111 HR 10409 IH: Fair Care Act of 2024
U.S. House of Representatives
2024-12-12
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.Short title; table of contents(a)This Act may be cited as the Fair Care Act of 2024
. (b)The table of contents for this Act is as follows:Sec. 1. Short title; table of contents.Title I—Modernization of health savings accountsSubtitle A—Modernization of health savings accounts and contributionsSec. 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 accountsSec. 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 InsuranceSubtitle A—Maintaining Protections for Patients with Preexisting ConditionsSec. 201. Guaranteed availability of coverage; prohibiting discrimination.Subtitle B—Expanding Coverage OptionsSec. 211. Definition of employer
under ERISA with respect to group health plans.Sec. 212. Short-term limited duration insurance.Subtitle C—Improving Commercial Health InsuranceSec. 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 AccountabilitySubtitle A—Provider and Insurer CompetitionSec. 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 TransparencySec. 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 InnovationSec. 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 TransparencySec. 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 ReformsSec. 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 ReformSec. 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 ReformsSubtitle A—Medicaid ReformsSec. 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 ReformsSec. 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 CompetitionSec. 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 ExpansionSec. 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.<enum>I</enum><header>Modernization of health savings accounts</header><subtitle id="H20A1C05D2E2B471995E13F16E22E019E"><enum>A</enum><header>Modernization of health savings accounts and contributions</header><section id="HAF9F9A0C7354433E980588C4C131FCB0" section-type="subsequent-section"><enum>101.</enum><header>Modernization of health savings accounts</header><subsection id="HCE9FE01EFE0744549CEE263459904CFB"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223</external-xref> of the Internal Revenue Code of 1986 is amended to read as follows:</text><quoted-block style="OLC" id="HFBEDDABCC4854C85983A6B99B78A5F45" display-inline="no-display-inline"><section id="HFBB0F06797F84619AE727959BF131B65"><enum>223.</enum><header>Health savings accounts</header><subsection id="H485207DC6863407BA1EF671BBB8AB152"><enum>(a)</enum><header>Deduction allowed</header><text>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.</text></subsection><subsection id="H7033B932BE58477EAA47CC0E1300BD89"><enum>(b)</enum><header>Limitations</header><paragraph id="HB3EEAE208C8B4E168B258800A09F69E0"><enum>(1)</enum><header>In general</header><text>The amount allowable as a deduction under subsection (a) with respect to any month is <fraction>1/12</fraction> of the dollar amount in effect under subsection (d)(2)(A) for the taxable year which included such month.</text></paragraph><paragraph id="H24F01ADF4432431891221487653A71FD"><enum>(2)</enum><header>Denial of deduction to dependents</header><text>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.</text></paragraph><paragraph id="H1433BB87ED3D45D8BBAFF385F4B4ECD9"><enum>(3)</enum><header>Increase in limit for individuals becoming eligible individuals after the beginning of the year</header><subparagraph id="H2BD86AEFF3E44675A620A4AF1B22934D"><enum>(A)</enum><header>In general</header><text>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—</text><clause id="H7C12AE1D5C0E4C529E3B4F1DF8FBD4DE"><enum>(i)</enum><text>as having been an eligible individual during each of the months in such taxable year, and</text></clause><clause id="H811AD1F22D9340549531FFE8ED7D62BF"><enum>(ii)</enum><text>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.</text></clause></subparagraph><subparagraph id="HB0B234C8000A43DFA91EC2372ECF0C84"><enum>(B)</enum><header>Failure to maintain qualified plan coverage</header><clause id="H575487EB2393497CBF5FD0B8BCA07E14"><enum>(i)</enum><header>In general</header><text>If, at any time during the testing period, the individual is not an eligible individual, then—</text><subclause id="H4ADB531385894B989B779AA9902535A9"><enum>(I)</enum><text>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</text></subclause><subclause id="H40E48D803509401CB6893432CEACD1B2"><enum>(II)</enum><text>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.</text></subclause></clause><clause id="H95D42048F3434320BC1F8F310214FBBB"><enum>(ii)</enum><header>Exception for disability or death</header><text>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)).</text></clause><clause id="H90BAE6DA8BDD477888C88B42686AC6D3"><enum>(iii)</enum><header>Testing period</header><text>The term <term>testing period</term> 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.</text></clause></subparagraph></paragraph></subsection><subsection id="H0E8264CF9AC348D29CF715EF018992B6"><enum>(c)</enum><header>Definitions and special rules</header><text>For purposes of this section—</text><paragraph id="H9771C008DCEF4FD48C1D16705F0639DC"><enum>(1)</enum><header>Eligible individual</header><text display-inline="yes-display-inline">The term <term>eligible individual</term> 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.</text></paragraph><paragraph id="HADB09BD30C1346F9B5207A89BD99D641"><enum>(2)</enum><header>Qualified plan</header><subparagraph id="H5D199540F02A427C8E82DC4507C0DC26"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The term <term>qualified health plan</term> 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.</text></subparagraph><subparagraph id="H4BD1B0CBACDA412FAF3EACAC64AF2263"><enum>(B)</enum><header>Exclusion of certain plans</header><text>Such term does not include a health plan if substantially all of its coverage is—</text><clause id="H1048CDDD4E864655BBA91EAF04E69700"><enum>(i)</enum><text>coverage for any benefit provided by permitted insurance, or </text></clause><clause id="H7248667C85914F36A4FC56E571C2E007"><enum>(ii)</enum><text>coverage (whether through insurance or otherwise) for accidents, disability, dental care, vision care, or long-term care.</text></clause></subparagraph></paragraph><paragraph id="H3A00881B01E042F9A40A85B3A8975E74"><enum>(3)</enum><header>Permitted insurance</header><text>The term <term>permitted insurance</term> means—</text><subparagraph id="H58FD8D8FF2DA4ABD96C7B10E73820855"><enum>(A)</enum><text>insurance if substantially all of the coverage provided under such insurance relates to—</text><clause id="HBF15464831714532918692C37CBBFBEB"><enum>(i)</enum><text>liabilities incurred under workers’ compensation laws,</text></clause><clause id="H2573B72D6F0542F9AA3680327CC57286"><enum>(ii)</enum><text>tort liabilities,</text></clause><clause id="H26E56E4C2EE947D09D752DE91DBE267F"><enum>(iii)</enum><text>liabilities relating to ownership or use of property, or</text></clause><clause id="HB8A4703EFD6244C1A865BC5A5BBF0379"><enum>(iv)</enum><text>such other similar liabilities as the Secretary may specify by regulations,</text></clause></subparagraph><subparagraph id="HFA7F6AEFB5C94473990EA97A565624AB"><enum>(B)</enum><text>insurance for a specified disease or illness, and</text></subparagraph><subparagraph id="H79FDFF4D9E444E6B9954A29E1C1AFB6A"><enum>(C)</enum><text>insurance paying a fixed amount per day (or other period) of hospitalization.</text></subparagraph></paragraph><paragraph id="H2ECBC174B95B426E9B0C661198F6B8F7"><enum>(4)</enum><header>Family coverage</header><text>The term <term>family coverage</term> means any coverage other than self-only coverage.</text></paragraph></subsection><subsection id="H50B2CEF8141A424E80C7E97A261FD6BD"><enum>(d)</enum><header>Health savings account</header><text>For purposes of this section—</text><paragraph id="HD78D79775E3848148C42776799FF9726"><enum>(1)</enum><header>In general</header><text>The term <term>health savings account</term> 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:</text><subparagraph id="H8CE7195060924E4CBB5BEBF775B058AF"><enum>(A)</enum><text>Except in the case of a rollover contribution described in subsection (f)(5) or section 220(f)(5), no contribution will be accepted—</text><clause id="H0A9825D355D647C2826B5DA17F9DC676"><enum>(i)</enum><text>unless it is in cash, or</text></clause><clause id="H396A2F55AD58495EADC188629A0E1EA8"><enum>(ii)</enum><text display-inline="yes-display-inline">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 </text></clause><clause id="HEDB739B9FAD447FB8AF507C1E944BA66"><enum>(iii)</enum><text>to the extent such contribution, when added to the balance of the account, exceeds the limitation amount specified in paragraph (2)(B).</text></clause></subparagraph><subparagraph id="HCCC6378D702E42A29E06DA908F4E6E5F"><enum>(B)</enum><text>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.</text></subparagraph><subparagraph id="HF739C0CC7CBD4D209E95D2CE52282E3A"><enum>(C)</enum><text>No part of the trust assets will be invested in life insurance contracts.</text></subparagraph><subparagraph id="H8E70B5FECFFE4BE89E1471E01E80C2C9"><enum>(D)</enum><text>The assets of the trust will not be commingled with other property except in a common trust fund or common investment fund.</text></subparagraph><subparagraph id="H6C0CDBF8453B41889102C379525ABD2D"><enum>(E)</enum><text>The interest of an individual in the balance in his account is nonforfeitable.</text></subparagraph></paragraph><paragraph id="H91383635B38948248ABCAFE3BDB853C7"><enum>(2)</enum><header>Limitations</header><subparagraph id="H9F45667DCF2947C1A3F5748D5FCCA60D"><enum>(A)</enum><header>Annual limitation</header><clause id="HC636F841791D410E8935476D2DBF6FB9"><enum>(i)</enum><header>In general</header><text>The limitation amount specified in this subparagraph is—</text><subclause id="HADCC82A95D2D42E9BCC08648CB7D08C8"><enum>(I)</enum><text display-inline="yes-display-inline">$5,000 in the case of a qualified health plan with an actuarial value of less than 40 percent,</text></subclause><subclause id="HE29B74ECFC5E4295B42542A7F35D6547"><enum>(II)</enum><text display-inline="yes-display-inline">$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</text></subclause><subclause id="HAE76DC1FD9FB4BFFB9E20A44BF21110E"><enum>(III)</enum><text display-inline="yes-display-inline">$3,600 in the case of a qualified health plan with an actuarial value that is 75 percent or more.</text></subclause></clause><clause id="H3BDA6CA5429B4EBAA0D57EEC2C401240"><enum>(ii)</enum><header>Actuarial value of qualified health plan</header><text>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.</text></clause></subparagraph><subparagraph id="HBB42F4D26F664C13991F59103F4D1058"><enum>(B)</enum><header>Account accumulation limitation</header><text>The limitation amount specified in this paragraph is $50,000.</text></subparagraph><subparagraph id="H7324B037B782431E8EB68210C6720555"><enum>(C)</enum><header>Indexing</header><clause id="H7DC5A9B140754B91B7706666015A78EF"><enum>(i)</enum><header>In general</header><text>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.</text></clause><clause id="HA997DDC0EE19445D98A9BBE93BFC0839"><enum>(ii)</enum><header>Medical care cost adjustment</header><text>For purposes of clause (i), the medical care cost adjustment for any calendar year is the percentage (if any) by which—</text><subclause id="HCC18E237210C44B2B4775389561FA5F0"><enum>(I)</enum><text>the medical care component of the C–CPI–U (as defined in section 1(f)(6)) for August of the preceding calendar year, exceeds</text></subclause><subclause id="H06F6082D09594ACC9B27F5964CB81A47"><enum>(II)</enum><text display-inline="yes-display-inline">such component of the C–CPI–U (as so defined) for August of 2024.</text></subclause></clause><clause id="H56090585A6D44E4593412374E2DE6366"><enum>(iii)</enum><header>Rounding</header><subclause id="H678662AA81354036B418089A67B4A8B9"><enum>(I)</enum><header>Annual limitation</header><text display-inline="yes-display-inline">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.</text></subclause><subclause id="H10E5BAFC098A4814B3CF58DFE9E19D2C"><enum>(II)</enum><header>Account limitation</header><text display-inline="yes-display-inline">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.</text></subclause></clause></subparagraph><subparagraph id="H92E7BD3C3C8242D59B2CB267B4F4CA57" commented="no"><enum>(D)</enum><header>Coordination with other contributions</header><text>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—</text><clause id="H19FD19FE8A5445248DDE84C8F2B6647F"><enum>(i)</enum><text>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</text></clause><clause id="H35D5E9B5296B4681BC49AB55E45DEC2E"><enum>(ii)</enum><text>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)).</text></clause></subparagraph></paragraph><paragraph id="HCDFE8308580D4C81B472925BB63D7D5F"><enum>(3)</enum><header>Qualified medical expenses</header><subparagraph id="HAF02EFE4A1DD4A4C842375293064E84E"><enum>(A)</enum><header>In general</header><text>The term <term>qualified medical expenses</term> 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.</text></subparagraph><subparagraph id="H3EA2DC2598C84ACEAEACF93400DCD957"><enum>(B)</enum><header>Health insurance may not be purchased from account</header><clause id="HCD31A452FE6B437B8471B63DAE1B3B14"><enum>(i)</enum><header>In general</header><text>Subparagraph (A) shall not apply to any payment for insurance.</text></clause><clause id="HEE7D9D32653F4CF8A70693A6FB80A34C"><enum>(ii)</enum><header>Exceptions</header><text>Clause (i) shall not apply to any expense for coverage under—</text><subclause id="HFA17FF36A6F642F8A909AA18971F4767"><enum>(I)</enum><text display-inline="yes-display-inline">a health plan during any period of continuation coverage required under any Federal law,</text></subclause><subclause id="H6B040AC481F84A85A1062D8C9713D086"><enum>(II)</enum><text>a qualified long-term care insurance contract (as defined in section 7702B(b)),</text></subclause><subclause id="H4389CEBFD4804981BB028C6E7EFC423C"><enum>(III)</enum><text>a health plan during a period in which the individual is receiving unemployment compensation under any Federal or State law, or</text></subclause><subclause id="H8F85BD7EEA8A4694A5EC476187238836"><enum>(IV)</enum><text>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).</text></subclause></clause><clause id="HB71376976AA1454CA7D406D2B6A20357"><enum>(iii)</enum><header>Exception for integrated health plans</header><text display-inline="yes-display-inline">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).</text></clause><clause id="H46B07DC2E9C34722B8A688F48C6A00BB"><enum>(iv)</enum><header>Exception for direct primary care service arrangements</header><subclause id="HBF275910442F4C7C981E21CC10DC7151"><enum>(I)</enum><header>In general</header><text display-inline="yes-display-inline">A direct primary care service arrangement shall not be treated as insurance for purposes of clause (i).</text></subclause><subclause id="H93B76C09F07D41DC84CE37803464F0E9"><enum>(II)</enum><header>Direct primary care service arrangement defined</header><text display-inline="yes-display-inline">For purposes of this clause, the term <term>direct primary care service arrangement</term> 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.</text></subclause></clause></subparagraph><subparagraph id="H7CC4CCA0374C4DEEABFF3BD6D1B0CF6E"><enum>(C)</enum><header>Menstrual care product</header><text>For purposes of this paragraph, the term <term>menstrual care product</term> means a tampon, pad, liner, cup, sponge, or similar product used by individuals with respect to menstruation or other genital-tract secretions.</text></subparagraph></paragraph><paragraph id="HAFD5985FFB054A06834E049B622CD244"><enum>(4)</enum><header>Account beneficiary</header><text>The term <term>account beneficiary</term> means the individual on whose behalf the health savings account was established.</text></paragraph><paragraph id="H0E89900237BD493FAD7300813FB92EE5"><enum>(5)</enum><header>Certain rules to Apply</header><text>Rules similar to the following rules shall apply for purposes of this section:</text><subparagraph id="H5283087765E94D6E8D57CAF740CD6A7C"><enum>(A)</enum><text>Section 219(d)(2) (relating to no deduction for rollovers).</text></subparagraph><subparagraph id="HF139F0E08E5545C68D043138CFA718E0"><enum>(B)</enum><text>Section 219(f)(3) (relating to time when contributions deemed made).</text></subparagraph><subparagraph id="H6D1B05EC986446B6B246EFD50D1233F4"><enum>(C)</enum><text>Except as provided in section 106(d), section 219(f)(5) (relating to employer payments).</text></subparagraph><subparagraph id="HE48296F26E044275979B3D083170BC33"><enum>(D)</enum><text>Section 408(g) (relating to community property laws).</text></subparagraph><subparagraph id="HD1BA84C5805B4F4688414FEC16ECCCFF"><enum>(E)</enum><text>Section 408(h) (relating to custodial accounts).</text></subparagraph></paragraph></subsection><subsection id="H511DCC8220724ACDAE8C6DDC588A60C5"><enum>(e)</enum><header>Tax treatment of accounts</header><paragraph id="HB7B98D8DCF34410885A0EDDF832A0742"><enum>(1)</enum><header>In general</header><text>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).</text></paragraph><paragraph id="H319753BE20DD4997B680D4C8B3E886EB"><enum>(2)</enum><header>Account terminations</header><text>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.</text></paragraph></subsection><subsection id="H364727CF79114190BBA3AF3B813DD31B"><enum>(f)</enum><header>Tax treatment of distributions</header><paragraph id="HA18DEFCD4B834D089521B670E050566F"><enum>(1)</enum><header>Amounts used for qualified medical expenses</header><text>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.</text></paragraph><paragraph id="HCCD5E1A2C2D1441FB9315DB2CFB2AC1C"><enum>(2)</enum><header>Inclusion of amounts not used for qualified medical expenses</header><text>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.</text></paragraph><paragraph id="HE066B329EA6F48A88D63C0A24D61401A"><enum>(3)</enum><header>Excess contributions returned before due date of return</header><subparagraph id="H3F5788A70E784B00B7D6819B0BDE5190"><enum>(A)</enum><header>In general</header><text>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—</text><clause id="HEF1494AA76254C73A28617C97A67D888"><enum>(i)</enum><text>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</text></clause><clause id="H64B9F635FB0F421885CD941A54E63271"><enum>(ii)</enum><text>such distribution is accompanied by the amount of net income attributable to such excess contribution.</text></clause><continuation-text continuation-text-level="subparagraph">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.</continuation-text></subparagraph><subparagraph id="HE77A92D3D6D64D8B9366D70CE50EF5DD"><enum>(B)</enum><header>Excess contribution</header><text>For purposes of subparagraph (A), the term <term>excess contribution</term> 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.</text></subparagraph></paragraph><paragraph id="HBAD921C9300B4337BE2267741A071A83"><enum>(4)</enum><header>Additional tax on distributions not used for qualified medical expenses</header><subparagraph id="HBDA714C75AC24012849F8978853CCBFE"><enum>(A)</enum><header>In general</header><text>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.</text></subparagraph><subparagraph id="H50D07B9123564BDBB6C738916035EAAF"><enum>(B)</enum><header>Exception for disability or death</header><text>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.</text></subparagraph><subparagraph id="HB5E4DD749BD3417EADF50CD5AE6A5BF7"><enum>(C)</enum><header>Exception for distributions after medicare eligibility</header><text>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.</text></subparagraph></paragraph><paragraph id="H7359C2B9E0FB4032BBB2A166F79D4873"><enum>(5)</enum><header>Rollover contribution</header><text>An amount is described in this paragraph as a rollover contribution if it meets the requirements of subparagraphs (A) and (B).</text><subparagraph id="HB3889B587E0E42139ECB44122830F2F5"><enum>(A)</enum><header>In general</header><text>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.</text></subparagraph><subparagraph id="HA230F87526514D43B861C799C4266E77"><enum>(B)</enum><header>Limitation</header><text>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.</text></subparagraph><subparagraph id="HFF8DB8560B2A4A1C9ACC5472C98C230D" commented="no"><enum>(C)</enum><header>Rollover from FSA, Archer MSA, and HRA</header><text>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.</text></subparagraph></paragraph><paragraph id="HAE30AFAF2E764377868ECAFCD7C181FE"><enum>(6)</enum><header>Coordination with medical expense deduction</header><text>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.</text></paragraph><paragraph id="H28702BE21B3C49A1AC54DA2C9048BAD8"><enum>(7)</enum><header>Transfer of account incident to divorce</header><text>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.</text></paragraph><paragraph id="HEF582776A362476DAC751B2B15691B1F"><enum>(8)</enum><header>Treatment after death of account beneficiary</header><subparagraph id="HD77F005B93924C04BCA59FFCC1816708"><enum>(A)</enum><header>Treatment if designated beneficiary is spouse</header><text>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.</text></subparagraph><subparagraph id="HE1D5B952A6E44CA8B6CE7DA9E7BFDA26"><enum>(B)</enum><header>Other cases</header><clause id="H39038F466F8E428BA25EA893A16AC237"><enum>(i)</enum><header>In general</header><text>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—</text><subclause id="H026A86CEE70440BE975BD069DDA591A0"><enum>(I)</enum><text>such account shall cease to be a health savings account as of the date of death, and</text></subclause><subclause id="H33EEF750257643F2B81F65562926E882"><enum>(II)</enum><text>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.</text></subclause></clause><clause id="HAC2068063124458B8E40E230E0C33A2B"><enum>(ii)</enum><header>Special rules</header><subclause id="H16F9928264D44633BBACDF167FAAD953"><enum>(I)</enum><header>Reduction of inclusion for predeath expenses</header><text>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.</text></subclause><subclause id="HD890BAA6EE644507817B1AF064DCBE32"><enum>(II)</enum><header>Deduction for estate taxes</header><text>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.</text></subclause></clause></subparagraph></paragraph></subsection><subsection id="H5BEFC9442BAC4B699F15925E2343D6EC"><enum>(g)</enum><header>Cost-of-Living adjustment</header><paragraph id="H262A6C5AA94446DB89F549AAFE190F04"><enum>(1)</enum><header>In general</header><text>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—</text><subparagraph id="H49556632D82F4BF7B06D5DEC9BF69B67"><enum>(A)</enum><text>such dollar amount, multiplied by</text></subparagraph><subparagraph id="HEFE60603F6E14821B5EA85BE42C31B85"><enum>(B)</enum><text>the cost-of-living adjustment determined under section 1(f)(3) for the calendar year in which such taxable year begins determined by substituting <quote>2024</quote> for <quote>2016</quote> in subparagraph (A)(ii) thereof.</text></subparagraph></paragraph><paragraph id="H9162C778AD9647B69141147A109F1537"><enum>(2)</enum><header>Rounding</header><text>If any increase under paragraph (1) is not a multiple of $50, such increase shall be rounded to the nearest multiple of $50.</text></paragraph></subsection><subsection id="HA38D5578DF4A44F8AA5CF60154DF2930"><enum>(h)</enum><header>Reports</header><text>The Secretary may require—</text><paragraph id="H42CD958207F3427AB3E33D9862A10039"><enum>(1)</enum><text>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</text></paragraph><paragraph id="H20BF5F908D9347268CA1F22F357C48A4"><enum>(2)</enum><text>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.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H74D45B9943DF4BA1AA54899671BC8737"><enum>(b)</enum><header>Employer contributions to health savings accounts</header><paragraph id="HBC6A4588F3DC47438A6E19A4B0453CA0"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 106(d) is amended to read as follows:</text><quoted-block style="OLC" id="H19719B9CCEAA4DBD9EA2464F45AE2024" display-inline="no-display-inline"><subsection id="H722F682023C742F599B8BC1518A3AF2F"><enum>(d)</enum><header>Contributions to health savings accounts</header><paragraph id="H2FED45AF14B444C1ADE120FE7FB078D8"><enum>(1)</enum><header>In general</header><text>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—</text><subparagraph id="H2DB662941A324FEE944148D35E0F5671"><enum>(A)</enum><text>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, </text></subparagraph><subparagraph id="H649A2EBCAEA348B3BD417EB87E3B94FA"><enum>(B)</enum><text>such amounts are contributed to an account which is integrated with an integration eligible health plan, </text></subparagraph><subparagraph id="H55C9BFB785D749BB90C89536408C7FBE"><enum>(C)</enum><text>such employer does not offer such employee coverage under any other accident or health plan,</text></subparagraph><subparagraph id="HC0C35A7557BD4068B6D0844711589CE2"><enum>(D)</enum><text>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,</text></subparagraph><subparagraph id="HD465AF1BABC24F8A89323B30991CE2CD"><enum>(E)</enum><text>such employer offers employees an opportunity to elect not to receive such amounts at least once per year and upon termination from employment, and</text></subparagraph><subparagraph id="HBF1C2CE77171491F89E4EBFD529F8122"><enum>(F)</enum><text>such employee is not covered under any health insurance offered by an employer of such employee’s spouse.</text></subparagraph></paragraph><paragraph id="H761E5D6613EE45E1BB5B57A761A45B55"><enum>(2)</enum><header>Integration eligible health plan</header><text>For purposes of this subsection, the term <term>integration eligible health plan</term> means—</text><subparagraph id="H34FE9DDDD08B4F06B2B23BB7E3D2E1F1"><enum>(A)</enum><text display-inline="yes-display-inline">any bronze, silver, or gold plan offered through an Exchange established under the Patient Protection and Affordable Care Act,</text></subparagraph><subparagraph id="HD7C83FC1CB6E41A4B4C52D7BA830E24D"><enum>(B)</enum><text display-inline="yes-display-inline">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,</text></subparagraph><subparagraph id="H9F07A7934F0248A09D1D4BF46E56461E"><enum>(C)</enum><text>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</text></subparagraph><subparagraph id="H5F3B86F6E7144C21BAE37472A1444BBE"><enum>(D)</enum><text>in the case of any student, coverage under a health plan which is conditioned on maintaining status as being such a student.</text></subparagraph></paragraph><paragraph id="H7214C06A30CD4EB099C6E9F11D16BDB7"><enum>(3)</enum><header>Integration of plans and accounts</header><text display-inline="yes-display-inline">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—</text><subparagraph id="H257BA840459945089853F1C936FADAEF"><enum>(A)</enum><text>the employee is the account beneficiary of such account and such employee is covered under an integration eligible health plan for such month,</text></subparagraph><subparagraph id="H0E416A8F9D87498F8EDEB28815AD5B92"><enum>(B)</enum><text>the employer verifies that the employee is so covered by requiring the submission of documentation to such employer, and</text></subparagraph><subparagraph id="H41C62F8AE9EA4B3198D367333A9D0AD2"><enum>(C)</enum><text>the employer makes contributions to such account for such month which are not less than the excess (if any) of—</text><clause id="HE3CF61E1806640F9A3C706A2A92A09F4"><enum>(i)</enum><text display-inline="yes-display-inline">the adjusted monthly premiums for the applicable second lowest cost silver plan with respect to the taxpayer, over</text></clause><clause id="HEA0225C088484782B382AB2F1A4006E7"><enum>(ii)</enum><text><fraction>1/12</fraction> of 9.5 percent of the taxpayer’s household income (within the meaning of section 36B).</text></clause></subparagraph></paragraph><paragraph id="HB7FC2B1B277749BF81FD9EE3E3806BDE"><enum>(4)</enum><header>Qualified class</header><text display-inline="yes-display-inline">For purposes of this subsection—</text><subparagraph id="HE4FAEF6A776D4137BC8FA2CC8DDC200C"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The term <term>qualified class</term> 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.</text></subparagraph><subparagraph id="HDD172602DD4A44D498F692550C6B91DF"><enum>(B)</enum><header>Rules related to class size</header><clause id="H55BA5FF6FF67429996A4B3CA4C0F64B6"><enum>(i)</enum><header>Minimum class size</header><text>A class shall not be treated as a qualified class unless in consisting of at least the following number of employees:</text><subclause id="HFDFF6ED875D2400C838909A601FF4525"><enum>(I)</enum><text>In the case of an employer with fewer than 100 employees, the lesser of 10 employees or all employees of the employer.</text></subclause><subclause id="HE922F7C04C3442DEA660428166E93855"><enum>(II)</enum><text>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).</text></subclause><subclause id="H1238515E9ADD418A9B399FEAC11A1FE8"><enum>(III)</enum><text>In the case of an employer with more than 200 employees, 20 employees.</text></subclause></clause><clause id="HF5CC328416494A0E97A298B59E3FF919"><enum>(ii)</enum><header>Combination of classes</header><text>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). </text></clause></subparagraph><subparagraph id="H39766A96555B43C8B563B7E19E596E13"><enum>(C)</enum><header>Permitted variation within qualified classes</header><text>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—</text><clause id="H8985AB2B5F93438684D7CC82D2E9287A"><enum>(i)</enum><text>number of dependents,</text></clause><clause id="H960C33380AAC40F795FC3A22E01209B0"><enum>(ii)</enum><text>age, if such variation based on age does not exceed a ratio of 3:1, and</text></clause><clause id="H484D707F948044289CD66D2AA41B11F4"><enum>(iii)</enum><text>chronic health condition, if such variation based on chronic health condition does not exceed a ratio of 1.2:1.</text></clause></subparagraph></paragraph><paragraph id="HD60D0A600C4F46D9A382DAFD3B8A6D98"><enum>(5)</enum><header>Coordination with ACA provisions</header><text>In the case of an integration eligible health plan which is integrated with a health savings account—</text><subparagraph id="H6E941F26925845ACA4997CCE1F10AFD5"><enum>(A)</enum><text>such plan shall be treated as an eligible employer-sponsored plan described in section 5000A(f)(1)(B),</text></subparagraph><subparagraph id="HF909E25A39084E10A26DF49EE2238C6C"><enum>(B)</enum><text>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</text></subparagraph><subparagraph id="HBA0947B2A4224E5CA7B7B9D0604C1F50"><enum>(C)</enum><text display-inline="yes-display-inline">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—</text><clause id="HB9452B3D503B49B6AF5B50C25A87B89C"><enum>(i)</enum><text>the adjusted monthly premiums for the applicable second lowest cost silver plan with respect to the taxpayer, over</text></clause><clause id="H8BF1BC8431D3480095A333A8547076C4"><enum>(ii)</enum><text>the contributions made the employer to such health savings account which are excludible from the gross income of the employee under this section.</text></clause></subparagraph></paragraph><paragraph id="H6DBA8896C4C149FFA6827CE0DA0A1454"><enum>(6)</enum><header>No constructive receipt</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="HA7C0A316E1244329A1F9D08320B07D51"><enum>(7)</enum><header>Special rule for deduction of employer contributions</header><text>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.</text></paragraph><paragraph id="HD71B1E990BD9476FBA23C534DC94D88E"><enum>(8)</enum><header>Employer health savings account contributions required to be shown on return</header><text>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.</text></paragraph><paragraph id="H3497704AB0C949AFA2A265DEDBC4B25B"><enum>(9)</enum><header>Health savings account contributions not part of COBRA coverage</header><text>Paragraph (1) shall not apply for purposes of section 4980B.</text></paragraph><paragraph id="HC2D1D9A6CE8C452C93F45EE7A653351B"><enum>(10)</enum><header>Definitions</header><text>Terms used in this subsection which are also used in section 223 shall have the same respective meanings as when used in such section.</text></paragraph><paragraph id="HADA4423216844741862E41DF96B977A0"><enum>(11)</enum><header>Regulations</header><text display-inline="yes-display-inline">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—</text><subparagraph id="HBF035219A6504F41B4BE6EEB3E7CC02A"><enum>(A)</enum><text>prevent employers from offering plans integrated with health savings accounts selectively to sicker workers, and</text></subparagraph><subparagraph id="HA6306C1396B5463CBB76007C561A3F7D"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><paragraph id="H97FCCF8CF1CD4B8D8E1E50818FE4B74C" commented="no"><enum>(12)</enum><header>Cross reference</header><text display-inline="yes-display-inline">For penalty on failure by employer to make comparable contributions to the health savings accounts of comparable employees, see section 4980G.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H183E1AC1BC88499EA0BB661D39E11B2D"><enum>(2)</enum><header>Nonapplication of ERISA</header><text display-inline="yes-display-inline">Contributions by an employer to a health savings account (as defined in <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223</external-xref> 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—</text><subparagraph id="H3E304231AA2942E9B553BD932642D235"><enum>(A)</enum><text>receipt of such contributions by the employee is voluntary,</text></subparagraph><subparagraph id="H2FF151F9F6CF47D19CF3FA0CF0040207"><enum>(B)</enum><text>the employer does not select or endorse the integration eligible health plan which is integrated with such account,</text></subparagraph><subparagraph id="H979F5196AFC14FD481B73498A5AB2CFD"><enum>(C)</enum><text>no premiums, other than premiums for the integration eligible health plan which is integrated with such account, are paid from the account,</text></subparagraph><subparagraph id="H744A539125234597BAD046FE0CE72CB6"><enum>(D)</enum><text>the employer receives no consideration (money or other benefit) in connection with the employee selecting or renewing a plan, and</text></subparagraph><subparagraph id="HD5D1C05449D943A490D5375AE45F3EF7"><enum>(E)</enum><text>each participant is notified annually that such contributions and such plan are not subject to the requirements of such Act.</text></subparagraph></paragraph></subsection><subsection id="H86C21A09F4E34F898E03AFF3BB2401FD"><enum>(c)</enum><header>Termination of certain other health care related tax benefits</header><paragraph id="HAE0CE74606F44913827DFB57B3927AAA"><enum>(1)</enum><header>Exclusion limited to self-funded major medical plan of employers</header><text>Section 105(b) of such Code is amended by striking <quote>paid,</quote> and inserting <quote>paid under a self-funded major medical plan of the employer</quote>.</text></paragraph><paragraph id="HEEE6A5D5F62C405B8B0D58CE37FD5AB2"><enum>(2)</enum><header>Exclusion not applicable to health reimbursement arrangements</header><text>Section 105(h) of such Code is amended to read as follows:</text><quoted-block style="OLC" id="H82B3C30ACDED45F98269699BEA59CE8F" display-inline="no-display-inline"><subsection id="H13F2649194E24A188A013D9EDD3751FA"><enum>(h)</enum><header>Exclusion not applicable to health reimbursement arrangements</header><text display-inline="yes-display-inline">Subsection (b) shall not apply to health reimbursement arrangements.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HB880BA8634364529A222D70E53302CCB"><enum>(3)</enum><header>Repeal of exclusions from income for Archer MSAs and FSAs</header><text display-inline="yes-display-inline">Section 106 of such Code is amended by striking subsection (b), (e) and (g).</text></paragraph><paragraph id="HB8F5F55D22494CAAA8C64CDD5294A968"><enum>(4)</enum><header>Termination of deduction for contributions to Archer MSAs</header><text>Section 220(a) of such Code is amended by adding at the end the following: <quote>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.</quote>.</text></paragraph></subsection><subsection id="HB0E65C034F534A1487229CBE151BEAF0"><enum>(d)</enum><header>Bankruptcy protections</header><text display-inline="yes-display-inline">Section 522 of title 11, United States Code, is amended by adding at the end the following new subsection: </text><quoted-block style="USC" id="H8DEED5C2DA054016B70A2BA053FC8CDC" display-inline="no-display-inline"><subsection id="HC43E903B785F426C928B3DBF6CB227F3"><enum>(r)</enum><text display-inline="yes-display-inline">For purposes of this section, any health savings account (as described in <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223</external-xref> 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.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HAB6B4EDB22304996969C4C139367C9BD"><enum>(e)</enum><header>Rollover of FSA, Archer MSA, HRA to health savings account</header><text display-inline="yes-display-inline">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 <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(f)(5)</external-xref> 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.</text></subsection><subsection id="HDFCB99890DE64635B2DA0D3BF8B2E5C8"><enum>(f)</enum><header>Effective dates</header><paragraph id="HF0DC17AD0A8C424D8DB8F7A7B6DB9347"><enum>(1)</enum><header>In general</header><text>The amendments made by subsections (a) and (b) shall apply to taxable years beginning after the date of the enactment of this Act.</text></paragraph><paragraph id="H47F66C68BE0846AC9B8C5B616857FC19"><enum>(2)</enum><header>Termination of certain other health care related tax benefits</header><text>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.</text></paragraph><paragraph id="H50CCA5257A304225AB67F9EB22127AB4"><enum>(3)</enum><header>Bankruptcy protections</header><text>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.</text></paragraph></subsection></section><section id="HD6A4FF995179426CB9874BCE048F7311"><enum>102.</enum><header>Unused premium tax credits may be deposited in health savings accounts</header><subsection id="H692A89E624C74DB6908173C5C08F9D77"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 36B is amended by redesignating subsection (h) as subsection (i) and by inserting after subsection (g) the following new subsection:</text><quoted-block style="OLC" id="HDD6707C2B2894AF18C3162CA56DA5ADC" display-inline="no-display-inline"><subsection id="H33582BA3240A4D7F891871294529CC31"><enum>(h)</enum><header>Excess credit may be deposited into a health savings account</header><paragraph id="H240BEAA234E740619CDE9E13D4DC5270"><enum>(1)</enum><header>In general</header><text>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.</text></paragraph><paragraph id="H81978CDE063D40DCB3C2035680257DEE"><enum>(2)</enum><header>Election to deposit excess credit into a health savings account</header><text>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.</text></paragraph><paragraph id="HF980CDA3DB0846ACB2CBC6E9607737F7"><enum>(3)</enum><header>Coordination with health savings account rules</header><text>Any amount deposited in a health savings account by the Secretary under this subsection shall—</text><subparagraph id="H954B4A0845FE4B5E800F658E93BDBD3F"><enum>(A)</enum><text>be includible in the gross income of the applicable taxpayer, and</text></subparagraph><subparagraph id="H3618A7FCD50F430CB5F5BB83DF7A437B"><enum>(B)</enum><text>be taken into account as an amount paid to such account for purposes of this section.</text></subparagraph></paragraph><paragraph id="HD1ED12213A2849F5A17BE744BDB04B19"><enum>(4)</enum><header>Treatment of deposits</header><text>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.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H7EEF7577499B406CB1F8E0F8A02E5E01"><enum>(b)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section><section id="H92FE1F9C8F0F44E1A4AD3F309AF30A86"><enum>103.</enum><header>Health Reimbursement Arrangements and Other Account-Based Group Health Plans</header><text display-inline="no-display-inline">The rule published by the Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department relating to <quote>Health Reimbursement Arrangements and Other Account-Based Group Health Plans</quote> (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.</text></section><section id="HDAFB03984252471B89ED45C86E89EEEC"><enum>104.</enum><header>Cost-sharing reduction payments as eligible contributions</header><subsection id="H5FE2180D38CF481FA8A4E36CD899EE75"><enum>(a)</enum><header>Alternative waiver for State innovation</header><text>Section 1332 of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18052">42 U.S.C. 18052</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block style="OLC" id="H13230EFA7BAB439489412537D194BFDA" display-inline="no-display-inline"><subsection id="HFA352EBBE7D14F8A8EEEEE7649FE73B4"><enum>(f)</enum><header>Alternative waiver for State innovation</header><paragraph id="HD2E096064B564434BB211E9876D8E3F3"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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).</text></paragraph><paragraph id="H8C2896558A3041AC9BA9847619197C91"><enum>(2)</enum><header>Pass-through funding</header><text display-inline="yes-display-inline">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—</text><subparagraph id="H6DC217C291F544E7BDBC35AB7CBC043A"><enum>(A)</enum><text>had the State not received such waiver;</text></subparagraph><subparagraph id="H8709149230874150986E2C52B83F4791"><enum>(B)</enum><text>had references to <quote>eligible insureds</quote> under section 1402 referred to <quote>qualifying insureds (as defined in section 1332(f))</quote>; </text></subparagraph><subparagraph id="HA44667C54426411FB3FEFD598DFE422F"><enum>(C)</enum><text display-inline="yes-display-inline">had, after application of clause (ii), in the case of a qualifying insured enrolled in the bronze level of coverage—</text><clause id="H192014AE048443F0923C480E87C40411"><enum>(i)</enum><text>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</text></clause><clause id="H7282BF60CE05455B8649E1BC25CED6DC"><enum>(ii)</enum><text>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</text></clause></subparagraph><subparagraph id="H67FA5E5B0DB341D58CA4DE6A0AF047C3"><enum>(D)</enum><text display-inline="yes-display-inline">had, after application of clause (ii), in the case of a qualifying insured enrolled in the copper level of coverage—</text><clause id="H293A99159C58432EA3C39237241B834A"><enum>(i)</enum><text display-inline="yes-display-inline">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</text></clause><clause id="H9DB7A483F87E42E2BE4DFF197BD3E655"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text></clause></subparagraph><continuation-text continuation-text-level="paragraph">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. </continuation-text></paragraph><paragraph id="HB053D063EE664B7C84B031A8C0B08F98"><enum>(3)</enum><header>Waiver consideration and transparency</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="H7910CD5F19094101951AE45993A9AEF3"><enum>(4)</enum><header>Determinations; term of waiver</header><text>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.</text></paragraph><paragraph id="H3B921E33A8834FCB82435B1544132DE2"><enum>(5)</enum><header>Definitions</header><text display-inline="yes-display-inline">For purposes of this subsection:</text><subparagraph id="HCEE8730987E444D9BF191D93D1F45E73"><enum>(A)</enum><header>Health savings account</header><text display-inline="yes-display-inline">The term <term>health savings account</term> has the meaning given such term in <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223</external-xref> of the Internal Revenue Code of 1986.</text></subparagraph><subparagraph id="HE887AC25D7C44AD8802683A87A55BDD4"><enum>(B)</enum><header>Qualifying insured</header><text>The term <term>qualifying insured</term> means, with respect to a State and a year, an individual—</text><clause id="H70D27B2F65784BB5AF8D01D22DFEA083"><enum>(i)</enum><text>who is enrolled in a health savings account;</text></clause><clause id="HF5E8D11F01D9446BB687BD37D3022572"><enum>(ii)</enum><text>who is enrolled for such year in a silver, bronze, or copper level coverage offered through an Exchange; and</text></clause><clause id="HC5D97C43D16B41C7AE41FC322E821209"><enum>(iii)</enum><text>whose household income is not more than 250 percent of the Federal poverty line for a family of the size involved.</text></clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H520CF0E442E64BC9A9AA5262A30E2171"><enum>(b)</enum><header>Additional amendments</header><text display-inline="yes-display-inline">Section 1402 of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18071">42 U.S.C. 18071</external-xref>) is amended by striking <quote>not less than 100 percent but</quote> and <quote>exceeds 100 percent but</quote> and <quote>more than 100 percent but</quote> each place such phrases appear.</text></subsection><subsection id="H6B5D1A87EFF843A89CC23B2A88DC053A"><enum>(c)</enum><header>Conforming amendments</header><text display-inline="yes-display-inline">Section 1332 of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18052">42 U.S.C. 18052</external-xref>), as amended by subsection (a), is further amended in subsection (a)(4)—</text><paragraph id="HC2FBFB08EA63424EBEF669976E7ED755"><enum>(1)</enum><text>in subparagraph (A) by striking the period and inserting <quote>, except in the case of a waiver described in subsection (f).</quote>; and</text></paragraph><paragraph id="HDAA3334FF398496A9B8599B9336D3BFC"><enum>(2)</enum><text>in subparagraph (B)(ii) by inserting after <quote>an application</quote> the following: <quote>(except in the case of a waiver described in subsection (f))</quote>.</text></paragraph></subsection><subsection id="H2A0755DF70C94E61B2D84D5114935C2C"><enum>(d)</enum><header>Appropriation for cost-Sharing payments</header><text display-inline="yes-display-inline">Section 1402 of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18071">42 U.S.C. 18071</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block style="OLC" id="H015BF15CAAB249C495523BA25D9EC188" display-inline="no-display-inline"><subsection id="HA369264CB1BD42D3ADAA835C37FCEA18"><enum>(g)</enum><header>Funding</header><paragraph id="HB685421FCB184EECAB91D0CCB7A2209C"><enum>(1)</enum><header>Appropriations</header><text>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.</text></paragraph><paragraph id="HD0D7A77A57064596873829546F0D285B"><enum>(2)</enum><header>Adjustments</header><text>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.</text></paragraph><paragraph id="H035E5771317B47BCA81D1994F7009510"><enum>(3)</enum><header>Limitation</header><text>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 <external-xref legal-doc="public-law" parsable-cite="pl/115/31">Public Law 115–31</external-xref> in the same manner and to the same extent as if such amounts for each such year were appropriated under such division.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="H4617B8A884944496959188D0BB235F19"><enum>105.</enum><header>Direct Primary Care</header><subsection id="HD1481281009D46AEB81D87D0C270D77D"><enum>(a)</enum><header>In general</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223(c)(1)</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph:</text><quoted-block id="H62E7B84F70E8429C99DEA863DC4AB646" style="OLC"><subparagraph id="H8F2800EEBFD0495AAE71325DCCF4B73E"><enum>(D)</enum><header>Treatment of direct primary care service arrangements</header><clause id="HA5546DA62CEF4C85A35528DF9DDA3C31"><enum>(i)</enum><header>In general</header><text>A direct primary care service arrangement shall not be treated as a health plan for purposes of subparagraph (A)(ii).</text></clause><clause id="H10814E8BC2D1456DB3A955DA3B0FF708"><enum>(ii)</enum><header>Direct primary care service arrangement</header><text>For purposes of this paragraph—</text><subclause id="HE3DA083BE095418C9960FC801458F81F"><enum>(I)</enum><header>In general</header><text>The term <term>direct primary care service arrangement</term> 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.