Budget neutral design methodology.--The 
            Secretary shall design the methodology to implement this 
            subparagraph so that the estimated total amount of 
            reductions in payments under this subsection equals the 
            estimated total amount of reductions in payments that would 
            otherwise occur under this subsection if this subparagraph 
            did not apply.''.
    (b) Changes in Risk Adjustment.--Section 1886(q)(3) of the Social 
Security Act (42 U.S.C. 1395ww(q)(3)), as amended by subsection (a), is 
further amended by adding at the end the following new subparagraph:
            ``(E) Changes in risk adjustment.--
                ``(i) Consideration of recommendations in impact 
            reports.--The Secretary may take into account the studies 
            conducted and the recommendations made by the Secretary 
            under section 2(d)(1) of the IMPACT Act of 2014 (Public Law 
            113-185; 42 U.S.C. 1395lll note) with respect to the 
            application under this subsection of risk adjustment 
            methodologies. Nothing in this clause shall be construed as 
            precluding consideration of the use of groupings of 
            hospitals.
                ``(ii) Consideration of exclusion of patient cases 
            based on v or other appropriate codes.--In promulgating 
            regulations to carry out this subsection with respect to 
            discharges occurring after fiscal year 2018, the Secretary 
            may consider the use of V or other ICD-related codes for 
            removal of a readmission. The Secretary may consider 
            modifying measures under this subsection to incorporate V 
            or other ICD-related codes at the same time as other 
            changes are being made under this subparagraph.
                ``(iii) Removal of certain readmissions.--In 
            promulgating regulations to carry out this subsection, with 
            respect to discharges occurring after fiscal year 2018, the 
            Secretary may consider removal as a readmission of an 
            admission that is classified within one or more of the 
            following: transplants, end-stage renal disease, burns, 
            trauma, psychosis, or substance abuse. The Secretary may 
            consider modifying measures under this subsection to remove 
            readmissions at the same time as other changes are being 
            made under this subparagraph.''.
    (c) MedPAC Study on Readmissions Program.--The Medicare Payment 
Advisory Commission shall conduct a study to review overall hospital 
readmissions described in section 1886(q)(5)(E) of the Social Security 
Act (42 U.S.C. 1395ww(q)(5)(E)) and whether such readmissions are 
related to any changes in outpatient and emergency services furnished. 
The Commission shall submit to Congress a report on such study in its 
report to Congress in June 2018.
SEC. 15003. FIVE-YEAR EXTENSION OF THE RURAL COMMUNITY HOSPITAL 
DEMONSTRATION PROGRAM.
    (a) Extension.--Section 410A of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (Public Law 108-173; 42 
U.S.C. 1395ww note) is amended--
        (1) in subsection (a)(5), by striking ``5-year extension 
    period'' and inserting ``10-year extension period''; and
        (2) in subsection (g)--
            (A) in the subsection heading, by striking ``Five-Year'' 
        and inserting ``Ten-Year'';
            (B) in paragraph (1), by striking ``additional 5-year'' and 
        inserting ``additional 10-year'';
            (C) by striking ``5-year extension period'' and inserting 
        ``10-year extension period'' each place it appears;
            (D) in paragraph (4)(B)--
                (i) in the matter preceding clause (i), by inserting 
            ``each 5-year period in'' after ``hospital during''; and
                (ii) in clause (i), by inserting ``each applicable 5-
            year period in'' after ``the first day of''; and
            (E) by adding at the end the following new paragraphs:
        ``(5) Other hospitals in demonstration program.--During the 
    second 5 years of the 10-year extension period, the Secretary shall 
    apply the provisions of paragraph (4) to rural community hospitals 
    that are not described in paragraph (4) but are participating in 
    the demonstration program under this section as of December 30, 
    2014, in a similar manner as such provisions apply to rural 
    community hospitals described in paragraph (4).
        ``(6) Expansion of demonstration program to rural areas in any 
    state.--
            ``(A) In general.--The Secretary shall, notwithstanding 
        subsection (a)(2) or paragraph (2) of this subsection, not 
        later than 120 days after the date of the enactment of this 
        paragraph, issue a solicitation for applications to select up 
        to the maximum number of additional rural community hospitals 
        located in any State to participate in the demonstration 
        program under this section for the second 5 years of the 10-
        year extension period without exceeding the limitation under 
        paragraph (3) of this subsection.
            ``(B) Priority.--In determining which rural community 
        hospitals that submitted an application pursuant to the 
        solicitation under subparagraph (A) to select for participation 
        in the demonstration program, the Secretary--
                ``(i) shall give priority to rural community hospitals 
            located in one of the 20 States with the lowest population 
            densities (as determined by the Secretary using the 2015 
            Statistical Abstract of the United States); and
                ``(ii) may consider--

                    ``(I) closures of hospitals located in rural areas 
                in the State in which the rural community hospital is 
                located during the 5-year period immediately preceding 
                the date of the enactment of this paragraph; and
                    ``(II) the population density of the State in which 
                the rural community hospital is located.''.

