    [Congressional Bills 119th Congress]
    [From the U.S. Government Publishing Office]
    [S. 891 Introduced in Senate (IS)]

    <DOC>

    119th CONGRESS
      1st Session
                                     S. 891

     To extend expiring health provisions and improve health care delivery.

    _______________________________________________________________________

                       IN THE SENATE OF THE UNITED STATES

                                 March 6, 2025

    Mr. Wyden (for himself and Mr. Sanders) introduced the following bill;
         which was read twice and referred to the Committee on Finance

    _______________________________________________________________________

                                     A BILL

     To extend expiring health provisions and improve health care delivery.

        Be it enacted by the Senate and House of Representatives of the
    United States of America in Congress assembled,

    SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

    Sec. 1. Short title; table of contents.
                               TITLE I--MEDICAID

    Sec. 101. Streamlined enrollment process for eligible out-of-state
                                providers under Medicaid and CHIP.
    Sec. 102. Making certain adjustments to coverage of home or community-
                                based services under Medicaid.
    Sec. 103. Removing certain age restrictions on Medicaid eligibility for
                                working adults with disabilities.
    Sec. 104. Medicaid State plan requirement for determining residency and
                                coverage for military families.
    Sec. 105. Ensuring the reliability of address information provided
                                under the Medicaid program.
    Sec. 106. Codifying certain Medicaid provider screening requirements
                                related to deceased providers.
    Sec. 107. Modifying certain State requirements for ensuring deceased
                                individuals do not remain enrolled.
    Sec. 108. One-year delay of Medicaid and CHIP requirements for health
                                screenings, referrals, and case management
                                services for eligible juveniles in public
                                institutions; State interim work plans.
    Sec. 109. State studies and HHS report on costs of providing maternity,
                                labor, and delivery services.
    Sec. 110. Modifying certain disproportionate share hospital allotments.
    Sec. 111. Modifying certain limitations on disproportionate share
                                hospital payment adjustments under the
                                Medicaid program.
    Sec. 112. Ensuring accurate payments to pharmacies under Medicaid.
    Sec. 113. Preventing the use of abusive spread pricing in Medicaid.
                               TITLE II--MEDICARE

    Sec. 201. Extension of increased inpatient hospital payment adjustment
                                for certain low-volume hospitals.
    Sec. 202. Extension of the Medicare-dependent hospital (MDH) program.
    Sec. 203. Extension of add-on payments for ambulance services.
    Sec. 204. Extending incentive payments for participation in eligible
                                alternative payment models.
    Sec. 205. Temporary payment increase under the Medicare physician fee
                                schedule to account for exceptional
                                circumstances.
    Sec. 206. Extension of funding for quality measure endorsement, input,
                                and selection.
    Sec. 207. Extension of funding outreach and assistance for low-income
                                programs.
    Sec. 208. Extension of the work geographic index floor.
    Sec. 209. Extension of certain telehealth flexibilities.
    Sec. 210. Requiring modifier for use of telehealth to conduct face-to-
                                face encounter prior to recertification of
                                eligibility for hospice care.
    Sec. 211. Extending acute hospital care at home waiver flexibilities.
    Sec. 212. Enhancing certain program integrity requirements for DME
                                under Medicare.
    Sec. 213. Guidance on furnishing services via telehealth to individuals
                                with limited English proficiency.
    Sec. 214. In-home cardiopulmonary rehabilitation flexibilities.
    Sec. 215. Inclusion of virtual diabetes prevention program suppliers in
                                MDPP Expanded Model.
    Sec. 216. Medication-induced movement disorder outreach and education.
    Sec. 217. Report on wearable medical devices.
    Sec. 218. Extension of temporary inclusion of authorized oral antiviral
                                drugs as covered part D drugs.
    Sec. 219. Extension of adjustment to calculation of hospice cap amount.
    Sec. 220. Multiyear contracting authority for MedPAC and MACPAC.
    Sec. 221. Contracting parity for MedPAC and MACPAC.
    Sec. 222. Adjustments to Medicare part D cost-sharing reductions for
                                low-income individuals.
    Sec. 223. Requiring Enhanced and Accurate Lists of (REAL) Health
                                Providers Act.
    Sec. 224. Medicare coverage of multi-cancer early detection screening
                                tests.
    Sec. 225. Medicare coverage of external infusion pumps and non-self-
                                administrable home infusion drugs.
    Sec. 226. Assuring pharmacy access and choice for Medicare
                                beneficiaries.
    Sec. 227. Modernizing and Ensuring PBM Accountability.
    Sec. 228. Requiring a separate identification number and an attestation
                                for each off-campus outpatient department
                                of a provider.
    Sec. 229. Medicare sequestration.
    Sec. 230. Medicare improvement fund.
                           TITLE III--HUMAN SERVICES

    Sec. 301. Sexual risk avoidance education extension.
    Sec. 302. Personal responsibility education extension.
    Sec. 303. Extension of funding for family-to-family health information
                                centers.
                       TITLE IV--PUBLIC HEALTH EXTENDERS

                             Subtitle A--Extensions

    Sec. 401. Extension for community health centers, National Health
                                Service Corps, and teaching health centers
                                that operate GME programs.
    Sec. 402. Extension of special diabetes programs.
                 Subtitle B--World Trade Center Health Program

    Sec. 411. 9/11 responder and survivor health funding corrections.
                      TITLE V--SUPPORT ACT REAUTHORIZATION

    Sec. 501. Short title.
                             Subtitle A--Prevention

    Sec. 511. Prenatal and postnatal health.
    Sec. 512. Monitoring and education regarding infections associated with
                                illicit drug use and other risk factors.
    Sec. 513. Preventing overdoses of controlled substances.
    Sec. 514. Support for individuals and families impacted by fetal
                                alcohol spectrum disorder.
    Sec. 515. Promoting State choice in PDMP systems.
    Sec. 516. First responder training program.
    Sec. 517. Donald J. Cohen National Child Traumatic Stress Initiative.
    Sec. 518. Protecting suicide prevention lifeline from cybersecurity
                                incidents.
    Sec. 519. Bruce's law.
    Sec. 520. Guidance on at-home drug disposal systems.
    Sec. 521. Assessment of opioid drugs and actions.
    Sec. 522. Grant program for State and Tribal response to opioid use
                                disorders.
                             Subtitle B--Treatment

    Sec. 531. Residential treatment program for pregnant and postpartum
                                women.
    Sec. 532. Improving access to addiction medicine providers.
    Sec. 533. Mental and behavioral health education and training grants.
    Sec. 534. Loan repayment program for substance use disorder treatment
                                workforce.
    Sec. 535. Development and dissemination of model training programs for
                                substance use disorder patient records.
    Sec. 536. Task force on best practices for trauma-informed
                                identification, referral, and support.
    Sec. 537. Grants to enhance access to substance use disorder treatment.
    Sec. 538. State guidance related to individuals with serious mental
                                illness and children with serious emotional
                                disturbance.
    Sec. 539. Reviewing the scheduling of approved products containing a
                                combination of buprenorphine and naloxone.
                              Subtitle C--Recovery

    Sec. 541. Building communities of recovery.
    Sec. 542. Peer support technical assistance center.
    Sec. 543. Comprehensive opioid recovery centers.
    Sec. 544. Youth prevention and recovery.
    Sec. 545. CAREER Act.
    Sec. 546. Addressing economic and workforce impacts of the opioid
                                crisis.
                       Subtitle D--Miscellaneous Matters

    Sec. 551. Delivery of a controlled substance by a pharmacy to a
                                prescribing practitioner.
    Sec. 552. Technical correction on controlled substances dispensing.
    Sec. 553. Required training for prescribers of controlled substances.
    Sec. 554. Extension of temporary order for fentanyl-related substances.
          TITLE VI--PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND RESPONSE

    Sec. 601. Short title.
               Subtitle A--State and Local Readiness and Response

    Sec. 611. Temporary reassignment of State and local personnel during a
                                public health emergency.
    Sec. 612. Public Health Emergency Preparedness program.
    Sec. 613. Hospital Preparedness Program.
    Sec. 614. Facilities and capacities of the Centers for Disease Control
                                and Prevention to combat public health
                                security threats.
    Sec. 615. Pilot program to support State medical stockpiles.
    Sec. 616. Enhancing domestic wastewater surveillance for pathogen
                                detection.
    Sec. 617. Reauthorization of Mosquito Abatement for Safety and Health
                                program.
                 Subtitle B--Federal Planning and Coordination

    Sec. 621. All-Hazards Emergency Preparedness and Response.
    Sec. 622. National Health Security Strategy.
    Sec. 623. Improving development and distribution of diagnostic tests.
    Sec. 624. Combating antimicrobial resistance.
    Sec. 625. Strategic National Stockpile and material threats.
    Sec. 626. Medical countermeasures for viral threats with pandemic
                                potential.
    Sec. 627. Public Health Emergency Medical Countermeasures Enterprise.
    Sec. 628. Fellowship and training programs.
    Sec. 629. Regional biocontainment research laboratories.
    Sec. 629A. Limitation related to countries of concern conducting
                                certain research.
              Subtitle C--Addressing the Needs of All Individuals

    Sec. 631. Improving access to certain programs.
    Sec. 632. Supporting at-risk individuals during emergency responses.
    Sec. 633. National advisory committees.
    Sec. 634. National Academies study on prizes.
                    Subtitle D--Additional Reauthorizations

    Sec. 641. Medical countermeasure priority review voucher.
    Sec. 642. Epidemic Intelligence Service.
    Sec. 643. Monitoring and distribution of certain medical
                                countermeasures.
    Sec. 644. Regional health care emergency preparedness and response
                                systems.
    Sec. 645. Emergency system for advance registration of volunteer health
                                professionals.
    Sec. 646. Ensuring collaboration and coordination in medical
                                countermeasure development.
    Sec. 647. Military and civilian partnership for trauma readiness.
    Sec. 648. National Disaster Medical System.
    Sec. 649. Volunteer Medical Reserve Corps.
    Sec. 649A. Epidemiology-laboratory capacity.
                       TITLE VII--PUBLIC HEALTH PROGRAMS

    Sec. 701. Action for dental health.
    Sec. 702. PREEMIE.
    Sec. 703. Preventing maternal deaths.
    Sec. 704. Sickle cell disease prevention and treatment.
    Sec. 705. Traumatic brain injuries.
    Sec. 706. Lifespan respite care.
    Sec. 707. Dr. Lorna Breen health care provider protection.
    Sec. 708. SCREENS for Cancer.
    Sec. 709. DeOndra Dixon INCLUDE Project.
    Sec. 710. IMPROVE Initiative.
    Sec. 711. Organ Procurement and Transplantation Network.
    Sec. 712. Honor Our Living Donors.
    Sec. 713. Program for pediatric studies of drugs.
                    TITLE VIII--FOOD AND DRUG ADMINISTRATION

                         Subtitle A--Give Kids a Chance

    Sec. 801. Research into pediatric uses of drugs; additional authorities
                                of Food and Drug Administration regarding
                                molecularly targeted cancer drugs.
    Sec. 802. Ensuring completion of pediatric study requirements.
    Sec. 803. FDA report on PREA enforcement.
    Sec. 804. Extension of authority to issue priority review vouchers to
                                encourage treatments for rare pediatric
                                diseases.
    Sec. 805. Limitations on exclusive approval or licensure of orphan
                                drugs.
       Subtitle B--United States-Abraham Accords Cooperation and Security

    Sec. 811. Establishment of Abraham Accords Office within Food and Drug
                                Administration.
                   TITLE IX--LOWERING PRESCRIPTION DRUG COSTS

    Sec. 901. Oversight of pharmacy benefit management services.
    Sec. 902. Full rebate pass through to plan; exception for innocent plan
                                fiduciaries.
    Sec. 903. Increasing transparency in generic drug applications.
    Sec. 904. Title 35 amendments.
                             TITLE X--MISCELLANEOUS

    Sec. 1001. Extension of safe harbor for absence of deductible for
                                telehealth.

                               TITLE I--MEDICAID

    SEC. 101. STREAMLINED ENROLLMENT PROCESS FOR ELIGIBLE OUT-OF-STATE
                  PROVIDERS UNDER MEDICAID AND CHIP.

        (a) In General.--Section 1902(kk) of the Social Security Act (42
    U.S.C. 1396a(kk)) is amended by adding at the end the following new
    paragraph:
                ``(10) Streamlined enrollment process for eligible out-of-
            state providers.--
                        ``(A) In general.--The State--
                                ``(i) adopts and implements a process to
                            allow an eligible out-of-State provider to
                            enroll under the State plan (or a waiver of
                            such plan) to furnish items and services to, or
                            order, prescribe, refer, or certify eligibility
                            for items and services for, qualifying
                            individuals without the imposition of screening
                            or enrollment requirements by such State that
                            exceed the minimum necessary for such State to
                            provide payment to an eligible out-of-State
                            provider under such State plan (or a waiver of
                            such plan), such as the provider's name and
                            National Provider Identifier (and such other
                            information specified by the Secretary); and
                                ``(ii) provides that an eligible out-of-
                            State provider that enrolls as a participating
                            provider in the State plan (or a waiver of such
                            plan) through such process shall be so enrolled
                            for a 5-year period, unless the provider is
                            terminated or excluded from participation
                            during such period.
                        ``(B) Definitions.--In this paragraph:
                                ``(i) Eligible out-of-state provider.--The
                            term `eligible out-of-State provider' means,
                            with respect to a State, a provider--
                                        ``(I) that is located in any other
                                    State;
                                        ``(II) that--
                                                ``(aa) was determined by
                                            the Secretary to have a limited
                                            risk of fraud, waste, and abuse
                                            for purposes of determining the
                                            level of screening to be
                                            conducted under section
                                            1866(j)(2), has been so
                                            screened under such section
                                            1866(j)(2), and is enrolled in
                                            the Medicare program under
                                            title XVIII; or
                                                ``(bb) was determined by
                                            the State agency administering
                                            or supervising the
                                            administration of the State
                                            plan (or a waiver of such plan)
                                            of such other State to have a
                                            limited risk of fraud, waste,
                                            and abuse for purposes of
                                            determining the level of
                                            screening to be conducted under
                                            paragraph (1) of this
                                            subsection, has been so
                                            screened under such paragraph
                                            (1), and is enrolled under such
                                            State plan (or a waiver of such
                                            plan); and
                                        ``(III) that has not been--
                                                ``(aa) excluded from
                                            participation in any Federal
                                            health care program pursuant to
                                            section 1128 or 1128A;
                                                ``(bb) excluded from
                                            participation in the State plan
                                            (or a waiver of such plan)
                                            pursuant to part 1002 of title
                                            42, Code of Federal Regulations
                                            (or any successor regulation),
                                            or State law; or
                                                ``(cc) terminated from
                                            participating in a Federal
                                            health care program or the
                                            State plan (or a waiver of such
                                            plan) for a reason described in
                                            paragraph (8)(A).
                                ``(ii) Qualifying individual.--The term
                            `qualifying individual' means an individual
                            under 21 years of age who is enrolled under the
                            State plan (or waiver of such plan).
                                ``(iii) State.--The term `State' means 1 of
                            the 50 States or the District of Columbia.''.
        (b) Conforming Amendments.--
                (1) Section 1902(a)(77) of the Social Security Act (42
            U.S.C. 1396a(a)(77)) is amended by inserting ``enrollment,''
            after ``screening,''.
                (2) The subsection heading for section 1902(kk) of such Act
            (42 U.S.C. 1396a(kk)) is amended by inserting ``enrollment,''
            after ``screening,''.
                (3) Section 2107(e)(1)(G) of such Act (42 U.S.C.
            1397gg(e)(1)(G)) is amended by inserting ``enrollment,'' after
            ``screening,''.
        (c) Effective Date.--The amendments made by this section shall take
    effect on the date that is 3 years after the date of enactment of this
    Act.

    SEC. 102. MAKING CERTAIN ADJUSTMENTS TO COVERAGE OF HOME OR COMMUNITY-
                  BASED SERVICES UNDER MEDICAID.

        (a) Increasing Transparency of HCBS Coverage Under Medicaid.--
                (1) In general.--Section 1915(c) of the Social Security Act
            (42 U.S.C. 1396n(c)) is amended--
                        (A) in paragraph (2)--
                                (i) in subparagraph (E)--
                                        (I) by inserting ``, not less
                                    frequently than'' before ``annually'';
                                    and
                                        (II) by inserting ``(including,
                                    with respect to such information
                                    provided on or after July 9, 2027, the
                                    information specified in paragraph
                                    (11))'' before the period at the end;
                                    and
                                (ii) by adding at the end the following
                            flush sentence:
            ``The Secretary shall make all information provided under
            subparagraph (E) on or after the date of the enactment of this
            sentence publicly available on the website of the Centers for
            Medicare & Medicaid Services.''; and
                        (B) by adding at the end the following new
                    paragraph:
                ``(11) For purposes of paragraph (2)(E), the information
            specified in this paragraph is the following:
                        ``(A) In the case of a State that limits the number
                    of individuals who may be provided home or community-
                    based services under a waiver granted under this
                    subsection and maintains a list of individuals waiting
                    to enroll in such waiver, a description of how the
                    State maintains such list, including--
                                ``(i) information on whether the State
                            screens individuals on such list to determine
                            whether such individuals are eligible to
                            receive such services under such waiver;
                                ``(ii) information on whether (and, if
                            applicable, how often) the State periodically
                            re-screens individuals on such list for
                            eligibility;
                                ``(iii) the number of people on such list
                            of individuals waiting to enroll in such
                            waiver; and
                                ``(iv) the average amount of time that
                            individuals newly enrolled in such waiver
                            within the past 12 months were on such list of
                            individuals waiting to enroll in such waiver.
                        ``(B) With respect to homemaker services, home
                    health aide services, personal care services, and
                    habilitation services furnished under waivers under
                    this subsection, by each such service type--
                                ``(i) for individuals newly receiving such
                            services within the past 12 months, the average
                            amount of time (which may be determined using
                            statistically valid random sampling of such
                            individuals) from when such services are
                            initially approved for such an individual to
                            when such individual begins receiving such
                            services; and
                                ``(ii) the percentage of authorized hours
                            (which may be determined using statistically
                            valid random sampling of individuals authorized
                            to receive such services) that are provided
                            within the past 12 months.''.
                (2) Conforming amendments.--Section 1915 of the Social
            Security Act (42 U.S.C. 1396n) is amended--
                        (A) in subsection (i) by adding at the end the
                    following new paragraph:
                ``(8) Reporting requirement.--With respect to homemaker
            services, home health aide services, personal care services,
            and habilitation services provided under this subsection on or
            after July 9, 2027, the State, not less frequently than
            annually, shall provide to the Secretary the same information
            regarding such services as the State is required to provide
            under subsection (c)(11)(B).'';
                        (B) in subsection (j)(2)(E), by inserting after the
                    second sentence the following: ``With respect to any
                    homemaker services, home health aide services, personal
                    care services, and habilitation services provided under
                    this subsection on or after July 9, 2027, the State,
                    not less frequently than annually, shall provide to the
                    Secretary the same information regarding such services
                    as the State is required to provide under subsection
                    (c)(11)(B).''; and
                        (C) in subsection (k)(3)(E)--
                                (i) by striking ``and'' after ``the cost of
                            such services and supports,''; and
                                (ii) by inserting before the period, the
                            following: ``, and with respect to homemaker
                            services, home health aide services, personal
                            care services, and habilitation services
                            provided under this subsection on or after July
                            9, 2027, not less frequently than annually, the
                            same information regarding such services as the
                            State is required to provide under subsection
                            (c)(11)(B)''.
        (b) Demonstration Program To Expand HCBS Coverage Under Section
    1915(c) Waivers.--Section 1915(c) of the Social Security Act (42 U.S.C.
    1396n(c)), as amended by subsection (a), is further amended--
                (1) in paragraph (2)(E), by inserting ``, and the
            information specified in paragraph (12)(C)(v), when
            applicable'' after ``paragraph (11)''; and
                (2) by adding at the end the following new paragraph:
                ``(12) Demonstration program to expand coverage for home or
            community-based services.--
                        ``(A) In general.--
                                ``(i) Approval.--Not later than 24 months
                            after the date on which the planning grants
                            under subparagraph (B) are awarded,
                            notwithstanding paragraph (1), the Secretary
                            may approve a waiver that is standalone from
                            any other waiver approved under this subsection
                            for not more than 5 States, selected in
                            accordance with clause (ii), to include as
                            medical assistance under the State plan of such
                            State, for the 3-year period beginning on the
                            date of such approval, payment for part or all
                            of the cost of home or community-based services
                            (other than room and board (as described in
                            paragraph (1))) approved by the Secretary which
                            are provided pursuant to a written plan of care
                            to individuals described in subparagraph
                            (C)(iii).
                                ``(ii) Selection criteria.--In selecting
                            States for purposes of clause (i), the
                            Secretary shall--
                                        ``(I) only select States that
                                    received a planning grant under
                                    subparagraph (B);
                                        ``(II) only select States that meet
                                    the requirements specified in
                                    subparagraph (C) and such other
                                    requirements as the Secretary may
                                    determine appropriate;
                                        ``(III) select States in a manner
                                    that ensures geographic diversity;
                                        ``(IV) give preference to States
                                    with a higher percentage (relative to
                                    other States that apply to be selected
                                    for purposes of clause (i)) of the
                                    total State population residing in
                                    rural areas (as determined by the
                                    Secretary);
                                        ``(V) give preference to States
                                    that have demonstrated more progress in
                                    rebalancing long-term services and
                                    supports systems under this title, as
                                    determined based on the relative share
                                    of individuals who use home or
                                    community-based services (as defined by
                                    the Secretary) under this title as a
                                    percentage of total individuals who use
                                    long-term services and supports (as
                                    defined by the Secretary) under this
                                    title (in the most recent year for
                                    which such data is available); and
                                        ``(VI) give preference to States
                                    that pursue a waiver under this
                                    paragraph that incorporates the
                                    provision of mental health services for
                                    adults with serious mental illness,
                                    children with serious emotional
                                    disturbances, or individuals with
                                    substance use disorder.
                        ``(B) Planning grants.--
                                ``(i) In general.--
                                        ``(I) Approval.--Not later than 18
                                    months after the date of the enactment
                                    of this paragraph, the Secretary shall
                                    award planning grants of not more than
                                    $5,000,000 each to not more than 10
                                    States for purposes of preparing to
                                    submit a request for a waiver under
                                    this subsection (including for costs to
                                    implement the waiver or other
                                    activities to expand the provision of
                                    home or community-based services under
                                    this section) to provide home or
                                    community-based services to individuals
                                    described in subparagraph (C)(iii).
                                        ``(II) Selection criteria.--In
                                    awarding planning grants under
                                    subclause (I), the Secretary shall use
                                    the selection criteria specified in
                                    subclauses (III) through (VI) of
                                    subparagraph (A)(ii).
                                ``(ii) Consultation.--A State that is
                            awarded a planning grant under clause (i)
                            shall, in preparing to submit a request for a
                            waiver described in such clause, consult with--
                                        ``(I) individuals in need of (and
                                    not receiving) home or community-based
                                    services, individuals receiving home or
                                    community-based services, and the
                                    caregivers of such individuals;
                                        ``(II) providers furnishing home or
                                    community-based services; and
                                        ``(III) such other stakeholders, as
                                    the Secretary may specify.
                        ``(C) State requirements.--In addition to the
                    requirements specified under this subsection (except
                    for the requirements described in subparagraphs (C) and
                    (D) of paragraph (2) and any other requirement the
                    Secretary determines to be inapplicable in the context
                    of a waiver relation to individuals who do not require
                    the level of care described in paragraph (1)), the
                    requirements specified in this paragraph are, with
                    respect to a State, the following:
                                ``(i) As of the date that such State
                            requests a waiver under this subsection to
                            provide home or community-based services to
                            individuals described in clause (iii), all
                            other waivers (if any) granted under this
                            subsection to such State meet the requirements
                            of this subsection.
                                ``(ii) The State demonstrates to the
                            Secretary that approval of a waiver under this
                            subsection with respect to individuals
                            described in clause (iii) will not result in a
                            material increase of the average amount of time
                            that individuals with respect to whom a
                            determination described in paragraph (1) has
                            been made will need to wait to receive home or
                            community-based services under any waiver
                            granted under this subsection, as determined by
                            the Secretary.
                                ``(iii) The State establishes needs-based
                            criteria, subject to the approval of the
                            Secretary, to identify individuals for whom a
                            determination described in paragraph (1) is not
                            applicable, who will be eligible for home or
                            community-based services under a waiver
                            approved under this paragraph, and specifies
                            the home or community-based services such
                            individuals so eligible will receive.
                                ``(iv) The State established needs-based
                            criteria for determining whether an individual
                            described in clause (iii) requires the level of
                            care provided in a hospital, nursing facility,
                            or an intermediate care facility for
                            individuals with developmental disabilities
                            under the State plan or under any waiver of
                            such plan that are more stringent than the
                            needs-based criteria established under clause
                            (iii) for determining eligibility for home or
                            community-based services.
                                ``(v) The State attests that the State's
                            average per capita expenditure for medical
                            assistance under the State plan (or waiver of
                            such plan) provided with respect to such
                            individuals enrolled in a waiver under this
                            paragraph will not exceed the State's average
                            per capita expenditures for medical assistance
                            for individuals receiving institutional care
                            under the State plan (or waiver of such plan)
                            for the duration that the waiver under this
                            paragraph is in effect.
                                ``(vi) The State provides to the Secretary
                            data (in such form and manner as the Secretary
                            may specify) regarding the number of
                            individuals described in clause (i) with
                            respect to a State seeking approval of a waiver
                            under this subsection, to whom the State will
                            make such services available under such waiver.
                                ``(vii) The State agrees to provide to the
                            Secretary, not less frequently than annually,
                            data for purposes of paragraph (2)(E) (in such
                            form and manner as the Secretary may specify)
                            regarding, with respect to each preceding year
                            in which a waiver under this subsection to
                            provide home and community-based services to
                            individuals described in clause (iii) was in
                            effect--
                                        ``(I) the cost (as such term is
                                    defined by the Secretary) of such
                                    services furnished to individuals
                                    described in clause (iii), broken down
                                    by type of service;
                                        ``(II) with respect to each type of
                                    home and community-based service
                                    provided under the waiver, the length
                                    of time that such individuals have
                                    received such service;
                                        ``(III) a comparison between the
                                    data described in subclause (I) and any
                                    comparable data available with respect
                                    to individuals with respect to whom a
                                    determination described in paragraph
                                    (1) has been made and with respect to
                                    individuals receiving institutional
                                    care under this title; and
                                        ``(IV) the number of individuals
                                    who have received home and community-
                                    based services under the waiver during
                                    the preceding year.''.
        (c) Non-Application of the Paperwork Reduction Act.--Chapter 35 of
    title 44, United States Code (commonly referred to as the ``Paperwork
    Reduction Act of 1995''), shall not apply to the implementation of the
    amendments made by subsections (a) and (b).
        (d) CMS Guidance to States on Interim Coverage Under Section 1915
    Home and Community-Based Services Authorities.--Not later than January
    1, 2027, the Secretary of Health and Human Services shall issue
    guidance to the States to clarify how a State may provide, with respect
    to an individual who is eligible for home and community-based services
    under section 1915 of the Social Security Act (42 U.S.C. 1396n),
    coverage of such services pursuant to a provisional written plan of
    care, pending finalization, with respect to such individual.
        (e) Funding.--
                (1) In general.--There are appropriated, out of any funds
            in the Treasury not otherwise obligated, $71,000,000 for fiscal
            year 2025, to remain available until expended, to the Secretary
            of Health and Human Services for purposes of carrying out
            subsection (d) and the amendments made by subsection (b).
                (2) Reservation for planning grants.--Of the amount
            appropriated under paragraph (1), the Secretary of Health and
            Human Services shall reserve $50,000,000 of such amount to
            award planning grants under the demonstration program
            established by the amendments made by subsection (b).

    SEC. 103. REMOVING CERTAIN AGE RESTRICTIONS ON MEDICAID ELIGIBILITY FOR
                  WORKING ADULTS WITH DISABILITIES.

        (a) Modification of Optional Buy-In Groups.--
                (1) In general.--Section 1902(a)(10)(A)(ii)(XV) of the
            Social Security Act (42 U.S.C. 1396a(a)(10)(A)(ii)(XV)) is
            amended by striking ``but less than 65,''.
                (2) Definition modification.--Section 1905(v)(1)(A) of the
            Social Security Act (42 U.S.C. 1396d(v)(1)(A)) is amended by
            striking ``, but less than 65,''.
        (b) Application to Certain States.--A State that, as of the date of
    enactment of this Act, provides for making medical assistance available
    to individuals described in subclause (XV) or (XVI) of section
    1902(a)(10)(A)(ii) of the Social Security Act (42 U.S.C.
    1396a(a)(10)(A)(ii)) shall not be regarded as failing to comply with
    the requirements of either such subclause (as amended by subsection
    (a)(1)) or with section 1905(v)(1)(A) of the Social Security Act (42
    U.S.C. 1396d(v)(1)(A)) (as amended by subsection (a)(2)) before January
    1, 2027.

    SEC. 104. MEDICAID STATE PLAN REQUIREMENT FOR DETERMINING RESIDENCY AND
                  COVERAGE FOR MILITARY FAMILIES.

        (a) In General.--Section 1902 of the Social Security Act (42 U.S.C.
    1396a) is amended--
                (1) in subsection (a)--
                        (A) in paragraph (86), by striking ``and'' at the
                    end;
                        (B) in paragraph (87), by striking the period at
                    the end and inserting ``; and''; and
                        (C) by inserting after paragraph (87), the
                    following new paragraph:
                ``(88) beginning January 1, 2028, provide, with respect to
            an active duty relocated individual (as defined in subsection
            (uu)(1))--
                        ``(A) that, for purposes of determining eligibility
                    for medical assistance under the State plan (or waiver
                    of such plan), such active duty relocated individual is
                    treated as a resident of the State unless such
                    individual voluntarily elects not to be so treated for
                    such purposes;
                        ``(B) that if, at the time of relocation (as
                    described in subsection (uu)(1)), such active duty
                    relocated individual is on a home and community-based
                    services waiting list (as defined in subsection
                    (uu)(2)), such individual remains on such list until--
                                ``(i) the State completes an assessment and
                            renders a decision with respect to the
                            eligibility of such individual to receive the
                            relevant home and community-based services at
                            the time a slot for such services becomes
                            available and, in the case such decision is a
                            denial of such eligibility, such individual has
                            exhausted the individual's opportunity for a
                            fair hearing; or
                                ``(ii) such individual elects to be removed
                            from such list; and
                        ``(C) payment for medical assistance furnished
                    under the State plan (or a waiver of the plan) on
                    behalf of such active duty relocated individual in the
                    military service relocation State (as referred to in
                    subsection (uu)(1)(B)(i)), to the extent that such
                    assistance is available in such military service
                    relocation State in accordance with such guidance as
                    the Secretary may issue to ensure access to such
                    assistance.''; and
                (2) by adding at the end the following new subsection:
        ``(uu) Active Duty Relocated Individual; Home and Community-Based
    Services Waiting List.--For purposes of subsection (a)(88) and this
    subsection:
                ``(1) Active duty relocated individual.--The term `active
            duty relocated individual' means an individual--
                        ``(A) who--
                                ``(i) is enrolled under the State plan (or
                            waiver of such plan); or
                                ``(ii) with respect to an individual
                            described in subparagraph (C)(ii), would be so
                            enrolled pursuant to subsection
                            (a)(10)(A)(ii)(VI) if such individual began
                            receiving home and community-based services;
                        ``(B) who--
                                ``(i) is a member of the Armed Forces
                            engaged in active duty service and is relocated
                            to another State (in this subsection referred
                            to as the `military service relocation State')
                            by reason of such service;
                                ``(ii) would be described in clause (i)
                            except that the individual stopped being
                            engaged in active duty service (including by
                            reason of retirement from such service) and the
                            last day on which the individual was engaged in
                            active duty service occurred not more than 12
                            months ago; or
                                ``(iii) is a dependent (as defined by the
                            Secretary) of a member described in clause (i)
                            or (ii) who relocates to the military service
                            relocation State with such member; and
                        ``(C) who--
                                ``(i) was receiving home and community-
                            based services (as defined in section
                            9817(a)(2)(B) of the American Rescue Plan Act
                            of 2021) at the time of such relocation; or
                                ``(ii) if the State maintains a home and
                            community-based services waiting list, was on
                            such home and community-based services waiting
                            list at the time of such relocation.
                ``(2) Home and community-based services waiting list.--The
            term `home and community-based services waiting list' means, in
            the case of a State that has a limit on the number of
            individuals who may receive home and community-based services
            under section 1115(a), section 1915(c), or section 1915(j), a
            list maintained by such State of individuals who are requesting
            to receive such services under 1 or more such sections but for
            whom the State has not yet completed an assessment and rendered
            a decision with respect to the eligibility of such individuals
            to receive the relevant home and community-based services at
            the time a slot for such services becomes available due to such
            limit.''.
        (b) Implementation Funding.--There are appropriated, out of any
    funds in the Treasury not otherwise obligated, $1,000,000 for each of
    fiscal years 2025 through 2029, to remain available until expended, to
    the Secretary of Health and Human Services for purposes of implementing
    the amendments made by subsection (a).

    SEC. 105. ENSURING THE RELIABILITY OF ADDRESS INFORMATION PROVIDED
                  UNDER THE MEDICAID PROGRAM.

        (a) In General.--Section 1902(a) of the Social Security Act (42
    U.S.C. 1396a(a)), as previously amended by this title, is amended--
                (1) in paragraph (87), by striking ``and'' at the end;
                (2) in paragraph (88), by striking the period at the end
            and inserting ``; and''; and
                (3) by inserting after paragraph (88) the following new
            paragraph:
                ``(89) beginning January 1, 2026, provide for a process to
            regularly obtain address information for individuals enrolled
            under such plan (or a waiver of such plan) from reliable data
            sources (as described in section 435.919(f)(1)(iii) of title
            42, Code of Federal Regulations (or a successor regulation))
            and act on any changes to such an address based on such
            information in accordance with such section (or successor
            regulation), except that this paragraph shall only apply in the
            case of the 50 States and the District of Columbia.''.
        (b) Application to CHIP.--Section 2107(e)(1) of the Social Security
    Act (42 U.S.C. 1397gg(e)(1)) is amended--
                (1) by redesignating subparagraphs (H) through (U) as
            subparagraphs (I) through (V), respectively; and
                (2) by inserting after subparagraph (G) the following new
            subparagraph:
                        ``(H) Section 1902(a)(89) (relating to regularly
                    obtaining address information for enrollees).''.
        (c) Ensuring Transmission of Address Information From Managed Care
    Organizations.--Section 1932 of the Social Security Act (42 U.S.C.
    1396u-2) is amended by adding at the end the following new subsection:
        ``(j) Transmission of Address Information.--Beginning January 1,
    2026, each contract under a State plan with a managed care entity under
    section 1903(m) shall provide that the entity transmits to the State
    any address information for an individual enrolled with the entity that
    is provided to such entity directly from, or verified by such entity
    directly with, such individual.''.

    SEC. 106. CODIFYING CERTAIN MEDICAID PROVIDER SCREENING REQUIREMENTS
                  RELATED TO DECEASED PROVIDERS.

        Section 1902(kk)(1) of the Social Security Act (42 U.S.C.
    1396a(kk)(1)) is amended--
                (1) by striking ``The State'' and inserting:
                        ``(A) In general.--The State''; and
                (2) by adding at the end the following new subparagraph:
                        ``(B) Additional provider screening.--Beginning
                    January 1, 2027, as part of the enrollment (or
                    reenrollment or revalidation of enrollment) of a
                    provider or supplier under this title, and not less
                    frequently than quarterly during the period that such
                    provider or supplier is so enrolled, the State conducts
                    a check of the Death Master File (as such term is
                    defined in section 203(d) of the Bipartisan Budget Act
                    of 2013) to determine whether such provider or supplier
                    is deceased.''.

    SEC. 107. MODIFYING CERTAIN STATE REQUIREMENTS FOR ENSURING DECEASED
                  INDIVIDUALS DO NOT REMAIN ENROLLED.

        Section 1902 of the Social Security Act (42 U.S.C. 1396a), as
    previously amended by this title, is amended--
                (1) in subsection (a)--
                        (A) in paragraph (88), by striking ``; and'' and
                    inserting a semicolon;
                        (B) in paragraph (89), by striking the period at
                    the end and inserting ``; and''; and
                        (C) by inserting after paragraph (89) the following
                    new paragraph:
                ``(90) provide that the State shall comply with the
            eligibility verification requirements under subsection (vv),
            except that this paragraph shall apply only in the case of the
            50 States and the District of Columbia.''; and
                (2) by adding at the end the following new subsection:
        ``(vv) Verification of Certain Eligibility Criteria.--
                ``(1) In general.--For purposes of subsection (a)(90), the
            eligibility verification requirements, beginning January 1,
            2026, are as follows:
                        ``(A) Quarterly screening to verify enrollee
                    status.--The State shall, not less frequently than
                    quarterly, review the Death Master File (as such term
                    is defined in section 203(d) of the Bipartisan Budget
                    Act of 2013) to determine whether any individuals
                    enrolled for medical assistance under the State plan
                    (or waiver of such plan) are deceased.
                        ``(B) Disenrollment under state plan.--If the State
                    determines, based on information obtained from the
                    Death Master File, that an individual enrolled for
                    medical assistance under the State plan (or waiver of
                    such plan) is deceased, the State shall--
                                ``(i) treat such information as factual
                            information confirming the death of a
                            beneficiary for purposes of section 431.213(a)
                            of title 42, Code of Federal Regulations (or
                            any successor regulation);
                                ``(ii) disenroll such individual from the
                            State plan (or waiver of such plan); and
                                ``(iii) discontinue any payments for
                            medical assistance under this title made on
                            behalf of such individual (other than payments
                            for any items or services furnished to such
                            individual prior to the death of such
                            individual).
                        ``(C) Reinstatement of coverage in the event of
                    error.--If a State determines that an individual was
                    misidentified as deceased based on information obtained
                    from the Death Master File, and was erroneously
                    disenrolled from medical assistance under the State
                    plan (or waiver of such plan) based on such
                    misidentification, the State shall immediately reenroll
                    such individual under the State plan (or waiver of such
                    plan), retroactive to the date of such disenrollment.
                ``(2) Rule of construction.--Nothing under this subsection
            shall be construed to preclude the ability of a State to use
            other electronic data sources to timely identify potentially
            deceased beneficiaries, so long as the State is also in
            compliance with the requirements of this subsection (and all
            other requirements under this title relating to Medicaid
            eligibility determination and redetermination).''.

    SEC. 108. ONE-YEAR DELAY OF MEDICAID AND CHIP REQUIREMENTS FOR HEALTH
                  SCREENINGS, REFERRALS, AND CASE MANAGEMENT SERVICES FOR
                  ELIGIBLE JUVENILES IN PUBLIC INSTITUTIONS; STATE INTERIM
                  WORK PLANS.

        (a) In General.--Section 5121(d) of subtitle C of title V of
    division FF of the Consolidated Appropriations Act, 2023 (Public Law
    117-328) is amended--
                (1) by striking ``The amendments made by this section'' and
            inserting the following:
                ``(1) In general.--Subject to paragraph (2), the amendments
            made by this section''; and
                (2) by adding at the end the following new paragraph:
                ``(2) Delay of date by which states must comply with
            certain juvenile justice-related requirements.--A State shall
            not be regarded as failing to comply with the requirements of
            section 1902(a)(84)(D) or 2102(d)(2) of the Social Security Act
            (42 U.S.C. 1396a(a)(84)(D), 1397bb(d)(2)) before January 1,
            2026.''.
        (b) Clarifying Nonapplication of Requirements to Individuals in
    Federal Custody.--
                (1) Medicaid.--
                        (A) Subparagraph (D) of section 1902(a)(84) of the
                    Social Security Act (42 U.S.C. 1396a(a)(84)), as added
                    by section 5121 of subtitle C of title V of division FF
                    of the Consolidated Appropriations Act, 2023 (Public
                    Law 117-328), is amended by striking ``an individual
                    who is an eligible juvenile'' and inserting ``an
                    individual (other than an individual who is in Federal
                    custody, including as an inmate in a Federal prison)
                    who is an eligible juvenile''.
                        (B) Section 5122(a) of subtitle C of title V of
                    division FF of the Consolidated Appropriations Act,
                    2023 (Public Law 117-328) is amended--
                                (i) by striking ``paragraph (31)'' each
                            place it appears and inserting ``the last
                            numbered paragraph''; and
                                (ii) in paragraph (1), by striking ``an
                            individual who is an eligible juvenile'' and
                            inserting ``an individual (other than an
                            individual who is in Federal custody, including
                            as an inmate in a Federal prison) who is an
                            eligible juvenile''.
                (2) CHIP.--
                        (A) Subsection (d)(2) of section 2102 of the Social
                    Security Act (42 U.S.C. 1397bb), as added by section
                    5121 of subtitle C of title V of division FF of the
                    Consolidated Appropriations Act, 2023 (Public Law 117-
                    328), is amended by striking ``a targeted low-income
                    child who'' and inserting ``a targeted low income child
                    (other than a child who is in Federal custody,
                    including as an inmate in a Federal prison) who''.
                        (B) Section 5122(b)(2) of subtitle C of title V of
                    division FF of the Consolidated Appropriations Act,
                    2023 (Public Law 117-328) is amended by striking ``a
                    child who is'' and inserting ``a child (other than a
                    child who is in Federal custody, including as an inmate
                    in a Federal prison) who is''.
                (3) Effective date.--The amendments made by this subsection
            shall take effect as if enacted on December 29, 2022.
        (c) Interim Work Plan.--Not later than June 30, 2025, each State
    (as such term is defined in section 1101(a)(1) of the Social Security
    Act (42 U.S.C. 1301(a)(1)) for purposes of titles XIX and XXI of such
    Act) shall submit to the Secretary of Health and Human Services an
    interim work plan, in such form and containing such information as the
    Secretary may specify, describing the State's progress towards
    implementing, and its plans to come into compliance with, the
    requirements imposed by the amendments made by section 5121 of subtitle
    C of title V of division FF of the Consolidated Appropriations Act,
    2023 (Public Law 117-328), consistent with the guidance issued by the
    Centers for Medicare & Medicaid Services in State Health Official
    Letter #24-004 on July 23, 2024.

    SEC. 109. STATE STUDIES AND HHS REPORT ON COSTS OF PROVIDING MATERNITY,
                  LABOR, AND DELIVERY SERVICES.

        (a) State Study.--
                (1) In general.--Not later than 24 months after the date of
            enactment of this Act, and every 5 years thereafter, each State
            (as such term is defined in section 1101(a)(1) of the Social
            Security Act (42 U.S.C. 1301(a)(1)) for purposes of titles XIX
            and XXI of such Act) shall conduct a study on the costs of
            providing maternity, labor, and delivery services in applicable
            hospitals (as defined in paragraph (3)) and submit the results
            of such study to the Secretary of Health and Human Services
            (referred to in this section as the ``Secretary'').
                (2) Content of study.--A State study required under
            paragraph (1) shall include the following information (to the
            extent practicable) with respect to maternity, labor, and
            delivery services furnished by applicable hospitals located in
            the State:
                        (A) An estimate of the cost of providing maternity,
                    labor, and delivery services at applicable hospitals,
                    based on the expenditures a representative sample of
                    such hospitals incurred for providing such services
                    during the 2 most recent years for which data is
                    available.
                        (B) An estimate of the cost of providing maternity,
                    labor, and delivery services at applicable hospitals
                    that ceased providing labor and delivery services
                    within the past 5 years, based on the expenditures a
                    representative sample of such hospitals incurred for
                    providing such services during the 2 most recent years
                    for which data is available.
                        (C) To the extent data allows, an analysis of the
                    extent to which geographic location, community
                    demographics, and local economic factors (as defined by
                    the Secretary) affect the cost of providing maternity,
                    labor, and delivery services at applicable hospitals,
                    including the cost of services that support the
                    provision of maternity, labor, and delivery services.
                        (D) The amounts applicable hospitals are paid for
                    maternity, labor, and delivery services, by geographic
                    location and hospital size, under--
                                (i) Medicare;
                                (ii) the State Medicaid program, including
                            payment amounts for such services under fee-
                            for-service payment arrangements and under
                            managed care (as applicable);
                                (iii) the State CHIP plan, including
                            payment amounts for such services under fee-
                            for-service payment arrangements and under
                            managed care (as applicable); and
                                (iv) private health insurance.
                        (E) A comparative payment rate analysis--
                                (i) comparing payment rates for maternity,
                            labor, and delivery services (inclusive of all
                            payments received by applicable hospitals for
                            furnishing maternity, labor, and delivery
                            services) under the State Medicaid fee-for-
                            service program to such payment rates for such
                            services under Medicare (as described in
                            section 447.203(b)(3) of title 42, Code of
                            Federal Regulations), other Federally-funded or
                            State-funded programs (including, to the extent
                            data is available, Medicaid managed care
                            rates), and to the payment rates for such
                            services, to the extent data is available, of
                            private health insurers within geographic areas
                            of the State; and
                                (ii) analyzing different payment methods
                            for such services, such as the use of bundled
                            payments, quality incentives, and low-volume
                            adjustments.
                        (F) An evaluation, using such methodology and
                    parameters established by the Secretary, of whether
                    each hospital located in the State that furnishes
                    maternity, labor, and delivery services is expected to
                    experience in the next 3 years significant changes in
                    particular expenditures or types of reimbursement for
                    maternity, labor, and delivery services.
                (3) Applicable hospital defined.--For purposes of this
            subsection, the term ``applicable hospital'' means any hospital
            located in a State that meets either of the following criteria:
                        (A) The hospital provides labor and delivery
                    services and more than 50 percent of the hospital's
                    births (in the most recent year for which such data is
                    available) are financed by the Medicaid program or
                    CHIP.
                        (B) The hospital--
                                (i) is located in a rural area (as defined
                            by the Federal Office of Rural Health Policy
                            for the purpose of rural health grant programs
                            administered by such Office);
                                (ii) based on the most recent 2 years of
                            data available (as determined by the
                            Secretary), furnished services for less than an
                            average of 300 births per year; and
                                (iii) provides labor and delivery services.
                (4) Assistance to small hospitals in compiling cost
            information.--There are appropriated to the Secretary for
            fiscal year 2025, $10,000,000 for the purpose of providing
            grants and technical assistance to a hospital described in
            paragraph (3)(B) to enable such hospital to compile detailed
            information for use in the State studies required under
            paragraph (1), to remain available until expended.
                (5) HHS report on state studies.--For each year in which a
            State is required to conduct a study under paragraph (1), the
            Secretary shall issue, not later than 12 months after the date
            on which the State submits to the Secretary the data described
            in such paragraph, a publicly available report that compiles
            and details the results of such study and includes the
            information described in paragraph (2).
        (b) HHS Report on National Data Collection Findings.--Not later
    than 3 years after the date of enactment of this Act, the Secretary
    shall submit to Congress, and make publicly available, a report
    analyzing the first studies conducted by States under subsection
    (a)(1), including recommendations for improving data collection on the
    cost of providing maternity, labor, and delivery services.
        (c) Implementation Funding.--In addition to the amount appropriated
    under subsection (a)(4), there are appropriated, out of any funds in
    the Treasury not otherwise obligated, $3,000,000 for fiscal year 2025,
    to remain available until expended, to the Secretary of Health and
    Human Services for purposes of implementing this section.

    SEC. 110. MODIFYING CERTAIN DISPROPORTIONATE SHARE HOSPITAL ALLOTMENTS.

        (a) Extending Tennessee DSH Allotments.--Section 1923(f)(6)(A)(vi)
    of the Social Security Act (42 U.S.C. 1396r-4(f)(6)(A)(vi)) is
    amended--
                (1) in the heading, by striking ``2025'' and inserting
            ``2026 and for the 1st quarter of fiscal year 2027'';
                (2) by striking ``fiscal year 2025'' and inserting ``fiscal
            year 2026''; and
                (3) by inserting ``, and the DSH allotment for Tennessee
            for the 1st quarter of fiscal year 2027, shall be $13,275,000''
            before the period.
        (b) Eliminating and Delaying DSH Allotment Reductions.--Section
    1923(f) of the Social Security Act (42 U.S.C. 1396r-4(f)) is amended--
                (1) in paragraph (7)(A)--
                        (A) in clause (i), in the matter preceding
                    subclause (I), by striking ``April 1, 2025,'' and all
                    that follows through ``2027'' and inserting ``January
                    1, 2027, and ending September 30, 2027, and for fiscal
                    year 2028''; and
                        (B) in clause (ii), by striking ``April 1, 2025,''
                    and all that follows through ``2027'' and inserting
                    ``January 1, 2027, and ending September 30, 2027, and
                    for fiscal year 2028''; and
                (2) in paragraph (8), by striking ``2027'' and inserting
            ``2028''.

    SEC. 111. MODIFYING CERTAIN LIMITATIONS ON DISPROPORTIONATE SHARE
                  HOSPITAL PAYMENT ADJUSTMENTS UNDER THE MEDICAID PROGRAM.

        (a) In General.--Section 1923(g) of the Social Security Act (42
    U.S.C. 1396r-4(g)) is amended--
                (1) in paragraph (1)--
                        (A) in subparagraph (A)--
                                (i) in the matter preceding clause (i), by
                            striking ``(other than a hospital described in
                            paragraph (2)(B))'';
                                (ii) in clause (i), by inserting ``with
                            respect to such hospital and year'' after
                            ``described in subparagraph (B)''; and
                                (iii) in clause (ii)--
                                        (I) in subclause (I), by striking
                                    ``and'' at the end;
                                        (II) in subclause (II), by striking
                                    the period and inserting ``; and''; and
                                        (III) by adding at the end the
                                    following new subclause:
                                        ``(III) payments made under title
                                    XVIII or by an applicable plan (as
                                    defined in section 1862(b)(8)(F)) for
                                    such services.''; and
                        (B) in subparagraph (B)--
                                (i) in the matter preceding clause (i), by
                            striking ``in this clause are'' and inserting
                            ``in this subparagraph are, with respect to a
                            hospital and a year,''; and
                                (ii) by adding at the end the following new
                            clause:
                                ``(iii) Individuals who are eligible for
                            medical assistance under the State plan or
                            under a waiver of such plan and for whom the
                            State plan or waiver is a payor for such
                            services after application of benefits under
                            title XVIII or under an applicable plan (as
                            defined in section 1862(b)(8)(F)), but only if
                            the hospital has in the aggregate incurred
                            costs exceeding payments under such State plan,
                            waiver, title XVIII, or applicable plan for
                            such services furnished to such individuals
                            during such year.'';
                (2) by striking paragraph (2);
                (3) by redesignating paragraph (3) as paragraph (2); and
                (4) in paragraph (2), as so redesignated, by striking
            ``Notwithstanding paragraph (2) of this subsection (as in
            effect on October 1, 2021), paragraph (2)'' and inserting
            ``Paragraph (2)''.
        (b) Effective Date.--
                (1) In general.--Except as provided in paragraph (2), the
            amendments made by this section shall apply to payment
            adjustments made under section 1923 of the Social Security Act
            (42 U.S.C. 1396r-4) for Medicaid State plan rate years
            beginning on or after the date of enactment of this Act.
                (2) State option to distribute unspent dsh allotments from
            prior years up to modified cap.--
                        (A) In general.--If, for any Medicaid State plan
                    rate year that begins on or after October 1, 2021, and
                    before the date of enactment of this Act, a State did
                    not spend the full amount of its Federal fiscal year
                    allotment under section 1923 of the Social Security Act
                    (42 U.S.C. 1396r-4) applicable to that State plan rate
                    year, the State may use the unspent portion of such
                    allotment to increase the amount of any payment
                    adjustment made to a hospital for such rate year,
                    provided that--
                                (i) such payment adjustment (as so
                            increased) is consistent with subsection (g) of
                            such section (as amended by this section); and
                                (ii) the total amount of all payment
                            adjustments for the State plan rate year (as so
                            increased) does not exceed the disproportionate
                            share hospital allotment for the State and
                            applicable Federal fiscal year under subsection
                            (f) of such section.
                        (B) No recoupment of payments already made to
                    hospitals.--A State shall not recoup any payment
                    adjustment made by the State to a hospital for a
                    Medicaid State plan rate year described in subparagraph
                    (A) if such payment adjustment is consistent with
                    section 1923(g) of such Act (42 U.S.C. 1396r-4(g)) as
                    in effect on October 1, 2021.
                        (C) Authority to permit retroactive modification of
                    state plan amendments to allow for increases.--
                                (i) In general.--Subject to paragraph (2),
                            solely for the purpose of allowing a State to
                            increase the amount of a payment adjustment to
                            a hospital for a Medicaid State plan rate year
                            described in subparagraph (A) pursuant to this
                            paragraph, a State may retroactively modify a
                            provision of the Medicaid State plan, a waiver
                            of such plan, or a State plan amendment that
                            relates to such rate year and the Secretary may
                            approve such modification.
                                (ii) Deadline.--A State may not submit a
                            request for approval of a retroactive
                            modification to a provision of the Medicaid
                            State plan, a waiver of such plan, or a State
                            plan amendment for a Medicaid State plan rate
                            year after the date by which the State is
                            required to submit the independent certified
                            audit for that State plan rate year as required
                            under section 1923(j)(2) of the Social Security
                            Act (42 U.S.C. 1396r-4(j)(2)).
                        (D) Reporting.--If a State increases a payment
                    adjustment made to a hospital for a Medicaid State plan
                    rate year pursuant to this paragraph, the State shall
                    include information on such increased payment
                    adjustment as part of the next annual report submitted
                    by the State under section 1923(j)(1) of the Social
                    Security Act (42 U.S.C. 1396r-4(j)(1)).

    SEC. 112. ENSURING ACCURATE PAYMENTS TO PHARMACIES UNDER MEDICAID.