</text></subclause><subclause id="HB27B94D29F6B4779A233C9539062C6BF"><enum>(II)</enum><header>Limitation</header><text>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).</text></subclause></clause><clause id="HB02F5D17BA094423B9D65CCB020F3709"><enum>(iii)</enum><header>Certain services specifically excluded from treatment as primary care services</header><text>For purposes of this paragraph, the term <term>primary care services</term> shall not include—</text><subclause id="H4E79DE7310654A5D9169F5C1044DD915"><enum>(I)</enum><text>procedures that require the use of general anesthesia, and</text></subclause><subclause id="HA840F9D2B99B44DEBEFCF28B4CAB0768"><enum>(II)</enum><text>laboratory services not typically administered in an ambulatory primary care setting.</text></subclause><continuation-text continuation-text-level="clause">The Secretary, after consultation with the Secretary of Health and Human Services, shall issue regulations or other guidance regarding the application of this clause.</continuation-text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H5E3832643CAF4642B8C8B17552B99704"><enum>(b)</enum><header>Direct primary care service arrangement fees treated as medical expenses</header><text>Section 223(d)(2)(C) is amended by striking <quote>or</quote> at the end of clause (iii), by striking the period at the end of clause (iv) and inserting <quote>, or</quote>, and by adding at the end the following new clause:</text><quoted-block id="H1F07DFCDF4E846D4A57792B99FB5A134" style="OLC"><subsection id="H3EFB97FF517F44F48C980D6731EBABA1"><enum>(v)</enum><text>any direct primary care service arrangement.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H106B4E02F15146FFB0E5F208C7EE5D98"><enum>(c)</enum><header>Inflation adjustment</header><text>Section 223(g)(1) of such Code is amended—</text><paragraph id="H8F2D8CA6659C4CF6A51CADBCC0F97989"><enum>(1)</enum><text>by inserting <quote>, (c)(1)(D)(ii)(II),</quote> after <quote>(b)(2),</quote> each place such term appears, and</text></paragraph><paragraph id="H00B2E3860B144E80A9A1D20C511C42A3"><enum>(2)</enum><text>in subparagraph (B), by inserting <quote>and (iii)</quote> after <quote>clause (ii)</quote> in clause (i), by striking <quote>and</quote> at the end of clause (i), by striking the period at the end of clause (ii) and inserting <quote>, and</quote>, and by inserting after clause (ii) the following new clause:</text><quoted-block id="HBD8F9B247CB54DC4A18E04D674D55636" style="OLC"><clause id="HCC40D93EC8734818B04C46EB09646C98"><enum>(iii)</enum><text>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.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HD24D68DD5A6948BBAE7C2925BBB883CD"><enum>(d)</enum><header>Reporting of direct primary care service arrangement fees on W–2</header><text>Section 6051(a) of such Code is amended by striking <quote>and</quote> at the end of paragraph (16), by striking the period at the end of paragraph (17) and inserting <quote>, and</quote>, and by inserting after paragraph (17) the following new paragraph:</text><quoted-block id="H76C49929C89D4F66A488A21C44F19F45" style="OLC"><paragraph id="H830AD517700745DAAAEC6954E73FE315"><enum>(18)</enum><text>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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H4533C8C2057E4493A19003B1960C3E5B"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall apply to months beginning after December 31, 2024, in taxable years ending after such date.</text></subsection></section></subtitle><subtitle id="HED52301B46F24D53BDA51B26403DFAB0"><enum>B</enum><header>Assistance to health savings accounts</header><section id="H7593E89D45A74F778035D4E4773A8FEF"><enum>111.</enum><header>One-time application of saver’s credit to contributions to health savings accounts</header><subsection id="HF139EB4E47E9436E8E8B992597BE8A8B"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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 <external-xref legal-doc="usc" parsable-cite="usc/26/25B">section 25B</external-xref> of the Internal Revenue Code of 1986.</text></subsection><subsection id="HD4E91501FD5A4F70B341C07D2F97BA3F"><enum>(b)</enum><header>Applicable taxable year</header><text>For purposes of this section, the term <term>applicable taxable year</term> 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.</text></subsection></section><section id="H135B61F0C0864FCDA3E45AEA804109D0"><enum>112.</enum><header>Grants for health savings account assistance and outreach</header><subsection id="H2F454ECFEFC24EA78AFC032BBDDA75C4"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Administrator shall establish a grant program to provide assistance to eligible entities to carry out the activities described in subsection (c).</text></subsection><subsection id="H842F3A8FB8D844278B6FC10BA756DAF0"><enum>(b)</enum><header>Application</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="H9C66D0C1CBE74323A3277D3C8426B331"><enum>(c)</enum><header>Use of funds</header><text display-inline="yes-display-inline">An eligible entity receiving a grant under this section shall use such funds to—</text><paragraph id="HF535C94100A14E3AAD2D14FAD3C79E3B"><enum>(1)</enum><text display-inline="yes-display-inline">distribute fair and impartial information to consumers about health savings accounts, including the availability of such accounts and how such accounts may be utilized;</text></paragraph><paragraph id="HBA39133D51F940F89E7971018283F76C" commented="no"><enum>(2)</enum><text>conduct activities to raise public awareness of health savings accounts;</text></paragraph><paragraph id="HB880961E35D94E05B29AE033E5ED0EE1" commented="no"><enum>(3)</enum><text>facilitate enrollment in health savings accounts; and</text></paragraph><paragraph id="H353DA458A16F454C9D6C063D93DE2991" commented="no"><enum>(4)</enum><text>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.</text></paragraph></subsection><subsection id="H756B698621C04609A02F45C2BFBB2D0A"><enum>(d)</enum><header>Amount</header><text display-inline="yes-display-inline">The Administrator may distribute up to $5,000,000 annually to be divided among grant recipients under this section.</text></subsection><subsection id="H26BA4682862D43BE988842361062599F"><enum>(e)</enum><header>Report</header><text>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.</text></subsection><subsection id="HF9264D531C0246DCBDBD60E3F0F22A64"><enum>(f)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text><paragraph id="H8A6DBEFF56954272BEE114199667F1D7"><enum>(1)</enum><header>Administrator</header><text display-inline="yes-display-inline">The term <term>Administrator</term> means the Administrator of the Centers for Medicare & Medicaid Services.</text></paragraph><paragraph id="H947BB720F85E4AB5B19FC90F87FD1A6E"><enum>(2)</enum><header>Consumer</header><text>The term <term>consumer</term> means an individual enrolled in, or seeking to enroll in, a health savings account.</text></paragraph><paragraph id="H78B49782C5074B6588229576B9C31904" commented="no"><enum>(3)</enum><header>Eligible entity</header><text>The term <term>eligible entity</term> includes the following:</text><subparagraph id="H2BB68EA6DDD848C7BC13B146941516BD" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">A State.</text></subparagraph><subparagraph id="H714C59B2D06744BF828F515610B61334" commented="no"><enum>(B)</enum><text>Trade.</text></subparagraph><subparagraph id="HD9AB65638AE644B089697EF08DE576BA" commented="no"><enum>(C)</enum><text display-inline="yes-display-inline">Industry.</text></subparagraph><subparagraph id="H94DF583CF03241F2BE7FAA3418DD5C92" commented="no"><enum>(D)</enum><text>Professional associations.</text></subparagraph><subparagraph id="HCEE51236C12642568A16FA2EE4AE4524" commented="no"><enum>(E)</enum><text>Commercial fishing industry organizations.</text></subparagraph><subparagraph id="H0AED1C0D17D049E3A6A462D625C719F7" commented="no"><enum>(F)</enum><text>Ranching and farming organizations.</text></subparagraph><subparagraph id="HD621BB4D87D6459ABB1A7343F34CBF03" commented="no"><enum>(G)</enum><text>Community and consumer-focused nonprofit groups.</text></subparagraph><subparagraph id="H2E54CECAFB124079AF0001F5CC4D65AB" commented="no"><enum>(H)</enum><text>Chambers of commerce.</text></subparagraph><subparagraph id="HABF7B9E163704867B40F8B9009FF8F89" commented="no"><enum>(I)</enum><text>Unions.</text></subparagraph><subparagraph id="H7E5EE4C8FC13485B84F6320B2F0835B2" commented="no"><enum>(J)</enum><text>Small business development centers (as defined in section 21 of the Small Business Act (<external-xref legal-doc="usc" parsable-cite="usc/15/648">15 U.S.C. 648</external-xref>)).</text></subparagraph><subparagraph id="H6F62558BA5CF46908566FC9F66FB130D" commented="no"><enum>(K)</enum><text>Other entities capable of carrying out the activities described under subsection (b).</text></subparagraph></paragraph><paragraph id="H50A88E16A3FB4DFCBFD08EB5041A2ECF"><enum>(4)</enum><header>Health savings account</header><text display-inline="yes-display-inline">The term <term>health savings account</term> has the meaning given such term in <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223</external-xref> of the Internal Revenue Code of 1986.</text></paragraph><paragraph id="H4CD7C98A597F47C8AC4A8459896FCA8C"><enum>(5)</enum><header>State</header><text>The term <term>State</term> means each of the several States, the District of Columbia, each territory and possession of the United States, and each federally recognized Indian Tribe.</text></paragraph></subsection></section><section id="HF741FE0CE93447BD96C414465B874C7A"><enum>113.</enum><header>New corporations required to use health savings accounts</header><text display-inline="no-display-inline">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.</text></section><section id="H98B145E7DE7B428C90A8820FA12C3705" section-type="subsequent-section"><enum>114.</enum><header>Federal employee health benefits and health savings accounts</header><subsection id="H58FBC8EB582240C9B87FB239722EA75B"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1312(d)(3)(D) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18032">42 U.S.C. 18032(d)(3)(D)</external-xref>) is amended—</text><paragraph id="HB2E017885D0E43728344FB59F3937DF4"><enum>(1)</enum><text>in the subparagraph heading, by striking <quote><header-in-text level="subparagraph" style="OLC">Members of Congress</header-in-text></quote> and inserting <quote><header-in-text level="subparagraph" style="OLC">President, Vice President, Members of Congress, and Federal employees</header-in-text></quote>;</text></paragraph><paragraph id="HEC714707B6C54A80872B4132374E592F"><enum>(2)</enum><text>in clause (i), in the matter preceding subclause (I)—</text><subparagraph id="HCEA9916D60C04DC49470D92F9979D77F"><enum>(A)</enum><text>by striking <quote>Members of Congress and congressional staff</quote> and inserting <quote>the President, Vice President, Members of Congress, and Federal employees</quote>; and</text></subparagraph><subparagraph id="HA376CC9500C148CF804D4E713BB3F578"><enum>(B)</enum><text>by striking <quote>a Member of Congress or congressional staff</quote> and inserting <quote>the President, the Vice President, a Member of Congress, or a Federal employee</quote>; and</text></subparagraph></paragraph><paragraph id="HCBA4075A0ADF47359232F52B62D3B52B"><enum>(3)</enum><text>in clause (ii), by amending subclause (II) to read as follows:</text><quoted-block display-inline="no-display-inline" id="H4E60AF3D102B4EFDAECC3536178E7E8D" style="OLC"><subclause id="H0B1A64AF86E54A3B9C6E216F7BBD33C3"><enum>(II)</enum><header>Federal employee</header><text display-inline="yes-display-inline">The term <term>Federal employee</term> means—</text><item id="H175D65D4405445C9B9DA9B5115E4F6E2"><enum>(aa)</enum><text>an <quote>employee</quote>, as such term is defined in section 2105 of title 5, United States Code; and</text></item><item commented="no" id="H0B78F3B0141F48F59233DDB2C663C2E8"><enum>(bb)</enum><text>includes an individual to whom subsection (c) or (f) of such section 2105 pertains (whether or not such individual satisfies item (aa)).</text></item></subclause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HADC1D114F86547DDA78C5FC64A2AD771"><enum>(b)</enum><header>Conversion to health savings accounts</header><text display-inline="yes-display-inline">Each plan offered under <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/89">chapter 89</external-xref> 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.</text></subsection></section></subtitle><enum>II</enum><header>Improving Private Health Insurance</header><subtitle id="H234E697FFA91494BAC23E53B87453E89"><enum>A</enum><header>Maintaining Protections for Patients with Preexisting Conditions</header><section section-type="subsequent-section" id="H6B50C443F6C348B0AFF97524AC2F37E9"><enum>201.</enum><header>Guaranteed availability of coverage; prohibiting discrimination</header><subsection id="HBA683CDC079A45D09198AB76345ABC86"><enum>(a)</enum><header>In general</header><text>Subtitle C of title I of the Health Insurance Portability and Accountability Act of 1996 (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HFE0567687441440392CFEA0FCE6481A3"><section section-type="subsequent-section" id="H8A5FD7D8C5D343F993F4F6FF97D38C32"><enum>196.</enum><header>Guaranteed availability of coverage</header><subsection id="H8C26344A71E1478B8CE69410DAAD8A3C"><enum>(a)</enum><header>Guaranteed issuance of coverage in the individual and group market</header><text>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.</text></subsection><subsection id="H5E3974A530E04B6D9E9DF918CECD42AD"><enum>(b)</enum><header>Enrollment</header><paragraph id="HD9770266C6F9446884C67D1DBD36094F"><enum>(1)</enum><header>Restriction</header><text>A health insurance issuer described in subsection (a) may restrict enrollment in coverage described in such subsection to open or special enrollment periods.</text></paragraph><paragraph id="HD1C267F3995343EF9AAEF1E47E026C94"><enum>(2)</enum><header>Establishment</header><text>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).</text></paragraph><paragraph id="H720CE392558D45068A08305C59DE09B0"><enum>(3)</enum><header>Regulations</header><text>The Secretary shall promulgate regulations with respect to enrollment periods under paragraphs (1) and (2).</text></paragraph></subsection><subsection id="H50F9B430707D4B37AEF269361F7B2DF3"><enum>(c)</enum><header>Special rules for network plans</header><paragraph id="HF08819D8DB494A10878A40CBD8AAADC9"><enum>(1)</enum><header>In general</header><text>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—</text><subparagraph id="H3D1E2C68AF764FBA811F7ED0C936AEFB"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="H30F5645066C943DE9AE329115FD06354"><enum>(B)</enum><text>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—</text><clause id="H9878E6D1C88446039BA494ED755A5963"><enum>(i)</enum><text>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</text></clause><clause id="H9D6E5770EB8D4A23959A3DF59A7BDC02"><enum>(ii)</enum><text>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.</text></clause></subparagraph></paragraph><paragraph id="HA63274CFE6DA4330BF5F57996E045F23"><enum>(2)</enum><header>180-day suspension upon denial of coverage</header><text>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.</text></paragraph></subsection><subsection id="H761BC6BCB5114E9A8140C2B04BAACB48"><enum>(d)</enum><header>Application of financial capacity limits</header><paragraph id="HD34844789E0B4A948D331E55D2418292"><enum>(1)</enum><header>In general</header><text>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—</text><subparagraph id="H2F67F81CCD2144EFB5F31A1EBF49DFAE"><enum>(A)</enum><text>it does not have the financial reserves necessary to underwrite additional coverage; and</text></subparagraph><subparagraph id="HDAA4AD4A697842CD922F2456D5387502"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><paragraph id="H3C7B04116CBE44A09BC8ACD0371BA998"><enum>(2)</enum><header>180-day suspension upon denial of coverage</header><text>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.</text></paragraph></subsection><subsection id="H18F79CBB6BA345ABBA82BA6C06B23821"><enum>(e)</enum><header>Definitions</header><text>In this section and in sections 197 through 199A:</text><paragraph id="H0BE5A8A100734236A4BD14570B0F1226"><enum>(1)</enum><text>The term <term>Secretary</term> means the Secretary of Health and Human Services.</text></paragraph><paragraph id="H65350ED33B4D4776AC0AC2C2B6CD0B1E"><enum>(2)</enum><text>The terms <term>genetic information</term>, <term>genetic test</term>, <term>group health plan</term>, <term>group market</term>, <term>health insurance coverage</term>, <term>health insurance issuer</term>, <term>group health insurance coverage</term>, <term>individual health insurance coverage</term>, <term>individual market</term>, and <term>underwriting purpose</term> have the meanings given such terms in section 2791 of the Public Health Service Act.</text></paragraph></subsection></section><section id="H5EE29A6DB09C47B599A381228CF5D505"><enum>197.</enum><header>Fair health insurance premiums</header><subsection id="HBB4267A62E45443C8D4AF69C657AB9E2"><enum>(a)</enum><header>Prohibiting discriminatory premium rates</header><paragraph id="H5231EF75BF7F4BCBB3DF4A123E564438"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">With respect to the premium rate charged by a health insurance issuer for health insurance coverage offered in the individual or small group market—</text><subparagraph id="H1A3CB7A0F0E44232B90E958DECAD4D1E"><enum>(A)</enum><text>such rate shall vary with respect to the particular plan or coverage involved only by—</text><clause id="H7486ECAEA8C64A838A81DDA947659B7A"><enum>(i)</enum><text>whether such plan or coverage covers an individual or family;</text></clause><clause id="H4EC5D294EF6645989ED815539197E586"><enum>(ii)</enum><text>rating area, as established in accordance with paragraph (2);</text></clause><clause id="H730DD7982A3F43C9B850EAFADAB5E7EA"><enum>(iii)</enum><text>age, except that such rate shall not vary by more than 5 to 1 for adults; and</text></clause><clause id="HC72279E0BA40449AB00BA1F7DD8DFA5C"><enum>(iv)</enum><text>tobacco use, except that such rate shall not vary by more than 1.5 to 1; and</text></clause></subparagraph><subparagraph id="H8295ACCD43B14C31BE6603BB11BE264F"><enum>(B)</enum><text>such rate shall not vary with respect to the particular plan or coverage involved by any other factor not described in subparagraph (A).</text></subparagraph></paragraph><paragraph id="HD0A4CB51984C4B4E9E9F6B1AE318BAC3"><enum>(2)</enum><header>Rating area</header><subparagraph id="HC9A83CDFBB6B4F5FB6EDC87A3A3C7882"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Each State shall establish 1 or more rating areas within that State for purposes of applying the requirements of this title.</text></subparagraph><subparagraph id="H2F288BA6614B4C94AA9BDF96C60592DB"><enum>(B)</enum><header>Secretarial review</header><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><paragraph id="HC2EA4663B1684230AD77B9A59A6014DD"><enum>(3)</enum><header>Permissible age bands</header><text display-inline="yes-display-inline">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).</text></paragraph><paragraph id="HAFC04203862947559F50DD5B15FC9476"><enum>(4)</enum><header>Application of variations based on age or tobacco use</header><text display-inline="yes-display-inline">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.</text></paragraph></subsection></section><section id="H2EE538164E334E2DBC8A19A08D188C8E"><enum>198.</enum><header>Prohibiting discrimination against individual participants and beneficiaries based on health status</header><subsection id="H49D70B73F01B44219BC6AE63C663AEE2"><enum>(a)</enum><header>In general</header><text>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:</text><paragraph id="H19013B8054E0410899A79E017AE98981"><enum>(1)</enum><text>Health status.</text></paragraph><paragraph id="H40F9C0F22227473B807FC07419A0AA33"><enum>(2)</enum><text>Medical condition (including both physical and mental illnesses).</text></paragraph><paragraph id="H5FAC3C9C2EE74C1A970F4201469CDC6D"><enum>(3)</enum><text>Claims experience.</text></paragraph><paragraph id="HEDDBDFDCB3EF400FA98BCB37FF507024"><enum>(4)</enum><text>Receipt of health care.</text></paragraph><paragraph id="H17C22D295B994354A841B148588F1E72"><enum>(5)</enum><text>Medical history.</text></paragraph><paragraph id="HEDB68F5ABF8948F09666CB8DB54A515B"><enum>(6)</enum><text>Genetic information.</text></paragraph><paragraph id="H615080387FC646879DA57CF8108144DF"><enum>(7)</enum><text>Evidence of insurability (including conditions arising out of acts of domestic violence).</text></paragraph><paragraph id="HFFCB4CE98EF94E48A7043975A793AE78"><enum>(8)</enum><text>Disability.</text></paragraph><paragraph id="HB721CCCBAF83445BBED04AB0F2E7C6B9"><enum>(9)</enum><text>Any other health status-related factor determined appropriate by the Secretary.</text></paragraph></subsection><subsection id="H47B56BA03CE342DB83DB58A19414B022"><enum>(b)</enum><header>In premium contributions</header><paragraph id="H53CDCB9FB4BD4295B23DED1F8EA0231B"><enum>(1)</enum><header>In general</header><text>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.</text></paragraph><paragraph id="H89D3326471C04D63AB08473BC31A43EF"><enum>(2)</enum><header>Construction</header><text>Nothing in paragraph (1) shall be construed—</text><subparagraph id="HB3D813BF8CC44757BC30CEC82A7A6C0C"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="H4B74A762FD52466E803C23ECEAA7EFDF"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><paragraph id="H6889998809BD442ABA2040999C1B35A4"><enum>(3)</enum><header>No group-based discrimination on basis of genetic information</header><subparagraph id="H11E44C2CC0D54DAEBD3D2B716045E9F5"><enum>(A)</enum><header>In general</header><text>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.</text></subparagraph><subparagraph id="H8D0F1ECDB252481193F105E7D375AF7F"><enum>(B)</enum><header>Rule of construction</header><text>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.</text></subparagraph></paragraph></subsection><subsection id="H7FC3D5BD13D24330BA8114EEA0386B46"><enum>(c)</enum><header>Genetic testing</header><paragraph id="H91274CBB43C14BF8B0F6489C5E57A353"><enum>(1)</enum><header>Limitation on requesting or requiring genetic testing</header><text>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.</text></paragraph><paragraph id="HB811FB6FBDF043A9B28ECBD60567719E"><enum>(2)</enum><header>Rule of construction</header><text>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.</text></paragraph><paragraph id="HDAE14789F1BA44F9888698730257BB0C"><enum>(3)</enum><header>Rule of construction regarding payment</header><subparagraph id="H4F77FAAFA254452C854B82B47F8D0812"><enum>(A)</enum><header>In general</header><text>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).</text></subparagraph><subparagraph id="HF7BF79C775DE4CEA94A942BC6A3F9740"><enum>(B)</enum><header>Limitation</header><text>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.</text></subparagraph></paragraph><paragraph id="HB3BB27241A9F4E3D830BE70B4642411B"><enum>(4)</enum><header>Research exception</header><text>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:</text><subparagraph id="HAC0CDBE67F604A9FB91AF0BD4BA8A8FF"><enum>(A)</enum><text>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.</text></subparagraph><subparagraph id="H1C1A04FB191448D5A81900BEEDC6E0E4"><enum>(B)</enum><text>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—</text><clause id="H5243478D27474EFB8FA8C88A2F3C0C7E"><enum>(i)</enum><text>compliance with the request is voluntary; and</text></clause><clause id="HCACF8F724DD043ADA44D73CA25044937"><enum>(ii)</enum><text>noncompliance will have no effect on enrollment status or premium or contribution amounts.</text></clause></subparagraph><subparagraph id="H49F61C0276C14E43BB86153899F92D23"><enum>(C)</enum><text>No genetic information collected or acquired under this paragraph shall be used for underwriting purposes.</text></subparagraph><subparagraph id="HEAE1A4D2B6BF4199B8A6FB81511235E7"><enum>(D)</enum><text>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.</text></subparagraph><subparagraph id="H1E15B14F42F84561ADCF2AA99F2AA515"><enum>(E)</enum><text>The plan or issuer complies with such other conditions as the Secretary may by regulation require for activities conducted under this paragraph.</text></subparagraph></paragraph></subsection><subsection id="HD999DE71A32B440FB6A87579D0B3A621"><enum>(d)</enum><header>Prohibition on collection of genetic information</header><paragraph id="HD0D920819B79446997F1BBBAB3CE710E"><enum>(1)</enum><header>In general</header><text>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.</text></paragraph><paragraph id="H60BEFF9371C7471591F157EB29A3963A"><enum>(2)</enum><header>Prohibition on collection of genetic information prior to enrollment</header><text>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.</text></paragraph><paragraph id="HA656B13C34F04B9B86AA1267907C3E2C"><enum>(3)</enum><header>Incidental collection</header><text>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).</text></paragraph></subsection><subsection id="H8FE1262821E04E95A2153DCA04AAB354"><enum>(e)</enum><header>Genetic information of a fetus or embryo</header><text>Any reference in this part to genetic information concerning an individual or family member of an individual shall—</text><paragraph id="H1F5109D3AF2F47588F34C777DAEE6D1B"><enum>(1)</enum><text>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</text></paragraph><paragraph id="HD494FE448DA0444DBF4470DF23DE0CEF"><enum>(2)</enum><text>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.</text></paragraph></subsection><subsection id="HFBA1A056604D4CAFA25F030025FD3B51"><enum>(f)</enum><header>Programs of health promotion or disease prevention</header><paragraph id="H28993F4D58D34BF9B27FCA9634CBECE3"><enum>(1)</enum><header>General provisions</header><subparagraph id="HF3250B1487C54CEE8CCCEFC49D398591"><enum>(A)</enum><header>General rule</header><text>For purposes of subsection (b)(2)(B), a program of health promotion or disease prevention (referred to in this subsection as a <quote>wellness program</quote>) 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.</text></subparagraph><subparagraph id="H24BB16E7DC554B13AD5176C44591DFEF"><enum>(B)</enum><header>No conditions based on health status factor</header><text>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.</text></subparagraph><subparagraph id="HBD811D77FE7443FBB40F4FAF3FD0127F"><enum>(C)</enum><header>Conditions based on health status factor</header><text>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.</text></subparagraph></paragraph><paragraph id="H16A6CEA4BA3047A89CCBD2140F171144"><enum>(2)</enum><header>Wellness programs not subject to requirements</header><text>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:</text><subparagraph id="H0AABF779CF774D729753B52CBB2B4743"><enum>(A)</enum><text>A program that reimburses all or part of the cost for memberships in a fitness center.</text></subparagraph><subparagraph id="H69A876EA1F4B4EF8811BC3C37686C571"><enum>(B)</enum><text>A diagnostic testing program that provides a reward for participation and does not base any part of the reward on outcomes.</text></subparagraph><subparagraph id="HE974877D38AC4AD88898730CBA391F1F"><enum>(C)</enum><text>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).</text></subparagraph><subparagraph id="HF303886742714B2C84F0B79E697911C8"><enum>(D)</enum><text>A program that reimburses individuals for the costs of smoking cessation programs without regard to whether the individual quits smoking.</text></subparagraph><subparagraph id="H949D0CC7C8264A998FB72B4D5D615BEA"><enum>(E)</enum><text>A program that provides a reward to individuals for attending a periodic health education seminar.</text></subparagraph></paragraph><paragraph id="H85B8FCAF98EB49918817EF3FC6B46ED0"><enum>(3)</enum><header>Wellness programs subject to requirements</header><text>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:</text><subparagraph id="H1F4B0B3F750A4DAF95607D5C7B31E159"><enum>(A)</enum><text>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.</text></subparagraph><subparagraph id="H2091013464DA46B69965C5CD952DA3F0"><enum>(B)</enum><text>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.</text></subparagraph><subparagraph id="H44F30255BAD64FA5A6613A760D581753"><enum>(C)</enum><text>The plan shall give individuals eligible for the program the opportunity to qualify for the reward under the program at least once each year.</text></subparagraph><subparagraph id="H98C63934E0C44BCD8FE48612E4554F52"><enum>(D)</enum><text>The full reward under the wellness program shall be made available to all similarly situated individuals. For such purpose, among other things:</text><clause id="H12939576BBEB4ED8BE3E8734FA7DA9AC"><enum>(i)</enum><text>The reward is not available to all similarly situated individuals for a period unless the wellness program allows—</text><subclause id="H10F9F360542F42EA95D07D6D0D6DC9C4"><enum>(I)</enum><text>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</text></subclause><subclause id="HEF1AF3A8089341DEA86B62AA23E580F2"><enum>(II)</enum><text>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.</text></subclause></clause><clause id="H508040C93C5F4D5E819F5866163318D3"><enum>(ii)</enum><text>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.</text></clause></subparagraph><subparagraph id="H05D93C9523C14FAD80FB38E472AB02C7"><enum>(E)</enum><text>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.</text></subparagraph></paragraph></subsection></section><section id="HD3039CE44F4E495C9B385C91F50F8C19"><enum>199.</enum><header>Prohibition of preexisting condition exclusions or other discrimination based on health status</header><subsection id="H6F19A491C14B476DAEEFBC40741DF9CC"><enum>(a)</enum><header>In general</header><text>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.</text></subsection><subsection id="H7E6E8A3CF9244052AE48879135F51838"><enum>(b)</enum><header>Definitions</header><text>For purposes of this section—</text><paragraph id="H4FE2BAEBD43942BCBAD83E47EF78A67B"><enum>(1)</enum><header>Preexisting condition exclusion</header><subparagraph id="H4857DDB51AA44186885092627DE262EE"><enum>(A)</enum><header>In general</header><text>The term <term>preexisting condition exclusion</term> 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.</text></subparagraph><subparagraph id="H810ADCB88F1E4371A1867DA163CA98B1"><enum>(B)</enum><header>Treatment of genetic information</header><text>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.</text></subparagraph></paragraph><paragraph id="H0BDD503F02FE4E20A6D6647C6F97FDB0"><enum>(2)</enum><header>Enrollment date</header><text>The term <term>enrollment date</term> 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.</text></paragraph><paragraph id="HCAAFA017E9824042909523A879225813"><enum>(3)</enum><header>Late enrollee</header><text>The term <term>late enrollee</term> means, with respect to coverage under a group health plan, a participant or beneficiary who enrolls under the plan other than during—</text><subparagraph id="H0BCA97E3F7754801A13216F1C976A0B1"><enum>(A)</enum><text>the first period in which the individual is eligible to enroll under the plan; or</text></subparagraph><subparagraph id="H290FC0BE1F074EC58EDAD220E0EC2985"><enum>(B)</enum><text>a special enrollment period under subsection (f).</text></subparagraph></paragraph><paragraph id="H5477AA9B1CD74780A28ADE89348B2F4A"><enum>(4)</enum><header>Waiting period</header><text>The term <term>waiting period</term> 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.</text></paragraph></subsection><subsection display-inline="no-display-inline" id="HCB9F51F60E89406FA23C370E638DAA85"><enum>(c)</enum><header>Rules relating to crediting previous coverage</header><paragraph id="H2979A20CA5AC420E867A5CB8BE57C550"><enum>(1)</enum><header>Creditable coverage defined</header><text>For purposes of this title, the term <term>creditable coverage</term> means, with respect to an individual, coverage of the individual under any of the following:</text><subparagraph id="HE56969CB88174276A0CC4D5BF0D3F92E"><enum>(A)</enum><text>A group health plan.</text></subparagraph><subparagraph id="HFB089F5F27934FF6B600FBC92CC134C0"><enum>(B)</enum><text>Health insurance coverage.</text></subparagraph><subparagraph id="HDB9C9B3153784A03A4F3EC5118C9C1F2"><enum>(C)</enum><text>Part A or part B of title XVIII of the Social Security Act.</text></subparagraph><subparagraph id="H07E6235BF0D24AC88C67D4EA056DB5F5"><enum>(D)</enum><text>Title XIX of the Social Security Act, other than coverage consisting solely of benefits under section 1928.</text></subparagraph><subparagraph id="H7C6D7035384642C68B2FB41C6E431E1F"><enum>(E)</enum><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/10/55">Chapter 55</external-xref> of title 10, United States Code.</text></subparagraph><subparagraph id="HC5A4C4FC84EB43F3BF1E0D38DB093791"><enum>(F)</enum><text>A medical care program of the Indian Health Service or of a tribal organization.</text></subparagraph><subparagraph id="H4673A70B53B14273B7A2227690658462"><enum>(G)</enum><text>A State health benefits risk pool.</text></subparagraph><subparagraph id="H0A2C6F143D1A4FE1981CEC54521B63A6"><enum>(H)</enum><text>A health plan offered under <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/89">chapter 89</external-xref> of title 5, United States Code.</text></subparagraph><subparagraph id="H9C0D19257EDA4186B87ED606E7A3B575"><enum>(I)</enum><text>A public health plan (as defined in regulations).</text></subparagraph><subparagraph id="H7B621BF4D9E34A9B8FE6B3E9FE9617FA"><enum>(J)</enum><text>A health benefit plan under section 5(e) of the Peace Corps Act (<external-xref legal-doc="usc" parsable-cite="usc/22/2504">22 U.S.C. 2504(e)</external-xref>).</text></subparagraph><continuation-text continuation-text-level="paragraph">Such term does not include coverage consisting solely of coverage of excepted benefits (as defined in section 2791(c)). </continuation-text></paragraph><paragraph id="H20BEEAFDD9084479A30EDA9CCB22B046"><enum>(2)</enum><header>Not counting periods before significant breaks in coverage</header><subparagraph id="H7E9DCFC570AF4A0384C9F502DA822A1F"><enum>(A)</enum><header>In general</header><text>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.</text></subparagraph><subparagraph id="HDF213A7DCA434FC7B386FF8F4F21C993"><enum>(B)</enum><header>Waiting period not treated as a break in coverage</header><text>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).</text></subparagraph><subparagraph id="HAFCFD540F3DB44F689998B8642E8FAF1"><enum>(C)</enum><header>TAA-eligible individuals</header><text>In the case of plan years beginning before January 1, 2014—</text><clause id="HB2104BA94DA14E4F90F22317AB0143A7"><enum>(i)</enum><header>TAA pre-certification period rule</header><text>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 <external-xref legal-doc="usc" parsable-cite="usc/26/7527">section 7527</external-xref> of the Internal Revenue Code of 1986 shall not be taken into account in determining the continuous period under subparagraph (A).</text></clause><clause id="H38906A69047B45D9BDF7B145979D7D85"><enum>(ii)</enum><header>Definitions</header><text>The terms <term>TAA-eligible individual</term> and <term>TAA-related loss of coverage</term> have the meanings given such terms in section 2205(b)(4).</text></clause></subparagraph></paragraph><paragraph id="H54D779C59A304725B9DA8225F6607ABF"><enum>(3)</enum><header>Method of crediting coverage</header><subparagraph id="HADDEC1F0E04E4900A2D4112044174837"><enum>(A)</enum><header>Standard method</header><text>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.</text></subparagraph><subparagraph id="H67CFEE036D124B9491984B31C9008572"><enum>(B)</enum><header>Election of alternative method</header><text>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.</text></subparagraph><subparagraph id="H32E68F990237423E89EE44C53D00CD2E"><enum>(C)</enum><header>Plan notice</header><text>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—</text><clause id="HFFE353205CE84024B179D8B14E374E1A"><enum>(i)</enum><text>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</text></clause><clause id="H1F5B34446E2D4DB19A505B9671B44FA2"><enum>(ii)</enum><text>include in such statements a description of the effect of this election.</text></clause></subparagraph><subparagraph id="H32160B58F05446E4A5CF9348A0DA136C"><enum>(D)</enum><header>Issuer notice</header><text>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—</text><clause id="H7A5D398E1DD24EDB97E9CDD3829EE77E"><enum>(i)</enum><text>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</text></clause><clause id="HD171FB6864DF4AE09FDC49707CE6EB2A"><enum>(ii)</enum><text>shall include in such statements a description of the effect of such election.</text></clause></subparagraph></paragraph><paragraph id="H4633D7ADA91F4168B234036396228D11"><enum>(4)</enum><header>Establishment of period</header><text>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.</text></paragraph></subsection><subsection display-inline="no-display-inline" id="H59C1092FFE3048C3A41A399738EC24B5"><enum>(d)</enum><header>Exceptions</header><paragraph id="H7DD9A4F9B3E04A0CA71992FE6F6672E5"><enum>(1)</enum><header>Exclusion not applicable to certain newborns</header><text>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.</text></paragraph><paragraph id="H9D7C0A4A25554FD09ADF75630585EBEF"><enum>(2)</enum><header>Exclusion not applicable to certain adopted children</header><text>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.</text></paragraph><paragraph id="HF312BD3855D04B9994C736943DF77A8F"><enum>(3)</enum><header>Exclusion not applicable to pregnancy</header><text>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.</text></paragraph><paragraph id="H943C227043154975BE00E9639BCBD6B6"><enum>(4)</enum><header>Loss if break in coverage</header><text>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.</text></paragraph></subsection><subsection display-inline="no-display-inline" id="H86F2F15F415445F2A3AA7F8FBA6A268D"><enum>(e)</enum><header>Certifications and disclosure of coverage</header><paragraph id="HE9B1D21285274DF9887D977DEDEA223A"><enum>(1)</enum><header>Requirement for certification of period of creditable coverage</header><subparagraph id="H558174B0770C4C81A10BE95B34C3FF70"><enum>(A)</enum><header>In general</header><text>A group health plan, and a health insurance issuer offering group or individual health insurance coverage, shall provide the certification described in subparagraph (B)—</text><clause id="H92FE31D22EBB4211801F5C62A3D88AD6"><enum>(i)</enum><text>at the time an individual ceases to be covered under the plan or otherwise becomes covered under a COBRA continuation provision;</text></clause><clause id="HEA5EF37D3F654CCD9445CEBC1D5FF296"><enum>(ii)</enum><text>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</text></clause><clause id="H8729AF828E8543C794549BB357EF5809"><enum>(iii)</enum><text>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.</text></clause><continuation-text continuation-text-level="subparagraph">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. </continuation-text></subparagraph><subparagraph id="H1A5A7A63142A4B3F8D8DDEDE8DF668CD"><enum>(B)</enum><header>Certification</header><text>The certification described in this subparagraph is a written certification of—</text><clause id="H34E6BF510DD2475E8407E2D445ADC736"><enum>(i)</enum><text>the period of creditable coverage of the individual under such plan and the coverage (if any) under such COBRA continuation provision; and</text></clause><clause id="H03C52A83CF3947B2AD4DC482BD314ABD"><enum>(ii)</enum><text>the waiting period (if any) (and affiliation period, if applicable) imposed with respect to the individual for any coverage under such plan.</text></clause></subparagraph><subparagraph id="HD202F224B14142D5B1543009F2B70547"><enum>(C)</enum><header>Issuer compliance</header><text>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.</text></subparagraph></paragraph><paragraph id="HE11FABAD80514D4DB7F33B796AF5D580"><enum>(2)</enum><header>Disclosure of information on previous benefits</header><text>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)—</text><subparagraph id="H004D6BE405D041F4B563F6F3BB5B0A1F"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="H19CEB0425B4A4987B158F79693FFBC45"><enum>(B)</enum><text>such entity may charge the requesting plan or issuer for the reasonable cost of disclosing such information.</text></subparagraph></paragraph><paragraph id="H1A2591DAF64D436FA8262358946C3CD0"><enum>(3)</enum><header>Regulations</header><text>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.</text></paragraph></subsection><subsection display-inline="no-display-inline" id="H4C80CAC9D7624AC188631BB7FA2B3314"><enum>(f)</enum><header>Special enrollment periods</header><paragraph id="H82CF2300370345A780446E61C24CFA26"><enum>(1)</enum><header>Individuals losing other coverage</header><text>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:</text><subparagraph id="H5E0903D4AE9840E4B2B742772474BFA6"><enum>(A)</enum><text>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.</text></subparagraph><subparagraph id="HB9BF29B057CC437ABC9D8D81D733EB01"><enum>(B)</enum><text>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.</text></subparagraph><subparagraph id="H71A4C318C384473BAE73931B8CCDA7A7"><enum>(C)</enum><text>The employee's or dependent's coverage described in subparagraph (A)—</text><clause id="H1CE51F510B354BD492B628701361E336"><enum>(i)</enum><text>was under a COBRA continuation provision and the coverage under such provision was exhausted; or</text></clause><clause id="H1D249DC454EC49E2ACC87D23438FC00E"><enum>(ii)</enum><text>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.</text></clause></subparagraph><subparagraph id="HEBF70758925747FAB7793E0822166004"><enum>(D)</enum><text>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).</text></subparagraph></paragraph><paragraph id="H70E35659E0714D43ACD9EA82C2E82DFB"><enum>(2)</enum><header>For dependent beneficiaries</header><subparagraph id="HCD10705F79CA4A62A92A7567C799DA33"><enum>(A)</enum><header>In general</header><text>If—</text><clause id="HE77CA9D018714C02B011A67D091B6317"><enum>(i)</enum><text>a group health plan makes coverage available with respect to a dependent of an individual;</text></clause><clause id="H93CFDC82CD874682BE03D0D935702C89"><enum>(ii)</enum><text>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</text></clause><clause id="H30D056CC6CA94A698C1DBCCCCD9EDC06"><enum>(iii)</enum><text>a person becomes such a dependent of the individual through marriage, birth, or adoption or placement for adoption,</text></clause><continuation-text continuation-text-level="subparagraph">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. </continuation-text></subparagraph><subparagraph id="H430C45E6F5244A4BB65B7E1EBC723821"><enum>(B)</enum><header>Dependent special enrollment period</header><text>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—</text><clause id="H94D43CCA3BCA4A418D69344A18E8B365"><enum>(i)</enum><text>the date dependent coverage is made available; or</text></clause><clause id="HE98446F3228A4DD184E40FA24C155B26"><enum>(ii)</enum><text>the date of the marriage, birth, or adoption or placement for adoption (as the case may be) described in subparagraph (A)(iii).</text></clause></subparagraph><subparagraph id="H9A473E277E7740F0BD0345EB411FFCAB"><enum>(C)</enum><header>No waiting period</header><text>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—</text><clause id="HA2CAE253C53740F590AE52F4163A2527"><enum>(i)</enum><text>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;</text></clause><clause id="H744A578A20C242BF976BE1517CC1ED72"><enum>(ii)</enum><text>in the case of a dependent's birth, as of the date of such birth; or</text></clause><clause id="HF579DCBED91A492EA758F2E226DDBBE7"><enum>(iii)</enum><text>in the case of a dependent's adoption or placement for adoption, the date of such adoption or placement for adoption.</text></clause></subparagraph></paragraph><paragraph id="H1868BB3A12244363A90129AC1A68AADB"><enum>(3)</enum><header>Special rules for application in case of Medicaid and CHIP</header><subparagraph id="H141DBD394AF248A384C0B96F139399A2"><enum>(A)</enum><header>In general</header><text>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:</text><clause id="HF315C69483804EB4959EDF600B3BB6A9"><enum>(i)</enum><header>Termination of Medicaid or CHIP coverage</header><text>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.</text></clause><clause id="H6ABD7548DC0D46A69689DAD0DA06574F"><enum>(ii)</enum><header>Eligibility for employment assistance under Medicaid or CHIP</header><text>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.</text></clause></subparagraph><subparagraph id="H8F1E1F8A3796496D93E68A6BE83CF9D9"><enum>(B)</enum><header>Coordination with Medicaid and CHIP</header><clause id="H207ACA75CA5548A8A8F92F6323CDD645"><enum>(i)</enum><header>Outreach to employees regarding availability of Medicaid and CHIP coverage</header><subclause id="HCE821DA5F0BD42CAA8A85F10297176A0"><enum>(I)</enum><header>In general</header><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/29/1181">29 U.S.C. 1181(f)(3)(B)(i)(II)</external-xref>).</text></subclause><subclause id="H77384DFCF1BF486F90D1E435645F4A36"><enum>(II)</enum><header>Option to provide concurrent with provision of plan materials to employee</header><text>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.</text></subclause></clause><clause id="H315AE7AF26AD4AC1923CE16A6D7F7D8F"><enum>(ii)</enum><header>Disclosure about group health plan benefits to States for medicaid and chip eligible individuals</header><text>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.</text></clause></subparagraph></paragraph></subsection><subsection display-inline="no-display-inline" id="H981E7FED02A04C49BBE97A0012EF2C95"><enum>(g)</enum><header>Use of Affiliation Period by HMOs as Alternative to Preexisting Condition Exclusion</header><paragraph id="HC0B3667B088749079D92EC322E3578AC"><enum>(1)</enum><header>In general</header><text>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—</text><subparagraph id="HC050DE3CC4CF41B0B0EC2C5DF4EA59F7"><enum>(A)</enum><text>such period is applied uniformly without regard to any health status-related factors; and</text></subparagraph><subparagraph id="HBA53C8A8EC7E481A8FAF4B4FA4D35362"><enum>(B)</enum><text>such period does not exceed 2 months (or 3 months in the case of a late enrollee).</text></subparagraph></paragraph><paragraph id="H7ECEC6D1B07643C7ACA3D5AB7BAB65A5"><enum>(2)</enum><header>Affiliation period</header><subparagraph id="H6719A15E8AB447AD8F049BC2FA0562DF"><enum>(A)</enum><header>Defined</header><text>For purposes of this title, the term <term>affiliation period</term> 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.</text></subparagraph><subparagraph id="HCFBA75B9A3114FAA986B64F76084EAC3"><enum>(B)</enum><header>Beginning</header><text>Such period shall begin on the enrollment date.</text></subparagraph><subparagraph id="HC09A4361A1DD4024AFC3457B96E0E65F"><enum>(C)</enum><header>Runs concurrently with waiting periods</header><text>An affiliation period under a plan shall run concurrently with any waiting period under the plan.</text></subparagraph></paragraph><paragraph id="H9D77D98F5D074D698BAF477B7C5BFAE9"><enum>(3)</enum><header>Alternative methods</header><text>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.</text></paragraph></subsection></section><section id="H4A3E3C151E4B43A6BFD8D00F11361B65"><enum>199A.</enum><header>Extension of dependent coverage</header><subsection id="H464BABF5674D451CB8FE5EC2D69BB349"><enum>(a)</enum><header>In general</header><text>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.</text></subsection><subsection id="H83387CAF389B4A46A5242814EAA1E533"><enum>(b)</enum><header>Regulations</header><text>The Secretary shall promulgate regulations to define the dependents to which coverage shall be made available under subsection (a).