    [Congressional Bills 118th Congress]
    [From the U.S. Government Publishing Office]
    [H.R. 10409 Introduced in House (IH)]

    <DOC>

    118th CONGRESS
      2d Session
                                   H. R. 10409

    To address the high costs of health care services, prescription drugs,
       and health insurance coverage in the United States, and for other
                                   purposes.

    _______________________________________________________________________

                        IN THE HOUSE OF REPRESENTATIVES

                               December 12, 2024

    Mr. Westerman introduced the following bill; which was referred to the
    Committee on Energy and Commerce, and in addition to the Committees on
     Ways and Means, Education and the Workforce, the Judiciary, Oversight
       and Accountability, Rules, the Budget, Armed Services, and House
       Administration, for a period to be subsequently determined by the
      Speaker, in each case for consideration of such provisions as fall
               within the jurisdiction of the committee concerned

    _______________________________________________________________________

                                     A BILL

    To address the high costs of health care services, prescription drugs,
       and health insurance coverage in the United States, and for other
                                   purposes.

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

    SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

        (a) Short Title.--This Act may be cited as the ``Fair Care Act of
    2024''.
        (b) Table of Contents.--The table of contents for this Act is as
    follows:

    Sec. 1. Short title; table of contents.
               TITLE I--MODERNIZATION OF HEALTH SAVINGS ACCOUNTS

     Subtitle A--Modernization of Health Savings Accounts and Contributions

    Sec. 101. Modernization of health savings accounts.
    Sec. 102. Unused premium tax credits may be deposited in health savings
                                accounts.
    Sec. 103. Health Reimbursement Arrangements and Other Account-Based
                                Group Health Plans.
    Sec. 104. Cost-sharing reduction payments as eligible contributions.
    Sec. 105. Direct Primary Care.
               Subtitle B--Assistance to Health Savings Accounts

    Sec. 111. One-time application of saver's credit to contributions to
                                health savings accounts.
    Sec. 112. Grants for health savings account assistance and outreach.
    Sec. 113. New corporations required to use health savings accounts.
    Sec. 114. Federal employee health benefits and health savings accounts.
                  TITLE II--IMPROVING PRIVATE HEALTH INSURANCE

       Subtitle A--Maintaining Protections for Patients With Preexisting
                                   Conditions

    Sec. 201. Guaranteed availability of coverage; prohibiting
                                discrimination.
                     Subtitle B--Expanding Coverage Options

    Sec. 211. Definition of ``employer'' under ERISA with respect to group
                                health plans.
    Sec. 212. Short-term limited duration insurance.
               Subtitle C--Improving Commercial Health Insurance

    Sec. 221. Invisible Guaranteed Coverage Pool Reinsurance Program; tax
                                on exchange plans.
    Sec. 222. Employer health insurance mandate repeal.
    Sec. 223. Refundable credits for coverage under a qualified health plan
                                for individuals offered employer-sponsored
                                insurance.
    Sec. 224. Inclusion in income of certain costs of employer-provided
                                coverage under health plans.
    Sec. 225. Change in permissible age variation in health insurance
                                premium rates.
    Sec. 226. Premium assistance adjustment to reflect age.
    Sec. 227. Premium assistance.
    Sec. 228. Adding copper plans to Exchanges.
    Sec. 229. Copper and bronze plans.
    Sec. 230. Waivers for State innovation.
    Sec. 231. Enrollment periods.
    Sec. 232. State-operated Exchanges flexibility for open enrollment
                                periods.
    Sec. 233. Promoting health plans that cover individuals in more than
                                one State.
            TITLE III--COMPETITION, TRANSPARENCY AND ACCOUNTABILITY

                  Subtitle A--Provider and Insurer Competition

    Sec. 301. Hospital consolidation.
    Sec. 302. Authority of Federal Trade Commission over certain tax-exempt
                                organizations.
    Sec. 303. Leveling the playing field between payers and providers.
    Sec. 304. Banning anticompetitive terms in facility and insurance
                                contracts that limit access to higher
                                quality, lower cost care.
    Sec. 305. Repealing eligibility of certain ACOs.
    Sec. 306. Repeal of health care reform provisions limiting Medicare
                                exception to the prohibition on certain
                                physician referrals for hospitals.
    Sec. 307. Alternative payment model for certain shoppable procedures.
                         Subtitle B--Price Transparency

    Sec. 321. Price transparency requirements.
    Sec. 322. Ensuring enrollee access to cost-sharing information.
    Sec. 323. Access of individuals to protected health information.
    Sec. 324. Timely bills for patients.
    Sec. 325. Advisory group on reducing burden of hospital administrative
                                requirements.
    Sec. 326. Data reporting to improve the transparency regarding how 340B
                                hospital covered entities provide care for
                                patients.
    Sec. 327. Requiring 340B drug discount program reports by DSH hospital
                                covered entities on low-income utilization
                                rate of outpatient hospital services.
    Sec. 328. Employer benefits reports.
    Sec. 329. Government Accountability Office study on profit- and
                                revenue-sharing in health care.
            Subtitle C--Prescription Drug Competition and Innovation

    Sec. 341. Expedited development and priority review for generic complex
                                drug products.
    Sec. 342. Preventing blocking of generic drugs.
    Sec. 343. Ensuring timely access to generics.
    Sec. 344. Preemption of State barriers to the substitution of
                                biosimilar products.
    Sec. 345. Increasing pharmaceutical options to treat an unmet medical
                                need.
    Sec. 346. Conditional approval of new human drugs for individuals with
                                rare, progressive, and serious diseases.
    Sec. 347. Consolidating exclusivity periods for drugs treating rare
                                diseases and conditions.
    Sec. 348. Exclusivity period for brand name biological products.
    Sec. 349. Regulation of manufacturer-sponsored co-pay contributions.
    Sec. 350. Antitrust exemption for private health insurance issuers to
                                negotiate wholesale acquisition prices of
                                prescription drugs purchased from drug
                                manufacturers.
    Sec. 351. Biological product innovation.
    Sec. 352. Biosimilar biological products.
    Sec. 353. Prompt approval of drugs related to safety information.
    Sec. 354. Congressional review of the Food and Drug Administration
                                rulemaking.
    Sec. 355. Government Accountability Office study of rules.
    Subtitle D--Prescription Drug and Pharmacy Benefit Manager Transparency

    Sec. 361. Patent disclosure requirements.
    Sec. 362. Requirements with respect to prescription drug benefits.
    Sec. 363. PBM transparency and elimination of DIR fees.
    Sec. 364. Health plan oversight of pharmacy benefit manager services.
    Sec. 365. Study by Comptroller General of United States.
          Subtitle E--Medicare and Medicaid Prescription Drug Reforms

    Sec. 371. Medicare part D modernization redesign.
    Sec. 372. Maximum monthly cap on cost-sharing payments under
                                prescription drug plans and MA-PD plans.
    Sec. 373. Market based part B pricing index.
    Sec. 374. Innovation model testing of Medicare drug payments.
    Sec. 375. Modification of maximum rebate amount under Medicaid drug
                                rebate program.
                     Subtitle F--Medical Malpractice Reform

    Sec. 381. Definitions.
    Sec. 382. Encouraging speedy resolution of claims.
    Sec. 383. Compensating patient injury.
    Sec. 384. Maximizing patient recovery.
    Sec. 385. Authorization of payment of future damages to claimants in
                                health care lawsuits.
    Sec. 386. Product liability for health care providers.
    Sec. 387. Effect on other laws.
    Sec. 388. Limitation on expert witness testimony.
    Sec. 389. Expert witness qualifications.
    Sec. 390. Communications following unanticipated outcome.
    Sec. 391. Affidavit of merit.
    Sec. 392. Notice of intent to commence lawsuit.
    Sec. 393. Limitation on liability for volunteer health care
                                professionals.
    Sec. 394. Rules of construction.
    Sec. 395. Effective date.
                    TITLE IV--MEDICARE AND MEDICAID REFORMS

                          Subtitle A--Medicaid Reforms

    Sec. 401. Medicaid payment reform.
    Sec. 402. Income limitations for refundable credits for coverage under
                                a qualified health plan.
    Sec. 403. Medicaid eligibility determinations.
    Sec. 404. Lowering safe harbor threshold with respect to State taxes on
                                health care providers.
    Sec. 405. Providing for State approval and implementation of specified
                                waivers under the Medicaid program.
    Sec. 406. Deduction for qualified charity care.
                          Subtitle B--Medicare Reforms

    Sec. 411. Off-campus provider-based department Medicare site neutral
                                payment.
    Sec. 412. Eliminating FEHBP eligibility for annuitants.
    Sec. 413. Elimination of Medicare eligibility for certain individuals.
    Sec. 414. Medicare part D tax deduction.
    Sec. 415. Repeal of net investment income tax.
    Sec. 416. Medicare coverage of bad debt.
                  Subtitle C--Medicare Choice and Competition

    Sec. 421. Competitive bidding and premiums under unified Medicare.
    Sec. 422. New unified eligibility and enrollment rules.
    Sec. 423. New benefit structure under unified Medicare.
    Sec. 424. Late enrollment penalty not to apply for months of any health
                                coverage.
    Sec. 425. Medigap reform.
    Sec. 426. ACO revision.
    Sec. 427. Primary care options.
    Sec. 428. General provisions; effective date.
               Subtitle D--Telehealth Improvements and Expansion

    Sec. 431. Expansion of coverage of telehealth services.
    Sec. 432. Expanding the use of telehealth through the waiver of certain
                                requirements.
    Sec. 433. Expanding the use of telehealth for mental health services.
    Sec. 434. Use of telehealth in emergency medical care.
    Sec. 435. Improvements to the process for adding telehealth services.
    Sec. 436. Rural health clinics and Federally qualified health centers.
    Sec. 437. Native American health facilities.
    Sec. 438. Waiver of telehealth restrictions during national
                                emergencies.
    Sec. 439. Use of telehealth in recertification for hospice care.
    Sec. 440. Clarification for fraud and abuse laws regarding technologies
                                provided to beneficiaries.
    Sec. 441. Study and report on increasing access to telehealth services
                                in the home.
    Sec. 442. Analysis of telehealth waivers in alternative payment models.
    Sec. 443. Model to allow additional health professionals to furnish
                                telehealth services.
    Sec. 444. Testing of models to examine the use of telehealth under the
                                Medicare program.

               TITLE I--MODERNIZATION OF HEALTH SAVINGS ACCOUNTS

     Subtitle A--Modernization of Health Savings Accounts and Contributions

    SEC. 101. MODERNIZATION OF HEALTH SAVINGS ACCOUNTS.

        (a) In General.--Section 223 of the Internal Revenue Code of 1986
    is amended to read as follows:

    ``SEC. 223. HEALTH SAVINGS ACCOUNTS.

        ``(a) Deduction Allowed.--In the case of an individual who is an
    eligible individual for any month during the taxable year, there shall
    be allowed as a deduction for the taxable year an amount equal to the
    aggregate amount paid in cash during such taxable year by or on behalf
    of such individual to a health savings account of such individual.
        ``(b) Limitations.--
                ``(1) In general.--The amount allowable as a deduction
            under subsection (a) with respect to any month is \1/12\ of the
            dollar amount in effect under subsection (d)(2)(A) for the
            taxable year which included such month.
                ``(2) Denial of deduction to dependents.--No deduction
            shall be allowed under this section to any individual with
            respect to whom a deduction under section 151 is allowable to
            another taxpayer for a taxable year beginning in the calendar
            year in which such individual's taxable year begins.
                ``(3) Increase in limit for individuals becoming eligible
            individuals after the beginning of the year.--
                        ``(A) In general.--For purposes of computing the
                    limitation under paragraph (1) for any taxable year, an
                    individual who is an eligible individual during the
                    last month of such taxable year shall be treated--
                                ``(i) as having been an eligible individual
                            during each of the months in such taxable year,
                            and
                                ``(ii) as having been enrolled, during each
                            of the months such individual is treated as an
                            eligible individual solely by reason of clause
                            (i), in the same qualified plan in which the
                            individual was enrolled for the last month of
                            such taxable year.
                        ``(B) Failure to maintain qualified plan
                    coverage.--
                                ``(i) In general.--If, at any time during
                            the testing period, the individual is not an
                            eligible individual, then--
                                        ``(I) gross income of the
                                    individual for the taxable year in
                                    which occurs the first month in the
                                    testing period for which such
                                    individual is not an eligible
                                    individual is increased by the
                                    aggregate amount of all contributions
                                    to the health savings account of the
                                    individual which could not have been
                                    made but for subparagraph (A), and
                                        ``(II) the tax imposed by this
                                    chapter for any taxable year on the
                                    individual shall be increased by 10
                                    percent of the amount of such increase.
                                ``(ii) Exception for disability or death.--
                            Subclauses (I) and (II) of clause (i) shall not
                            apply if the individual ceased to be an
                            eligible individual by reason of the death of
                            the individual or the individual becoming
                            disabled (within the meaning of section
                            72(m)(7)).
                                ``(iii) Testing period.--The term `testing
                            period' means the period beginning with the
                            last month of the taxable year referred to in
                            subparagraph (A) and ending on the last day of
                            the 12th month following such month.
        ``(c) Definitions and Special Rules.--For purposes of this
    section--
                ``(1) Eligible individual.--The term `eligible individual'
            means, with respect to any month, any individual if such
            individual is covered under a qualified plan as of the 1st day
            of such month.
                ``(2) Qualified plan.--
                        ``(A) In general.--The term `qualified health plan'
                    means any health plan, including employer plans,
                    individual plans, short term plans, Medicare, Medicaid,
                    VA health care, TRICARE, Indian health service, health
                    care sharing ministries, and association health plans.
                        ``(B) Exclusion of certain plans.--Such term does
                    not include a health plan if substantially all of its
                    coverage is--
                                ``(i) coverage for any benefit provided by
                            permitted insurance, or
                                ``(ii) coverage (whether through insurance
                            or otherwise) for accidents, disability, dental
                            care, vision care, or long-term care.
                ``(3) Permitted insurance.--The term `permitted insurance'
            means--
                        ``(A) insurance if substantially all of the
                    coverage provided under such insurance relates to--
                                ``(i) liabilities incurred under workers'
                            compensation laws,
                                ``(ii) tort liabilities,
                                ``(iii) liabilities relating to ownership
                            or use of property, or
                                ``(iv) such other similar liabilities as
                            the Secretary may specify by regulations,
                        ``(B) insurance for a specified disease or illness,
                    and
                        ``(C) insurance paying a fixed amount per day (or
                    other period) of hospitalization.
                ``(4) Family coverage.--The term `family coverage' means
            any coverage other than self-only coverage.
        ``(d) Health Savings Account.--For purposes of this section--
                ``(1) In general.--The term `health savings account' means
            a trust created or organized in the United States as a health
            savings account exclusively for the purpose of paying the
            qualified medical expenses of the account beneficiary, but only
            if the written governing instrument creating the trust meets
            the following requirements:
                        ``(A) Except in the case of a rollover contribution
                    described in subsection (f)(5) or section 220(f)(5), no
                    contribution will be accepted--
                                ``(i) unless it is in cash, or
                                ``(ii) to the extent such contribution,
                            when added to previous contributions to the
                            trust for the calendar year, exceeds the
                            limitation amount specified in paragraph
                            (2)(A), or
                                ``(iii) to the extent such contribution,
                            when added to the balance of the account,
                            exceeds the limitation amount specified in
                            paragraph (2)(B).
                        ``(B) The trustee is a bank (as defined in section
                    408(n)), an insurance company (as defined in section
                    816), or another person who demonstrates to the
                    satisfaction of the Secretary that the manner in which
                    such person will administer the trust will be
                    consistent with the requirements of this section.
                        ``(C) No part of the trust assets will be invested
                    in life insurance contracts.
                        ``(D) The assets of the trust will not be
                    commingled with other property except in a common trust
                    fund or common investment fund.
                        ``(E) The interest of an individual in the balance
                    in his account is nonforfeitable.
                ``(2) Limitations.--
                        ``(A) Annual limitation.--
                                ``(i) In general.--The limitation amount
                            specified in this subparagraph is--
                                        ``(I) $5,000 in the case of a
                                    qualified health plan with an actuarial
                                    value of less than 40 percent,
                                        ``(II) $4,300 in the case of a
                                    qualified health plan with an actuarial
                                    value that is 40 percent or more and
                                    less than 75 percent, and
                                        ``(III) $3,600 in the case of a
                                    qualified health plan with an actuarial
                                    value that is 75 percent or more.
                                ``(ii) Actuarial value of qualified health
                            plan.--For purposes of clause (i), the
                            actuarial value of a qualified health plan is
                            the percentage of the total average costs of
                            covered benefits under the health plan.
                        ``(B) Account accumulation limitation.--The
                    limitation amount specified in this paragraph is
                    $50,000.
                        ``(C) Indexing.--
                                ``(i) In general.--In the case of any
                            taxable year beginning in a calendar year after
                            2025, each dollar amount contained in
                            subparagraphs (A)(i) and (B) shall be increased
                            by the medical care cost adjustment of such
                            amount for such calendar year.
                                ``(ii) Medical care cost adjustment.--For
                            purposes of clause (i), the medical care cost
                            adjustment for any calendar year is the
                            percentage (if any) by which--
                                        ``(I) the medical care component of
                                    the C-CPI-U (as defined in section
                                    1(f)(6)) for August of the preceding
                                    calendar year, exceeds
                                        ``(II) such component of the C-CPI-
                                    U (as so defined) for August of 2024.
                                ``(iii) Rounding.--
                                        ``(I) Annual limitation.--If any
                                    increase in a dollar amount contained
                                    in subparagraph (A)(i) determined under
                                    clause (i) is not a multiple of $100,
                                    such increase shall be rounded to the
                                    nearest multiple of $100.
                                        ``(II) Account limitation.--If any
                                    increase in the dollar amount contained
                                    in subparagraph (B) determined under
                                    clause (i) is not a multiple of $1,000,
                                    such increase shall be rounded to the
                                    nearest multiple of $1,000.
                        ``(D) Coordination with other contributions.--The
                    limitation which would (but for this paragraph) apply
                    under subparagraphs (A) and (B) to an individual for
                    any taxable year shall be reduced (but not below zero)
                    by the sum of--
                                ``(i) the aggregate amount contributed to
                            health savings accounts of such individual
                            which is excludable from the taxpayer's gross
                            income for such taxable year under section
                            106(d) (and such amount shall not be allowed as
                            a deduction under subsection (a)), and
                                ``(ii) the aggregate amount contributed to
                            health savings accounts of such individual for
                            such taxable year under section 408(d)(9) (and
                            such amount shall not be allowed as a deduction
                            under subsection (a)).
                ``(3) Qualified medical expenses.--
                        ``(A) In general.--The term `qualified medical
                    expenses' means, with respect to an account
                    beneficiary, amounts paid by such beneficiary for
                    medical care (as defined in section 213(d)) for such
                    individual, the spouse of such individual, and any
                    dependent (as defined in section 152, determined
                    without regard to subsections (b)(1), (b)(2), and
                    (d)(1)(B) thereof) of such individual, but only to the
                    extent such amounts are not compensated for by
                    insurance or otherwise. For purposes of this
                    subparagraph, amounts paid for menstrual care products
                    shall be treated as paid for medical care.
                        ``(B) Health insurance may not be purchased from
                    account.--
                                ``(i) In general.--Subparagraph (A) shall
                            not apply to any payment for insurance.
                                ``(ii) Exceptions.--Clause (i) shall not
                            apply to any expense for coverage under--
                                        ``(I) a health plan during any
                                    period of continuation coverage
                                    required under any Federal law,
                                        ``(II) a qualified long-term care
                                    insurance contract (as defined in
                                    section 7702B(b)),
                                        ``(III) a health plan during a
                                    period in which the individual is
                                    receiving unemployment compensation
                                    under any Federal or State law, or
                                        ``(IV) in the case of an account
                                    beneficiary who has attained the age
                                    specified in section 1811 of the Social
                                    Security Act, any health insurance
                                    other than a medicare supplemental
                                    policy (as defined in section 1882 of
                                    the Social Security Act).
                                ``(iii) Exception for integrated health
                            plans.--Clause (i) shall not apply to any
                            expense for coverage under an integration
                            eligible health plan which is integrated with
                            the health savings account within the meaning
                            of section 106(d).
                                ``(iv) Exception for direct primary care
                            service arrangements.--
                                        ``(I) In general.--A direct primary
                                    care service arrangement shall not be
                                    treated as insurance for purposes of
                                    clause (i).
                                        ``(II) Direct primary care service
                                    arrangement defined.--For purposes of
                                    this clause, the term `direct primary
                                    care service arrangement' means an
                                    arrangement under which an individual
                                    is provided medical care (as defined in
                                    section 213(d)(1), determined without
                                    regard to subparagraph (E) thereof)
                                    consisting solely of primary care
                                    services provided by primary care
                                    practitioners (as defined in section
                                    1833(x)(2)(A) of the Social Security
                                    Act, determined without regard to
                                    clause (ii) thereof), if the sole
                                    compensation for such care is a fixed
                                    periodic fee.
                        ``(C) Menstrual care product.--For purposes of this
                    paragraph, the term `menstrual care product' means a
                    tampon, pad, liner, cup, sponge, or similar product
                    used by individuals with respect to menstruation or
                    other genital-tract secretions.
                ``(4) Account beneficiary.--The term `account beneficiary'
            means the individual on whose behalf the health savings account
            was established.
                ``(5) Certain rules to apply.--Rules similar to the
            following rules shall apply for purposes of this section:
                        ``(A) Section 219(d)(2) (relating to no deduction
                    for rollovers).
                        ``(B) Section 219(f)(3) (relating to time when
                    contributions deemed made).
                        ``(C) Except as provided in section 106(d), section
                    219(f)(5) (relating to employer payments).
                        ``(D) Section 408(g) (relating to community
                    property laws).
                        ``(E) Section 408(h) (relating to custodial
                    accounts).
        ``(e) Tax Treatment of Accounts.--
                ``(1) In general.--A health savings account is exempt from
            taxation under this subtitle unless such account has ceased to
            be a health savings account. Notwithstanding the preceding
            sentence, any such account is subject to the taxes imposed by
            section 511 (relating to imposition of tax on unrelated
            business income of charitable, etc. organizations).
                ``(2) Account terminations.--Rules similar to the rules of
            paragraphs (2) and (4) of section 408(e) shall apply to health
            savings accounts, and any amount treated as distributed under
            such rules shall be treated as not used to pay qualified
            medical expenses.
        ``(f) Tax Treatment of Distributions.--
                ``(1) Amounts used for qualified medical expenses.--Any
            amount paid or distributed out of a health savings account
            which is used exclusively to pay qualified medical expenses of
            any account beneficiary shall not be includible in gross
            income.
                ``(2) Inclusion of amounts not used for qualified medical
            expenses.--Any amount paid or distributed out of a health
            savings account which is not used exclusively to pay the
            qualified medical expenses of the account beneficiary shall be
            included in the gross income of such beneficiary.
                ``(3) Excess contributions returned before due date of
            return.--
                        ``(A) In general.--If any excess contribution is
                    contributed for a taxable year to any health savings
                    account of an individual, paragraph (2) shall not apply
                    to distributions from the health savings accounts of
                    such individual (to the extent such distributions do
                    not exceed the aggregate excess contributions to all
                    such accounts of such individual for such year) if--
                                ``(i) such distribution is received by the
                            individual on or before the last day prescribed
                            by law (including extensions of time) for
                            filing such individual's return for such
                            taxable year, and
                                ``(ii) such distribution is accompanied by
                            the amount of net income attributable to such
                            excess contribution.
                    Any net income described in clause (ii) shall be
                    included in the gross income of the individual for the
                    taxable year in which it is received.
                        ``(B) Excess contribution.--For purposes of
                    subparagraph (A), the term `excess contribution' means
                    any contribution (other than a rollover contribution
                    described in paragraph (5) or section 220(f)(5)) which
                    is neither excludable from gross income under section
                    106(d) nor deductible under this section.
                ``(4) Additional tax on distributions not used for
            qualified medical expenses.--
                        ``(A) In general.--The tax imposed by this chapter
                    on the account beneficiary for any taxable year in
                    which there is a payment or distribution from a health
                    savings account of such beneficiary which is includible
                    in gross income under paragraph (2) shall be increased
                    by 20 percent of the amount which is so includible.
                        ``(B) Exception for disability or death.--
                    Subparagraph (A) shall not apply if the payment or
                    distribution is made after the account beneficiary
                    becomes disabled within the meaning of section 72(m)(7)
                    or dies.
                        ``(C) Exception for distributions after medicare
                    eligibility.--Subparagraph (A) shall not apply to any
                    payment or distribution after the date on which the
                    account beneficiary attains the age specified in
                    section 1811 of the Social Security Act.
                ``(5) Rollover contribution.--An amount is described in
            this paragraph as a rollover contribution if it meets the
            requirements of subparagraphs (A) and (B).
                        ``(A) In general.--Paragraph (2) shall not apply to
                    any amount paid or distributed from a health savings
                    account to the account beneficiary to the extent the
                    amount received is paid into a health savings account
                    for the benefit of such beneficiary not later than the
                    60th day after the day on which the beneficiary
                    receives the payment or distribution.
                        ``(B) Limitation.--This paragraph shall not apply
                    to any amount described in subparagraph (A) received by
                    an individual from a health savings account if, at any
                    time during the 1-year period ending on the day of such
                    receipt, such individual received any other amount
                    described in subparagraph (A) from a health savings
                    account which was not includible in the individual's
                    gross income because of the application of this
                    paragraph.
                        ``(C) Rollover from fsa, archer msa, and hra.--An
                    amount is described in this subparagraph for a calendar
                    year as a rollover contribution if the amount is the
                    remaining balance in a health flexible spending
                    account, Archer MSA, or health reimbursement
                    arrangement that is contributed to the health savings
                    account for a taxable year ending on or before one year
                    after the date of the enactment of this subparagraph.
                ``(6) Coordination with medical expense deduction.--For
            purposes of determining the amount of the deduction under
            section 213, any payment or distribution out of a health
            savings account for qualified medical expenses shall not be
            treated as an expense paid for medical care.
                ``(7) Transfer of account incident to divorce.--The
            transfer of an individual's interest in a health savings
            account to an individual's spouse or former spouse under a
            divorce or separation instrument described in clause (i) of
            section 121(d)(3)(C) shall not be considered a taxable transfer
            made by such individual notwithstanding any other provision of
            this subtitle, and such interest shall, after such transfer, be
            treated as a health savings account with respect to which such
            spouse is the account beneficiary.
                ``(8) Treatment after death of account beneficiary.--
                        ``(A) Treatment if designated beneficiary is
                    spouse.--If the account beneficiary's surviving spouse
                    acquires such beneficiary's interest in a health
                    savings account by reason of being the designated
                    beneficiary of such account at the death of the account
                    beneficiary, such health savings account shall be
                    treated as if the spouse were the account beneficiary.
                        ``(B) Other cases.--
                                ``(i) In general.--If, by reason of the
                            death of the account beneficiary, any person
                            acquires the account beneficiary's interest in
                            a health savings account in a case to which
                            subparagraph (A) does not apply--
                                        ``(I) such account shall cease to
                                    be a health savings account as of the
                                    date of death, and
                                        ``(II) an amount equal to the fair
                                    market value of the assets in such
                                    account on such date shall be
                                    includible if such person is not the
                                    estate of such beneficiary, in such
                                    person's gross income for the taxable
                                    year which includes such date, or if
                                    such person is the estate of such
                                    beneficiary, in such beneficiary's
                                    gross income for the last taxable year
                                    of such beneficiary.
                                ``(ii) Special rules.--
                                        ``(I) Reduction of inclusion for
                                    predeath expenses.--The amount
                                    includible in gross income under clause
                                    (i) by any person (other than the
                                    estate) shall be reduced by the amount
                                    of qualified medical expenses which
                                    were incurred by the decedent before
                                    the date of the decedent's death and
                                    paid by such person within 1 year after
                                    such date.
                                        ``(II) Deduction for estate
                                    taxes.--An appropriate deduction shall
                                    be allowed under section 691(c) to any
                                    person (other than the decedent or the
                                    decedent's spouse) with respect to
                                    amounts included in gross income under
                                    clause (i) by such person.
        ``(g) Cost-of-Living Adjustment.--
                ``(1) In general.--In the case of any taxable year
            beginning after December 31, 2025, each dollar amount in
            paragraphs (2) and (3) of subsection (c) shall be increased by
            an amount equal to--
                        ``(A) such dollar amount, multiplied by
                        ``(B) the cost-of-living adjustment determined
                    under section 1(f)(3) for the calendar year in which
                    such taxable year begins determined by substituting
                    `2024' for `2016' in subparagraph (A)(ii) thereof.
                ``(2) Rounding.--If any increase under paragraph (1) is not
            a multiple of $50, such increase shall be rounded to the
            nearest multiple of $50.
        ``(h) Reports.--The Secretary may require--
                ``(1) the trustee of a health savings account to make such
            reports regarding such account to the Secretary and to the
            account beneficiary with respect to contributions,
            distributions, the return of excess contributions, and such
            other matters as the Secretary determines appropriate, and
                ``(2) any person who provides an individual with a
            qualified health plan to make such reports to the Secretary and
            to the account beneficiary with respect to such plan as the
            Secretary determines appropriate.''.
        (b) Employer Contributions to Health Savings Accounts.--
                (1) In general.--Section 106(d) is amended to read as
            follows:
        ``(d) Contributions to Health Savings Accounts.--
                ``(1) In general.--In the case of an employee who is an
            eligible individual, amounts contributed by such employee's
            employer to any health savings account of such employee shall
            be treated as employer-provided coverage for medical expenses
            under an accident or health plan to the extent--
                        ``(A) such amounts do not exceed twice the
                    limitation in effect under section 223(b)(2)
                    (determined without regard to this subsection) which is
                    applicable to such employee for such taxable year,
                        ``(B) such amounts are contributed to an account
                    which is integrated with an integration eligible health
                    plan,
                        ``(C) such employer does not offer such employee
                    coverage under any other accident or health plan,
                        ``(D) such employer offers such amounts only to
                    members of a qualified class of employees and offers
                    such amounts to all members of any such qualified
                    class,
                        ``(E) such employer offers employees an opportunity
                    to elect not to receive such amounts at least once per
                    year and upon termination from employment, and
                        ``(F) such employee is not covered under any health
                    insurance offered by an employer of such employee's
                    spouse.
                ``(2) Integration eligible health plan.--For purposes of
            this subsection, the term `integration eligible health plan'
            means--
                        ``(A) any bronze, silver, or gold plan offered
                    through an Exchange established under the Patient
                    Protection and Affordable Care Act,
                        ``(B) entitlement to benefits under part A of title
                    XVIII of the Social Security Act and enrollment under
                    part B of such title, including enrollment under a
                    Medicare Advantage plan under part C of such title,
                        ``(C) in the case of any individual who has not
                    attained age 30 or is determined by the Secretary
                    (after consultation with the Secretary of Health and
                    Human Services) to have a hardship, coverage under a
                    catastrophic plan, and
                        ``(D) in the case of any student, coverage under a
                    health plan which is conditioned on maintaining status
                    as being such a student.
                ``(3) Integration of plans and accounts.--For purposes of
            this subsection, an account shall be treated as integrated with
            an integration eligible health plan (and such plan shall be
            treated as integrated with such account) for any month if--
                        ``(A) the employee is the account beneficiary of
                    such account and such employee is covered under an
                    integration eligible health plan for such month,
                        ``(B) the employer verifies that the employee is so
                    covered by requiring the submission of documentation to
                    such employer, and
                        ``(C) the employer makes contributions to such
                    account for such month which are not less than the
                    excess (if any) of--
                                ``(i) the adjusted monthly premiums for the
                            applicable second lowest cost silver plan with
                            respect to the taxpayer, over
                                ``(ii) \1/12\ of 9.5 percent of the
                            taxpayer's household income (within the meaning
                            of section 36B).
                ``(4) Qualified class.--For purposes of this subsection--
                        ``(A) In general.--The term `qualified class' means
                    only the following: All employees; Full-time employees;
                    Part-time employees; Seasonal employees; Employees
                    covered under a collective bargaining agreement;
                    Employees in a waiting period; Foreign employees who
                    work abroad; Employees working in the same geographic
                    location (same insurance rating area, State, or multi-
                    State region); Salaried workers; Non-Salaried workers
                    (such as hourly workers); Temporary employees of
                    staffing firms.
                        ``(B) Rules related to class size.--
                                ``(i) Minimum class size.--A class shall
                            not be treated as a qualified class unless in
                            consisting of at least the following number of
                            employees:
                                        ``(I) In the case of an employer
                                    with fewer than 100 employees, the
                                    lesser of 10 employees or all employees
                                    of the employer.
                                        ``(II) In the case of an employer
                                    with at least 100 and not more than 200
                                    employees, 10 percent of the number of
                                    such employees (if not a whole number,
                                    rounded down to the next lowest whole
                                    number).
                                        ``(III) In the case of an employer
                                    with more than 200 employees, 20
                                    employees.
                                ``(ii) Combination of classes.--Two or more
                            qualified classes described in subparagraph (A)
                            may be combined if each such class separately
                            would not satisfy the requirement of clause
                            (i).
                        ``(C) Permitted variation within qualified
                    classes.--An employer shall not fail to meet the
                    requirements of paragraph (1)(D) solely because the
                    amounts offered to members of a qualified class vary on
                    the basis of--
                                ``(i) number of dependents,
                                ``(ii) age, if such variation based on age
                            does not exceed a ratio of 3:1, and
                                ``(iii) chronic health condition, if such
                            variation based on chronic health condition
                            does not exceed a ratio of 1.2:1.
                ``(5) Coordination with aca provisions.--In the case of an
            integration eligible health plan which is integrated with a
            health savings account--
                        ``(A) such plan shall be treated as an eligible
                    employer-sponsored plan described in section
                    5000A(f)(1)(B),
                        ``(B) if an individual receives contributions to
                    such account which are excludible from the gross income
                    of such individual under this section during any
                    taxable year, no credit shall be allowed under section
                    36B with respect to such individual for such taxable
                    year, and
                        ``(C) for purposes of section 36B(c)(2)(C)(i)(II),
                    the employee's required contribution with respect to
                    such plan shall be treated as being equal to the excess
                    (if any) of--
                                ``(i) the adjusted monthly premiums for the
                            applicable second lowest cost silver plan with
                            respect to the taxpayer, over
                                ``(ii) the contributions made the employer
                            to such health savings account which are
                            excludible from the gross income of the
                            employee under this section.
                ``(6) No constructive receipt.--No amount shall be included
            in the gross income of any employee solely because the employee
            may choose between the contributions referred to in paragraph
            (1) and employer contributions to another health plan of the
            employer.
                ``(7) Special rule for deduction of employer
            contributions.--Any employer contribution to a health savings
            account, if otherwise allowable as a deduction under this
            chapter, shall be allowed only for the taxable year in which
            paid.
                ``(8) Employer health savings account contributions
            required to be shown on return.--Every individual required to
            file a return under section 6012 for the taxable year shall
            include on such return the aggregate amount contributed by
            employers to the health savings accounts of such individual or
            such individual's spouse for such taxable year.
                ``(9) Health savings account contributions not part of
            cobra coverage.--Paragraph (1) shall not apply for purposes of
            section 4980B.
                ``(10) Definitions.--Terms used in this subsection which
            are also used in section 223 shall have the same respective
            meanings as when used in such section.
                ``(11) Regulations.--The Secretaries of Treasury, Labor,
            and Health and Human Services shall each issue such regulations
            or other guidance as may be necessary or appropriate to carry
            out the purposes of this subsection, including regulations or
            other guidance to--
                        ``(A) prevent employers from offering plans
                    integrated with health savings accounts selectively to
                    sicker workers, and
                        ``(B) establish a safe harbor that helps employers
                    determine whether contributions to health savings
                    accounts with respect to which there is an integrated
                    health plan comply with affordability requirements
                    under the Patient Protection and Affordable Care Act
                    and the amendments made by such Act.
                ``(12) Cross reference.--For penalty on failure by employer
            to make comparable contributions to the health savings accounts
            of comparable employees, see section 4980G.''.
                (2) Nonapplication of erisa.--Contributions by an employer
            to a health savings account (as defined in section 223 of the
            Internal Revenue Code of 1986), and an integration eligible
            health plan which is integrated with such account (within the
            meaning of such section), shall not be treated as a plan for
            purposes of the Employee Retirement Income Security Act of 1974
            if--
                        (A) receipt of such contributions by the employee
                    is voluntary,
                        (B) the employer does not select or endorse the
                    integration eligible health plan which is integrated
                    with such account,
                        (C) no premiums, other than premiums for the
                    integration eligible health plan which is integrated
                    with such account, are paid from the account,
                        (D) the employer receives no consideration (money
                    or other benefit) in connection with the employee
                    selecting or renewing a plan, and
                        (E) each participant is notified annually that such
                    contributions and such plan are not subject to the
                    requirements of such Act.
        (c) Termination of Certain Other Health Care Related Tax
    Benefits.--
                (1) Exclusion limited to self-funded major medical plan of
            employers.--Section 105(b) of such Code is amended by striking
            ``paid,'' and inserting ``paid under a self-funded major
            medical plan of the employer''.
                (2) Exclusion not applicable to health reimbursement
            arrangements.--Section 105(h) of such Code is amended to read
            as follows:
        ``(h) Exclusion Not Applicable to Health Reimbursement
    Arrangements.--Subsection (b) shall not apply to health reimbursement
    arrangements.''.
                (3) Repeal of exclusions from income for archer msas and
            fsas.--Section 106 of such Code is amended by striking
            subsection (b), (e) and (g).
                (4) Termination of deduction for contributions to archer
            msas.--Section 220(a) of such Code is amended by adding at the
            end the following: ``No amount shall be allowed as a deduction
            under the preceding sentence for any taxable year beginning
            after one year after the date of the enactment of this
            sentence.''.
        (d) Bankruptcy Protections.--Section 522 of title 11, United States
    Code, is amended by adding at the end the following new subsection:
        ``(r) For purposes of this section, any health savings account (as
    described in section 223 of the Internal Revenue Code of 1986) shall be
    treated in the same manner as an individual retirement account
    described in section 408 of such Code.''.
        (e) Rollover of FSA, Archer MSA, HRA to Health Savings Account.--
    Notwithstanding any other provision of law, if the remaining balance in
    a health flexible spending arrangement, Archer MSA, or health
    reimbursement arrangement is transferred to a health savings account
    before the end of any taxable year ending on or before one year after
    the date of the enactment of this Act, such transfer shall be treated
    as a rollover to the health savings account under section 223(f)(5) of
    the Internal Revenue Code of 1986 and the distribution from the health
    flexible spending arrangement, Archer MSA, or health reimbursement
    arrangement shall not be includible in gross income.
        (f) Effective Dates.--
                (1) In general.--The amendments made by subsections (a) and
            (b) shall apply to taxable years beginning after the date of
            the enactment of this Act.
                (2) Termination of certain other health care related tax
            benefits.--The amendments made by subsection (c) shall apply to
            taxable years beginning after the date which is 1 year after
            the date of the enactment of this Act.
                (3) Bankruptcy protections.--The amendment made by
            subsection (d) shall apply to cases commencing under title 11,
            United States Code, after the date of the enactment of this
            Act.

    SEC. 102. UNUSED PREMIUM TAX CREDITS MAY BE DEPOSITED IN HEALTH SAVINGS
                  ACCOUNTS.

        (a) In General.--Section 36B is amended by redesignating subsection
    (h) as subsection (i) and by inserting after subsection (g) the
    following new subsection:
        ``(h) Excess Credit May Be Deposited Into a Health Savings
    Account.--
                ``(1) In general.--If the amount described in subparagraph
            (B) of subsection (b)(2) exceeds the amount described in
            subparagraph (A) of such subsection with respect to any
            coverage month and an election under paragraph (2) is in effect
            with respect to the applicable taxpayer, the Secretary shall
            deposit such excess into a health savings account of such
            taxpayer.
                ``(2) Election to deposit excess credit into a health
            savings account.--A taxpayer may elect (at such time and in
            such manner as the Secretary may provide) to have the Secretary
            deposit the excess described in paragraph (1) into a health
            savings account of the taxpayer. Any such election shall only
            be treated as being in effect if the taxpayer provides the
            Secretary with such information as the Secretary may require to
            allow the Secretary to make such deposit.
                ``(3) Coordination with health savings account rules.--Any
            amount deposited in a health savings account by the Secretary
            under this subsection shall--
                        ``(A) be includible in the gross income of the
                    applicable taxpayer, and
                        ``(B) be taken into account as an amount paid to
                    such account for purposes of this section.
                ``(4) Treatment of deposits.--For purposes of section 1324
            of title 31, United States Code, any deposit made under this
            subsection shall be treated as a credit allowed under this
            section.''.
        (b) Effective Date.--The amendments made by this section shall
    apply to taxable years beginning after the date of the enactment of
    this Act.

    SEC. 103. HEALTH REIMBURSEMENT ARRANGEMENTS AND OTHER ACCOUNT-BASED
                  GROUP HEALTH PLANS.

        The rule published by the Internal Revenue Service, the Employee
    Benefits Security Administration, and the Health and Human Services
    Department relating to ``Health Reimbursement Arrangements and Other
    Account-Based Group Health Plans'' (June 20, 2019) shall have the force
    and effect of law. Health Reimbursement Arrangements as described in
    this rule are subject to all sections in this title.

    SEC. 104. COST-SHARING REDUCTION PAYMENTS AS ELIGIBLE CONTRIBUTIONS.

        (a) Alternative Waiver for State Innovation.--Section 1332 of the
    Patient Protection and Affordable Care Act (42 U.S.C. 18052) is amended
    by adding at the end the following new subsection:
        ``(f) Alternative Waiver for State Innovation.--
                ``(1) In general.--Notwithstanding any preceding provision
            of this section, a State may apply to the Secretary for the
            waiver of any requirement of subsection (a)(2) with respect to
            health insurance coverage within that State for plan years
            beginning on or after January 1, 2025, if instead of complying
            with section 1402 the State provides for the distribution of
            funding received under paragraph (2) to health savings accounts
            of qualifying individuals with respect to such State. Such
            application shall be filed at such time and in such manner as
            the Secretary may require, and shall include such information
            as the Secretary may require (including a 10-year budget plan
            for such plan that is budget neutral for the Federal
            Government).
                ``(2) Pass-through funding.--With respect to a State waiver
            under paragraph (1), under which, due to the structure of such
            waiver, individuals in the State would not qualify for cost-
            sharing reductions under section 1402 for which they would
            otherwise be eligible, the Secretary shall provide for an
            alternative means by which an amount is transferred to the
            State equal to the aggregate amount of such reductions that
            would have been paid on behalf of the participants in the
            Exchanges established under this title--
                        ``(A) had the State not received such waiver;
                        ``(B) had references to `eligible insureds' under
                    section 1402 referred to `qualifying insureds (as
                    defined in section 1332(f))';
                        ``(C) had, after application of clause (ii), in the
                    case of a qualifying insured enrolled in the bronze
                    level of coverage--
                                ``(i) the percentages specified in
                            subclauses (I), (II), and (III) of section
                            1402(c)(1)(B) were references to 84 percent, 77
                            percent, and 63 percent, respectively; and
                                ``(ii) the references in subparagraphs (A),
                            (B), and (C) of section 1402(c)(2) to 94
                            percent, 87 percent, and 73 percent,
                            respectively, were references to 84 percent, 77
                            percent, and 63 percent, respectively; and
                        ``(D) had, after application of clause (ii), in the
                    case of a qualifying insured enrolled in the copper
                    level of coverage--
                                ``(i) the percentages specified in
                            subclauses (I), (II), and (III) of section
                            1402(c)(1)(B) were references to 74 percent, 67
                            percent, and 53 percent, respectively; and
                                ``(ii) the references in subparagraphs (A),
                            (B), and (C) of section 1402(c)(2) to 94
                            percent, 87 percent, and 73 percent,
                            respectively, were references to 74 percent, 67
                            percent, and 53 percent, respectively.
            The amount transferred pursuant to the previous sentence shall
            be determined annually by the Secretary, taking into
            consideration the experience of other States with respect to
            participation in an Exchange and reductions provided under such
            provisions to residents of the other States, and shall be paid
            to the State for purposes of implementing such waiver.
                ``(3) Waiver consideration and transparency.--The
            provisions of paragraph (4) of subsection (a) shall apply to an
            application for a waiver under paragraph (1) in the same manner
            as such provisions apply with respect to an application for a
            waiver under subsection (a)(1), except that, for purposes of
            this paragraph, the provisions of subsection (a)(4)(B)(ii)
            shall not apply.
                ``(4) Determinations; term of waiver.--The provisions of
            subsections (d) and (e) shall apply with respect to a
            determination with respect to an application under paragraph
            (1), and with respect to the term of a waiver under such
            paragraph, in the same manner as such provisions apply with
            respect to a determination with respect to an application under
            subsection (a)(1), and with respect to the term of a waiver
            under such subsection.
                ``(5) Definitions.--For purposes of this subsection:
                        ``(A) Health savings account.--The term `health
                    savings account' has the meaning given such term in
                    section 223 of the Internal Revenue Code of 1986.
                        ``(B) Qualifying insured.--The term `qualifying
                    insured' means, with respect to a State and a year, an
                    individual--
                                ``(i) who is enrolled in a health savings
                            account;
                                ``(ii) who is enrolled for such year in a
                            silver, bronze, or copper level coverage
                            offered through an Exchange; and
                                ``(iii) whose household income is not more
                            than 250 percent of the Federal poverty line
                            for a family of the size involved.''.
        (b) Additional Amendments.--Section 1402 of the Patient Protection
    and Affordable Care Act (42 U.S.C. 18071) is amended by striking ``not
    less than 100 percent but'' and ``exceeds 100 percent but'' and ``more
    than 100 percent but'' each place such phrases appear.
        (c) Conforming Amendments.--Section 1332 of the Patient Protection
    and Affordable Care Act (42 U.S.C. 18052), as amended by subsection
    (a), is further amended in subsection (a)(4)--
                (1) in subparagraph (A) by striking the period and
            inserting ``, except in the case of a waiver described in
            subsection (f).''; and
                (2) in subparagraph (B)(ii) by inserting after ``an
            application'' the following: ``(except in the case of a waiver
            described in subsection (f))''.
        (d) Appropriation for Cost-Sharing Payments.--Section 1402 of the
    Patient Protection and Affordable Care Act (42 U.S.C. 18071) is amended
    by adding at the end the following new subsection:
        ``(g) Funding.--
                ``(1) Appropriations.--Out of any funds in the Treasury not
            otherwise appropriated, there is appropriated such sums as may
            be necessary to, subject to paragraph (2), provide health
            benefits coverage through payment to issuers (under this
            section or through advance payment by the Secretary of the
            Treasury under section 1412(c)(3)) of the amounts computed
            under this section for each of plan years 2025 through 2029.
                ``(2) Adjustments.--Notwithstanding any other provision of
            law, payments and other actions for adjustments to obligations
            incurred prior to December 31, 2025, may be made through
            December 31, 2023.
                ``(3) Limitation.--Amounts appropriated under paragraph (1)
            for each of plan years 2025 through 2029 are subject to the
            requirements and limitations under sections 506 and 507 of
            division H of Public Law 115-31 in the same manner and to the
            same extent as if such amounts for each such year were
            appropriated under such division.''.

    SEC. 105. DIRECT PRIMARY CARE.

        (a) In General.--Section 223(c)(1) of the Internal Revenue Code of
    1986 is amended by adding at the end the following new subparagraph:
                        ``(D) Treatment of direct primary care service
                    arrangements.--
                                ``(i) In general.--A direct primary care
                            service arrangement shall not be treated as a
                            health plan for purposes of subparagraph
                            (A)(ii).
                                ``(ii) Direct primary care service
                            arrangement.--For purposes of this paragraph--
                                        ``(I) In general.--The term `direct
                                    primary care service arrangement'
                                    means, with respect to any individual,
                                    an arrangement under which such
                                    individual is provided medical care (as
                                    defined in section 213(d)) consisting
                                    solely of primary care services
                                    provided by primary care practitioners
                                    (as defined in section 1833(x)(2)(A) of
                                    the Social Security Act, determined
                                    without regard to clause (ii) thereof),
                                    if the sole compensation for such care
                                    is a fixed periodic fee.
                                        ``(II) Limitation.--With respect to
                                    any individual for any month, such term
                                    shall not include any arrangement if
                                    the aggregate fees for all direct
                                    primary care service arrangements
                                    (determined without regard to this
                                    subclause) with respect to such
                                    individual for such month exceed $150
                                    (twice such dollar amount in the case
                                    of an individual with any direct
                                    primary care service arrangement (as so
                                    determined) that covers more than one
                                    individual).
                                ``(iii) Certain services specifically
                            excluded from treatment as primary care
                            services.--For purposes of this paragraph, the
                            term `primary care services' shall not
                            include--
                                        ``(I) procedures that require the
                                    use of general anesthesia, and
                                        ``(II) laboratory services not
                                    typically administered in an ambulatory
                                    primary care setting.
                            The Secretary, after consultation with the
                            Secretary of Health and Human Services, shall
                            issue regulations or other guidance regarding
                            the application of this clause.''.
        (b) Direct Primary Care Service Arrangement Fees Treated as Medical
    Expenses.--Section 223(d)(2)(C) is amended by striking ``or'' at the
    end of clause (iii), by striking the period at the end of clause (iv)
    and inserting ``, or'', and by adding at the end the following new
    clause:
        ``(v) any direct primary care service arrangement.''.
        (c) Inflation Adjustment.--Section 223(g)(1) of such Code is
    amended--
                (1) by inserting ``, (c)(1)(D)(ii)(II),'' after ``(b)(2),''
            each place such term appears, and
                (2) in subparagraph (B), by inserting ``and (iii)'' after
            ``clause (ii)'' in clause (i), by striking ``and'' at the end
            of clause (i), by striking the period at the end of clause (ii)
            and inserting ``, and'', and by inserting after clause (ii) the
            following new clause:
                                ``(iii) in the case of the dollar amount in
                            subsection (c)(1)(D)(ii)(II) for taxable years
                            beginning in calendar years after 2025,
                            calendar year 2024.''.
        (d) Reporting of Direct Primary Care Service Arrangement Fees on W-
    2.--Section 6051(a) of such Code is amended by striking ``and'' at the
    end of paragraph (16), by striking the period at the end of paragraph
    (17) and inserting ``, and'', and by inserting after paragraph (17) the
    following new paragraph:
                ``(18) in the case of a direct primary care service
            arrangement (as defined in section 223(c)(1)(D)(ii)) which is
            provided in connection with employment, the aggregate fees for
            such arrangement for such employee.''.
        (e) Effective Date.--The amendments made by this section shall
    apply to months beginning after December 31, 2024, in taxable years
    ending after such date.

               Subtitle B--Assistance to Health Savings Accounts

    SEC. 111. ONE-TIME APPLICATION OF SAVER'S CREDIT TO CONTRIBUTIONS TO
                  HEALTH SAVINGS ACCOUNTS.

        (a) In General.--In the case of an applicable taxable year,
    contributions to any health savings account of the taxpayer during such
    taxable year shall be treated as a qualified retirement savings
    contribution for purposes of section 25B of the Internal Revenue Code
    of 1986.
        (b) Applicable Taxable Year.--For purposes of this section, the
    term ``applicable taxable year'' means any taxable year elected by the
    taxpayer (at such time and in such manner as the Secretary of the
    Treasury may provide) which begins during the 3-year period beginning 1
    year after the date of the enactment of this Act. A taxpayer may not
    elect not more than 1 applicable taxable year under this subsection.

    SEC. 112. GRANTS FOR HEALTH SAVINGS ACCOUNT ASSISTANCE AND OUTREACH.

        (a) In General.--The Administrator shall establish a grant program
    to provide assistance to eligible entities to carry out the activities
    described in subsection (c).
        (b) Application.--An eligible entity shall submit an application to
    the Administrator in such time and in such manner as the Administrator
    may require, providing that such application requires a demonstration
    of the existence of a relationship with, or the ability to establish a
    relationship with, an employer, employee, self-employed individual, or
    consumer eligible to enroll in a health savings account.
        (c) Use of Funds.--An eligible entity receiving a grant under this
    section shall use such funds to--
                (1) distribute fair and impartial information to consumers
            about health savings accounts, including the availability of
            such accounts and how such accounts may be utilized;
                (2) conduct activities to raise public awareness of health
            savings accounts;
                (3) facilitate enrollment in health savings accounts; and
                (4) refer individuals enrolled in a health savings account
            to the appropriate official, organization, or State agency for
            the purpose of addressing a complaint, grievance, or other
            question with respect to such health savings account.
        (d) Amount.--The Administrator may distribute up to $5,000,000
    annually to be divided among grant recipients under this section.
        (e) Report.--Not later than one year after the date on which the
    last of the grant periods awarded under this section ends, the
    Administrator shall submit a report to the Congress on the
    effectiveness of the grants provided under this section.
        (f) Definitions.--In this section:
                (1) Administrator.--The term ``Administrator'' means the
            Administrator of the Centers for Medicare & Medicaid Services.
                (2) Consumer.--The term ``consumer'' means an individual
            enrolled in, or seeking to enroll in, a health savings account.
                (3) Eligible entity.--The term ``eligible entity'' includes
            the following:
                        (A) A State.
                        (B) Trade.
                        (C) Industry.
                        (D) Professional associations.
                        (E) Commercial fishing industry organizations.
                        (F) Ranching and farming organizations.
                        (G) Community and consumer-focused nonprofit
                    groups.
                        (H) Chambers of commerce.
                        (I) Unions.
                        (J) Small business development centers (as defined
                    in section 21 of the Small Business Act (15 U.S.C.
                    648)).
                        (K) Other entities capable of carrying out the
                    activities described under subsection (b).
                (4) Health savings account.--The term ``health savings
            account'' has the meaning given such term in section 223 of the
            Internal Revenue Code of 1986.
                (5) State.--The term ``State'' means each of the several
            States, the District of Columbia, each territory and possession
            of the United States, and each federally recognized Indian
            Tribe.

    SEC. 113. NEW CORPORATIONS REQUIRED TO USE HEALTH SAVINGS ACCOUNTS.

        Notwithstanding any other provision of law, a corporation
    incorporated after December 31, 2024, may not receive tax benefits for
    offering employees health insurance. The previous sentence shall not
    apply to health savings account contributions offered by such a
    corporation.

    SEC. 114. FEDERAL EMPLOYEE HEALTH BENEFITS AND HEALTH SAVINGS ACCOUNTS.

        (a) In General.--Section 1312(d)(3)(D) of the Patient Protection
    and Affordable Care Act (42 U.S.C. 18032(d)(3)(D)) is amended--
                (1) in the subparagraph heading, by striking ``Members of
            congress'' and inserting ``President, vice president, members
            of congress, and federal employees'';
                (2) in clause (i), in the matter preceding subclause (I)--
                        (A) by striking ``Members of Congress and
                    congressional staff'' and inserting ``the President,
                    Vice President, Members of Congress, and Federal
                    employees''; and
                        (B) by striking ``a Member of Congress or
                    congressional staff'' and inserting ``the President,
                    the Vice President, a Member of Congress, or a Federal
                    employee''; and
                (3) in clause (ii), by amending subclause (II) to read as
            follows:
                                        ``(II) Federal employee.--The term
                                    `Federal employee' means--
                                                ``(aa) an `employee', as
                                            such term is defined in section
                                            2105 of title 5, United States
                                            Code; and
                                                ``(bb) includes an
                                            individual to whom subsection
                                            (c) or (f) of such section 2105
                                            pertains (whether or not such
                                            individual satisfies item
                                            (aa)).''.
        (b) Conversion to Health Savings Accounts.--Each plan offered under
    chapter 89 of title 5, United States Code, shall be converted into a
    health savings account deposit and funded at the level of the second-
    least expensive silver plan available through the Exchange where the
    applicable individual resides.

                  TITLE II--IMPROVING PRIVATE HEALTH INSURANCE

       Subtitle A--Maintaining Protections for Patients With Preexisting
                                   Conditions

    SEC. 201. GUARANTEED AVAILABILITY OF COVERAGE; PROHIBITING
                  DISCRIMINATION.

        (a) In General.--Subtitle C of title I of the Health Insurance
    Portability and Accountability Act of 1996 (Public Law 104-191) is
    amended by adding at the end the following:

    ``SEC. 196. GUARANTEED AVAILABILITY OF COVERAGE.