    (b) Change in Timing for Report.--Subsection (e) of such section 
410A is amended--
        (1) by striking ``Not later than 6 months after the completion 
    of the demonstration program under this section'' and inserting 
    ``Not later than August 1, 2018''; and
        (2) by striking ``such program'' and inserting ``the 
    demonstration program under this section''.
SEC. 15004. REGULATORY RELIEF FOR LTCHS.
    (a) Technical Change to the Medicare Long-Term Care Hospital 
Moratorium Exception.--
        (1) In general.--Section 114(d)(7) of the Medicare, Medicaid, 
    and SCHIP Extension Act of 2007 (42 U.S.C. 1395ww note), as amended 
    by sections 3106(b) and 10312(b) of Public Law 111-148, section 
    1206(b)(2) of the Pathway for SGR Reform Act of 2013 (division B of 
    Public Law 113-67), and section 112 of the Protecting Access to 
    Medicare Act of 2014 (Public Law 113-93), is amended by striking 
    ``The moratorium under paragraph (1)(A)'' and inserting ``Any 
    moratorium under paragraph (1)''.
        (2) Effective date.--The amendment made by paragraph (1) shall 
    take effect as if included in the enactment of section 112 of the 
    Protecting Access to Medicare Act of 2014.
    (b) Modification to Medicare Long-Term Care Hospital High Cost 
Outlier Payments.--Section 1886(m) of the Social Security Act (42 
U.S.C. 1395ww(m)) is amended by adding at the end the following new 
paragraph:
        ``(7) Treatment of high cost outlier payments.--
            ``(A) Adjustment to the standard federal payment rate for 
        estimated high cost outlier payments.--Under the system 
        described in paragraph (1), for fiscal years beginning on or 
        after October 1, 2017, the Secretary shall reduce the standard 
        Federal payment rate as if the estimated aggregate amount of 
        high cost outlier payments for standard Federal payment rate 
        discharges for each such fiscal year would be equal to 8 
        percent of estimated aggregate payments for standard Federal 
        payment rate discharges for each such fiscal year.
            ``(B) Limitation on high cost outlier payment amounts.--
        Notwithstanding subparagraph (A), the Secretary shall set the 
        fixed loss amount for high cost outlier payments such that the 
        estimated aggregate amount of high cost outlier payments made 
        for standard Federal payment rate discharges for fiscal years 
        beginning on or after October 1, 2017, shall be equal to 
        99.6875 percent of 8 percent of estimated aggregate payments 
        for standard Federal payment rate discharges for each such 
        fiscal year.
            ``(C) Waiver of budget neutrality.--Any reduction in 
        payments resulting from the application of subparagraph (B) 
        shall not be taken into account in applying any budget 
        neutrality provision under such system.
            ``(D) No effect on site neutral high cost outlier payment 
        rate.--This paragraph shall not apply with respect to the 
        computation of the applicable site neutral payment rate under 
        paragraph (6).''.
SEC. 15005. SAVINGS FROM IPPS MACRA PAY-FOR THROUGH NOT APPLYING 
DOCUMENTATION AND CODING ADJUSTMENTS.
    Section 7(b)(1)(B) of the TMA, Abstinence Education, and QI 
Programs Extension Act of 2007 (Public Law 110-90), as amended by 
section 631(b) of the American Taxpayer Relief Act of 2012 (Public Law 
112-240) and section 414(1)(B)(iii) of the Medicare Access and CHIP 
Reauthorization Act of 2015 (Public Law 114-10), is amended in clause 
(iii) by striking ``an increase of 0.5 percentage points for discharges 
occurring during each of fiscal years 2018 through 2023'' and inserting 
``an increase of 0.4588 percentage points for discharges occurring 
during fiscal year 2018 and 0.5 percentage points for discharges 
occurring during each of fiscal years 2019 through 2023''.
SEC. 15006. EXTENSION OF CERTAIN LTCH MEDICARE PAYMENT RULES.
    (a) 25-Percent Patient Threshold Payment Adjustment.--Section 
114(c)(1)(A) of the Medicare, Medicaid, and SCHIP Extension Act of 2007 
(42 U.S.C. 1395ww note), as amended by section 4302(a) of division B of 
the American Recovery and Reinvestment Act (Public Law 111-5), sections 
3106(a) and 10312(a) of Public Law 111-148, and section 1206(b)(1)(B) 
of the Pathway for SGR Reform Act of 2013 (division B of Public Law 
113-67), is amended by striking ``for a 9-year period'' and inserting 
``through June 30, 2016, and for discharges occurring on or after 
October 1, 2016, and before October 1, 2017''.
    (b) Payment for Hospitals-Within-Hospitals.--Section 114(c)(2) of 
the Medicare, Medicaid, and SCHIP Extension Act of 2007 (42 U.S.C. 
1395ww note), as amended by section 4302(a) of division B of the 
American Recovery and Reinvestment Act (Public Law 111-5), sections 
3106(a) and 10312(a) of Public Law 111-148, and section 1206(b)(1)(A) 
of the Pathway for SGR Reform Act of 2013 (division B of Public Law 
113-67), is amended--
        (1) in subparagraph (A), by inserting ``or any similar 
    provision,'' after ``Regulations,'';
        (2) in subparagraph (B)--
            (A) in clause (i), by inserting ``or any similar 
        provision,'' after ``Regulations,''; and
            (B) in clause (ii), by inserting ``, or any similar 
        provision,'' after ``Regulations''; and
        (3) in subparagraph (C), by striking ``for a 9-year period'' 
    and inserting ``through June 30, 2016, and for discharges occurring 
    on or after October 1, 2016, and before October 1, 2017''.
SEC. 15007. APPLICATION OF RULES ON THE CALCULATION OF HOSPITAL LENGTH 
OF STAY TO ALL LTCHS.
    (a) In General.--Section 1206(a)(3) of the Pathway for SGR Reform 
Act of 2013 (division B of Public Law 113-67; 42 U.S.C. 1395ww note) is 
amended--
        (1) by striking subparagraph (B);
        (2) by striking ``site neutral basis.--'' and all that follows 
    through ``For discharges occurring'' and inserting ``site neutral 
    basis.--For discharges occurring'';
        (3) by striking ``subject to subparagraph (B),''; and
        (4) by redesignating clauses (i) and (ii) as subparagraphs (A) 
    and (B), respectively, and moving each of such subparagraphs (as so 
    redesignated) 2 ems to the left.
    (b) Effective Date.--The amendments made by subsection (a) shall be 
effective as if included in the enactment of section 1206(a)(3) of the 
Pathway for SGR Reform Act of 2013 (division B of Public Law 113-67; 42 
U.S.C. 1395ww note).
SEC. 15008. CHANGE IN MEDICARE CLASSIFICATION FOR CERTAIN HOSPITALS.
    (a) In General.--Subsection (d)(1)(B)(iv) of section 1886 of the 
Social Security Act (42 U.S.C. 1395ww) is amended--
        (1) in subclause (I), by striking ``or'' at the end;
        (2) in subclause (II)--
            (A) by striking ``, or'' at the end and inserting a 
        semicolon;
            (B) by redesignating such subclause as clause (vi) and by 
        moving it to immediately follow clause (v); and
            (C) in clause (v), by striking the semicolon at the end and 
        inserting ``, or''; and
        (3) by striking ``(iv)(I) a hospital'' and inserting ``(iv) a 
    hospital''.
    (b) Conforming Payment References.--The second sentence of 
subsection (d)(1)(B) of such section is amended--
        (1) by inserting ``(as in effect as of such date)'' after 
    ``clause (iv)''; and
        (2) by inserting ``(or, in the case of a hospital described in 
    clause (iv)(II), as so in effect, shall be classified under clause 
    (vi) on and after the effective date of such clause (vi) and for 
    cost reporting periods beginning on or after January 1, 2015, shall 
    not be subject to subsection (m) as of the date of such 
    classification)'' after ``so classified''.
    (c) Application.--
        (1) In general.--For cost reporting periods beginning on or 
    after January 1, 2015, in the case of an applicable hospital (as 
    defined in paragraph (3)), the following shall apply:
            (A) Payment for inpatient operating costs shall be made on 
        a reasonable cost basis in the manner provided in section 
        412.526(c)(3) of title 42, Code of Federal Regulations (as in 
        effect on January 1, 2015) and in any subsequent modifications.
            (B) Payment for capital costs shall be made in the manner 
        provided by section 412.526(c)(4) of title 42, Code of Federal 
        Regulations (as in effect on such date).
            (C) Claims for payment for Medicare beneficiaries who are 
        discharged on or after January 1, 2017, shall be processed as 
        claims which are paid on a reasonable cost basis as described 
        in section 412.526(c) of title 42, Code of Federal Regulations 
        (as in effect on such date).
        (2) Applicable hospital defined.--In this subsection, the term 
    ``applicable hospital'' means a hospital that is classified under 
    clause (iv)(II) of section 1886(d)(1)(B) of the Social Security Act 
    (42 U.S.C. 1395ww(d)(1)(B)) on the day before the date of the 
    enactment of this Act and which is classified under clause (vi) of 
    such section, as redesignated and moved by subsection (a), on or 
    after such date of enactment.
    (d) Conforming Technical Amendments.--
        (1) Section 1899B(a)(2)(A)(iv) of the Social Security Act (42 
    U.S.C. 1395lll(a)(2)(A)(iv)) is amended by striking 
    ``1886(d)(1)(B)(iv)(II)'' and inserting ``1886(d)(1)(B)(vi)''.
        (2) Section 1886(m)(5)(F) of such Act (42 U.S.C. 
    1395ww(m)(5)(F)) is amended in each of clauses (i) and (ii) by 
    striking ``(d)(1)(B)(iv)(II)'' and inserting ``(d)(1)(B)(vi)''.
SEC. 15009. TEMPORARY EXCEPTION TO THE APPLICATION OF THE MEDICARE LTCH 
SITE NEUTRAL PROVISIONS FOR CERTAIN SPINAL CORD SPECIALTY HOSPITALS.
    (a) Exception.--Section 1886(m)(6) of the Social Security Act (42 
U.S.C. 1395ww(m)(6)) is amended--
        (1) in subparagraph (A)(i), by striking ``and (E)'' and 
    inserting ``, (E), and (F)''; and
        (2) by adding at the end the following new subparagraph:
            ``(F) Temporary exception for certain spinal cord specialty 
        hospitals.--For discharges in cost reporting periods beginning 
        during fiscal years 2018 and 2019, subparagraph (A)(i) shall 
        not apply (and payment shall be made to a long-term care 
        hospital without regard to this paragraph) if such discharge is 
        from a long-term care hospital that meets each of the following 
        requirements:
                ``(i) Not-for-profit.--The long-term care hospital was 
            a not-for-profit long-term care hospital on June 1, 2014, 
            as determined by cost report data.
                ``(ii) Primarily providing treatment for catastrophic 
            spinal cord or acquired brain injuries or other paralyzing 
            neuromuscular conditions.--Of the discharges in calendar 
            year 2013 from the long-term care hospital for which 
            payment was made under this section, at least 50 percent 
            were classified under MS-LTCH-DRGs 28, 29, 52, 57, 551, 
            573, and 963.
                ``(iii) Significant out-of-state admissions.--

                    ``(I) In general.--The long-term care hospital 
                discharged inpatients (including both individuals 
                entitled to, or enrolled for, benefits under this title 
                and individuals not so entitled or enrolled) during 
                fiscal year 2014 who had been admitted from at least 20 
                of the 50 States, determined by the States of residency 
                of such inpatients and based on such data submitted by 
                the hospital to the Secretary as the Secretary may 
                require.
                    ``(II) Implementation.--Notwithstanding any other 
                provision of law, the Secretary may implement subclause 
                (I) by program instruction or otherwise.
                    ``(III) Non-application of paperwork reduction 
                act.--Chapter 35 of title 44, United States Code, shall 
                not apply to data collected under this clause.''.

    (b) Study and Report on the Status and Viability of Certain Spinal 
Cord Specialty Long-Term Care Hospitals.--
        (1) Study.--The Comptroller General of the United States shall 
    conduct a study on long-term care hospitals described in section 
    1886(m)(6)(F) of the Social Security Act, as added by subsection 
    (a). Such report shall include an analysis of the following:
            (A) The impact on such hospitals of the classification and 
        facility licensure by State agencies of such hospitals.
            (B) The Medicare payment rates for such hospitals.
            (C) Data on the number and health care needs of Medicare 
        beneficiaries who have been diagnosed with catastrophic spinal 
        cord or acquired brain injuries or other paralyzing 
        neuromuscular conditions (as described within the discharge 
        classifications specified in clause (ii) of such section) who 
        are receiving services from such hospitals.
        (2) Report.--Not later than October 1, 2018, the Comptroller 
    General shall submit to Congress a report on the study conducted 
    under paragraph (1), including recommendations for such legislation 
    and administrative action as the Comptroller General determines 
    appropriate.
SEC. 15010. TEMPORARY EXTENSION TO THE APPLICATION OF THE MEDICARE LTCH 
SITE NEUTRAL PROVISIONS FOR CERTAIN DISCHARGES WITH SEVERE WOUNDS.
    (a) In General.--Section 1886(m)(6) of the Social Security Act (42 
U.S.C. 1395ww(m)(6)), as amended by section 15009, is further amended--
        (1) in subparagraph (A)(i) by striking ``and (F)'' and 
    inserting ``(F), and (G)'';
        (2) in subparagraph (E)(i)(I)(aa), by striking ``the amendment 
    made'' and all that follows before the semicolon and inserting 
    ``the last sentence of subsection (d)(1)(B)''; and
        (3) by adding at the end the following new subparagraph:
            ``(G) Additional temporary exception for certain severe 
        wound discharges from certain long-term care hospitals.--
                ``(i) In general.--For a discharge occurring in a cost 
            reporting period beginning during fiscal year 2018, 
            subparagraph (A)(i) shall not apply (and payment shall be 
            made to a long-term care hospital without regard to this 
            paragraph) if such discharge--

                    ``(I) is from a long-term care hospital identified 
                by the last sentence of subsection (d)(1)(B);
                    ``(II) is classified under MS-LTCH-DRG 602, 603, 
                539, or 540; and
                    ``(III) is with respect to an individual treated by 
                a long-term care hospital for a severe wound.