</text></subsection><subsection id="H6081DF0DCA834ADC9983680309DD35EF"><enum>(c)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed to modify the definition of <quote>dependent</quote> as used in the Internal Revenue Code of 1986 with respect to the tax treatment of the cost of coverage.</text></subsection></section><section id="H566666EBB27543A29ED14426C9220215"><enum>199B.</enum><header>Annual limitation on cost-sharing</header><subsection id="H7D00E97CBFD346A8B4AD6DFFB49109BE"><enum>(a)</enum><header>In general</header><paragraph id="H275B14A5CA394FE7A09ABD416C56811A"><enum>(1)</enum><header>2014</header><text>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 <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)(2)(A)(ii)</external-xref> of the Internal Revenue Code of 1986 for self-only and family coverage, respectively, for taxable years beginning in 2014.</text></paragraph><paragraph id="H8B700C00D3D1430DBB88FCDF0B46E7CB"><enum>(2)</enum><header>2015 and later</header><text>In the case of any plan year beginning in a calendar year after 2014, the limitation under this paragraph shall—</text><subparagraph id="H3454629C17B44F96AA368CAB18A835E0"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="H13D14A59CD454AFABE0A2726928B7050"><enum>(B)</enum><text>in the case of other coverage, twice the amount in effect under subparagraph (A).</text></subparagraph><continuation-text continuation-text-level="paragraph">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. </continuation-text></paragraph></subsection><subsection id="HDAE126BE282F4BEC9D40A8C420972062"><enum>(b)</enum><header>Cost-Sharing</header><text>In this section:</text><paragraph id="H365958C09AA0457D8E539B26140FBF94"><enum>(1)</enum><header>In general</header><text>The term <term>cost-sharing</term> includes—</text><subparagraph id="HD469A7C1F135409BBA9F4C42374C3270"><enum>(A)</enum><text>deductibles, coinsurance, copayments, or similar charges; and</text></subparagraph><subparagraph id="H7B85E84914B14A10B601C9572F8086AB"><enum>(B)</enum><text>any other expenditure required of an insured individual which is a qualified medical expense (within the meaning of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(d)(2)</external-xref> of the Internal Revenue Code of 1986) with respect to essential health benefits covered under the plan.</text></subparagraph></paragraph><paragraph id="H1E7BE9DCED1A44BA8643E4E561C510BE"><enum>(2)</enum><header>Exceptions</header><text>Such term does not include premiums, balance billing amounts for non-network providers, or spending for non-covered services.</text></paragraph></subsection><subsection id="H60BF94DDF64C4A2EB1DF6D9B338C8B56"><enum>(c)</enum><header>Premium adjustment percentage</header><text>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).</text></subsection></section><section id="H490458EFECD44050A6C07A681C0758CC"><enum>199C.</enum><header>Enforcement of certain health insurance requirements</header><subsection id="HE83892CE39894E769AAB645F511C78CC"><enum>(a)</enum><header>State Enforcement</header><paragraph id="HF94076756ED14CFFA1DC581607323BF8"><enum>(1)</enum><header>State authority</header><text>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.</text></paragraph><paragraph id="H33B94FB3C906486C8040DCA301D9063B"><enum>(2)</enum><header>Failure to implement provisions</header><text>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.</text></paragraph></subsection><subsection id="H609677CAF34D4C86BBF235982C25EE21"><enum>(b)</enum><header>Secretarial Enforcement Authority</header><paragraph id="HE64C28B293584AA6B0EBEC3B750FE2D1"><enum>(1)</enum><header>Limitation</header><text>The provisions of this subsection shall apply to enforcement of a provision (or provisions) described in subsection (a)(2) only—</text><subparagraph id="H1B214D89CFBC46C393E17FE14D21CCC3"><enum>(A)</enum><text>as provided under such subsection; and</text></subparagraph><subparagraph id="HC3BFAE32509A4114A8C52AD63A01C8C1"><enum>(B)</enum><text>with respect to individual health insurance coverage or group health plans that are non-Federal governmental plans.</text></subparagraph></paragraph><paragraph id="H24C40307331F4A1B9B79EB70D7B705A1"><enum>(2)</enum><header>Imposition of penalties</header><text>In the cases described in paragraph (1)—</text><subparagraph id="HD0709E6E13FE45AA8982CCCE36E2C304"><enum>(A)</enum><header>In general</header><text>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.</text></subparagraph><subparagraph id="HF2E7DFA75DC34AFBBAF909E6DF025555"><enum>(B)</enum><header>Liability for penalty</header><text>In the case of a failure by—</text><clause id="H37D1E05804DE49ACA8E6F8983849ACAF"><enum>(i)</enum><text>a health insurance issuer, the issuer is liable for such penalty; or</text></clause><clause id="HE147FBA58FDF48E4A8FD1DBE392B7442"><enum>(ii)</enum><text>a group health plan that is a non-Federal governmental plan which is—</text><subclause id="HDFE904B78DAD45E19A3936F7B1D0E47B"><enum>(I)</enum><text>sponsored by 2 or more employers, the plan is liable for such penalty; or</text></subclause><subclause id="HA8642931990544DA960C47BC0849A3BD"><enum>(II)</enum><text>not so sponsored, the employer is liable for such penalty.</text></subclause></clause></subparagraph><subparagraph id="HF55083142AB0471A95FBF374119018FC"><enum>(C)</enum><header>Amount of penalty</header><clause id="HFE737775F4034AD382E473E1E1FEB135"><enum>(i)</enum><header>In general</header><text>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.</text></clause><clause id="H458127BBE18E4738BD98A7D82B49E49E"><enum>(ii)</enum><header>Considerations in imposition</header><text>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.</text></clause><clause id="HCAB34AA3511B41A1B9938BF1639448E2"><enum>(iii)</enum><header>Limitations</header><subclause id="H32CA2EE5489849FBBF784CA0DEECBBFE"><enum>(I)</enum><header>Penalty not to apply where failure not discovered exercising reasonable diligence</header><text>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.</text></subclause><subclause id="H6F85659EF2EF42179D0801E87D098B56"><enum>(II)</enum><header>Penalty not to apply to failures corrected within 30 days</header><text>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.</text></subclause></clause></subparagraph><subparagraph id="H337B1F2B79A44FE5B82E8AC571255797"><enum>(D)</enum><header>Administrative review</header><clause id="H317908FAE48941FCBF141638ADE8B324"><enum>(i)</enum><header>Opportunity for hearing</header><text>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.</text></clause><clause id="HD3E23127F5FE4C7A9E8A3FC99CC8FBFF"><enum>(ii)</enum><header>Hearing procedure</header><text>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).</text></clause></subparagraph><subparagraph id="HA06B5B8015C94B86957DBFBF649B9C64"><enum>(E)</enum><header>Judicial review</header><clause id="HC24631C89F6D4A3592A8636EEDABEF93"><enum>(i)</enum><header>Filing of action for review</header><text>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.</text></clause><clause id="H144FB23A7A4744AFA22C91A0A0C1EB01"><enum>(ii)</enum><header>Certification of administrative record</header><text>The Secretary shall promptly certify and file in such court the record upon which the penalty was imposed.</text></clause><clause id="H6B86B815278744A2981697677ECEA91F"><enum>(iii)</enum><header>Standard for review</header><text>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.</text></clause><clause id="HAF5D8C449DE9480897428A633EA837F4"><enum>(iv)</enum><header>Appeal</header><text>Any final decision, order, or judgment of the district court concerning such review shall be subject to appeal as provided in <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/28/83">chapter 83</external-xref> of title 28 of such Code.</text></clause></subparagraph><subparagraph id="HD323A32421F64DC5B2E5EAE2C0677B11"><enum>(F)</enum><header>Failure to pay assessment; maintenance of action</header><clause id="HC5044032BA7F4774A78A4AA73522923B"><enum>(i)</enum><header>Failure to pay assessment</header><text>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.</text></clause><clause id="H6A399A3FEC4147D6B3E490989188CCAE"><enum>(ii)</enum><header>Nonreviewability</header><text>In such action the validity and appropriateness of the final order imposing the penalty shall not be subject to review.</text></clause></subparagraph><subparagraph id="H6225214D7BAD4F35A3337A6BFE6546DD"><enum>(G)</enum><header>Payment of penalties</header><text>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.</text></subparagraph></paragraph><paragraph id="H5A78CF49FCCA4DBC82BF8DAC5ADD2A5F"><enum>(3)</enum><header>Enforcement authority relating to genetic discrimination</header><subparagraph id="H316B872CF292483B993BEF5B8927470E"><enum>(A)</enum><header>General rule</header><text>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.</text></subparagraph><subparagraph id="HE3913D2181FC40CA923C8455CD82A691"><enum>(B)</enum><header>Amount</header><clause id="HCFA06379E7544633ADF123754B816022"><enum>(i)</enum><header>In general</header><text>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.</text></clause><clause id="H2EB6D7283083428BBAF41F4667E36B7A"><enum>(ii)</enum><header>Noncompliance period</header><text>For purposes of this paragraph, the term <term>noncompliance period</term> means, with respect to any failure, the period—</text><subclause id="H69DC957C112E4CB1A01A28C83A50E137"><enum>(I)</enum><text>beginning on the date such failure first occurs; and</text></subclause><subclause id="HE827CBB8BD004EC382D6CF6B07672703"><enum>(II)</enum><text>ending on the date the failure is corrected.</text></subclause></clause></subparagraph><subparagraph id="H1E19F97FAE914B4DA59BCB49926AABAB"><enum>(C)</enum><header>Minimum penalties where failure discovered</header><text>Notwithstanding clauses (i) and (ii) of subparagraph (D):</text><clause id="H88CB4E8F94AD44AFB6AB086660B9F379"><enum>(i)</enum><header>In general</header><text>In the case of 1 or more failures with respect to an individual—</text><subclause id="HB10A65EC54C748968D98A087E4DA6774"><enum>(I)</enum><text>which are not corrected before the date on which the plan receives a notice from the Secretary of such violation; and</text></subclause><subclause id="HED28305A4EAA4E26B28F8C1A6BD5791F"><enum>(II)</enum><text>which occurred or continued during the period involved;</text></subclause><continuation-text continuation-text-level="clause">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. </continuation-text></clause><clause id="H3C75C460B7084371A33B60FA8043E6E6"><enum>(ii)</enum><header>Higher minimum penalty where violations are more than de minimis</header><text>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 <quote>$15,000</quote> for <quote>$2,500</quote> with respect to such person.</text></clause></subparagraph><subparagraph id="H0767F6996B65428E83B462C0C653485A"><enum>(D)</enum><header>Limitations</header><clause id="H5FB2B808D131489A8040AB4E457EC978"><enum>(i)</enum><header>Penalty not to apply where failure not discovered exercising reasonable diligence</header><text>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.</text></clause><clause id="H7C7C67E3F8AD4289B75FEDC8886E51B6"><enum>(ii)</enum><header>Penalty not to apply to failures corrected within certain periods</header><text>No penalty shall be imposed by subparagraph (A) on any failure if—</text><subclause id="H425A07DD9A8B409C9562B486AE4CB140"><enum>(I)</enum><text>such failure was due to reasonable cause and not to willful neglect; and</text></subclause><subclause id="H6D33CD96750D42589742B136735BFBA9"><enum>(II)</enum><text>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.</text></subclause></clause><clause id="H197834C75C8C4F18AA48023436F94852"><enum>(iii)</enum><header>Overall limitation for unintentional failures</header><text>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—</text><subclause id="HB224227BF3744F06A71B6F9E3E15B951"><enum>(I)</enum><text>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</text></subclause><subclause id="HCBA9A000ED7342379CD1C70DFDF0316F"><enum>(II)</enum><text>$500,000.</text></subclause></clause></subparagraph><subparagraph id="H54B999E1F99D45CABC67AA92F203837A"><enum>(E)</enum><header>Waiver by Secretary</header><text>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.</text></subparagraph></paragraph></subsection><subsection id="H8607A79C85FB4B89BA700FDC7D41CCD0"><enum>(c)</enum><header>Definitions</header><text>For purposes of this section:</text><paragraph id="H9E4D1B827E2F4127A15F07CB81137DFA"><enum>(1)</enum><header>Governmental plan</header><text display-inline="yes-display-inline">The term <term>governmental plan</term> has the meaning given such term under section 3(32) of the Employee Retirement Income Security Act of 1974 and any Federal governmental plan.</text></paragraph><paragraph id="H3BE05BFBC6824446AF9E08FF5C687E48"><enum>(2)</enum><header>Federal governmental plan</header><text display-inline="yes-display-inline">The term <term>‘Federal governmental plan’</term> 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.</text></paragraph><paragraph id="H597CCBBA8B604FCBAC8D72EB3098AAD5"><enum>(3)</enum><header>Non-Federal governmental plan</header><text>The term <term>non-Federal governmental plan</term> means a governmental plan that is not a Federal governmental plan.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H94208779B4814B1DAC3FEEA21B1D8DF4"><enum>(b)</enum><header>Conforming amendment</header><text>The table of contents under section 1(b) of the Health Insurance Portability and Accountability Act of 1996 (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>) is amended by inserting after the item relating to section 195 the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HCEDFF621F4F9445F9BD809A8E885DD3C"><toc container-level="quoted-block-container" idref="HFE0567687441440392CFEA0FCE6481A3" lowest-bolded-level="division-lowest-bolded" lowest-level="section" quoted-block="no-quoted-block" regeneration="yes-regeneration"><toc-entry idref="H8A5FD7D8C5D343F993F4F6FF97D38C32" level="section">Sec. 196. Guaranteed availability of coverage. </toc-entry><toc-entry idref="H5EE29A6DB09C47B599A381228CF5D505" level="section">Sec. 197. Fair health insurance premiums. </toc-entry><toc-entry idref="H2EE538164E334E2DBC8A19A08D188C8E" level="section">Sec. 198. Prohibiting discrimination against individual participants and beneficiaries based on health status. </toc-entry><toc-entry idref="HD3039CE44F4E495C9B385C91F50F8C19" level="section">Sec. 199. Prohibition of preexisting condition exclusions or other discrimination based on health status. </toc-entry><toc-entry level="section" bold="off">Sec. 199A. Extension of dependent coverage. </toc-entry><toc-entry level="section" bold="off">Sec. 199B. Annual limitation on cost-sharing. </toc-entry><toc-entry idref="H490458EFECD44050A6C07A681C0758CC" level="section">Sec. 199C. Enforcement of certain health insurance requirements.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HA671E46B7A574862A64C2096B3E7B16C"><enum>(c)</enum><header>ERISA and IRC Enforcement</header><paragraph id="H29A4FB22C6B2462A8AF5958B6D482846"><enum>(1)</enum><header>ERISA</header><text>Subpart B of part 7 of title I of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1185">29 U.S.C. 1185 et seq.</external-xref>) is amended by adding at the end the following new section:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA9BF70D344224779AF29C024EA4D1DCD"><section id="H50BA5C254F904F84BA3E74C5C02B0A15"><enum>716.</enum><header>Other market reforms</header><text display-inline="no-display-inline">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.</text></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HC1A0C76C0E3F41249AB18512185BB5EE"><enum>(2)</enum><header>IRC</header><text>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:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H2B39E77912E84A25A06C3252E693D914"><section id="H9556F480AD114AD582C6E70A5177CEC8"><enum>9816.</enum><header>Other market reforms</header><text display-inline="no-display-inline">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.</text></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HA5196DDC45B9493CB758C95C949E9ED1"><enum>(d)</enum><header>Effective date</header><text>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 (<external-xref legal-doc="public-law" parsable-cite="pl/111/148">Public Law 111–148</external-xref>) in its entirety.</text></subsection></section></subtitle><subtitle id="HAC9BBEB889364E0A879D9DB674B6A5A5"><enum>B</enum><header>Expanding Coverage Options</header><section id="H294841F341E344A59D7644E018D7D8C8"><enum>211.</enum><header>Definition of <quote>employer</quote> under ERISA with respect to group health plans</header><subsection id="H910CE6AD26AA4C8A8D0D2E757FD6A22A"><enum>(a)</enum><header>Definition of employer</header><text>Section 3(5) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1002">29 U.S.C. 1002(5)</external-xref>) is amended by striking the period and inserting <quote>(which, with respect to a group health plan, shall be determined in accordance with criteria that includes the criteria under section 735).</quote>.</text></subsection><subsection id="H1BF9385503824DD18BD2B7CC70B1A930"><enum>(b)</enum><header>Group health plans</header><text>Part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1181">29 U.S.C. 1181 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="H131B9158DA744EE686D23A7B27AF7DAA" style="OLC"><section id="HEB41AE635E644B4BAD8D6919DE0AEC96"><enum>735.</enum><header>Definition of <quote>employer</quote> with respect to group health plans</header><subsection id="H4AAD7D6BE8DE4D678DB5A4A0C72FF88D"><enum>(a)</enum><header>In general</header><text>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.</text></subsection><subsection id="H24BC4DF329A049F8A4A0F20BAD2039B0"><enum>(b)</enum><header>Requirements</header><text>The requirements under this subsection are each of the following:</text><paragraph id="HD5C07B52AAAD42588FF20A9DAD4D896F"><enum>(1)</enum><text>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.</text></paragraph><paragraph id="H14A38C9C2E534570B7E5F8249A14D95C"><enum>(2)</enum><text>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.</text></paragraph><paragraph id="HA8A2F8B4E73F4646B1A3AD2C72160451"><enum>(3)</enum><text>The group or association has—</text><subparagraph id="H8B069041D20549388E56B5A0A228A31E"><enum>(A)</enum><text>a formal organizational structure with a governing body; and</text></subparagraph><subparagraph id="H9652DBC45E5D4443AD0B68CCD8CC8D2F"><enum>(B)</enum><text>by-laws or other similar indications of formality.</text></subparagraph></paragraph><paragraph id="H858301A8C3714735833D9AB88AA3BCF9"><enum>(4)</enum><text>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.</text></paragraph><paragraph id="H6E0337769D1741F3ABAAA8F412DEECF8"><enum>(5)</enum><text>The employer members shall have a commonality of interest as described in subsection (d).</text></paragraph><paragraph id="HA58CE333BEEF4B02865E484124E9734F"><enum>(6)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HFF1C1E06B2344C24A06FEBB7AE67889A"><enum>(A)</enum><text>The group or association shall not make health coverage through the group health plan available other than to—</text><clause id="H8B9076BBE1BE4D74A97A713A8159F0B7" indent="up1"><enum>(i)</enum><text>an employee of a current employer member of the group or association;</text></clause><clause id="H4E59BCFAE93E4CA28542EE88DF0B3EF7" indent="up1"><enum>(ii)</enum><text>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</text></clause><clause id="H59BD7E4B8F0543ACBB3652F1D502B577" indent="up1"><enum>(iii)</enum><text>a beneficiary of an individual described in clause (i) or (ii), such as a spouse or dependent child.</text></clause></subparagraph><subparagraph id="H5F0D242FDE6749F98D6A55A484FA6084" indent="up1"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><paragraph id="H3F7C47E3F3C44203BEC483BC75436B24"><enum>(7)</enum><text>The group or association, and any health coverage offered by the group or association, shall comply with the nondiscrimination provisions under subsection (e).</text></paragraph><paragraph id="HB558F59B791A4321BE569737CA79CEA9"><enum>(8)</enum><text>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.</text></paragraph></subsection><subsection id="HD809B3AEDC844E43BC1DF734830FA8D2"><enum>(c)</enum><header>Substantial business purpose</header><paragraph id="HBFE86B0DAB4D48958CA9723EE7C31B86"><enum>(1)</enum><header>In general</header><text>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.</text></paragraph><paragraph id="H633D3F6DE3DA421C968AB21DCACE063E"><enum>(2)</enum><header>Business purpose</header><text>For purposes of subsection (b)(1) and paragraph (1), a business purpose shall—</text><subparagraph id="H0AA2449E595749D5AA6C1AD2943D8C2B"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="H69E5948F0DA44F018A8ADBE554B7CF09"><enum>(B)</enum><text>not be required to be a for-profit activity.</text></subparagraph></paragraph></subsection><subsection id="H00DA035BED894F799FCC851DE1612F49"><enum>(d)</enum><header>Commonality of interest</header><paragraph id="HA0C50B249963497293E1D9918F8380B1"><enum>(1)</enum><header>In general</header><text>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—</text><subparagraph id="H185C9CC2D10F49C3AAA43D1494162647"><enum>(A)</enum><text>the employers are in the same trade, industry, line of business, or profession; or</text></subparagraph><subparagraph id="H7E816F6F993845BD908B3F71C314AD38"><enum>(B)</enum><text>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).</text></subparagraph></paragraph><paragraph id="H1721842D19D74329B84C7A0E264E29D7"><enum>(2)</enum><header>Same trade, industry, or line of business</header><text>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.</text></paragraph><paragraph id="H02D8D59073954E17AE6E5CCA1A5E2E50"><enum>(3)</enum><header>Nondiscrimination</header><text>The standards under paragraph (1) shall not be implemented in a manner that is subterfuge for discrimination as is prohibited under subsection (e).</text></paragraph></subsection><subsection id="HD9B6C98844884ABB95A2E0245B7700BC"><enum>(e)</enum><header>Nondiscrimination</header><paragraph id="H862B6D7E15E34FF9A074F447BA8474C0"><enum>(1)</enum><header>In general</header><text>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:</text><subparagraph id="HACB52E94853349A0A7BE989869858889"><enum>(A)</enum><text>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.</text></subparagraph><subparagraph id="H007BDA554D084EBB931F4280796C8B7F"><enum>(B)</enum><text>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).</text></subparagraph><subparagraph id="H6BE929828D8648C9AB9995DE1BE73224"><enum>(C)</enum><text>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).</text></subparagraph><subparagraph id="HDF083502617E476E8DF440B62B5DF15A"><enum>(D)</enum><text>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.</text></subparagraph></paragraph><paragraph id="H9A1E7546A8D8451A960B20F78D3499BB"><enum>(2)</enum><header>Definition of health factor</header><text>For purposes of this subsection, the term <term>health factor</term> 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).</text></paragraph></subsection><subsection id="HE02ED48B8CFD4296A5946B411CCFE3BA"><enum>(f)</enum><header>Dual treatment of working owners as employers and employees</header><paragraph id="HFADA22A2AD8B46AEA56F46C6DB572E22"><enum>(1)</enum><header>In general</header><text>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.</text></paragraph><paragraph id="HF5CF308FDA4A4A07A43908FAA086FABC"><enum>(2)</enum><header>Working owner</header><subparagraph id="H94379692E4304ADCBE188F6BD5B7AA18"><enum>(A)</enum><header>Eligibility</header><text>A person shall qualify as a <term>working owner</term> if a responsible fiduciary of the group health plan reasonably determines that the person—</text><clause id="HD09098C2857742DF922F1B6B02B0A3D9"><enum>(i)</enum><text>does not have any common law employees;</text></clause><clause id="H989EBDD7998C45B09F1A40994BE20EB3"><enum>(ii)</enum><text>has an ownership right of any nature in a trade or business, whether incorporated or unincorporated, including a partner and other self-employed individual;</text></clause><clause id="H33337CF25D8E4F05999BB15FEB9A0BA1"><enum>(iii)</enum><text>is earning wages or self-employment income from the trade or business for providing personal services to the trade or business; and</text></clause><clause id="H6CBD81BAA638419B9E85E282837590C1"><enum>(iv)</enum><text>either—</text><subclause id="H8EB61EE020D5436B9A492E0C0AB5E859"><enum>(I)</enum><text>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</text></subclause><subclause id="HE1F2B9FB84E84D19BC15217CFA5DAEF4"><enum>(II)</enum><text>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.</text></subclause></clause></subparagraph><subparagraph id="H28A135D089424A40AF878FA49966D10C"><enum>(B)</enum><header>Determination</header><text>The determination under subparagraph (A) shall be made when the person first becomes eligible for coverage under the group health plan.</text></subparagraph><subparagraph id="H940D67C29BEC4C6F881693AFDB74CB6B"><enum>(C)</enum><header>Reasonable monitoring procedures</header><text>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.</text></subparagraph></paragraph></subsection><subsection commented="no" id="H4C96C457D829462096DECD6A1957A17E"><enum>(g)</enum><header>Applicability</header><paragraph commented="no" id="HDCA347164DBC4C25B5EB663A8CB195CF"><enum>(1)</enum><header>Fully insured</header><text>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.</text></paragraph><paragraph commented="no" id="H4AB55F4432974030A09D53B01238A1B9"><enum>(2)</enum><header>Plans expanding to include broader group</header><text>This section shall apply beginning on January 1, 2025, with respect to a group or association of employers sponsoring a group health plan that—</text><subparagraph commented="no" id="H2C366EAFF4FF415DB889AC25DE9CD51C"><enum>(A)</enum><text>is not fully insured;</text></subparagraph><subparagraph commented="no" id="HD0BBCEAA13B54D10B848244AEB36E8C5"><enum>(B)</enum><text>is in existence on June 21, 2024;</text></subparagraph><subparagraph commented="no" id="HE4D02E60464A4230B22194FBA87665B0"><enum>(C)</enum><text>meets the requirements that applied with respect to such plan before June 21, 2024; and</text></subparagraph><subparagraph commented="no" id="HAA94195CF271435A9D667DB458CD657A"><enum>(D)</enum><text>chooses to be a plan sponsored under this section (and subject to the requirements under subsections (b) through (f)).</text></subparagraph></paragraph><paragraph commented="no" id="HE8136479A78A4377BB85A84F57F1B941"><enum>(3)</enum><header>Other association health plans</header><text>This section shall apply beginning on April 1, 2025, with respect to any other group or association of employers sponsoring a group health plan.</text></paragraph><paragraph commented="no" id="H889104A4A04747178EE238A486D27B85"><enum>(4)</enum><header>Other criteria in advisory opinions</header><text>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 <short-title>Fair Care Act of 2024</short-title>, 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.</text></paragraph></subsection><subsection commented="no" id="H874E11B873D0463BA6E6CAE6BC9CC11D"><enum>(h)</enum><header>Determination of employer or joint employer status</header><paragraph commented="no" id="H9030CB10AC5A490D9DB97D15AECC5379"><enum>(1)</enum><header>In general</header><text>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.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC3C1BE865FBB4F82AC3B95BD0CA22D06"><enum>(2)</enum><header>Application of provision</header><text>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.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H040C90279AC840DD93BF0B72FB5D2226"><enum>(i)</enum><header>Rule of construction</header><text>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.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="H11F091F78C874AE787D4EABC87C9811B"><enum>212.</enum><header>Short-term limited duration insurance</header><subsection id="H8398BAD96CF7471AA779F25F296BF91F"><enum>(a)</enum><header>Definition</header><text>Section 2791(b) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-91">42 U.S.C. 300gg–91(b)</external-xref>) is amended by adding at the end the following:</text><quoted-block id="H4D17B61FBE984C13BFB03B7334E748EC" style="OLC"><paragraph id="H6117CD31E6C748EAB58218C8ED89A350"><enum>(6)</enum><header>Short-term limited duration insurance</header><text>The term <term>short-term limited duration insurance</term> 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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H3EAE5F9FBC0B425F96A78C5F266C62F6"><enum>(b)</enum><header>Guaranteed renewability</header><text>Section 2703 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-2">42 U.S.C. 300gg–2</external-xref>) is amended—</text><paragraph id="HD0E87359E8D64B9C88F5A6C93493B201"><enum>(1)</enum><text>in subsection (a), by inserting <quote>or offers short-term limited duration insurance</quote> after <quote>group market</quote>; and</text></paragraph><paragraph id="HDC12394EC8934DB58417F8C724D7781F"><enum>(2)</enum><text>by adding at the end the following:</text><quoted-block id="HA16F797848944F2A980C6791A3B4CA1D" style="OLC"><subsection id="HD03A46A3D7D24CC2B2EE10B3C54745A2"><enum>(f)</enum><header>Application to short-Term limited duration insurance</header><paragraph id="H30616EF19C74411EB542AA562F120C2B"><enum>(1)</enum><header>In general</header><text>In applying this section in the case of short-term limited duration insurance—</text><subparagraph id="HBA81A558EB6F4C00A366012EB1159006"><enum>(A)</enum><text>a reference to <quote>health insurance coverage</quote> with respect to such coverage offered in the individual market shall be deemed to include short-term limited duration insurance; and</text></subparagraph><subparagraph id="H4AD325663BB34DBAAB5BC07CA22FD395"><enum>(B)</enum><text>a reference to <quote>health insurance issuer</quote> with respect to health insurance coverage offered in the individual market shall be deemed to include an issuer of short-term limited duration insurance.</text></subparagraph></paragraph><paragraph id="H739BEEDD83784216BE3D502AF91BCC02"><enum>(2)</enum><header>Special rule for short-term limited duration insurance</header><text>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.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H46A49903F59C40D790067CE6CBE9B20A"><enum>(c)</enum><header>Applicability</header><text>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.</text></subsection></section></subtitle><subtitle id="H666CE6FAD029448386E1645DA7E02ED9"><enum>C</enum><header>Improving Commercial Health Insurance</header><section id="H06694F0F855E4CFCB58D690BD2E3F959"><enum>221.</enum><header>Invisible Guaranteed Coverage Pool Reinsurance Program; tax on exchange plans</header><subsection id="H5F6F9473AB9B452B9310B2494CB8C71B"><enum>(a)</enum><header>Establishment</header><text display-inline="yes-display-inline">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 <quote>IGCPR program</quote>).</text></subsection><subsection id="HFB0D091E791249978BA49EE5F157DE8F"><enum>(b)</enum><header>State grants</header><text>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.</text></subsection><subsection id="H3414EE3D0F4043BC99DC1CA46F7D9CC5"><enum>(c)</enum><header>Federal default</header><paragraph id="H7CF92A53BFAC4FC4BC19DA88E63974C9"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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).</text></paragraph><paragraph id="H415760DA73BC441BAAC5AAD7382F0746"><enum>(2)</enum><header>Federal default qualifying Invisible Guaranteed Coverage Pool</header><text display-inline="yes-display-inline">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—</text><subparagraph id="H08520E2692014DC792B910CCD0ADD304"><enum>(A)</enum><text display-inline="yes-display-inline">high-risk individuals designated for cession to the pool shall be designated by the ceding issuer;</text></subparagraph><subparagraph id="HD38074EDB95947CAB44E324E146B7EF6"><enum>(B)</enum><text>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;</text></subparagraph><subparagraph id="H91C0AA1892FF4AEB8F3527FE0A358E0F"><enum>(C)</enum><text>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</text></subparagraph><subparagraph id="HEE45E0E6C04847AC9FC59B3539B9A57A"><enum>(D)</enum><text>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.</text></subparagraph></paragraph></subsection><subsection id="H3C28616E2C574F388E41B9900A251D8F"><enum>(d)</enum><header>Allocation methodology</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="H8C679F8FFA5F4474A508FBA80E784262"><enum>(e)</enum><header>Qualifying Invisible Guaranteed Coverage Pool</header><text display-inline="yes-display-inline">For purposes of this section, the term <term>qualifying Invisible Guaranteed Coverage Pool</term> 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—</text><paragraph id="H6C63A06C1B8946E6B46AAF3523AE9271" commented="no"><enum>(1)</enum><text>the premium amount the ceding issuer shall pay to the reinsurance pool;</text></paragraph><paragraph id="HAE01DFEFB466495DBA02B676154FEB5B" commented="no"><enum>(2)</enum><text>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</text></paragraph><paragraph id="H2D16629A688F4DB2A4B6F6C311F691AC" commented="no"><enum>(3)</enum><text>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.</text></paragraph></subsection><subsection id="H8FAFE11C14F84F219DB631A6FEFA3B86"><enum>(f)</enum><header>Appropriations</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="HEEFCDAA641CF4AEF90D10EAE6AFB5E0B" display-inline="no-display-inline"><enum>(g)</enum><header>Tax on health insurance plans sold on exchanges</header><paragraph id="H14CF9706A3304EE7A6E415D0DAFD6CED"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/34">Chapter 34</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new subchapter: </text><quoted-block style="OLC" id="HB2FE860C27E94CAB92E4806506A51265" display-inline="no-display-inline"><subchapter id="H49F1E88083CF407E8C51510E0512FC42"><enum>C</enum><header>Additional tax on health insurance plans sold by insurers offering plans on exchanges</header><toc regeneration="no-regeneration"><toc-entry level="section">Sec. 4401. Additional tax on health insurance plans sold by insurers offering plans on exchanges.</toc-entry></toc><section id="H527D4702AF734929A401CAB5DBA0F289"><enum>4401.</enum><header>Additional tax on health insurance plans sold by insurers offering plans on exchanges</header><subsection id="HB000C41AF1F14B06B2BD013D7A24745D" commented="no"><enum>(a)</enum><header>Imposition of tax</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="H3D124B101F374BDE89F610874C0D7CDE"><enum>(b)</enum><header>Liability</header><text display-inline="yes-display-inline">The tax imposed by subsection (a) shall be paid by the plan sponsor.</text></subsection></section></subchapter><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HBC85D167D90E45A7AE8D9964E8916D12"><enum>(2)</enum><header>Conforming amendment</header><text display-inline="yes-display-inline">The table of subchapters for <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/34">chapter 34</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following item: </text><quoted-block style="OLC" id="H2B8C243F7CFC43E599890BEBCA557034" display-inline="no-display-inline"><toc regeneration="no-regeneration"><toc-entry level="subchapter">Subchapter C—Additional tax on health insurance plans sold by insurers offering plans on exchanges</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HAECF083E638F4766960D780363A4D28E"><enum>(3)</enum><header>Effective date</header><text>The amendments made by this subsection shall apply with respect to months beginning after the date of enactment of this Act.</text></paragraph></subsection><subsection id="H7DF89FBA0A274EAD899733549F5BFF15"><enum>(h)</enum><header>Report</header><text display-inline="yes-display-inline">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.</text></subsection></section><section id="H1C6489895E9540D2B9AC3D71FB7C805A"><enum>222.</enum><header>Employer health insurance mandate repeal</header><subsection id="H964BA93399FF4392A29905919A4D83A6"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/43">Chapter 43</external-xref> of the Internal Revenue Code of 1986 is amended by striking section 4980H.</text></subsection><subsection id="H910EF323700F4FE0AED2957A86C12F81"><enum>(b)</enum><header>Repeal of Related Reporting Requirements</header><text display-inline="yes-display-inline">Subpart D of part III of subchapter A of chapter 61 of such Code is amended by striking section 6056.</text></subsection><subsection id="H26CC80617CA749FD9698711F7785CE55"><enum>(c)</enum><header>Conforming amendments</header><paragraph id="HB4F06DF7EC004DA9B9738AE632CE11FB"><enum>(1)</enum><text display-inline="yes-display-inline">Section 6724(d)(1)(B) of such Code is amended by inserting <quote>or</quote> at the end of clause (xxiii), by striking <quote>or</quote> at the end of clause (xxiv), and by striking clause (xxv).</text></paragraph><paragraph id="HD58D1131C8204D2F9C7F6EC5E5D9517C"><enum>(2)</enum><text>Section 6724(d)(2) of such Code is amended by inserting <quote>or</quote> at the end of subparagraph (GG) and by striking subparagraph (HH).</text></paragraph><paragraph id="H4C7E100F2DE2478EADA92FB8D5ECEDDF"><enum>(3)</enum><text>The table of sections for chapter 43 of such Code is amended by striking the item relating to section 4980H.</text></paragraph><paragraph id="H3E51378C63CA44649B18F1B937AD890B"><enum>(4)</enum><text>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.</text></paragraph><paragraph id="H08F75FCC400542E18A3D7F54DF4ED1EE"><enum>(5)</enum><text>Section 1513 of the Patient Protection and Affordable Care Act is amended by striking subsection (c).</text></paragraph></subsection><subsection id="H9ED692B4283549C18D3B3E2112A6A198"><enum>(d)</enum><header>Effective date</header><paragraph id="H970ECC5C60B6485E90B9C99DF5E35FE4"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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. </text></paragraph><paragraph id="HE2CFD268953C4DF2AC352F1D620AEAD0"><enum>(2)</enum><header>Repeal of study and report</header><text display-inline="yes-display-inline">The amendment made by subsection (c)(5) shall take effect on the date of the enactment of this Act.</text></paragraph></subsection></section><section id="H5E6E96058C4344488E67DDCEBEEB5710"><enum>223.</enum><header>Refundable credits for coverage under a qualified health plan for individuals offered employer-sponsored insurance</header><subsection id="HED1C905AD4D74DE884BCE99F7D9543A1"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/36B">Section 36B(c)(2)</external-xref> of the Internal Revenue Code of 1986 is amended—</text><paragraph id="H5FCB2B7839114EF08425F2A925F03FB9"><enum>(1)</enum><text>in subparagraph (B)(i), by inserting <quote>or section 5000A(f)(1)(B)</quote>, and</text></paragraph><paragraph id="HAF3B1D0B25314CA9BCD3A17A2BA344D2"><enum>(2)</enum><text>by striking subparagraph (C).</text></paragraph></subsection><subsection id="H49D8CC1E772446D482C13540FB63C70E"><enum>(b)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section><section id="H87727A9E7B8E425EA39E1B90EBBDBBFD" commented="no"><enum>224.</enum><header>Inclusion in income of certain costs of employer-provided coverage under health plans</header><subsection id="HCC9AA87B3C054E53830DC60109ACD095" commented="no"><enum>(a)</enum><header>In general</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/106">Section 106</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new subsection: </text><quoted-block style="OLC" id="HBCB01D1FDC6D4C64A356A10B2A7B650F" display-inline="no-display-inline"><subsection id="HF168A779D3224AA8822AC8DCEDA7907B" commented="no"><enum>(h)</enum><header>Limitation</header><paragraph id="HA3C8520434F24438951B43DA6984E623" commented="no"><enum>(1)</enum><header>In general</header><text>Subsection (a) shall not apply to the extent that employer-provided coverage under health plans for an employee for a taxable year exceeds—</text><subparagraph id="HFC220E80D72D4B2E96A2901764F8F841" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">$10,200 for self-only coverage, and</text></subparagraph><subparagraph id="HFEE4BE611A734564ABF644177E4292A9" commented="no"><enum>(B)</enum><text>$27,500 for all other coverage.</text></subparagraph></paragraph><paragraph id="HCE6C4F14D8C44F3EB5D28832BD1ABFB0" display-inline="no-display-inline"><enum>(2)</enum><header>In general</header><text display-inline="yes-display-inline">In the case of any calendar year after 2025, the dollar amounts in paragraph (1) shall each be increased by an amount equal to—</text><subparagraph id="H5A3C09F3D60C4B63A95DE00A6EE45A04"><enum>(A)</enum><text>such dollar amount, multiplied by—</text></subparagraph><subparagraph id="H5F63CB68685F4FF88A54C7EDB4EFB68E"><enum>(B)</enum><text>the cost-of-living adjustment determined under section 1(f)(3) for such calendar year, determined—</text><clause id="HB0B1A1EE45D74B42981E38516EDC8262"><enum>(i)</enum><text>by substituting <quote>calendar year 2024</quote> for <quote>calendar year 2018</quote> in subparagraph (A)(ii) thereof, and</text></clause><clause id="H055CFE1CC358433EBB3E0275B3E516CB"><enum>(ii)</enum><text>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.</text></clause></subparagraph></paragraph><paragraph id="H03D0FE57707A4759B202CEBAB116B0A8"><enum>(3)</enum><header>Terms related to CPI</header><subparagraph id="H64303AB20DB04DB0B2A288133CCB1A27"><enum>(A)</enum><header>Annual percentage increase</header><text>For purposes of subparagraph (B)(ii)(II), the term <term>annual percentage increase</term> means the percentage (if any) by which C–CPI–U for any year exceeds the C–CPI–U for the prior year.</text></subparagraph><subparagraph id="H5BDCACC0B9B64E3FB58C65BD49A1261D"><enum>(B)</enum><header>Other terms</header><text>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.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H1366EDE7680345D288BEE3FBD02942B3" commented="no"><enum>(b)</enum><header>Effective date</header><text>The amendments made by this section shall apply with respect to taxable years beginning after December 31, 2024.</text></subsection></section><section id="H9B15200B5C9849AE9DE69CFE6A0C3286"><enum>225.</enum><header>Change in permissible age variation in health insurance premium rates</header><text display-inline="no-display-inline">Section 2701(a)(1)(A)(iii) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg">42 U.S.C. 300gg(a)(1)(A)(iii)</external-xref>) is amended by inserting after <quote>(consistent with section 2707(c))</quote> the following: <quote>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))</quote>.</text></section><section id="H0179907D4C0540E5A01AAA28EAFF1553"><enum>226.</enum><header>Premium assistance adjustment to reflect age</header><subsection id="HD981F13BBCE44E73A0CDF6D5FA10E04E" commented="no"><enum>(a)</enum><header>Modification of applicable percentage</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/36B">Section 36B(b)(3)(A)</external-xref> of the Internal Revenue Code of 1986 is amended to read as follows:</text><quoted-block style="OLC" id="H69878EE14ECD4A669FCE7EA6F598C49C" display-inline="no-display-inline"><subparagraph id="H3DE12DA7033D43E0A2EDA5AB8F4B6888" commented="no"><enum>(A)</enum><header>Applicable percentage</header><clause id="HE45B893D79DA45E19F479BFD1745B155" commented="no"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">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:</text><table table-type="" table-template-name="Generic: 1 text, 10 num" align-to-level="section" frame="topbot" colsep="1" rowsep="0" blank-lines-before="1" line-rules="hor-ver" rule-weights="4.4.4.0.0.0"><tgroup cols="11" rowsep="0" thead-tbody-ldg-size="8.7.8" grid-typeface="1.1"><colspec colname="column1" coldef="txt-no-ldr" min-data-value="56" colwidth="127pts"></colspec><colspec colname="column2" align="right" coldef="txt" min-data-value="20" colwidth="45pts"></colspec><colspec colname="column3" align="right" coldef="txt" min-data-value="20" colwidth="45pts"></colspec><colspec colname="column4" align="right" coldef="txt" min-data-value="20" colwidth="45pts"></colspec><colspec colname="column5" align="right" coldef="txt" min-data-value="20" colwidth="45pts"></colspec><colspec colname="column6" align="right" coldef="txt" min-data-value="20" colwidth="45pts"></colspec><colspec colname="column7" align="right" coldef="txt" min-data-value="20" colwidth="45pts"></colspec><colspec colname="column8" align="right" coldef="txt" min-data-value="20" colwidth="45pts"></colspec><colspec colname="column9" align="right" coldef="txt" min-data-value="20" colwidth="45pts"></colspec><colspec colname="column10" align="right" coldef="txt" min-data-value="20" colwidth="45pts"></colspec><colspec colname="column11" align="right" coldef="txt" min-data-value="20" colwidth="45pts"></colspec><thead><row><entry namest="column1" morerows="1" align="justify" valign="top" colname="column1">In the case of household income<linebreak></linebreak> (expressed as a percent of the poverty line) <linebreak></linebreak>within the<linebreak></linebreak> following<linebreak></linebreak> income tier:</entry><entry namest="column2" nameend="column3" morerows="0" rowsep="1" align="center" colname="column2">Up to Age 29</entry><entry namest="column4" nameend="column5" morerows="0" rowsep="1" align="center" colname="column4">Age 30–39</entry><entry namest="column6" nameend="column7" morerows="0" rowsep="1" align="center" colname="column6">Age 40–49</entry><entry namest="column8" nameend="column9" morerows="0" rowsep="1" align="center" colname="column8">Age 50–59</entry><entry namest="column10" nameend="column11" morerows="0" rowsep="1" align="center" colname="column10">Over Age 59</entry></row><row><entry namest="column2" morerows="0" colname="column2">Initial %</entry><entry namest="column3" morerows="0" colname="column3">Final %</entry><entry namest="column4" morerows="0" colname="column4">Initial %</entry><entry namest="column5" morerows="0" colname="column5">Final %</entry><entry namest="column6" morerows="0" colname="column6">Initial %</entry><entry namest="column7" morerows="0" colname="column7">Final %</entry><entry namest="column8" morerows="0" colname="column8">Initial %</entry><entry namest="column9" morerows="0" colname="column9">Final %</entry><entry namest="column10" morerows="0" colname="column10">Initial %</entry><entry namest="column11" morerows="0" colname="column11">Final %</entry></row></thead><tbody><row><entry rowsep="0" align="left" stub-definition="txt-ldr" stub-hierarchy="1" leader-modify="clr-ldr" colname="column1">Up to 100%</entry><entry rowsep="0" align="right" colname="column2">0</entry><entry rowsep="0" align="right" colname="column3">0</entry><entry rowsep="0" align="right" colname="column4">0</entry><entry rowsep="0" align="right" colname="column5">0</entry><entry rowsep="0" align="right" colname="column6">0</entry><entry rowsep="0" align="right" colname="column7">0</entry><entry rowsep="0" align="right" colname="column8">0</entry><entry rowsep="0" align="right" colname="column9">0</entry><entry rowsep="0" align="right" colname="column10">0</entry><entry rowsep="0" align="right" colname="column11">0</entry></row><row><entry rowsep="0" align="left" stub-definition="txt-ldr" stub-hierarchy="1" leader-modify="clr-ldr" colname="column1">100%–133%</entry><entry rowsep="0" align="right" colname="column2">2</entry><entry rowsep="0" align="right" colname="column3">2</entry><entry rowsep="0" align="right" colname="column4">2</entry><entry rowsep="0" align="right" colname="column5">2</entry><entry rowsep="0" align="right" colname="column6">2</entry><entry rowsep="0" align="right" colname="column7">2</entry><entry rowsep="0" align="right" colname="column8">2</entry><entry rowsep="0" align="right" colname="column9">2</entry><entry rowsep="0" align="right" colname="column10">2</entry><entry rowsep="0" align="right" colname="column11">2</entry></row><row><entry rowsep="0" align="left" stub-definition="txt-ldr" stub-hierarchy="1" leader-modify="clr-ldr" colname="column1">133%–150%</entry><entry rowsep="0" align="right" colname="column2">3</entry><entry rowsep="0" align="right" colname="column3">4.3</entry><entry rowsep="0" align="right" colname="column4">3</entry><entry rowsep="0" align="right" colname="column5">4.3</entry><entry rowsep="0" align="right" colname="column6">3</entry><entry rowsep="0" align="right" colname="column7">4.3</entry><entry rowsep="0" align="right" colname="column8">3</entry><entry rowsep="0" align="right" colname="column9">4.3</entry><entry rowsep="0" align="right" colname="column10">3</entry><entry rowsep="0" align="right" colname="column11">4.3</entry></row><row><entry rowsep="0" align="left" stub-definition="txt-ldr" stub-hierarchy="1" leader-modify="clr-ldr" colname="column1">150%–200%</entry><entry rowsep="0" align="right" colname="column2">4.3</entry><entry rowsep="0" align="right" colname="column3">6.7</entry><entry rowsep="0" align="right" colname="column4">4.3</entry><entry rowsep="0" align="right" colname="column5">6.7</entry><entry rowsep="0" align="right" colname="column6">4.3</entry><entry rowsep="0" align="right" colname="column7">6.7</entry><entry rowsep="0" align="right" colname="column8">4.3</entry><entry rowsep="0" align="right" colname="column9">6.7</entry><entry rowsep="0" align="right" colname="column10">4.3</entry><entry rowsep="0" align="right" colname="column11">6.7</entry></row><row><entry rowsep="0" align="left" stub-definition="txt-ldr" stub-hierarchy="1" leader-modify="clr-ldr" colname="column1">200%–250%</entry><entry rowsep="0" align="right" colname="column2">6.7</entry><entry rowsep="0" align="right" colname="column3">6.7</entry><entry rowsep="0" align="right" colname="column4">6.7</entry><entry rowsep="0" align="right" colname="column5">7.6</entry><entry rowsep="0" align="right" colname="column6">6.7</entry><entry rowsep="0" align="right" colname="column7">8.3</entry><entry rowsep="0" align="right" colname="column8">6.7</entry><entry rowsep="0" align="right" colname="column9">8.3</entry><entry rowsep="0" align="right" colname="column10">6.7</entry><entry rowsep="0" align="right" colname="column11">8.3</entry></row><row><entry rowsep="0" align="left" stub-definition="txt-ldr" stub-hierarchy="1" leader-modify="clr-ldr" colname="column1">250%–300%</entry><entry rowsep="0" align="right" colname="column2">6.7</entry><entry rowsep="0" align="right" colname="column3">6.7</entry><entry rowsep="0" align="right" colname="column4">7.6</entry><entry rowsep="0" align="right" colname="column5">7.6</entry><entry rowsep="0" align="right" colname="column6">8.3</entry><entry rowsep="0" align="right" colname="column7">9.8</entry><entry rowsep="0" align="right" colname="column8">8.3</entry><entry rowsep="0" align="right" colname="column9">9.8</entry><entry rowsep="0" align="right" colname="column10">8.3</entry><entry rowsep="0" align="right" colname="column11">9.8</entry></row><row><entry rowsep="0" align="left" stub-definition="txt-ldr" stub-hierarchy="1" leader-modify="clr-ldr" colname="column1">300%–400%</entry><entry rowsep="0" align="right" colname="column2">6.7</entry><entry rowsep="0" align="right" colname="column3">7</entry><entry rowsep="0" align="right" colname="column4">7.6</entry><entry rowsep="0" align="right" colname="column5">8</entry><entry rowsep="0" align="right" colname="column6">9.8</entry><entry rowsep="0" align="right" colname="column7">10</entry><entry rowsep="0" align="right" colname="column8">9.8</entry><entry rowsep="0" align="right" colname="column9">10</entry><entry rowsep="0" align="right" colname="column10">9.8</entry><entry rowsep="0" align="right" colname="column11">10</entry></row><row><entry rowsep="0" align="left" stub-definition="txt-ldr" stub-hierarchy="1" leader-modify="clr-ldr" colname="column1">400%–600%</entry><entry rowsep="0" align="right" colname="column2">7</entry><entry rowsep="0" align="right" colname="column3">9</entry><entry rowsep="0" align="right" colname="column4">8</entry><entry rowsep="0" align="right" colname="column5">10</entry><entry rowsep="0" align="right" colname="column6">10</entry><entry rowsep="0" align="right" colname="column7">15</entry><entry rowsep="0" align="right" colname="column8">10</entry><entry rowsep="0" align="right" colname="column9">15</entry><entry rowsep="0" align="right" colname="column10">10</entry><entry rowsep="0" align="right" colname="column11">15</entry></row></tbody></tgroup></table></clause><clause id="H5854AD807299402E8BFDCAAF90F432DE" commented="no"><enum>(ii)</enum><header>Age determinations</header><subclause id="HD2C2B2E80BAA453CBF7F132F7D3589E8" commented="no"><enum>(I)</enum><header>In general</header><text>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.