        ``(a) Guaranteed Issuance of Coverage in the Individual and Group
    Market.--Subject to subsections (b) through (d), each health insurance
    issuer that offers health insurance coverage in the individual or group
    market in a State must accept every employer and individual in the
    State that applies for such coverage.
        ``(b) Enrollment.--
                ``(1) Restriction.--A health insurance issuer described in
            subsection (a) may restrict enrollment in coverage described in
            such subsection to open or special enrollment periods.
                ``(2) Establishment.--A health insurance issuer described
            in subsection (a) shall, in accordance with the regulations
            promulgated under paragraph (3), establish special enrollment
            periods for qualifying events (under section 603 of the
            Employee Retirement Income Security Act of 1974).
                ``(3) Regulations.--The Secretary shall promulgate
            regulations with respect to enrollment periods under paragraphs
            (1) and (2).
        ``(c) Special Rules for Network Plans.--
                ``(1) In general.--In the case of a health insurance issuer
            that offers health insurance coverage in the group and
            individual market through a network plan, the issuer may--
                        ``(A) limit the employers that may apply for such
                    coverage to those with eligible individuals who live,
                    work, or reside in the service area for such network
                    plan; and
                        ``(B) within the service area of such plan, deny
                    such coverage to such employers and individuals if the
                    issuer has demonstrated, if required, to the applicable
                    State authority that--
                                ``(i) it will not have the capacity to
                            deliver services adequately to enrollees of any
                            additional groups or any additional individuals
                            because of its obligations to existing group
                            contract holders and enrollees; and
                                ``(ii) it is applying this paragraph
                            uniformly to all employers and individuals
                            without regard to the claims experience of
                            those individuals, employers and their
                            employees (and their dependents), or any health
                            status-related factor relating to such
                            individuals, employees, and dependents.
                ``(2) 180-day suspension upon denial of coverage.--An
            issuer, upon denying health insurance coverage in any service
            area in accordance with paragraph (1)(B), may not offer
            coverage in the group or individual market within such service
            area for a period of 180 days after the date such coverage is
            denied.
        ``(d) Application of Financial Capacity Limits.--
                ``(1) In general.--A health insurance issuer may deny
            health insurance coverage in the group or individual market if
            the issuer has demonstrated, if required, to the applicable
            State authority that--
                        ``(A) it does not have the financial reserves
                    necessary to underwrite additional coverage; and
                        ``(B) it is applying this paragraph uniformly to
                    all employers and individuals in the group or
                    individual market in the State consistent with
                    applicable State law and without regard to the claims
                    experience of those individuals, employers and their
                    employees (and their dependents) or any health status-
                    related factor relating to such individuals, employees,
                    and dependents.
                ``(2) 180-day suspension upon denial of coverage.--A health
            insurance issuer upon denying health insurance coverage in
            connection with group health plans in accordance with paragraph
            (1) in a State may not offer coverage in connection with group
            health plans in the group or individual market in the State for
            a period of 180 days after the date such coverage is denied or
            until the issuer has demonstrated to the applicable State
            authority, if required under applicable State law, that the
            issuer has sufficient financial reserves to underwrite
            additional coverage, whichever is later. An applicable State
            authority may provide for the application of this subsection on
            a service-area-specific basis.
        ``(e) Definitions.--In this section and in sections 197 through
    199A:
                ``(1) The term `Secretary' means the Secretary of Health
            and Human Services.
                ``(2) The terms `genetic information', `genetic test',
            `group health plan', `group market', `health insurance
            coverage', `health insurance issuer', `group health insurance
            coverage', `individual health insurance coverage', `individual
            market', and `underwriting purpose' have the meanings given
            such terms in section 2791 of the Public Health Service Act.

    ``SEC. 197. FAIR HEALTH INSURANCE PREMIUMS.

        ``(a) Prohibiting Discriminatory Premium Rates.--
                ``(1) In general.--With respect to the premium rate charged
            by a health insurance issuer for health insurance coverage
            offered in the individual or small group market--
                        ``(A) such rate shall vary with respect to the
                    particular plan or coverage involved only by--
                                ``(i) whether such plan or coverage covers
                            an individual or family;
                                ``(ii) rating area, as established in
                            accordance with paragraph (2);
                                ``(iii) age, except that such rate shall
                            not vary by more than 5 to 1 for adults; and
                                ``(iv) tobacco use, except that such rate
                            shall not vary by more than 1.5 to 1; and
                        ``(B) such rate shall not vary with respect to the
                    particular plan or coverage involved by any other
                    factor not described in subparagraph (A).
                ``(2) Rating area.--
                        ``(A) In general.--Each State shall establish 1 or
                    more rating areas within that State for purposes of
                    applying the requirements of this title.
                        ``(B) Secretarial review.--The Secretary shall
                    review the rating areas established by each State under
                    subparagraph (A) to ensure the adequacy of such areas
                    for purposes of carrying out the requirements of this
                    title. If the Secretary determines a State's rating
                    areas are not adequate, or that a State does not
                    establish such areas, the Secretary may establish
                    rating areas for that State.
                ``(3) Permissible age bands.--The Secretary, in
            consultation with the National Association of Insurance
            Commissioners, shall define the permissible age bands for
            rating purposes under paragraph (1)(A)(iii).
                ``(4) Application of variations based on age or tobacco
            use.--With respect to family coverage under a group health plan
            or health insurance coverage, the rating variations permitted
            under clauses (iii) and (iv) of paragraph (1)(A) shall be
            applied based on the portion of the premium that is
            attributable to each family member covered under the plan or
            coverage.

    ``SEC. 198. PROHIBITING DISCRIMINATION AGAINST INDIVIDUAL PARTICIPANTS
                  AND BENEFICIARIES BASED ON HEALTH STATUS.

        ``(a) In General.--A group health plan and a health insurance
    issuer offering group or individual health insurance coverage may not
    establish rules for eligibility (including continued eligibility) of
    any individual to enroll under the terms of the plan or coverage based
    on any of the following health status-related factors in relation to
    the individual or a dependent of the individual:
                ``(1) Health status.
                ``(2) Medical condition (including both physical and mental
            illnesses).
                ``(3) Claims experience.
                ``(4) Receipt of health care.
                ``(5) Medical history.
                ``(6) Genetic information.
                ``(7) Evidence of insurability (including conditions
            arising out of acts of domestic violence).
                ``(8) Disability.
                ``(9) Any other health status-related factor determined
            appropriate by the Secretary.
        ``(b) In Premium Contributions.--
                ``(1) In general.--A group health plan, and a health
            insurance issuer offering group or individual health insurance
            coverage, may not require any individual (as a condition of
            enrollment or continued enrollment under the plan) to pay a
            premium or contribution which is greater than such premium or
            contribution for a similarly situated individual enrolled in
            the plan on the basis of any health status-related factor in
            relation to the individual or to an individual enrolled under
            the plan as a dependent of the individual.
                ``(2) Construction.--Nothing in paragraph (1) shall be
            construed--
                        ``(A) to restrict the amount that an employer or
                    individual may be charged for coverage under a group
                    health plan except as provided in paragraph (3) or
                    individual health coverage, as the case may be; or
                        ``(B) to prevent a group health plan, and a health
                    insurance issuer offering group health insurance
                    coverage, from establishing premium discounts or
                    rebates or modifying otherwise applicable copayments or
                    deductibles in return for adherence to programs of
                    health promotion and disease prevention.
                ``(3) No group-based discrimination on basis of genetic
            information.--
                        ``(A) In general.--For purposes of this section, a
                    group health plan, and health insurance issuer offering
                    group health insurance coverage in connection with a
                    group health plan, may not adjust premium or
                    contribution amounts for the group covered under such
                    plan on the basis of genetic information.
                        ``(B) Rule of construction.--Nothing in
                    subparagraph (A) or in paragraphs (1) and (2) of
                    subsection (d) shall be construed to limit the ability
                    of a health insurance issuer offering group or
                    individual health insurance coverage to increase the
                    premium for an employer based on the manifestation of a
                    disease or disorder of an individual who is enrolled in
                    the plan. In such case, the manifestation of a disease
                    or disorder in one individual cannot also be used as
                    genetic information about other group members and to
                    further increase the premium for the employer.
        ``(c) Genetic Testing.--
                ``(1) Limitation on requesting or requiring genetic
            testing.--A group health plan, and a health insurance issuer
            offering health insurance coverage in connection with a group
            health plan, shall not request or require an individual or a
            family member of such individual to undergo a genetic test.
                ``(2) Rule of construction.--Paragraph (1) shall not be
            construed to limit the authority of a health care professional
            who is providing health care services to an individual to
            request that such individual undergo a genetic test.
                ``(3) Rule of construction regarding payment.--
                        ``(A) In general.--Nothing in paragraph (1) shall
                    be construed to preclude a group health plan, or a
                    health insurance issuer offering health insurance
                    coverage in connection with a group health plan, from
                    obtaining and using the results of a genetic test in
                    making a determination regarding payment (as such term
                    is defined for the purposes of applying the regulations
                    promulgated by the Secretary under part C of title XI
                    of the Social Security Act and section 264 of this Act,
                    as may be revised from time to time) consistent with
                    subsection (a).
                        ``(B) Limitation.--For purposes of subparagraph
                    (A), a group health plan, or a health insurance issuer
                    offering health insurance coverage in connection with a
                    group health plan, may request only the minimum amount
                    of information necessary to accomplish the intended
                    purpose.
                ``(4) Research exception.--Notwithstanding paragraph (1), a
            group health plan, or a health insurance issuer offering health
            insurance coverage in connection with a group health plan, may
            request, but not require, that a participant or beneficiary
            undergo a genetic test if each of the following conditions is
            met:
                        ``(A) The request is made pursuant to research that
                    complies with part 46 of title 45, Code of Federal
                    Regulations, or equivalent Federal regulations, and any
                    applicable State or local law or regulations for the
                    protection of human subjects in research.
                        ``(B) The plan or issuer clearly indicates to each
                    participant or beneficiary, or in the case of a minor
                    child, to the legal guardian of such beneficiary, to
                    whom the request is made that--
                                ``(i) compliance with the request is
                            voluntary; and
                                ``(ii) noncompliance will have no effect on
                            enrollment status or premium or contribution
                            amounts.
                        ``(C) No genetic information collected or acquired
                    under this paragraph shall be used for underwriting
                    purposes.
                        ``(D) The plan or issuer notifies the Secretary in
                    writing that the plan or issuer is conducting
                    activities pursuant to the exception provided for under
                    this paragraph, including a description of the
                    activities conducted.
                        ``(E) The plan or issuer complies with such other
                    conditions as the Secretary may by regulation require
                    for activities conducted under this paragraph.
        ``(d) Prohibition on Collection of Genetic Information.--
                ``(1) In general.--A group health plan, and a health
            insurance issuer offering health insurance coverage in
            connection with a group health plan, shall not request,
            require, or purchase genetic information for underwriting
            purposes.
                ``(2) Prohibition on collection of genetic information
            prior to enrollment.--A group health plan, and a health
            insurance issuer offering health insurance coverage in
            connection with a group health plan, shall not request,
            require, or purchase genetic information with respect to any
            individual prior to such individual's enrollment under the plan
            or coverage in connection with such enrollment.
                ``(3) Incidental collection.--If a group health plan, or a
            health insurance issuer offering health insurance coverage in
            connection with a group health plan, obtains genetic
            information incidental to the requesting, requiring, or
            purchasing of other information concerning any individual, such
            request, requirement, or purchase shall not be considered a
            violation of paragraph (2) if such request, requirement, or
            purchase is not in violation of paragraph (1).
        ``(e) Genetic Information of a Fetus or Embryo.--Any reference in
    this part to genetic information concerning an individual or family
    member of an individual shall--
                ``(1) with respect to such an individual or family member
            of an individual who is a pregnant woman, include genetic
            information of any fetus carried by such pregnant woman; and
                ``(2) with respect to an individual or family member
            utilizing an assisted reproductive technology, include genetic
            information of any embryo legally held by the individual or
            family member.
        ``(f) Programs of Health Promotion or Disease Prevention.--
                ``(1) General provisions.--
                        ``(A) General rule.--For purposes of subsection
                    (b)(2)(B), a program of health promotion or disease
                    prevention (referred to in this subsection as a
                    `wellness program') shall be a program offered by an
                    employer that is designed to promote health or prevent
                    disease that meets the applicable requirements of this
                    subsection.
                        ``(B) No conditions based on health status
                    factor.--If none of the conditions for obtaining a
                    premium discount or rebate or other reward for
                    participation in a wellness program is based on an
                    individual satisfying a standard that is related to a
                    health status factor, such wellness program shall not
                    violate this section if participation in the program is
                    made available to all similarly situated individuals
                    and the requirements of paragraph (2) are complied
                    with.
                        ``(C) Conditions based on health status factor.--If
                    any of the conditions for obtaining a premium discount
                    or rebate or other reward for participation in a
                    wellness program is based on an individual satisfying a
                    standard that is related to a health status factor,
                    such wellness program shall not violate this section if
                    the requirements of paragraph (3) are complied with.
                ``(2) Wellness programs not subject to requirements.--If
            none of the conditions for obtaining a premium discount or
            rebate or other reward under a wellness program as described in
            paragraph (1)(B) are based on an individual satisfying a
            standard that is related to a health status factor (or if such
            a wellness program does not provide such a reward), the
            wellness program shall not violate this section if
            participation in the program is made available to all similarly
            situated individuals. The following programs shall not have to
            comply with the requirements of paragraph (3) if participation
            in the program is made available to all similarly situated
            individuals:
                        ``(A) A program that reimburses all or part of the
                    cost for memberships in a fitness center.
                        ``(B) A diagnostic testing program that provides a
                    reward for participation and does not base any part of
                    the reward on outcomes.
                        ``(C) A program that encourages preventive care
                    related to a health condition through the waiver of the
                    copayment or deductible requirement under a group
                    health plan for the costs of certain items or services
                    related to a health condition (such as prenatal care or
                    well-baby visits).
                        ``(D) A program that reimburses individuals for the
                    costs of smoking cessation programs without regard to
                    whether the individual quits smoking.
                        ``(E) A program that provides a reward to
                    individuals for attending a periodic health education
                    seminar.
                ``(3) Wellness programs subject to requirements.--If any of
            the conditions for obtaining a premium discount, rebate, or
            reward under a wellness program as described in paragraph
            (1)(C) is based on an individual satisfying a standard that is
            related to a health status factor, the wellness program shall
            not violate this section if the following requirements are
            complied with:
                        ``(A) The reward for the wellness program, together
                    with the reward for other wellness programs with
                    respect to the plan that requires satisfaction of a
                    standard related to a health status factor, shall not
                    exceed 30 percent of the cost of employee-only coverage
                    under the plan. If, in addition to employees or
                    individuals, any class of dependents (such as spouses
                    or spouses and dependent children) may participate
                    fully in the wellness program, such reward shall not
                    exceed 30 percent of the cost of the coverage in which
                    an employee or individual and any dependents are
                    enrolled. For purposes of this paragraph, the cost of
                    coverage shall be determined based on the total amount
                    of employer and employee contributions for the benefit
                    package under which the employee is (or the employee
                    and any dependents are) receiving coverage. A reward
                    may be in the form of a discount or rebate of a premium
                    or contribution, a waiver of all or part of a cost-
                    sharing mechanism (such as deductibles, copayments, or
                    coinsurance), the absence of a surcharge, or the value
                    of a benefit that would otherwise not be provided under
                    the plan. The Secretaries of Labor, Health and Human
                    Services, and the Treasury may increase the reward
                    available under this subparagraph to up to 50 percent
                    of the cost of coverage if the Secretaries determine
                    that such an increase is appropriate.
                        ``(B) The wellness program shall be reasonably
                    designed to promote health or prevent disease. A
                    program complies with the preceding sentence if the
                    program has a reasonable chance of improving the health
                    of, or preventing disease in, participating individuals
                    and it is not overly burdensome, is not a subterfuge
                    for discriminating based on a health status factor, and
                    is not highly suspect in the method chosen to promote
                    health or prevent disease.
                        ``(C) The plan shall give individuals eligible for
                    the program the opportunity to qualify for the reward
                    under the program at least once each year.
                        ``(D) The full reward under the wellness program
                    shall be made available to all similarly situated
                    individuals. For such purpose, among other things:
                                ``(i) The reward is not available to all
                            similarly situated individuals for a period
                            unless the wellness program allows--
                                        ``(I) for a reasonable alternative
                                    standard (or waiver of the otherwise
                                    applicable standard) for obtaining the
                                    reward for any individual for whom, for
                                    that period, it is unreasonably
                                    difficult due to a medical condition to
                                    satisfy the otherwise applicable
                                    standard; and
                                        ``(II) for a reasonable alternative
                                    standard (or waiver of the otherwise
                                    applicable standard) for obtaining the
                                    reward for any individual for whom, for
                                    that period, it is medically
                                    inadvisable to attempt to satisfy the
                                    otherwise applicable standard.
                                ``(ii) If reasonable under the
                            circumstances, the plan or issuer may seek
                            verification, such as a statement from an
                            individual's physician, that a health status
                            factor makes it unreasonably difficult or
                            medically inadvisable for the individual to
                            satisfy or attempt to satisfy the otherwise
                            applicable standard.
                        ``(E) The plan or issuer involved shall disclose in
                    all plan materials describing the terms of the wellness
                    program the availability of a reasonable alternative
                    standard (or the possibility of waiver of the otherwise
                    applicable standard) required under subparagraph (D).
                    If plan materials disclose that such a program is
                    available, without describing its terms, the disclosure
                    under this subparagraph shall not be required.

    ``SEC. 199. PROHIBITION OF PREEXISTING CONDITION EXCLUSIONS OR OTHER
                  DISCRIMINATION BASED ON HEALTH STATUS.

        ``(a) In General.--A group health plan and a health insurance
    issuer offering group or individual health insurance coverage may not
    impose any preexisting condition exclusion with respect to such plan or
    coverage.
        ``(b) Definitions.--For purposes of this section--
                ``(1) Preexisting condition exclusion.--
                        ``(A) In general.--The term `preexisting condition
                    exclusion' means, with respect to coverage, a
                    limitation or exclusion of benefits relating to a
                    condition based on the fact that the condition was
                    present before the date of enrollment for such
                    coverage, whether or not any medical advice, diagnosis,
                    care, or treatment was recommended or received before
                    such date.
                        ``(B) Treatment of genetic information.--Genetic
                    information shall not be treated as a condition
                    described in subsection (a)(1) in the absence of a
                    diagnosis of the condition related to such information.
                ``(2) Enrollment date.--The term `enrollment date' means,
            with respect to an individual covered under a group health plan
            or health insurance coverage, the date of enrollment of the
            individual in the plan or coverage or, if earlier, the first
            day of the waiting period for such enrollment.
                ``(3) Late enrollee.--The term `late enrollee' means, with
            respect to coverage under a group health plan, a participant or
            beneficiary who enrolls under the plan other than during--
                        ``(A) the first period in which the individual is
                    eligible to enroll under the plan; or
                        ``(B) a special enrollment period under subsection
                    (f).
                ``(4) Waiting period.--The term `waiting period' means,
            with respect to a group health plan and an individual who is a
            potential participant or beneficiary in the plan, the period
            that must pass with respect to the individual before the
            individual is eligible to be covered for benefits under the
            terms of the plan.
        ``(c) Rules Relating to Crediting Previous Coverage.--
                ``(1) Creditable coverage defined.--For purposes of this
            title, the term `creditable coverage' means, with respect to an
            individual, coverage of the individual under any of the
            following:
                        ``(A) A group health plan.
                        ``(B) Health insurance coverage.
                        ``(C) Part A or part B of title XVIII of the Social
                    Security Act.
                        ``(D) Title XIX of the Social Security Act, other
                    than coverage consisting solely of benefits under
                    section 1928.
                        ``(E) Chapter 55 of title 10, United States Code.
                        ``(F) A medical care program of the Indian Health
                    Service or of a tribal organization.
                        ``(G) A State health benefits risk pool.
                        ``(H) A health plan offered under chapter 89 of
                    title 5, United States Code.
                        ``(I) A public health plan (as defined in
                    regulations).
                        ``(J) A health benefit plan under section 5(e) of
                    the Peace Corps Act (22 U.S.C. 2504(e)).
            Such term does not include coverage consisting solely of
            coverage of excepted benefits (as defined in section 2791(c)).
                ``(2) Not counting periods before significant breaks in
            coverage.--
                        ``(A) In general.--A period of creditable coverage
                    shall not be counted, with respect to enrollment of an
                    individual under a group or individual health plan, if,
                    after such period and before the enrollment date, there
                    was a 63-day period during all of which the individual
                    was not covered under any creditable coverage.
                        ``(B) Waiting period not treated as a break in
                    coverage.--For purposes of subparagraph (A) and
                    subsection (d)(4), any period that an individual is in
                    a waiting period for any coverage under a group or
                    individual health plan (or for group health insurance
                    coverage) or is in an affiliation period (as defined in
                    subsection (g)(2)) shall not be taken into account in
                    determining the continuous period under subparagraph
                    (A).
                        ``(C) TAA-eligible individuals.--In the case of
                    plan years beginning before January 1, 2014--
                                ``(i) TAA pre-certification period rule.--
                            In the case of a TAA-eligible individual, the
                            period beginning on the date the individual has
                            a TAA-related loss of coverage and ending on
                            the date that is 7 days after the date of the
                            issuance by the Secretary (or by any person or
                            entity designated by the Secretary) of a
                            qualified health insurance costs credit
                            eligibility certificate for such individual for
                            purposes of section 7527 of the Internal
                            Revenue Code of 1986 shall not be taken into
                            account in determining the continuous period
                            under subparagraph (A).
                                ``(ii) Definitions.--The terms `TAA-
                            eligible individual' and `TAA-related loss of
                            coverage' have the meanings given such terms in
                            section 2205(b)(4).
                ``(3) Method of crediting coverage.--
                        ``(A) Standard method.--Except as otherwise
                    provided under subparagraph (B), for purposes of
                    applying subsection (a)(3), a group health plan, and a
                    health insurance issuer offering group or individual
                    health insurance coverage, shall count a period of
                    creditable coverage without regard to the specific
                    benefits covered during the period.
                        ``(B) Election of alternative method.--A group
                    health plan, or a health insurance issuer offering
                    group or individual health insurance, may elect to
                    apply subsection (a)(3) based on coverage of benefits
                    within each of several classes or categories of
                    benefits specified in regulations rather than as
                    provided under subparagraph (A). Such election shall be
                    made on a uniform basis for all participants and
                    beneficiaries. Under such election a group or
                    individual health plan or issuer shall count a period
                    of creditable coverage with respect to any class or
                    category of benefits if any level of benefits is
                    covered within such class or category.
                        ``(C) Plan notice.--In the case of an election with
                    respect to a group health plan under subparagraph (B)
                    (whether or not health insurance coverage is provided
                    in connection with such plan), the plan shall--
                                ``(i) prominently state in any disclosure
                            statements concerning the plan, and state to
                            each enrollee at the time of enrollment under
                            the plan, that the plan has made such election;
                            and
                                ``(ii) include in such statements a
                            description of the effect of this election.
                        ``(D) Issuer notice.--In the case of an election
                    under subparagraph (B) with respect to health insurance
                    coverage offered by an issuer in the individual or
                    group market, the issuer--
                                ``(i) shall prominently state in any
                            disclosure statements concerning the coverage,
                            and to each employer at the time of the offer
                            or sale of the coverage, that the issuer has
                            made such election; and
                                ``(ii) shall include in such statements a
                            description of the effect of such election.
                ``(4) Establishment of period.--Periods of creditable
            coverage with respect to an individual shall be established
            through presentation of certifications described in subsection
            (e) or in such other manner as may be specified in regulations.
        ``(d) Exceptions.--
                ``(1) Exclusion not applicable to certain newborns.--
            Subject to paragraph (4), a group health plan, and a health
            insurance issuer offering group or individual health insurance
            coverage, may not impose any preexisting condition exclusion in
            the case of an individual who, as of the last day of the 30-day
            period beginning with the date of birth, is covered under
            creditable coverage.
                ``(2) Exclusion not applicable to certain adopted
            children.--Subject to paragraph (4), a group health plan, and a
            health insurance issuer offering group or individual health
            insurance coverage, may not impose any preexisting condition
            exclusion in the case of a child who is adopted or placed for
            adoption before attaining 18 years of age and who, as of the
            last day of the 30-day period beginning on the date of the
            adoption or placement for adoption, is covered under creditable
            coverage. The previous sentence shall not apply to coverage
            before the date of such adoption or placement for adoption.
                ``(3) Exclusion not applicable to pregnancy.--A group
            health plan, and health insurance issuer offering group or
            individual health insurance coverage, may not impose any
            preexisting condition exclusion relating to pregnancy as a
            preexisting condition.
                ``(4) Loss if break in coverage.--Paragraphs (1) and (2)
            shall no longer apply to an individual after the end of the
            first 63-day period during all of which the individual was not
            covered under any creditable coverage.
        ``(e) Certifications and Disclosure of Coverage.--
                ``(1) Requirement for certification of period of creditable
            coverage.--
                        ``(A) In general.--A group health plan, and a
                    health insurance issuer offering group or individual
                    health insurance coverage, shall provide the
                    certification described in subparagraph (B)--
                                ``(i) at the time an individual ceases to
                            be covered under the plan or otherwise becomes
                            covered under a COBRA continuation provision;
                                ``(ii) in the case of an individual
                            becoming covered under such a provision, at the
                            time the individual ceases to be covered under
                            such provision; and
                                ``(iii) on the request on behalf of an
                            individual made not later than 24 months after
                            the date of cessation of the coverage described
                            in clause (i) or (ii), whichever is later.
                    The certification under clause (i) may be provided, to
                    the extent practicable, at a time consistent with
                    notices required under any applicable COBRA
                    continuation provision.
                        ``(B) Certification.--The certification described
                    in this subparagraph is a written certification of--
                                ``(i) the period of creditable coverage of
                            the individual under such plan and the coverage
                            (if any) under such COBRA continuation
                            provision; and
                                ``(ii) the waiting period (if any) (and
                            affiliation period, if applicable) imposed with
                            respect to the individual for any coverage
                            under such plan.
                        ``(C) Issuer compliance.--To the extent that
                    medical care under a group health plan consists of
                    group health insurance coverage, the plan is deemed to
                    have satisfied the certification requirement under this
                    paragraph if the health insurance issuer offering the
                    coverage provides for such certification in accordance
                    with this paragraph.
                ``(2) Disclosure of information on previous benefits.--In
            the case of an election described in subsection (c)(3)(B) by a
            group health plan or health insurance issuer, if the plan or
            issuer enrolls an individual for coverage under the plan and
            the individual provides a certification of coverage of the
            individual under paragraph (1)--
                        ``(A) upon request of such plan or issuer, the
                    entity which issued the certification provided by the
                    individual shall promptly disclose to such requesting
                    plan or issuer information on coverage of classes and
                    categories of health benefits available under such
                    entity's plan or coverage; and
                        ``(B) such entity may charge the requesting plan or
                    issuer for the reasonable cost of disclosing such
                    information.
                ``(3) Regulations.--The Secretary shall establish rules to
            prevent an entity's failure to provide information under
            paragraph (1) or (2) with respect to previous coverage of an
            individual from adversely affecting any subsequent coverage of
            the individual under another group health plan or health
            insurance coverage.
        ``(f) Special Enrollment Periods.--
                ``(1) Individuals losing other coverage.--A group health
            plan, and a health insurance issuer offering group health
            insurance coverage in connection with a group health plan,
            shall permit an employee who is eligible, but not enrolled, for
            coverage under the terms of the plan (or a dependent of such an
            employee if the dependent is eligible, but not enrolled, for
            coverage under such terms) to enroll for coverage under the
            terms of the plan if each of the following conditions is met:
                        ``(A) The employee or dependent was covered under a
                    group health plan or had health insurance coverage at
                    the time coverage was previously offered to the
                    employee or dependent.
                        ``(B) The employee stated in writing at such time
                    that coverage under a group health plan or health
                    insurance coverage was the reason for declining
                    enrollment, but only if the plan sponsor or issuer (if
                    applicable) required such a statement at such time and
                    provided the employee with notice of such requirement
                    (and the consequences of such requirement) at such
                    time.
                        ``(C) The employee's or dependent's coverage
                    described in subparagraph (A)--
                                ``(i) was under a COBRA continuation
                            provision and the coverage under such provision
                            was exhausted; or
                                ``(ii) was not under such a provision and
                            either the coverage was terminated as a result
                            of loss of eligibility for the coverage
                            (including as a result of legal separation,
                            divorce, death, termination of employment, or
                            reduction in the number of hours of employment)
                            or employer contributions toward such coverage
                            were terminated.
                        ``(D) Under the terms of the plan, the employee
                    requests such enrollment not later than 30 days after
                    the date of exhaustion of coverage described in
                    subparagraph (C)(i) or termination of coverage or
                    employer contribution described in subparagraph
                    (C)(ii).
                ``(2) For dependent beneficiaries.--
                        ``(A) In general.--If--
                                ``(i) a group health plan makes coverage
                            available with respect to a dependent of an
                            individual;
                                ``(ii) the individual is a participant
                            under the plan (or has met any waiting period
                            applicable to becoming a participant under the
                            plan and is eligible to be enrolled under the
                            plan but for a failure to enroll during a
                            previous enrollment period); and
                                ``(iii) a person becomes such a dependent
                            of the individual through marriage, birth, or
                            adoption or placement for adoption,
                    the group health plan shall provide for a dependent
                    special enrollment period described in subparagraph (B)
                    during which the person (or, if not otherwise enrolled,
                    the individual) may be enrolled under the plan as a
                    dependent of the individual, and in the case of the
                    birth or adoption of a child, the spouse of the
                    individual may be enrolled as a dependent of the
                    individual if such spouse is otherwise eligible for
                    coverage.
                        ``(B) Dependent special enrollment period.--A
                    dependent special enrollment period under this
                    subparagraph shall be a period of not less than 30 days
                    and shall begin on the later of--
                                ``(i) the date dependent coverage is made
                            available; or
                                ``(ii) the date of the marriage, birth, or
                            adoption or placement for adoption (as the case
                            may be) described in subparagraph (A)(iii).
                        ``(C) No waiting period.--If an individual seeks to
                    enroll a dependent during the first 30 days of such a
                    dependent special enrollment period, the coverage of
                    the dependent shall become effective--
                                ``(i) in the case of marriage, not later
                            than the first day of the first month beginning
                            after the date the completed request for
                            enrollment is received;
                                ``(ii) in the case of a dependent's birth,
                            as of the date of such birth; or
                                ``(iii) in the case of a dependent's
                            adoption or placement for adoption, the date of
                            such adoption or placement for adoption.
                ``(3) Special rules for application in case of medicaid and
            chip.--
                        ``(A) In general.--A group health plan, and a
                    health insurance issuer offering group health insurance
                    coverage in connection with a group health plan, shall
                    permit an employee who is eligible, but not enrolled,
                    for coverage under the terms of the plan (or a
                    dependent of such an employee if the dependent is
                    eligible, but not enrolled, for coverage under such
                    terms) to enroll for coverage under the terms of the
                    plan if either of the following conditions is met:
                                ``(i) Termination of medicaid or chip
                            coverage.--The employee or dependent is covered
                            under a Medicaid plan under title XIX of the
                            Social Security Act or under a State child
                            health plan under title XXI of such Act and
                            coverage of the employee or dependent under
                            such a plan is terminated as a result of loss
                            of eligibility for such coverage and the
                            employee requests coverage under the group
                            health plan (or health insurance coverage) not
                            later than 60 days after the date of
                            termination of such coverage.
                                ``(ii) Eligibility for employment
                            assistance under medicaid or chip.--The
                            employee or dependent becomes eligible for
                            assistance, with respect to coverage under the
                            group health plan or health insurance coverage,
                            under such Medicaid plan or State child health
                            plan (including under any waiver or
                            demonstration project conducted under or in
                            relation to such a plan), if the employee
                            requests coverage under the group health plan
                            or health insurance coverage not later than 60
                            days after the date the employee or dependent
                            is determined to be eligible for such
                            assistance.
                        ``(B) Coordination with medicaid and chip.--
                                ``(i) Outreach to employees regarding
                            availability of medicaid and chip coverage.--
                                        ``(I) In general.--Each employer
                                    that maintains a group health plan in a
                                    State that provides medical assistance
                                    under a State Medicaid plan under title
                                    XIX of the Social Security Act, or
                                    child health assistance under a State
                                    child health plan under title XXI of
                                    such Act, in the form of premium
                                    assistance for the purchase of coverage
                                    under a group health plan, shall
                                    provide to each employee a written
                                    notice informing the employee of
                                    potential opportunities then currently
                                    available in the State in which the
                                    employee resides for premium assistance
                                    under such plans for health coverage of
                                    the employee or the employee's
                                    dependents. For purposes of compliance
                                    with this subclause, the employer may
                                    use any State-specific model notice
                                    developed in accordance with section
                                    701(f)(3)(B)(i)(II) of the Employee
                                    Retirement Income Security Act of 1974
                                    (29 U.S.C. 1181(f)(3)(B)(i)(II)).
                                        ``(II) Option to provide concurrent
                                    with provision of plan materials to
                                    employee.--An employer may provide the
                                    model notice applicable to the State in
                                    which an employee resides concurrent
                                    with the furnishing of materials
                                    notifying the employee of health plan
                                    eligibility, concurrent with materials
                                    provided to the employee in connection
                                    with an open season or election process
                                    conducted under the plan, or concurrent
                                    with the furnishing of the summary plan
                                    description as provided in section
                                    104(b) of the Employee Retirement
                                    Income Security Act of 1974.
                                ``(ii) Disclosure about group health plan
                            benefits to states for medicaid and chip
                            eligible individuals.--In the case of an
                            enrollee in a group health plan who is covered
                            under a Medicaid plan of a State under title
                            XIX of the Social Security Act or under a State
                            child health plan under title XXI of such Act,
                            the plan administrator of the group health plan
                            shall disclose to the State, upon request,
                            information about the benefits available under
                            the group health plan in sufficient
                            specificity, as determined under regulations of
                            the Secretary of Health and Human Services in
                            consultation with the Secretary that require
                            use of the model coverage coordination
                            disclosure form developed under section
                            311(b)(1)(C) of the Children's Health Insurance
                            Reauthorization Act of 2009, so as to permit
                            the State to make a determination (under
                            paragraph (2)(B), (3), or (10) of section
                            2105(c) of the Social Security Act or
                            otherwise) concerning the cost-effectiveness of
                            the State providing medical or child health
                            assistance through premium assistance for the
                            purchase of coverage under such group health
                            plan and in order for the State to provide
                            supplemental benefits required under paragraph
                            (10)(E) of such section or other authority.
        ``(g) Use of Affiliation Period by HMOs as Alternative to
    Preexisting Condition Exclusion.--
                ``(1) In general.--A health maintenance organization which
            offers health insurance coverage in connection with a group
            health plan and which does not impose any preexisting condition
            exclusion allowed under subsection (a) with respect to any
            particular coverage option may impose an affiliation period for
            such coverage option, but only if--
                        ``(A) such period is applied uniformly without
                    regard to any health status-related factors; and
                        ``(B) such period does not exceed 2 months (or 3
                    months in the case of a late enrollee).
                ``(2) Affiliation period.--
                        ``(A) Defined.--For purposes of this title, the
                    term `affiliation period' means a period which, under
                    the terms of the health insurance coverage offered by
                    the health maintenance organization, must expire before
                    the health insurance coverage becomes effective. The
                    organization is not required to provide health care
                    services or benefits during such period and no premium
                    shall be charged to the participant or beneficiary for
                    any coverage during the period.
                        ``(B) Beginning.--Such period shall begin on the
                    enrollment date.
                        ``(C) Runs concurrently with waiting periods.--An
                    affiliation period under a plan shall run concurrently
                    with any waiting period under the plan.
                ``(3) Alternative methods.--A health maintenance
            organization described in paragraph (1) may use alternative
            methods, from those described in such paragraph, to address
            adverse selection as approved by the State insurance
            commissioner or official or officials designated by the State
            to enforce the requirements of this part for the State involved
            with respect to such issuer.

    ``SEC. 199A. EXTENSION OF DEPENDENT COVERAGE.

        ``(a) In General.--A group health plan and a health insurance
    issuer offering group or individual health insurance coverage that
    provides dependent coverage of children shall continue to make such
    coverage available for an adult child (who is not married) until the
    child turns 26 years of age. Nothing in this section shall require a
    health plan or a health insurance issuer described in the preceding
    sentence to make coverage available for a child of a child receiving
    dependent coverage.
        ``(b) Regulations.--The Secretary shall promulgate regulations to
    define the dependents to which coverage shall be made available under
    subsection (a).
        ``(c) Rule of Construction.--Nothing in this section shall be
    construed to modify the definition of `dependent' as used in the
    Internal Revenue Code of 1986 with respect to the tax treatment of the
    cost of coverage.

    ``SEC. 199B. ANNUAL LIMITATION ON COST-SHARING.

        ``(a) In General.--
                ``(1) 2014.--The cost-sharing incurred under a group health
            plan or group or individual health insurance coverage with
            respect to self-only coverage or coverage other than self-only
            coverage for a plan year beginning in 2014 shall not exceed the
            dollar amounts in effect under section 223(c)(2)(A)(ii) of the
            Internal Revenue Code of 1986 for self-only and family
            coverage, respectively, for taxable years beginning in 2014.
                ``(2) 2015 and later.--In the case of any plan year
            beginning in a calendar year after 2014, the limitation under
            this paragraph shall--
                        ``(A) in the case of self-only coverage, be equal
                    to the dollar amount under paragraph (1) for self-only
                    coverage for plan years beginning in 2014, increased by
                    an amount equal to the product of that amount and the
                    premium adjustment percentage under subsection (c) for
                    the calendar year; and
                        ``(B) in the case of other coverage, twice the
                    amount in effect under subparagraph (A).
            If the amount of any increase under subparagraph (A) is not a
            multiple of $50, such increase shall be rounded to the next
            lowest multiple of $50.
        ``(b) Cost-Sharing.--In this section:
                ``(1) In general.--The term `cost-sharing' includes--
                        ``(A) deductibles, coinsurance, copayments, or
                    similar charges; and
                        ``(B) any other expenditure required of an insured
                    individual which is a qualified medical expense (within
                    the meaning of section 223(d)(2) of the Internal
                    Revenue Code of 1986) with respect to essential health
                    benefits covered under the plan.
                ``(2) Exceptions.--Such term does not include premiums,
            balance billing amounts for non-network providers, or spending
            for non-covered services.
        ``(c) Premium Adjustment Percentage.--For purposes of subsection
    (a)(2)(A), the premium adjustment percentage for any calendar year is
    the percentage (if any) by which the average per capita premium for
    health insurance coverage in the United States for the preceding
    calendar year (as estimated by the Secretary no later than October 1 of
    such preceding calendar year) exceeds such average per capita premium
    for 2013 (as determined by the Secretary).

    ``SEC. 199C. ENFORCEMENT OF CERTAIN HEALTH INSURANCE REQUIREMENTS.

        ``(a) State Enforcement.--
                ``(1) State authority.--Each State may require that health
            insurance issuers that issue, sell, renew, or offer health
            insurance coverage in the State in the individual or group
            market meet the requirements of this part with respect to such
            issuers.
                ``(2) Failure to implement provisions.--In the case of a
            determination by the Secretary that a State has failed to
            substantially enforce a provision (or provisions) of sections
            196 through 199A with respect to health insurance issuers in
            the State, the Secretary shall enforce such provision (or
            provisions) under subsection (b) insofar as they relate to the
            issuance, sale, renewal, and offering of health insurance
            coverage in connection with group health plans or individual
            health insurance coverage in such State.
        ``(b) Secretarial Enforcement Authority.--
                ``(1) Limitation.--The provisions of this subsection shall
            apply to enforcement of a provision (or provisions) described
            in subsection (a)(2) only--
                        ``(A) as provided under such subsection; and
                        ``(B) with respect to individual health insurance
                    coverage or group health plans that are non-Federal
                    governmental plans.
                ``(2) Imposition of penalties.--In the cases described in
            paragraph (1)--
                        ``(A) In general.--Subject to the succeeding
                    provisions of this subsection, any non-Federal
                    governmental plan that is a group health plan and any
                    health insurance issuer that fails to meet a provision
                    of this part applicable to such plan or issuer is
                    subject to a civil money penalty under this subsection.
                        ``(B) Liability for penalty.--In the case of a
                    failure by--
                                ``(i) a health insurance issuer, the issuer
                            is liable for such penalty; or
                                ``(ii) a group health plan that is a non-
                            Federal governmental plan which is--
                                        ``(I) sponsored by 2 or more
                                    employers, the plan is liable for such
                                    penalty; or
                                        ``(II) not so sponsored, the
                                    employer is liable for such penalty.
                        ``(C) Amount of penalty.--
                                ``(i) In general.--The maximum amount of
                            penalty imposed under this paragraph is $100
                            for each day for each individual with respect
                            to which such a failure occurs.
                                ``(ii) Considerations in imposition.--In
                            determining the amount of any penalty to be
                            assessed under this paragraph, the Secretary
                            shall take into account the previous record of
                            compliance of the entity being assessed with
                            the applicable provisions of this part and the
                            gravity of the violation.
                                ``(iii) Limitations.--
                                        ``(I) Penalty not to apply where
                                    failure not discovered exercising
                                    reasonable diligence.--No civil money
                                    penalty shall be imposed under this
                                    paragraph on any failure during any
                                    period for which it is established to
                                    the satisfaction of the Secretary that
                                    none of the entities against whom the
                                    penalty would be imposed knew, or
                                    exercising reasonable diligence would
                                    have known, that such failure existed.
                                        ``(II) Penalty not to apply to
                                    failures corrected within 30 days.--No
                                    civil money penalty shall be imposed
                                    under this paragraph on any failure if
                                    such failure was due to reasonable
                                    cause and not to willful neglect, and
                                    such failure is corrected during the
                                    30-day period beginning on the first
                                    day any of the entities against whom
                                    the penalty would be imposed knew, or
                                    exercising reasonable diligence would
                                    have known, that such failure existed.
                        ``(D) Administrative review.--
                                ``(i) Opportunity for hearing.--The entity
                            assessed shall be afforded an opportunity for
                            hearing by the Secretary upon request made
                            within 30 days after the date of the issuance
                            of a notice of assessment. In such hearing the
                            decision shall be made on the record pursuant
                            to section 554 of title 5, United States Code.
                            If no hearing is requested, the assessment
                            shall constitute a final and unappealable
                            order.
                                ``(ii) Hearing procedure.--If a hearing is
                            requested, the initial agency decision shall be
                            made by an administrative law judge, and such
                            decision shall become the final order unless
                            the Secretary modifies or vacates the decision.
                            Notice of intent to modify or vacate the
                            decision of the administrative law judge shall
                            be issued to the parties within 30 days after
                            the date of the decision of the judge. A final
                            order which takes effect under this paragraph
                            shall be subject to review only as provided
                            under subparagraph (E).
                        ``(E) Judicial review.--
                                ``(i) Filing of action for review.--Any
                            entity against whom an order imposing a civil
                            money penalty has been entered after an agency
                            hearing under this paragraph may obtain review
                            by the United States district court for any
                            district in which such entity is located or the
                            United States District Court for the District
                            of Columbia by filing a notice of appeal in
                            such court within 30 days from the date of such
                            order, and simultaneously sending a copy of
                            such notice by registered mail to the
                            Secretary.
                                ``(ii) Certification of administrative
                            record.--The Secretary shall promptly certify
                            and file in such court the record upon which
                            the penalty was imposed.
                                ``(iii) Standard for review.--The findings
                            of the Secretary shall be set aside only if
                            found to be unsupported by substantial evidence
                            as provided by section 706(2)(E) of title 5,
                            United States Code.
                                ``(iv) Appeal.--Any final decision, order,
                            or judgment of the district court concerning
                            such review shall be subject to appeal as
                            provided in chapter 83 of title 28 of such
                            Code.
                        ``(F) Failure to pay assessment; maintenance of
                    action.--
                                ``(i) Failure to pay assessment.--If any
                            entity fails to pay an assessment after it has
                            become a final and unappealable order, or after
                            the court has entered final judgment in favor
                            of the Secretary, the Secretary shall refer the
                            matter to the Attorney General who shall
                            recover the amount assessed by action in the
                            appropriate United States district court.
                                ``(ii) Nonreviewability.--In such action
                            the validity and appropriateness of the final
                            order imposing the penalty shall not be subject
                            to review.
                        ``(G) Payment of penalties.--Except as otherwise
                    provided, penalties collected under this paragraph
                    shall be paid to the Secretary (or other officer)
                    imposing the penalty and shall be available without
                    appropriation and until expended for the purpose of
                    enforcing the provisions with respect to which the
                    penalty was imposed.
                ``(3) Enforcement authority relating to genetic
            discrimination.--
                        ``(A) General rule.--In the cases described in
                    paragraph (1), notwithstanding the provisions of
                    paragraph (2)(C), the succeeding subparagraphs of this
                    paragraph shall apply with respect to an action under
                    this subsection by the Secretary with respect to any
                    failure of a health insurance issuer in connection with
                    a group health plan, to meet the requirements of
                    subsection (a)(1)(F), (b)(3), (c), or (d) of section
                    196 or section 197 or 196(b)(1) with respect to genetic
                    information in connection with the plan.
                        ``(B) Amount.--
                                ``(i) In general.--The amount of the
                            penalty imposed under this paragraph shall be
                            $100 for each day in the noncompliance period
                            with respect to each participant or beneficiary
                            to whom such failure relates.
                                ``(ii) Noncompliance period.--For purposes
                            of this paragraph, the term `noncompliance
                            period' means, with respect to any failure, the
                            period--
                                        ``(I) beginning on the date such
                                    failure first occurs; and
                                        ``(II) ending on the date the
                                    failure is corrected.
                        ``(C) Minimum penalties where failure discovered.--
                    Notwithstanding clauses (i) and (ii) of subparagraph
                    (D):
                                ``(i) In general.--In the case of 1 or more
                            failures with respect to an individual--
                                        ``(I) which are not corrected
                                    before the date on which the plan
                                    receives a notice from the Secretary of
                                    such violation; and
                                        ``(II) which occurred or continued
                                    during the period involved;
                            the amount of penalty imposed by subparagraph
                            (A) by reason of such failures with respect to
                            such individual shall not be less than $2,500.
                                ``(ii) Higher minimum penalty where
                            violations are more than de minimis.--To the
                            extent violations for which any person is
                            liable under this paragraph for any year are
                            more than de minimis, clause (i) shall be
                            applied by substituting `$15,000' for `$2,500'
                            with respect to such person.
                        ``(D) Limitations.--
                                ``(i) Penalty not to apply where failure
                            not discovered exercising reasonable
                            diligence.--No penalty shall be imposed by
                            subparagraph (A) on any failure during any
                            period for which it is established to the
                            satisfaction of the Secretary that the person
                            otherwise liable for such penalty did not know,
                            and exercising reasonable diligence would not
                            have known, that such failure existed.
                                ``(ii) Penalty not to apply to failures
                            corrected within certain periods.--No penalty
                            shall be imposed by subparagraph (A) on any
                            failure if--
                                        ``(I) such failure was due to
                                    reasonable cause and not to willful
                                    neglect; and
                                        ``(II) such failure is corrected
                                    during the 30-day period beginning on
                                    the first date the person otherwise
                                    liable for such penalty knew, or
                                    exercising reasonable diligence would
                                    have known, that such failure existed.
                                ``(iii) Overall limitation for
                            unintentional failures.--In the case of
                            failures which are due to reasonable cause and
                            not to willful neglect, the penalty imposed by
                            subparagraph (A) for failures shall not exceed
                            the amount equal to the lesser of--
                                        ``(I) 10 percent of the aggregate
                                    amount paid or incurred by the employer
                                    (or predecessor employer) during the
                                    preceding taxable year for group health
                                    plans; or
                                        ``(II) $500,000.
                        ``(E) Waiver by secretary.--In the case of a
                    failure which is due to reasonable cause and not to
                    willful neglect, the Secretary may waive part or all of
                    the penalty imposed by subparagraph (A) to the extent
                    that the payment of such penalty would be excessive
                    relative to the failure involved.
        ``(c) Definitions.--For purposes of this section:
                ``(1) Governmental plan.--The term `governmental plan' has
            the meaning given such term under section 3(32) of the Employee
            Retirement Income Security Act of 1974 and any Federal
            governmental plan.
                ``(2) Federal governmental plan.--The term ``Federal
            governmental plan'' means a governmental plan established or
            maintained for its employees by the Government of the United
            States or by any agency or instrumentality of such Government.
                ``(3) Non-federal governmental plan.--The term `non-Federal
            governmental plan' means a governmental plan that is not a
            Federal governmental plan.''.
        (b) Conforming Amendment.--The table of contents under section 1(b)
    of the Health Insurance Portability and Accountability Act of 1996
    (Public Law 104-191) is amended by inserting after the item relating to
    section 195 the following:

    ``Sec. 196. Guaranteed availability of coverage.
    ``Sec. 197. Fair health insurance premiums.
    ``Sec. 198. Prohibiting discrimination against individual participants
                                and beneficiaries based on health status.
    ``Sec. 199. Prohibition of preexisting condition exclusions or other
                                discrimination based on health status.
    ``Sec. 199A. Extension of dependent coverage.
    ``Sec. 199B. Annual limitation on cost-sharing.
    ``Sec. 199C. Enforcement of certain health insurance requirements.''.
        (c) ERISA and IRC Enforcement.--
                (1) ERISA.--Subpart B of part 7 of title I of the Employee
            Retirement Income Security Act of 1974 (29 U.S.C. 1185 et seq.)
            is amended by adding at the end the following new section:

    ``SEC. 716. OTHER MARKET REFORMS.

        ``Sections 196 and 197 of the Health Insurance Portability and
    Accountability Act of 1996 shall apply to health insurance issuers
    providing health insurance coverage in connection with group health
    plans, and sections 198 through 199B of such Act shall apply to group
    health plans and health insurance issuers providing health insurance
    coverage in connection with group health plans, as if included in this
    subpart, and to the extent that any provision of this part conflicts
    with a provision of such section 196 or 197 with respect to health
    insurance issuers providing health insurance coverage in connection
    with group health plans or of such section 198, 199, 199A, or 199B with
    respect to group health plans or health insurance issuers providing
    health insurance coverage in connection with group health plans, the
    provisions of such sections 196 through 199B shall apply.''.
                (2) IRC.--Subchapter B of chapter 100 of subtitle K of
            title 26 of the Internal Revenue Code of 1986 is amended by
            adding at the end the following new section:

    ``SEC. 9816. OTHER MARKET REFORMS.

        ``Sections 196 and 197 of the Health Insurance Portability and
    Accountability Act of 1996 shall apply to health insurance issuers
    providing health insurance coverage in connection with group health
    plans, and sections 198 through 199B of such Act shall apply to group
    health plans and health insurance issuers providing health insurance
    coverage in connection with group health plans, as if included in this
    subchapter, and to the extent that any provision of this chapter
    conflicts with a provision of such section 196 or 197 with respect to
    health insurance issuers providing health insurance coverage in
    connection with group health plans or of such section 198, 199, 199A,
    or 199B with respect to group health plans or health insurance issuers
    providing health insurance coverage in connection with group health
    plans, the provisions of such sections 196 through 199B shall apply.''.
        (d) Effective Date.--The amendments made by this section shall take
    effect on the date on which the Supreme Court of the United States
    issues a decision striking down the Patient Protection and Affordable
    Care Act (Public Law 111-148) in its entirety.

                     Subtitle B--Expanding Coverage Options

    SEC. 211. DEFINITION OF ``EMPLOYER'' UNDER ERISA WITH RESPECT TO GROUP
                  HEALTH PLANS.

        (a) Definition of Employer.--Section 3(5) of the Employee
    Retirement Income Security Act of 1974 (29 U.S.C. 1002(5)) is amended
    by striking the period and inserting ``(which, with respect to a group
    health plan, shall be determined in accordance with criteria that
    includes the criteria under section 735).''.
        (b) Group Health Plans.--Part 7 of subtitle B of title I of the
    Employee Retirement Income Security Act of 1974 (29 U.S.C. 1181 et
    seq.) is amended by adding at the end the following:

    ``SEC. 735. DEFINITION OF `EMPLOYER' WITH RESPECT TO GROUP HEALTH
                  PLANS.