        (a) In General.--Section 1927(f) of the Social Security Act (42
    U.S.C. 1396r-8(f)) is amended--
                (1) in paragraph (1)(A)--
                        (A) by redesignating clause (ii) as clause (iii);
                    and
                        (B) by striking ``and'' after the semicolon at the
                    end of clause (i) and all that precedes it through
                    ``(1)'' and inserting the following:
                ``(1) Determining pharmacy actual acquisition costs.--The
            Secretary shall conduct a survey of retail community pharmacy
            drug prices and applicable non-retail pharmacy drug prices to
            determine national average drug acquisition cost benchmarks (as
            such term is defined by the Secretary) as follows:
                        ``(A) Use of vendor.--The Secretary may contract
                    services for--
                                ``(i) with respect to retail community
                            pharmacies, the determination of retail survey
                            prices of the national average drug acquisition
                            cost for covered outpatient drugs that
                            represent a nationwide average of consumer
                            purchase prices for such drugs, net of all
                            discounts, rebates, and other price concessions
                            (to the extent any information with respect to
                            such discounts, rebates, and other price
                            concessions is available) based on a monthly
                            survey of such pharmacies;
                                ``(ii) with respect to applicable non-
                            retail pharmacies--
                                        ``(I) the determination of survey
                                    prices, separate from the survey prices
                                    described in clause (i), of the non-
                                    retail national average drug
                                    acquisition cost for covered outpatient
                                    drugs that represent a nationwide
                                    average of consumer purchase prices for
                                    such drugs, net of all discounts,
                                    rebates, and other price concessions
                                    (to the extent any information with
                                    respect to such discounts, rebates, and
                                    other price concessions is available)
                                    based on a monthly survey of such
                                    pharmacies; and
                                        ``(II) at the discretion of the
                                    Secretary, for each type of applicable
                                    non-retail pharmacy, the determination
                                    of survey prices, separate from the
                                    survey prices described in clause (i)
                                    or subclause (I) of this clause, of the
                                    national average drug acquisition cost
                                    for such type of pharmacy for covered
                                    outpatient drugs that represent a
                                    nationwide average of consumer purchase
                                    prices for such drugs, net of all
                                    discounts, rebates, and other price
                                    concessions (to the extent any
                                    information with respect to such
                                    discounts, rebates, and other price
                                    concessions is available) based on a
                                    monthly survey of such pharmacies;
                                    and'';
                (2) in subparagraph (B) of paragraph (1), by striking
            ``subparagraph (A)(ii)'' and inserting ``subparagraph
            (A)(iii)'';
                (3) in subparagraph (D) of paragraph (1), by striking
            clauses (ii) and (iii) and inserting the following:
                                ``(ii) The vendor must update the Secretary
                            no less often than monthly on the survey prices
                            for covered outpatient drugs.
                                ``(iii) The vendor must differentiate, in
                            collecting and reporting survey data, for all
                            cost information collected, whether a pharmacy
                            is a retail community pharmacy or an applicable
                            non-retail pharmacy, including whether such
                            pharmacy is an affiliate (as defined in
                            subsection (k)(14)), and, in the case of an
                            applicable non-retail pharmacy, which type of
                            applicable non-retail pharmacy it is using the
                            relevant pharmacy type indicators included in
                            the guidance required by subsection (d)(2) of
                            section 112 of the Bipartisan Health Care
                            Act.'';
                (4) by adding at the end of paragraph (1) the following:
                        ``(F) Survey reporting.--In order to meet the
                    requirement of section 1902(a)(54), a State shall
                    require that any retail community pharmacy or
                    applicable non-retail pharmacy in the State that
                    receives any payment, reimbursement, administrative
                    fee, discount, rebate, or other price concession
                    related to the dispensing of covered outpatient drugs
                    to individuals receiving benefits under this title,
                    regardless of whether such payment, reimbursement,
                    administrative fee, discount, rebate, or other price
                    concession is received from the State or a managed care
                    entity or other specified entity (as such terms are
                    defined in section 1903(m)(9)(D)) directly or from a
                    pharmacy benefit manager or another entity that has a
                    contract with the State or a managed care entity or
                    other specified entity (as so defined), shall respond
                    to surveys conducted under this paragraph.
                        ``(G) Survey information.--Information on national
                    drug acquisition prices obtained under this paragraph
                    shall be made publicly available in a form and manner
                    to be determined by the Secretary and shall include at
                    least the following:
                                ``(i) The monthly response rate to the
                            survey including a list of pharmacies not in
                            compliance with subparagraph (F).
                                ``(ii) The sampling methodology and number
                            of pharmacies sampled monthly.
                                ``(iii) Information on price concessions to
                            pharmacies, including discounts, rebates, and
                            other price concessions, to the extent that
                            such information may be publicly released and
                            has been collected by the Secretary as part of
                            the survey.
                        ``(H) Penalties.--
                                ``(i) In general.--Subject to clauses (ii),
                            (iii), and (iv), the Secretary shall enforce
                            the provisions of this paragraph with respect
                            to a pharmacy through the establishment of
                            civil money penalties applicable to a retail
                            community pharmacy or an applicable non-retail
                            pharmacy.
                                ``(ii) Basis for penalties.--The Secretary
                            shall impose a civil money penalty established
                            under this subparagraph on a retail community
                            pharmacy or applicable non-retail pharmacy if--
                                        ``(I) the retail pharmacy or
                                    applicable non-retail pharmacy refuses
                                    or otherwise fails to respond to a
                                    request for information about prices in
                                    connection with a survey under this
                                    subsection;
                                        ``(II) knowingly provides false
                                    information in response to such a
                                    survey; or
                                        ``(III) otherwise fails to comply
                                    with the requirements established under
                                    this paragraph.
                                ``(iii) Parameters for penalties.--
                                        ``(I) In general.--A civil money
                                    penalty established under this
                                    subparagraph may be assessed with
                                    respect to each violation, and with
                                    respect to each non-compliant retail
                                    community pharmacy (including a
                                    pharmacy that is part of a chain) or
                                    non-compliant applicable non-retail
                                    pharmacy (including a pharmacy that is
                                    part of a chain), in an amount not to
                                    exceed $100,000 for each such
                                    violation.
                                        ``(II) Considerations.--In
                                    determining the amount of a civil money
                                    penalty imposed under this
                                    subparagraph, the Secretary may
                                    consider the size, business structure,
                                    and type of pharmacy involved, as well
                                    as the type of violation and other
                                    relevant factors, as determined
                                    appropriate by the Secretary.
                                ``(iv) Rule of application.--The provisions
                            of section 1128A (other than subsections (a)
                            and (b)) shall apply to a civil money penalty
                            under this subparagraph in the same manner as
                            such provisions apply to a civil money penalty
                            or proceeding under section 1128A(a).
                        ``(I) Limitation on use of applicable non-retail
                    pharmacy pricing information.--No State shall use
                    pricing information reported by applicable non-retail
                    pharmacies under subparagraph (A)(ii) to develop or
                    inform payment methodologies for retail community
                    pharmacies.'';
                (5) in paragraph (2)--
                        (A) in subparagraph (A), by inserting ``, including
                    payment rates and methodologies for determining
                    ingredient cost reimbursement under managed care
                    entities or other specified entities (as such terms are
                    defined in section 1903(m)(9)(D)),'' after ``under this
                    title''; and
                        (B) in subparagraph (B), by inserting ``and the
                    basis for such dispensing fees'' before the semicolon;
                (6) by redesignating paragraph (4) as paragraph (5);
                (7) by inserting after paragraph (3) the following new
            paragraph:
                ``(4) Oversight.--
                        ``(A) In general.--The Inspector General of the
                    Department of Health and Human Services shall conduct
                    periodic studies of the survey data reported under this
                    subsection, as appropriate, including with respect to
                    substantial variations in acquisition costs or other
                    applicable costs, as well as with respect to how
                    internal transfer prices and related party transactions
                    may influence the costs reported by pharmacies that are
                    affiliates (as defined in subsection (k)(14)) or are
                    owned by, controlled by, or related under a common
                    ownership structure with a wholesaler, distributor, or
                    other entity that acquires covered outpatient drugs
                    relative to costs reported by pharmacies not affiliated
                    with such entities. The Inspector General shall provide
                    periodic updates to Congress on the results of such
                    studies, as appropriate, in a manner that does not
                    disclose trade secrets or other proprietary
                    information.
                        ``(B) Appropriation.--There is appropriated to the
                    Inspector General of the Department of Health and Human
                    Services, out of any money in the Treasury not
                    otherwise appropriated, $5,000,000 for fiscal year
                    2025, to remain available until expended, to carry out
                    this paragraph.''; and
                (8) in paragraph (5), as so redesignated--
                        (A) by inserting ``, and $9,000,000 for fiscal year
                    2025 and each fiscal year thereafter,'' after ``2010'';
                    and
                        (B) by inserting ``Funds appropriated under this
                    paragraph for fiscal year 2025 and any subsequent
                    fiscal year shall remain available until expended.''
                    after the period.
        (b) Definitions.--Section 1927(k) of the Social Security Act (42
    U.S.C. 1396r-8(k)) is amended--
                (1) in the matter preceding paragraph (1), by striking ``In
            the section'' and inserting ``In this section''; and
                (2) by adding at the end the following new paragraphs:
                ``(12) Applicable non-retail pharmacy.--The term
            `applicable non-retail pharmacy' means a pharmacy that is
            licensed as a pharmacy by the State and that is not a retail
            community pharmacy, including a pharmacy that dispenses
            prescription medications to patients primarily through mail and
            specialty pharmacies. Such term does not include nursing home
            pharmacies, long-term care facility pharmacies, hospital
            pharmacies, clinics, charitable or not-for-profit pharmacies,
            government pharmacies, or low dispensing pharmacies (as defined
            by the Secretary).
                ``(13) Affiliate.--The term `affiliate' means any entity
            that is owned by, controlled by, or related under a common
            ownership structure with a pharmacy benefit manager or a
            managed care entity or other specified entity (as such terms
            are defined in section 1903(m)(9)(D)).''.
        (c) Effective Date.--
                (1) In general.--Subject to paragraph (2), the amendments
            made by this section shall take effect on the first day of the
            first quarter that begins on or after the date that is 6 months
            after the date of enactment of this Act.
                (2) Delayed application to applicable non-retail
            pharmacies.--The pharmacy survey requirements established by
            the amendments to section 1927(f) of the Social Security Act
            (42 U.S.C. 1396r-8(f)) made by this section shall apply to
            retail community pharmacies beginning on the effective date
            described in paragraph (1), but shall not apply to applicable
            non-retail pharmacies until the first day of the first quarter
            that begins on or after the date that is 18 months after the
            date of enactment of this Act.
        (d) Identification of Applicable Non-Retail Pharmacies.--
                (1) In general.--Not later than January 1, 2026, the
            Secretary of Health and Human Services shall, in consultation
            with stakeholders as appropriate, publish guidance specifying
            pharmacies that meet the definition of applicable non-retail
            pharmacies (as such term is defined in subsection (k)(12) of
            section 1927 of the Social Security Act (42 U.S.C. 1396r-8), as
            added by subsection (b)), and that will be subject to the
            survey requirements under subsection (f)(1) of such section, as
            amended by subsection (a).
                (2) Inclusion of pharmacy type indicators.--The guidance
            published under paragraph (1) shall include pharmacy type
            indicators to distinguish between different types of applicable
            non-retail pharmacies, such as pharmacies that dispense
            prescriptions primarily through the mail and pharmacies that
            dispense prescriptions that require special handling or
            distribution. An applicable non-retail pharmacy may be
            identified through multiple pharmacy type indicators.
        (e) Implementation.--
                (1) In general.--Notwithstanding any other provision of
            law, the Secretary of Health and Human Services may implement
            the amendments made by this section by program instruction or
            otherwise.
                (2) Nonapplication of administrative procedure act.--
            Implementation of the amendments made by this section shall be
            exempt from the requirements of section 553 of title 5, United
            States Code.
        (f) Nonapplication of Paperwork Reduction Act.--Chapter 35 of title
    44, United States Code, shall not apply to any data collection
    undertaken by the Secretary of Health and Human Services under section
    1927(f) of the Social Security Act (42 U.S.C. 1396r-8(f)), as amended
    by this section.

    SEC. 113. PREVENTING THE USE OF ABUSIVE SPREAD PRICING IN MEDICAID.

        (a) In General.--Section 1927 of the Social Security Act (42 U.S.C.
    1396r-8) is amended--
                (1) in subsection (e), by adding at the end the following
            new paragraph:
                ``(6) Transparent prescription drug pass-through pricing
            required.--
                        ``(A) In general.--A contract between the State and
                    a pharmacy benefit manager (referred to in this
                    paragraph as a `PBM'), or a contract between the State
                    and a managed care entity or other specified entity (as
                    such terms are defined in section 1903(m)(9)(D) and
                    collectively referred to in this paragraph as the
                    `entity') that includes provisions making the entity
                    responsible for coverage of covered outpatient drugs
                    dispensed to individuals enrolled with the entity,
                    shall require that payment for such drugs and related
                    administrative services (as applicable), including
                    payments made by a PBM on behalf of the State or
                    entity, is based on a transparent prescription drug
                    pass-through pricing model under which--
                                ``(i) any payment made by the entity or the
                            PBM (as applicable) for such a drug--
                                        ``(I) is limited to--
                                                ``(aa) ingredient cost; and
                                                ``(bb) a professional
                                            dispensing fee that is not less
                                            than the professional
                                            dispensing fee that the State
                                            would pay if the State were
                                            making the payment directly in
                                            accordance with the State plan;
                                        ``(II) is passed through in its
                                    entirety (except as reduced under
                                    Federal or State laws and regulations
                                    in response to instances of waste,
                                    fraud, or abuse) by the entity or PBM
                                    to the pharmacy or provider that
                                    dispenses the drug; and
                                        ``(III) is made in a manner that is
                                    consistent with sections 447.502,
                                    447.512, 447.514, and 447.518 of title
                                    42, Code of Federal Regulations (or any
                                    successor regulation) as if such
                                    requirements applied directly to the
                                    entity or the PBM, except that any
                                    payment by the entity or the PBM for
                                    the ingredient cost of such drug
                                    purchased by a covered entity (as
                                    defined in subsection (a)(5)(B)) may
                                    exceed the actual acquisition cost (as
                                    defined in 447.502 of title 42, Code of
                                    Federal Regulations, or any successor
                                    regulation) for such drug if--
                                                ``(aa) such drug was
                                            subject to an agreement under
                                            section 340B of the Public
                                            Health Service Act;
                                                ``(bb) such payment for the
                                            ingredient cost of such drug
                                            does not exceed the maximum
                                            payment that would have been
                                            made by the entity or the PBM
                                            for the ingredient cost of such
                                            drug if such drug had not been
                                            purchased by such covered
                                            entity; and
                                                ``(cc) such covered entity
                                            reports to the Secretary (in a
                                            form and manner specified by
                                            the Secretary), on an annual
                                            basis and with respect to
                                            payments for the ingredient
                                            costs of such drugs so
                                            purchased by such covered
                                            entity that are in excess of
                                            the actual acquisition costs
                                            for such drugs, the aggregate
                                            amount of such excess;
                                ``(ii) payment to the entity or the PBM (as
                            applicable) for administrative services
                            performed by the entity or PBM is limited to an
                            administrative fee that reflects the fair
                            market value (as defined by the Secretary) of
                            such services;
                                ``(iii) the entity or the PBM (as
                            applicable) makes available to the State, and
                            the Secretary upon request in a form and manner
                            specified by the Secretary, all costs and
                            payments related to covered outpatient drugs
                            and accompanying administrative services (as
                            described in clause (ii)) incurred, received,
                            or made by the entity or the PBM, broken down
                            (as specified by the Secretary), to the extent
                            such costs and payments are attributable to an
                            individual covered outpatient drug, by each
                            such drug, including any ingredient costs,
                            professional dispensing fees, administrative
                            fees (as described in clause (ii)), post-sale
                            and post-invoice fees, discounts, or related
                            adjustments such as direct and indirect
                            remuneration fees, and any and all other
                            remuneration, as defined by the Secretary; and
                                ``(iv) any form of spread pricing whereby
                            any amount charged or claimed by the entity or
                            the PBM (as applicable) that exceeds the amount
                            paid to the pharmacies or providers on behalf
                            of the State or entity, including any post-sale
                            or post-invoice fees, discounts, or related
                            adjustments such as direct and indirect
                            remuneration fees or assessments, as defined by
                            the Secretary, (after allowing for an
                            administrative fee as described in clause (ii))
                            is not allowable for purposes of claiming
                            Federal matching payments under this title.
                        ``(B) Publication of information.--The Secretary
                    shall publish, not less frequently than on an annual
                    basis and in a manner that does not disclose the
                    identity of a particular covered entity or
                    organization, information received by the Secretary
                    pursuant to subparagraph (A)(iii)(III) that is broken
                    out by State and by each of the following categories of
                    covered entity within each such State:
                                ``(i) Covered entities described in
                            subparagraph (A) of section 340B(a)(4) of the
                            Public Health Service Act.
                                ``(ii) Covered entities described in
                            subparagraphs (B) through (K) of such section.
                                ``(iii) Covered entities described in
                            subparagraph (L) of such section.
                                ``(iv) Covered entities described in
                            subparagraph (M) of such section.
                                ``(v) Covered entities described in
                            subparagraph (N) of such section.
                                ``(vi) Covered entities described in
                            subparagraph (O) of such section.''; and
                (2) in subsection (k), as previously amended by this title,
            by adding at the end the following new paragraph:
                ``(14) Pharmacy benefit manager.--The term `pharmacy
            benefit manager' means any person or entity that, either
            directly or through an intermediary, acts as a price negotiator
            or group purchaser on behalf of a State, managed care entity
            (as defined in section 1903(m)(9)(D)), or other specified
            entity (as so defined), or manages the prescription drug
            benefits provided by a State, managed care entity, or other
            specified entity, including the processing and payment of
            claims for prescription drugs, the performance of drug
            utilization review, the processing of drug prior authorization
            requests, the managing of appeals or grievances related to the
            prescription drug benefits, contracting with pharmacies,
            controlling the cost of covered outpatient drugs, or the
            provision of services related thereto. Such term includes any
            person or entity that acts as a price negotiator (with regard
            to payment amounts to pharmacies and providers for a covered
            outpatient drug or the net cost of the drug) or group purchaser
            on behalf of a State, managed care entity, or other specified
            entity or that carries out 1 or more of the other activities
            described in the preceding sentence, irrespective of whether
            such person or entity calls itself a pharmacy benefit
            manager.''.
        (b) Conforming Amendments.--Section 1903(m) of such Act (42 U.S.C.
    1396b(m)) is amended--
                (1) in paragraph (2)(A)(xiii)--
                        (A) by striking ``and (III)'' and inserting
                    ``(III)'';
                        (B) by inserting before the period at the end the
                    following: ``, and (IV) if the contract includes
                    provisions making the entity responsible for coverage
                    of covered outpatient drugs, the entity shall comply
                    with the requirements of section 1927(e)(6)''; and
                        (C) by moving the margin 2 ems to the left; and
                (2) by adding at the end the following new paragraph:
                ``(10) 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 an other specified entity (as defined
            in paragraph (9)(D)(iii)) unless such services are provided in
            accordance with a contract between the State and such entity
            which satisfies the requirements of paragraph (2)(A)(xiii).''.
        (c) Effective Date.--The amendments made by this section shall
    apply to contracts between States and managed care entities, other
    specified entities, or pharmacy benefit managers that have an effective
    date beginning on or after the date that is 18 months after the date of
    enactment of this Act.
        (d) Implementation.--
                (1) In general.--Notwithstanding any other provision of
            law, the Secretary of Health and Human Services may implement
            the amendments made by this section by program instruction or
            otherwise.
                (2) Nonapplication of administrative procedure act.--
            Implementation of the amendments made by this section shall be
            exempt from the requirements of section 553 of title 5, United
            States Code.
        (e) Nonapplication of Paperwork Reduction Act.--Chapter 35 of title
    44, United States Code, shall not apply to any data collection
    undertaken by the Secretary of Health and Human Services under section
    1927(e) of the Social Security Act (42 U.S.C. 1396r-8(e)), as amended
    by this section.

                               TITLE II--MEDICARE

    SEC. 201. EXTENSION OF INCREASED INPATIENT HOSPITAL PAYMENT ADJUSTMENT
                  FOR CERTAIN LOW-VOLUME HOSPITALS.

        (a) In General.--Section 1886(d)(12) of the Social Security Act (42
    U.S.C. 1395ww(d)(12)) is amended--
                (1) in subparagraph (B), in the matter preceding clause
            (i), by striking ``fiscal year 2025 beginning on April 1, 2025,
            and ending on September 30, 2025, and in fiscal year 2026'' and
            inserting ``fiscal year 2026 beginning on January 1, 2026, and
            ending on September 30, 2026, and in fiscal year 2027'';
                (2) in subparagraph (C)(i)--
                        (A) in the matter preceding subclause (I), by
                    striking ``through 2024 and the portion of fiscal year
                    2025 beginning on October 1, 2024, and ending on March
                    31, 2025'' and inserting ``through 2025 and the portion
                    of fiscal year 2026 beginning on October 1, 2025, and
                    ending on December 31, 2025'';
                        (B) in subclause (III), by striking ``through 2024
                    and the portion of fiscal year 2025 beginning on
                    October 1, 2024, and ending on March 31, 2025'' and
                    inserting ``through 2025 and the portion of fiscal year
                    2026 beginning on October 1, 2025, and ending on
                    December 31, 2025''; and
                        (C) in subclause (IV), by striking ``fiscal year
                    2025 beginning on April 1, 2025, and ending on
                    September 30, 2025, and fiscal year 2026'' and
                    inserting ``fiscal year 2026 beginning on January 1,
                    2026, and ending on September 30, 2026, and fiscal year
                    2027''; and
                (3) in subparagraph (D)--
                        (A) in the matter preceding clause (i), by striking
                    ``through 2024 or during the portion of fiscal year
                    2025 beginning on October 1, 2024, and ending on March
                    31, 2025'' and inserting ``through 2025 or during the
                    portion of fiscal year 2026 beginning on October 1,
                    2025, and ending on December 31, 2025''; and
                        (B) in clause (ii), by striking ``through 2024 and
                    the portion of fiscal year 2025 beginning on October 1,
                    2024, and ending on March 31, 2025'' and inserting
                    ``through 2025 and the portion of fiscal year 2026
                    beginning on October 1, 2025, and ending on December
                    31, 2025''.
        (b) Implementation.--Notwithstanding any other provision of law,
    the Secretary of Health and Human Services may implement the amendments
    made by this section by program instruction or otherwise.

    SEC. 202. EXTENSION OF THE MEDICARE-DEPENDENT HOSPITAL (MDH) PROGRAM.

        (a) In General.--Section 1886(d)(5)(G) of the Social Security Act
    (42 U.S.C. 1395ww(d)(5)(G)) is amended--
                (1) in clause (i), by striking ``April 1, 2025'' and
            inserting ``January 1, 2026''; and
                (2) in clause (ii)(II), by striking ``April 1, 2025'' and
            inserting ``January 1, 2026''.
        (b) Conforming Amendments.--
                (1) In general.--Section 1886(b)(3)(D) of the Social
            Security Act (42 U.S.C. 1395ww(b)(3)(D)) is amended--
                        (A) in the matter preceding clause (i), by striking
                    ``April 1, 2025'' and inserting ``January 1, 2026'';
                    and
                        (B) in clause (iv), by striking ``through fiscal
                    year 2024 and the portion of fiscal year 2025 beginning
                    on October 1, 2024, and ending on March 31, 2025'' and
                    inserting ``through fiscal year 2025 and the portion of
                    fiscal year 2026 beginning on October 1, 2025, and
                    ending on December 31, 2025''.
                (2) Permitting hospitals to decline reclassification.--
            Section 13501(e)(2) of the Omnibus Budget Reconciliation Act of
            1993 (42 U.S.C. 1395ww note) is amended by striking ``through
            fiscal year 2024, or the portion of fiscal year 2025 beginning
            on October 1, 2024, and ending on March 31, 2025'' and
            inserting ``through fiscal year 2025, or the portion of fiscal
            year 2026 beginning on October 1, 2025, and ending on December
            31, 2025''.

    SEC. 203. EXTENSION OF ADD-ON PAYMENTS FOR AMBULANCE SERVICES.

        Section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)) is
    amended--
                (1) in paragraph (12)(A), by striking ``April 1, 2025'' and
            inserting ``January 1, 2027''; and
                (2) in paragraph (13), by striking ``April 1, 2025'' each
            place it appears and inserting ``January 1, 2027'' in each such
            place.

    SEC. 204. EXTENDING INCENTIVE PAYMENTS FOR PARTICIPATION IN ELIGIBLE
                  ALTERNATIVE PAYMENT MODELS.

        (a) In General.--Section 1833(z) of the Social Security Act (42
    U.S.C. 1395l(z)) is amended--
                (1) in paragraph (1)(A)--
                        (A) by striking ``with 2026'' and inserting ``with
                    2027''; and
                        (B) by inserting ``, or, with respect to 2027, 3.53
                    percent'' after ``1.88 percent'';
                (2) in paragraph (2)--
                        (A) in subparagraph (B)--
                                (i) in the heading, by striking ``2026''
                            and inserting ``2027''; and
                                (ii) in the matter preceding clause (i), by
                            striking ``2026'' and inserting ``2027'';
                        (B) in subparagraph (C)--
                                (i) in the heading, by striking ``2027''
                            and inserting ``2028''; and
                                (ii) in the matter preceding clause (i), by
                            striking ``2027'' and inserting ``2028''; and
                        (C) in subparagraph (D), by striking ``and 2026''
                    and inserting ``2026, and 2027''; and
                (3) in paragraph (4)(B), by inserting ``or, with respect to
            2027, 3.53 percent'' after ``1.88 percent''.
        (b) Conforming Amendments.--Section 1848(q)(1)(C)(iii) of the
    Social Security Act (42 U.S.C. 1395w-4(q)(1)(C)(iii)) is amended--
                (1) in subclause (II), by striking ``2026'' and inserting
            ``2027''; and
                (2) in subclause (III), by striking ``2027'' and inserting
            ``2028''.

    SEC. 205. TEMPORARY PAYMENT INCREASE UNDER THE MEDICARE PHYSICIAN FEE
                  SCHEDULE TO ACCOUNT FOR EXCEPTIONAL CIRCUMSTANCES.

        (a) In General.--Section 1848(t)(1) of the Social Security Act (42
    U.S.C. 1395w-4(t)(1)) is amended--
                (1) in subparagraph (D), by striking ``and'' at the end;
                (2) in subparagraph (E), by striking the period at the end
            and inserting ``; and''; and
                (3) by adding at the end the following new subparagraph:
                        ``(F) such services furnished on or after March 15,
                    2025, and before January 1, 2026, by 3.5375 percent.''.
        (b) Conforming Amendment.--Section 1848(c)(2)(B)(iv)(V) is amended
    by striking ``or 2024'' and inserting ``2024, or 2025''.

    SEC. 206. EXTENSION OF FUNDING FOR QUALITY MEASURE ENDORSEMENT, INPUT,
                  AND SELECTION.

        Section 1890(d)(2) of the Social Security Act (42 U.S.C.
    1395aaa(d)(2)) is amended--
                (1) in the first sentence--
                        (A) by striking ``$11,030,000'' and inserting
                    ``$14,000,000''; and
                        (B) by striking ``March 31, 2025'' and inserting
                    ``December 31, 2025''; and
                (2) in the third sentence, by striking ``March 31, 2025''
            and inserting ``December 31, 2025''.

    SEC. 207. EXTENSION OF FUNDING OUTREACH AND ASSISTANCE FOR LOW-INCOME
                  PROGRAMS.

        (a) State Health Insurance Assistance Programs.--Subsection
    (a)(1)(B) of section 119 of the Medicare Improvements for Patients and
    Providers Act of 2008 (42 U.S.C. 1395b-3 note) is amended--
                (1) in clause (xiii), by striking ``and'' at the end;
                (2) in clause (xiv), by striking the period and inserting
            ``; and''; and
                (3) by inserting after clause (xiv) the following new
            clause:
                                ``(xv) for the period beginning on April 1,
                            2025, and ending on December 31, 2026,
                            $26,250,000.''.
        (b) Area Agencies on Aging.--Subsection (b)(1)(B) of such section
    119 is amended--
                (1) in clause (xiii), by striking ``and'' at the end;
                (2) in clause (xiv), by striking the period and inserting
            ``; and''; and
                (3) by inserting after clause (xiv) the following new
            clause:
                                ``(xv) for the period beginning on April 1,
                            2025, and ending on December 31, 2026,
                            $26,250,000.''.
        (c) Aging and Disability Resource Centers.--Subsection (c)(1)(B) of
    such section 119 is amended--
                (1) in clause (xiii), by striking ``and'' at the end;
                (2) in clause (xiv), by striking the period and inserting
            ``; and''; and
                (3) by inserting after clause (xiv) the following new
            clause:
                                ``(xv) for the period beginning on April 1,
                            2025, and ending on December 31, 2026,
                            $7,750,000.''.
        (d) Coordination of Efforts To Inform Older Americans About
    Benefits Available Under Federal and State Programs.--Subsection (d)(2)
    of such section 119 is amended--
                (1) in clause (xiii), by striking ``and'' at the end;
                (2) in clause (xiv), by striking the period and inserting
            ``; and''; and
                (3) by inserting after clause (xiv) the following new
            clause:
                                ``(xv) for the period beginning on April 1,
                            2025, and ending on December 31, 2026,
                            $26,250,000.''.

    SEC. 208. EXTENSION OF THE WORK GEOGRAPHIC INDEX FLOOR.

        Section 1848(e)(1)(E) of the Social Security Act (42 U.S.C. 1395w-
    4(e)(1)(E)) is amended by striking ``April 1, 2025'' and inserting
    ``January 1, 2026''.

    SEC. 209. EXTENSION OF CERTAIN TELEHEALTH FLEXIBILITIES.

        (a) Removing Geographic Requirements and Expanding Originating
    Sites for Telehealth Services.--Section 1834(m) of the Social Security
    Act (42 U.S.C. 1395m(m)) is amended--
                (1) in paragraph (2)(B)(iii), by striking ``ending March
            31, 2025'' and inserting ``ending December 31, 2026''; and
                (2) in paragraph (4)(C)(iii), by striking ``ending on March
            31, 2025'' and inserting ``ending on December 31, 2026''.
        (b) Expanding Practitioners Eligible To Furnish Telehealth
    Services.--Section 1834(m)(4)(E) of the Social Security Act (42 U.S.C.
    1395m(m)(4)(E)) is amended by striking ``ending on March 31, 2025'' and
    inserting ``ending on December 31, 2026''.
        (c) Extending Telehealth Services for Federally Qualified Health
    Centers and Rural Health Clinics.--Section 1834(m)(8) of the Social
    Security Act (42 U.S.C. 1395m(m)(8)) is amended--
                (1) in subparagraph (A), by striking ``ending on March 31,
            2025'' and inserting ``ending on December 31, 2026'';
                (2) in subparagraph (B)--
                        (A) in the subparagraph heading, by inserting
                    ``before april 1, 2025'' after ``rule'';
                        (B) in clause (i), by striking ``during the periods
                    for which subparagraph (A) applies'' and inserting
                    ``before April 1, 2025''; and
                        (C) in clause (ii), by inserting ``furnished to an
                    eligible telehealth individual before April 1, 2025''
                    after ``telehealth services''; and
                (3) by adding at the end the following new subparagraph:
                        ``(C) Payment rule for portion of 2025 and 2026.--
                                ``(i) In general.--A telehealth service
                            furnished to an eligible telehealth individual
                            by a Federally qualified health center or rural
                            health clinic on or after April 1, 2025, and
                            before January 1, 2027, shall be paid as a
                            Federally qualified health center service or
                            rural health clinic service (as applicable)
                            under the prospective payment system
                            established under section 1834(o) or the
                            methodology for all-inclusive rates established
                            under section 1833(a)(3), respectively.
                                ``(ii) Treatment of costs.--Costs
                            associated with the furnishing of telehealth
                            services by a Federally qualified health center
                            or rural health clinic on or after April 1,
                            2025, and before January 1, 2027, shall be
                            considered allowable costs for purposes of the
                            prospective payment system established under
                            section 1834(o) and the methodology for all-
                            inclusive rates established under section
                            1833(a)(3), as applicable.
                                ``(iii) Requiring modifiers.--Not later
                            than July 1, 2025, the Secretary shall
                            establish requirements to include 1 or more
                            codes or modifiers, as determined appropriate
                            by the Secretary, in the case of claims for
                            telehealth services furnished to an eligible
                            telehealth individual by a Federally qualified
                            health center or rural health clinic.''.
        (d) Delaying the In-Person Requirements Under Medicare for Mental
    Health Services Furnished Through Telehealth and Telecommunications
    Technology.--
                (1) Delay in requirements for mental health services
            furnished through telehealth.--Section 1834(m)(7)(B)(i) of the
            Social Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is amended,
            in the matter preceding subclause (I), by striking ``April 1,
            2025'' and inserting ``January 1, 2027''.
                (2) Mental health visits furnished by rural health
            clinics.--Section 1834(y)(2) of the Social Security Act (42
            U.S.C. 1395m(y)(2)) is amended by striking ``April 1, 2025''
            and inserting ``January 1, 2027''.
                (3) Mental health visits furnished by federally qualified
            health centers.--Section 1834(o)(4)(B) of the Social Security
            Act (42 U.S.C. 1395m(o)(4)(B)) is amended by striking ``April
            1, 2025'' and inserting ``January 1, 2027''.
        (e) Allowing for the Furnishing of Audio-Only Telehealth
    Services.--Section 1834(m)(9) of the Social Security Act (42 U.S.C.
    1395m(m)(9)) is amended by striking ``ending on March 31, 2025'' and
    inserting ``ending on December 31, 2026''.
        (f) Extending Use of Telehealth To Conduct Face-to-Face Encounter
    Prior to Recertification of Eligibility for Hospice Care.--Section
    1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C.
    1395f(a)(7)(D)(i)(II)) is amended--
                (1) by striking ``ending on March 31, 2025'' and inserting
            ``ending on December 31, 2026''; and
                (2) by inserting ``, except that this subclause shall not
            apply in the case of such an encounter with an individual
            occurring on or after April 1, 2025, if such individual is
            located in an area that is subject to a moratorium on the
            enrollment of hospice programs under this title pursuant to
            section 1866(j)(7), if such individual is receiving hospice
            care from a provider that is subject to enhanced oversight
            under this title pursuant to section 1866(j)(3), or if such
            encounter is performed by a hospice physician or nurse
            practitioner who is not enrolled under section 1866(j) and is
            not an opt-out physician or practitioner (as defined in section
            1802(b)(6)(D))'' before the semicolon.
        (g) Requiring Modifiers for Telehealth Services in Certain
    Instances.--Section 1834(m) of the Social Security Act (42 U.S.C.
    1395m(m)) is amended by adding at the end the following new paragraph:
                ``(10) Required use of modifiers in certain instances.--Not
            later than January 1, 2026, the Secretary shall establish
            requirements to include 1 or more codes or modifiers, as
            determined appropriate by the Secretary, in the case of--
                        ``(A) claims for telehealth services under this
                    subsection that are furnished through a telehealth
                    virtual platform--
                                ``(i) by a physician or practitioner that
                            contracts with an entity that owns such virtual
                            platform; or
                                ``(ii) for which a physician or
                            practitioner has a payment arrangement with an
                            entity for use of such virtual platform; and
                        ``(B) claims for telehealth services under this
                    subsection that are furnished incident to a physician's
                    or practitioner's professional service.''.
        (h) Program Instruction Authority.--The Secretary of Health and
    Human Services may implement the amendments made by this section
    through program instruction or otherwise.

    SEC. 210. REQUIRING MODIFIER FOR USE OF TELEHEALTH TO CONDUCT FACE-TO-
                  FACE ENCOUNTER PRIOR TO RECERTIFICATION OF ELIGIBILITY
                  FOR HOSPICE CARE.

        Section 1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C.
    1395f(a)(7)(D)(i)(II)), as amended by section 209(f), is further
    amended by inserting ``, but only if, in the case of such an encounter
    occurring on or after January 1, 2026, any hospice claim includes 1 or
    more modifiers or codes (as specified by the Secretary) to indicate
    that such encounter was conducted via telehealth'' after ``as
    determined appropriate by the Secretary''.

    SEC. 211. EXTENDING ACUTE HOSPITAL CARE AT HOME WAIVER FLEXIBILITIES.

        Section 1866G of the Social Security Act (42 U.S.C. 1395cc-7) is
    amended--
                (1) in the section heading, by inserting ``the thomas r.
            carper, tim scott, brad r. wenstrup, d.p.m., and earl
            blumenauer'' after ``extension of'';
                (2) in subsection (a)--
                        (A) in paragraph (1)--
                                (i) by striking ``March 31, 2025'' and
                            inserting ``December 31, 2029''; and
                                (ii) by striking ``in the Acute Hospital
                            Care at Home initiative of the Secretary'' and
                            inserting ``in the Thomas R. Carper, Tim Scott,
                            Brad R. Wenstrup, D.P.M., and Earl Blumenauer
                            Acute Hospital Care at Home initiative of the
                            Secretary (in this section referred to as the
                            `Acute Hospital Care at Home initiative')'';
                        (B) in paragraph (2), by striking ``of the
                    Secretary''; and
                        (C) in paragraph (3)(E), by adding at the end the
                    following new flush sentence:
                    ``The Secretary may require that such data and
                    information be submitted through a hospital's cost
                    report, through such survey instruments as the
                    Secretary may develop, through medical record
                    information, or through such other means as the
                    Secretary determines appropriate.'';
                (3) in subsection (b)--
                        (A) in the subsection heading, by striking
                    ``Study'' and inserting ``Initial Study'';
                        (B) in paragraph (1)(A), by striking ``of the
                    Secretary''; and
                        (C) in paragraph (3), by inserting ``or subsection
                    (c)'' before the period at the end;
                (4) by redesignating subsections (c) and (d) as subsections
            (d) and (e), respectively; and
                (5) by inserting after subsection (b) the following new
            subsection:
        ``(c) Subsequent Study and Report.--
                ``(1) In general.--Not later than September 30, 2028, the
            Secretary shall conduct a study to--
                        ``(A) analyze, to the extent practicable, the
                    criteria established by hospitals under the Acute
                    Hospital Care at Home initiative to determine which
                    individuals may be furnished services under such
                    initiative; and
                        ``(B) analyze and compare (both within and between
                    hospitals participating in the initiative, and relative
                    to comparable hospitals that do not participate in the
                    initiative, for relevant parameters such as diagnosis-
                    related groups)--
                                ``(i) quality of care furnished to
                            individuals with similar conditions and
                            characteristics in the inpatient setting and
                            through the Acute Hospital Care at Home
                            initiative, including health outcomes, hospital
                            readmission rates (including readmissions both
                            within and beyond 30 days post-discharge),
                            hospital mortality rates, length of stay,
                            infection rates, composition of care team
                            (including the types of labor used, such as
                            contracted labor), the ratio of nursing staff,
                            transfers from the hospital to the home,
                            transfers from the home to the hospital
                            (including the timing, frequency, and causes of
                            such transfers), transfers and discharges to
                            post-acute care settings (including the timing,
                            frequency, and causes of such transfers and
                            discharges), and patient and caregiver
                            experience of care;
                                ``(ii) clinical conditions treated and
                            diagnosis-related groups of discharges from
                            inpatient settings relative to discharges from
                            the Acute Hospital Care at Home initiative;
                                ``(iii) costs incurred by the hospital for
                            furnishing care in inpatient settings relative
                            to costs incurred by the hospital for
                            furnishing care through the Acute Hospital Care
                            at Home initiative, including costs relating to
                            staffing, equipment, food, prescriptions, and
                            other services, as determined by the Secretary;
                                ``(iv) the quantity, mix, and intensity of
                            services (such as in-person visits and virtual
                            contacts with patients and the intensity of
                            such services) furnished in inpatient settings
                            relative to the Acute Hospital Care at Home
                            initiative, and, to the extent practicable, the
                            nature and extent of family or caregiver
                            involvement;
                                ``(v) socioeconomic information on
                            individuals treated in comparable inpatient
                            settings relative to the initiative, including
                            racial and ethnic data, income, housing,
                            geographic proximity to the brick-and-mortar
                            facility and whether such individuals are
                            dually eligible for benefits under this title
                            and title XIX; and
                                ``(vi) the quality of care, outcomes,
                            costs, quantity and intensity of services, and
                            other relevant metrics between individuals who
                            entered into the Acute Hospital Care at Home
                            initiative directly from an emergency
                            department compared with individuals who
                            entered into the Acute Hospital Care at Home
                            initiative directly from an existing inpatient
                            stay in a hospital.
                ``(2) Selection bias.--In conducting the study under
            paragraph (1), the Secretary shall, to the extent practicable,
            analyze and compare individuals who participate and do not
            participate in the initiative controlling for selection bias or
            other factors that may impact the reliability of data.
                ``(3) Report.--Not later than September 30, 2028, the
            Secretary of Health and Human Services shall post on a website
            of the Centers for Medicare & Medicaid Services a report on the
            study conducted under paragraph (1).
                ``(4) Funding.--In addition to amounts otherwise available,
            there is appropriated to the Centers for Medicare & Medicaid
            Services Program Management Account for fiscal year 2026, out
            of any amounts in the Treasury not otherwise appropriated,
            $6,000,000, respectively, to remain available until expended,
            for purposes of carrying out this section.''.

    SEC. 212. ENHANCING CERTAIN PROGRAM INTEGRITY REQUIREMENTS FOR DME
                  UNDER MEDICARE.

        (a) Durable Medical Equipment.--
                (1) In general.--Section 1834(a) of the Social Security Act
            (42 U.S.C. 1395m(a)) is amended by adding at the end the
            following new paragraph:
                ``(23) Master list inclusion and claim review for certain
            items.--
                        ``(A) Master list inclusion.--Beginning January 1,
                    2028, for purposes of the Master List described in
                    section 414.234(b) of title 42, Code of Federal
                    Regulations (or any successor regulation), an item for
                    which payment may be made under this subsection shall
                    be treated as having aberrant billing patterns (as such
                    term is used for purposes of such section) if the
                    Secretary determines that, without explanatory
                    contributing factors (such as furnishing emergent care
                    services), a substantial number of claims for such
                    items under this subsection are for such items ordered
                    by a physician or practitioner who has not previously
                    (during a period of not less than 24 months, as
                    established by the Secretary) furnished to the
                    individual involved any item or service for which
                    payment may be made under this title.
                        ``(B) Claim review.--With respect to items
                    furnished on or after January 1, 2028, that are
                    included on the Master List pursuant to subparagraph
                    (A), if such an item is not subject to a determination
                    of coverage in advance pursuant to paragraph (15)(C),
                    the Secretary may conduct prepayment review of claims
                    for payment for such item.''.
                (2) Conforming amendment for prosthetic devices, orthotics,
            and prosthetics.--Section 1834(h)(3) of the Social Security Act
            (42 U.S.C. 1395m(h)(3)) is amended by inserting ``, and
            paragraph (23) of subsection (a) shall apply to prosthetic
            devices, orthotics, and prosthetics in the same manner as such
            provision applies to items for which payment may be made under
            such subsection'' before the period at the end.
        (b) Report on Identifying Clinical Diagnostic Laboratory Tests at
    High Risk for Fraud and Effective Mitigation Measures.--Not later than
    January 1, 2026, the Inspector General of the Department of Health and
    Human Services shall submit to Congress a report assessing fraud risks
    relating to claims for clinical diagnostic laboratory tests for which
    payment may be made under section 1834A of the Social Security Act (42
    U.S.C. 1395m-1) and effective tools for reducing such fraudulent
    claims. The report may include information regarding--
                (1) which, if any, clinical diagnostic laboratory tests are
            identified as being at high risk of fraudulent claims, and an
            analysis of the factors that contribute to such risk;
                (2) with respect to a clinical diagnostic laboratory test
            identified under paragraph (1) as being at high risk of
            fraudulent claims--
                        (A) the amount payable under such section 1834A
                    with respect to such test;
                        (B) the number of such tests furnished to
                    individuals enrolled under part B of title XVIII of the
                    Social Security Act (42 U.S.C. 1395j et seq.);
                        (C) whether an order for such a test was more
                    likely to come from a provider with whom the individual
                    involved did not have a prior relationship, as
                    determined on the basis of prior payment experience;
                    and
                        (D) the frequency with which a claim for payment
                    under such section 1834A included the payment modifier
                    identified by code 59 or 91; and
                (3) suggested strategies for reducing the number of
            fraudulent claims made with respect to tests so identified as
            being at high risk, including--
                        (A) an analysis of whether the Centers for Medicare
                    & Medicaid Services can detect aberrant billing
                    patterns with respect to such tests in a timely manner;
                        (B) any strategies for identifying and monitoring
                    the providers who are outliers with respect to the
                    number of such tests that such providers order; and
                        (C) targeted education efforts to mitigate improper
                    billing for such tests; and
                (4) such other information as the Inspector General
            determines appropriate.

    SEC. 213. GUIDANCE ON FURNISHING SERVICES VIA TELEHEALTH TO INDIVIDUALS
                  WITH LIMITED ENGLISH PROFICIENCY.

        (a) In General.--Not later than 1 year after the date of the
    enactment of this section, the Secretary of Health and Human Services,
    in consultation with 1 or more entities from each of the categories
    described in paragraphs (1) through (7) of subsection (b), shall issue
    and disseminate, or update and revise as applicable, guidance for the
    entities described in such subsection on the following:
                (1) Best practices on facilitating and integrating use of
            interpreters during a telemedicine appointment.
                (2) Best practices on providing accessible instructions on
            how to access telecommunications systems (as such term is used
            for purposes of section 1834(m) of the Social Security Act (42
            U.S.C. 1395m(m)) for individuals with limited English
            proficiency.
                (3) Best practices on improving access to digital patient
            portals for individuals with limited English proficiency.
                (4) Best practices on integrating the use of video
            platforms that enable multi-person video calls furnished via a
            telecommunications system for purposes of providing
            interpretation during a telemedicine appointment for an
            individual with limited English proficiency.
                (5) Best practices for providing patient materials,
            communications, and instructions in multiple languages,
            including text message appointment reminders and prescription
            information.
        (b) Entities Described.--For purposes of subsection (a), an entity
    described in this subsection is an entity in 1 or more of the following
    categories:
                (1) Health information technology service providers,
            including--
                        (A) electronic medical record companies;
                        (B) remote patient monitoring companies; and
                        (C) telehealth or mobile health vendors and
                    companies.
                (2) Health care providers, including--
                        (A) physicians; and
                        (B) hospitals.
                (3) Health insurers.
                (4) Language service companies.
                (5) Interpreter or translator professional associations.
                (6) Health and language services quality certification
            organizations.
                (7) Patient and consumer advocates, including such
            advocates that work with individuals with limited English
            proficiency.

    SEC. 214. IN-HOME CARDIOPULMONARY REHABILITATION FLEXIBILITIES.

        (a) In General.--Section 1861(eee)(2) of the Social Security Act
    (42 U.S.C. 1395x(eee)(2)) is amended--
                (1) in subparagraph (A)(ii), by inserting ``(including,
            with respect to items and services furnished through audio and
            video real-time communications technology (excluding audio-
            only) on or after April 1, 2025, and before January 1, 2027, in
            the home of an individual who is an outpatient of the
            hospital)'' after ``outpatient basis''; and
                (2) in subparagraph (B), by inserting ``(including, with
            respect to items and services furnished through audio and video
            real-time communications technology on or after April 1, 2025,
            and before January 1, 2027, the virtual presence of such
            physician, physician assistant, nurse practitioner, or clinical
            nurse specialist)'' after ``under the program''.
        (b) Program Instruction Authority.--Notwithstanding any other
    provision of law, the Secretary of Health and Human Services may
    implement the amendments made by this section by program instruction or
    otherwise.

    SEC. 215. INCLUSION OF VIRTUAL DIABETES PREVENTION PROGRAM SUPPLIERS IN
                  MDPP EXPANDED MODEL.

        (a) In General.--Not later than January 1, 2026, the Secretary
    shall revise the regulations under parts 410 and 424 of title 42, Code
    of Federal Regulations, to provide that, for the period beginning
    January 1, 2026, and ending December 31, 2030--
                (1) an entity may participate in the MDPP by offering only
            online MDPP services via synchronous or asynchronous technology
            or telecommunications if such entity meets the conditions for
            enrollment as an MDPP supplier (as specified in section
            424.205(b) of title 42, Code of Federal Regulations (or a
            successor regulation));
                (2) if an entity participates in the MDPP in the manner
            described in paragraph (1)--
                        (A) the administrative location of such entity
                    shall be the address of the entity on file under the
                    Diabetes Prevention Recognition Program; and
                        (B) in the case of online MDPP services furnished
                    by such entity to an MDPP beneficiary who was not
                    located in the same State as the entity at the time
                    such services were furnished, the entity shall not be
                    prohibited from submitting a claim for payment for such
                    services solely by reason of the location of such
                    beneficiary at such time; and
                (3) no limit is applied on the number of times an
            individual may enroll in the MDPP.
        (b) Definitions.--In this section:
                (1) MDPP.--The term ``MDPP'' means the Medicare Diabetes
            Prevention Program conducted under section 1115A of the Social
            Security Act (42 U.S.C. 1315a), as described in the final rule
            published in the Federal Register entitled ``Medicare and
            Medicaid Programs; CY 2024 Payment Policies Under the Physician
            Fee Schedule and Other Changes to Part B Payment and Coverage
            Policies; Medicare Shared Savings Program Requirements;
            Medicare Advantage; Medicare and Medicaid Provider and Supplier
            Enrollment Policies; and Basic Health Program'' (88 Fed. Reg.
            78818 (November 16, 2023)) (or a successor regulation).
                (2) Regulatory terms.--The terms ``Diabetes Prevention
            Recognition Program'', ``full CDC DPRP recognition'', ``MDPP
            beneficiary'', ``MDPP services'', and ``MDPP supplier'' have
            the meanings given each such term in section 410.79(b) of title
            42, Code of Federal Regulations.
                (3) Secretary.--The term ``Secretary'' means the Secretary
            of Health and Human Services.

    SEC. 216. MEDICATION-INDUCED MOVEMENT DISORDER OUTREACH AND EDUCATION.

        Not later than January 1, 2026, the Secretary shall use existing
    communications mechanisms to provide education and outreach to
    physicians and appropriate non-physician practitioners participating
    under the Medicare program under title XVIII of the Social Security Act
    (42 U.S.C. 1395 et seq.) with respect to periodic screening for
    medication-induced movement disorders that are associated with the
    treatment of mental health disorders in at-risk patients, as well as
    resources related to clinical guidelines and best practices for
    furnishing such screening services through telehealth. Such education
    and outreach shall include information on how to account for such
    screening services in evaluation and management code selection. The
    Secretary shall, to the extent practicable, seek input from relevant
    stakeholders to inform such education and outreach. Such education and
    outreach may also address other relevant screening services furnished
    through telehealth, as the Secretary determines appropriate.

    SEC. 217. REPORT ON WEARABLE MEDICAL DEVICES.

        Not later than 18 months after the date of the enactment of this
    Act, the Comptroller General of the United States shall conduct a
    technology assessment of, and submit to Congress a report on, the
    capabilities and limitations of wearable medical devices used to
    support clinical decision-making. Such report shall include a
    description of--
                (1) the potential for such devices to accurately prescribe
            treatments;
                (2) an examination of the benefits and challenges of
            artificial intelligence to augment such capabilities; and
                (3) policy options to enhance the benefits and mitigate
            potential challenges of developing or using such devices.

    SEC. 218. EXTENSION OF TEMPORARY INCLUSION OF AUTHORIZED ORAL ANTIVIRAL
                  DRUGS AS COVERED PART D DRUGS.

        Section 1860D-2(e)(1)(C) of the Social Security Act (42 U.S.C.
    1395w-102(e)(1)(C)) is amended by striking ``March 31, 2025'' and
    inserting ``December 31, 2025''.

    SEC. 219. EXTENSION OF ADJUSTMENT TO CALCULATION OF HOSPICE CAP AMOUNT.

        Section 1814(i)(2)(B) of the Social Security Act (42 U.S.C.
    1395f(i)(2)(B)) is amended--
                (1) in clause (ii), by striking ``2033'' and inserting
            ``2034''; and
                (2) in clause (iii), by striking ``2033'' and inserting
            ``2034''.

    SEC. 220. MULTIYEAR CONTRACTING AUTHORITY FOR MEDPAC AND MACPAC.

        Section 3904 of title 41, United States Code, is amended by adding
    at the end the following new subsections:
        ``(i) The Medicare Payment Advisory Commission.--The Medicare
    Payment Advisory Commission may use available funds to enter into
    contracts for the procurement of severable services for a period that
    begins in one fiscal year and ends in the next fiscal year and may
    enter into multiyear contracts for the acquisition of property and
    services to the same extent as executive agencies under the authority
    of sections 3902 and 3903 of this title.
        ``(j) The Medicaid and CHIP Payment and Access Commission.--The
    Medicaid and CHIP Payment and Access Commission may use available funds
    to enter into contracts for the procurement of severable services for a
    period that begins in one fiscal year and ends in the next fiscal year
    and may enter into multiyear contracts for the acquisition of property
    and services to the same extent as executive agencies under the
    authority of sections 3902 and 3903 of this title.''.

    SEC. 221. CONTRACTING PARITY FOR MEDPAC AND MACPAC.

        In fiscal year 2025 and thereafter, for all contracts for goods and
    services to which the Medicare and Payment Advisory Commission or the
    Medicaid and CHIP Payment and Access Commission is a party, the
    following Federal Acquisition Regulation (FAR) clauses will apply: FAR
    52.232-39 and FAR 52.233-4 (or a successor clause).

    SEC. 222. ADJUSTMENTS TO MEDICARE PART D COST-SHARING REDUCTIONS FOR
                  LOW-INCOME INDIVIDUALS.

        Section 1860D-14(a) of the Social Security Act (42 U.S.C. 1395w-
    114(a)) is amended--
                (1) in paragraph (1)(D)(ii), by striking ``that does not
            exceed $1 for'' and all that follows through the period at the
            end and inserting ``that does not exceed--
                                        ``(I) for a plan year before 2027--
                                                ``(aa) for a generic drug
                                            or a preferred drug that is a
                                            multiple source drug (as
                                            defined in section
                                            1927(k)(7)(A)(i)), $1 or, if
                                            less, the copayment amount
                                            applicable to an individual
                                            under clause (iii); and
                                                ``(bb) for any other drug,
                                            $3 or, if less, the copayment
                                            amount applicable to an
                                            individual under clause (iii);
                                            and
                                        ``(II) for plan year 2027 and each
                                    subsequent plan year--
                                                ``(aa) for a generic drug,
                                            $0;
                                                ``(bb) for a preferred drug
                                            that is a multiple source drug
                                            (as defined in section
                                            1927(k)(7)(A)(i)), the dollar
                                            amount applied under this
                                            clause for such a drug for the
                                            preceding plan year, increased
                                            by the annual percentage
                                            increase in the consumer price
                                            index (all items; U.S. city
                                            average) as of September of
                                            such preceding year, or, if
                                            less, the copayment amount
                                            applicable to an individual
                                            under clause (iii); and
                                                ``(cc) for a drug not
                                            described in either item (aa)
                                            or (bb), the dollar amount
                                            applied under this clause for
                                            such a drug for the preceding
                                            plan year, increased in the
                                            manner specified in item (bb),
                                            or, if less, the copayment
                                            amount applicable to an
                                            individual under clause (iii).
                            Any amount established under item (bb) or (cc)
                            of subclause (II), that is based on an increase
                            of $1 or $3, that is not a multiple of 5 cents
                            or 10 cents, respectively, shall be rounded to
                            the nearest multiple of 5 cents or 10 cents,
                            respectively.''; and
                (2) in paragraph (4)(A)(ii), by inserting ``(before 2027)''
            after ``a subsequent year''.

    SEC. 223. REQUIRING ENHANCED AND ACCURATE LISTS OF (REAL) HEALTH
                  PROVIDERS ACT.