</text></subclause><subclause id="H601F467E1BD843759DE15B7A46E7BCAE" commented="no"><enum>(II)</enum><header>Joint returns</header><text>In the case of a joint return, the age of the older spouse shall be taken into account under clause (i).</text></subclause></clause><clause id="H766286EC15224FA2B60AA7D76890F37D" commented="no"><enum>(iii)</enum><header>Indexing</header><text display-inline="yes-display-inline">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—</text><subclause id="H83FC9F74BB404250BB72A214D3C83360"><enum>(I)</enum><text>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</text></subclause><subclause id="HB41C86510E55445093C9D4EFD0CD392A"><enum>(II)</enum><text> 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.</text></subclause></clause><clause id="H476C77F2270A4E6EA9BEA81C8D93BBCC" commented="no"><enum>(iv)</enum><header>Failsafe</header><text display-inline="yes-display-inline">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.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H403C762A6EFE4B14854A65DA437AAA6F"><enum>(b)</enum><header>Expansion of eligibility</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/36B">Section 36B</external-xref> of the Internal Revenue Code of 1986 is amended—</text><paragraph id="H141BB86240D64C0C8F8B2B672A612CEE"><enum>(1)</enum><text>in subsection (c)(1)(A), by striking <quote>400</quote> and inserting <quote>600</quote>; and </text></paragraph><paragraph id="H116BC0207D7B4F72812F5BDF7F4CBEFD"><enum>(2)</enum><text>in subsection (f)(2)(B)(i), by striking <quote>400</quote> each place such reference appears and inserting <quote>600</quote> in each such place.</text></paragraph></subsection><subsection id="H7882C92641F54DA9A641EE23C79DA55B"><enum>(c)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendment made by this section shall apply to taxable years beginning after December 31, 2024.</text></subsection></section><section id="H14D11855F66B433DBFEC23F56FF9120C"><enum>227.</enum><header>Premium assistance</header><text display-inline="no-display-inline">Notwithstanding any other provision of law, the Secretary of the Treasury shall calculate the credit allowable under <external-xref legal-doc="usc" parsable-cite="usc/26/36B">section 36B</external-xref> 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. </text></section><section id="H3BA854A2573448A8A45802C718E7EA71"><enum>228.</enum><header>Adding copper plans to Exchanges</header><subsection id="H70046AE0260643349B9C13D9FC915C3D"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1302 of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18022">42 U.S.C. 18022</external-xref>) is amended—</text><paragraph id="H61F129B4635F4678BA92FA7D09C0B322"><enum>(1)</enum><text>in subsection (a)(3), by inserting <quote>copper,</quote> after <quote>either the</quote>; </text></paragraph><paragraph id="HD978E5B946944831BFD15ECD0B602EBA"><enum>(2)</enum><text>in subsection (c), by adding at the end the following new paragraph:</text><quoted-block style="OLC" id="HEB4C320123E044BE9B49F0F4B8EFACD9" display-inline="no-display-inline"><paragraph id="H03D7C1DFCD3E4052879DD79566E0A05C"><enum>(5)</enum><header>Special rule for copper plans</header><text display-inline="yes-display-inline">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. </text></paragraph><after-quoted-block>; </after-quoted-block></quoted-block></paragraph><paragraph id="H91884A1203874394B9CC547AD83B1626"><enum>(3)</enum><text>in subsection (d)—</text><subparagraph id="H6435FDC442F24AB8BAA2FA4DEDC5DC98"><enum>(A)</enum><text>in paragraph (1), by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="H1829FFF03EA44803983203657D939170" display-inline="no-display-inline"><subparagraph id="H7620A57B2C16428E90A44455755E9906"><enum>(E)</enum><header>Copper level</header><text display-inline="yes-display-inline">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.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="H7591C2F064E140CA9A44813063708B2A"><enum>(B)</enum><text>in paragraph (4)—</text><clause id="HC7E4FB2AC92A406699D77C214801E194"><enum>(i)</enum><text>by inserting <quote>copper,</quote> after <quote>any reference to a</quote>; and</text></clause><clause id="HEA40C92C44F445AA856A760349DFB7DB"><enum>(ii)</enum><text>by inserting <quote>copper,</quote> after <quote>providing a</quote>; and </text></clause></subparagraph></paragraph><paragraph id="H48F9920AF494489184301BA9083E866D"><enum>(4)</enum><text>in subsection (e)(1), by inserting <quote>copper,</quote> after <quote>not providing a</quote>. </text></paragraph></subsection><subsection id="HBE7B6AA369A84E8C9A5A49A4D709C09B"><enum>(b)</enum><header>Effective date</header><text>The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2025.</text></subsection></section><section id="H7AD5F1E29B9640E28C06F449C1D131DC"><enum>229.</enum><header>Copper and bronze plans</header><text display-inline="no-display-inline">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. </text></section><section id="HE5BC9140611E4636B04E7F65B4BFFF11" section-type="subsequent-section"><enum>230.</enum><header>Waivers for State innovation</header><subsection id="H5E5D19C36DFB4A27B2FC86B9D93E437C"><enum>(a)</enum><header>Streamlining the State Application Process</header><text display-inline="yes-display-inline">Section 1332 of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18052">42 U.S.C. 18052</external-xref>) is amended—</text><paragraph id="HF974E3AB10C14AF98BED9946DCFF646F"><enum>(1)</enum><text>in subsection (a)(1)(C), by striking <quote>the law</quote> and inserting <quote>a law or has in effect a certification</quote>; and</text></paragraph><paragraph id="H74529DC2883A41169A199DF8C66B5692"><enum>(2)</enum><text>in subsection (b)(2)—</text><subparagraph id="HD412E921D405476199CBA7E3930B45E9"><enum>(A)</enum><text>in the paragraph heading, by inserting <quote><header-in-text level="paragraph" style="OLC">or certify</header-in-text></quote> after <quote><header-in-text level="paragraph" style="OLC">law</header-in-text></quote>;</text></subparagraph><subparagraph id="H3B07F8B6CC584882A159022DDDA26884"><enum>(B)</enum><text>in subparagraph (A)—</text><clause id="H778A8A57890440448C844EB8ADD5AD4C"><enum>(i)</enum><text>by striking <quote>A law</quote> and inserting the following:</text><quoted-block display-inline="no-display-inline" id="H8CBADCB219244D4BA302A5509D539038" style="OLC"><clause id="H8A3AA0119BDD47E09067C269B7BB45A4"><enum>(i)</enum><header>Laws</header><text>A law</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause id="H8D324C9674C2423B9889F2E07F27DCE3"><enum>(ii)</enum><text>by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="HC780364CFA5F4D0D9C46A8417D7B1264" style="OLC"><clause id="H86B1719E3242410B8270343F765BE82E"><enum>(ii)</enum><header>Certifications</header><text>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).</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="HFBE02F776EF444C3B5C63B5545930B68"><enum>(C)</enum><text>in subparagraph (B)—</text><clause id="H2B7211AE1D5A4C35B7231F54C439B7DD"><enum>(i)</enum><text>in the subparagraph heading, by striking <quote><header-in-text level="paragraph" style="OLC">of opt out</header-in-text></quote>; and</text></clause><clause id="H57C445BAB6B24FEC9CD17F25578D766B"><enum>(ii)</enum><text>by striking <quote>may repeal a law</quote> 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—</text><quoted-block display-inline="no-display-inline" id="HF9AF8E39DDCB4CF6904393B28643656E" style="OLC"><clause id="H57A02B4CB9134BDA84AD017DB71CB400"><enum>(i)</enum><text>repealing a law described in subparagraph (A)(i); or</text></clause><clause id="H6760D0DEF81B45D48B8EAF57DD59BFDF"><enum>(ii)</enum><text>terminating a certification described in subparagraph (A)(ii), through a certification for such termination signed by the Governor of the State.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph></subsection><subsection id="HE8F5275578E24DFB97D9807C40E430A3"><enum>(b)</enum><header>Providing expedited approval of State waivers</header><text>Section 1332(d) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18052">42 U.S.C. 18052(d)</external-xref>) is amended—</text><paragraph id="HB6FC9A44433241DCB601DAB44E540922"><enum>(1)</enum><text>in paragraph (1) by striking <quote>180</quote> and inserting <quote>90</quote>; and</text></paragraph><paragraph id="H688BBDEB365B48C09112ECC5B08CE065"><enum>(2)</enum><text>by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="HCAF09309B9044C19BFCECA5CC698BE48" style="OLC"><paragraph id="HA6700A84C09048D296BA1309C6F03F71"><enum>(3)</enum><header>Expedited determination</header><subparagraph id="HA8BF4B883EBC404C842448218EB9FDFF"><enum>(A)</enum><header>In general</header><text>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—</text><clause id="H109C7BDA96AB40D4B4DE145BF6E7C893"><enum>(i)</enum><text>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</text></clause><clause id="H520872A08E554C619B2545F4B09DCB89"><enum>(ii)</enum><text>is for a waiver that is the same or substantially similar to a waiver that the Secretary already has approved for another State.</text></clause></subparagraph><subparagraph id="HF2C7274AEDE948D2AA7BC85FB2B6B71D"><enum>(B)</enum><header>Approval</header><clause id="H9BEFC538118543108E828A05A1B876B4"><enum>(i)</enum><header>Urgent situations</header><subclause id="H521AFBBA9B654C58B43B0D0796E8904E"><enum>(I)</enum><header>Provisional approval</header><text>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.</text></subclause><subclause id="H2BE1F2DC49F9439A8068ACA9C819BDFF"><enum>(II)</enum><header>Full approval</header><text>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.</text></subclause></clause><clause id="HE7736F7E497446848E28E4F3686BAF06"><enum>(ii)</enum><header>Approval of same or similar applications</header><text>An approval of a waiver under subparagraph (A)(ii) shall be subject to the terms of subsection (e).</text></clause></subparagraph><subparagraph id="H6116E944E193412EA973339F3496DF27"><enum>(C)</enum><header>GAO study</header><text>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.</text></subparagraph></paragraph><after-quoted-block>. </after-quoted-block></quoted-block></paragraph></subsection><subsection id="HA5D179AC21464809BDF54837A4C25DDA"><enum>(c)</enum><header>Providing certainty for State-Based reforms</header><text>Section 1332(e) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18052">42 U.S.C. 18052(e)</external-xref>) is amended by striking <quote>No waiver</quote> and all that follows through the period at the end and inserting the following: “A waiver under this section—</text><quoted-block display-inline="no-display-inline" id="HEC09C0D83B734ADCA59CB9D16D69171F" style="OLC"><paragraph id="H607C11C2B5834ED5A751B69ABC65AF30"><enum>(1)</enum><text>shall be in effect for a period of 6 years unless the State requests a shorter duration;</text></paragraph><paragraph id="H615A1B09473B46AB82C7BCD4FF1B80A6"><enum>(2)</enum><text>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</text></paragraph><paragraph id="H933CC825240C4650BA7B421191618EF0"><enum>(3)</enum><text>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.</text></paragraph><after-quoted-block>. </after-quoted-block></quoted-block></subsection><subsection id="H3FD1D76FECEA430CACF23F71F7766A7B"><enum>(d)</enum><header>Ensuring Patient Access to More Flexible Health Plans</header><text>Section 1332(b)(1)(B) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18052">42 U.S.C. 18052(b)(1)(B)</external-xref>) is amended by striking <quote>at least as affordable</quote> and inserting <quote>of comparable affordability, including for low-income individuals, individuals with serious health needs, and other vulnerable populations,</quote>.</text></subsection><subsection id="HC5E8A4EEB8494352AD6761043A58DC82" commented="no"><enum>(e)</enum><header>Applicability</header><text>The amendments made by this Act to section 1332 of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18052">42 U.S.C. 18052</external-xref>)—</text><paragraph id="H0CF7819A077A48B78EC7B018B4BA5740" commented="no"><enum>(1)</enum><text>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</text></paragraph><paragraph id="HD4CBA65C2BFF47659976DE1D4FFC26F5" commented="no"><enum>(2)</enum><text>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.</text></paragraph></subsection></section><section id="HE1B7201FBE6A475F9154A6D83A835462"><enum>231.</enum><header>Enrollment periods</header><subsection id="HFE9037EB50CD4E259F28D2AFB0E35261"><enum>(a)</enum><header>Exchanges</header><text display-inline="yes-display-inline">Paragraph (7) of section 1311(c) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18031">42 U.S.C. 18031(c)</external-xref>), as added by section 106, is amended by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="HB03CBA95544F43CC8A2C78E0E26804A1" display-inline="no-display-inline"><subparagraph id="H7C2FEA271607470180D26341FDE20B2B"><enum>(B)</enum><header>Enrollments other than during initial, open, and special enrollment periods</header><text display-inline="yes-display-inline">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).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H5805B8E582394038B1FBF56F49B27EDC"><enum>(b)</enum><header>Health plans</header><text>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:</text><quoted-block style="OLC" id="HFB08AF12FA694701AEE7E2242A138C47" display-inline="no-display-inline"><section id="H9F9182B0F9F64CB5834CE68D35DFB138"><enum>2710.</enum><header>Enrollment outside of initial, open, and special enrollment period</header><text display-inline="no-display-inline">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.</text></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="HEC65A0DFC1C64632A49FC24FCC503E46"><enum>232.</enum><header>State-operated Exchanges flexibility for open enrollment periods</header><text display-inline="no-display-inline">Section 1311(c) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18031">42 U.S.C. 18031(c)</external-xref>) is amended—</text><paragraph id="H0D9F5436AEA84D8C8E11DA5D8CB92892"><enum>(1)</enum><text>in paragraph (6), by striking <quote>The Secretary</quote> and inserting <quote>Subject to paragraph (7), the Secretary</quote>; and</text></paragraph><paragraph id="H41D33C5A87C44BE6B6B1200D8DA018E2"><enum>(2)</enum><text>by adding at the end the following new paragraph:</text><quoted-block style="OLC" id="HBD187BB8CE11405FB5116ABC116FECC4" display-inline="no-display-inline"><paragraph id="HC575D0D7E48B4E3596D98565D788773E"><enum>(7)</enum><header>Flexibility for enrollment periods</header><subparagraph id="H304D15DF2A504E6987B0817A2FCEE550"><enum>(A)</enum><header>State-operated Exchanges open enrollment periods</header><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="H66065E70E6D248D6A0C993E552C2B3F8"><enum>233.</enum><header>Promoting health plans that cover individuals in more than one State</header><text display-inline="no-display-inline">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.</text></section></subtitle><enum>III</enum><header>Competition, Transparency and Accountability</header><subtitle id="HE64770335D034271A2C013BA8965607D"><enum>A</enum><header>Provider and Insurer Competition</header><section id="HCFD5B8B2B2434B3FA2F8344F7A25C4F5"><enum>301.</enum><header>Hospital consolidation</header><subsection id="H0CEA37700F1B42AC9DCB7356B2255C7F"><enum>(a)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="HB31A2472A22140F6BCAD88C8081DDF1D"><enum>(b)</enum><header>Medicare Advantage rates applied to certain HHI hospitals</header><paragraph id="H3135C7F441AB4BD581C80092B9D0953A"><enum>(1)</enum><header>In general</header><text>Section 1866(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395cc">42 U.S.C. 1395cc(a)</external-xref>) is amended—</text><subparagraph id="HEDBCE7ACD6D344DDB598CE414FDDF201"><enum>(A)</enum><text>in paragraph (1)—</text><clause id="H7CF185E7EEE544CEA5D9E82739A72464"><enum>(i)</enum><text>in subparagraph (X), by striking <quote>and</quote> at the end;</text></clause><clause id="HCB81C1A0043B4C43AB059372BB694793"><enum>(ii)</enum><text>in subparagraph (Y), by striking the period at the end and inserting <quote>; and</quote>; and</text></clause><clause id="H9E9C2AF63B1545C0958EA7D3F9EC3C59"><enum>(iii)</enum><text>by inserting after subparagraph (Y) the following new subparagraph:</text><quoted-block id="HC70EF53AFC1549F18EE0C683EB4A3223" style="OLC"><subparagraph id="H4707CC311A0D4D55B70648932F1B1972"><enum>(Z)</enum><text>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.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="HE73D9C6105FC4C2AA3DDD7506248D4D0"><enum>(B)</enum><text>by adding at the end the following new paragraph:</text><quoted-block id="H1F038692FA1D4639BDBDBA0D1A70E4D3" style="OLC"><paragraph id="HE4FD1AC085544DB0AEA6C3AD270563B8"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H9231C2715C6743709EB7FCACD036A31B"><enum>(A)</enum><text>The requirement under paragraph (1)(Z) shall not apply in the case of a hospital in a hospital referral region if—</text><clause id="H69F8568D578346ABBAED4F127018BEB0" indent="up1"><enum>(i)</enum><text>the HRR market share of such hospital (as determined under subparagraph (B)) is less than 0.15; or</text></clause><clause id="H0314D18F57184A678B4786D914CB5C11" indent="up1"><enum>(ii)</enum><text>the hospital is located in a rural area (as defined in section 1886(d)(2)(D)).</text></clause></subparagraph><subparagraph id="HEB952ADAB6ED4B5A8DE59671DC8F09F4" indent="up1"><enum>(B)</enum><text>For purposes of subparagraph (A), the HRR market share of a hospital in a hospital referral region is equal to—</text><clause id="HA55F096A2C83404CAAE13F05EB3DDDED"><enum>(i)</enum><text>the total revenue of the hospital, divided by</text></clause><clause id="H4E6571C65DDE4F06BCFA3842AC6E00B6"><enum>(ii)</enum><text>the total revenue of all hospitals in the hospital referral region.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H7899BE60E4354654892A838357B0DA76"><enum>(2)</enum><header>Effective date</header><text>The amendments made by this subsection shall apply with respect to items and services furnished on or after January 1, 2025.</text></paragraph></subsection><subsection id="H49D360DA26A9444CA22FEEF465B8EE14"><enum>(c)</enum><header>Grants for hospital infrastructure improvement</header><paragraph id="H07D1C6E268C14DECB0FBDB41E895435F"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="H1E2F55820DF246DFAB532D8D7C2978E7"><enum>(2)</enum><header>Uses</header><text>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.</text></paragraph><paragraph id="HB3721C4050F24AA49901631068EFD697"><enum>(3)</enum><header>Eligibility</header><subparagraph id="H6CB1032D010C413D96CF8641DDA1889D"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></subparagraph><subparagraph id="HDC4B8C8F6E914CA08F8BBE7E5C0545B2"><enum>(B)</enum><header>Eligible State</header><text>For purposes of this subsection, the term <term>eligible State</term> means a State that meets any one or more of the following qualifying criteria:</text><clause id="HFF0960BA1DC949C89B11C3187F545302"><enum>(i)</enum><text display-inline="yes-display-inline">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.</text></clause><clause id="HD3A6A8C4579D4BB29DD55667A276CDC4" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">The State has in effect State scope of practice laws that—</text><subclause id="HAC20BF5598094A37A27CCEF15CC52E56" commented="no"><enum>(I)</enum><text>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</text></subclause><subclause id="H9E2D5F6EE5A5437593D42A08272F437C" commented="no"><enum>(II)</enum><text>provide that the only justification for limiting the scope of practice of a health care provider is safety to the public.</text></subclause></clause><clause id="HEA15E6F670454D9D9BC96BBB53FDF3D4" commented="no"><enum>(iii)</enum><text display-inline="yes-display-inline">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.</text></clause><clause id="HBF480AD3C89C446C9BAA869E70BFA3F3"><enum>(iv)</enum><text display-inline="yes-display-inline">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.</text></clause><clause id="HE77DE82478E1416B88A71419FDF532F8"><enum>(v)</enum><text display-inline="yes-display-inline">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. </text></clause></subparagraph></paragraph><paragraph id="HCDC8F45C787845F3A94CF1EDFCD67C5C"><enum>(4)</enum><header>Funding</header><text display-inline="yes-display-inline">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.</text></paragraph></subsection><subsection id="HE0D97FFDA0354C24A1480BE1CFD733F5"><enum>(d)</enum><header>Critical access hospital reimbursement rates</header><paragraph id="HB03A7B2401A14D5EB8FF856F142DB8F1"><enum>(1)</enum><header>Part A</header><text>Section 1814(l)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395f">42 U.S.C. 1395f(l)(1)</external-xref>) is amended by inserting <quote>(or, for 2025, 102, plus 1 percentage point for each subsequent year through 2033, and 110 for each subsequent year thereafter)</quote> after <quote>101</quote>.</text></paragraph><paragraph id="HF41B877A45A44545BB3FBB8434125881"><enum>(2)</enum><header>Part B</header><text display-inline="yes-display-inline">Section 1834(g)(1) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(g)(1)</external-xref>) is amended by inserting <quote>(or, for 2025, 102, plus 1 percentage point for each subsequent year through 2033, and 110 for each subsequent year thereafter)</quote> after <quote>101</quote>. </text></paragraph></subsection></section><section id="H469B0101162F4B86B01E8B378224E5DA" section-type="subsequent-section"><enum>302.</enum><header>Authority of Federal Trade Commission over certain tax-exempt organizations</header><text display-inline="no-display-inline">Section 4 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/44">15 U.S.C. 44</external-xref>) is amended, in the undesignated paragraph relating to the definition of the term <term>Corporation</term>—</text><paragraph id="HC65CD22042604B70905CE38847FE892D"><enum>(1)</enum><text>by striking <quote>, and any</quote> and inserting <quote>, any</quote>; and</text></paragraph><paragraph id="H6751CCA9BD714CCE923BA4535A4034BF"><enum>(2)</enum><text>by inserting before the period at the end the following: <quote>, and any organization described in <external-xref legal-doc="usc" parsable-cite="usc/26/501">section 501(c)(3)</external-xref> of the Internal Revenue Code of 1986 that is exempt from taxation under section 501(a) of such Code</quote>.</text></paragraph></section><section id="H94F3CE28511441BFBDB74C344B77F0E6"><enum>303.</enum><header>Leveling the playing field between payers and providers</header><subsection id="H828706060C8D443E9BEA97F6F5C20375"><enum>(a)</enum><header>Exemption</header><text>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.</text></subsection><subsection id="H44AD14A820734B95AC135BBE227168D2"><enum>(b)</enum><header>Definitions</header><text>For purposes of this section:</text><paragraph id="HC67FB2C38D21464DAF2C066C4ACAE8C8"><enum>(1)</enum><header>Antitrust laws</header><text>The term <term>antitrust laws</term> has the meaning given it in subsection (a) of the 1st section of the Clayton Act (<external-xref legal-doc="usc" parsable-cite="usc/15/12">15 U.S.C. 12(a)</external-xref>), except that such term includes section 5 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45</external-xref>) to the extent such section 5 applies to unfair methods of competition.</text></paragraph><paragraph id="H0B4E85A73C4247CEB48D0E499CBD9E3A"><enum>(2)</enum><header>Health insurance issuer</header><text>The term <term>health insurance issuer</term> 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 (<external-xref legal-doc="usc" parsable-cite="usc/29/1144">29 U.S.C. 1144(b)(2)</external-xref>). Such term does not include a group health plan.</text></paragraph><paragraph id="HC63271A6900E4262B29C35247687A87A"><enum>(3)</enum><header>Health maintenance organization</header><text>The term <term>health maintenance organization</term> means—</text><subparagraph id="H31FB9532C25C4BF994D3875A25D7B268"><enum>(A)</enum><text>a Federally qualified health maintenance organization (as defined in section 300e(a) of title 42 of the United States Code),</text></subparagraph><subparagraph id="H6FFB6157356D4A7C9965472E29131D51"><enum>(B)</enum><text>an organization recognized under State law as a health maintenance organization, or</text></subparagraph><subparagraph id="HE94D8C0D2821410A94F537EA72C6C647"><enum>(C)</enum><text>a similar organization regulated under State law for solvency in the same manner and to the same extent as such a health maintenance organization.</text></subparagraph></paragraph></subsection><subsection id="HBA643D0E6942427C95927E8626A89042"><enum>(c)</enum><header>Effective date</header><text>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.</text></subsection></section><section id="HF03A1133F37944018162CD39181F94DE"><enum>304.</enum><header>Banning anticompetitive terms in facility and insurance contracts that limit access to higher quality, lower cost care</header><subsection id="H2AFFBCEC1180405FA50400E96A3CDE1C"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 2729B of the Public Health Service Act, as added by section 301, is amended by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="H25EA878366A94885959C5AB067ABE117" style="OLC"><subsection id="H052EB60281BD4115BF2B38A684E61308"><enum>(b)</enum><header>Protecting Health Plans Network Design Flexibility</header><paragraph id="H10F6CCF22E5D446389F34E8C500A8E41"><enum>(1)</enum><header>In general</header><text>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—</text><subparagraph id="H6BD9A8A44E644F64BFA9C1DE544A70C0"><enum>(A)</enum><text>restricts the group health plan or health insurance issuer from—</text><clause id="HF93E40F391DE4221A247593CB310F785"><enum>(i)</enum><text>directing or steering enrollees to other health care providers; or</text></clause><clause id="H59AD7874CB6840ABBB2BF54176883F9D"><enum>(ii)</enum><text>offering incentives to encourage enrollees to utilize specific health care providers;</text></clause></subparagraph><subparagraph id="H312E05527FD140A0BAB5EEEDCFF7D1FA"><enum>(B)</enum><text>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;</text></subparagraph><subparagraph id="H896B24F4BE9E4C00820375B3F523968A"><enum>(C)</enum><text>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</text></subparagraph><subparagraph id="H58A05C8A5A3E490E9190DD56F4682798"><enum>(D)</enum><text>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.</text></subparagraph></paragraph><paragraph id="H1CECD592F267414E91DB0D633A1B69CE"><enum>(2)</enum><header>Additional requirement for self-insured plans</header><text>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.</text></paragraph><paragraph id="H1C8869D0652B4054BD5256DC3944A637"><enum>(3)</enum><header>Exception for certain group model issuers</header><text>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—</text><subparagraph id="HE944659DD35F4615A2EE17F20B7F72E0"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="H2DDB5BA8AF5440DBB8902976A73CDA24"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><paragraph id="H2B6379C83661473A8DC4309189A649CC"><enum>(4)</enum><header>Attestation</header><text>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.</text></paragraph></subsection><subsection id="H4DC836E9E80B4EB89C36015DAE2B5228"><enum>(c)</enum><header>Maintenance of existing HIPAA, GINA, and ADA protections</header><text>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).</text></subsection><subsection id="H402C91E715614F0984067816692B6300"><enum>(d)</enum><header>Regulations</header><text>The Secretary, not later than 1 year after the date of enactment of the <short-title>Fair Care Act of 2024</short-title>, shall promulgate regulations to carry out this section.</text></subsection><subsection id="HA36E8B5C8F1043C7B0C633B483697538"><enum>(e)</enum><header>Rule of construction</header><text>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.</text></subsection><subsection id="HE2396AACC25448A98766F2168B7FE7C1"><enum>(f)</enum><header>Clarification with respect to antitrust laws</header><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/15/12">15 U.S.C. 12(a)</external-xref>).</text></subsection><after-quoted-block>. </after-quoted-block></quoted-block></subsection><subsection commented="no" display-inline="no-display-inline" id="H4D82E1ACB0FC4410A72CD86B887643BF"><enum>(b)</enum><header>Effective date</header><text>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.</text></subsection></section><section id="H31AC53CAF9F8444DAA538DFD08227BA5"><enum>305.</enum><header>Repealing eligibility of certain ACOs</header><subsection id="H1E09B645F2B645A38784CC5E870CFACE"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1899(b)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395jjj">42 U.S.C. 1395jjj(b)(1)</external-xref>) is amended by striking subparagraphs (C) through (E).</text></subsection><subsection id="H5CC5DA8A4087477B902FB344D4074BAE"><enum>(b)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall take effect on January 1, 2025.</text></subsection></section><section id="HBC5D95A83D5C489B89EA8B78FA7F68E9"><enum>306.</enum><header>Repeal of health care reform provisions limiting Medicare exception to the prohibition on certain physician referrals for hospitals</header><text display-inline="no-display-inline">Sections 6001 and 10601 of the Patient Protection and Affordable Care Act (<external-xref legal-doc="public-law" parsable-cite="pl/111/148">Public Law 111–148</external-xref>; 124 Stat. 684, 1005) and section 1106 of the Health Care and Education Reconciliation Act of 2010 (<external-xref legal-doc="public-law" parsable-cite="pl/111/152">Public Law 111–152</external-xref>; 124 Stat. 1049) are repealed and the provisions of law amended by such sections are restored as if such sections had never been enacted.</text></section><section id="H1331A48ADF3E4F79B9A17446F41DD137"><enum>307.</enum><header>Alternative payment model for certain shoppable procedures</header><subsection id="H8C02EA60A4F54432BB96E8A80159A3A8"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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 (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-91">42 U.S.C. 300gg–91</external-xref>)) 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.</text></subsection><subsection id="H1720C59B9CEE44E1B39546A71426D985"><enum>(b)</enum><header>Definition</header><text display-inline="yes-display-inline">For purposes of this section, the term <term>shoppable procedure</term> means a procedure specified by the Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) 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.</text></subsection><subsection id="HEFAFD67C7FBB407EB15B837D516C78A0"><enum>(c)</enum><header>Set payment rules</header><text>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—</text><paragraph id="H81C45E85C602430D8D2DA259139F8EBA"><enum>(1)</enum><text>be disclosed prior to beginning of each plan year such payment is in effect and shall not vary during such plan year;</text></paragraph><paragraph id="H0EF42960BF3A49EDB9733AC00C079D74"><enum>(2)</enum><text>be the same amount with respect to the same shoppable procedure furnished in a geographic area (as defined by the Secretary);</text></paragraph><paragraph id="HB4A9E648383048009A4ABC7CD347A4C2"><enum>(3)</enum><text>not be less than the median negotiated rate for all group health plans and health insurance coverage offered in such area for such procedure;</text></paragraph><paragraph id="H8253A04B077F412FA4394F9C2B6BB2F4"><enum>(4)</enum><text>be made available to an enrollee under such plan or such coverage regardless of the provider or facility furnishing the shoppable procedure;</text></paragraph><paragraph id="H2953C321BA3B4DB5AA134CFE8B744776"><enum>(5)</enum><text>represent the entirety of the payment obligation of such plan or such issuer with respect to such procedure; and</text></paragraph><paragraph id="H899FD49CF36C4DBC998BF5B3250FCF63"><enum>(6)</enum><text>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.</text></paragraph></subsection><subsection id="H432D58D2382C4DDC85B10DAF676512BC"><enum>(d)</enum><header>Provision of price information</header><text>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).</text></subsection><subsection id="H21088AF8C1E945EB9F6BE62DFB6ED898"><enum>(e)</enum><header>EHB waiver authority</header><text>The Secretary may waive such provisions of section 1302(b) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18022">42 U.S.C. 18022(b)</external-xref>) 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).</text></subsection></section></subtitle><subtitle id="HC90E81EE9ADA40749D142882DDB00B51"><enum>B</enum><header>Price Transparency</header><section id="HE05891F5472E44A297ED1887424352CA"><enum>321.</enum><header>Price transparency requirements</header><subsection id="H44771A09700746D5B79C07DFC04D954B"><enum>(a)</enum><header>Hospitals</header><text>Section 2718(e) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-18">42 U.S.C. 300gg–18(e)</external-xref>) is amended—</text><paragraph id="HE04FF1498F7149FE8EDA55D22BDFA32B"><enum>(1)</enum><text>by striking <quote>Each hospital</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H0611B19C0FAC433983AEF185B58ACCA7"><paragraph id="HE95509E7ED0F4DF88CB5826C7CDC85A8"><enum>(1)</enum><header>In general</header><text>Each hospital</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph id="H827F7A27B3CA43D484F20231926A48E8"><enum>(2)</enum><text>by inserting <quote>, in a machine-readable format, via open application program interfaces (APIs)</quote> after <quote>a list</quote>;</text></paragraph><paragraph id="H67A7FD87AFE842A1A71EF161B8FDDBDE"><enum>(3)</enum><text>by inserting <quote>, 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</quote> before the period; and</text></paragraph><paragraph id="H42110986237D4F03BC366B1647DC81F2"><enum>(4)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H8494D1D2F1B0410594B7E605D247B4AF"><paragraph id="H2295007DA36346B789D3F1D1717BC4AD"><enum>(2)</enum><header>Definition of standard charges</header><text>Notwithstanding any other provision of law, for purposes of paragraph (1), the term <term>standard charges</term> 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.</text></paragraph><paragraph id="H0AA8DE2EB6B649F986ECB2EF6E9E044D"><enum>(3)</enum><header>Enforcement</header><text>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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H329E4319BEFA4EBD846CCA7AE8CEA045"><enum>(b)</enum><header>Transparency in coverage</header><text>Section 1311(e)(3) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18031">42 U.S.C. 18031(e)(3)</external-xref>) is amended—</text><paragraph id="HA34BEF4BB9824277B33B61243EA02AC5"><enum>(1)</enum><text>in subparagraph (A)—</text><subparagraph id="HC6B671C5E6B64A9BB693568B14E94576"><enum>(A)</enum><text>in clause (vii), by inserting before the period the following: <quote>, 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</quote>;</text></subparagraph><subparagraph id="H9255D4E446B94D398B91F95FE13B47C3"><enum>(B)</enum><text>by designating clause (ix) as clause (x); and</text></subparagraph><subparagraph id="H389759F50CB745E5A1A46B16DE0B47CA"><enum>(C)</enum><text>by inserting after clause (viii), the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HFDE269C54A7C41C8967D5BA4B2A9A4E2"><clause id="HB1B86F30F1404A6CA7EF2BA051D1A5C4"><enum>(ix)</enum><text>Information on the specific negotiated payment rates between the plan and health care providers for all items and services covered under the plan.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HA8D3E685E3B8497BA081CB544881197A"><enum>(2)</enum><text>in subparagraph (B)—</text><subparagraph id="H0066638E89C94CC09C352E341171C731"><enum>(A)</enum><text>in the heading, by striking <quote><header-in-text style="OLC" level="subparagraph">use</header-in-text></quote> and inserting <quote><header-in-text style="OLC" level="subparagraph">delivery methods and use</header-in-text></quote>;</text></subparagraph><subparagraph id="H57A27D2425EE48FFAFF89107DE1883EB"><enum>(B)</enum><text>by inserting <quote>, as applicable,</quote> after <quote>English proficiency</quote>; and</text></subparagraph><subparagraph id="HF3D608E130094321BC7565C223904D0F"><enum>(C)</enum><text>by inserting after the second sentence, the following: <quote>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.</quote>;</text></subparagraph></paragraph><paragraph id="H84B0EEFA979C42478DB9E5C25AA49B87"><enum>(3)</enum><text>in subparagraph (C)—</text><subparagraph id="HD097669029CA4D43BEF6FA72EDE8F804"><enum>(A)</enum><text>in the first sentence, by inserting <quote>or out-of-network provider</quote> after <quote>item or service by a participating provider</quote>;</text></subparagraph><subparagraph id="HFC8FA145477C42768F53A55BFDF0178D"><enum>(B)</enum><text>in the second sentence, by striking <quote>through an Internet website</quote> and inserting <quote>free of charge, in machine readable format, through an Internet website, and via open APIs, in accordance with standards established by the Secretary,</quote>; and</text></subparagraph><subparagraph id="HB41D1E8B188443F1A757F67096D45D7D"><enum>(C)</enum><text>by adding at the end the following: <quote>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.</quote>; and</text></subparagraph></paragraph><paragraph id="H9BE26FFAA78F4FEC925E532FBEFD4299"><enum>(4)</enum><text>in subparagraph (D) by striking <quote>subparagraph (A)</quote> and inserting <quote>subparagraphs (A), (B), and (C)</quote>.</text></paragraph></subsection></section><section id="HE801531E1663485CA7ADBF6C1BDE47E7"><enum>322.</enum><header>Ensuring enrollee access to cost-sharing information</header><subsection id="HDB058AF12C09485C8AE83F4DA78EE73D"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Subpart II of part A of title XXVII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-11">42 U.S.C. 300gg–11 et seq.</external-xref>), as amended by the preceding sections, is further amended by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="H7792757D8D1B4ACF8FFF7711DAF73E75" style="OLC"><section id="H851C4D2806E94B4DBBE0E70A61975CFF"><enum>2729F.</enum><header>Provision of cost-sharing information</header><subsection id="HAD16B4D6F50F46C5AD784F494CB32B33"><enum>(a)</enum><header>Provider disclosures</header><text display-inline="yes-display-inline">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—</text><paragraph id="H9ED0C300532647AEBB5AE6F1B2B24C36"><enum>(1)</enum><text display-inline="yes-display-inline">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</text></paragraph><paragraph id="H3F3A1EB2150148AAAE4877E607067E8D"><enum>(2)</enum><text>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.</text></paragraph></subsection><subsection id="H08935A9347E44A0581D58F7C75CAE070"><enum>(b)</enum><header>Insurer disclosures</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="HD1EF5566DE2B4F18B1A55943F8688C06"><enum>(c)</enum><header>Enforcement</header><paragraph id="H757C9C697EBB4AB39E1956B8BEA1A4F3"><enum>(1)</enum><header>In general</header><text>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.</text></paragraph><paragraph id="HD44B59D66E514CBD9ECE5DF78FB67989"><enum>(2)</enum><header>Procedure</header><text>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.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection commented="no" display-inline="no-display-inline" id="HE421D511A66E4EF1B1EF260D7A100A2B"><enum>(b)</enum><header>Effective date</header><text>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.</text></subsection></section><section id="HD30E7853F3FB4663980B03A753E82F7D"><enum>323.</enum><header>Access of individuals to protected health information</header><text display-inline="no-display-inline">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.</text></section><section id="H3638AB313AF644EBA4F080D2E23F0052"><enum>324.</enum><header>Timely bills for patients</header><subsection id="HAFC8CE60A1774B8D87FC3387B9C57BE5"><enum>(a)</enum><header>In general</header><paragraph id="HA4C4405DE52E4783ACC91B5ACE3B28F6"><enum>(1)</enum><header>Amendment</header><text display-inline="yes-display-inline">Part P of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280g">42 U.S.C. 280g et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="H40E77EC490374FD880A4965D2EE99418" style="OLC"><section id="H557A9AFB8B23415C956CCEF15B93D6AF"><enum>399V–7.</enum><header>Timely bills for patients</header><subsection id="H63E99070FF0D489AA291BA54671CEEC3"><enum>(a)</enum><header>In general</header><text>The Secretary shall require—</text><paragraph id="H10E8F754AAB5442985557B508EF6165F"><enum>(1)</enum><text>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</text></paragraph><paragraph id="HE2C544D54D954FF08877F0E7DEB986CC"><enum>(2)</enum><text>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.</text></paragraph></subsection><subsection id="H50B357BEB188464686108185C645A25E"><enum>(b)</enum><header>Payment after billing</header><text>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.</text></subsection><subsection id="HFD404E6C862540949C65D4607B61FA54"><enum>(c)</enum><header>Effect of violation</header><paragraph id="H3B6CC9CA0B9A4F378F8A68340941720B"><enum>(1)</enum><header>Notification and refund requirements</header><subparagraph id="H4DF683F5C0894D8A93C16E68E83D72FA"><enum>(A)</enum><header>Provider lists</header><text>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.</text></subparagraph><subparagraph id="HE56FF53F51C44B61AFF2EA4062730560"><enum>(B)</enum><header>Billing</header><text>If a facility or practitioner bills a patient after the 45-calendar-day period described in subsection (a)(2), such facility or practitioner shall—</text><clause id="H5A00EE104A2F4D21B8F28B2C5997F8D4"><enum>(i)</enum><text>report such bill to the Secretary; and</text></clause><clause id="HE7C19994444E4E22B11FDF9648178B57"><enum>(ii)</enum><text>refund the patient for the full amount paid in response to such bill with interest, at a rate determined by the Secretary.</text></clause></subparagraph></paragraph><paragraph id="HFAE5C1B4B56A4F789E1FDD7B087285DF"><enum>(2)</enum><header>Civil monetary penalties</header><subparagraph id="HC7472C2B1E2E4C0F921B2C9BE60B5AB9"><enum>(A)</enum><header>In general</header><text>The Secretary may impose civil monetary penalties of up to $10,000 a day on any facility or practitioner that—</text><clause id="H35B536F78B564C159AC15A5591F69493"><enum>(i)</enum><text>fails to provide a list required under subsection (a)(1) more than 10 times, beginning on the date of such tenth failure;</text></clause><clause id="HD8140FB061CF43748B17BCB59ABAC9B2"><enum>(ii)</enum><text>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;</text></clause><clause commented="no" id="H0441279847DE4C2888E57A8C666B6351"><enum>(iii)</enum><text>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</text></clause><clause commented="no" id="H2B6798EA6D6548A5A3B89BE3CA28B71B"><enum>(iv)</enum><text>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.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H547C5E8E7CC7406DBD015D9E1AE68A83"><enum>(B)</enum><header>Procedure</header><text>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.