                ``(ii) Severe wound defined.--In this subparagraph, the 
            term `severe wound' means a wound which is a stage 3 wound, 
            stage 4 wound, unstageable wound, non-healing surgical 
            wound, or fistula as identified in the claim from the long-
            term care hospital.
                ``(iii) Wound defined.--In this subparagraph, the term 
            `wound' means an injury involving division of tissue or 
            rupture of the integument or mucous membrane with exposure 
            to the external environment.''.
    (c) Study and Report to Congress.--
        (1) Study.--The Comptroller General of the United States shall, 
    in consultation with relevant stakeholders, conduct a study on the 
    treatment needs of individuals entitled to benefits under part A of 
    title XVIII of the Social Security Act or enrolled under part B of 
    such title who require specialized wound care, and the cost, for 
    such individuals and the Medicare program under such title, of 
    treating severe wounds in rural and urban areas. Such study shall 
    include an assessment of--
            (A) access of such individuals to appropriate levels of 
        care for such cases;
            (B) the potential impact that section 1886(m)(6)(A)(i) of 
        such Act (42 U.S.C. 1395ww(m)(6)(A)(i)) will have on the 
        access, quality, and cost of care for such individuals; and
            (C) how to appropriately pay for such care under the 
        Medicare program under such title.
        (2) Report.--Not later than October 1, 2020, the Comptroller 
    General shall submit to Congress a report on the study conducted 
    under paragraph (1), including recommendations for such legislation 
    and administrative action as the Comptroller General determines 
    appropriate.

           TITLE XVI--PROVISIONS RELATING TO MEDICARE PART B

SEC. 16001. CONTINUING MEDICARE PAYMENT UNDER HOPD PROSPECTIVE PAYMENT 
SYSTEM FOR SERVICES FURNISHED BY MID-BUILD OFF-CAMPUS OUTPATIENT 
DEPARTMENTS OF PROVIDERS.
    (a) In General.--Section 1833(t)(21) of the Social Security Act (42 
U.S.C. 1395l(t)(21)) is amended--
        (1) in subparagraph (B)--
            (A) in clause (i), by striking ``clause (ii)'' and 
        inserting ``the subsequent provisions of this subparagraph''; 
        and
            (B) by adding at the end the following new clauses:
                ``(iii) Deemed treatment for 2017.--For purposes of 
            applying clause (ii) with respect to applicable items and 
            services furnished during 2017, a department of a provider 
            (as so defined) not described in such clause is deemed to 
            be billing under this subsection with respect to covered 
            OPD services furnished prior to November 2, 2015, if the 
            Secretary received from the provider prior to December 2, 
            2015, an attestation (pursuant to section 413.65(b)(3) of 
            title 42 of the Code of Federal Regulations) that such 
            department was a department of a provider (as so defined).
                ``(iv) Alternative exception beginning with 2018.--For 
            purposes of paragraph (1)(B)(v) and this paragraph with 
            respect to applicable items and services furnished during 
            2018 or a subsequent year, the term `off-campus outpatient 
            department of a provider' also shall not include a 
            department of a provider (as so defined) that is not 
            described in clause (ii) if--

                    ``(I) the Secretary receives from the provider an 
                attestation (pursuant to such section 413.65(b)(3)) not 
                later than December 31, 2016 (or, if later, 60 days 
                after the date of the enactment of this clause), that 
                such department met the requirements of a department of 
                a provider specified in section 413.65 of title 42 of 
                the Code of Federal Regulations;
                    ``(II) the provider includes such department as 
                part of the provider on its enrollment form in 
                accordance with the enrollment process under section 
                1866(j); and
                    ``(III) the department met the mid-build 
                requirement of clause (v) and the Secretary receives, 
                not later than 60 days after the date of the enactment 
                of this clause, from the chief executive officer or 
                chief operating officer of the provider a written 
                certification that the department met such requirement.

                ``(v) Mid-build requirement described.--The mid-build 
            requirement of this clause is, with respect to a department 
            of a provider, that before November 2, 2015, the provider 
            had a binding written agreement with an outside unrelated 
            party for the actual construction of such department.
                ``(vii) Audit.--Not later than December 31, 2018, the 
            Secretary shall audit the compliance with requirements of 
            clause (iv) with respect to each department of a provider 
            to which such clause applies. If the Secretary finds as a 
            result of an audit under this clause that the applicable 
            requirements were not met with respect to such department, 
            the department shall not be excluded from the term `off-
            campus outpatient department of a provider' under such 
            clause.
                ``(viii) Implementation.--For purposes of implementing 
            clauses (iii) through (vii):

                    ``(I) Notwithstanding any other provision of law, 
                the Secretary may implement such clauses by program 
                instruction or otherwise.
                    ``(II) Subchapter I of chapter 35 of title 44, 
                United States Code, shall not apply.
                    ``(III) For purposes of carrying out this 
                subparagraph with respect to clauses (iii) and (iv) 
                (and clause (vii) insofar as it relates to clause 
                (iv)), $10,000,000 shall be available from the Federal 
                Supplementary Medical Insurance Trust Fund under 
                section 1841, to remain available until December 31, 
                2018.''; and

        (2) in subparagraph (E), by adding at the end the following new 
    clause:
                ``(iv) The determination of an audit under subparagraph 
            (B)(vii).''.
    (b) Effective Date.--The amendments made by this section shall be 
effective as if included in the enactment of section 603 of the 
Bipartisan Budget Act of 2015 (Public Law 114-74).
SEC. 16002. TREATMENT OF CANCER HOSPITALS IN OFF-CAMPUS OUTPATIENT 
DEPARTMENT OF A PROVIDER POLICY.
    (a) In General.--Section 1833(t)(21)(B) of the Social Security Act 
(42 U.S.C. 1395l(t)(21)(B)), as amended by section 16001(a), is 
amended--
        (1) by inserting after clause (v) the following new clause:
                ``(vi) Exclusion for certain cancer hospitals.--For 
            purposes of paragraph (1)(B)(v) and this paragraph with 
            respect to applicable items and services furnished during 
            2017 or a subsequent year, the term `off-campus outpatient 
            department of a provider' also shall not include a 
            department of a provider (as so defined) that is not 
            described in clause (ii) if the provider is a hospital 
            described in section 1886(d)(1)(B)(v) and--

                    ``(I) in the case of a department that met the 
                requirements of section 413.65 of title 42 of the Code 
                of Federal Regulations after November 1, 2015, and 
                before the date of the enactment of this clause, the 
                Secretary receives from the provider an attestation 
                that such department met such requirements not later 
                than 60 days after such date of enactment; or
                    ``(II) in the case of a department that meets such 
                requirements after such date of enactment, the 
                Secretary receives from the provider an attestation 
                that such department meets such requirements not later 
                than 60 days after the date such requirements are first 
                met with respect to such department.'';

        (2) in clause (vii), by inserting after the first sentence the 
    following: ``Not later than 2 years after the date the Secretary 
    receives an attestation under clause (vi) relating to compliance of 
    a department of a provider with requirements referred to in such 
    clause, the Secretary shall audit the compliance with such 
    requirements with respect to the department.''; and
        (3) in clause (viii)(III), by adding at the end the following: 
    ``For purposes of carrying out this subparagraph with respect to 
    clause (vi) (and clause (vii) insofar as it relates to such 
    clause), $2,000,000 shall be available from the Federal 
    Supplementary Medical Insurance Trust Fund under section 1841, to 
    remain available until expended.''.
    (b) Offsetting Savings.--Section 1833(t)(18) of the Social Security 
Act (42 U.S.C. 1395l(t)(18)) is amended--
        (1) in subparagraph (B), by inserting ``, subject to 
    subparagraph (C),'' after ``shall''; and
        (2) by adding at the end the following new subparagraph:
            ``(C) Target pcr adjustment.--In applying section 419.43(i) 
        of title 42 of the Code of Federal Regulations to implement the 
        appropriate adjustment under this paragraph for services 
        furnished on or after January 1, 2018, the Secretary shall use 
        a target PCR that is 1.0 percentage points less than the target 
        PCR that would otherwise apply. In addition to the percentage 
        point reduction under the previous sentence, the Secretary may 
        consider making an additional percentage point reduction to 
        such target PCR that takes into account payment rates for 
        applicable items and services described in paragraph (21)(C) 
        other than for services furnished by hospitals described in 
        section 1886(d)(1)(B)(v). In making any budget neutrality 
        adjustments under this subsection for 2018 or a subsequent 
        year, the Secretary shall not take into account the reduced 
        expenditures that result from the application of this 
        subparagraph.''.
    (c) Effective Date.--The amendments made by this section shall be 
effective as if included in the enactment of section 603 of the 
Bipartisan Budget Act of 2015 (Public Law 114-74).
SEC. 16003. TREATMENT OF ELIGIBLE PROFESSIONALS IN AMBULATORY SURGICAL 
CENTERS FOR MEANINGFUL USE AND MIPS.
    Section 1848(a)(7)(D) of the Social Security Act (42 U.S.C. 1395w-
4(a)(7)(D)) is amended--
        (1) by striking ``hospital-based eligible professionals'' and 
    all that follows through ``No payment'' and inserting the 
    following: ``hospital-based and ambulatory surgical center-based 
    eligible professionals.--
                ``(i) Hospital-based.--No payment''; and
        (2) by adding at the end the following new clauses:
                ``(ii) Ambulatory surgical center-based.--Subject to 
            clause (iv), no payment adjustment may be made under 
            subparagraph (A) for 2017 and 2018 in the case of an 
            eligible professional with respect to whom substantially 
            all of the covered professional services furnished by such 
            professional are furnished in an ambulatory surgical 
            center.
                ``(iii) Determination.--The determination of whether an 
            eligible professional is an eligible professional described 
            in clause (ii) may be made on the basis of--

                    ``(I) the site of service (as defined by the 
                Secretary); or
                    ``(II) an attestation submitted by the eligible 
                professional.