        (a) In General.--Section 1852(c) of the Social Security Act (42
    U.S.C. 1395w-22(c)) is amended--
                (1) in paragraph (1)(C)--
                        (A) by striking ``plan, and any'' and inserting
                    ``plan, any''; and
                        (B) by inserting the following before the period at
                    the end: ``, and, in the case of a specified MA plan
                    (as defined in paragraph (3)(C)), for plan year 2027
                    and subsequent plan years, the information described in
                    paragraph (3)(B)''; and
                (2) by adding at the end the following new paragraph:
                ``(3) Provider directory accuracy.--
                        ``(A) In general.--For plan year 2027 and
                    subsequent plan years, each MA organization offering a
                    specified MA plan (as defined in subparagraph (C))
                    shall, for each such plan offered by the organization--
                                ``(i) maintain, on a publicly available
                            internet website, an accurate provider
                            directory that includes the information
                            described in subparagraph (B);
                                ``(ii) not less frequently than once every
                            90 days (or, in the case of a hospital or any
                            other facility determined appropriate by the
                            Secretary, at a lesser frequency specified by
                            the Secretary but in no case less frequently
                            than once every 12 months), verify the provider
                            directory information of each provider listed
                            in such directory and, if applicable, update
                            such provider directory information;
                                ``(iii) if the organization is unable to
                            verify such information with respect to a
                            provider, include in such directory an
                            indication that the information of such
                            provider may not be up-to-date; and
                                ``(iv) remove a provider from such
                            directory within 5 business days if the
                            organization determines that the provider is no
                            longer a provider participating in the network
                            of such plan.
                        ``(B) Provider directory information.--The
                    information described in this subparagraph is
                    information enrollees may need to access covered
                    benefits from a provider with which such organization
                    offering such plan has an agreement for furnishing
                    items and services covered under such plan such as
                    name, specialty, contact information, primary office or
                    facility address, whether the provider is accepting new
                    patients, accommodations for people with disabilities,
                    cultural and linguistic capabilities, and telehealth
                    capabilities.
                        ``(C) Specified ma plan.--In this paragraph, the
                    term `specified MA plan' means--
                                ``(i) a network-based plan (as defined in
                            subsection (d)(5)(C)); or
                                ``(ii) a Medicare Advantage private fee-
                            for-service plan (as defined in section
                            1859(b)(2)) that meets the access standards
                            under subsection (d)(4), in whole or in part,
                            through entering into contracts or agreements
                            as provided for under subparagraph (B) of such
                            subsection.''.
        (b) Accountability for Provider Directory Accuracy.--
                (1) Cost sharing for services furnished based on reliance
            on incorrect provider directory information.--Section 1852(d)
            of the Social Security Act (42 U.S.C. 1395w-22(d)) is amended--
                        (A) in paragraph (1)(C)--
                                (i) in clause (ii), by striking ``or'' at
                            the end;
                                (ii) in clause (iii), by striking the
                            semicolon at the end and inserting ``, or'';
                            and
                                (iii) by adding at the end the following
                            new clause:
                                ``(iv) the services are furnished by a
                            provider that is not participating in the
                            network of a specified MA plan (as defined in
                            subsection (c)(3)(C)) but is listed in the
                            provider directory of such plan on the date on
                            which the appointment is made, as described in
                            paragraph (7)(A);''; and
                        (B) by adding at the end the following new
                    paragraph:
                ``(7) Cost sharing for services furnished based on reliance
            on incorrect provider directory information.--
                        ``(A) In general.--For plan year 2027 and
                    subsequent plan years, if an enrollee is furnished an
                    item or service by a provider that is not participating
                    in the network of a specified MA plan (as defined in
                    subsection (c)(3)(C)) but is listed in the provider
                    directory of such plan (as required to be provided to
                    an enrollee pursuant to subsection (c)(1)(C)) on the
                    date on which the appointment is made, and if such item
                    or service would otherwise be covered under such plan
                    if furnished by a provider that is participating in the
                    network of such plan, the MA organization offering such
                    plan shall ensure that the enrollee is only responsible
                    for the lesser of--
                                ``(i) the amount of cost sharing that would
                            apply if such provider had been participating
                            in the network of such plan; or
                                ``(ii) the amount of cost sharing that
                            would otherwise apply (without regard to this
                            subparagraph).
                        ``(B) Notification requirement.--For plan year 2027
                    and subsequent plan years, each MA organization that
                    offers a specified MA plan shall--
                                ``(i) notify enrollees of their cost-
                            sharing protections under this paragraph and
                            make such notifications, to the extent
                            practicable, by not later than the first day of
                            an annual, coordinated election period under
                            section 1851(e)(3) with respect to a year;
                                ``(ii) include information regarding such
                            cost-sharing protections in the provider
                            directory of each specified MA plan offered by
                            the MA organization.; and
                                ``(iii) notify enrollees of their cost-
                            sharing protections under this paragraph in an
                            explanation of benefits.''.
                (2) Required provider directory accuracy analysis and
            reports.--
                        (A) In general.--Section 1857(e) of the Social
                    Security Act (42 U.S.C. 1395w-27(e)) is amended by
                    adding at the end the following new paragraph:
                ``(6) Provider directory accuracy analysis and reports.--
                        ``(A) In general.--Beginning with plan years
                    beginning on or after January 1, 2027, subject to
                    subparagraph (C), a contract under this section with an
                    MA organization shall require the organization, for
                    each specified MA plan (as defined in section
                    1852(c)(3)(C)) offered by the organization to annually
                    do the following:
                                ``(i) Conduct an analysis estimating the
                            accuracy of the provider directory information
                            of such plan using a random sample of providers
                            included in such provider directory as follows:
                                        ``(I) Such a random sample shall
                                    include a random sample of each
                                    specialty of providers with a high
                                    inaccuracy rate of provider directory
                                    information relative to other
                                    specialties of providers, as determined
                                    by the Secretary.
                                        ``(II) For purposes of subclause
                                    (I), one type of specialty may be
                                    providers specializing in mental health
                                    or substance use disorder treatment.
                                ``(ii) Submit to the Secretary a report
                            containing the results of the analysis
                            conducted under clause (i), including an
                            accuracy score for such provider directory
                            information (as determined using a plan
                            verification method specified by the Secretary
                            under subparagraph (B)(i)).
                        ``(B) Determination of accuracy score.--
                                ``(i) In general.--The Secretary shall
                            specify plan verification methods, such as
                            using telephonic verification or other
                            approaches using data sources maintained by an
                            MA organization or using publicly available
                            data sets, that MA organizations may use for
                            estimating accuracy scores of the provider
                            directory information of specified MA plans
                            offered by such organizations.
                                ``(ii) Accuracy score methodology.--With
                            respect to each such method specified by the
                            Secretary as described in clause (i), the
                            Secretary shall specify a methodology for MA
                            organizations to use in estimating such
                            accuracy scores. Each such methodology shall
                            take into account the administrative burden on
                            plans and providers and the relative importance
                            of certain provider directory information on
                            enrollee ability to access care.
                        ``(C) Exception.--The Secretary may waive the
                    requirements of this paragraph in the case of a
                    specified MA plan with low enrollment (as defined by
                    the Secretary).
                        ``(D) Transparency.--Beginning with plan years
                    beginning on or after January 1, 2028, the Secretary
                    shall post accuracy scores (as reported under
                    subparagraph (A)(ii)), in a machine readable file, on
                    the internet website of the Centers for Medicare &
                    Medicaid Services.''.
                        (B) Provision of information to beneficiaries.--
                    Section 1851(d)(4) of the Social Security Act (42
                    U.S.C. 1395w-21(d)(4)) is amended by adding at the end
                    the following new subparagraph:
                        ``(F) Provider directory.--Beginning with plan
                    years beginning on or after January 1, 2028, the
                    accuracy score of the plan's provider directory (as
                    reported under section 1857(e)(6)(A)(ii)) listed
                    prominently on the plan's provider directory.''.
                        (C) Funding.--In addition to amounts otherwise
                    available, there is appropriated to the Centers for
                    Medicare & Medicaid Services Program Management
                    Account, out of any money in the Treasury not otherwise
                    appropriated, $4,000,000 for fiscal year 2025, to
                    remain available until expended, to carry out the
                    amendments made by this paragraph.
                (3) GAO study and report.--
                        (A) Analysis.--The Comptroller General of the
                    United States (in this paragraph referred to as the
                    ``Comptroller General'') shall conduct a study of the
                    implementation of the amendments made by paragraphs (1)
                    and (2). To the extent data are available and reliable,
                    such study shall include an analysis of--
                                (i) the use of cost-sharing protections
                            required under section 1852(d)(7)(A) of the
                            Social Security Act, as added by paragraph (1);
                                (ii) the trends in provider directory
                            information accuracy scores under section
                            1857(e)(6)(A)(ii) of the Social Security Act
                            (as added by paragraph (2)(A)), both overall
                            and among providers specializing in mental
                            health or substance use disorder treatment;
                                (iii) provider response rates by plan
                            verification methods;
                                (iv) administrative costs to providers and
                            Medicare Advantage organizations; and
                                (v) other items determined appropriate by
                            the Comptroller General.
                        (B) Report.--Not later than January 15, 2032, the
                    Comptroller General shall submit to Congress a report
                    containing the results of the study conducted under
                    subparagraph (A), together with recommendations for
                    such legislation and administrative action as the
                    Comptroller General determines appropriate.
        (c) Guidance on Maintaining Accurate Provider Directories.--
                (1) Stakeholder meeting.--
                        (A) In general.--Not later than 3 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 hold a public meeting to
                    receive input on approaches for maintaining accurate
                    provider directories for Medicare Advantage plans under
                    part C of title XVIII of the Social Security Act (42
                    U.S.C. 1395w-21 et seq.), including input on approaches
                    for reducing administrative burden, such as data
                    standardization, and best practices to maintain
                    accurate provider directory information.
                        (B) Participants.--Participants of the meeting
                    under subparagraph (A) shall include representatives
                    from the Centers for Medicare & Medicaid Services and
                    the Assistant Secretary for Technology Policy and
                    Office of the National Coordinator for Health
                    Information Technology. Such meeting shall be open to
                    the public. To the extent practicable, the Secretary
                    shall include health care providers, companies that
                    specialize in relevant technologies, health insurers,
                    and patient advocates.
                (2) Guidance to medicare advantage organizations.--Not
            later than 12 months after the date of enactment of this Act,
            the Secretary shall issue guidance to Medicare Advantage
            organizations offering Medicare Advantage plans under part C of
            title XVIII of the Social Security Act (42 U.S.C. 1395w-21 et
            seq.) on maintaining accurate provider directories for such
            plans, taking into consideration input received during the
            stakeholder meeting under paragraph (1). Such guidance may
            include the following, as determined appropriate by the
            Secretary:
                        (A) Best practices for Medicare Advantage
                    organizations on how to work with providers to maintain
                    the accuracy of provider directories and reduce
                    provider and Medicare Advantage organization burden
                    with respect to maintaining the accuracy of provider
                    directories.
                        (B) Information on data sets and data sources with
                    information that could be used by Medicare Advantage
                    organizations to maintain accurate provider
                    directories.
                        (C) Approaches for utilizing data sources
                    maintained by Medicare Advantage organizations and
                    publicly available data sets to maintain accurate
                    provider directories.
                        (D) Information to be included in provider
                    directories that may be useful for Medicare
                    beneficiaries to assess plan networks when selecting a
                    plan and accessing providers participating in plan
                    networks during the plan year.
                (3) Guidance to part b providers.--Not later than 12 months
            after the date of enactment of this Act, the Secretary shall
            issue guidance to providers of services and suppliers who
            furnish items or services for which benefits are available
            under part B of title XVIII of the Social Security Act (42
            U.S.C. 1395j et seq.) on when to update the National Plan and
            Provider Enumeration System for information changes.

    SEC. 224. MEDICARE COVERAGE OF MULTI-CANCER EARLY DETECTION SCREENING
                  TESTS.

        (a) Coverage.--Section 1861 of the Social Security Act (42 U.S.C.
    1395x) is amended--
                (1) in subsection (s)(2)--
                        (A) by striking the semicolon at the end of
                    subparagraph (JJ) and inserting ``; and''; and
                        (B) by adding at the end the following new
                    subparagraph:
                        ``(KK) multi-cancer early detection screening tests
                    (as defined in subsection (nnn));''; and
                (2) by adding at the end the following new subsection:
        ``(nnn) Multi-Cancer Early Detection Screening Tests.--
                ``(1) In general.--The term `multi-cancer early detection
            screening test' means a test furnished to an individual for the
            concurrent detection of multiple cancer types across multiple
            organ sites on or after January 1, 2029, that--
                        ``(A) is cleared under section 510(k), classified
                    under section 513(f)(2), or approved under section 515
                    of the Federal Food, Drug, and Cosmetic Act;
                        ``(B) is--
                                ``(i) a genomic sequencing blood or blood
                            product test that includes the analysis of
                            cell-free nucleic acids; or
                                ``(ii) a test based on samples of
                            biological material that provide results
                            comparable to those obtained with a test
                            described in clause (i), as determined by the
                            Secretary; and
                        ``(C) the Secretary determines is--
                                ``(i) reasonable and necessary for the
                            prevention or early detection of an illness or
                            disability; and
                                ``(ii) appropriate for individuals entitled
                            to benefits under part A or enrolled under part
                            B.
                ``(2) NCD process.--In making determinations under
            paragraph (1)(C) regarding the coverage of a new test, the
            Secretary shall use the process for making national coverage
            determinations (as defined in section 1869(f)(1)(B)) under this
            title.''.
        (b) Payment and Standards for Multi-Cancer Early Detection
    Screening Tests.--
                (1) In general.--Section 1834 of the Social Security Act
            (42 U.S.C. 1395m) is amended by adding at the end the following
            new subsection:
        ``(aa) Payment and Standards for Multi-Cancer Early Detection
    Screening Tests.--
                ``(1) Payment amount.--The payment amount for a multi-
            cancer early detection screening test (as defined in section
            1861(nnn)) is--
                        ``(A) with respect to such a test furnished before
                    January 1, 2031, equal to the payment amount in effect
                    on the date of the enactment of this subsection for a
                    multi-target stool screening DNA test covered pursuant
                    to section 1861(pp)(1)(D); and
                        ``(B) with respect to such a test furnished on or
                    after January 1, 2031, equal to the lesser of--
                                ``(i) the amount described in subparagraph
                            (A); or
                                ``(ii) the payment amount determined for
                            such test under section 1834A.
                ``(2) Limitations.--
                        ``(A) In general.--No payment may be made under
                    this part for a multi-cancer early detection screening
                    test furnished during a year to an individual if--
                                ``(i) such individual--
                                        ``(I) is under 50 years of age; or
                                        ``(II) as of January 1 of such
                                    year, has attained the age specified in
                                    subparagraph (B) for such year; or
                                ``(ii) such a test was furnished to the
                            individual during the previous 11 months.
                        ``(B) Age specified.--For purposes of subparagraph
                    (A)(i)(II), the age specified in this subparagraph is--
                                ``(i) for 2029, 65 years of age; and
                                ``(ii) for a succeeding year, the age
                            specified in this subparagraph for the
                            preceding year, increased by 1 year.
                        ``(C) Standards following uspstf rating of a or
                    b.--In the case of a multi-cancer early detection
                    screening test that is recommended with a grade of A or
                    B by the United States Preventive Services Task Force,
                    beginning on the date on which coverage for such test
                    is provided pursuant to section 1861(ddd)(1), the
                    preceding provisions of this paragraph shall not
                    apply.''.
                (2) Conforming amendments.--
                        (A) Section 1833 of the Social Security Act (42
                    U.S.C. 1395l) is amended--
                                (i) in subsection (a)--
                                        (I) in paragraph (1)(D)(i)(I), by
                                    striking ``section 1834(d)(1)'' and
                                    inserting ``subsection (d)(1) or (aa)
                                    of section 1834''; and
                                        (II) in paragraph (2)(D)(i)(I), by
                                    striking ``section 1834(d)(1)'' and
                                    inserting ``subsection (d)(1) or (aa)
                                    of section 1834''; and
                                (ii) in subsection (h)(1)(A), by striking
                            ``section 1834(d)(1)'' and inserting
                            ``subsections (d)(1) and (aa) of section
                            1834''.
                        (B) Section 1862(a)(1)(A) of the Social Security
                    Act (42 U.S.C. 1395y(a)(1)(A)) is amended--
                                (i) by striking ``or additional preventive
                            services'' and inserting ``, additional
                            preventive services''; and
                                (ii) by inserting ``, or multi-cancer early
                            detection screening tests (as defined in
                            section 1861(nnn))'' after ``(as described in
                            section 1861(ddd)(1))''.
        (c) Rule of Construction Relating to Other Cancer Screening
    Tests.--Nothing in this section, including the amendments made by this
    section, shall be construed--
                (1) in the case of an individual who undergoes a multi-
            cancer early detection screening test, to affect coverage under
            part B of title XVIII of the Social Security Act for other
            cancer screening tests covered under such title, such as
            screening tests for breast, cervical, colorectal, lung, or
            prostate cancer; or
                (2) in the case of an individual who undergoes another
            cancer screening test, to affect coverage under such part for a
            multi-cancer early detection screening test or the use of such
            a test as a diagnostic or confirmatory test for a result of the
            other cancer screening test.

    SEC. 225. MEDICARE COVERAGE OF EXTERNAL INFUSION PUMPS AND NON-SELF-
                  ADMINISTRABLE HOME INFUSION DRUGS.

        (a) In General.--Section 1861(n) of the Social Security Act (42
    U.S.C. 1395x(n)) is amended by adding at the end the following new
    sentence: ``Beginning with the first calendar quarter beginning on or
    after the date that is 1 year after the date of the enactment of this
    sentence, an external infusion pump and associated home infusion drug
    (as defined in subsection (iii)(3)(C)) or other associated supplies
    that do not meet the appropriate for use in the home requirement
    applied to the definition of durable medical equipment under section
    414.202 of title 42, Code of Federal Regulations (or any successor to
    such regulation) shall be treated as meeting such requirement if each
    of the following criteria is satisfied:
                ``(1) The prescribing information approved by the Food and
            Drug Administration for the home infusion drug associated with
            the pump instructs that the drug should be administered by or
            under the supervision of a health care professional.
                ``(2) A qualified home infusion therapy supplier (as
            defined in subsection (iii)(3)(D)) administers or supervises
            the administration of the drug or biological in a safe and
            effective manner in the patient's home (as defined in
            subsection (iii)(3)(B)).
                ``(3) The prescribing information described in paragraph
            (1) instructs that the drug should be infused at least 12 times
            per year--
                        ``(A) intravenously or subcutaneously; or
                        ``(B) at infusion rates that the Secretary
                    determines would require the use of an external
                    infusion pump.''.
        (b) Cost Sharing Notification.--The Secretary of Health and Human
    Services shall ensure that patients are notified of the cost sharing
    for electing home infusion therapy compared to other applicable
    settings of care for the furnishing of infusion drugs under the
    Medicare program.

    SEC. 226. ASSURING PHARMACY ACCESS AND CHOICE FOR MEDICARE
                  BENEFICIARIES.

        (a) In General.--Section 1860D-4(b)(1) of the Social Security Act
    (42 U.S.C. 1395w-104(b)(1)) is amended by striking subparagraph (A) and
    inserting the following:
                        ``(A) In general.--
                                ``(i) Participation of any willing
                            pharmacy.--A PDP sponsor offering a
                            prescription drug plan shall permit any
                            pharmacy that meets the standard contract terms
                            and conditions under such plan to participate
                            as a network pharmacy of such plan.
                                ``(ii) Contract terms and conditions.--
                                        ``(I) In general.--Notwithstanding
                                    any other provision of law, for plan
                                    years beginning on or after January 1,
                                    2028, in accordance with clause (i),
                                    contract terms and conditions offered
                                    by such PDP sponsor shall be reasonable
                                    and relevant according to standards
                                    established by the Secretary under
                                    subclause (II).
                                        ``(II) Standards.--Not later than
                                    the first Monday in April of 2027, the
                                    Secretary shall establish standards for
                                    reasonable and relevant contract terms
                                    and conditions for purposes of this
                                    clause.
                                        ``(III) Request for information.--
                                    Not later than April 1, 2026, for
                                    purposes of establishing the standards
                                    under subclause (II), the Secretary
                                    shall issue a request for information
                                    to seek input on trends in prescription
                                    drug plan and network pharmacy contract
                                    terms and conditions, current
                                    prescription drug plan and network
                                    pharmacy contracting practices, whether
                                    pharmacy reimbursement and dispensing
                                    fees paid by PDP sponsors to network
                                    pharmacies sufficiently cover the
                                    ingredient and operational costs of
                                    such pharmacies, the use and
                                    application of pharmacy quality
                                    measures by PDP sponsors for network
                                    pharmacies, PDP sponsor restrictions or
                                    limitations on the dispensing of
                                    covered part D drugs by network
                                    pharmacies (or any subsets of such
                                    pharmacies), PDP sponsor auditing
                                    practices for network pharmacies, areas
                                    in current regulations or program
                                    guidance related to contracting between
                                    prescription drug plans and network
                                    pharmacies requiring clarification or
                                    additional specificity, factors for
                                    consideration in determining the
                                    reasonableness and relevance of
                                    contract terms and conditions between
                                    prescription drug plans and network
                                    pharmacies, and other issues as
                                    determined appropriate by the
                                    Secretary.''.
        (b) Essential Retail Pharmacies.--Section 1860D-42 of the Social
    Security Act (42 U.S.C. 1395w-152) is amended by adding at the end the
    following new subsection:
        ``(e) Essential Retail Pharmacies.--
                ``(1) In general.--With respect to plan years beginning on
            or after January 1, 2028, the Secretary shall publish reports,
            at least once every 2 years until 2034, and periodically
            thereafter, that provide information, to the extent feasible,
            on--
                        ``(A) trends in ingredient cost reimbursement,
                    dispensing fees, incentive payments and other fees paid
                    by PDP sponsors offering prescription drug plans and MA
                    organizations offering MA-PD plans under this part to
                    essential retail pharmacies (as defined in paragraph
                    (2)) with respect to the dispensing of covered part D
                    drugs, including a comparison of such trends between
                    essential retail pharmacies and pharmacies that are not
                    essential retail pharmacies;
                        ``(B) trends in amounts paid to PDP sponsors
                    offering prescription drug plans and MA organizations
                    offering MA-PD plans under this part by essential
                    retail pharmacies with respect to the dispensing of
                    covered part D drugs, including a comparison of such
                    trends between essential retail pharmacies and
                    pharmacies that are not essential retail pharmacies;
                        ``(C) trends in essential retail pharmacy
                    participation in pharmacy networks and preferred
                    pharmacy networks for prescription drug plans offered
                    by PDP sponsors and MA-PD plans offered by MA
                    organizations under this part, including a comparison
                    of such trends between essential retail pharmacies and
                    pharmacies that are not essential retail pharmacies;
                        ``(D) trends in the number of essential retail
                    pharmacies, including variation in such trends by
                    geographic region or other factors;
                        ``(E) a comparison of cost-sharing for covered part
                    D drugs dispensed by essential retail pharmacies that
                    are network pharmacies for prescription drug plans
                    offered by PDP sponsors and MA-PD plans offered by MA
                    organizations under this part and cost-sharing for
                    covered part D drugs dispensed by other network
                    pharmacies for such plans located in similar geographic
                    areas that are not essential retail pharmacies;
                        ``(F) a comparison of the volume of covered part D
                    drugs dispensed by essential retail pharmacies that are
                    network pharmacies for prescription drug plans offered
                    by PDP sponsors and MA-PD plans offered by MA
                    organizations under this part and such volume of
                    dispensing by network pharmacies for such plans located
                    in similar geographic areas that are not essential
                    retail pharmacies, including information on any
                    patterns or trends in such comparison specific to
                    certain types of covered part D drugs, such as generic
                    drugs or drugs specified as specialty drugs by a PDP
                    sponsor under a prescription drug plan or an MA
                    organization under an MA-PD plan; and
                        ``(G) a comparison of the information described in
                    subparagraphs (A) through (F) between essential retail
                    pharmacies that are network pharmacies for prescription
                    drug plans offered by PDP sponsors under this part and
                    essential retail pharmacies that are network pharmacies
                    for MA-PD plans offered by MA organizations under this
                    part.
                ``(2) Definition of essential retail pharmacy.--In this
            subsection, the term `essential retail pharmacy' means, with
            respect to a plan year, a retail pharmacy that--
                        ``(A) is not a pharmacy that is an affiliate as
                    defined in paragraph (4); and
                        ``(B) is located in--
                                ``(i) a medically underserved area (as
                            designated pursuant to section 330(b)(3)(A) of
                            the Public Health Service Act);
                                ``(ii) a rural area in which there is no
                            other retail pharmacy within 10 miles, as
                            determined by the Secretary;
                                ``(iii) a suburban area in which there is
                            no other retail pharmacy within 2 miles, as
                            determined by the Secretary; or
                                ``(iv) an urban area in which there is no
                            other retail pharmacy within 1 mile, as
                            determined by the Secretary.
                ``(3) List of essential retail pharmacies.--
                        ``(A) Publication of list of essential retail
                    pharmacies.--For each plan year (beginning with plan
                    year 2028), the Secretary shall publish, on a publicly
                    available internet website of the Centers for Medicare
                    & Medicaid Services, a list of pharmacies that meet the
                    criteria described in subparagraphs (A) and (B) of
                    paragraph (2) to be considered an essential retail
                    pharmacy.
                        ``(B) Required submissions from pdp sponsors.--For
                    each plan year (beginning with plan year 2028), each
                    PDP sponsor offering a prescription drug plan and each
                    MA organization offering an MA-PD plan shall submit to
                    the Secretary, for the purposes of determining retail
                    pharmacies that meet the criterion specified in
                    subparagraph (A) of paragraph (2), a list of retail
                    pharmacies that are affiliates of such sponsor or
                    organization, or are affiliates of a pharmacy benefit
                    manager acting on behalf of such sponsor or
                    organization, at a time, and in a form and manner,
                    specified by the Secretary.
                        ``(C) Reporting by pdp sponsors and ma
                    organizations.--For each plan year beginning with plan
                    year 2027, each PDP sponsor offering a prescription
                    drug plan and each MA organization offering an MA-PD
                    plan under this part shall submit to the Secretary
                    information on incentive payments and other fees paid
                    by such sponsor or organization to pharmacies, insofar
                    as any such payments or fees are not otherwise
                    reported, at a time, and in a form and manner,
                    specified by the Secretary.
                        ``(D) Implementation.--Notwithstanding any other
                    provision of law, the Secretary may implement this
                    paragraph by program instruction or otherwise.
                        ``(E) Nonapplication of paperwork reduction act.--
                    Chapter 35 of title 44, United States Code, shall not
                    apply to the implementation of this paragraph.
                ``(4) Definition of affiliate; pharmacy benefit manager.--
            In this subsection, the terms `affiliate' and `pharmacy benefit
            manager' have the meaning given those terms in section 1860D-
            12(h)(7).''.
        (c) Enforcement.--
                (1) In general.--Section 1860D-4(b)(1) of the Social
            Security Act (42 U.S.C. 1395w-104(b)(1)) is amended by adding
            at the end the following new subparagraph:
                        ``(F) Enforcement of standards for reasonable and
                    relevant contract terms and conditions.--
                                ``(i) Allegation submission process.--
                                        ``(I) In general.--Not later than
                                    January 1, 2028, the Secretary shall
                                    establish a process through which a
                                    pharmacy may submit to the Secretary an
                                    allegation of a violation by a PDP
                                    sponsor offering a prescription drug
                                    plan of the standards for reasonable
                                    and relevant contract terms and
                                    conditions under subparagraph (A)(ii),
                                    or of subclause (VIII) of this clause.
                                        ``(II) Frequency of submission.--
                                                ``(aa) In general.--Except
                                            as provided in item (bb), the
                                            allegation submission process
                                            under this clause shall allow
                                            pharmacies to submit any
                                            allegations of violations
                                            described in subclause (I) not
                                            more frequently than once per
                                            plan year per contract between
                                            a pharmacy and a PDP sponsor.
                                                ``(bb) Allegations relating
                                            to contract modifications.--In
                                            the case where a contract
                                            between a pharmacy and a PDP
                                            sponsor is modified following
                                            the submission of allegations
                                            by a pharmacy with respect to
                                            such contract and plan year,
                                            the allegation submission
                                            process under this clause shall
                                            allow such pharmacy to submit
                                            an additional allegation
                                            related to those modifications
                                            with respect to such contract
                                            and plan year.
                                        ``(III) Access to relevant
                                    documents and materials.--A PDP sponsor
                                    subject to an allegation under this
                                    clause--
                                                ``(aa) shall provide
                                            documents or materials, as
                                            specified by the Secretary,
                                            including contract offers made
                                            by such sponsor to such
                                            pharmacy or correspondence
                                            related to such offers, to the
                                            Secretary at a time, and in a
                                            form and manner, specified by
                                            the Secretary; and
                                                ``(bb) shall not prohibit
                                            or otherwise limit the ability
                                            of a pharmacy to submit such
                                            documents or materials to the
                                            Secretary for the purpose of
                                            submitting an allegation or
                                            providing evidence for such an
                                            allegation under this clause.
                                        ``(IV) Standardized template.--The
                                    Secretary shall establish a
                                    standardized template for pharmacies to
                                    use for the submission of allegations
                                    described in subclause (I). Such
                                    template shall require that the
                                    submission include a certification by
                                    the pharmacy that the information
                                    included is accurate, complete, and
                                    true to the best of the knowledge,
                                    information, and belief of such
                                    pharmacy.
                                        ``(V) Preventing frivolous
                                    allegations.--In the case where the
                                    Secretary determines that a pharmacy
                                    has submitted frivolous allegations
                                    under this clause on a routine basis,
                                    the Secretary may temporarily prohibit
                                    such pharmacy from using the allegation
                                    submission process under this clause,
                                    as determined appropriate by the
                                    Secretary.
                                        ``(VI) Exemption from freedom of
                                    information act.--Allegations submitted
                                    under this clause shall be exempt from
                                    disclosure under section 552 of title
                                    5, United States Code.
                                        ``(VII) Rule of construction.--
                                    Nothing in this clause shall be
                                    construed as limiting the ability of a
                                    pharmacy to pursue other legal actions
                                    or remedies, consistent with applicable
                                    Federal or State law, with respect to a
                                    potential violation of a requirement
                                    described in this subparagraph.
                                        ``(VIII) Anti-retaliation and anti-
                                    coercion.--Consistent with applicable
                                    Federal or State law, a PDP sponsor
                                    shall not--
                                                ``(aa) retaliate against a
                                            pharmacy for submitting any
                                            allegations under this clause;
                                            or
                                                ``(bb) coerce, intimidate,
                                            threaten, or interfere with the
                                            ability of a pharmacy to submit
                                            any such allegations.
                                ``(ii) Investigation.--The Secretary shall
                            investigate, as determined appropriate by the
                            Secretary, allegations submitted pursuant to
                            clause (i).
                                ``(iii) Enforcement.--
                                        ``(I) In general.--In the case
                                    where the Secretary determines that a
                                    PDP sponsor offering a prescription
                                    drug plan has violated the standards
                                    for reasonable and relevant contract
                                    terms and conditions under subparagraph
                                    (A)(ii), the Secretary may use
                                    authorities under sections 1857(g) and
                                    1860D-12(b)(3)(E) to impose civil
                                    monetary penalties or other
                                    intermediate sanctions.
                                        ``(II) Application of civil
                                    monetary penalties.--The provisions of
                                    section 1128A (other than subsections
                                    (a) and (b)) shall apply to a civil
                                    monetary penalty under this clause in
                                    the same manner as such provisions
                                    apply to a penalty or proceeding under
                                    section 1128A(a).''.
                (2) Conforming amendment.--Section 1857(g)(1) of the Social
            Security Act (42 U.S.C. 1395w-27(g)(1)) is amended--
                        (A) in subparagraph (J), by striking ``or'' after
                    the semicolon;
                        (B) by redesignating subparagraph (K) as
                    subparagraph (L);
                        (C) by inserting after subparagraph (J), the
                    following new subparagraph:
                        ``(K) fails to comply with the standards for
                    reasonable and relevant contract terms and conditions
                    under subparagraph (A)(ii) of section 1860D-4(b)(1);
                    or'';
                        (D) in subparagraph (L), as redesignated by
                    subparagraph (B), by striking ``through (J)'' and
                    inserting ``through (K)''; and
                        (E) in the flush matter following subparagraph (L),
                    as so redesignated, by striking ``subparagraphs (A)
                    through (K)'' and inserting ``subparagraphs (A) through
                    (L)''.
        (d) Accountability of Pharmacy Benefit Managers for Violations of
    Reasonable and Relevant Contract Terms and Conditions.--
                (1) In general.--Section 1860D-12(b) of the Social Security
            Act (42 U.S.C. 1395w-112) is amended by adding at the end the
            following new paragraph:
                ``(9) Accountability of pharmacy benefit managers for
            violations of reasonable and relevant contract terms and
            conditions.--For plan years beginning on or after January 1,
            2028, each contract entered into with a PDP sponsor under this
            part with respect to a prescription drug plan offered by such
            sponsor shall provide that any pharmacy benefit manager acting
            on behalf of such sponsor has a written agreement with the PDP
            sponsor under which the pharmacy benefit manager agrees to
            reimburse the PDP sponsor for any amounts paid by such sponsor
            under section 1860D-4(b)(1)(F)(iii)(I) to the Secretary as a
            result of a violation described in such section if such
            violation is related to a responsibility delegated to the
            pharmacy benefit manager by such PDP sponsor.''.
                (2) MA-PD plans.--Section 1857(f)(3) of the Social Security
            Act (42 U.S.C. 1395w-27(f)(3)) is amended by adding at the end
            the following new subparagraph:
                        ``(F) Accountability of pharmacy benefit managers
                    for violations of reasonable and relevant contract
                    terms.--For plan years beginning on or after January 1,
                    2028, section 1860D-12(b)(9).''.
        (e) Biennial Report on Enforcement and Oversight of Pharmacy Access
    Requirements.--Section 1860D-42 of the Social Security Act (42 U.S.C.
    1395w-152), as amended by subsection (b), is amended by adding at the
    end the following new subsection:
        ``(f) Biennial Report on Enforcement and Oversight of Pharmacy
    Access Requirements.--
                ``(1) In general.--Not later than 2 years after the date of
            enactment of this subsection, and at least once every 2 years
            thereafter, the Secretary shall publish a report on enforcement
            and oversight actions and activities undertaken by the
            Secretary with respect to the requirements under section 1860D-
            4(b)(1).
                ``(2) Limitation.--A report under paragraph (1) shall not
            disclose--
                        ``(A) identifiable information about individuals or
                    entities unless such information is otherwise publicly
                    available; or
                        ``(B) trade secrets with respect to any
                    entities.''.
        (f) Funding.--In addition to amounts otherwise available, there is
    appropriated to the Centers for Medicare & Medicaid Services Program
    Management Account, out of any money in the Treasury not otherwise
    appropriated, $188,000,000 for fiscal year 2025, to remain available
    until expended, to carry out this section.

    SEC. 227. MODERNIZING AND ENSURING PBM ACCOUNTABILITY.

        (a) In General.--
                (1) Prescription drug plans.--Section 1860D-12 of the
            Social Security Act (42 U.S.C. 1395w-112) is amended by adding
            at the end the following new subsection:
        ``(h) Requirements Relating to Pharmacy Benefit Managers.--For plan
    years beginning on or after January 1, 2028:
                ``(1) Agreements with pharmacy benefit managers.--Each
            contract entered into with a PDP sponsor under this part with
            respect to a prescription drug plan offered by such sponsor
            shall provide that any pharmacy benefit manager acting on
            behalf of such sponsor has a written agreement with the PDP
            sponsor under which the pharmacy benefit manager, and any
            affiliates of such pharmacy benefit manager, as applicable,
            agree to meet the following requirements:
                        ``(A) No income other than bona fide service
                    fees.--
                                ``(i) In general.--The pharmacy benefit
                            manager and any affiliate of such pharmacy
                            benefit manager shall not derive any
                            remuneration with respect to any services
                            provided on behalf of any entity or individual,
                            in connection with the utilization of covered
                            part D drugs, from any such entity or
                            individual other than bona fide service fees,
                            subject to clauses (ii) and (iii).
                                ``(ii) Incentive payments.--For the
                            purposes of this subsection, an incentive
                            payment (as determined by the Secretary) paid
                            by a PDP sponsor to a pharmacy benefit manager
                            that is performing services on behalf of such
                            sponsor shall be deemed a `bona fide service
                            fee' (even if such payment does not otherwise
                            meet the definition of such term under
                            paragraph (7)(B)) if such payment is a flat
                            dollar amount, is consistent with fair market
                            value (as specified by the Secretary), is
                            related to services actually performed by the
                            pharmacy benefit manager or affiliate of such
                            pharmacy benefit manager, on behalf of the PDP
                            sponsor making such payment, in connection with
                            the utilization of covered part D drugs, and
                            meets additional requirements, if any, as
                            determined appropriate by the Secretary.
                                ``(iii) Clarification on rebates and
                            discounts used to lower costs for covered part
                            d drugs.--Rebates, discounts, and other price
                            concessions received by a pharmacy benefit
                            manager or an affiliate of a pharmacy benefit
                            manager from manufacturers, even if such price
                            concessions are calculated as a percentage of a
                            drug's price, shall not be considered a
                            violation of the requirements of clause (i) if
                            they are fully passed through to a PDP sponsor
                            and are compliant with all regulatory and
                            subregulatory requirements related to direct
                            and indirect remuneration for manufacturer
                            rebates under this part, including in cases
                            where a PDP sponsor is acting as a pharmacy
                            benefit manager on behalf of a prescription
                            drug plan offered by such PDP sponsor.
                                ``(iv) Evaluation of remuneration
                            arrangements.--Components of subsets of
                            remuneration arrangements (such as fees or
                            other forms of compensation paid to or retained
                            by the pharmacy benefit manager or affiliate of
                            such pharmacy benefit manager), as determined
                            appropriate by the Secretary, between pharmacy
                            benefit managers or affiliates of such pharmacy
                            benefit managers, as applicable, and other
                            entities involved in the dispensing or
                            utilization of covered part D drugs (including
                            PDP sponsors, manufacturers, pharmacies, and
                            other entities as determined appropriate by the
                            Secretary) shall be subject to review by the
                            Secretary, in consultation with the Office of
                            the Inspector General of the Department of
                            Health and Human Services, as determined
                            appropriate by the Secretary. The Secretary, in
                            consultation with the Office of the Inspector
                            General, shall review whether remuneration
                            under such arrangements is consistent with fair
                            market value (as specified by the Secretary)
                            through reviews and assessments of such
                            remuneration, as determined appropriate.
                                ``(v) Disgorgement.--The pharmacy benefit
                            manager shall disgorge any remuneration paid to
                            such pharmacy benefit manager or an affiliate
                            of such pharmacy benefit manager in violation
                            of this subparagraph to the PDP sponsor.
                                ``(vi) Additional requirements.--The
                            pharmacy benefit manager shall--
                                        ``(I) enter into a written
                                    agreement with any affiliate of such
                                    pharmacy benefit manager, under which
                                    the affiliate shall identify and
                                    disgorge any remuneration described in
                                    clause (v) to the pharmacy benefit
                                    manager; and
                                        ``(II) attest, subject to any
                                    requirements determined appropriate by
                                    the Secretary, that the pharmacy
                                    benefit manager has entered into a
                                    written agreement described in
                                    subclause (I) with any relevant
                                    affiliate of the pharmacy benefit
                                    manager.
                        ``(B) Transparency regarding guarantees and cost
                    performance evaluations.--The pharmacy benefit manager
                    shall--
                                ``(i) define, interpret, and apply, in a
                            fully transparent and consistent manner for
                            purposes of calculating or otherwise evaluating
                            pharmacy benefit manager performance against
                            pricing guarantees or similar cost performance
                            measurements related to rebates, discounts,
                            price concessions, or net costs, terms such
                            as--
                                        ``(I) `generic drug', in a manner
                                    consistent with the definition of the
                                    term under section 423.4 of title 42,
                                    Code of Federal Regulations, or a
                                    successor regulation;
                                        ``(II) `brand name drug', in a
                                    manner consistent with the definition
                                    of the term under section 423.4 of
                                    title 42, Code of Federal Regulations,
                                    or a successor regulation;
                                        ``(III) `specialty drug';
                                        ``(IV) `rebate'; and
                                        ``(V) `discount';
                                ``(ii) identify any drugs, claims, or price
                            concessions excluded from any pricing guarantee
                            or other cost performance measure in a clear
                            and consistent manner; and
                                ``(iii) where a pricing guarantee or other
                            cost performance measure is based on a pricing
                            benchmark other than the wholesale acquisition
                            cost (as defined in section 1847A(c)(6)(B)) of
                            a drug, calculate and provide a wholesale
                            acquisition cost-based equivalent to the
                            pricing guarantee or other cost performance
                            measure.
                        ``(C) Provision of information.--
                                ``(i) In general.--Not later than July 1 of
                            each year, beginning in 2028, the pharmacy
                            benefit manager shall submit to the PDP
                            sponsor, and to the Secretary, a report, in
                            accordance with this subparagraph, and shall
                            make such report available to such sponsor at
                            no cost to such sponsor in a format specified
                            by the Secretary under paragraph (5). Each such
                            report shall include, with respect to such PDP
                            sponsor and each plan offered by such sponsor,
                            the following information with respect to the
                            previous plan year:
                                        ``(I) A list of all drugs covered
                                    by the plan that were dispensed
                                    including, with respect to each such
                                    drug--
                                                ``(aa) the brand name,
                                            generic or non-proprietary
                                            name, and National Drug Code;
                                                ``(bb) the number of plan
                                            enrollees for whom the drug was
                                            dispensed, the total number of
                                            prescription claims for the
                                            drug (including original
                                            prescriptions and refills,
                                            counted as separate claims),
                                            and the total number of dosage
                                            units of the drug dispensed;
                                                ``(cc) the number of
                                            prescription claims described
                                            in item (bb) by each type of
                                            dispensing channel through
                                            which the drug was dispensed,
                                            including retail, mail order,
                                            specialty pharmacy, long term
                                            care pharmacy, home infusion
                                            pharmacy, or other types of
                                            pharmacies or providers;
                                                ``(dd) the average
                                            wholesale acquisition cost,
                                            listed as cost per day's
                                            supply, cost per dosage unit,
                                            and cost per typical course of
                                            treatment (as applicable);
                                                ``(ee) the average
                                            wholesale price for the drug,
                                            listed as price per day's
                                            supply, price per dosage unit,
                                            and price per typical course of
                                            treatment (as applicable);
                                                ``(ff) the total out-of-
                                            pocket spending by plan
                                            enrollees on such drug after
                                            application of any benefits
                                            under the plan, including plan
                                            enrollee spending through
                                            copayments, coinsurance, and
                                            deductibles;
                                                ``(gg) total rebates paid
                                            by the manufacturer on the drug
                                            as reported under the Detailed
                                            DIR Report (or any successor
                                            report) submitted by such
                                            sponsor to the Centers for
                                            Medicare & Medicaid Services;
                                                ``(hh) all other direct or
                                            indirect remuneration on the
                                            drug as reported under the
                                            Detailed DIR Report (or any
                                            successor report) submitted by
                                            such sponsor to the Centers for
                                            Medicare & Medicaid Services;
                                                ``(ii) the average pharmacy
                                            reimbursement amount paid by
                                            the plan for the drug in the
                                            aggregate and disaggregated by
                                            dispensing channel identified
                                            in item (cc);
                                                ``(jj) the average National
                                            Average Drug Acquisition Cost
                                            (NADAC); and
                                                ``(kk) total manufacturer-
                                            derived revenue, inclusive of
                                            bona fide service fees,
                                            attributable to the drug and
                                            retained by the pharmacy
                                            benefit manager and any
                                            affiliate of such pharmacy
                                            benefit manager.
                                        ``(II) In the case of a pharmacy
                                    benefit manager that has an affiliate
                                    that is a retail, mail order, or
                                    specialty pharmacy, with respect to
                                    drugs covered by such plan that were
                                    dispensed, the following information:
                                                ``(aa) The percentage of
                                            total prescriptions that were
                                            dispensed by pharmacies that
                                            are an affiliate of the
                                            pharmacy benefit manager for
                                            each drug.
                                                ``(bb) The interquartile
                                            range of the total combined
                                            costs paid by the plan and plan
                                            enrollees, per dosage unit, per
                                            course of treatment, per 30-day
                                            supply, and per 90-day supply
                                            for each drug dispensed by
                                            pharmacies that are not an
                                            affiliate of the pharmacy
                                            benefit manager and that are
                                            included in the pharmacy
                                            network of such plan.
                                                ``(cc) The interquartile
                                            range of the total combined
                                            costs paid by the plan and plan
                                            enrollees, per dosage unit, per
                                            course of treatment, per 30-day
                                            supply, and per 90-day supply
                                            for each drug dispensed by
                                            pharmacies that are an
                                            affiliate of the pharmacy
                                            benefit manager and that are
                                            included in the pharmacy
                                            network of such plan.
                                                ``(dd) The lowest total
                                            combined cost paid by the plan
                                            and plan enrollees, per dosage
                                            unit, per course of treatment,
                                            per 30-day supply, and per 90-
                                            day supply, for each drug that
                                            is available from any pharmacy
                                            included in the pharmacy
                                            network of such plan.
                                                ``(ee) The difference
                                            between the average acquisition
                                            cost of the affiliate, such as
                                            a pharmacy or other entity that
                                            acquires prescription drugs,
                                            that initially acquires the
                                            drug and the amount reported
                                            under subclause (I)(jj) for
                                            each drug.
                                                ``(ff) A list inclusive of
                                            the brand name, generic or non-
                                            proprietary name, and National
                                            Drug Code of covered part D
                                            drugs subject to an agreement
                                            with a covered entity under
                                            section 340B of the Public
                                            Health Service Act for which
                                            the pharmacy benefit manager or
                                            an affiliate of the pharmacy
                                            benefit manager had a contract
                                            or other arrangement with such
                                            a covered entity in the service
                                            area of such plan.
                                        ``(III) Where a drug approved under
                                    section 505(c) of the Federal Food,
                                    Drug, and Cosmetic Act (referred to in
                                    this subclause as the `listed drug') is
                                    covered by the plan, the following
                                    information:
                                                ``(aa) A list of currently
                                            marketed generic drugs approved
                                            under section 505(j) of the
                                            Federal Food, Drug, and
                                            Cosmetic Act pursuant to an
                                            application that references
                                            such listed drug that are not
                                            covered by the plan, are
                                            covered on the same formulary
                                            tier or a formulary tier
                                            typically associated with
                                            higher cost-sharing than the
                                            listed drug, or are subject to
                                            utilization management that the
                                            listed drug is not subject to.
                                                ``(bb) The estimated
                                            average beneficiary cost-
                                            sharing under the plan for a
                                            30-day supply of the listed
                                            drug.
                                                ``(cc) Where a generic drug
                                            listed under item (aa) is on a
                                            formulary tier typically
                                            associated with higher cost-
                                            sharing than the listed drug,
                                            the estimated average cost-
                                            sharing that a beneficiary
                                            would have paid for a 30-day
                                            supply of each of the generic
                                            drugs described in item (aa),
                                            had the plan provided coverage
                                            for such drugs on the same
                                            formulary tier as the listed
                                            drug.
                                                ``(dd) A written
                                            justification for providing
                                            more favorable coverage of the
                                            listed drug than the generic
                                            drugs described in item (aa).
                                                ``(ee) The number of
                                            currently marketed generic
                                            drugs approved under section
                                            505(j) of the Federal Food,
                                            Drug, and Cosmetic Act pursuant
                                            to an application that
                                            references such listed drug.
                                        ``(IV) Where a reference product
                                    (as defined in section 351(i) of the
                                    Public Health Service Act) is covered
                                    by the plan, the following information:
                                                ``(aa) A list of currently
                                            marketed biosimilar biological
                                            products licensed under section
                                            351(k) of the Public Health
                                            Service Act pursuant to an
                                            application that refers to such
                                            reference product that are not
                                            covered by the plan, are
                                            covered on the same formulary
                                            tier or a formulary tier
                                            typically associated with
                                            higher cost-sharing than the
                                            reference product, or are
                                            subject to utilization
                                            management that the reference
                                            product is not subject to.
                                                ``(bb) The estimated
                                            average beneficiary cost-
                                            sharing under the plan for a
                                            30-day supply of the reference
                                            product.
                                                ``(cc) Where a biosimilar
                                            biological product listed under
                                            item (aa) is on a formulary
                                            tier typically associated with
                                            higher cost-sharing than the
                                            reference product, the
                                            estimated average cost-sharing
                                            that a beneficiary would have
                                            paid for a 30-day supply of
                                            each of the biosimilar
                                            biological products described
                                            in item (aa), had the plan
                                            provided coverage for such
                                            products on the same formulary
                                            tier as the reference product.
                                                ``(dd) A written
                                            justification for providing
                                            more favorable coverage of the
                                            reference product than the
                                            biosimilar biological product
                                            described in item (aa).
                                                ``(ee) The number of
                                            currently marketed biosimilar
                                            biological products licensed
                                            under section 351(k) of the
                                            Public Health Service Act,
                                            pursuant to an application that
                                            refers to such reference
                                            product.
                                        ``(V) Total gross spending on
                                    covered part D drugs by the plan, not
                                    net of rebates, fees, discounts, or
                                    other direct or indirect remuneration.
                                        ``(VI) The total amount retained by
                                    the pharmacy benefit manager or an
                                    affiliate of such pharmacy benefit
                                    manager in revenue related to
                                    utilization of covered part D drugs
                                    under that plan, inclusive of bona fide
                                    service fees.
                                        ``(VII) The total spending on
                                    covered part D drugs net of rebates,
                                    fees, discounts, or other direct and
                                    indirect remuneration by the plan.
                                        ``(VIII) An explanation of any
                                    benefit design parameters under such
                                    plan that encourage plan enrollees to
                                    fill prescriptions at pharmacies that
                                    are an affiliate of such pharmacy
                                    benefit manager, such as mail and
                                    specialty home delivery programs, and
                                    retail and mail auto-refill programs.
                                        ``(IX) The following information:
                                                ``(aa) A list of all
                                            brokers, consultants, advisors,
                                            and auditors that receive
                                            compensation from the pharmacy
                                            benefit manager or an affiliate
                                            of such pharmacy benefit
                                            manager for referrals,
                                            consulting, auditing, or other
                                            services offered to PDP
                                            sponsors related to pharmacy
                                            benefit management services.
                                                ``(bb) The amount of
                                            compensation provided by such
                                            pharmacy benefit manager or
                                            affiliate to each such broker,
                                            consultant, advisor, and
                                            auditor.
                                                ``(cc) The methodology for
                                            calculating the amount of
                                            compensation provided by such
                                            pharmacy benefit manager or
                                            affiliate, for each such
                                            broker, consultant, advisor,
                                            and auditor.
                                        ``(X) A list of all affiliates of
                                    the pharmacy benefit manager.
                                        ``(XI) A summary document submitted
                                    in a standardized template developed by
                                    the Secretary that includes such
                                    information described in subclauses (I)
                                    through (X).
                                ``(ii) Written explanation of contracts or
                            agreements with drug manufacturers.--
                                        ``(I) In general.--The pharmacy
                                    benefit manager shall, not later than
                                    30 days after the finalization of any
                                    contract or agreement between such
                                    pharmacy benefit manager or an
                                    affiliate of such pharmacy benefit
                                    manager and a drug manufacturer (or
                                    subsidiary, agent, or entity affiliated
                                    with such drug manufacturer) that makes
                                    rebates, discounts, payments, or other
                                    financial incentives related to one or
                                    more covered part D drugs or other
                                    prescription drugs, as applicable, of
                                    the manufacturer directly or indirectly
                                    contingent upon coverage, formulary
                                    placement, or utilization management
                                    conditions on any other covered part D
                                    drugs or other prescription drugs, as
                                    applicable, submit to the PDP sponsor a
                                    written explanation of such contract or
                                    agreement.
                                        ``(II) Requirements.--A written
                                    explanation under subclause (I) shall--
                                                ``(aa) include the
                                            manufacturer subject to the
                                            contract or agreement, all
                                            covered part D drugs and other
                                            prescription drugs, as
                                            applicable, subject to the
                                            contract or agreement and the
                                            manufacturers of such drugs,
                                            and a high-level description of
                                            the terms of such contract or
                                            agreement and how such terms
                                            apply to such drugs; and
                                                ``(bb) be certified by the
                                            Chief Executive Officer, Chief
                                            Financial Officer, or General
                                            Counsel of such pharmacy
                                            benefit manager, or affiliate
                                            of such pharmacy benefit
                                            manager, as applicable, or an
                                            individual delegated with the
                                            authority to sign on behalf of
                                            one of these officers, who
                                            reports directly to the
                                            officer.
                                        ``(III) Definition of other
                                    prescription drugs.--For purposes of
                                    this clause, the term `other
                                    prescription drugs' means prescription
                                    drugs covered as supplemental benefits
                                    under this part or prescription drugs
                                    paid outside of this part.
                        ``(D) Audit rights.--
                                ``(i) In general.--Not less than once a
                            year, at the request of the PDP sponsor, the
                            pharmacy benefit manager shall allow for an
                            audit of the pharmacy benefit manager to ensure
                            compliance with all terms and conditions under
                            the written agreement described in this
                            paragraph and the accuracy of information
                            reported under subparagraph (C).
                                ``(ii) Auditor.--The PDP sponsor shall have
                            the right to select an auditor. The pharmacy
                            benefit manager shall not impose any
                            limitations on the selection of such auditor.
                                ``(iii) Provision of information.--The
                            pharmacy benefit manager shall make available
                            to such auditor all records, data, contracts,
                            and other information necessary to confirm the
                            accuracy of information provided under
                            subparagraph (C), subject to reasonable
                            restrictions on how such information must be
                            reported to prevent redisclosure of such
                            information.
                                ``(iv) Timing.--The pharmacy benefit
                            manager must provide information under clause
                            (iii) and other information, data, and records
                            relevant to the audit to such auditor within 6
                            months of the initiation of the audit and
                            respond to requests for additional information
                            from such auditor within 30 days after the
                            request for additional information.
                                ``(v) Information from affiliates.--The
                            pharmacy benefit manager shall be responsible
                            for providing to such auditor information
                            required to be reported under subparagraph (C)
                            or under clause (iii) of this subparagraph that
                            is owned or held by an affiliate of such
                            pharmacy benefit manager.
                ``(2) Enforcement.--
                        ``(A) In general.--Each PDP sponsor shall--
                                ``(i) disgorge to the Secretary any amounts
                            disgorged to the PDP sponsor by a pharmacy
                            benefit manager under paragraph (1)(A)(v);
                                ``(ii) require, in a written agreement with
                            any pharmacy benefit manager acting on behalf
                            of such sponsor or affiliate of such pharmacy
                            benefit manager, that such pharmacy benefit
                            manager or affiliate reimburse the PDP sponsor
                            for any civil money penalty imposed on the PDP
                            sponsor as a result of the failure of the
                            pharmacy benefit manager or affiliate to meet
                            the requirements of paragraph (1) that are
                            applicable to the pharmacy benefit manager or
                            affiliate under the agreement; and
                                ``(iii) require, in a written agreement
                            with any such pharmacy benefit manager acting
                            on behalf of such sponsor or affiliate of such
                            pharmacy benefit manager, that such pharmacy
                            benefit manager or affiliate be subject to
                            punitive remedies for breach of contract for
                            failure to comply with the requirements
                            applicable under paragraph (1).
                        ``(B) Reporting of alleged violations.--The
                    Secretary shall make available and maintain a mechanism
                    for manufacturers, PDP sponsors, pharmacies, and other
                    entities that have contractual relationships with
                    pharmacy benefit managers or affiliates of such
                    pharmacy benefit managers to report, on a confidential
                    basis, alleged violations of paragraph (1)(A) or
                    subparagraph (C).
                        ``(C) Anti-retaliation and anti-coercion.--
                    Consistent with applicable Federal or State law, a PDP
                    sponsor shall not--
                                ``(i) retaliate against an individual or
                            entity for reporting an alleged violation under
                            subparagraph (B); or
                                ``(ii) coerce, intimidate, threaten, or
                            interfere with the ability of an individual or
                            entity to report any such alleged violations.
                ``(3) Certification of compliance.--
                        ``(A) In general.--Each PDP sponsor shall furnish
                    to the Secretary (at a time and in a manner specified
                    by the Secretary) an annual certification of compliance
                    with this subsection, as well as such information as
                    the Secretary determines necessary to carry out this
                    subsection.
                        ``(B) Implementation.--Notwithstanding any other
                    provision of law, the Secretary may implement this
                    paragraph by program instruction or otherwise.
                ``(4) Rule of construction.--Nothing in this subsection
            shall be construed as--
                        ``(A) prohibiting flat dispensing fees or
                    reimbursement or payment for ingredient costs
                    (including customary, industry-standard discounts
                    directly related to drug acquisition that are retained
                    by pharmacies or wholesalers) to entities that acquire
                    or dispense prescription drugs; or
                        ``(B) modifying regulatory requirements or sub-
                    regulatory program instruction or guidance related to
                    pharmacy payment, reimbursement, or dispensing fees.
                ``(5) Standard formats.--
                        ``(A) In general.--Not later than June 1, 2027, the
                    Secretary shall specify standard, machine-readable
                    formats for pharmacy benefit managers to submit annual
                    reports required under paragraph (1)(C)(i).
                        ``(B) Implementation.--Notwithstanding any other
                    provision of law, the Secretary may implement this
                    paragraph by program instruction or otherwise.
                ``(6) Confidentiality.--
                        ``(A) In general.--Information disclosed by a
                    pharmacy benefit manager, an affiliate of a pharmacy
                    benefit manager, a PDP sponsor, or a pharmacy under
                    this subsection that is not otherwise publicly
                    available or available for purchase shall not be
                    disclosed by the Secretary or a PDP sponsor receiving
                    the information, except that the Secretary may disclose
                    the information for the following purposes:
                                ``(i) As the Secretary determines necessary
                            to carry out this part.
                                ``(ii) To permit the Comptroller General to
                            review the information provided.
                                ``(iii) To permit the Director of the
                            Congressional Budget Office to review the
                            information provided.
                                ``(iv) To permit the Executive Director of
                            the Medicare Payment Advisory Commission to
                            review the information provided.
                                ``(v) To the Attorney General for the
                            purposes of conducting oversight and
                            enforcement under this title.
                                ``(vi) To the Inspector General of the
                            Department of Health and Human Services in
                            accordance with its authorities under the
                            Inspector General Act of 1978 (section 406 of
                            title 5, United States Code), and other
                            applicable statutes.
                        ``(B) Restriction on use of information.--The
                    Secretary, the Comptroller General, the Director of the
                    Congressional Budget Office, and the Executive Director
                    of the Medicare Payment Advisory Commission shall not
                    report on or disclose information disclosed pursuant to
                    subparagraph (A) to the public in a manner that would
                    identify--
                                ``(i) a specific pharmacy benefit manager,
                            affiliate, pharmacy, manufacturer, wholesaler,
                            PDP sponsor, or plan; or
                                ``(ii) contract prices, rebates, discounts,
                            or other remuneration for specific drugs in a
                            manner that may allow the identification of
                            specific contracting parties or of such
                            specific drugs.
                ``(7) Definitions.--For purposes of this subsection:
                        ``(A) Affiliate.--The term `affiliate' means, with
                    respect to any pharmacy benefit manager or PDP sponsor,
                    any entity that, directly or indirectly--
                                ``(i) owns or is owned by, controls or is
                            controlled by, or is otherwise related in any
                            ownership structure to such pharmacy benefit
                            manager or PDP sponsor; or
                                ``(ii) acts as a contractor, principal, or
                            agent to such pharmacy benefit manager or PDP
                            sponsor, insofar as such contractor, principal,
                            or agent performs any of the functions
                            described under subparagraph (C).
                        ``(B) Bona fide service fee.--The term `bona fide
                    service fee' means a fee that is reflective of the fair
                    market value (as specified by the Secretary, through
                    notice and comment rulemaking) for a bona fide,
                    itemized service actually performed on behalf of an
                    entity, that the entity would otherwise perform (or
                    contract for) in the absence of the service arrangement
                    and that is not passed on in whole or in part to a
                    client or customer, whether or not the entity takes
                    title to the drug. Such fee must be a flat dollar
                    amount and shall not be directly or indirectly based
                    on, or contingent upon--
                                ``(i) drug price, such as wholesale
                            acquisition cost or drug benchmark price (such
                            as average wholesale price);
                                ``(ii) the amount of discounts, rebates,
                            fees, or other direct or indirect remuneration
                            with respect to covered part D drugs dispensed
                            to enrollees in a prescription drug plan,
                            except as permitted pursuant to paragraph
                            (1)(A)(ii);
                                ``(iii) coverage or formulary placement
                            decisions or the volume or value of any
                            referrals or business generated between the
                            parties to the arrangement; or
                                ``(iv) any other amounts or methodologies
                            prohibited by the Secretary.
                        ``(C) Pharmacy benefit manager.--The term `pharmacy
                    benefit manager' means any person or entity that,
                    either directly or through an intermediary, acts as a
                    price negotiator or group purchaser on behalf of a PDP
                    sponsor or prescription drug plan, or manages the
                    prescription drug benefits provided by such sponsor or
                    plan, including the processing and payment of claims
                    for prescription drugs, the performance of drug
                    utilization review, the processing of drug prior
                    authorization requests, the adjudication of appeals or
                    grievances related to the prescription drug benefit,
                    contracting with network pharmacies, controlling the
                    cost of covered part D drugs, or the provision of
                    related services. Such term includes any person or
                    entity that carries out one or more of the activities
                    described in the preceding sentence, irrespective of
                    whether such person or entity calls itself a `pharmacy
                    benefit manager'.''.
                (2) MA-PD plans.--Section 1857(f)(3) of the Social Security
            Act (42 U.S.C. 1395w-27(f)(3)), as amended by section
            226(d)(2), is amended by adding at the end the following new
            subparagraph:
                        ``(G) Requirements relating to pharmacy benefit
                    managers.--For plan years beginning on or after January
                    1, 2028, section 1860D-12(h).''.
                (3) Nonapplication of paperwork reduction act.--Chapter 35
            of title 44, United States Code, shall not apply to the
            implementation of this subsection.
                (4) Funding.--
                        (A) Secretary.--In addition to amounts otherwise
                    available, there is appropriated to the Centers for
                    Medicare & Medicaid Services Program Management
                    Account, out of any money in the Treasury not otherwise
                    appropriated, $113,000,000 for fiscal year 2025, to
                    remain available until expended, to carry out this
                    subsection.
                        (B) OIG.--In addition to amounts otherwise
                    available, there is appropriated to the Inspector
                    General of the Department of Health and Human Services,
                    out of any money in the Treasury not otherwise
                    appropriated, $20,000,000 for fiscal year 2025, to
                    remain available until expended, to carry out this
                    subsection.
        (b) GAO Study and Report on Price-Related Compensation Across the
    Supply Chain.--
                (1) Study.--The Comptroller General of the United States
            (in this subsection referred to as the ``Comptroller General'')
            shall conduct a study describing the use of compensation and
            payment structures related to a prescription drug's price
            within the retail prescription drug supply chain in part D of
            title XVIII of the Social Security Act (42 U.S.C. 1395w-101 et
            seq.). Such study shall summarize information from Federal
            agencies and industry experts, to the extent available, with
            respect to the following:
                        (A) The type, magnitude, other features (such as
                    the pricing benchmarks used), and prevalence of
                    compensation and payment structures related to a
                    prescription drug's price, such as calculating fee
                    amounts as a percentage of a prescription drug's price,
                    between intermediaries in the prescription drug supply
                    chain, including--
                                (i) pharmacy benefit managers;
                                (ii) PDP sponsors offering prescription
                            drug plans and Medicare Advantage organizations
                            offering MA-PD plans;
                                (iii) drug wholesalers;
                                (iv) pharmacies;
                                (v) manufacturers;
                                (vi) pharmacy services administrative
                            organizations;
                                (vii) brokers, auditors, consultants, and
                            other entities that--
                                        (I) advise PDP sponsors offering
                                    prescription drug plans and Medicare
                                    Advantage organizations offering MA-PD
                                    plans regarding pharmacy benefits; or
                                        (II) review PDP sponsor and
                                    Medicare Advantage organization
                                    contracts with pharmacy benefit
                                    managers; and
                                (viii) other service providers that
                            contract with any of the entities described in
                            clauses (i) through (vii) that may use price-
                            related compensation and payment structures,
                            such as rebate aggregators (or other entities
                            that negotiate or process price concessions on
                            behalf of pharmacy benefit managers, plan
                            sponsors, or pharmacies).
                        (B) The primary business models and compensation
                    structures for each category of intermediary described
                    in subparagraph (A).
                        (C) Variation in price-related compensation
                    structures between affiliated entities (such as
                    entities with common ownership, either full or partial,
                    and subsidiary relationships) and unaffiliated
                    entities.
                        (D) Potential conflicts of interest among
                    contracting entities related to the use of prescription
                    drug price-related compensation structures, such as the
                    potential for fees or other payments set as a
                    percentage of a prescription drug's price to advantage
                    formulary selection, distribution, or purchasing of
                    prescription drugs with higher prices.
                        (E) Notable differences, if any, in the use and
                    level of price-based compensation structures over time
                    and between different market segments, such as under
                    part D of title XVIII of the Social Security Act (42
                    U.S.C. 1395w-101 et seq.) and the Medicaid program
                    under title XIX of such Act (42 U.S.C. 1396 et seq.).
                        (F) The effects of drug price-related compensation
                    structures and alternative compensation structures on
                    Federal health care programs and program beneficiaries,
                    including with respect to cost-sharing, premiums,
                    Federal outlays, biosimilar and generic drug adoption
                    and utilization, drug shortage risks, and the potential
                    for fees set as a percentage of a drug's price to
                    advantage the formulary selection, distribution, or
                    purchasing of drugs with higher prices.
                        (G) Other issues determined to be relevant and
                    appropriate by the Comptroller General.
                (2) Report.--Not later than 2 years after the date of
            enactment of this section, the Comptroller General shall submit
            to Congress a report containing the results of the study
            conducted under paragraph (1), together with recommendations
            for such legislation and administrative action as the
            Comptroller General determines appropriate.
        (c) MedPAC Reports on Agreements With Pharmacy Benefit Managers
    With Respect to Prescription Drug Plans and MA-PD Plans.--
                (1) In general.--The Medicare Payment Advisory Commission
            shall submit to Congress the following reports:
                        (A) Initial report.--Not later than the first March
                    15 occurring after the date that is 2 years after the
                    date on which the Secretary makes the data available to
                    the Commission, a report regarding agreements with
                    pharmacy benefit managers with respect to prescription
                    drug plans and MA-PD plans. Such report shall include,
                    to the extent practicable--
                                (i) a description of trends and patterns,
                            including relevant averages, totals, and other
                            figures for the types of information submitted;
                                (ii) an analysis of any differences in
                            agreements and their effects on plan enrollee
                            out-of-pocket spending and average pharmacy
                            reimbursement, and other impacts; and
                                (iii) any recommendations the Commission
                            determines appropriate.
                        (B) Final report.--Not later than 2 years after the
                    date on which the Commission submits the initial report
                    under subparagraph (A), a report describing any changes
                    with respect to the information described in
                    subparagraph (A) over time, together with any
                    recommendations the Commission determines appropriate.
                (2) Funding.--In addition to amounts otherwise available,
            there is appropriated to the Medicare Payment Advisory
            Commission, out of any money in the Treasury not otherwise
            appropriated, $1,000,000 for fiscal year 2025, to remain
            available until expended, to carry out this subsection.