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF842CD4E98F548F7A1E34BAD092C643C"><enum>(3)</enum><header>Safe harbor</header><text>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—</text><subparagraph id="H1101A58E34C043E999801720214409EA"><enum>(A)</enum><text>makes a good-faith attempt to send a bill within 30 days but is unable to do so because of an incorrect address; or</text></subparagraph><subparagraph id="H5D3BB5F7F05B49A89EE654B1ED3F8DB0"><enum>(B)</enum><text>experiences extenuating circumstances (as defined by the Secretary), such as a hurricane or cyberattack, that may reasonably delay delivery of a timely bill.</text></subparagraph></paragraph></subsection></section><after-quoted-block>. </after-quoted-block></quoted-block></paragraph><paragraph id="HB486F457645A4E76BFCF90AD28BBE6F6"><enum>(2)</enum><header>Rulemaking</header><text>Not later than 1 year after the date of enactment of this Act, the Secretary shall promulgate final regulations to define the term <term>extenuating circumstance</term> for purposes of section 399V–7(c)(3)(B) of the Public Health Service Act, as added by paragraph (1).</text></paragraph></subsection><subsection id="H8D972DFAE18840AE948A3B930F2B3F5D"><enum>(b)</enum><header>Group health plan and health insurance issuer requirements</header><text>Subpart II of part A of title XXVII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-11">42 U.S.C. 300gg–11</external-xref>), as amended by the preceding sections, is further amended by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="HA074CD26967C46CCB2100B39B6C40329" style="OLC"><section id="HAD3E7B4D080141DCB3D5660201816873"><enum>2729D.</enum><header>Timely bills for patients</header><subsection id="H9D72C95541FD495894BFD8F3DC3FA3AE"><enum>(a)</enum><header>In general</header><text>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).</text></subsection><subsection id="HE6CC431FD10B458D9CC0951D07945BB7"><enum>(b)</enum><header>Clarification</header><text>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).</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection commented="no" display-inline="no-display-inline" id="HFC91DE9F3F6D4A01A46DEF5402943183"><enum>(c)</enum><header>Effective date</header><text>The amendments made by subsections (a) and (b) shall take effect 6 months after the date of enactment of this Act.</text></subsection></section><section id="H206C579B2110432EA549E99894ECDC51"><enum>325.</enum><header>Advisory group on reducing burden of hospital administrative requirements</header><subsection id="HD8210C090887410D9B2FE6254D6B1866"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="HC3F18E0602114F84BA6A635350AC6E16"><enum>(b)</enum><header>Recommendations</header><text>Not later than January 1, 2026, the advisory board convened under this section shall—</text><paragraph id="HF870A499BE334AFE81041ADA7177DC85"><enum>(1)</enum><text>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</text></paragraph><paragraph id="HF04A83B9C34D46149468C69C3A01A74E"><enum>(2)</enum><text>submit to Congress recommendations described under subsection (a) for legislative proposals.</text></paragraph></subsection><subsection id="HEEB1E941D36B47BC9E4D16F3C7419902" commented="no"><enum>(c)</enum><header>Membership</header><text>The advisory board under this section shall consist of the following members:</text><paragraph id="H082CFAC747FE4BA981B134922DD516CD" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">Three representatives of companies that have—</text><subparagraph id="H73D415C3984F44748BE90B6E40C94239" commented="no"><enum>(A)</enum><text>geographically distributed workforces; </text></subparagraph><subparagraph id="H67CC2C12FE4045D391585AF675E527E4" commented="no"><enum>(B)</enum><text>at least 10,000 employees; and</text></subparagraph><subparagraph id="H919C219FCCF4447DA9113DE31656C05B" commented="no"><enum>(C)</enum><text>no more than 10 percent of such employees in any single State.</text></subparagraph></paragraph><paragraph id="HE475E55F08904E0D952963C5EAFEDB92" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">Three representatives of health insurance issuers and health plans, consisting of—</text><subparagraph id="HFC9DA185DF7B45F79AE3423A93E75437" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">one representative of for-profit health insurance issuers and health plans with at least 20,000,000 enrollees in the employer-sponsored market;</text></subparagraph><subparagraph id="H06161D248BE54987AA05A803157EB8E2" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">one representative of non-profit health insurance issuers and health plans operating in at least 5 States; and</text></subparagraph><subparagraph id="H59468438A3F84215B2D32585C403B75B" commented="no"><enum>(C)</enum><text display-inline="yes-display-inline">one representative of non-profit health insurance issuers and health plans operating in a rural State (as defined by the Census Bureau).</text></subparagraph></paragraph><paragraph id="H09A8728B3D6943A5B68F3AB4AA613AAD" commented="no"><enum>(3)</enum><text display-inline="yes-display-inline">Seven public policy experts in the field of hospital consolidation.</text></paragraph></subsection></section><section id="HCFEE76632883482498719B529716F56F"><enum>326.</enum><header>Data reporting to improve the transparency regarding how <enum-in-header>340</enum-in-header>B hospital covered entities provide care for patients</header><text display-inline="no-display-inline">Section 340B of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/256b">42 U.S.C. 256b</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block display-inline="no-display-inline" id="H55C73DC86F4043C796E8CE7F0872DAB4" style="OLC"><subsection id="H3FB9901F8AFF4DC8BBF746620AB68957"><enum>(f)</enum><header>Data reporting To improve the transparency regarding how hospital covered entities provide care for patients</header><paragraph id="H4ED80100CD214D2BAF627CB424144CD3"><enum>(1)</enum><header>In general</header><text>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:</text><subparagraph id="HCDA1AF1AE6324E558055AB8846F0887D"><enum>(A)</enum><text>The following information:</text><clause id="HBECF8A721D33478C83B73DB44A673CF6"><enum>(i)</enum><text>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).</text></clause><clause id="H00D85F2BEEC3420CAED53796F8180CBB"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text></clause></subparagraph><subparagraph id="HF634020816A34BCA8BFE9E74FFF2D7C1"><enum>(B)</enum><text>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.</text></subparagraph><subparagraph id="H82D28BD5865947E98195C99CF11CF473"><enum>(C)</enum><text>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.</text></subparagraph><subparagraph id="HC34C937A19C14413A6DBBA3EF2E92CA6"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><paragraph id="H0126008E6D94452084DE52ED8BE40800"><enum>(2)</enum><header>Availability of information</header><subparagraph id="H66B168A67DC040B5B53CB9371B1DA213"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></subparagraph><subparagraph id="HC816BF54614C42DB94AD01563AA0DEB5"><enum>(B)</enum><header>Format</header><text>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.</text></subparagraph></paragraph><paragraph id="H7D423351DD144E0389023B3556B456F6"><enum>(3)</enum><header>Interim final regulations</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="H5EFB8691EF604AA2A06307091AB3A5CD"><enum>(4)</enum><header>Reports to Congress</header><subparagraph id="H5707323F57C040FDBF57E021D0E94095"><enum>(A)</enum><header>OIG report</header><text>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).</text></subparagraph><subparagraph id="H26E4EE8248CF48149BA4CC0DAA6F74C5"><enum>(B)</enum><header>GAO reports</header><clause id="H117B08DAF8064F688BD7D7DE8871B5C6"><enum>(i)</enum><header>Initial report</header><text display-inline="yes-display-inline">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—</text><subclause id="HAEFE5E4778A949589E55992F6D59B323"><enum>(I)</enum><text>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);</text></subclause><subclause id="H23CB99F9D0BE44F7A643028FC8F4242F"><enum>(II)</enum><text display-inline="yes-display-inline">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</text></subclause><subclause id="HCB450380B29244C5994AD1D2535F1842"><enum>(III)</enum><text display-inline="yes-display-inline">analyzing how these contracts define low-income individuals and whether the Secretary reviews such determinations.</text></subclause></clause><clause id="HE13FAF30406B4526B15EFD3E36C87177"><enum>(ii)</enum><header>Subsequent report</header><text display-inline="yes-display-inline">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.</text></clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H1E794AF6DFAB4955819330A99E5B0477" section-type="subsequent-section"><enum>327.</enum><header>Requiring <enum-in-header>340</enum-in-header>B drug discount program reports by DSH hospital covered entities on low-income utilization rate of outpatient hospital services</header><subsection id="HA2674A273720487CB6A830304D6AD518"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 340B(d)(2) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/256b">42 U.S.C. 256b(d)(2)</external-xref>) is amended—</text><paragraph id="H195D4D0320984B8FAEC5E2C3D51EE6F8"><enum>(1)</enum><text>in subparagraph (B)(i), by inserting before the period at the end the following: <quote>, 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)</quote>; and</text></paragraph><paragraph id="H90F42E4E2CAC4794B47D62AA0B8A1521"><enum>(2)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="H16CE7E3A01024393A6788BA93CB2832C" display-inline="no-display-inline"><subparagraph id="H5930FF02D614442CA2BBAFB703F17AF4"><enum>(C)</enum><header>Information on low-income utilization rate of outpatient hospital services</header><clause id="H3FD94DCBB5E7483DBDC98F1824669588"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">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—</text><subclause id="H6C50B6986BBB47A796A21904C4987D45"><enum>(I)</enum><text>the low-income outpatient utilization rate of such covered entity for the most recent fiscal year; and</text></subclause><subclause id="H50C91D07EC354F8CA262AB2095BC55C6"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text></subclause></clause><clause id="H03DC02C9D72440CA98CBFD5BC38D8630"><enum>(ii)</enum><header>Low-income outpatient utilization rate defined</header><text display-inline="yes-display-inline">In this subparagraph, the term <term>low-income outpatient utilization rate</term> has the meaning given the term <term>low-income utilization rate</term> under paragraph (3) of section 1923(b) of the Social Security Act, except that—</text><subclause id="H61C84FB487D24B91BDC477D7D0729352"><enum>(I)</enum><text>clauses (i) and (ii) of subparagraph (A) of such paragraph shall be applied as if—</text><item id="HF5B76DD0BAC743E18F2D4A13D9E645E2"><enum>(aa)</enum><text>each reference to <quote>patient services</quote> were a reference to <quote>patient services furnished on an outpatient basis</quote>; and</text></item><item id="H711427E3782748309E150A71806A1A10"><enum>(bb)</enum><text display-inline="yes-display-inline">for purposes of clause (i)(II) of this subparagraph, each reference to <quote>hospital</quote> were a reference to <quote>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</quote>; and</text></item></subclause><subclause id="HCC6F3D0B2570491F85EC756114911B68"><enum>(II)</enum><text>clauses (i) and (ii) of subparagraph (B) of such paragraph shall be applied as if—</text><item id="H44446FD91E0F42AF8508385D0FB4D82E"><enum>(aa)</enum><text>each reference to <quote>inpatient hospital services</quote> were a reference to <quote>outpatient hospital services</quote>; and</text></item><item id="H4F38342348954866BC7A95598A84B492"><enum>(bb)</enum><text>for purposes of clause (i)(II) each reference to <quote>hospital’s charges</quote> were a reference to <quote>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</quote>.</text></item></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H259B52EC8EC141EDB139BC76C8E62D5D"><enum>(b)</enum><header>Annual reports</header><text display-inline="yes-display-inline">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).</text></subsection></section><section id="H34B9795C2FAC4A1785EEE37C88B3DFDB" commented="no"><enum>328.</enum><header>Employer benefits reports</header><subsection id="H784A325E970A452690FCFC815E1F746F" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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:</text><paragraph id="HA4EBFAE95DEC46339C56A14B9B10FB87" commented="no"><enum>(1)</enum><text>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).</text></paragraph><paragraph id="H688EA5D22BFD4F159966A92AEC64916C" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text></paragraph></subsection><subsection id="H4644990E4DC94935ACC1A511B08BF5C8" commented="no"><enum>(b)</enum><header>Limitation</header><text>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.</text></subsection><subsection id="HD91963408451427D9C7B83B85DBF556C" commented="no"><enum>(c)</enum><header>Penalty</header><text>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.</text></subsection><subsection id="HC896CDE18C11429AAB9DCBD0F4754966" commented="no"><enum>(d)</enum><header>Definitions</header><text>In this section, the terms <term>group health plan</term>, <term>group health insurance coverage</term>, <term>health insurance issuer</term>, and <term>sponsor</term> have the meaning given such terms in section 2791 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-91">42 U.S.C. 300gg–91</external-xref>).</text></subsection></section><section id="H5B65E94E11FC487A8669C78EBCF0A1DC"><enum>329.</enum><header>Government Accountability Office study on profit- and revenue-sharing in health care</header><subsection id="H03A1803BD0D641848803A3DCCC7BAD01"><enum>(a)</enum><header>Study</header><text>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—</text><paragraph id="H7A7DFD81B30543B88D0914CB341F7463"><enum>(1)</enum><text>describe what is known about profit- and revenue-sharing relationships in the commercial health care markets, including those relationships that—</text><subparagraph id="HDD6A584848B946D0902D9B19420FF260"><enum>(A)</enum><text>involve one or more—</text><clause id="HE959900C219A4E3F88686FBD251C41FF"><enum>(i)</enum><text>physician groups that practice within a hospital included in the profit- or revenue-sharing relationship, or refer patients to such hospital;</text></clause><clause id="HFB367E3253654965902C8EA341D52BC3"><enum>(ii)</enum><text>laboratory, radiology, or pharmacy services that are delivered to privately insured patients of such hospital;</text></clause><clause id="H2A39AF6468924002A698FCCEBC493E3A"><enum>(iii)</enum><text>surgical services;</text></clause><clause id="HF90FE72B364B49F89247794137B8067A"><enum>(iv)</enum><text>hospitals or group purchasing organizations; or</text></clause><clause id="H2E9F6516CA494685B8CFF9A9718A397B"><enum>(v)</enum><text>rehabilitation or physical therapy facilities or services; and</text></clause></subparagraph><subparagraph id="HF222EA94976541FDBA2DCFA6AFFB7CAF"><enum>(B)</enum><text>include revenue- or profit-sharing whether through a joint venture, management or professional services agreement, or other form of gain-sharing contract;</text></subparagraph></paragraph><paragraph id="H334EAD735C684B778F41ADA68002DD0F"><enum>(2)</enum><text>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</text></paragraph><paragraph id="H2BFAA69D999D40DB98764817C063C03C"><enum>(3)</enum><text>as appropriate, make recommendations to improve Federal oversight of such relationships.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HEBA54532CC934B8F9717CAFEE1A8C821"><enum>(b)</enum><header>Report</header><text>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.</text></subsection></section></subtitle><subtitle id="H5DD3894ED54240918F02F0EC9EE85A82"><enum>C</enum><header>Prescription Drug Competition and Innovation</header><section id="HBA955F70CF4D46D5A04B3D9356DE0A3B" section-type="subsequent-section"><enum>341.</enum><header>Expedited development and priority review for generic complex drug products</header><text display-inline="no-display-inline">Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et seq.</external-xref>) is amended by adding at the end the following: </text><quoted-block style="OLC" id="HB118BA48A3D74CBEB946D236239A9D5F" display-inline="no-display-inline"><section id="H31C1C31FF82247B1A0AAC83E577D4363"><enum>524C.</enum><header>Expedited development and priority review for generic complex drug products</header><subsection id="HAFD51BBEE45041239B4728ECDF3FE4E5"><enum>(a)</enum><header>Establishment of program</header><text display-inline="yes-display-inline">The Secretary shall establish a program to expedite the development of, and provide priority review under section 505(j) for, generic complex drug products.<italic></italic></text></subsection><subsection id="H0E94A14B5D174DAA901B721A175E2A55"><enum>(b)</enum><header>Request for designation</header><text display-inline="yes-display-inline">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. </text></subsection><subsection id="HA42868A0778B4819890615B4085B8496"><enum>(c)</enum><header>Designation process</header><paragraph id="HC45926A8A48D45ED9ED0517BBC425704"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="HF2EF266C0C9D4831BFC31B5F5E92FEAD"><enum>(2)</enum><header>Review</header><text>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.</text></paragraph><paragraph id="H311B8A0442F246A1B9484927F9EDD069"><enum>(3)</enum><header>Withdrawal</header><text display-inline="yes-display-inline">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.<italic></italic></text></paragraph></subsection><subsection id="H586F562661A64AE88614A185F70F6DB6"><enum>(d)</enum><header>Expedited development and priority review guidance</header><paragraph id="H24B65BE9A8444A91B1D284AD36D08498"><enum>(1)</enum><header>Content</header><text display-inline="yes-display-inline"><italic></italic>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—</text><subparagraph id="HB949D324953A4A91B654D5A09CB75F2C"><enum>(A)</enum><text>set forth the process by which a person may seek a designation under subsection (c); </text></subparagraph><subparagraph id="HFCB63A5159294C1DB01EE75E20066B23"><enum>(B)</enum><text>provide a template for requests under subsection (b); </text></subparagraph><subparagraph id="H4628E718CC9B42A993C63026C15F3D00"><enum>(C)</enum><text>identify the criteria the Secretary will use in evaluating a request for designation under this section; and </text></subparagraph><subparagraph id="H209428318E51468CA5C1DE0E8AEFAB03"><enum>(D)</enum><text>identify the criteria and processes the Secretary will use to expedite the development and review of products designated under this section.</text></subparagraph></paragraph><paragraph id="HBC2BE8DD0369475281EC8A8224D24921"><enum>(2)</enum><header>Process</header><text>Prior to finalizing the guidance under paragraph (1), the Secretary shall seek public comment on a draft version of that guidance.</text></paragraph></subsection><subsection id="HFFED5A421B7049B396017B32C048C2DF"><enum>(e)</enum><header>Generic complex drug product defined</header><text>In this section, the term <term>generic complex drug product</term> 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—</text><paragraph id="H9B084640AECD4B64B7C24B470B36E51E"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H602AC4730ECA4FA488F9C1A6F52626FC"><enum>(A)</enum><text>contains complex active ingredients (such as peptides, polymeric compounds, complex mixtures of active ingredients, and naturally sourced ingredients);</text></subparagraph><subparagraph id="H1D3108BE2EED4E29AE512542DE99A12D" indent="up1"><enum>(B)</enum><text>is composed of complex formulations (such as liposomes or colloids);</text></subparagraph><subparagraph id="HB693EFA78EA0418BB90ADB3139D0ECB0" indent="up1"><enum>(C)</enum><text>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</text></subparagraph><subparagraph id="H99830A7DC9FE4689BA5F7BEF8C246DFF" indent="up1"><enum>(D)</enum><text>involves a complex dosage form (such as transdermals, metered dose inhalers, or extended release injectables);</text></subparagraph></paragraph><paragraph id="H20405D0F01C04F2AB5021C19A5C68A6C"><enum>(2)</enum><text display-inline="yes-display-inline">presents as a complex drug-device combination product (such as auto injectors or metered dose inhalers); or</text></paragraph><paragraph id="H649B9DF94322400A8EA708CB9E49BD81"><enum>(3)</enum><text display-inline="yes-display-inline">is a product that would benefit from early scientific engagement due to complexity or uncertainty concerning the approval pathway under section 505(j). </text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="HB676C63F56D24D729E44860652F1F107"><enum>342.</enum><header>Preventing blocking of generic drugs</header><subsection id="HE1C80C3DD1354998B6D0DE1D9AA33B83"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(j)(5)(B)(iv)</external-xref>) is amended—</text><paragraph id="H2D3CB961CEE94B2E8C1E2A70636648EF"><enum>(1)</enum><text>in subclause (I), by striking <quote>180 days after the date</quote> and all that follows through <quote>by any first applicant</quote> and inserting <quote>180 days after the earlier of the dates described in items (aa) and (bb) of subclause (II)</quote>;</text></paragraph><paragraph id="H18E8C2B8DAEE46759E1AE7C0331F8865"><enum>(2)</enum><text>by redesignating subclause (II) as subclause (III); and</text></paragraph><paragraph id="HAA7B185E6F2F41D681BE69EE4483AC6F"><enum>(3)</enum><text>by inserting after subclause (I) the following:</text><quoted-block style="OLC" id="HA38D9EE78C2B4B3B90A5FBF74F8E764D" display-inline="no-display-inline"><subclause id="HF110D76B6AAF43F08E863DFF47F4E492"><enum>(II)</enum><header>Dates described</header><item id="H7FF14C22FB63450C951D460BE92DFD03"><enum>(aa)</enum><header>First date</header><text display-inline="yes-display-inline">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.</text></item><item id="H6492109A690F47C7A78D8278AEB28419"><enum>(bb)</enum><header>Second date</header><text>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:</text><subitem id="H4DC3950692F146B1BD26883EA356086F"><enum>(AA)</enum><text>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.</text></subitem><subitem id="HE20E0DBE20684CDA96B573BA437B91CF"><enum>(BB)</enum><text>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.</text></subitem><subitem id="HE1438B93A295462F80BDBC2CF54D3FC2"><enum>(CC)</enum><text>Approval of an application for the drug submitted by at least one first applicant would not be precluded under clause (iii).</text></subitem></item></subclause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H72892F31658B496D8D87371E18EC8A56"><enum>(b)</enum><header>Information</header><text>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 <quote>Secretary</quote>) 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.</text></subsection></section><section id="HD2C72468895344DA938DC3ED7E259BA0"><enum>343.</enum><header>Ensuring timely access to generics</header><text display-inline="no-display-inline">Section 505(q) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(q)</external-xref>) is amended—</text><paragraph id="HD390BECF88764F7998E23CD2DF320BE6"><enum>(1)</enum><text>in paragraph (1)—</text><subparagraph id="HC62FE98C948A44179A00F72E34D9D4D1"><enum>(A)</enum><text>in subparagraph (A)(i), by inserting <quote>, 10.31,</quote> after <quote>10.30</quote>;</text></subparagraph><subparagraph id="HC9EF9FDA8CF9496B8C8D9FC3A246E24B"><enum>(B)</enum><text>in subparagraph (E)—</text><clause id="H206AA72DFBA34B0D98FE4117718465A4"><enum>(i)</enum><text>by striking <quote>application and</quote> and inserting <quote>application or</quote>;</text></clause><clause id="HA52C04C64AAE4AA4B15F52E6E61A3019"><enum>(ii)</enum><text>by striking <quote>If the Secretary</quote> and inserting the following:</text><quoted-block display-inline="no-display-inline" id="HAB91F40EB42649C3AAB965093E46F7E3" style="OLC"><clause id="HD924B526FBA048BD940976A340BBA77E"><enum>(i)</enum><header>In general</header><text>If the Secretary</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause><clause id="H377EF60953184E43B2FBF42F897885CA"><enum>(iii)</enum><text>by striking the second sentence and inserting the following:</text><quoted-block display-inline="no-display-inline" id="H7F452C2CB77648CCB3DE8F40DC07CF3C" style="OLC"><clause id="HD4B3DA57895C4002838971D8EE151464"><enum>(ii)</enum><header>Primary purpose of delaying</header><subclause id="H630375D58461449E8D43D3FE93EC0FE4"><enum>(I)</enum><header>In general</header><text>In determining whether a petition was submitted with the primary purpose of delaying an application, the Secretary may consider the following factors:</text><item id="HF32C89BA0B184F9D95A7F9C3EFB36D2A"><enum>(aa)</enum><text>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.</text></item><item id="HCCEBE0945E2B4FB68D35461567C120B5"><enum>(bb)</enum><text>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.</text></item><item id="H5CB2D3E20D484FA3ABB489602F29E1F5"><enum>(cc)</enum><text>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.</text></item><item id="H73CA7F5B0591433EAEAF306E852F4B1D"><enum>(dd)</enum><text>Whether the petition was submitted without relevant data or information in support of the scientific positions forming the basis of such petition.</text></item><item id="H11C44D749EB347DB941F60222FC8ABD1"><enum>(ee)</enum><text>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.</text></item><item id="H0E12EE7597CC47DBA9336DACB12CBB82"><enum>(ff)</enum><text>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.</text></item><item id="H1D7FDF92D92449EEAEF022781DAFAEBF"><enum>(gg)</enum><text>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.</text></item><item id="H462BE00F8E504B07A667145E6FDE4EAD"><enum>(hh)</enum><text>Other relevant and appropriate factors, which the Secretary shall describe in guidance.</text></item></subclause><subclause id="HCFC0E8DA798F453CAC1A172545F9074B"><enum>(II)</enum><header>Guidance</header><text>The Secretary may issue or update guidance, as appropriate, to describe factors the Secretary considers in accordance with subclause (I).</text></subclause></clause><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause id="H5A4761E39C704B7EBD2778C9E6C3275C"><enum>(iv)</enum><text>by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="H58F41CB9050C42F290D0B005D7B4706B" style="OLC"><clause id="H6F35D77B50F246E789BD22094D6379E0"><enum>(iii)</enum><header>Referral to the Federal Trade Commission</header><text>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.</text></clause><after-quoted-block>; </after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="HBDDBABEB88944173BC1CB0E5804D166C"><enum>(C)</enum><text>by striking subparagraph (F);</text></subparagraph><subparagraph commented="no" id="H3FFDB6968C374F27A8FBEACA5FCBB0C2"><enum>(D)</enum><text>by redesignating subparagraphs (G) through (I) as subparagraphs (F) through (H), respectively; and</text></subparagraph><subparagraph id="H221334DF3AF94F50ADEE571F44FF5387"><enum>(E)</enum><text>in subparagraph (H), as so redesignated, by striking <quote>submission of this petition</quote> and inserting <quote>submission of this document</quote>;</text></subparagraph></paragraph><paragraph id="H7A839E4573F447849B6BD0117AB8FC19"><enum>(2)</enum><text>in paragraph (2)—</text><subparagraph id="HF12FEEF2A1144EF8812EC84FE86E6135"><enum>(A)</enum><text>by redesignating subparagraphs (A) through (C) as subparagraphs (C) through (E), respectively;</text></subparagraph><subparagraph id="HA84D3946EA51442D9D0463CEC972A7EC"><enum>(B)</enum><text>by inserting before subparagraph (C), as so redesignated, the following:</text><quoted-block display-inline="no-display-inline" id="H0E59D4A66A934CB0B0B5DD68BD65DE42" style="OLC"><subparagraph id="H20C7D083BD564312B90D64B63AB04772"><enum>(A)</enum><header>In general</header><text>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.</text></subparagraph><subparagraph id="H1694635D797D44EA9C1FB119E27CD8D8"><enum>(B)</enum><header>Timely submission of citizen petition</header><text>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.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="HE90396018F0A4654821627C6B336F7B1"><enum>(C)</enum><text>in subparagraph (C), as so redesignated—</text><clause id="H93E24FA6049A420795AF031318A8BC53"><enum>(i)</enum><text>in the heading, by striking <quote><header-in-text level="subparagraph" style="OLC">within 150 days</header-in-text></quote>;</text></clause><clause id="H06708566C7884A41B529627D05CB5216"><enum>(ii)</enum><text>in clause (i), by striking <quote>during the 150-day period referred to in paragraph (1)(F),</quote>; and</text></clause><clause id="H9737BBDE62FE44B3B731232EBE5FAEB9"><enum>(iii)</enum><text>by amending clause (ii) to read as follows:</text><quoted-block display-inline="no-display-inline" id="H2E13DE0100DE4760ACFC9EFB18B864DB" style="OLC"><clause id="H45130108484C42F6B8FC30D9373A30EA"><enum>(ii)</enum><text>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.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="HD69F9FC577224573A636DADEF8D77D7D"><enum>(D)</enum><text>by amending subparagraph (D), as so redesignated, to read as follows:</text><quoted-block display-inline="no-display-inline" id="HA53DE7DFD7704442A4E1B7AAD9B40461" style="OLC"><subparagraph id="H0FC19EAD448E4C6098A26224C3CD994C"><enum>(D)</enum><header>Dismissal of certain civil actions</header><clause id="H6F5BDD28205D41D094EB48B69D1F8E7F"><enum>(i)</enum><header>Petition</header><text>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.</text></clause><clause id="H987C9DB8D1054E348E0367BEE7509BB6"><enum>(ii)</enum><header>Timeliness</header><text>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.</text></clause><clause id="HBED12A9F1ACA463C907DEA38132CFBD5"><enum>(iii)</enum><header>Final response</header><text>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.</text></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="HB1028950EF7941BBA9BAC56CAAFE26AD"><enum>(E)</enum><text>in clause (iii) of subparagraph (E), as so redesignated, by striking <quote>as defined under subparagraph (2)(A)</quote> and inserting <quote>within the meaning of subparagraph (C)</quote>; and</text></subparagraph></paragraph><paragraph id="HD83C06E6A7264BD2B98215FD749A216D"><enum>(3)</enum><text>in paragraph (4)—</text><subparagraph id="H7A67237B07974A2AA26CCE787C2B04B7"><enum>(A)</enum><text>by striking <quote><header-in-text level="paragraph" style="OLC">Exceptions</header-in-text></quote> and all that follows through <quote>This subsection does</quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Exceptions.—</header-in-text>This subsection does</quote>;</text></subparagraph><subparagraph id="HB24C0A83BD6A411C8A0B3418F7CD706E"><enum>(B)</enum><text>by striking subparagraph (B); and</text></subparagraph><subparagraph id="HE7605CC220044ACBBA0F58EAEC909B68"><enum>(C)</enum><text>by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and adjusting the margins accordingly.</text></subparagraph></paragraph></section><section id="H3BAE7AE39E934176AB8DD84ED75B9B7A"><enum>344.</enum><header>Preemption of State barriers to the substitution of biosimilar products</header><text display-inline="no-display-inline">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.</text></section><section id="H0A657B3FABCF47B7B4CB2BD03CE8D8E1"><enum>345.</enum><header>Increasing pharmaceutical options to treat an unmet medical need</header><text display-inline="no-display-inline">Subsection (b) of section 506 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356">21 U.S.C. 356</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" id="H8A0E7137B6414538BC4A9F7C4B2DC428" display-inline="no-display-inline"><paragraph id="HE695EA751BF245B389D519123288354A"><enum>(4)</enum><header>Unmet medical need</header><text display-inline="yes-display-inline">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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H76FE97B4EC37408BAB5F43C6CE8D9A7A"><enum>346.</enum><header>Conditional approval of new human drugs for individuals with rare, progressive, and serious diseases</header><subsection id="H48FDE123D4AB4058A0B37403304E6547"><enum>(a)</enum><header>In general</header><text>Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et seq.</external-xref>), as amended by section 341, is further amended by adding at the end of the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HFD21C90B70AB4142B3042BE37B2C29AB"><section id="HA801EDB5CED745F29526AF0CB05849AA"><enum>524D.</enum><header>Conditional approval of human drugs for individuals with rare, progressive, and serious diseases</header><subsection id="H84EF8EA61AF64075AFCD1D470A9BCE6E"><enum>(a)</enum><header>Conditional approval; priority review; other designations</header><paragraph id="H2AA2ECF1301D4CADB0F18C5F9BC35409"><enum>(1)</enum><header>In general</header><text>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). </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE798124C929443CBADD18CD13C75A911"><enum>(2)</enum><header>Priority review</header><text display-inline="yes-display-inline">The Secretary shall give priority review to an application for conditional approval of an eligible drug described in subsection (b).</text></paragraph><paragraph id="HEB96266E56534FE0BDBC6015328FB856"><enum>(3)</enum><header>Other designations</header><text>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.</text></paragraph><paragraph id="HE7F5438199C84460BEFA5CF9D4F52E89"><enum>(4)</enum><header>Other programs</header><text>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. </text></paragraph></subsection><subsection id="HC489F65320B142B29BFFBE09A32B1F3E"><enum>(b)</enum><header>Eligibility</header><paragraph commented="no" display-inline="no-display-inline" id="H9A16E305BF6048AE9ACE29090E04DCC0"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">A drug may be eligible for conditional approval under this section if such drug is intended to treat a disease or condition that is—</text><subparagraph id="HD96C50C971EC4D1FBE7B14843522F99E"><enum>(A)</enum><text>rapidly progressive, terminal, and has substantial unmet medical need, as determined by the Secretary; or</text></subparagraph><subparagraph id="HE8B04FE491C04FB68180B520200892E6"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><paragraph id="H24268C6B8AC642449867D6D36FF614DA" commented="no"><enum>(2)</enum><header>Exclusion from eligibility</header><text>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.</text></paragraph></subsection><subsection id="H21DB1F86C8EF4D86B19387A93C3E0105"><enum>(c)</enum><header>Standard of review for conditional approval</header><paragraph id="H91D3A31A967F4985A5A7ABB654FC4D98"><enum>(1)</enum><header>Requirements</header><text>The Secretary shall only approve an application for conditional approval of a drug under this section if—</text><subparagraph commented="no" display-inline="no-display-inline" id="H7003DFBFEC3E446EB288A01BF966048D"><enum>(A)</enum><text display-inline="yes-display-inline">the Secretary determines that—</text><clause id="H030C039FFC34484FBBEDE9E93A51EE6F"><enum>(i)</enum><subclause commented="no" display-inline="yes-display-inline" id="HACD088B8FA8E46A3ADA460974A9DD320"><enum>(I)</enum><text>evidence of safety for the drug has been established by—</text><item commented="no" display-inline="no-display-inline" id="H4BB6D9B198BA4A8CA7305C12CC5657A4" indent="up1"><enum>(aa)</enum><text display-inline="yes-display-inline">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</text></item><item commented="no" display-inline="no-display-inline" indent="up1" id="H277253FE790C4033BF7D2CF354F190BB"><enum>(bb)</enum><text display-inline="yes-display-inline">another demonstration of safety, as determined appropriate by the Secretary; and </text></item></subclause><subclause commented="no" display-inline="no-display-inline" id="HCE8C177B40EB4A72A72945753F1F1D04" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">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</text></subclause></clause><clause id="H5F79727C5267451B944CFB7FF40307E3"><enum>(ii)</enum><text>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—</text><subclause commented="no" display-inline="no-display-inline" id="HAB0D60EB3431423FB8D1092290866FD3"><enum>(I)</enum><text display-inline="yes-display-inline">evidence of safety for the drug has been established in accordance with clause (i)(I); and</text></subclause><subclause id="H089B6096E2214D128137C99C51C33785"><enum>(II)</enum><text>the drug shows preliminary evidence of clinical effectiveness based upon studies in animal models; and</text></subclause></clause></subparagraph><subparagraph id="HE50BDFC253B74C9B9B8123EB96FC8B2A"><enum>(B)</enum><text>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. </text></subparagraph></paragraph><paragraph id="H380383AE7B424ED3B6EF9C5F8C8A43C3"><enum>(2)</enum><header>Rolling, real-time review</header><subparagraph id="H1ABD7CE559AB4DEAB96233E3B2FAFCD4"><enum>(A)</enum><header>In general</header><text>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—</text><clause commented="no" display-inline="no-display-inline" id="H9F20D68ABBC545CC980EC5B25FAEDD9D"><enum>(i)</enum><text display-inline="yes-display-inline">a schedule for submission of information necessary to make the application complete; and </text></clause><clause commented="no" display-inline="no-display-inline" id="H38E0E1A8B36C46C7870A7369BDC130AE"><enum>(ii)</enum><text display-inline="yes-display-inline">a payment of any fee that may be required under section 736.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H156C826107374CC5835121C98BC7B432"><enum>(B)</enum><header>Review</header><text display-inline="yes-display-inline">The Secretary—</text><clause commented="no" display-inline="no-display-inline" id="H6A53246DADAC49F0A5BF84C3E4FC0C7C"><enum>(i)</enum><text display-inline="yes-display-inline">shall evaluate each application submitted under subparagraph (A) to assess whether such application is complete or ready to be filed; and </text></clause><clause commented="no" display-inline="no-display-inline" id="HB32B8E9B67DF49E2A005EE3C76A0FB1A"><enum>(ii)</enum><text display-inline="yes-display-inline">may commence review of portions of such application for approval. </text></clause></subparagraph></paragraph><paragraph id="H6111376355FD49AB941460B730B74FE8"><enum>(3)</enum><header>Use of real-world evidence</header><subparagraph commented="no" display-inline="no-display-inline" id="H23EA032A2EAF4FA6B93E93FFBDE352A2"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></subparagraph><subparagraph id="H9A4E798639B443A6B105154B4F2C6CF4" commented="no"><enum>(B)</enum><header>Data integrity requirements</header><text>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 <quote>Data Standards for Drug and Biological Product Submissions Containing Real-World Data</quote> and dated December 2023 (or successor guidance).</text></subparagraph></paragraph></subsection><subsection id="HA9DC750E02D1493FBA5952184DE09F55"><enum>(d)</enum><header>FDA authority To withdraw conditional approval</header><paragraph commented="no" display-inline="no-display-inline" id="H6DD2B642A85749B1B1D5B0D41648CB18"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary may withdraw the conditional approval of a drug under this section if—</text><subparagraph id="HE4CA20E3F35140FB8DBFA1BB3A603DBB"><enum>(A)</enum><text>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;</text></subparagraph><subparagraph id="H3EEC8C74DE2B4303BD5701B2ABB3FDAF"><enum>(B)</enum><text>the Secretary determines that the application for conditional approval submitted under subsection (a)(1) contained an untrue statement of material fact; or</text></subparagraph><subparagraph id="HAAF0A4D1DBE640948D61C4308831256B"><enum>(C)</enum><text>the Secretary determines that the drug is no longer eligible under subsection (b).</text></subparagraph></paragraph><paragraph id="H3A666E61ABDB40399DF323C04A4521F0"><enum>(2)</enum><header>FDA examination authority</header><subparagraph commented="no" display-inline="no-display-inline" id="H6FA8F88F5FAB40259036FF8DE830383D"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of determining whether to withdraw the conditional approval of a drug under paragraph (1), the Secretary may—</text><clause commented="no" display-inline="no-display-inline" id="H59D920D0016D40948EB8BFF20D335AD2"><enum>(i)</enum><text display-inline="yes-display-inline">review any available clinical data made available through clinical trials or an observational registry under subsection (g), applicable to such drug; and</text></clause><clause commented="no" display-inline="no-display-inline" id="HBD607DD450B84927B3CB006589EC5948"><enum>(ii)</enum><text>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.</text></clause></subparagraph><subparagraph id="H23933FAE79634D95AF2A85C57326B823"><enum>(B)</enum><header>Transparency</header><clause commented="no" display-inline="no-display-inline" id="H7ABA37E7E29C4984AC410FF5B154A60A"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></clause><clause commented="no" display-inline="no-display-inline" id="HF423E860554B40A9ADB81ECECEFE2E40"><enum>(ii)</enum><header>Fines</header><text display-inline="yes-display-inline">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.</text></clause></subparagraph></paragraph><paragraph id="H70037A811E384D01ABDE6BD0E685C13B"><enum>(3)</enum><header>Effect of withdrawal</header><subparagraph commented="no" display-inline="no-display-inline" id="H09F9966C9168469EB0381BBED48A6FB3"><enum>(A)</enum><header>Availability to new patients</header><clause commented="no" display-inline="no-display-inline" id="H5FFFE0AC6BB348389E27C615CC4FC76D"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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. </text></clause><clause commented="no" display-inline="no-display-inline" id="HB527FAC365A545BEBB37F4E8DE59FF27"><enum>(ii)</enum><header>Effect</header><text display-inline="yes-display-inline">Nothing in this subparagraph shall be construed to require—</text><subclause commented="no" display-inline="no-display-inline" id="H935460E036584BAEB31DBC9084FC3FD2"><enum>(I)</enum><text display-inline="yes-display-inline">a patient to continue taking a conditionally approved drug if such patient decides to stop taking such drug; or </text></subclause><subclause commented="no" display-inline="no-display-inline" id="HF044E8C9C05A4DF284AD882A55D0059A"><enum>(II)</enum><text display-inline="yes-display-inline">the sponsor to ensure such drug continues to be manufactured after the date of withdrawal.</text></subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDCC9FEC0996F49E68F49A050D861E59D"><enum>(B)</enum><header>Civil monetary penalty</header><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><paragraph id="HD7C754FB718948E2BA9599896D1C8B3B"><enum>(4)</enum><header>Withdrawal notice</header><text>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. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD13FD5EDBCA149218C27D65583F99034"><enum>(5)</enum><header>Appeals</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="HA528F75C135640E1BF3BE0EA0BDE3853"><enum>(6)</enum><header>Automatic withdrawal</header><subparagraph commented="no" display-inline="no-display-inline" id="HC812379042AC42D28C41599A6DDC5BF9"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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. </text></subparagraph><subparagraph id="H4CAC9412D4DE44E09E0288169A3126B0"><enum>(B)</enum><header>Marketing requirement</header><text>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.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H62904C9E12A34A378A84ED325236CB0C"><enum>(C)</enum><header>No right to appeal; effect of automatic withdrawal</header><clause commented="no" display-inline="no-display-inline" id="H627FD41CC7B447CDA11092D8006250C2"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A sponsor shall not have the right to appeal an automatic withdrawal under this paragraph.</text></clause><clause commented="no" display-inline="no-display-inline" id="H84E6620A6C80465F90D5F3F88DE07E26"><enum>(ii)</enum><header>Effect</header><text display-inline="yes-display-inline">The Secretary shall have no means or power to prevent an automatic withdrawal under this paragraph from occurring.</text></clause></subparagraph></paragraph></subsection><subsection id="HEAE925E9C39341D8BDA90DE109BC0CBB"><enum>(e)</enum><header>Labeling; review of materials</header><paragraph commented="no" display-inline="no-display-inline" id="H5B28AED938DF4676A9FB8F715955AF05"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Sponsors may not make available to patients a drug conditionally approved under this section, unless—</text><subparagraph id="HA8CA9AE9832147D7BE8FFF5D5C31F4ED"><enum>(A)</enum><text>all labeling and advertising of such drug contains the statement <quote>conditionally approved for a limited population</quote> in a prominent manner and adjacent to, and not more prominent than—</text><clause id="H47F849BB8D794F3585468DE928AE0A37"><enum>(i)</enum><text>the proprietary name of such drug, if any; or</text></clause><clause id="HBB6D6BE0D5604A2BBD5914E153F267EF"><enum>(ii)</enum><text>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</text></clause></subparagraph><subparagraph id="H9CBEB9CD2669481981EE963A547BEDFB"><enum>(B)</enum><text>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: <quote>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.</quote>. </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7B28C3900D7E4F269C1698DAFFE6B31C"><enum>(2)</enum><header>Submission</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="HFB666728EC934F85924D55B55377458D"><enum>(3)</enum><header>Public list</header><text>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. </text></paragraph></subsection><subsection id="H1DE8370254904AD78AB8EC6984D11193"><enum>(f)</enum><header>Renewal of conditional approval; requirement To bring drug to market</header><paragraph id="H39CD0AF7041346FCB17F0746B09BB5F0"><enum>(1)</enum><header>Duration; renewals</header><text>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.</text></paragraph><paragraph id="H67703E63AC904ABD9DA8D4A951A660AE"><enum>(2)</enum><header>Applications for renewal of conditional approval</header><subparagraph commented="no" display-inline="no-display-inline" id="HB6C7AAA71ABA42E39CA830F19F69206F"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEE2A68CAF3E148D98EBFE1DDCAEC8893"><enum>(B)</enum><header>Process for granting renewals</header><text display-inline="yes-display-inline">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. </text></subparagraph><subparagraph id="H735414C8086542C99A6EF457341C28AA"><enum>(C)</enum><header>Exemption for small population diseases</header><clause commented="no" display-inline="no-display-inline" id="H717AFC8FA0C6479BAA315C6268F25DB2"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">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)). </text></clause><clause commented="no" display-inline="no-display-inline" id="H54D0DAF59CF64385B3E6FFB892E69A38"><enum>(ii)</enum><header>Application for exemption</header><text display-inline="yes-display-inline">Sponsors may submit an application for exemption under this subparagraph not later than 180 days before the date on which the conditional approval expires. </text></clause><clause commented="no" display-inline="no-display-inline" id="HB8D16186A2D2498D884665D438F7BFAE"><enum>(iii)</enum><header>Application process</header><text display-inline="yes-display-inline">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. </text></clause><clause commented="no" display-inline="no-display-inline" id="H2AEC10272B4444028A97A2AFB3218D13"><enum>(iv)</enum><header>Deadline</header><text display-inline="yes-display-inline">The Secretary shall approve or deny an application under this subparagraph before the date on which the conditional approval expires. </text></clause><clause commented="no" display-inline="no-display-inline" id="H78B7AC50AD29443F9A0EBDF60ED5EBBF"><enum>(v)</enum><header>Appeals</header><text display-inline="yes-display-inline">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.