            Determinations made under subclauses (I) and (II) shall be 
            made without regard to any employment or billing 
            arrangement between the eligible professional and any other 
            supplier or provider of services.
                ``(iv) Sunset.--Clause (ii) shall no longer apply as of 
            the first year that begins more than 3 years after the date 
            on which the Secretary determines, through notice and 
            comment rulemaking, that certified EHR technology 
            applicable to the ambulatory surgical center setting is 
            available.''.
SEC. 16004. CONTINUING ACCESS TO HOSPITALS ACT OF 2016.
    (a) Extension of Enforcement Instruction on Supervision 
Requirements for Outpatient Therapeutic Services in Critical Access and 
Small Rural Hospitals Through 2016.--Section 1 of Public Law 113-198, 
as amended by section 1 of Public Law 114-112, is amended--
        (1) in the heading, by striking ``2014 and 2015'' and inserting 
    ``2016''; and
        (2) by striking ``and 2015'' and inserting ``, 2015, and 
    2016''.
    (b) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Medicare Payment Advisory Commission (established 
under section 1805 of the Social Security Act (42 U.S.C. 1395b-6)) 
shall submit to Congress a report analyzing the effect of the extension 
of the enforcement instruction under section 1 of Public Law 113-198, 
as amended by section 1 of Public Law 114-112 and subsection (a) of 
this section, on the access to health care by Medicare beneficiaries, 
on the economic impact and the impact upon hospital staffing needs, and 
on the quality of health care furnished to such beneficiaries.
SEC. 16005. DELAY OF IMPLEMENTATION OF MEDICARE FEE SCHEDULE 
ADJUSTMENTS FOR WHEELCHAIR ACCESSORIES AND SEATING SYSTEMS WHEN USED IN 
CONJUNCTION WITH COMPLEX REHABILITATION TECHNOLOGY (CRT) WHEELCHAIRS.
    Section 2(a) of the Patient Access and Medicare Protection Act (42 
U.S.C. 1305 note) is amended by striking ``January 1, 2017'' and 
inserting ``July 1, 2017''.
SEC. 16006. ALLOWING PHYSICAL THERAPISTS TO UTILIZE LOCUM TENENS 
ARRANGEMENTS UNDER MEDICARE.
    (a) In General.--The first sentence of section 1842(b)(6) of the 
Social Security Act (42 U.S.C. 1395u(b)(6)), as amended by section 
5012, is further amended--
        (1) by striking ``and'' before ``(I)''; and
        (2) by inserting before the period at the end the following: 
    ``, and (J) in the case of outpatient physical therapy services 
    furnished by physical therapists in a health professional shortage 
    area (as defined in section 332(a)(1)(A) of the Public Health 
    Service Act), a medically underserved area (as designated pursuant 
    to section 330(b)(3)(A) of such Act), or a rural area (as defined 
    in section 1886(d)(2)(D)), subparagraph (D) of this sentence shall 
    apply to such services and therapists in the same manner as such 
    subparagraph applies to physicians' services furnished by 
    physicians''.
    (b) Effective Date; Implementation.--
        (1) Effective date.--The amendments made by subsection (a) 
    shall apply to services furnished beginning not later than six 
    months after the date of the enactment of this Act.
        (2) Implementation.--The Secretary of Health and Human Services 
    may implement subparagraph (J) of section 1842(b)(6) of the Social 
    Security Act (42 U.S.C. 1395u(b)(6)), as added by subsection 
    (a)(2), by program instruction or otherwise.
SEC. 16007. EXTENSION OF THE TRANSITION TO NEW PAYMENT RATES FOR 
DURABLE MEDICAL EQUIPMENT UNDER THE MEDICARE PROGRAM.
    (a) In General.--The Secretary of Health and Human Services shall 
extend the transition period described in clause (i) of section 
414.210(g)(9) of title 42, Code of Federal Regulations, from June 30, 
2016, to December 31, 2016 (with the full implementation described in 
clause (ii) of such section applying to items and services furnished 
with dates of service on or after January 1, 2017).
    (b) Study and Report.--
        (1) Study.--
            (A) In general.--The Secretary of Health and Human Services 
        shall conduct a study that examines the impact of applicable 
        payment adjustments upon--
                (i) the number of suppliers of durable medical 
            equipment that, on a date that is not before January 1, 
            2016, and not later than December 31, 2016, ceased to 
            conduct business as such suppliers; and
                (ii) the availability of durable medical equipment, 
            during the period beginning on January 1, 2016, and ending 
            on December 31, 2016, to individuals entitled to benefits 
            under part A of title XVIII of the Social Security Act (42 
            U.S.C. 1395 et seq.) or enrolled under part B of such 
            title.
            (B) Definitions.--For purposes of this subsection, the 
        following definitions apply:
                (i) Supplier; durable medical equipment.--The terms 
            ``supplier'' and ``durable medical equipment'' have the 
            meanings given such terms by section 1861 of the Social 
            Security Act (42 U.S.C. 1395x).
                (ii) Applicable payment adjustment.--The term 
            ``applicable payment adjustment'' means a payment 
            adjustment described in section 414.210(g) of title 42, 
            Code of Federal Regulations, that is phased in by paragraph 
            (9)(i) of such section. For purposes of the preceding 
            sentence, a payment adjustment that is phased in pursuant 
            to the extension under subsection (a) shall be considered a 
            payment adjustment that is phased in by such paragraph 
            (9)(i).
        (2) Report.--The Secretary of Health and Human Services shall, 
    not later than January 12, 2017, submit to the Committees on Ways 
    and Means and on Energy and Commerce of the House of 
    Representatives, and to the Committee on Finance of the Senate, a 
    report on the findings of the study conducted under paragraph (1).
SEC. 16008. REQUIREMENTS IN DETERMINING ADJUSTMENTS USING INFORMATION 
FROM COMPETITIVE BIDDING PROGRAMS.
    (a) In General.--Section 1834(a)(1)(G) of the Social Security Act 
(42 U.S.C. 1395m(a)(1)(G)) is amended by adding at the end the 
following new sentence: ``In the case of items and services furnished 
on or after January 1, 2019, in making any adjustments under clause 
(ii) or (iii) of subparagraph (F), under subsection (h)(1)(H)(ii), or 
under section 1842(s)(3)(B), the Secretary shall--
                ``(i) solicit and take into account stakeholder input; 
            and
                ``(ii) take into account the highest amount bid by a 
            winning supplier in a competitive acquisition area and a 
            comparison of each of the following with respect to non-
            competitive acquisition areas and competitive acquisition 
            areas:

                    ``(I) The average travel distance and cost 
                associated with furnishing items and services in the 
                area.
                    ``(II) The average volume of items and services 
                furnished by suppliers in the area.
                    ``(III) The number of suppliers in the area.''.

    (b) Conforming Amendments.--(1) Section 1834(h)(1)(H)(ii) of the 
Social Security Act (42 U.S.C. 1395m(h)(1)(H)(ii)) is amended by 
striking ``the Secretary'' and inserting ``subject to subsection 
(a)(1)(G), the Secretary''.
    (2) Section 1842(s)(3)(B) of the Social Security Act (42 U.S.C. 
1395m(s)(3)(B)) is amended by striking ``the Secretary'' and inserting 
``subject to section 1834(a)(1)(G), the Secretary''.