    SEC. 228. REQUIRING A SEPARATE IDENTIFICATION NUMBER AND AN ATTESTATION
                  FOR EACH OFF-CAMPUS OUTPATIENT DEPARTMENT OF A PROVIDER.

        (a) In General.--Section 1833(t) of the Social Security Act (42
    U.S.C. 1395l(t)) is amended by adding at the end the following new
    paragraph:
                ``(23) Use of unique health identifiers; attestation.--
                        ``(A) In general.--No payment may be made under
                    this subsection (or under an applicable payment system
                    pursuant to paragraph (21)) for items and services
                    furnished on or after January 1, 2026, by an off-campus
                    outpatient department of a provider (as defined in
                    subparagraph (C)) unless--
                                ``(i) such department has obtained, and
                            such items and services are billed under, a
                            standard unique health identifier for health
                            care providers (as described in section
                            1173(b)) that is separate from such identifier
                            for such provider;
                                ``(ii) such provider has submitted to the
                            Secretary, during the 2-year period ending on
                            the date such items and services are so
                            furnished, an initial provider-based status
                            attestation that such department is compliant
                            with the requirements described in section
                            413.65 of title 42, Code of Federal Regulations
                            (or a successor regulation); and
                                ``(iii) after such provider has submitted
                            an attestation under clause (ii), such provider
                            has submitted a subsequent attestation within
                            the timeframe specified by the Secretary.
                        ``(B) Process for submission and review.--Not later
                    than 1 year after the date of enactment of this
                    paragraph, the Secretary shall, through notice and
                    comment rulemaking, establish a process for each
                    provider with an off-campus outpatient department of a
                    provider to submit an initial and subsequent
                    attestation pursuant to clauses (ii) and (iii),
                    respectively, of subparagraph (A), and for the
                    Secretary to review each such attestation and
                    determine, through site visits, remote audits, or other
                    means (as determined appropriate by the Secretary),
                    whether such department is compliant with the
                    requirements described in such subparagraph.
                        ``(C) Off-campus outpatient department of a
                    provider defined.--For purposes of this paragraph, the
                    term `off-campus outpatient department of a provider'
                    means a department of a provider (as defined in section
                    413.65 of title 42, Code of Federal Regulations, or any
                    successor regulation) that is not located--
                                ``(i) on the campus (as defined in such
                            section) of such provider; or
                                ``(ii) within the distance (described in
                            such definition of campus) from a remote
                            location of a hospital facility (as defined in
                            such section).''.
        (b) HHS OIG Analysis.--Not later than January 1, 2030, the
    Inspector General of the Department of Health and Human Services shall
    submit to Congress--
                (1) an analysis of the process established by the Secretary
            of Health and Human Services to conduct the reviews and
            determinations described in section 1833(t)(23)(B) of the
            Social Security Act, as added by subsection (a) of this
            section; and
                (2) recommendations based on such analysis, as the
            Inspector General determines appropriate.

    SEC. 229. MEDICARE SEQUESTRATION.

        Section 251A(6) of the Balanced Budget and Emergency Deficit
    Control Act of 1985 (2 U.S.C. 901a(6)) is amended--
                (1) in subparagraph (D), by striking ``such that,'' and all
            that follows and inserting ``such that the payment reduction
            shall be 2.0 percent.''; and
                (2) by adding at the end the following:
                ``(F) On the date on which the President submits the budget
            under section 1105 of title 31, United States Code, for fiscal
            year 2033, the President shall order a sequestration of
            payments for the Medicare programs specified in section 256(d),
            effective upon issuance, such that, notwithstanding the 2
            percent limit specified in subparagraph (A) for such payments--
                        ``(i) with respect to the first 2 months in which
                    such order is effective for such fiscal year, the
                    payment reduction shall be 2.0 percent; and
                        ``(ii) with respect to the last 10 months in which
                    such order is effective for such fiscal year, the
                    payment reduction shall be 0 percent.''.

    SEC. 230. MEDICARE IMPROVEMENT FUND.

        Section 1898(b)(1) of the Social Security Act (42 U.S.C.
    1395iii(b)(1)) is amended by striking ``$1,251,000,000'' and inserting
    ``$1,938,000,000''.

                           TITLE III--HUMAN SERVICES

    SEC. 301. SEXUAL RISK AVOIDANCE EDUCATION EXTENSION.

        Section 510 of the Social Security Act (42 U.S.C. 710) is amended--
                (1) in subsection (a)--
                        (A) in paragraph (1)--
                                (i) by striking ``and for the period'' and
                            inserting ``for the period'';
                                (ii) by inserting ``for the period
                            beginning on April 1, 2025, and ending on
                            September 30, 2025, and for the period
                            beginning on October 1, 2025, and ending on
                            December 31, 2025,'' before ``allot to each
                            State''; and
                                (iii) by striking ``for fiscal year 2024 or
                            2025'' and inserting ``for fiscal year 2024,
                            2025, or 2026''; and
                        (B) in paragraph (2), by striking ``or 2025'' each
                    place it appears and inserting ``, 2025, or 2026''; and
                (2) in subsection (f)(1), by striking ``and for the period
            beginning on October 1, 2024, and ending on March 31, 2025, an
            amount equal to the pro rata portion of the amount appropriated
            for the corresponding period for fiscal year 2024'' and
            inserting ``for the period beginning on October 1, 2024, and
            ending on March 31, 2025, and for the period beginning on April
            1, 2025, and ending on September 30, 2025, an amount equal to
            the pro rata portion of the amount appropriated for the
            corresponding period for fiscal year 2024, and for the period
            beginning on October 1, 2025, and ending on December 31, 2025,
            an amount equal to the pro rata portion of the amount
            appropriated for the corresponding period for fiscal year
            2025''

    SEC. 302. PERSONAL RESPONSIBILITY EDUCATION EXTENSION.

        Section 513 of the Social Security Act (42 U.S.C. 713) is amended--
                (1) in subsection (a)(1)--
                        (A) in subparagraph (A), in the matter preceding
                    clause (i)--
                                (i) by striking ``and for the period'' and
                            inserting ``for the period''; and
                                (ii) by inserting ``for the period
                            beginning on April 1, 2025, and ending on
                            September 30, 2025, and for the period
                            beginning on October 1, 2025, and ending on
                            December 31, 2025,'' before ``the Secretary
                            shall allot''; and
                        (B) in subparagraph (B)(i)--
                                (i) by striking ``and for the period'' and
                            inserting ``for the period''; and
                                (ii) by inserting ``, for the period
                            beginning on April 1, 2025, and ending on
                            September 30, 2025, and for the period
                            beginning on October 1, 2025, and ending on
                            December 31, 2025'' before the period;
                (2) in subsection (c)(3), by striking ``fiscal year 2024 or
            2025'' and inserting ``fiscal year 2024, 2025, or 2026''; and
                (3) in subsection (f), by striking ``and for the period
            beginning on October 1, 2024, and ending on March 31, 2025, an
            amount equal to the pro rata portion of the amount appropriated
            for the corresponding period for fiscal year 2024'' and
            inserting ``for the period beginning on October 1, 2024, and
            ending on March 31, 2025, and for the period beginning on April
            1, 2025, and ending on September 30, 2025, an amount equal to
            the pro rata portion of the amount appropriated for the
            corresponding period for fiscal year 2024, and for the period
            beginning on October 1, 2025, and ending on December 31, 2025,
            an amount equal to the pro rata portion of the amount
            appropriated for the corresponding period for fiscal year
            2025''.

    SEC. 303. EXTENSION OF FUNDING FOR FAMILY-TO-FAMILY HEALTH INFORMATION
                  CENTERS.

        Section 501(c)(1)(A)(viii) of the Social Security Act (42 U.S.C.
    701(c)(1)(A)(viii)) is amended--
                (1) by striking ``$3,000,000'' and inserting
            ``$7,500,000''; and
                (2) by striking ``for the portion of fiscal year 2025
            before April 1, 2025'' and inserting ``for the period beginning
            on October 1, 2024, and ending on December 31, 2025''.

                       TITLE IV--PUBLIC HEALTH EXTENDERS

                             Subtitle A--Extensions

    SEC. 401. EXTENSION FOR COMMUNITY HEALTH CENTERS, NATIONAL HEALTH
                  SERVICE CORPS, AND TEACHING HEALTH CENTERS THAT OPERATE
                  GME PROGRAMS.

        (a) Extension for Community Health Centers.--Section 10503(b)(1) of
    the Patient Protection and Affordable Care Act (42 U.S.C. 254b-2(b)(1))
    is amended--
                (1) in subparagraph (H), by striking ``and'' at the end;
                (2) in subparagraph (I), by striking the period and
            inserting ``, and $2,315,342,466 for the period beginning on
            April 1, 2025, and ending on September 30, 2025; and''; and
                (3) by adding at the end the following:
                        ``(J) $4,600,000,000 for fiscal year 2026; and''.
        (b) Extension for the National Health Service Corps.--Section
    10503(b)(2) of the Patient Protection and Affordable Care Act (42
    U.S.C. 254b-2(b)(2)) is amended--
                (1) in subparagraph (I), by striking ``and'' at the end;
                (2) in subparagraph (J), by striking the period and
            inserting ``, and $176,712,329 for the period beginning on
            April 1, 2025, and ending on September 30, 2025; and''; and
                (3) by adding at the end the following:
                        ``(J) $350,000,000 for fiscal year 2026.''.
        (c) Teaching Health Centers That Operate Graduate Medical Education
    Programs.--Section 340H(g)(1) of the Public Health Service Act (42
    U.S.C. 256h(g)(1)) is amended--
                (1) in subparagraph (D), by striking ``; and'' and
            inserting a semicolon;
                (2) in subparagraph (E), by striking the period and
            inserting a semicolon; and
                (3) by adding at the end the following: ``
                        ``(F) $112,849,315 for the period beginning on
                    January 1, 2025, and ending on September 30, 2025;
                        ``(G) $225,000,000 for fiscal year 2026;
                        ``(H) $250,000,000 for fiscal year 2027;
                        ``(I) $275,000,000 for fiscal year 2028; and
                        ``(J) $300,000,000 for fiscal year 2029.''.
        (d) Application of Provisions.--Amounts appropriated pursuant to
    the amendments made by this section shall be subject to the
    requirements contained in Public Law 118-47 for funds for programs
    authorized under sections 330 through 340 of the Public Health Service
    Act (42 U.S.C. 254b et seq.).
        (e) Conforming Amendments.--Section 3014(h)(4) of title 18, United
    States Code, is amended by striking ``and section 3101(d) of the Health
    Extensions and Other Matters Act, 2025'' and inserting ``section
    3101(d) of the Health Extensions and Other Matters Act, 2025, and
    section 401(d) of the Bipartisan Health Care Act''.

    SEC. 402. EXTENSION OF SPECIAL DIABETES PROGRAMS.

        (a) Extension of Special Diabetes Programs for Type I Diabetes.--
    Section 330B(b)(2) of the Public Health Service Act (42 U.S.C. 254c-
    2(b)(2)) is amended--
                (1) in subparagraph (E), by striking ``and'' at the end;
                (2) in subparagraph (F), by striking the period at the end
            and inserting ``, and $110,327,296 for the period beginning on
            April 1, 2025, and ending on September 30, 2025; and''; and
                (3) by adding at the end the following:
                        ``(G) $200,000,000 for fiscal year 2026, to remain
                    available until expended.''.
        (b) Extending Funding for Special Diabetes Programs for Indians.--
    Section 330C(c)(2) of the Public Health Service Act (42 U.S.C. 254c-
    3(c)(2)) is amended--
                (1) in subparagraph (E), by striking ``and'' at the end;
                (2) in subparagraph (F), by striking the period at the end
            and inserting ``, and $110,327,296 for the period beginning on
            April 1, 2025, and ending on September 30, 2025; and''; and
                (3) by adding at the end the following:
                        ``(G) $200,000,000 for fiscal year 2026, to remain
                    available until expended.''.

                 Subtitle B--World Trade Center Health Program

    SEC. 411. 9/11 RESPONDER AND SURVIVOR HEALTH FUNDING CORRECTIONS.

        (a) In General.--Section 3351(a)(2)(A) of the Public Health Service
    Act (42 U.S.C. 300mm-61(a)(2)(A)) is amended--
                (1) in clause (x), by striking ``; and'' and inserting a
            semicolon;
                (2) by redesignating clause (xi) as clause (xii); and
                (3) by inserting after clause (x), the following:
                                ``(xi) for each of fiscal years 2026
                            through 2040--
                                        ``(I) the amount determined under
                                    this subparagraph for the previous
                                    fiscal year multiplied by 1.05;
                                    multiplied by
                                        ``(II) the ratio of--
                                                ``(aa) the total number of
                                            individuals enrolled in the WTC
                                            Program on July 1 of such
                                            previous fiscal year; to
                                                ``(bb) the total number of
                                            individuals so enrolled on July
                                            1 of the fiscal year prior to
                                            such previous fiscal year;
                                            and''.
        (b) Report to Congress.--
                (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 conduct an assessment of anticipated budget authority and
            outlays of the World Trade Center Health Program (referred to
            in this subsection as the ``Program'') through the duration of
            the Program and submit a report summarizing such assessment
            to--
                        (A) the Speaker and minority leader of the House of
                    Representatives;
                        (B) the majority and minority leaders of the
                    Senate;
                        (C) the Committee on Health, Education, Labor, and
                    Pensions and the Committee on the Budget of the Senate;
                    and
                        (D) the Committee on Energy and Commerce and the
                    Committee on the Budget of the House of
                    Representatives.
                (2) Inclusions.--The report required under paragraph (1)
            shall include--
                        (A) a projection of Program budgetary needs on a
                    per-fiscal year basis through fiscal year 2090;
                        (B) a review of Program modeling for each of fiscal
                    years 2017 through the fiscal year prior to the fiscal
                    year in which the report is issued to assess how
                    anticipated budgetary needs compared to actual
                    expenditures;
                        (C) an assessment of the projected budget authority
                    and expenditures of the Program through fiscal year
                    2090 by comparing--
                                (i) such projected authority and
                            expenditures resulting from application of
                            section 3351(a)(2)(A) of the Public Health
                            Service Act (42 U.S.C. 300mm-61(a)(2)(A)), as
                            amended by subsection (a); and
                                (ii) such projected authority and
                            expenditures that would result if such section
                            were amended so that the formula under clause
                            (xi) of such section, as amended by subsection
                            (a), were to be extended through fiscal year
                            2090; and
                        (D) any recommendations of the Secretary to make
                    changes to the formula under such section
                    3351(a)(2)(A), as so amended, to fully offset
                    anticipated Program expenditures through fiscal year
                    2090.
        (c) Technical Amendments.--Title XXXIII of the Public Health
    Service Act (42 U.S.C. 300mm et seq.) is amended--
                (1) in section 3352(d) (42 U.S.C. 300mm-62(d)), by striking
            ``Any amounts'' and inserting ``Any unobligated amounts'';
                (2) in section 3353(d) (42 U.S.C. 300mm-63(d)), by striking
            ``Any amounts'' and inserting ``Any unobligated amounts''; and
                (3) in section 3354(d) (42 U.S.C. 300mm-64(d)), by striking
            ``Any amounts'' and inserting ``Any unobligated amounts''.

                      TITLE V--SUPPORT ACT REAUTHORIZATION

    SEC. 501. SHORT TITLE.

        This title may be cited as the ``SUPPORT for Patients and
    Communities Reauthorization Act of 2025''.

                             Subtitle A--Prevention

    SEC. 511. PRENATAL AND POSTNATAL HEALTH.

        Section 317L(d) of the Public Health Service Act (42 U.S.C. 247b-
    13(d)) is amended by striking ``such sums as may be necessary for each
    of the fiscal years 2019 through 2023'' and inserting ``$4,250,000 for
    each of fiscal years 2025 through 2029''.

    SEC. 512. MONITORING AND EDUCATION REGARDING INFECTIONS ASSOCIATED WITH
                  ILLICIT DRUG USE AND OTHER RISK FACTORS.

        Section 317N(d) of the Public Health Service Act (42 U.S.C. 247b-
    15(d)) is amended by striking ``fiscal years 2019 through 2023'' and
    inserting ``fiscal years 2025 through 2029''.

    SEC. 513. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.

        (a) In General.--Section 392A of the Public Health Service Act (42
    U.S.C. 280b-1) is amended--
                (1) in subsection (a)(2)--
                        (A) in subparagraph (C), by inserting ``and
                    associated risks'' before the period at the end; and
                        (B) in subparagraph (D), by striking ``opioids''
                    and inserting ``substances causing overdose''; and
                (2) in subsection (b)(2)--
                        (A) in subparagraph (B), by inserting ``, and
                    associated risk factors,'' after ``such overdoses'';
                        (B) in subparagraph (C), by striking ``coding'' and
                    inserting ``monitoring and identifying'';
                        (C) in subparagraph (E)--
                                (i) by inserting a comma after ``public
                            health laboratories''; and
                                (ii) by inserting ``and other emerging
                            substances related'' after ``analogues''; and
                        (D) in subparagraph (F), by inserting ``and
                    associated risk factors'' after ``overdoses''.
        (b) Additional Grants.--Section 392A(a)(3) of the Public Health
    Service Act (42 U.S.C. 280b-1(a)(3)) is amended--
                (1) in the matter preceding subparagraph (A), by striking
            ``and Indian Tribes--'' and inserting ``and Indian Tribes for
            the following purposes:'';
                (2) by amending subparagraph (A) to read as follows:
                        ``(A) To carry out innovative projects for grantees
                    to detect, identify, and rapidly respond to controlled
                    substance misuse, abuse, and overdoses, and associated
                    risk factors, including changes in patterns of such
                    controlled substance use. Such projects may include the
                    use of innovative, evidence-based strategies for
                    detecting such patterns, such as wastewater
                    surveillance, if proven to support actionable
                    prevention strategies, in a manner consistent with
                    applicable Federal and State privacy laws.''; and
                (3) in subparagraph (B), by striking ``for any'' and
            inserting ``For any''.
        (c) Authorization of Appropriations.--Section 392A(e) of the Public
    Health Service Act (42 U.S.C. 280b-1(e)) is amended by striking
    ``$496,000,000 for each of fiscal years 2019 through 2023'' and
    inserting ``$505,579,000 for each of fiscal years 2025 through 2029''.

    SEC. 514. SUPPORT FOR INDIVIDUALS AND FAMILIES IMPACTED BY FETAL
                  ALCOHOL SPECTRUM DISORDER.

        (a) In General.--Part O of title III of the Public Health Service
    Act (42 U.S.C. 280f et seq.) is amended to read as follows:

        ``PART O--FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM

    ``SEC. 399H. FETAL ALCOHOL SPECTRUM DISORDERS PREVENTION, INTERVENTION,
                  AND SERVICES DELIVERY PROGRAM.

        ``(a) In General.--The Secretary shall establish or continue
    activities to support a comprehensive fetal alcohol spectrum disorders
    (referred to in this section as `FASD') education, prevention,
    identification, intervention, and services delivery program, which may
    include--
                ``(1) an education and public awareness program to support,
            conduct, and evaluate the effectiveness of--
                        ``(A) educational programs targeting health
                    professions schools, social and other supportive
                    services, educators and counselors and other service
                    providers in all phases of childhood development, and
                    other relevant service providers, concerning the
                    prevention, identification, and provision of services
                    for infants, children, adolescents and adults with
                    FASD;
                        ``(B) strategies to educate school-age children,
                    including pregnant and high-risk youth, concerning
                    FASD;
                        ``(C) public and community awareness programs
                    concerning FASD; and
                        ``(D) strategies to coordinate information and
                    services across affected community agencies, including
                    agencies providing social services such as foster care,
                    adoption, and social work, agencies providing health
                    services, and agencies involved in education,
                    vocational training and civil and criminal justice;
                ``(2) supporting and conducting research on FASD, as
            appropriate, including to--
                        ``(A) develop appropriate medical diagnostic
                    methods for identifying FASD; and
                        ``(B) develop effective culturally and
                    linguistically appropriate evidence-based or evidence-
                    informed interventions and appropriate supports for
                    preventing prenatal alcohol exposure, which may co-
                    occur with exposure to other substances;
                ``(3) building State and Tribal capacity for the
            identification, treatment, and support of individuals with FASD
            and their families, which may include--
                        ``(A) utilizing and adapting existing Federal,
                    State, or Tribal programs to include FASD
                    identification and FASD-informed support;
                        ``(B) developing and expanding screening and
                    diagnostic capacity for FASD;
                        ``(C) developing, implementing, and evaluating
                    targeted FASD-informed intervention programs for FASD;
                        ``(D) providing training with respect to FASD for
                    professionals across relevant sectors; and
                        ``(E) disseminating information about FASD and
                    support services to affected individuals and their
                    families; and
                ``(4) an applied research program concerning intervention
            and prevention to support and conduct service demonstration
            projects, clinical studies and other research models providing
            advocacy, educational and vocational training, counseling,
            medical and mental health, and other supportive services, as
            well as models that integrate and coordinate such services,
            that are aimed at the unique challenges facing individuals with
            Fetal Alcohol Syndrome or Fetal Alcohol Effect and their
            families.
        ``(b) Grants and Technical Assistance.--
                ``(1) In general.--The Secretary may award grants,
            cooperative agreements and contracts and provide technical
            assistance to eligible entities to carry out subsection (a).
                ``(2) Eligible entities.--To be eligible to receive a
            grant, or enter into a cooperative agreement or contract, under
            this section, an entity shall--
                        ``(A) be a State, Indian Tribe or Tribal
                    organization, local government, scientific or academic
                    institution, or nonprofit organization; and
                        ``(B) prepare and submit to the Secretary an
                    application at such time, in such manner, and
                    containing such information as the Secretary may
                    require, including a description of the activities that
                    the entity intends to carry out using amounts received
                    under this section.
                ``(3) Additional application contents.--The Secretary may
            require that an eligible entity include in the application
            submitted under paragraph (2)(B)--
                        ``(A) a designation of an individual to serve as a
                    FASD State or Tribal coordinator of activities such
                    eligible entity proposes to carry out through a grant,
                    cooperative agreement, or contract under this section;
                    and
                        ``(B) a description of an advisory committee the
                    entity will establish to provide guidance for the
                    entity on developing and implementing a statewide or
                    Tribal strategic plan to prevent FASD and provide for
                    the identification, treatment, and support of
                    individuals with FASD and their families.
        ``(c) Definition of FASD-Informed.--For purposes of this section,
    the term `FASD-informed', with respect to support or an intervention
    program, means that such support or intervention program uses
    culturally and linguistically informed evidence-based or practice-based
    interventions and appropriate resources to support an improved quality
    of life for an individual with FASD and the family of such individual.

    ``SEC. 399I. STRENGTHENING CAPACITY AND EDUCATION FOR FETAL ALCOHOL
                  SPECTRUM DISORDERS.

        ``(a) In General.--The Secretary shall award grants, contracts, or
    cooperative agreements, as the Secretary determines appropriate, to
    public or nonprofit private entities with demonstrated expertise in the
    field of fetal alcohol spectrum disorders (referred to in this section
    as `FASD'). Such awards shall be for the purposes of building local,
    Tribal, State, and nationwide capacities to prevent the occurrence of
    FASD by carrying out the programs described in subsection (b).
        ``(b) Programs.--An entity receiving an award under subsection (a)
    may use such award for the following purposes:
                ``(1) Developing and supporting public education and
            outreach activities to raise public awareness of the risks
            associated with alcohol consumption during pregnancy.
                ``(2) Acting as a clearinghouse for evidence-based
            resources on FASD prevention, identification, and culturally
            and linguistically appropriate best practices to help inform
            systems of care for individuals with FASD across their
            lifespan.
                ``(3) Increasing awareness and understanding of
            efficacious, evidence-based screening tools and culturally and
            linguistically appropriate evidence-based intervention services
            and best practices, which may include improving the capacity
            for State, Tribal, and local affiliates.
                ``(4) Providing technical assistance to recipients of
            grants, cooperative agreements, or contracts under section
            399H, as appropriate.
        ``(c) Application.--To be eligible for a grant, contract, or
    cooperative agreement under this section, an entity shall submit to the
    Secretary an application at such time, in such manner, and containing
    such information as the Secretary may require.
        ``(d) Subcontracting.--A public or private nonprofit entity may
    carry out the following activities required under this section through
    contracts or cooperative agreements with other public and private
    nonprofit entities with demonstrated expertise in FASD:
                ``(1) Resource development and dissemination.
                ``(2) Intervention services.
                ``(3) Training and technical assistance.

    ``SEC. 399J. AUTHORIZATION OF APPROPRIATIONS.

        ``There are authorized to be appropriated to carry out this part
    $12,500,000 for each of fiscal years 2025 through 2029.''.
        (b) Report.--Not later than 4 years after the date of enactment of
    this Act, and every year thereafter, the Secretary of Health and Human
    Services shall prepare and 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--
                (1) a review of the activities carried out pursuant to
            sections 399H and 399I of the Public Health Service Act, as
            amended, to advance public education and awareness of fetal
            alcohol spectrum disorders (referred to in this section as
            ``FASD'');
                (2) a description of--
                        (A) the activities carried out pursuant to such
                    sections 399H and 399I to identify, prevent, and treat
                    FASD; and
                        (B) methods used to evaluate the outcomes of such
                    activities; and
                (3) an assessment of activities carried out pursuant to
            such sections 399H and 399I to support individuals with FASD.

    SEC. 515. PROMOTING STATE CHOICE IN PDMP SYSTEMS.

        Section 399O(h) of the Public Health Service Act (42 U.S.C. 280g-
    3(h)) is amended by adding at the end the following:
                ``(5) Promoting state choice.--Nothing in this section
            shall be construed to authorize the Secretary to require States
            to use a specific vendor or a specific interoperability
            connection other than to align with nationally recognized,
            consensus-based open standards, such as in accordance with
            sections 3001 and 3004.''.

    SEC. 516. FIRST RESPONDER TRAINING PROGRAM.

        Section 546 of the Public Health Service Act (42 U.S.C. 290ee-1) is
    amended--
                (1) in subsection (a), by striking ``tribes and tribal''
            and inserting ``Tribes and Tribal'';
                (2) in subsections (a), (c), and (d)--
                        (A) by striking ``approved or cleared'' each place
                    it appears and inserting ``approved, cleared, or
                    otherwise legally marketed''; and
                        (B) by striking ``opioid'' each place it appears;
                (3) in subsection (f)--
                        (A) by striking ``approved or cleared'' each place
                    it appears and inserting ``approved, cleared, or
                    otherwise legally marketed'';
                        (B) in paragraph (1), by striking ``opioid'';
                        (C) in paragraph (2)--
                                (i) by striking ``opioid and heroin'' and
                            inserting ``opioid, heroin, and other drug'';
                            and
                                (ii) by striking ``opioid overdose'' and
                            inserting ``overdose''; and
                        (D) in paragraph (3), by striking ``opioid and
                    heroin''; and
                (4) in subsection (h), by striking ``$36,000,000 for each
            of fiscal years 2019 through 2023'' and inserting ``$56,000,000
            for each of fiscal years 2025 through 2029''.

    SEC. 517. DONALD J. COHEN NATIONAL CHILD TRAUMATIC STRESS INITIATIVE.

        (a) Technical Amendment.--The second part G of title V of the
    Public Health Service Act (42 U.S.C. 290kk et seq.), as added by
    section 144 of the Community Renewal Tax Relief Act (Public Law 106-
    554), is amended--
                (1) by redesignating such part as part J; and
                (2) by redesignating sections 581 through 584 as sections
            596 through 596C, respectively.
        (b) In General.--Section 582 of the Public Health Service Act (42
    U.S.C. 290hh-1) is amended--
                (1) in the section heading, by striking ``violence related
            stress'' and inserting ``traumatic events'';
                (2) in subsection (a)--
                        (A) in the matter preceding paragraph (1), by
                    striking ``tribes and tribal'' and inserting ``Tribes
                    and Tribal''; and
                        (B) in paragraph (2), by inserting ``and
                    dissemination'' after ``the development'';
                (3) in subsection (b), by inserting ``and dissemination''
            after ``the development'';
                (4) in subsection (d)--
                        (A) by striking ``The NCTSI'' and inserting the
                    following:
                ``(1) Coordinating center.--The NCTSI''; and
                        (B) by adding at the end the following:
                ``(2) Nctsi grantees.--In carrying out subsection (a)(2),
            NCTSI grantees shall develop trainings and other resources, as
            applicable and appropriate, to support implementation of the
            evidence-based practices developed and disseminated under such
            subsection.'';
                (5) in subsection (e)--
                        (A) by redesignating paragraphs (1) and (2) as
                    subparagraphs (A) and (B), respectively, and adjusting
                    the margins accordingly;
                        (B) in subparagraph (A), as so redesignated, by
                    inserting ``and implementation'' after ``the
                    dissemination'';
                        (C) by striking ``The NCTSI'' and inserting the
                    following:
                ``(1) Coordinating center.--The NCTSI''; and
                        (D) by adding at the end the following:
                ``(2) Nctsi grantees.--NCTSI grantees shall, as
            appropriate, collaborate with other such grantees, the NCTSI
            coordinating center, and the Secretary in carrying out
            subsections (a)(2) and (d)(2).'';
                (6) by amending subsection (h) to read as follows:
        ``(h) Application and Evaluation.--To be eligible to receive a
    grant, contract, or cooperative agreement under subsection (a), a
    public or nonprofit private entity or an Indian Tribe or Tribal
    organization shall submit to the Secretary an application at such time,
    in such manner, and containing such information and assurances as the
    Secretary may require, including--
                ``(1) a plan for the evaluation of the activities funded
            under the grant, contract, or agreement, including both process
            and outcomes evaluation, and the submission of an evaluation at
            the end of the project period; and
                ``(2) a description of how such entity, Indian Tribe, or
            Tribal organization will support efforts led by the Secretary
            or the NCTSI coordinating center, as applicable, to evaluate
            activities carried out under this section.''; and
                (7) by amending subsection (j) to read as follows:
        ``(j) Authorization of Appropriations.--There is authorized to be
    appropriated to carry out this section--
                ``(1) $93,887,000 for fiscal year 2025;
                ``(2) $95,000,000 for fiscal year 2026;
                ``(3) $97,000,000 for fiscal year 2027;
                ``(4) $100,000,000 for fiscal year 2028; and
                ``(5) $100,000,000 for fiscal year 2029.''.

    SEC. 518. PROTECTING SUICIDE PREVENTION LIFELINE FROM CYBERSECURITY
                  INCIDENTS.

        (a) National Suicide Prevention Lifeline Program.--Section 520E-
    3(b) of the Public Health Service Act (42 U.S.C. 290bb-36c(b)) is
    amended--
                (1) in paragraph (4), by striking ``and'' at the end;
                (2) in paragraph (5), by striking the period at the end and
            inserting ``; and''; and
                (3) by adding at the end the following:
                ``(6) taking such steps as may be necessary to ensure the
            suicide prevention hotline is protected from cybersecurity
            incidents and eliminates known cybersecurity
            vulnerabilities.''.
        (b) Reporting.--Section 520E-3 of the Public Health Service Act (42
    U.S.C. 290bb-36c) is amended--
                (1) by redesignating subsection (f) as subsection (g); and
                (2) by inserting after subsection (e) the following:
        ``(f) Cybersecurity Reporting.--
                ``(1) Notification.--
                        ``(A) In general.--The program's network
                    administrator receiving Federal funding pursuant to
                    subsection (a) shall report to the Assistant Secretary,
                    in a manner that protects personal privacy, consistent
                    with applicable Federal and State privacy laws--
                                ``(i) any identified cybersecurity
                            vulnerabilities to the program within a
                            reasonable amount of time after identification
                            of such a vulnerability; and
                                ``(ii) any identified cybersecurity
                            incidents to the program within a reasonable
                            amount of time after identification of such
                            incident.
                        ``(B) Local and regional crisis centers.--Local and
                    regional crisis centers participating in the program
                    shall report to the program's network administrator
                    identified under subparagraph (A), in a manner that
                    protects personal privacy, consistent with applicable
                    Federal and State privacy laws--
                                ``(i) any identified cybersecurity
                            vulnerabilities to the program within a
                            reasonable amount of time after identification
                            of such vulnerability; and
                                ``(ii) any identified cybersecurity
                            incidents to the program within a reasonable
                            amount of time after identification of such
                            incident.
                ``(2) Notification.--If the program's network administrator
            receiving funding pursuant to subsection (a) discovers, or is
            informed by a local or regional crisis center pursuant to
            paragraph (1)(B) of, a cybersecurity vulnerability or incident,
            within a reasonable amount of time after such discovery or
            receipt of information, such entity shall report the
            vulnerability or incident to the Assistant Secretary.
                ``(3) Clarification.--
                        ``(A) Oversight.--
                                ``(i) Local and regional crisis centers.--
                            Except as provided in clause (ii), local and
                            regional crisis centers participating in the
                            program shall oversee all technology each
                            center employs in the provision of services as
                            a participant in the program.
                                ``(ii) Network administrator.--The
                            program's network administrator receiving
                            Federal funding pursuant to subsection (a)
                            shall oversee the technology each crisis center
                            employs in the provision of services as a
                            participant in the program if such oversight
                            responsibilities are established in the
                            applicable network participation agreement.
                        ``(B) Supplement, not supplant.--The cybersecurity
                    incident reporting requirements under this subsection
                    shall supplement, and not supplant, cybersecurity
                    incident reporting requirements under other provisions
                    of applicable Federal law that are in effect on the
                    date of the enactment of the SUPPORT for Patients and
                    Communities Reauthorization Act of 2025.''.
        (c) Study.--Not later than 180 days after the date of the enactment
    of this Act, the Comptroller General of the United States shall--
                (1) conduct and complete a study that evaluates
            cybersecurity risks and vulnerabilities associated with the 9-
            8-8 National Suicide Prevention Lifeline; and
                (2) submit a report on the findings of 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.

    SEC. 519. BRUCE'S LAW.

        (a) Youth Prevention and Recovery.--Section 7102(c) of the SUPPORT
    for Patients and Communities Act (42 U.S.C. 290bb-7a(c)) is amended--
                (1) in paragraph (3)(A)(i), by inserting ``, which may
            include strategies to increase education and awareness of the
            potency and dangers of synthetic opioids (including drugs
            contaminated with fentanyl) and, as appropriate, other emerging
            drug use or misuse issues'' before the semicolon; and
                (2) in paragraph (4)(A), by inserting ``and strategies to
            increase education and awareness of the potency and dangers of
            synthetic opioids (including drugs contaminated with fentanyl)
            and, as appropriate, emerging drug use or misuse issues''
            before the semicolon.
        (b) Interdepartmental Substance Use Disorders Coordinating
    Committee.--Section 7022 of the SUPPORT for Patients and Communities
    Act (42 U.S.C. 290aa note) is amended--
                (1) by striking subsection (g) and inserting the following:
        ``(g) Working Groups.--
                ``(1) In general.--The Committee may establish working
            groups for purposes of carrying out the duties described in
            subsection (e). Any such working group shall be composed of
            members of the Committee (or the designees of such members) and
            may hold such meetings as are necessary to carry out the duties
            delegated to the working group.
                ``(2) Additional federal interagency work group on fentanyl
            contamination of illegal drugs.--
                        ``(A) Establishment.--The Secretary, acting through
                    the Committee, shall establish a Federal Interagency
                    Work Group on Fentanyl Contamination of Illegal Drugs
                    (referred to in this paragraph as the `Work Group')
                    consisting of representatives from relevant Federal
                    departments and agencies on the Committee.
                        ``(B) Consultation.--The Work Group shall consult
                    with relevant stakeholders and subject matter experts,
                    including--
                                ``(i) State, Tribal, and local subject
                            matter experts in reducing, preventing, and
                            responding to drug overdose caused by fentanyl-
                            contamination of illicit drugs; and
                                ``(ii) family members of both adults and
                            youth who have overdosed by fentanyl-
                            contaminated illicit drugs.
                        ``(C) Duties.--The Work Group shall--
                                ``(i) examine Federal efforts to reduce and
                            prevent drug overdose by fentanyl-contaminated
                            illicit drugs;
                                ``(ii) identify strategies to improve
                            State, Tribal, and local responses to overdose
                            by fentanyl-contaminated illicit drugs;
                                ``(iii) coordinate with the Secretary, as
                            appropriate, in carrying out activities to
                            raise public awareness of synthetic opioids and
                            other emerging drug use and misuse issues;
                                ``(iv) make recommendations to Congress for
                            improving Federal programs, including with
                            respect to the coordination of efforts across
                            such programs; and
                                ``(v) make recommendations for educating
                            youth on the potency and dangers of drugs
                            contaminated by fentanyl.
                        ``(D) Annual report to secretary.--The Work Group
                    shall annually prepare and submit to the Secretary, the
                    Committee on Health, Education, Labor, and Pensions of
                    the Senate, and the Committee on Energy and Commerce
                    and the Committee on Education and the Workforce of the
                    House of Representatives, a report on the activities
                    carried out by the Work Group under subparagraph (C),
                    including recommendations to reduce and prevent drug
                    overdose by fentanyl contamination of illegal drugs, in
                    all populations, and specifically among youth at risk
                    for substance misuse.''; and
                (2) by striking subsection (i) and inserting the following:
                                ``(i) Sunset.--The Committee shall
                            terminate on September 30, 2029.''.

    SEC. 520. GUIDANCE ON AT-HOME DRUG DISPOSAL SYSTEMS.

        (a) In General.--Not later than one year after the date of
    enactment of this Act, the Secretary of Health and Human Services, in
    consultation with the Administrator of the Drug Enforcement
    Administration, shall publish guidance to facilitate the use of at-home
    safe disposal systems for applicable drugs.
        (b) Contents.--The guidance under subsection (a) shall include--
                (1) recommended standards for effective at-home drug
            disposal systems to meet applicable requirements enforced by
            the Food and Drug Administration;
                (2) recommended information to include as instructions for
            use to disseminate with at-home drug disposal systems;
                (3) best practices and educational tools to support the use
            of an at-home drug disposal system, as appropriate; and
                (4) recommended use of licensed health providers for the
            dissemination of education, instruction, and at-home drug
            disposal systems, as appropriate.

    SEC. 521. ASSESSMENT OF OPIOID DRUGS AND ACTIONS.

        (a) In General.--Not later than one 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 publish on the
    website of the Food and Drug Administration (referred to in this
    section as the ``FDA'') a report that outlines a plan for assessing
    opioid analgesic drugs that are approved under section 505 of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) that addresses the
    public health effects of such opioid analgesic drugs as part of the
    benefit-risk assessment and the activities of the FDA that relate to
    facilitating the development of nonaddictive medical products intended
    to treat pain or addiction. Such report shall include--
                (1) an update on the actions taken by the FDA to consider
            the effectiveness, safety, benefit-risk profile, and use of
            approved opioid analgesic drugs;
                (2) a timeline for an assessment of the potential need, as
            appropriate, for labeling changes, revised or additional
            postmarketing requirements, enforcement actions, or withdrawals
            for opioid analgesic drugs;
                (3) an overview of the steps that the FDA has taken to
            support the development and approval of nonaddictive medical
            products intended to treat pain or addiction, and actions
            planned to further support the development and approval of such
            products; and
                (4) an overview of the consideration by the FDA of clinical
            trial methodologies for analgesic drugs, including the enriched
            enrollment randomized withdrawal methodology, and the benefits
            and drawbacks associated with different trial methodologies for
            such drugs, incorporating any public input received under
            subsection (b).
        (b) Public Input.--In carrying out subsection (a), the Secretary
    shall provide an opportunity for public input concerning the regulation
    by the FDA of opioid analgesic drugs, including scientific evidence
    that relates to conditions of use, safety, or benefit-risk assessment
    (including consideration of the public health effects) of such opioid
    analgesic drugs.

    SEC. 522. GRANT PROGRAM FOR STATE AND TRIBAL RESPONSE TO OPIOID USE
                  DISORDERS.

        The activities carried out pursuant to section 1003(b)(4)(A) of the
    21st Century Cures Act (42 U.S.C. 290ee-3a(b)(4)(A)) may include
    facilitating access to products used to prevent overdose deaths by
    detecting the presence of one or more substances, such as fentanyl and
    xylazine test strips, to the extent the purchase and possession of such
    products is consistent with Federal and State law.

                             Subtitle B--Treatment

    SEC. 531. RESIDENTIAL TREATMENT PROGRAM FOR PREGNANT AND POSTPARTUM
                  WOMEN.

        Section 508 of the Public Health Service Act (42 U.S.C. 290bb-1) is
    amended--
                (1) in subsection (d)(11)(C), by striking ``providing
            health services'' and inserting ``providing health care
            services'';
                (2) in subsection (g)--
                        (A) by inserting ``a plan describing'' after ``will
                    provide''; and
                        (B) by adding at the end the following: ``Such plan
                    may include a description of how such applicant will
                    target outreach to women disproportionately impacted by
                    maternal substance use disorder.''; and
                (3) in subsection (s), by striking ``$29,931,000 for each
            of fiscal years 2019 through 2023'' and inserting ``$38,931,000
            for each of fiscal years 2025 through 2029''.

    SEC. 532. IMPROVING ACCESS TO ADDICTION MEDICINE PROVIDERS.

        Section 597 of the Public Health Service Act (42 U.S.C. 290ll) is
    amended--
                (1) in subsection (a)(1), by inserting ``diagnosis,'' after
            ``related to''; and
                (2) in subsection (b), by inserting ``addiction medicine,''
            after ``psychiatry,''.

    SEC. 533. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.

        Section 756(f) of the Public Health Service Act (42 U.S.C. 294e-
    1(f)) is amended by striking ``fiscal years 2023 through 2027'' and
    inserting ``fiscal years 2025 through 2029''.

    SEC. 534. LOAN REPAYMENT PROGRAM FOR SUBSTANCE USE DISORDER TREATMENT
                  WORKFORCE.

        Section 781(j) of the Public Health Service Act (42 U.S.C. 295h(j))
    is amended by striking ``$25,000,000 for each of fiscal years 2019
    through 2023'' and inserting ``$40,000,000 for each of fiscal years
    2025 through 2029''.

    SEC. 535. DEVELOPMENT AND DISSEMINATION OF MODEL TRAINING PROGRAMS FOR
                  SUBSTANCE USE DISORDER PATIENT RECORDS.

        Section 7053 of the SUPPORT for Patients and Communities Act (42
    U.S.C. 290dd-2 note) is amended by striking subsection (e).

    SEC. 536. TASK FORCE ON BEST PRACTICES FOR TRAUMA-INFORMED
                  IDENTIFICATION, REFERRAL, AND SUPPORT.

        Section 7132 of the SUPPORT for Patients and Communities Act
    (Public Law 115-271; 132 Stat. 4046) is amended--
                (1) in subsection (b)(1)--
                        (A) by redesignating subparagraph (CC) as
                    subparagraph (DD); and
                        (B) by inserting after subparagraph (BB) the
                    following:
                        ``(CC) The Administration for Community Living.'';
                (2) in subsection (d)(1), in the matter preceding
            subparagraph (A), by inserting ``, developmental disability
            service providers'' before ``, individuals who are''; and
                (3) in subsection (i), by striking ``2023'' and inserting
            ``2029''.

    SEC. 537. GRANTS TO ENHANCE ACCESS TO SUBSTANCE USE DISORDER TREATMENT.

        Section 3203 of the SUPPORT for Patients and Communities Act (21
    U.S.C. 823 note) is amended--
                (1) by striking subsection (b); and
                (2) by striking ``(a) In General.--The Secretary'' and
            inserting the following: ``The Secretary''.

    SEC. 538. STATE GUIDANCE RELATED TO INDIVIDUALS WITH SERIOUS MENTAL
                  ILLNESS AND CHILDREN WITH SERIOUS EMOTIONAL DISTURBANCE.

        (a) Review of Use of Certain Funding.--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''), acting
    through the Assistant Secretary for Mental Health and Substance Use,
    shall conduct a review of State use of funds made available under the
    Community Mental Health Services Block Grant program under subpart I of
    part B of title XIX of the Public Health Service Act (42 U.S.C. 300x et
    seq.) (referred to in this section as the ``block grant program'') for
    first episode psychosis activities. Such review shall consider the
    following:
                (1) How States use funds for evidence-based treatments and
            services according to the standard of care for individuals with
            early serious mental illness and children with a serious
            emotional disturbance.
                (2) The percentages of the State funding under the block
            grant program expended on early serious mental illness and
            first episode psychosis, and the number of individuals served
            under such funds.
        (b) Report and Guidance.--
                (1) Report.--Not later than 180 days after the completion
            of the review under subsection (a), the Secretary 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 describing--
                        (A) the findings of the review under subsection
                    (a); and
                        (B) any recommendations for changes to the block
                    grant program that would facilitate improved outcomes
                    for individuals with serious mental illness and
                    children with serious emotional disturbance.
                (2) Guidance.--Not later than 1 year after the date on
            which the report is submitted under paragraph (1), the
            Secretary shall update the guidance provided to States under
            the block grant program on coordinated specialty care and other
            evidence-based mental health care services for individuals with
            serious mental illness and children with a serious emotional
            disturbance, based on the findings and recommendations of such
            report.

    SEC. 539. REVIEWING THE SCHEDULING OF APPROVED PRODUCTS CONTAINING A
                  COMBINATION OF BUPRENORPHINE AND NALOXONE.

        (a) Secretary of HHS.--The Secretary of Health and Human Services
    shall, consistent with the requirements and procedures set forth in
    sections 201 and 202 of the Controlled Substances Act (21 U.S.C. 811,
    812)--
                (1) review the relevant data pertaining to the scheduling
            of products containing a combination of buprenorphine and
            naloxone that have been approved under section 505 of the
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
                (2) if appropriate, request that the Attorney General
            initiate rulemaking proceedings to revise the schedules
            accordingly with respect to such products.
        (b) Attorney General.--The Attorney General shall review any
    request made by the Secretary of Health and Human Services under
    subsection (a)(2) and determine whether to initiate proceedings to
    revise the schedules in accordance with the criteria set forth in
    sections 201 and 202 of the Controlled Substances Act (21 U.S.C. 811,
    812).

                              Subtitle C--Recovery

    SEC. 541. BUILDING COMMUNITIES OF RECOVERY.

        Section 547(f) of the Public Health Service Act (42 U.S.C. 290ee-
    2(f)) is amended by striking ``$5,000,000 for each of fiscal years 2019
    through 2023'' and inserting ``$16,000,000 for each of fiscal years
    2025 through 2029''.

    SEC. 542. PEER SUPPORT TECHNICAL ASSISTANCE CENTER.

        Section 547A of the Public Health Service Act (42 U.S.C. 290ee-2a)
    is amended--
                (1) in subsection (b)(4), by striking ``building; and'' and
            inserting the following: ``building, such as--
                        ``(A) professional development of peer support
                    specialists; and
                        ``(B) making recovery support services available in
                    nonclinical settings; and'';
                (2) by redesignating subsections (d) and (e) as subsections
            (e) and (f), respectively;
                (3) by inserting after subsection (c) the following:
        ``(d) Regional Centers.--
                ``(1) In general.--The Secretary may establish one regional
            technical assistance center (referred to in this subsection as
            the `Regional Center'), with existing resources, to assist the
            Center in carrying out activities described in subsection (b)
            within the geographic region of such Regional Center in a
            manner that is tailored to the needs of such region.
                ``(2) Evaluation.--Not later than 4 years after the date of
            enactment of the SUPPORT for Patients and Communities
            Reauthorization Act of 2025, the Secretary shall evaluate the
            activities of the Regional Center and 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 findings of such evaluation,
            including--
                        ``(A) a description of the distinct roles and
                    responsibilities of the Regional Center and the Center;
                        ``(B) available information relating to the
                    outcomes of the Regional Center under this subsection,
                    such as any impact on the operations and efficiency of
                    the Center relating to requests for technical
                    assistance and support within the region of such
                    Regional Center;
                        ``(C) a description of any gaps or areas of
                    duplication relating to the activities of the Regional
                    Center and the Center within such region; and
                        ``(D) recommendations relating to the modification,
                    expansion, or termination of the Regional Center under
                    this subsection.
                ``(3) Termination.--This subsection shall terminate on
            September 30, 2029.''; and
                (4) in subsection (f), as so redesignated, by striking
            ``$1,000,000 for each of fiscal years 2019 through 2023'' and
            inserting ``$2,000,000 for each of fiscal years 2025 through
            2029''.

    SEC. 543. COMPREHENSIVE OPIOID RECOVERY CENTERS.

        Section 552 of the Public Health Service Act (42 U.S.C. 290ee-7) is
    amended--
                (1) in subsection (d)(2)--
                        (A) in the matter preceding subparagraph (A), by
                    striking ``and in such manner'' and inserting ``, in
                    such manner, and containing such information and
                    assurances, including relevant documentation,''; and
                        (B) in subparagraph (A), by striking ``is capable
                    of coordinating with other entities to carry out'' and
                    inserting ``has the demonstrated capability to carry
                    out, through referral or contractual arrangements'';
                (2) in subsection (h)--
                        (A) by redesignating paragraphs (1) through (4) as
                    subparagraphs (A) through (D), respectively, and
                    adjusting the margins accordingly;
                        (B) by striking ``With respect to'' and inserting
                    the following:
                ``(1) In general.--With respect to''; and
                        (C) by adding at the end the following:
                ``(2) Additional reporting for certain eligible entities.--
            An entity carrying out activities described in subsection (g)
            through referral or contractual arrangements shall include in
            the submissions required under paragraph (1) information
            related to the status of such referrals or contractual
            arrangements, including an assessment of whether such referrals
            or contractual arrangements are supporting the ability of such
            entity to carry out such activities.''; and
                (3) in subsection (j), by striking ``2019 through 2023''
            and inserting ``2025 through 2029''.

    SEC. 544. YOUTH PREVENTION AND RECOVERY.

        Section 7102(c) of the SUPPORT for Patients and Communities Act (42
    U.S.C. 290bb-7a(c)) (as amended by section 110(a)) is amended--
                (1) in paragraph (2)--
                        (A) in subparagraph (A)--
                                (i) in clause (i)--
                                        (I) by inserting ``, or a
                                    consortium of local educational
                                    agencies,'' after ``a local educational
                                    agency''; and
                                        (II) by striking ``high schools''
                                    and inserting ``secondary schools'';
                                    and
                                (ii) in clause (vi), by striking ``tribe,
                            or tribal'' and inserting ``Tribe, or Tribal'';
                        (B) by amending subparagraph (E) to read as
                    follows:
                        ``(E) Indian tribe; tribal organization.--The terms
                    `Indian Tribe' and `Tribal organization' have the
                    meanings given such terms in section 4 of the Indian
                    Self-Determination and Education Assistance Act (25
                    U.S.C. 5304).'';
                        (C) by redesignating subparagraph (K) as
                    subparagraph (L); and
                        (D) by inserting after subparagraph (J) the
                    following:
                        ``(K) Secondary school.--The term `secondary
                    school' has the meaning given such term in section 8101
                    of the Elementary and Secondary Education Act of 1965
                    (20 U.S.C. 7801).'';
                (2) in paragraph (3)(A), in the matter preceding clause
            (i)--
                        (A) by striking ``and abuse''; and
                        (B) by inserting ``at increased risk for substance
                    misuse'' after ``specific populations'';
                (3) in paragraph (4)--
                        (A) in the matter preceding subparagraph (A), by
                    striking ``Indian tribes'' and inserting ``Indian
                    Tribes'';
                        (B) in subparagraph (A), by striking ``and abuse'';
                    and
                        (C) in subparagraph (B), by striking ``peer
                    mentoring'' and inserting ``peer-to-peer support'';
                (4) in paragraph (5), by striking ``tribal'' and inserting
            ``Tribal'';
                (5) in paragraph (6)(A)--
                        (A) in clause (iv), by striking ``; and'' and
                    inserting a semicolon; and
                        (B) by adding at the end the following:
                                ``(vi) a plan to sustain the activities
                            carried out under the grant program, after the
                            grant program has ended; and'';
                (6) in paragraph (8), by striking ``2022'' and inserting
            ``2027''; and
                (7) by amending paragraph (9) to read as follows:
                ``(9) Authorization of appropriations.--To carry out this
            subsection, there are authorized to be appropriated--
                        ``(A) $10,000,000 for fiscal year 2025;
                        ``(B) $12,000,000 for fiscal year 2026;
                        ``(C) $13,000,000 for fiscal year 2027;
                        ``(D) $14,000,000 for fiscal year 2028; and
                        ``(E) $15,000,000 for fiscal year 2029.''.