</text></clause></subparagraph></paragraph><paragraph id="HA1C68495EA7143DEAA8572FC3DDE6CA7"><enum>(3)</enum><header>Additional preliminary evidence of effectiveness</header><text>The information described in this paragraph is the following: </text><subparagraph id="H728E0C82EB4A4F98AB9B96102923A13F" commented="no"><enum>(A)</enum><header>For the first approval renewal</header><text>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).</text></subparagraph><subparagraph id="HD78D2FEDC72645B299235E882D4C5B99" commented="no"><enum>(B)</enum><header>For the second approval renewal</header><text>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).</text></subparagraph><subparagraph id="H6BE186B67F3748E5B8A65A0AF3028D4D"><enum>(C)</enum><header>For the final approval renewal</header><text>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—</text><clause commented="no" display-inline="no-display-inline" id="H9C4A27481617491AB8E42323EF4A5E26"><enum>(i)</enum><text display-inline="yes-display-inline">for patients who have benefitted from such drug to retain access to such drug; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H41A5AB78B2474DD69224516E1E6A500E"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text></clause></subparagraph><subparagraph id="HD4ACD5D19F044098AE24525A5464E957"><enum>(D)</enum><header>Definition</header><text>In this paragraph, the term <term>preliminary evidence of effectiveness</term> means—</text><clause commented="no" display-inline="no-display-inline" id="H292561A7450540F5B1519D55354D7055"><enum>(i)</enum><text display-inline="yes-display-inline">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);</text></clause><clause commented="no" display-inline="no-display-inline" id="H2CDEF3ED9538467BA348C08349A029EF"><enum>(ii)</enum><text display-inline="yes-display-inline">real-world evidence (as defined in section 505F(b)); or</text></clause><clause commented="no" display-inline="no-display-inline" id="H9D06A9C39C0A49C782D87D16D1495759"><enum>(iii)</enum><text display-inline="yes-display-inline">evidence from an observational registry under subsection (g).</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0FBDE7E82E8C47E9995EF7C87D385432"><enum>(4)</enum><header>Denial of renewal on the basis of data fraud</header><text>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.</text></paragraph></subsection><subsection id="HE66F587F856449C8BCC6F60E882EFF01"><enum>(g)</enum><header>Observational registries</header><paragraph id="H4EABC7D6A08E4692A3FFBDD89D299F74"><enum>(1)</enum><header>Establishment</header><subparagraph commented="no" display-inline="no-display-inline" id="H67518248572847F4A77049B36087F52A"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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. </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H466CB63C69FC45A2A8CB1634278B48BA"><enum>(B)</enum><header>Registries</header><text display-inline="yes-display-inline">In establishing an observational registry for a drug under subparagraph (A), the sponsor may—</text><clause commented="no" display-inline="no-display-inline" id="H3EE0667162514320B37F66DFA4F8342E"><enum>(i)</enum><text display-inline="yes-display-inline">establish a new observational registry;</text></clause><clause commented="no" display-inline="no-display-inline" id="HDC95802EAAC546B6A12538CD74B89F61"><enum>(ii)</enum><text display-inline="yes-display-inline">use an existing observational registry that pertains to the disease or condition such drug is intended to treat;</text></clause><clause commented="no" display-inline="no-display-inline" id="H27DEA923593F4949B2D53BBBA5438F33"><enum>(iii)</enum><text display-inline="yes-display-inline">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 </text></clause><clause commented="no" display-inline="no-display-inline" id="H677C44CDB96E4DA4A77D52861A7CE567"><enum>(iv)</enum><text display-inline="yes-display-inline">combine 2 or more existing observational registries that pertain to the disease or condition such drug is intended to treat.</text></clause></subparagraph><subparagraph id="H5481247ECD564A358C71DAC584A0B0C1"><enum>(C)</enum><header>Approval of registry and right to appeal</header><text>Not later than 180 days after the date of enactment of this section, the Secretary shall establish—</text><clause commented="no" display-inline="no-display-inline" id="H54ABE70999154194A29FFF65D5A7EA5D"><enum>(i)</enum><text display-inline="yes-display-inline">a process to approve or deny the establishment of an observational registry under subparagraph (A); and</text></clause><clause commented="no" display-inline="no-display-inline" id="H11BFCBA791FA4E91AD490A9435213452"><enum>(ii)</enum><text display-inline="yes-display-inline">a process for sponsors that received such a denial to appeal the denial. </text></clause></subparagraph></paragraph><paragraph id="HE1B433A05D2E4F9496E78285A84A48E6"><enum>(2)</enum><header>Requirement for patients to enroll in observational registry</header><subparagraph commented="no" display-inline="no-display-inline" id="H155A9580F1FC476FA4D6FA3AFF1AF1D8"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text>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).</text></subparagraph><subparagraph id="HCB8C4C62B2E1479497678767A8D5EC38"><enum>(B)</enum><header>Informed consent</header><clause commented="no" display-inline="no-display-inline" id="H62BBEE2CE8DF47D0B96390CFB12BFEBF"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Prior to enrolling in an observational registry under subparagraph (A), a patient shall provide informed consent in accordance with clause (ii).</text></clause><clause id="H1B465F1C59BC4E64888CEA4A1F21911B" commented="no"><enum>(ii)</enum><header>Application of certain requirements</header><text>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. </text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE48CC3202CA74CCCA97A99DED54E8F1B"><enum>(3)</enum><header>Submission of patient data</header><subparagraph commented="no" display-inline="no-display-inline" id="H4CF9616387BF4EF0A6FB2A6F060FE35A"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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). </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H714D8E5C3834492EAB23D06B1DAA7907"><enum>(B)</enum><header>Submission standards</header><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><paragraph id="HA24EF289A1924E578A57FA0EF7E9BDD8"><enum>(4)</enum><header>Requirements for registries</header><text>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. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H645F27574E0C4290B8CA1B3BED4CCD92"><enum>(5)</enum><header>Risk and benefit data</header><subparagraph commented="no" display-inline="no-display-inline" id="HCF293CAA7A7449EBBF047AF400C57AC2"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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). </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1C330AD0F0304A8BB10AD45D47AC835A"><enum>(B)</enum><header>Online portal</header><text display-inline="yes-display-inline">The Secretary shall operate an online portal on an existing website of the Secretary for sponsors to submit data described in subparagraph (A).</text></subparagraph></paragraph><paragraph id="HAD9C183B5EF1444E9B15876630157E04"><enum>(6)</enum><header>Accessibility</header><subparagraph commented="no" display-inline="no-display-inline" id="H3DBB1BD90AAA4D53879EEBBE80F70C9F"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">An observational registry described in paragraph (1) shall—</text><clause id="HCA372727D1BD4386B510E9F4CC3199F3"><enum>(i)</enum><text>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</text></clause><clause id="HDDABB5B942D44878A0A3B96F77DA5F07"><enum>(ii)</enum><text>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. </text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0DDFD642B68B45EB9588FC12E51B175F"><enum>(B)</enum><header>Approved researchers and medical professionals</header><text display-inline="yes-display-inline">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). </text></subparagraph></paragraph><paragraph id="H0599C5E7FA7D48CA8ACE19D355B1C3FE"><enum>(7)</enum><header>Effect</header><text>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.</text></paragraph></subsection><subsection id="H10F526A575764C848B9F63F11600E41F"><enum>(h)</enum><header>Pursuit of a different indication</header><paragraph commented="no" display-inline="no-display-inline" id="HBF687F05DABC49A1A6E215B0AB2602A9"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H54E14FF9E9734558B6C17B9041D21E9E"><enum>(2)</enum><header>Process</header><text display-inline="yes-display-inline">Not later than 180 days after the date of enactment of this section, the Secretary shall establish a process for petitions under paragraph (1). </text></paragraph></subsection><subsection id="H3851947002E7438BAC345461CA2B0DE5"><enum>(i)</enum><header>Transition to other forms of approval</header><paragraph id="H1516691089A34EB38A9D15D4A1F7AF42"><enum>(1)</enum><header>In general</header><text>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).</text></paragraph><paragraph id="HA38DB838C18F45CEAE88D913FE14B5C1"><enum>(2)</enum><header>Consideration of certain evidence</header><text>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). </text></paragraph></subsection><subsection id="H12A3ABCFBEA5493E8790EA6917F2E216"><enum>(j)</enum><header>Informed consent</header><paragraph commented="no" display-inline="no-display-inline" id="H5841792EA9054E6EAACB630CAA784748"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Prior to being prescribed a drug conditionally approved under this section, a patient shall provide informed consent in accordance with paragraph (2).</text></paragraph><paragraph id="HC2BDDB7082094416A3F1DEA84FEAB7B0" commented="no"><enum>(2)</enum><header>Application of certain requirements</header><text>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.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCC72522E75714DF7A6B74967FAF42816"><enum>(3)</enum><header>Observational registries</header><text display-inline="yes-display-inline">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).</text></paragraph><paragraph id="H0DCC796237D147009AD42FD474064A92"><enum>(4)</enum><header>Common rule</header><text>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 <quote>Common Rule</quote>) (or successor regulations), if applicable.</text></paragraph></subsection><subsection id="H216DFBBC78A24335A52BAE2C00AEEA13"><enum>(k)</enum><header>Limitation on liability</header><text>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.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H39031BD90BE64E0FA86F4731DEBEA8A9"><enum>(l)</enum><header>Report to Congress</header><paragraph id="HD4FCE2910DC444039F5A00F85C0ECE2F"><enum>(1)</enum><header>In general</header><text>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—</text><subparagraph id="HB99B03DC781044988F911A2FD2CB9909"><enum>(A)</enum><text>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;</text></subparagraph><subparagraph id="H2FE8849F7722456689C02C0664EA33FC"><enum>(B)</enum><text>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;</text></subparagraph><subparagraph id="H272BB947BCF245BBA5104A8FC8F4B99C"><enum>(C)</enum><text>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</text></subparagraph><subparagraph id="HB73893C99D1646429DF686F6CB4B9069"><enum>(D)</enum><text>the number of all applications granted and denied conditional approval under this section.</text></subparagraph></paragraph><paragraph id="H833802EB73AB40088C50E0143C6CE4CD"><enum>(2)</enum><header>Sponsor participation</header><text>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. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA2F0365BD7514198AB17DB61858260C7"><enum>(3)</enum><header>Notice authority</header><text display-inline="yes-display-inline">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).</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H8F0727CFA4C843C48F89675122BF8718"><enum>(b)</enum><header>Conforming amendment</header><text>Section 505(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(a)</external-xref>) is amended by inserting <quote>, or there is in effect a conditional approval under section 524C with respect to such drug</quote> before the period.</text></subsection><subsection id="HCE26BC63C6F94C1D9AE36D9721C37BCF"><enum>(c)</enum><header>Reimbursement</header><paragraph id="H7AE0408E84744CA8AE8EF299BBD75DDB"><enum>(1)</enum><header>Private health insurers</header><text>Section 2719A of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-19a">42 U.S.C. 300gg–19a</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H115276E2DA854478BF09EC4CEA9BCCF8"><subsection id="H2A1345BB673E4815A6558C6CA47E6A45" commented="no"><enum>(f)</enum><header>Coverage of certain drugs</header><text display-inline="yes-display-inline">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.</text></subsection><after-quoted-block>. </after-quoted-block></quoted-block></paragraph><paragraph id="H9FEAF32C33514251A61D415EA097E702"><enum>(2)</enum><header>Federal health care programs</header><text>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).</text></paragraph><paragraph id="H80C761DF2E8A4D2496DF7C42C98C3545"><enum>(3)</enum><header>Conforming amendment</header><text>Section 1927(k)(2)(A)(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(k)(2)(A)(i)</external-xref>) is amended—</text><subparagraph id="HC4332BEFA2DA4689AE770CF49333D094"><enum>(A)</enum><text>by striking <quote>or which</quote> and inserting <quote>, which</quote>; and</text></subparagraph><subparagraph id="HA756F91F2D9045D3A5F66A0F3FDADBD9"><enum>(B)</enum><text>by inserting <quote>, or which is conditionally approved under section 524D of such Act</quote> before the semicolon. </text></subparagraph></paragraph></subsection></section><section id="H17F8D73CCFD74CD3A1F9C9D85C6C3E80"><enum>347.</enum><header>Consolidating exclusivity periods for drugs treating rare diseases and conditions</header><subsection id="H287F5AAF933D456EBDB99430DCE3DE3E"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 527(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360cc">21 U.S.C. 360cc(a)</external-xref>) is amended to read as follows:</text><quoted-block style="OLC" id="HE1052E195C3F45539847403132C4AE49" display-inline="no-display-inline"><subsection id="HA398268E980148FF868ABB716AF3FA22"><enum>(a)</enum><header>Exclusivity</header><paragraph id="H436DA127B9694DCC90667E0D26917692"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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).</text></paragraph><paragraph id="H97FEA75BB6914343A5AB7CD459FD72F8"><enum>(2)</enum><header>Exclusivity period described</header><text display-inline="yes-display-inline">The exclusivity period described in this paragraph, with respect to a drug designated under section 526 for a rare disease or condition, is—</text><subparagraph id="H70AAE695FFCA4517BFD28014D7F87511"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="HC93086197FE7464486F8600139DD5A7C"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><paragraph id="HC68F8EB4856E44E695043613523CD69F"><enum>(3)</enum><header>Limitation</header><text display-inline="yes-display-inline">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.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H15A6CE3047DD48E1AD564BE7E44DB40C"><enum>(b)</enum><header>Conforming amendments</header><paragraph id="H8EE00FBBF92E4D31AC6D53EFDB302989"><enum>(1)</enum><text>Section 505(j)(5)(B)(iv)(II)(dd)(AA) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360cc">21 U.S.C. 360cc</external-xref>) is amended by striking <quote>7-year period</quote> and inserting <quote>period</quote>.</text></paragraph><paragraph id="HEBDCECB533D646F388AB844CAC18FC79"><enum>(2)</enum><text>Section 505A(b)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360cc">21 U.S.C. 360cc</external-xref>) is amended by striking <quote>rather than seven years;</quote> and inserting <quote>, or three years and six months, rather than seven years or three years, respectively;</quote>.</text></paragraph><paragraph id="H547F8709F1794BEC8B49E0511A8E2303"><enum>(3)</enum><text display-inline="yes-display-inline">Section 505A(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360cc">21 U.S.C. 360cc</external-xref>) is amended by striking <quote>rather than seven years;</quote> and inserting <quote>, or three years and six months, rather than seven years or three years, respectively;</quote>.</text></paragraph><paragraph id="HAD20C71DEDC84DDDB3929FE2A8CD25D0"><enum>(4)</enum><text>Section 505E(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360cc">21 U.S.C. 360cc</external-xref>) is amended by striking <quote>7-year period</quote> and inserting <quote>exclusivity periods</quote>.</text></paragraph><paragraph id="H683EE2AC0EFB4F47937AA439544F3C2D"><enum>(5)</enum><text>Section 527(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360cc">21 U.S.C. 360cc</external-xref>) is amended by striking <quote>the 7-year period</quote> and inserting <quote>any exclusivity period</quote>.</text></paragraph><paragraph id="H7C901A2D22684A7A8C93AD6A4F9B9147"><enum>(6)</enum><text display-inline="yes-display-inline">Section 351(m)(2)(B) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) is amended by striking <quote>rather than 7 years</quote> and inserting <quote>or 3 years and 6 months, rather than 7 years or 3 years, respectively</quote>.</text></paragraph><paragraph id="HEB1ACBDDC15E44CAB3167002B830702C"><enum>(7)</enum><text>Section 351(m)(3)(B) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) is amended by striking <quote>rather than 7 years</quote> and inserting <quote>or 3 years and 6 months, rather than 7 years or 3 years, respectively</quote>.</text></paragraph></subsection></section><section id="H197A91662F024BEAB7B7696905A1796F"><enum>348.</enum><header>Exclusivity period for brand name biological products</header><subsection id="H7378A3ACD2AE4BD0A206624F7A1F97D1"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 351(k)(7)(A) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)(7)(A)</external-xref>) is amended by striking <quote>12 years</quote> and inserting <quote>5 years</quote>.</text></subsection><subsection id="H390C1D7C472B48E7A3FD7A0BD9632F00"><enum>(b)</enum><header>Conforming changes</header><text display-inline="yes-display-inline">Paragraphs (2)(A) and (3)(A) of section 351(m) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(m)</external-xref>) is amended by striking <quote>12 years</quote> each place it appears and inserting <quote>5 years</quote>.</text></subsection><subsection id="HDA4B241C1B15427EAFD8CD26D233FCDF"><enum>(c)</enum><header>Applicability</header><text display-inline="yes-display-inline">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 (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>)) is licensed under subsection (a) of such section on or after the date of enactment of this Act.</text></subsection></section><section id="HCDE53C55CA284A93A0D1EE47DA97BEBB"><enum>349.</enum><header>Regulation of manufacturer-sponsored co-pay contributions</header><text display-inline="no-display-inline">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.</text></section><section id="H8AAD09E9B1904DA6B65D3D32731F5C1B" display-inline="no-display-inline" section-type="subsequent-section"><enum>350.</enum><header>Antitrust exemption for private health insurance issuers to negotiate wholesale acquisition prices of prescription drugs purchased from drug manufacturers</header><subsection id="H0B58B0A0ACA146A8813DFE2D00A21DFE"><enum>(a)</enum><header>Exemption</header><text>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.</text></subsection><subsection id="H99649175A2FE4CF8ABF457A4E58DADCF"><enum>(b)</enum><header>Definitions</header><text>For purposes of this section:</text><paragraph id="H3B8A1AA14738409E8F4293EC655D91E1"><enum>(1)</enum><header>Antitrust laws</header><text>The term <term>antitrust laws</term> has the meaning given such term in subsection (a) of the 1st section of the Clayton Act (<external-xref legal-doc="usc" parsable-cite="usc/15/12">15 U.S.C. 12(a)</external-xref>), except that such term includes section 5 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45</external-xref>) to the extent such section 5 applies to unfair methods of competition.</text></paragraph><paragraph id="H00E0BE068BCC42018D17B506E7D17058"><enum>(2)</enum><header>Health insurance issuer</header><text>The term <term>health insurance issuer</term> 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 (<external-xref legal-doc="usc" parsable-cite="usc/29/1144">29 U.S.C. 1144(b)(2)</external-xref>)). Such term does not include a group health plan.</text></paragraph><paragraph id="H08080987AB3447DA8EA2570FD4732DFB"><enum>(3)</enum><header>Health maintenance organization</header><text>The term <term>health maintenance organization</term> means—</text><subparagraph id="H4707D30B2B6A4C18BD511D9964BC13EF"><enum>(A)</enum><text>a health maintenance organization (as defined in section 1301(a) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300e">42 U.S.C. 300e(a)</external-xref>);</text></subparagraph><subparagraph id="H59008C24F28442D38FB6617B12952D26"><enum>(B)</enum><text>an organization recognized under State law as a health maintenance organization; or</text></subparagraph><subparagraph id="H4EC212FEF62F494FB95D51618261B087"><enum>(C)</enum><text>a similar organization regulated under State law for solvency in the same manner and to the same extent as such a health maintenance organization.</text></subparagraph></paragraph><paragraph id="H5D82681DF04F4303A35C21832826C695"><enum>(4)</enum><header>Manufacturer</header><text>The term <term>manufacturer</term> means any person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug.</text></paragraph><paragraph id="H9E04F582F3E74E0D9E96FCD5095441A7"><enum>(5)</enum><header>Prescription drug</header><text>The term <term>prescription drug</term> 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 (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353(b)</external-xref>).</text></paragraph></subsection><subsection id="H82EE8BFBBD9E47DFA667C78A94EA9991"><enum>(c)</enum><header>Effective date</header><text>This section shall not apply with respect to any conduct that occurs before the date of enactment of this Act.</text></subsection></section><section id="H538B6A124AD1487E9BD85A4DE7AF9F20"><enum>351.</enum><header>Biological product innovation</header><text display-inline="no-display-inline">Section 351(j) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(j)</external-xref>) is amended—</text><paragraph id="H28ADBA69793B4B368E5780630B8C5504"><enum>(1)</enum><text>by striking <quote>except that a product</quote> and inserting “except that—</text><quoted-block display-inline="no-display-inline" id="H1F0E19E0917A45F1B854F3666FFC9EAD" style="OLC"><paragraph id="H5222769FE14146689100B523E2FFA039"><enum>(1)</enum><text>a product</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph id="HA8F2D7CA9B914E93A3DEE633FB50E2D9"><enum>(2)</enum><text>by striking <quote>Act.</quote> and inserting <quote>Act; and</quote>; and</text></paragraph><paragraph id="H32DA5729024E456D8017352CD3B14B10"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="HF04EEEDD44DD4905BB7519FE34CF2EF9" style="OLC"><paragraph id="HA1C619AA19E84791B6DD8722A957C94B"><enum>(2)</enum><text>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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="H027C6F09614E4047B9835DBCECB81C93" commented="no"><enum>352.</enum><header>Biosimilar biological products</header><subsection id="H1C14AAB4F22E4CFF8BBF16A7D738A54E" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>) is amended—</text><paragraph id="H9AA8DEA915C248C3AF752CFA4B425BF8" commented="no"><enum>(1)</enum><text>in the subsection heading, by striking <quote><header-in-text level="subsection" style="OLC">or Interchangeable</header-in-text></quote>;</text></paragraph><paragraph id="H1063E6F19ADC49F78E890D965A23E69C" commented="no"><enum>(2)</enum><text>in paragraph (2)—</text><subparagraph id="H3C645D3504884BC09FFD47F70A2E5E45" commented="no"><enum>(A)</enum><text>by striking subparagraph (B);</text></subparagraph><subparagraph id="HEA032849CCF44E26A7D90522E0077839" commented="no"><enum>(B)</enum><text>by redesignating clauses (ii) and (iii) of subparagraph (A) as subparagraphs (B) and (C), respectively, and adjusting the margins accordingly;</text></subparagraph><subparagraph id="HEA4CD3E98B6242FB8F5FA182B76B91DE" commented="no"><enum>(C)</enum><text>in subparagraph (A)— </text><clause id="HE6DC1F7CEF084BA8AAAB15863266116D" commented="no"><enum>(i)</enum><text>in clause (i), by redesignating subclauses (I) through (V) as clauses (i) through (v), respectively, and adjusting the margins accordingly;</text></clause><clause id="H890E16B9CE35407CA0CC8876C89C0B65" commented="no"><enum>(ii)</enum><text>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</text></clause><clause id="H93B7C957E7E740BEBF0F7626457FFA8A" commented="no"><enum>(iii)</enum><text>by striking <quote><header-in-text level="subparagraph" style="OLC"><enum-in-header>(A)</enum-in-header> IN GENERAL</header-in-text></quote> and all that follows through <quote>An application submitted under this subsection shall include information</quote> and inserting the following:</text><quoted-block style="OLC" id="H227F3119B00A48CF883E9B9893EC5667" display-inline="no-display-inline"><subparagraph id="H6E2AD19017264B2982B2664DB163AD5A" commented="no"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">An application submitted under this subsection shall include information</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="HC96D446803C245AC805C3D1D708A6165" commented="no"><enum>(D)</enum><text>in subparagraph (B), as so redesignated by subparagraph (B) of this paragraph, by striking <quote>clause (i)(I)</quote> and inserting <quote>subparagraph (A)(i)</quote>; and</text></subparagraph><subparagraph id="HB7AF4FBC551F471186B39C9FED176481" commented="no"><enum>(E)</enum><text>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;</text></subparagraph></paragraph><paragraph id="HDD8F4E12EEAC49D19D95BAE42D588AD4" commented="no"><enum>(3)</enum><text>by amending paragraph (4) to read as follows:</text><quoted-block style="OLC" id="HD051E246204548ACBB9374C0C5E558B2" display-inline="no-display-inline"><paragraph id="H036BF335F61544C59720335F9D2041D0" commented="no"><enum>(4)</enum><header>Interchangeability</header><subparagraph id="H9A3873A2832843AD9E4D99AF39782C09" commented="no"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">A biological product licensed under this subsection shall be deemed to be interchangeable with the reference product.</text></subparagraph><subparagraph id="H32E60CB9D5054EC59E2A261CC01D6E83" commented="no"><enum>(B)</enum><header>Congressional briefing prior to certain study requirements</header><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph id="HBD9C87FBA00E42EBA719B1CB92ACBF10" commented="no"><enum>(4)</enum><text>by striking paragraph (6);</text></paragraph><paragraph id="H9194E9D4B8A94ED4BCEE66D9752B782A" commented="no"><enum>(5)</enum><text>in paragraph (8)(D)—</text><subparagraph id="HA232129B95AE46F7B92FB534359712B3" commented="no"><enum>(A)</enum><text>in clause (i), by striking <quote>class; and</quote> and inserting <quote>class.</quote>;</text></subparagraph><subparagraph id="H85A42D2C57CE4214B6E07B70B180E35F" commented="no"><enum>(B)</enum><text>by striking clause (ii); and</text></subparagraph><subparagraph id="HC9F87C4B59C8431DA3FFB7322A7E38C2" commented="no"><enum>(C)</enum><text>by striking <quote>description of—</quote> and all that follows through <quote>criteria that the Secretary</quote> and inserting <quote>description of the criteria that the Secretary</quote>; and</text></subparagraph></paragraph><paragraph id="H18AC05763F1B494CBFCCE8574B8B4D89"><enum>(6)</enum><text>in paragraph (9)(A)(iv), by striking <quote>paragraph (6) or</quote>. </text></paragraph></subsection><subsection id="H15913447AF944F98AA2076C677B01860" commented="no"><enum>(b)</enum><header>Conforming amendments</header><paragraph id="H91272741855A4D57A17242E49B25E1BF" commented="no"><enum>(1)</enum><text>Section 351(i)(3) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(i)(3)</external-xref>) is amended by striking <quote>that is shown to meet the standards described in subsection (k)(4)</quote> and inserting <quote>licensed under subsection (k)</quote>.</text></paragraph><paragraph id="H7F06F9D3300B435A9F6A31FD3F275001" commented="no"><enum>(2)</enum><text>Section 352A of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/263-1">42 U.S.C. 263–1</external-xref>) is amended by striking <quote>and interchangeable biosimilar biological products</quote> each place it appears.</text></paragraph><paragraph id="H28B282A4C29B495CB1DB2352EE2FB4F4" commented="no"><enum>(3)</enum><text>Section 744G(14) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-51">21 U.S.C. 379j–51(14)</external-xref>) is amended by striking <quote>, 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</quote>.</text></paragraph><paragraph id="HE2E4B35354794E78B6B2287C87A181B1" commented="no"><enum>(4)</enum><text>Section 505B(l) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(l)</external-xref>) is amended to read as follows:</text><quoted-block style="OLC" id="H64B17D48CDBD4EA2AAF07AB1795245E8" display-inline="no-display-inline"><subsection id="H2144548151CD4D55A45D97DE05D363FC" commented="no"><enum>(l)</enum><header>Biosimilar biological products</header><text display-inline="yes-display-inline">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—</text><paragraph id="H61548B03645B40D8B79F9D19A073AF71" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">a condition of use that has not been previously approved for the reference product; or</text></paragraph><paragraph id="H4FD27965026449A18ED692CCB0F00EA2" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">a dosage form, strength, or route of administration that differs from that of the reference product.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HF8246D7CDB564817850BBBF76E68B53F" commented="no"><enum>(c)</enum><header>Application</header><text>The amendment made by subsection (a)(4) to section 351(k)(6) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)(6)</external-xref>) 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.</text></subsection></section><section id="H10781E5DEFB1446C9D507188BC39569F"><enum>353.</enum><header>Prompt approval of drugs related to safety information</header><text display-inline="no-display-inline">Section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) is amended by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="HB70C2F39D20F4DD7B70FD1AEFC783D49" style="OLC"><subsection id="H610928C201EC497AA30AF4A54F536901"><enum>(aa)</enum><header>Prompt Approval of Drugs When safety information Is Added to Labeling</header><paragraph id="HCFC0A3C707A24939B8854F3D2AEFEDF6"><enum>(1)</enum><header>General rule</header><text>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.</text></paragraph><paragraph id="H19F46183F2CA4D4382EF094F5F490023"><enum>(2)</enum><header>Labeling</header><text>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.</text></paragraph><paragraph id="H0F43ED854B1D40CEB3A3ABE61B3E12C3"><enum>(3)</enum><header>Availability and scope of exclusivity</header><text>This subsection does not affect—</text><subparagraph id="H2934BCFD44EC4A95982220C8EAB43A74"><enum>(A)</enum><text>the availability or scope of exclusivity or an extension of exclusivity described in subparagraph (A) or (B) of section 505A(o)(3);</text></subparagraph><subparagraph id="H1DE504C18D8846D2B044495548CFB6F4"><enum>(B)</enum><text>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—</text><clause id="H54129AEBA5444E85AB94D910C0D8F954"><enum>(i)</enum><text>clause (iii) or (iv) of subsection (j)(5)(F);</text></clause><clause id="HBDD681EAC1924A52978F945BE9BCFDE6"><enum>(ii)</enum><text>clause (iii) or (iv) of subsection (c)(3)(E); or</text></clause><clause id="H87E7F1B5F7EF4FC7843FF9CC1A02B857"><enum>(iii)</enum><text>section 527(a); or</text></clause></subparagraph><subparagraph id="H4BE0B5695CC44E26BF776DAB2D9BDD15"><enum>(C)</enum><text>except as expressly provided in paragraphs (1) and (2), the operation of this section or section 527.</text></subparagraph></paragraph></subsection><after-quoted-block>. </after-quoted-block></quoted-block></section><section id="HB681BE2789AA403F9C9F068BED2E10A7"><enum>354.</enum><header>Congressional review of the Food and Drug Administration rulemaking</header><subsection id="H090AFB4E0BC14E06A663F8C4B4EBD434"><enum>(a)</enum><header>Congressional review</header><text display-inline="yes-display-inline">Part I of title 5, United States Code, is amended by inserting after chapter 8 the following:</text><quoted-block display-inline="no-display-inline" id="H449762E3B31A4D5188FEC90E5C731031" style="USC"><chapter commented="no" id="HD1184F1DA6814BDB9972F07F0D6D9B31" level-type="subsequent"><enum>8a</enum><header display-inline="yes-display-inline">Congressional Review of Food and Drug Administration Rulemaking</header><toc container-level="chapter-container" quoted-block="no-quoted-block" lowest-level="section" idref="HD1184F1DA6814BDB9972F07F0D6D9B31" regeneration="yes-regeneration" lowest-bolded-level="division-lowest-bolded"><toc-entry level="section">Sec. </toc-entry><toc-entry level="section">810. Applicability. </toc-entry><toc-entry idref="HE42E203D405A43FBAE6C8F1FB4BF2588" level="section">811. Congressional review. </toc-entry><toc-entry idref="H94633F025DE8425D98DD1A603D63D399" level="section">812. Congressional approval procedure for major rules. </toc-entry><toc-entry idref="H06FF42FA263D4731A7F46E77192ED0C8" level="section">813. Congressional disapproval procedure for nonmajor rules. </toc-entry><toc-entry idref="H7079A4C69D5B4B57B4DA81F506DBAA3A" level="section">814. Definitions. </toc-entry><toc-entry idref="HA6D535175B97423E9C14744615F8B845" level="section">815. Judicial review. </toc-entry><toc-entry idref="H4408E7F0768241C4A60CC0EC9F4C3B00" level="section">816. Exemption for monetary policy. </toc-entry><toc-entry idref="H8FF5D93D5D38450BAB2ECB92BECD8858" level="section">817. Effective date of certain rules. </toc-entry><toc-entry idref="HF21339B44FFF47E9AA03AD04FE1C28D3" level="section">818. Regulatory cut-go requirement. </toc-entry><toc-entry idref="H9824382954BA4B98AF43442B9E45D691" level="section">819. Review of rules currently in effect.</toc-entry></toc><section id="H5CBAF9CBDB3F4DCB8E1E574874F47AC0"><enum>810.</enum><header>Applicability</header><text display-inline="no-display-inline">This chapter applies in lieu of chapter 8 with respect to the Food and Drug Administration.</text></section><section commented="no" display-inline="no-display-inline" id="HE42E203D405A43FBAE6C8F1FB4BF2588" section-type="subsequent-section"><enum>811.</enum><header display-inline="yes-display-inline">Congressional review</header><subsection commented="no" display-inline="no-display-inline" id="H3BAC0F050C844943BB9D7458AFC2DA5E"><enum>(a)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H01111500303E453A9B9F861E7EE694A7"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H35E7EBA662314B599886FA92471A7553"><enum>(A)</enum><text display-inline="yes-display-inline">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—</text><clause commented="no" display-inline="no-display-inline" id="H0641F13E21BD49709D2C7DE22C1347A3" indent="up2"><enum>(i)</enum><text display-inline="yes-display-inline">a copy of the rule;</text></clause><clause commented="no" display-inline="no-display-inline" id="HE3B694D00D444DAF8EE36F02AB77BBA8" indent="up2"><enum>(ii)</enum><text display-inline="yes-display-inline">a concise general statement relating to the rule;</text></clause><clause commented="no" display-inline="no-display-inline" id="H8B9C5D3AFAE64110BE4C42F620B3AEF9" indent="up2"><enum>(iii)</enum><text display-inline="yes-display-inline">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);</text></clause><clause id="HF4652A7E6E314E4395C537F27407A200" indent="up2"><enum>(iv)</enum><text>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</text></clause><clause id="H72FC0A5F1B4847D7A09E974D76FFDFF5" indent="up2"><enum>(v)</enum><text>the proposed effective date of the rule.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6753E2F36EEB425FB7B5CBBD60265C9F" indent="up2"><enum>(B)</enum><text display-inline="yes-display-inline">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—</text><clause commented="no" display-inline="no-display-inline" id="H4A7E76C16C984F9F89489042DB085E0A"><enum>(i)</enum><text display-inline="yes-display-inline">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;</text></clause><clause commented="no" display-inline="no-display-inline" id="H48CF02D9326B429C93578CD74AB742C8"><enum>(ii)</enum><text display-inline="yes-display-inline">the Food and Drug Administration’s actions pursuant to sections 603, 604, 605, 607, and 609 of this title;</text></clause><clause commented="no" display-inline="no-display-inline" id="H8EFB238C9FF7456A8F7EA03031B5AC53"><enum>(iii)</enum><text display-inline="yes-display-inline">the Food and Drug Administration’s actions pursuant to sections 202, 203, 204, and 205 of the Unfunded Mandates Reform Act of 1995; and</text></clause><clause commented="no" display-inline="no-display-inline" id="HA3CB600F850240299E9402D92AB21F85"><enum>(iv)</enum><text display-inline="yes-display-inline">any other relevant information or requirements under any other Act and any relevant Executive orders.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H69CCC3150CB54586B9F32FFB8AAA0BB8" indent="up2"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF28D3B410F60434CA45A48A305B9EB87" indent="up1"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HAB5AA8727D644236B07172E809E81722"><enum>(A)</enum><text display-inline="yes-display-inline">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.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H266ABF4EBA4E431387F8130121CD0570" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">The Food and Drug Administration shall cooperate with the Comptroller General by providing information relevant to the Comptroller General’s report under subparagraph (A).</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB892172CE4C64436B88B4C1F5EDB17DB" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3AC980577FF34E53B8C5B988DEFB5B6E" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">A nonmajor rule shall take effect as provided by section 813 after submission to Congress under paragraph (1).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8E8C80D65F1141D58B89701B91CB4771" indent="up1"><enum>(5)</enum><text display-inline="yes-display-inline">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.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HD6CA099B0B234820BB563B8B55F17A84"><enum>(b)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HBC7F15C37BB64FC0A7A27357B266D17D"><enum>(1)</enum><text display-inline="yes-display-inline">A major rule shall not take effect unless the Congress enacts a joint resolution of approval described under section 812.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF0A776B8B99F4EF9898FC77C46E3AE72" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H4FAFD487737F4C048D1F442DE9B6A2C0"><enum>(c)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H6C634368081E4D4AA472A22B1890C85C"><enum>(1)</enum><text display-inline="yes-display-inline">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.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H06B4B61FBE4F496F94FD7A256153BA85" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">Paragraph (1) applies to a determination made by the President by Executive order that the major rule should take effect because such rule is—</text><subparagraph commented="no" display-inline="no-display-inline" id="H90CF1624B3914E828E9C8E133FC7BD34"><enum>(A)</enum><text display-inline="yes-display-inline">necessary because of an imminent threat to health or safety or other emergency;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H19A7306C9EEA458EA1198CCD079C6613"><enum>(B)</enum><text display-inline="yes-display-inline">necessary for the enforcement of criminal laws;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H56FBC2D634664CAE9EFE82341AE3BC0B"><enum>(C)</enum><text display-inline="yes-display-inline">necessary for national security; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEAD8392B0F8542DFB52389A039879604"><enum>(D)</enum><text display-inline="yes-display-inline">issued pursuant to any statute implementing an international trade agreement.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC1F0FBD399CA47999398EC7CC615195A" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">An exercise by the President of the authority under this subsection shall have no effect on the procedures under section 812.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H229D11380DD14C82968067EC6A6650C3"><enum>(d)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H67D8EE69ACEA44BF8556D08DFF3F56BE"><enum>(1)</enum><text display-inline="yes-display-inline">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—</text><subparagraph commented="no" display-inline="no-display-inline" id="HEAFF8B19B81B47C18CED9C66BEFE85E5" indent="up1"><enum>(A)</enum><text display-inline="yes-display-inline">in the case of the Senate, 60 session days; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD704EF19059342959C458F15EF7422A9" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">in the case of the House of Representatives, 60 legislative days,</text></subparagraph></paragraph><continuation-text commented="no" continuation-text-level="subsection">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. </continuation-text><paragraph commented="no" display-inline="no-display-inline" id="HFE9DA8D4C80946958CEFACB32342D659" indent="up1"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H2FA41846CE7E4479B9B7EAB642BD2ED3"><enum>(A)</enum><text display-inline="yes-display-inline">In applying sections 812 and 813 for purposes of such additional review, a rule described under paragraph (1) shall be treated as though—</text><clause commented="no" display-inline="no-display-inline" id="H9986FCEF706449F8856052AE0ED4A2E8" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">such rule were published in the Federal Register on—</text><subclause commented="no" display-inline="no-display-inline" id="HDE498122B81D47968AF95980D5C113B4"><enum>(I)</enum><text display-inline="yes-display-inline">in the case of the Senate, the 15th session day; or</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HB6C78A52146F4B408ED851481451091C"><enum>(II)</enum><text display-inline="yes-display-inline">in the case of the House of Representatives, the 15th legislative day,</text></subclause><continuation-text commented="no" continuation-text-level="clause">after the succeeding session of Congress first convenes; and </continuation-text></clause><clause commented="no" display-inline="no-display-inline" id="H56456A9767B54B67954F1169792C5047" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">a report on such rule were submitted to Congress under subsection (a)(1) on such date.</text></clause></subparagraph><subparagraph id="H92AE599082C8400F891A963903DB7C12" indent="up1"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9743A61D9A3D4362B6B6E132D306A687" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">A rule described under paragraph (1) shall take effect as otherwise provided by law (including other subsections of this section).</text></paragraph></subsection></section><section id="H94633F025DE8425D98DD1A603D63D399"><enum>812.</enum><header>Congressional approval procedure for major rules</header><subsection id="HD77B5F256E9B4CE1978169F8361BBD68"><enum>(a)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HDB6F9964FAA64AB99E12F74456550159"><enum>(1)</enum><text>For purposes of this section, the term <term>joint resolution</term> means only a joint resolution addressing a report classifying a rule as major pursuant to section 811(a)(1)(A)(iii) that—</text><subparagraph id="H55A30C72855B493E94881502F5778249" indent="up1"><enum>(A)</enum><text>bears no preamble;</text></subparagraph><subparagraph id="H8014507D200546C28B37C5A416C8FE71" indent="up1"><enum>(B)</enum><text>bears the following title (with blanks filled as appropriate): <quote>Approving the rule submitted by ___ relating to ___.</quote>;</text></subparagraph><subparagraph id="HFCB9064587BB41AC9913A245F0D16B09" indent="up1"><enum>(C)</enum><text>includes after its resolving clause only the following (with blanks filled as appropriate): <quote>That Congress approves the rule submitted by ___ relating to ___.</quote>; and</text></subparagraph><subparagraph id="H119CE892C8EB43A7BDAD9CBB2F4FCFBF" indent="up1"><enum>(D)</enum><text>is introduced pursuant to paragraph (2).</text></subparagraph></paragraph><paragraph id="H5D87E5A4000446D38ACA01F11C699632" indent="up1"><enum>(2)</enum><text>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)—</text><subparagraph id="HFB17A715996E4363A5AD923F953BD91D"><enum>(A)</enum><text>in the case of the House of Representatives, within 3 legislative days; and</text></subparagraph><subparagraph id="HC6B1B03E829A4F94B893FA35B2A5A162"><enum>(B)</enum><text>in the case of the Senate, within 3 session days.</text></subparagraph></paragraph><paragraph id="HA2AF3EC8F9334693B0DA00C55D5AE972" indent="up1"><enum>(3)</enum><text>A joint resolution described in paragraph (1) shall not be subject to amendment at any stage of proceeding.</text></paragraph></subsection><subsection id="HA2F6B4109CF04D07A75125168FC4EAC4"><enum>(b)</enum><text>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.</text></subsection><subsection id="H1E1E92D7F9CD43F89902CC45F38BFD80"><enum>(c)</enum><text display-inline="yes-display-inline">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.</text></subsection><subsection id="H7A2BC69115E44678AC57A65DB94ED499"><enum>(d)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H7116C1B18E8B457385332F01AE437E99"><enum>(1)</enum><text>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.</text></paragraph><paragraph id="HAC556D2BC80A4C37B633BE97582DA6F6" indent="up1"><enum>(2)</enum><text>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.</text></paragraph><paragraph id="H82D00C275C66482595BA13EB1618EB9A" indent="up1"><enum>(3)</enum><text>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.</text></paragraph><paragraph id="H0387657B91F24FE7BA44B541644C56F4" indent="up1"><enum>(4)</enum><text>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.</text></paragraph></subsection><subsection id="H0AEF0B0FEFE04951A23A1D6FE564840B"><enum>(e)</enum><text display-inline="yes-display-inline">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.</text></subsection><subsection id="H7C424247DEE1494B83735E1F5A9E2885"><enum>(f)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H9B774852E42B4FBEB4CA697BBB57E1BB"><enum>(1)</enum><text>If, before passing a joint resolution described in subsection (a), one House receives from the other a joint resolution having the same text, then—</text><subparagraph id="H55F298579A4142EE978A7FFED03656D0" indent="up1"><enum>(A)</enum><text>the joint resolution of the other House shall not be referred to a committee; and</text></subparagraph><subparagraph id="H09F1530F19B64EA2836D38AEB414D7F6" indent="up1"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><paragraph id="H106CFF04FE6E4984962DB2B825CA6FCA" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">This subsection shall not apply to the House of Representatives if the joint resolution received from the Senate is a revenue measure.</text></paragraph></subsection><subsection commented="no" id="H38DC4C3836DD4358A44E37275CE1822C"><enum>(g)</enum><text>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.