        ``(a) In General.--A group or association of employers that meets
    the criteria under subsection (b) shall be considered an employer under
    section 3(5) for purposes of sponsoring a group health plan.
        ``(b) Requirements.--The requirements under this subsection are
    each of the following:
                ``(1) The primary purpose of the group or association may
            be to offer and provide health coverage to its employer members
            and their employees, if such group or association has at least
            1 substantial business purpose, as described in subsection (c),
            unrelated to offering and providing health coverage or other
            employee benefits to its employer members and their employees.
                ``(2) Each employer member of the group or association
            participating in the group health plan is a person acting
            directly as an employer of at least 1 employee who is a
            participant covered under the plan.
                ``(3) The group or association has--
                        ``(A) a formal organizational structure with a
                    governing body; and
                        ``(B) by-laws or other similar indications of
                    formality.
                ``(4) The functions and activities of the group or
            association shall be controlled by the employer members of the
            group or association, and the employer members of the group or
            association that participate in the group health plan shall
            control the plan. Control under this paragraph shall be in form
            and substance.
                ``(5) The employer members shall have a commonality of
            interest as described in subsection (d).
                ``(6)(A) The group or association shall not make health
            coverage through the group health plan available other than
            to--
                        ``(i) an employee of a current employer member of
                    the group or association;
                        ``(ii) a former employee of a current employer
                    member of the group or association who became eligible
                    for coverage under the group health plan when the
                    former employee was an employee of the employer; and
                        ``(iii) a beneficiary of an individual described in
                    clause (i) or (ii), such as a spouse or dependent
                    child.
                ``(B) Notwithstanding subparagraph (A), the group or
            association shall not make health coverage through the group
            health plan available to any individual (or beneficiaries of
            the individual) for any plan year following the plan year in
            which the plan determines pursuant to reasonable monitoring
            procedures described in subsection (f)(2)(C) that the
            individual ceases to meet the conditions described in
            subsection (f)(2) for being a working owner (unless the
            individual again meets those conditions), except as may be
            required by section 601.
                ``(7) The group or association, and any health coverage
            offered by the group or association, shall comply with the
            nondiscrimination provisions under subsection (e).
                ``(8) The group or association shall not be a health
            insurance issuer, or owned or controlled by such a health
            insurance issuer or by a subsidiary or affiliate of such a
            health insurance issuer, other than to the extent such entities
            participate in the group or association in their capacity as
            employer members of the group or association.
        ``(c) Substantial Business Purpose.--
                ``(1) In general.--For purposes of subsection (b)(1), a
            substantial business purpose shall exist if the group or
            association would be a viable entity in the absence of
            sponsoring an employee benefit plan.
                ``(2) Business purpose.--For purposes of subsection (b)(1)
            and paragraph (1), a business purpose shall--
                        ``(A) include promoting common business interests
                    of the members of the group or association or the
                    common economic interests in a given trade or employer
                    community; and
                        ``(B) not be required to be a for-profit activity.
        ``(d) Commonality of Interest.--
                ``(1) In general.--Subject to paragraph (3), employer
            members of the group or association shall be treated as having
            a commonality of interest for purposes of subsection (b)(5)
            if--
                        ``(A) the employers are in the same trade,
                    industry, line of business, or profession; or
                        ``(B) each employer has a principal place of
                    business in the same region that does not exceed the
                    boundaries of a single State or a metropolitan area
                    (even if the metropolitan area includes more than 1
                    State).
                ``(2) Same trade, industry, or line of business.--In the
            case of a group or association that is sponsoring a group
            health plan under this section and that is itself an employer
            member of the group or association, the group or association
            shall be deemed for purposes of paragraph (1)(A) to be in the
            same trade, industry, line of business, or profession, as
            applicable, as the other employer members of the group or
            association.
                ``(3) Nondiscrimination.--The standards under paragraph (1)
            shall not be implemented in a manner that is subterfuge for
            discrimination as is prohibited under subsection (e).
        ``(e) Nondiscrimination.--
                ``(1) In general.--A group or association of employers
            sponsoring a group health plan under this section, and any
            health coverage sponsored by such group or association, shall
            comply with each of the following:
                        ``(A) The group or association shall not condition
                    employer membership in the group or association on any
                    health factor of any individual who is or may become
                    eligible to participate in the group health plan
                    sponsored by the group or association.
                        ``(B) The group health plan sponsored by the group
                    or association shall comply with the rules under
                    section 2590.702(b) of title 29, Code of Federal
                    Regulations (as in effect on June 21, 2018), with
                    respect to nondiscrimination in rules for eligibility
                    for benefits, subject to subparagraph (D).
                        ``(C) The group health plan sponsored by the group
                    or association shall comply with the rules under
                    section 2590.702(c) of title 29, Code of Federal
                    Regulations (as in effect on June 21, 2018), with
                    respect to nondiscrimination in premiums or
                    contributions required by any participant or
                    beneficiary for coverage under the plan, subject to
                    subparagraph (D).
                        ``(D) In applying subparagraphs (B) and (C), the
                    group or association may not treat the employees of
                    different employer members of the group or association
                    as distinct groups of similarly-situated individuals
                    based on a health factor of 1 or more individuals.
                ``(2) Definition of health factor.--For purposes of this
            subsection, the term `health factor' has the meaning given such
            term in section 2590.702(a) of title 29, Code of Federal
            Regulations (as in effect on June 21, 2018).
        ``(f) Dual Treatment of Working Owners as Employers and
    Employees.--
                ``(1) In general.--A person determined in accordance with
            paragraph (2) to be a working owner of a trade or business may
            qualify as both an employer and as an employee of the trade or
            business for purposes of the requirements under subsection (b),
            including the requirements under paragraphs (2) and (6) of such
            subsection.
                ``(2) Working owner.--
                        ``(A) Eligibility.--A person shall qualify as a
                    `working owner' if a responsible fiduciary of the group
                    health plan reasonably determines that the person--
                                ``(i) does not have any common law
                            employees;
                                ``(ii) has an ownership right of any nature
                            in a trade or business, whether incorporated or
                            unincorporated, including a partner and other
                            self-employed individual;
                                ``(iii) is earning wages or self-employment
                            income from the trade or business for providing
                            personal services to the trade or business; and
                                ``(iv) either--
                                        ``(I) works on average at least 20
                                    hours per week, or at least 80 hours
                                    per month, providing personal services
                                    to the person's trade or business; or
                                        ``(II) has wages or self-employment
                                    income from such trade or business that
                                    at least equals the person's cost of
                                    coverage for participation by the
                                    person, and any covered beneficiaries,
                                    in the group health plan sponsored by
                                    the group or association in which the
                                    person is participating.
                        ``(B) Determination.--The determination under
                    subparagraph (A) shall be made when the person first
                    becomes eligible for coverage under the group health
                    plan.
                        ``(C) Reasonable monitoring procedures.--A
                    responsible fiduciary of the group health plan shall,
                    through reasonable monitoring procedures, periodically
                    confirm the continued eligibility of a person to
                    qualify as a working owner under subparagraph (A) for
                    purposes of meeting the requirements under subsection
                    (b) for the group health plan sponsored under this
                    section.
        ``(g) Applicability.--
                ``(1) Fully insured.--This section shall apply beginning on
            September 1, 2024, with respect to a group or association of
            employers sponsoring a group health plan that is fully insured.
                ``(2) Plans expanding to include broader group.--This
            section shall apply beginning on January 1, 2025, with respect
            to a group or association of employers sponsoring a group
            health plan that--
                        ``(A) is not fully insured;
                        ``(B) is in existence on June 21, 2024;
                        ``(C) meets the requirements that applied with
                    respect to such plan before June 21, 2024; and
                        ``(D) chooses to be a plan sponsored under this
                    section (and subject to the requirements under
                    subsections (b) through (f)).
                ``(3) Other association health plans.--This section shall
            apply beginning on April 1, 2025, with respect to any other
            group or association of employers sponsoring a group health
            plan.
                ``(4) Other criteria in advisory opinions.--The criteria
            under this section shall not invalidate any criteria provided
            in an advisory opinion, in effect on or after the date of
            enactment of the Fair Care Act of 2024, that the Secretary may
            use to determine if a group or association of employers is an
            employer under section 3(5) for purposes of sponsoring a group
            health plan.
        ``(h) Determination of Employer or Joint Employer Status.--
                ``(1) In general.--Participating in or facilitating a group
            health plan sponsored by a bona fide group or association of
            employers pursuant to subsection (a) shall not be construed as
            establishing an employer or joint employer relationship under
            any Federal or State law.
                ``(2) Application of provision.--Paragraph (1) shall apply
            to a group health plan sponsored or facilitated by a franchisor
            and any franchisee, by multiple franchisors for the benefit of
            the employees of such franchisors and their franchisees, by
            multiple franchisees for the benefit of the employees of such
            franchisees, by a franchisor whose franchisee or franchisees
            participate or participates in the plan, or by a person or
            entity that contracts with any individual as an independent
            contractor for whom the plan benefits.
        ``(i) Rule of Construction.--Nothing in this section shall be
    construed as repealing or otherwise limiting the application of this
    Act (including section 712 relating to mental health parity) to group
    health plans and employee welfare benefit plans.''.

    SEC. 212. SHORT-TERM LIMITED DURATION INSURANCE.

        (a) Definition.--Section 2791(b) of the Public Health Service Act
    (42 U.S.C. 300gg-91(b)) is amended by adding at the end the following:
                ``(6) Short-term limited duration insurance.--The term
            `short-term limited duration insurance' means health insurance
            coverage provided pursuant to a contract with a health
            insurance issuer that has an expiration date specified in the
            contract (not taking into account any extensions that may be
            elected by the policyholder with or without the issuer's
            consent) that is less than 12 months after the original
            effective date of the contract.''.
        (b) Guaranteed Renewability.--Section 2703 of the Public Health
    Service Act (42 U.S.C. 300gg-2) is amended--
                (1) in subsection (a), by inserting ``or offers short-term
            limited duration insurance'' after ``group market''; and
                (2) by adding at the end the following:
        ``(f) Application to Short-Term Limited Duration Insurance.--
                ``(1) In general.--In applying this section in the case of
            short-term limited duration insurance--
                        ``(A) a reference to `health insurance coverage'
                    with respect to such coverage offered in the individual
                    market shall be deemed to include short-term limited
                    duration insurance; and
                        ``(B) a reference to `health insurance issuer' with
                    respect to health insurance coverage offered in the
                    individual market shall be deemed to include an issuer
                    of short-term limited duration insurance.
                ``(2) Special rule for short-term limited duration
            insurance.--In the case of short-term limited duration
            insurance, at the time of application for enrollment in such
            insurance coverage, an issuer of such insurance may offer
            renewability of such coverage, and an individual may decline
            renewability of such coverage in accordance with this section,
            and the contract between such individual and the health
            insurance issuer shall specify whether the individual opted for
            renewability or no renewability.''.
        (c) Applicability.--The amendments made by subsections (a) and (b)
    shall apply with respect to contracts for short-term limited duration
    insurance that take effect on or after January 1, 2025.

               Subtitle C--Improving Commercial Health Insurance

    SEC. 221. INVISIBLE GUARANTEED COVERAGE POOL REINSURANCE PROGRAM; TAX
                  ON EXCHANGE PLANS.

        (a) Establishment.--Not later than 2 years after the date of
    enactment of this Act, the Secretary of Health and Human Services shall
    establish the Invisible Guaranteed Coverage Pool Reinsurance Program
    (in this section referred to as the ``IGCPR program'').
        (b) State Grants.--Under the IGCPR program, the Secretary shall,
    from amounts appropriated under subsection (f) for a fiscal year, award
    grants to States for such fiscal year, in amounts determined in
    accordance with the allocation methodology specified under subsection
    (d). Such grants shall be used for the purpose of establishing or
    maintaining a qualifying Invisible Guaranteed Coverage Pool for the
    State.
        (c) Federal Default.--
                (1) In general.--In the case of a State that does not, by a
            date and in a manner specified by the Secretary, choose to be
            awarded a grant under subsection (b) for a fiscal year to
            operate a qualifying Invisible Guaranteed Coverage Pool for the
            State, the Secretary shall, from amounts appropriated under
            subsection (f) for such fiscal year, use the allocation
            determined for the State under subsection (d) for participation
            of such State in the Federal default qualifying Invisible
            Guaranteed Coverage Pool described in paragraph (2).
                (2) Federal default qualifying invisible guaranteed
            coverage pool.--The Federal default qualifying high risk pool
            is, with respect to each State that chooses not to be awarded a
            grant under subsection (b) with respect to a fiscal year for
            which funds are appropriated under subsection (f), an Invisible
            Guaranteed Coverage Pool under which health insurance issuers
            participating in the Exchange of such a State, with respect to
            designated individuals who are enrolled in health insurance
            coverage and are expected to experience higher than average
            health costs as determined by the insurer, cede risk to the
            pool, without affecting the premium paid by the designated
            individuals or their terms of coverage. With respect to such
            pool--
                        (A) high-risk individuals designated for cession to
                    the pool shall be designated by the ceding issuer;
                        (B) the premium amount the ceding issuer shall pay
                    to the reinsurance pool shall be 90 percent of the
                    premium paid to the issuer for the coverage;
                        (C) the ceding issuer shall retain the same risk
                    under the ceded policies as under any other policy of
                    the issuer with respect to the first $10,000 of
                    benefits for each ceded policy involved and will not
                    retain any risk under ceded policies after such first
                    $10,000 of benefits; and
                        (D) after a ceding issuer, with respect to a ceded
                    policy, no longer retains risk under such policy
                    pursuant to subparagraph (C), the negotiated rate under
                    such policy for items and services shall be payable at
                    the reimbursement rate under the Medicare program under
                    title XVIII of the Social Security Act for such items
                    and services, or in the case of items and services for
                    which payment is available under the policy but not the
                    Medicare program, at a rate determined by the
                    Secretary.
        (d) Allocation Methodology.--Not later than six months after the
    establishment of the IGCPR program, the Secretary shall specify an
    allocation methodology for determining the amount of funds appropriated
    under subsection (f) for a fiscal year to be allocated for each State
    for purposes of subsections (b) and (c). Such methodology shall be
    based on the number of residents of each State and the general health
    status of such residents.
        (e) Qualifying Invisible Guaranteed Coverage Pool.--For purposes of
    this section, the term ``qualifying Invisible Guaranteed Coverage
    Pool'' means, with respect to a State, a method of designation under
    which health insurance issuers identify individuals who experience
    higher than average health costs as determined by the State and are
    enrolled in health insurance coverage offered in the individual market,
    and cede the risk of spending more than $10,000 on health care services
    for a single individual to the pool without affecting the premium paid
    by the designated individuals or their terms of coverage. With respect
    to such pool, the State, or an entity operating the pool on behalf of
    the State, shall establish--
                (1) the premium amount the ceding issuer shall pay to the
            reinsurance pool;
                (2) the applicable attachment points or coinsurance
            percentages if the ceding issuer retains any portion of the
            risk under ceded policies, except that the provisions of
            subparagraphs (C) and (D) of subsection (c)(2) shall apply to
            such high risk pool in the same manner as such clauses apply to
            the Federal default high risk pool; and
                (3) the mechanism by which high-risk individuals are
            designated for cession to the pool, which may include a list of
            designated high-cost health conditions.
        (f) Appropriations.--There is appropriated to the Secretary of
    Health and Human Services $200,000,000,000 to carry out this section
    for the period of the first 10 years after the establishment of the
    IGCPR program.
        (g) Tax on Health Insurance Plans Sold on Exchanges.--
                (1) In general.--Chapter 34 of the Internal Revenue Code of
            1986 is amended by adding at the end the following new
            subchapter:

       ``Subchapter C--Additional Tax on Health Insurance Plans Sold by
                      Insurers Offering Plans on Exchanges

    ``Sec. 4401. Additional tax on health insurance plans sold by insurers
                                offering plans on exchanges.

    ``SEC. 4401. ADDITIONAL TAX ON HEALTH INSURANCE PLANS SOLD BY INSURERS
                  OFFERING PLANS ON EXCHANGES.

        ``(a) Imposition of Tax.--There is imposed a tax of $4 for each
    policy month of each health insurance policy sold by insurers offering
    plans through an Exchange established under the Patient Protection and
    Affordable Care Act.
        ``(b) Liability.--The tax imposed by subsection (a) shall be paid
    by the plan sponsor.''.
                (2) Conforming amendment.--The table of subchapters for
            chapter 34 of the Internal Revenue Code of 1986 is amended by
            adding at the end the following item:

       ``subchapter c--additional tax on health insurance plans sold by
                    insurers offering plans on exchanges''.

                (3) Effective date.--The amendments made by this subsection
            shall apply with respect to months beginning after the date of
            enactment of this Act.
        (h) Report.--The Secretary of Health and Human Services, in
    collaboration with the Comptroller General of the United States, shall
    submit to Congress, not later than 5 years after the date of enactment
    of this Act, and again 5 years thereafter, a report on the status of
    reinsurance pool funding, along with any recommendations with respect
    to future allocations or funding methods for such pool.

    SEC. 222. EMPLOYER HEALTH INSURANCE MANDATE REPEAL.

        (a) In General.--Chapter 43 of the Internal Revenue Code of 1986 is
    amended by striking section 4980H.
        (b) Repeal of Related Reporting Requirements.--Subpart D of part
    III of subchapter A of chapter 61 of such Code is amended by striking
    section 6056.
        (c) Conforming Amendments.--
                (1) Section 6724(d)(1)(B) of such Code is amended by
            inserting ``or'' at the end of clause (xxiii), by striking
            ``or'' at the end of clause (xxiv), and by striking clause
            (xxv).
                (2) Section 6724(d)(2) of such Code is amended by inserting
            ``or'' at the end of subparagraph (GG) and by striking
            subparagraph (HH).
                (3) The table of sections for chapter 43 of such Code is
            amended by striking the item relating to section 4980H.
                (4) The table of sections for subpart D of part III of
            subchapter A of chapter 61 of such Code is amended by striking
            the item relating to section 6056.
                (5) Section 1513 of the Patient Protection and Affordable
            Care Act is amended by striking subsection (c).
        (d) Effective Date.--
                (1) In general.--Except as otherwise provided in this
            subsection, the amendments made by this section shall apply to
            months and other periods beginning after December 31, 2024.
                (2) Repeal of study and report.--The amendment made by
            subsection (c)(5) shall take effect on the date of the
            enactment of this Act.

    SEC. 223. REFUNDABLE CREDITS FOR COVERAGE UNDER A QUALIFIED HEALTH PLAN
                  FOR INDIVIDUALS OFFERED EMPLOYER-SPONSORED INSURANCE.

        (a) In General.--Section 36B(c)(2) of the Internal Revenue Code of
    1986 is amended--
                (1) in subparagraph (B)(i), by inserting ``or section
            5000A(f)(1)(B)'', and
                (2) by striking subparagraph (C).
        (b) Effective Date.--The amendments made by this section shall
    apply to taxable years beginning after the date of the enactment of
    this Act.

    SEC. 224. INCLUSION IN INCOME OF CERTAIN COSTS OF EMPLOYER-PROVIDED
                  COVERAGE UNDER HEALTH PLANS.

        (a) In General.--Section 106 of the Internal Revenue Code of 1986
    is amended by adding at the end the following new subsection:
        ``(h) Limitation.--
                ``(1) In general.--Subsection (a) shall not apply to the
            extent that employer-provided coverage under health plans for
            an employee for a taxable year exceeds--
                        ``(A) $10,200 for self-only coverage, and
                        ``(B) $27,500 for all other coverage.
                ``(2) In general.--In the case of any calendar year after
            2025, the dollar amounts in paragraph (1) shall each be
            increased by an amount equal to--
                        ``(A) such dollar amount, multiplied by--
                        ``(B) the cost-of-living adjustment determined
                    under section 1(f)(3) for such calendar year,
                    determined--
                                ``(i) by substituting `calendar year 2024'
                            for `calendar year 2018' in subparagraph
                            (A)(ii) thereof, and
                                ``(ii) by substituting for the C-CPI-U
                            referred to in section 1(f)(3)(A) the amount
                            that such CPI would have been if the annual
                            percentage increase in CPI with respect to each
                            year after 2023 and before 2033 had been one
                            percentage point greater.
                ``(3) Terms related to cpi.--
                        ``(A) Annual percentage increase.--For purposes of
                    subparagraph (B)(ii)(II), the term `annual percentage
                    increase' means the percentage (if any) by which C-CPI-
                    U for any year exceeds the C-CPI-U for the prior year.
                        ``(B) Other terms.--Terms used in this paragraph
                    which are also used in section 1(f)(3) shall have the
                    same meanings as when used in such section.''.
        (b) Effective Date.--The amendments made by this section shall
    apply with respect to taxable years beginning after December 31, 2024.

    SEC. 225. CHANGE IN PERMISSIBLE AGE VARIATION IN HEALTH INSURANCE
                  PREMIUM RATES.

        Section 2701(a)(1)(A)(iii) of the Public Health Service Act (42
    U.S.C. 300gg(a)(1)(A)(iii)) is amended by inserting after ``(consistent
    with section 2707(c))'' the following: ``or, for plan years beginning
    on or after January 1, 2025, as the Secretary may implement through
    interim final regulation, 5 to 1 for adults (consistent with section
    2707(c))''.

    SEC. 226. PREMIUM ASSISTANCE ADJUSTMENT TO REFLECT AGE.

        (a) Modification of Applicable Percentage.--Section 36B(b)(3)(A) of
    the Internal Revenue Code of 1986 is amended to read as follows:
                        ``(A) Applicable percentage.--
                                ``(i) In general.--The applicable
                            percentage for any taxable year shall be the
                            percentage such that the applicable percentage
                            for any taxpayer whose household income is
                            within an income tier specified in the
                            following table shall increase, on a sliding
                            scale in a linear manner, from the initial
                            percentage to the final percentage specified in
                            such table for such income tier with respect to
                            a taxpayer of the age involved:

    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
      ``In the case of              Up to Age 29                         Age 30-39                          Age 40-49                         Age 50-59                        Over Age 59
      household income  ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
      (expressed as a
       percent of the
       poverty line)
         within the          Initial %          Final %          Initial %         Final %         Initial %         Final %         Initial %         Final %         Initial %         Final %
     following  income
           tier:
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Up to 100%           0...............  0...............  0...............  0..............  0..............  0..............  0..............  0..............  0..............  0
    100%-133%            2...............  2...............  2...............  2..............  2..............  2..............  2..............  2..............  2..............  2
    133%-150%            3...............  4.3.............  3...............  4.3............  3..............  4.3............  3..............  4.3............  3..............  4.3
    150%-200%            4.3.............  6.7.............  4.3.............  6.7............  4.3............  6.7............  4.3............  6.7............  4.3............  6.7
    200%-250%            6.7.............  6.7.............  6.7.............  7.6............  6.7............  8.3............  6.7............  8.3............  6.7............  8.3
    250%-300%            6.7.............  6.7.............  7.6.............  7.6............  8.3............  9.8............  8.3............  9.8............  8.3............  9.8
    300%-400%            6.7.............  7...............  7.6.............  8..............  9.8............  10.............  9.8............  10.............  9.8............  10
    400%-600%            7...............  9...............  8...............  10.............  10.............  15.............  10.............  15.............  10.............  15
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

                                ``(ii) Age determinations.--
                                        ``(I) In general.--For purposes of
                                    clause (i), the age of the taxpayer
                                    taken into account under clause (i)
                                    with respect to any taxable year is the
                                    age attained by such taxpayer before
                                    the close of such taxable year.
                                        ``(II) Joint returns.--In the case
                                    of a joint return, the age of the older
                                    spouse shall be taken into account
                                    under clause (i).
                                ``(iii) Indexing.--In the case of any
                            taxable year beginning after calendar year
                            2024, the initial and final percentages
                            contained in clause (i) shall be adjusted to
                            reflect--
                                        ``(I) the excess (if any) of the
                                    rate of premium growth for the period
                                    beginning with calendar year 2013 and
                                    ending with calendar year 2024, over
                                    the rate of income growth for such
                                    period, and
                                        ``(II) in addition to any
                                    adjustment under subclause (I), the
                                    excess (if any) of the rate of premium
                                    growth for calendar year 2024, over the
                                    rate of growth in the consumer price
                                    index for calendar year 2024.
                                ``(iv) Failsafe.--Clause (iii)(II) shall
                            apply only if the aggregate amount of premium
                            tax credits under this section and cost-sharing
                            reductions under section 1402 of the Patient
                            Protection and Affordable Care Act for the
                            preceding calendar year exceeds an amount equal
                            to 0.504 percent of the gross domestic product
                            for such calendar year.''.
        (b) Expansion of Eligibility.--Section 36B of the Internal Revenue
    Code of 1986 is amended--
                (1) in subsection (c)(1)(A), by striking ``400'' and
            inserting ``600''; and
                (2) in subsection (f)(2)(B)(i), by striking ``400'' each
            place such reference appears and inserting ``600'' in each such
            place.
        (c) Effective Date.--The amendment made by this section shall apply
    to taxable years beginning after December 31, 2024.

    SEC. 227. PREMIUM ASSISTANCE.

        Notwithstanding any other provision of law, the Secretary of the
    Treasury shall calculate the credit allowable under section 36B of the
    Internal Revenue Code of 1986 based on the taxpayer's prior year tax
    return and the Secretary of Health and Human Services shall provide for
    open enrollment periods that end on April 15.

    SEC. 228. ADDING COPPER PLANS TO EXCHANGES.

        (a) In General.--Section 1302 of the Patient Protection and
    Affordable Care Act (42 U.S.C. 18022) is amended--
                (1) in subsection (a)(3), by inserting ``copper,'' after
            ``either the'';
                (2) in subsection (c), by adding at the end the following
            new paragraph:
                ``(5) Special rule for copper plans.--A health plan in the
            copper level of coverage (as described in subsection (d)(1)(E))
            shall be deemed to meet the requirements of this subsection.'';
                (3) in subsection (d)--
                        (A) in paragraph (1), by adding at the end the
                    following new subparagraph:
                        ``(E) Copper level.--A plan in the copper level
                    shall provide a level of coverage that is designed to
                    provide benefits that are actuarially equivalent to 50
                    percent of the full actuarial value of the benefits
                    provided under the plan and will have out-of-pocket
                    limits that are 30 percent higher than bronze plans.'';
                    and
                        (B) in paragraph (4)--
                                (i) by inserting ``copper,'' after ``any
                            reference to a''; and
                                (ii) by inserting ``copper,'' after
                            ``providing a''; and
                (4) in subsection (e)(1), by inserting ``copper,'' after
            ``not providing a''.
        (b) Effective Date.--The amendments made by this section shall
    apply with respect to plan years beginning on or after January 1, 2025.

    SEC. 229. COPPER AND BRONZE PLANS.

        Notwithstanding any other provision of law, refundable credits for
    coverage under a qualified health plan and cost-sharing reductions may
    be used to purchase bronze and copper plans.

    SEC. 230. WAIVERS FOR STATE INNOVATION.

        (a) Streamlining the State Application Process.--Section 1332 of
    the Patient Protection and Affordable Care Act (42 U.S.C. 18052) is
    amended--
                (1) in subsection (a)(1)(C), by striking ``the law'' and
            inserting ``a law or has in effect a certification''; and
                (2) in subsection (b)(2)--
                        (A) in the paragraph heading, by inserting ``or
                    certify'' after ``law'';
                        (B) in subparagraph (A)--
                                (i) by striking ``A law'' and inserting the
                            following:
                                ``(i) Laws.--A law''; and
                                (ii) by adding at the end the following:
                                ``(ii) Certifications.--A certification
                            described in this paragraph is a document,
                            signed by the Governor of the State, that
                            certifies that such Governor has the authority
                            under existing Federal and State law to take
                            action under this section, including
                            implementation of the State plan under
                            subsection (a)(1)(B).''; and
                        (C) in subparagraph (B)--
                                (i) in the subparagraph heading, by
                            striking ``of opt out''; and
                                (ii) by striking ``may repeal a law'' and
                            all that follows through the period at the end
                            and inserting the following: ``may terminate
                            the authority provided under the waiver with
                            respect to the State by--
                                ``(i) repealing a law described in
                            subparagraph (A)(i); or
                                ``(ii) terminating a certification
                            described in subparagraph (A)(ii), through a
                            certification for such termination signed by
                            the Governor of the State.''.
        (b) Providing Expedited Approval of State Waivers.--Section 1332(d)
    of the Patient Protection and Affordable Care Act (42 U.S.C. 18052(d))
    is amended--
                (1) in paragraph (1) by striking ``180'' and inserting
            ``90''; and
                (2) by adding at the end the following:
                ``(3) Expedited determination.--
                        ``(A) In general.--With respect to any application
                    under subsection (a)(1) submitted on or after the date
                    of this paragraph or any such application submitted
                    prior to such date of enactment and under review by the
                    Secretary on such date of enactment, the Secretary
                    shall make a determination on such application, using
                    the criteria for approval otherwise applicable under
                    this section, not later than 45 days after the receipt
                    of such application, and shall allow the public notice
                    and comment at the State and Federal levels described
                    under subsection (a)(4) to occur concurrently if such
                    State application--
                                ``(i) is submitted in response to an urgent
                            situation, with respect to areas in the State
                            that the Secretary determines are at risk for
                            excessive premium increases or having no health
                            plans offered in the applicable health
                            insurance market for the current or following
                            plan year; or
                                ``(ii) is for a waiver that is the same or
                            substantially similar to a waiver that the
                            Secretary already has approved for another
                            State.
                        ``(B) Approval.--
                                ``(i) Urgent situations.--
                                        ``(I) Provisional approval.--A
                                    waiver approved under the expedited
                                    determination process under
                                    subparagraph (A)(i) shall be in effect
                                    for a period of 3 years, unless the
                                    State requests a shorter duration.
                                        ``(II) Full approval.--Subject to
                                    the requirements for approval otherwise
                                    applicable under this section, not
                                    later than 1 year before the expiration
                                    of a provisional waiver period
                                    described in subclause (I) with respect
                                    to an application described in
                                    subparagraph (A)(i), the Secretary
                                    shall make a determination on whether
                                    to extend the approval of such waiver
                                    for the full term of the waiver
                                    requested by the State, for a total
                                    approval period not to exceed 6 years.
                                    The Secretary may request additional
                                    information as the Secretary determines
                                    appropriate to make such determination.
                                ``(ii) Approval of same or similar
                            applications.--An approval of a waiver under
                            subparagraph (A)(ii) shall be subject to the
                            terms of subsection (e).
                        ``(C) GAO study.--Not later than 5 years after the
                    date of enactment of this paragraph, the Comptroller
                    General of the United States shall conduct a review of
                    all waivers approved pursuant to an application under
                    subparagraph (A)(ii) to evaluate whether such waivers
                    met the requirements of subsection (b)(1) and whether
                    the applications should have qualified for such
                    expedited process.''.
        (c) Providing Certainty for State-Based Reforms.--Section 1332(e)
    of the Patient Protection and Affordable Care Act (42 U.S.C. 18052(e))
    is amended by striking ``No waiver'' and all that follows through the
    period at the end and inserting the following: ``A waiver under this
    section--
                ``(1) shall be in effect for a period of 6 years unless the
            State requests a shorter duration;
                ``(2) may be renewed, subject to the State meeting the
            criteria for approval otherwise applicable under this section,
            for unlimited additional 6-year periods upon application by the
            State; and
                ``(3) may not be suspended or terminated, in whole or in
            part, by the Secretary at any time before the date of
            expiration of the waiver period (including any renewal period
            under paragraph (2)), unless the Secretary determines that the
            State materially failed to comply with the terms and conditions
            of the waiver.''.
        (d) Ensuring Patient Access to More Flexible Health Plans.--Section
    1332(b)(1)(B) of the Patient Protection and Affordable Care Act (42
    U.S.C. 18052(b)(1)(B)) is amended by striking ``at least as
    affordable'' and inserting ``of comparable affordability, including for
    low-income individuals, individuals with serious health needs, and
    other vulnerable populations,''.
        (e) Applicability.--The amendments made by this Act to section 1332
    of the Patient Protection and Affordable Care Act (42 U.S.C. 18052)--
                (1) with respect to applications for waivers under such
            section 1332 submitted after the date of enactment of this Act
            and applications for such waivers submitted prior to such date
            of enactment and under review by the Secretary on the date of
            enactment, shall take effect on the date of enactment of this
            Act; and
                (2) with respect to applications for waivers approved under
            such section 1332 before the date of enactment of this Act,
            shall not require reconsideration of whether such applications
            meet the requirements of such section 1332, except that, at the
            request of a State, the Secretary shall recalculate the amount
            of funding provided under subsection (a)(3) of such section.

    SEC. 231. ENROLLMENT PERIODS.

        (a) Exchanges.--Paragraph (7) of section 1311(c) of the Patient
    Protection and Affordable Care Act (42 U.S.C. 18031(c)), as added by
    section 106, is amended by adding at the end the following new
    subparagraph:
                        ``(B) Enrollments other than during initial, open,
                    and special enrollment periods.--Beginning with plan
                    year 2025, an Exchange may provide for enrollments
                    during periods in addition to open enrollment periods
                    described in subparagraph (A) or paragraph (6) and
                    special enrollment periods described in paragraph
                    (6).''.
        (b) Health Plans.--Subpart I of part A of title XXVII of the Public
    Health Service Act is amended by adding at the end the following new
    section:

    ``SEC. 2710. ENROLLMENT OUTSIDE OF INITIAL, OPEN, AND SPECIAL
                  ENROLLMENT PERIOD.

        ``Beginning with plan year 2025, a group health plan and a health
    insurance issuer offering group or individual health insurance coverage
    may provide for enrollment in such plan or coverage during periods in
    addition to initial, open, or special enrollment periods. In the case
    that an individual enrolls in such plan or coverage during a period
    pursuant to the previous sentence, the plan or issuer may charge the
    individual a one-time enrollment fee.''.

    SEC. 232. STATE-OPERATED EXCHANGES FLEXIBILITY FOR OPEN ENROLLMENT
                  PERIODS.

        Section 1311(c) of the Patient Protection and Affordable Care Act
    (42 U.S.C. 18031(c)) is amended--
                (1) in paragraph (6), by striking ``The Secretary'' and
            inserting ``Subject to paragraph (7), the Secretary''; and
                (2) by adding at the end the following new paragraph:
                ``(7) Flexibility for enrollment periods.--
                        ``(A) State-operated exchanges open enrollment
                    periods.--In the case of an Exchange operated by a
                    State, beginning with plan years of 1 year after the
                    date of enactment of this Act, the Exchange may provide
                    for open enrollment periods (after the initial
                    enrollment period) every 12, 24, or 36 months, as
                    determined by the State.''.

    SEC. 233. PROMOTING HEALTH PLANS THAT COVER INDIVIDUALS IN MORE THAN
                  ONE STATE.

        There are appropriated, out of amounts in the Treasury not
    otherwise appropriated, $10,000,000 to be made available by no later
    than 1 year after the date of enactment of this Act, to the Center for
    Medicare & Medicaid Innovation to fund new research or pilot programs
    dedicated to pursuing viable methods of enrolling individuals in health
    insurance programs that cross State lines.

            TITLE III--COMPETITION, TRANSPARENCY AND ACCOUNTABILITY

                  Subtitle A--Provider and Insurer Competition

    SEC. 301. HOSPITAL CONSOLIDATION.

        (a) Authorization of Appropriations.--There is authorized to be
    appropriated $160,000,000 to the Federal Trade Commission to hire staff
    to investigate, as consistent with the Sherman Antitrust Act and other
    relevant Federal laws, anti-competitive mergers and practices under
    such laws to the extent such mergers and practices relate to providers
    of inpatient and outpatient health care services, as defined by the
    Secretary of Health and Human Services.
        (b) Medicare Advantage Rates Applied to Certain HHI Hospitals.--
                (1) In general.--Section 1866(a) of the Social Security Act
            (42 U.S.C. 1395cc(a)) is amended--
                        (A) in paragraph (1)--
                                (i) in subparagraph (X), by striking
                            ``and'' at the end;
                                (ii) in subparagraph (Y), by striking the
                            period at the end and inserting ``; and''; and
                                (iii) by inserting after subparagraph (Y)
                            the following new subparagraph:
                        ``(Z) subject to paragraph (4), in the case of a
                    hospital located in a county whose population density
                    is above the median population density for all counties
                    in the United States with respect to which there is a
                    Herfindahl-Hirschman Index (HHI) of greater than 4,000,
                    to apply the average reimbursement rate with respect to
                    individuals (regardless of whether such an individual
                    is entitled to or eligible for benefits under this
                    title, but excluding individuals eligible for medical
                    assistance under a State plan under title XIX)
                    furnished items and services at such hospital that
                    would be billable under this title for such items and
                    services if furnished by such hospital to an individual
                    enrolled under part C.''; and
                        (B) by adding at the end the following new
                    paragraph:
                ``(4)(A) The requirement under paragraph (1)(Z) shall not
            apply in the case of a hospital in a hospital referral region
            if--
                        ``(i) the HRR market share of such hospital (as
                    determined under subparagraph (B)) is less than 0.15;
                    or
                        ``(ii) the hospital is located in a rural area (as
                    defined in section 1886(d)(2)(D)).
                ``(B) For purposes of subparagraph (A), the HRR market
            share of a hospital in a hospital referral region is equal to--
                        ``(i) the total revenue of the hospital, divided by
                        ``(ii) the total revenue of all hospitals in the
                    hospital referral region.''.
                (2) Effective date.--The amendments made by this subsection
            shall apply with respect to items and services furnished on or
            after January 1, 2025.
        (c) Grants for Hospital Infrastructure Improvement.--
                (1) In general.--The Secretary of Health and Human Services
            shall carry out a grant program under which the Secretary shall
            provide grants to eligible States, in accordance with this
            subsection.
                (2) Uses.--An eligible State receiving a grant under this
            subsection may use such grant to improve the State hospital
            infrastructure and to supplement any other funds provided for a
            purpose authorized under a State or local hospital grant
            program under State law.
                (3) Eligibility.--
                        (A) In general.--An eligible State may receive not
                    more than one grant under this subsection with respect
                    to each qualifying criterion described in subparagraph
                    (B) that is met by the State.
                        (B) Eligible state.--For purposes of this
                    subsection, the term ``eligible State'' means a State
                    that meets any one or more of the following qualifying
                    criteria:
                                (i) The State does not have in effect any
                            State certificate of need law that requires a
                            health care provider to provide to a regulatory
                            body a certification that the community needs
                            the services provided by the health care
                            provider.
                                (ii) The State has in effect State scope of
                            practice laws that--
                                        (I) allow advanced practice
                                    providers (such as nurse practitioners,
                                    advanced practice registered nurses,
                                    clinical nurse specialists, and
                                    physician assistants) to evaluate
                                    patients; diagnose, order, and
                                    interpret diagnostic tests; and
                                    initiate and manage treatments; or
                                        (II) provide that the only
                                    justification for limiting the scope of
                                    practice of a health care provider is
                                    safety to the public.
                                (iii) The State does not have in effect any
                            State laws that require managed care plans to
                            accept into the network of such plan any
                            qualified provider who is willing to accept the
                            terms and conditions of the managed care plan.
                                (iv) The State does not have in effect any
                            Certificate of Public Advantage laws that
                            clearly articulate the State's intent to
                            displace competition in favor of regulation or
                            that violate State or Federal antitrust laws.
                                (v) The State does not have in effect any
                            network adequacy laws regulating a health
                            plan's ability to deliver benefits by providing
                            reasonable access to a sufficient number of in-
                            network primary care and specialty physicians,
                            as well as all health care services included
                            under the terms of an insuree's contract with a
                            health insurer.
                (4) Funding.--There is authorized to be appropriated to
            carry out this subsection $1,000,000,000 for each of the fiscal
            years 2025 through 2034. Funds appropriated under this
            paragraph shall remain available until expended.
        (d) Critical Access Hospital Reimbursement Rates.--
                (1) Part a.--Section 1814(l)(1) of the Social Security Act
            (42 U.S.C. 1395f(l)(1)) is amended by inserting ``(or, for
            2025, 102, plus 1 percentage point for each subsequent year
            through 2033, and 110 for each subsequent year thereafter)''
            after ``101''.
                (2) Part b.--Section 1834(g)(1) of such Act (42 U.S.C.
            1395m(g)(1)) is amended by inserting ``(or, for 2025, 102, plus
            1 percentage point for each subsequent year through 2033, and
            110 for each subsequent year thereafter)'' after ``101''.

    SEC. 302. AUTHORITY OF FEDERAL TRADE COMMISSION OVER CERTAIN TAX-EXEMPT
                  ORGANIZATIONS.

        Section 4 of the Federal Trade Commission Act (15 U.S.C. 44) is
    amended, in the undesignated paragraph relating to the definition of
    the term ``Corporation''--
                (1) by striking ``, and any'' and inserting ``, any''; and
                (2) by inserting before the period at the end the
            following: ``, and any organization described in section
            501(c)(3) of the Internal Revenue Code of 1986 that is exempt
            from taxation under section 501(a) of such Code''.

    SEC. 303. LEVELING THE PLAYING FIELD BETWEEN PAYERS AND PROVIDERS.

        (a) Exemption.--It shall not be a violation of the antitrust laws
    for one or more private health insurer issuers or their designated
    agents to jointly negotiate prices of particular hospital services with
    a hospital provider with regards to the reimbursement policies of the
    insurers for those services.
        (b) Definitions.--For purposes of this section:
                (1) Antitrust laws.--The term ``antitrust laws'' has the
            meaning given it in subsection (a) of the 1st section of the
            Clayton Act (15 U.S.C. 12(a)), except that such term includes
            section 5 of the Federal Trade Commission Act (15 U.S.C. 45) to
            the extent such section 5 applies to unfair methods of
            competition.
                (2) Health insurance issuer.--The term ``health insurance
            issuer'' means an insurance company, insurance service, or
            insurance organization (including a health maintenance
            organization, as defined in subparagraph (C)) which is licensed
            to engage in the business of insurance in a State and which is
            subject to State law which regulates insurance (within the
            meaning of section 514(b)(2) of the Employee Retirement Income
            Security Act of 1974 (29 U.S.C. 1144(b)(2)). Such term does not
            include a group health plan.
                (3) Health maintenance organization.--The term ``health
            maintenance organization'' means--
                        (A) a Federally qualified health maintenance
                    organization (as defined in section 300e(a) of title 42
                    of the United States Code),
                        (B) an organization recognized under State law as a
                    health maintenance organization, or
                        (C) a similar organization regulated under State
                    law for solvency in the same manner and to the same
                    extent as such a health maintenance organization.
        (c) Effective Date.--This section shall take effect on the date of
    the enactment of this Act but shall not apply with respect to conduct
    that occurs before such date.

    SEC. 304. BANNING ANTICOMPETITIVE TERMS IN FACILITY AND INSURANCE
                  CONTRACTS THAT LIMIT ACCESS TO HIGHER QUALITY, LOWER COST
                  CARE.

        (a) In General.--Section 2729B of the Public Health Service Act, as
    added by section 301, is amended by adding at the end the following:
        ``(b) Protecting Health Plans Network Design Flexibility.--
                ``(1) In general.--A group health plan or a health
            insurance issuer offering group or individual health insurance
            coverage shall not enter into an agreement with a provider,
            network or association of providers, or other service provider
            offering access to a network of service providers if such
            agreement, directly or indirectly--
                        ``(A) restricts the group health plan or health
                    insurance issuer from--
                                ``(i) directing or steering enrollees to
                            other health care providers; or
                                ``(ii) offering incentives to encourage
                            enrollees to utilize specific health care
                            providers;
                        ``(B) requires the group health plan or health
                    insurance issuer to enter into any additional contract
                    with an affiliate of the provider, such as an affiliate
                    of the provider, as a condition of entering into a
                    contract with such provider;
                        ``(C) requires the group health plan or health
                    insurance issuer to agree to payment rates or other
                    terms for any affiliate not party to the contract of
                    the provider involved; or
                        ``(D) restricts other group health plans or health
                    insurance issuers not party to the contract from paying
                    a lower rate for items or services than the contracting
                    plan or issuer pays for such items or services.
                ``(2) Additional requirement for self-insured plans.--A
            self-insured group health plan shall not enter into an
            agreement with a provider, network or association of providers,
            third-party administrator, or other service provider offering
            access to a network of providers if such agreement directly or
            indirectly requires the group health plan to certify, attest,
            or otherwise confirm in writing that the group health plan is
            bound by restrictive contracting terms between the service
            provider and a third-party administrator that the group health
            plan is not party to, without a disclosure that such terms
            exist.
                ``(3) Exception for certain group model issuers.--Paragraph
            (1)(A) shall not apply to a group health plan or health
            insurance issuer offering group or individual health insurance
            coverage with respect to--
                        ``(A) a health maintenance organization (as defined
                    in section 2791(b)(3)), if such health maintenance
                    organization operates primarily through exclusive
                    contracts with multi-specialty physician groups, nor to
                    any arrangement between such a health maintenance
                    organization and its affiliates; or
                        ``(B) a value-based network arrangement, such as an
                    exclusive provider network, accountable care
                    organization, center of excellence, a provider
                    sponsored health insurance issuer that operates
                    primarily through aligned multi-specialty physician
                    group practices or integrated health systems, or such
                    other similar network arrangements as determined by the
                    Secretary through rulemaking.
                ``(4) Attestation.--A group health plan or health insurance
            issuer offering group or individual health insurance coverage
            shall annually submit to, as applicable, the applicable
            authority described in section 2723 or the Secretary of Labor,
            an attestation that such plan or issuer is in compliance with
            the requirements of this subsection.
        ``(c) Maintenance of Existing HIPAA, GINA, and ADA Protections.--
    Nothing in this section shall modify, reduce, or eliminate the existing
    privacy protections and standards provided by reason of State and
    Federal law, including the requirements of parts 160 and 164 of title
    45, Code of Federal Regulations (or any successor regulations).
        ``(d) Regulations.--The Secretary, not later than 1 year after the
    date of enactment of the Fair Care Act of 2024, shall promulgate
    regulations to carry out this section.
        ``(e) Rule of Construction.--Nothing in this section shall be
    construed to limit network design or cost or quality initiatives by a
    group health plan or health insurance issuer, including accountable
    care organizations, exclusive provider organizations, networks that
    tier providers by cost or quality or steer enrollees to centers of
    excellence, or other pay-for-performance programs.
        ``(f) Clarification With Respect to Antitrust Laws.--Compliance
    with this section does not constitute compliance with the antitrust
    laws, as defined in subsection (a) of the first section of the Clayton
    Act (15 U.S.C. 12(a)).''.
        (b) Effective Date.--Section 2729B of the Public Health Service Act
    (as added by section 301 and amended by subsection (a)) shall apply
    with respect to any contract entered into on or after the date that is
    18 months after the date of enactment of this Act. With respect to an
    applicable contract that is in effect on the date of enactment of this
    Act, such section 2729B shall apply on the earlier of the date of
    renewal of such contract or 3 years after such date of enactment.

    SEC. 305. REPEALING ELIGIBILITY OF CERTAIN ACOS.

        (a) In General.--Section 1899(b)(1) of the Social Security Act (42
    U.S.C. 1395jjj(b)(1)) is amended by striking subparagraphs (C) through
    (E).
        (b) Effective Date.--The amendment made by subsection (a) shall
    take effect on January 1, 2025.

    SEC. 306. REPEAL OF HEALTH CARE REFORM PROVISIONS LIMITING MEDICARE
                  EXCEPTION TO THE PROHIBITION ON CERTAIN PHYSICIAN
                  REFERRALS FOR HOSPITALS.

        Sections 6001 and 10601 of the Patient Protection and Affordable
    Care Act (Public Law 111-148; 124 Stat. 684, 1005) and section 1106 of
    the Health Care and Education Reconciliation Act of 2010 (Public Law
    111-152; 124 Stat. 1049) are repealed and the provisions of law amended
    by such sections are restored as if such sections had never been
    enacted.

    SEC. 307. ALTERNATIVE PAYMENT MODEL FOR CERTAIN SHOPPABLE PROCEDURES.

        (a) In General.--A group health plan and a health insurance issuer
    offering group or individual health insurance coverage (as such terms
    are defined in section 2791 of the Public Health Service Act (42 U.S.C.
    300gg-91)) may elect, with respect to a plan year, to provide a set
    payment amount to an enrollee under such plan or coverage for certain
    shoppable procedures (as defined in subsection (b)) in accordance with
    the provisions of this section in lieu of otherwise providing coverage
    for such a procedure under such plan or coverage, but only if the
    enrollee so agrees to such set payment amount.
        (b) Definition.--For purposes of this section, the term ``shoppable
    procedure'' means a procedure specified by the Secretary of Health and
    Human Services (in this section referred to as the ``Secretary'') with
    respect to which individuals may be expected to compare prices for such
    procedure of health care providers and facilities, including primary
    and preventive services, prenatal care and childbirth, common surgeries
    that can be scheduled, and other similar services.
        (c) Set Payment Rules.--A set payment described in subsection (a)
    under a group health plan or group or individual health insurance
    coverage offered by a health insurance issuer shall--
                (1) be disclosed prior to beginning of each plan year such
            payment is in effect and shall not vary during such plan year;
                (2) be the same amount with respect to the same shoppable
            procedure furnished in a geographic area (as defined by the
            Secretary);
                (3) not be less than the median negotiated rate for all
            group health plans and health insurance coverage offered in
            such area for such procedure;
                (4) be made available to an enrollee under such plan or
            such coverage regardless of the provider or facility furnishing
            the shoppable procedure;
                (5) represent the entirety of the payment obligation of
            such plan or such issuer with respect to such procedure; and
                (6) may be retained by such enrollee to the extent that the
            amount of such payment exceeds the amount charged by such
            provider or facility for such procedure.
        (d) Provision of Price Information.--Each health care provider and
    facility that may furnish a shoppable procedure during a year shall
    post in a public area a notice containing the prices that will be
    charged by such provider of facility with respect to each such
    procedure to individuals making payment for such services pursuant to a
    set payment amount described in subsection (a).
        (e) EHB Waiver Authority.--The Secretary may waive such provisions
    of section 1302(b) of the Patient Protection and Affordable Care Act
    (42 U.S.C. 18022(b)) with respect to a group health plan, health
    insurance issuer offering group or individual health insurance
    coverage, and a plan year as the Secretary determines necessary to
    allow for the provision of set payment amounts described in subsection
    (a).

                         Subtitle B--Price Transparency

    SEC. 321. PRICE TRANSPARENCY REQUIREMENTS.

        (a) Hospitals.--Section 2718(e) of the Public Health Service Act
    (42 U.S.C. 300gg-18(e)) is amended--
                (1) by striking ``Each hospital'' and inserting the
            following:
                ``(1) In general.--Each hospital'';
                (2) by inserting ``, in a machine-readable format, via open
            application program interfaces (APIs)'' after ``a list'';
                (3) by inserting ``, along with such additional information
            as the Secretary may require with respect to such charges for
            purposes of promoting public awareness of hospital pricing in
            advance of receiving a hospital item or service'' before the
            period; and
                (4) by adding at the end the following:
                ``(2) Definition of standard charges.--Notwithstanding any
            other provision of law, for purposes of paragraph (1), the term
            `standard charges' means the rates hospitals, including
            providers or entities that contract with or practice at a
            hospital, charge for all items and services at a minimum,
            chargemaster rates, rates that hospitals negotiate with third
            party payers across all plans, including those related to a
            patient's specific plan, discounted cash prices, and other
            rates determined by the Secretary.
                ``(3) Enforcement.--In addition to any other enforcement
            actions or penalties that may apply under subsection (b)(3) or
            another provision of law, a hospital that fails to provide the
            information required by this subsection and has not completed a
            corrective action plan to comply with the requirements of such
            subsection shall be subject to a civil monetary penalty of an
            amount not to exceed $300 per day that the violation is ongoing
            as determined by the Secretary. Such penalty shall be imposed
            and collected in the same manner as civil money penalties under
            subsection (a) of section 1128A of the Social Security Act are
            imposed and collected.''.
        (b) Transparency in Coverage.--Section 1311(e)(3) of the Patient
    Protection and Affordable Care Act (42 U.S.C. 18031(e)(3)) is amended--
                (1) in subparagraph (A)--
                        (A) in clause (vii), by inserting before the period
                    the following: ``, including, for all items and
                    services covered under the plan, aggregate information
                    on specific payments the plan has made to out-of-
                    network health care providers on behalf of plan
                    enrollees'';
                        (B) by designating clause (ix) as clause (x); and
                        (C) by inserting after clause (viii), the
                    following:
                                ``(ix) Information on the specific
                            negotiated payment rates between the plan and
                            health care providers for all items and
                            services covered under the plan.'';
                (2) in subparagraph (B)--
                        (A) in the heading, by striking ``use'' and
                    inserting ``delivery methods and use'';
                        (B) by inserting ``, as applicable,'' after
                    ``English proficiency''; and
                        (C) by inserting after the second sentence, the
                    following: ``The Secretary shall establish standards
                    for electronic delivery and access to such information
                    by individuals, free of charge, in machine readable
                    format, through an Internet website and via open
                    APIs.'';
                (3) in subparagraph (C)--
                        (A) in the first sentence, by inserting ``or out-
                    of-network provider'' after ``item or service by a
                    participating provider'';
                        (B) in the second sentence, by striking ``through
                    an Internet website'' and inserting ``free of charge,
                    in machine readable format, through an Internet
                    website, and via open APIs, in accordance with
                    standards established by the Secretary,''; and
                        (C) by adding at the end the following: ``Such
                    information shall include specific negotiated rates
                    that allow for comparison between providers and across
                    plans, and related to a patient's specific plan,
                    including after an enrollee has exceeded their
                    deductible responsibility.''; and
                (4) in subparagraph (D) by striking ``subparagraph (A)''
            and inserting ``subparagraphs (A), (B), and (C)''.

    SEC. 322. ENSURING ENROLLEE ACCESS TO COST-SHARING INFORMATION.

        (a) In General.--Subpart II of part A of title XXVII of the Public
    Health Service Act (42 U.S.C. 300gg-11 et seq.), as amended by the
    preceding sections, is further amended by adding at the end the
    following:

    ``SEC. 2729F. PROVISION OF COST-SHARING INFORMATION.

        ``(a) Provider Disclosures.--A provider that is in-network with
    respect to a group health plan or a health insurance issuer offering
    group or individual health insurance coverage shall provide to an
    enrollee in the plan or coverage who submits a request for the
    information described in paragraph (1) or (2), together with accurate
    and complete information about the enrollee's coverage under the
    applicable plan or coverage--
                ``(1) as soon as practicable and not later than 2 business
            days after the enrollee requests such information, a good faith
            estimate of the expected enrollee cost-sharing for the
            provision of a particular health care service (including any
            service that is reasonably expected to be provided in
            conjunction with such specific service); and
                ``(2) as soon as practicable and not later than 2 business
            days after an enrollee requests such information, the contact
            information for any ancillary providers for a scheduled health
            care service.
        ``(b) Insurer Disclosures.--A group health plan or a health
    insurance issuer offering group or individual health insurance coverage
    shall provide an enrollee in the plan or coverage with a good faith
    estimate of the enrollee's cost-sharing (including deductibles,
    copayments, and coinsurance) for which the enrollee would be
    responsible for paying with respect to a specific health care service
    (including any service that is reasonably expected to be provided in
    conjunction with such specific service), as soon as practicable and not
    later than 2 business days after a request for such information by an
    enrollee.
        ``(c) Enforcement.--
                ``(1) In general.--Subject to paragraph (2), a health care
            provider that violates a requirement under subsection (a) shall
            be subject to a civil monetary penalty of not more than $10,000
            for each act constituting such violation.
                ``(2) 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 money penalties under this subsection in the
            same manner as such provisions apply to a penalty or proceeding
            under section 1128A of the Social Security Act.''.
        (b) Effective Date.--Section 2729G of the Public Health Service
    Act, as added by subsection (a), shall apply with respect to plan years
    beginning on or after the date that is 18 months after the date of
    enactment of this Act.

    SEC. 323. ACCESS OF INDIVIDUALS TO PROTECTED HEALTH INFORMATION.

        The provisions of section 164.524 of title 45, Code of Federal
    Regulations, as in effect on the day before the date of the enactment
    of this Act, shall have the force and effect of law.

    SEC. 324. TIMELY BILLS FOR PATIENTS.

        (a) In General.--
                (1) Amendment.--Part P of title III of the Public Health
            Service Act (42 U.S.C. 280g et seq.) is amended by adding at
            the end the following:

    ``SEC. 399V-7. TIMELY BILLS FOR PATIENTS.

        ``(a) In General.--The Secretary shall require--
                ``(1) health care facilities, or in the case of
            practitioners providing services outside of such a facility,
            practitioners, to provide to patients a list of services
            rendered during the visit to such facility or practitioner,
            and, in the case of a facility, the name of the provider for
            each such service, upon discharge or end of the visit or by
            postal or electronic communication as soon as practicable and
            not later than 5 calendar days after discharge or date of
            visit; and
                ``(2) health care facilities and practitioners to furnish
            all adjudicated bills to the patient as soon as practicable,
            but not later than 45 calendar days after discharge or date of
            visit.
        ``(b) Payment After Billing.--No patient may be required to pay a
    bill for health care services any earlier than 35 days after the
    postmark date of a bill for such services.
        ``(c) Effect of Violation.--
                ``(1) Notification and refund requirements.--
                        ``(A) Provider lists.--If a facility or
                    practitioner fails to provide a patient a list as
                    required under subsection (a)(1), such facility or
                    practitioner shall report such failure to the
                    Secretary.
                        ``(B) Billing.--If a facility or practitioner bills
                    a patient after the 45-calendar-day period described in
                    subsection (a)(2), such facility or practitioner
                    shall--
                                ``(i) report such bill to the Secretary;
                            and
                                ``(ii) refund the patient for the full
                            amount paid in response to such bill with
                            interest, at a rate determined by the
                            Secretary.
                ``(2) Civil monetary penalties.--
                        ``(A) In general.--The Secretary may impose civil
                    monetary penalties of up to $10,000 a day on any
                    facility or practitioner that--
                                ``(i) fails to provide a list required
                            under subsection (a)(1) more than 10 times,
                            beginning on the date of such tenth failure;
                                ``(ii) submits more than 10 bills outside
                            of the period described in subsection (a)(2),
                            beginning on the date on which such facility or
                            practitioner sends the tenth such bill;
                                ``(iii) fails to report to the Secretary
                            any failure to provide lists as required under
                            paragraph (1)(A), beginning on the date that is
                            45 calendar days after discharge or visit; or
                                ``(iv) fails to send any bill as required
                            under subsection (a)(2), beginning on the date
                            that is 45 calendar days after the date of
                            discharge or visit, as applicable.
                        ``(B) 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 money penalties
                    under this subsection in the same manner as such
                    provisions apply to a penalty or proceeding under
                    section 1128A of the Social Security Act.
                ``(3) Safe harbor.--The Secretary may exempt a practitioner
            or facility from the penalties under paragraph (2)(A) or extend
            the period of time specified under subsection (a)(2) for
            compliance with such subsection if a practitioner or facility--
                        ``(A) makes a good-faith attempt to send a bill
                    within 30 days but is unable to do so because of an
                    incorrect address; or
                        ``(B) experiences extenuating circumstances (as
                    defined by the Secretary), such as a hurricane or
                    cyberattack, that may reasonably delay delivery of a
                    timely bill.''.
                (2) Rulemaking.--Not later than 1 year after the date of
            enactment of this Act, the Secretary shall promulgate final
            regulations to define the term ``extenuating circumstance'' for
            purposes of section 399V-7(c)(3)(B) of the Public Health
            Service Act, as added by paragraph (1).
        (b) Group Health Plan and Health Insurance Issuer Requirements.--
    Subpart II of part A of title XXVII of the Public Health Service Act
    (42 U.S.C. 300gg-11), as amended by the preceding sections, is further
    amended by adding at the end the following:

    ``SEC. 2729D. TIMELY BILLS FOR PATIENTS.

        ``(a) In General.--A group health plan or health insurance issuer
    offering group or individual health insurance coverage shall have in
    place business practices with respect to in-network facilities and
    practitioners to ensure that claims are adjudicated in order to
    facilitate facility and practitioner compliance with the requirements
    under section 399V-7(a).
        ``(b) Clarification.--Nothing in subsection (a) prohibits a
    provider and a group health plan or health insurance issuer from
    establishing in a contract the timeline for submission by either party
    to the other party of billing information, adjudication, sending of
    remittance information, or any other coordination required between the
    provider and the plan or issuer necessary for meeting the deadline
    described in section 399V-7(a)(2).''.
        (c) Effective Date.--The amendments made by subsections (a) and (b)
    shall take effect 6 months after the date of enactment of this Act.

    SEC. 325. ADVISORY GROUP ON REDUCING BURDEN OF HOSPITAL ADMINISTRATIVE
                  REQUIREMENTS.

