    [Congressional Bills 114th Congress]
    [From the U.S. Government Publishing Office]
    [H.R. 34 Engrossed Amendment House (EAH)]

    <DOC>
                    In the House of Representatives, U. S.,

                                                         November 30, 2016.
        Resolved, That the House agree to the amendment of the Senate to
    the bill (H.R. 34) entitled ``An Act to authorize and strengthen the
    tsunami detection, forecast, warning, research, and mitigation program
    of the National Oceanic and Atmospheric Administration, and for other
    purposes.'', with the following

                      HOUSE AMENDMENT TO SENATE AMENDMENT:

                In lieu of the matter proposed to be added after the
          enacting clause, insert the following:

    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. 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. 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.

                Attest:

                                                                     Clerk.
    114th CONGRESS

      2d Session

                                    H.R. 34

    _______________________________________________________________________

                      HOUSE AMENDMENT TO SENATE AMENDMENT