    SEC. 545. CAREER ACT.

        (a) In General.--Section 7183 of the SUPPORT for Patients and
    Communities Act (42 U.S.C. 290ee-8) is amended--
                (1) in the section heading, by inserting ``; treatment,
            recovery, and workforce support grants'' after ``career act'';
                (2) in subsection (b), by inserting ``each'' before ``for a
            period'';
                (3) in subsection (c)--
                        (A) in paragraph (1), by striking ``the rates
                    described in paragraph (2)'' and inserting ``the
                    average rates for calendar years 2018 through 2022
                    described in paragraph (2)''; and
                        (B) by amending paragraph (2) to read as follows:
                ``(2) Rates.--The rates described in this paragraph are the
            following:
                        ``(A) The highest age-adjusted average rates of
                    drug overdose deaths for calendar years 2018 through
                    2022 based on data from the Centers for Disease Control
                    and Prevention, including, if necessary, provisional
                    data for calendar year 2022.
                        ``(B) The highest average rates of unemployment for
                    calendar years 2018 through 2022 based on data provided
                    by the Bureau of Labor Statistics.
                        ``(C) The lowest average labor force participation
                    rates for calendar years 2018 through 2022 based on
                    data provided by the Bureau of Labor Statistics.'';
                (4) in subsection (g)--
                        (A) in each of paragraphs (1) and (3), by
                    redesignating subparagraphs (A) and (B) as clauses (i)
                    and (ii), respectively, and adjusting the margins
                    accordingly;
                        (B) by redesignating paragraphs (1) through (3) as
                    subparagraphs (A) through (C), respectively, and
                    adjusting the margins accordingly;
                        (C) in the matter preceding subparagraph (A) (as so
                    redesignated), by striking ``An entity'' and inserting
                    the following:
                ``(1) In general.--An entity''; and
                        (D) by adding at the end the following:
                ``(2) Transportation services.--An entity receiving a grant
            under this section may use not more than 5 percent of the funds
            for providing transportation for individuals to participate in
            an activity supported by a grant under this section, which
            transportation shall be to or from a place of work or a place
            where the individual is receiving vocational education or job
            training services or receiving services directly linked to
            treatment of or recovery from a substance use disorder.
                ``(3) Limitation.--The Secretary may not require an entity
            to, or give priority to an entity that plans to, use the funds
            of a grant under this section for activities that are not
            specified in this subsection.'';
                (5) in subsection (i)(2), by inserting ``, which shall
            include employment and earnings outcomes described in
            subclauses (I) and (III) of section 116(b)(2)(A)(i) of the
            Workforce Innovation and Opportunity Act (29 U.S.C.
            3141(b)(2)(A)(i)) with respect to the participation of such
            individuals with a substance use disorder in programs and
            activities funded by the grant under this section'' after
            ``subsection (g)'';
                (6) in subsection (j)--
                        (A) in paragraph (1), by inserting ``for grants
                    awarded prior to the date of enactment of the SUPPORT
                    for Patients and Communities Reauthorization Act of
                    2025'' after ``grant period under this section''; and
                        (B) in paragraph (2)--
                                (i) in the matter preceding subparagraph
                            (A), by striking ``2 years after submitting the
                            preliminary report required under paragraph
                            (1)'' and inserting ``September 30, 2029''; and
                                (ii) in subparagraph (A), by striking
                            ``(g)(3)'' and inserting ``(g)(1)(C)''; and
                (7) in subsection (k), by striking ``$5,000,000 for each of
            fiscal years 2019 through 2023'' and inserting ``$12,000,000
            for each of fiscal years 2025 through 2029''.
        (b) Reauthorization of the CAREER Act; Recovery Housing Pilot
    Program.--
                (1) In general.--Section 8071 of the SUPPORT for Patients
            and Communities Act (42 U.S.C. 5301 note; Public Law 115-271)
            is amended--
                        (A) by striking the section heading and inserting
                    ``career act; recovery housing pilot program'';
                        (B) in subsection (a), by striking ``through 2023''
                    and inserting ``through 2029'';
                        (C) in subsection (b)--
                                (i) in paragraph (1), by striking ``not
                            later than 60 days after the date of enactment
                            of this Act'' and inserting ``not later than 60
                            days after the date of enactment of the SUPPORT
                            for Patients and Communities Reauthorization
                            Act of 2025''; and
                                (ii) in paragraph (2)(B)(i)--
                                        (I) in subclause (I)--
                                                (aa) by striking ``for
                                            calendar years 2013 through
                                            2017''; and
                                                (bb) by inserting ``for
                                            calendar years 2018 through
                                            2022'' after ``rates of
                                            unemployment'';
                                        (II) in subclause (II)--
                                                (aa) by striking ``for
                                            calendar years 2013 through
                                            2017''; and
                                                (bb) by inserting ``for
                                            calendar years 2018 through
                                            2022'' after ``participation
                                            rates''; and
                                        (III) by striking subclause (III)
                                    and inserting the following:
                                        ``(III) The highest age-adjusted
                                    average rates of drug overdose deaths
                                    for calendar years 2018 through 2022
                                    based on data from the Centers for
                                    Disease Control and Prevention,
                                    including, if necessary, provisional
                                    data for calendar year 2022.''; and
                        (D) in subsection (f), by striking ``For the 2-year
                    period following the date of enactment of this Act,
                    the'' and inserting ``The''.
                (2) Conforming amendment.--Subtitle F of title VIII of the
            SUPPORT for Patients and Communities Act (Public Law 115-271;
            132 Stat. 4095) is amended by striking the subtitle heading and
            inserting the following: ``Subtitle F--CAREER Act; Recovery
            Housing Pilot Program'' .
        (c) Clerical Amendments.--The table of contents in section 1(b) of
    the SUPPORT for Patients and Communities Act (Public Law 115-271; 132
    Stat. 3894) is amended--
                (1) by striking the item relating to section 7183 and
            inserting the following:

    ``Sec. 7183. CAREER Act; treatment, recovery, and workforce support
                                grants.'';
                (2) by striking the item relating to subtitle F of title
            VIII and inserting the following:

        ``Subtitle F--CAREER Act; Recovery Housing Pilot Program''; and

                (3) by striking the item relating to section 8071 and
            inserting the following:

    ``Sec. 8071. CAREER Act; Recovery Housing Pilot Program.''.

    SEC. 546. ADDRESSING ECONOMIC AND WORKFORCE IMPACTS OF THE OPIOID
                  CRISIS.

        Section 8041(g)(1) of the SUPPORT for Patients and Communities Act
    (29 U.S.C. 3225a(g)(1)) is amended by striking ``2023'' and inserting
    ``2029''.

                       Subtitle D--Miscellaneous Matters

    SEC. 551. DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY TO A
                  PRESCRIBING PRACTITIONER.

        Section 309A(a) of the Controlled Substances Act (21 U.S.C.
    829a(a)) is amended by striking paragraph (2) and inserting the
    following:
                ``(2) the controlled substance is a drug in schedule III,
            IV, or V to be administered--
                        ``(A) by injection or implantation for the purpose
                    of maintenance or detoxification treatment; or
                        ``(B) subject to a risk evaluation and mitigation
                    strategy pursuant to section 505-1 of the Federal Food,
                    Drug, and Cosmetic Act (21 U.S.C. 355-1) that includes
                    elements to assure safe use of the drug described in
                    subsection (f)(3)(E) of such section, including a
                    requirement for post-administration monitoring by a
                    health care provider.''.

    SEC. 552. TECHNICAL CORRECTION ON CONTROLLED SUBSTANCES DISPENSING.

        Effective as if included in the enactment of Public Law 117-328--
                (1) section 1252(a) of division FF of Public Law 117-328
            (136 Stat. 5681) is amended, in the matter being inserted into
            section 302(e) of the Controlled Substances Act, by striking
            ``303(g)'' and inserting ``303(h)'';
                (2) section 1262 of division FF of Public Law 117-328 (136
            Stat. 5681) is amended--
                        (A) in subsection (a)--
                                (i) in the matter preceding paragraph (1),
                            by striking ``303(g)'' and inserting
                            ``303(h)'';
                                (ii) in the matter being stricken by
                            subsection (a)(2), by striking ``(g)(1)'' and
                            inserting ``(h)(1)''; and
                                (iii) in the matter being inserted by
                            subsection (a)(2), by striking ``(g)
                            Practitioners'' and inserting ``(h)
                            Practitioners''; and
                        (B) in subsection (b)--
                                (i) in the matter being stricken by
                            paragraph (1), by striking ``303(g)(1)'' and
                            inserting ``303(h)(1)'';
                                (ii) in the matter being inserted by
                            paragraph (1), by striking ``303(g)'' and
                            inserting ``303(h)'';
                                (iii) in the matter being stricken by
                            paragraph (2)(A), by striking ``303(g)(2)'' and
                            inserting ``303(h)(2)'';
                                (iv) in the matter being stricken by
                            paragraph (3), by striking ``303(g)(2)(B)'' and
                            inserting ``303(h)(2)(B)'';
                                (v) in the matter being stricken by
                            paragraph (5), by striking ``303(g)'' and
                            inserting ``303(h)''; and
                                (vi) in the matter being stricken by
                            paragraph (6), by striking ``303(g)'' and
                            inserting ``303(h)''; and
                (3) section 1263(b) of division FF of Public Law 117-328
            (136 Stat. 5685) is amended--
                        (A) by striking ``303(g)(2)'' and inserting
                    ``303(h)(2)''; and
                        (B) by striking ``(21 U.S.C. 823(g)(2))'' and
                    inserting ``(21 U.S.C. 823(h)(2))''.

    SEC. 553. REQUIRED TRAINING FOR PRESCRIBERS OF CONTROLLED SUBSTANCES.

        (a) In General.--Section 303 of the Controlled Substances Act (21
    U.S.C. 823) is amended--
                (1) by redesignating the second subsection designated as
            subsection (l) as subsection (m); and
                (2) in subsection (m)(1), as so redesignated--
                        (A) in subparagraph (A)--
                                (i) in clause (iv)--
                                        (I) in subclause (I)--
                                                (aa) by inserting ``the
                                            American Academy of Family
                                            Physicians, the American
                                            Podiatric Medical Association,
                                            the Academy of General
                                            Dentistry, the American
                                            Optometric Association,''
                                            before ``or any other
                                            organization'';
                                                (bb) by striking ``or the
                                            Commission'' and inserting
                                            ``the Commission''; and
                                                (cc) by inserting ``, or
                                            the Council on Podiatric
                                            Medical Education'' before the
                                            semicolon at the end; and
                                        (II) in subclause (III), by
                                    inserting ``or the American Academy of
                                    Family Physicians'' after
                                    ``Association''; and
                                (ii) in clause (v), in the matter preceding
                            subclause (I)--
                                        (I) by striking ``osteopathic
                                    medicine, dental surgery'' and
                                    inserting ``osteopathic medicine,
                                    podiatric medicine, dental surgery'';
                                    and
                                        (II) by striking ``or dental
                                    medicine curriculum'' and inserting
                                    ``or dental or podiatric medicine
                                    curriculum''; and
                        (B) in subparagraph (B)--
                                (i) in clause (i)--
                                        (I) by inserting ``the American
                                    Pharmacists Association, the
                                    Accreditation Council on Pharmacy
                                    Education, the American Psychiatric
                                    Nurses Association, the American
                                    Academy of Nursing, the American
                                    Academy of Family Physicians,'' before
                                    ``or any other organization''; and
                                        (II) by inserting ``, the American
                                    Academy of Family Physicians,'' before
                                    ``or the Accreditation Council''; and
                                (ii) in clause (ii)--
                                        (I) by striking ``or accredited
                                    school'' and inserting ``, an
                                    accredited school''; and
                                        (II) by inserting ``, or an
                                    accredited school of pharmacy'' before
                                    ``in the United States''.
        (b) Effective Date.--The amendment made by subsection (a) shall
    take effect as if enacted on December 29, 2022.

    SEC. 554. EXTENSION OF TEMPORARY ORDER FOR FENTANYL-RELATED SUBSTANCES.

        Effective as if included in the enactment of the Temporary
    Reauthorization and Study of the Emergency Scheduling of Fentanyl
    Analogues Act (Public Law 116-114), section 2 of such Act is amended by
    striking ``March 31, 2025'' and inserting ``September 30, 2026''.

          TITLE VI--PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND RESPONSE

    SEC. 601. SHORT TITLE.

        This title may be cited as the ``Pandemic and All-Hazards
    Preparedness and Response Act''.

               Subtitle A--State and Local Readiness and Response

    SEC. 611. TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A
                  PUBLIC HEALTH EMERGENCY.

        Section 319(e) of the Public Health Service Act (42 U.S.C. 247d(e))
    is amended--
                (1) in paragraph (1), by striking ``tribal organization or
            such Governor or tribal organization's designee'' and inserting
            ``Tribal organization or the designee of the Governor or Tribal
            organization, or the State or Tribal health official'';
                (2) in paragraph (2)(B)--
                        (A) in the matter preceding clause (i), by striking
                    ``tribal organization'' and inserting ``Tribal
                    organization, or the State or Tribal health official'';
                    and
                        (B) in clause (v), by striking ``tribal
                    organization'' and inserting ``Tribal organization or
                    State or Tribal health official'';
                (3) in paragraph (6)--
                        (A) in the matter preceding subparagraph (A)--
                                (i) by striking ``Reauthorization Act of
                            2013'' and inserting ``and Response Act''; and
                                (ii) by striking ``appropriate committees
                            of the Congress'' and inserting ``Committee on
                            Health, Education, Labor, and Pensions of the
                            Senate and the Committee on Energy and Commerce
                            of the House of Representatives''; and
                        (B) in subparagraph (A), by inserting ``, including
                    requests from State or Tribal health officials'' before
                    the semicolon;
                (4) in paragraph (7)(A), by striking ``tribal
            organization'' and inserting ``Tribal organization''; and
                (5) in paragraph (8), by striking ``March 31, 2025'' and
            inserting ``December 31, 2026''.

    SEC. 612. PUBLIC HEALTH EMERGENCY PREPAREDNESS PROGRAM.

        Section 319C-1 of the Public Health Service Act (42 U.S.C. 247d-3a)
    is amended--
                (1) in subsection (b)(2)--
                        (A) in subparagraph (A)(ii), by striking
                    ``influenza'' and inserting ``response planning''; and
                        (B) in subparagraph (H), by inserting ``, such as
                    community-based organizations, including faith-based
                    organizations, and other public and private entities''
                    after ``stakeholders'';
                (2) in subsection (g)--
                        (A) in paragraph (1), in the matter preceding
                    subparagraph (A), by inserting ``and the ability of
                    each entity receiving an award under subsection (a) to
                    respond to all-hazards threats'' before the period at
                    the end of the first sentence;
                        (B) in paragraph (2)--
                                (i) in the paragraph heading, by striking
                            ``influenza'' and inserting ``response''; and
                                (ii) in subparagraph (A)--
                                        (I) by striking ``to pandemic
                                    influenza'' and inserting ``to a
                                    pathogen causing a pandemic, including
                                    pandemic influenza''; and
                                        (II) by striking ``such pandemic
                                    influenza'' and inserting ``such
                                    pandemic response'';
                        (C) in paragraph (5)--
                                (i) in the paragraph heading, by striking
                            ``influenza'' and inserting ``pandemic
                            response'';
                                (ii) in the matter preceding subparagraph
                            (A), by striking ``2019'' and inserting
                            ``2026'';
                                (iii) in subparagraph (A), by striking
                            ``2018'' and inserting ``2025''; and
                                (iv) in subparagraph (B), by striking
                            ``pandemic influenza'' and inserting ``a
                            pathogen causing a pandemic''; and
                        (D) in paragraph (6)--
                                (i) in subparagraph (A), in the matter
                            preceding clause (i), by striking ``The amounts
                            described in this paragraph are the following
                            amounts that are payable to an entity for
                            activities described in this section or section
                            319C-2'' and inserting ``The Secretary shall
                            withhold from an entity pursuant to paragraph
                            (5) for noncompliance with the requirements of
                            this section or section 319C-2 as follows'';
                            and
                                (ii) in subparagraph (B), by inserting
                            ``with respect to the requirements of this
                            section or section 319C-2'' after ``paragraph
                            (5)''; and
                (3) in subsection (h)(1)(A), by striking ``$685,000,000 for
            each of fiscal years 2019 through 2023'' and inserting
            ``$735,000,000 for each of fiscal years 2025 and 2026, to
            remain available through December 31, 2026''.

    SEC. 613. HOSPITAL PREPAREDNESS PROGRAM.

        (a) Increasing Participation by EMS in the Hospital Preparedness
    Program.--
                (1) In general.--Section 319C-2 of the Public Health
            Service Act (42 U.S.C. 247d-3b) is amended--
                        (A) in subsection (b)(1)(A)--
                                (i) in clause (iii)(III), by striking ``;
                            and'' and inserting a semicolon; and
                                (ii) by striking clause (iv) and inserting
                            the following:
                                ``(iv) one or more emergency medical
                            service organizations; and
                                ``(v) to the extent practicable, one or
                            more emergency management organizations; and'';
                            and
                        (B) in subsection (g)(1)--
                                (i) by striking ``(1) Local response
                            capabilities'' and inserting:
                ``(1) Local response capabilities.--
                        ``(A) Program coordination.--'';
                                (ii) by striking ``extent practicable,
                            ensure'' and inserting the following: ``extent
                            practicable--
                                ``(i) ensure'';
                                (iii) by striking the period and inserting
                            ``; and''; and
                                (iv) by adding at the end the following:
                                ``(ii) seek to increase participation of
                            eligible entities described in subsection
                            (b)(1)(A) with lower participation rates
                            relative to other eligible entities, such as
                            emergency medical services organizations and
                            health care facilities in underserved areas.''.
                (2) Preferences.--Section 319C-2(d)(1)(A)(iii) of the
            Public Health Service Act (42 U.S.C. 247d-3b(d)(1)(A)(iii)) is
            amended by striking ``subsection (b)(1)(A)(ii)'' and inserting
            ``clauses (ii) and (iv) of subsection (b)(1)(A)''.
        (b) Improving Medical Readiness and Response Capabilities.--Section
    319C-2 of the Public Health Service Act (42 U.S.C. 247d-3b) is
    amended--
                (1) in subsection (b)(2)--
                        (A) in subparagraph (A), by striking ``and'' at the
                    end;
                        (B) in subparagraph (B), by striking the period and
                    inserting ``; and''; and
                        (C) by inserting at the end the following:
                ``(C) designate a lead entity to administer such award and
            support coordination between entities described in this
            subsection.'';
                (2) in subsection (g)(1), as amended by subsection
            (a)(1)(B), by adding at the end the following:
                        ``(B) Regional operations.--An eligible entity
                    shall establish and maintain, or leverage an existing,
                    capability to enable coordination of regional medical
                    operations, which may include systems to facilitate
                    information sharing and coordination, within a
                    coalition described under subsection (b)(1)(A) and, as
                    appropriate, among multiple coalitions that are in
                    close geographic proximity to each other.''; and
                (3) in subsection (j)(1)--
                        (A) in subparagraph (A), by striking ``for each of
                    fiscal years 2019 through 2023'' and inserting ``for
                    each of fiscal years 2025 and 2026, to remain available
                    through December 31, 2026''; and
                        (B) in subparagraph (B)(iii), by striking
                    ``September 30, 2023'' and inserting ``December 31,
                    2026''.

    SEC. 614. FACILITIES AND CAPACITIES OF THE CENTERS FOR DISEASE CONTROL
                  AND PREVENTION TO COMBAT PUBLIC HEALTH SECURITY THREATS.

        Section 319D(h) of the Public Health Service Act (42 U.S.C. 247d-
    4(h)) is amended--
                (1) in paragraph (1), by striking ``$25,000,000 for each of
            fiscal years 2022 and 2023'' and inserting ``$40,000,000 for
            each of fiscal years 2025 and 2026'', to remain available
            through December 31, 2026; and
                (2) in paragraph (2), by striking ``2022 and 2023'' and
            inserting ``2025 and 2026, to remain available through December
            31, 2026''.

    SEC. 615. PILOT PROGRAM TO SUPPORT STATE MEDICAL STOCKPILES.

        (a) In General.--Section 319F-2(i) of the Public Health Service Act
    (42 U.S.C. 247d-6b(i)) is amended--
                (1) in paragraph (2)(B)(i)--
                        (A) in subclause (I), by striking ``and 2024'' and
                    inserting ``through 2025''; and
                        (B) in subclause (II), by striking ``2025'' and
                    inserting ``2026'';
                (2) in paragraph (4)--
                        (A) in subparagraph (G), by striking ``; and'' at
                    the end and inserting a semicolon;
                        (B) by redesignating subparagraph (H) as
                    subparagraph (I);
                        (C) by inserting after subparagraph (G) the
                    following:
                        ``(H) facilitate the sharing of best practices
                    among States within a consortia of States in receipt of
                    funding related to establishing and maintaining a
                    stockpile of medical products; and''; and
                        (D) in subparagraph (I), as so redesignated, by
                    striking ``State efforts'' and inserting ``State or
                    regional efforts'';
                (3) by redesignating paragraphs (5) through (9) as
            paragraphs (6) through (10), respectively;
                (4) by inserting after paragraph (4) the following:
                ``(5) Coordination.--An entity in receipt of an award under
            paragraph (1), in carrying out the activities under this
            subsection, shall coordinate with appropriate health care
            entities, health officials, and emergency management officials
            within the jurisdiction of such State or States.''; and
                (5) in paragraph (10), as so redesignated, by striking
            ``$3,500,000,000 for each of fiscal years 2023 and 2024'' and
            inserting ``$3,365,000,000 for fiscal year 2025, and
            $3,265,000,000 for fiscal year 2026''.
        (b) GAO Report.--Section 2409(b) of the PREVENT Pandemics Act
    (Public Law 117-328) is amended--
                (1) in paragraph (2), by striking ``; and'' and inserting a
            semicolon;
                (2) in paragraph (3), by striking the period and inserting
            ``; and''; and
                (3) by adding at the end the following:
                ``(4) the impact of any regional stockpiling approaches
            carried out under subsection (i)(1) of section 319F-2 of the
            Public Health Service Act (42 U.S.C. 247d-6b).''.

    SEC. 616. ENHANCING DOMESTIC WASTEWATER SURVEILLANCE FOR PATHOGEN
                  DETECTION.

        (a) In General.--Title III of the Public Health Service Act is
    amended by inserting after section 317V (42 U.S.C. 247b-24) the
    following:

    ``SEC. 317W. WASTEWATER SURVEILLANCE FOR PATHOGEN DETECTION.

        ``(a) Wastewater Surveillance System.--The Secretary, acting
    through the Director of the Centers for Disease Control and Prevention
    and in coordination with other Federal departments and agencies, shall
    award grants, contracts, or cooperative agreements to eligible entities
    to establish, maintain, or improve activities related to the detection
    and monitoring of infectious diseases through wastewater for public
    health emergency preparedness and response purposes.
        ``(b) Eligible Entities.--To be eligible to receive an award under
    this section, an entity shall--
                ``(1) be a State, Tribal, or local health department, or a
            partnership between such a health department and other public
            and private entities; and
                ``(2) submit to the Secretary an application at such time,
            in such manner, and containing such information as the
            Secretary may reasonably require, which shall include--
                        ``(A) a description of activities proposed to be
                    carried out pursuant to an award under subsection (a);
                        ``(B) factors such entity proposes to use to select
                    wastewater sampling sites;
                        ``(C) factors such entity proposes to use to
                    determine whether a response to findings from such
                    wastewater sampling may be warranted, and a plan for
                    responding, as appropriate, consistent with applicable
                    plans developed by such entity pursuant to section
                    319C-1;
                        ``(D) a plan to sustain such wastewater
                    surveillance activities described in such application
                    following the conclusion of the award period; and
                        ``(E) any additional information the Secretary may
                    require.
        ``(c) Consideration.--In making awards under subsection (a), the
    Secretary may give priority to eligible entities that have submitted an
    application that--
                ``(1) details plans to provide public access to
            deidentified data generated through such wastewater
            surveillance activities in a manner that allows for comparison
            to such data generated by other recipients of an award under
            subsection (a); and
                ``(2) provides an assessment of community needs related to
            ongoing infectious disease monitoring, including estimates of
            the incidence and prevalence of infectious diseases that can be
            detected in wastewater and availability, at the time of the
            application, of other forms of infectious disease detection in
            the jurisdiction.
        ``(d) Use of Funds.--An eligible entity shall, as appropriate, use
    amounts awarded under this section to--
                ``(1) establish or enhance existing capacity and
            capabilities to conduct wastewater sampling, testing, and
            related analysis;
                ``(2) conduct wastewater surveillance, as appropriate, in
            areas or facilities with increased risk of infectious disease
            outbreaks and limited ability to utilize other forms of
            infectious disease detection, such as at individual facilities,
            institutions, and locations in rural areas or areas in which
            wastewater is not treated through the relevant local utility of
            the jurisdiction; and
                ``(3) implement projects that use evidence-based or
            innovative practices to conduct wastewater surveillance
            activities.
        ``(e) Partnerships.--In carrying out activities under this section,
    eligible entities shall identify opportunities to partner with other
    public or private entities to leverage relevant capabilities maintained
    by such entities, as appropriate and consistent with this section.
        ``(f) Technical Assistance.--The Secretary, in consultation with
    the heads of other applicable Federal agencies and departments, as
    appropriate, shall provide technical assistance to recipients of awards
    under this section to facilitate the planning, development, and
    implementation of activities described in subsection (d).
        ``(g) Authorization of Appropriations.--To carry out this section,
    there is authorized to be appropriated $20,000,000 for each of fiscal
    years 2025 and 2026, to remain available through December 31, 2026.''.
        (b) Wastewater Surveillance Research.--
                (1) In general.--The Secretary of Health and Human Services
            (in this subsection referred to as the ``Secretary'') shall
            continue to conduct or support research on the use of
            wastewater surveillance to detect and monitor emerging
            infectious diseases, which may include--
                        (A) research to improve the efficiency and
                    effectiveness of wastewater sample collection and
                    analysis and increase the sensitivity and specificity
                    of wastewater testing methods; and
                        (B) implementation and development of evidence-
                    based practices to facilitate the estimation of the
                    incidence and prevalence of infectious disease within a
                    community.
                (2) Non-duplication of effort.--The Secretary shall ensure
            that activities carried out under this subsection do not
            unnecessarily duplicate efforts of other agencies and offices
            within the Department of Health and Human Services related to
            wastewater surveillance.

    SEC. 617. REAUTHORIZATION OF MOSQUITO ABATEMENT FOR SAFETY AND HEALTH
                  PROGRAM.

        Section 317S of the Public Health Service Act (42 U.S.C. 247b-21)
    is amended--
                (1) in subsection (a)(3)(A), by striking ``subsection
            (b)(3)'' and inserting ``subsection (b)(4)'';
                (2) in subsection (b)--
                        (A) by redesignating paragraphs (3) through (6) as
                    paragraphs (4) through (7), respectively; and
                        (B) by inserting after paragraph (2) the following:
                ``(3) Considerations.--The Secretary may consider the use
            of innovative and novel technology for mosquito prevention and
            control in making grants under paragraph (1).'';
                (3) by amending subsection (d) to read as follows:
        ``(d) Uses of Funds.--Amounts appropriated under subsection (f) may
    be used by the Secretary to provide training and technical assistance
    with respect to the planning, development, and operation of assessments
    and plans under subsection (a) and control programs under subsection
    (b). The Secretary may provide such training and technical assistance
    directly or through awards of grants or contracts to public and private
    entities.''; and
                (4) in subsection (f)(1), by striking ``2019 through 2023''
            and inserting ``2025 and 2026, to remain available through
            December 31, 2026''.

                 Subtitle B--Federal Planning and Coordination

    SEC. 621. ALL-HAZARDS EMERGENCY PREPAREDNESS AND RESPONSE.

        Section 2811 of the Public Health Service Act (42 U.S.C. 300hh-10)
    is amended--
                (1) in subsection (b)--
                        (A) in paragraph (3)--
                                (i) by striking ``Oversee advanced
                            research, development, and procurement'' and
                            inserting the following:
                        ``(A) In general.--Oversee advanced research,
                    development, procurement, and replenishment''; and
                                (ii) by adding at the end the following:
                        ``(B) Development of requirements.--Lead the
                    development and approval, and, on a routine basis, the
                    review and update, of requirements for such
                    countermeasures and products, including related
                    capabilities, to inform the advanced research,
                    development, procurement, and replenishment decisions
                    of the Secretary.'';
                        (B) in paragraph (4)--
                                (i) in subparagraph (F)--
                                        (I) in the matter preceding clause
                                    (i), by striking ``and in consultation
                                    with the Secretary of Homeland
                                    Security,''; and
                                        (II) in clause (i), by inserting
                                    ``enhance'' after ``capabilities and'';
                                (ii) in subparagraph (G)--
                                        (I) in the matter preceding clause
                                    (i), by inserting ``the Office of
                                    Pandemic Preparedness and Response
                                    Policy,'' after ``Veterans Affairs,'';
                                        (II) in clause (i), by striking
                                    ``based on'' and inserting ``based on--
                                    '';
                                        (III) in clause (ii), by striking
                                    ``; and'' at the end and inserting a
                                    semicolon;
                                        (IV) in clause (iii), by striking
                                    the period and inserting ``; and''; and
                                        (V) by adding at the end the
                                    following:
                                ``(iv) that include, as appropriate,
                            participation by relevant industry, academia,
                            professional societies, and other
                            stakeholders.'';
                                (iii) in subparagraph (H)--
                                        (I) by inserting ``and the Director
                                    of the Office of Pandemic Preparedness
                                    and Response Policy'' after ``Security
                                    Affairs''; and
                                        (II) by inserting ``and medical
                                    product and supply capacity planning
                                    pursuant to subparagraph (J), including
                                    discussion of any relevant identified
                                    supply chain vulnerabilities'' before
                                    the period at the end;
                                (iv) in subparagraph (I), by inserting
                            ``the Director of the Office of Pandemic
                            Preparedness and Response Policy,'' after
                            ``Security Affairs,''; and
                                (v) in subparagraph (J)(i), in the matter
                            preceding subclause (I), by inserting
                            ``(including ancillary medical supplies and
                            components of medical products, such as active
                            pharmaceutical ingredients, key starting
                            materials, medical device components, testing
                            kits, reagents, and other testing supplies)''
                            after ``supply needs''; and
                        (C) in paragraph (7)--
                                (i) in the matter preceding subparagraph
                            (A), by inserting ``and the requirements
                            developed pursuant to paragraph (3)(B)'' after
                            ``subsection (d)'';
                                (ii) by redesignating subparagraphs (E) and
                            (F) as subparagraphs (F) and (G), respectively;
                            and
                                (iii) by inserting after subparagraph (D)
                            the following:
                        ``(E) include a professional judgment of
                    anticipated budget needs for each future fiscal year
                    accounted for in such plan to account for the full
                    range of anticipated medical countermeasure needs and
                    life-cycle costs to address such priorities and
                    requirements;'';
                (2) in subsection (d)--
                        (A) by amending paragraph (1) to read as follows:
                ``(1) In general.--Not later than March 15, 2020, and
            biennially thereafter, the Assistant Secretary for Preparedness
            and Response shall develop and 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 coordinated strategy for medical
            countermeasures to address chemical, biological, radiological,
            and nuclear threats, informed by the requirements developed
            pursuant to subsection (b)(3)(B). Not later than 180 days after
            the submission of such strategy to such committees, the
            Assistant Secretary for Preparedness and Response shall submit
            an accompanying implementation plan to such committees. In
            developing such a strategy and plan, the Assistant Secretary
            for Preparedness and Response shall consult with the Public
            Health Emergency Medical Countermeasures Enterprise established
            under section 2811-1. Such strategy and plan shall be known as
            the Public Health Emergency Medical Countermeasures Enterprise
            Strategy and Implementation Plan.''; and
                        (B) in paragraph (2), in the matter preceding
                    subparagraph (A), by inserting ``strategy and'' before
                    ``plan''; and
                (3) in subsection (f)--
                        (A) in paragraph (1), in the matter preceding
                    subparagraph (A), by inserting ``, including such
                    agents that are an emerging infectious disease'' after
                    ``become a pandemic''; and
                        (B) in paragraph (2)(A), by striking ``$250,000,000
                    for each of fiscal years 2019 through 2023'' and
                    inserting ``$335,000,000 for each of fiscal years 2025
                    and 2026, to remain available through December 31,
                    2026''.

    SEC. 622. NATIONAL HEALTH SECURITY STRATEGY.

        Section 2802 of the Public Health Service Act (42 U.S.C. 300hh-1)
    is amended--
                (1) in subsection (a)(3)--
                        (A) by striking ``In 2022, the'' and inserting
                    ``The''; and
                        (B) by inserting ``, maintaining, and sustaining''
                    after ``establishing''; and
                (2) in subsection (b)--
                        (A) in paragraph (2)--
                                (i) in subparagraph (A), by inserting
                            ``that support interagency coordination and
                            availability of information, as appropriate''
                            before the period;
                                (ii) in subparagraph (B), by inserting
                            ``rapid testing,'' after ``and supplies,'';
                        (B) in paragraph (3)--
                                (i) in the matter preceding subparagraph
                            (A), by inserting ``and blood banks'' after
                            ``dental health facilities'';
                                (ii) in subparagraph (C), by inserting
                            ``and current capacity of facilities within
                            such systems, as applicable'' before the
                            period; and
                                (iii) in subparagraph (D), by inserting
                            ``and other medical products and medical
                            supplies consistent with the activities carried
                            out under section 2811(b)(4)(J)'' before the
                            period;
                        (C) in paragraph (5), by inserting ``applicable
                    federally funded activities and'' after ``(including'';
                        (D) in paragraph (8)--
                                (i) in subparagraph (A), by inserting
                            ``public health and medical'' before
                            ``activities''; and
                                (ii) in subparagraph (B), by striking
                            ``familiarity with'' and inserting
                            ``understanding of, and coordination
                            between,'';
                        (E) by redesignating paragraphs (9) and (10) as
                    paragraphs (10) and (12), respectively;
                        (F) by inserting after paragraph (8) the following:
                ``(9) Other settings.--Supporting Federal, State, local,
            and Tribal coordination and planning with respect to facilities
            in which there is an increased risk of infectious disease
            outbreaks, including such facilities that address the needs of
            at-risk individuals, in the event of a public health emergency
            declared under section 319.'';
                        (G) by inserting after subparagraph (10), as so
                    redesignated, the following:
                ``(11) Other hazards.--Assessing current and potential
            health security threats from natural disasters with respect to
            public health and medical preparedness and response.'';
                        (H) by inserting after paragraph (12), as so
                    redesignated, the following:
                ``(13) Cybersecurity resiliency of health care systems.--
            Consistent with the requirements of section 2218 of the
            Homeland Security Act of 2002, strengthening the ability of
            States, local communities, and Tribal communities to prepare
            for, respond to, and be resilient against cybersecurity
            vulnerabilities or cybersecurity attacks that affect public
            health and health information technology, and encouraging
            health care facilities to use recognized security practices
            meeting or exceeding the approaches established under section
            405(d) of the Cybersecurity Act of 2015.''; and
                        (I) by striking ``tribal'' each place it appears
                    and inserting ``Tribal''.

    SEC. 623. IMPROVING DEVELOPMENT AND DISTRIBUTION OF DIAGNOSTIC TESTS.

        Section 319B of the Public Health Service Act (42 U.S.C. 247d-2) is
    amended to read as follows:

    ``SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBUTION OF DIAGNOSTIC
                  TESTS.

        ``(a) Diagnostic Testing Preparedness Plan.--The Secretary shall
    develop, make publicly available, not later than 1 year after the date
    of enactment of the Pandemic and All-Hazards Preparedness and Response
    Act, and update not less frequently than every 3 years thereafter, a
    plan for the rapid development, validation, authorization, manufacture,
    procurement, and distribution of diagnostic tests, and for rapid
    scaling of testing capacity, in response to chemical, biological,
    radiological, or nuclear threats, including emerging infectious
    diseases, for which a public health emergency is declared under section
    319, or that has significant potential to cause such a public health
    emergency.
        ``(b) Purposes.--The purpose of the plan under subsection (a) shall
    be to--
                ``(1) facilitate the development and utilization of
            diagnostic tests;
                ``(2) describe the processes for the rapid development,
            validation, authorization, manufacture, procurement, and
            distribution of diagnostic tests, and for rapid scaling of
            testing capacity; and
                ``(3) facilitate coordination and collaboration among
            public and private entities to improve the rapid development
            and utilization of diagnostic testing during a public health
            emergency.
        ``(c) Considerations.--The plan under subsection (a) shall take
    into consideration--
                ``(1) domestic capacity, including any such capacity
            established through partnerships with public and private
            entities pursuant to subsection (e), to support the
            development, validation, manufacture, procurement, and
            distribution of tests, and the rapid scaling of testing
            capacity;
                ``(2) novel technologies and platforms that--
                        ``(A) may be used to improve testing capabilities,
                    including--
                                ``(i) high-throughput laboratory
                            diagnostics;
                                ``(ii) point-of-care diagnostics; and
                                ``(iii) rapid at-home diagnostics;
                        ``(B) improve the accessibility of diagnostic
                    tests; and
                        ``(C) facilitate the development and manufacture of
                    diagnostic tests;
                ``(3) medical supply needs related to testing, including
            diagnostic testing, equipment, supplies, and component parts,
            and any potential vulnerabilities related to the availability
            of such medical supplies and related planning needs, consistent
            with section 2811(b)(4)(J);
                ``(4) strategies for the rapid and efficient distribution
            of tests locally, regionally, or nationwide and appropriate
            scaling of laboratory testing capacity; and
                ``(5) assessment of such strategies through drills and
            operational exercises carried out under section 2811(b)(4)(G),
            as appropriate.
        ``(d) Coordination.--To inform the development and update of the
    plan under subsection (a), and in carrying out activities to implement
    such plan, the Secretary shall coordinate with industry, such as device
    manufacturers, clinical and reference laboratories, and medical product
    distributors, States, local governmental entities, Indian Tribes and
    Tribal organizations, and other relevant public and private entities.
        ``(e) Capacity Building.--The Secretary may contract with public
    and private entities, as appropriate, to increase domestic capacity in
    the rapid development, validation, authorization, manufacture,
    procurement, and distribution of diagnostic tests, as appropriate, to
    State, local, and Tribal health departments and other appropriate
    entities for immediate public health response activities to address an
    infectious disease with respect to which a public health emergency is
    declared under section 319, or that has significant potential to cause
    such a public health emergency.''.

    SEC. 624. COMBATING ANTIMICROBIAL RESISTANCE.

        (a) In General.--Section 319E of the Public Health Service Act (42
    U.S.C. 247d-5) is amended--
                (1) in subsection (a)--
                        (A) in paragraph (1), by inserting ``and
                    activities'' after ``Federal programs'';
                        (B) in paragraph (2)--
                                (i) by striking ``public health
                            constituencies, manufacturers, veterinary and
                            medical professional societies and others'' and
                            inserting ``the Advisory Council described in
                            subsection (b) and relevant public and private
                            entities''; and
                                (ii) by inserting ``, pursuant to paragraph
                            (4),'' after ``comprehensive plan'';
                        (C) by amending paragraph (3) to read as follows:
                ``(3) Agenda.--The task force described in paragraph (1)
            shall consider factors the Secretary considers appropriate,
            including factors to--
                        ``(A) slow the emergence of resistant bacteria and
                    fungi and prevent the spread of resistant infections;
                        ``(B) strengthen activities to combat resistance
                    with respect to zoonotic diseases;
                        ``(C) advance development and use of rapid and
                    innovative capabilities, including diagnostic tests,
                    for identification and characterization of resistant
                    bacteria and fungi;
                        ``(D) accelerate basic and applied research and
                    development for new antibiotics, antifungals, and other
                    related therapeutics and vaccines; and
                        ``(E) support international collaboration and
                    capacities for antimicrobial-resistance prevention,
                    detection, and control.'';
                        (D) by redesignating paragraph (4) as paragraph
                    (5);
                        (E) by inserting after paragraph (3) the following:
                ``(4) Action plan.--Not later than October 1, 2026, and
            every 5 years thereafter, the task force described in paragraph
            (1) shall develop and 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 plan regarding Federal programs and
            activities to combat antimicrobial resistance, including
            measurable outcomes, as appropriate, informed by--
                        ``(A) the agenda described in paragraph (3);
                        ``(B) input provided by the Advisory Council
                    described in subsection (b); and
                        ``(C) input from other relevant stakeholders
                    provided pursuant to paragraph (2).'';
                (2) by redesignating subsections (b) through (o) as
            subsections (c) through (p), respectively;
                (3) by inserting after subsection (a) the following:
        ``(b) Advisory Council.--
                ``(1) In general.--The Secretary may continue the
            Presidential Advisory Council on Combating Antibiotic-Resistant
            Bacteria, referred to in this subsection as the `Advisory
            Council'.
                ``(2) Duties.--The Advisory Council shall advise and
            provide information and recommendations to the Secretary,
            acting through the Task Force established under subsection (a),
            regarding Federal programs and activities intended to reduce or
            combat antimicrobial-resistant bacteria or fungi that may
            present a public health threat and improve capabilities to
            prevent, diagnose, mitigate, or treat such resistance. Such
            advice, information, and recommendations may be related to
            improving Federal efforts related to factors described in
            subsection (a)(3) and other topics related to antimicrobial
            resistance, as appropriate.
                ``(3) Meetings and coordination.--
                        ``(A) Meetings.--The Advisory Council shall meet
                    not less frequently than biannually and, to the extent
                    practicable, in coordination with meetings of the task
                    force established under subsection (a).
                        ``(B) Coordination.--The Advisory Council shall, to
                    the greatest extent practicable, coordinate activities
                    carried out by the Council with the task force
                    established under subsection (a).
                ``(4) FACA.--Chapter 10 of title 5, United States Code,
            shall apply to the activities and duties of the Advisory
            Council.
                ``(5) Sunset.--
                        ``(A) In general.--The Advisory Council under this
                    subsection shall terminate on December 31, 2026.
                        ``(B) Extension of advisory council.--Not later
                    than October 1, 2026, the Secretary 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 includes a
                    recommendation on whether the Advisory Council should
                    be extended, and identifying whether there are other
                    committees, councils, or task forces that have
                    overlapping or similar duties to that of the Advisory
                    Council, and whether such committees, councils, or task
                    forces should be combined, restructured, or eliminated,
                    including with respect to the task force established
                    under subsection (a).''; and
                (4) in subsection (n), as so redesignated, by striking
            ``(f) through (j)'' and inserting ``(g) through (k)''.
        (b) Conforming Amendment.--Section 505 of the Pandemic and All-
    Hazards Preparedness and Advancing Innovation Act of 2019 (42 U.S.C.
    247d-5 note; Public Law 116-22) is amended by striking subsection (a)
    and all that follows through ``Not later'' in subsection (e) and
    inserting the following:
        ``Not later''.

    SEC. 625. STRATEGIC NATIONAL STOCKPILE AND MATERIAL THREATS.

        Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b)
    is amended--
                (1) in subsection (a)--
                        (A) in paragraph (2)--
                                (i) in subparagraph (A), by inserting
                            ``Such review shall include a description of
                            how the Secretary manages and mitigates risks
                            associated with gaps between current inventory
                            levels and stockpiling goals, prioritizes such
                            risks, and tracks progress toward mitigation of
                            such risks.'' after the first sentence; and
                                (ii) in subparagraph (B)(i), by amending
                            subclause (IV) to read as follows:
                                        ``(IV) the emergency health
                                    security threat or threats such
                                    countermeasure procurement is intended
                                    to address, including--
                                                ``(aa) whether such
                                            procurement is consistent with
                                            meeting emergency health
                                            security needs associated with
                                            such threat or threats; and
                                                ``(bb) in the case of a
                                            countermeasure that addresses a
                                            biological agent, whether such
                                            agent has an increased
                                            likelihood to become resistant
                                            to, more resistant to, or
                                            evade, such countermeasure
                                            relative to other available
                                            medical countermeasures;'';
                        (B) in paragraph (3)--
                                (i) in subparagraph (B), by striking ``are
                            followed, regularly reviewed, and updated with
                            respect to such stockpile'' and inserting
                            ``with respect to such stockpile are followed,
                            regularly reviewed, and updated to reflect best
                            practices'';
                                (ii) in subparagraph (I), by inserting ``,
                            through a standard operating procedure,'' after
                            ``ensure'';
                                (iii) by redesignating subparagraphs (H)
                            through (K) as subparagraphs (I) through (L),
                            respectively;
                                (iv) by inserting after subparagraph (G)
                            the following:
                        ``(H) utilize tools to enable the timely and
                    accurate tracking of the contents of the stockpile
                    throughout the deployment of such contents, including
                    tracking of the location and geographic distribution
                    and utilization of such contents;'';
                                (v) in subparagraph (K), as so
                            redesignated, by striking ``; and'' at the end
                            and inserting a semicolon;
                                (vi) in subparagraph (L), as so
                            redesignated, by striking the period and
                            inserting ``; and''; and
                                (vii) by adding at the end the following:
                        ``(M) communicate to relevant vendors regarding
                    modifications, renewals, extensions, or terminations of
                    contracts, or the intent to exercise options for such
                    contracts, within 30 days, as practicable, of such
                    determination, including through the development of a
                    contract notification process.'';
                        (C) in paragraph (5)(B), in the matter preceding
                    clause (i), by inserting ``, which may accompany the
                    review required under paragraph (2),'' after
                    ``Representatives a report''; and
                        (D) in paragraph (6)(A)--
                                (i) by redesignating clauses (viii) through
                            (x) as clauses (ix) through (xi), respectively;
                            and
                                (ii) by inserting after clause (vii) the
                            following:
                                ``(viii) with respect to any change in the
                            Federal organizational management of the
                            stockpile, an assessment and comparison of any
                            differences in the processes and operations
                            resulting from such change, including--
                                        ``(I) planning for potential
                                    countermeasure deployment,
                                    distribution, or dispensing
                                    capabilities;
                                        ``(II) organizational structure;
                                        ``(III) communication with relevant
                                    stakeholders related to procurement
                                    decisions;
                                        ``(IV) processes related to
                                    procurement, deployment, and use of
                                    stockpiled countermeasures;
                                        ``(V) communication and
                                    coordination with the Public Health
                                    Emergency Medical Countermeasures
                                    Enterprise and other related Federal
                                    entities;
                                        ``(VI) inventory management; and
                                        ``(VII) availability and use of
                                    resources for such activities;''; and
                (2) in subsection (c)(2)(C), by striking ``promptly'' and
            inserting ``, not later than 60 days after each such
            determination,'';
                (3) in subsection (f)(1), by striking ``$610,000,000 for
            each of fiscal years 2019 through 2021, and $750,000,000 for
            each of fiscal years 2022 and 2023'' and inserting
            ``$1,100,000,000 for fiscal year 2025, and $1,210,000,000 for
            fiscal year 2026''; and
                (4) in subsection (g)(1), by striking ``2019 through 2028''
            and inserting ``2025 through 2034''.

    SEC. 626. MEDICAL COUNTERMEASURES FOR VIRAL THREATS WITH PANDEMIC
                  POTENTIAL.

        Section 319L of the Public Health Service Act (42 U.S.C. 247d-7e)
    is amended--
                (1) in subsection (c)--
                        (A) in paragraph (4)--
                                (i) in subparagraph (D)--
                                        (I) in clause (ii), by striking ``;
                                    and'' and inserting a semicolon; and
                                        (II) by redesignating clause (iii)
                                    as clause (iv); and
                                        (III) by inserting after clause
                                    (ii) the following:
                                ``(iii) research and development of medical
                            countermeasures for priority virus families
                            that have significant potential to cause a
                            pandemic, including such countermeasures that
                            take either pathogen-specific or pathogen-
                            agnostic approaches, and platform technologies
                            to improve the development and manufacture of
                            such medical countermeasures; and''; and
                                (ii) in subparagraph (F)(ii), by inserting
                            ``or priority virus families and other viral
                            pathogens that pose a threat due to their
                            significant potential to cause a pandemic,''
                            after ``pandemic influenza,''; and
                        (B) in paragraph (5), by adding at the end the
                    following:
                        ``(I) Notification.--In awarding contracts, grants,
                    cooperative agreements, or other transactions under
                    this section, the Secretary shall communicate to
                    relevant vendors regarding modifications, renewals,
                    extensions, or terminations of contracts, including
                    through the development of a contract notification
                    process, within 30 days of such determination, as
                    practicable.'';
                (2) in subsection (d)(2), by striking ``$611,700,000 for
            each of fiscal years 2019 through 2023'' and inserting
            ``$950,000,000 for each of fiscal years 2025 and 2026''; and
                (3) in subsection (e)(1), by amending subparagraph (D) to
            read as follows:
                        ``(D) Sunset.--This paragraph shall cease to have
                    force or effect after December 31, 2026.''.

    SEC. 627. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE.

        Section 2811-1 of the Public Health Service Act (42 U.S.C. 300hh-
    10a) is amended--
                (1) in subsection (b)--
                        (A) by redesignating paragraph (11) as paragraph
                    (13);
                        (B) by inserting after paragraph (10) the
                    following:
                ``(11) The Director of the Biomedical Advanced Research and
            Development Authority.
                ``(12) The Director of the Strategic National Stockpile.'';
            and
                        (C) in paragraph (13), as so redesignated, by
                    striking ``the Director of the Biomedical Advanced
                    Research and Development Authority, the Director of the
                    Strategic National Stockpile, the Director of the
                    National Institute of Allergy and Infectious
                    Diseases,'' and inserting ``the Director of the
                    National Institute of Allergy and Infectious
                    Diseases''; and
                (2) in subsection (c)--
                        (A) in paragraph (1)--
                                (i) by redesignating subparagraph (D) as
                            subparagraph (E); and
                                (ii) by inserting after subparagraph (C)
                            the following:
                        ``(D) Assist the Secretary in developing strategies
                    for appropriate and evidence-based allocation and
                    distribution of countermeasures to jurisdictions, in a
                    manner that supports the availability and use of such
                    countermeasures, for public health and medical
                    preparedness and response needs.'';
                        (B) in paragraph (2), by inserting ``relevant
                    stakeholders, including industry,'' after ``consider
                    input from''; and
                        (C) by adding at the end the following:
                ``(3) Information sharing.--The Secretary shall, as
            appropriate and in a manner that does not compromise national
            security, communicate and share information related to
            recommendations made and strategies developed under paragraph
            (1) with relevant stakeholders, including industry and State,
            local, and Tribal public health departments.''.

    SEC. 628. FELLOWSHIP AND TRAINING PROGRAMS.

        Section 317G of the Public Health Service Act (42 U.S.C. 247b-8) is
    amended--
                (1) by striking ``The Secretary,'' and inserting the
            following:
        ``(a) In General.--The Secretary,''; and
                (2) by adding at the end the following:
        ``(b) Noncompetitive Conversion.--
                ``(1) In general.--The Secretary may noncompetitively
            convert an individual who has completed an epidemiology,
            surveillance, or laboratory fellowship or training program
            under subsection (a) to a career-conditional appointment
            without regard to the provisions of subchapter I of chapter 33
            of title 5, United States Code, provided that such individual
            meets qualification requirements for the appointment.''.

    SEC. 629. REGIONAL BIOCONTAINMENT RESEARCH LABORATORIES.

        (a) In General.--The Secretary of Health and Human Services
    (referred to in this section as the ``Secretary'') shall make awards to
    establish or maintain, as applicable, not fewer than 12 regional
    biocontainment laboratories, for purposes of--
                (1) conducting biomedical research to support public health
            and medical preparedness for, and rapid response to, biological
            agents, including emerging infectious diseases;
                (2) ensuring the availability of surge capacity for
            purposes of responding to such biological agents;
                (3) supporting information sharing between, and the
            dissemination of findings to, researchers and other relevant
            individuals to facilitate collaboration between industry and
            academia; and
                (4) providing, as appropriate and applicable, technical
            assistance and training to researchers and other relevant
            individuals to support the biomedical research workforce in
            improving the management and mitigation of safety and security
            risks in the conduct of research involving such biological
            agents.
        (b) Requirements.--As a condition of receiving a grant under this
    section, a regional biocontainment laboratory shall agree to such
    oversight activities as the Secretary determines appropriate, including
    periodic meetings with relevant officials of the Department of Health
    and Human Services, facility inspections, and other activities as
    necessary and appropriate to ensure compliance with the terms and
    conditions of such award.
        (c) Working Group.--The Secretary shall establish a Working Group,
    consisting of a representative from each entity in receipt of an award
    under subsection (a). The Working Group shall make recommendations to
    the Secretary in administering awards under this section, for purposes
    of--
                (1) improving the quality and consistency of applicable
            procedures and practices within laboratories funded pursuant to
            subsection (a); and
                (2) ensuring coordination, as appropriate, of federally
            funded activities carried out at such laboratories.
        (d) Definition.--In this section, the term ``regional
    biocontainment laboratory'' means a Biosafety or Animal Biosafety
    Level-3 and Level-2 facility located at an institution in the United
    States that is designated by the Secretary to carry out the activities
    described in subsection (a).
        (e) Authorization of Appropriations.--To carry out this section,
    there are authorized to be appropriated $52,000,000 for each of fiscal
    years 2025 and 2026, to remain available through December 31, 2026.
        (f) Administrative Expenses.--Of the amount available to carry out
    this section for a fiscal year, the Secretary may use not more than 5
    percent for the administrative expenses of carrying out this section,
    including expenses related to carrying out subsection (c).
        (g) Report to Congress.--Not later than 1 year after the date of
    the enactment of this Act, and biannually thereafter, the Secretary, in
    consultation with the heads of applicable Federal departments and
    agencies shall 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 activities and accomplishments of the regional
            biocontainment laboratories;
                (2) any published or disseminated research findings based
            on research conducted in such laboratories in the applicable
            year;
                (3) oversight activities carried out by the Secretary
            pursuant to subsection (b);
                (4) activities undertaken by the Secretary to take into
            consideration the capacity and capabilities of the network of
            regional biocontainment laboratories in activities to prepare
            for and respond to biological agents, which may include
            leveraging such capacity and capabilities to support the
            Laboratory Response Network, as applicable and appropriate;
                (5) plans for the maintenance and sustainment of federally
            funded activities conducted at the regional biocontainment
            laboratories, consistent with the strategy required under
            section 2312 of the PREVENT Pandemics Act (Public Law 117-328);
            and
                (6) activities undertaken by the Secretary to coordinate
            with the heads of other relevant Federal departments and
            agencies to ensure that work carried out by each such facility
            on behalf of the Secretary and such other relevant heads is
            prioritized, is complementary to the work carried out by other
            such facilities and other relevant federally funded activities,
            and avoids unnecessary duplication.

    SEC. 629A. LIMITATION RELATED TO COUNTRIES OF CONCERN CONDUCTING
                  CERTAIN RESEARCH.

        Section 2315(c) of the PREVENT Pandemics Act (42 U.S.C. 6627) is
    amended to read as follows:
        ``(c) Limitations on Countries of Concern Conducting Certain
    Research.--
                ``(1) In general.--The Secretary of Health and Human
            Services (referred to in this subsection as the `Secretary')
            shall not fund research that may reasonably be anticipated to
            involve the creation, transfer, and use of enhanced pathogens
            of pandemic potential or biological agents or toxins listed
            pursuant to section 351A(a)(1) of the Public Health Service Act
            if such research is conducted by a foreign entity at a facility
            located in a country that is determined to be a country of
            concern as defined in paragraph (2).
                ``(2) Countries of concern.--
                        ``(A) Definition.--For purposes of this subsection,
                    a `country of concern' means the People's Republic of
                    China, the Democratic People's Republic of Korea, the
                    Russian Federation, the Islamic Republic of Iran, and
                    any other country as determined pursuant to
                    subparagraph (B).
                        ``(B) Additional countries.--The Director of
                    National Intelligence (referred to in this subsection
                    as the `Director') shall, in consultation with the
                    Secretary, add additional countries of concern for
                    purposes of paragraph (1), only if--
                                ``(i) the Director determines that evidence
                            exists that a country has malicious intent
                            related to the creation, enhancement, transfer,
                            or use of pathogens of pandemic potential or
                            biological agents or toxins listed pursuant to
                            such section 351A(a)(1); and
                                ``(ii) in a manner that does not compromise
                            national security, the Director provides such
                            evidence in a report submitted to the Committee
                            on Health, Education, Labor, and Pensions of
                            the Senate and the Committee on Energy and
                            Commerce of the House of Representatives.
                        ``(C) Limitation.--Paragraph (1) shall not take
                    effect with respect to a country of concern identified
                    under subparagraph (B) until the date that is 15 days
                    after the date on which the Director submits the report
                    described in subparagraph (B)(ii).
                ``(3) Clarification.--
                        ``(A) In general.--The requirement of paragraph (1)
                    may be waived by the President for the duration of the
                    initial response to an outbreak of a novel emerging
                    infectious disease if the President determines that
                    such requirement impedes the ability of the Federal
                    Government to immediately respond to such outbreak.
                        ``(B) Notification.--The President shall notify
                    such committees of Congress not later than 48 hours
                    after exercising the waiver under subparagraph (A), and
                    shall provide updates to such committees related to the
                    use of such waiver every 15 days thereafter.
                ``(4) Sunset.--The limitation under this subsection shall
            expire on December 31, 2026.''.