                 TITLE XVII--OTHER MEDICARE PROVISIONS

SEC. 17001. DELAY IN AUTHORITY TO TERMINATE CONTRACTS FOR MEDICARE 
ADVANTAGE PLANS FAILING TO ACHIEVE MINIMUM QUALITY RATINGS.
    (a) Findings.--Consistent with the studies provided under the 
IMPACT Act of 2014 (Public Law 113-185), it is the intent of Congress--
        (1) to continue to study and request input on the effects of 
    socioeconomic status and dual-eligible populations on the Medicare 
    Advantage STARS rating system before reforming such system with the 
    input of stakeholders; and
        (2) pending the results of such studies and input, to provide 
    for a temporary delay in authority of the Centers for Medicare & 
    Medicaid Services (CMS) to terminate Medicare Advantage plan 
    contracts solely on the basis of performance of plans under the 
    STARS rating system.
    (b) Delay in MA Contract Termination Authority for Plans Failing To 
Achieve Minimum Quality Ratings.--Section 1857(h) of the Social 
Security Act (42 U.S.C. 1395w-27(h)) is amended by adding at the end 
the following new paragraph:
        ``(3) Delay in contract termination authority for plans failing 
    to achieve minimum quality rating.--During the period beginning on 
    the date of the enactment of this paragraph and through the end of 
    plan year 2018, the Secretary may not terminate a contract under 
    this section with respect to the offering of an MA plan by a 
    Medicare Advantage organization solely because the MA plan has 
    failed to achieve a minimum quality rating under the 5-star rating 
    system under section 1853(o)(4).''.
SEC. 17002. REQUIREMENT FOR ENROLLMENT DATA REPORTING FOR MEDICARE.
    Section 1874 of the Social Security Act (42 U.S.C. 1395kk) is 
amended by adding at the end the following new subsection:
    ``(g) Requirement for Enrollment Data Reporting.--
        ``(1) In general.--Each year (beginning with 2016), the 
    Secretary shall submit to the Committees on Ways and Means and 
    Energy and Commerce of the House of Representatives and the 
    Committee on Finance of the Senate a report on Medicare enrollment 
    data (and, in the case of part A, on data on individuals receiving 
    benefits under such part) as of a date in such year specified by 
    the Secretary. Such data shall be presented--
            ``(A) by Congressional district and State; and
            ``(B) in a manner that provides for such data based on--
                ``(i) fee-for-service enrollment (as defined in 
            paragraph (2));
                ``(ii) enrollment under part C (including separate for 
            aggregate enrollment in MA-PD plans and aggregate 
            enrollment in MA plans that are not MA-PD plans); and
                ``(iii) enrollment under part D.
        ``(2) Fee-for-service enrollment defined.--For purpose of 
    paragraph (1)(B)(i), the term `fee-for-service enrollment' means 
    aggregate enrollment (including receipt of benefits other than 
    through enrollment) under--
            ``(A) part A only;
            ``(B) part B only; and
            ``(C) both part A and part B.''.
SEC. 17003. UPDATING THE WELCOME TO MEDICARE PACKAGE.
    (a) In General.--Not later than 12 months after the last day of the 
period for the request of information described in subsection (b), the 
Secretary of Health and Human Services shall, taking into consideration 
information collected pursuant to subsection (b), update the 
information included in the Welcome to Medicare package to include 
information, presented in a clear and simple manner, about options for 
receiving benefits under the Medicare program under title XVIII of the 
Social Security Act (42 U.S.C. 1395 et seq.), including through the 
original medicare fee-for-service program under parts A and B of such 
title (42 U.S.C. 1395c et seq., 42 U.S.C. 1395j et seq.), Medicare 
Advantage plans under part C of such title (42 U.S.C. 1395w-21 et 
seq.), and prescription drug plans under part D of such title (42 
U.S.C. 1395w-101 et seq.)). The Secretary shall make subsequent updates 
to the information included in the Welcome to Medicare package as 
appropriate.
    (b) Request for Information.--Not later than 6 months after the 
date of the enactment of this Act, the Secretary of Health and Human 
Services shall request information, including recommendations, from 
stakeholders (including patient advocates, issuers, and employers) on 
information included in the Welcome to Medicare package, including 
pertinent data and information regarding enrollment and coverage for 
Medicare eligible individuals.
SEC. 17004. NO PAYMENT FOR ITEMS AND SERVICES FURNISHED BY NEWLY 
ENROLLED PROVIDERS OR SUPPLIERS WITHIN A TEMPORARY MORATORIUM AREA.
    (a) Medicare.--Section 1866(j)(7) of the Social Security Act (42 
U.S.C. 1395cc(j)(7)) is amended--
        (1) in the paragraph heading, by inserting ``; nonpayment'' 
    before the period; and
        (2) by adding at the end the following new subparagraph:
            ``(C) Nonpayment.--
                ``(i) In general.--No payment may be made under this 
            title or under a program described in subparagraph (A) with 
            respect to an item or service described in clause (ii) 
            furnished on or after October 1, 2017.
                ``(ii) Item or service described.--An item or service 
            described in this clause is an item or service furnished--

                    ``(I) within a geographic area with respect to 
                which a temporary moratorium imposed under subparagraph 
                (A) is in effect; and
                    ``(II) by a provider of services or supplier that 
                meets the requirements of clause (iii).

                ``(iii) Requirements.--For purposes of clause (ii), the 
            requirements of this clause are that a provider of services 
            or supplier--

                    ``(I) enrolls under this title on or after the 
                effective date of such temporary moratorium; and
                    ``(II) is within a category of providers of 
                services and suppliers (as described in subparagraph 
                (A)) subject to such temporary moratorium.

                ``(iv) Prohibition on charges for specified items or 
            services.--In no case shall a provider of services or 
            supplier described in clause (ii)(II) charge an individual 
            or other person for an item or service described in clause 
            (ii) furnished on or after October 1, 2017, to an 
            individual entitled to benefits under part A or enrolled 
            under part B or an individual under a program specified in 
            subparagraph (A).''.
    (b) Conforming Amendments.--
        (1) Medicaid.--
            (A) In general.--Section 1903(i)(2) of the Social Security 
        Act (42 U.S.C. 1396b(i)(2)), as amended by section 5005(a)(4), 
        is further amended--
                (i) in subparagraph (C), by striking ``or'' at the end; 
            and
                (ii) by adding at the end the following new 
            subparagraph:
            ``(E) with respect to any amount expended for such an item 
        or service furnished during calendar quarters beginning on or 
        after October 1, 2017, subject to section 
        1902(kk)(4)(A)(ii)(II), within a geographic area that is 
        subject to a moratorium imposed under section 1866(j)(7) by a 
        provider or supplier that meets the requirements specified in 
        subparagraph (C)(iii) of such section, during the period of 
        such moratorium; or''.
            (B) Exception with respect to access.--Section 
        1902(kk)(4)(A)(ii) of the Social Security Act (42 U.S.C. 
        1396a(kk)(4)(A)(ii)) is amended to read as follows:
                ``(ii) Exceptions.--

                    ``(I) Compliance with moratorium.--A State shall 
                not be required to comply with a temporary moratorium 
                described in clause (i) if the State determines that 
                the imposition of such temporary moratorium would 
                adversely impact beneficiaries' access to medical 
                assistance.
                    ``(II) FFP available.--Notwithstanding section 
                1903(i)(2)(E), payment may be made to a State under 
                this title with respect to amounts expended for items 
                and services described in such section if the 
                Secretary, in consultation with the State agency 
                administering the State plan under this title (or a 
                waiver of the plan), determines that denying payment to 
                the State pursuant to such section would adversely 
                impact beneficiaries' access to medical assistance. ''.

            (C) State plan requirement with respect to limitation on 
        charges to beneficiaries.--Section 1902(kk)(4)(A) of the Social 
        Security Act (42 U.S.C. 1396a(kk)(4)(A)) is amended by adding 
        at the end the following new clause:
                ``(iii) Limitation on charges to beneficiaries.--With 
            respect to any amount expended for items or services 
            furnished during calendar quarters beginning on or after 
            October 1, 2017, the State prohibits, during the period of 
            a temporary moratorium described in clause (i), a provider 
            meeting the requirements specified in subparagraph (C)(iii) 
            of section 1866(j)(7) from charging an individual or other 
            person eligible to receive medical assistance under the 
            State plan under this title (or a waiver of the plan) for 
            an item or service described in section 1903(i)(2)(E) 
            furnished to such an individual.''.
        (2) Correcting amendments to related provisions.--
            (A) Section 1866(j).--Section 1866(j) of the Social 
        Security Act (42 U.S.C. 1395cc(j)) is amended--
                (i) in paragraph (1)(A)--

                    (I) by striking ``paragraph (4)'' and inserting 
                ``paragraph (5)'';
                    (II) by striking ``moratoria in accordance with 
                paragraph (5)'' and inserting ``moratoria in accordance 
                with paragraph (7)''; and
                    (III) by striking ``paragraph (6)'' and inserting 
                ``paragraph (9)''; and

                (ii) by redesignating the second paragraph (8) 
            (redesignated by section 1304(1) of Public Law 111-152) as 
            paragraph (9).
            (B) Section 1902(kk).--Section 1902(kk) of such Act (42 
        U.S.C. 1396a(kk)) is amended--
                (i) in paragraph (1), by striking ``section 
            1886(j)(2)'' and inserting ``section 1866(j)(2)'';
                (ii) in paragraph (2), by striking ``section 
            1886(j)(3)'' and inserting ``section 1866(j)(3)'';
                (iii) in paragraph (3), by striking ``section 
            1886(j)(4)'' and inserting ``section 1866(j)(5)''; and
                (iv) in paragraph (4)(A), by striking ``section 
            1886(j)(6)'' and inserting ``section 1866(j)(7)''.
SEC. 17005. PRESERVATION OF MEDICARE BENEFICIARY CHOICE UNDER MEDICARE 
ADVANTAGE.
    Section 1851(e)(2) of the Social Security Act (42 U.S.C. 1395w-
21(e)(2)) is amended--
        (1) in subparagraph (C)--
            (A) in the heading, by inserting ``from 2011 through 2018'' 
        after ``45-day period''; and
            (B) by inserting ``and ending with 2018'' after ``beginning 
        with 2011''; and
        (2) by adding at the end the following new subparagraph:
            ``(G) Continuous open enrollment and disenrollment for 
        first 3 months in 2016 and subsequent years.--
                ``(i) In general.--Subject to clause (ii) and 
            subparagraph (D)--