        (a) In General.--Not later than January 1, 2025, the Secretary of
    Health and Human Services shall convene an advisory group to provide,
    in accordance with this section, recommendations on ways the Federal
    Government could reduce the burden of administrative requirements on
    hospitals.
        (b) Recommendations.--Not later than January 1, 2026, the advisory
    board convened under this section shall--
                (1) submit to the Secretary of Health and Human Services
            recommendations described under subsection (a) for executive
            action and any recommendations for State actions for potential
            consideration in making grants under section 2(c) to States;
            and
                (2) submit to Congress recommendations described under
            subsection (a) for legislative proposals.
        (c) Membership.--The advisory board under this section shall
    consist of the following members:
                (1) Three representatives of companies that have--
                        (A) geographically distributed workforces;
                        (B) at least 10,000 employees; and
                        (C) no more than 10 percent of such employees in
                    any single State.
                (2) Three representatives of health insurance issuers and
            health plans, consisting of--
                        (A) one representative of for-profit health
                    insurance issuers and health plans with at least
                    20,000,000 enrollees in the employer-sponsored market;
                        (B) one representative of non-profit health
                    insurance issuers and health plans operating in at
                    least 5 States; and
                        (C) one representative of non-profit health
                    insurance issuers and health plans operating in a rural
                    State (as defined by the Census Bureau).
                (3) Seven public policy experts in the field of hospital
            consolidation.

    SEC. 326. DATA REPORTING TO IMPROVE THE TRANSPARENCY REGARDING HOW 340B
                  HOSPITAL COVERED ENTITIES PROVIDE CARE FOR PATIENTS.

        Section 340B of the Public Health Service Act (42 U.S.C. 256b) is
    amended by adding at the end the following new subsection:
        ``(f) Data Reporting To Improve the Transparency Regarding How
    Hospital Covered Entities Provide Care for Patients.--
                ``(1) In general.--Beginning on the date that is 14 months
            after the date of the enactment of this subsection, and
            annually thereafter, subject to subparagraph (C), a covered
            entity described in subparagraph (L) or (M) of subsection
            (a)(4), unless otherwise indicated, shall report on the
            following, with respect to the previous year, in such a manner
            and form as specified by the Secretary:
                        ``(A) The following information:
                                ``(i) With respect to such covered entity
                            and with respect to each child site of such
                            entity (as referenced in paragraph (11)), the
                            number and percentage of individuals who are
                            dispensed or administered drugs that are
                            subject to an agreement under this section,
                            organized by form of health insurance coverage
                            of such individuals (including at least by the
                            Medicare program under title XVIII of the
                            Social Security Act, the Medicaid program under
                            title XIX of such Act, health insurance
                            coverage offered in the individual or group
                            market or a group health plan (as such terms
                            are defined in section 2791), and uninsured).
                                ``(ii) With respect to each such child site
                            of such entity, the total costs incurred at
                            each such site and the cost incurred at each
                            such site for charity care as defined in line
                            23 of worksheet S-10 to the Medicare cost
                            report or in any successor form.
                        ``(B) The aggregate amount of gross reimbursement
                    received by each such covered entity (including child
                    sites of such entity) described in such subparagraph
                    (L) or (M) for all drugs purchased that are subject to
                    an agreement under this section and the entity's
                    aggregate acquisition cost for such drugs.
                        ``(C) In the case of covered entity described in
                    subparagraph (L) of subsection (a)(4), at the time of
                    application and recertification (and at least annually
                    thereafter), the contract that is the basis for
                    eligibility under the requirement under clause (i) of
                    such subparagraph and any modifications to such
                    contract for purposes of review by the Secretary.
                        ``(D) With respect to such covered entity and with
                    respect to each child site of such entity, the name of
                    all third-party vendors or other similar entities that
                    the covered entity contracts with to provide services
                    associated with the program under this section.
                ``(2) Availability of information.--
                        ``(A) In general.--The Secretary shall make data
                    reported by covered entities under subparagraphs (A),
                    (C), and (D) of paragraph (1) available on the public
                    website of the Department of Health and Human Services
                    in an electronic and searchable format, which may
                    include the 340B Office of Pharmacy Affairs Information
                    System or a successor to such system.
                        ``(B) Format.--Data made available under
                    subparagraph (A) shall be made available in a manner
                    that shows each category of data reported both in the
                    aggregate and identified by covered entities described
                    in subparagraphs (L) and (M) of subsection (a)(4) and
                    child sites of such covered entities. In carrying out
                    this paragraph, with respect to data reported pursuant
                    to paragraph (1)(C), the Secretary shall ensure that
                    any proprietary information shall be redacted from
                    contracts submitted pursuant to such paragraph (1)(C)
                    before posting such data.
                ``(3) Interim final regulations.--The Secretary shall issue
            interim final regulations no later than the date that is 6
            months after the date of the enactment of this subsection, to
            carry out this subsection and shall finalize such regulations
            prior to the end of the moratorium period to which subsection
            (a)(11) applies.
                ``(4) Reports to congress.--
                        ``(A) OIG report.--Not later than 2 years after the
                    date of the enactment of this subsection, the Office of
                    the Inspector General shall submit to Congress a final
                    report on the level of charity care provided by covered
                    entities described in subparagraphs (L) and (M) of
                    subsection (a)(4) and separately by child sites of such
                    covered entities, as reported in paragraph (1)(A).
                        ``(B) GAO reports.--
                                ``(i) Initial report.--Not later than 1
                            year after the date of the enactment of this
                            subsection, the Comptroller General of the
                            United States shall submit to Congress a
                            report--
                                        ``(I) analyzing the State and local
                                    government contracts intended to
                                    satisfy the requirement under
                                    subsection (a)(4)(L)(i) for a covered
                                    entity to qualify as an entity
                                    described in subparagraph (L) of
                                    subsection (a)(4);
                                        ``(II) assessing the amount of care
                                    such contracts obligate such entity to
                                    provide to low-income individuals
                                    ineligible for Medicare under title
                                    XVIII of the Social Security Act and
                                    Medicaid under title XIX of such Act;
                                    and
                                        ``(III) analyzing how these
                                    contracts define low-income individuals
                                    and whether the Secretary reviews such
                                    determinations.
                                ``(ii) Subsequent report.--Not later than 2
                            years after the date of the enactment of this
                            subsection, the Comptroller General of the
                            United States shall submit to Congress a final
                            report on the information collected under
                            paragraph (1)(B) regarding the difference
                            between the aggregate gross reimbursement and
                            aggregate acquisition costs received by each
                            such covered entity (including child sites of
                            such entity) for drugs subject to an agreement
                            under this section.''.

    SEC. 327. REQUIRING 340B DRUG DISCOUNT PROGRAM REPORTS BY DSH HOSPITAL
                  COVERED ENTITIES ON LOW-INCOME UTILIZATION RATE OF
                  OUTPATIENT HOSPITAL SERVICES.

        (a) In General.--Section 340B(d)(2) of the Public Health Service
    Act (42 U.S.C. 256b(d)(2)) is amended--
                (1) in subparagraph (B)(i), by inserting before the period
            at the end the following: ``, including, with respect to such
            updates made on or after one year after the date of enactment
            of the Act, by requiring covered entities described in
            subsection (a)(4)(L) to submit (and to so regularly update)
            information described in subparagraph (C)''; and
                (2) by adding at the end the following new subparagraph:
                        ``(C) Information on low-income utilization rate of
                    outpatient hospital services.--
                                ``(i) In general.--For purposes of
                            subparagraph (B)(i), the information described
                            in this subparagraph, with respect to a covered
                            entity described in subsection (a)(4)(L) and an
                            update under such subparagraph (B)(i), is--
                                        ``(I) the low-income outpatient
                                    utilization rate of such covered entity
                                    for the most recent fiscal year; and
                                        ``(II) the low-income outpatient
                                    utilization rate of off-site outpatient
                                    facilities, clinics, eligible off-site
                                    locations, and associated sites of such
                                    entity identified as child sites of
                                    such entity pursuant to the
                                    identification system under
                                    subparagraph (B)(iv) for the most
                                    recent fiscal year.
                                ``(ii) Low-income outpatient utilization
                            rate defined.--In this subparagraph, the term
                            `low-income outpatient utilization rate' has
                            the meaning given the term `low-income
                            utilization rate' under paragraph (3) of
                            section 1923(b) of the Social Security Act,
                            except that--
                                        ``(I) clauses (i) and (ii) of
                                    subparagraph (A) of such paragraph
                                    shall be applied as if--
                                                ``(aa) each reference to
                                            `patient services' were a
                                            reference to `patient services
                                            furnished on an outpatient
                                            basis'; and
                                                ``(bb) for purposes of
                                            clause (i)(II) of this
                                            subparagraph, each reference to
                                            `hospital' were a reference to
                                            `off-site outpatient
                                            facilities, clinics, eligible
                                            off-site locations, and
                                            associated sites of the
                                            hospital that are identified as
                                            child sites of the hospital
                                            pursuant to the identification
                                            system under section
                                            340B(d)(2)(B)(iv) of the Public
                                            Health Service Act'; and
                                        ``(II) clauses (i) and (ii) of
                                    subparagraph (B) of such paragraph
                                    shall be applied as if--
                                                ``(aa) each reference to
                                            `inpatient hospital services'
                                            were a reference to `outpatient
                                            hospital services'; and
                                                ``(bb) for purposes of
                                            clause (i)(II) each reference
                                            to `hospital's charges' were a
                                            reference to `charges of the
                                            off-site outpatient facilities,
                                            clinics, eligible off-site
                                            locations, and associated sites
                                            of the hospital that are
                                            identified as child sites of
                                            the hospital pursuant to the
                                            identification system under
                                            section 340B(d)(2)(B)(iv) of
                                            the Public Health Service
                                            Act'.''.
        (b) Annual Reports.--Not later than 1 year after the date of
    enactment of this Act, and annually thereafter, the Administrator of
    the Health Resources and Services Administration shall submit to
    Congress a report on information submitted by covered entities for the
    previous year pursuant to the amendments made by subsection (a).

    SEC. 328. EMPLOYER BENEFITS REPORTS.

        (a) In General.--Subject to subsection (b), for each plan year
    beginning on or after 1 year after the date of enactment of this Act, a
    group health plan and a health insurance issuer offering group health
    insurance coverage shall provide to each individual enrolled in such
    plan or such coverage for such plan year a notification containing the
    following:
                (1) The amount the sponsor of such group health plan
            expended with respect to such individual under such plan for
            such plan year (or, in the case of a health insurance issuer
            offering group health insurance coverage, the amount the
            employer of such individual contributed for such coverage for
            such individual for such plan year).
                (2) The amount the sponsor of such group health plan
            expended with respect to such individual under such plan for
            each previous plan year (or, in the case of a health insurance
            issuer offering group health insurance coverage, the amount the
            employer of such individual contributed for such coverage for
            such individual for each previous plan year), if applicable.
        (b) Limitation.--Subsection (a) shall not apply to a group health
    plan, or a health insurance issuer offering group health insurance
    coverage, for a plan year if, for such plan year, the number of
    individuals enrolled under such plan or such coverage was less than
    100.
        (c) Penalty.--In the case that the Secretary of Health and Human
    Services determines that a group health plan or a health insurance
    issuer offering group health insurance failed to provide the notice
    required under subsection (a), the Secretary may impose a civil
    monetary penalty on the sponsor of such plan or such issuer, as
    applicable, in an amount not to exceed $100 per individual enrolled in
    such plan or such coverage per day that such sponsor or issuer failed
    to provide such notification to such individual.
        (d) Definitions.--In this section, the terms ``group health plan'',
    ``group health insurance coverage'', ``health insurance issuer'', and
    ``sponsor'' have the meaning given such terms in section 2791 of the
    Public Health Service Act (42 U.S.C. 300gg-91).

    SEC. 329. GOVERNMENT ACCOUNTABILITY OFFICE STUDY ON PROFIT- AND
                  REVENUE-SHARING IN HEALTH CARE.

        (a) Study.--Not later than 1 year after the date of enactment of
    this Act, the Comptroller General of the United States shall conduct a
    study to--
                (1) describe what is known about profit- and revenue-
            sharing relationships in the commercial health care markets,
            including those relationships that--
                        (A) involve one or more--
                                (i) physician groups that practice within a
                            hospital included in the profit- or revenue-
                            sharing relationship, or refer patients to such
                            hospital;
                                (ii) laboratory, radiology, or pharmacy
                            services that are delivered to privately
                            insured patients of such hospital;
                                (iii) surgical services;
                                (iv) hospitals or group purchasing
                            organizations; or
                                (v) rehabilitation or physical therapy
                            facilities or services; and
                        (B) include revenue- or profit-sharing whether
                    through a joint venture, management or professional
                    services agreement, or other form of gain-sharing
                    contract;
                (2) describe Federal oversight of such relationships,
            including authorities of the Department of Health and Human
            Services and the Federal Trade Commission to review such
            relationships and their potential to increase costs for
            patients, and identify limitations in such oversight; and
                (3) as appropriate, make recommendations to improve Federal
            oversight of such relationships.
        (b) Report.--Not later than 1 year after the date of enactment of
    this Act, the Comptroller General of the United States shall prepare
    and submit a report on the study conducted under subsection (a) to the
    Committee on Health, Education, Labor, and Pensions of the Senate and
    the Committee on Education and Labor and Committee on Energy and
    Commerce of the House of Representatives.

            Subtitle C--Prescription Drug Competition and Innovation

    SEC. 341. EXPEDITED DEVELOPMENT AND PRIORITY REVIEW FOR GENERIC COMPLEX
                  DRUG PRODUCTS.

        Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 351 et seq.) is amended by adding at the end the
    following:

    ``SEC. 524C. EXPEDITED DEVELOPMENT AND PRIORITY REVIEW FOR GENERIC
                  COMPLEX DRUG PRODUCTS.

        ``(a) Establishment of Program.--The Secretary shall establish a
    program to expedite the development of, and provide priority review
    under section 505(j) for, generic complex drug products.
        ``(b) Request for Designation.--A sponsor of a generic complex drug
    product may request that the Secretary designate such product for
    expedited development and priority review under this section.
        ``(c) Designation Process.--
                ``(1) In general.--Not later than 60 calendar days after
            the receipt of a request under subsection (b), the Secretary
            shall determine whether the product that is the subject of the
            request meets the criteria under subsection (e) to be
            considered a generic complex drug product. If the Secretary
            determines that the product meets the criteria, the Secretary
            shall designate the product for expedited development and
            priority review.
                ``(2) Review.--Review of a request under subsection (b)
            shall be undertaken by a team that is composed of experienced
            staff and senior managers of the Food and Drug Administration.
                ``(3) Withdrawal.--The Secretary may not withdraw a
            designation granted under this section on the basis of the
            criteria under subsection (e) no longer applying because of the
            subsequent clearance or approval of any other product.
        ``(d) Expedited Development and Priority Review Guidance.--
                ``(1) Content.--Not later than 1 year after the date of
            enactment of this section, the Secretary shall issue guidance
            on the implementation of this section. Such guidance shall--
                        ``(A) set forth the process by which a person may
                    seek a designation under subsection (c);
                        ``(B) provide a template for requests under
                    subsection (b);
                        ``(C) identify the criteria the Secretary will use
                    in evaluating a request for designation under this
                    section; and
                        ``(D) identify the criteria and processes the
                    Secretary will use to expedite the development and
                    review of products designated under this section.
                ``(2) Process.--Prior to finalizing the guidance under
            paragraph (1), the Secretary shall seek public comment on a
            draft version of that guidance.
        ``(e) Generic Complex Drug Product Defined.--In this section, the
    term `generic complex drug product' means a product that represents a
    complex therapy that consists of or includes a drug that has been
    approved under section 505(j) and that--
                ``(1)(A) contains complex active ingredients (such as
            peptides, polymeric compounds, complex mixtures of active
            ingredients, and naturally sourced ingredients);
                ``(B) is composed of complex formulations (such as
            liposomes or colloids);
                ``(C) requires a complex route of delivery (such as locally
            acting drugs such as dermatological products and complex
            ophthalmological products and otic dosage forms that are
            formulated as suspensions, emulsions, or gels); or
                ``(D) involves a complex dosage form (such as transdermals,
            metered dose inhalers, or extended release injectables);
                ``(2) presents as a complex drug-device combination product
            (such as auto injectors or metered dose inhalers); or
                ``(3) is a product that would benefit from early scientific
            engagement due to complexity or uncertainty concerning the
            approval pathway under section 505(j).''.

    SEC. 342. PREVENTING BLOCKING OF GENERIC DRUGS.

        (a) In General.--Section 505(j)(5)(B)(iv) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amended--
                (1) in subclause (I), by striking ``180 days after the
            date'' and all that follows through ``by any first applicant''
            and inserting ``180 days after the earlier of the dates
            described in items (aa) and (bb) of subclause (II)'';
                (2) by redesignating subclause (II) as subclause (III); and
                (3) by inserting after subclause (I) the following:
                                        ``(II) Dates described.--
                                                ``(aa) First date.--The
                                            date described in this item is
                                            the date of the first
                                            commercial marketing of the
                                            drug (including the commercial
                                            marketing of the listed drug)
                                            by any first applicant.
                                                ``(bb) Second date.--The
                                            date described in this item is
                                            the date on which all of the
                                            following conditions are first
                                            met, provided no application
                                            submitted by any first
                                            applicant is approved on or
                                            before such date:

                                                        ``(AA) An
                                                    application for the
                                                    drug submitted by an
                                                    applicant other than a
                                                    first applicant has
                                                    received tentative
                                                    approval and could
                                                    receive approval, if no
                                                    first applicant were
                                                    eligible for 180-day
                                                    exclusivity under this
                                                    clause, and such
                                                    applicant has not
                                                    entered into an
                                                    agreement that would
                                                    prevent commercial
                                                    marketing upon approval
                                                    and has submitted a
                                                    notification to the
                                                    Secretary documenting
                                                    that it has not entered
                                                    into an agreement that
                                                    would prevent
                                                    commercial marketing.

                                                        ``(BB) Thirty-three
                                                    months have passed
                                                    since the date of
                                                    submission of an
                                                    application for the
                                                    drug by one first
                                                    applicant, if there is
                                                    only one first
                                                    applicant, or, in the
                                                    case of more than one
                                                    first applicant, 33
                                                    months have passed
                                                    since the date of
                                                    submission of all such
                                                    applications.

                                                        ``(CC) Approval of
                                                    an application for the
                                                    drug submitted by at
                                                    least one first
                                                    applicant would not be
                                                    precluded under clause
                                                    (iii).''.

        (b) Information.--Not later than 60 days after the date of
    enactment of this Act, the Secretary of Health and Human Services
    (referred to in this subsection as the ``Secretary'') shall publish, as
    appropriate and available, information sufficient to allow applicants
    to assess whether the conditions described in subitems (AA) through
    (CC) of section 505(j)(5)(B)(iv)(II)(bb) of the Federal Food, Drug, and
    Cosmetic Act (as amended by subsection (a)) have been or will be
    satisfied for all applications where the exclusivity period under
    (iv)(I) of section 505(j)(5)(B) of the Federal Food, Drug, and Cosmetic
    Act (as so amended) has not expired, and shall provide updates to
    reflect the most recent information available to the Secretary.

    SEC. 343. ENSURING TIMELY ACCESS TO GENERICS.

        Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 355(q)) is amended--
                (1) in paragraph (1)--
                        (A) in subparagraph (A)(i), by inserting ``,
                    10.31,'' after ``10.30'';
                        (B) in subparagraph (E)--
                                (i) by striking ``application and'' and
                            inserting ``application or'';
                                (ii) by striking ``If the Secretary'' and
                            inserting the following:
                                ``(i) In general.--If the Secretary'';
                                (iii) by striking the second sentence and
                            inserting the following:
                                ``(ii) Primary purpose of delaying.--
                                        ``(I) In general.--In determining
                                    whether a petition was submitted with
                                    the primary purpose of delaying an
                                    application, the Secretary may consider
                                    the following factors:
                                                ``(aa) Whether the petition
                                            was submitted in accordance
                                            with paragraph (2)(B), based on
                                            when the petitioner knew or
                                            reasonably should have known
                                            the relevant information relied
                                            upon to form the basis of such
                                            petition.
                                                ``(bb) Whether the
                                            petitioner has submitted
                                            multiple or serial petitions or
                                            supplements to petitions
                                            raising issues that reasonably
                                            could have been known to the
                                            petitioner at the time of
                                            submission of the earlier
                                            petition or petitions.
                                                ``(cc) Whether the petition
                                            was submitted close in time to
                                            a known, first date upon which
                                            an application under subsection
                                            (b)(2) or (j) of this section
                                            or section 351(k) of the Public
                                            Health Service Act could be
                                            approved.
                                                ``(dd) Whether the petition
                                            was submitted without relevant
                                            data or information in support
                                            of the scientific positions
                                            forming the basis of such
                                            petition.
                                                ``(ee) Whether the petition
                                            raises the same or
                                            substantially similar issues as
                                            a prior petition to which the
                                            Secretary has responded
                                            substantively already,
                                            including if the subsequent
                                            submission follows such
                                            response from the Secretary
                                            closely in time.
                                                ``(ff) Whether the petition
                                            requests changing the
                                            applicable standards that other
                                            applicants are required to
                                            meet, including requesting
                                            testing, data, or labeling
                                            standards that are more onerous
                                            or rigorous than the standards
                                            the Secretary has determined to
                                            be applicable to the listed
                                            drug, reference product, or
                                            petitioner's version of the
                                            same drug.
                                                ``(gg) The petitioner's
                                            record of submitting petitions
                                            to the Food and Drug
                                            Administration that have been
                                            determined by the Secretary to
                                            have been submitted with the
                                            primary purpose of delay.
                                                ``(hh) Other relevant and
                                            appropriate factors, which the
                                            Secretary shall describe in
                                            guidance.
                                        ``(II) Guidance.--The Secretary may
                                    issue or update guidance, as
                                    appropriate, to describe factors the
                                    Secretary considers in accordance with
                                    subclause (I).''; and
                                (iv) by adding at the end the following:
                                ``(iii) Referral to the federal trade
                            commission.--The Secretary shall establish
                            procedures for referring to the Federal Trade
                            Commission any petition or supplement to a
                            petition that the Secretary determines was
                            submitted with the primary purpose of delaying
                            approval of an application. Such procedures
                            shall include notification to the petitioner by
                            the Secretary.'';
                        (C) by striking subparagraph (F);
                        (D) by redesignating subparagraphs (G) through (I)
                    as subparagraphs (F) through (H), respectively; and
                        (E) in subparagraph (H), as so redesignated, by
                    striking ``submission of this petition'' and inserting
                    ``submission of this document'';
                (2) in paragraph (2)--
                        (A) by redesignating subparagraphs (A) through (C)
                    as subparagraphs (C) through (E), respectively;
                        (B) by inserting before subparagraph (C), as so
                    redesignated, the following:
                        ``(A) In general.--A person shall submit a petition
                    to the Secretary under paragraph (1) before filing a
                    civil action in which the person seeks to set aside,
                    delay, rescind, withdraw, or prevent submission,
                    review, or approval of an application submitted under
                    subsection (b)(2) or (j) of this section or section
                    351(k) of the Public Health Service Act. Such petition
                    and any supplement to such a petition shall describe
                    all information and arguments that form the basis of
                    the relief requested in any civil action described in
                    the previous sentence.
                        ``(B) Timely submission of citizen petition.--A
                    petition and any supplement to a petition shall be
                    submitted not later than 60 days after the date on
                    which the person first knew, or reasonably should have
                    known, the information that forms the basis of the
                    request made in the petition or supplement.'';
                        (C) in subparagraph (C), as so redesignated--
                                (i) in the heading, by striking ``within
                            150 days'';
                                (ii) in clause (i), by striking ``during
                            the 150-day period referred to in paragraph
                            (1)(F),''; and
                                (iii) by amending clause (ii) to read as
                            follows:
                                ``(ii) on or after the date that is 151
                            days after the date of submission of the
                            petition, the Secretary approves or has
                            approved the application that is the subject of
                            the petition without having made such a final
                            decision.'';
                        (D) by amending subparagraph (D), as so
                    redesignated, to read as follows:
                        ``(D) Dismissal of certain civil actions.--
                                ``(i) Petition.--If a person files a civil
                            action against the Secretary in which a person
                            seeks to set aside, delay, rescind, withdraw,
                            or prevent submission, review, or approval of
                            an application submitted under subsection
                            (b)(2) or (j) of this section or section 351(k)
                            of the Public Health Service Act without
                            complying with the requirements of subparagraph
                            (A), the court shall dismiss without prejudice
                            the action for failure to exhaust
                            administrative remedies.
                                ``(ii) Timeliness.--If a person files a
                            civil action against the Secretary in which a
                            person seeks to set aside, delay, rescind,
                            withdraw, or prevent submission, review, or
                            approval of an application submitted under
                            subsection (b)(2) or (j) of this section or
                            section 351(k) of the Public Health Service Act
                            without complying with the requirements of
                            subparagraph (B), the court shall dismiss with
                            prejudice the action for failure to timely file
                            a petition.
                                ``(iii) Final response.--If a civil action
                            is filed against the Secretary with respect to
                            any issue raised in a petition timely filed
                            under paragraph (1) in which the petitioner
                            requests that the Secretary take any form of
                            action that could, if taken, set aside, delay,
                            rescind, withdraw, or prevent submission,
                            review, or approval of an application submitted
                            under subsection (b)(2) or (j) of this section
                            or section 351(k) of the Public Health Service
                            Act before the Secretary has taken final agency
                            action on the petition within the meaning of
                            subparagraph (C), the court shall dismiss
                            without prejudice the action for failure to
                            exhaust administrative remedies.''; and
                        (E) in clause (iii) of subparagraph (E), as so
                    redesignated, by striking ``as defined under
                    subparagraph (2)(A)'' and inserting ``within the
                    meaning of subparagraph (C)''; and
                (3) in paragraph (4)--
                        (A) by striking ``Exceptions'' and all that follows
                    through ``This subsection does'' and inserting
                    ``Exceptions.--This subsection does'';
                        (B) by striking subparagraph (B); and
                        (C) by redesignating clauses (i) and (ii) as
                    subparagraphs (A) and (B), respectively, and adjusting
                    the margins accordingly.

    SEC. 344. PREEMPTION OF STATE BARRIERS TO THE SUBSTITUTION OF
                  BIOSIMILAR PRODUCTS.

        No State, or any political subdivision thereof, may, under any
    circumstances, prohibit a pharmacy or pharmacist from dispensing, in
    place of a biological reference product, any biosimilar that the Food
    and Drug Administration has designated as an interchangeable product
    for that biological reference product.

    SEC. 345. INCREASING PHARMACEUTICAL OPTIONS TO TREAT AN UNMET MEDICAL
                  NEED.

        Subsection (b) of section 506 of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 356) is amended by adding at the end the
    following:
                ``(4) Unmet medical need.--For purposes of paragraph (1), a
            drug to address an unmet medical need for a disease or
            condition shall be deemed to address such medical need if fewer
            than 3 available drugs exist for the treatment of such disease
            or condition.''.

    SEC. 346. CONDITIONAL APPROVAL OF NEW HUMAN DRUGS FOR INDIVIDUALS WITH
                  RARE, PROGRESSIVE, AND SERIOUS DISEASES.

        (a) In General.--Subchapter A of chapter V of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by section
    341, is further amended by adding at the end of the following:

    ``SEC. 524D. CONDITIONAL APPROVAL OF HUMAN DRUGS FOR INDIVIDUALS WITH
                  RARE, PROGRESSIVE, AND SERIOUS DISEASES.

        ``(a) Conditional Approval; Priority Review; Other Designations.--
                ``(1) In general.--The sponsor of a drug may file with the
            Secretary an application for conditional approval of an
            eligible drug described in subsection (b). The Secretary shall
            approve or deny such application in accordance with subsection
            (c).
                ``(2) Priority review.--The Secretary shall give priority
            review to an application for conditional approval of an
            eligible drug described in subsection (b).
                ``(3) Other designations.--If a drug that is granted
            conditional approval under this section is eligible for a
            special designation by the Secretary under this Act, including
            as a drug for a rare disease or condition under section 526,
            all applicable benefits of such other designation shall be
            available for use under such conditional approval, including
            any tax credits and waiving of fees under chapter VII.
                ``(4) Other programs.--A sponsor of a drug seeking
            conditional approval of such drug under this section may also
            seek designation, exclusivity, or approval, as applicable, of
            such drug under other applicable provisions of this Act or the
            Public Health Service Act, subject to the requirements of such
            provisions.
        ``(b) Eligibility.--
                ``(1) In general.--A drug may be eligible for conditional
            approval under this section if such drug is intended to treat a
            disease or condition that is--
                        ``(A) rapidly progressive, terminal, and has
                    substantial unmet medical need, as determined by the
                    Secretary; or
                        ``(B) a rare disease or condition (as defined in
                    section 526(a)(2)) that results in a substantially
                    shortened lifespan, substantial reduction in quality of
                    life, or other substantial adverse health effects, as
                    determined by the Secretary.
                ``(2) Exclusion from eligibility.--A drug that is intended
            to treat or respond to a material threat identified by the
            Secretary of Homeland Security under section 319F-
            2(c)(2)(A)(ii) of the Public Health Service Act shall not be
            eligible for conditional approval under this section.
        ``(c) Standard of Review for Conditional Approval.--
                ``(1) Requirements.--The Secretary shall only approve an
            application for conditional approval of a drug under this
            section if--
                        ``(A) the Secretary determines that--
                                ``(i)(I) evidence of safety for the drug
                            has been established by--
                                        ``(aa) the completion of a phase 1
                                    clinical investigation of the drug (as
                                    described in section 312.21 of title
                                    21, Code of Federal Regulations (or
                                    successor regulations)); or
                                        ``(bb) another demonstration of
                                    safety, as determined appropriate by
                                    the Secretary; and
                                ``(II) evidence of effectiveness in
                            treating a given indication (which indication
                            is congruent with the eligibility requirements
                            of subsection (b)), as established by an
                            ongoing or completed phase 2 clinical
                            investigation of the drug (as described in
                            section 312.21 of title 21, Code of Federal
                            Regulations (or successor regulations)); or
                                ``(ii) in the case of a drug that is
                            intended to treat a terminal pediatric rare
                            disease or condition (as defined in section
                            526(a)(2)) that does not predominately affect
                            adults--
                                        ``(I) evidence of safety for the
                                    drug has been established in accordance
                                    with clause (i)(I); and
                                        ``(II) the drug shows preliminary
                                    evidence of clinical effectiveness
                                    based upon studies in animal models;
                                    and
                        ``(B) the sponsor has provided a written
                    affirmation of the sponsor's intent to pursue under
                    section 505 of this Act or section 351 of the Public
                    Health Service Act approval of the drug, which
                    affirmation shall include a justification and a plan
                    for pursuing such approval.
                ``(2) Rolling, real-time review.--
                        ``(A) In general.--If the Secretary determines,
                    after preliminary evaluation of data submitted by the
                    sponsor, that a drug may meet the standard for
                    conditional approval, the sponsor may submit portions
                    of an application for conditional approval of a drug
                    under this section for evaluation by the Secretary
                    before the sponsor submits a complete application,
                    which submission shall include--
                                ``(i) a schedule for submission of
                            information necessary to make the application
                            complete; and
                                ``(ii) a payment of any fee that may be
                            required under section 736.
                        ``(B) Review.--The Secretary--
                                ``(i) shall evaluate each application
                            submitted under subparagraph (A) to assess
                            whether such application is complete or ready
                            to be filed; and
                                ``(ii) may commence review of portions of
                            such application for approval.
                ``(3) Use of real-world evidence.--
                        ``(A) In general.--The Secretary shall allow the
                    use of real-world evidence (as defined in section
                    505F(b)), including real-world data used to generate
                    real-world evidence, and of external sources of data,
                    including prospective or retrospective natural history
                    data, to support an application for conditional
                    approval under this section.
                        ``(B) Data integrity requirements.--In using
                    evidence described in subparagraph (A) to support an
                    application for conditional approval under this
                    section, the sponsor shall consider the guidance of the
                    Food and Drug Administration entitled `Data Standards
                    for Drug and Biological Product Submissions Containing
                    Real-World Data' and dated December 2023 (or successor
                    guidance).
        ``(d) FDA Authority To Withdraw Conditional Approval.--
                ``(1) In general.--The Secretary may withdraw the
            conditional approval of a drug under this section if--
                        ``(A) after adequate review of appropriate safety
                    data, including data from an observational registry
                    established under subsection (g), the Secretary
                    determines that such data no longer supports
                    conditional approval;
                        ``(B) the Secretary determines that the application
                    for conditional approval submitted under subsection
                    (a)(1) contained an untrue statement of material fact;
                    or
                        ``(C) the Secretary determines that the drug is no
                    longer eligible under subsection (b).
                ``(2) FDA examination authority.--
                        ``(A) In general.--For purposes of determining
                    whether to withdraw the conditional approval of a drug
                    under paragraph (1), the Secretary may--
                                ``(i) review any available clinical data
                            made available through clinical trials or an
                            observational registry under subsection (g),
                            applicable to such drug; and
                                ``(ii) determine whether the sponsor of
                            such drug is in violation of a requirement
                            established under paragraph (3) or (4) of
                            section 505(o) or section 505-1 with respect to
                            the drug.
                        ``(B) Transparency.--
                                ``(i) In general.--The Secretary may
                            require drug sponsors and observational
                            registries under subsection (g) to submit the
                            data described in subparagraph (A) for the
                            purposes of the review under that subparagraph.
                                ``(ii) Fines.--The Secretary may levy fines
                            on sponsors and observational registries that
                            do not comply with a request for data under
                            clause (i) within such reasonable timeframe as
                            is established by the Secretary.
                ``(3) Effect of withdrawal.--
                        ``(A) Availability to new patients.--
                                ``(i) In general.--If a conditional
                            approval is withdrawn under this subsection,
                            the sponsor may not make the drug available to
                            any new patients, but may continue to make such
                            drug available to patients who started taking
                            the drug prior to the date of withdrawal.
                                ``(ii) Effect.--Nothing in this
                            subparagraph shall be construed to require--
                                        ``(I) a patient to continue taking
                                    a conditionally approved drug if such
                                    patient decides to stop taking such
                                    drug; or
                                        ``(II) the sponsor to ensure such
                                    drug continues to be manufactured after
                                    the date of withdrawal.
                        ``(B) Civil monetary penalty.--Any sponsor who
                    makes available to new patients a drug for which
                    conditional approval has been withdrawn under this
                    subsection shall be subject to such civil monetary
                    penalty as is determined by the Secretary.
                ``(4) Withdrawal notice.--Upon determining to withdraw the
            conditional approval of a drug under paragraph (1), the
            Secretary shall submit written notice to the sponsor of such
            drug and such withdrawal shall be effective on the date that is
            14 days after the date of such submission of notice.
                ``(5) Appeals.--Not later than 180 days after the date of
            enactment of this section, the Secretary, by rule, shall
            establish a process by which a sponsor of a drug for which
            conditional approval was withdrawn under paragraph (1) may
            appeal such withdrawal.
                ``(6) Automatic withdrawal.--
                        ``(A) In general.--If the sponsor of a drug that
                    receives conditional approval under this section does
                    not submit an application for renewal of such
                    conditional approval under subsection (f)(2) by the
                    deadline under that subsection, such conditional
                    approval shall automatically be withdrawn in accordance
                    with paragraph (3) on the date on which such
                    conditional approval expires.
                        ``(B) Marketing requirement.--If any drug that
                    receives conditional approval under this section is not
                    brought to market within 1 year of the date on which
                    the conditional approval is granted, such conditional
                    approval, along with any benefits described in
                    subsection (a)(3), shall automatically be withdrawn in
                    accordance with paragraph (3) on such date.
                        ``(C) No right to appeal; effect of automatic
                    withdrawal.--
                                ``(i) In general.--A sponsor shall not have
                            the right to appeal an automatic withdrawal
                            under this paragraph.
                                ``(ii) Effect.--The Secretary shall have no
                            means or power to prevent an automatic
                            withdrawal under this paragraph from occurring.
        ``(e) Labeling; Review of Materials.--
                ``(1) In general.--Sponsors may not make available to
            patients a drug conditionally approved under this section,
            unless--
                        ``(A) all labeling and advertising of such drug
                    contains the statement `conditionally approved for a
                    limited population' in a prominent manner and adjacent
                    to, and not more prominent than--
                                ``(i) the proprietary name of such drug, if
                            any; or
                                ``(ii) if there is no proprietary name, the
                            established name of such drug, if any, as
                            defined in section 502(e)(3), or, in the case
                            of a drug that is a biological product, the
                            proper name, as defined by regulation; and
                        ``(B) the prescribing information for the drug
                    required by section 201.57 of title 21, Code of Federal
                    Regulations (or any successor regulation) includes the
                    following statement: `This drug is conditionally
                    approved for use in a limited and specific population.
                    This drug has not received full approval by the Food
                    and Drug Administration. Conditional approval of this
                    drug may be withdrawn at short notice.'.
                ``(2) Submission.--Not later than 45 days before such
            materials are distributed, all promotional, educational, and
            marketing materials for such drug shall be submitted to the
            Secretary for review.
                ``(3) Public list.--The Secretary shall maintain a list of
            all drugs conditionally approved under this section on a
            publicly accessible website. Such website shall briefly
            describe what each conditionally approved drug is and list the
            1 or more diseases or conditions for which the drug is
            indicated.
        ``(f) Renewal of Conditional Approval; Requirement To Bring Drug to
    Market.--
                ``(1) Duration; renewals.--The conditional approval for a
            drug under this section is effective for a 2-year period. The
            sponsor may request renewal of such conditional approval for up
            to 3 subsequent 2-year periods. Conditional approval with
            respect to a drug shall not exceed a total of 8 years from the
            initial date the drug was granted conditional approval.
                ``(2) Applications for renewal of conditional approval.--
                        ``(A) In general.--Except as provided in
                    subparagraph (C), the sponsor of a drug seeking a
                    renewal of conditional approval for such drug under
                    this subsection shall submit to the Secretary, not
                    later than 180 days before the date on which such
                    conditional approval expires, an application that
                    contains the applicable information described in
                    paragraph (3) in a standardized format determined by
                    the Secretary.
                        ``(B) Process for granting renewals.--Not later
                    than 180 days after the date of enactment of this
                    section, the Secretary, by rule, shall establish the
                    process for granting a renewal under this subsection.
                        ``(C) Exemption for small population diseases.--
                                ``(i) In general.--The Secretary shall
                            exempt from the requirements of subparagraph
                            (A) and paragraph (3) an application for a
                            renewal of conditional approval for a drug
                            under this subsection if the Secretary
                            determines that the population affected by the
                            disease or condition that the drug is intended
                            to treat does not support additional
                            preliminary evidence of effectiveness (as
                            defined in paragraph (3)(D)).
                                ``(ii) Application for exemption.--Sponsors
                            may submit an application for exemption under
                            this subparagraph not later than 180 days
                            before the date on which the conditional
                            approval expires.
                                ``(iii) Application process.--Not later
                            than 180 days after the date of enactment of
                            this section, the Secretary shall establish a
                            standardized application process for purposes
                            of this subparagraph.
                                ``(iv) Deadline.--The Secretary shall
                            approve or deny an application under this
                            subparagraph before the date on which the
                            conditional approval expires.
                                ``(v) Appeals.--Not later than 180 days
                            after the date of enactment of this section,
                            the Secretary shall establish a process under
                            which a sponsor my appeal a denial of an
                            application under this subparagraph.
                ``(3) Additional preliminary evidence of effectiveness.--
            The information described in this paragraph is the following:
                        ``(A) For the first approval renewal.--With respect
                    to an application under paragraph (2) for the first
                    renewal of conditional approval for a drug under this
                    subsection, additional preliminary evidence of
                    effectiveness of the drug, as compared to the evidence
                    provided in the initial application for conditional
                    approval for the drug under subsection (c).
                        ``(B) For the second approval renewal.--With
                    respect to an application under paragraph (2) for the
                    second renewal of conditional approval for a drug under
                    this subsection, additional preliminary evidence of
                    effectiveness of the drug, as compared to the evidence
                    provided in the renewal application described in
                    subparagraph (A).
                        ``(C) For the final approval renewal.--With respect
                    to an application under paragraph (2) for the third
                    renewal of conditional approval for a drug under this
                    subsection, a written affirmation from the head of the
                    drug's review division of the Office of New Drugs or
                    the Office of Therapeutic Products asserting that a
                    third renewal is necessary--
                                ``(i) for patients who have benefitted from
                            such drug to retain access to such drug; and
                                ``(ii) to generate additional preliminary
                            evidence of effectiveness for the purposes of
                            attaining approval under section 505 of this
                            Act or section 351 of the Public Health Service
                            Act.
                        ``(D) Definition.--In this paragraph, the term
                    `preliminary evidence of effectiveness' means--
                                ``(i) clinical evidence generated by an
                            ongoing or completed clinical trial conducted
                            in accordance with section 11.22 of title 42,
                            Code of Federal Regulations (or successor
                            regulations);
                                ``(ii) real-world evidence (as defined in
                            section 505F(b)); or
                                ``(iii) evidence from an observational
                            registry under subsection (g).
                ``(4) Denial of renewal on the basis of data fraud.--The
            Secretary may deny the application for renewal of conditional
            approval for a drug under this subsection if the Secretary, in
            conducting a review under subsection (d)(2), finds that the
            evidence provided in such application under subparagraph (A) or
            (B) of paragraph (3) was fraudulently manipulated by the
            applicable observational registry and that such application
            substantially relies on such data.
        ``(g) Observational Registries.--
                ``(1) Establishment.--
                        ``(A) In general.--Subject to subparagraph (C), the
                    sponsor of a drug conditionally approved under this
                    section shall establish an observational registry, for
                    patients who are or will be treated with such drug,
                    that pertains to the disease or condition that the drug
                    is intended to treat.
                        ``(B) Registries.--In establishing an observational
                    registry for a drug under subparagraph (A), the sponsor
                    may--
                                ``(i) establish a new observational
                            registry;
                                ``(ii) use an existing observational
                            registry that pertains to the disease or
                            condition such drug is intended to treat;
                                ``(iii) combine 1 or more existing
                            observational registries that pertain to the
                            disease or condition such drug is intended to
                            treat with a new observational registry; or
                                ``(iv) combine 2 or more existing
                            observational registries that pertain to the
                            disease or condition such drug is intended to
                            treat.
                        ``(C) Approval of registry and right to appeal.--
                    Not later than 180 days after the date of enactment of
                    this section, the Secretary shall establish--
                                ``(i) a process to approve or deny the
                            establishment of an observational registry
                            under subparagraph (A); and
                                ``(ii) a process for sponsors that received
                            such a denial to appeal the denial.
                ``(2) Requirement for patients to enroll in observational
            registry.--
                        ``(A) In general.--A drug conditionally approved
                    under this section shall not be made available to a
                    patient unless such patient is enrolled in the
                    applicable observational registry described in
                    paragraph (1).
                        ``(B) Informed consent.--
                                ``(i) In general.--Prior to enrolling in an
                            observational registry under subparagraph (A),
                            a patient shall provide informed consent in
                            accordance with clause (ii).
                                ``(ii) Application of certain
                            requirements.--The requirements for informed
                            consent under part 50 of subchapter A of
                            chapter I of title 21, Code of Federal
                            Regulations (or successor regulations), shall
                            apply to enrollment an observational registry
                            under this paragraph.
                ``(3) Submission of patient data.--
                        ``(A) In general.--The sponsor of a drug
                    conditionally approved under this section shall be
                    responsible for obtaining and submitting patient data
                    to the applicable observational registry described in
                    paragraph (1).
                        ``(B) Submission standards.--Not later than 180
                    days after the date of enactment of this section, the
                    Secretary shall establish data submission standards for
                    sponsors to comply with for purposes of subparagraph
                    (A) to ensure that registry data is consistent and
                    clinically informed.
                ``(4) Requirements for registries.--An observational
            registry described in paragraph (1) for a drug conditionally
            approved under this section may be operated by the sponsor of
            such drug or, at the sponsor's discretion, a third party, for-
            profit organization, or nonprofit organization.
                ``(5) Risk and benefit data.--
                        ``(A) In general.--The sponsor of a drug
                    conditionally approved under this section shall submit
                    relevant risk and benefit data to the applicable
                    observational registry described in paragraph (1).
                        ``(B) Online portal.--The Secretary shall operate
                    an online portal on an existing website of the
                    Secretary for sponsors to submit data described in
                    subparagraph (A).
                ``(6) Accessibility.--
                        ``(A) In general.--An observational registry
                    described in paragraph (1) shall--
                                ``(i) not later than 30 days after receipt
                            of a request, provide patients (or their
                            designated representatives) with access to such
                            patient's personal registry information; and
                                ``(ii) provide approved researchers and
                            medical professionals access to de-identified
                            and aggregated data from the registry for the
                            purposes of indication- and disease-specific
                            and translational research into conditions and
                            diseases relating to the disease or condition
                            that the drug tracked by the observational
                            registry is intended to treat.
                        ``(B) Approved researchers and medical
                    professionals.--Not later than 180 days after the date
                    of enactment of this section, the Secretary, by rule,
                    shall establish a process for approving researchers and
                    medical professionals for purposes of subparagraph
                    (A)(ii).
                ``(7) Effect.--Nothing in this section shall be construed
            to modify or limit the Secretary's authority to require for a
            drug conditionally approved under this section any type of
            postapproval study under any other provision of law, including
            sections 505(o)(3), 505B, and 506.
        ``(h) Pursuit of a Different Indication.--
                ``(1) In general.--In the case of a drug conditionally
            approved under this section for which such approval was
            withdrawn under subsection (d), expired under subsection
            (f)(1), or was denied for renewal under subsection (f)(4), not
            later than 2 years after the date of withdrawal, expiration, or
            denial, as applicable, the sponsor of such drug shall have the
            opportunity to petition the Secretary to receive conditional
            approval of such drug, in accordance with this section, for a
            different indication.
                ``(2) Process.--Not later than 180 days after the date of
            enactment of this section, the Secretary shall establish a
            process for petitions under paragraph (1).
        ``(i) Transition to Other Forms of Approval.--
                ``(1) In general.--A drug that receives conditional
            approval under this section may be granted approval under
            section 505 of this Act or section 351 of the Public Health
            Service Act during the period in which such conditional
            approval is in effect. Effective on the date on which approval
            for such drug is granted under section 505 of this Act or
            section 351 of the Public Health Service Act, such conditional
            approval shall be automatically withdrawn in accordance with
            subsection (d)(3).
                ``(2) Consideration of certain evidence.--In determining
            whether to approve under section 505 of this Act or section 351
            of the Public Health Service Act a drug that has received
            conditional approval under this section, the Secretary may
            consider evidence from the observational registry for the drug
            under subsection (g).
        ``(j) Informed Consent.--
                ``(1) In general.--Prior to being prescribed a drug
            conditionally approved under this section, a patient shall
            provide informed consent in accordance with paragraph (2).
                ``(2) Application of certain requirements.--The
            requirements for informed consent under part 50 of subchapter A
            of chapter I of title 21, Code of Federal Regulations (or
            successor regulations), shall apply to drugs conditionally
            approved under this section.
                ``(3) Observational registries.--An observational registry
            established for a drug in accordance with subsection (g) may
            obtain, and maintain records of, informed consent of a patient
            on behalf of the drug sponsor, in accordance with paragraph
            (2).
                ``(4) Common rule.--Drugs conditionally approved under this
            section shall comply with subpart A of part 46 of title 45,
            Code of Federal Regulations (commonly known as the `Common
            Rule') (or successor regulations), if applicable.
        ``(k) Limitation on Liability.--With respect to any claim under
    State law relating to a drug made available pursuant to a grant of
    conditional approval under this section, no liability shall lie against
    a sponsor or manufacturer of the drug, or any health care provider who
    prescribes or administers the drug, absent intentional wrongdoing.
        ``(l) Report to Congress.--
                ``(1) In general.--Not later than 2 years after the date of
            enactment of this section, and once every 2 years thereafter,
            the Secretary, in collaboration with drug sponsors, shall
            submit a report to Congress on all drugs granted conditional
            approval under this section. Such report shall include--
                        ``(A) an estimated number of patients treated with
                    each such drug, and the number of patients tracked in
                    an observational registry under subsection (g) with
                    respect to each such drug, if applicable;
                        ``(B) a discussion, at an aggregate level, of the
                    types and amounts of data obtained through
                    observational registries under subsection (g), such as
                    patient treatments and uses, length of use, side
                    effects encountered, relevant biomarkers, scan results,
                    cause of death and how long the patient lived, and
                    adverse drug effects;
                        ``(C) a list of all such drugs for which an
                    application for approval under this section, or an
                    application for an extension of conditional approval
                    under this section, has been submitted; and
                        ``(D) the number of all applications granted and
                    denied conditional approval under this section.
                ``(2) Sponsor participation.--Not later than 180 days
            before the date on which the Secretary submits a report under
            paragraph (1), the sponsor of a drug conditionally approved
            under this section shall provide to the Secretary the
            information described in subparagraphs (A) and (B) of paragraph
            (1), as applicable.
                ``(3) Notice authority.--The Secretary may notify sponsors
            of drugs conditionally approved under this section and
            observational registries under subsection (g) as necessary to
            complete a report under paragraph (1).''.
        (b) Conforming Amendment.--Section 505(a) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 355(a)) is amended by inserting ``,
    or there is in effect a conditional approval under section 524C with
    respect to such drug'' before the period.
        (c) Reimbursement.--
                (1) Private health insurers.--Section 2719A of the Public
            Health Service Act (42 U.S.C. 300gg-19a) is amended by adding
            at the end the following:
        ``(f) Coverage of Certain Drugs.--A group health plan or health
    insurance issuer offering group or individual health insurance coverage
    shall provide coverage for, and shall not impose any cost sharing
    requirements for, drugs conditionally approved under section 524D of
    the Federal Food, Drug, and Cosmetic Act for patients who have the
    disease or condition the drug is intended to treat.''.
                (2) Federal health care programs.--The requirement under
            subsection (f) of section 2719A of the Public Health Service
            Act (as added by paragraph (1)) shall apply with respect to
            coverage determinations under a Federal health care program (as
            defined in section 1128B(f) of the Social Security Act (42
            U.S.C. 1320a-7b(f))) in the same manner such requirement
            applies under such subsection (f).
                (3) Conforming amendment.--Section 1927(k)(2)(A)(i) of the
            Social Security Act (42 U.S.C. 1396r-8(k)(2)(A)(i)) is
            amended--
                        (A) by striking ``or which'' and inserting ``,
                    which''; and
                        (B) by inserting ``, or which is conditionally
                    approved under section 524D of such Act'' before the
                    semicolon.

    SEC. 347. CONSOLIDATING EXCLUSIVITY PERIODS FOR DRUGS TREATING RARE
                  DISEASES AND CONDITIONS.

        (a) In General.--Section 527(a) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 360cc(a)) is amended to read as follows:
        ``(a) Exclusivity.--
                ``(1) In general.--Except as provided in subsection (b), if
            the Secretary approves an application filed pursuant to section
            505, or issues a license under section 351 of the Public Health
            Service Act, for a drug designated under section 526 for a rare
            disease or condition, the Secretary may not approve an
            application filed pursuant to section 505, or issue a license
            under section 351 of the Public Health Service Act, for the
            same drug for the same disease or condition for a person who is
            not the holder of such approved application or of such license
            until the expiration of the exclusivity period described in
            paragraph (2).
                ``(2) Exclusivity period described.--The exclusivity period
            described in this paragraph, with respect to a drug designated
            under section 526 for a rare disease or condition, is--
                        ``(A) a single 7-year period of exclusivity with
                    respect to the first designation of such drug under
                    such section for that rare disease or condition; or
                        ``(B) in the case of a drug that has previously
                    received a period of exclusivity under paragraph (1), a
                    single 3-year period of exclusivity with respect to any
                    subsequent designation of such drug under such section
                    for any other rare disease or condition.
                ``(3) Limitation.--In the case of a drug that has received
            two periods of exclusivity pursuant to paragraph (1), no
            additional exclusivity period under this section is available
            with respect to such drug, regardless of whether such drug has
            been designated under section 526 for a rare disease or
            condition that is distinct from the rare disease or condition
            for which such exclusivity periods were granted.''.
        (b) Conforming Amendments.--
                (1) Section 505(j)(5)(B)(iv)(II)(dd)(AA) of the Federal
            Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended by
            striking ``7-year period'' and inserting ``period''.
                (2) Section 505A(b)(1)(A)(ii) of the Federal Food, Drug,
            and Cosmetic Act (21 U.S.C. 360cc) is amended by striking
            ``rather than seven years;'' and inserting ``, or three years
            and six months, rather than seven years or three years,
            respectively;''.
                (3) Section 505A(c)(1)(A)(ii) of the Federal Food, Drug,
            and Cosmetic Act (21 U.S.C. 360cc) is amended by striking
            ``rather than seven years;'' and inserting ``, or three years
            and six months, rather than seven years or three years,
            respectively;''.
                (4) Section 505E(a) of the Federal Food, Drug, and Cosmetic
            Act (21 U.S.C. 360cc) is amended by striking ``7-year period''
            and inserting ``exclusivity periods''.
                (5) Section 527(b) of the Federal Food, Drug, and Cosmetic
            Act (21 U.S.C. 360cc) is amended by striking ``the 7-year
            period'' and inserting ``any exclusivity period''.
                (6) Section 351(m)(2)(B) of the Public Health Service Act
            (42 U.S.C. 262) is amended by striking ``rather than 7 years''
            and inserting ``or 3 years and 6 months, rather than 7 years or
            3 years, respectively''.
                (7) Section 351(m)(3)(B) of the Public Health Service Act
            (42 U.S.C. 262) is amended by striking ``rather than 7 years''
            and inserting ``or 3 years and 6 months, rather than 7 years or
            3 years, respectively''.

    SEC. 348. EXCLUSIVITY PERIOD FOR BRAND NAME BIOLOGICAL PRODUCTS.

        (a) In General.--Section 351(k)(7)(A) of the Public Health Service
    Act (42 U.S.C. 262(k)(7)(A)) is amended by striking ``12 years'' and
    inserting ``5 years''.
        (b) Conforming Changes.--Paragraphs (2)(A) and (3)(A) of section
    351(m) of the Public Health Service Act (42 U.S.C. 262(m)) is amended
    by striking ``12 years'' each place it appears and inserting ``5
    years''.
        (c) Applicability.--This section and the amendments made by this
    section apply only with respect to a biological product for which the
    reference product (as such term is used in section 351 of the Public
    Health Service Act (42 U.S.C. 262)) is licensed under subsection (a) of
    such section on or after the date of enactment of this Act.

    SEC. 349. REGULATION OF MANUFACTURER-SPONSORED CO-PAY CONTRIBUTIONS.

        Notwithstanding any other provision of law, the Secretary of Health
    and Human Services may establish a mechanism to regulate drug
    manufacturers' financial contributions to patient out-of-pocket costs,
    such as drug co-pays.

    SEC. 350. ANTITRUST EXEMPTION FOR PRIVATE HEALTH INSURANCE ISSUERS TO
                  NEGOTIATE WHOLESALE ACQUISITION PRICES OF PRESCRIPTION
                  DRUGS PURCHASED FROM DRUG MANUFACTURERS.

        (a) Exemption.--It shall not be a violation of the antitrust laws
    for one or more private health insurance issuers or their designated
    agents to jointly negotiate wholesale acquisition prices of a
    prescription drug with a manufacturer of a prescription drug with
    regards to the reimbursement policies of the insurers of the
    manufacturer's drugs so long as no one single wholesale acquisition
    price is jointly determined between the insurance issuers or their
    designated agents.
        (b) Definitions.--For purposes of this section:
                (1) Antitrust laws.--The term ``antitrust laws'' has the
            meaning given such term in subsection (a) of the 1st section of
            the Clayton Act (15 U.S.C. 12(a)), except that such term
            includes section 5 of the Federal Trade Commission Act (15
            U.S.C. 45) to the extent such section 5 applies to unfair
            methods of competition.
                (2) Health insurance issuer.--The term ``health insurance
            issuer'' means an insurance company, insurance service, or
            insurance organization (including a health maintenance
            organization) which is licensed to engage in the business of
            insurance in a State and which is subject to State law which
            regulates insurance (within the meaning of section 514(b)(2) of
            the Employee Retirement Income Security Act of 1974 (29 U.S.C.
            1144(b)(2))). Such term does not include a group health plan.
                (3) Health maintenance organization.--The term ``health
            maintenance organization'' means--
                        (A) a health maintenance organization (as defined
                    in section 1301(a) of the Public Health Service Act (42
                    U.S.C. 300e(a));
                        (B) an organization recognized under State law as a
                    health maintenance organization; or
                        (C) a similar organization regulated under State
                    law for solvency in the same manner and to the same
                    extent as such a health maintenance organization.
                (4) Manufacturer.--The term ``manufacturer'' means any
            person who is engaged in manufacturing, preparing, propagating,
            compounding, processing, packaging, repackaging, or labeling of
            a prescription drug.
                (5) Prescription drug.--The term ``prescription drug''
            means any human drug required by Federal law or regulation to
            be dispensed only by a prescription, including finished dosage
            forms and active ingredients subject to section 503(b) of the
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)).
        (c) Effective Date.--This section shall not apply with respect to
    any conduct that occurs before the date of enactment of this Act.