</text></subsection><subsection id="H6ED5D45603F44FDDA9BEA983A92BDE0C"><enum>(h)</enum><text>This section and section 813 are enacted by Congress—</text><paragraph id="H9A1841AE6ACB4FF4ACE634EF830E5063"><enum>(1)</enum><text>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</text></paragraph><paragraph id="H0E24F19DDB7740828A7EA656F1DBA232"><enum>(2)</enum><text>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.</text></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H06FF42FA263D4731A7F46E77192ED0C8" section-type="subsequent-section"><enum>813.</enum><header display-inline="yes-display-inline">Congressional disapproval procedure for nonmajor rules</header><subsection commented="no" display-inline="no-display-inline" id="H999203C58EE442288CB1B0BA7D3FDF89"><enum>(a)</enum><text display-inline="yes-display-inline">For purposes of this section, the term <term>joint resolution</term> 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: <quote>That Congress disapproves the nonmajor rule submitted by the ___ relating to ___, and such rule shall have no force or effect.</quote> (The blank spaces being appropriately filled in).</text></subsection><subsection id="H0123B959CEFF4526A6DE35CA2739D744"><enum>(b)</enum><text>A joint resolution described in subsection (a) shall be referred to the committees in each House of Congress with jurisdiction.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H5A0F057489364F58B289FF8CF87A4D69"><enum>(c)</enum><text display-inline="yes-display-inline">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.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H28671B50183646349CCE4837E1E76171"><enum>(d)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HDBC24680BBEA4F0BACAA568F1CE04EC8"><enum>(1)</enum><text display-inline="yes-display-inline">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.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8FBA08816E544AF5B013B536F71E796F" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H94B84B351C1D4BB38EF976587EE4B9FC" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD0117C287EA645A9B7FF658A45518D56" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">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.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H55032D1D576140BE8307AB454A689F3C"><enum>(e)</enum><text display-inline="yes-display-inline">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—</text><paragraph commented="no" display-inline="no-display-inline" id="H3C8237052476428A909AB7B02BC41AF9"><enum>(1)</enum><text display-inline="yes-display-inline">after the expiration of the 60 session days beginning with the applicable submission or publication date; or</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H19B53AB8D1E64C3EB18E9CC607BC16B9"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H248B4FE114964E4EA6AF53A700404DC1"><enum>(f)</enum><text display-inline="yes-display-inline">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:</text><paragraph id="H4E153B075B2841B4936B4A3804603E3E"><enum>(1)</enum><text>The joint resolution of the other House shall not be referred to a committee.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H75B56CA914854CE7B7ABF8709CEF78D2"><enum>(2)</enum><text display-inline="yes-display-inline">With respect to a joint resolution described in subsection (a) of the House receiving the joint resolution—</text><subparagraph commented="no" display-inline="no-display-inline" id="H846C36D9413947E3B0E7E96EF88CDE89"><enum>(A)</enum><text display-inline="yes-display-inline">the procedure in that House shall be the same as if no joint resolution had been received from the other House; but</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H71A5F22B3CE04C99942E1EF05837070C"><enum>(B)</enum><text display-inline="yes-display-inline">the vote on final passage shall be on the joint resolution of the other House.</text></subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H7079A4C69D5B4B57B4DA81F506DBAA3A" section-type="subsequent-section"><enum>814.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">For purposes of this chapter:</text><paragraph commented="no" display-inline="no-display-inline" id="HFB359F9C7979458A86C9626B708E609D"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>major rule</term> 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—</text><subparagraph id="H656EBDACF81245F39B3A75C56C14CB4E"><enum>(A)</enum><text>an annual cost on the economy of $100,000,000 or more, adjusted annually for inflation;</text></subparagraph><subparagraph id="H0783A370B16A4354B21FAF020E54FB34"><enum>(B)</enum><text>a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or</text></subparagraph><subparagraph id="HDE0DA07538EA4869BD371F044B0A42E7"><enum>(C)</enum><text>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.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H16617B5A82AE442CA86919BC475FE3E3"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>nonmajor rule</term> means any rule of the Food and Drug Administration that is not a major rule.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3035587D819B4E0C8548E9CCF84341F7"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>rule</term> has the meaning given such term in section 551, except that such term does not include—</text><subparagraph commented="no" display-inline="no-display-inline" id="H25B8B9E1198045AEA193F18E622B9698"><enum>(A)</enum><text display-inline="yes-display-inline">any rule of particular applicability;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAABA681A6047490EB11EC05FD921E37F"><enum>(B)</enum><text display-inline="yes-display-inline">any rule relating to agency management or personnel; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H06BCB56B2A264EE6AE081219C349E04E"><enum>(C)</enum><text display-inline="yes-display-inline">any rule of agency organization, procedure, or practice that does not substantially affect the rights or obligations of non-agency parties.</text></subparagraph></paragraph><paragraph id="HA6A0E8EA40AE469FBF28CF54706E156B"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>submission date or publication date</term>, except as otherwise provided in this chapter, means—</text><subparagraph id="H13B030339EA5460B8857A53C41383B5D"><enum>(A)</enum><text>in the case of a major rule, the date on which the Congress receives the report submitted under section 811(a)(1); and</text></subparagraph><subparagraph id="HEBF5E837B69D49CDB58C085A44E04848"><enum>(B)</enum><text>in the case of a nonmajor rule, the later of—</text><clause id="H9A7C598FD1F4450780D5C8520650A988"><enum>(i)</enum><text display-inline="yes-display-inline">the date on which the Congress receives the report submitted under section 811(a)(1); and</text></clause><clause id="H760DB71A04CD472DA910C85AEBD867BC"><enum>(ii)</enum><text>the date on which the nonmajor rule is published in the Federal Register, if so published.</text></clause></subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" id="HA6D535175B97423E9C14744615F8B845" section-type="subsequent-section"><enum>815.</enum><header display-inline="yes-display-inline">Judicial review</header><subsection id="HD78D45F464F14A1B83CA4D75A1E4F8B0"><enum>(a)</enum><text display-inline="yes-display-inline">No determination, finding, action, or omission under this chapter shall be subject to judicial review.</text></subsection><subsection id="H6B82D3E8FD964F729BDBBF87BFC87617"><enum>(b)</enum><text display-inline="yes-display-inline">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.</text></subsection><subsection id="HF9693A4F7BDF43CB9D9B612A5D90238B"><enum>(c)</enum><text display-inline="yes-display-inline">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.</text></subsection></section><section commented="no" display-inline="no-display-inline" id="H4408E7F0768241C4A60CC0EC9F4C3B00" section-type="subsequent-section"><enum>816.</enum><header display-inline="yes-display-inline">Exemption for monetary policy</header><text display-inline="no-display-inline">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.</text></section><section commented="no" display-inline="no-display-inline" id="H8FF5D93D5D38450BAB2ECB92BECD8858" section-type="subsequent-section"><enum>817.</enum><header display-inline="yes-display-inline">Effective date of certain rules</header><text display-inline="no-display-inline">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.</text></section><section id="HF21339B44FFF47E9AA03AD04FE1C28D3"><enum>818.</enum><header>Regulatory cut-go requirement</header><text display-inline="no-display-inline">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.</text></section><section id="H9824382954BA4B98AF43442B9E45D691" display-inline="no-display-inline"><enum>819.</enum><header>Review of rules currently in effect</header><subsection id="HAA1E58BFC03C4CF785F4EE8EF1653EA1"><enum>(a)</enum><header>Annual review</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="HB0DAE3218CEA46C4976C71E5E94E5BEE"><enum>(b)</enum><header>Sunset for eligible rules not extended</header><text>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.</text></subsection><subsection id="H972109E47F4143518A7BBF111D401D23"><enum>(c)</enum><header>Consolidation; severability</header><text display-inline="yes-display-inline">In applying sections 811, 812, and 813 to eligible rules under this section, the following shall apply:</text><paragraph id="H2092789D54B541BF84533B08EBA6E4A5"><enum>(1)</enum><text>The words <quote>take effect</quote> shall be read as <quote>continue in effect</quote>.</text></paragraph><paragraph id="H3B066AF2F42D44A39FC1624C7B62B7E5"><enum>(2)</enum><text display-inline="yes-display-inline">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: <quote>That Congress approves the rules submitted by the __ for the year __.</quote> (The blank spaces being appropriately filled in).</text></paragraph><paragraph id="H135F01273061428BA4CEDC3AE5C1BAB7"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="H70A07EDA52AC498391B3539C430C9FB5"><enum>(4)</enum><text>A member of either House may move that a separate joint resolution be required for a specified rule.</text></paragraph></subsection><subsection id="H8F1A989B036E4A9E952C545228F72310"><enum>(d)</enum><header>Definition</header><text display-inline="yes-display-inline">In this section, the term <term>eligible rule</term> means a rule that is in effect as of the date of enactment of this section.</text></subsection></section></chapter><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H979369CC5002417E8D12E6CB3FD4AB4C"><enum>(b)</enum><header>Budgetary effects of rules subject to section 922 of title 5, United States Code</header><text>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:</text><quoted-block display-inline="no-display-inline" id="HE7DDD0CACABA46C49E41F7719BFF139E" style="OLC"><subparagraph id="HB338A55BA76A44A183BF101374A7C546"><enum>(E)</enum><header>Budgetary effects of rules subject to section 922 of title 5, United States Code</header><text display-inline="yes-display-inline">Any rules subject to the congressional approval procedure set forth in section 922 of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/8">chapter 8</external-xref> 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.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H0CBC019B7DB64C3B9694817FEE14BDF1"><enum>(c)</enum><header>Government Accountability Office study of rules</header><paragraph id="H876156313EBF483BB1E086F500231476"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Comptroller General of the United States shall conduct a study to determine, as of the date of the enactment of this Act—</text><subparagraph id="HDF3467C8E6C9431BA12486CF6887ADC9"><enum>(A)</enum><text>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;</text></subparagraph><subparagraph id="HC7E21A5844CF45B5A86E79D0C7C4FD04"><enum>(B)</enum><text display-inline="yes-display-inline">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</text></subparagraph><subparagraph id="H4DC3FAD556BC489A9C0E1760EAF475E0"><enum>(C)</enum><text>the total estimated economic cost imposed by all such rules.</text></subparagraph></paragraph><paragraph id="H73A08C069C1A4A119773AFB27C6B673C"><enum>(2)</enum><header>Report</header><text>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).</text></paragraph></subsection><subsection id="H012432DEDB9A4C58B0C0D5AB3B2999D0"><enum>(d)</enum><header>Effective date</header><text>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.</text></subsection></section><section id="H8BF1E2E15EE0470DBF42B2D91D4901B5"><enum>355.</enum><header>Government Accountability Office study of rules</header><subsection id="H3EAE345CC7F343DC85C16C288DA401B9"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Comptroller General of the United States shall conduct a study to determine, as of the date of the enactment of this Act—</text><paragraph id="HCBB1A032CF654DDF974247644DC7552C"><enum>(1)</enum><text>how many rules (as such term is defined in section 804 of title 5, United States Code) were in effect;</text></paragraph><paragraph id="HF5FE2B42B3BE4052A01794A316265153"><enum>(2)</enum><text display-inline="yes-display-inline">how many major rules (as such term is defined in section 804 of title 5, United States Code) were in effect; and</text></paragraph><paragraph id="HAFF2463ADC8F4AAE9E18031029686444"><enum>(3)</enum><text>the total estimated economic cost imposed by all such rules.</text></paragraph></subsection><subsection id="HE5CE2C6A53414447BDB7FD15304930FD"><enum>(b)</enum><header>Report</header><text>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).</text></subsection></section></subtitle><subtitle id="HB9F6721D67E14844B5FAE040FFC53C4C"><enum>D</enum><header>Prescription Drug and Pharmacy Benefit Manager Transparency</header><section id="H26838E130A1D4B8090140502DF58F698" display-inline="no-display-inline" section-type="subsequent-section"><enum>361.</enum><header>Patent disclosure requirements</header><subsection id="H237BF281441841CF9B24E3ABFD9BF5A2"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) is amended by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="HE0C02F2E53AD4802822BC6A4EF761F57" style="OLC"><subsection id="H5B1AAA050AAF4DE68DC8D10A674DA2DB"><enum>(o)</enum><header>Additional requirements with respect to patents</header><paragraph id="H0BFB75A9F509457B9D7726D0EAFF3193"><enum>(1)</enum><header>Approved application holder listing requirements</header><subparagraph id="HBF5F10F01C9E47BFA18941E6A740EC20"><enum>(A)</enum><header>In general</header><text>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)).</text></subparagraph><subparagraph id="H097B378DC7BD4C889C3029D61E5509F7"><enum>(B)</enum><header>Previously approved or licensed biological products</header><clause id="H8760CB5FE04645BC80B7132F0447F18B"><enum>(i)</enum><header>Products approved under section 351 of the PHSA</header><text>Not later than 30 days after the date of enactment of the <short-title>Fair Care Act of 2024</short-title>, 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)).</text></clause><clause id="HB2B95E71029940388CD6919A3E3276BB"><enum>(ii)</enum><header>Products approved under section 505 of the FFDCA</header><text>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)).</text></clause></subparagraph><subparagraph id="HC0EC5D25851C4010B83758DF5FC55EE1"><enum>(C)</enum><header>Updates</header><text>The holder of a biological product license approved under subsection (a) or (k) shall submit to the Secretary a list that includes—</text><clause id="H7A9BB3175EA6410EB7D3F88AE43AF43B"><enum>(i)</enum><text>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—</text><subclause id="HE03A1673208F498E891081F88C8CF434"><enum>(I)</enum><text>the date of issuance of such patent by the United States Patent and Trademark Office; or</text></subclause><subclause id="H727476B786B748C18E7558F0696BE3ED"><enum>(II)</enum><text>the date of approval of a supplemental application for the biological product; and</text></subclause></clause><clause id="H48BBC8BE391D4DDDAC1395F63B2D41FC"><enum>(ii)</enum><text>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.</text></clause></subparagraph></paragraph><paragraph id="HA597A8E9F04549D3A26B7F638ABF6146"><enum>(2)</enum><header>Publication of information</header><subparagraph id="HCE1E5A3BAA5449BC8085CE8DB9BE0C28"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Within 1 year of the date of enactment of the <short-title>Fair Care Act of 2024</short-title>, the Secretary shall publish and make available to the public a single, easily searchable, list that includes—</text><clause id="H11AFE4340DC14EDBA43F76953CC245D7"><enum>(i)</enum><text display-inline="yes-display-inline">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;</text></clause><clause id="H51AD06EF9DD04476A5AB9548CACF4033"><enum>(ii)</enum><text display-inline="yes-display-inline">with respect to each biological product described in clause (i), each patent submitted in accordance with paragraph (1);</text></clause><clause id="HB39F3F0371C241FB8095DA5273E02868"><enum>(iii)</enum><text display-inline="yes-display-inline">the date of licensure and application number for each such biological product;</text></clause><clause id="H71D75239E55C475B8577972E3E85BDFF"><enum>(iv)</enum><text>the marketing status, dosage form, route of administration, strength, and, if applicable, reference product, for each such biological product;</text></clause><clause id="H4CBC5ABBBFDF44DB94D58F24E3C72913"><enum>(v)</enum><text>the licensure status for each such biological product, including whether the license at the time of listing is approved, withdrawn, or revoked;</text></clause><clause commented="no" id="H2EFC4CB6B06142F59FAC7611BE1698E0"><enum>(vi)</enum><text>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;</text></clause><clause id="H1768CDF54FB64E64B2139EC74538A1D1"><enum>(vii)</enum><text>information regarding any determination related to biosimilarity or interchangeability for each such biological product; and</text></clause><clause id="H26DA1FB0A7704E709E76958E1D5F4097"><enum>(viii)</enum><text>information regarding approved indications for each such biological product, in such manner as the Secretary determines appropriate.</text></clause></subparagraph><subparagraph id="H97CA48F419A24E409A86F3E60AADF4BF"><enum>(B)</enum><header>Updates</header><text display-inline="yes-display-inline">Every 30 days after the publication of the first list under subparagraph (A), the Secretary shall revise the list to include—</text><clause id="HB70ABB23F3CE404E93492C3D39D505B3"><enum>(i)</enum><subclause commented="no" display-inline="yes-display-inline" id="H7BA3C4D1579F4DA1A583D6F7758F6F24"><enum>(I)</enum><text display-inline="yes-display-inline">each biological product licensed under subsection (a) or (k) during the 30-day period; and</text></subclause><subclause id="HBFF5D6F98DFE48A5B619614F26500929" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">with respect to each biological product described in subclause (I), the information described in clauses (i) through (viii) of subparagraph (A); and</text></subclause></clause><clause id="H616A1277BB454FD7B6603CB3EE1EA264"><enum>(ii)</enum><text>any updates to information previously published in accordance with subparagraph (A).</text></clause></subparagraph></paragraph><paragraph id="HC57653EAF35E46E586B57E39041D94DC"><enum>(3)</enum><header>Patents required to be disclosed</header><text>In this section, a <term>patent required to be disclosed</term> 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.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H24D28F650526415486C41E0934040D5B"><enum>(b)</enum><header>Disclosure of patents</header><text>Section 351(l)(3)(A)(i) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(l)(3)(A)(i)</external-xref>) is amended by inserting <quote>included in the list provided by the reference product sponsor under subsection (o)(1)</quote> after <quote>a list of patents</quote>.</text></subsection><subsection id="H403CF13E1A3A42C18CE1F6E17B808A61"><enum>(c)</enum><header>Restriction on claims of patent infringement</header><text>Section 271(e) of title 35, United States Code, is amended by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="H8848B71DCE6A49C3AE2EB6B622AFAAD7" style="OLC"><paragraph id="HF0D08699E66D494E81C7A2902F139692"><enum>(7)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(o)(1)</external-xref>), 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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HDFD0878DC7C743D99DC6D34CF8FB2C0F"><enum>(d)</enum><header>Regulations</header><text>The Secretary of Health and Human Services may promulgate regulations to carry out subsection (o) of section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>), as added by subsection (a).</text></subsection><subsection id="H4EB9F440A5C74923B969EB00223D4D1F"><enum>(e)</enum><header>Rule of construction</header><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>).</text></subsection></section><section id="HDD502B2F071A45C38D0E3EC4C0D89A7F"><enum>362.</enum><header>Requirements with respect to prescription drug benefits</header><subsection id="HDA78848FFBDC40728CD33BF8EF891329"><enum>(a)</enum><header>In general</header><text>Subpart II of part A of title XXVII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-11">42 U.S.C. 300gg–11 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block id="HC97B2239E8A9488887B489C9D3740866" style="OLC"><section id="H9E8679D5BD5C42188C07D70A06F75FCE"><enum>2729A.</enum><header>Requirements with respect to prescription drug benefits</header><text display-inline="no-display-inline">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—</text><paragraph id="H8567816334464AF693F44517D463FC54"><enum>(1)</enum><text>any such reduction in price is reflected at the point of sale to the enrollee; and</text></paragraph><paragraph id="H17F627EFBB674553AE0260B6032D68B1"><enum>(2)</enum><text>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.</text></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HB10EED3978CE441C928AA9124719E923"><enum>(b)</enum><header>Effective date</header><text>Section 2729A of the Public Health Service Act, as added by subsection (a), shall take effect on January 1, 2025.</text></subsection></section><section id="HC9391CCEAF924BBD823A300700068E6E" commented="no"><enum>363.</enum><header>PBM transparency and elimination of DIR fees</header><subsection id="H790D34C275DE46B2BE62D29C941356DC" commented="no"><enum>(a)</enum><header>Prohibiting medicare PDP sponsors and MA–PD organizations from retroactively reducing payment on clean claims submitted by pharmacies</header><paragraph id="H380A73F7A514400CBBC471CC89821005" commented="no"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1860D–12(b)(4)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)(4)(A)</external-xref>) is amended by adding at the end the following new clause:</text><quoted-block style="OLC" id="H8FA2F6A968B04BE0A0A43A814A9C8C6F" display-inline="no-display-inline"><clause id="HFFF11BCA612A4278B466411DA6D95EE9" commented="no"><enum>(iv)</enum><header>Prohibiting retroactive reductions in payments on clean claims</header><text display-inline="yes-display-inline">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.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H96F699306CB84E9D927C881B194FE2C9" commented="no"><enum>(2)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendment made by subsection (a) shall apply with respect to contracts entered into on or after January 1, 2025.</text></paragraph></subsection><subsection id="H8908CD2F2EBE4AD9A2F652E3D110BD3F" commented="no"><enum>(b)</enum><header>Elimination of DIR fees</header><paragraph id="H43E21A1217544D5C88D77B984B7DE1CD" commented="no"><enum>(1)</enum><header>Pharmacy benefits manager standards under the Medicare program for prescription drug plans and MA–PD plans</header><subparagraph id="H12D41339C7D2486E90D4F53EB5E3FB64" commented="no"><enum>(A)</enum><header>In general</header><text>Section 1860D–12(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block display-inline="no-display-inline" id="H8591A887199C4CB780E20BE1B80C4ABC" style="OLC"><paragraph id="H0807D7402D9C40C387F6BF22A371D67A" commented="no"><enum>(7)</enum><header>Pharmacy benefits manager transparency requirements</header><text>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 <quote>PBM</quote>) 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:</text><subparagraph id="H6E7363FD984046B4B6701B682E45DC89" commented="no"><enum>(A)</enum><text>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.</text></subparagraph><subparagraph id="H008858BBC46649059F153C5C5CB639F6" commented="no"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph><subparagraph id="HD560885903F849C7A3E90F383A549C1E" commented="no"><enum>(B)</enum><header>Regular update of prescription drug pricing standard</header><text>Paragraph (6) of section 1860D–12(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)</external-xref>) is amended to read as follows:</text><quoted-block display-inline="no-display-inline" id="H78933D1DC34049B08E05A023588E7C17" style="OLC"><paragraph id="HA545789BF8064717B7BFAF2510C62CE3" commented="no"><enum>(6)</enum><header>Regular update of prescription drug pricing standard</header><subparagraph id="HEA950F85A5C24FB4A6E880C5A0050E57" commented="no"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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—</text><clause id="H232D73D668AE471AB062572A23E98743" commented="no"><enum>(i)</enum><text>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;</text></clause><clause id="HCB0F4AABC8C3447C8B5399EE664C6F98" commented="no"><enum>(ii)</enum><text>disclose to applicable pharmacies and the contracting entities of such pharmacies the sources used for making any such update immediately without requirement of request;</text></clause><clause id="H15BB10ED9A6A4D6F879EFF45C06D9295" commented="no"><enum>(iii)</enum><text display-inline="yes-display-inline">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;</text></clause><clause id="HADB6D59482CA4DD9982BEACB5E6024B2" commented="no"><enum>(iv)</enum><text display-inline="yes-display-inline">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</text></clause><clause id="HF0AB7482D64449639BF4EC1FF0C8FB18" commented="no"><enum>(v)</enum><text display-inline="yes-display-inline">provide all such pricing data in an .xml spreadsheet format or a comparable easily accessible and complete spreadsheet format.</text></clause></subparagraph><subparagraph id="H7F4BFD6861A748B9852818296E106D84" commented="no"><enum>(B)</enum><header>Prescription drug pricing standard defined</header><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph><subparagraph id="HDA1FEE8FD2E941149DFCBAAB273D03EA" commented="no"><enum>(C)</enum><header>Effective date</header><text>The amendments made by this section shall apply to plan years beginning on or after January 1, 2025.</text></subparagraph></paragraph><paragraph id="H1E462B5037E6467AA14649868AA89BA7" commented="no"><enum>(2)</enum><header>Regular update of prescription drug pricing standard under TRICARE retail pharmacy program</header><text>Section 1074g(d) of title 10, United States Code, is amended by adding at the end the following new paragraph:</text><quoted-block display-inline="no-display-inline" id="H2EC29C1B82CA4AD69DD469996AD54182" style="USC"><paragraph id="H0113945F5BA74D72AA3FD238077A9174" indent="up1" commented="no"><enum>(3)</enum><text display-inline="yes-display-inline">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 (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)(6)</external-xref>) to ensure the provision of information regarding the pricing standard for prescription drugs.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H188E5AA6AC95482BB061F10246481549" commented="no"><enum>(3)</enum><header>Prescription drug transparency in the Federal Employees Health Benefits program</header><subparagraph id="H7C48F1D544DD4134A3E73D2A450FB04A" commented="no"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Section 8902 of title 5, United States Code, is amended by adding at the end the following new subsections:</text><quoted-block display-inline="no-display-inline" id="H41AC4BE89F5243A791D280266375DE8E" style="USC"><subsection id="H67513E1A9EAC49DD9B0A93E253E3819D" commented="no"><enum>(p)</enum><text display-inline="yes-display-inline">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 <quote>PBM</quote>) 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:</text><paragraph id="HD4AAD4B2838E462B972BAFBC2A80E832" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="HAC34A6C19A6F4729A30874F4AC0C37E8" commented="no"><enum>(2)</enum><text>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.</text></paragraph></subsection><subsection id="H9932610C38554DFEBA0A6350F10E462E" commented="no"><enum>(q)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H9C76ADF025974882B300C35292B51EB0"><enum>(1)</enum><text>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—</text><subparagraph id="HC28EE33C1C6446FA906EB01CC190A91F" indent="up1" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text></subparagraph><subparagraph id="HF16E87F0D5764C5298B024110200ED14" indent="up1" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">disclose to applicable pharmacies and the contracting entities of such pharmacies the sources used for making any such update immediately without requirement of request;</text></subparagraph><subparagraph id="H0BB5413F1B6644E5BF59AC0D96C4B651" indent="up1" commented="no"><enum>(C)</enum><text>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;</text></subparagraph><subparagraph id="H6C06325F14EF4337833193F1261C6525" indent="up1" commented="no"><enum>(D)</enum><text>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</text></subparagraph><subparagraph id="H1B9F6459DB1B4005ACF1AFBC4CE108F3" indent="up1" commented="no"><enum>(E)</enum><text display-inline="yes-display-inline">provide all such pricing data in an .xml spreadsheet format or a comparable easily accessible and complete spreadsheet format.</text></subparagraph></paragraph><paragraph id="H7266559F7BC14578A1EB790DEB80C4B9" indent="up1" commented="no"><enum>(2)</enum><text>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.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph><subparagraph id="H217CE4970E454F5584656BF582698C79" commented="no"><enum>(B)</enum><header>Application</header><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph></subsection></section><section id="H5A1FBACD72D6465A980392E9187B1D8D"><enum>364.</enum><header>Health plan oversight of pharmacy benefit manager services</header><text display-inline="no-display-inline">Subpart II of part A of title XXVII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-11">42 U.S.C. 300gg–11 et seq.</external-xref>), as amended by the preceding sections, is further amended by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="HC6642CAD4B77431A8F62A2279A1AD609" style="OLC"><section id="H3074FEBDF22B4AF4940242979509BCD6"><enum>2729E.</enum><header>Health plan oversight of pharmacy benefit manager services</header><subsection id="H03A8C8FB57FA4BF98F467C687EF28863"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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).</text></subsection><subsection id="H3B6E731B08C244FCBD6ED196E67D5ED7"><enum>(b)</enum><header>Reports to group plan sponsors</header><paragraph id="HB0C3D2A8D27142C0B9E89CAA9428E050"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Beginning with the first plan year that begins after the date of enactment of the <short-title>Fair Care Act of 2024</short-title>, 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—</text><subparagraph id="H8F83D789CF014CA8AE5D2022081A83A6"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text></subparagraph><subparagraph id="H7DC0C6C7B59C470D8D429F5966848B1E"><enum>(B)</enum><text display-inline="yes-display-inline">a list of each covered drug dispensed during the reporting period, including, with respect to each such drug during the reporting period—</text><clause id="H2539F629EE8F4D24A76B05E0626904B7"><enum>(i)</enum><text>the brand name, chemical entity, and National Drug Code;</text></clause><clause id="H2A2E6991B356445CA17D09853AE9AF52"><enum>(ii)</enum><text>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;</text></clause><clause id="HF9A0FEB99C874119BDD135F7D055BFED"><enum>(iii)</enum><text>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;</text></clause><clause id="H7EE447DB702144CC89761C5E0FF21289"><enum>(iv)</enum><text>the total out-of-pocket spending by enrollees on such drug, including enrollee spending through copayments, coinsurance, and deductibles; and</text></clause><clause id="H51F9FB42633D4A5881A261F74ED36C55"><enum>(v)</enum><text>for any drug for which gross spending of the group health plan or health insurance coverage exceeded $10,000 during the reporting period—</text><subclause id="HC4BBFFFED5B0432B940EBFD842208FDD"><enum>(I)</enum><text>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</text></subclause><subclause id="H8D837E645E714F799D02C5A475AF181B"><enum>(II)</enum><text>the rationale for preferred formulary placement of a particular drug or drugs in that therapeutic category or class;</text></subclause></clause></subparagraph><subparagraph id="H698D455A36A74D18B1E58527C7FB4CD2"><enum>(C)</enum><text>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—</text><clause id="HB00EFC81F1E54676B432428147717B75"><enum>(i)</enum><text>total gross spending by the plan, before manufacturer rebates, fees, or other manufacturer remuneration;</text></clause><clause id="HB50173EEFC514730AD9DBF1C7822F3D9"><enum>(ii)</enum><text>the number of enrollees who filled a prescription for a drug in that category or class;</text></clause><clause id="H803E17A2C48F4B60B2721D82FA0E498D"><enum>(iii)</enum><text>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;</text></clause><clause id="HC6B073B097E244C3800C179DE00D51AC"><enum>(iv)</enum><text>the total out-of-pocket spending by enrollees, including enrollee spending through copayments, coinsurance, and deductibles; and</text></clause><clause id="H02E2DE78938143C98727595AD768D378"><enum>(v)</enum><text>for each therapeutic category or class under which 3 or more drugs are included on the formulary of such plan or coverage—</text><subclause id="HEB5CB9510B3748AD8950CB90612ED611"><enum>(I)</enum><text>the amount received, or expected to be received, from drug manufacturers in rebates, fees, alternative discounts, or other remuneration—</text><item id="HFDA9B4D95276429AA545BBC3F1463A0F"><enum>(aa)</enum><text>to be paid by drug manufacturers for claims incurred during the reporting period; or</text></item><item id="HF2F47B127242494187488668658614E8"><enum>(bb)</enum><text>that is related to utilization of drugs, in such therapeutic category or class;</text></item></subclause><subclause id="HA5D1907E32784567948D128DACA0A1B0"><enum>(II)</enum><text>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</text></subclause><subclause id="H60DC379370114905830CC7AD112C8F58"><enum>(III)</enum><text>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;</text></subclause></clause></subparagraph><subparagraph id="H3E5FF84CCF1F4EAD937DA01B866F8B03"><enum>(D)</enum><text>total gross spending on prescription drugs by the plan or coverage during the reporting period, before rebates and other manufacturer fees or remuneration;</text></subparagraph><subparagraph id="H0D1AE8133DAE4D7D99EDE97DD1EC09F7"><enum>(E)</enum><text>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;</text></subparagraph><subparagraph id="HC601DAC4D0324BF8A216D6FB0C90B77C"><enum>(F)</enum><text>the total net spending on prescription drugs by the health plan or health insurance coverage during the reporting period; and</text></subparagraph><subparagraph id="H652A0F35C5A045DC84D580BF77F1C888"><enum>(G)</enum><text>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.</text></subparagraph></paragraph><paragraph commented="no" id="H8EF6C7AFC4C14D678E1FFF920C66C403"><enum>(2)</enum><header>Privacy requirements</header><text>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.</text></paragraph><paragraph id="HCEC5F8621DC941199DD1378A358CDE75"><enum>(3)</enum><header>Disclosure and redisclosure</header><subparagraph id="H6C84E3BAB82A4AB48EE1D30ED045172B"><enum>(A)</enum><header>Limitation to business associates</header><text>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).</text></subparagraph><subparagraph id="HD2DEC2C1989943DCAE0B67158BFECD4A"><enum>(B)</enum><header>Clarification regarding public disclosure of information</header><text>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.</text></subparagraph><subparagraph id="H6803CAEE53394E9BAC8089A19F5F198B"><enum>(C)</enum><header>Limited form of report</header><text>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.</text></subparagraph></paragraph></subsection><subsection id="H1F719FF9DEAA4B138CE74C09179243AE"><enum>(c)</enum><header>Limitations on spread pricing</header><paragraph id="H72220B65815C447CA35F41147EF58249"><enum>(1)</enum><header>Prescription drug transactions with pharmacies independent of the issuer or pharmacy benefits manager</header><text>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.</text></paragraph><paragraph id="H5BBC5D5AA2274CB0B49C27E499DEA25E"><enum>(2)</enum><header>Intra-company prescription drug transactions</header><text>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—</text><subparagraph id="H60927C9DA3944903B69B0E5F5CE089DF"><enum>(A)</enum><text>the amount paid to the pharmacy for acquisition of the drug; or</text></subparagraph><subparagraph id="HB73AA5C2CD424863A0C602D0213C44D7"><enum>(B)</enum><text>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).</text></subparagraph></paragraph><paragraph id="H379854836C834D8A88F017E7A90491C8"><enum>(3)</enum><header>Supplementary reporting for intra-company prescription drug transactions</header><text>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—</text><subparagraph id="HE219D14DF5E24114848BFCB062FFF0D2"><enum>(A)</enum><text>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;</text></subparagraph><subparagraph id="H3A6493334A0649E1BF71120302DBF660"><enum>(B)</enum><text>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</text></subparagraph><subparagraph id="HB17AE823483F47B589D98DC0E8A4374D"><enum>(C)</enum><text>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—</text><clause id="HB56477E97ADF4B65B2E2E111EDC4EAB5"><enum>(i)</enum><text>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;</text></clause><clause id="H592D94242DED466087C335CF9DA5E182"><enum>(ii)</enum><text>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;</text></clause><clause id="HC7DD3C9CFD0E421582B953B795A6ED65"><enum>(iii)</enum><text>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 </text></clause><clause id="HC7966D6A627848C995987792F51E3896"><enum>(iv)</enum><text>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.</text></clause></subparagraph></paragraph></subsection><subsection id="H4302DE0CDDB244AE90E4D26C5CEF06C9"><enum>(d)</enum><header>Full rebate pass-Through to plan</header><paragraph id="HA160C945AE7D4351880EED1D5B71CE93"><enum>(1)</enum><header>In general</header><text>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.</text></paragraph><paragraph id="H836315B8DAF140569B973DE4190E6546"><enum>(2)</enum><header>Form and manner of remittance</header><text>Such rebates, fees, alternative discounts, and other remuneration shall be—</text><subparagraph id="HBADD2236541C48B48EC272143259D276"><enum>(A)</enum><text>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;</text></subparagraph><subparagraph id="HB193F14C92924A7BA44FCEC6CCA7035D"><enum>(B)</enum><text>fully disclosed and enumerated to the group health plan sponsor, as described in (b)(1);</text></subparagraph><subparagraph id="H2B5235EFC33845538FBDD532047EC6C4"><enum>(C)</enum><text>available for audit by the plan sponsor, or a third party designated by a plan sponsor no less than once per plan year; and</text></subparagraph><subparagraph id="H1F764D4F6F5B48B1B17DE159CDCFC139"><enum>(D)</enum><text>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.</text></subparagraph></paragraph><paragraph id="H0A5E5BA522264869A4920490E7D7AC00"><enum>(3)</enum><header>Audit of rebate contracts</header><text>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.</text></paragraph></subsection><subsection id="HFC80225987F34AA5B10BDF39C67CD044"><enum>(e)</enum><header>Enforcement</header><paragraph id="H0B9811480BFD4DE6A88CE9B9E6B63869"><enum>(1)</enum><header>In general</header><text>The Secretary, in consultation with the Secretary of Labor and the Secretary of the Treasury, shall enforce this section.</text></paragraph><paragraph id="H34AC85D681D84868805BF11D959DF872"><enum>(2)</enum><header>Failure to provide timely information</header><text>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.</text></paragraph><paragraph id="HF3D91C4FCA18488BA661DBABC7F7523E"><enum>(3)</enum><header>False information</header><text>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.</text></paragraph><paragraph id="HADBA18DCB8A444B982CC7C6A7F16FF11"><enum>(4)</enum><header>Procedure</header><text>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.</text></paragraph><paragraph id="HB5E27548594C422F83A08994E772C889"><enum>(5)</enum><header>Safe harbor</header><text>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.</text></paragraph></subsection><subsection id="HA81B49C2EF624F9A8F9355D6352D0014"><enum>(f)</enum><header>Rule of construction</header><text>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.</text></subsection><subsection id="H5855F95FBF044C04A3CA01F69E08796F"><enum>(g)</enum><header>Definitions</header><text>In this section—</text><paragraph commented="no" id="H5E06FAEF0FDF4D1ABC19DE283DF33CD0"><enum>(1)</enum><text>the term <term>similarly situated pharmacy</term> 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</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H041556410EA3480DA9D6D5C22273D294"><enum>(2)</enum><text>the term <term>wholesale acquisition cost</term> has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H5970A48D5C7C4AEE935D64018EE6C748"><enum>365.</enum><header>Study by Comptroller General of United States</header><subsection id="H5DC15D4C49F64882898B5C2A0C04B84C"><enum>(a)</enum><header>In general</header><text>The Comptroller General of the United States (referred to in this section as the <quote>Comptroller General</quote>) shall, in consultation with appropriate stakeholders, conduct a study on the role of pharmacy benefit managers.</text></subsection><subsection id="H6D4ED73E9DBF4106B229353704C8E458"><enum>(b)</enum><header>Permissible examination</header><text>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:</text><paragraph id="HA3AA9EAD5F324BB3BAE6A9C5C75FDB3E"><enum>(1)</enum><text>The role that pharmacy benefit managers play in the pharmaceutical supply chain.</text></paragraph><paragraph id="H722D3A14DEEA4E289F47AF781FC2AD75"><enum>(2)</enum><text>The state of competition among pharmacy benefit managers, including the market share for the Nation’s largest pharmacy benefit managers.</text></paragraph><paragraph id="H9EA85CA752264899AFE43F65FE3124E2"><enum>(3)</enum><text>The use of rebates and fees by pharmacy benefit managers, including—</text><subparagraph id="H1664AACC008C49E1BCEFE07ECCB55C9B"><enum>(A)</enum><text>the extent to which rebates are passed on to health plans and whether such rebates are passed on to individuals enrolled in such plans;</text></subparagraph><subparagraph id="H97454A0BF88144B1B910D009E3DD4C2D"><enum>(B)</enum><text>the extent to which rebates are kept by such pharmacy benefit managers; and</text></subparagraph><subparagraph id="H328C7C012DDD40728418D1C1E52A6228"><enum>(C)</enum><text>the role of any fees charged by such pharmacy benefit managers.</text></subparagraph></paragraph><paragraph id="H6591924DCA3E4EBFA03A9E53D90EFE12"><enum>(4)</enum><text>Whether pharmacy benefit managers structure their formularies in favor of high-rebate prescription drugs over lower-cost, lower-rebate alternatives.</text></paragraph><paragraph id="HA154B266410A40A7A25326C41F7BF383"><enum>(5)</enum><text>The average prior authorization approval time for pharmacy benefit managers.</text></paragraph><paragraph id="H5FD13C7175054E8A99F49DC105DF3B38"><enum>(6)</enum><text>Factors affecting the use of step therapy by pharmacy benefit managers.</text></paragraph></subsection><subsection id="H1D19934FE9EA416A9AFD2510F53FE046"><enum>(c)</enum><header>Report</header><text>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.</text></subsection></section></subtitle><subtitle id="H73FD846887D649CB9CB680EC2FE38542"><enum>E</enum><header>Medicare and Medicaid Prescription Drug Reforms</header><section id="H84FB8633C54E49848A7D23B3C17E7FED"><enum>371.</enum><header>Medicare part D modernization redesign</header><subsection id="H18516441168247DB8E741ECBC297B473"><enum>(a)</enum><header>Benefit structure redesign</header><text>Section 1860D–2(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(b)</external-xref>) is amended—</text><paragraph id="H5C2F12C5F2634CCA9A527C5284946694"><enum>(1)</enum><text>in paragraph (2)—</text><subparagraph id="HD21ED65249944B0DB7B7A749D3F88C6F"><enum>(A)</enum><text>in subparagraph (A), in the matter preceding clause (i), by inserting <quote>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</quote> after <quote>paragraph (3)</quote>;</text></subparagraph><subparagraph id="HEC8A560B76CA4D8C897EEDA0B45FDE3D"><enum>(B)</enum><text>in subparagraph (C)—</text><clause id="H306FCA0AD7E4401DA5028E143B14529E"><enum>(i)</enum><text>in clause (i), in the matter preceding subclause (I), by inserting <quote>for a year preceding 2025, </quote> after <quote>paragraph (4),</quote>; and</text></clause><clause id="H3806E849270540A09D7B4AACA864EC98"><enum>(ii)</enum><text>in clause (ii)(III), by striking <quote>and each subsequent year</quote> and inserting <quote>, 2021, 2022, 2023, and 2024</quote>; and</text></clause></subparagraph><subparagraph id="H64290BDB410249CE9BAC3EBDF828DD4F"><enum>(C)</enum><text>in subparagraph (D)—</text><clause id="HEEE37102F6754FBD86337A5C1E1951FB"><enum>(i)</enum><text>in clause (i)—</text><subclause id="HD8BE7C3F9970451F9CA6FA5154AB3D2C"><enum>(I)</enum><text>in the matter preceding subclause (I), by inserting <quote>for a year preceding 2025, </quote> after <quote>paragraph (4),</quote>; and</text></subclause><subclause id="HB4714CC2B7324CAB8A492B8F90C14740"><enum>(II)</enum><text>in subclause (I)(bb), by striking <quote>a year after 2018</quote> and inserting <quote>each of years 2018 through 2024</quote>; and</text></subclause></clause><clause id="HD24DDE9BD1B34DF392BEE069BE8572B3"><enum>(ii)</enum><text>in clause (ii)(V), by striking <quote>2019 and each subsequent year</quote> and inserting <quote>each of years 2019 through 2024</quote>;</text></clause></subparagraph></paragraph><paragraph id="H5D5D5E27809946CBBDB081EB5C672820"><enum>(2)</enum><text>in paragraph (3)(A)—</text><subparagraph id="HCB23FF32357A4816A9A7DE61F86CB3D0"><enum>(A)</enum><text>in the matter preceding clause (i), by inserting <quote>for a year preceding 2025,</quote> after <quote>and (4),</quote>; and</text></subparagraph><subparagraph id="HE100EB3167514E94AE5BF12F9C4602DC"><enum>(B)</enum><text>in clause (ii), by striking <quote>for a subsequent year</quote> and inserting <quote>for each of years 2007 through 2024</quote>;</text></subparagraph></paragraph><paragraph id="H55157115DD48490A984BD019A5C148D4"><enum>(3)</enum><text>in paragraph (4)—</text><subparagraph id="H9D7706231921467096B261AAC70505AC"><enum>(A)</enum><text>in subparagraph (A)—</text><clause id="HEC8A1B0F6AA9439B890FF8C6E64BB3E4"><enum>(i)</enum><text>in clause (i)—</text><subclause id="HECEC4C6FD43D45A399A1B6A1D82772DD"><enum>(I)</enum><text>by redesignating subclauses (I) and (II) as items (aa) and (bb), respectively, and indenting appropriately;</text></subclause><subclause id="HDE2F05A83A844CE5A929FDCFC928B266"><enum>(II)</enum><text>in the matter preceding item (aa), as redesignated by subclause (I), by striking <quote>is equal to the greater of—</quote> and inserting “is equal to—</text><quoted-block style="OLC" display-inline="no-display-inline" id="HBDFE218421354A17967200A45CC52C88"><subclause id="H5B9F3FC1608145C69A36FBF7874CC3B3"><enum>(I)</enum><text>for a year preceding 2025, the greater of—</text></subclause><after-quoted-block>;</after-quoted-block></quoted-block></subclause><subclause id="HBFDCCAC092AC4B1F9008B31C97D41829"><enum>(III)</enum><text>by striking the period at the end of item (bb), as redesignated by subclause (I), and inserting <quote>; and</quote>; and</text></subclause><subclause id="H45ED61726A0447D997DC0477C41F8564"><enum>(IV)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HAB2C5D246D854ECCB5C093B2DED42B79"><subclause id="H82039E2C561E4681A02C0F631A7EAF15"><enum>(II)</enum><text>for 2025 and each succeeding year, $0.