              Subtitle C--Addressing the Needs of All Individuals

    SEC. 631. IMPROVING ACCESS TO CERTAIN PROGRAMS.

        (a) Procedures Related to the Transition of Certain Claims.--
                (1) Procedures for correcting submissions.--
                        (A) Requests initially submitted under section
                    319f-4.--
                                (i) In general.--In the case of a request
                            for compensation submitted under section 319F-4
                            of the Public Health Service Act (42 U.S.C.
                            247d-6e) for an injury or death related to a
                            medical product for active immunization to
                            prevent coronavirus disease 2019 that the
                            Secretary determines to be ineligible pursuant
                            to subsection (b)(4)(B) of such section 319F-4,
                            the Secretary shall, not later than 30 days
                            after such determination, notify the individual
                            submitting the request of such determination.
                                (ii) Submission of petition.--An individual
                            who receives a notification described in clause
                            (i) shall be eligible to submit a petition to
                            the United States Court of Federal Claims under
                            section 2111 of the Public Health Service Act
                            (42 U.S.C. 300aa-11) with respect to the same
                            medical product administration claimed in the
                            request submitted under section 319F-4 of such
                            Act (42 U.S.C. 247d-6e), provided such petition
                            is submitted not later than the later of--
                                        (I) 1 year after receiving such
                                    notification under clause (i); or
                                        (II) the last date on which the
                                    individual otherwise would be eligible
                                    to submit a petition relating to such
                                    injury, as specified in section 2116 of
                                    such Act (42 U.S.C. 300aa-16).
                                (iii) Eligibility.--To be eligible to
                            submit a petition in accordance with clause
                            (ii), the petitioner shall have submitted the
                            request that was determined to be ineligible as
                            described in clause (i) not later than the
                            applicable deadline for filing a petition under
                            such section 2116.
                        (B) Requests initially submitted under section
                    2111.--
                                (i) In general.--If a special master
                            determines that--
                                        (I) a petition submitted under
                                    section 2111 of the Public Health
                                    Service Act (42 U.S.C. 300aa-11)
                                    related to a medical product for active
                                    immunization to prevent coronavirus
                                    disease 2019 that is ineligible for the
                                    program under subtitle 2 of title XXI
                                    of the Public Health Service Act (42
                                    U.S.C. 300aa-10 et seq.) because it
                                    relates to a medical product
                                    administered at a time when the medical
                                    product was not included in the table
                                    under section 2114 of such Act (42
                                    U.S.C. 300aa-14); and
                                        (II) the medical product was
                                    administered when it was a covered
                                    countermeasure subject to a declaration
                                    under section 319F-3(b) of such Act (42
                                    U.S.C. 247d-6d(b)),
                            the special master shall, not later than 30
                            days after such determination, notify the
                            petitioner of such determination.
                                (ii) Submission of request.--An individual
                            who receives a notification described in clause
                            (i) shall be eligible to submit a request for
                            compensation under section 319F-4(b) of the
                            Public Health Service Act (42 U.S.C. 247d-
                            6e(b)) with respect to the same medical product
                            administration claimed in the petition
                            submitted under section 2111 of such Act (42
                            U.S.C. 300aa-11)--
                                        (I) not later than 1 year after
                                    receiving such notification; or
                                        (II) in the case that the
                                    notification is issued after judicial
                                    review of the petition under subsection
                                    (e) or (f) of section 2112 of such Act
                                    (42 U.S.C. 300aa-12), not later than 1
                                    year after the judgment of the United
                                    States Court of Federal Claims or the
                                    mandate is issued by the United States
                                    Court of Appeals for the Federal
                                    Circuit pursuant to such subsection (e)
                                    or (f).
                                (iii) Eligibility.--To be eligible to
                            submit a request for compensation in accordance
                            with clause (ii), the individual submitting the
                            request shall have submitted the petition under
                            section 2111 of the Public Health Service Act
                            (42 U.S.C. 300aa-11) that was determined to be
                            ineligible not later than 1 year after the date
                            of administration of the medical product.
                (2) Changes to certain programs.--
                        (A) Section 319f-4.--Section 319F-4 of the Public
                    Health Service Act (42 U.S.C. 247d-6e) is amended--
                                (i) in subsection (b)(4)--
                                        (I) by striking ``Except as
                                    provided'' and inserting the following:
                        ``(A) In general.--Except as provided''; and
                                        (II) by adding at the end the
                                    following:
                        ``(B) Exclusion of injuries eligible for petition
                    under title xxi.--Notwithstanding any other provision
                    of this section, no individual may be eligible for
                    compensation under this section with respect to a
                    vaccine that, at the time it was administered, was
                    included in the Vaccine Injury Table under section
                    2114.''; and
                                (ii) in subsection (d)(3)--
                                        (I) by striking ``This section''
                                    and inserting the following:
                        ``(A) In general.--This section''; and
                                        (II) by adding at the end the
                                    following:
                        ``(B) Exhaustion of remedies.--A covered individual
                    shall not be considered to have exhausted remedies as
                    described in paragraph (1), nor be eligible to seek
                    remedy under section 319F-3(d), unless such individual
                    has provided to the Secretary all supporting
                    documentation necessary to facilitate the
                    determinations required under subsection (b)(4).''.
                        (B) Title xxi.--Title XXI of the Public Health
                    Service Act (42 U.S.C. 300aa-1 et seq.) is amended--
                                (i) in section 2111(a)(2)(A) (42 U.S.C.
                            300aa-11(a)(2)(A)), in the matter preceding
                            clause (i), by inserting ``containing the
                            information required under subsection (c)''
                            after ``unless a petition'';
                                (ii) in section 2112(d) (42 U.S.C. 300aa-
                            12(d))--
                                        (I) by adding at the end of
                                    paragraph (1) the following: ``Such
                                    designation shall not occur until the
                                    petitioner has filed all materials
                                    required under section 2111(c).''; and
                                        (II) in paragraph (3)(A)(ii), by
                                    striking ``the petition was filed'' and
                                    inserting ``on which the chief special
                                    master makes the designation pursuant
                                    to paragraph (1)'';
                                (iii) in section 2114(e) (42 U.S.C. 300aa-
                            14(e)), by adding at the end the following:
                ``(4) Licensure requirement.--Notwithstanding paragraphs
            (2) and (3), the Secretary may not revise the Vaccine Injury
            Table to include a vaccine for which the Centers for Disease
            Control and Prevention has issued a recommendation for routine
            use in children or pregnant women until at least one
            application for such vaccine has been approved under section
            351. Upon such revision of the Vaccine Injury Table, all
            vaccines in a vaccine category on the Vaccine Injury Table,
            including vaccines authorized under emergency use pursuant to
            section 564 of the Federal Food, Drug, and Cosmetic Act, shall
            be considered included in the Vaccine Injury Table.''; and
                                (iv) in section 2116 (42 U.S.C. 300aa-16),
                            by adding at the end the following:
        ``(d) Clarification.--Notwithstanding subsections (a) and (b), an
    injury or death related to a vaccine administered at a time when the
    vaccine was a covered countermeasure subject to a declaration under
    section 319F-3(b) shall not be eligible for compensation under the
    Program.''.
        (b) Accelerating Injury Compensation Program Administration and
    Ensuring Program Integrity.--
                (1) Petitions for compensation.--Section 2111(a)(2)(A)(i)
            of the Public Health Service Act (42 U.S.C. 300aa-
            11(a)(2)(A)(i)) is amended--
                        (A) in subclause (I), by striking ``, and'' and
                    inserting a semicolon;
                        (B) in subclause (II)--
                                (i) by moving the margin 2 ems to the
                            right; and
                                (ii) by striking ``, or'' and inserting ``;
                            and''; and
                        (C) by adding at the end the following:
                        ``(III) the judgment described in subclause (I)
                    does not result from a petitioner's motion to dismiss
                    the case; or''.
                (2) Determination of good faith.--Section 2115(e)(1) of the
            Public Health Service Act (42 U.S.C. 300aa-15(e)(1)) is amended
            by adding at the end the following: ``When making a
            determination of good faith under this paragraph, the special
            master or court may consider whether the petitioner
            demonstrated an intention to obtain compensation on such
            petition and was not merely seeking to satisfy the exhaustion
            requirement under section 2121(b).''.
        (c) Extension of Deadlines To Submit Requests for Compensation for
    Certain Injuries.--
                (1) In general.--With respect to claims filed under section
            319F-4 of the Public Health Service Act (42 U.S.C. 247d-6e)
            alleging a covered injury caused by the administration or use
            of a covered countermeasure pursuant to a declaration under
            section 319F-3(b) of such Act (42 U.S.C. 247d-6d(b)) relating
            to coronavirus disease 2019, the following shall apply:
                        (A) Notwithstanding the filing deadline applicable
                    under such section 319F-4, the claim shall be filed
                    within 3 years of the administration or use of the
                    covered countermeasure, or 1 year after the date of
                    enactment of this Act, whichever is later, and, if a
                    claim filed under such section 319F-4 with respect to
                    such administration or use was filed before the date of
                    enactment of this Act and denied on the basis of having
                    not been filed within the time period required under
                    subsection (b)(4) of such section 319F-4, such claim
                    may be refiled pursuant to this subparagraph.
                        (B) With respect to a claim relating to the
                    administration of a medical product for active
                    immunization to prevent coronavirus disease 2019 such a
                    claim may be filed under the such section 319F-4 only
                    if the administration of such vaccine occurred prior to
                    the addition of the vaccine to the Vaccine Injury Table
                    under section 2114 of the Public Health Service Act (42
                    U.S.C. 300aa-14).

    SEC. 632. SUPPORTING AT-RISK INDIVIDUALS DURING EMERGENCY RESPONSES.

        (a) Technical Assistance for At-Risk Individuals and Disasters.--
                (1) In general.--The Secretary of Health and Human Services
            (referred to in this section as the ``Secretary'') may provide
            appropriate technical assistance to States, localities, Tribes,
            and other applicable entities related to addressing the unique
            needs and considerations of at-risk individuals, as defined in
            section 2802(b)(4) of the Public Health Service Act (42 U.S.C.
            300hh-1(b)(4)), in the event of a public health emergency
            declared by the Secretary pursuant to section 319 of the Public
            Health Service Act (42 U.S.C. 247d).
                (2) Technical assistance.--The technical assistance
            described in paragraph (1) shall include--
                        (A) developing, identifying, evaluating, and
                    disseminating evidence-based or evidence-informed
                    strategies to improve health and address other near-
                    term or long-term outcomes for at-risk individuals
                    related to public health emergencies, including by
                    addressing such unique needs and considerations in
                    carrying out public health and medical activities to
                    prepare for, respond to, and recover from, such public
                    health emergencies; and
                        (B) assisting applicable entities, through
                    contracts or cooperative agreements, as appropriate, in
                    the implementation of such evidence-based strategies.
                (3) Consultation.--In carrying out activities under
            paragraph (2), the Secretary shall take into consideration
            relevant findings and recommendations of, and, as appropriate,
            consult with, the National Advisory Committee on Individuals
            with Disabilities and Disasters established under section 2811C
            of the Public Health Service Act (42 U.S.C. 300hh-10d), the
            National Advisory Committee on Children and Disasters under
            section 2811A of such Act (42 U.S.C. 300hh-10b), and the
            National Advisory Committee on Seniors and Disasters under
            section 2811B of such Act (42 U.S.C. 300hh-10c).
        (b) Crisis Standards of Care.--Not later than 2 years after the
    date of enactment of this Act, the Secretary, acting through the
    Director of the Office for Civil Rights of the Department of Health and
    Human Services, shall issue guidance to States and localities on the
    development or modification of State and local crisis standards of care
    for use during the response to a public health emergency declared by
    the Governor of a State or by the Secretary under section 319 of the
    Public Health Service Act (42 U.S.C. 247d), or a major disaster or
    emergency declared by the President under section 401 or 501,
    respectively, of the Robert T. Stafford Disaster Relief and Emergency
    Assistance Act (42 U.S.C. 5170, 5191) to ensure that such standards of
    care are consistent with the nondiscrimination requirements of section
    504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), title II of the
    Americans with Disabilities Act of 1990 (42 U.S.C. 12131 et seq.), and
    the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.).

    SEC. 633. NATIONAL ADVISORY COMMITTEES.

        (a) National Advisory Committee on Children and Disasters.--
    Subsection (g) of section 2811A of the Public Health Service Act (42
    U.S.C. 300hh-10b) is amended to read as follows:
        ``(g) Sunset.--
                ``(1) In general.--The Advisory Committee shall terminate
            on December 31, 2026.
                ``(2) Extension of advisory committee.--Not later than
            October 1, 2025, the Secretary shall submit to Congress a
            recommendation on whether the Advisory Committee should be
            extended beyond the date described in paragraph (1).''.
        (b) National Advisory Committee on Seniors and Disasters.--Section
    2811B of the Public Health Service Act (42 U.S.C. 300hh-10c) is
    amended--
                (1) in subsection (d)--
                        (A) in paragraph (1)--
                                (i) by inserting ``and departments'' after
                            ``agencies''; and
                                (ii) by striking ``17 members'' and
                            inserting ``25 members''; and
                        (B) in paragraph (2)--
                                (i) by striking subparagraphs (J) and (K);
                                (ii) by redesignating subparagraphs (A)
                            through (I) and (L) as clauses (i) through (x),
                            respectively, and adjusting the margins
                            accordingly;
                                (iii) by inserting before clause (i), as so
                            redesignated, the following:
                        ``(B) Federal members.--The Federal members shall
                    include the following:''; and
                                (iv) by inserting before subparagraph (B),
                            as so designated, the following:
                        ``(A) Non-federal members.--The Secretary in
                    consultation with such other heads of agencies and
                    departments as may be appropriate, shall appoint to the
                    Advisory Committee under paragraph (1) at least 13
                    individuals, including the following:
                                ``(i) At least 3 non-Federal health care
                            providers with expertise in geriatric medical
                            disaster planning, preparedness, response, or
                            recovery.
                                ``(ii) At least 3 representatives of State,
                            local, territorial, or Tribal agencies with
                            expertise in geriatric disaster planning,
                            preparedness, response, or recovery.
                                ``(iii) At least 2 non-Federal
                            professionals with training in gerontology,
                            such as social workers, scientists, human
                            services specialists, or other non-medical
                            professionals, with experience in disaster
                            planning, preparedness, response, or recovery
                            among other adults.''; and
                (2) by amending subsection (g) to read as follows:
        ``(g) Sunset.--The Advisory Committee shall terminate on December
    31, 2026.''.
        (c) National Advisory Committee on Individuals With Disabilities
    and Disasters.--Section 2811C of the Public Health Service Act (42
    U.S.C. 300hh-10d) is amended--
                (1) by redesignating subsections (c) through (g) as
            subsections (d) through (h), respectively;
                (2) by inserting after subsection (b) the following:
        ``(c) Additional Duties.--The Advisory Committee may provide advice
    and recommendations to the Secretary with respect to individuals with
    disabilities and the medical and public health grants and cooperative
    agreements as applicable to preparedness and response activities under
    this title and title III.'';
                (3) in subsection (d), as so redesignated--
                        (A) in paragraph (1), by striking ``17 members''
                    and inserting ``25 members'';
                        (B) in paragraph (2)--
                                (i) by striking subparagraphs (K) through
                            (M);
                                (ii) by redesignating subparagraphs (A)
                            through (J) as clauses (i) through (x),
                            respectively, and adjusting the margins
                            accordingly;
                                (iii) by inserting before clause (i), as so
                            redesignated, the following:
                        ``(B) Federal members.--The Federal members shall
                    include the following:'';
                                (iv) by adding at the end of subparagraph
                            (B), as so designated, the following:
                                ``(xi) Representatives of such other
                            Federal agencies as the Secretary determines
                            necessary to fulfill the duties of the Advisory
                            Committee.''; and
                                (v) by inserting before subparagraph (B),
                            as so designated, the following:
                        ``(A) Non-federal members.--The Secretary in
                    consultation with such other heads of agencies and
                    departments as may be appropriate, shall appoint to the
                    Advisory Committee under paragraph (1) at least 13
                    individuals, including the following:
                                ``(i) At least 4 non-Federal health care
                            professionals with expertise in disability
                            accessibility before, during, and after
                            disasters, medical and mass care disaster
                            planning, preparedness, response, or recovery.
                                ``(ii) At least 3 representatives of State,
                            local, Tribal, or territorial agencies with
                            expertise in disaster planning, preparedness,
                            response, or recovery for individuals with
                            disabilities.
                                ``(iii) At least 4 individuals with a
                            disability with expertise in disaster planning,
                            preparedness, response, or recovery for
                            individuals with disabilities.
                                ``(iv) Other members as the Secretary
                            determines appropriate, of whom--
                                        ``(I) at least one such member
                                    shall represent a local, State, or
                                    national organization with expertise in
                                    individuals with disabilities;
                                        ``(II) at least one such member
                                    shall be an individual with a
                                    disability; and
                                        ``(III) at least one such member
                                    shall be an individual with expertise
                                    in the needs of housing services,
                                    including during the response to, and
                                    recovery from, disasters.''; and
                        (C) by adding at the end the following:
                ``(3) Consideration.--In appointing members, including the
            Chair, to the Committee under this subsection, the Secretary
            may give consideration to disability status.''; and
                (4) by amending subsection (h), as so redesignated, to read
            as follows:
        ``(h) Sunset.--The Advisory Committee shall terminate on December
    31, 2026.''.

    SEC. 634. NATIONAL ACADEMIES STUDY ON PRIZES.

        (a) In General.--Not later than 90 days after the date of enactment
    of this Act, the Secretary of Health and Human Services shall seek to
    enter into an agreement with the National Academies of Sciences,
    Engineering, and Medicine (referred to in this section as the
    ``National Academies'') to conduct a study to examine--
                (1) alternative models for directly funding, or stimulating
            investment in, biomedical research and development that delink
            research and development costs from the prices of drugs,
            including the progressive replacement of patents and regulatory
            exclusivities on new drugs with a combination of expanded
            support for research and innovation prizes to reward the
            successful development of drugs or achievement of related
            milestones;
                (2) the dollar amount of innovation prizes for different
            stages of research and development of different classes or
            types of drugs, and total annual funding, that would be
            necessary to stimulate investment sufficient to achieve such
            successful drug development and related milestones;
                (3) the relative effectiveness and efficiency of such
            alternative models in stimulating innovation, compared to the
            status quo that includes patents and regulatory exclusivities;
                (4) strategies to implement such alternative models
            described in paragraph (1), including a phased transition; and
                (5) the anticipated economic and societal impacts of such
            alternative models, including an assessment of impact on--
                        (A) the number and variety of new drugs that would
                    be developed, approved, and marketed in the United
                    States, including such new drugs intended to prevent,
                    diagnose, or treat a rare disease or condition;
                        (B) the rate at which new drugs would be developed,
                    approved, and marketed in the United States;
                        (C) access to medication;
                        (D) health outcomes;
                        (E) average lifespan and disease burden in the
                    United States;
                        (F) the number of manufacturers that would be
                    seeking approval for a drug or bringing a drug to
                    market for the first time;
                        (G) Federal discretionary and mandatory spending;
                    and
                        (H) public and private insurance markets.
        (b) Requirements.--In conducting the study pursuant to subsection
    (a), the National Academies shall hold not fewer than 2 public
    listening sessions to solicit feedback from interested parties,
    including representatives of academia, professional societies, patient
    advocates, public health organizations, relevant Federal departments
    and agencies, drug developers, representatives of other relevant
    industries, and subject matter experts.
        (c) Report.--Not later than 2 years after the agreement under
    subsection (a), the National Academies 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 on the study conducted pursuant to subsection (a).

                    Subtitle D--Additional Reauthorizations

    SEC. 641. MEDICAL COUNTERMEASURE PRIORITY REVIEW VOUCHER.

        Section 565A(g) of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 360bbb-4a) is amended by striking ``October 1, 2023'' and
    inserting ``December 31, 2026''.

    SEC. 642. EPIDEMIC INTELLIGENCE SERVICE.

        Section 317F(c)(2) of the Public Health Service Act (42 U.S.C.
    247b-7(c)(2)) is amended by striking ``2019 through 2023'' and
    inserting ``2025 and 2026, to remain available through December 31,
    2026''.

    SEC. 643. MONITORING AND DISTRIBUTION OF CERTAIN MEDICAL
                  COUNTERMEASURES.

        Section 319A(e) of the Public Health Service Act (42 U.S.C. 247d-
    1(e)) is amended by striking ``2019 through 2023'' and inserting ``2025
    and 2026, to remain available through December 31, 2026''.

    SEC. 644. REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND RESPONSE
                  SYSTEMS.

        Section 319C-3 of the Public Health Service Act (42 U.S.C. 247d-3c)
    is amended--
                (1) in subsection (b)(3), by striking ``under the'' and all
            that follows through ``such Act)'' and inserting ``under law'';
            and
                (2) in subsection (e)(2), by striking ``September 30,
            2023'' and inserting ``December 31, 2026''.

    SEC. 645. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF VOLUNTEER HEALTH
                  PROFESSIONALS.

                (1) In general.--Section 319I of the Public Health Service
            Act (42 U.S.C. 247d-7b) is amended--
                        (A) in subsection (a), by striking ``Not later than
                    12 months after the date of enactment of the Pandemic
                    and All-Hazards Preparedness Act, the Secretary shall
                    link existing State verification systems to maintain a
                    single national interoperable network of systems,'' and
                    inserting ``The Secretary shall continue to maintain a
                    single national interoperable network of verification
                    systems,'' and
                        (B) in subsection (k), by striking ``2019 through
                    2023'' and inserting ``2025 and 2026, to remain
                    available through December 31, 2026''.

    SEC. 646. ENSURING COLLABORATION AND COORDINATION IN MEDICAL
                  COUNTERMEASURE DEVELOPMENT.

        Section 319L-1(b) of the Public Health Service Act (42 U.S.C. 247d-
    7f(b)) is amended by striking ``March 31, 2025'' and inserting
    ``December 31, 2026''.

    SEC. 647. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS.

        Section 1291(g) of the Public Health Service Act (42 U.S.C. 300d-
    91(g)) is amended by striking ``2019 through 2023'' and inserting
    ``2025 and 2026, to remain available through December 31, 2026''.

    SEC. 648. NATIONAL DISASTER MEDICAL SYSTEM.

        Section 2812 of the Public Health Service Act (42 U.S.C. 300hh-11)
    is amended--
                (1) in subsection (c)(4)(B), by striking ``March 31, 2025''
            and inserting ``December 31, 2026''; and
                (2) in subsection (g), by striking ``$57,400,000 for each
            of fiscal years 2019 through 2023'' and inserting ``$65,900,000
            for each of fiscal years 2025 and 2026, to remain available
            through December 31, 2026''.

    SEC. 649. VOLUNTEER MEDICAL RESERVE CORPS.

        Section 2813(i) of the Public Health Service Act (42 U.S.C. 300hh-
    15(i)) is amended by striking ``2019 through 2023'' and inserting
    ``2025 through 2026, to remain available through December 31, 2026''.

    SEC. 649A. EPIDEMIOLOGY-LABORATORY CAPACITY.

        Section 2821(b) of the Public Health Service Act (42 U.S.C. 300hh-
    31(b)) is amended, in the matter preceding paragraph (1), by striking
    ``2019 through 2023'' and inserting ``2025 and 2026, to remain
    available through December 31, 2026''.

                       TITLE VII--PUBLIC HEALTH PROGRAMS

    SEC. 701. ACTION FOR DENTAL HEALTH.

        Section 340G(f) of the Public Health Service Act (42 U.S.C.
    256g(f)) is amended by striking ``$13,903,000 for each of fiscal years
    2019 through 2023'' and inserting ``$15,000,000 for each of fiscal
    years 2025 through 2029, to remain available until expended''.

    SEC. 702. PREEMIE.

        (a) Research Relating to Preterm Labor and Delivery and the Care,
    Treatment, and Outcomes of Preterm and Low Birthweight Infants.--
                (1) In general.--Section 3(e) of the Prematurity Research
            Expansion and Education for Mothers who deliver Infants Early
            Act (42 U.S.C. 247b-4f(e)) is amended by striking ``fiscal
            years 2019 through 2023'' and inserting ``fiscal years 2025
            through 2029''.
                (2) Technical correction.--Effective as if included in the
            enactment of the PREEMIE Reauthorization Act of 2018 (Public
            Law 115-328), section 2 of such Act is amended, in the matter
            preceding paragraph (1), by striking ``Section 2'' and
            inserting ``Section 3''.
        (b) Interagency Working Group.--Section 5(a) of the PREEMIE
    Reauthorization Act of 2018 (Public Law 115-328) is amended by striking
    ``The Secretary of Health and Human Services, in collaboration with
    other departments, as appropriate, may establish'' and inserting ``Not
    later than 18 months after the date of the enactment of the Bipartisan
    Health Care Act, the Secretary of Health and Human Services, in
    collaboration with other departments, as appropriate, shall
    establish''.
        (c) Study on Preterm Births.--
                (1) In general.--The Secretary of Health and Human Services
            shall enter into appropriate arrangements with the National
            Academies of Sciences, Engineering, and Medicine under which
            the National Academies shall--
                        (A) not later than 30 days after the date of
                    enactment of this Act, convene a committee of experts
                    in maternal health to study premature births in the
                    United States; and
                        (B) upon completion of the study under subparagraph
                    (A)--
                                (i) approve by consensus a report on the
                            results of such study;
                                (ii) include in such report--
                                        (I) an assessment of each of the
                                    topics listed in paragraph (2);
                                        (II) the analysis required by
                                    paragraph (3); and
                                        (III) the raw data used to develop
                                    such report; and
                                (iii) not later than 24 months after the
                            date of enactment of this Act, transmit such
                            report to--
                                        (I) the Secretary of Health and
                                    Human Services;
                                        (II) the Committee on Energy and
                                    Commerce of the House of
                                    Representatives; and
                                        (III) the Committee on Finance and
                                    the Committee on Health, Education,
                                    Labor, and Pensions of the Senate.
                (2) Assessment topics.--The topics listed in this
            subsection are each of the following:
                        (A) The financial costs of premature birth to
                    society, including--
                                (i) an analysis of stays in neonatal
                            intensive care units and the cost of such
                            stays;
                                (ii) long-term costs of stays in such units
                            to society and the family involved post-
                            discharge; and
                                (iii) health care costs for families post-
                            discharge from such units (such as medications,
                            therapeutic services, co-payments for visits,
                            and specialty equipment).
                        (B) The factors that impact preterm birth rates.
                        (C) Opportunities for earlier detection of
                    premature birth risk factors, including--
                                (i) opportunities to improve maternal and
                            infant health; and
                                (ii) opportunities for public health
                            programs to provide support and resources for
                            parents in-hospital, in non-hospital settings,
                            and post-discharge.
                (3) Analysis.--The analysis required by this subsection is
            an analysis of--
                        (A) targeted research strategies to develop
                    effective drugs, treatments, or interventions to bring
                    at-risk pregnancies to term;
                        (B) State and other programs' best practices with
                    respect to reducing premature birth rates; and
                        (C) precision medicine and preventative care
                    approaches starting early in the life course (including
                    during pregnancy) with a focus on behavioral and
                    biological influences on premature birth, child health,
                    and the trajectory of such approaches into adulthood.

    SEC. 703. PREVENTING MATERNAL DEATHS.

        (a) Maternal Mortality Review Committee.--Section 317K(d) of the
    Public Health Service Act (42 U.S.C. 247b-12(d)) is amended--
                (1) in paragraph (1)(A), by inserting ``(including
            obstetricians and gynecologists)'' after ``clinical
            specialties''; and
                (2) in paragraph (3)(A)(i)--
                        (A) in subclause (I), by striking ``as applicable''
                    and inserting ``if available''; and
                        (B) in subclause (III), by striking ``, as
                    appropriate'' and inserting ``and coordinating with
                    death certifiers to improve the collection of death
                    record reports and the quality of death records,
                    including by amending cause of death information on a
                    death certificate, as appropriate''.
        (b) Best Practices Relating to the Prevention of Maternal
    Mortality.--Section 317K of the Public Health Service Act (42 U.S.C.
    247b-12) is amended--
                (1) by redesignating subsections (e) and (f) as subsections
            (f) and (g), respectively; and
                (2) by inserting after subsection (d) the following:
        ``(e) Best Practices Relating to the Prevention of Maternal
    Mortality.--
                ``(1) In general.--The Secretary, acting through the
            Director of the Centers for Disease Control and Prevention,
            shall, in consultation with the Administrator of the Health
            Resources and Services Administration, disseminate to
            hospitals, State professional society groups, and perinatal
            quality collaboratives, best practices on how to prevent
            maternal mortality and morbidity that consider and reflect best
            practices identified through other relevant Federal maternal
            health programs.
                ``(2) Frequency.--The Secretary, acting through the
            Director of the Centers for Disease Control and Prevention,
            shall disseminate the best practices referred to in paragraph
            (1) not less than once per fiscal year.''.
        (c) Extension.--Subsection (g) of section 317K of the Public Health
    Service Act (42 U.S.C. 247b-12), as redesignated by subsection (b), is
    amended by striking ``$58,000,000 for each of fiscal years 2019 through
    2023'' and inserting ``$100,000,000 for each of fiscal years 2025
    through 2029''.

    SEC. 704. SICKLE CELL DISEASE PREVENTION AND TREATMENT.

        (a) In General.--Section 1106(b) of the Public Health Service Act
    (42 U.S.C. 300b-5(b)) is amended--
                (1) in paragraph (1)(A)(iii), by striking ``prevention and
            treatment of sickle cell disease'' and inserting ``treatment of
            sickle cell disease and the prevention and treatment of
            complications of sickle cell disease'';
                (2) in paragraph (2)(D), by striking ``prevention and
            treatment of sickle cell disease'' and inserting ``treatment of
            sickle cell disease and the prevention and treatment of
            complications of sickle cell disease'';
                (3) in paragraph (3)--
                        (A) in subparagraph (A), by striking ``enter into a
                    contract with'' and inserting ``make a grant to, or
                    enter into a contract or cooperative agreement with,'';
                    and
                        (B) in subparagraph (B), in each of clauses (ii)
                    and (iii), by striking ``prevention and treatment of
                    sickle cell disease'' and inserting ``treatment of
                    sickle cell disease and the prevention and treatment of
                    complications of sickle cell disease''; and
                (4) in paragraph (6), by striking ``$4,455,000 for each of
            fiscal years 2019 through 2023'' and inserting ``$8,205,000 for
            each of fiscal years 2025 through 2029''.
        (b) Sense of Congress.--It is the sense of Congress that further
    research should be undertaken to expand the understanding of the causes
    of, and to find cures for, heritable blood disorders, including sickle
    cell disease.

    SEC. 705. TRAUMATIC BRAIN INJURIES.

        (a) The Bill Pascrell, Jr., National Program for Traumatic Brain
    Injury Surveillance and Registries.--
                (1) Prevention of traumatic brain injury.--Section 393B of
            the Public Health Service Act (42 U.S.C. 280b-1c) is amended--
                        (A) in subsection (a), by inserting ``and
                    prevalence'' after ``incidence'';
                        (B) in subsection (b)--
                                (i) in paragraph (1), by inserting ``and
                            reduction of associated injuries and
                            fatalities'' before the semicolon;
                                (ii) in paragraph (2), by inserting ``and
                            related risk factors'' before the semicolon;
                            and
                                (iii) in paragraph (3)--
                                        (I) in the matter preceding
                                    subparagraph (A), by striking ``2020''
                                    each place it appears and inserting
                                    ``2030''; and
                                        (II) in subparagraph (A)--
                                                (aa) in clause (i), by
                                            striking ``; and'' and
                                            inserting a semicolon;
                                                (bb) by redesignating
                                            clause (ii) as clause (iv);
                                                (cc) by inserting after
                                            clause (i) the following:
                                ``(ii) populations at higher risk of
                            traumatic brain injury, including populations
                            whose increased risk is due to occupational or
                            circumstantial factors;
                                ``(iii) causes of, and risk factors for,
                            traumatic brain injury; and''; and
                                                (dd) in clause (iv), as so
                                            redesignated, by striking
                                            ``arising from traumatic brain
                                            injury'' and inserting ``,
                                            which may include related
                                            mental health and other
                                            conditions, arising from
                                            traumatic brain injury,
                                            including''; and
                        (C) in subsection (c), by inserting ``, and other
                    relevant Federal departments and agencies'' before the
                    period at the end.
                (2) National program for traumatic brain injury
            surveillance and registries.--Section 393C of the Public Health
            Service Act (42 U.S.C. 280b-1d) is amended--
                        (A) by amending the section heading to read as
                    follows: ``the bill pascrell, jr., national program for
                    traumatic brain injury surveillance and registries'';
                        (B) in subsection (a)--
                                (i) in the matter preceding paragraph (1),
                            by inserting ``to identify populations that may
                            be at higher risk for traumatic brain injuries,
                            to collect data on the causes of, and risk
                            factors for, traumatic brain injuries,'' after
                            ``related disability,'';
                                (ii) in paragraph (1), by inserting ``,
                            including the occupation of the individual,
                            when relevant to the circumstances surrounding
                            the injury'' before the semicolon; and
                                (iii) in paragraph (4), by inserting
                            ``short- and long-term'' before ``outcomes'';
                        (C) by striking subsection (b);
                        (D) by redesignating subsection (c) as subsection
                    (b);
                        (E) in subsection (b), as so redesignated, by
                    inserting ``and evidence-based practices to identify
                    and address concussion'' before the period at the end;
                    and
                        (F) by adding at the end the following:
        ``(c) Availability of Information.--The Secretary, acting through
    the Director of the Centers for Disease Control and Prevention, shall
    make publicly available aggregated information on traumatic brain
    injury and concussion described in this section, including on the
    website of the Centers for Disease Control and Prevention. Such
    website, to the extent feasible, shall include aggregated information
    on populations that may be at higher risk for traumatic brain injuries
    and strategies for preventing or reducing risk of traumatic brain
    injury that are tailored to such populations.''.
                (3) Authorization of appropriations.--Section 394A of the
            Public Health Service Act (42 U.S.C. 280b-3) is amended--
                        (A) in subsection (a), by striking ``1994, and''
                    and inserting ``1994,''; and
                        (B) in subsection (b), by striking ``2020 through
                    2024'' and inserting ``2025 through 2029''.
        (b) State Grant Programs.--
                (1) State grants for projects regarding traumatic brain
            injury.--Section 1252 of the Public Health Service Act (42
            U.S.C. 300d-52) is amended--
                        (A) in subsection (b)(2)--
                                (i) by inserting ``, taking into
                            consideration populations that may be at higher
                            risk for traumatic brain injuries'' after
                            ``outreach programs''; and
                                (ii) by inserting ``Tribal,'' after
                            ``State,'';
                        (B) in subsection (c), by adding at the end the
                    following:
                ``(3) Maintenance of effort.--With respect to activities
            for which a grant awarded under subsection (a) is to be
            expended, a State or American Indian consortium shall agree to
            maintain expenditures of non-Federal amounts for such
            activities at a level that is not less than the level of such
            expenditures maintained by the State or American Indian
            consortium for the fiscal year preceding the fiscal year for
            which the State or American Indian consortium receives such a
            grant.
                ``(4) Waiver.--The Secretary may, upon the request of a
            State or American Indian consortium, waive not more than 50
            percent of the matching fund amount under paragraph (1), if the
            Secretary determines that such matching fund amount would
            result in an inability of the State or American Indian
            consortium to carry out the purposes under subsection (a). A
            waiver provided by the Secretary under this paragraph shall
            apply only to the fiscal year involved.'';
                        (C) in subsection (e)(3)(B)--
                                (i) by striking ``(such as third party
                            payers, State agencies, community-based
                            providers, schools, and educators)''; and
                                (ii) by inserting ``(such as third party
                            payers, State agencies, community-based
                            providers, schools, and educators)'' after
                            ``professionals'';
                        (D) in subsection (h), by striking paragraphs (1)
                    and (2) and inserting the following:
                ``(1) American indian consortium; state.--The terms
            `American Indian consortium' and `State' have the meanings
            given such terms in section 1253.
                ``(2) Traumatic brain injury.--
                        ``(A) In general.--Subject to subparagraph (B), the
                    term `traumatic brain injury'--
                                ``(i) means an acquired injury to the
                            brain;
                                ``(ii) may include--
                                        ``(I) brain injuries caused by
                                    anoxia due to trauma; and
                                        ``(II) damage to the brain from an
                                    internal or external source that
                                    results in infection, toxicity,
                                    surgery, or vascular disorders not
                                    associated with aging; and
                                ``(iii) does not include brain dysfunction
                            caused by congenital or degenerative disorders,
                            or birth trauma.
                        ``(B) Revisions to definition.--The Secretary may
                    revise the definition of the term `traumatic brain
                    injury' under this paragraph, as the Secretary
                    determines necessary, after consultation with States
                    and other appropriate public or nonprofit private
                    entities.''; and
                        (E) in subsection (i), by striking ``2020 through
                    2024'' and inserting ``2025 through 2029''.
                (2) State grants for protection and advocacy services.--
            Section 1253(l) of the Public Health Service Act (42 U.S.C.
            300d-53(l)) is amended by striking ``2020 through 2024'' and
            inserting ``2025 through 2029''.
        (c) Report to Congress.--Not later than 2 years after the date of
    enactment of this Act, the Secretary of Health and Human Services
    (referred to in this Act as the ``Secretary'') 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 contains--
                (1) an overview of populations who may be at higher risk
            for traumatic brain injury, such as individuals affected by
            domestic violence or sexual assault and public safety officers
            as defined in section 1204 of the Omnibus Crime Control and
            Safe Streets Act of 1968 (34 U.S.C. 10284);
                (2) an outline of existing surveys and activities of the
            Centers for Disease Control and Prevention on traumatic brain
            injuries and any steps the agency has taken to address gaps in
            data collection related to such higher risk populations, which
            may include leveraging surveys such as the National Intimate
            Partner and Sexual Violence Survey to collect data on traumatic
            brain injuries;
                (3) an overview of any outreach or education efforts to
            reach such higher risk populations; and
                (4) any challenges associated with reaching such higher
            risk populations.
        (d) Study on Long-Term Symptoms or Conditions Related to Traumatic
    Brain Injury.--
                (1) In general.--The Secretary, in consultation with
            stakeholders and the heads of other relevant Federal
            departments and agencies, as appropriate, shall conduct, either
            directly or through a contract with a nonprofit private entity,
            a study to--
                        (A) examine the incidence and prevalence of long-
                    term or chronic symptoms or conditions in individuals
                    who have experienced a traumatic brain injury;
                        (B) examine the evidence base of research related
                    to the chronic effects of traumatic brain injury across
                    the lifespan;
                        (C) examine any correlations between traumatic
                    brain injury and increased risk of other conditions,
                    such as dementia and mental health conditions;
                        (D) assess existing services available for
                    individuals with such long-term or chronic symptoms or
                    conditions; and
                        (E) identify any gaps in research related to such
                    long-term or chronic symptoms or conditions of
                    individuals who have experienced a traumatic brain
                    injury.
                (2) Public report.--Not later than 2 years after the date
            of enactment of this Act, the Secretary shall--
                        (A) 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 findings, conclusions, and
                    recommendations of the study described in paragraph
                    (1); and
                        (B) in the case that such study is conducted
                    directly by the Secretary, make the report described in
                    subparagraph (A) publicly available on the website of
                    the Department of Health and Human Services.

    SEC. 706. LIFESPAN RESPITE CARE.

        (a) Definition of Family Caregiver.--Section 2901(5) of the Public
    Health Service Act (42 U.S.C. 300ii(5)) is amended by striking ``unpaid
    adult'' and inserting ``unpaid individual''.
        (b) Funding.--Section 2905 of the Public Health Service Act (42
    U.S.C. 300ii-4) is amended by striking ``fiscal years 2020 through
    fiscal year 2024'' and inserting ``fiscal years 2025 through 2029''.

    SEC. 707. DR. LORNA BREEN HEALTH CARE PROVIDER PROTECTION.

        (a) Dissemination of Best Practices.-- Section 2 of the Dr. Lorna
    Breen Health Care Provider Protection Act (Public Law 117-105) is
    amended by striking ``2 years'' and inserting ``5 years''.
        (b) Education and Awareness Initiative Encouraging Use of Mental
    Health and Substance Use Disorder Services by Health Care
    Professionals.--Section 3 of the Dr. Lorna Breen Health Care Provider
    Protection Act (Public Law 117-105) is amended--
                (1) in subsection (b), by inserting ``and annually
            thereafter,'' after ``of this Act,''; and
                (2) in subsection (c), by striking ``2022 through 2024''
            and inserting ``2025 through 2029''.
        (c) Programs To Promote Mental Health Among the Health Professional
    Workforce.--The second section 764 of the Public Health Service Act (42
    U.S.C. 294t), as added by section 4 of the Dr. Lorna Breen Health Care
    Provider Protection Act (Public Law 117-105), is amended--
                (1) by redesignating such section 764 as section 764A;
                (2) in subsection (a)(3)--
                        (A) by striking ``to eligible entities in'' and
                    inserting ``to eligible entities that--
                        ``(A) are in'';
                        (B) by striking the period and inserting ``; or'';
                    and
                        (C) by adding at the end the following:
                        ``(B) have a focus on the reduction of
                    administrative burden on health care workers.'';
                (3) in subsection (c), by inserting ``not less than'' after
            ``period of''; and
                (4) in subsection (f), by striking ``2022 through 2024''
            and inserting ``2025 through 2029''.

    SEC. 708. SCREENS FOR CANCER.

        (a) National Breast and Cervical Cancer Early Detection Program.--
    Title XV of the Public Health Service Act (42 U.S.C. 300k et seq.) is
    amended--
                (1) in section 1501 (42 U.S.C. 300k)--
                        (A) in subsection (a)--
                                (i) in paragraph (2), by striking ``the
                            provision of appropriate follow-up services and
                            support services such as case management'' and
                            inserting ``that appropriate follow-up services
                            are provided'';
                                (ii) in paragraph (3), by striking
                            ``programs for the detection and control'' and
                            inserting ``for the prevention, detection, and
                            control'';
                                (iii) in paragraph (4), by striking ``the
                            detection and control'' and inserting ``the
                            prevention, detection, and control'';
                                (iv) in paragraph (5)--
                                        (I) by striking ``monitor'' and
                                    inserting ``ensure''; and
                                        (II) by striking ``; and'' and
                                    inserting a semicolon;
                                (v) by redesignating paragraph (6) as
                            paragraph (9);
                                (vi) by inserting after paragraph (5) the
                            following:
                ``(6) to enhance appropriate support activities to increase
            breast and cervical cancer screenings, such as navigation of
            health care services, implementation of evidence-based or
            evidence-informed strategies to increase breast and cervical
            cancer screening in health care settings, and facilitation of
            access to health care settings;
                ``(7) to reduce disparities in breast and cervical cancer
            incidence, morbidity, and mortality, including in populations
            with higher than average rates;
                ``(8) to improve access to breast and cervical cancer
            screening and diagnostic services and reduce related barriers,
            including factors that relate to negative health outcomes;
            and''; and
                                (vii) in paragraph (9), as so redesignated,
                            by striking ``through (5)'' and inserting
                            ``through (8)''; and
                        (B) by striking subsection (d);
                (2) in section 1503 (42 U.S.C. 300m)--
                        (A) in subsection (a)--
                                (i) in paragraph (1), by striking ``that,
                            initially'' and all that follows through the
                            semicolon and inserting ``that appropriate
                            breast and cervical cancer screening and
                            diagnostic services are provided consistent
                            with relevant evidence-based recommendations;
                            and'';
                                (ii) by striking paragraphs (2) and (4);
                                (iii) by redesignating paragraph (3) as
                            paragraph (2); and
                                (iv) in paragraph (2), as so redesignated,
                            by striking ``; and'' and inserting a period;
                            and
                        (B) by striking subsection (d);
                (3) in section 1508(b) (42 U.S.C. 300n-4(b))--
                        (A) by striking ``1 year after the date of the
                    enactment of the National Breast and Cervical Cancer
                    Early Detection Program Reauthorization of 2007, and
                    annually thereafter,'' and inserting ``2 years after
                    the date of enactment of the Bipartisan Health Care
                    Act, and every 5 years thereafter,'';
                        (B) by striking ``Labor and Human Resources'' and
                    inserting ``Health, Education, Labor, and Pensions'';
                    and
                        (C) by striking ``preceding fiscal year'' and
                    inserting ``preceding 2 fiscal years in the case of the
                    first report after the date of enactment of the
                    Bipartisan Health Care Act and preceding 5 fiscal years
                    for each report thereafter''; and
                (4) in section 1510(a) (42 U.S.C. 300n-5(a))--
                        (A) by striking ``2011, and'' and inserting
                    ``2011,''; and
                        (B) by inserting ``, and $235,500,000 for each of
                    fiscal years 2025 through 2029'' before the period at
                    the end before the period at the end.
        (b) GAO Study.--Not later than September 30, 2027, the Comptroller
    General of the United States shall 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 work of the
    National Breast and Cervical Cancer Early Detection Program,
    including--
                (1) an estimate of the number of individuals eligible for
            services provided under such program;
                (2) a summary of trends in the number of individuals served
            through such program; and
                (3) an assessment of any factors that may be driving the
            trends identified under paragraph (2), including any barriers
            to accessing breast and cervical cancer screenings provided by
            such program.

    SEC. 709. DEONDRA DIXON INCLUDE PROJECT.

        Part B of title IV of the Public Health Service Act (42 U.S.C. 284
    et seq.) is amended by adding at the end the following:

    ``SEC. 409K. DOWN SYNDROME RESEARCH.

        ``(a) In General.--The Director of NIH shall carry out a program of
    research, training, and investigation related to Down syndrome to be
    known as the `INvestigation of Co-occurring conditions across the
    Lifespan to Understand Down syndromE Project' or the `INCLUDE Project'.
        ``(b) Program Elements.--The program under subsection (a) shall
    include--
                ``(1) high-risk, high reward research on the effects of
            trisomy 21 on human development and health;
                ``(2) promoting research for participants with Down
            syndrome across the lifespan, including cohort studies to
            facilitate improved understanding of Down syndrome and co-
            occurring conditions and development of new interventions;
                ``(3) expanding the number of clinical trials that are
            inclusive of, or expressly for, participants with Down
            syndrome, including novel biomedical and pharmacological
            interventions and other therapies designed to promote or
            enhance activities of daily living;
                ``(4) research on the biological mechanisms in individuals
            with Down syndrome pertaining to structural, functional, and
            behavioral anomalies and dysfunction as well as stunted growth;
                ``(5) supporting research to improve diagnosis and
            treatment of conditions co-occurring with Down syndrome,
            including the identification of biomarkers related to risk
            factors, diagnosis, and clinical research and therapeutics;
                ``(6) research on the causes of increased prevalence, and
            concurrent treatment, of co-occurring conditions, such as
            Alzheimer's disease and related dementias and autoimmunity, in
            individuals with Down syndrome; and
                ``(7) research, training, and investigation on improving
            the quality of life of individuals with Down syndrome and their
            families.
        ``(c) Coordination; Prioritizing Nonduplicative Research.--The
    Director of NIH shall ensure that--
                ``(1) the programs and activities of the institutes and
            centers of the National Institutes of Health relating to Down
            syndrome and co-occurring conditions are coordinated, including
            through the Office of the Director of NIH and priority-setting
            reviews conducted pursuant to section 402(b)(3); and
                ``(2) such institutes and centers, prioritize, as
            appropriate, Down syndrome research that does not duplicate
            existing research activities of the National Institutes of
            Health.
        ``(d) Consultation With Stakeholders.--In carrying out activities
    under this section, the Director of NIH shall, as appropriate and to
    the maximum extent feasible, consult with relevant stakeholders,
    including patient advocates, to ensure that such activities take into
    consideration the needs of individuals with Down syndrome.
        ``(e) Biennial Reports to Congress.--
                ``(1) In general.--The Director of NIH shall submit, on a
            biennial basis, to the Committee on Energy and Commerce and the
            Subcommittee on Labor, Health and Human Services, Education,
            and Related Agencies of the Committee on Appropriations of the
            House of Representatives and the Committee on Health,
            Education, Labor, and Pensions and the Subcommittee on Labor,
            Health and Human Services, Education, and Related Agencies of
            the Committee on Appropriations of the Senate, a report that
            catalogs the research conducted or supported under this
            section.
                ``(2) Contents.--Each report under paragraph (1) shall
            include--
                        ``(A) identification of the institute or center
                    involved;
                        ``(B) a statement of whether the research is or was
                    being carried out directly by such institute or center
                    or by multiple institutes and centers; and
                        ``(C) identification of any resulting real-world
                    evidence that is or may be used for clinical research
                    and medical care for patients with Down syndrome.''.

    SEC. 710. IMPROVE INITIATIVE.

        Part B of title IV of the Public Health Service Act (42 U.S.C. 284
    et seq.), as amended by section 710, is further amended by adding at
    the end the following:

    ``SEC. 409L. IMPROVE INITIATIVE.

        ``(a) In General.--The Director of the National Institutes of
    Health shall carry out a program of research to improve health outcomes
    to be known as the Implementing a Maternal health and PRegnancy
    Outcomes Vision for Everyone Initiative (referred to in this section as
    the `Initiative').
        ``(b) Objectives.--The Initiative shall--
                ``(1) advance research to--
                        ``(A) reduce preventable causes of maternal
                    mortality and severe maternal morbidity;
                        ``(B) reduce health disparities related to maternal
                    health outcomes, including such disparities associated
                    with medically underserved populations; and
                        ``(C) improve health for pregnant and postpartum
                    women before, during, and after pregnancy;
                ``(2) use an integrated approach to understand the factors,
            including biological, behavioral, and other factors, that
            affect maternal mortality and severe maternal morbidity by
            building an evidence base for improved outcomes in specific
            regions of the United States; and
                ``(3) target health disparities associated with maternal
            mortality and severe maternal morbidity by--
                        ``(A) implementing and evaluating community-based
                    interventions for disproportionately affected women;
                    and
                        ``(B) identifying risk factors and the underlying
                    biological mechanisms associated with leading causes of
                    maternal mortality and severe maternal morbidity in the
                    United States.
        ``(c) Sunset.--The authority under this section shall expire on
    September 30, 2029.''.

    SEC. 711. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.

        Section 372 of the Public Health Service Act (42 U.S.C. 274) is
    amended--
                (1) in subsection (b)(2)--
                        (A) by moving the margins of subparagraphs (M)
                    through (O) 2 ems to the left;
                        (B) in subparagraph (A)--
                                (i) in clause (i), by striking ``, and''
                            and inserting ``; and''; and
                                (ii) in clause (ii), by striking the comma
                            at the end and inserting a semicolon;
                        (C) in subparagraph (C), by striking ``twenty-four-
                    hour telephone service'' and inserting ``24-hour
                    telephone or information technology service'';
                        (D) in each of subparagraphs (B) through (M), by
                    striking the comma at the end and inserting a
                    semicolon;
                        (E) in subparagraph (N), by striking
                    ``transportation, and'' and inserting
                    ``transportation;'';
                        (F) in subparagraph (O), by striking the period and
                    inserting a semicolon; and
                        (G) by adding at the end the following:
                ``(P) encourage the integration of electronic health
            records systems through application programming interfaces (or
            successor technologies) among hospitals, organ procurement
            organizations, and transplant centers, including the use of
            automated electronic hospital referrals and the grant of
            remote, electronic access to hospital electronic health records
            of potential donors by organ procurement organizations, in a
            manner that complies with the privacy regulations promulgated
            under the Health Insurance Portability and Accountability Act
            of 1996, at part 160 of title 45, Code of Federal Regulations,
            and subparts A, C, and E of part 164 of such title (or any
            successor regulations); and
                ``(Q) consider establishing a dashboard to display the
            number of transplants performed, the types of transplants
            performed, the number and types of organs that entered the
            Organ Procurement and Transplantation Network system and failed
            to be transplanted, and other appropriate statistics, which
            should be updated more frequently than annually.''; and
                (2) by adding at the end the following:
        ``(d) Registration Fees.--
                ``(1) In general.--The Secretary may collect registration
            fees from any member of the Organ Procurement and
            Transplantation Network for each transplant candidate such
            member places on the list described in subsection (b)(2)(A)(i).
            Such registration fees shall be collected and distributed only
            to support the operation of the Organ Procurement and
            Transplantation Network. Such registration fees are authorized
            to remain available until expended.
                ``(2) Collection.--The Secretary may collect the
            registration fees under paragraph (1) directly or through
            awards made under subsection (b)(1)(A).
                ``(3) Distribution.--Any amounts collected under this
            subsection shall--
                        ``(A) be credited to the currently applicable
                    appropriation, account, or fund of the Department of
                    Health and Human Services as discretionary offsetting
                    collections; and
                        ``(B) be available, only to the extent and in the
                    amounts provided in advance in appropriations Acts, to
                    distribute such fees among awardees described in
                    subsection (b)(1)(A).
                ``(4) Transparency.--The Secretary shall--
                        ``(A) promptly post on the website of the Organ
                    Procurement and Transplantation Network--
                                ``(i) the amount of registration fees
                            collected under this subsection from each
                            member of the Organ Procurement and
                            Transplantation Network; and
                                ``(ii) a list of activities such fees are
                            used to support; and
                        ``(B) update the information posted pursuant to
                    subparagraph (A), as applicable for each calendar
                    quarter for which fees are collected under paragraph
                    (1).
                ``(5) GAO review.--Not later than 2 years after the date of
            enactment of this subsection, the Comptroller General of the
            United States shall, to the extent data are available--
                        ``(A) conduct a review concerning the activities
                    under this subsection; and
                        ``(B) submit to the Committee on Health, Education,
                    Labor, and Pensions and the Committee on Finance of the
                    Senate and the Committee on Energy and Commerce of the
                    House of Representatives, a report on such review,
                    including related recommendations, as applicable.
                ``(6) Sunset.--The authority to collect registration fees
            under paragraph (1) shall expire on the date that is 3 years
            after the date of enactment of the Bipartisan Health Care
            Act.''.

    SEC. 712. HONOR OUR LIVING DONORS.

        (a) No Consideration of Income of Organ Recipient.--Section 377 of
    the Public Health Service Act (42 U.S.C. 274f) is amended--
                (1) by redesignating subsections (c) through (f) as
            subsections (d) through (g), respectively;
                (2) by inserting after subsection (b) the following:
        ``(c) No Consideration of Income of Organ Recipient.--The recipient
    of a grant under this section, in providing reimbursement to a donating
    individual through such grant, shall not give any consideration to the
    income of the organ recipient.''; and
                (3) in subsection (f), as so redesignated--
                        (A) in paragraph (1), by striking ``subsection
                    (c)(1)'' and inserting ``subsection (d)(1)''; and
                        (B) in paragraph (2), by striking ``subsection
                    (c)(2)'' and inserting ``subsection (d)(2)''.
        (b) Removal of Expectation of Payments by Organ Recipients.--
    Section 377(e) of the Public Health Service Act (42 U.S.C. 274f(e)), as
    redesignated by subsection (a)(1), is amended--
                (1) in paragraph (1), by adding ``or'' at the end;
                (2) in paragraph (2), by striking ``; or'' and inserting a
            period; and
                (3) by striking paragraph (3).
        (c) Annual Report.--Section 377 of the Public Health Service Act
    (42 U.S.C. 274f), as amended by subsections (a) and (b), is amended by
    adding at the end the following:
        ``(h) Annual Report.--Not later than December 31 of each year,
    beginning in fiscal year 2026, the Secretary shall--
                ``(1) prepare, submit to the Congress, and make public a
            report on whether grants under this section provided adequate
            funding during the preceding fiscal year to reimburse all
            donating individuals participating in the grant program under
            this section for all qualifying expenses; and
                ``(2) include in each such report--
                        ``(A) the estimated number of all donating
                    individuals participating in the grant program under
                    this section who did not receive reimbursement for all
                    qualifying expenses during the preceding fiscal year;
                    and
                        ``(B) the total amount of funding that is estimated
                    to be necessary to fully reimburse all donating
                    individuals participating in the grant program under
                    this section for all qualifying expenses.''.

    SEC. 713. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

        Section 409I(d)(1) of the Public Health Service Act (42 U.S.C.
    284m(d)(1)) is amended by striking ``section,'' and all that follows
    through the period at the end and inserting ``section, $25,000,000 for
    each of fiscal years 2025 through 2027.''.

                    TITLE VIII--FOOD AND DRUG ADMINISTRATION

                         Subtitle A--Give Kids a Chance

    SEC. 801. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL AUTHORITIES
                  OF FOOD AND DRUG ADMINISTRATION REGARDING MOLECULARLY
                  TARGETED CANCER DRUGS.