    SEC. 351. BIOLOGICAL PRODUCT INNOVATION.

        Section 351(j) of the Public Health Service Act (42 U.S.C. 262(j))
    is amended--
                (1) by striking ``except that a product'' and inserting
            ``except that--
                ``(1) a product'';
                (2) by striking ``Act.'' and inserting ``Act; and''; and
                (3) by adding at the end the following:
                ``(2) no requirement under such Act regarding an official
            compendium (as defined in section 201(j) of such Act), or other
            reference in such Act to an official compendium (as so
            defined), shall apply with respect to a biological product
            subject to regulation under this section.''.

    SEC. 352. BIOSIMILAR BIOLOGICAL PRODUCTS.

        (a) In General.--Section 351(k) of the Public Health Service Act
    (42 U.S.C. 262(k)) is amended--
                (1) in the subsection heading, by striking ``or
            Interchangeable'';
                (2) in paragraph (2)--
                        (A) by striking subparagraph (B);
                        (B) by redesignating clauses (ii) and (iii) of
                    subparagraph (A) as subparagraphs (B) and (C),
                    respectively, and adjusting the margins accordingly;
                        (C) in subparagraph (A)--
                                (i) in clause (i), by redesignating
                            subclauses (I) through (V) as clauses (i)
                            through (v), respectively, and adjusting the
                            margins accordingly;
                                (ii) in clause (i), as so redesignated by
                            clause (i) of this subparagraph, by
                            redesignating items (aa) through (cc) as
                            subclauses (I) through (III), respectively, and
                            adjusting the margins accordingly; and
                                (iii) by striking ``(A) in general'' and
                            all that follows through ``An application
                            submitted under this subsection shall include
                            information'' and inserting the following:
                        ``(A) In general.--An application submitted under
                    this subsection shall include information'';
                        (D) in subparagraph (B), as so redesignated by
                    subparagraph (B) of this paragraph, by striking
                    ``clause (i)(I)'' and inserting ``subparagraph
                    (A)(i)''; and
                        (E) in subparagraph (C), as so redesignated by
                    subparagraph (B) of this paragraph, by redesignating
                    subclauses (I) through (III) as clauses (i) through
                    (iii), respectively, and by adjusting the margins
                    accordingly;
                (3) by amending paragraph (4) to read as follows:
                ``(4) Interchangeability.--
                        ``(A) In general.--A biological product licensed
                    under this subsection shall be deemed to be
                    interchangeable with the reference product.
                        ``(B) Congressional briefing prior to certain study
                    requirements.--The Secretary may require the sponsor of
                    an application submitted under this section to conduct
                    a study to evaluate the risk, in terms of safety,
                    purity, or potency, of alternating or switching between
                    the use of the biological product that is the subject
                    of the application and the reference product, if,
                    before requiring such a study, the Secretary first
                    holds a private briefing with the chair and ranking
                    member of the Committee on Health, Education, Labor,
                    and Pensions of the Senate and the chair and the
                    ranking member of the Committee on Energy and Commerce
                    of the House of Representatives, to explain why such a
                    study is necessary for the biological product, what
                    information the Secretary expects such a study to
                    reveal, what alternatives to such study have been
                    considered, and why those alternatives are not
                    sufficient.'';
                (4) by striking paragraph (6);
                (5) in paragraph (8)(D)--
                        (A) in clause (i), by striking ``class; and'' and
                    inserting ``class.'';
                        (B) by striking clause (ii); and
                        (C) by striking ``description of--'' and all that
                    follows through ``criteria that the Secretary'' and
                    inserting ``description of the criteria that the
                    Secretary''; and
                (6) in paragraph (9)(A)(iv), by striking ``paragraph (6)
            or''.
        (b) Conforming Amendments.--
                (1) Section 351(i)(3) of the Public Health Service Act (42
            U.S.C. 262(i)(3)) is amended by striking ``that is shown to
            meet the standards described in subsection (k)(4)'' and
            inserting ``licensed under subsection (k)''.
                (2) Section 352A of the Public Health Service Act (42
            U.S.C. 263-1) is amended by striking ``and interchangeable
            biosimilar biological products'' each place it appears.
                (3) Section 744G(14) of the Federal Food, Drug, and
            Cosmetic Act (21 U.S.C. 379j-51(14)) is amended by striking ``,
            including a supplement requesting that the Secretary determine
            that the biosimilar biological product meets the standards for
            interchangeability described in section 351(k)(4) of the Public
            Health Service Act''.
                (4) Section 505B(l) of the Federal Food, Drug, and Cosmetic
            Act (21 U.S.C. 355c(l)) is amended to read as follows:
        ``(l) Biosimilar Biological Products.--A biological product for
    which an application is submitted under section 351(k) of the Public
    Health Service Act shall be considered to have a new active ingredient
    for purposes of this section, except that a pediatric assessment shall
    not be required for a claimed indication in a relevant pediatric
    population if the assessment would involve--
                ``(1) a condition of use that has not been previously
            approved for the reference product; or
                ``(2) a dosage form, strength, or route of administration
            that differs from that of the reference product.''.
        (c) Application.--The amendment made by subsection (a)(4) to
    section 351(k)(6) of the Public Health Service Act (42 U.S.C.
    262(k)(6)) shall apply only with respect to applications approved under
    section 351(k) of such Act on or after the date of enactment of this
    Act. Any period of exclusivity granted under section 351(k)(6) of such
    Act with respect to an application approved under such section 351(k)
    before the date of enactment of this Act shall apply in accordance with
    such section 351(k)(6), as in effect on the day before the date of
    enactment of this Act.

    SEC. 353. PROMPT APPROVAL OF DRUGS RELATED TO SAFETY INFORMATION.

        Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    355) is amended by adding at the end the following:
        ``(aa) Prompt Approval of Drugs When Safety Information Is Added to
    Labeling.--
                ``(1) General rule.--A drug for which an application has
            been submitted or approved under subsection (b)(2) or (j) shall
            not be considered ineligible for approval under this section or
            misbranded under section 502 on the basis that the labeling of
            the drug omits safety information, including contraindications,
            warnings, precautions, dosing, administration, or other
            information pertaining to safety, when the omitted safety
            information is protected by exclusivity under clause (iii) or
            (iv) of subsection (j)(5)(F), clause (iii) or (iv) of
            subsection (c)(3)(E), or section 527(a), or by an extension of
            such exclusivity under section 505A or 505E.
                ``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of
            subsection (j)(5)(F), clauses (iii) and (iv) of subsection
            (c)(3)(E), or section 527, the Secretary shall require that the
            labeling of a drug approved pursuant to an application
            submitted under subsection (b)(2) or (j) that omits safety
            information described in paragraph (1) include a statement of
            any appropriate safety information that the Secretary considers
            necessary to assure safe use.
                ``(3) Availability and scope of exclusivity.--This
            subsection does not affect--
                        ``(A) the availability or scope of exclusivity or
                    an extension of exclusivity described in subparagraph
                    (A) or (B) of section 505A(o)(3);
                        ``(B) the question of the eligibility for approval
                    under this section of any application described in
                    subsection (b)(2) or (j) that omits any other aspect of
                    labeling protected by exclusivity under--
                                ``(i) clause (iii) or (iv) of subsection
                            (j)(5)(F);
                                ``(ii) clause (iii) or (iv) of subsection
                            (c)(3)(E); or
                                ``(iii) section 527(a); or
                        ``(C) except as expressly provided in paragraphs
                    (1) and (2), the operation of this section or section
                    527.''.

    SEC. 354. CONGRESSIONAL REVIEW OF THE FOOD AND DRUG ADMINISTRATION
                  RULEMAKING.

        (a) Congressional Review.--Part I of title 5, United States Code,
    is amended by inserting after chapter 8 the following:

      ``CHAPTER 8a--CONGRESSIONAL REVIEW OF FOOD AND DRUG ADMINISTRATION
                                   RULEMAKING

    ``Sec.
    ``810. Applicability.
    ``811. Congressional review.
    ``812. Congressional approval procedure for major rules.
    ``813. Congressional disapproval procedure for nonmajor rules.
    ``814. Definitions.
    ``815. Judicial review.
    ``816. Exemption for monetary policy.
    ``817. Effective date of certain rules.
    ``818. Regulatory cut-go requirement.
    ``819. Review of rules currently in effect.
    ``Sec. 810. Applicability
        ``This chapter applies in lieu of chapter 8 with respect to the
    Food and Drug Administration.
    ``Sec. 811. Congressional review
        ``(a)(1)(A) Before a rule may take effect, the Food and Drug
    Administration shall satisfy the requirements of section 818 and shall
    publish in the Federal Register a list of information on which the rule
    is based, including data, scientific and economic studies, and cost-
    benefit analyses, and identify how the public can access such
    information online, and shall submit to each House of the Congress and
    to the Comptroller General a report containing--
                ``(i) a copy of the rule;
                ``(ii) a concise general statement relating to the rule;
                ``(iii) a classification of the rule as a major or nonmajor
            rule, including an explanation of the classification
            specifically addressing each criteria for a major rule
            contained within sections 814(2)(A), 814(2)(B), and 814(2)(C);
                ``(iv) a list of any other related regulatory actions
            intended to implement the same statutory provision or
            regulatory objective as well as the individual and aggregate
            economic effects of those actions; and
                ``(v) the proposed effective date of the rule.
        ``(B) On the date of the submission of the report under
    subparagraph (A), the Food and Drug Administration shall submit to the
    Comptroller General and make available to each House of Congress--
                ``(i) a complete copy of the cost-benefit analysis of the
            rule, if any, including an analysis of any jobs added or lost,
            differentiating between public and private sector jobs;
                ``(ii) the Food and Drug Administration's actions pursuant
            to sections 603, 604, 605, 607, and 609 of this title;
                ``(iii) the Food and Drug Administration's actions pursuant
            to sections 202, 203, 204, and 205 of the Unfunded Mandates
            Reform Act of 1995; and
                ``(iv) any other relevant information or requirements under
            any other Act and any relevant Executive orders.
        ``(C) Upon receipt of a report submitted under subparagraph (A),
    each House shall provide copies of the report to the chairman and
    ranking member of each standing committee with jurisdiction under the
    rules of the House of Representatives or the Senate to report a bill to
    amend the provision of law under which the rule is issued.
        ``(2)(A) The Comptroller General shall provide a report on each
    major rule to the committees of jurisdiction by the end of 15 calendar
    days after the submission or publication date. The report of the
    Comptroller General shall include an assessment of the Food and Drug
    Administration's compliance with procedural steps required by paragraph
    (1)(B) and an assessment of whether the major rule imposes any new
    limits or mandates on private-sector activity.
        ``(B) The Food and Drug Administration shall cooperate with the
    Comptroller General by providing information relevant to the
    Comptroller General's report under subparagraph (A).
        ``(3) A major rule relating to a report submitted under paragraph
    (1) shall take effect upon enactment of a joint resolution of approval
    described in section 812 or as provided for in the rule following
    enactment of a joint resolution of approval described in section 812,
    whichever is later.
        ``(4) A nonmajor rule shall take effect as provided by section 813
    after submission to Congress under paragraph (1).
        ``(5) If a joint resolution of approval relating to a major rule is
    not enacted within the period provided in subsection (b)(2), then a
    joint resolution of approval relating to the same rule may not be
    considered under this chapter in the same Congress by either the House
    of Representatives or the Senate.
        ``(b)(1) A major rule shall not take effect unless the Congress
    enacts a joint resolution of approval described under section 812.
        ``(2) If a joint resolution described in subsection (a) is not
    enacted into law by the end of 70 session days or legislative days, as
    applicable, beginning on the date on which the report referred to in
    section 811(a)(1)(A) is received by Congress (excluding days either
    House of Congress is adjourned for more than 3 days during a session of
    Congress), then the rule described in that resolution shall be deemed
    not to be approved and such rule shall not take effect.
        ``(c)(1) Notwithstanding any other provision of this section
    (except subject to paragraph (3)), a major rule may take effect for one
    90-calendar-day period if the President makes a determination under
    paragraph (2) and submits written notice of such determination to the
    Congress.
        ``(2) Paragraph (1) applies to a determination made by the
    President by Executive order that the major rule should take effect
    because such rule is--
                ``(A) necessary because of an imminent threat to health or
            safety or other emergency;
                ``(B) necessary for the enforcement of criminal laws;
                ``(C) necessary for national security; or
                ``(D) issued pursuant to any statute implementing an
            international trade agreement.
        ``(3) An exercise by the President of the authority under this
    subsection shall have no effect on the procedures under section 812.
        ``(d)(1) In addition to the opportunity for review otherwise
    provided under this chapter, in the case of any rule for which a report
    was submitted in accordance with subsection (a)(1)(A) during the period
    beginning on the date occurring--
                ``(A) in the case of the Senate, 60 session days; or
                ``(B) in the case of the House of Representatives, 60
            legislative days,
    before the date the Congress is scheduled to adjourn a session of
    Congress through the date on which the same or succeeding Congress
    first convenes its next session, sections 812 and 813 shall apply to
    such rule in the succeeding session of Congress.
        ``(2)(A) In applying sections 812 and 813 for purposes of such
    additional review, a rule described under paragraph (1) shall be
    treated as though--
                ``(i) such rule were published in the Federal Register on--
                        ``(I) in the case of the Senate, the 15th session
                    day; or
                        ``(II) in the case of the House of Representatives,
                    the 15th legislative day,
            after the succeeding session of Congress first convenes; and
                ``(ii) a report on such rule were submitted to Congress
            under subsection (a)(1) on such date.
        ``(B) Nothing in this paragraph shall be construed to affect the
    requirement under subsection (a)(1) that a report shall be submitted to
    Congress before a rule can take effect.
        ``(3) A rule described under paragraph (1) shall take effect as
    otherwise provided by law (including other subsections of this
    section).
    ``Sec. 812. Congressional approval procedure for major rules
        ``(a)(1) For purposes of this section, the term `joint resolution'
    means only a joint resolution addressing a report classifying a rule as
    major pursuant to section 811(a)(1)(A)(iii) that--
                ``(A) bears no preamble;
                ``(B) bears the following title (with blanks filled as
            appropriate): `Approving the rule submitted by ___ relating to
            ___.';
                ``(C) includes after its resolving clause only the
            following (with blanks filled as appropriate): `That Congress
            approves the rule submitted by ___ relating to ___.'; and
                ``(D) is introduced pursuant to paragraph (2).
        ``(2) After a House of Congress receives a report classifying a
    rule as major pursuant to section 811(a)(1)(A)(iii), the majority
    leader of that House (or his or her respective designee) shall
    introduce (by request, if appropriate) a joint resolution described in
    paragraph (1)--
                ``(A) in the case of the House of Representatives, within 3
            legislative days; and
                ``(B) in the case of the Senate, within 3 session days.
        ``(3) A joint resolution described in paragraph (1) shall not be
    subject to amendment at any stage of proceeding.
        ``(b) A joint resolution described in subsection (a) shall be
    referred in each House of Congress to the committees having
    jurisdiction over the provision of law under which the rule is issued.
        ``(c) In the Senate, if the committee or committees to which a
    joint resolution described in subsection (a) has been referred have not
    reported it at the end of 15 session days after its introduction, such
    committee or committees shall be automatically discharged from further
    consideration of the resolution and it shall be placed on the calendar.
    A vote on final passage of the resolution shall be taken on or before
    the close of the 15th session day after the resolution is reported by
    the committee or committees to which it was referred, or after such
    committee or committees have been discharged from further consideration
    of the resolution.
        ``(d)(1) In the Senate, when the committee or committees to which a
    joint resolution is referred have reported, or when a committee or
    committees are discharged (under subsection (c)) from further
    consideration of a joint resolution described in subsection (a), it is
    at any time thereafter in order (even though a previous motion to the
    same effect has been disagreed to) for a motion to proceed to the
    consideration of the joint resolution, and all points of order against
    the joint resolution (and against consideration of the joint
    resolution) are waived. The motion is not subject to amendment, or to a
    motion to postpone, or to a motion to proceed to the consideration of
    other business. A motion to reconsider the vote by which the motion is
    agreed to or disagreed to shall not be in order. If a motion to proceed
    to the consideration of the joint resolution is agreed to, the joint
    resolution shall remain the unfinished business of the Senate until
    disposed of.
        ``(2) In the Senate, debate on the joint resolution, and on all
    debatable motions and appeals in connection therewith, shall be limited
    to not more than 2 hours, which shall be divided equally between those
    favoring and those opposing the joint resolution. A motion to further
    limit debate is in order and not debatable. An amendment to, or a
    motion to postpone, or a motion to proceed to the consideration of
    other business, or a motion to recommit the joint resolution is not in
    order.
        ``(3) In the Senate, immediately following the conclusion of the
    debate on a joint resolution described in subsection (a), and a single
    quorum call at the conclusion of the debate if requested in accordance
    with the rules of the Senate, the vote on final passage of the joint
    resolution shall occur.
        ``(4) Appeals from the decisions of the Chair relating to the
    application of the rules of the Senate to the procedure relating to a
    joint resolution described in subsection (a) shall be decided without
    debate.
        ``(e) In the House of Representatives, if any committee to which a
    joint resolution described in subsection (a) has been referred has not
    reported it to the House at the end of 15 legislative days after its
    introduction, such committee shall be discharged from further
    consideration of the joint resolution, and it shall be placed on the
    appropriate calendar. On the second and fourth Thursdays of each month
    it shall be in order at any time for the Speaker to recognize a Member
    who favors passage of a joint resolution that has appeared on the
    calendar for at least 5 legislative days to call up that joint
    resolution for immediate consideration in the House without
    intervention of any point of order. When so called up a joint
    resolution shall be considered as read and shall be debatable for 1
    hour equally divided and controlled by the proponent and an opponent,
    and the previous question shall be considered as ordered to its passage
    without intervening motion. It shall not be in order to reconsider the
    vote on passage. If a vote on final passage of the joint resolution has
    not been taken by the third Thursday on which the Speaker may recognize
    a Member under this subsection, such vote shall be taken on that day.
        ``(f)(1) If, before passing a joint resolution described in
    subsection (a), one House receives from the other a joint resolution
    having the same text, then--
                ``(A) the joint resolution of the other House shall not be
            referred to a committee; and
                ``(B) the procedure in the receiving House shall be the
            same as if no joint resolution had been received from the other
            House until the vote on passage, when the joint resolution
            received from the other House shall supplant the joint
            resolution of the receiving House.
        ``(2) This subsection shall not apply to the House of
    Representatives if the joint resolution received from the Senate is a
    revenue measure.
        ``(g) If either House has not taken a vote on final passage of the
    joint resolution by the last day of the period described in section
    811(b)(2), then such vote shall be taken on that day.
        ``(h) This section and section 813 are enacted by Congress--
                ``(1) as an exercise of the rulemaking power of the Senate
            and House of Representatives, respectively, and as such is
            deemed to be part of the rules of each House, respectively, but
            applicable only with respect to the procedure to be followed in
            that House in the case of a joint resolution described in
            subsection (a) and superseding other rules only where
            explicitly so; and
                ``(2) with full recognition of the Constitutional right of
            either House to change the rules (so far as they relate to the
            procedure of that House) at any time, in the same manner and to
            the same extent as in the case of any other rule of that House.
    ``Sec. 813. Congressional disapproval procedure for nonmajor rules
        ``(a) For purposes of this section, the term `joint resolution'
    means only a joint resolution introduced in the period beginning on the
    date on which the report referred to in section 811(a)(1)(A) is
    received by Congress and ending 60 days thereafter (excluding days
    either House of Congress is adjourned for more than 3 days during a
    session of Congress), the matter after the resolving clause of which is
    as follows: `That Congress disapproves the nonmajor rule submitted by
    the ___ relating to ___, and such rule shall have no force or effect.'
    (The blank spaces being appropriately filled in).
        ``(b) A joint resolution described in subsection (a) shall be
    referred to the committees in each House of Congress with jurisdiction.
        ``(c) In the Senate, if the committee to which is referred a joint
    resolution described in subsection (a) has not reported such joint
    resolution (or an identical joint resolution) at the end of 15 session
    days after the date of introduction of the joint resolution, such
    committee may be discharged from further consideration of such joint
    resolution upon a petition supported in writing by 30 Members of the
    Senate, and such joint resolution shall be placed on the calendar.
        ``(d)(1) In the Senate, when the committee to which a joint
    resolution is referred has reported, or when a committee is discharged
    (under subsection (c)) from further consideration of a joint resolution
    described in subsection (a), it is at any time thereafter in order
    (even though a previous motion to the same effect has been disagreed
    to) for a motion to proceed to the consideration of the joint
    resolution, and all points of order against the joint resolution (and
    against consideration of the joint resolution) are waived. The motion
    is not subject to amendment, or to a motion to postpone, or to a motion
    to proceed to the consideration of other business. A motion to
    reconsider the vote by which the motion is agreed to or disagreed to
    shall not be in order. If a motion to proceed to the consideration of
    the joint resolution is agreed to, the joint resolution shall remain
    the unfinished business of the Senate until disposed of.
        ``(2) In the Senate, debate on the joint resolution, and on all
    debatable motions and appeals in connection therewith, shall be limited
    to not more than 10 hours, which shall be divided equally between those
    favoring and those opposing the joint resolution. A motion to further
    limit debate is in order and not debatable. An amendment to, or a
    motion to postpone, or a motion to proceed to the consideration of
    other business, or a motion to recommit the joint resolution is not in
    order.
        ``(3) In the Senate, immediately following the conclusion of the
    debate on a joint resolution described in subsection (a), and a single
    quorum call at the conclusion of the debate if requested in accordance
    with the rules of the Senate, the vote on final passage of the joint
    resolution shall occur.
        ``(4) Appeals from the decisions of the Chair relating to the
    application of the rules of the Senate to the procedure relating to a
    joint resolution described in subsection (a) shall be decided without
    debate.
        ``(e) In the Senate, the procedure specified in subsection (c) or
    (d) shall not apply to the consideration of a joint resolution
    respecting a nonmajor rule--
                ``(1) after the expiration of the 60 session days beginning
            with the applicable submission or publication date; or
                ``(2) if the report under section 811(a)(1)(A) was
            submitted during the period referred to in section 811(d)(1),
            after the expiration of the 60 session days beginning on the
            15th session day after the succeeding session of Congress first
            convenes.
        ``(f) If, before the passage by one House of a joint resolution of
    that House described in subsection (a), that House receives from the
    other House a joint resolution described in subsection (a), then the
    following procedures shall apply:
                ``(1) The joint resolution of the other House shall not be
            referred to a committee.
                ``(2) With respect to a joint resolution described in
            subsection (a) of the House receiving the joint resolution--
                        ``(A) the procedure in that House shall be the same
                    as if no joint resolution had been received from the
                    other House; but
                        ``(B) the vote on final passage shall be on the
                    joint resolution of the other House.
    ``Sec. 814. Definitions
        ``For purposes of this chapter:
                ``(1) The term `major rule' means any rule of the Food and
            Drug Administration, including an interim final rule, that the
            Administrator of the Office of Information and Regulatory
            Affairs of the Office of Management and Budget finds has
            resulted in or is likely to result in--
                        ``(A) an annual cost on the economy of $100,000,000
                    or more, adjusted annually for inflation;
                        ``(B) a major increase in costs or prices for
                    consumers, individual industries, Federal, State, or
                    local government agencies, or geographic regions; or
                        ``(C) significant adverse effects on competition,
                    employment, investment, productivity, innovation, or on
                    the ability of United States-based enterprises to
                    compete with foreign-based enterprises in domestic and
                    export markets.
                ``(2) The term `nonmajor rule' means any rule of the Food
            and Drug Administration that is not a major rule.
                ``(3) The term `rule' has the meaning given such term in
            section 551, except that such term does not include--
                        ``(A) any rule of particular applicability;
                        ``(B) any rule relating to agency management or
                    personnel; or
                        ``(C) any rule of agency organization, procedure,
                    or practice that does not substantially affect the
                    rights or obligations of non-agency parties.
                ``(4) The term `submission date or publication date',
            except as otherwise provided in this chapter, means--
                        ``(A) in the case of a major rule, the date on
                    which the Congress receives the report submitted under
                    section 811(a)(1); and
                        ``(B) in the case of a nonmajor rule, the later
                    of--
                                ``(i) the date on which the Congress
                            receives the report submitted under section
                            811(a)(1); and
                                ``(ii) the date on which the nonmajor rule
                            is published in the Federal Register, if so
                            published.
    ``Sec. 815. Judicial review
        ``(a) No determination, finding, action, or omission under this
    chapter shall be subject to judicial review.
        ``(b) Notwithstanding subsection (a), a court may determine whether
    the Food and Drug Administration has completed the necessary
    requirements under this chapter for a rule to take effect.
        ``(c) The enactment of a joint resolution of approval under section
    812 shall not be interpreted to serve as a grant or modification of
    statutory authority by Congress for the promulgation of a rule, shall
    not extinguish or affect any claim, whether substantive or procedural,
    against any alleged defect in a rule, and shall not form part of the
    record before the court in any judicial proceeding concerning a rule
    except for purposes of determining whether or not the rule is in
    effect.
    ``Sec. 816. Exemption for monetary policy
        ``Nothing in this chapter shall apply to rules that concern
    monetary policy proposed or implemented by the Board of Governors of
    the Federal Reserve System or the Federal Open Market Committee.
    ``Sec. 817. Effective date of certain rules
        ``Notwithstanding section 811, any rule other than a major rule
    which the Food and Drug Administration for good cause finds (and
    incorporates the finding and a brief statement of reasons therefore in
    the rule issued) that notice and public procedure thereon are
    impracticable, unnecessary, or contrary to the public interest, shall
    take effect at such time as the Food and Drug Administration
    determines.
    ``Sec. 818. Regulatory cut-go requirement
        ``In making any new rule, the Food and Drug Administration shall
    identify a rule or rules that may be amended or repealed to completely
    offset any annual costs of the new rule to the United States economy.
    Before the new rule may take effect, the Food and Drug Administration
    shall make each such repeal or amendment. In making such an amendment
    or repeal, the Food and Drug Administration shall comply with the
    requirements of subchapter II of chapter 5, but the Food and Drug
    Administration may consolidate proceedings under subchapter II (of
    chapter 5) with proceedings on the new rule.
    ``Sec. 819. Review of rules currently in effect
        ``(a) Annual Review.--Beginning on the date that is 6 months after
    the date of enactment of this section and annually thereafter for the 9
    years following, the Food and Drug Administration shall designate not
    less than 10 percent of eligible rules made by the Food and Drug
    Administration for review, and shall submit a report including each
    such eligible rule in the same manner as a report under section
    811(a)(1). Section 811, section 812, and section 813 shall apply to
    each such rule, subject to subsection (c) of this section. No eligible
    rule previously designated may be designated again.
        ``(b) Sunset for Eligible Rules Not Extended.--Beginning after the
    date that is 10 years after the date of enactment of this section, if
    Congress has not enacted a joint resolution of approval for that
    eligible rule, that eligible rule shall not continue in effect.
        ``(c) Consolidation; Severability.--In applying sections 811, 812,
    and 813 to eligible rules under this section, the following shall
    apply:
                ``(1) The words `take effect' shall be read as `continue in
            effect'.
                ``(2) Except as provided in paragraph (3), a single joint
            resolution of approval shall apply to all eligible rules in a
            report designated for a year, and the matter after the
            resolving clause of that joint resolution is as follows: `That
            Congress approves the rules submitted by the __ for the year
            __.' (The blank spaces being appropriately filled in).
                ``(3) It shall be in order to consider any amendment that
            provides for specific conditions on which the approval of a
            particular eligible rule included in the joint resolution is
            contingent.
                ``(4) A member of either House may move that a separate
            joint resolution be required for a specified rule.
        ``(d) Definition.--In this section, the term `eligible rule' means
    a rule that is in effect as of the date of enactment of this
    section.''.
        (b) Budgetary Effects of Rules Subject to Section 922 of Title 5,
    United States Code.--Section 257(b)(2) of the Balanced Budget and
    Emergency Deficit Control Act of 1985 is amended by adding at the end
    the following new subparagraph:
                        ``(E) Budgetary effects of rules subject to section
                    922 of title 5, united states code.--Any rules subject
                    to the congressional approval procedure set forth in
                    section 922 of chapter 8 of title 5, United States
                    Code, affecting budget authority, outlays, or receipts
                    shall be assumed to be effective unless it is not
                    approved in accordance with such section.''.
        (c) Government Accountability Office Study of Rules.--
                (1) In general.--The Comptroller General of the United
            States shall conduct a study to determine, as of the date of
            the enactment of this Act--
                        (A) how many rules (as such term is defined in
                    section 814 of title 5, United States Code) of the Food
                    and Drug Administration were in effect;
                        (B) how many major rules (as such term is defined
                    in section 814 of title 5, United States Code) of the
                    Food and Drug Administration were in effect; and
                        (C) the total estimated economic cost imposed by
                    all such rules.
                (2) Report.--Not later than 1 year after the date of the
            enactment of this Act, the Comptroller General of the United
            States shall submit a report to Congress that contains the
            findings of the study conducted under paragraph (1).
        (d) Effective Date.--Subsections (a) and (b), and the amendments
    made by such sections, shall take effect beginning on the date that is
    1 year after the date of enactment of this Act.

    SEC. 355. GOVERNMENT ACCOUNTABILITY OFFICE STUDY OF RULES.

        (a) In General.--The Comptroller General of the United States shall
    conduct a study to determine, as of the date of the enactment of this
    Act--
                (1) how many rules (as such term is defined in section 804
            of title 5, United States Code) were in effect;
                (2) how many major rules (as such term is defined in
            section 804 of title 5, United States Code) were in effect; and
                (3) the total estimated economic cost imposed by all such
            rules.
        (b) Report.--Not later than 1 year after the date of the enactment
    of this Act, the Comptroller General of the United States shall submit
    a report to Congress that contains the findings of the study conducted
    under subsection (a).

    Subtitle D--Prescription Drug and Pharmacy Benefit Manager Transparency

    SEC. 361. PATENT DISCLOSURE REQUIREMENTS.

        (a) In General.--Section 351 of the Public Health Service Act (42
    U.S.C. 262) is amended by adding at the end the following:
        ``(o) Additional Requirements With Respect to Patents.--
                ``(1) Approved application holder listing requirements.--
                        ``(A) In general.--Beginning on the date of
                    enactment of this subsection, within 30 days of
                    approval of an application under subsection (a) or (k),
                    the holder of such approved application shall submit to
                    the Secretary a list of each patent required to be
                    disclosed (as described in paragraph (3)).
                        ``(B) Previously approved or licensed biological
                    products.--
                                ``(i) Products approved under section 351
                            of the phsa.--Not later than 30 days after the
                            date of enactment of the Fair Care Act of 2024,
                            the holder of a biological product license that
                            was approved under subsection (a) or (k) before
                            the date of enactment of such Act shall submit
                            to the Secretary a list of each patent required
                            to be disclosed (as described in paragraph
                            (3)).
                                ``(ii) Products approved under section 505
                            of the ffdca.--Not later than 30 days after
                            March 23, 2021, the holder of an approved
                            application for a biological product under
                            section 505 of the Federal Food, Drug, and
                            Cosmetic Act that is deemed to be a license for
                            the biological product under this section on
                            March 23, 2021, shall submit a list of each
                            patent required to be disclosed (as described
                            in paragraph (3)).
                        ``(C) Updates.--The holder of a biological product
                    license approved under subsection (a) or (k) shall
                    submit to the Secretary a list that includes--
                                ``(i) any patent first required to be
                            disclosed (as described in paragraph (3)) after
                            the submission under subparagraph (A) or (B),
                            as applicable, within 30 days of the earlier
                            of--
                                        ``(I) the date of issuance of such
                                    patent by the United States Patent and
                                    Trademark Office; or
                                        ``(II) the date of approval of a
                                    supplemental application for the
                                    biological product; and
                                ``(ii) any patent, or any claim with
                            respect to a patent, included on the list
                            pursuant to this paragraph with respect to the
                            biological product subsequently determined to
                            be invalid or unenforceable, within 30 days of
                            a determination of patent invalidity.
                ``(2) Publication of information.--
                        ``(A) In general.--Within 1 year of the date of
                    enactment of the Fair Care Act of 2024, the Secretary
                    shall publish and make available to the public a
                    single, easily searchable, list that includes--
                                ``(i) the official and proprietary name of
                            each biological product licensed under
                            subsection (a) or (k), and of each biological
                            product application approved under section 505
                            of the Federal Food, Drug, and Cosmetic Act and
                            deemed to be a license for the biological
                            product under this section on March 23, 2021;
                                ``(ii) with respect to each biological
                            product described in clause (i), each patent
                            submitted in accordance with paragraph (1);
                                ``(iii) the date of licensure and
                            application number for each such biological
                            product;
                                ``(iv) the marketing status, dosage form,
                            route of administration, strength, and, if
                            applicable, reference product, for each such
                            biological product;
                                ``(v) the licensure status for each such
                            biological product, including whether the
                            license at the time of listing is approved,
                            withdrawn, or revoked;
                                ``(vi) any period of any exclusivity under
                            subsection (k)(7)(A) or subsection (k)(7)(B) of
                            this section or section 527 of the Federal
                            Food, Drug, and Cosmetic Act, and any extension
                            of such period in accordance with subsection
                            (m) of this section with respect to each such
                            biological product, and the date on which such
                            exclusivity expires;
                                ``(vii) information regarding any
                            determination related to biosimilarity or
                            interchangeability for each such biological
                            product; and
                                ``(viii) information regarding approved
                            indications for each such biological product,
                            in such manner as the Secretary determines
                            appropriate.
                        ``(B) Updates.--Every 30 days after the publication
                    of the first list under subparagraph (A), the Secretary
                    shall revise the list to include--
                                ``(i)(I) each biological product licensed
                            under subsection (a) or (k) during the 30-day
                            period; and
                                ``(II) with respect to each biological
                            product described in subclause (I), the
                            information described in clauses (i) through
                            (viii) of subparagraph (A); and
                                ``(ii) any updates to information
                            previously published in accordance with
                            subparagraph (A).
                ``(3) Patents required to be disclosed.--In this section, a
            `patent required to be disclosed' is any patent for which the
            holder of a biological product license approved under
            subsection (a) or (k), or a biological product application
            approved under section 505 of the Federal Food, Drug, and
            Cosmetic Act and deemed to be a license for a biological
            product under this section on March 23, 2021, believes a claim
            of patent infringement could reasonably be asserted by the
            holder, or by a patent owner that has granted an exclusive
            license to the holder with respect to the biological product
            that is the subject of such license, if a person not licensed
            by the holder engaged in the making, using, offering to sell,
            selling, or importing into the United States of the biological
            product that is the subject of such license.''.
        (b) Disclosure of Patents.--Section 351(l)(3)(A)(i) of the Public
    Health Service Act (42 U.S.C. 262(l)(3)(A)(i)) is amended by inserting
    ``included in the list provided by the reference product sponsor under
    subsection (o)(1)'' after ``a list of patents''.
        (c) Restriction on Claims of Patent Infringement.--Section 271(e)
    of title 35, United States Code, is amended by adding at the end the
    following:
                ``(7) The owner of a patent that should have been included
            in the list described in section 351(o)(1) of the Public Health
            Service Act (42 U.S.C. 262(o)(1)), including any updates
            required under subparagraph (C) of that section, but was not
            timely included in such list, may not bring an action under
            this section for infringement of the patent.''.
        (d) Regulations.--The Secretary of Health and Human Services may
    promulgate regulations to carry out subsection (o) of section 351 of
    the Public Health Service Act (42 U.S.C. 262), as added by subsection
    (a).
        (e) Rule of Construction.--Nothing in this Act, including an
    amendment made by this Act, shall be construed to require or allow the
    Secretary of Health and Human Services to delay the licensing of a
    biological product under section 351 of the Public Health Service Act
    (42 U.S.C. 262).

    SEC. 362. REQUIREMENTS WITH RESPECT TO PRESCRIPTION DRUG BENEFITS.

        (a) In General.--Subpart II of part A of title XXVII of the Public
    Health Service Act (42 U.S.C. 300gg-11 et seq.) is amended by adding at
    the end the following:

    ``SEC. 2729A. REQUIREMENTS WITH RESPECT TO PRESCRIPTION DRUG BENEFITS.

        ``A group health plan or a health insurance issuer offering group
    or individual health insurance coverage shall not, and shall ensure
    that any entity that provides pharmacy benefits management services
    under a contract with any such health plan or health insurance coverage
    does not, receive from a drug manufacturer a reduction in price or
    other remuneration with respect to any prescription drug received by an
    enrollee in the plan or coverage and covered by the plan or coverage,
    unless--
                ``(1) any such reduction in price is reflected at the point
            of sale to the enrollee; and
                ``(2) any such other remuneration is a flat fee-based
            service fee that a manufacturer of prescription drugs pays to a
            pharmacy benefit manager for services rendered to the
            manufacturer that relate to arrangements by the pharmacy
            benefit manager to provide pharmacy benefit management services
            to a health plan or health insurance issuer, if certain
            conditions established by the Secretary are met, including
            requirements that the fees are transparent to the health plan
            or health insurance issuer.''.
        (b) Effective Date.--Section 2729A of the Public Health Service
    Act, as added by subsection (a), shall take effect on January 1, 2025.

    SEC. 363. PBM TRANSPARENCY AND ELIMINATION OF DIR FEES.

        (a) Prohibiting Medicare PDP Sponsors and MA-PD Organizations From
    Retroactively Reducing Payment on Clean Claims Submitted by
    Pharmacies.--
                (1) In general.--Section 1860D-12(b)(4)(A) of the Social
            Security Act (42 U.S.C. 1395w-112(b)(4)(A)) is amended by
            adding at the end the following new clause:
                                ``(iv) Prohibiting retroactive reductions
                            in payments on clean claims.--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
                            after the date of receipt of a clean claim
                            submitted by a pharmacy, the PDP sponsor (or an
                            agent of the PDP sponsor) may not retroactively
                            reduce payment on such claim directly or
                            indirectly through aggregated effective rate or
                            otherwise except in the case such claim is
                            found to not be a clean claim (such as in the
                            case of a claim lacking required substantiating
                            documentation) during the course of a routine
                            audit as permitted pursuant to written
                            agreement between the PDP sponsor (or such an
                            agent) and such pharmacy. The previous sentence
                            shall not prohibit any retroactive increase in
                            payment to a pharmacy pursuant to a written
                            agreement between a PDP sponsor (or an agent of
                            such sponsor) and such pharmacy.''.
                (2) Effective date.--The amendment made by subsection (a)
            shall apply with respect to contracts entered into on or after
            January 1, 2025.
        (b) Elimination of DIR Fees.--
                (1) Pharmacy benefits manager standards under the medicare
            program for prescription drug plans and ma-pd plans.--
                        (A) In general.--Section 1860D-12(b) of the Social
                    Security Act (42 U.S.C. 1395w-112(b)) is amended by
                    adding at the end the following new paragraph:
                ``(7) Pharmacy benefits manager transparency
            requirements.--Each contract entered into with a PDP sponsor
            under this part with respect to a prescription drug plan
            offered by such sponsor or with an MA organization offering an
            MA-PD plan under part C shall provide that the sponsor or
            organization, respectively, may not enter into a contract with
            any pharmacy benefits manager (referred to in this paragraph as
            a `PBM') to manage the prescription drug coverage provided
            under such plan, or to control the costs of the prescription
            drug coverage under such plan, unless the PBM adheres to the
            following criteria when handling personally identifiable
            utilization and claims data or other sensitive patient data:
                        ``(A) The PBM may not transmit any personally
                    identifiable utilization, protected health information,
                    or claims data, with respect to a plan enrollee, to a
                    pharmacy owned by a PBM if the plan enrollee has not
                    voluntarily elected in writing or via secure electronic
                    means to fill that particular prescription at the PBM-
                    owned pharmacy.
                        ``(B) The PBM may not require that a plan enrollee
                    use a retail pharmacy, mail order pharmacy, specialty
                    pharmacy, or other pharmacy entity providing pharmacy
                    services in which the PBM has an ownership interest or
                    that has an ownership interest in the PBM, or provide
                    an incentive to a plan enrollee to encourage the
                    enrollee to use a retail pharmacy, mail order pharmacy,
                    specialty pharmacy, or other pharmacy entity providing
                    pharmacy services in which the PBM has an ownership
                    interest or that has an ownership interest in the PBM,
                    if the incentive is applicable only to such
                    pharmacies.''.
                        (B) Regular update of prescription drug pricing
                    standard.--Paragraph (6) of section 1860D-12(b) of the
                    Social Security Act (42 U.S.C. 1395w-112(b)) is amended
                    to read as follows:
                ``(6) Regular update of prescription drug pricing
            standard.--
                        ``(A) In general.--If the PDP sponsor of a
                    prescription drug plan (or MA organization offering an
                    MA-PD plan) uses a standard for reimbursement (as
                    described in subparagraph (B)) of pharmacies based on
                    the cost of a drug, each contract entered into with
                    such sponsor under this part (or organization under
                    part C) with respect to the plan shall provide that the
                    sponsor (or organization) shall--
                                ``(i) update such standard not less
                            frequently than once every 7 days, beginning
                            with an initial update on January 1 of each
                            year, to accurately reflect the market price of
                            acquiring the drug;
                                ``(ii) disclose to applicable pharmacies
                            and the contracting entities of such pharmacies
                            the sources used for making any such update
                            immediately without requirement of request;
                                ``(iii) if the source for such a standard
                            for reimbursement is not publicly available,
                            disclose to the applicable pharmacies and the
                            respective contracting entities of such
                            pharmacies all individual drug prices to be so
                            updated in advance of the use of such prices
                            for the reimbursement of claims;
                                ``(iv) establish a process to appeal,
                            investigate, and resolve disputes regarding
                            individual drug prices that are less than the
                            pharmacy acquisition price for such drug, which
                            must be adjudicated within 7 days of the
                            pharmacy filing its appeal; and
                                ``(v) provide all such pricing data in an
                            .xml spreadsheet format or a comparable easily
                            accessible and complete spreadsheet format.
                        ``(B) Prescription drug pricing standard defined.--
                    For purposes of subparagraph (A), a standard for
                    reimbursement of a pharmacy is any methodology or
                    formula for varying the pricing of a drug or drugs
                    during the term of the pharmacy reimbursement contract
                    that is based on the cost of the drug involved,
                    including drug pricing references and amounts that are
                    based upon average wholesale price, wholesale average
                    cost, average manufacturer price, average sales price,
                    maximum allowable cost (MAC), or other costs, whether
                    publicly available or not.''.
                        (C) Effective date.--The amendments made by this
                    section shall apply to plan years beginning on or after
                    January 1, 2025.
                (2) Regular update of prescription drug pricing standard
            under tricare retail pharmacy program.--Section 1074g(d) of
            title 10, United States Code, is amended by adding at the end
            the following new paragraph:
        ``(3) To the extent practicable, with respect to the TRICARE retail
    pharmacy program described in subsection (a)(2)(E)(ii), the Secretary
    shall ensure that a contract entered into with a TRICARE managed care
    support contractor includes requirements described in section 1860D-
    12(b)(6) of the Social Security Act (42 U.S.C. 1395w-112(b)(6)) to
    ensure the provision of information regarding the pricing standard for
    prescription drugs.''.
                (3) Prescription drug transparency in the federal employees
            health benefits program.--
                        (A) In general.--Section 8902 of title 5, United
                    States Code, is amended by adding at the end the
                    following new subsections:
        ``(p) A contract may not be made or a plan approved under this
    chapter under which a carrier has an agreement with a pharmacy benefits
    manager (in this subsection referred to as a `PBM') to manage
    prescription drug coverage or to control the costs of the prescription
    drug coverage unless the carrier and PBM adhere to the following
    criteria:
                ``(1) The PBM may not transmit any personally identifiable
            utilization, protected health information, or claims data with
            respect to an individual enrolled under such contract or plan
            to a pharmacy owned by the PBM if the individual has not
            voluntarily elected in writing or via secure electronic means
            to fill that particular prescription at such a pharmacy.
                ``(2) The PBM may not require that an individual enrolled
            under such contract or plan use a retail pharmacy, mail order
            pharmacy, specialty pharmacy, or other pharmacy entity
            providing pharmacy services in which the PBM has an ownership
            interest or that has an ownership interest in the PBM or
            provide an incentive to a plan enrollee to encourage the
            enrollee to use a retail pharmacy, mail order pharmacy,
            specialty pharmacy, or other pharmacy entity providing pharmacy
            services in which the PBM has an ownership interest or that has
            an ownership interest in the PBM, if the incentive is
            applicable only to such pharmacies.
        ``(q)(1) If a contract made or plan approved under this chapter
    provides for a standard for reimbursement (as described in paragraph
    (2)) with respect to a prescription drug plan, such contract or plan
    shall provide that the applicable carrier--
                ``(A) update such standard not less frequently than once
            every 7 days, beginning with an initial update on January 1 of
            each year, to accurately reflect the market price of acquiring
            the drug;
                ``(B) disclose to applicable pharmacies and the contracting
            entities of such pharmacies the sources used for making any
            such update immediately without requirement of request;
                ``(C) if the source for such a standard for reimbursement
            is not publicly available, disclose to the applicable
            pharmacies and contracting entities of such pharmacies all
            individual drug prices to be so updated in advance of the use
            of such prices for the reimbursement of claims;
                ``(D) establish a process to appeal, investigate, and
            resolve disputes regarding individual drug prices that are less
            than the pharmacy acquisition price for such drug, which must
            be adjudicated within 7 days of the pharmacy filing its appeal;
            and
                ``(E) provide all such pricing data in an .xml spreadsheet
            format or a comparable easily accessible and complete
            spreadsheet format.
        ``(2) For purposes of paragraph (1), a standard for reimbursement
    of a pharmacy is any methodology or formula for varying the pricing of
    a drug or drugs during the term of the pharmacy reimbursement contract
    that is based on the cost of the drug involved, including drug pricing
    references and amounts that are based upon average wholesale price,
    wholesale average cost, average manufacturer price, average sales
    price, maximum allowable cost, or other costs, whether publicly
    available or not.''.
                        (B) Application.--The amendment made by
                    subparagraph (A) shall apply to any contract entered
                    into under section 8902 of title 5, United States Code,
                    on or after the date of enactment of this section.

    SEC. 364. HEALTH PLAN OVERSIGHT OF PHARMACY BENEFIT MANAGER SERVICES.

        Subpart II of part A of title XXVII of the Public Health Service
    Act (42 U.S.C. 300gg-11 et seq.), as amended by the preceding sections,
    is further amended by adding at the end the following:

    ``SEC. 2729E. HEALTH PLAN OVERSIGHT OF PHARMACY BENEFIT MANAGER
                  SERVICES.

        ``(a) In General.--A group health plan or health insurance issuer
    offering group health insurance coverage or an entity or subsidiary
    providing pharmacy benefits management services shall not enter into a
    contract with a drug manufacturer, distributor, wholesaler,
    subcontractor, rebate aggregator, or any associated third party that
    limits the disclosure of information to plan sponsors in such a manner
    that prevents the plan or coverage, or an entity or subsidiary
    providing pharmacy benefits management services on behalf of a plan or
    coverage from making the reports described in subsection (b).
        ``(b) Reports to Group Plan Sponsors.--
                ``(1) In general.--Beginning with the first plan year that
            begins after the date of enactment of the Fair Care Act of
            2024, not less frequently than once every 6 months, a health
            insurance issuer offering group health insurance coverage or an
            entity providing pharmacy benefits management services on
            behalf of a group health plan shall submit to the plan sponsor
            (as defined in section 3(16)(B) of the Employee Retirement
            Income Security Act of 1974) of such group health plan or
            health insurance coverage a report in accordance with this
            subsection and make such report available to the plan sponsor
            in a machine-readable format. Each such report shall include,
            with respect to the applicable group health plan or health
            insurance coverage--
                        ``(A) information collected from drug manufacturers
                    by such issuer or entity on the total amount of
                    copayment assistance dollars paid, or copayment cards
                    applied, that were funded by the drug manufacturer with
                    respect to the enrollees in such plan or coverage;
                        ``(B) a list of each covered drug dispensed during
                    the reporting period, including, with respect to each
                    such drug during the reporting period--
                                ``(i) the brand name, chemical entity, and
                            National Drug Code;
                                ``(ii) the number of enrollees for whom the
                            drug was filled during the plan year, the total
                            number of prescription fills for the drug
                            (including original prescriptions and refills),
                            and the total number of dosage units of the
                            drug dispensed across the plan year, including
                            whether the dispensing channel was by retail,
                            mail order, or specialty pharmacy;
                                ``(iii) the wholesale acquisition cost,
                            listed as cost per days supply and cost per
                            pill, or in the case of a drug in another form,
                            per dose;
                                ``(iv) the total out-of-pocket spending by
                            enrollees on such drug, including enrollee
                            spending through copayments, coinsurance, and
                            deductibles; and
                                ``(v) for any drug for which gross spending
                            of the group health plan or health insurance
                            coverage exceeded $10,000 during the reporting
                            period--
                                        ``(I) a list of all other available
                                    drugs in the same therapeutic category
                                    or class, including brand name drugs
                                    and biological products and generic
                                    drugs or biosimilar biological products
                                    that are in the same therapeutic
                                    category or class; and
                                        ``(II) the rationale for preferred
                                    formulary placement of a particular
                                    drug or drugs in that therapeutic
                                    category or class;
                        ``(C) a list of each therapeutic category or class
                    of drugs that were dispensed under the health plan or
                    health insurance coverage during the reporting period,
                    and, with respect to each such therapeutic category or
                    class of drugs, during the reporting period--
                                ``(i) total gross spending by the plan,
                            before manufacturer rebates, fees, or other
                            manufacturer remuneration;
                                ``(ii) the number of enrollees who filled a
                            prescription for a drug in that category or
                            class;
                                ``(iii) if applicable to that category or
                            class, a description of the formulary tiers and
                            utilization mechanisms (such as prior
                            authorization or step therapy) employed for
                            drugs in that category or class;
                                ``(iv) the total out-of-pocket spending by
                            enrollees, including enrollee spending through
                            copayments, coinsurance, and deductibles; and
                                ``(v) for each therapeutic category or
                            class under which 3 or more drugs are included
                            on the formulary of such plan or coverage--
                                        ``(I) the amount received, or
                                    expected to be received, from drug
                                    manufacturers in rebates, fees,
                                    alternative discounts, or other
                                    remuneration--
                                                ``(aa) to be paid by drug
                                            manufacturers for claims
                                            incurred during the reporting
                                            period; or
                                                ``(bb) that is related to
                                            utilization of drugs, in such
                                            therapeutic category or class;
                                        ``(II) the total net spending,
                                    after deducting rebates, price
                                    concessions, alternative discounts or
                                    other remuneration from drug
                                    manufacturers, by the health plan or
                                    health insurance coverage on that
                                    category or class of drugs; and
                                        ``(III) the net price per course of
                                    treatment or 30-day supply incurred by
                                    the health plan or health insurance
                                    coverage and its enrollees, after
                                    manufacturer rebates, fees, and other
                                    remuneration for drugs dispensed within
                                    such therapeutic category or class
                                    during the reporting period;
                        ``(D) total gross spending on prescription drugs by
                    the plan or coverage during the reporting period,
                    before rebates and other manufacturer fees or
                    remuneration;
                        ``(E) total amount received, or expected to be
                    received, by the health plan or health insurance
                    coverage in drug manufacturer rebates, fees,
                    alternative discounts, and all other remuneration
                    received from the manufacturer or any third party,
                    other than the plan sponsor, related to utilization of
                    drug or drug spending under that health plan or health
                    insurance coverage during the reporting period;
                        ``(F) the total net spending on prescription drugs
                    by the health plan or health insurance coverage during
                    the reporting period; and
                        ``(G) amounts paid directly or indirectly in
                    rebates, fees, or any other type of remuneration to
                    brokers, consultants, advisors, or any other individual
                    or firm who referred the group health plan's or health
                    insurance issuer's business to the pharmacy benefit
                    manager.
                ``(2) Privacy requirements.--Health insurance issuers
            offering group health insurance coverage and entities providing
            pharmacy benefits management services on behalf of a group
            health plan shall provide information under paragraph (1) in a
            manner consistent with the privacy, security, and breach
            notification regulations promulgated under section 264(c) of
            the Health Insurance Portability and Accountability Act of 1996
            (or successor regulations), and shall restrict the use and
            disclosure of such information according to such privacy
            regulations.
                ``(3) Disclosure and redisclosure.--
                        ``(A) Limitation to business associates.--A group
                    health plan receiving a report under paragraph (1) may
                    disclose such information only to business associates
                    of such plan as defined in section 160.103 of title 45,
                    Code of Federal Regulations (or successor regulations).
                        ``(B) Clarification regarding public disclosure of
                    information.--Nothing in this section prevents a health
                    insurance issuer offering group health insurance
                    coverage or an entity providing pharmacy benefits
                    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 issuer or
                    entity may not restrict disclosure of such report to
                    governmental agencies pursuant to an investigation or
                    enforcement action.
                        ``(C) Limited form of report.--The Secretary shall
                    define through rulemaking a limited form of the report
                    under paragraph (1) required of plan sponsors who are
                    drug manufacturers, drug wholesalers, or other direct
                    participants in the drug supply chain, in order to
                    prevent anti-competitive behavior.
        ``(c) Limitations on Spread Pricing.--
                ``(1) Prescription drug transactions with pharmacies
            independent of the issuer or pharmacy benefits manager.--If the
            pharmacy that dispenses a prescription drug to an enrollee in a
            group health plan or group or individual health insurance
            coverage is not wholly or partially owned by such plan, such
            issuer, or an entity providing pharmacy benefit management
            services under such plan or coverage, such plan, issuer, or
            entity shall not charge the plan, issuer, or enrollee a price
            for such prescription drug that exceeds the price paid to the
            pharmacy.
                ``(2) Intra-company prescription drug transactions.--If the
            mail order, specialty, or retail pharmacy that dispenses a
            prescription drug to an enrollee in a group health plan or
            health insurance coverage is wholly or partially owned by, and
            submits claims to, such health insurance issuer or an entity
            providing pharmacy benefit management services under a group
            health plan or group or individual health insurance coverage,
            the price charged for such drug by such pharmacy to such group
            health plan or health insurance issuer offering group or
            individual health insurance coverage may not exceed the lesser
            of--
                        ``(A) the amount paid to the pharmacy for
                    acquisition of the drug; or
                        ``(B) the median price charged to the group health
                    plan or health insurance issuer when the same drug is
                    dispensed to enrollees in the plan or coverage by other
                    similarly situated pharmacies not wholly or partially
                    owned by the health insurance issuer or entity
                    providing pharmacy benefits management services, as
                    described in paragraph (1).
                ``(3) Supplementary reporting for intra-company
            prescription drug transactions.--A health insurance issuer of
            group health insurance coverage or an entity providing pharmacy
            benefits management services under a group health plan or group
            health insurance coverage that conducts transactions with a
            wholly or partially owned pharmacy, as described in paragraph
            (2), shall submit, together with the report under subsection
            (b), a supplementary report every 6 months to the plan sponsor
            that includes--
                        ``(A) an explanation of any benefit design
                    parameters that encourage enrollees in the plan or
                    coverage to fill prescriptions at mail order,
                    specialty, or retail pharmacies that are wholly or
                    partially owned by that issuer or entity;
                        ``(B) the percentage of total prescriptions charged
                    to the plan, coverage, or enrollees in the plan or
                    coverage, that were dispensed by mail order, specialty,
                    or retail pharmacies that are wholly or partially owned
                    by the issuer or entity providing pharmacy benefits
                    management services; and
                        ``(C) a list of all drugs dispensed by such wholly
                    or partially-owned pharmacy and charged to the plan or
                    coverage, or enrollees of the plan or coverage, during
                    the applicable quarter, and, with respect to each
                    drug--
                                ``(i) the amount charged per course of
                            treatment or 30-day supply with respect to
                            enrollees in the plan or coverage, including
                            amounts charged to the plan or coverage and
                            amounts charged to the enrollee;
                                ``(ii) the median amount charged to the
                            plan or coverage, per course of treatment or
                            30-day supply, including amounts paid by the
                            enrollee, when the same drug is dispensed by
                            other pharmacies that are not wholly or
                            partially owned by the issuer or entity and
                            that are included in the pharmacy network of
                            that plan or coverage;
                                ``(iii) the interquartile range of the
                            costs, per course of treatment or 30-day
                            supply, including amounts paid by the enrollee,
                            when the same drug is dispensed by other
                            pharmacies that are not wholly or partially
                            owned by the issuer or entity and that are
                            included in the pharmacy network of that plan
                            or coverage; and
                                ``(iv) the lowest cost per course of
                            treatment or 30-day supply, for such drug,
                            including amounts charged to the plan or issuer
                            and enrollee, that is available from any
                            pharmacy included in the network of the plan or
                            coverage.
        ``(d) Full Rebate Pass-Through to Plan.--
                ``(1) In general.--A pharmacy benefits manager, a third-
            party administrator of a group health plan, a health insurance
            issuer offering group health insurance coverage, or an entity
            providing pharmacy benefits management services under such
            health plan or health insurance coverage shall remit 100
            percent of rebates, fees, alternative discounts, and all other
            remuneration received from a pharmaceutical manufacturer,
            distributor or any other third party, that are related to
            utilization of drugs under such health plan or health insurance
            coverage, to the group health plan.
                ``(2) Form and manner of remittance.--Such rebates, fees,
            alternative discounts, and other remuneration shall be--
                        ``(A) remitted to the group health plan in a timely
                    fashion after the period for which such rebates, fees,
                    or other remuneration is calculated, and in no case
                    later than 90 days after the end of such period;
                        ``(B) fully disclosed and enumerated to the group
                    health plan sponsor, as described in (b)(1);
                        ``(C) available for audit by the plan sponsor, or a
                    third party designated by a plan sponsor no less than
                    once per plan year; and
                        ``(D) returned to the issuer or entity providing
                    pharmaceutical benefit management services by the group
                    health plan if audits by such issuer or entity indicate
                    that the amounts received are incorrect after such
                    amounts have been paid to the group health plan.
                ``(3) Audit of rebate contracts.--A pharmacy benefits
            manager, a third-party administrator of a group health plan, a
            health insurance issuer offering group health insurance
            coverage, or an entity providing pharmacy benefits management
            services under such health plan or health insurance coverage
            shall make rebate contracts with drug manufacturers available
            for audit by such plan sponsor or designated third party,
            subject to confidentiality agreements to prevent re-disclosure
            of such contracts.
        ``(e) Enforcement.--
                ``(1) In general.--The Secretary, in consultation with the
            Secretary of Labor and the Secretary of the Treasury, shall
            enforce this section.
                ``(2) Failure to provide timely information.--A health
            insurance issuer or an entity providing pharmacy benefit
            management services that violates subsection (a), fails to
            provide information required under subsection (b), engages in
            spread pricing as defined in subsection (c), or fails to comply
            with the requirements of subsection (d), or a drug manufacturer
            that fails to provide information under subsection (b)(1)(A),
            in a timely manner 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, entity
            providing pharmacy benefit management services, or drug
            manufacturer that knowingly provides false information under
            this section shall be subject to a civil money penalty in an
            amount not to exceed $100,000 for each item of false
            information. Such civil money 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 subsection (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 section 1128A of the Social Security Act.
                ``(5) Safe harbor.--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
            this section.
        ``(f) Rule of Construction.--Nothing in this section shall be
    construed to prohibit payments to entities offering pharmacy benefits
    management services for bona fide services using a fee structure not
    contemplated by this section, provided that such fees are transparent
    to group health plans and health insurance issuers.
        ``(g) Definitions.--In this section--
                ``(1) the term `similarly situated pharmacy' means, with
            respect to a particular pharmacy, another pharmacy that is
            approximately the same size (as measured by the number of
            prescription drugs dispensed), and that serves patients in the
            same geographical area, whether through physical locations or
            mail order; and
                ``(2) the term `wholesale acquisition cost' has the meaning
            given such term in section 1847A(c)(6)(B) of the Social
            Security Act.''.