                    ``(I) in the case of an MA eligible individual who 
                is enrolled in an MA plan, at any time during the first 
                3 months of a year (beginning with 2019); or
                    ``(II) in the case of an individual who first 
                becomes an MA eligible individual during a year 
                (beginning with 2019) and enrolls in an MA plan, during 
                the first 3 months during such year in which the 
                individual is an MA eligible individual;

            such MA eligible individual may change the election under 
            subsection (a)(1).
                ``(ii) Limitation of one change during open enrollment 
            period each year.--An individual may change the election 
            pursuant to clause (i) only once during the applicable 3-
            month period described in such clause in each year. The 
            limitation under this clause shall not apply to changes in 
            elections effected during an annual, coordinated election 
            period under paragraph (3) or during a special enrollment 
            period under paragraph (4).
                ``(iii) Limited application to part d.--Clauses (i) and 
            (ii) of this subparagraph shall only apply with respect to 
            changes in enrollment in a prescription drug plan under 
            part D in the case of an individual who, previous to such 
            change in enrollment, is enrolled in a Medicare Advantage 
            plan.
                ``(iv) Limitations on marketing.-- Pursuant to 
            subsection (j), no unsolicited marketing or marketing 
            materials may be sent to an individual described in clause 
            (i) during the continuous open enrollment and disenrollment 
            period established for the individual under such clause, 
            notwithstanding marketing guidelines established by the 
            Centers for Medicare & Medicaid Services.''.
SEC. 17006. ALLOWING END-STAGE RENAL DISEASE BENEFICIARIES TO CHOOSE A 
MEDICARE ADVANTAGE PLAN.
    (a) Removing Prohibition.--
        (1) In general.--Section 1851(a)(3) of the Social Security Act 
    (42 U.S.C. 1395w-21(a)(3)) is amended--
            (A) by striking subparagraph (B); and
            (B) by striking ``eligible individual'' and all that 
        follows through ``In this title, subject to subparagraph (B),'' 
        and inserting ``eligible individual.--In this title,''.
        (2) Conforming amendments.--
            (A) Section 1852(b)(1) of the Social Security Act (42 
        U.S.C. 1395w-22(b)(1)) is amended--
                (i) by striking subparagraph (B); and
                (ii) by striking ``Beneficiaries'' and all that follows 
            through ``A Medicare+Choice organization'' and inserting 
            ``Beneficiaries.--A Medicare Advantage organization''.
            (B) Section 1859(b)(6) of the Social Security Act (42 
        U.S.C. 1395w-28(b)(6)) is amended, in the last sentence, by 
        striking ``may waive'' and all that follows through 
        ``subparagraph and''.
        (3) Effective date.--The amendments made by this subsection 
    shall apply with respect to plan years beginning on or after 
    January 1, 2021.
    (b) Excluding Costs for Kidney Acquisitions From MA Benchmark.--
Section 1853 of the Social Security Act (42 U.S.C. 1395w-23) is 
amended--
        (1) in subsection (k)--
            (A) in paragraph (1)--
                (i) in the matter preceding subparagraph (A), by 
            striking ``paragraphs (2) and (4)'' and inserting 
            ``paragraphs (2), (4), and (5)''; and
                (ii) in subparagraph (B)(i), by striking ``paragraphs 
            (2) and (4)'' and inserting ``paragraphs (2), (4), and 
            (5)''; and
            (B) by adding at the end the following new paragraph:
        ``(5) Exclusion of costs for kidney acquisitions from 
    capitation rates.--After determining the applicable amount for an 
    area for a year under paragraph (1) (beginning with 2021), the 
    Secretary shall adjust such applicable amount to exclude from such 
    applicable amount the Secretary's estimate of the standardized 
    costs for payments for organ acquisitions for kidney transplants 
    covered under this title (including expenses covered under section 
    1881(d)) in the area for the year.''; and
        (2) in subsection (n)(2)--
            (A) in subparagraph (A)(i), by inserting ``and, for 2021 
        and subsequent years, the exclusion of payments for organ 
        acquisitions for kidney transplants from the capitation rate as 
        described in subsection (k)(5)'' before the semicolon at the 
        end;
            (B) in subparagraph (E), in the matter preceding clause 
        (i), by striking ``subparagraph (F)'' and inserting 
        ``subparagraphs (F) and (G)''; and
            (C) by adding at the end the following new subparagraph:
            ``(G) Application of kidney acquisitions adjustment.--The 
        base payment amount specified in subparagraph (E) for a year 
        (beginning with 2021) shall be adjusted in the same manner 
        under paragraph (5) of subsection (k) as the applicable amount 
        is adjusted under such subsection.''.
    (c) FFS Coverage of Kidney Acquisitions.--
        (1) In general.--Section 1852(a)(1)(B)(i) of the Social 
    Security Act (42 U.S.C. 1395w-22(a)(1)(B)(i)) is amended by 
    inserting ``or coverage for organ acquisitions for kidney 
    transplants, including as covered under section 1881(d)'' after 
    ``hospice care''.
        (2) Conforming amendment.--Section 1851(i) of the Social 
    Security Act (42 U.S.C. 1395w-21(i)) is amended by adding at the 
    end the following new paragraph:
        ``(3) FFS payment for expenses for kidney acquisitions.--
    Paragraphs (1) and (2) shall not apply with respect to expenses for 
    organ acquisitions for kidney transplants described in section 
    1852(a)(1)(B)(i).''.
        (3) Effective date.--The amendments made by this subsection 
    shall apply with respect to plan years beginning on or after 
    January 1, 2021.
    (d) Evaluation of Quality.--
        (1) In general.--The Secretary of Health and Human Services (in 
    this subsection referred to as the ``Secretary'') shall conduct an 
    evaluation of whether the 5-star rating system based on the data 
    collected under section 1852(e) of the Social Security Act (42 
    U.S.C. 1395w-22(e)) should include a quality measure specifically 
    related to care for enrollees in Medicare Advantage plans under 
    part C of title XVIII of such Act determined to have end-stage 
    renal disease.
        (2) Public availability.--Not later than April 1, 2020, the 
    Secretary shall post on the Internet website of the Centers for 
    Medicare & Medicaid Services the results of the evaluation under 
    paragraph (1).
    (e) Report.--Not later than December 31, 2023, the Secretary of 
Health and Human Services (in this subsection referred to as the 
``Secretary'') shall submit to Congress a report on the impact of the 
provisions of, and amendments made by, this section with respect to the 
following:
        (1) Spending under--
            (A) the original Medicare fee-for-service program under 
        parts A and B of title XVIII of the Social Security Act; and
            (B) the Medicare Advantage program under part C of such 
        title.
        (2) The number of enrollees determined to have end-stage renal 
    disease--
            (A) in the original Medicare fee-for-service program; and
            (B) in the Medicare Advantage program.
        (3) The sufficiency of the amount of data under the original 
    Medicare fee-for-service program for individuals determined to have 
    end-stage renal disease for purposes of determining payment rates 
    for end-stage renal disease under the Medicare Advantage program.
    (f) Improvements to Risk Adjustment Under Medicare Advantage.--
        (1) In general.--Section 1853(a)(1) of the Social Security Act 
    (42 U.S.C. 1395w-23(a)(1)) is amended--
            (A) in subparagraph (C)(i), by striking ``The Secretary'' 
        and inserting ``Subject to subparagraph (I), the Secretary''; 
        and
            (B) by adding at the end the following new subparagraph:
            ``(I) Improvements to risk adjustment for 2019 and 
        subsequent years.--
                ``(i) In general.--In order to determine the 
            appropriate adjustment for health status under subparagraph 
            (C)(i), the following shall apply:

                    ``(I) Taking into account total number of diseases 
                or conditions.--The Secretary shall take into account 
                the total number of diseases or conditions of an 
                individual enrolled in an MA plan. The Secretary shall 
                make an additional adjustment under such subparagraph 
                as the number of diseases or conditions of an 
                individual increases.
                    ``(II) Using at least 2 years of diagnostic data.--
                The Secretary may use at least 2 years of diagnosis 
                data.
                    ``(III) Providing separate adjustments for dual 
                eligible individuals.--With respect to individuals who 
                are dually eligible for benefits under this title and 
                title XIX, the Secretary shall make separate 
                adjustments for each of the following:

                        ``(aa) Full-benefit dual eligible individuals 
                    (as defined in section 1935(c)(6)).
                        ``(bb) Such individuals not described in item 
                    (aa).

                    ``(IV) Evaluation of mental health and substance 
                use disorders.--The Secretary shall evaluate the impact 
                of including additional diagnosis codes related to 
                mental health and substance use disorders in the risk 
                adjustment model.
                    ``(V) Evaluation of chronic kidney disease.--The 
                Secretary shall evaluate the impact of including the 
                severity of chronic kidney disease in the risk 
                adjustment model.
                    ``(VI) Evaluation of payment rates for end-stage 
                renal disease.--The Secretary shall evaluate whether 
                other factors (in addition to those described in 
                subparagraph (H)) should be taken into consideration 
                when computing payment rates under such subparagraph.