        (a) In General.--
                (1) Additional active ingredient for application drug;
            limitation regarding novel-combination application drug.--
            Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act
            (21 U.S.C. 355c(a)(3)) is amended--
                        (A) by redesignating subparagraphs (B) and (C) as
                    subparagraphs (C) and (D), respectively; and
                        (B) by striking subparagraph (A) and inserting the
                    following:
                        ``(A) In general.--For purposes of paragraph
                    (1)(B), the investigation described in this paragraph
                    is a molecularly targeted pediatric cancer
                    investigation of--
                                ``(i) the drug or biological product for
                            which the application referred to in such
                            paragraph is submitted; or
                                ``(ii) such drug or biological product used
                            in combination with--
                                        ``(I) an active ingredient of a
                                    drug or biological product--
                                                ``(aa) for which an
                                            approved application under
                                            section 505(j) under this Act
                                            or under section 351(k) of the
                                            Public Health Service Act is in
                                            effect; and
                                                ``(bb) that is determined
                                            by the Secretary, after
                                            consultation with the
                                            applicant, to be part of the
                                            standard of care for treating a
                                            pediatric cancer; or
                                        ``(II) an active ingredient of a
                                    drug or biological product--
                                                ``(aa) for which an
                                            approved application under
                                            section 505(b) of this Act or
                                            section 351(a) of the Public
                                            Health Service Act to treat an
                                            adult cancer is in effect and
                                            is held by the same person
                                            submitting the application
                                            under paragraph (1)(B); and
                                                ``(bb) that is directed at
                                            a molecular target that the
                                            Secretary determines to be
                                            substantially relevant to the
                                            growth or progression of a
                                            pediatric cancer.
                        ``(B) Additional requirements.--
                                ``(i) Design of investigation.--A
                            molecularly targeted pediatric cancer
                            investigation referred to in subparagraph (A)
                            shall be designed to yield clinically
                            meaningful pediatric study data that is
                            gathered using appropriate formulations for
                            each age group for which the study is required,
                            regarding dosing, safety, and preliminary
                            efficacy to inform potential pediatric
                            labeling.
                                ``(ii) Limitation.--An investigation
                            described in subparagraph (A)(ii) may be
                            required only if the drug or biological product
                            for which the application referred to in
                            paragraph (1)(B) contains either--
                                        ``(I) a single new active
                                    ingredient; or
                                        ``(II) more than one active
                                    ingredient, if an application for the
                                    combination of active ingredients has
                                    not previously been approved but each
                                    active ingredient is in a drug product
                                    that has been previously approved to
                                    treat an adult cancer.
                                ``(iii) Results of already-completed
                            preclinical studies of application drug.--With
                            respect to an investigation required pursuant
                            to paragraph (1)(B), the Secretary may require
                            the results of any completed preclinical
                            studies relevant to the initial pediatric study
                            plan be submitted to the Secretary at the same
                            time that the initial pediatric study plan
                            required under subsection (e)(1) is submitted.
                                ``(iv) Rule of construction regarding
                            inactive ingredients.--With respect to a
                            combination of active ingredients referred to
                            in subparagraph (A)(ii), such subparagraph
                            shall not be construed as addressing the use of
                            inactive ingredients with such combination.''.
                (2) Determination of applicable requirements.--Section
            505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21
            U.S.C. 355c(e)(1)) is amended by adding at the end the
            following: ``The Secretary shall determine whether subparagraph
            (A) or (B) of subsection (a)(1) applies with respect to an
            application before the date on which the applicant is required
            to submit the initial pediatric study plan under paragraph
            (2)(A).''.
                (3) Clarifying applicability.--Section 505B(a)(1) of the
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) is
            amended by adding at the end the following:
                        ``(C) Rule of construction.--No application that is
                    subject to the requirements of subparagraph (B) shall
                    be subject to the requirements of subparagraph (A), and
                    no application (or supplement to an application) that
                    is subject to the requirements of subparagraph (A)
                    shall be subject to the requirements of subparagraph
                    (B).''.
                (4) Conforming amendments.--Section 505B(a) of the Federal
            Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended--
                        (A) in paragraph (3)(C), as redesignated by
                    paragraph (1)(A) of this subsection, by striking
                    ``investigations described in this paragraph'' and
                    inserting ``investigations referred to in subparagraph
                    (A)''; and
                        (B) in paragraph (3)(D), as redesignated by
                    paragraph (1)(A) of this subsection, by striking ``the
                    assessments under paragraph (2)(B)'' and inserting
                    ``the assessments required under paragraph (1)(A)''.
        (b) Guidance.--The Secretary of Health and Human Services, acting
    through the Commissioner of Food and Drugs, shall--
                (1) not later than 12 months after the date of enactment of
            this Act, issue draft guidance on the implementation of the
            amendments made by subsection (a); and
                (2) not later than 12 months after closing the comment
            period on such draft guidance, finalize such guidance.
        (c) Applicability.--The amendments made by this section apply with
    respect to any application under section 505(b) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 355(b)) and any application under
    section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)),
    that is submitted on or after the date that is 3 years after the date
    of enactment of this Act.
        (d) Reports to Congress.--
                (1) Secretary of health and human services.--Not later than
            6 years after the date of enactment of this Act, the Secretary
            of Health and Human Services 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 Secretary's efforts, in coordination
            with industry, to ensure implementation of the amendments made
            by subsection (a).
                (2) GAO study and report.--
                        (A) Study.--Not later than 8 years after the date
                    of enactment of this Act, the Comptroller General of
                    the United States shall conduct a study of the
                    effectiveness of requiring assessments and
                    investigations described in section 505B of the Federal
                    Food, Drug, and Cosmetic Act (21 U.S.C.355c), as
                    amended by subsection (a), in the development of drugs
                    and biological products for pediatric cancer
                    indications, including consideration of any benefits
                    to, or burdens on, pediatric cancer drug development.
                        (B) Findings.--Not later than 10 years after the
                    date of enactment of this Act, the Comptroller General
                    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 containing the findings of the study conducted
                    under subparagraph (A).

    SEC. 802. ENSURING COMPLETION OF PEDIATRIC STUDY REQUIREMENTS.

        (a) Equal Accountability for Pediatric Study Requirements.--Section
    505B(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d))
    is amended--
                (1) in paragraph (1), by striking ``Beginning 270'' and
            inserting ``Noncompliance letter.--Beginning 270'';
                (2) in paragraph (2)--
                        (A) by striking ``The drug or'' and inserting
                    ``Effect of noncompliance.--The drug or''; and
                        (B) by striking ``(except that the drug or
                    biological product shall not be subject to action under
                    section 303)'' and inserting ``(except that the drug or
                    biological product shall be subject to action under
                    section 303 only if such person demonstrated a lack of
                    due diligence in satisfying the applicable
                    requirement)''; and
                (3) by adding at the end the following:
                ``(3) Limitation.--The Secretary shall not issue
            enforcement actions under section 303 for failures under this
            subsection in the case of a drug or biological product that is
            no longer marketed.''.
        (b) Due Diligence.--Section 505B(d) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 355c(d)), as amended by subsection (a), is
    further amended by adding at the end the following:
                ``(4) Due diligence.--Before the Secretary may conclude
            that a person failed to submit or otherwise meet a requirement
            as described in the matter preceding paragraph (1), the
            Secretary shall--
                        ``(A) issue a noncompliance letter pursuant to
                    paragraph (1);
                        ``(B) provide such person with a 45-day period
                    beginning on the date of receipt of such noncompliance
                    letter to respond in writing as set forth in such
                    paragraph; and
                        ``(C) after reviewing such written response,
                    determine whether the person demonstrated a lack of due
                    diligence in satisfying such requirement.''.
        (c) Conforming Amendments.--Section 303(f)(4)(A) of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(4)(A)) is amended by
    striking ``or 505-1'' and inserting ``505-1, or 505B''.
        (d) Transition Rule.--The Secretary of Health and Human Services
    may take enforcement action under section 303 of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 333) only for failures described in
    section 505B(d) of such Act (21 U.S.C. 355c(d)) that occur on or after
    the date that is 180 days after the date of enactment of this Act.

    SEC. 803. FDA REPORT ON PREA ENFORCEMENT.

        Section 508(b) of the Food and Drug Administration Safety and
    Innovation Act (21 U.S.C. 355c-1(b)) is amended--
                (1) in paragraph (11), by striking the semicolon at the end
            and inserting ``, including an evaluation of compliance with
            deadlines provided for in deferrals and deferral extensions;'';
                (2) in paragraph (15), by striking ``and'' at the end;
                (3) in paragraph (16), by striking the period at the end
            and inserting ``; and''; and
                (4) by adding at the end the following:
                ``(17) a listing of penalties, settlements, or payments
            under section 303 of the Federal Food, Drug, and Cosmetic Act
            (21 U.S.C. 353) for failure to comply with requirements under
            such section 505B, including, for each penalty, settlement, or
            payment, the name of the drug, the sponsor thereof, and the
            amount of the penalty, settlement, or payment imposed; and''.

    SEC. 804. EXTENSION OF AUTHORITY TO ISSUE PRIORITY REVIEW VOUCHERS TO
                  ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES.

        (a) Extension.--Paragraph (5) of section 529(b) of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by
    striking ``December 20, 2024, unless'' and all that follows through the
    period at the end and inserting ``September 30, 2029.''.
        (b) User Fee Payment.--Section 529(c)(4) of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 360ff(c)(4)) is amended by striking
    subparagraph (A) and inserting the following:
                        ``(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. All other user fees associated with the human
                    drug application shall be due as required by the
                    Secretary or under applicable law.''.
        (c) GAO Report on Effectiveness of Rare Pediatric Disease Priority
    Voucher Awards in Incentivizing Rare Pediatric Disease Drug
    Development.--
                (1) GAO study.--
                        (A) Study.--The Comptroller General of the United
                    States shall conduct a study of the effectiveness of
                    awarding rare pediatric disease priority vouchers under
                    section 529 of the Federal Food, Drug, and Cosmetic Act
                    (21 U.S.C. 360ff), as amended by subsection (a), in the
                    development of human drug products that treat or
                    prevent rare pediatric diseases (as defined in such
                    section 529).
                        (B) Contents of study.--In conducting the study
                    under subparagraph (A), the Comptroller General shall
                    examine the following:
                                (i) The indications for each drug or
                            biological product that--
                                        (I) is the subject of a rare
                                    pediatric disease product application
                                    (as defined in section 529 of the
                                    Federal Food, Drug, and Cosmetic Act
                                    (21 U.S.C. 360ff)) for which a priority
                                    review voucher was awarded; and
                                        (II) was approved under section 505
                                    of the Federal Food, Drug, and Cosmetic
                                    Act (42 U.S.C. 355) or licensed under
                                    section 351 of the Public Health
                                    Service Act (42 U.S.C. 262).
                                (ii) Whether, and to what extent, an unmet
                            need related to the treatment or prevention of
                            a rare pediatric disease was met through the
                            approval or licensure of such a drug or
                            biological product.
                                (iii) The size of the company to which a
                            priority review voucher was awarded under
                            section 529 of the Federal Food, Drug, and
                            Cosmetic Act (21 U.S.C. 360ff) for such a drug
                            or biological product.
                                (iv) The value of such priority review
                            voucher if transferred.
                                (v) Identification of each drug for which a
                            priority review voucher awarded under such
                            section 529 was used.
                                (vi) The size of the company using each
                            priority review voucher awarded under such
                            section 529.
                                (vii) The length of the period of time
                            between the date on which a priority review
                            voucher was awarded under such section 529 and
                            the date on which it was used.
                                (viii) Whether, and to what extent, an
                            unmet need related to the treatment or
                            prevention of a rare pediatric disease was met
                            through the approval under section 505 of the
                            Federal Food, Drug, and Cosmetic Act (42 U.S.C.
                            355) or licensure under section 351 of the
                            Public Health Service Act (42 U.S.C. 262) of a
                            drug for which a priority review voucher was
                            used.
                                (ix) Whether, and to what extent, companies
                            were motivated by the availability of priority
                            review vouchers under section 529 of the
                            Federal Food, Drug, and Cosmetic Act (21 U.S.C.
                            360ff) to attempt to develop a drug for a rare
                            pediatric disease.
                                (x) Whether, and to what extent, pediatric
                            review vouchers awarded under such section were
                            successful in stimulating development and
                            expedited patient access to drug products for
                            treatment or prevention of a rare pediatric
                            disease that wouldn't otherwise take place
                            without the incentive provided by such
                            vouchers.
                                (xi) The impact of such priority review
                            vouchers on the workload, review process, and
                            public health prioritization efforts of the
                            Food and Drug Administration.
                                (xii) Any other incentives in Federal law
                            that exist for companies developing drugs or
                            biological products described in clause (i).
                (2) Report on findings.--Not later than 5 years after the
            date of the enactment of this Act, 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
            containing the findings of the study conducted under paragraph
            (1).

    SEC. 805. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICENSURE OF ORPHAN
                  DRUGS.

        (a) In General.--Section 527 of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 360cc) is amended--
                (1) in subsection (a), in the matter following paragraph
            (2), by striking ``same disease or condition'' and inserting
            ``same approved use or indication within such rare disease or
            condition'';
                (2) in subsection (b)--
                        (A) in the matter preceding paragraph (1), by
                    striking ``same rare disease or condition'' and
                    inserting ``same approved use or indication for which
                    such 7-year period applies to such already approved or
                    licensed drug''; and
                        (B) in paragraph (1), by inserting ``, relating to
                    the approved use or indication,'' after ``the needs'';
                (3) in subsection (c)(1), by striking ``same rare disease
            or condition as the already approved drug'' and inserting
            ``same use or indication for which the already approved or
            licensed drug was approved or licensed''; and
                (4) by adding at the end the following:
        ``(f) Approved Use or Indication Defined.--In this section, the
    term `approved use or indication' means the use or indication approved
    under section 505 of this Act or licensed under section 351 of the
    Public Health Service Act for a drug designated under section 526 for a
    rare disease or condition.''.
        (b) Application of Amendments.--The amendments made by subsection
    (a) shall apply with respect to any drug designated under section 526
    of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb),
    regardless of the date on which the drug was so designated, and
    regardless of the date on which the drug was approved under section 505
    of such Act (21 U.S.C. 355) or licensed under section 351 of the Public
    Health Service Act (42 U.S.C. 262).

       Subtitle B--United States-Abraham Accords Cooperation and Security

    SEC. 811. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE WITHIN FOOD AND DRUG
                  ADMINISTRATION.

        (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. 1015. ABRAHAM ACCORDS OFFICE.

        ``(a) In General.--The Secretary, acting through the Commissioner
    of Food and Drugs, shall establish within the Food and Drug
    Administration an office, to be known as the Abraham Accords Office, to
    be headed by a director.
        ``(b) Office.--Not later than 2 years after the date of enactment
    of this section, the Secretary shall--
                ``(1) in consultation with the governments of Abraham
            Accords countries, as well as appropriate United States
            Government diplomatic and security personnel--
                        ``(A) select the location of the Abraham Accords
                    Office in an Abraham Accords country; and
                        ``(B) establish such office; and
                ``(2) assign to such office such personnel of the Food and
            Drug Administration as the Secretary determines necessary to
            carry out the functions of such office.
        ``(c) Duties.--The Secretary, acting through the Director of the
    Abraham Accords Office, shall--
                ``(1) after the Abraham Accords Office is established--
                        ``(A) as part of the Food and Drug Administration's
                    work to strengthen the international oversight of
                    regulated commodities, provide technical assistance to
                    regulatory partners in Abraham Accords countries on
                    strengthening regulatory oversight and converging
                    regulatory requirements for the oversight of regulated
                    products, including good manufacturing practices and
                    other issues relevant to manufacturing medical products
                    that are regulated by the Food and Drug Administration;
                    and
                        ``(B) facilitate interactions between the Food and
                    Drug Administration and interested parties in Abraham
                    Accords countries, including by sharing relevant
                    information regarding United States regulatory pathways
                    with such parties, and facilitate feedback on the
                    research, development, and manufacturing of products
                    regulated in accordance with this Act; and
                ``(2) carry out other functions and activities as the
            Secretary determines to be necessary to carry out this section.
        ``(d) Abraham Accords Country Defined.--In this section, the term
    `Abraham Accords country' means a country identified by the Department
    of State as having signed the Abraham Accords Declaration.
        ``(e) National Security.--Nothing in this section shall be
    construed to require any action inconsistent with a national security
    recommendation provided by the Federal Government.''.
        (b) Report to Congress.--
                (1) In general.--Not later than 3 years after the date of
            enactment of this Act, the Secretary of Health and Human
            Services shall submit to the Congress a report on the Abraham
            Accords Office, including--
                        (A) an evaluation of how the Office has advanced
                    progress toward conformance with Food and Drug
                    Administration regulatory requirements by manufacturers
                    in the Abraham Accords countries;
                        (B) a numerical count of parties that the Office
                    has helped facilitate interactions or feedback pursuant
                    to section 1015(c)(1)(B) of the Federal Food, Drug, and
                    Cosmetic Act (as added by subsection (a));
                        (C) a summary of technical assistance provided to
                    regulatory partners in Abraham Accords countries
                    pursuant to subparagraph (A) of such section
                    1015(c)(1); and
                        (D) recommendations for increasing and improving
                    coordination between the Food and Drug Administration
                    and entities in Abraham Accords countries.
                (2) Abraham accords country defined.--In this subsection,
            the term ``Abraham Accords country'' has the meaning given such
            term in section 1015(d) of the Federal Food, Drug, and Cosmetic
            Act (as added by subsection (a)).

                   TITLE IX--LOWERING PRESCRIPTION DRUG COSTS

    SEC. 901. OVERSIGHT OF PHARMACY BENEFIT MANAGEMENT SERVICES.

        (a) Public Health Service Act.--Title XXVII of the Public Health
    Service Act (42 U.S.C. 300gg et seq.) is amended--
                (1) in part D (42 U.S.C. 300gg-111 et seq.), by adding at
            the end the following new section:

    ``SEC. 2799A-11. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BENEFIT
                  MANAGEMENT SERVICES.

        ``(a) In General.--For plan years beginning on or after the date
    that is 30 months after the date of enactment of this section (referred
    to in this subsection and subsection (b) as the `effective date'), a
    group health plan or a health insurance issuer offering group health
    insurance coverage, or an entity providing pharmacy benefit management
    services on behalf of such a plan or issuer, shall not enter into a
    contract, including an extension or renewal of a contract, entered into
    on or after the effective date, with an applicable entity unless such
    applicable entity agrees to--
                ``(1) not limit or delay the disclosure of information to
            the group health plan (including such a plan offered through a
            health insurance issuer) in such a manner that prevents an
            entity providing pharmacy benefit management services on behalf
            of a group health plan or health insurance issuer offering
            group health insurance coverage from making the reports
            described in subsection (b); and
                ``(2) provide the entity providing pharmacy benefit
            management services on behalf of a group health plan or health
            insurance issuer relevant information necessary to make the
            reports described in subsection (b).
        ``(b) Reports.--
                ``(1) In general.--For plan years beginning on or after the
            effective date, in the case of any contract between a group
            health plan or a health insurance issuer offering group health
            insurance coverage offered in connection with such a plan and
            an entity providing pharmacy benefit management services on
            behalf of such plan or issuer, including an extension or
            renewal of such a contract, entered into on or after the
            effective date, the entity providing pharmacy benefit
            management services on behalf of such a group health plan or
            health insurance issuer, not less frequently than every 6
            months (or, at the request of a group health plan, not less
            frequently than quarterly, and under the same conditions,
            terms, and cost of the semiannual report under this
            subsection), shall submit to the group health plan a report in
            accordance with this section. Each such report shall be made
            available to such group health plan in plain language, in a
            machine-readable format, and as the Secretary may determine,
            other formats. Each such report shall include the information
            described in paragraph (2).
                ``(2) Information described.--For purposes of paragraph
            (1), the information described in this paragraph is, with
            respect to drugs covered by a group health plan or group health
            insurance coverage offered by a health insurance issuer in
            connection with a group health plan during each reporting
            period--
                        ``(A) in the case of a group health plan that is
                    offered by a specified large employer or that is a
                    specified large plan, and is not offered as health
                    insurance coverage, or in the case of health insurance
                    coverage for which the election under paragraph (3) is
                    made for the applicable reporting period--
                                ``(i) a list of drugs for which a claim was
                            filed and, with respect to each such drug on
                            such list--
                                        ``(I) the contracted compensation
                                    paid by the group health plan or health
                                    insurance issuer for each covered drug
                                    (identified by the National Drug Code)
                                    to the entity providing pharmacy
                                    benefit management services or other
                                    applicable entity on behalf of the
                                    group health plan or health insurance
                                    issuer;
                                        ``(II) the contracted compensation
                                    paid to the pharmacy, by any entity
                                    providing pharmacy benefit management
                                    services or other applicable entity on
                                    behalf of the group health plan or
                                    health insurance issuer, for each
                                    covered drug (identified by the
                                    National Drug Code);
                                        ``(III) for each such claim, the
                                    difference between the amount paid
                                    under subclause (I) and the amount paid
                                    under subclause (II);
                                        ``(IV) the proprietary name,
                                    established name or proper name, and
                                    the National Drug Code;
                                        ``(V) for each claim for the drug
                                    (including original prescriptions and
                                    refills) and for each dosage unit of
                                    the drug for which a claim was filed,
                                    the type of dispensing channel used to
                                    furnish the drug, including retail,
                                    mail order, or specialty pharmacy;
                                        ``(VI) with respect to each drug
                                    dispensed, for each type of dispensing
                                    channel (including retail, mail order,
                                    or specialty pharmacy)--
                                                ``(aa) whether such drug is
                                            a brand name drug or a generic
                                            drug, and--

                                                        ``(AA) in the case
                                                    of a brand name drug,
                                                    the wholesale
                                                    acquisition cost,
                                                    listed as cost per days
                                                    supply and cost per
                                                    dosage unit, on the
                                                    date such drug was
                                                    dispensed; and

                                                        ``(BB) in the case
                                                    of a generic drug, the
                                                    average wholesale
                                                    price, listed as cost
                                                    per days supply and
                                                    cost per dosage unit,
                                                    on the date such drug
                                                    was dispensed; and

                                                ``(bb) the total number
                                            of--

                                                        ``(AA) prescription
                                                    claims (including
                                                    original prescriptions
                                                    and refills);

                                                        ``(BB) participants
                                                    and beneficiaries for
                                                    whom a claim for such
                                                    drug was filed through
                                                    the applicable
                                                    dispensing channel;

                                                        ``(CC) dosage units
                                                    and dosage units per
                                                    fill of such drug; and

                                                        ``(DD) days supply
                                                    of such drug per fill;

                                        ``(VII) the net price per course of
                                    treatment or single fill, such as a 30-
                                    day supply or 90-day supply to the plan
                                    or coverage after rebates, fees,
                                    alternative discounts, or other
                                    remuneration received from applicable
                                    entities;
                                        ``(VIII) the total amount of out-
                                    of-pocket spending by participants and
                                    beneficiaries on such drug, including
                                    spending through copayments,
                                    coinsurance, and deductibles, but not
                                    including any amounts spent by
                                    participants and beneficiaries on drugs
                                    not covered under the plan or coverage,
                                    or for which no claim is submitted
                                    under the plan or coverage;
                                        ``(IX) the total net spending on
                                    the drug;
                                        ``(X) the total amount received, or
                                    expected to be received, by the plan or
                                    issuer from any applicable entity in
                                    rebates, fees, alternative discounts,
                                    or other remuneration;
                                        ``(XI) the total amount received,
                                    or expected to be received, by the
                                    entity providing pharmacy benefit
                                    management services, from applicable
                                    entities, in rebates, fees, alternative
                                    discounts, or other remuneration from
                                    such entities--
                                                ``(aa) for claims incurred
                                            during the reporting period;
                                            and
                                                ``(bb) that is related to
                                            utilization of such drug or
                                            spending on such drug; and
                                        ``(XII) to the extent feasible,
                                    information on the total amount of
                                    remuneration for such drug, including
                                    copayment assistance dollars paid,
                                    copayment cards applied, or other
                                    discounts provided by each drug
                                    manufacturer (or entity administering
                                    copayment assistance on behalf of such
                                    drug manufacturer), to the participants
                                    and beneficiaries enrolled in such plan
                                    or coverage;
                                ``(ii) a list of each therapeutic class (as
                            defined by the Secretary) for which a claim was
                            filed under the group health plan or health
                            insurance coverage during the reporting period,
                            and, with respect to each such therapeutic
                            class--
                                        ``(I) the total gross spending on
                                    drugs in such class before rebates,
                                    price concessions, alternative
                                    discounts, or other remuneration from
                                    applicable entities;
                                        ``(II) the net spending in such
                                    class after such rebates, price
                                    concessions, alternative discounts, or
                                    other remuneration from applicable
                                    entities;
                                        ``(III) the total amount received,
                                    or expected to be received, by the
                                    entity providing pharmacy benefit
                                    management services, from applicable
                                    entities, in rebates, fees, alternative
                                    discounts, or other remuneration from
                                    such entities--
                                                ``(aa) for claims incurred
                                            during the reporting period;
                                            and
                                                ``(bb) that is related to
                                            utilization of drugs or drug
                                            spending;
                                        ``(IV) the average net spending per
                                    30-day supply and per 90-day supply by
                                    the plan or by the issuer with respect
                                    to such coverage and its participants
                                    and beneficiaries, among all drugs
                                    within the therapeutic class for which
                                    a claim was filed during the reporting
                                    period;
                                        ``(V) the number of participants
                                    and beneficiaries who filled a
                                    prescription for a drug in such class,
                                    including the National Drug Code for
                                    each such drug;
                                        ``(VI) if applicable, a description
                                    of the formulary tiers and utilization
                                    mechanisms (such as prior authorization
                                    or step therapy) employed for drugs in
                                    that class; and
                                        ``(VII) the total out-of-pocket
                                    spending under the plan or coverage by
                                    participants and beneficiaries,
                                    including spending through copayments,
                                    coinsurance, and deductibles, but not
                                    including any amounts spent by
                                    participants and beneficiaries on drugs
                                    not covered under the plan or coverage
                                    or for which no claim is submitted
                                    under the plan or coverage;
                                ``(iii) with respect to any drug for which
                            gross spending under the group health plan or
                            health insurance coverage exceeded $10,000
                            during the reporting period or, in the case
                            that gross spending under the group health plan
                            or coverage exceeded $10,000 during the
                            reporting period with respect to fewer than 50
                            drugs, with respect to the 50 prescription
                            drugs with the highest spending during the
                            reporting period--
                                        ``(I) a list of all other drugs in
                                    the same therapeutic class as such
                                    drug;
                                        ``(II) if applicable, the rationale
                                    for the formulary placement of such
                                    drug in that therapeutic category or
                                    class, selected from a list of standard
                                    rationales established by the
                                    Secretary, in consultation with
                                    stakeholders; and
                                        ``(III) any change in formulary
                                    placement compared to the prior plan
                                    year; and
                                ``(iv) in the case that such plan or issuer
                            (or an entity providing pharmacy benefit
                            management services on behalf of such plan or
                            issuer) has an affiliated pharmacy or pharmacy
                            under common ownership, including mandatory
                            mail and specialty home delivery programs,
                            retail and mail auto-refill programs, and cost
                            sharing assistance incentives funded by an
                            entity providing pharmacy benefit services--
                                        ``(I) an explanation of any benefit
                                    design parameters that encourage or
                                    require participants and beneficiaries
                                    in the plan or coverage to fill
                                    prescriptions at mail order, specialty,
                                    or retail pharmacies;
                                        ``(II) the percentage of total
                                    prescriptions dispensed by such
                                    pharmacies to participants or
                                    beneficiaries in such plan or coverage;
                                    and
                                        ``(III) a list of all drugs
                                    dispensed by such pharmacies to
                                    participants or beneficiaries enrolled
                                    in such plan or coverage, and, with
                                    respect to each drug dispensed--
                                                ``(aa) the amount charged,
                                            per dosage unit, per 30-day
                                            supply, or per 90-day supply
                                            (as applicable) to the plan or
                                            issuer, and to participants and
                                            beneficiaries;
                                                ``(bb) the median amount
                                            charged to such plan or issuer,
                                            and the interquartile range of
                                            the costs, per dosage unit, per
                                            30-day supply, and per 90-day
                                            supply, including amounts paid
                                            by the participants and
                                            beneficiaries, when the same
                                            drug is dispensed by other
                                            pharmacies that are not
                                            affiliated with or under common
                                            ownership with the entity and
                                            that are included in the
                                            pharmacy network of such plan
                                            or coverage;
                                                ``(cc) the lowest cost per
                                            dosage unit, per 30-day supply
                                            and per 90-day supply, for each
                                            such drug, including amounts
                                            charged to the plan or coverage
                                            and to participants and
                                            beneficiaries, that is
                                            available from any pharmacy
                                            included in the network of such
                                            plan or coverage; and
                                                ``(dd) the net acquisition
                                            cost per dosage unit, per 30-
                                            day supply, and per 90-day
                                            supply, if such drug is subject
                                            to a maximum price discount;
                                            and
                        ``(B) with respect to any group health plan,
                    including group health insurance coverage offered in
                    connection with such a plan, regardless of whether the
                    plan or coverage is offered by a specified large
                    employer or whether it is a specified large plan--
                                ``(i) a summary document for the group
                            health plan that includes such information
                            described in clauses (i) through (iv) of
                            subparagraph (A), as specified by the Secretary
                            through guidance, program instruction, or
                            otherwise (with no requirement of notice and
                            comment rulemaking), that the Secretary
                            determines useful to group health plans for
                            purposes of selecting pharmacy benefit
                            management services, such as an estimated net
                            price to group health plan and participant or
                            beneficiary, a cost per claim, the fee
                            structure or reimbursement model, and estimated
                            cost per participant or beneficiary;
                                ``(ii) a summary document for plans and
                            issuers to provide to participants and
                            beneficiaries, which shall be made available to
                            participants or beneficiaries upon request to
                            their group health plan (including in the case
                            of group health insurance coverage offered in
                            connection with such a plan), that--
                                        ``(I) contains such information
                                    described in clauses (iii), (iv), (v),
                                    and (vi), as applicable, as specified
                                    by the Secretary through guidance,
                                    program instruction, or otherwise (with
                                    no requirement of notice and comment
                                    rulemaking) that the Secretary
                                    determines useful to participants or
                                    beneficiaries in better understanding
                                    the plan or coverage or benefits under
                                    such plan or coverage;
                                        ``(II) contains only aggregate
                                    information; and
                                        ``(III) states that participants
                                    and beneficiaries may request specific,
                                    claims-level information required to be
                                    furnished under subsection (c) from the
                                    group health plan or health insurance
                                    issuer; and
                                ``(iii) with respect to drugs covered by
                            such plan or coverage during such reporting
                            period--
                                        ``(I) the total net spending by the
                                    plan or coverage for all such drugs;
                                        ``(II) the total amount received,
                                    or expected to be received, by the plan
                                    or issuer from any applicable entity in
                                    rebates, fees, alternative discounts,
                                    or other remuneration; and
                                        ``(III) to the extent feasible,
                                    information on the total amount of
                                    remuneration for such drugs, including
                                    copayment assistance dollars paid,
                                    copayment cards applied, or other
                                    discounts provided by each drug
                                    manufacturer (or entity administering
                                    copayment assistance on behalf of such
                                    drug manufacturer) to participants and
                                    beneficiaries;
                                ``(iv) amounts paid directly or indirectly
                            in rebates, fees, or any other type of
                            compensation (as defined in section
                            408(b)(2)(B)(ii)(dd)(AA) of the Employee
                            Retirement Income Security Act) to brokerage
                            firms, brokers, consultants, advisors, or any
                            other individual or firm, for--
                                        ``(I) the referral of the group
                                    health plan's or health insurance
                                    issuer's business to an entity
                                    providing pharmacy benefit management
                                    services, including the identity of the
                                    recipient of such amounts;
                                        ``(II) consideration of the entity
                                    providing pharmacy benefit management
                                    services by the group health plan or
                                    health insurance issuer; or
                                        ``(III) the retention of the entity
                                    by the group health plan or health
                                    insurance issuer;
                                ``(v) an explanation of any benefit design
                            parameters that encourage or require
                            participants and beneficiaries in such plan or
                            coverage to fill prescriptions at mail order,
                            specialty, or retail pharmacies that are
                            affiliated with or under common ownership with
                            the entity providing pharmacy benefit
                            management services under such plan or
                            coverage, including mandatory mail and
                            specialty home delivery programs, retail and
                            mail auto-refill programs, and cost-sharing
                            assistance incentives directly or indirectly
                            funded by such entity; and
                                ``(vi) total gross spending on all drugs
                            under the plan or coverage during the reporting
                            period.
                ``(3) Opt-in for group health insurance coverage offered by
            a specified large employer or that is a specified large plan.--
            In the case of group health insurance coverage offered in
            connection with a group health plan that is offered by a
            specified large employer or is a specified large plan, such
            group health plan may, on an annual basis, for plan years
            beginning on or after the date that is 30 months after the date
            of enactment of this section, elect to require an entity
            providing pharmacy benefit management services on behalf of the
            health insurance issuer to submit to such group health plan a
            report that includes all of the information described in
            paragraph (2)(A), in addition to the information described in
            paragraph (2)(B).
                ``(4) Privacy requirements.--
                        ``(A) In general.--An entity providing pharmacy
                    benefit management services on behalf of a group health
                    plan or a health insurance issuer offering group health
                    insurance coverage shall report information under
                    paragraph (1) in a manner consistent with the privacy
                    regulations promulgated under section 13402(a) of the
                    Health Information Technology for Economic and Clinical
                    Health Act and consistent with the privacy regulations
                    promulgated under the Health Insurance Portability and
                    Accountability Act of 1996 in part 160 and subparts A
                    and E of part 164 of title 45, Code of Federal
                    Regulations (or successor regulations) (referred to in
                    this paragraph as the `HIPAA privacy regulations') and
                    shall restrict the use and disclosure of such
                    information according to such privacy regulations and
                    such HIPAA privacy regulations.
                        ``(B) Additional requirements.--
                                ``(i) In general.--An entity providing
                            pharmacy benefit management services on behalf
                            of a group health plan or health insurance
                            issuer offering group health insurance coverage
                            that submits a report under paragraph (1) shall
                            ensure that such report contains only summary
                            health information, as defined in section
                            164.504(a) of title 45, Code of Federal
                            Regulations (or successor regulations).
                                ``(ii) Restrictions.--In carrying out this
                            subsection, a group health plan shall comply
                            with section 164.504(f) of title 45, Code of
                            Federal Regulations (or a successor
                            regulation), and a plan sponsor shall act in
                            accordance with the terms of the agreement
                            described in such section.
                        ``(C) Rule of construction.--
                                ``(i) Nothing in this section shall be
                            construed to modify the requirements for the
                            creation, receipt, maintenance, or transmission
                            of protected health information under the HIPAA
                            privacy regulations.
                                ``(ii) Nothing in this section shall be
                            construed to affect the application of any
                            Federal or State privacy or civil rights law,
                            including the HIPAA privacy regulations, the
                            Genetic Information Nondiscrimination Act of
                            2008 (Public Law 110-233) (including the
                            amendments made by such Act), the Americans
                            with Disabilities Act of 1990 (42 U.S.C. 12101
                            et seq.), section 504 of the Rehabilitation Act
                            of 1973 (29 U.S.C. 794), section 1557 of the
                            Patient Protection and Affordable Care Act (42
                            U.S.C. 18116), title VI of the Civil Rights Act
                            of 1964 (42 U.S.C. 2000d), and title VII of the
                            Civil Rights Act of 1964 (42 U.S.C. 2000e).
                        ``(D) Written notice.--Each plan year, group health
                    plans, including with respect to group health insurance
                    coverage offered in connection with a group health
                    plan, shall provide to each participant or beneficiary
                    written notice informing the participant or beneficiary
                    of the requirement for entities providing pharmacy
                    benefit management services on behalf of the group
                    health plan or health insurance issuer offering group
                    health insurance coverage to submit reports to group
                    health plans under paragraph (1), as applicable, which
                    may include incorporating such notification in plan
                    documents provided to the participant or beneficiary,
                    or providing individual notification.
                        ``(E) Limitation to business associates.--A group
                    health plan receiving a report under paragraph (1) may
                    disclose such information only to the entity from which
                    the report was received or to that entity's business
                    associates as defined in section 160.103 of title 45,
                    Code of Federal Regulations (or successor regulations)
                    or as permitted by the HIPAA privacy regulations.
                        ``(F) Clarification regarding public disclosure of
                    information.--Nothing in this section shall prevent an
                    entity providing pharmacy benefit management services
                    on behalf of a group health plan or health insurance
                    issuer offering group health insurance coverage, from
                    placing reasonable restrictions on the public
                    disclosure of the information contained in a report
                    described in paragraph (1), except that such plan,
                    issuer, or entity may not--
                                ``(i) restrict disclosure of such report to
                            the Department of Health and Human Services,
                            the Department of Labor, or the Department of
                            the Treasury; or
                                ``(ii) prevent disclosure for the purposes
                            of subsection (c), or any other public
                            disclosure requirement under this section.
                        ``(G) Limited form of report.--The Secretary shall
                    define through rulemaking a limited form of the report
                    under paragraph (1) required with respect to any group
                    health plan established by a plan sponsor that is, or
                    is affiliated with, a drug manufacturer, drug
                    wholesaler, or other direct participant in the drug
                    supply chain, in order to prevent anti-competitive
                    behavior.
                ``(5) Standard format and regulations.--
                        ``(A) In general.--Not later than 18 months after
                    the date of enactment of this section, the Secretary
                    shall specify through rulemaking a standard format for
                    entities providing pharmacy benefit management services
                    on behalf of group health plans and health insurance
                    issuers offering group health insurance coverage, to
                    submit reports required under paragraph (1).
                        ``(B) Additional regulations.--Not later than 18
                    months after the date of enactment of this section, the
                    Secretary shall, through rulemaking, promulgate any
                    other final regulations necessary to implement the
                    requirements of this section. In promulgating such
                    regulations, the Secretary shall, to the extent
                    practicable, align the reporting requirements under
                    this section with the reporting requirements under
                    section 2799A-10.
        ``(c) Requirement To Provide Information to Participants or
    Beneficiaries.--A group health plan, including with respect to group
    health insurance coverage offered in connection with a group health
    plan, upon request of a participant or beneficiary, shall provide to
    such participant or beneficiary--
                ``(1) the summary document described in subsection
            (b)(2)(B)(ii); and
                ``(2) the information described in subsection
            (b)(2)(A)(i)(III) with respect to a claim made by or on behalf
            of such participant or beneficiary.
        ``(d) Enforcement.--
                ``(1) In general.--The Secretary shall enforce this
            section. The enforcement authority under this subsection shall
            apply only with respect to group health plans (including group
            health insurance coverage offered in connection with such a
            plan) to which the requirements of subparts I and II of part A
            and part D apply in accordance with section 2722, and with
            respect to entities providing pharmacy benefit management
            services on behalf of such plans and applicable entities
            providing services on behalf of such plans.
                ``(2) Failure to provide information.--A group health plan,
            a health insurance issuer offering group health insurance
            coverage, an entity providing pharmacy benefit management
            services on behalf of such a plan or issuer, or an applicable
            entity providing services on behalf of such a plan or issuer
            that violates subsection (a); an entity providing pharmacy
            benefit management services on behalf of such a plan or issuer
            that fails to provide the information required under subsection
            (b); or a group health plan that fails to provide the
            information required under subsection (c), shall be subject to
            a civil monetary penalty in the amount of $10,000 for each day
            during which such violation continues or such information is
            not disclosed or reported.
                ``(3) False information.--A health insurance issuer, an
            entity providing pharmacy benefit management services, or a
            third party administrator providing services on behalf of such
            issuer offered by a health insurance issuer that knowingly
            provides false information under this section shall be subject
            to a civil monetary penalty in an amount not to exceed $100,000
            for each item of false information. Such civil monetary penalty
            shall be in addition to other penalties as may be prescribed by
            law.
                ``(4) Procedure.--The provisions of section 1128A of the
            Social Security Act, other than subsections (a) and (b) and the
            first sentence of subsection (c)(1) of such section shall apply
            to civil monetary penalties under this subsection in the same
            manner as such provisions apply to a penalty or proceeding
            under such section.
                ``(5) Waivers.--The Secretary may waive penalties under
            paragraph (2), or extend the period of time for compliance with
            a requirement of this section, for an entity in violation of
            this section that has made a good-faith effort to comply with
            the requirements in this section.
        ``(e) Rule of Construction.--Nothing in this section shall be
    construed to permit a health insurance issuer, group health plan,
    entity providing pharmacy benefit management services on behalf of a
    group health plan or health insurance issuer, or other entity to
    restrict disclosure to, or otherwise limit the access of, the Secretary
    to a report described in subsection (b)(1) or information related to
    compliance with subsections (a), (b), (c), or (d) by such issuer, plan,
    or entity.
        ``(f) Definitions.--In this section:
                ``(1) Applicable entity.--The term `applicable entity'
            means--
                        ``(A) an applicable group purchasing organization,
                    drug manufacturer, distributor, wholesaler, rebate
                    aggregator (or other purchasing entity designed to
                    aggregate rebates), or associated third party;
                        ``(B) any subsidiary, parent, affiliate, or
                    subcontractor of a group health plan, health insurance
                    issuer, entity that provides pharmacy benefit
                    management services on behalf of such a plan or issuer,
                    or any entity described in subparagraph (A); or
                        ``(C) such other entity as the Secretary may
                    specify through rulemaking.
                ``(2) Applicable group purchasing organization.--The term
            `applicable group purchasing organization' means a group
            purchasing organization that is affiliated with or under common
            ownership with an entity providing pharmacy benefit management
            services.
                ``(3) Contracted compensation.--The term `contracted
            compensation' means the sum of any ingredient cost and
            dispensing fee for a drug (inclusive of the out-of-pocket costs
            to the participant or beneficiary), or another analogous
            compensation structure that the Secretary may specify through
            regulations.
                ``(4) Gross spending.--The term `gross spending', with
            respect to prescription drug benefits under a group health plan
            or health insurance coverage, means the amount spent by a group
            health plan or health insurance issuer on prescription drug
            benefits, calculated before the application of rebates, fees,
            alternative discounts, or other remuneration.
                ``(5) Net spending.--The term `net spending', with respect
            to prescription drug benefits under a group health plan or
            health insurance coverage, means the amount spent by a group
            health plan or health insurance issuer on prescription drug
            benefits, calculated after the application of rebates, fees,
            alternative discounts, or other remuneration.
                ``(6) Plan sponsor.--The term `plan sponsor' has the
            meaning given such term in section 3(16)(B) of the Employee
            Retirement Income Security Act of 1974.
                ``(7) Remuneration.--The term `remuneration' has the
            meaning given such term by the Secretary through rulemaking,
            which shall be reevaluated by the Secretary every 5 years.
                ``(8) Specified large employer.--The term `specified large
            employer' means, in connection with a group health plan
            (including group health insurance coverage offered in
            connection with such a plan) established or maintained by a
            single employer, with respect to a calendar year or a plan
            year, as applicable, an employer who employed an average of at
            least 100 employees on business days during the preceding
            calendar year or plan year and who employs at least 1 employee
            on the first day of the calendar year or plan year.
                ``(9) Specified large plan.--The term `specified large
            plan' means a group health plan (including group health
            insurance coverage offered in connection with such a plan)
            established or maintained by a plan sponsor described in clause
            (ii) or (iii) of section 3(16)(B) of the Employee Retirement
            Income Security Act of 1974 that had an average of at least 100
            participants on business days during the preceding calendar
            year or plan year, as applicable.
                ``(10) Wholesale acquisition cost.--The term `wholesale
            acquisition cost' has the meaning given such term in section
            1847A(c)(6)(B) of the Social Security Act.''; and
                (2) in section 2723 (42 U.S.C. 300gg-22)--
                        (A) in subsection (a)--
                                (i) in paragraph (1), by inserting ``(other
                            than section 2799A-11)'' after ``part D''; and
                                (ii) in paragraph (2), by inserting
                            ``(other than section 2799A-11)'' after ``part
                            D''; and
                        (B) in subsection (b)--
                                (i) in paragraph (1), by inserting ``(other
                            than section 2799A-11)'' after ``part D'';
                                (ii) in paragraph (2)(A), by inserting
                            ``(other than section 2799A-11)'' after ``part
                            D''; and
                                (iii) in paragraph (2)(C)(ii), by inserting
                            ``(other than section 2799A-11)'' after ``part
                            D''.
        (b) Employee Retirement Income Security Act of 1974.--
                (1) In general.--Subtitle B of title I of the Employee
            Retirement Income Security Act of 1974 (29 U.S.C. 1021 et seq.)
            is amended--
                        (A) in subpart B of part 7 (29 U.S.C. 1185 et
                    seq.), by adding at the end the following:

    ``SEC. 726. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BENEFIT
                  MANAGEMENT SERVICES.

        ``(a) In General.--For plan years beginning on or after the date
    that is 30 months after the date of enactment of this section (referred
    to in this subsection and subsection (b) as the `effective date'), a
    group health plan or a health insurance issuer offering group health
    insurance coverage, or an entity providing pharmacy benefit management
    services on behalf of such a plan or issuer, shall not enter into a
    contract, including an extension or renewal of a contract, entered into
    on or after the effective date, with an applicable entity unless such
    applicable entity agrees to--
                ``(1) not limit or delay the disclosure of information to
            the group health plan (including such a plan offered through a
            health insurance issuer) in such a manner that prevents an
            entity providing pharmacy benefit management services on behalf
            of a group health plan or health insurance issuer offering
            group health insurance coverage from making the reports
            described in subsection (b); and
                ``(2) provide the entity providing pharmacy benefit
            management services on behalf of a group health plan or health
            insurance issuer relevant information necessary to make the
            reports described in subsection (b).
        ``(b) Reports.--
                ``(1) In general.--For plan years beginning on or after the
            effective date, in the case of any contract between a group
            health plan or a health insurance issuer offering group health
            insurance coverage offered in connection with such a plan and
            an entity providing pharmacy benefit management services on
            behalf of such plan or issuer, including an extension or
            renewal of such a contract, entered into on or after the
            effective date, the entity providing pharmacy benefit
            management services on behalf of such a group health plan or
            health insurance issuer, not less frequently than every 6
            months (or, at the request of a group health plan, not less
            frequently than quarterly, and under the same conditions,
            terms, and cost of the semiannual report under this
            subsection), shall submit to the group health plan a report in
            accordance with this section. Each such report shall be made
            available to such group health plan in plain language, in a
            machine-readable format, and as the Secretary may determine,
            other formats. Each such report shall include the information
            described in paragraph (2).
                ``(2) Information described.--For purposes of paragraph
            (1), the information described in this paragraph is, with
            respect to drugs covered by a group health plan or group health
            insurance coverage offered by a health insurance issuer in
            connection with a group health plan during each reporting
            period--
                        ``(A) in the case of a group health plan that is
                    offered by a specified large employer or that is a
                    specified large plan, and is not offered as health
                    insurance coverage, or in the case of health insurance
                    coverage for which the election under paragraph (3) is
                    made for the applicable reporting period--
                                ``(i) a list of drugs for which a claim was
                            filed and, with respect to each such drug on
                            such list--
                                        ``(I) the contracted compensation
                                    paid by the group health plan or health
                                    insurance issuer for each covered drug
                                    (identified by the National Drug Code)
                                    to the entity providing pharmacy
                                    benefit management services or other
                                    applicable entity on behalf of the
                                    group health plan or health insurance
                                    issuer;
                                        ``(II) the contracted compensation
                                    paid to the pharmacy, by any entity
                                    providing pharmacy benefit management
                                    services or other applicable entity on
                                    behalf of the group health plan or
                                    health insurance issuer, for each
                                    covered drug (identified by the
                                    National Drug Code);
                                        ``(III) for each such claim, the
                                    difference between the amount paid
                                    under subclause (I) and the amount paid
                                    under subclause (II);
                                        ``(IV) the proprietary name,
                                    established name or proper name, and
                                    the National Drug Code;
                                        ``(V) for each claim for the drug
                                    (including original prescriptions and
                                    refills) and for each dosage unit of
                                    the drug for which a claim was filed,
                                    the type of dispensing channel used to
                                    furnish the drug, including retail,
                                    mail order, or specialty pharmacy;
                                        ``(VI) with respect to each drug
                                    dispensed, for each type of dispensing
                                    channel (including retail, mail order,
                                    or specialty pharmacy)--
                                                ``(aa) whether such drug is
                                            a brand name drug or a generic
                                            drug, and--

                                                        ``(AA) in the case
                                                    of a brand name drug,
                                                    the wholesale
                                                    acquisition cost,
                                                    listed as cost per days
                                                    supply and cost per
                                                    dosage unit, on the
                                                    date such drug was
                                                    dispensed; and

                                                        ``(BB) in the case
                                                    of a generic drug, the
                                                    average wholesale
                                                    price, listed as cost
                                                    per days supply and
                                                    cost per dosage unit,
                                                    on the date such drug
                                                    was dispensed; and

                                                ``(bb) the total number
                                            of--

                                                        ``(AA) prescription
                                                    claims (including
                                                    original prescriptions
                                                    and refills);

                                                        ``(BB) participants
                                                    and beneficiaries for
                                                    whom a claim for such
                                                    drug was filed through
                                                    the applicable
                                                    dispensing channel;

                                                        ``(CC) dosage units
                                                    and dosage units per
                                                    fill of such drug; and

                                                        ``(DD) days supply
                                                    of such drug per fill;