    SEC. 365. STUDY BY COMPTROLLER GENERAL OF UNITED STATES.

        (a) In General.--The Comptroller General of the United States
    (referred to in this section as the ``Comptroller General'') shall, in
    consultation with appropriate stakeholders, conduct a study on the role
    of pharmacy benefit managers.
        (b) Permissible Examination.--In conducting the study required
    under subsection (a), the Comptroller General may examine various
    qualitative and quantitative aspects of the role of pharmacy benefit
    managers, such as the following:
                (1) The role that pharmacy benefit managers play in the
            pharmaceutical supply chain.
                (2) The state of competition among pharmacy benefit
            managers, including the market share for the Nation's largest
            pharmacy benefit managers.
                (3) The use of rebates and fees by pharmacy benefit
            managers, including--
                        (A) the extent to which rebates are passed on to
                    health plans and whether such rebates are passed on to
                    individuals enrolled in such plans;
                        (B) the extent to which rebates are kept by such
                    pharmacy benefit managers; and
                        (C) the role of any fees charged by such pharmacy
                    benefit managers.
                (4) Whether pharmacy benefit managers structure their
            formularies in favor of high-rebate prescription drugs over
            lower-cost, lower-rebate alternatives.
                (5) The average prior authorization approval time for
            pharmacy benefit managers.
                (6) Factors affecting the use of step therapy by pharmacy
            benefit managers.
        (c) Report.--Not later than 3 years after the date of enactment of
    this Act, the Comptroller General shall submit to the Secretary of
    Health and Human Services, the Committee on Health, Education, Labor,
    and Pensions of the Senate, and the Committee on Energy and Commerce of
    the House of Representatives a report containing the results of the
    study conducted under subsection (a), including policy recommendations.

          Subtitle E--Medicare and Medicaid Prescription Drug Reforms

    SEC. 371. MEDICARE PART D MODERNIZATION REDESIGN.

        (a) Benefit Structure Redesign.--Section 1860D-2(b) of the Social
    Security Act (42 U.S.C. 1395w-102(b)) is amended--
                (1) in paragraph (2)--
                        (A) in subparagraph (A), in the matter preceding
                    clause (i), by inserting ``for a year preceding 2025
                    and for costs above the annual deductible specified in
                    paragraph (1) and up to the annual out-of-pocket
                    threshold specified in paragraph (4)(B) for 2025 and
                    each subsequent year'' after ``paragraph (3)'';
                        (B) in subparagraph (C)--
                                (i) in clause (i), in the matter preceding
                            subclause (I), by inserting ``for a year
                            preceding 2025,'' after ``paragraph (4),''; and
                                (ii) in clause (ii)(III), by striking ``and
                            each subsequent year'' and inserting ``, 2021,
                            2022, 2023, and 2024''; and
                        (C) in subparagraph (D)--
                                (i) in clause (i)--
                                        (I) in the matter preceding
                                    subclause (I), by inserting ``for a
                                    year preceding 2025,'' after
                                    ``paragraph (4),''; and
                                        (II) in subclause (I)(bb), by
                                    striking ``a year after 2018'' and
                                    inserting ``each of years 2018 through
                                    2024''; and
                                (ii) in clause (ii)(V), by striking ``2019
                            and each subsequent year'' and inserting ``each
                            of years 2019 through 2024'';
                (2) in paragraph (3)(A)--
                        (A) in the matter preceding clause (i), by
                    inserting ``for a year preceding 2025,'' after ``and
                    (4),''; and
                        (B) in clause (ii), by striking ``for a subsequent
                    year'' and inserting ``for each of years 2007 through
                    2024'';
                (3) in paragraph (4)--
                        (A) in subparagraph (A)--
                                (i) in clause (i)--
                                        (I) by redesignating subclauses (I)
                                    and (II) as items (aa) and (bb),
                                    respectively, and indenting
                                    appropriately;
                                        (II) in the matter preceding item
                                    (aa), as redesignated by subclause (I),
                                    by striking ``is equal to the greater
                                    of--'' and inserting ``is equal to--
                                        ``(I) for a year preceding 2025,
                                    the greater of--'';
                                        (III) by striking the period at the
                                    end of item (bb), as redesignated by
                                    subclause (I), and inserting ``; and'';
                                    and
                                        (IV) by adding at the end the
                                    following:
                                        ``(II) for 2025 and each succeeding
                                    year, $0.''; and
                                (ii) in clause (ii)--
                                        (I) by striking ``clause (i)(I)''
                                    and inserting ``clause (i)(I)(aa)'';
                                    and
                                        (II) by adding at the end the
                                    following new sentence: ``The Secretary
                                    shall continue to calculate the dollar
                                    amounts specified in clause (i)(I)(aa),
                                    including with the adjustment under
                                    this clause, after 2024 for purposes of
                                    section 1860D-14(a)(1)(D)(iii).'';
                        (B) in subparagraph (B)--
                                (i) in clause (i)--
                                        (I) in subclause (V), by striking
                                    ``or'' at the end;
                                        (II) in subclause (VI)--
                                                (aa) by striking ``for a
                                            subsequent year'' and inserting
                                            ``for 2021 through 2024''; and
                                                (bb) by striking the period
                                            at the end and inserting a
                                            semicolon; and
                                        (III) by adding at the end the
                                    following new subclauses:
                                        ``(VII) for 2025, is equal to
                                    $3,100; or
                                        ``(VIII) for a subsequent year, is
                                    equal to the amount specified in this
                                    subparagraph for the previous year,
                                    increased by the annual percentage
                                    increase described in paragraph (6) for
                                    the year involved.''; and
                                (ii) in clause (ii), by striking ``clause
                            (i)(II)'' and inserting ``clause (i)'';
                        (C) in subparagraph (C)(i), by striking ``and for
                    amounts'' and inserting ``and for a year preceding 2025
                    for amounts''; and
                        (D) in subparagraph (E), by striking ``In
                    applying'' and inserting ``For each of 2011 through
                    2024, in applying''.
        (b) Reduction in Beneficiary Coinsurance.--
                (1) In general.--Section 1860D-2(b)(2)(A) of the Social
            Security Act (42 U.S.C. 1395w-102(b)(2)(A)), as amended by
            subsection (a), is amended--
                        (A) by redesignating clauses (i) and (ii) as
                    subclauses (I) and (II) and moving such subclauses 2
                    ems to the right;
                        (B) by striking ``25 percent coinsurance.--Subject
                    to'' and inserting ``Coinsurance.--
                                ``(i) In general.--Subject to'';
                        (C) in each of subclauses (I) and (II), as
                    redesignated by subparagraph (A), by striking ``25
                    percent'' and inserting ``the applicable percentage (as
                    defined in clause (ii))''; and
                        (D) by adding at the end the following new clause:
                                ``(ii) Applicable percentage defined.--For
                            purposes of clause (i), the term `applicable
                            percentage' means--
                                        ``(I) for a year preceding 2025, 25
                                    percent; and
                                        ``(II) for 2025 and each subsequent
                                    year, 20 percent.''.
                (2) Conforming amendment.--Section 1860D-14(a)(2)(D) of the
            Social Security Act (42 U.S.C. 1395w-114(a)(2)(D)) is amended
            by striking ``25 percent'' and inserting ``the applicable
            percentage''.
        (c) Decreasing Reinsurance Payment Amount.--Section 1860D-15(b) of
    the Social Security Act (42 U.S.C. 1395w-115(b)) is amended--
                (1) in paragraph (1)--
                        (A) by striking ``equal to 80 percent'' and
                    inserting ``equal to--
                        ``(A) for a year preceding 2025, 80 percent'';
                        (B) in subparagraph (A), as added by paragraph (1),
                    by striking the period at the end and inserting ``;
                    and''; and
                        (C) by adding at the end the following new
                    subparagraph:
                        ``(B) for 2025 and each subsequent year, the sum
                    of--
                                ``(i) an amount equal to the applicable
                            percentage specified in paragraph (5)(A) of
                            such allowable reinsurance costs attributable
                            to that portion of gross prescription drug
                            costs as specified in paragraph (3) incurred in
                            the coverage year after such individual has
                            incurred costs that exceed the annual out-of-
                            pocket threshold specified in section 1860D-
                            2(b)(4)(B) with respect to applicable drugs (as
                            defined in section 1860D-14B(g)(2)); and
                                ``(ii) an amount equal to the applicable
                            percentage specified in paragraph (5)(B) of
                            allowable reinsurance costs attributable to
                            that portion of gross prescription drug costs
                            as specified in paragraph (3) incurred in the
                            coverage year after such individual has
                            incurred costs that exceed the annual out-of-
                            pocket threshold specified in section 1860D-
                            2(b)(4)(B) with respect to covered part D drugs
                            that are not applicable drugs (as so
                            defined).''; and
                (2) by adding at the end the following new paragraph:
                ``(5) Applicable percentage specified.--For purposes of
            paragraph (1)(B), the applicable percentage specified in this
            paragraph is--
                        ``(A) with respect to applicable drugs (as defined
                    in section 1860D-14B(g)(2))--
                                ``(i) for 2025, 60 percent;
                                ``(ii) for 2026, 40 percent; and
                                ``(iii) for 2027 and each subsequent year,
                            20 percent; and
                        ``(B) with respect to covered part D drugs that are
                    not applicable drugs (as so defined)--
                                ``(i) for 2025, 80 percent;
                                ``(ii) for 2026, 60 percent; and
                                ``(iii) for 2027 and each subsequent year,
                            40 percent.''.
        (d) Manufacturer Discount Program During Initial and Catastrophic
    Phases of Coverage.--
                (1) In general.--Part D of title XVIII of the Social
            Security Act is amended by inserting after section 1860D-14A
            (42 U.S.C. 1495w-114) the following new section:

    ``SEC. 1860D-14B. MANUFACTURER DISCOUNT PROGRAM.

        ``(a) Establishment.--The Secretary shall establish a manufacturer
    discount program (in this section referred to as the `program'). Under
    the program, the Secretary shall enter into agreements described in
    subsection (b) with manufacturers and provide for the performance of
    the duties described in subsection (c). The Secretary shall establish a
    model agreement for use under the program by not later than January 1,
    2025, in consultation with manufacturers, and allow for comment on such
    model agreement.
        ``(b) Terms of Agreement.--
                ``(1) In general.--
                        ``(A) Agreement.--An agreement under this section
                    shall require the manufacturer to provide applicable
                    beneficiaries access to discounted prices for
                    applicable drugs of the manufacturer that are dispensed
                    on or after January 1, 2025.
                        ``(B) Provision of discounted prices at the point-
                    of-sale.--The discounted prices described in
                    subparagraph (A) shall be provided to the applicable
                    beneficiary at the pharmacy or by the mail order
                    service at the point-of-sale of an applicable drug.
                ``(2) Provision of appropriate data.--Each manufacturer
            with an agreement in effect under this section shall collect
            and have available appropriate data, as determined by the
            Secretary, to ensure that it can demonstrate to the Secretary
            compliance with the requirements under the program.
                ``(3) Compliance with requirements for administration of
            program.--Each manufacturer with an agreement in effect under
            this section shall comply with requirements imposed by the
            Secretary or a third party with a contract under subsection
            (d)(3), as applicable, for purposes of administering the
            program, including any determination under subparagraph (A) of
            subsection (c)(1) or procedures established under such
            subsection (c)(1).
                ``(4) Length of agreement.--
                        ``(A) In general.--An agreement under this section
                    shall be effective for an initial period of not less
                    than 12 months and shall be automatically renewed for a
                    period of not less than 1 year unless terminated under
                    subparagraph (B).
                        ``(B) Termination.--
                                ``(i) By the secretary.--The Secretary may
                            provide for termination of an agreement under
                            this section for a knowing and willful
                            violation of the requirements of the agreement
                            or other good cause shown. Such termination
                            shall not be effective earlier than 30 days
                            after the date of notice to the manufacturer of
                            such termination. The Secretary shall provide,
                            upon request, a manufacturer with a hearing
                            concerning such a termination, and such hearing
                            shall take place prior to the effective date of
                            the termination with sufficient time for such
                            effective date to be repealed if the Secretary
                            determines appropriate.
                                ``(ii) By a manufacturer.--A manufacturer
                            may terminate an agreement under this section
                            for any reason. Any such termination shall be
                            effective, with respect to a plan year--
                                        ``(I) if the termination occurs
                                    before January 30 of a plan year, as of
                                    the day after the end of the plan year;
                                    and
                                        ``(II) if the termination occurs on
                                    or after January 30 of a plan year, as
                                    of the day after the end of the
                                    succeeding plan year.
                                ``(iii) Effectiveness of termination.--Any
                            termination under this subparagraph shall not
                            affect discounts for applicable drugs of the
                            manufacturer that are due under the agreement
                            before the effective date of its termination.
                                ``(iv) Notice to third party.--The
                            Secretary shall provide notice of such
                            termination to a third party with a contract
                            under subsection (d)(3) within not less than 30
                            days before the effective date of such
                            termination.
                ``(5) Effective date of agreement.--An agreement under this
            section shall take effect on a date determined appropriate by
            the Secretary, which may be at the start of a calendar quarter.
        ``(c) Duties Described.--The duties described in this subsection
    are the following:
                ``(1) Administration of program.--Administering the
            program, including--
                        ``(A) the determination of the amount of the
                    discounted price of an applicable drug of a
                    manufacturer;
                        ``(B) the establishment of procedures under which
                    discounted prices are provided to applicable
                    beneficiaries at pharmacies or by mail order service at
                    the point-of-sale of an applicable drug;
                        ``(C) the establishment of procedures to ensure
                    that, not later than the applicable number of calendar
                    days after the dispensing of an applicable drug by a
                    pharmacy or mail order service, the pharmacy or mail
                    order service is reimbursed for an amount equal to the
                    difference between--
                                ``(i) the negotiated price of the
                            applicable drug; and
                                ``(ii) the discounted price of the
                            applicable drug;
                        ``(D) the establishment of procedures to ensure
                    that the discounted price for an applicable drug under
                    this section is applied before any coverage or
                    financial assistance under other health benefit plans
                    or programs that provide coverage or financial
                    assistance for the purchase or provision of
                    prescription drug coverage on behalf of applicable
                    beneficiaries as the Secretary may specify; and
                        ``(E) providing a reasonable dispute resolution
                    mechanism to resolve disagreements between
                    manufacturers, applicable beneficiaries, and the third
                    party with a contract under subsection (d)(3).
                ``(2) Monitoring compliance.--
                        ``(A) In general.--The Secretary shall monitor
                    compliance by a manufacturer with the terms of an
                    agreement under this section.
                        ``(B) Notification.--If a third party with a
                    contract under subsection (d)(3) determines that the
                    manufacturer is not in compliance with such agreement,
                    the third party shall notify the Secretary of such
                    noncompliance for appropriate enforcement under
                    subsection (e).
                ``(3) Collection of data from prescription drug plans and
            ma-pd plans.--The Secretary may collect appropriate data from
            prescription drug plans and MA-PD plans in a timeframe that
            allows for discounted prices to be provided for applicable
            drugs under this section.
        ``(d) Administration.--
                ``(1) In general.--Subject to paragraph (2), the Secretary
            shall provide for the implementation of this section, including
            the performance of the duties described in subsection (c).
                ``(2) Limitation.--In providing for the implementation of
            this section, the Secretary shall not receive or distribute any
            funds of a manufacturer under the program.
                ``(3) Contract with third parties.--The Secretary shall
            enter into a contract with 1 or more third parties to
            administer the requirements established by the Secretary in
            order to carry out this section. At a minimum, the contract
            with a third party under the preceding sentence shall require
            that the third party--
                        ``(A) receive and transmit information between the
                    Secretary, manufacturers, and other individuals or
                    entities the Secretary determines appropriate;
                        ``(B) receive, distribute, or facilitate the
                    distribution of funds of manufacturers to appropriate
                    individuals or entities in order to meet the
                    obligations of manufacturers under agreements under
                    this section;
                        ``(C) provide adequate and timely information to
                    manufacturers, consistent with the agreement with the
                    manufacturer under this section, as necessary for the
                    manufacturer to fulfill its obligations under this
                    section; and
                        ``(D) permit manufacturers to conduct periodic
                    audits, directly or through contracts, of the data and
                    information used by the third party to determine
                    discounts for applicable drugs of the manufacturer
                    under the program.
                ``(4) Performance requirements.--The Secretary shall
            establish performance requirements for a third party with a
            contract under paragraph (3) and safeguards to protect the
            independence and integrity of the activities carried out by the
            third party under the program under this section.
                ``(5) Administration.--Chapter 35 of title 44, United
            States Code, shall not apply to the program under this section.
                ``(6) Funding.--For purposes of carrying out this section,
            the Secretary shall provide for the transfer, from the Federal
            Supplementary Medical Insurance Trust Fund under section 1841
            to the Centers for Medicare & Medicaid Services Program
            Management Account, of $4,000,000 for each of fiscal years 2024
            through 2027, to remain available until expended.''.
        ``(e) Enforcement.--
                ``(1) Audits.--Each manufacturer with an agreement in
            effect under this section shall be subject to periodic audit by
            the Secretary.
                ``(2) Civil money penalty.--
                        ``(A) In general.--The Secretary shall impose a
                    civil money penalty on a manufacturer that fails to
                    provide applicable beneficiaries discounts for
                    applicable drugs of the manufacturer in accordance with
                    such agreement for each such failure in an amount the
                    Secretary determines is commensurate with the sum of--
                                ``(i) the amount that the manufacturer
                            would have paid with respect to such discounts
                            under the agreement, which will then be used to
                            pay the discounts which the manufacturer had
                            failed to provide; and
                                ``(ii) 25 percent of such amount.
                        ``(B) Application.--The provisions of section 1128A
                    (other than subsections (a) and (b)) shall apply to a
                    civil money penalty under this paragraph in the same
                    manner as such provisions apply to a penalty or
                    proceeding under section 1128A(a).
        ``(f) Clarification Regarding Availability of Other Covered Part D
    Drugs.--Nothing in this section shall prevent an applicable beneficiary
    from purchasing a covered part D drug that is not an applicable drug
    (including a generic drug or a drug that is not on the formulary of the
    prescription drug plan or MA-PD plan that the applicable beneficiary is
    enrolled in).
        ``(g) Definitions.--In this section:
                ``(1) Applicable beneficiary.--The term `applicable
            beneficiary' means an individual who, on the date of dispensing
            a covered part D drug--
                        ``(A) is enrolled in a prescription drug plan or an
                    MA-PD plan;
                        ``(B) is not enrolled in a qualified retiree
                    prescription drug plan; and
                        ``(C) has incurred costs for covered part D drugs
                    in the year that are above the annual deductible
                    specified in section 1860D-2(b)(1) for such year.
                ``(2) Applicable drug.--The term `applicable drug' means,
            with respect to an applicable beneficiary, a covered part D
            drug--
                        ``(A) approved under a new drug application under
                    section 505(c) of the Federal Food, Drug, and Cosmetic
                    Act or, in the case of a biologic product, licensed
                    under section 351 of the Public Health Service Act
                    (including a product licensed under subsection (k) of
                    such section 351); and
                        ``(B)(i) if the PDP sponsor of the prescription
                    drug plan or the MA organization offering the MA-PD
                    plan uses a formulary, which is on the formulary of the
                    prescription drug plan or MA-PD plan that the
                    applicable beneficiary is enrolled in;
                        ``(ii) if the PDP sponsor of the prescription drug
                    plan or the MA organization offering the MA-PD plan
                    does not use a formulary, for which benefits are
                    available under the prescription drug plan or MA-PD
                    plan that the applicable beneficiary is enrolled in; or
                        ``(iii) is provided through an exception or appeal.
                ``(3) Applicable number of calendar days.--The term
            `applicable number of calendar days' means--
                        ``(A) with respect to claims for reimbursement
                    submitted electronically, 14 days; and
                        ``(B) with respect to claims for reimbursement
                    submitted otherwise, 30 days.
                ``(4) Discounted price.--
                        ``(A) In general.--The term `discounted price'
                    means--
                                ``(i) with respect to an applicable drug
                            dispensed for an applicable beneficiary who has
                            incurred costs that are below the annual out-
                            of-pocket threshold specified in section 1860D-
                            2(b)(4)(B) for the year, 93 percent of the
                            negotiated price of the applicable drug of a
                            manufacturer; and
                                ``(ii) with respect to an applicable drug
                            dispensed for an applicable beneficiary who has
                            incurred costs for covered part D drugs in the
                            year that are equal to or exceed the annual
                            out-of-pocket threshold specified in section
                            1860D-2(b)(4)(B) for the year, 86 percent of
                            the negotiated price of the applicable drug of
                            a manufacturer.
                        ``(B) Clarification.--Nothing in this section shall
                    be construed as affecting the responsibility of an
                    applicable beneficiary for payment of a dispensing fee
                    for an applicable drug.
                        ``(C) Clarification for certain claims.--With
                    respect to the amount of the negotiated price of an
                    individual claim for an applicable drug with respect to
                    an applicable beneficiary, the manufacturer of the
                    applicable drug shall provide--
                                ``(i) the discounted price under clause (i)
                            of subparagraph (A) only on the portion of the
                            negotiated price of the applicable drug that
                            falls above the deductible specified in section
                            1860D-2(b)(1) for the year and below the annual
                            out-of-pocket threshold specified in section
                            1860D-2(b)(4)(B) for the year; and
                                ``(ii) the discounted price under clause
                            (ii) of subparagraph (A) only on the portion of
                            the negotiated price of the applicable drug
                            that falls at or above such annual out-of-
                            pocket threshold.
                ``(5) Manufacturer.--The term `manufacturer' means any
            entity which is engaged in the production, preparation,
            propagation, compounding, conversion, or processing of
            prescription drug products, either directly or indirectly by
            extraction from substances of natural origin, or independently
            by means of chemical synthesis, or by a combination of
            extraction and chemical synthesis. Such term does not include a
            wholesale distributor of drugs or a retail pharmacy licensed
            under State law.
                ``(6) Negotiated price.--The term `negotiated price' has
            the meaning given such term in section 1860D-2(d)(1)(B), except
            that such negotiated price shall not include any dispensing fee
            for the applicable drug.
                ``(7) Qualified retiree prescription drug plan.--The term
            `qualified retiree prescription drug plan' has the meaning
            given such term in section 1860D-22(a)(2).''.
                (2) Sunset of medicare coverage gap discount program.--
            Section 1860D-14A of the Social Security Act (42 U.S.C. 1395-
            114a) is amended--
                        (A) in subsection (a), in the first sentence, by
                    striking ``The Secretary'' and inserting ``Subject to
                    subsection (h), the Secretary''; and
                        (B) by adding at the end the following new
                    subsection:
        ``(h) Sunset of Program.--
                ``(1) In general.--The program shall not apply to
            applicable drugs dispensed on or after January 1, 2025, and,
            subject to paragraph (2), agreements under this section shall
            be terminated as of such date.
                ``(2) Continued application for applicable drugs dispensed
            prior to sunset.--The provisions of this section (including all
            responsibilities and duties) shall continue to apply after
            January 1, 2025, with respect to applicable drugs dispensed
            prior to such date.''.
                (3) Inclusion of actuarial value of manufacturer discounts
            in bids.--Section 1860D-11 of the Social Security Act (42
            U.S.C. 1395w-111) is amended--
                        (A) in subsection (b)(2)(C)(iii)--
                                (i) by striking ``assumptions regarding the
                            reinsurance'' and inserting ``assumptions
                            regarding--
                                        ``(I) the reinsurance''; and
                                (ii) by adding at the end the following:
                                        ``(II) for 2025 and each subsequent
                                    year, the manufacturer discounts
                                    provided under section 1860D-14B
                                    subtracted from the actuarial value to
                                    produce such bid; and''; and
                        (B) in subsection (c)(1)(C)--
                                (i) by striking ``an actuarial valuation of
                            the reinsurance'' and inserting ``an actuarial
                            valuation of--
                                ``(i) the reinsurance'';
                                (ii) in clause (i), as added by clause (i)
                            of this subparagraph, by adding ``and'' at the
                            end; and
                                (iii) by adding at the end the following:
                                ``(ii) for 2025 and each subsequent year,
                            the manufacturer discounts provided under
                            section 1860D-14B;''.
                (4) Clarification regarding exclusion of manufacturer
            discounts from troop.--Section 1860D-2(b)(4) of the Social
            Security Act (42 U.S.C. 1395w-102(b)(4)) is amended--
                        (A) in subparagraph (C), by inserting ``and subject
                    to subparagraph (F)'' after ``subparagraph (E)''; and
                        (B) by adding at the end the following new
                    subparagraph:
                        ``(F) Clarification regarding exclusion of
                    manufacturer discounts.--In applying subparagraph (A),
                    incurred costs shall not include any manufacturer
                    discounts provided under section 1860D-14B.''.
        (e) Determination of Allowable Reinsurance Costs.--Section 1860D-
    15(b) of the Social Security Act (42 U.S.C. 1395w-115(b)) is amended--
                (1) in paragraph (2)--
                        (A) by striking ``costs.--For purposes'' and
                    inserting ``costs.--
                        ``(A) In general.--Subject to subparagraph (B), for
                    purposes''; and
                        (B) by adding at the end the following new
                    subparagraph:
                        ``(B) Inclusion of manufacturer discounts on
                    applicable drugs.--For purposes of applying
                    subparagraph (A), the term `allowable reinsurance
                    costs' shall include the portion of the negotiated
                    price (as defined in section 1860D-14B(g)(6)) of an
                    applicable drug (as defined in section 1860D-14B(g)(2))
                    that was paid by a manufacturer under the manufacturer
                    discount program under section 1860D-14B.''; and
                (2) in paragraph (3)--
                        (A) in the first sentence, by striking ``For
                    purposes'' and inserting ``Subject to paragraph (2)(B),
                    for purposes''; and
                        (B) in the second sentence, by inserting ``or, in
                    the case of an applicable drug, by a manufacturer''
                    after ``by the individual or under the plan''.
        (f) Updating Risk Adjustment Methodologies To Account for Part D
    Modernization Redesign.--Section 1860D-15(c) of the Social Security Act
    (42 U.S.C. 1395w-115(c)) is amended by adding at the end the following
    new paragraph:
                ``(3) Updating risk adjustment methodologies to account for
            part d modernization redesign.--The Secretary shall update the
            risk adjustment methodologies used to adjust bid amounts
            pursuant to this subsection as appropriate to take into account
            changes in benefits under this part pursuant to the amendments
            made by section 371 of the Fair Care Act of 2024.''.
        (g) Conditions for Coverage of Drugs Under This Part.--Section
    1860D-43 of the Social Security Act (42 U.S.C. 1395w-153) is amended--
                (1) in subsection (a)--
                        (A) in paragraph (2), by striking ``and'' at the
                    end;
                        (B) in paragraph (3), by striking the period at the
                    end and inserting a semicolon; and
                        (C) by adding at the end the following new
                    paragraphs:
                ``(4) participate in the manufacturer discount program
            under section 1860D-14B;
                ``(5) have entered into and have in effect an agreement
            described in subsection (b) of such section 1860D-14B with the
            Secretary; and
                ``(6) have entered into and have in effect, under terms and
            conditions specified by the Secretary, a contract with a third
            party that the Secretary has entered into a contract with under
            subsection (d)(3) of such section 1860D-14B.'';
                (2) by striking subsection (b) and inserting the following:
        ``(b) Effective Date.--Paragraphs (1) through (3) of subsection (a)
    shall apply to covered part D drugs dispensed under this part on or
    after January 1, 2011, and before January 1, 2025, and paragraphs (4)
    through (6) of such subsection shall apply to covered part D drugs
    dispensed on or after January 1, 2025.''; and
                (3) in subsection (c), by striking paragraph (2) and
            inserting the following:
                ``(2) the Secretary determines that in the period beginning
            on January 1, 2011, and ending on December 31, 2011 (with
            respect to paragraphs (1) through (3) of subsection (a)), or
            the period beginning on January 1, 2025, and ending December
            31, 2025 (with respect to paragraphs (4) through (6) of such
            subsection), there were extenuating circumstances.''.
        (h) Conforming Amendments.--
                (1) Section 1860D-2 of the Social Security Act (42 U.S.C.
            1395w-102) is amended--
                        (A) in subsection (a)(2)(A)(i)(I), by striking ``,
                    or an increase in the initial'' and inserting ``or for
                    a year preceding 2025 an increase in the initial'';
                        (B) in subsection (c)(1)(C)--
                                (i) in the subparagraph heading, by
                            striking ``at initial coverage limit''; and
                                (ii) by inserting ``for a year preceding
                            2025 or the annual out-of-pocket threshold
                            specified in subsection (b)(4)(B) for the year
                            for 2025 and each subsequent year'' after
                            ``subsection (b)(3) for the year'' each place
                            it appears; and
                        (C) in subsection (d)(1)(A), by striking ``or an
                    initial'' and inserting ``or for a year preceding 2025
                    an initial''.
                (2) Section 1860D-4(a)(4)(B)(i) of the Social Security Act
            (42 U.S.C. 1395w-104(a)(4)(B)(i)) is amended by striking ``the
            initial'' and inserting ``for a year preceding 2025, the
            initial''.
                (3) Section 1860D-14(a) of the Social Security Act (42
            U.S.C. 1395w-114(a)) is amended--
                        (A) in paragraph (1)--
                                (i) in subparagraph (C), by striking ``The
                            continuation'' and inserting ``For a year
                            preceding 2025, the continuation'';
                                (ii) in subparagraph (D)(iii), by striking
                            ``1860D-2(b)(4)(A)(i)(I)'' and inserting
                            ``1860D-2(b)(4)(A)(i)(I)(aa)''; and
                                (iii) in subparagraph (E), by striking
                            ``The elimination'' and inserting ``For a year
                            preceding 2025, the elimination''; and
                        (B) in paragraph (2)--
                                (i) in subparagraph (C), by striking ``The
                            continuation'' and inserting ``For a year
                            preceding 2025, the continuation''; and
                                (ii) in subparagraph (E)--
                                        (I) by inserting ``for a year
                                    preceding 2025,'' after ``subsection
                                    (c)''; and
                                        (II) by striking ``1860D-
                                    2(b)(4)(A)(i)(I)'' and inserting
                                    ``1860D-2(b)(4)(A)(i)(I)(aa)''.
                (4) Section 1860D-21(d)(7) of the Social Security Act (42
            U.S.C. 1395w-131(d)(7)) is amended by striking ``section 1860D-
            2(b)(B)(4)(B)(i)'' and inserting ``section 1860D-
            2(b)(B)(4)(C)(i)''.
                (5) Section 1860D-22(a)(2)(A) of the Social Security Act
            (42 U.S.C. 1395w-132(a)(2)(A)) is amended--
                        (A) by striking ``the value of any discount'' and
                    inserting the following: ``the value of--
                                ``(i) for years prior to 2025, any
                            discount'';
                        (B) in clause (i), as inserted by subparagraph (A)
                    of this paragraph, by striking the period at the end
                    and inserting ``; and''; and
                        (C) by adding at the end the following new clause:
                                ``(ii) for 2025 and each subsequent year,
                            any discount provided pursuant to section
                            1860D-14B.''.
                (6) Section 1860D-41(a)(6) of the Social Security Act (42
            U.S.C. 1395w-151(a)(6)) is amended--
                        (A) by inserting ``for a year before 2025'' after
                    ``1860D-2(b)(3)''; and
                        (B) by inserting ``for such year'' before the
                    period.
        (i) Effective Date.--The amendments made by this section shall
    apply to plan year 2025 and subsequent plan years.

    SEC. 372. MAXIMUM MONTHLY CAP ON COST-SHARING PAYMENTS UNDER
                  PRESCRIPTION DRUG PLANS AND MA-PD PLANS.

        (a) In General.--Section 1860D-2(b) of the Social Security Act (42
    U.S.C. 1395w-102(b)), as amended by section 121, is amended--
                (1) in paragraph (2)--
                        (A) in subparagraph (A), by striking ``and (D)''
                    and inserting ``, (D), and (E)''; and
                        (B) by adding at the end the following new
                    subparagraph:
                        ``(E) Maximum monthly cap on cost-sharing
                    payments.--
                                ``(i) In general.--For plan years beginning
                            on or after January 1, 2025, the Secretary
                            shall, through notice and comment rulemaking,
                            establish a process under which each PDP
                            sponsor offering a prescription drug plan and
                            each MA organization offering an MA-PD plan
                            shall provide to any enrollee, including an
                            enrollee who is a subsidy eligible individual
                            (as defined in paragraph (3) of section 1860D-
                            14(a)), the option to elect with respect to a
                            plan year to have their monthly cost-sharing
                            payments under the plan capped in accordance
                            with this subparagraph.
                                ``(ii) Determination of maximum monthly
                            cap.--For each month in the plan year after an
                            enrollee in a prescription drug plan or an MA-
                            PD plan has made an election pursuant to clause
                            (i), the PDP sponsor or MA organization shall
                            determine a maximum monthly cap (as defined in
                            clause (iv)) for such enrollee.
                                ``(iii) Beneficiary monthly payments.--With
                            respect to an enrollee who has made an election
                            pursuant to clause (i), for each month
                            described in clause (ii), the PDP sponsor or MA
                            organization shall bill such enrollee an amount
                            (not to exceed the maximum monthly cap) for the
                            out-of-pocket costs of such enrollee in such
                            month.
                                ``(iv) Maximum monthly cap defined.--In
                            this subparagraph, the term `maximum monthly
                            cap' means, with respect to an enrollee--
                                        ``(I) for the first month in which
                                    this subparagraph applies, an amount
                                    determined by calculating--
                                                ``(aa) the annual out-of-
                                            pocket threshold specified in
                                            paragraph (4)(B) minus the
                                            incurred costs of the enrollee
                                            as described in paragraph
                                            (4)(C); divided by
                                                ``(bb) the number of months
                                            remaining in the plan year; and
                                        ``(II) for a subsequent month, an
                                    amount determined by calculating--
                                                ``(aa) the sum of any
                                            remaining out-of-pocket costs
                                            owed by the enrollee from a
                                            previous month that have not
                                            yet been billed to the enrollee
                                            and any additional costs
                                            incurred by the enrollee;
                                            divided by
                                                ``(bb) the number of months
                                            remaining in the plan year.
                                ``(v) Additional requirements.--The
                            following requirements shall apply with respect
                            to the option to make an election pursuant to
                            clause (i) under this subparagraph:
                                        ``(I) Secretarial
                                    responsibilities.--The Secretary shall
                                    provide information to part D eligible
                                    individuals on the option to make such
                                    election through educational materials,
                                    including through the notices provided
                                    under section 1804(a).
                                        ``(II) Timing of election.--An
                                    enrollee in a prescription drug plan or
                                    an MA-PD plan may make such an
                                    election--
                                                ``(aa) prior to the
                                            beginning of the plan year; or
                                                ``(bb) in any month during
                                            the plan year.
                                        ``(III) PDP sponsor and ma
                                    organization responsibilities.--Each
                                    PDP sponsor offering a prescription
                                    drug plan or MA organization offering
                                    an MA-PD plan--
                                                ``(aa) may not limit the
                                            option for an enrollee to make
                                            such an election to certain
                                            covered part D drugs;
                                                ``(bb) shall, prior to the
                                            plan year, notify prospective
                                            enrollees of the option to make
                                            such an election in promotional
                                            materials;
                                                ``(cc) shall include
                                            information on such option in
                                            enrollee educational materials;
                                                ``(dd) shall have in place
                                            a mechanism to notify a
                                            pharmacy during the plan year
                                            when an enrollee incurs out-of-
                                            pocket costs with respect to
                                            covered part D drugs that make
                                            it likely the enrollee may
                                            benefit from making such an
                                            election;
                                                ``(ee) shall provide that a
                                            pharmacy, after receiving a
                                            notification described in item
                                            (dd) with respect to an
                                            enrollee, informs the enrollee
                                            of such notification;
                                                ``(ff) shall ensure that
                                            such an election by an enrollee
                                            has no effect on the amount
                                            paid to pharmacies (or the
                                            timing of such payments) with
                                            respect to covered part D drugs
                                            dispensed to the enrollee; and
                                                ``(gg) shall have in place
                                            a financial reconciliation
                                            process to correct inaccuracies
                                            in payments made by an enrollee
                                            under this subparagraph with
                                            respect to covered part D drugs
                                            during the plan year.
                                        ``(IV) Failure to pay amount
                                    billed.--If an enrollee fails to pay
                                    the amount billed for a month as
                                    required under this subparagraph, the
                                    election of the enrollee pursuant to
                                    clause (i) shall be terminated and
                                    enrollee shall pay the cost-sharing
                                    otherwise applicable for any covered
                                    part D drugs subsequently dispensed to
                                    the enrollee up to the annual out-of-
                                    pocket threshold specified in paragraph
                                    (4)(B).
                                        ``(V) Clarification regarding past
                                    due amounts.--Nothing in this
                                    subparagraph shall be construed as
                                    prohibiting a PDP sponsor or an MA
                                    organization from billing an enrollee
                                    for an amount owed under this
                                    subparagraph.
                                        ``(VI) Treatment of unsettled
                                    balances.--Any unsettled balances with
                                    respect to amounts owed under this
                                    subparagraph shall be treated as plan
                                    losses and the Secretary shall not be
                                    liable for any such balances outside of
                                    those assumed as losses estimated in
                                    plan bids.''; and
                (2) in paragraph (4)--
                        (A) in subparagraph (C), by striking ``and subject
                    to subparagraph (F)'' and inserting ``and subject to
                    subparagraphs (F) and (G)''; and
                        (B) by adding at the end the following new
                    subparagraph:
                        ``(G) Inclusion of costs paid under maximum monthly
                    cap option.--In applying subparagraph (A), with respect
                    to an enrollee who has made an election pursuant to
                    clause (i) of paragraph (2)(E), costs shall be treated
                    as incurred if such costs are paid by a PDP sponsor or
                    an MA organization under the process provided under
                    such paragraph.''.
        (b) Application to Alternative Prescription Drug Coverage.--Section
    1860D-2(c) of the Social Security Act (42 U.S.C. 1395w-102(c)) is
    amended by adding at the end the following new paragraph:
                ``(4) Same maximum monthly cap on cost-sharing.--For plan
            years beginning on or after January 1, 2025, the maximum
            monthly cap on cost-sharing payments under the process provided
            under subsection (b)(2)(E) shall apply to such coverage.''.

    SEC. 373. MARKET BASED PART B PRICING INDEX.

        Notwithstanding any provision of part B of title XVIII of the
    Social Security Act, the Secretary of Health and Human Services may
    make payments for drugs payable under such part based on an
    international pricing index. In using such an index, the Secretary
    shall take into account whether the market of each country included in
    such index is a price-controlled or free market and give more weight
    under such index to countries with market-based drug policies.

    SEC. 374. INNOVATION MODEL TESTING OF MEDICARE DRUG PAYMENTS.

        Notwithstanding any provision of section 1115A, the Secretary of
    Health and Human Services may, under such section, test a model to
    integrate benefits provided for drugs under parts A, B, and D of title
    XVIII of the Social Security Act.

    SEC. 375. MODIFICATION OF MAXIMUM REBATE AMOUNT UNDER MEDICAID DRUG
                  REBATE PROGRAM.

        (a) In General.--Subparagraph (D) of section 1927(c)(2) of the
    Social Security Act (42 U.S.C. 1396r-8(c)(2)) is amended to read as
    follows:
                        ``(D) Maximum rebate amount.--
                                ``(i) In general.--Except as provided in
                            clause (ii), in no case shall the sum of the
                            amounts applied under paragraph (1)(A)(ii) and
                            this paragraph with respect to each dosage form
                            and strength of a single source drug or an
                            innovator multiple source drug for a rebate
                            period exceed--
                                        ``(I) for rebate periods beginning
                                    after December 31, 2009, and before
                                    September 30, 2025, 100 percent of the
                                    average manufacturer price of the drug;
                                    and
                                        ``(II) for rebate periods beginning
                                    on or after October 1, 2025, 125
                                    percent of the average manufacturer
                                    price of the drug.
                                ``(ii) No maximum amount for drugs if amp
                            increases outpace inflation.--
                                        ``(I) In general.--If the average
                                    manufacturer price with respect to each
                                    dosage form and strength of a single
                                    source drug or an innovator multiple
                                    source drug increases on or after
                                    October 1, 2025, and such increased
                                    average manufacturer price exceeds the
                                    inflation-adjusted average manufacturer
                                    price determined with respect to such
                                    drug under subclause (II) for the
                                    rebate period, clause (i) shall not
                                    apply and there shall be no limitation
                                    on the sum of the amounts applied under
                                    paragraph (1)(A)(ii) and this paragraph
                                    for the rebate period with respect to
                                    each dosage form and strength of the
                                    single source drug or innovator
                                    multiple source drug.
                                        ``(II) Inflation-adjusted average
                                    manufacturer price defined.--In this
                                    clause, the term `inflation-adjusted
                                    average manufacturer price' means, with
                                    respect to a single source drug or an
                                    innovator multiple source drug and a
                                    rebate period, the average manufacturer
                                    price for each dosage form and strength
                                    of the drug for the calendar quarter
                                    beginning July 1, 1990 (without regard
                                    to whether or not the drug has been
                                    sold or transferred to an entity,
                                    including a division or subsidiary of
                                    the manufacturer, after the 1st day of
                                    such quarter), increased by the
                                    percentage by which the consumer price
                                    index for all urban consumers (United
                                    States city average) for the month
                                    before the month in which the rebate
                                    period begins exceeds such index for
                                    September 1990.''.
        (b) Treatment of Subsequently Approved Drugs.--Section
    1927(c)(2)(B) of the Social Security Act (42 U.S.C. 1396r-8(c)(2)(B))
    is amended by inserting ``and clause (ii)(II) of subparagraph (D)''
    after ``clause (ii)(II) of subparagraph (A)''.
        (c) Technical Amendments.--Section 1927(c)(3)(C)(ii)(IV) of the
    Social Security Act (42 U.S.C. 1396r-9(c)(3)(C)(ii)(IV)) is amended--
                (1) by striking ``subparagraph (A)'' and inserting
            ``paragraph (3)(A)''; and
                (2) by striking ``this subparagraph'' and inserting
            ``paragraph (3)(C)''.

                     Subtitle F--Medical Malpractice Reform

    SEC. 381. DEFINITIONS.

        In this Act:
                (1) Alternative dispute resolution system; adr.--The term
            ``alternative dispute resolution system'' or ``ADR'' means a
            system that provides for the resolution of health care lawsuits
            in a manner other than through a civil action brought in a
            State or Federal court.
                (2) Claimant.--The term ``claimant'' means any person who
            brings a health care lawsuit, including a person who asserts or
            claims a right to legal or equitable contribution, indemnity,
            or subrogation, arising out of a health care liability claim or
            action, and any person on whose behalf such a claim is asserted
            or such an action is brought, whether deceased, incompetent, or
            a minor.
                (3) Collateral source benefits.--The term ``collateral
            source benefits'' means any amount paid or reasonably likely to
            be paid in the future to or on behalf of the claimant, or any
            service, product, or other benefit provided or reasonably
            likely to be provided in the future to or on behalf of the
            claimant, as a result of the injury or wrongful death, pursuant
            to--
                        (A) any State or Federal health, sickness, income-
                    disability, accident, or workers' compensation law;
                        (B) any health, sickness, income-disability, or
                    accident insurance that provides health benefits or
                    income-disability coverage;
                        (C) any contract or agreement of any group,
                    organization, partnership, or corporation to provide,
                    pay for, or reimburse the cost of medical, hospital,
                    dental, or income-disability benefits; and
                        (D) any other publicly or privately funded program.
                (4) Contingent fee.--The term ``contingent fee'' includes
            all compensation to any person or persons which is payable only
            if a recovery is effected on behalf of one or more claimants.
                (5) Economic damages.--The term ``economic damages'' means
            objectively verifiable monetary losses incurred as a result of
            the provision or use of (or failure to provide or use) health
            care services or medical products, such as past and future
            medical expenses, loss of past and future earnings, cost of
            obtaining domestic services, loss of employment, and loss of
            business or employment opportunities, unless otherwise defined
            under applicable State law. In no circumstances shall damages
            for health care services or medical products exceed the amount
            actually paid or incurred by or on behalf of the claimant.
                (6) Future damages.--The term ``future damages'' means any
            damages that are incurred after the date of judgment,
            settlement, or other resolution (including mediation, or any
            other form of alternative dispute resolution).
                (7) Health care lawsuit.--The term ``health care lawsuit''
            means any health care liability claim concerning the provision
            of goods or services for which coverage was provided in whole
            or in part via a Federal program, subsidy or tax benefit, or
            any health care liability action concerning the provision of
            goods or services for which coverage was provided in whole or
            in part via a Federal program, subsidy or tax benefit, brought
            in a State or Federal court or pursuant to an alternative
            dispute resolution system, against a health care provider
            regardless of the theory of liability on which the claim is
            based, or the number of claimants, plaintiffs, defendants, or
            other parties, or the number of claims or causes of action, in
            which the claimant alleges a health care liability claim. Such
            term does not include a claim or action which is based on
            criminal liability; which seeks civil fines or penalties paid
            to Federal, State, or local government; or which is grounded in
            antitrust.
                (8) Health care liability action.--The term ``health care
            liability action'' means a civil action brought in a State or
            Federal court or pursuant to an alternative dispute resolution
            system, against a health care provider regardless of the theory
            of liability on which the claim is based, or the number of
            plaintiffs, defendants, or other parties, or the number of
            causes of action, in which the claimant alleges a health care
            liability claim.
                (9) Health care liability claim.--The term ``health care
            liability claim'' means a demand by any person, whether or not
            pursuant to ADR, against a health care provider, including, but
            not limited to, third-party claims, cross-claims, counter-
            claims, or contribution claims, which are based upon the
            provision or use of (or the failure to provide or use) health
            care services or medical products, regardless of the theory of
            liability on which the claim is based, or the number of
            plaintiffs, defendants, or other parties, or the number of
            causes of action.
                (10) Health care provider.--The term ``health care
            provider'' means any person or entity required by State or
            Federal laws or regulations to be licensed, registered, or
            certified to provide health care services, and being either so
            licensed, registered, or certified, or exempted from such
            requirement by other statute or regulation, as well as any
            other individual or entity defined as a health care provider,
            health care professional, or health care institution under
            State law.
                (11) Health care services.--The term ``health care
            services'' means the provision of any goods or services
            (including safety, professional, or administrative services
            directly related to health care) by a health care provider, or
            by any individual working under the supervision of a health
            care provider, that relates to the diagnosis, prevention, or
            treatment of any human disease or impairment, or the assessment
            or care of the health of human beings.
                (12) Medical product.--The term ``medical product'' means a
            drug, device, or biological product intended for humans, and
            the terms ``drug'', ``device'', and ``biological product'' have
            the meanings given such terms in sections 201(g)(1) and 201(h)
            of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(g)(1)
            and (h)) and section 351(a) of the Public Health Service Act
            (42 U.S.C. 262(a)), respectively, including any component or
            raw material used therein, but excluding health care services.
                (13) Noneconomic damages.--The term ``noneconomic damages''
            means damages for physical and emotional pain, suffering,
            inconvenience, physical impairment, mental anguish,
            disfigurement, loss of enjoyment of life, loss of society and
            companionship, loss of consortium (other than loss of domestic
            service), hedonic damages, injury to reputation, and all other
            nonpecuniary losses of any kind or nature incurred as a result
            of the provision or use of (or failure to provide or use)
            health care services or medical products, unless otherwise
            defined under applicable State law.
                (14) Recovery.--The term ``recovery'' means the net sum
            recovered after deducting any disbursements or costs incurred
            in connection with prosecution or settlement of the claim,
            including all costs paid or advanced by any person. Costs of
            health care incurred by the plaintiff and the attorneys' office
            overhead costs or charges for legal services are not deductible
            disbursements or costs for such purpose.
                (15) Representative.--The term ``representative'' means a
            legal guardian, attorney, person designated to make decisions
            on behalf of a patient under a medical power of attorney, or
            any person recognized in law or custom as a patient's agent.
                (16) State.--The term ``State'' means each of the several
            States, the District of Columbia, the Commonwealth of Puerto
            Rico, the Virgin Islands, Guam, American Samoa, the Northern
            Mariana Islands, the Trust Territory of the Pacific Islands,
            and any other territory or possession of the United States, or
            any political subdivision thereof.

    SEC. 382. ENCOURAGING SPEEDY RESOLUTION OF CLAIMS.

        (a) Statute of Limitations.--
                (1) In general.--Except as provided in paragraph (2), the
            time for the commencement of a health care lawsuit shall be,
            whichever occurs first of the following:
                        (A) Three years after the date of the occurrence of
                    the breach or tort.
                        (B) Three years after the date the medical or
                    health care treatment that is the subject of the claim
                    is completed.
                        (C) One year after the claimant discovers, or
                    through the use of reasonable diligence should have
                    discovered, the injury.
                (2) Tolling.--In no event shall the time for commencement
            of a health care lawsuit exceed 3 years after the date of the
            occurrence of the breach or tort or 3 years after the date the
            medical or health care treatment that is the subject of the
            claim is completed (whichever occurs first) unless tolled for
            any of the following--
                        (A) upon proof of fraud;
                        (B) intentional concealment; or
                        (C) the presence of a foreign body, which has no
                    therapeutic or diagnostic purpose or effect, in the
                    person of the injured person.
                (3) Actions by a minor.--Actions by a minor shall be
            commenced within 3 years after the date of the occurrence of
            the breach or tort or 3 years after the date of the medical or
            health care treatment that is the subject of the claim is
            completed (whichever occurs first) except that actions by a
            minor under the full age of 6 years shall be commenced within 3
            years after the date of the occurrence of the breach or tort, 3
            years after the date of the medical or health care treatment
            that is the subject of the claim is completed, or 1 year after
            the injury is discovered, or through the use of reasonable
            diligence should have been discovered, or prior to the minor's
            8th birthday, whichever provides a longer period. Such time
            limitation shall be tolled for minors for any period during
            which a parent or guardian and a health care provider have
            committed fraud or collusion in the failure to bring an action
            on behalf of the injured minor.
        (b) State Flexibility.--No provision of subsection (a) shall be
    construed to preempt any State law (whether effective before, on, or
    after the date of the enactment of this Act) that--
                (1) specifies a time period of less than 3 years after the
            date of injury or less than 1 year after the claimant
            discovers, or through the use of reasonable diligence should
            have discovered, the injury, for the filing of a health care
            lawsuit;
                (2) that specifies a different time period for the filing
            of lawsuits by a minor;
                (3) that triggers the time period based on the date of the
            alleged negligence; or
                (4) establishes a statute of repose for the filing of a
            health care lawsuit.

    SEC. 383. COMPENSATING PATIENT INJURY.

        (a) Unlimited Amount of Damages for Actual Economic Losses in
    Health Care Lawsuits.--In any health care lawsuit, nothing in this Act
    shall limit a claimant's recovery of the full amount of the available
    economic damages, notwithstanding the limitation in subsection (b).
        (b) Additional Noneconomic Damages.--In any health care lawsuit,
    the amount of noneconomic damages, if available, shall not exceed
    $250,000, regardless of the number of parties against whom the action
    is brought or the number of separate claims or actions brought with
    respect to the same injury.
        (c) No Discount of Award for Noneconomic Damages.--For purposes of
    applying the limitation in subsection (b), future noneconomic damages
    shall not be discounted to present value. The jury shall not be
    informed about the maximum award for noneconomic damages. An award for
    noneconomic damages in excess of $250,000 shall be reduced either
    before the entry of judgment, or by amendment of the judgment after
    entry of judgment, and such reduction shall be made before accounting
    for any other reduction in damages required by law. If separate awards
    are rendered for past and future noneconomic damages and the combined
    awards exceed $250,000, the future noneconomic damages shall be reduced
    first.
        (d) Fair Share Rule.--In any health care lawsuit, each party shall
    be liable for that party's several share of any damages only and not
    for the share of any other person. Each party shall be liable only for
    the amount of damages allocated to such party in direct proportion to
    such party's percentage of responsibility. Whenever a judgment of
    liability is rendered as to any party, a separate judgment shall be
    rendered against each such party for the amount allocated to such
    party. For purposes of this section, the trier of fact shall determine
    the proportion of responsibility of each party for the claimant's harm.
        (e) State Flexibility.--No provision of this section shall be
    construed to preempt any State law (whether effective before, on, or
    after the date of the enactment of this Act) that specifies a
    particular monetary amount of economic or noneconomic damages (or the
    total amount of damages) that may be awarded in a health care lawsuit,
    regardless of whether such monetary amount is greater or lesser than is
    provided for under this section.

    SEC. 384. MAXIMIZING PATIENT RECOVERY.