                ``(ii) Phased-in implementation.--The Secretary shall 
            phase-in any changes to risk adjustment payment amounts 
            under subparagraph (C)(i) under this subparagraph over a 3-
            year period, beginning with 2019, with such changes being 
            fully implemented for 2022 and subsequent years.
                ``(iii) Opportunity for review and public comment.--The 
            Secretary shall provide an opportunity for review of the 
            proposed changes to such risk adjustment payment amounts 
            under this subparagraph and a public comment period of not 
            less than 60 days before implementing such changes.''.
        (2) Studies and reports.--
            (A) Reports on the risk adjustment system.--
                (i) Medpac evaluation and report.--

                    (I) Evaluation.--The Medicare Payment Advisory 
                Commission shall conduct an evaluation of the impact of 
                the provisions of, and amendments made by, this section 
                on risk scores for enrollees in Medicare Advantage 
                plans under part C of title XVIII of the Social 
                Security Act and payments to Medicare Advantage plans 
                under such part, including the impact of such 
                provisions and amendments on the overall accuracy of 
                risk scores under the Medicare Advantage program.
                    (II) Report.--Not later than July 1, 2020, the 
                Medicare Payment Advisory Commission shall submit to 
                Congress a report on the evaluation under subclause 
                (I), together with recommendations for such legislation 
                and administrative action as the Commission determines 
                appropriate.

                (ii) Reports by secretary of health and human 
            services.--Not later than December 31, 2018, and every 3 
            years thereafter, the Secretary of Health and Human 
            Services shall submit to Congress a report on the risk 
            adjustment model and the ESRD risk adjustment model under 
            the Medicare Advantage program under part C of title XVIII 
            of the Social Security Act, including any revisions to 
            either such model since the previous report. Such report 
            shall include information on how such revisions impact the 
            predictive ratios under either such model for groups of 
            enrollees in Medicare Advantage plans, including very high 
            and very low cost enrollees, and groups defined by the 
            number of chronic conditions of enrollees.
            (B) Study and report on functional status.--
                (i) Study.--The Comptroller General of the United 
            States (in this subparagraph referred to as the 
            ``Comptroller General'') shall conduct a study on how to 
            most accurately measure the functional status of enrollees 
            in Medicare Advantage plans and whether the use of such 
            functional status would improve the accuracy of risk 
            adjustment payments under the Medicare Advantage program 
            under part C of title XVIII of the Social Security Act. 
            Such study shall include an analysis of the challenges in 
            collecting and reporting functional status information for 
            Medicare Advantage plans under such part, providers of 
            services and suppliers under the Medicare program, and the 
            Centers for Medicare & Medicaid Services.
                (ii) Report.--Not later than June 30, 2018, the 
            Comptroller General shall submit to Congress a report 
            containing the results of the study under clause (i), 
            together with recommendations for such legislation and 
            administrative action as the Comptroller General determines 
            appropriate.
SEC. 17007. IMPROVEMENTS TO THE ASSIGNMENT OF BENEFICIARIES UNDER THE 
MEDICARE SHARED SAVINGS PROGRAM.
    Section 1899(c) of the Social Security Act (42 U.S.C. 1395jjj(c)) 
is amended--
        (1) by striking ``utilization of primary'' and inserting 
    ``utilization of--
        ``(1) in the case of performance years beginning on or after 
    April 1, 2012, primary'';
        (2) in paragraph (1), as added by paragraph (1) of this 
    section, by striking the period at the end and inserting ``; and'';
        (3) by adding at the end the following new paragraph:
        ``(2) in the case of performance years beginning on or after 
    January 1, 2019, services provided under this title by a Federally 
    qualified health center or rural health clinic (as those terms are 
    defined in section 1861(aa)), as may be determined by the 
    Secretary.''.

                     TITLE XVIII--OTHER PROVISIONS

SEC. 18001. EXCEPTION FROM GROUP HEALTH PLAN REQUIREMENTS FOR QUALIFIED 
SMALL EMPLOYER HEALTH REIMBURSEMENT ARRANGEMENTS.
    (a) Amendments to the Internal Revenue Code of 1986 and the Patient 
Protection and Affordable Care Act.--
        (1) In general.--Section 9831 of the Internal Revenue Code of 
    1986 is amended by adding at the end the following new subsection:
    ``(d) Exception for Qualified Small Employer Health Reimbursement 
Arrangements.--
        ``(1) In general.--For purposes of this title (except as 
    provided in section 4980I(f)(4) and notwithstanding any other 
    provision of this title), the term `group health plan' shall not 
    include any qualified small employer health reimbursement 
    arrangement.
        ``(2) Qualified small employer health reimbursement 
    arrangement.--For purposes of this subsection--
            ``(A) In general.--The term `qualified small employer 
        health reimbursement arrangement' means an arrangement which--
                ``(i) is described in subparagraph (B), and
                ``(ii) is provided on the same terms to all eligible 
            employees of the eligible employer.
            ``(B) Arrangement described.--An arrangement is described 
        in this subparagraph if--
                ``(i) such arrangement is funded solely by an eligible 
            employer and no salary reduction contributions may be made 
            under such arrangement,
                ``(ii) such arrangement provides, after the employee 
            provides proof of coverage, for the payment of, or 
            reimbursement of, an eligible employee for expenses for 
            medical care (as defined in section 213(d)) incurred by the 
            eligible employee or the eligible employee's family members 
            (as determined under the terms of the arrangement), and
                ``(iii) the amount of payments and reimbursements 
            described in clause (ii) for any year do not exceed $4,950 
            ($10,000 in the case of an arrangement that also provides 
            for payments or reimbursements for family members of the 
            employee).
            ``(C) Certain variation permitted.--For purposes of 
        subparagraph (A)(ii), an arrangement shall not fail to be 
        treated as provided on the same terms to each eligible employee 
        merely because the employee's permitted benefit under such 
        arrangement varies in accordance with the variation in the 
        price of an insurance policy in the relevant individual health 
        insurance market based on--
                ``(i) the age of the eligible employee (and, in the 
            case of an arrangement which covers medical expenses of the 
            eligible employee's family members, the age of such family 
            members), or
                ``(ii) the number of family members of the eligible 
            employee the medical expenses of which are covered under 
            such arrangement.
        The variation permitted under the preceding sentence shall be 
        determined by reference to the same insurance policy with 
        respect to all eligible employees.
            ``(D) Rules relating to maximum dollar limitation.--
                ``(i) Amount prorated in certain cases.--In the case of 
            an individual who is not covered by an arrangement for the 
            entire year, the limitation under subparagraph (B)(iii) for 
            such year shall be an amount which bears the same ratio to 
            the amount which would (but for this clause) be in effect 
            for such individual for such year under subparagraph 
            (B)(iii) as the number of months for which such individual 
            is covered by the arrangement for such year bears to 12.
                ``(ii) Inflation adjustment.--In the case of any year 
            beginning after 2016, each of the dollar amounts in 
            subparagraph (B)(iii) shall be increased by an amount equal 
            to--

                    ``(I) such dollar amount, multiplied by
                    ``(II) the cost-of-living adjustment determined 
                under section 1(f)(3) for the calendar year in which 
                the taxable year begins, determined by substituting 
                `calendar year 2015' for `calendar year 1992' in 
                subparagraph (B) thereof.

            If any dollar amount increased under the preceding sentence 
            is not a multiple of $50, such dollar amount shall be 
            rounded to the next lowest multiple of $50.
        ``(3) Other definitions.--For purposes of this subsection--
            ``(A) Eligible employee.--The term `eligible employee' 
        means any employee of an eligible employer, except that the 
        terms of the arrangement may exclude from consideration 
        employees described in any clause of section 105(h)(3)(B) 
        (applied by substituting `90 days' for `3 years' in clause (i) 
        thereof).
            ``(B) Eligible employer.--The term `eligible employer' 
        means an employer that--
                ``(i) is not an applicable large employer as defined in 
            section 4980H(c)(2), and
                ``(ii) does not offer a group health plan to any of its 
            employees.
            ``(C) Permitted benefit.--The term `permitted benefit' 
        means, with respect to any eligible employee, the maximum 
        dollar amount of payments and reimbursements which may be made 
        under the terms of the qualified small employer health 
        reimbursement arrangement for the year with respect to such 
        employee.
        ``(4) Notice.--
            ``(A) In general.--An employer funding a qualified small 
        employer health reimbursement arrangement for any year shall, 
        not later than 90 days before the beginning of such year (or, 
        in the case of an employee who is not eligible to participate 
        in the arrangement as of the beginning of such year, the date 
        on which such employee is first so eligible), provide a written 
        notice to each eligible employee which includes the information 
        described in subparagraph (B).
            ``(B) Contents of notice.--The notice required under 
        subparagraph (A) shall include each of the following:
                ``(i) A statement of the amount which would be such 
            eligible employee's permitted benefit under the arrangement 
            for the year.
                ``(ii) A statement that the eligible employee should 
            provide the information described in clause (i) to any 
            health insurance exchange to which the employee applies for 
            advance payment of the premium assistance tax credit.
                ``(iii) A statement that if the employee is not covered 
            under minimum essential coverage for any month the employee 
            may be subject to tax under section 5000A for such month 
            and reimbursements under the arrangement may be includible 
            in gross income.''.
        (2) Limitation on exclusion from gross income.--Section 106 of 
    such Code is amended by adding at the end the following:
    ``(g) Qualified Small Employer Health Reimbursement Arrangement.--
For purposes of this section and section 105, payments or 
reimbursements from a qualified small employer health reimbursement 
arrangement (as defined in section 9831(d)) of an individual for 
medical care (as defined in section 213(d)) shall not be treated as 
paid or reimbursed under employer-provided coverage for medical 
expenses under an accident or health plan if for the month in which 
such medical care is provided the individual does not have minimum 
essential coverage (within the meaning of section 5000A(f)).''.
        (3) Coordination with health insurance premium credit.--Section 
    36B(c) of such Code is amended by adding at the end the following 
    new paragraph:
        ``(4) Special rules for qualified small employer health 
    reimbursement arrangements.--
            ``(A) In general.--The term `coverage month' shall not 
        include any month with respect to an employee (or any spouse or 
        dependent of such employee) if for such month the employee is 
        provided a qualified small employer health reimbursement 
        arrangement which constitutes affordable coverage.
            ``(B) Denial of double benefit.--In the case of any 
        employee who is provided a qualified small employer health 
        reimbursement arrangement for any coverage month (determined 
        without regard to subparagraph (A)), the credit otherwise 
        allowable under subsection (a) to the taxpayer for such month 
        shall be reduced (but not below zero) by the amount described 
        in subparagraph (C)(i)(II) for such month.
            ``(C) Affordable coverage.--For purposes of subparagraph 
        (A), a qualified small employer health reimbursement 
        arrangement shall be treated as constituting affordable 
        coverage for a month if--
                ``(i) the excess of--