                                        ``(VII) the net price per course of
                                    treatment or single fill, such as a 30-
                                    day supply or 90-day supply to the plan
                                    or coverage after rebates, fees,
                                    alternative discounts, or other
                                    remuneration received from applicable
                                    entities;
                                        ``(VIII) the total amount of out-
                                    of-pocket spending by participants and
                                    beneficiaries on such drug, including
                                    spending through copayments,
                                    coinsurance, and deductibles, but not
                                    including any amounts spent by
                                    participants and beneficiaries on drugs
                                    not covered under the plan or coverage,
                                    or for which no claim is submitted
                                    under the plan or coverage;
                                        ``(IX) the total net spending on
                                    the drug;
                                        ``(X) the total amount received, or
                                    expected to be received, by the plan or
                                    issuer from any applicable entity in
                                    rebates, fees, alternative discounts,
                                    or other remuneration;
                                        ``(XI) the total amount received,
                                    or expected to be received, by the
                                    entity providing pharmacy benefit
                                    management services, from applicable
                                    entities, in rebates, fees, alternative
                                    discounts, or other remuneration from
                                    such entities--
                                                ``(aa) for claims incurred
                                            during the reporting period;
                                            and
                                                ``(bb) that is related to
                                            utilization of such drug or
                                            spending on such drug; and
                                        ``(XII) to the extent feasible,
                                    information on the total amount of
                                    remuneration for such drug, including
                                    copayment assistance dollars paid,
                                    copayment cards applied, or other
                                    discounts provided by each drug
                                    manufacturer (or entity administering
                                    copayment assistance on behalf of such
                                    drug manufacturer), to the participants
                                    and beneficiaries enrolled in such plan
                                    or coverage;
                                ``(ii) a list of each therapeutic class (as
                            defined by the Secretary) for which a claim was
                            filed under the group health plan or health
                            insurance coverage during the reporting period,
                            and, with respect to each such therapeutic
                            class--
                                        ``(I) the total gross spending on
                                    drugs in such class before rebates,
                                    price concessions, alternative
                                    discounts, or other remuneration from
                                    applicable entities;
                                        ``(II) the net spending in such
                                    class after such rebates, price
                                    concessions, alternative discounts, or
                                    other remuneration from applicable
                                    entities;
                                        ``(III) the total amount received,
                                    or expected to be received, by the
                                    entity providing pharmacy benefit
                                    management services, from applicable
                                    entities, in rebates, fees, alternative
                                    discounts, or other remuneration from
                                    such entities--
                                                ``(aa) for claims incurred
                                            during the reporting period;
                                            and
                                                ``(bb) that is related to
                                            utilization of drugs or drug
                                            spending;
                                        ``(IV) the average net spending per
                                    30-day supply and per 90-day supply by
                                    the plan or by the issuer with respect
                                    to such coverage and its participants
                                    and beneficiaries, among all drugs
                                    within the therapeutic class for which
                                    a claim was filed during the reporting
                                    period;
                                        ``(V) the number of participants
                                    and beneficiaries who filled a
                                    prescription for a drug in such class,
                                    including the National Drug Code for
                                    each such drug;
                                        ``(VI) if applicable, a description
                                    of the formulary tiers and utilization
                                    mechanisms (such as prior authorization
                                    or step therapy) employed for drugs in
                                    that class; and
                                        ``(VII) the total out-of-pocket
                                    spending under the plan or coverage by
                                    participants and beneficiaries,
                                    including spending through copayments,
                                    coinsurance, and deductibles, but not
                                    including any amounts spent by
                                    participants and beneficiaries on drugs
                                    not covered under the plan or coverage
                                    or for which no claim is submitted
                                    under the plan or coverage;
                                ``(iii) with respect to any drug for which
                            gross spending under the group health plan or
                            health insurance coverage exceeded $10,000
                            during the reporting period or, in the case
                            that gross spending under the group health plan
                            or coverage exceeded $10,000 during the
                            reporting period with respect to fewer than 50
                            drugs, with respect to the 50 prescription
                            drugs with the highest spending during the
                            reporting period--
                                        ``(I) a list of all other drugs in
                                    the same therapeutic class as such
                                    drug;
                                        ``(II) if applicable, the rationale
                                    for the formulary placement of such
                                    drug in that therapeutic category or
                                    class, selected from a list of standard
                                    rationales established by the
                                    Secretary, in consultation with
                                    stakeholders; and
                                        ``(III) any change in formulary
                                    placement compared to the prior plan
                                    year; and
                                ``(iv) in the case that such plan or issuer
                            (or an entity providing pharmacy benefit
                            management services on behalf of such plan or
                            issuer) has an affiliated pharmacy or pharmacy
                            under common ownership, including mandatory
                            mail and specialty home delivery programs,
                            retail and mail auto-refill programs, and cost
                            sharing assistance incentives funded by an
                            entity providing pharmacy benefit services--
                                        ``(I) an explanation of any benefit
                                    design parameters that encourage or
                                    require participants and beneficiaries
                                    in the plan or coverage to fill
                                    prescriptions at mail order, specialty,
                                    or retail pharmacies;
                                        ``(II) the percentage of total
                                    prescriptions dispensed by such
                                    pharmacies to participants or
                                    beneficiaries in such plan or coverage;
                                    and
                                        ``(III) a list of all drugs
                                    dispensed by such pharmacies to
                                    participants or beneficiaries enrolled
                                    in such plan or coverage, and, with
                                    respect to each drug dispensed--
                                                ``(aa) the amount charged,
                                            per dosage unit, per 30-day
                                            supply, or per 90-day supply
                                            (as applicable) to the plan or
                                            issuer, and to participants and
                                            beneficiaries;
                                                ``(bb) the median amount
                                            charged to such plan or issuer,
                                            and the interquartile range of
                                            the costs, per dosage unit, per
                                            30-day supply, and per 90-day
                                            supply, including amounts paid
                                            by the participants and
                                            beneficiaries, when the same
                                            drug is dispensed by other
                                            pharmacies that are not
                                            affiliated with or under common
                                            ownership with the entity and
                                            that are included in the
                                            pharmacy network of such plan
                                            or coverage;
                                                ``(cc) the lowest cost per
                                            dosage unit, per 30-day supply
                                            and per 90-day supply, for each
                                            such drug, including amounts
                                            charged to the plan or coverage
                                            and to participants and
                                            beneficiaries, that is
                                            available from any pharmacy
                                            included in the network of such
                                            plan or coverage; and
                                                ``(dd) the net acquisition
                                            cost per dosage unit, per 30-
                                            day supply, and per 90-day
                                            supply, if such drug is subject
                                            to a maximum price discount;
                                            and
                        ``(B) with respect to any group health plan,
                    including group health insurance coverage offered in
                    connection with such a plan, regardless of whether the
                    plan or coverage is offered by a specified large
                    employer or whether it is a specified large plan--
                                ``(i) a summary document for the group
                            health plan that includes such information
                            described in clauses (i) through (iv) of
                            subparagraph (A), as specified by the Secretary
                            through guidance, program instruction, or
                            otherwise (with no requirement of notice and
                            comment rulemaking), that the Secretary
                            determines useful to group health plans for
                            purposes of selecting pharmacy benefit
                            management services, such as an estimated net
                            price to group health plan and participant or
                            beneficiary, a cost per claim, the fee
                            structure or reimbursement model, and estimated
                            cost per participant or beneficiary;
                                ``(ii) a summary document for plans and
                            issuers to provide to participants and
                            beneficiaries, which shall be made available to
                            participants or beneficiaries upon request to
                            their group health plan (including in the case
                            of group health insurance coverage offered in
                            connection with such a plan), that--
                                        ``(I) contains such information
                                    described in clauses (iii), (iv), (v),
                                    and (vi), as applicable, as specified
                                    by the Secretary through guidance,
                                    program instruction, or otherwise (with
                                    no requirement of notice and comment
                                    rulemaking) that the Secretary
                                    determines useful to participants or
                                    beneficiaries in better understanding
                                    the plan or coverage or benefits under
                                    such plan or coverage;
                                        ``(II) contains only aggregate
                                    information; and
                                        ``(III) states that participants
                                    and beneficiaries may request specific,
                                    claims-level information required to be
                                    furnished under subsection (c) from the
                                    group health plan or health insurance
                                    issuer; and
                                ``(iii) with respect to drugs covered by
                            such plan or coverage during such reporting
                            period--
                                        ``(I) the total net spending by the
                                    plan or coverage for all such drugs;
                                        ``(II) the total amount received,
                                    or expected to be received, by the plan
                                    or issuer from any applicable entity in
                                    rebates, fees, alternative discounts,
                                    or other remuneration; and
                                        ``(III) to the extent feasible,
                                    information on the total amount of
                                    remuneration for such drugs, including
                                    copayment assistance dollars paid,
                                    copayment cards applied, or other
                                    discounts provided by each drug
                                    manufacturer (or entity administering
                                    copayment assistance on behalf of such
                                    drug manufacturer) to participants and
                                    beneficiaries;
                                ``(iv) amounts paid directly or indirectly
                            in rebates, fees, or any other type of
                            compensation (as defined in section
                            408(b)(2)(B)(ii)(dd)(AA)) to brokerage firms,
                            brokers, consultants, advisors, or any other
                            individual or firm, for--
                                        ``(I) the referral of the group
                                    health plan's or health insurance
                                    issuer's business to an entity
                                    providing pharmacy benefit management
                                    services, including the identity of the
                                    recipient of such amounts;
                                        ``(II) consideration of the entity
                                    providing pharmacy benefit management
                                    services by the group health plan or
                                    health insurance issuer; or
                                        ``(III) the retention of the entity
                                    by the group health plan or health
                                    insurance issuer;
                                ``(v) an explanation of any benefit design
                            parameters that encourage or require
                            participants and beneficiaries in such plan or
                            coverage to fill prescriptions at mail order,
                            specialty, or retail pharmacies that are
                            affiliated with or under common ownership with
                            the entity providing pharmacy benefit
                            management services under such plan or
                            coverage, including mandatory mail and
                            specialty home delivery programs, retail and
                            mail auto-refill programs, and cost-sharing
                            assistance incentives directly or indirectly
                            funded by such entity; and
                                ``(vi) total gross spending on all drugs
                            under the plan or coverage during the reporting
                            period.
                ``(3) Opt-in for group health insurance coverage offered by
            a specified large employer or that is a specified large plan.--
            In the case of group health insurance coverage offered in
            connection with a group health plan that is offered by a
            specified large employer or is a specified large plan, such
            group health plan may, on an annual basis, for plan years
            beginning on or after the date that is 30 months after the date
            of enactment of this section, elect to require an entity
            providing pharmacy benefit management services on behalf of the
            health insurance issuer to submit to such group health plan a
            report that includes all of the information described in
            paragraph (2)(A), in addition to the information described in
            paragraph (2)(B).
                ``(4) Privacy requirements.--
                        ``(A) In general.--An entity providing pharmacy
                    benefit management services on behalf of a group health
                    plan or a health insurance issuer offering group health
                    insurance coverage shall report information under
                    paragraph (1) in a manner consistent with the privacy
                    regulations promulgated under section 13402(a) of the
                    Health Information Technology for Economic and Clinical
                    Health Act (42 U.S.C. 17932(a)) and consistent with the
                    privacy regulations promulgated under the Health
                    Insurance Portability and Accountability Act of 1996 in
                    part 160 and subparts A and E of part 164 of title 45,
                    Code of Federal Regulations (or successor regulations)
                    (referred to in this paragraph as the `HIPAA privacy
                    regulations') and shall restrict the use and disclosure
                    of such information according to such privacy
                    regulations and such HIPAA privacy regulations.
                        ``(B) Additional requirements.--
                                ``(i) In general.--An entity providing
                            pharmacy benefit management services on behalf
                            of a group health plan or health insurance
                            issuer offering group health insurance coverage
                            that submits a report under paragraph (1) shall
                            ensure that such report contains only summary
                            health information, as defined in section
                            164.504(a) of title 45, Code of Federal
                            Regulations (or successor regulations).
                                ``(ii) Restrictions.--In carrying out this
                            subsection, a group health plan shall comply
                            with section 164.504(f) of title 45, Code of
                            Federal Regulations (or a successor
                            regulation), and a plan sponsor shall act in
                            accordance with the terms of the agreement
                            described in such section.
                        ``(C) Rule of construction.--
                                ``(i) Nothing in this section shall be
                            construed to modify the requirements for the
                            creation, receipt, maintenance, or transmission
                            of protected health information under the HIPAA
                            privacy regulations.
                                ``(ii) Nothing in this section shall be
                            construed to affect the application of any
                            Federal or State privacy or civil rights law,
                            including the HIPAA privacy regulations, the
                            Genetic Information Nondiscrimination Act of
                            2008 (Public Law 110-233) (including the
                            amendments made by such Act), the Americans
                            with Disabilities Act of 1990 (42 U.S.C. 12101
                            et seq.), section 504 of the Rehabilitation Act
                            of 1973 (29 U.S.C. 794), section 1557 of the
                            Patient Protection and Affordable Care Act (42
                            U.S.C. 18116), title VI of the Civil Rights Act
                            of 1964 (42 U.S.C. 2000d), and title VII of the
                            Civil Rights Act of 1964 (42 U.S.C. 2000e).
                        ``(D) Written notice.--Each plan year, group health
                    plans, including with respect to group health insurance
                    coverage offered in connection with a group health
                    plan, shall provide to each participant or beneficiary
                    written notice informing the participant or beneficiary
                    of the requirement for entities providing pharmacy
                    benefit management services on behalf of the group
                    health plan or health insurance issuer offering group
                    health insurance coverage to submit reports to group
                    health plans under paragraph (1), as applicable, which
                    may include incorporating such notification in plan
                    documents provided to the participant or beneficiary,
                    or providing individual notification.
                        ``(E) Limitation to business associates.--A group
                    health plan receiving a report under paragraph (1) may
                    disclose such information only to the entity from which
                    the report was received or to that entity's business
                    associates as defined in section 160.103 of title 45,
                    Code of Federal Regulations (or successor regulations)
                    or as permitted by the HIPAA privacy regulations.
                        ``(F) Clarification regarding public disclosure of
                    information.--Nothing in this section shall prevent an
                    entity providing pharmacy benefit management services
                    on behalf of a group health plan or health insurance
                    issuer offering group health insurance coverage, from
                    placing reasonable restrictions on the public
                    disclosure of the information contained in a report
                    described in paragraph (1), except that such plan,
                    issuer, or entity may not--
                                ``(i) restrict disclosure of such report to
                            the Department of Health and Human Services,
                            the Department of Labor, or the Department of
                            the Treasury; or
                                ``(ii) prevent disclosure for the purposes
                            of subsection (c), or any other public
                            disclosure requirement under this section.
                        ``(G) Limited form of report.--The Secretary shall
                    define through rulemaking a limited form of the report
                    under paragraph (1) required with respect to any group
                    health plan established by a plan sponsor that is, or
                    is affiliated with, a drug manufacturer, drug
                    wholesaler, or other direct participant in the drug
                    supply chain, in order to prevent anti-competitive
                    behavior.
                ``(5) Standard format and regulations.--
                        ``(A) In general.--Not later than 18 months after
                    the date of enactment of this section, the Secretary
                    shall specify through rulemaking a standard format for
                    entities providing pharmacy benefit management services
                    on behalf of group health plans and health insurance
                    issuers offering group health insurance coverage, to
                    submit reports required under paragraph (1).
                        ``(B) Additional regulations.--Not later than 18
                    months after the date of enactment of this section, the
                    Secretary shall, through rulemaking, promulgate any
                    other final regulations necessary to implement the
                    requirements of this section. In promulgating such
                    regulations, the Secretary shall, to the extent
                    practicable, align the reporting requirements under
                    this section with the reporting requirements under
                    section 725.
        ``(c) Requirement To Provide Information to Participants or
    Beneficiaries.--A group health plan, including with respect to group
    health insurance coverage offered in connection with a group health
    plan, upon request of a participant or beneficiary, shall provide to
    such participant or beneficiary--
                ``(1) the summary document described in subsection
            (b)(2)(B)(ii); and
                ``(2) the information described in subsection
            (b)(2)(A)(i)(III) with respect to a claim made by or on behalf
            of such participant or beneficiary.
        ``(d) Rule of Construction.--Nothing in this section shall be
    construed to permit a health insurance issuer, group health plan,
    entity providing pharmacy benefit management services on behalf of a
    group health plan or health insurance issuer, or other entity to
    restrict disclosure to, or otherwise limit the access of, the Secretary
    to a report described in subsection (b)(1) or information related to
    compliance with subsections (a), (b), or (c) of this section or section
    502(c)(13) by such issuer, plan, or entity.
        ``(e) Definitions.--In this section:
                ``(1) Applicable entity.--The term `applicable entity'
            means--
                        ``(A) an applicable group purchasing organization,
                    drug manufacturer, distributor, wholesaler, rebate
                    aggregator (or other purchasing entity designed to
                    aggregate rebates), or associated third party;
                        ``(B) any subsidiary, parent, affiliate, or
                    subcontractor of a group health plan, health insurance
                    issuer, entity that provides pharmacy benefit
                    management services on behalf of such a plan or issuer,
                    or any entity described in subparagraph (A); or
                        ``(C) such other entity as the Secretary may
                    specify through rulemaking.
                ``(2) Applicable group purchasing organization.--The term
            `applicable group purchasing organization' means a group
            purchasing organization that is affiliated with or under common
            ownership with an entity providing pharmacy benefit management
            services.
                ``(3) Contracted compensation.--The term `contracted
            compensation' means the sum of any ingredient cost and
            dispensing fee for a drug (inclusive of the out-of-pocket costs
            to the participant or beneficiary), or another analogous
            compensation structure that the Secretary may specify through
            regulations.
                ``(4) Gross spending.--The term `gross spending', with
            respect to prescription drug benefits under a group health plan
            or health insurance coverage, means the amount spent by a group
            health plan or health insurance issuer on prescription drug
            benefits, calculated before the application of rebates, fees,
            alternative discounts, or other remuneration.
                ``(5) Net spending.--The term `net spending', with respect
            to prescription drug benefits under a group health plan or
            health insurance coverage, means the amount spent by a group
            health plan or health insurance issuer on prescription drug
            benefits, calculated after the application of rebates, fees,
            alternative discounts, or other remuneration.
                ``(6) Plan sponsor.--The term `plan sponsor' has the
            meaning given such term in section 3(16)(B).
                ``(7) Remuneration.--The term `remuneration' has the
            meaning given such term by the Secretary through rulemaking,
            which shall be reevaluated by the Secretary every 5 years.
                ``(8) Specified large employer.--The term `specified large
            employer' means, in connection with a group health plan
            (including group health insurance coverage offered in
            connection with such a plan) established or maintained by a
            single employer, with respect to a calendar year or a plan
            year, as applicable, an employer who employed an average of at
            least 100 employees on business days during the preceding
            calendar year or plan year and who employs at least 1 employee
            on the first day of the calendar year or plan year.
                ``(9) Specified large plan.--The term `specified large
            plan' means a group health plan (including group health
            insurance coverage offered in connection with such a plan)
            established or maintained by a plan sponsor described in clause
            (ii) or (iii) of section 3(16)(B) that had an average of at
            least 100 participants on business days during the preceding
            calendar year or plan year, as applicable.
                ``(10) Wholesale acquisition cost.--The term `wholesale
            acquisition cost' has the meaning given such term in section
            1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w-
            3a(c)(6)(B)).'';
                        (B) in section 502 (29 U.S.C. 1132)--
                                (i) in subsection (a)(6), by striking ``or
                            (9)'' and inserting ``(9), or (13)'';
                                (ii) in subsection (b)(3), by striking
                            ``under subsection (c)(9)'' and inserting
                            ``under paragraphs (9) and (13) of subsection
                            (c)''; and
                                (iii) in subsection (c), by adding at the
                            end the following:
                ``(13) Secretarial enforcement authority relating to
            oversight of pharmacy benefit management services.--
                        ``(A) Failure to provide information.--The
                    Secretary may impose a penalty against a plan
                    administrator of a group health plan, a health
                    insurance issuer offering group health insurance
                    coverage, or an entity providing pharmacy benefit
                    management services on behalf of such a plan or issuer,
                    or an applicable entity (as defined in section 726(f))
                    that violates section 726(a); an entity providing
                    pharmacy benefit management services on behalf of such
                    a plan or issuer that fails to provide the information
                    required under section 726(b); or any person who causes
                    a group health plan to fail to provide the information
                    required under section 726(c), in the amount of $10,000
                    for each day during which such violation continues or
                    such information is not disclosed or reported.
                        ``(B) False information.--The Secretary may impose
                    a penalty against a plan administrator of a group
                    health plan, a health insurance issuer offering group
                    health insurance coverage, an entity providing pharmacy
                    benefit management services, or an applicable entity
                    (as defined in section 726(f)) that knowingly provides
                    false information under section 726, in an amount not
                    to exceed $100,000 for each item of false information.
                    Such penalty shall be in addition to other penalties as
                    may be prescribed by law.
                        ``(C) Waivers.--The Secretary may waive penalties
                    under subparagraph (A), or extend the period of time
                    for compliance with a requirement of this section, for
                    an entity in violation of section 726 that has made a
                    good-faith effort to comply with the requirements of
                    section 726.''; and
                        (C) in section 732(a) (29 U.S.C. 1191a(a)), by
                    striking ``section 711'' and inserting ``sections 711
                    and 726''.
                (2) Clerical amendment.--The table of contents in section 1
            of the Employee Retirement Income Security Act of 1974 (29
            U.S.C. 1001 et seq.) is amended by inserting after the item
            relating to section 725 the following new item:

    ``Sec. 726. Oversight of entities that provide pharmacy benefit
                                management services.''.
        (c) Internal Revenue Code of 1986.--
                (1) In general.--Chapter 100 of the Internal Revenue Code
            of 1986 is amended--
                        (A) by adding at the end of subchapter B the
                    following:

    ``SEC. 9826. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BENEFIT
                  MANAGEMENT SERVICES.

        ``(a) In General.--For plan years beginning on or after the date
    that is 30 months after the date of enactment of this section (referred
    to in this subsection and subsection (b) as the `effective date'), a
    group health plan, or an entity providing pharmacy benefit management
    services on behalf of such a plan, shall not enter into a contract,
    including an extension or renewal of a contract, entered into on or
    after the effective date, with an applicable entity unless such
    applicable entity agrees to--
                ``(1) not limit or delay the disclosure of information to
            the group health plan in such a manner that prevents an entity
            providing pharmacy benefit management services on behalf of a
            group health plan from making the reports described in
            subsection (b); and
                ``(2) provide the entity providing pharmacy benefit
            management services on behalf of a group health plan relevant
            information necessary to make the reports described in
            subsection (b).
        ``(b) Reports.--
                ``(1) In general.--For plan years beginning on or after the
            effective date, in the case of any contract between a group
            health plan and an entity providing pharmacy benefit management
            services on behalf of such plan, including an extension or
            renewal of such a contract, entered into on or after the
            effective date, the entity providing pharmacy benefit
            management services on behalf of such a group health plan, not
            less frequently than every 6 months (or, at the request of a
            group health plan, not less frequently than quarterly, and
            under the same conditions, terms, and cost of the semiannual
            report under this subsection), shall submit to the group health
            plan a report in accordance with this section. Each such report
            shall be made available to such group health plan in plain
            language, in a machine-readable format, and as the Secretary
            may determine, other formats. Each such report shall include
            the information described in paragraph (2).
                ``(2) Information described.--For purposes of paragraph
            (1), the information described in this paragraph is, with
            respect to drugs covered by a group health plan during each
            reporting period--
                        ``(A) in the case of a group health plan that is
                    offered by a specified large employer or that is a
                    specified large plan, and is not offered as health
                    insurance coverage, or in the case of health insurance
                    coverage for which the election under paragraph (3) is
                    made for the applicable reporting period--
                                ``(i) a list of drugs for which a claim was
                            filed and, with respect to each such drug on
                            such list--
                                        ``(I) the contracted compensation
                                    paid by the group health plan for each
                                    covered drug (identified by the
                                    National Drug Code) to the entity
                                    providing pharmacy benefit management
                                    services or other applicable entity on
                                    behalf of the group health plan;
                                        ``(II) the contracted compensation
                                    paid to the pharmacy, by any entity
                                    providing pharmacy benefit management
                                    services or other applicable entity on
                                    behalf of the group health plan, for
                                    each covered drug (identified by the
                                    National Drug Code);
                                        ``(III) for each such claim, the
                                    difference between the amount paid
                                    under subclause (I) and the amount paid
                                    under subclause (II);
                                        ``(IV) the proprietary name,
                                    established name or proper name, and
                                    the National Drug Code;
                                        ``(V) for each claim for the drug
                                    (including original prescriptions and
                                    refills) and for each dosage unit of
                                    the drug for which a claim was filed,
                                    the type of dispensing channel used to
                                    furnish the drug, including retail,
                                    mail order, or specialty pharmacy;
                                        ``(VI) with respect to each drug
                                    dispensed, for each type of dispensing
                                    channel (including retail, mail order,
                                    or specialty pharmacy)--
                                                ``(aa) whether such drug is
                                            a brand name drug or a generic
                                            drug, and--

                                                        ``(AA) in the case
                                                    of a brand name drug,
                                                    the wholesale
                                                    acquisition cost,
                                                    listed as cost per days
                                                    supply and cost per
                                                    dosage unit, on the
                                                    date such drug was
                                                    dispensed; and

                                                        ``(BB) in the case
                                                    of a generic drug, the
                                                    average wholesale
                                                    price, listed as cost
                                                    per days supply and
                                                    cost per dosage unit,
                                                    on the date such drug
                                                    was dispensed; and

                                                ``(bb) the total number
                                            of--

                                                        ``(AA) prescription
                                                    claims (including
                                                    original prescriptions
                                                    and refills);

                                                        ``(BB) participants
                                                    and beneficiaries for
                                                    whom a claim for such
                                                    drug was filed through
                                                    the applicable
                                                    dispensing channel;

                                                        ``(CC) dosage units
                                                    and dosage units per
                                                    fill of such drug; and

                                                        ``(DD) days supply
                                                    of such drug per fill;

                                        ``(VII) the net price per course of
                                    treatment or single fill, such as a 30-
                                    day supply or 90-day supply to the plan
                                    after rebates, fees, alternative
                                    discounts, or other remuneration
                                    received from applicable entities;
                                        ``(VIII) the total amount of out-
                                    of-pocket spending by participants and
                                    beneficiaries on such drug, including
                                    spending through copayments,
                                    coinsurance, and deductibles, but not
                                    including any amounts spent by
                                    participants and beneficiaries on drugs
                                    not covered under the plan, or for
                                    which no claim is submitted under the
                                    plan;
                                        ``(IX) the total net spending on
                                    the drug;
                                        ``(X) the total amount received, or
                                    expected to be received, by the plan
                                    from any applicable entity in rebates,
                                    fees, alternative discounts, or other
                                    remuneration;
                                        ``(XI) the total amount received,
                                    or expected to be received, by the
                                    entity providing pharmacy benefit
                                    management services, from applicable
                                    entities, in rebates, fees, alternative
                                    discounts, or other remuneration from
                                    such entities--
                                                ``(aa) for claims incurred
                                            during the reporting period;
                                            and
                                                ``(bb) that is related to
                                            utilization of such drug or
                                            spending on such drug; and
                                        ``(XII) to the extent feasible,
                                    information on the total amount of
                                    remuneration for such drug, including
                                    copayment assistance dollars paid,
                                    copayment cards applied, or other
                                    discounts provided by each drug
                                    manufacturer (or entity administering
                                    copayment assistance on behalf of such
                                    drug manufacturer), to the participants
                                    and beneficiaries enrolled in such
                                    plan;
                                ``(ii) a list of each therapeutic class (as
                            defined by the Secretary) for which a claim was
                            filed under the group health plan during the
                            reporting period, and, with respect to each
                            such therapeutic class--
                                        ``(I) the total gross spending on
                                    drugs in such class before rebates,
                                    price concessions, alternative
                                    discounts, or other remuneration from
                                    applicable entities;
                                        ``(II) the net spending in such
                                    class after such rebates, price
                                    concessions, alternative discounts, or
                                    other remuneration from applicable
                                    entities;
                                        ``(III) the total amount received,
                                    or expected to be received, by the
                                    entity providing pharmacy benefit
                                    management services, from applicable
                                    entities, in rebates, fees, alternative
                                    discounts, or other remuneration from
                                    such entities--
                                                ``(aa) for claims incurred
                                            during the reporting period;
                                            and
                                                ``(bb) that is related to
                                            utilization of drugs or drug
                                            spending;
                                        ``(IV) the average net spending per
                                    30-day supply and per 90-day supply by
                                    the plan and its participants and
                                    beneficiaries, among all drugs within
                                    the therapeutic class for which a claim
                                    was filed during the reporting period;
                                        ``(V) the number of participants
                                    and beneficiaries who filled a
                                    prescription for a drug in such class,
                                    including the National Drug Code for
                                    each such drug;
                                        ``(VI) if applicable, a description
                                    of the formulary tiers and utilization
                                    mechanisms (such as prior authorization
                                    or step therapy) employed for drugs in
                                    that class; and
                                        ``(VII) the total out-of-pocket
                                    spending under the plan by participants
                                    and beneficiaries, including spending
                                    through copayments, coinsurance, and
                                    deductibles, but not including any
                                    amounts spent by participants and
                                    beneficiaries on drugs not covered
                                    under the plan or for which no claim is
                                    submitted under the plan;
                                ``(iii) with respect to any drug for which
                            gross spending under the group health plan
                            exceeded $10,000 during the reporting period
                            or, in the case that gross spending under the
                            group health plan exceeded $10,000 during the
                            reporting period with respect to fewer than 50
                            drugs, with respect to the 50 prescription
                            drugs with the highest spending during the
                            reporting period--
                                        ``(I) a list of all other drugs in
                                    the same therapeutic class as such
                                    drug;
                                        ``(II) if applicable, the rationale
                                    for the formulary placement of such
                                    drug in that therapeutic category or
                                    class, selected from a list of standard
                                    rationales established by the
                                    Secretary, in consultation with
                                    stakeholders; and
                                        ``(III) any change in formulary
                                    placement compared to the prior plan
                                    year; and
                                ``(iv) in the case that such plan (or an
                            entity providing pharmacy benefit management
                            services on behalf of such plan) has an
                            affiliated pharmacy or pharmacy under common
                            ownership, including mandatory mail and
                            specialty home delivery programs, retail and
                            mail auto-refill programs, and cost sharing
                            assistance incentives funded by an entity
                            providing pharmacy benefit services--
                                        ``(I) an explanation of any benefit
                                    design parameters that encourage or
                                    require participants and beneficiaries
                                    in the plan to fill prescriptions at
                                    mail order, specialty, or retail
                                    pharmacies;
                                        ``(II) the percentage of total
                                    prescriptions dispensed by such
                                    pharmacies to participants or
                                    beneficiaries in such plan; and
                                        ``(III) a list of all drugs
                                    dispensed by such pharmacies to
                                    participants or beneficiaries enrolled
                                    in such plan, and, with respect to each
                                    drug dispensed--
                                                ``(aa) the amount charged,
                                            per dosage unit, per 30-day
                                            supply, or per 90-day supply
                                            (as applicable) to the plan,
                                            and to participants and
                                            beneficiaries;
                                                ``(bb) the median amount
                                            charged to such plan, and the
                                            interquartile range of the
                                            costs, per dosage unit, per 30-
                                            day supply, and per 90-day
                                            supply, including amounts paid
                                            by the participants and
                                            beneficiaries, when the same
                                            drug is dispensed by other
                                            pharmacies that are not
                                            affiliated with or under common
                                            ownership with the entity and
                                            that are included in the
                                            pharmacy network of such plan;
                                                ``(cc) the lowest cost per
                                            dosage unit, per 30-day supply
                                            and per 90-day supply, for each
                                            such drug, including amounts
                                            charged to the plan and to
                                            participants and beneficiaries,
                                            that is available from any
                                            pharmacy included in the
                                            network of such plan; and
                                                ``(dd) the net acquisition
                                            cost per dosage unit, per 30-
                                            day supply, and per 90-day
                                            supply, if such drug is subject
                                            to a maximum price discount;
                                            and
                        ``(B) with respect to any group health plan,
                    regardless of whether the plan is offered by a
                    specified large employer or whether it is a specified
                    large plan--
                                ``(i) a summary document for the group
                            health plan that includes such information
                            described in clauses (i) through (iv) of
                            subparagraph (A), as specified by the Secretary
                            through guidance, program instruction, or
                            otherwise (with no requirement of notice and
                            comment rulemaking), that the Secretary
                            determines useful to group health plans for
                            purposes of selecting pharmacy benefit
                            management services, such as an estimated net
                            price to group health plan and participant or
                            beneficiary, a cost per claim, the fee
                            structure or reimbursement model, and estimated
                            cost per participant or beneficiary;
                                ``(ii) a summary document for plans to
                            provide to participants and beneficiaries,
                            which shall be made available to participants
                            or beneficiaries upon request to their group
                            health plan, that--
                                        ``(I) contains such information
                                    described in clauses (iii), (iv), (v),
                                    and (vi), as applicable, as specified
                                    by the Secretary through guidance,
                                    program instruction, or otherwise (with
                                    no requirement of notice and comment
                                    rulemaking) that the Secretary
                                    determines useful to participants or
                                    beneficiaries in better understanding
                                    the plan or benefits under such plan;
                                        ``(II) contains only aggregate
                                    information; and
                                        ``(III) states that participants
                                    and beneficiaries may request specific,
                                    claims-level information required to be
                                    furnished under subsection (c) from the
                                    group health plan; and
                                ``(iii) with respect to drugs covered by
                            such plan during such reporting period--
                                        ``(I) the total net spending by the
                                    plan for all such drugs;
                                        ``(II) the total amount received,
                                    or expected to be received, by the plan
                                    from any applicable entity in rebates,
                                    fees, alternative discounts, or other
                                    remuneration; and
                                        ``(III) to the extent feasible,
                                    information on the total amount of
                                    remuneration for such drugs, including
                                    copayment assistance dollars paid,
                                    copayment cards applied, or other
                                    discounts provided by each drug
                                    manufacturer (or entity administering
                                    copayment assistance on behalf of such
                                    drug manufacturer) to participants and
                                    beneficiaries;
                                ``(iv) amounts paid directly or indirectly
                            in rebates, fees, or any other type of
                            compensation (as defined in section
                            408(b)(2)(B)(ii)(dd)(AA) of the Employee
                            Retirement Income Security Act (29 U.S.C.
                            1108(b)(2)(B)(ii)(dd)(AA))) to brokerage firms,
                            brokers, consultants, advisors, or any other
                            individual or firm, for--
                                        ``(I) the referral of the group
                                    health plan's business to an entity
                                    providing pharmacy benefit management
                                    services, including the identity of the
                                    recipient of such amounts;
                                        ``(II) consideration of the entity
                                    providing pharmacy benefit management
                                    services by the group health plan; or
                                        ``(III) the retention of the entity
                                    by the group health plan;
                                ``(v) an explanation of any benefit design
                            parameters that encourage or require
                            participants and beneficiaries in such plan to
                            fill prescriptions at mail order, specialty, or
                            retail pharmacies that are affiliated with or
                            under common ownership with the entity
                            providing pharmacy benefit management services
                            under such plan, including mandatory mail and
                            specialty home delivery programs, retail and
                            mail auto-refill programs, and cost-sharing
                            assistance incentives directly or indirectly
                            funded by such entity; and
                                ``(vi) total gross spending on all drugs
                            under the plan during the reporting period.
                ``(3) Opt-in for group health insurance coverage offered by
            a specified large employer or that is a specified large plan.--
            In the case of group health insurance coverage offered in
            connection with a group health plan that is offered by a
            specified large employer or is a specified large plan, such
            group health plan may, on an annual basis, for plan years
            beginning on or after the date that is 30 months after the date
            of enactment of this section, elect to require an entity
            providing pharmacy benefit management services on behalf of the
            health insurance issuer to submit to such group health plan a
            report that includes all of the information described in
            paragraph (2)(A), in addition to the information described in
            paragraph (2)(B).
                ``(4) Privacy requirements.--
                        ``(A) In general.--An entity providing pharmacy
                    benefit management services on behalf of a group health
                    plan shall report information under paragraph (1) in a
                    manner consistent with the privacy regulations
                    promulgated under section 13402(a) of the Health
                    Information Technology for Economic and Clinical Health
                    Act (42 U.S.C. 17932(a)) and consistent with the
                    privacy regulations promulgated under the Health
                    Insurance Portability and Accountability Act of 1996 in
                    part 160 and subparts A and E of part 164 of title 45,
                    Code of Federal Regulations (or successor regulations)
                    (referred to in this paragraph as the `HIPAA privacy
                    regulations') and shall restrict the use and disclosure
                    of such information according to such privacy
                    regulations and such HIPAA privacy regulations.
                        ``(B) Additional requirements.--
                                ``(i) In general.--An entity providing
                            pharmacy benefit management services on behalf
                            of a group health plan that submits a report
                            under paragraph (1) shall ensure that such
                            report contains only summary health
                            information, as defined in section 164.504(a)
                            of title 45, Code of Federal Regulations (or
                            successor regulations).
                                ``(ii) Restrictions.--In carrying out this
                            subsection, a group health plan shall comply
                            with section 164.504(f) of title 45, Code of
                            Federal Regulations (or a successor
                            regulation), and a plan sponsor shall act in
                            accordance with the terms of the agreement
                            described in such section.
                        ``(C) Rule of construction.--
                                ``(i) Nothing in this section shall be
                            construed to modify the requirements for the
                            creation, receipt, maintenance, or transmission
                            of protected health information under the HIPAA
                            privacy regulations.
                                ``(ii) Nothing in this section shall be
                            construed to affect the application of any
                            Federal or State privacy or civil rights law,
                            including the HIPAA privacy regulations, the
                            Genetic Information Nondiscrimination Act of
                            2008 (Public Law 110-233) (including the
                            amendments made by such Act), the Americans
                            with Disabilities Act of 1990 (42 U.S.C. 12101
                            et seq.), section 504 of the Rehabilitation Act
                            of 1973 (29 U.S.C. 794), section 1557 of the
                            Patient Protection and Affordable Care Act (42
                            U.S.C. 18116), title VI of the Civil Rights Act
                            of 1964 (42 U.S.C. 2000d), and title VII of the
                            Civil Rights Act of 1964 (42 U.S.C. 2000e).
                        ``(D) Written notice.--Each plan year, group health
                    plans shall provide to each participant or beneficiary
                    written notice informing the participant or beneficiary
                    of the requirement for entities providing pharmacy
                    benefit management services on behalf of the group
                    health plan to submit reports to group health plans
                    under paragraph (1), as applicable, which may include
                    incorporating such notification in plan documents
                    provided to the participant or beneficiary, or
                    providing individual notification.
                        ``(E) Limitation to business associates.--A group
                    health plan receiving a report under paragraph (1) may
                    disclose such information only to the entity from which
                    the report was received or to that entity's business
                    associates as defined in section 160.103 of title 45,
                    Code of Federal Regulations (or successor regulations)
                    or as permitted by the HIPAA privacy regulations.
                        ``(F) Clarification regarding public disclosure of
                    information.--Nothing in this section shall prevent an
                    entity providing pharmacy benefit management services
                    on behalf of a group health plan, from placing
                    reasonable restrictions on the public disclosure of the
                    information contained in a report described in
                    paragraph (1), except that such plan or entity may
                    not--
                                ``(i) restrict disclosure of such report to
                            the Department of Health and Human Services,
                            the Department of Labor, or the Department of
                            the Treasury; or
                                ``(ii) prevent disclosure for the purposes
                            of subsection (c), or any other public
                            disclosure requirement under this section.
                        ``(G) Limited form of report.--The Secretary shall
                    define through rulemaking a limited form of the report
                    under paragraph (1) required with respect to any group
                    health plan established by a plan sponsor that is, or
                    is affiliated with, a drug manufacturer, drug
                    wholesaler, or other direct participant in the drug
                    supply chain, in order to prevent anti-competitive
                    behavior.
                ``(5) Standard format and regulations.--
                        ``(A) In general.--Not later than 18 months after
                    the date of enactment of this section, the Secretary
                    shall specify through rulemaking a standard format for
                    entities providing pharmacy benefit management services
                    on behalf of group health plans, to submit reports
                    required under paragraph (1).
                        ``(B) Additional regulations.--Not later than 18
                    months after the date of enactment of this section, the
                    Secretary shall, through rulemaking, promulgate any
                    other final regulations necessary to implement the
                    requirements of this section. In promulgating such
                    regulations, the Secretary shall, to the extent
                    practicable, align the reporting requirements under
                    this section with the reporting requirements under
                    section 9825.
        ``(c) Requirement To Provide Information to Participants or
    Beneficiaries.--A group health plan, upon request of a participant or
    beneficiary, shall provide to such participant or beneficiary--
                ``(1) the summary document described in subsection
            (b)(2)(B)(ii); and
                ``(2) the information described in subsection
            (b)(2)(A)(i)(III) with respect to a claim made by or on behalf
            of such participant or beneficiary.
        ``(d) Rule of Construction.--Nothing in this section shall be
    construed to permit a health insurance issuer, group health plan,
    entity providing pharmacy benefit management services on behalf of a
    group health plan or health insurance issuer, or other entity to
    restrict disclosure to, or otherwise limit the access of, the Secretary
    to a report described in subsection (b)(1) or information related to
    compliance with subsections (a), (b), or (c) of this section or section
    4980D(g) by such issuer, plan, or entity.
        ``(e) Definitions.--In this section:
                ``(1) Applicable entity.--The term `applicable entity'
            means--
                        ``(A) an applicable group purchasing organization,
                    drug manufacturer, distributor, wholesaler, rebate
                    aggregator (or other purchasing entity designed to
                    aggregate rebates), or associated third party;
                        ``(B) any subsidiary, parent, affiliate, or
                    subcontractor of a group health plan, health insurance
                    issuer, entity that provides pharmacy benefit
                    management services on behalf of such a plan or issuer,
                    or any entity described in subparagraph (A); or
                        ``(C) such other entity as the Secretary may
                    specify through rulemaking.
                ``(2) Applicable group purchasing organization.--The term
            `applicable group purchasing organization' means a group
            purchasing organization that is affiliated with or under common
            ownership with an entity providing pharmacy benefit management
            services.
                ``(3) Contracted compensation.--The term `contracted
            compensation' means the sum of any ingredient cost and
            dispensing fee for a drug (inclusive of the out-of-pocket costs
            to the participant or beneficiary), or another analogous
            compensation structure that the Secretary may specify through
            regulations.
                ``(4) Gross spending.--The term `gross spending', with
            respect to prescription drug benefits under a group health
            plan, means the amount spent by a group health plan on
            prescription drug benefits, calculated before the application
            of rebates, fees, alternative discounts, or other remuneration.
                ``(5) Net spending.--The term `net spending', with respect
            to prescription drug benefits under a group health plan, means
            the amount spent by a group health plan on prescription drug
            benefits, calculated after the application of rebates, fees,
            alternative discounts, or other remuneration.
                ``(6) Plan sponsor.--The term `plan sponsor' has the
            meaning given such term in section 3(16)(B) of the Employee
            Retirement Income Security Act of 1974 (29 U.S.C. 1002(16)(B)).
                ``(7) Remuneration.--The term `remuneration' has the
            meaning given such term by the Secretary, through rulemaking,
            which shall be reevaluated by the Secretary every 5 years.
                ``(8) Specified large employer.--The term `specified large
            employer' means, in connection with a group health plan
            established or maintained by a single employer, with respect to
            a calendar year or a plan year, as applicable, an employer who
            employed an average of at least 100 employees on business days
            during the preceding calendar year or plan year and who employs
            at least 1 employee on the first day of the calendar year or
            plan year.
                ``(9) Specified large plan.--The term `specified large
            plan' means a group health plan established or maintained by a
            plan sponsor described in clause (ii) or (iii) of section
            3(16)(B) of the Employee Retirement Income Security Act of 1974
            (29 U.S.C. 1002(16)(B)) that had an average of at least 100
            participants on business days during the preceding calendar
            year or plan year, as applicable.
                ``(10) Wholesale acquisition cost.--The term `wholesale
            acquisition cost' has the meaning given such term in section
            1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w-
            3a(c)(6)(B)).'';
                (2) Exception for certain group health plans.--Section
            9831(a)(2) of the Internal Revenue Code of 1986 is amended by
            inserting ``other than with respect to section 9826,'' before
            ``any group health plan''.
                (3) Enforcement.--Section 4980D of the Internal Revenue
            Code of 1986 is amended by adding at the end the following new
            subsection:
        ``(g) Application to Requirements Imposed on Certain Entities
    Providing Pharmacy Benefit Management Services.--In the case of any
    requirement under section 9826 that applies with respect to an entity
    providing pharmacy benefit management services on behalf of a group
    health plan, any reference in this section to such group health plan
    (and the reference in subsection (e)(1) to the employer) shall be
    treated as including a reference to such entity.''.
                (4) Clerical amendment.--The table of sections for
            subchapter B of chapter 100 of the Internal Revenue Code of
            1986 is amended by adding at the end the following new item:

    ``Sec. 9826. Oversight of entities that provide pharmacy benefit
                                management services.''.

    SEC. 902. FULL REBATE PASS THROUGH TO PLAN; EXCEPTION FOR INNOCENT PLAN
                  FIDUCIARIES.

        (a) In General.--Section 408(b)(2) of the Employee Retirement
    Income Security Act of 1974 (29 U.S.C. 1108(b)(2)) is amended--
                (1) in subparagraph (B)(viii)--
                        (A) by redesignating subclauses (II) through (IV)
                    as subclauses (III) through (V), respectively;
                        (B) in subclause (I)--
                                (i) by striking ``subclause (II)'' and
                            inserting ``subclause (III)''; and
                                (ii) by striking ``subclauses (II) and
                            (III)'' and inserting ``subclauses (III) and
                            (IV)''; and
                        (C) by inserting after subclause (I) the following:
                ``(II) Pursuant to subsection (a), subparagraphs (C) and
            (D) of section 406(a)(1) shall not apply to a responsible plan
            fiduciary, notwithstanding any failure to remit required
            amounts under subparagraph (C)(i), if the following conditions
            are met:
                        ``(aa) The responsible plan fiduciary did not know
                    that the covered service provider failed or would fail
                    to make required remittances and reasonably believed
                    that the covered service provider remitted such
                    required amounts.
                        ``(bb) The responsible plan fiduciary, upon
                    discovering that the covered service provider failed to
                    remit the required amounts, requests in writing that
                    the covered service provider remit such amounts.
                        ``(cc) If the covered service provider fails to
                    comply with a written request described in subclause
                    (III) within 90 days of the request, the responsible
                    plan fiduciary notifies the Secretary of the covered
                    service provider's failure, in accordance with
                    subclauses (III) and (IV).''; and
                (2) by adding at the end the following:
                ``(C)(i)(I) For plan years beginning on or after the date
            that is 30 months after the date of enactment of this
            subparagraph (referred to in this clause as the `effective
            date'), no contract or arrangement or renewal or extension of a
            contract or arrangement, entered into on or after the effective
            date, for services between a covered plan and a covered service
            provider, through a health insurance issuer offering group
            health insurance coverage, a third-party administrator, an
            entity providing pharmacy benefit management services, or other
            entity, for pharmacy benefit management services, is reasonable
            within the meaning of this paragraph unless such entity
            providing pharmacy benefit management services--
                        ``(aa) remits 100 percent of rebates, fees,
                    alternative discounts, and other remuneration received
                    from any applicable entity that are related to
                    utilization of drugs or drug spending under such health
                    plan or health insurance coverage, to the group health
                    plan or health insurance issuer offering group health
                    insurance coverage; and
                        ``(bb) does not enter into any contract for
                    pharmacy benefit management services on behalf of such
                    a plan or coverage, with an applicable entity unless
                    100 percent of rebates, fees, alternative discounts,
                    and other remuneration received under such contract
                    that are related to the utilization of drugs or drug
                    spending under such group health plan or health
                    insurance coverage are remitted to the group health
                    plan or health insurance issuer by the entity providing
                    pharmacy benefit management services.
                ``(II) Nothing in subclause (I) shall be construed to
            affect the term of a contract or arrangement, as in effect on
            the effective date (as described in such subclause), except
            that such subclause shall apply to any renewal or extension of
            such a contract or arrangement entered into on or after such
            effective date, as so described.
                ``(ii) With respect to such rebates, fees, alternative
            discounts, and other remuneration--
                        ``(I) the rebates, fees, alternative discounts, and
                    other remuneration under clause (i)(I) shall be--
                                ``(aa) remitted--
                                        ``(AA) on a quarterly basis, to the
                                    group health plan or the group health
                                    insurance issuer, not later than 90
                                    days after the end of each quarter; or
                                        ``(BB) in the case of an
                                    underpayment in a remittance for a
                                    prior quarter, as soon as practicable,
                                    but not later than 90 days after notice
                                    of the underpayment is first given;
                                ``(bb) fully disclosed and enumerated to
                            the group health plan or health insurance
                            issuer; and
                                ``(cc) returned to the covered service
                            provider for pharmacy benefit management
                            services on behalf of the group health plan if
                            any audit by a plan sponsor, issuer or a third
                            party designated by a plan sponsor, indicates
                            that the amounts received are incorrect after
                            such amounts have been paid to the group health
                            plan or health insurance issuer;
                        ``(II) the Secretary may establish procedures for
                    the remittance of rebates fees, alternative discounts,
                    and other remuneration under subclause (I)(aa) and the
                    disclosure of rebates, fees, alternative discounts, and
                    other remuneration under subclause (I)(bb); and
                        ``(III) the records of such rebates, fees,
                    alternative discounts, and other remuneration shall be
                    available for audit by the plan sponsor, issuer, or a
                    third party designated by a plan sponsor, not less than
                    once per plan year.
                ``(iii) To ensure that an entity providing pharmacy benefit
            management services is able to meet the requirements of clause
            (ii)(I), a rebate aggregator (or other purchasing entity
            designed to aggregate rebates) and an applicable group
            purchasing organization shall remit such rebates to the entity
            providing pharmacy benefit management services not later than
            45 days after the end of each quarter.
                ``(iv) A third-party administrator of a group health plan,
            a health insurance issuer offering group health insurance
            coverage, or a covered service provider for pharmacy benefit
            management services under such health plan or health insurance
            coverage shall make rebate contracts with rebate aggregators or
            drug manufacturers available for audit by such plan sponsor or
            designated third party, subject to reasonable restrictions (as
            determined by the Secretary) on confidentiality to prevent re-
            disclosure of such contracts or use of such information in
            audits for purposes unrelated to this section.
                ``(v) Audits carried out under clauses (ii)(III) and (iv)
            shall be performed by an auditor selected by the responsible
            plan fiduciary. Payment for such audits shall not be made,
            whether directly or indirectly, by the entity providing
            pharmacy benefit management services.
                ``(vi) Nothing in this subparagraph shall be construed to--
                        ``(I) prohibit reasonable payments to entities
                    offering pharmacy benefit management services for bona
                    fide services using a fee structure not described in
                    this subparagraph, provided that such fees are
                    transparent and quantifiable to group health plans and
                    health insurance issuers;
                        ``(II) require a third-party administrator of a
                    group health plan or covered service provider for
                    pharmacy benefit management services under such health
                    plan or health insurance coverage to remit bona fide
                    service fees to the group health plan;
                        ``(III) limit the ability of a group health plan or
                    health insurance issuer to pass through rebates, fees,
                    alternative discounts, and other remuneration to the
                    participant or beneficiary; or
                        ``(IV) modify the requirements for the creation,
                    receipt, maintenance, or transmission of protected
                    health information under the privacy regulations
                    promulgated under the Health Insurance Portability and
                    Accountability Act of 1996 in part 160 and subparts A
                    and E of part 164 of title 45, Code of Federal
                    Regulations (or successor regulations).
                ``(vii) For purposes of this subparagraph--
                        ``(I) the terms `applicable entity' and `applicable
                    group purchasing organization' have the meanings given
                    such terms in section 726(e);
                        ``(II) the terms `covered plan', `covered service
                    provider', and `responsible plan fiduciary' have the
                    meanings given such terms in subparagraph (B); and
                        ``(III) the terms `group health insurance
                    coverage', `health insurance coverage', and `health
                    insurance issuer' have the meanings given such terms in
                    section 733.''.
        (b) Rule of Construction.--Subclause (II)(aa) of section
    408(b)(2)(B)(viii) of the Employee Retirement Income Security Act of
    1974 (29 U.S.C. 1108(b)(2)(B)(viii)), as amended by subsection (a),
    shall not be construed to relieve or limit a responsible plan fiduciary
    from the duty to monitor the practices of any covered service provider
    that contracts with the applicable covered plan, including for the
    purposes of ensuring the reasonableness of compensation. For purposes
    of this subsection, the terms ``covered plan'', ``covered service
    provider'', and ``responsible plan fiduciary'' have the meanings given
    such terms in section 408(b)(2)(B)(ii) of the Employee Retirement
    Income Security Act of 1974 (29 U.S.C. 1108(b)(2)(B)(ii)).
        (c) Clarification of Covered Service Provider.--
                (1) Services.--
                        (A) In general.--Section 408(b)(2)(B)(ii)(I)(bb) of
                    the Employee Retirement Income Security Act of 1974 (29
                    U.S.C. 1108(b)(2)(B)(ii)(I)(bb)) is amended--
                                (i) in subitem (AA) by striking ``Brokerage
                            services,'' and inserting ``Services (including
                            brokerage services),''; and
                                (ii) in subitem (BB)--
                                        (I) by striking ``Consulting,'' and
                                    inserting ``Other services,''; and
                                        (II) by striking ``related to the
                                    development or implementation of plan
                                    design'' and all that follows through
                                    the period at the end and inserting
                                    ``including any of the following: plan
                                    design, insurance or insurance product
                                    selection (including vision and
                                    dental), recordkeeping, medical
                                    management, benefits administration
                                    selection (including vision and
                                    dental), stop-loss insurance, pharmacy
                                    benefit management services, wellness
                                    design and management services,
                                    transparency tools, group purchasing
                                    organization agreements and services,
                                    participation in and services from
                                    preferred vendor panels, disease
                                    management, compliance services,
                                    employee assistance programs, or third-
                                    party administration services, or
                                    consulting services related to any such
                                    services.''.
                        (B) Sense of congress.--It is the sense of Congress
                    that the amendment made by subparagraph (A) clarifies
                    the existing requirement of covered service providers
                    with respect to services described in section
                    408(b)(2)(B)(ii)(I)(bb)(BB) of the Employee Retirement
                    Income Security Act of 1974 (29 U.S.C.
                    1108(b)(2)(B)(ii)(I)(bb)(BB)) that were in effect since
                    the application date described in section 202(e) of the
                    No Surprises Act (Public Law 116-260; 29 U.S.C. 1108
                    note), and does not impose any additional requirement
                    under section 408(b)(2)(B) of such Act.
                (2) Certain arrangements for pharmacy benefit management
            services considered as indirect.--
                        (A) In general.--Section 408(b)(2)(B)(i) of the
                    Employee Retirement Income Security Act of 1974 (29
                    U.S.C. 1108(b)(2)(B)(i)) is amended--
                                (i) by striking ``requirements of this
                            clause'' and inserting ``requirements of this
                            subparagraph''; and
                                (ii) by adding at the end the following:
                            ``For purposes of applying section 406(a)(1)(C)
                            with respect to a transaction described under
                            this subparagraph or subparagraph (C), a
                            contract or arrangement for services between a
                            covered plan and an entity providing services
                            to the plan, including a health insurance
                            issuer providing health insurance coverage in
                            connection with the covered plan, in which such
                            entity contracts, in connection with such plan,
                            with a service provider for pharmacy benefit
                            management services, shall be considered an
                            indirect furnishing of goods, services, or
                            facilities between the covered plan and the
                            service provider for pharmacy benefit
                            management services acting as the party in
                            interest.''.
                        (B) Health insurance issuer and health insurance
                    coverage defined.--Section 408(b)(2)(B)(ii)(I)(aa) of
                    such Act (29 U.S.C. 1108(b)(2)(B)(ii)(I)(aa)) is
                    amended by inserting before the period at the end ``and
                    the terms `health insurance coverage' and `health
                    insurance issuer' have the meanings given such terms in
                    section 733(b)''.
                        (C) Technical amendment.--Section
                    408(b)(2)(B)(ii)(I)(aa) of the Employee Retirement
                    Income Security Act of 1974 (29 U.S.C.
                    1108(b)(2)(B)(ii)(I)(aa)) is amended by inserting
                    ``in'' after ``defined''.

    SEC. 903. INCREASING TRANSPARENCY IN GENERIC DRUG APPLICATIONS.

        (a) In General.--Section 505(j)(3) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the
    following:
        ``(H)(i) Upon request (in controlled correspondence or an analogous
    process) by a person that has submitted or intends to submit an
    abbreviated application under this subsection for a drug that is
    required by regulation to contain one or more of the same inactive
    ingredients in the same concentrations as the listed drug referred to,
    or for which the Secretary determines there is a scientific
    justification for an approach that is in vitro, in whole or in part, to
    be used to demonstrate bioequivalence for a drug if such a drug
    contains one or more of the same inactive ingredients in the same
    concentrations as the listed drug referred to, the Secretary shall
    inform the person whether such drug is qualitatively and quantitatively
    the same as the listed drug. The Secretary may also provide such
    information to such a person on the Secretary's own initiative during
    the review of an abbreviated application under this subsection for such
    drug.
        ``(ii) Notwithstanding section 301(j), if the Secretary determines
    that such drug is not qualitatively or quantitatively the same as the
    listed drug, the Secretary shall identify and disclose to the person--
                ``(I) the ingredient or ingredients that cause such drug
            not to be qualitatively or quantitatively the same as the
            listed drug; and
                ``(II) for any ingredient for which there is an identified
            quantitative deviation, the amount of such deviation.
        ``(iii) If the Secretary determines that such drug is qualitatively
    and quantitatively the same as the listed drug, the Secretary shall not
    change or rescind such determination after the submission of an
    abbreviated application for such drug under this subsection unless--
                ``(I) the formulation of the listed drug has been changed
            and the Secretary has determined that the prior listed drug
            formulation was withdrawn for reasons of safety or
            effectiveness; or
                ``(II) the Secretary makes a written determination that the
            prior determination must be changed because an error has been
            identified.
        ``(iv) If the Secretary makes a written determination described in
    clause (iii)(II), the Secretary shall provide notice and a copy of the
    written determination to the person making the request under clause
    (i).
        ``(v) The disclosures authorized under clauses (i) and (ii) are
    disclosures authorized by law, including for purposes of section 1905
    of title 18, United States Code. This subparagraph shall not otherwise
    be construed to authorize the disclosure of nonpublic qualitative or
    quantitative information about the ingredients in a listed drug, or to
    affect the status, if any, of such information as trade secret or
    confidential commercial information for purposes of section 301(j) of
    this Act, section 552 of title 5, United States Code, or section 1905
    of title 18, United States Code.''.
        (b) Guidance.--
                (1) In general.--Not later than one year after the date of
            enactment of this Act, the Secretary of Health and Human
            Services shall issue draft guidance, or update guidance,
            describing how the Secretary will determine whether a drug is
            qualitatively and quantitatively the same as the listed drug
            (as such terms are used in section 505(j)(3)(H) of the Federal
            Food, Drug, and Cosmetic Act, as added by subsection (a)),
            including with respect to assessing pH adjusters.
                (2) Process.--In issuing guidance under this subsection,
            the Secretary of Health and Human Services shall--
                        (A) publish draft guidance;
                        (B) provide a period of at least 60 days for
                    comment on the draft guidance; and
                        (C) after considering any comments received and not
                    later than one year after the close of the comment
                    period on the draft guidance, publish final guidance.
        (c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug,
    and Cosmetic Act, as added by subsection (a), applies beginning on the
    date of enactment of this Act, irrespective of the date on which the
    guidance required by subsection (b) is finalized.

    SEC. 904. TITLE 35 AMENDMENTS.

        (a) In General.--Section 271(e) of title 35, United States Code, is
    amended--
                (1) in paragraph (2)(C), in the flush text following clause
            (ii), by adding at the end the following: ``With respect to a
            submission described in clause (ii), the act of infringement
            shall extend to any patent that claims the biological product,
            a method of using the biological product, or a method or
            product used to manufacture the biological product.''; and
                (2) by adding at the end the following:
        ``(7)(A) Subject to subparagraphs (C), (D), and (E), if the sponsor
    of an approved application for a reference product, as defined in
    section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))
    (referred to in this paragraph as the `reference product sponsor'),
    brings an action for infringement under this section against an
    applicant for approval of a biological product under section 351(k) of
    such Act that references that reference product (referred to in this
    paragraph as the `subsection (k) applicant'), the reference product
    sponsor may assert in the action a total of not more than 20 patents of
    the type described in subparagraph (B), not more than 10 of which shall
    have issued after the date specified in section 351(l)(7)(A) of such
    Act.
        ``(B) The patents described in this subparagraph are patents that
    satisfy each of the following requirements:
                ``(i) Patents that claim the biological product that is the
            subject of an application under section 351(k) of the Public
            Health Service Act (42 U.S.C. 262(k)) (or a use of that
            product) or a method or product used in the manufacture of such
            biological product.
                ``(ii) Patents that are included on the list of patents
            described in paragraph (3)(A) of section 351(l) of the Public
            Health Service Act (42 U.S.C. 262(l)), including as provided
            under paragraph (7) of such section 351(l).
                ``(iii) Patents that--
                        ``(I) have an actual filing date of more than 4
                    years after the date on which the reference product is
                    approved; or
                        ``(II) include a claim to a method in a
                    manufacturing process that is not used by the reference
                    product sponsor.
        ``(C) The court in which an action described in subparagraph (A) is
    brought may increase the number of patents limited under that
    subparagraph--
                ``(i) if the request to increase that number is made
            without undue delay; and
                ``(ii)(I) if the interest of justice so requires; or
                ``(II) for good cause shown, which--
                        ``(aa) shall be established if the subsection (k)
                    applicant fails to provide information required section
                    351(k)(2)(A) of the Public Health Service Act (42
                    U.S.C. 262(k)(2)(A)) that would enable the reference
                    product sponsor to form a reasonable belief with
                    respect to whether a claim of infringement under this
                    section could reasonably be asserted; and
                        ``(bb) may be established--
                                ``(AA) if there is a material change to the
                            biological product (or process with respect to
                            the biological product) of the subsection (k)
                            applicant that is the subject of the
                            application;
                                ``(BB) if, with respect to a patent on the
                            supplemental list described in section
                            351(l)(7)(A) of Public Health Service Act (42
                            U.S.C. 262(l)(7)(A)), the patent would have
                            issued before the date specified in such
                            section 351(l)(7)(A) but for the failure of the
                            Office to issue the patent or a delay in the
                            issuance of the patent, as described in
                            paragraph (1) of section 154(b) and subject to
                            the limitations under paragraph (2) of such
                            section 154(b); or
                                ``(CC) for another reason that shows good
                            cause, as determined appropriate by the court.
        ``(D) In determining whether good cause has been shown for the
    purposes of subparagraph (C)(ii)(II), a court may consider whether the
    reference product sponsor has provided a reasonable description of the
    identity and relevance of any information beyond the subsection (k)
    application that the court believes is necessary to enable the court to
    form a belief with respect to whether a claim of infringement under
    this section could reasonably be asserted.
        ``(E) The limitation imposed under subparagraph (A)--
                ``(i) shall apply only if the subsection (k) applicant
            completes all actions required under paragraphs (2)(A),
            (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of section 351(l)
            of the Public Health Service Act (42 U.S.C. 262(l)); and
                ``(ii) shall not apply with respect to any patent that
            claims, with respect to a biological product, a method for
            using that product in therapy, diagnosis, or prophylaxis, such
            as an indication or method of treatment or other condition of
            use.''.
        (b) Applicability.--The amendments made by subsection (a) shall
    apply with respect to an application submitted under section 351(k) of
    the Public Health Service Act (42 U.S.C. 262(k)) on or after the date
    of enactment of this Act.

                             TITLE X--MISCELLANEOUS

    SEC. 1001. EXTENSION OF SAFE HARBOR FOR ABSENCE OF DEDUCTIBLE FOR
                  TELEHEALTH.

        Section 223(c)(2)(E)(ii) of the Internal Revenue Code of 1986 is
    amended to read as follows:
                                ``(ii) Safe harbor for absence of
                            deductible for telehealth.--
                                        ``(I) In general.--In the case of
                                    an eligible month or an eligible plan
                                    year, a plan shall not fail to be
                                    treated as a high deductible health
                                    plan by reason of failing to have a
                                    deductible for telehealth and other
                                    remote care services.
                                        ``(II) Eligible month.--For
                                    purposes of this clause, the term
                                    `eligible month' means months beginning
                                    after March 31, 2022, and before
                                    January 1, 2023, and months beginning
                                    after March 31, 2025, and before
                                    January 1, 2026.
                                        ``(III) Eligible plan year.--For
                                    purposes of this clause, the term
                                    `eligible plan year' means plan years
                                    beginning--
                                                ``(aa) on or before
                                            December 31, 2021,
                                                ``(bb) after December 31,
                                            2022, and before January 1,
                                            2025, or
                                                ``(cc) after December 31,
                                            2024, and before January 1,
                                            2027.''.
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