        (a) Court Supervision of Share of Damages Actually Paid to
    Claimants.--In any health care lawsuit, the court shall supervise the
    arrangements for payment of damages to protect against conflicts of
    interest that may have the effect of reducing the amount of damages
    awarded that are actually paid to claimants. In particular, in any
    health care lawsuit in which the attorney for a party claims a
    financial stake in the outcome by virtue of a contingent fee, the court
    shall have the power to restrict the payment of a claimant's damage
    recovery to such attorney, and to redirect such damages to the claimant
    based upon the interests of justice and principles of equity. In no
    event shall the total of all contingent fees for representing all
    claimants in a health care lawsuit exceed the following limits:
                (1) Forty percent of the first $50,000 recovered by the
            claimant(s).
                (2) Thirty-three and one-third percent of the next $50,000
            recovered by the claimant(s).
                (3) Twenty-five percent of the next $500,000 recovered by
            the claimant(s).
                (4) Fifteen percent of any amount by which the recovery by
            the claimant(s) is in excess of $600,000.
        (b) Applicability.--The limitations in this section shall apply
    whether the recovery is by judgment, settlement, mediation,
    arbitration, or any other form of alternative dispute resolution. In a
    health care lawsuit involving a minor or incompetent person, a court
    retains the authority to authorize or approve a fee that is less than
    the maximum permitted under this section. The requirement for court
    supervision in the first two sentences of subsection (a) applies only
    in civil actions.
        (c) State Flexibility.--No provision of this section shall be
    construed to preempt any State law (whether effective before, on, or
    after the date of the enactment of this Act) that specifies a lesser
    percentage or lesser total value of damages which may be claimed by an
    attorney representing a claimant in a health care lawsuit.

    SEC. 385. AUTHORIZATION OF PAYMENT OF FUTURE DAMAGES TO CLAIMANTS IN
                  HEALTH CARE LAWSUITS.

        (a) In General.--In any health care lawsuit, if an award of future
    damages, without reduction to present value, equaling or exceeding
    $50,000 is made against a party with sufficient insurance or other
    assets to fund a periodic payment of such a judgment, the court shall,
    at the request of any party, enter a judgment ordering that the future
    damages be paid by periodic payments, in accordance with the Uniform
    Periodic Payment of Judgments Act promulgated by the National
    Conference of Commissioners on Uniform State Laws.
        (b) Applicability.--This section applies to all actions which have
    not been first set for trial or retrial before the effective date of
    this Act.
        (c) State Flexibility.--No provision of this section shall be
    construed to preempt any State law (whether effective before, on, or
    after the date of the enactment of this Act) that specifies periodic
    payments for future damages at any amount other than $50,000 or that
    mandates such payments absent the request of either party.

    SEC. 386. PRODUCT LIABILITY FOR HEALTH CARE PROVIDERS.

        A health care provider who prescribes, or who dispenses pursuant to
    a prescription, a medical product approved, licensed, or cleared by the
    Food and Drug Administration shall not be named as a party to a product
    liability lawsuit involving such product and shall not be liable to a
    claimant in a class action lawsuit against the manufacturer,
    distributor, or seller of such product.

    SEC. 387. EFFECT ON OTHER LAWS.

        (a) Vaccine Injury.--
                (1) To the extent that title XXI of the Public Health
            Service Act establishes a Federal rule of law applicable to a
            civil action brought for a vaccine-related injury or death--
                        (A) this Act does not affect the application of the
                    rule of law to such an action; and
                        (B) any rule of law prescribed by this subtitle in
                    conflict with a rule of law of such title XXI shall not
                    apply to such action.
                (2) If there is an aspect of a civil action brought for a
            vaccine-related injury or death to which a Federal rule of law
            under title XXI of the Public Health Service Act does not
            apply, then this subtitle or otherwise applicable law (as
            determined under this subtitle) will apply to such aspect of
            such action.
        (b) Other Federal Law.--Except as provided in this section, nothing
    in this subtitle shall be deemed to affect any defense available to a
    defendant in a health care lawsuit or action under any other provision
    of Federal law.

    SEC. 388. LIMITATION ON EXPERT WITNESS TESTIMONY.

        (a) In General.--No person in a health care profession requiring
    licensure under the laws of a State shall be competent to testify in
    any court of law to establish the following facts--
                (1) the recognized standard of acceptable professional
            practice and the specialty thereof, if any, that the defendant
            practices, which shall be the type of acceptable professional
            practice recognized in the defendant's community or in a
            community similar to the defendant's community that was in
            place at the time the alleged injury or wrongful action
            occurred;
                (2) that the defendant acted with less than or failed to
            act with ordinary and reasonable care in accordance with the
            recognized standard; and
                (3) that as a proximate result of the defendant's negligent
            act or omission, the claimant suffered injuries which would not
            otherwise have occurred,
    unless the person was licensed to practice, in the State or a
    contiguous bordering State, a profession or specialty which would make
    the person's expert testimony relevant to the issues in the case and
    had practiced this profession or specialty in one of these States
    during the year preceding the date that the alleged injury or wrongful
    act occurred.
        (b) Applicability.--The requirements set forth in subsection (a)
    shall also apply to expert witnesses testifying for the defendant as
    rebuttal witnesses.
        (c) Waiver Authority.--The court may waive the requirements in this
    subsection if it determines that the appropriate witnesses otherwise
    would not be available.

    SEC. 389. EXPERT WITNESS QUALIFICATIONS.

        (a) In General.--In any health care lawsuit, an individual shall
    not give expert testimony on the appropriate standard of practice or
    care involved unless the individual is licensed as a health
    professional in one or more States and the individual meets the
    following criteria:
                (1) If the party against whom or on whose behalf the
            testimony is to be offered is or claims to be a specialist, the
            expert witness shall specialize at the time of the occurrence
            that is the basis for the lawsuit in the same specialty or
            claimed specialty as the party against whom or on whose behalf
            the testimony is to be offered. If the party against whom or on
            whose behalf the testimony is to be offered is or claims to be
            a specialist who is board certified, the expert witness shall
            be a specialist who is board certified in that specialty or
            claimed specialty.
                (2) During the 1-year period immediately preceding the
            occurrence of the action that gave rise to the lawsuit, the
            expert witness shall have devoted a majority of the
            individual's professional time to one or more of the following:
                        (A) The active clinical practice of the same health
                    profession as the defendant and, if the defendant is or
                    claims to be a specialist, in the same specialty or
                    claimed specialty.
                        (B) The instruction of students in an accredited
                    health professional school or accredited residency or
                    clinical research program in the same health profession
                    as the defendant and, if the defendant is or claims to
                    be a specialist, in an accredited health professional
                    school or accredited residency or clinical research
                    program in the same specialty or claimed specialty.
                (3) If the defendant is a general practitioner, the expert
            witness shall have devoted a majority of the witness's
            professional time in the 1-year period preceding the occurrence
            of the action giving rise to the lawsuit to one or more of the
            following:
                        (A) Active clinical practice as a general
                    practitioner.
                        (B) Instruction of students in an accredited health
                    professional school or accredited residency or clinical
                    research program in the same health profession as the
                    defendant.
        (b) Lawsuits Against Entities.--If the defendant in a health care
    lawsuit is an entity that employs a person against whom or on whose
    behalf the testimony is offered, the provisions of subsection (a) apply
    as if the person were the party or defendant against whom or on whose
    behalf the testimony is offered.
        (c) Power of Court.--Nothing in this section shall limit the power
    of the trial court in a health care lawsuit to disqualify an expert
    witness on grounds other than the qualifications set forth under this
    subsection.
        (d) Limitation.--An expert witness in a health care lawsuit shall
    not be permitted to testify if the fee of the witness is in any way
    contingent on the outcome of the lawsuit.
        (e) State Flexibility.--No provision of this section shall be
    construed to preempt any State law (whether effective before, on, or
    after the date of the enactment of this Act) that places additional
    qualification requirements upon any individual testifying as an expert
    witness.

    SEC. 390. COMMUNICATIONS FOLLOWING UNANTICIPATED OUTCOME.

        (a) Provider Communications.--In any health care liability action,
    any and all statements, affirmations, gestures, or conduct expressing
    apology, fault, sympathy, commiseration, condolence, compassion, or a
    general sense of benevolence which are made by a health care provider
    or an employee of a health care provider to the patient, a relative of
    the patient, or a representative of the patient and which relate to the
    discomfort, pain, suffering, injury, or death of the patient as the
    result of the unanticipated outcome of medical care shall be
    inadmissible for any purpose as evidence of an admission of liability
    or as evidence of an admission against interest.
        (b) State Flexibility.--No provision of this section shall be
    construed to preempt any State law (whether effective before, on, or
    after the date of the enactment of this Act) that makes additional
    communications inadmissible as evidence of an admission of liability or
    as evidence of an admission against interest.

    SEC. 391. AFFIDAVIT OF MERIT.

        (a) Required Filing.--Subject to subsection (b), the plaintiff in a
    health care lawsuit alleging negligence or, if the plaintiff is
    represented by an attorney, the plaintiff's attorney shall file
    simultaneously with the health care lawsuit an affidavit of merit
    signed by a health professional who meets the requirements for an
    expert witness under section 242 of this Act. The affidavit of merit
    shall certify that the health professional has reviewed the notice and
    all medical records supplied to him or her by the plaintiff's attorney
    concerning the allegations contained in the notice and shall contain a
    statement of each of the following:
                (1) The applicable standard of practice or care.
                (2) The health professional's opinion that the applicable
            standard of practice or care was breached by the health
            professional or health facility receiving the notice.
                (3) The actions that should have been taken or omitted by
            the health professional or health facility in order to have
            complied with the applicable standard of practice or care.
                (4) The manner in which the breach of the standard of
            practice or care was the proximate cause of the injury alleged
            in the notice.
                (5) A listing of the medical records reviewed.
        (b) Filing Extension.--Upon motion of a party for good cause shown,
    the court in which the complaint is filed may grant the plaintiff or,
    if the plaintiff is represented by an attorney, the plaintiff's
    attorney an additional 28 days in which to file the affidavit required
    under subsection (a).
        (c) State Flexibility.--No provision of this section shall be
    construed to preempt any State law (whether effective before, on, or
    after the date of the enactment of this Act) that establishes
    additional requirements for the filing of an affidavit of merit or
    similar pre-litigation documentation.

    SEC. 392. NOTICE OF INTENT TO COMMENCE LAWSUIT.

        (a) Advance Notice.--A person shall not commence a health care
    lawsuit against a health care provider unless the person has given the
    health care provider 90 days written notice before the action is
    commenced.
        (b) Exceptions.--A health care lawsuit against a health care
    provider filed within 6 months of the statute of limitations expiring
    as to any claimant, or within 1 year of the statute of repose expiring
    as to any claimant, shall be exempt from compliance with this section.
        (c) State Flexibility.--No provision of this section shall be
    construed to preempt any State law (whether effective before, on, or
    after the date of the enactment of this Act) that establishes a
    different time period for the filing of written notice.

    SEC. 393. LIMITATION ON LIABILITY FOR VOLUNTEER HEALTH CARE
                  PROFESSIONALS.

        (a) In General.--Title II of the Public Health Service Act (42
    U.S.C. 202 et seq.) is amended by inserting after section 224 the
    following:

    ``SEC. 224A. LIMITATION ON LIABILITY FOR VOLUNTEER HEALTH CARE
                  PROFESSIONALS.

        ``(a) Limitation on Liability.--A physician shall not be liable
    under Federal or State law in any civil action for any harm caused by
    an act or omission of such physician, or attending medical personnel
    supporting such physician, if such act or omission--
                ``(1) occurs in the course of furnishing qualified charity
            care (as such term is defined in section 199B of the Internal
            Revenue Code of 1986); and
                ``(2) was not grossly negligent.
        ``(b) Preemption.--This section preempts the laws of a State or any
    political subdivision of a State to the extent that such laws are
    inconsistent with this section, unless such laws provide greater
    protection from liability for a defendant.
        ``(c) Definitions.--In this section:
                ``(1) Physician.--The term `physician' has the meaning
            given such term by section 1861(r) of the Social Security Act.
                ``(2) Attending medical personnel.--The term `attending
            medical personnel' means an individual who is licensed to
            directly support a physician in furnishing medical services.''.
        (b) Effective Date.--The amendments made by this section shall
    apply to any claim filed to the extent that it is with respect to acts
    or omissions occurring after the date of the enactment of this Act.

    SEC. 394. RULES OF CONSTRUCTION.

        (a) Health Care Lawsuits.--Unless otherwise specified in this
    subtitle, the provisions governing health care lawsuits set forth in
    this subtitle preempt, subject to subsections (b) and (c), State law to
    the extent that State law prevents the application of any provisions of
    law established by or under this subtitle. The provisions governing
    health care lawsuits set forth in this subtitle supersede chapter 171
    of title 28, United States Code, to the extent that such chapter--
                (1) provides for a greater amount of damages or contingent
            fees, a longer period in which a health care lawsuit may be
            commenced, or a reduced applicability or scope of periodic
            payment of future damages, than provided in this subtitle; or
                (2) prohibits the introduction of evidence regarding
            collateral source benefits, or mandates or permits subrogation
            or a lien on collateral source benefits.
        (b) Protection of States' Rights and Other Laws.--Any issue that is
    not governed by any provision of law established by or under this
    subtitle (including State standards of negligence) shall be governed by
    otherwise applicable State or Federal law.
        (c) State Flexibility.--No provision of this subtitle shall be
    construed to preempt any defense available to a party in a health care
    lawsuit under any other provision of State or Federal law.

    SEC. 395. EFFECTIVE DATE.

        This subtitle shall apply to any health care lawsuit brought in a
    Federal or State court, or subject to an alternative dispute resolution
    system, that is initiated on or after the date of the enactment of this
    subtitle, except that any health care lawsuit arising from an injury
    occurring prior to the date of the enactment of this subtitle shall be
    governed by the applicable statute of limitations provisions in effect
    at the time the cause of action accrued.

                    TITLE IV--MEDICARE AND MEDICAID REFORMS

                          Subtitle A--Medicaid Reforms

    SEC. 401. MEDICAID PAYMENT REFORM.

        (a) In General.--Title XIX of the Social Security Act (42 U.S.C.
    1396 et seq.) is amended by inserting after section 1903 the following
    section:

    ``SEC. 1903A. REFORMED PAYMENT TO STATES.

        ``(a) Reformed Payment System.--
                ``(1) In general.--For quarters beginning on or after the
            implementation date (as defined in subsection (k)(1)), in the
            case of a State that elects (in a time and manner specified by
            the Secretary) to apply this section, in lieu of amounts
            otherwise payable to such State under this title (including any
            payments attributable to section 1923), except as otherwise
            provided in this section, the amount payable to such State
            shall be equal to the sum of the following:
                        ``(A) Adjusted aggregate beneficiary-based
                    amount.--The aggregate beneficiary-based amount
                    specified in subsection (b) for the quarter and the
                    State, adjusted under subsection (e).
                        ``(B) Chronic care quality bonus.--The amount (if
                    any) of the chronic care quality bonus payment
                    specified in subsection (f) for the quarter for the
                    State.
                ``(2) Requirement of state share.--
                        ``(A) In general.--A State shall make, from non-
                    Federal funds, expenditures in an amount equal to its
                    State share (as determined under subparagraph (B)) for
                    a quarter for items, services, and other costs for
                    which, but for paragraph (1), Federal funds would have
                    been payable under this title.
                        ``(B) State share.--The State share for a State for
                    a quarter in a fiscal year is equal to the product of--
                                ``(i) the aggregate beneficiary-based
                            amount specified in subsection (b) for the
                            quarter and the State; and
                                ``(ii) the ratio of--
                                        ``(I) the State percentage
                                    described in subparagraph (D)(ii) for
                                    such State and fiscal year; to
                                        ``(II) the Federal percentage
                                    described in subparagraph (D)(i) for
                                    such State and fiscal year.
                        ``(C) Nonpayment for failure to pay state share.--
                                ``(i) In general.--If a State fails to
                            expend the amount required under subparagraph
                            (A) for a quarter in a fiscal year, the amount
                            payable to the State under paragraph (1) shall
                            be reduced by the product of the amount by
                            which the State payment is less than the State
                            share and the ratio of--
                                        ``(I) the Federal percentage
                                    described in subparagraph (D)(i) for
                                    such State and fiscal year; to
                                        ``(II) the State percentage
                                    described in subparagraph (D)(ii) for
                                    such State and fiscal year.
                                ``(ii) Grace period.--A State shall not be
                            considered to have failed to provide payment of
                            its required State share for a quarter under
                            subparagraph (A) if the aggregate State payment
                            towards the State's required State share for
                            the 4-quarter period beginning with such
                            quarter exceeds the required State share amount
                            for such 4-quarter period.
                        ``(D) Federal and state percentages.--In this
                    paragraph, with respect to a State and a fiscal year:
                                ``(i) Federal percentage.--The Federal
                            percentage described in this clause is 75
                            percent or, if higher, the Federal medical
                            assistance percentage for such State for such
                            fiscal year.
                                ``(ii) State percentage.--The State
                            percentage described in this clause is 100
                            percent minus the Federal percentage described
                            in clause (i).
                        ``(E) Rules for crediting toward state share.--
                                ``(i) General limitation to matchable
                            expenditures.--A payment for expenditures shall
                            not be counted toward the State share under
                            subparagraph (A) unless Federal payments may be
                            used for such expenditures consistent with
                            paragraph (3)(B).
                                ``(ii) Further limitations on allowable
                            expenditures.--A payment for expenditures shall
                            not be counted towards the State share under
                            subparagraph (A) if the expenditure is for any
                            of the following:
                                        ``(I) Abortion.--Expenditures for
                                    an abortion.
                                        ``(II) Intergovernmental
                                    transfers.--An expenditure that is
                                    attributable to an intergovernmental
                                    transfer.
                                        ``(III) Certified public
                                    expenditures.--An expenditure that is
                                    attributable to certified public
                                    expenditures.
                                ``(iii) Crediting fraud and abuse
                            recoveries.--Amounts recovered by a State
                            through the operation of its Medicaid fraud and
                            abuse control unit described in section 1903(q)
                            shall be fully counted toward the State share
                            under subparagraph (A).
                        ``(F) Construction.--Nothing in the paragraph shall
                    be construed as preventing a State from expending, from
                    non-Federal funds, an amount under this title in excess
                    of the amount of the State share.
                        ``(G) Determination based upon submitted claims.--
                    In applying this paragraph with respect to expenditures
                    of a State for a quarter, the determination of the
                    expenditures for such State for such quarter shall be
                    made after the end of the period (which, as of the date
                    of the enactment of this section, is 2 years) for which
                    the Secretary accepts claims for payment under this
                    title with respect to such quarter.
                ``(3) Use of federal payments.--
                        ``(A) Application of medicaid limitations.--A State
                    may only use Federal payments received under subsection
                    (a) for expenditures for which Federal funds would have
                    been payable under this title but for this section.
                        ``(B) Limitation for certain eligibles.--
                                ``(i) Application of 100 percent federal
                            poverty line limit on eligibility.--Subject to
                            clause (iii), a State may not use such Federal
                            payments to provide medical assistance for an
                            individual who has an income (as determined
                            under clause (ii)) that exceeds 100 percent of
                            the poverty line (as defined in section
                            2110(c)(5)) applicable to a family of the size
                            involved.
                                ``(ii) Determination of income using
                            modified adjusted gross income without any 5
                            percent increase.--In determining income for
                            purposes of clause (i) under section
                            1902(e)(14) (relating to modified adjusted
                            gross income), the following rules shall apply:
                                        ``(I) Application of spend down.--
                                    The State shall take into account the
                                    costs incurred for medical care or for
                                    any other type of remedial care
                                    recognized under State law in the same
                                    manner and to the same extent that such
                                    State takes such costs into account for
                                    purposes of section 1902(a)(17).
                                        ``(II) Disregard of 5 percent
                                    increase.--Subparagraph (I) of section
                                    1902(e)(14) (relating to a 5 percent
                                    reduction) shall not apply.
                                ``(iii) Exception.--Clause (i) shall not
                            apply to an individual who is--
                                        ``(I) a woman described in clause
                                    (i) of section 1903(v)(4)(A);
                                        ``(II) a child who is an individual
                                    described in clause (i) of section
                                    1905(a);
                                        ``(III) enrolled in a State plan
                                    under this title as of the date of the
                                    enactment of this section for the
                                    period of continuous enrollment; or
                                        ``(IV) described in section
                                    1902(e)(14)(D) (relating to modified
                                    adjusted gross income).
                                ``(iv) Clarification related to community
                            spouse.--Nothing in this subparagraph shall
                            supersede the application of section 1924
                            (related to community spouse income and
                            assets).
                ``(4) Exceptions for pass-through payments.--
                        ``(A) In general.--Paragraph (1) shall not apply,
                    and amounts shall continue to be payable under this
                    title (and not under subsection (a)), in the case of
                    the following payments (and related administrative
                    costs and expenditures):
                                ``(i) Payments to territories.--Payments to
                            a State other than the 50 States and the
                            District of Columbia.
                                ``(ii) Medicare cost-sharing.--Payments
                            attributable to Medicare cost-sharing under
                            section 1905(p).
                                ``(iii) Pediatric vaccines.--Payments
                            attributable to section 1928.
                                ``(iv) Emergency services for certain
                            individuals.--Payments for treatment of
                            emergency medical conditions attributable to
                            the application of section 1903(v)(2).
                                ``(v) Indian health care facilities.--
                            Payments for medical assistance described in
                            the third sentence of section 1905(b).
                                ``(vi) Employer-sponsored insurance
                            (esi).--Payments for medical assistance
                            attributable to payments to employers for
                            employer-sponsored health benefits coverage.
                                ``(vii) Other populations with limited
                            benefit coverage.--Other payments that are
                            determined by the Secretary to be related to a
                            specified population for which the medical
                            assistance under this title is limited and does
                            not include any inpatient, nursing facility, or
                            long-term care services.
                        ``(B) Certain expenses.--Paragraph (1) shall not
                    apply, and amounts shall continue to be payable under
                    this title (and not under subsection (a)), in the case
                    of the following:
                                ``(i) Administration of medicare
                            prescription drug benefit.--Expenditures
                            described in section 1935(b) (relating to
                            administration of the Medicare prescription
                            drug benefit).
                                ``(ii) Payments for hit bonuses.--Payments
                            under section 1903(a)(3)(F) (relating to
                            payments to encourage the adoption and use of
                            certified EHR technology).
                                ``(iii) Payments for design, development,
                            and installation of mmis and eligibility
                            systems.--Payments under subparagraphs (A)(i)
                            and (H)(i) of section 1903(a)(3) for
                            expenditures for design, development, and
                            installation of the Medicaid management
                            information systems and mechanized verification
                            and information retrieval systems (related to
                            eligibility).
                ``(5) Payment of amounts.--
                        ``(A) In general.--Except as the Secretary may
                    otherwise provide, amounts shall be payable to a State
                    under subsection (a) in the same manner as amounts are
                    payable under subsection (d) of section 1903 to a State
                    under subsection (a) of such section.
                        ``(B) Information and forms.--
                                ``(i) Submission.--As a condition of
                            receiving payment under subsection (a), a State
                            shall submit such information, in such form,
                            and manner, as the Secretary shall specify,
                            including information necessary to make the
                            computations under subsections (c)(2)(C) and
                            (e).
                                ``(ii) Uniform reporting.--The Secretary
                            shall develop such forms as may be needed to
                            assure a system of uniform reporting of such
                            information across States.
                        ``(C) Required reporting of information on medical
                    loss ratios for managed care.--The information required
                    to be reported under subparagraph (B)(i) shall include
                    information on the medical loss ratio with respect to
                    coverage provided under each Medicaid managed care plan
                    with a contract with the State under section 1903(m) or
                    1932.
        ``(b) Aggregate Beneficiary-Based Amount.--
                ``(1) In general.--The aggregate beneficiary-based amount
            specified in this subsection for a State for a quarter is equal
            to the sum of the products, for each of the categories of
            Medicaid beneficiaries specified in paragraph (2), of the
            following:
                        ``(A) Beneficiary-based quarterly amount.--The
                    beneficiary-based quarterly amount for such category
                    computed under subsection (c) for such State for such
                    quarter.
                        ``(B) Number of individuals in category.--Subject
                    to subsection (d), the average number of Medicaid
                    beneficiaries enrolled in such category in the State in
                    such quarter.
                ``(2) Categories.--The categories specified in this
            paragraph are the following:
                        ``(A) Elderly.--A category of Medicaid
                    beneficiaries who are 65 years of age or older.
                        ``(B) Blind or disabled.--A category of Medicaid
                    beneficiaries not described in subparagraph (A) who are
                    described in section 1937(a)(2)(B)(ii).
                        ``(C) Children.--A category of Medicaid
                    beneficiaries not described in subparagraph (B) who are
                    under 21 years of age.
                        ``(D) Other adults.--A category of any Medicaid
                    beneficiaries who are not described in a previous
                    subparagraph of this paragraph.
        ``(c) Computation of Per Beneficiary, Per Category Quarterly
    Amount.--
                ``(1) In general.--For a State, for each category of
            beneficiary for a quarter--
                        ``(A) First reform year.--For quarters in the first
                    reform year (as defined in subsection (k)(2)), the
                    beneficiary-based quarterly amount is equal to \1/4\ of
                    the base average per beneficiary Federal payments for
                    such State for such category determined under paragraph
                    (2), increased by a factor that reflects the sum of the
                    following:
                                ``(i) Historical medical care component of
                            cpi through previous reform year.--The
                            percentage increase in the historical medical
                            care component of the Consumer Price Index for
                            all urban consumers (U.S. city average) from
                            the midpoint of the base fiscal year (as
                            defined in paragraph (6)) to the midpoint of
                            the fiscal year preceding the first reform
                            year.
                                ``(ii) Projected medical care component of
                            cpi for the first reform year.--The percentage
                            increase in the projected medical care
                            component of the Consumer Price Index for all
                            urban consumers (U.S. city average) from the
                            midpoint of the previous fiscal year referred
                            to in clause (i) to the midpoint of the first
                            reform year.
                        ``(B) Second and third reform years.--The
                    beneficiary-based quarterly amount for a State for a
                    category for quarters in the second reform year or the
                    third reform year is equal to the beneficiary-based
                    quarterly amount under this paragraph for such State
                    and category for the previous reform year increased by
                    the per beneficiary percentage increase (as defined in
                    subparagraph (E)) for such category and reform year.
                        ``(C) Fourth through tenth reform years.--The
                    beneficiary-based quarterly amount for a State for a
                    category for quarters in a reform year beginning with
                    the fourth reform year and ending with the tenth reform
                    year is--
                                ``(i) in the case of a State that is a high
                            per beneficiary State or a low per beneficiary
                            State (as defined in paragraph (4)(B)(iii)) for
                            the category, the amount determined under
                            clause (i) or (ii) of paragraph (4)(B) for such
                            State, category, and reform year; or
                                ``(ii) in the case of any other State, the
                            beneficiary-based quarterly amount under this
                            paragraph for such State and category for the
                            previous reform year increased by the per
                            beneficiary percentage increase for such
                            category and reform year.
                        ``(D) Eleventh reform year and subsequent reform
                    years.--The beneficiary-based quarterly amount for a
                    State for a category for quarters in a reform year
                    beginning with the eleventh reform year is equal to the
                    beneficiary-based quarterly amount under this paragraph
                    for such State and category for the previous reform
                    year increased by the per beneficiary percentage
                    increase for such category and reform year.
                        ``(E) Annual percentage increase beginning with
                    second reform year.--For purposes of this subsection,
                    the term `per beneficiary percentage increase' means,
                    for a reform year, the sum of--
                                ``(i) the projected percentage change in
                            nominal gross domestic product from the
                            midpoint of the previous reform year to the
                            midpoint of the reform year for which the
                            percentage increase is being applied; and
                                ``(ii) one percentage point.
                ``(2) Base per beneficiary, per category amount for each
            state.--
                        ``(A) Average per category.--
                                ``(i) In general.--The Secretary shall
                            determine, consistent with this paragraph and
                            paragraph (3), a base per beneficiary, per
                            category amount for each of the 50 States and
                            the District of Columbia equal to the average
                            amount, per Medicaid beneficiary, of Federal
                            payments under this title, including payments
                            attributable to disproportionate share hospital
                            payments under section 1923, for each of the
                            categories of beneficiaries under subsection
                            (b)(2) for the base fiscal year for each of the
                            50 States and the District of Columbia.
                                ``(ii) Best available data.--The
                            determination under clause (i) shall initially
                            be estimated by the Secretary, based upon the
                            best available data at the time the
                            determination is made.
                                ``(iii) Updates.--The determination under
                            clause (i) shall be updated by the Secretary on
                            an annual basis based upon improved data. The
                            Secretary shall adjust the amounts under
                            subsection (a)(1)(A) to reflect changes in the
                            amounts so determined based on such updates.
                        ``(B) Exclusion of pass-through payments.--In
                    computing base per beneficiary, per category amounts
                    under subparagraph (A)(i) the Secretary shall exclude
                    payments described in subsection (a)(4).
                        ``(C) Standardization.--
                                ``(i) In general.--In computing each such
                            amount, the Secretary shall standardize the
                            amount in order to remove the variation
                            attributable to the following:
                                        ``(I) Risk factors.--Such risk
                                    factors as age, health and disability
                                    status (including high cost medical
                                    conditions), gender, institutional
                                    status, and such other factors as the
                                    Secretary determines to be appropriate,
                                    so as to ensure actuarial equivalence.
                                        ``(II) Geographic.--Variations in
                                    costs on a county-by-county basis.
                                ``(ii) Method of standardization.--
                                        ``(I) Consultation in development
                                    of risk standardization.--In developing
                                    the methodology for risk
                                    standardization for purposes of clause
                                    (i)(I), the Secretary shall consult
                                    with the Medicaid and CHIP Payment and
                                    Access Commission, the Medicare Payment
                                    Advisory Commission, and the National
                                    Association of Medicaid Directors.
                                        ``(II) Method for risk
                                    standardization.--In carrying out
                                    clause (i)(I), the Secretary may apply
                                    the hierarchal condition category
                                    methodology under section
                                    1853(a)(1)(C). If the Secretary uses
                                    such methodology, the Secretary shall
                                    adjust the application of such
                                    methodology to take into account the
                                    differences in services provided under
                                    this title compared to title XVIII,
                                    such as the coverage of long term care,
                                    pregnancy, and pediatric services.
                                        ``(III) Method for geographic
                                    standardization.--The Secretary shall
                                    apply the standardization under clause
                                    (i)(II) in a manner similar to that
                                    applied under section
                                    1853(c)(4)(A)(iii).
                                ``(iii) Application on a national, budget
                            neutral basis.--The standardization under
                            clause (i) shall be designed and implemented on
                            a uniform national basis and shall be budget
                            neutral so as to not result in any aggregate
                            change in payments under subsection (a).
                                ``(iv) Response to new risk.--Subject to
                            clause (iii), the Secretary may adjust the
                            standardization under clause (i) to respond
                            promptly to new instances of communicable
                            diseases and other public health hazards.
                                ``(v) Reference to application of risk
                            adjustment.--For rules related to the
                            application of risk adjustment to amounts under
                            subsection (a)(1)(A), see subsection (e).
                        ``(D) Adjustment for temporary fmap increases.--In
                    computing each base per beneficiary, per category
                    amounts under subparagraph (A)(i) the Secretary shall
                    disregard portions of payments that are attributable to
                    a temporary increase in the Federal matching rates,
                    including those attributable to the following:
                                ``(i) PPACA disaster fmap.--Section
                            1905(aa).
                                ``(ii) ARRA.--Section 5001 of the American
                            Recovery and Reinvestment Act of 2009 (42
                            U.S.C. 1396d note).
                                ``(iii) Extraordinary employer pension
                            contribution.--Section 614 of the Children's
                            Health Insurance Program Reauthorization Act of
                            2009 (42 U.S.C. 1396d note).
                ``(3) Allocation of nonmedical assistance payments.--The
            Secretary shall establish rules for the allocation of payments
            under this title (other than those payments described in
            paragraph (1) or (5) of section 1903(a) and including such
            payments attributable to section 1923)--
                        ``(A) among different categories of beneficiaries;
                    and
                        ``(B) between payments included under subsection
                    (a)(1) and payments described in subsection (a)(4).
                ``(4) Transition to a corridor around the national
            average.--
                        ``(A) Determination of national average base per
                    beneficiary, per category amount.--Subject to
                    subparagraph (C), the Secretary shall determine a
                    national average base per beneficiary, per category
                    amount equal to the average of the base per
                    beneficiary, per category amounts for each of the 50
                    States and the District of Columbia determined under
                    paragraph (2), weighted by the average number of
                    beneficiaries in each such category and State as
                    determined by the Secretary consistent with subsection
                    (d) for the base fiscal year.
                        ``(B) Transition adjustment.--
                                ``(i) High per beneficiary states.--In the
                            case of a high per beneficiary State (as
                            defined in clause (iii)(I)) for a category, the
                            beneficiary-based quarterly amount for such
                            State and category for a quarter in a reform
                            year (beginning with the fourth reform year and
                            ending with the tenth reform year) is equal to
                            the sum of--
                                        ``(I) the product of the State-
                                    specific factor for such reform year
                                    (as defined in clause (iv)) and the
                                    beneficiary-based quarterly amount that
                                    would otherwise be determined under
                                    paragraph (1) for such State and
                                    category if the State were a State
                                    described in clause (ii) of paragraph
                                    (1)(C), instead of a State described in
                                    clause (i) of such paragraph; and
                                        ``(II) the product of 1 minus the
                                    State-specific factor for such reform
                                    year and the beneficiary-based
                                    quarterly amount that would otherwise
                                    be determined under paragraph (1) for a
                                    State and category if the base per
                                    beneficiary, per category amount
                                    determined under paragraph (2) for the
                                    State and category were equal to 110
                                    percent of the national average base
                                    per beneficiary, per category amount
                                    determined under subparagraph (A) for
                                    such category.
                                ``(ii) Low per beneficiary states.--In the
                            case of a low per beneficiary State (as defined
                            in clause (iii)(II)) for a category, the
                            beneficiary-based quarterly amount for such
                            State and category for a quarter in a reform
                            year (beginning with the fourth reform year and
                            ending with the tenth reform year) is equal to
                            the sum of--
                                        ``(I) the product of the State-
                                    specific factor for such reform year
                                    and the beneficiary-based quarterly
                                    amount that would otherwise be
                                    determined under paragraph (1) for such
                                    State and category if the State were a
                                    State described in clause (ii) of
                                    paragraph (1)(C), instead of a State
                                    described in clause (i) of such
                                    paragraph; and
                                        ``(II) the product of 1 minus the
                                    State-specific factor for such reform
                                    year and the beneficiary-based
                                    quarterly amount that would otherwise
                                    be determined under paragraph (1) for a
                                    State and category if the base per
                                    beneficiary, per category amount
                                    determined under paragraph (2) for the
                                    State and category were equal to 90
                                    percent of the national average base
                                    per beneficiary, per category amount
                                    determined under subparagraph (A) for
                                    such category.
                                ``(iii) High and low per beneficiary states
                            defined.--In this subparagraph:
                                        ``(I) High per beneficiary state.--
                                    The term `high per beneficiary State'
                                    means, with respect to a category, a
                                    State for which the base per
                                    beneficiary, per category amount
                                    determined under paragraph (2) for such
                                    category is greater than 110 percent of
                                    the national average base per
                                    beneficiary, per category amount
                                    determined under subparagraph (A) for
                                    such category.
                                        ``(II) Low per beneficiary state.--
                                    The term `low per beneficiary State'
                                    means, with respect to a category, a
                                    State for which the base per
                                    beneficiary, per category amount
                                    determined under paragraph (2) for such
                                    category is less than 90 percent of the
                                    national average base per beneficiary,
                                    per category amount determined under
                                    subparagraph (A) for such category.
                                ``(iv) State-specific factor.--In this
                            subparagraph, the term `State-specific factor'
                            means--
                                        ``(I) for the fourth reform year,
                                    \7/8\; and
                                        ``(II) for a subsequent reform
                                    year, the State-specific factor under
                                    this clause for the previous reform
                                    year minus \1/8.\
                        ``(C) No additional expenditures.--
                                ``(i) Determination of increase in federal
                            expenditures.--For each category for each
                            reform year (beginning with the fourth reform
                            year and ending with the tenth reform year),
                            the Secretary shall determine whether the
                            application of this paragraph--
                                        ``(I) to the category for the
                                    reform year will result in an aggregate
                                    increase in the aggregate Federal
                                    expenditures under subsection (a); and
                                        ``(II) to all the categories for
                                    the reform year will result in a net
                                    aggregate increase in the aggregate
                                    Federal expenditures under subsection
                                    (a).
                                ``(ii) Adjustment.--If the Secretary
                            determines under clause (i)(II) that the
                            application of this paragraph to all the
                            categories for a reform year will result in a
                            net aggregate increase in the aggregate Federal
                            expenditures under subsection (a), the
                            Secretary shall reduce the national average
                            base per beneficiary, per category amount
                            computed under subparagraph (A) for each of the
                            categories determined under clause (i)(I) for
                            which there will be an aggregate increase in
                            the aggregate Federal expenditures under
                            subsection (a) by such uniform percentage as
                            will ensure that there is no net aggregate
                            Federal expenditure increase described in
                            clause (i)(II) for the reform year.
                ``(5) Reports on per beneficiary rates; appeals.--
                        ``(A) Report to states.--Not later than 8 months
                    after the date of the enactment of this section, the
                    Secretary shall submit to each State the Secretary's
                    initial determination of--
                                ``(i) the base per beneficiary, per
                            category amounts under paragraph (2) for such
                            State; and
                                ``(ii) the national average base per
                            beneficiary, per category amounts under
                            paragraph (4)(A).
                        ``(B) Opportunity to appeal.--Not later than 3
                    months after the date a State receives notice of the
                    Secretary's initial determination of such base per
                    beneficiary, per category amounts for such State under
                    subparagraph (A)(i), the State may file with the
                    Secretary, in a form and manner specified by the
                    Secretary, an appeal of such determination.
                        ``(C) Determination on appeal.--Not later than 3
                    months after receiving such an appeal, the Secretary
                    shall make a final determination on such amounts for
                    such State. If no such appeal is received for a State,
                    the Secretary's initial determination under
                    subparagraph (A)(i) shall become final.
                ``(6) Base fiscal year defined.--In this section, the term
            `base fiscal year' means the latest fiscal year, ending before
            the date of the enactment of this section, for which the
            Secretary determines that adequate data are available to make
            the computations required under this subsection.
        ``(d) Not Counting Individuals To Account for Excluded Payments.--
    Under rules specified by the Secretary, individuals shall not be
    counted as Medicaid beneficiaries for purposes of subsection (b)(1)(B)
    and subsection (c)(2)(A) to the extent that such individuals--
                ``(1) are receiving medical assistance for which payments
            described under subsection (a)(4)(A) are made; or
                ``(2) would not have been eligible to enroll under the
            State plan (or waiver of such plan) in the State in which such
            individual is so enrolled if the rules for eligibility for
            enrollment under such plan (or waiver) were the same as such
            rules for eligibility in effect as of January 1, 2009.
        ``(e) Risk Adjustment.--
                ``(1) In general.--The amount under subsection (a)(1)(A)
            shall be adjusted under this subsection in an appropriate
            manner, specified by the Secretary and consistent with
            paragraph (2), to take into account--
                        ``(A) the factors described in subsection
                    (c)(2)(C)(i)(I) within a category of beneficiaries; and
                        ``(B) variations in costs on a county-by-county
                    basis for medical assistance and administrative
                    expenses.
                ``(2) Method of adjustment.--
                        ``(A) In general.--The adjustments under paragraph
                    (1) shall be made in a manner similar to the manner in
                    which similar adjustments are made under subsection
                    (c)(2)(C) and consistent with the requirements of
                    clause (iii) of such subsection and subparagraph (B).
                        ``(B) Biannual update of risk adjustment
                    methodology.--In applying clause (i)(I) of subsection
                    (c)(2)(C) for purposes of subparagraph (A), the
                    Secretary shall, in consultation with the entities
                    described in clause (ii)(I) of such subsection, update
                    the risk adjustment methodology applied as appropriate
                    not less often than every 2 years.
        ``(f) Chronic Care Quality Bonus Payments.--
                ``(1) Determination of bonus payments.--If the Secretary
            determines that, based on the reports under paragraph (5), with
            respect to categories of chronic disease for which chronic care
            performance targets had been established under paragraph (3)
            for each category of Medicaid beneficiaries specified under
            subsection (b)(2) such targets have been met by a State for a
            reform year, the Secretary shall make an additional payment to
            such State in the amount specified in paragraph (6) for each
            quarter in the succeeding reform year. Such payments shall be
            made in a manner specified by the Secretary and may only be
            used consistent with subsection (a)(3).
                ``(2) Identification of categories of chronic disease.--The
            Secretary shall determine the categories of chronic disease for
            which bonus payments may be available under this subsection for
            each category of Medicaid beneficiaries.
                ``(3) Adoption of quality measurement system and
            identification of performance targets.--
                        ``(A) System and data.--With respect to the
                    categories of chronic disease under paragraph (2), the
                    Secretary shall adopt a quality measurement system that
                    uses data described in paragraph (4) and is similar to
                    the Five-Star Quality Rating System used to indicate
                    the performance of Medicare Advantage plans under part
                    C of title XVIII.
                        ``(B) Targets.--Using such system and data, the
                    Secretary shall establish for each reform year the
                    chronic care performance targets for purposes of the
                    payments under paragraph (1). Such performance targets
                    shall be established in consultation with States,
                    associations representing individuals with chronic
                    illnesses, entities providing treatment to such
                    individuals for such chronic illnesses, and other
                    stakeholders, including the National Association of
                    Medicaid Directors and the National Governors
                    Association.
                ``(4) Data to be used.--The data to be used under paragraph
            (3) shall include--
                        ``(A) data collected through methods such as--
                                ``(i) the `Healthcare Effectiveness Data
                            and Information Set' (also known as `HEDIS')
                            (or an appropriate successor performance
                            measurement tool);
                                ``(ii) the `Consumer Assessment of
                            Healthcare Providers and Systems' (also known
                            as `CAHPS') (or an appropriate successor
                            performance measurement tool); and
                                ``(iii) the `Health Outcomes Survey' (also
                            known as `HOS') (or an appropriate successor
                            performance measurement tool); and
                        ``(B) other data collected by the State.
                ``(5) Reports.--
                        ``(A) In general.--Each State shall collect,
                    analyze, and report to the Secretary, at a frequency
                    and in a manner to be established by the Secretary,
                    data described in paragraph (4) that permit the
                    Secretary to monitor the State's performance relative
                    to the chronic care performance targets established
                    under paragraph (3).
                        ``(B) Review and verification.--The Secretary may
                    review the data collected by the State under
                    subparagraph (A) to verify the State's analysis of such
                    data with respect to the performance targets under
                    paragraph (3).
                ``(6) Amount of bonus payments.--
                        ``(A) In general.--Subject to subparagraphs (B) and
                    (C), with respect to each category of Medicaid
                    beneficiaries, in the case of a State that the
                    Secretary determines, based on the chronic care
                    performance targets set under paragraph (3) for a
                    reform year for such category, performs--
                                ``(i) in the top five States in such
                            category, subject to subparagraph (C)(ii), the
                            amount of the bonus for each quarter in the
                            succeeding reform year shall be 10 percent of
                            the payment amount otherwise paid to the State
                            under subsection (a) for individuals enrolled
                            under the plan within such category;
                                ``(ii) in the next five States in such
                            category, subject to subparagraph (C)(ii), the
                            amount of the bonus for each such quarter shall
                            be 5 percent of the payment amount otherwise
                            paid to the State under subsection (a) for
                            individuals enrolled under the plan within such
                            category;
                                ``(iii) in the next five States in such
                            category, subject to clauses (i) and (iii) of
                            subparagraph (C), the amount of the bonus for
                            each such quarter shall be 3 percent of the
                            payment amount otherwise paid to the State
                            under subsection (a) for individuals enrolled
                            under the plan within such category;
                                ``(iv) in the next five States in such
                            category, subject to clauses (i) and (iii) of
                            subparagraph (C), the amount of the bonus for
                            each such quarter shall be 2 percent of the
                            payment amount otherwise paid to the State
                            under subsection (a) for individuals enrolled
                            under the plan within such category; and
                                ``(v) in the next five States in such
                            category, subject to clauses (i) and (iii) of
                            subparagraph (C), the amount of the bonus for
                            each such quarter shall be 1 percent of the
                            payment amount otherwise paid to the State
                            under subsection (a) for individuals enrolled
                            under the plan within such category.
                        ``(B) Aggregate annual limit for each category of
                    medicaid beneficiaries.--
                                ``(i) In general.--In no case may the
                            aggregate amount of bonuses under this
                            subsection for quarters in a reform year for a
                            category of Medicaid beneficiaries exceed the
                            limit specified in clause (ii) for the reform
                            year.
                                ``(ii) Limit.--The limit specified in this
                            clause--
                                        ``(I) for the second reform year is
                                    equal to $250,000,000; or
                                        ``(II) for a subsequent reform year
                                    is equal to the limit specified in this
                                    clause for the previous reform year
                                    increased by the per beneficiary
                                    percentage increase determined under
                                    paragraph (1)(E) of subsection (c).
                        ``(C) Limitation and proration of bonuses based on
                    application of aggregate limit.--
                                ``(i) No bonus for third or subsequent
                            tiers unless aggregate limit not reached on
                            first two tiers.--No bonus shall be payable
                            under clause (iii), (iv), or (v) of
                            subparagraph (A) for a category of Medicaid
                            beneficiaries for a quarter in a reform year
                            unless the aggregate amount of bonuses under
                            clauses (i) and (ii) of such subparagraph for
                            such category and reform year is less than the
                            limit specified in subparagraph (B)(ii) for the
                            reform year.
                                ``(ii) Proration for first two tiers.--If
                            the aggregate amount of bonuses under clauses
                            (i) and (ii) of subparagraph (A) for a category
                            of Medicaid beneficiaries for quarters in a
                            reform year exceeds the limit specified in
                            subparagraph (B)(ii) for the reform year, the
                            amount of each such bonus shall be prorated in
                            a manner so the aggregate amount of such
                            bonuses is equal to such limit.
                                ``(iii) Proration for next three tiers.--If
                            the aggregate amount of bonuses under clauses
                            (i) and (ii) of subparagraph (A) for a category
                            of Medicaid beneficiaries for quarters in a
                            reform year is less than the limit specified in
                            subparagraph (B)(ii) for the reform year, but
                            the aggregate amount of bonuses under clauses
                            (i) through (v) of subparagraph (A) for the
                            category and such quarters in the reform year
                            exceeds the limit specified in subparagraph
                            (B)(ii) for the reform year, the amount of each
                            bonus in clauses (iii), (iv), and (v) of
                            subparagraph (A) shall be prorated in a manner
                            so the aggregate amount of all the bonuses
                            under subparagraph (A) is equal to such limit.
        ``(g) State Option for Receiving Medicare Payments for Full-Benefit
    Dual Eligible Individuals.--
                ``(1) In general.--Under this subsection a State may elect
            for quarters beginning on or after the implementation date in a
            reform year to receive payment from the Secretary under
            paragraph (3). As a condition of receiving such payment, the
            State shall agree to provide to full-benefit dual eligible
            individuals eligible for medical assistance under the State
            plan--
                        ``(A) the medical assistance to which such eligible
                    individuals would otherwise be entitled under this
                    title; and
                        ``(B) any items and services which such eligible
                    individuals would otherwise receive under title XVIII.
                ``(2) Provider payment requirement.--
                        ``(A) In general.--A State electing the option
                    under this subsection shall provide payment to health
                    care providers for the items and services described
                    under paragraph (1)(B) at a rate that is not less than
                    the rate at which payments would be made to such
                    providers for such items and services under title
                    XVIII.
                        ``(B) Flexibility in payment methods.--Nothing in
                    subparagraph (A) shall be construed as preventing a
                    State from using alternative payment methodologies
                    (such as bundled payments or the use of accountable
                    care organizations (as such term is used in section
                    1899)) for purposes of making payments to health care
                    providers for items and services provided to dual
                    eligible individuals in the State under the option
                    under this subsection.
                ``(3) Payments to states in lieu of medicare payments.--
            With respect to a full-benefit dual eligible individual, in the
            case of a State that elects the option under paragraph (1) for
            quarters in a reform year--
                        ``(A) the Secretary shall not make any payment
                    under title XVIII for items and services furnished to
                    such individual for such quarters; and
                        ``(B) the Secretary shall pay to the State, in
                    addition to the amounts paid to such State under
                    subsection (a), the amount that the Secretary would,
                    but for this subsection, otherwise pay under title
                    XVIII for items and services furnished to such an
                    individual in such State for such quarters.
                ``(4) Full-benefit dual eligible individual defined.--In
            this subsection, the term `full-benefit dual eligible
            individual' means an individual who meets the requirements of
            section 1935(c)(6)(A)(ii).
        ``(h) Audits.--The Secretary shall conduct such audits on the
    number and classification of Medicaid beneficiaries under such
    subsections and expenditures under this section as may be necessary to
    ensure appropriate payments under this section.
        ``(i) Treatment of Waivers.--
                ``(1) No impact on current waivers.--In the case of a
            waiver of requirements of this title pursuant to section 1115
            or other law that is in effect as of the date of the enactment
            of this section, nothing in this section shall be construed to
            affect such waiver for the period of the waiver as approved as
            of such date.
                ``(2) Application of budget neutrality to subsequent
            waivers and renewals taking section into account.--In the case
            of a waiver of requirements of this title pursuant to section
            1115 or other law that is approved or renewed after the date of
            the enactment of this section, to the extent that such approval
            or renewal is conditioned upon a demonstration of budget
            neutrality, budget neutrality shall be determined taking into
            account the application of this section.
        ``(j) Report to Congress.--Not later than January 1 of the second
    reform year, the Secretary shall submit to Congress a report on the
    implementation of this section.
        ``(k) Definitions.--In this section:
                ``(1) Implementation date.--The term `implementation date'
            means--
                        ``(A) July 1, 2025, if this section is enacted on
                    or before July 1, 2024; or
                        ``(B) July 1, 2026, if this section is enacted
                    after July 1, 2024.
                ``(2) Reform years.--
                        ``(A) The term `reform year' means a fiscal year
                    beginning with the first reform year.
                        ``(B) The term `first reform year' means the fiscal
                    year in which the implementation date occurs.
                        ``(C) The terms `second', `third', and successive
                    similar terms mean, with respect to a reform year, the
                    second, third, or successive reform year, respectively,
                    succeeding the first reform year.''.
        (b) Conforming Amendments.--
                (1) Continued application of clawback provisions.--
                        (A) Continued application.--Subsections (a) and
                    (c)(1)(C) of section 1935 of such Act (42 U.S.C. 1396u-
                    5) are each amended by inserting ``or 1903A(a)'' after
                    ``1903(a)''.
                        (B) Technical amendment.--Section 1935(d)(1) of the
                    Social Security Act (42 U.S.C. 1396u-5(d)(1)) is
                    amended by inserting ``except as provided in section
                    1903A(g)'' after ``any other provision of this title''.
                (2) Payment rules under section 1903.--
                        (A) Section 1903(a) of the Social Security Act (42
                    U.S.C. 1396b(a)) is amended, in the matter before
                    paragraph (1), by inserting ``and section 1903A'' after
                    ``except as otherwise provided in this section''.
                        (B) Section 1903(d) of such Act (42 U.S.C.
                    1396b(d)) is amended--
                                (i) in paragraph (1), by inserting ``and
                            under section 1903A'' after ``subsections (a)
                            and (b)'';
                                (ii) in paragraph (2)--
                                        (I) in subparagraph (A), by
                                    inserting ``or section 1903A'' after
                                    ``was made under this section''; and
                                        (II) in subparagraph (B), by
                                    inserting ``or section 1903A'' after
                                    ``under subsection (a)'';
                                (iii) in paragraph (4)--
                                        (I) by striking ``under this
                                    subsection'' and inserting ``, with
                                    respect to this section or section
                                    1903A, under this subsection''; and
                                        (II) by striking ``under this
                                    section'' and inserting ``under the
                                    respective section''; and
                                (iv) in paragraph (5), by inserting ``or
                            section 1903A'' after ``overpayment under this
                            section''.
                (3) Conforming waiver authority.--Section 1115(a)(2)(A) of
            the Social Security Act (42 U.S.C. 1315(a)(2)(A)) is amended by
            striking ``or 1903'' and inserting ``1903, or 1903A''.
                (4) Report on additional conforming amendments needed.--Not
            later than 6 months after the date of the enactment of this
            Act, the Secretary of Health and Human Services shall submit to
            Congress a report that includes a description of any additional
            technical and conforming amendments to law that are required to
            properly carry out this Act.

    SEC. 402. INCOME LIMITATIONS FOR REFUNDABLE CREDITS FOR COVERAGE UNDER
                  A QUALIFIED HEALTH PLAN.

        (a) In General.--Subparagraphs (A) and (B) of section 36B(c)(1) of
    the Internal Revenue Code of 1986 are amended by inserting after ``100
    percent'' each place such term appears the following: ``(or, in the
    case of a taxpayer enrolled through an Exchange utilized by such State
    that makes the election described in section 1903A of the Social
    Security Act, the percentage established by such State under part A of
    title IV of such Act for purposes of eligibility under title XIX of
    such Act as of January 1, 2009)''.
        (b) Effective Date.--The amendments made by this section shall
    apply with respect to taxable years beginning after the date of the
    enactment of this Act.

    SEC. 403. MEDICAID ELIGIBILITY DETERMINATIONS.

        (a) State Flexibility To Use Contractors To Make Eligibility
    Determinations on Behalf of State.--Section 1902(a)(5) of the Social
    Security Act (42 U.S.C. 1396a(a)(5)) is amended by inserting before the
    semicolon at the end the following: ``, but such determinations of
    eligibility may be made, at the option of a State, under a contract
    with another State or local agency or a contractor so long as the
    contract does not provide incentives for the agency or contractor to
    delay eligibility determinations or to deny eligibility for individuals
    otherwise eligible for medical assistance''.
        (b) Frequency of Eligibility Redeterminations.--Section 1902(e)(14)
    of the Social Security Act (42 U.S.C. 1396a(e)(14)) is amended by
    adding at the end the following:
                        ``(L) Frequency of eligibility redeterminations.--
                    Beginning on October 1, 2024, and notwithstanding
                    subparagraph (H), in the case of an individual whose
                    eligibility for medical assistance under the State plan
                    under this title (or a waiver of such plan) is
                    determined based on the application of modified
                    adjusted gross income under subparagraph (A) and who is
                    so eligible on the basis of clause (i)(VIII), (ii)(XX),
                    or (ii)(XXIII) of subsection (a)(10)(A), at the option
                    of the State, the State plan may provide that the
                    individual's eligibility shall be redetermined every 6
                    months (or such shorter number of months as the State
                    may elect).''.

    SEC. 404. LOWERING SAFE HARBOR THRESHOLD WITH RESPECT TO STATE TAXES ON
                  HEALTH CARE PROVIDERS.

         Section 1903(w)(4)(C)(ii) of the Social Security Act (42 U.S.C.
    1396b(w)(4)(C)(ii)) is amended--
                (1) by striking ``of fiscal years beginning'' and inserting
            ``of fiscal years--
                        ``(I) beginning''; and
                (2) by striking ``it appears.'' and inserting the
            following: ``it appears;
                        ``(II) beginning on or after January 1, 2025, and
                    before January 1, 2034, `4 percent' shall be
                    substituted for `6 percent' each place it appears;
                        ``(III) beginning on or after January 1, 2034, and
                    before January 1, 2039, `3 percent' shall be
                    substituted for `6 percent' each place it appears;
                        ``(IV) beginning on or after January 1, 2039, and
                    before January 1, 2044, `2 percent' shall be
                    substituted for `6 percent' each place it appears;
                        ``(V) beginning on or after January 1, 2044, and
                    before January 1, 2049, `1 percent' shall be
                    substituted for `6 percent' each place it appears; and
                        ``(VI) beginning on or after January 1, 2049, `0
                    percent' shall be substituted for `6 percent' each
                    place it appears.''.

    SEC. 405. PROVIDING FOR STATE APPROVAL AND IMPLEMENTATION OF SPECIFIED
                  WAIVERS UNDER THE MEDICAID PROGRAM.