                    ``(I) the amount that would be paid by the employee 
                as the premium for such month for self-only coverage 
                under the second lowest cost silver plan offered in the 
                relevant individual health insurance market, over
                    ``(II) \1/12\ of the employee's permitted benefit 
                (as defined in section 9831(d)(3)(C)) under such 
                arrangement, does not exceed--

                ``(ii) \1/12\ of 9.5 percent of the employee's 
            household income.
            ``(D) Qualified small employer health reimbursement 
        arrangement.--For purposes of this paragraph, the term 
        `qualified small employer health reimbursement arrangement' has 
        the meaning given such term by section 9831(d)(2).
            ``(E) Coverage for less than entire year.--In the case of 
        an employee who is provided a qualified small employer health 
        reimbursement arrangement for less than an entire year, 
        subparagraph (C)(i)(II) shall be applied by substituting `the 
        number of months during the year for which such arrangement was 
        provided' for `12'.
            ``(F) Indexing.--In the case of plan years beginning in any 
        calendar year after 2014, the Secretary shall adjust the 9.5 
        percent amount under subparagraph (C)(ii) in the same manner as 
        the percentages are adjusted under subsection (b)(3)(A)(ii).''.
        (4) Application of excise tax on high cost employer-sponsored 
    health coverage.--
            (A) In general.--Section 4980I(f)(4) of such Code is 
        amended by adding at the end the following: ``Section 
        9831(d)(1) shall not apply for purposes of this section.''.
            (B) Determination of cost of coverage.--Section 4980I(d)(2) 
        of such Code is amended by redesignating subparagraph (D) as 
        subparagraph (E) and by inserting after subparagraph (C) the 
        following new subparagraph:
            ``(D) Qualified small employer health reimbursement 
        arrangements.--In the case of applicable employer-sponsored 
        coverage consisting of coverage under any qualified small 
        employer health reimbursement arrangement (as defined in 
        section 9831(d)(2)), the cost of coverage shall be equal to the 
        amount described in section 6051(a)(15).''.
        (5) Enforcement of notice requirement.--Section 6652 of such 
    Code is amended by adding at the end the following new subsection:
    ``(o) Failure to Provide Notices With Respect to Qualified Small 
Employer Health Reimbursement Arrangements.--In the case of each 
failure to provide a written notice as required by section 9831(d)(4), 
unless it is shown that such failure is due to reasonable cause and not 
willful neglect, there shall be paid, on notice and demand of the 
Secretary and in the same manner as tax, by the person failing to 
provide such written notice, an amount equal to $50 per employee per 
incident of failure to provide such notice, but the total amount 
imposed on such person for all such failures during any calendar year 
shall not exceed $2,500.''.
        (6) Reporting.--
            (A) W-2 reporting.--Section 6051(a) of such Code is amended 
        by striking ``and'' at the end of paragraph (13), by striking 
        the period at the end of paragraph (14) and inserting ``, 
        and'', and by inserting after paragraph (14) the following new 
        paragraph:
        ``(15) the total amount of permitted benefit (as defined in 
    section 9831(d)(3)(C)) for the year under a qualified small 
    employer health reimbursement arrangement (as defined in section 
    9831(d)(2)) with respect to the employee.''.
            (B) Information required to be provided by exchange subsidy 
        applicants.--Section 1411(b)(3) of the Patient Protection and 
        Affordable Care Act is amended by redesignating subparagraph 
        (B) as subparagraph (C) and by inserting after subparagraph (A) 
        the following new subparagraph:
            ``(B) Certain individual health insurance policies obtained 
        through small employers.--The amount of the enrollee's 
        permitted benefit (as defined in section 9831(d)(3)(C) of the 
        Internal Revenue Code of 1986) under a qualified small employer 
        health reimbursement arrangement (as defined in section 
        9831(d)(2) of such Code).''.
        (7) Effective dates.--
            (A) In general.--Except as otherwise provided in this 
        paragraph, the amendments made by this subsection shall apply 
        to years beginning after December 31, 2016.
            (B) Transition relief.--The relief under Treasury Notice 
        2015-17 shall be treated as applying to any plan year beginning 
        on or before December 31, 2016.
            (C) Coordination with health insurance premium credit.--The 
        amendments made by paragraph (3) shall apply to taxable years 
        beginning after December 31, 2016.
            (D) Employee notice.--
                (i) In general.--The amendments made by paragraph (5) 
            shall apply to notices with respect to years beginning 
            after December 31, 2016.
                (ii) Transition relief.--For purposes of section 
            6652(o) of the Internal Revenue Code of 1986 (as added by 
            this Act), a person shall not be treated as failing to 
            provide a written notice as required by section 9831(d)(4) 
            of such Code if such notice is so provided not later than 
            90 days after the date of the enactment of this Act.
            (E) W-2 reporting.--The amendments made by paragraph (6)(A) 
        shall apply to calendar years beginning after December 31, 
        2016.
            (F) Information provided by exchange subsidy applicants.--
                (i) In general.--The amendments made by paragraph 
            (6)(B) shall apply to applications for enrollment made 
            after December 31, 2016.
                (ii) Verification.--Verification under section 1411 of 
            the Patient Protection and Affordable Care Act of 
            information provided under section 1411(b)(3)(B) of such 
            Act shall apply with respect to months beginning after 
            October 2016.
                (iii) Transitional relief.--In the case of an 
            application for enrollment under section 1411(b) of the 
            Patient Protection and Affordable Care Act made before 
            April 1, 2017, the requirement of section 1411(b)(3)(B) of 
            such Act shall be treated as met if the information 
            described therein is provided not later than 30 days after 
            the date on which the applicant receives the notice 
            described in section 9831(d)(4) of the Internal Revenue 
            Code of 1986.
        (8) Substantiation requirements.--The Secretary of the Treasury 
    (or his designee) may issue substantiation requirements as 
    necessary to carry out this subsection.
    (b) Amendments to the Employee Retirement Income Security Act of 
1974.--
        (1) In general.--Section 733(a)(1) of the Employee Retirement 
    Income Security Act of 1974 (29 U.S.C. 1191b(a)(1)) is amended by 
    adding at the end the following: ``Such term shall not include any 
    qualified small employer health reimbursement arrangement (as 
    defined in section 9831(d)(2) of the Internal Revenue Code of 
    1986).''.
        (2) Exception from continuation coverage requirements, etc.--
    Section 607(1) of such Act (29 U.S.C. 1167(1)) is amended by adding 
    at the end the following: ``Such term shall not include any 
    qualified small employer health reimbursement arrangement (as 
    defined in section 9831(d)(2) of the Internal Revenue Code of 
    1986).''.
        (3) Effective date.--The amendments made by this subsection 
    shall apply to plan years beginning after December 31, 2016.
    (c) Amendments to the Public Health Service Act.--
        (1) In general.--Section 2791(a)(1) of the Public Health 
    Service Act (42 U.S.C. 300gg-91(a)(1)) is amended by adding at the 
    end the following: ``Except for purposes of part C of title XI of 
    the Social Security Act (42 U.S.C. 1320d et seq.), such term shall 
    not include any qualified small employer health reimbursement 
    arrangement (as defined in section 9831(d)(2) of the Internal 
    Revenue Code of 1986).''.
        (2) Exception from continuation coverage requirements.--Section 
    2208(1) of the Public Health Service Act (42 U.S.C. 300bb-8(1)) is 
    amended by adding at the end the following: ``Such term shall not 
    include any qualified small employer health reimbursement 
    arrangement (as defined in section 9831(d)(2) of the Internal 
    Revenue Code of 1986).''.
        (3) Effective date.--The amendments made by this subsection 
    shall apply to plan years beginning after December 31, 2016.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
```