        Section 1115 of the Social Security Act (42 U.S.C. 1315) is
    amended--
                (1) in subsection (d)--
                        (A) in paragraph (1), by striking ``An
                    application'' and inserting ``Subject to paragraph (4),
                    an application''; and
                        (B) by adding at the end the following new
                    paragraph:
                ``(4)(A) An experimental, pilot, or demonstration project
            undertaken under subsection (a) may be approved or renewed by a
            State if such project is described in subparagraph (B).
                ``(B) An experimental, pilot, or demonstration project is
            described in this subparagraph if such project provides for a
            waiver of requirements with respect to a State plan (or a
            waiver of such plan) under title XIX such that--
                        ``(i) individuals enrolled under such plan (or such
                    waiver) may elect to participate in such project with
                    respect to a year; and
                        ``(ii) such individuals who elect to so participate
                    are furnished with primary care services (as described
                    in section 223(c)(1)(D)(ii)(I) of the Internal Revenue
                    Code of 1986) through a direct primary care service
                    arrangement (as defined in such section).
                ``(C) For purposes of a State's approval or renewal of an
            experimental, pilot, or demonstration project under
            subparagraph (A), each reference to `the Secretary' in
            subsection (a) shall be deemed to be a reference to `the
            State'.''; and
                (2) in subsection (e), by inserting ``(other than such a
            project that is described in paragraph (4)(B))'' before the
            period at the end.

    SEC. 406. DEDUCTION FOR QUALIFIED CHARITY CARE.

        (a) In General.--Part VI of subchapter B of chapter 1 of the
    Internal Revenue Code of 1986 is amended by adding at the end the
    following new section:

    ``SEC. 199B. QUALIFIED CHARITY CARE.

        ``(a) In General.--There shall be allowed as a deduction for the
    taxable year an amount equal to--
                ``(1) in the case of a direct primary care physician, an
            amount equal to the sum of--
                        ``(A) the fee (as published on a publicly available
                    website of such physician) for physicians' services
                    that are qualified charity care furnished by such
                    taxpayer during such year, and
                        ``(B) for each visit by a patient to such physician
                    during which qualified charity care is furnished, half
                    of so much of the lowest subscription fee of such
                    physician that is attributable to a month, and
                ``(2) in the case of any other individual, the unreimbursed
            Medicare-based value of qualified charity care furnished by
            such taxpayer during such year.
        ``(b) Definitions.--For purposes of this section:
                ``(1) Unreimbursed medicare-based value.--The term
            `unreimbursed Medicare-based value' means, with respect to
            physicians' services, the amount payable for such services
            under the physician fee schedule established under section 1848
            of the Social Security Act.
                ``(2) Qualified charity care.--The term `qualified charity
            care' means physicians' services that are furnished--
                        ``(A) without expectation of reimbursement, and
                        ``(B) to an individual enrolled--
                                ``(i) under a State plan under title XIX of
                            the Social Security Act (or a waiver of such
                            plan), or
                                ``(ii) under a State child health plan
                            under title XXI of the Social Security Act (or
                            a waiver of such plan).
                ``(3) Direct primary care physician.--The term `direct
            primary care physician' means a physician (as defined in
            section 1861(r) of the Social Security Act) who provides
            primary care--
                        ``(A) to individuals who have paid a periodic
                    subscription fee, and
                        ``(B) in exchange for a fee that is published on a
                    publicly available website of such physician.
                ``(4) Physicians' services.--The term `physicians'
            services' has the meaning given such term by section 1861(q) of
            the Social Security Act.
        ``(c) Limitation.--The amount allowed as a deduction under
    subsection (a) for a taxable year shall not exceed the gross receipts
    attributable to physicians' services furnished by the taxpayer during
    the taxable year.''.
        (b) Clerical Amendment.--The table of sections for part VI of
    subchapter B of chapter 1 of the Internal Revenue Code of 1986 is
    amended by adding at the end the following new item:

    ``Sec. 199B. Qualified charity care.''.

                          Subtitle B--Medicare Reforms

    SEC. 411. OFF-CAMPUS PROVIDER-BASED DEPARTMENT MEDICARE SITE NEUTRAL
                  PAYMENT.

        (a) 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:
        ``(x) Off-Campus Provider-Based Department Medicare Site Neutral
    Payment.--
                ``(1) In general.--With respect to items and services
            furnished in an off-campus provider-based department, payment
            under this section for such items and services shall be the
            amount determined under the fee schedule under section 1848 for
            such items and services furnished if furnished in a physician
            office setting.
                ``(2) Off-campus provider-based department.--For purposes
            of this subsection, the term `off-campus provider-based
            department' has such meaning as specified by the Secretary.''.
        (b) Effective Date.--The amendment made by subsection (a) shall
    apply with respect to items and services furnished on or after January
    1, 2025.

    SEC. 412. ELIMINATING FEHBP ELIGIBILITY FOR ANNUITANTS.

        Section 8905(b) of title 5, United States Code, is amended--
                (1) in the matter preceding paragraph (1), by striking
            ``An'' and inserting ``Consistent with the last sentence of
            this subsection, an''; and
                (2) by adding at the end the following: ``. An individual
            who is entitled to benefits under part A of title XVIII of the
            Social Security Act (42 U.S.C. 1395c et seq.) by reason of
            section 226 or 226A of such Act (42 U.S.C. 426, 426-1), or
            otherwise eligible to enroll under such part pursuant to
            section 1818 or 1818A of such Act (42 U.S.C. 1395i-2, 1395i-
            2a), and who first becomes an annuitant after the date of
            enactment of this sentence may not continue enrollment in any
            health benefits plan under this chapter.''.

    SEC. 413. ELIMINATION OF MEDICARE ELIGIBILITY FOR CERTAIN INDIVIDUALS.

        (a) Enrollment Prohibition.--
                (1) Part b.--Section 1836 of the Social Security Act (42
            U.S.C. 1395o) is amended by striking the period at the end and
            inserting ``, except that an individual who attains age 65 on
            or after January 1, 2032, and is an individual who, upon
            attaining such age, has earned $10,000,000 or more in lifetime
            wages, shall not be eligible to so enroll.''.
                (2) Part d.--Section 1860D-1(a)(3)(A) of such Act (42
            U.S.C. 1395w-101(a)(3)(A)) is amended by striking the period at
            the end and inserting ``, excluding an individual who, upon
            attaining age 65, has earned $10,000,000 or more in lifetime
            wages.''.
        (b) Medigap.--Section 1882 of the Social Security Act (42 U.S.C.
    1395ss) is amended by adding at the end the following new subsection:
        ``(aa) Additional Limitation on Newly Eligible Beneficiaries.--
                ``(1) In general.--Notwithstanding any other provision of
            this section, on or after January 1, 2032, a medicare
            supplemental policy may not be sold or issued to a targeted
            newly eligible Medicare beneficiary.
                ``(2) Targeted newly eligible medicare beneficiary.--For
            purposes of this subsection, the term `targeted newly eligible
            Medicare beneficiary' means an individual who, upon attaining
            the age of 65, has earned $10,000,000 or more in lifetime
            wages.''.

    SEC. 414. MEDICARE PART D TAX DEDUCTION.

        (a) In General.--Section 139A of the Internal Revenue Code of 1986
    is amended by adding at the end the following: ``This section shall not
    be taken into account for purposes of determining whether any deduction
    is allowable with respect to any cost taken into account in determining
    such payment.''.
        (b) Effective Date.--The amendment made by this section shall apply
    to taxable years beginning after December 31, 2022.

    SEC. 415. REPEAL OF NET INVESTMENT INCOME TAX.

        (a) In General.--Subtitle A of the Internal Revenue Code of 1986 is
    amended by striking chapter 2A.
        (b) Effective Date.--The amendment made by this section shall apply
    to taxable years beginning after December 31, 2024.

    SEC. 416. MEDICARE COVERAGE OF BAD DEBT.

        Section 1861(v)(1) of the Social Security Act (42 U.S.C.
    1395(v)(1)) is amended--
                (1) in subparagraph (T)--
                        (A) in clause (iv), by striking ``and'' at the end;
                        (B) in clause (v)--
                                (i) by striking ``during fiscal year'' and
                            inserting ``during fiscal years'';
                                (ii) by striking ``or a subsequent fiscal
                            year'' and inserting ``through 2024''; and
                                (iii) by striking the period at the end and
                            inserting ``, and''; and
                        (C) by adding at the end the following new clause:
                ``(vi) for cost reporting periods beginning during fiscal
            year 2025 or a subsequent fiscal year, by the percent
            applicable for cost reporting periods beginning during the
            previous fiscal year, increased (through fiscal year 2027) by
            10 percentage points.'';
                (2) in subparagraph (V)--
                        (A) in clause (i)--
                                (i) in subclause (III), by striking ``and''
                            at the end;
                                (ii) in subclause (IV)--
                                        (I) by striking ``during fiscal
                                    year'' and inserting ``during fiscal
                                    years 2017 through 2024''; and
                                        (II) by striking the period at the
                                    end and inserting ``; and''; and
                                (iii) by adding at the end the following
                            new subclause:
                        ``(V) for cost reporting periods beginning during
                    fiscal year 2025 or a subsequent fiscal year, the
                    percent applicable for cost reporting periods beginning
                    during the previous fiscal year, increased (through
                    fiscal year 2027) by 10 percentage points.''; and
                        (B) in clause (ii)--
                                (i) in subclause (III), by striking ``and''
                            at the end; and
                                (ii) in subclause (IV)--
                                        (I) by striking ``a subsequent
                                    fiscal year'' and inserting ``fiscal
                                    years 2015 through 2024'';
                                        (II) by striking the period at the
                                    end and inserting ``; and''; and
                                        (III) by adding at the end the
                                    following new subclause:
                        ``(V) for cost reporting periods beginning during
                    fiscal year 2025 or a subsequent fiscal year, shall be
                    reduced by the percent applicable for cost reporting
                    periods beginning during the previous fiscal year,
                    increased (through fiscal year 2027) by 10 percentage
                    points.''; and
                (3) in subparagraph (W)(i)--
                        (A) in subclause (II), by striking ``and'' at the
                    end;
                        (B) in subclause (III)--
                                (i) by striking ``during a subsequent
                            fiscal year'' and inserting ``during fiscal
                            years 2015 through 2024''; and
                                (ii) by striking the period at the end and
                            inserting ``; and''; and
                        (C) by adding at the end the following new
                    subclause:
                ``(IV) for cost reporting periods beginning during fiscal
            year 2025 or a subsequent fiscal year, by the percent
            applicable for cost reporting periods beginning during the
            previous fiscal year, increased (through fiscal year 2027) by
            10 percentage points.''.

                  Subtitle C--Medicare Choice and Competition

    SEC. 421. COMPETITIVE BIDDING AND PREMIUMS UNDER UNIFIED MEDICARE.

        (a) In General.--Part E of title XVIII of the Social Security Act,
    as added by section 101 and amended by section 103, is further amended
    by adding at the end the following:

                 ``Subpart 3--Competitive Bidding and Premiums

    ``SEC. 1860E-31. APPLICATION OF COMPETITIVE BIDDING IN ENROLLMENT.

        ``(a) In General.--Notwithstanding any other provision of this
    title, the Secretary shall, beginning with plan year 2025, establish a
    method whereby individuals enrolling under this title so enroll through
    an online process designed to highlight enrollment options for such
    individuals and allow such individuals to compare costs of enrollment
    in such options.
        ``(b) Enrollment Options.--For purposes of subsection (a), the
    Secretary shall make the following options available to individuals for
    enrollment under this title:
                ``(1) Traditional fee-for-service coverage.
                ``(2) provider-led risk-bearing plans (also known as ACOs).
                ``(3) Medicare Advantage plans.
        ``(c) Medicare Advantage Plan Actuarial Value Requirement.--Each
    Medicare Advantage plan offered through the process described in
    subsection (a) shall have an actuarial value equal to traditional fee-
    for-service coverage under parts A and B.
        ``(d) MA Direct Deposit of Certain Rebates.--In the case of an
    Medicare Advantage plan with a bid for a year that involves a premium
    differential between such bid and the benchmark for such year and plan,
    such plan shall provide for a direct deposit of such differential if
    the applicable enrollee in such plan does not elect any supplemental
    coverage under such plan.
        ``(e) Enrollment in Prescription Drug Coverage.--As part of the
    method described in subsection (a), the Secretary shall establish a
    process to allow an individual to enroll in prescription drug coverage.
    In the case of an individual who enrolls in a Medicare Advantage plan,
    such coverage shall be provided under such plan. In a case of an
    individual who enrolls in an ACO, such coverage shall be provided under
    such network. In the case of an individual who enrolls under
    traditional fee-for-service coverage, such drug coverage shall be
    provided through a prescription drug plan.
        ``(f) Supplemental Benefits.--
                ``(1) MA plans.--An MA plan is allowed to offer two
            different packages of supplemental benefits (these packages are
            available only to individuals who select such plans).
                ``(2) ACOs.--ACOs may limit supplemental options for their
            enrollees to Medigap plans with contractual ties.
                ``(3) Fee-for-service.--Fee-for-service individuals may
            select supplemental coverage from Medigap policies.

    ``SEC. 1860E-32. COMPETITION.

        ``(a) Bid Areas.--Market areas used for bid submissions for
    Medicare Advantage plans, ACOs, and for calculation per person fee-for-
    services costs shall be metropolitan statistical regions plus
    associated regions.
        ``(b) Premiums.--Medicare payment benchmark by market area shall be
    calculated based on weighted average (by enrollment in previous year)
    of the premium bids from MA plans, ACOs, and the per person costs of
    fee-for-service, less the statutory part B premium.
        ``(c) Beneficiary Responsibility.--Beneficiaries shall pay the
    difference between Medicare payment and required premium of the plan
    they choose, and get 100 percent of the savings by choosing a plan with
    a premium below the benchmark.
        ``(d) Transition.--For beneficiaries who are in fee-for-service at
    the time of the enactment of this section, there shall be a limit on
    the amount of a premium increase allowable by year of no more than $20
    per month compared to what such premium would have otherwise been if
    this subpart had not been enacted for each year through the fifth year.
        ``(e) Multiyear Contracts.--A Medicare Advantage plan may offer to
    beneficiaries multiyear contracts with guaranteed premiums over such
    years, bearing the risk of any change in payments from the Secretary in
    subsequent years. A beneficiary enrolling under such a contract shall
    be exempt from the method described in subsection (a).''.
        (b) Conforming Amendments.--
                (1) Section 1853(a)(1)(A) of the Social Security Act is
            amended by striking ``and section 1859(e)(4)'' and inserting
            ``, section 1859(e)(4), and subpart 3 of part E''.
                (2) Section 1853(j) of such Act is amended by inserting
            ``and subpart 3 of part E'' after ``subsection (o)''.
                (3) Section 1854 of such Act is amended--
                        (A) in subsection (a), after the heading, by
                    inserting ``Subject to subpart 3 of part E:'';
                        (B) in subsection (b), after the heading, by
                    inserting ``Subject to subpart 3 of part E:'';
                        (C) in subsection (d), after the heading, by
                    inserting ``Subject to subpart 3 of part E:''; and
                        (D) in subsection (e), after the heading, by
                    inserting ``Subject to subpart 3 of part E:''.

    SEC. 422. NEW UNIFIED ELIGIBILITY AND ENROLLMENT RULES.

        (a) In General.--Title XVIII of the Social Security Act is
    amended--
                (1) by redesignating part E as part F; and
                (2) by inserting after part D the following new part:

                 ``PART E--MEDICARE WITH CHOICE AND COMPETITION

                    ``Subpart 1--Opt-Out and Auto-Enrollment

    ``SEC. 1860E-11. PART A OPT-OUT AND MA AUTO-ENROLLMENT.

        ``(a) Permitting Individuals To Opt Out of Part A Coverage Without
    Losing Social Security Benefits.--
                ``(1) In general.--The Secretary shall establish--
                        ``(A) a process by which an individual otherwise
                    entitled to benefits under part A may elect (at a time
                    and in a manner specified under the process) to waive
                    such entitlement; and
                        ``(B) a process by which an individual who elects
                    to waive such entitlement may revoke (at a time and in
                    a manner specified under the process) such waiver.
            The process under subparagraph (B) shall be coordinated with
            the enrollment process under section 1837 for part B.
                ``(2) Application of late enrollment penalty.--An
            individual who revokes a waiver under paragraph (1)(B) shall be
            subject to a late enrollment penalty as applied under section
            1860E-32(c)(2)(C).
                ``(3) No impact on title ii benefits.--Notwithstanding any
            other provision of law, an election of an individual to waive
            entitlement to benefits under part A under paragraph (1)(A)
            shall not result in any loss of benefits under title II.
                ``(4) Deemed opt-out.--
                        ``(A) An election of an individual to waive
                    entitlement to benefits under part A under paragraph
                    (1)(A) is also deemed the filing of a notice of
                    termination of benefits under part B pursuant to
                    section 1838(b)(1).
                        ``(B) The termination of benefits under part B
                    pursuant to section 1838(b) is also deemed to be a
                    waiver of any entitlement to benefits under part A.
        ``(b) Special Open Enrollment Period Without Late Enrollment
    Penalty for Current Part A Only or Part B Only Enrollees.--
    Notwithstanding any other provision of law, in the case of an
    individual who as of the general effective date, is entitled to
    benefits under part A but not enrolled under part B, or who is enrolled
    under part B but not entitled to benefits (or enrolled) under part A,
    beginning as of such date, such individual shall be deemed to be
    enrolled under part B or part A, respectively, unless such individual
    elects to be enrolled (or entitled to benefits) under neither of such
    parts during a special open enrollment period specified by the
    Secretary. No increase in the monthly premium of an individual pursuant
    to section 1839(b) or section 1818(c) shall be effected in the case of
    any such individual who is deemed enrolled under part B or part A
    pursuant to the previous sentence with respect to any period prior to
    the date of such enrollment.
        ``(c) Auto Enrollment of Dual Eligible Individuals Under Medicare
    Advantage Plans.--
                ``(1) In general.--Except in the case of a State that has
            elected the maintenance of effort option described in section
            1944(b)(2), in the case of an individual described in
            subparagraph (A)(ii) of section 1935(c)(6) (taking into account
            the application of subparagraph (B) of such section), the
            Secretary shall establish a process for the enrollment in an
            MA-PD plan that is a managed care plan under part C that has a
            monthly beneficiary premium that does not exceed the premium
            assistance available under section 1860E-41(b)(1)(A). If there
            is more than one such plan available, the Secretary shall
            enroll such an individual on a random basis among all such
            plans in the PDP region.
                ``(2) Right to disenroll.--Nothing in paragraph (1) shall
            prevent such an individual from declining enrollment in any
            such plan (and thereby obtaining coverage under Medicare fee-
            for-service) or from changing enrollment in such a plan to
            another MA-PD plan.

    ``SEC. 1860E-12. COORDINATION WITH PART D.

        ``(a) Deemed Enrollment Under Part D.--
                ``(1) In general.--The Secretary shall establish a process
            that, beginning as of the general effective date, provides for
            the enrollment in a prescription drug plan that has a monthly
            base beneficiary premium that does not exceed the weighted
            average of premiums for such plans that provide standard
            prescription drug coverage (as defined in section 1860D-2(b))
            with respect to the area involved (on a random basis among all
            such plans in the applicable PDP region) of each Medicare
            enrollee (as defined in section 1860E-51) who--
                        ``(A) failed to enroll in such a prescription drug
                    plan during the applicable enrollment or coverage
                    election period under section 1860D-1(b); and
                        ``(B) failed to elect not to enroll in such a
                    prescription drug plan during an applicable opt-out
                    period described in paragraph (2).
            Nothing in the previous sentence shall prevent such an
            individual from declining or changing such enrollment. Such
            process shall be carried out in the same manner as the process
            described in section 1860D-1(b)(1)(C).
                ``(2) Opt-out periods.--The process under paragraph (1)
            shall provide for the opportunity to make an election described
            in subparagraph (B) of such paragraph during an opt-out period
            that is coordinated with the relevant enrollment or coverage
            election period under section 1860D-1.
                ``(3) Late enrollment penalties.--In the case of an
            individual who makes an election described in paragraph (1)(B)
            and then enrolls in a prescription drug plan, the late
            enrollment penalty under section 1860D-13(b) shall apply to the
            monthly beneficiary premium of such individual, except that in
            applying such section, any reference to the initial enrollment
            period of such individual shall be deemed to be a reference to
            the opt-out period under paragraph (2) during which the
            individual elected not to enroll in a prescription drug plan.
                ``(4) No late enrollment penalty for current fee-for-
            service beneficiaries without drug coverage.--In the case of an
            individual who is a Medicare enrollee before the date of
            enactment of this section and who was not enrolled under a
            prescription drug plan before being enrolled under such a plan
            pursuant to paragraph (1), there shall be no increase in the
            base beneficiary premium of an individual under section 1860D-
            13 by a late enrollment penalty under subsection (b) of such
            section with respect to any period prior to the date of such
            enrollment.
        ``(b) Reference to Required Prescription Drug Coverage Under Part
    C.--For provision requiring coverage under MA plans to include
    prescription drug coverage, see section 1860E-26.''.
        (b) Limitation on Medicaid Benefits for Full-Benefit Dual Eligible
    Individuals.--Section 1902 of the Social Security Act (42 U.S.C. 1396a)
    is amended by adding at the end the following new subsection:
        ``(ll) Limitation on Benefits for Full-Benefit Dual Eligible
    Individuals.--Effective as of the general effective date (as specified
    in section 1860E-62), except in the case of a State which has elected
    the option described in section 1944(b)(2), in the case of an
    individual described in subparagraph (A)(ii) of section 1935(c)(6)
    (taking into account the application of subparagraph (B) of such
    section), notwithstanding any other provision of law, medical
    assistance shall not be available under this title for any items and
    services for which payment may be made under title XVIII.''.
        (c) Medicaid Maintenance of Effort and Alternatives.--Title XIX of
    the Social Security Act is amended by inserting after section 1943 the
    following new section:

        ``maintenance of effort options for full-benefit dual eligible
                                  individuals

        ``Sec. 1944.  (a) In General.--Effective as of the general
    effective date (as specified in section 1860E-62), a State shall elect,
    in a form and manner specified by the Secretary, a maintenance of
    effort option described in subsection (b). In the case of a State that
    fails to make such an election, the State shall be deemed to have
    elected the option described in subsection (b)(3).
        ``(b) Maintenance of Effort Options Described.--The following are
    maintenance of effort options described in this subsection for a State,
    which shall apply to all individuals described in subparagraph (A)(ii)
    of section 1935(c)(6) (taking into account the application of
    subparagraph (B) of such section) for such State:
                ``(1) Enrollment of dual eligibles in comprehensive
            medicaid managed care plan.--
                        ``(A) In general.--The State enrolls all such
                    individuals in a comprehensive Medicaid managed care
                    plan offered by a managed care entity under section
                    1932.
                        ``(B) Payment of subsidy amount to state.--In the
                    case of a State that elects the option under this
                    paragraph with respect to an individual, the Secretary
                    established under section 1860E-51 shall pay to the
                    State the same amount that the individual would be
                    entitled to have paid as an income-related premium
                    subsidy under section 1860E-41(b)(1)(A) plus the amount
                    that the Secretary estimates would have been paid with
                    respect to the individual under part D (including the
                    actuarial value of subsidy payments under sections
                    1860D-13 and 1860D-14). Such payment shall be made in
                    appropriate part from the Federal Hospital Insurance
                    Trust Fund under section 1817 and the Federal
                    Supplementary Medical Insurance Trust Fund under
                    section 1841.
                        ``(C) Relation to part d rules.--In the case of a
                    State that has elected the option under this paragraph,
                    notwithstanding any other provision of law--
                                ``(i) the coverage provided under this
                            option shall be in lieu of any coverage that
                            may otherwise be provided under part D; and
                                ``(ii) the payment to the State under
                            subparagraph (B) shall be in lieu of any
                            payments otherwise made with respect to such
                            individual under such part.
                ``(2) Other innovative alternatives.--
                        ``(A) In general.--The State submits to the
                    Secretary, and has approved by the Secretary, an
                    innovative alternative proposal relating to
                    coordinating coverage of such individuals under
                    Medicare and the State plan under title XIX.
                        ``(B) Process for review.--With respect to
                    proposals submitted to the Secretary under subparagraph
                    (A), the Secretary shall approve such a proposal if the
                    State demonstrates with respect to the proposal that--
                                ``(i) there would be no increased cost to
                            the Federal Government if it were approved; and
                                ``(ii) there would be no reduction in the
                            quality of care provided to such individuals if
                            the proposal were approved.''.
        (d) Conforming Amendments.--
                (1) Section 226.--Section 226 of the Social Security Act
            (42 U.S.C. 426) is amended--
                        (A) in subsection (a), in the matter preceding
                    paragraph (1), by inserting ``, subject to section
                    1860E-11(a)'' after ``individual who'';
                        (B) in subsection (b), in the matter preceding
                    paragraph (1), by inserting ``, subject to section
                    1860E-11(a)'' after ``individual who''; and
                        (C) in subsection (c), in the matter preceding
                    paragraph (1), by inserting ``, subject to section
                    1860E-11(a)'' after ``subsection (a)''.
                (2) Section 226A.--Section 226A(a) of such Act (42 U.S.C.
            426-1(a)) is amended, in the matter preceding paragraph (1), by
            inserting ``and subject to section 1860E-11(a)'' after ``or
            title XVIII''.
                (3) Section 1932.--Section 1932(a)(2)(B) of the Social
            Security Act (42 U.S.C. 1396u-2(a)(2)(B)) is amended by
            striking ``A State'' and inserting ``Except in the case of a
            State that has elected the maintenance of effort option
            described in section 1944(b)(2), a State''.

    SEC. 423. NEW BENEFIT STRUCTURE UNDER UNIFIED MEDICARE.

        (a) In General.--Part E of title XVIII of the Social Security Act,
    as added by section 251, is amended by adding at the end the following:

                        ``Subpart 2--Out-of-Pocket Limit

    ``SEC. 1860E-21. OUT-OF-POCKET LIMIT.

        ``(a) In General.--Beginning with 2025, in the case of a Medicare
    enrollee, if the amount of the out-of-pocket cost-sharing of such
    enrollee for a calendar year equals or exceeds the catastrophic limit
    under subsection (b) for that year--
                ``(1) the enrollee shall not be responsible for additional
            out-of-pocket cost-sharing incurred during that year; and
                ``(2) the Secretary shall establish procedures under which
            the Secretary shall, in appropriate part from the Part A
            Medicare FFS Account under section 1817 and the Part B Medicare
            FFS Account under section 1841--
                        ``(A) pay on behalf of the enrollee the amount of
                    the additional out-of-pocket cost-sharing described in
                    paragraph (1) attributable to deductibles and
                    coinsurance described in subsection (c)(1); and
                        ``(B) reimburse the enrollee the amount of the
                    additional out-of-pocket cost-sharing described in
                    paragraph (1) attributable to deductibles and
                    coinsurance described in subsection (c)(2).
        ``(b) Catastrophic Limit.--The amount of the catastrophic limit
    under this subsection for a year shall be the dollar amount in effect
    under section 223(c)(2)(A)(ii) of the Internal Revenue Code of 1986 for
    self-only coverage for taxable years beginning in such year.
        ``(c) Out-of-Pocket Cost-Sharing Defined.--In this section, the
    term `out-of-pocket cost-sharing' means, with respect to an individual,
    the amount of costs incurred by the individual that are attributable
    to--
                ``(1) deductibles and coinsurance imposed under part A or
            part B; and
                ``(2) deductibles and coinsurance imposed under standard
            prescription drug coverage pursuant to section 1860D-2(b) or
            alternative prescription drug coverage pursuant to section
            1860D-2(c) offered by a prescription drug plan.''.
        (b) Application of Out-of-Pocket Limit to MA-PD Plans.--
                (1) In general.--Section 1852(a)(1)(B) of the Social
            Security Act (42 U.S.C. 1395w-22(a)(1)(B)) is amended--
                        (A) in clause (i), by striking ``clause (iii)'' and
                    inserting ``clauses (iii) and (vi)''; and
                        (B) by adding at the end the following new clause:
                                ``(vi) Out-of-pocket limit.--The provisions
                            of section 1860E-21--
                                        ``(I) shall apply to individuals
                                    enrolled under an MA-PD plan in the
                                    same manner as such provisions apply to
                                    Medicare enrollees under such section,
                                    except that in lieu of the application
                                    of subsection (a)(2) of such section
                                    the MA-PD plan shall establish
                                    procedures to provide for payment of
                                    any additional out-of-pocket cost-
                                    sharing described in subsection (a)(1)
                                    of such section incurred by individuals
                                    enrolled under the MA-PD plan; and
                                        ``(II) as applied under subclause
                                    (I), may not be waived by application
                                    of this subparagraph.
                            In applying subsection (b) of section 1860E-21
                            pursuant to the previous sentence, an MA-PD
                            plan may substitute a dollar amount that is
                            less than the dollar amount specified under
                            such subsection.''.
                (2) Exempting ma-pd plans offering alternative prescription
            drug coverage from part d deductible and out-of-pocket limit
            requirements.--Section 1860D-2(c) of the Social Security Act
            (42 U.S.C. 1395w-102(c)) is amended--
                        (A) in paragraph (2), by striking ``The
                    deductible'' and inserting ``In the case of a
                    prescription drug plan, the deductible''; and
                        (B) in paragraph (3), by striking ``The coverage
                    provides'' and inserting ``In the case of a
                    prescription drug plan, the coverage provides''.
        (c) Prescription Drug Plans Required To Report Enrollees' Out-of-
    Pocket Cost-Sharing.--Section 1860D-12(b) of the Social Security Act
    (42 U.S.C. 1395w-112(b)) is amended by adding at the end the following
    new paragraph:
                ``(7) Out-of-pocket cost-sharing reports.--Each contract
            entered into with a PDP sponsor under this part with respect to
            a prescription drug plan offered by such sponsor shall require
            that, with respect to each claim submitted for items or
            services furnished to an individual enrolled under the plan
            pursuant to the contract, the sponsor submits to the Secretary
            information on the amount of out-of-pocket cost-sharing (as
            defined in section 1860E-23(c)) applicable to such enrollee for
            such items or services.''.
        (d) Conforming Amendments.--
                (1) Section 1813 of the Social Security Act (42 U.S.C.
            1395e) is amended--
                        (A) in subsection (a), by inserting ``Subject to
                    subpart 2 of part E:'' before paragraph (1); and
                        (B) in subsection (b), by inserting ``Subject to
                    subpart 2 of part E:'' before paragraph (1).
                (2) Section 1833 of such Act (42 U.S.C. 1395l) is amended--
                        (A) in subsection (a), in the matter preceding
                    paragraph (1), by inserting ``and subpart 2 of part E''
                    after ``succeeding provisions of this section'';
                        (B) in subsection (b), in the first sentence, by
                    striking ``Before applying'' and inserting ``Subject to
                    subpart 2 of part E, before applying'';
                        (C) in subsection (c)(1), in the matter preceding
                    subparagraph (A), by inserting ``subject to subpart 2
                    of part E,'' after ``this part,'';
                        (D) in subsection (f), by striking ``In
                    establishing'' and inserting ``Subject to subpart 2 of
                    part E, in establishing''; and
                        (E) in subsection (g)(1), by inserting ``and
                    subpart 2 of part E'' and ``paragraphs (4) and (5)''.
                (3) Section 1882(a)(2) of such Act is amended by striking
            ``No medicare'' and inserting ``Subject to section 1860E-24(c),
            no medicare''.

    SEC. 424. LATE ENROLLMENT PENALTY NOT TO APPLY FOR MONTHS OF ANY HEALTH
                  COVERAGE.

        (a) In General.--Section 1839(b) of the Social Security Act (42
    U.S.C. 1395r) is amended in the second sentence, by inserting before
    the period at the end the following: ``or months during which the
    individual has any other health coverage''.
        (b) Effective Date.--The amendment made by paragraph (1) shall
    apply for months of coverage beginning after the date of the enactment
    of this Act.

    SEC. 425. MEDIGAP REFORM.

        Notwithstanding any provision of section 1882 of the Social
    Security Act (42 U.S.C. 1395ss), as of the date of the enactment of
    this Act, no policy may be offered under such section that does not
    provide guaranteed coverage (without regard to an individual's
    preexisting conditions, if any) to all individuals eligible to enroll
    under such policy.

    SEC. 426. ACO REVISION.

        (a) Enrollment.--Enrollment in such an ACO under such title shall
    be based on the method established under part E of such title. Such a
    network shall bear full risk in the event payments under such title do
    not equal or exceed liabilities under such network.
        (b) Direction of Payment.--An ACO may direct that any payments
    under such title be made to a centralized entity rather than to an
    individual provider or supplier.
        (c) Bids.--The Secretary of Health and Human Services shall
    establish a process whereby such networks compete using a bidding
    process similar to that described in part E of such title for Medicare
    Advantage plans.

    SEC. 427. PRIMARY CARE OPTIONS.

        (a) Selection of Primary Care Physician.--The Secretary shall
    establish a mechanism under which an individual enrolled under part B
    of title XVIII of the Social Security Act may select such individual's
    primary care physician. Such an individual shall not be liable for more
    than $5 for each visit to such selected physician.
        (b) Payment to Physician.--A physician selected under subsection
    (a) shall receive a monthly fee in lieu of any other payment under such
    part B for evaluation and monitoring of such individual. The Secretary
    shall provide a list of standardized benefits that are included in such
    payment, including telephone and email communications, office visits,
    preventive care, and vaccinations.

    SEC. 428. GENERAL PROVISIONS; EFFECTIVE DATE.

        Part E of title XVIII of the Social Security Act, as inserted by
    section 101(a)(2) and as previously amended, is further amended by
    adding at the end the following new subpart:

                        ``Subpart 5.--General Provisions

    ``SEC. 1860E-51. APPLICABILITY; DEFINITIONS.

        ``(a) In General.--The provisions of this Act are superseded to the
    extent inconsistent with the provisions of this part.
        ``(b) Terminology.--For purposes of this part:
                ``(1) Medicare enrollee.--
                        ``(A) In general.--The term `Medicare enrollee'
                    means--
                                ``(i) an individual entitled to (or
                            enrolled for benefits) under part A and
                            enrolled under part B; and
                                ``(ii) except as otherwise specified, an
                            individual described in section 1860E-11(a)(3).
                        ``(B) Treatment.--Any reference in this Act (or any
                    other Act) in effect before the date of the enactment
                    of this part, to an individual entitled to benefits
                    under part A or enrolled under part B shall be deemed a
                    reference to a Medicare enrollee.
                ``(2) Medicare fee-for-service.--The term `Medicare fee-
            for-service' means the original Medicare fee-for-service
            program under parts A and B, as modified by this part, and does
            not include part C or part D.
                ``(3) Medicare fee-for-service enrollee.--The term
            `Medicare fee-for-service enrollee' means a Medicare enrollee
            who is not enrolled under a Medicare Advantage plan under part
            C.

    ``SEC. 1860E-61. GENERAL EFFECTIVE DATE.

        ``Except as otherwise specified, the provisions of this part shall
    apply to items and services furnished on or after January 1, 2025, and
    to plan years beginning on or after such date (referred to in this
    title as the `general effective date').''.

               Subtitle D--Telehealth Improvements and Expansion

    SEC. 431. EXPANSION OF COVERAGE OF TELEHEALTH SERVICES.

        (a) Covered Services.--Section 1834(m)(4)(F)(i) of the Social
    Security Act (42 U.S.C. 1395m(m)(4)(F)(i)) is amended--
                (1) by striking ``and office'' and inserting ``office'';
            and
                (2) by inserting: ``respiratory services, audiology
            services (as defined in section 1861(ll)), outpatient therapy
            services (including physical therapy, occupational therapy, and
            speech-language pathology services)'' after ``the
            Secretary)),''.
        (b) Providers.--Subsection (m) of section 1834 of such Act (42
    U.S.C. 1395m) is amended--
                (1) in paragraph (1), by striking ``or a practitioner
            (described in section 1842(b)(18)(C))'' and inserting ``, a
            practitioner (described in section 1842(b)(18)(C)), or an
            applicable professional (as defined in paragraph (4)(G))'';
                (2) by striking ``physician or practitioner'' each time it
            appears in such subsection and inserting ``physician,
            practitioner, or applicable professional'';
                (3) in paragraph (3)(A)--
                        (A) in the heading, by striking ``Physician and
                    practitioner'' and inserting ``Physician, practitioner,
                    and applicable professional''; and
                        (B) by striking ``physicians or practitioners'' and
                    inserting ``physicians, practitioners, or applicable
                    professionals''; and
                (4) in paragraph (4), by adding at the end the following
            new subparagraph:
                        ``(G) Applicable professional.--The term
                    `applicable professional' means, with respect to
                    services furnished on or after the date that is 6
                    months after the date of the enactment of this
                    subparagraph, a certified diabetes educator or
                    licensed--
                                ``(i) respiratory therapist;
                                ``(ii) audiologist;
                                ``(iii) occupational therapist;
                                ``(iv) physical therapist; or
                                ``(v) speech language pathologist.''.
        (c) Home-Based Monitoring Services for Congestive Heart Failure and
    Chronic Obstructive Pulmonary Disease.--
                (1) Coverage of remote patient monitoring services for
            certain chronic health conditions.--Section 1861(s)(2) of the
            Social Security Act (42 U.S.C. 1395x(s)(2)) is amended--
                        (A) in subparagraph (GG), by striking ``and'' at
                    the end;
                        (B) in subparagraph (HH), by inserting ``and'' at
                    the end; and
                        (C) by inserting after subparagraph (HH) the
                    following new subparagraph:
                        ``(II) applicable remote patient monitoring
                    services (as defined in paragraph (1)(A) of subsection
                    (iii));''.
                (2) Services described.--Section 1861 of the Social
            Security Act (42 U.S.C. 1395x) is amended by adding at the end
            the following new subsection:
        ``(kkk) Remote Patient Monitoring Services for Chronic Health
    Conditions.--
                ``(1)(A) The term `applicable remote patient monitoring
            services' means remote patient monitoring services (as defined
            in subparagraph (B)) furnished to provide for the monitoring,
            evaluation, and management of an individual with a covered
            chronic condition (as defined in paragraph (2)), insofar as
            such services are for the management of such chronic condition.
                ``(B) The term `remote patient monitoring services' means
            services furnished through remote patient monitoring technology
            (as defined in subparagraph (C)).
                ``(C) The term `remote patient monitoring technology' means
            a coordinated system that uses one or more home-based or mobile
            monitoring devices that automatically transmit vital sign data
            or information on activities of daily living and may include
            responses to assessment questions collected on the devices
            wirelessly or through a telecommunications connection to a
            server that complies with the Federal regulations (concerning
            the privacy of individually identifiable health information)
            promulgated under section 264(c) of the Health Insurance
            Portability and Accountability Act of 1996, as part of an
            established plan of care for that patient that includes the
            review and interpretation of that data by a health care
            professional.
                ``(2) For purposes of paragraph (1), the term `covered
            chronic health condition' means applicable conditions (as
            defined in and applied under section 1886(q)(5)) when under
            chronic care management (identified as of July 1, 2015, by
            HCPCS code 99490 (and as subsequently modified by the
            Secretary)).
                ``(3)(A) Payment may be made under this part for applicable
            remote patient monitoring services provided to an individual
            during a period of up to 90 days and such additional period as
            provided for under subparagraph (B).
                ``(B) The 90-day period described in subparagraph (A), with
            respect to an individual, may be renewed by the physician who
            provides chronic care management to such individual if the
            individual continues to qualify for such management.''.
                (3) Payment under the physician fee schedule.--Section 1848
            of the Social Security Act (42 U.S.C. 1395w-4) is amended--
                        (A) in subsection (c)--
                                (i) in paragraph (2)(B)--
                                        (I) in clause (ii)(II), by striking
                                    ``and (v)'' and inserting ``(v), and
                                    (vii)''; and
                                        (II) by adding at the end the
                                    following new clause:
                                ``(vii) Budgetary treatment of certain
                            services.--The additional expenditures
                            attributable to services described in section
                            1861(s)(2)(II) shall not be taken into account
                            in applying clause (ii)(II).''; and
                                (ii) by adding at the end the following new
                            paragraph:
                ``(7) Treatment of applicable remote patient monitoring
            services.--
                        ``(A) In determining relative value units for
                    applicable remote patient monitoring services (as
                    defined in section 1861(iii)(1)(A)), the Secretary, in
                    consultation with appropriate physician groups,
                    practitioner groups, and supplier groups, shall take
                    into consideration--
                                ``(i) physician or practitioner resources,
                            including physician or practitioner time and
                            the level of intensity of services provided,
                            based on--
                                        ``(I) the frequency of evaluation
                                    necessary to manage the individual
                                    being furnished the services;
                                        ``(II) the complexity of the
                                    evaluation, including the information
                                    that must be obtained, reviewed, and
                                    analyzed; and
                                        ``(III) the number of possible
                                    diagnoses and the number of management
                                    options that must be considered;
                                ``(ii) practice expense costs associated
                            with such services, including the direct costs
                            associated with installation and information
                            transmission, costs of remote patient
                            monitoring technology (including equipment and
                            software), device delivery costs, and resource
                            costs necessary for patient monitoring and
                            followup (but not including costs of any
                            related item or non-physician service otherwise
                            reimbursed under this title); and
                                ``(iii) malpractice expense resources.
                        ``(B) Using the relative value units determined in
                    subparagraph (A), the Secretary shall provide for
                    separate payment for such services and shall not adjust
                    the relative value units assigned to other services
                    that might otherwise have been determined to include
                    such separately paid remote patient monitoring
                    services.''; and
                        (B) in subsection (j)(3), by inserting ``(2)(II),''
                    after ``health risk assessment),''.

    SEC. 432. EXPANDING THE USE OF TELEHEALTH THROUGH THE WAIVER OF CERTAIN
                  REQUIREMENTS.

        (a) In General.--Section 1834(m) of the Social Security Act (42
    U.S.C. 1395m(m)) is amended--
                (1) in paragraph (4)(C)(i), by striking ``and (7)'' and
            inserting ``(7), and (8)''; and
                (2) by adding at the end the following:
                ``(8) Authority to waive requirements and limitations if
            certain conditions met.--
                        ``(A) In general.--Notwithstanding the preceding
                    provisions of this subsection, in the case of
                    telehealth services furnished on or after January 1,
                    2025, the Secretary may waive any restriction
                    applicable to payment for telehealth services under
                    this subsection that is described in subparagraph (B),
                    but only if the Secretary determines that such waiver
                    would not deny or limit the coverage or provision of
                    benefits under this title, and--
                                ``(i) the Secretary determines that the
                            waiver is expected to reduce spending under
                            this title without reducing the quality of care
                            or improve the quality of patient care without
                            increasing spending; or
                                ``(ii) the waiver would apply to telehealth
                            services furnished in originating sites located
                            in a high-need health professional shortage
                            area (as designated pursuant to section
                            332(a)(1)(A) of the Public Health Service Act
                            (42 U.S.C. 254e(a)(1)(A))).
                        ``(B) Restrictions described.--For purposes of this
                    paragraph, restrictions applicable to payment for
                    telehealth services under paragraph (1) are--
                                ``(i) requirements relating to
                            qualifications for an originating site under
                            paragraph (4)(C)(ii);
                                ``(ii) any geographic limitations under
                            paragraph (4)(C)(i) (other than applicable
                            State law requirements, including State
                            licensure requirements);
                                ``(iii) any limitation on the type of
                            technology used to furnish telehealth services;
                                ``(iv) any limitation on the type of
                            provider of services or supplier who may
                            furnish telehealth services (other than the
                            requirement that the provider of services or
                            supplier is enrolled under this title);
                                ``(v) any limitation on specific services
                            designated as telehealth services pursuant to
                            this subsection (provided the Secretary
                            determines that such services are clinically
                            appropriate to furnish remotely); or
                                ``(vi) any other limitation relating to the
                            furnishing of telehealth services under this
                            title identified by the Secretary.
                        ``(C) Public comment.--The Secretary shall
                    establish a process by which stakeholders may (on at
                    least an annual basis) provide public comment for
                    waivers under this paragraph.
                        ``(D) Periodic review of waivers.--The Secretary
                    shall periodically, but not more often than every 3
                    years, reassess each waiver under this paragraph to
                    determine whether the waiver continues to meet the
                    conditions applicable under subparagraph (A).''.
        (b) Posting of Information.--Not later than 2 years after the date
    on which a waiver under section 1834(m)(8) of the Social Security Act,
    as added by subsection (a), first becomes effective, and at least
    biennially thereafter, the Secretary of Health and Human Services shall
    post on the internet website of the Centers for Medicare & Medicaid
    Services--
                (1) the number of Medicare beneficiaries receiving
            telehealth services by reason of each waiver under such
            section;
                (2) the impact of such waivers on expenditures and
            utilization under title XVIII of the Social Security Act (42
            U.S.C. 1395 et seq.); and
                (3) other outcomes, as determined appropriate by the
            Secretary.

    SEC. 433. EXPANDING THE USE OF TELEHEALTH FOR MENTAL HEALTH SERVICES.

        (a) In General.--Section 1834(m) of the Social Security Act (42
    U.S.C. 1395m(m)), as amended by the preceding sections, is amended--
                (1) in paragraph (4)(C)(i), by striking ``and (8)'' and
            inserting ``(8), and (9)''; and
                (2) by adding at the end the following:
                ``(9) Treatment of mental health services furnished through
            telehealth.--The geographic requirements described in paragraph
            (4)(C)(i) (other than applicable State law requirements,
            including State licensure requirements) shall not apply with
            respect to telehealth services that are mental health services
            (as determined by the Secretary) furnished on or after January
            1, 2025, to an eligible telehealth individual at an originating
            site described in paragraph (4)(C)(ii) (other than an
            originating site described in subclause (IX) of such
            paragraph).''.
        (b) Inclusion of the Home as an Originating Site.--Section
    1834(m)(4)(C)(ii)(X) of such Act (42 U.S.C. 1395m(m)(4)(C)(ii)(X)) is
    amended by striking ``paragraph (7)'' and inserting ``paragraphs (7)
    and (9)''.
        (c) Additional Services.--As part of the implementation of the
    amendments made by this section, the Secretary of Health and Human
    Services shall consider whether additional services should be added to
    the services specified in paragraph (4)(F)(i) of section 1834(m) of
    such Act (42 U.S.C. 1395m) for authorized payment under paragraph (1)
    of such section.

    SEC. 434. USE OF TELEHEALTH IN EMERGENCY MEDICAL CARE.

        (a) In General.--Section 1834(m) of the Social Security Act (42
    U.S.C. 1395m(m)), as amended by the preceding sections, is amended--
                (1) in paragraph (4)(C)(i), by striking ``and (9)'' and
            inserting ``(9), and (10)''; and
                (2) by adding at the end the following:
                ``(10) Treatment of emergency medical care furnished
            through telehealth.--The geographic requirements described in
            paragraph (4)(C)(i) (other than applicable State law
            requirements, including State licensure requirements) shall not
            apply with respect to telehealth services that are services for
            emergency medical care (as determined by the Secretary)
            furnished on or after January 1, 2025, to an eligible
            telehealth individual at an originating site described in
            subclause (II), (V), or (VII) of paragraph (4)(C)(ii).''.
        (b) Additional Services.--As part of the implementation of the
    amendments made by this section, the Secretary of Health and Human
    Services shall consider whether additional services should be added to
    the services specified in paragraph (4)(F)(i) of section 1834(m) of
    such Act (42 U.S.C. 1395m) for authorized payment under paragraph (1)
    of such section.

    SEC. 435. IMPROVEMENTS TO THE PROCESS FOR ADDING TELEHEALTH SERVICES.

        The Secretary shall undertake a review of the process established
    pursuant to section 1834(m)(4)(F)(ii) of the Social Security Act (42
    U.S.C. 1395m(m)(4)(F)(ii)), and based on the results of such review--
                (1) implement revisions to the process so that the criteria
            to add services prioritizes, as appropriate, improved access to
            care through telehealth services; and
                (2) provide clarification on what requests to add
            telehealth services under such process should include.

    SEC. 436. RURAL HEALTH CLINICS AND FEDERALLY QUALIFIED HEALTH CENTERS.

        (a) Expansion of Originating Sites.--Section 1834(m)(4)(C) of the
    Social Security Act (42 U.S.C. 1395m(m)(4)(C)), as amended by the
    preceding sections, is amended--
                (1) in clause (i), by striking ``and (10)'' and inserting
            ``and (10), and subject to clause (iii),''; and
                (2) by adding at the end the following new clause:
                                ``(iii) Rural health clinics and federally
                            qualified health centers.--The term
                            `originating site' shall also include any
                            Federally qualified health center and any rural
                            health clinic (as such terms are defined in
                            section 1861(aa)) at which the eligible
                            telehealth individual is located at the time
                            the service is furnished via a
                            telecommunications system, whether or not the
                            individual is located in an area described in
                            clause (i), insofar as such sites are not
                            otherwise included in the definition of
                            originating site under such clause, subject to
                            applicable State law requirements, including
                            State licensure requirements.''.
        (b) Expansion of Distant Sites.--Section 1834(m) of the Social
    Security Act (42 U.S.C. 1395m(m)) is amended--
                (1) in the first sentence of paragraph (1)--
                        (A) by striking ``or a practitioner (described in
                    section 1842(b)(18)(C))'' and inserting ``, a
                    practitioner (described in section 1842(b)(18)(C)), a
                    Federally qualified health center, or a rural health
                    clinic''; and
                        (B) by striking ``or practitioner'' and inserting
                    ``, practitioner, Federally qualified health center, or
                    rural health clinic'';
                (2) in paragraph (2)(A)--
                        (A) by inserting ``or to a Federally qualified
                    health center or rural health clinic that serves as a
                    distant site'' after ``a distant site''; and
                        (B) by striking ``such physician or practitioner''
                    and inserting ``such physician, practitioner, Federally
                    qualified health center, or rural health clinic''; and
                (3) in paragraph (4)--
                        (A) in subparagraph (A), by inserting ``and
                    includes a Federally qualified health center or rural
                    health clinic that furnishes a telehealth service to an
                    eligible individual'' before the period at the end; and
                        (B) in subparagraph (F), by adding at the end the
                    following new clause:
                                ``(iii) Inclusion of rural health clinic
                            services and federally qualified health center
                            services furnished using telehealth.--For
                            purposes of this subparagraph, the term
                            `telehealth services' includes a rural health
                            clinic service or Federally qualified health
                            center service that is furnished using
                            telehealth to the extent that payment codes
                            corresponding to services identified by the
                            Secretary under clause (i) or (ii) are listed
                            on the corresponding claim for such rural
                            health clinic service or Federally qualified
                            health center service.''.
        (c) Effective Date.--The amendments made by this section shall
    apply to services furnished on or after January 1, 2023.

    SEC. 437. NATIVE AMERICAN HEALTH FACILITIES.

        (a) In General.--Section 1834(m)(4)(C) of the Social Security Act
    (42 U.S.C. 1395m(m)(4)(C)), as amended by the preceding sections, is
    amended--
                (1) in clause (i), by striking ``clause (iii)'' and
            inserting ``clauses (iii) and (iv)''; and
                (2) by adding at the end the following new clause:
                                ``(iv) Native american health facilities.--
                            The originating site requirements described in
                            clauses (i) and (ii) shall not apply with
                            respect to a facility of the Indian Health
                            Service, whether operated by such Service, or
                            by an Indian tribe (as that term is defined in
                            section 4 of the Indian Health Care Improvement
                            Act (25 U.S.C. 1603)) or a tribal organization
                            (as that term is defined in section 4 of the
                            Indian Self-Determination and Education
                            Assistance Act (25 U.S.C. 5304)), or a facility
                            of the Native Hawaiian health care systems
                            authorized under the Native Hawaiian Health
                            Care Improvement Act (42 U.S.C. 11701 et
                            seq.).''.
        (b) No Originating Site Facility Fee for New Sites.--Section
    1834(m)(2)(B)(i) of the Social Security Act (42 U.S.C.
    1395m(m)(2)(B)(i)) is amended, in the matter preceding subclause (I),
    by inserting ``(other than an originating site that is only described
    in clause (iv) of paragraph (4)(C), and does not meet the requirement
    for an originating site under clause (i) of such paragraph)'' after
    ``the originating site''.
        (c) Effective Date.--The amendments made by this section shall
    apply to services furnished on or after January 1, 2025.

    SEC. 438. WAIVER OF TELEHEALTH RESTRICTIONS DURING NATIONAL
                  EMERGENCIES.

        Section 1135(b) of the Social Security Act (42 U.S.C. 1320b-5(b))
    is amended--
                (1) in paragraph (6), by striking ``and'' after the
            semicolon;
                (2) in paragraph (7), by striking the period at the end and
            inserting ``; and''; and
                (3) by adding at the end the following:
                ``(8) requirements for payment for telehealth services
            under section 1834(m).''.

    SEC. 439. USE OF TELEHEALTH IN RECERTIFICATION FOR HOSPICE CARE.

        (a) In General.--Section 1814(a)(7)(D)(i) of the Social Security
    Act (42 U.S.C. 1395f(a)(7)(D)(i)) is amended by inserting ``(including
    through use of telehealth, notwithstanding the requirements in section
    1834(m)(4)(C))'' after ``face-to-face encounter''.
        (b) GAO Report.--Not later than 3 years after the date of enactment
    of this Act, the Comptroller General of the United States shall submit
    a report to Congress evaluating the impact of the amendment made by
    subsection (a) on--
                (1) the number and percentage of beneficiaries recertified
            for the Medicare hospice benefit at 180 days and for subsequent
            benefit periods;
                (2) the appropriateness for hospice care of the patients
            recertified through the use of telehealth; and
                (3) any other factors determined appropriate by the
            Comptroller General.

    SEC. 440. CLARIFICATION FOR FRAUD AND ABUSE LAWS REGARDING TECHNOLOGIES
                  PROVIDED TO BENEFICIARIES.

        Section 1128A(i)(6) of the Social Security Act (42 U.S.C. 1320a-
    7a(i)(6)) is amended--
                (1) in subparagraph (I), by striking ``; or'' and inserting
            a semicolon;
                (2) in subparagraph (J), by striking the period at the end
            and inserting ``; or''; and
                (3) by adding at the end the following new subparagraph:
                        ``(K) the provision of technologies (as defined by
                    the Secretary) on or after the date of the enactment of
                    this subparagraph, by a provider of services or
                    supplier (as such terms are defined for purposes of
                    title XVIII) directly to an individual who is entitled
                    to benefits under part A of title XVIII, enrolled under
                    part B of such title, or both, for the purpose of
                    furnishing telehealth services, remote patient
                    monitoring services, or other services furnished
                    through the use of technology (as defined by the
                    Secretary), if--
                                ``(i) the technologies are not offered as
                            part of any advertisement or solicitation; and
                                ``(ii) the provision of the technologies
                            meets any other requirements set forth in
                            regulations promulgated by the Secretary.''.

    SEC. 441. STUDY AND REPORT ON INCREASING ACCESS TO TELEHEALTH SERVICES
                  IN THE HOME.

        (a) MedPAC Study.--The Medicare Payment Advisory Commission (in
    this section referred to as the ``Commission'') shall conduct a study
    on increasing access under the Medicare program under title XVIII of
    the Social Security Act (42 U.S.C. 1395 et seq.) to telehealth services
    in the home. Such study shall include an analysis of the following:
                (1) How different payers allow the home to be an
            originating site for telehealth services.
                (2) Particular types of telehealth services or subgroups of
            beneficiaries with respect to which allowing the home to be an
            originating site under the Medicare program would be suitable.
        (b) Report.--Not later than 24 months after the date of the
    enactment of this Act, the Commission shall submit to Congress a report
    containing the results of the study conducted under subsection (a),
    together with recommendations for such legislation and administrative
    action as the Commission determines appropriate.

    SEC. 442. ANALYSIS OF TELEHEALTH WAIVERS IN ALTERNATIVE PAYMENT MODELS.

        The second sentence of section 1115A(g) of the Social Security Act
    (42 U.S.C. 1315a(g)) is amended by inserting ``an analysis of waivers
    under section (d)(1) related to telehealth and the impact on quality
    and spending under the applicable titles of such waivers,'' after
    ``subsection (c),''.

    SEC. 443. MODEL TO ALLOW ADDITIONAL HEALTH PROFESSIONALS TO FURNISH
                  TELEHEALTH SERVICES.

        Section 1115A(b)(2)(B) of the Social Security Act (42 U.S.C.
    1315a(b)(2)(B)) is amended by adding at the end the following new
    clause:
                                ``(xxviii) Allowing health professionals
                            who are not otherwise eligible under section
                            1834(m) to furnish telehealth services to
                            furnish such services.''.

    SEC. 444. TESTING OF MODELS TO EXAMINE THE USE OF TELEHEALTH UNDER THE
                  MEDICARE PROGRAM.

        Section 1115A(b)(2) of the Social Security Act (42 U.S.C.
    1315a(b)(2)) is amended by adding at the end the following new
    subparagraph:
                        ``(D) Testing models to examine use of telehealth
                    under medicare.--The Secretary shall consider testing
                    under this subsection models to examine the use of
                    telehealth under title XVIII.''.
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