</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause><clause id="H63CED8972A534945AE4AEC9E28CB992E"><enum>(ii)</enum><text>in clause (ii)—</text><subclause id="H2599A832562A46828D5A46E1A8F996BB"><enum>(I)</enum><text>by striking <quote>clause (i)(I)</quote> and inserting <quote>clause (i)(I)(aa)</quote>; and</text></subclause><subclause commented="no" id="HCD0E25844CE7421A8B146406B6839635"><enum>(II)</enum><text>by adding at the end the following new sentence: <quote>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).</quote>;</text></subclause></clause></subparagraph><subparagraph id="H226218B358694106BC98A65297D72553"><enum>(B)</enum><text>in subparagraph (B)—</text><clause id="HC746F8DC6BB94DDAA09C2419D4531395"><enum>(i)</enum><text>in clause (i)—</text><subclause id="H79A22DC07F6D4E48BD40C2860E28584D"><enum>(I)</enum><text>in subclause (V), by striking <quote>or</quote> at the end;</text></subclause><subclause id="H0178DD10A3B949F4B72C3FC46FDD2330"><enum>(II)</enum><text>in subclause (VI)—</text><item id="H0811D542E311410CA5AC52D290640D7E"><enum>(aa)</enum><text>by striking <quote>for a subsequent year</quote> and inserting <quote>for 2021 through 2024</quote>; and</text></item><item id="H5D278BEE470E4347B93C843BD673B037"><enum>(bb)</enum><text>by striking the period at the end and inserting a semicolon; and</text></item></subclause><subclause id="H289EFE7480C548B78CF8C3997D153979"><enum>(III)</enum><text>by adding at the end the following new subclauses:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H31AE15FC11C74B1E92E9DA21EF7AE030"><subclause id="HC11CB7B84AD44CE09D0D3EBC52668DA4"><enum>(VII)</enum><text>for 2025, is equal to $3,100; or</text></subclause><subclause id="HE2D6CFC5107747339F1A71F2C48AC704"><enum>(VIII)</enum><text>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.</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause><clause id="H90CE3FA7266D47B6991916565AF92844"><enum>(ii)</enum><text>in clause (ii), by striking <quote>clause (i)(II)</quote> and inserting <quote>clause (i)</quote>;</text></clause></subparagraph><subparagraph id="H6CF86B36DF934DB18166AE85A17B6947"><enum>(C)</enum><text>in subparagraph (C)(i), by striking <quote>and for amounts</quote> and inserting <quote>and for a year preceding 2025 for amounts</quote>; and</text></subparagraph><subparagraph id="H133B50D0B69B4EF09E0BF476BF57E6EB"><enum>(D)</enum><text>in subparagraph (E), by striking <quote>In applying</quote> and inserting <quote>For each of 2011 through 2024, in applying</quote>.</text></subparagraph></paragraph></subsection><subsection id="HA92608D6F5754DEBA7ED0136CCDDEF81"><enum>(b)</enum><header>Reduction in beneficiary coinsurance</header><paragraph id="H142DD6147E0B4685AE13BF191B8D3BE9"><enum>(1)</enum><header>In general</header><text>Section 1860D–2(b)(2)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(b)(2)(A)</external-xref>), as amended by subsection (a), is amended—</text><subparagraph id="H4D45402172134EA79FA621FDDAAF5575"><enum>(A)</enum><text>by redesignating clauses (i) and (ii) as subclauses (I) and (II) and moving such subclauses 2 ems to the right;</text></subparagraph><subparagraph id="H7F561F7EB00E4872A6CB7BD611D1C805"><enum>(B)</enum><text>by striking <quote><header-in-text level="subparagraph" style="OLC">25 percent coinsurance</header-in-text>.—Subject to</quote> and inserting “<header-in-text level="subparagraph" style="OLC">Coinsurance</header-in-text>.—</text><quoted-block style="OLC" display-inline="no-display-inline" id="H51D9771528694EE4B290687B15EEFBCE"><clause id="HC1A048A6686F419C9FE35C4DC28AB392"><enum>(i)</enum><header>In general</header><text>Subject to</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="HF1C465D01D6E433FA9D0B3503014BAD4"><enum>(C)</enum><text>in each of subclauses (I) and (II), as redesignated by subparagraph (A), by striking <quote>25 percent</quote> and inserting <quote>the applicable percentage (as defined in clause (ii))</quote>; and</text></subparagraph><subparagraph id="HF872DF3FFADA46729FDDB659FB8F3F5E"><enum>(D)</enum><text>by adding at the end the following new clause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H11E1A2D894C2474B89A8A6CD0B5576C2"><clause id="H9E6A253737454D66BD699224E4DEE1EF"><enum>(ii)</enum><header>Applicable percentage defined</header><text>For purposes of clause (i), the term <term>applicable percentage</term> means—</text><subclause id="H298CCE428AAD4E9FAF7FED402DED877F"><enum>(I)</enum><text>for a year preceding 2025, 25 percent; and</text></subclause><subclause id="HEC539197129E4AC89DCC2F38CD52B4B0"><enum>(II)</enum><text>for 2025 and each subsequent year, 20 percent.</text></subclause></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HDB6113A9AE904781A3087CD4731ED578"><enum>(2)</enum><header>Conforming amendment</header><text>Section 1860D–14(a)(2)(D) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-114">42 U.S.C. 1395w–114(a)(2)(D)</external-xref>) is amended by striking <quote>25 percent</quote> and inserting <quote>the applicable percentage</quote>.</text></paragraph></subsection><subsection id="H6633C771542446D38C3CB0DC5BFCDF2D"><enum>(c)</enum><header>Decreasing reinsurance payment amount</header><text>Section 1860D–15(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-115">42 U.S.C. 1395w–115(b)</external-xref>) is amended—</text><paragraph id="HE7994160DDE24F82AEA3A2DF7FB96353"><enum>(1)</enum><text>in paragraph (1)—</text><subparagraph id="H23CC9C70952C44A1AAA1F1FB299FD26A"><enum>(A)</enum><text>by striking <quote>equal to 80 percent</quote> and inserting “equal to—</text><quoted-block style="OLC" display-inline="no-display-inline" id="H7AE15CE6038849A9B38316415ADEC23C"><subparagraph id="HE238BE214D704A948D5D85E6D748E7D5"><enum>(A)</enum><text>for a year preceding 2025, 80 percent</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="HBFB3F7F3F09C4CCCA5C666A803B95FD1"><enum>(B)</enum><text>in subparagraph (A), as added by paragraph (1), by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph id="H349D72D4CDA146D98A786C4EC2817F22"><enum>(C)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HE3C60F418B404D8DB8BA1074A0C96688"><subparagraph id="H4567BDE9A7294225A4FE2F82C49675E0"><enum>(B)</enum><text>for 2025 and each subsequent year, the sum of—</text><clause id="HA3842C0502CD4A7F98F8305569ACEAF9"><enum>(i)</enum><text>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</text></clause><clause id="H802469F8FA5B4C2B8A86DF772A10FAB6"><enum>(ii)</enum><text>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).</text></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H0964AEB216694CA398F63013C7B6982E"><enum>(2)</enum><text>by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HE2A5D511028F4486AA4F63D3CE8E5A10"><paragraph id="H4417F43233A04F00A795DB5FA10E2A1E"><enum>(5)</enum><header>Applicable percentage specified</header><text>For purposes of paragraph (1)(B), the applicable percentage specified in this paragraph is—</text><subparagraph id="HDFA2B51C761B48CF92A9309AEECAE7FB"><enum>(A)</enum><text>with respect to applicable drugs (as defined in section 1860D–14B(g)(2))—</text><clause id="H05D360508E3249838EACF969CF082B8D"><enum>(i)</enum><text>for 2025, 60 percent;</text></clause><clause id="HAB513FFCF2064D0C93440E82243DA254"><enum>(ii)</enum><text>for 2026, 40 percent; and</text></clause><clause id="H524EF7D29CE3400FA95F17975460B953"><enum>(iii)</enum><text>for 2027 and each subsequent year, 20 percent; and</text></clause></subparagraph><subparagraph id="HABFAEE8A01954E49A0DA3CE1A16BF547"><enum>(B)</enum><text>with respect to covered part D drugs that are not applicable drugs (as so defined)—</text><clause id="HE58E2B74A0C844C6AEED616B92180400"><enum>(i)</enum><text>for 2025, 80 percent;</text></clause><clause id="HDD82FC767190469AB6D6D941036D77C7"><enum>(ii)</enum><text>for 2026, 60 percent; and</text></clause><clause id="H698B03D1DF7644098F8CAA1DC5BEA207"><enum>(iii)</enum><text>for 2027 and each subsequent year, 40 percent.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H1A05C762F9164AB2B07FDA7749DA7B81"><enum>(d)</enum><header>Manufacturer discount program during initial and catastrophic phases of coverage</header><paragraph id="H3EA232798B2248D38316E96A2648DC39"><enum>(1)</enum><header>In general</header><text>Part D of title XVIII of the Social Security Act is amended by inserting after section 1860D–14A (<external-xref legal-doc="usc" parsable-cite="usc/42/1495w-114">42 U.S.C. 1495w–114</external-xref>) the following new section:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HF32C86FF71744A1ABBCF60314FC4CAA7"><section id="H0888283E91264D2EB532778CBB253317"><enum>1860D–14B.</enum><header>Manufacturer discount program</header><subsection id="H29A90351843D482994AEB5D3872B4B67"><enum>(a)</enum><header>Establishment</header><text>The Secretary shall establish a manufacturer discount program (in this section referred to as the <quote>program</quote>). 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.</text></subsection><subsection id="H253D507368C2407CA809F87C39969AEC"><enum>(b)</enum><header>Terms of agreement</header><paragraph id="H290C96667EDC4DD19C6424CD9D1C93CF"><enum>(1)</enum><header>In general</header><subparagraph id="HD6A63886C2424458AA15EE975FF5CEF5"><enum>(A)</enum><header>Agreement</header><text>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.</text></subparagraph><subparagraph id="H4232EECE54D24E2A817FFACD4B9D129F"><enum>(B)</enum><header>Provision of discounted prices at the point-of-sale</header><text>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.</text></subparagraph></paragraph><paragraph id="H1AE1DE10895C406691FA7835BB7BB601"><enum>(2)</enum><header>Provision of appropriate data</header><text>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.</text></paragraph><paragraph id="H61C78DE2EE19490CB92655B714A12F57"><enum>(3)</enum><header>Compliance with requirements for administration of program</header><text>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).</text></paragraph><paragraph id="HA0558F7A7F8E476A8EE9C574653CE3ED"><enum>(4)</enum><header>Length of agreement</header><subparagraph id="HF034D586EE3848559095675E53369309"><enum>(A)</enum><header>In general</header><text>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).</text></subparagraph><subparagraph id="H6822554FC21D42ED82563998B745BED4"><enum>(B)</enum><header>Termination</header><clause id="H3A790947CCCD46659AE497BA90FD069A"><enum>(i)</enum><header>By the Secretary</header><text>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.</text></clause><clause id="HBAF6ED377E3E48A9B59906DD8D55FDD7"><enum>(ii)</enum><header>By a manufacturer</header><text>A manufacturer may terminate an agreement under this section for any reason. Any such termination shall be effective, with respect to a plan year—</text><subclause id="H48C02CE552DC4863BD5591A5532BA12A"><enum>(I)</enum><text>if the termination occurs before January 30 of a plan year, as of the day after the end of the plan year; and</text></subclause><subclause id="HBC34594E0B1948AEAD1CED54A5F04E74"><enum>(II)</enum><text>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.</text></subclause></clause><clause id="H1FE1EE134F494E178E30602CD1F9047C"><enum>(iii)</enum><header>Effectiveness of termination</header><text>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.</text></clause><clause id="H367C06C27FCE4EC8BADB0F5C37F47378"><enum>(iv)</enum><header>Notice to third party</header><text>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.</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9C25F4250F2B41E183B4C27008702E71"><enum>(5)</enum><header display-inline="yes-display-inline">Effective date of agreement</header><text display-inline="yes-display-inline">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.</text></paragraph></subsection><subsection id="HBC6A489BFA254844934C1C51C3CE7BA8"><enum>(c)</enum><header>Duties described</header><text>The duties described in this subsection are the following:</text><paragraph id="H108E6F1748474CDC83128445A1B1E24E"><enum>(1)</enum><header>Administration of program</header><text>Administering the program, including—</text><subparagraph id="HEB4A691BE9E64C74B88B592A1E52EDA6"><enum>(A)</enum><text>the determination of the amount of the discounted price of an applicable drug of a manufacturer;</text></subparagraph><subparagraph id="H1F5FB6C8D3A348B0919E14FF72409F11"><enum>(B)</enum><text>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;</text></subparagraph><subparagraph id="H6FBC0A14F8A9497F93275BE1EBAFC30A"><enum>(C)</enum><text>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—</text><clause id="HEAAC3EAEF2774A56AF6B643CCDABBC01"><enum>(i)</enum><text>the negotiated price of the applicable drug; and</text></clause><clause id="H78E1AB7C74BB42D28C60DB85A37FB376"><enum>(ii)</enum><text>the discounted price of the applicable drug;</text></clause></subparagraph><subparagraph id="HD8501FB8AACB4347AAFD480CA0D168D5"><enum>(D)</enum><text>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</text></subparagraph><subparagraph id="H9582DEB9CA1046929588EB395F0AEF69"><enum>(E)</enum><text>providing a reasonable dispute resolution mechanism to resolve disagreements between manufacturers, applicable beneficiaries, and the third party with a contract under subsection (d)(3).</text></subparagraph></paragraph><paragraph id="HDAA22CC0D34D44ED9B9A6E59667C6490"><enum>(2)</enum><header>Monitoring compliance</header><subparagraph id="HAEB5AF237E2248AB8245C7831871FB21"><enum>(A)</enum><header>In general</header><text>The Secretary shall monitor compliance by a manufacturer with the terms of an agreement under this section.</text></subparagraph><subparagraph id="H8F80F51D15324D07B9CE2A22B5E9BF28"><enum>(B)</enum><header>Notification</header><text>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).</text></subparagraph></paragraph><paragraph id="HE385CF37355B433D9E0C875911D0E7F2"><enum>(3)</enum><header>Collection of data from prescription drug plans and ma–pd plans</header><text>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.</text></paragraph></subsection><subsection id="HAE8DFB71F1F14801B46A3094D7E5BBF7"><enum>(d)</enum><header>Administration</header><paragraph id="H5FFFDA324DC140B79C08FA3721F39B76"><enum>(1)</enum><header>In general</header><text>Subject to paragraph (2), the Secretary shall provide for the implementation of this section, including the performance of the duties described in subsection (c).</text></paragraph><paragraph id="H989A5DC7723E43B7AA3F258F1D16A9E7"><enum>(2)</enum><header>Limitation</header><text>In providing for the implementation of this section, the Secretary shall not receive or distribute any funds of a manufacturer under the program.</text></paragraph><paragraph id="HDAA532C70E7940AAB536B8085F5A4476"><enum>(3)</enum><header>Contract with third parties</header><text>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—</text><subparagraph id="H500F55A938AD4CE086BCB59D4BE2EFFE"><enum>(A)</enum><text>receive and transmit information between the Secretary, manufacturers, and other individuals or entities the Secretary determines appropriate;</text></subparagraph><subparagraph id="HAB3755E0FCB24A6AABA3EAD9C8D2FBDB"><enum>(B)</enum><text>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;</text></subparagraph><subparagraph id="H560B52C801694F9A813444C84A3EF28B"><enum>(C)</enum><text>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</text></subparagraph><subparagraph id="H51475CABAFE847F39FEAF0A78E15A3AF"><enum>(D)</enum><text>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.</text></subparagraph></paragraph><paragraph id="H8750303B689B4857AD4918825533A58C"><enum>(4)</enum><header>Performance requirements</header><text>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.</text></paragraph><paragraph id="H85F5B4CCDA6C4EABA96590A3E64F1DC5"><enum>(5)</enum><header>Administration</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/44/35">Chapter 35</external-xref> of title 44, United States Code, shall not apply to the program under this section.</text></paragraph><paragraph id="H2E1DE5A04E8E4DAE9526D675E5C7A774"><enum>(6)</enum><header>Funding</header><text>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.”.</text></paragraph></subsection><subsection id="H1BD895F92C59434F9F0D61A7108EE2D4"><enum>(e)</enum><header>Enforcement</header><paragraph id="H08CC5982281C4ACAA7BD8847F00233E9"><enum>(1)</enum><header>Audits</header><text>Each manufacturer with an agreement in effect under this section shall be subject to periodic audit by the Secretary.</text></paragraph><paragraph id="HEA59A911869646F9BC70A0B979B96C8B"><enum>(2)</enum><header>Civil money penalty</header><subparagraph id="HFC38912FC6764D7985B692F847585538"><enum>(A)</enum><header>In general</header><text>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—</text><clause id="HF2458D2ED13D4F55B5272CABA7E8505D"><enum>(i)</enum><text>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</text></clause><clause id="H999E66D710CE486D97834C77F5807D96"><enum>(ii)</enum><text>25 percent of such amount.</text></clause></subparagraph><subparagraph id="HBB97249C092C49FA8685B98527B17D59"><enum>(B)</enum><header>Application</header><text>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).</text></subparagraph></paragraph></subsection><subsection id="H964DAD6830674B69BDFC029E0A6173E0"><enum>(f)</enum><header>Clarification regarding availability of other covered part d drugs</header><text>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).</text></subsection><subsection id="HD76D4908992947B5BBA9E13DE9FCAA3B"><enum>(g)</enum><header>Definitions</header><text>In this section:</text><paragraph id="HBB66E72F4ADF49D5BF6F766975DAE647"><enum>(1)</enum><header>Applicable beneficiary</header><text>The term <term>applicable beneficiary</term> means an individual who, on the date of dispensing a covered part D drug—</text><subparagraph id="H6A59953AD7C1401D93CD2A363F8770B3"><enum>(A)</enum><text>is enrolled in a prescription drug plan or an MA–PD plan;</text></subparagraph><subparagraph id="HDD62BFB3978E4C89A242A89C27EB4942"><enum>(B)</enum><text>is not enrolled in a qualified retiree prescription drug plan; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H17FF4B6BFCF14F3299F52F19EA254EAF"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><paragraph id="H24E229667B3C4D0D8E3031C79E3F26AF"><enum>(2)</enum><header>Applicable drug</header><text>The term <term>applicable drug</term> means, with respect to an applicable beneficiary, a covered part D drug—</text><subparagraph id="H892285EAB3B54195A0F0D71E54F4410E"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="H2BF9AFEBD91644FF81078BFB463D470A"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H9CCA314F144F4D339530BBEDD43AA559"><enum>(i)</enum><text>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;</text></clause><clause id="HBB3016E118694A82B40826A41A187361" indent="up1"><enum>(ii)</enum><text>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</text></clause><clause id="H80E95BDAE76C4AC8B79121AA7E88FF2B" indent="up1"><enum>(iii)</enum><text>is provided through an exception or appeal.</text></clause></subparagraph></paragraph><paragraph id="H6F614A1232114AD6A6C920E73E80D18F"><enum>(3)</enum><header>Applicable number of calendar days</header><text>The term <term>applicable number of calendar days</term> means—</text><subparagraph id="H84EF0D6E4104448680D322CA470A82FD"><enum>(A)</enum><text>with respect to claims for reimbursement submitted electronically, 14 days; and</text></subparagraph><subparagraph id="H368B3BA594F84C37B516AAE7F5F7D30B"><enum>(B)</enum><text>with respect to claims for reimbursement submitted otherwise, 30 days.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7BFAD604974A4EFD915D847915B8C1CD"><enum>(4)</enum><header display-inline="yes-display-inline">Discounted price</header><subparagraph commented="no" display-inline="no-display-inline" id="HFCB8F97971224B8C812A37395BAEEC0A"><enum>(A)</enum><header>In general</header><text>The term <term>discounted price</term> means—</text><clause commented="no" display-inline="no-display-inline" id="HD0D72337316E4BBE898B70CF1574CB34"><enum>(i)</enum><text>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</text></clause><clause commented="no" display-inline="no-display-inline" id="H015A8DFA59C54FBEA54DC176AB98592E"><enum>(ii)</enum><text>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.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE53E3CB5DCE74517ACA405268538FB74"><enum>(B)</enum><header display-inline="yes-display-inline">Clarification</header><text display-inline="yes-display-inline">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.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD1614714F9D74294810B61647432C0F9"><enum>(C)</enum><header>Clarification for certain claims</header><text>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—</text><clause commented="no" display-inline="no-display-inline" id="H72E8D0223B424BA295263105678E7DE9"><enum>(i)</enum><text>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</text></clause><clause commented="no" display-inline="no-display-inline" id="HEE18847072474819B4D369A35E0691BC"><enum>(ii)</enum><text>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. </text></clause></subparagraph></paragraph><paragraph id="HD1D232FF63AC4B94AEE24E56347D6C84"><enum>(5)</enum><header>Manufacturer</header><text>The term <term>manufacturer</term> 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.</text></paragraph><paragraph id="HF4C0B42F40274E22A9F2BF023FC588D7"><enum>(6)</enum><header>Negotiated price</header><text>The term <term>negotiated price</term> 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.</text></paragraph><paragraph id="H523CBFF58E914322BCF3B24C83426259"><enum>(7)</enum><header>Qualified retiree prescription drug plan</header><text>The term <term>qualified retiree prescription drug plan</term> has the meaning given such term in section 1860D–22(a)(2).</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H408561A79BD84CF7AFD4C5D3303139FA"><enum>(2)</enum><header>Sunset of Medicare coverage gap discount program</header><text>Section 1860D–14A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395-114a">42 U.S.C. 1395–114a</external-xref>) is amended—</text><subparagraph id="H965B582461324699B46430925B4A6E78"><enum>(A)</enum><text>in subsection (a), in the first sentence, by striking <quote>The Secretary</quote> and inserting <quote>Subject to subsection (h), the Secretary</quote>; and</text></subparagraph><subparagraph id="HCE0791F9AB7F4E17B74E9F617C723736"><enum>(B)</enum><text>by adding at the end the following new subsection:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H3135B085107D49D88FF6270391B821E9"><subsection id="H6F96A1FF00654B7D84BAE13CC850B85E"><enum>(h)</enum><header>Sunset of program</header><paragraph id="H8CDF76F3C4A045659F0FC2E8DC0DB753"><enum>(1)</enum><header>In general</header><text>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.</text></paragraph><paragraph id="H8F458DA598324DBDA2836BB4E7C70594"><enum>(2)</enum><header>Continued application for applicable drugs dispensed prior to sunset</header><text>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.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H82C2BAF3ECA14A9E814757F0337BABFD"><enum>(3)</enum><header>Inclusion of actuarial value of manufacturer discounts in bids</header><text>Section 1860D–11 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-111">42 U.S.C. 1395w–111</external-xref>) is amended—</text><subparagraph id="HA508F710763D47DD9AD66DD35AF514E6"><enum>(A)</enum><text>in subsection (b)(2)(C)(iii)—</text><clause id="H8F2A16DB16384F35B806839727492658"><enum>(i)</enum><text>by striking <quote>assumptions regarding the reinsurance</quote> and inserting “assumptions regarding—</text><quoted-block style="OLC" display-inline="no-display-inline" id="H142DB60B845645B19C343D75C4EE5CB9"><subclause id="H3C3A4431CBDB44C898008D39D3BCF6BD"><enum>(I)</enum><text>the reinsurance</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause id="HF713A55B6E464BC8A61E96DAFEDC6478"><enum>(ii)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HF9CE1D8815C346DC872149D3FD867DEA"><subclause id="H3EFCBE61B3164AC9A8BDBE4FFD0349A5"><enum>(II)</enum><text>for 2025 and each subsequent year, the manufacturer discounts provided under section 1860D–14B subtracted from the actuarial value to produce such bid; and</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="HCCDA9ACDD0F2427BBF786FE6839868AD"><enum>(B)</enum><text>in subsection (c)(1)(C)—</text><clause id="HEDC657ADCA7F4E52B318007815791ADE"><enum>(i)</enum><text>by striking <quote>an actuarial valuation of the reinsurance</quote> and inserting “an actuarial valuation of—</text><quoted-block style="OLC" display-inline="no-display-inline" id="HC1787F946C7948E1B9F92F3BFEF1D87A"><clause id="HA12C952EC7EF4022BC906FEE25767724"><enum>(i)</enum><text>the reinsurance</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause><clause id="H52DC40BFADC34AE79D27F245F32C8AE7"><enum>(ii)</enum><text>in clause (i), as added by clause (i) of this subparagraph, by adding <quote>and</quote> at the end; and</text></clause><clause id="H110329B2DBE34447AEF4535D252EF4F5"><enum>(iii)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H50A5CE3ACAE64442B4D3F40D6FE0C3A9"><clause id="HB7DDB78CBE8841298328504BDBBEB32E"><enum>(ii)</enum><text>for 2025 and each subsequent year, the manufacturer discounts provided under section 1860D–14B;</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph commented="no" id="HD06CE3DE24854AC187CBC41620E32352"><enum>(4)</enum><header>Clarification regarding exclusion of manufacturer discounts from TrOOP</header><text>Section 1860D–2(b)(4) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(b)(4)</external-xref>) is amended—</text><subparagraph id="HCFD79E52D13C4688A0E8239D575D1A84"><enum>(A)</enum><text>in subparagraph (C), by inserting <quote>and subject to subparagraph (F)</quote> after <quote>subparagraph (E)</quote>; and</text></subparagraph><subparagraph id="HF577778352184ED09B4989D29DBD07BD"><enum>(B)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H15FE448FF3324A2CB597D4156D18E72E"><subparagraph id="HF6BA02B209524B2E954731A624E94B4C"><enum>(F)</enum><header>Clarification regarding exclusion of manufacturer discounts</header><text>In applying subparagraph (A), incurred costs shall not include any manufacturer discounts provided under section 1860D–14B.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection><subsection id="H6FEE9DE093BA4DC1BD84AA34C455C3EC"><enum>(e)</enum><header>Determination of allowable reinsurance costs</header><text>Section 1860D–15(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-115">42 U.S.C. 1395w–115(b)</external-xref>) is amended—</text><paragraph id="HA21605A7AA874053B75EC97A37AEED05"><enum>(1)</enum><text>in paragraph (2)—</text><subparagraph id="H6205B8A4FC864FF9AA14BE0382F517F2"><enum>(A)</enum><text>by striking <quote><header-in-text level="paragraph" style="OLC">costs</header-in-text>.—For purposes</quote> and inserting “<header-in-text level="paragraph" style="OLC">costs</header-in-text>.—</text><quoted-block style="OLC" display-inline="no-display-inline" id="H4C782EA418CE411E8E5E87F4434510E6"><subparagraph id="HB5707009643C47D494E81441D8333850"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (B), for purposes</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="H3910277DD4DE4898BC20D576B532F255"><enum>(B)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HC9C526C81AAD4595B018B3CF8A2B0E3E"><subparagraph id="H761456B05BEE4ADCAB1D01E5241E4276"><enum>(B)</enum><header>Inclusion of manufacturer discounts on applicable drugs</header><text>For purposes of applying subparagraph (A), the term <term>allowable reinsurance costs</term> 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.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H33F85871112D4FBD940F20632FD7B611"><enum>(2)</enum><text>in paragraph (3)—</text><subparagraph id="HD14347C63D2D46788D03A5A2F7157B5B"><enum>(A)</enum><text>in the first sentence, by striking <quote>For purposes</quote> and inserting <quote>Subject to paragraph (2)(B), for purposes</quote>; and</text></subparagraph><subparagraph id="H7484C9728AA04D75944382F686503D3C"><enum>(B)</enum><text>in the second sentence, by inserting <quote>or, in the case of an applicable drug, by a manufacturer</quote> after <quote>by the individual or under the plan</quote>.</text></subparagraph></paragraph></subsection><subsection id="H68B1CA4A810B44B8A266764031D30775"><enum>(f)</enum><header>Updating risk adjustment methodologies To account for part D modernization redesign</header><text>Section 1860D–15(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-115">42 U.S.C. 1395w–115(c)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HE829D28E5F434EC2BFB1C7A97447439A"><paragraph id="H79269D91E1AD474C98A0F368FC324E7B"><enum>(3)</enum><header>Updating risk adjustment methodologies to account for part D modernization redesign</header><text>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 <short-title>Fair Care Act of 2024</short-title>.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection commented="no" id="HD892DAF08C3D4BE99E8D16A3FDA8A14B"><enum>(g)</enum><header>Conditions for coverage of drugs under this part</header><text>Section 1860D–43 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-153">42 U.S.C. 1395w–153</external-xref>) is amended—</text><paragraph commented="no" id="HE628D712639B464683AE6064179760EC"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph commented="no" id="H6B64DEBBCA934A5396ACC951F34E0698"><enum>(A)</enum><text>in paragraph (2), by striking <quote>and</quote> at the end;</text></subparagraph><subparagraph commented="no" id="H10B9C6F0B97B48B8885C8538C491AFE4"><enum>(B)</enum><text>in paragraph (3), by striking the period at the end and inserting a semicolon; and</text></subparagraph><subparagraph commented="no" id="H8DDF0D18EDA3415BA1BDA82F3177611F"><enum>(C)</enum><text>by adding at the end the following new paragraphs:</text><quoted-block id="HE635690552AE4975B40D56139C84E314" style="OLC"><paragraph commented="no" id="H2743D82B0E624C6A8166DACBDAE5CF62"><enum>(4)</enum><text>participate in the manufacturer discount program under section 1860D–14B;</text></paragraph><paragraph commented="no" id="H68E1FAEA97B54B58BBBDC8AC38F8B8F9"><enum>(5)</enum><text>have entered into and have in effect an agreement described in subsection (b) of such section 1860D–14B with the Secretary; and</text></paragraph><paragraph commented="no" id="H6C041243638144BAA5AA1A6B272AAA81"><enum>(6)</enum><text>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.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" id="H5CF8632442F3490B857272011F236A33"><enum>(2)</enum><text>by striking subsection (b) and inserting the following:</text><quoted-block id="HC24274F927F643218A1AD33F7A1B11B2" style="OLC"><subsection commented="no" id="HA663D2B52891419081CE4DA4472F46AD"><enum>(b)</enum><header>Effective date</header><text>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.</text></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph commented="no" id="HC4FC700199364623A2C2DCA0D43FFBA8"><enum>(3)</enum><text>in subsection (c), by striking paragraph (2) and inserting the following:</text><quoted-block id="H6F6C379901DB4698B782E793A70D2350" style="OLC"><paragraph commented="no" id="HD8AFF2A1DAC446E5A9918AFE108D3868"><enum>(2)</enum><text>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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H87F9504DA866429F9674F6E9E6559E65"><enum>(h)</enum><header>Conforming amendments</header><paragraph id="HCE5816C7A8074084877516552246E0B3"><enum>(1)</enum><text>Section 1860D–2 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102</external-xref>) is amended—</text><subparagraph id="H1074FECF18CC4A1192AD8B0F0FC6FDE4"><enum>(A)</enum><text>in subsection (a)(2)(A)(i)(I), by striking <quote>, or an increase in the initial</quote> and inserting <quote>or for a year preceding 2025 an increase in the initial</quote>;</text></subparagraph><subparagraph id="H73C1F2E7330E42B68DA5D81E59958174"><enum>(B)</enum><text>in subsection (c)(1)(C)—</text><clause id="HFA680CD4F75C4CAB994C1D94411D4B78"><enum>(i)</enum><text>in the subparagraph heading, by striking <quote><header-in-text level="subparagraph" style="OLC">at initial coverage limit</header-in-text></quote>; and</text></clause><clause id="HBCF659DC3B6348D78E0D015608B75DCC"><enum>(ii)</enum><text>by inserting <quote>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</quote> after <quote>subsection (b)(3) for the year</quote> each place it appears; and</text></clause></subparagraph><subparagraph id="HB222758043BC4AE1BDB2DF94C9750681"><enum>(C)</enum><text>in subsection (d)(1)(A), by striking <quote>or an initial</quote> and inserting <quote>or for a year preceding 2025 an initial</quote>.</text></subparagraph></paragraph><paragraph id="HCB8EDDD64C964936BB06D7F699FE9827"><enum>(2)</enum><text>Section 1860D–4(a)(4)(B)(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104(a)(4)(B)(i)</external-xref>) is amended by striking <quote>the initial</quote> and inserting <quote>for a year preceding 2025, the initial</quote>.</text></paragraph><paragraph id="HAAF271ABA58D45DE8ACCA8D23012C9B6"><enum>(3)</enum><text>Section 1860D–14(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-114">42 U.S.C. 1395w–114(a)</external-xref>) is amended—</text><subparagraph id="H42C35315D99C4D77AE5DB6BF84A52042"><enum>(A)</enum><text>in paragraph (1)—</text><clause id="HE135BA184DB543BE9148B2919F68BFD1"><enum>(i)</enum><text>in subparagraph (C), by striking <quote>The continuation</quote> and inserting <quote>For a year preceding 2025, the continuation</quote>;</text></clause><clause id="HED703B52C1AA47119B04ECB7C34C1092"><enum>(ii)</enum><text>in subparagraph (D)(iii), by striking <quote>1860D–2(b)(4)(A)(i)(I)</quote> and inserting <quote>1860D–2(b)(4)(A)(i)(I)(aa)</quote>; and</text></clause><clause id="HBB53E7018A604C0588A351421682AFD0"><enum>(iii)</enum><text>in subparagraph (E), by striking <quote>The elimination</quote> and inserting <quote>For a year preceding 2025, the elimination</quote>; and </text></clause></subparagraph><subparagraph id="H4285AF541936497E87DCDCD44FE2512A"><enum>(B)</enum><text>in paragraph (2)—</text><clause id="H6A95C79995B14A90B77A85FAFF28BB1A"><enum>(i)</enum><text>in subparagraph (C), by striking <quote>The continuation</quote> and inserting <quote>For a year preceding 2025, the continuation</quote>; and</text></clause><clause id="H1AB2FA18BA334D6E9E83E608306367EB"><enum>(ii)</enum><text>in subparagraph (E)—</text><subclause id="H860217CA28314D5991212FDA8C6EB353"><enum>(I)</enum><text>by inserting <quote>for a year preceding 2025,</quote> after <quote>subsection (c)</quote>; and</text></subclause><subclause id="H393382EDFF594A9BBF22C350B5EE7136"><enum>(II)</enum><text>by striking <quote>1860D–2(b)(4)(A)(i)(I)</quote> and inserting <quote>1860D–2(b)(4)(A)(i)(I)(aa)</quote>.</text></subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBE05E956F4BC43B59B4BB4E49C1D8E8E"><enum>(4)</enum><text display-inline="yes-display-inline">Section 1860D–21(d)(7) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-131">42 U.S.C. 1395w–131(d)(7)</external-xref>) is amended by striking <quote>section 1860D–2(b)(B)(4)(B)(i)</quote> and inserting <quote>section 1860D–2(b)(B)(4)(C)(i)</quote>.</text></paragraph><paragraph id="HF6C62D27BC1C489592826B4F5C7FAD9F"><enum>(5)</enum><text display-inline="yes-display-inline">Section 1860D–22(a)(2)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-132">42 U.S.C. 1395w–132(a)(2)(A)</external-xref>) is amended—</text><subparagraph id="HC46FFAFBA622411EA78EF154D4D33C02"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>the value of any discount</quote> and inserting the following: “the value of—</text><quoted-block style="OLC" display-inline="no-display-inline" id="H81135C9CA71846E7AEFFE2B390221B29"><clause id="H5645BB6D8D9B43D99C7575D39626DEE3"><enum>(i)</enum><text display-inline="yes-display-inline">for years prior to 2025, any discount</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="HB3470929E73F4D138E57ED17D195FA99"><enum>(B)</enum><text>in clause (i), as inserted by subparagraph (A) of this paragraph, by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph id="H6F0CC85E0A5E476A87653A8C284825A4"><enum>(C)</enum><text>by adding at the end the following new clause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HF81E08BB3F5D477EB2CB6DBF99A88662"><clause commented="no" id="H98FCCAE0F7A942ABA8B3A56F183D1987"><enum>(ii)</enum><text>for 2025 and each subsequent year, any discount provided pursuant to section 1860D–14B.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HB4F4F94579CE45AEA121AE99581C7C1B"><enum>(6)</enum><text>Section 1860D–41(a)(6) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-151">42 U.S.C. 1395w–151(a)(6)</external-xref>) is amended—</text><subparagraph id="H75C12AE17064432B803D1EC70682EE34"><enum>(A)</enum><text>by inserting <quote>for a year before 2025</quote> after <quote>1860D–2(b)(3)</quote>; and</text></subparagraph><subparagraph id="HAFE5F66874A248CBBBD7F25E827A5EF7"><enum>(B)</enum><text>by inserting <quote>for such year</quote> before the period.</text></subparagraph></paragraph></subsection><subsection id="H882AC6C13C4547F0A0C36AA6C986852E"><enum>(i)</enum><header>Effective date</header><text>The amendments made by this section shall apply to plan year 2025 and subsequent plan years.</text></subsection></section><section id="HA4EED4A11B5B4DDFBB0115430C6913CB"><enum>372.</enum><header>Maximum monthly cap on cost-sharing payments under prescription drug plans and MA–PD plans</header><subsection id="HB59DDB59B08F47EC9709B301E0939609"><enum>(a)</enum><header>In general</header><text>Section 1860D–2(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(b)</external-xref>), as amended by section 121, is amended—</text><paragraph id="H98DFDFE1BE2343B0A548F5D537BA482F"><enum>(1)</enum><text>in paragraph (2)—</text><subparagraph id="H278AD52FBD744F2FBFBFABE460467BB8"><enum>(A)</enum><text>in subparagraph (A), by striking <quote>and (D)</quote> and inserting <quote>, (D), and (E)</quote>; and</text></subparagraph><subparagraph id="H64756FD999A44FD5AE94480A28250BB1"><enum>(B)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA173DC631E1C47C38B309C64CE278D7D"><subparagraph id="H8692C28B86F54DB2918F702952661CC8"><enum>(E)</enum><header>Maximum monthly cap on cost-sharing payments</header><clause id="HEC99CB1ACD3D483E8A130B874C9F9A1C"><enum>(i)</enum><header>In general</header><text>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.</text></clause><clause id="HD8CD4A337E0E47BB8B1AC0EB4496529A"><enum>(ii)</enum><header>Determination of maximum monthly cap</header><text>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.</text></clause><clause id="H891F9A8B3D2A4F559704D8D20F0AD0E0"><enum>(iii)</enum><header>Beneficiary monthly payments</header><text>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.</text></clause><clause id="HD8DA0C14D28E4046A3C431D62C80685B"><enum>(iv)</enum><header>Maximum monthly cap defined</header><text>In this subparagraph, the term <term>maximum monthly cap</term> means, with respect to an enrollee—</text><subclause id="H8B114095F73F40758A6EC44740075CA0"><enum>(I)</enum><text>for the first month in which this subparagraph applies, an amount determined by calculating—</text><item id="HCCA9E06CB347482EB95A87D81E31E8E4"><enum>(aa)</enum><text>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</text></item><item id="H6F68F7C72109462E922F1DA82D0FA66F"><enum>(bb)</enum><text>the number of months remaining in the plan year; and</text></item></subclause><subclause id="HC069500CBE9E46BD9D6F6A4CF0506615"><enum>(II)</enum><text>for a subsequent month, an amount determined by calculating—</text><item id="H430707A2A501448DBAAFF3AD7BB3EF95"><enum>(aa)</enum><text>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</text></item><item id="H447056DB245B415CAD731A4F95872BE9"><enum>(bb)</enum><text>the number of months remaining in the plan year.</text></item></subclause></clause><clause id="HC1D6FDB511664656A1560BA0B5384031"><enum>(v)</enum><header>Additional requirements</header><text>The following requirements shall apply with respect to the option to make an election pursuant to clause (i) under this subparagraph:</text><subclause id="H7B9EF3F0EB7647D799F6B21EE6A0F21E"><enum>(I)</enum><header>Secretarial responsibilities</header><text>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).</text></subclause><subclause id="H1FEA2AD272214B20942DB6B9BB267862"><enum>(II)</enum><header>Timing of election</header><text>An enrollee in a prescription drug plan or an MA–PD plan may make such an election—</text><item id="H78F6F56AC8A545EE8DFB8195BCDF8B38"><enum>(aa)</enum><text>prior to the beginning of the plan year; or</text></item><item id="H062A77740ED74D698E8FE3BC005E9ED9"><enum>(bb)</enum><text>in any month during the plan year.</text></item></subclause><subclause id="HB292809C4FC64130B221C0B0EAD4806E"><enum>(III)</enum><header>PDP sponsor and MA organization responsibilities</header><text>Each PDP sponsor offering a prescription drug plan or MA organization offering an MA–PD plan—</text><item id="H94BC1F657BFF48979AE066AA55DAB646"><enum>(aa)</enum><text>may not limit the option for an enrollee to make such an election to certain covered part D drugs; </text></item><item id="H2B032070BE9C464385C25CFA7CA719BE"><enum>(bb)</enum><text>shall, prior to the plan year, notify prospective enrollees of the option to make such an election in promotional materials;</text></item><item id="H1A6313C4123346BABAB10670D1D447D4"><enum>(cc)</enum><text>shall include information on such option in enrollee educational materials;</text></item><item id="H32A0DC7412D54A0BABE4314F5FFBBB25"><enum>(dd)</enum><text>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;</text></item><item id="HADB6DDAA39E34949AE2298B4C694D447"><enum>(ee)</enum><text>shall provide that a pharmacy, after receiving a notification described in item (dd) with respect to an enrollee, informs the enrollee of such notification;</text></item><item id="H90C95D2BA84C46FA96E0E5D874E38F62"><enum>(ff)</enum><text>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</text></item><item commented="no" id="H3B3FC2270E8C4C67A4408FA3464EEDD8"><enum>(gg)</enum><text>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.</text></item></subclause><subclause id="H4CC1625D38D84C0C9F85E40249F2069C"><enum>(IV)</enum><header>Failure to pay amount billed</header><text>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).</text></subclause><subclause id="HBF53863B4E0B49C583A374F183CF3327"><enum>(V)</enum><header>Clarification regarding past due amounts</header><text>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. </text></subclause><subclause id="H93774DA166E749D287DE8C81EC22E70D"><enum>(VI)</enum><header>Treatment of unsettled balances</header><text>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.</text></subclause></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H7CE22A4FDB9F48F596420E12276D5E97"><enum>(2)</enum><text>in paragraph (4)—</text><subparagraph id="H8DA57327A0AD4CD79A95FD96032AFBFD"><enum>(A)</enum><text>in subparagraph (C), by striking <quote>and subject to subparagraph (F)</quote> and inserting <quote>and subject to subparagraphs (F) and (G)</quote>; and</text></subparagraph><subparagraph id="H9D97A3B497424072A14B57E87676FEB9"><enum>(B)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H4C3B918553F54F5DA6806C1917E50DD4"><subparagraph id="HC231184B325A4DD291DFB632CBC4675A"><enum>(G)</enum><header>Inclusion of costs paid under maximum monthly cap option</header><text>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.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection><subsection id="H55F8EA73C338450789BFD7ACAF8BDF5F"><enum>(b)</enum><header>Application to alternative prescription drug coverage</header><text>Section 1860D–2(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(c)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HCD3DE8563D9248F7A2BEF79593DD0409"><paragraph id="H9DF7E8A37023430DA888B7A053ACC812"><enum>(4)</enum><header>Same maximum monthly cap on cost-sharing</header><text>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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="HD7B8DB930C314AB5B320B6E83AC3E749"><enum>373.</enum><header>Market based part B pricing index</header><text display-inline="no-display-inline">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. </text></section><section id="H5B96060EDB2A4D4EBD0592404DC0A0BC" commented="no"><enum>374.</enum><header>Innovation model testing of Medicare drug payments</header><text display-inline="no-display-inline">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.</text></section><section id="HB5AFFE286CCD4F04ABAAA7C709BB0B5C"><enum>375.</enum><header>Modification of maximum rebate amount under Medicaid drug rebate program</header><subsection id="H9C6FC0FD2C6A4732A0E0F2B4A0F476D5"><enum>(a)</enum><header>In general</header><text>Subparagraph (D) of section 1927(c)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(c)(2)</external-xref>) is amended to read as follows:</text><quoted-block id="HEB52193C5C024734A894326D57A01B1D" style="OLC"><subparagraph id="H81FB8B5957024DAC9F8157BD0B569D8A"><enum>(D)</enum><header>Maximum rebate amount</header><clause id="H98C4C39D847147B0AE2FE1D9C53FE9B2"><enum>(i)</enum><header>In general</header><text>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—</text><subclause id="H30EC0B7D6AF24CDEB61F42DF20B15B2E"><enum>(I)</enum><text>for rebate periods beginning after December 31, 2009, and before September 30, 2025, 100 percent of the average manufacturer price of the drug; and</text></subclause><subclause id="H6BEA9BF2EF50449DB60463620F8D1DB1"><enum>(II)</enum><text>for rebate periods beginning on or after October 1, 2025, 125 percent of the average manufacturer price of the drug.</text></subclause></clause><clause id="H03342D1A459B49B490F46302AF7DC29F"><enum>(ii)</enum><header>No maximum amount for drugs if AMP increases outpace inflation</header><subclause id="HE1A72DC2B5AE47B59B7EB69F07046D6A"><enum>(I)</enum><header>In general</header><text>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.</text></subclause><subclause id="H92034348A70644B2BC26C9BC517264E9"><enum>(II)</enum><header>Inflation-adjusted average manufacturer price defined</header><text>In this clause, the term <term>inflation-adjusted average manufacturer price</term> 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.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HEC138915FB594991AB70C2DAA320BFF7"><enum>(b)</enum><header>Treatment of subsequently approved drugs</header><text>Section 1927(c)(2)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(c)(2)(B)</external-xref>) is amended by inserting <quote>and clause (ii)(II) of subparagraph (D)</quote> after <quote>clause (ii)(II) of subparagraph (A)</quote>.</text></subsection><subsection id="H7EA5915F2E914BE58230099A491A84F9"><enum>(c)</enum><header>Technical amendments</header><text>Section 1927(c)(3)(C)(ii)(IV) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-9">42 U.S.C. 1396r–9(c)(3)(C)(ii)(IV)</external-xref>) is amended—</text><paragraph id="H87742503CCA5460D9E1DFA8CA1D915F5"><enum>(1)</enum><text>by striking <quote>subparagraph (A)</quote> and inserting <quote>paragraph (3)(A)</quote>; and</text></paragraph><paragraph id="HC955B3220B684AD782CDA3BAB4473712"><enum>(2)</enum><text>by striking <quote>this subparagraph</quote> and inserting <quote>paragraph (3)(C)</quote>.</text></paragraph></subsection></section></subtitle><subtitle id="HBACAA18A83F54F8D90B449D44008ECF2"><enum>F</enum><header>Medical Malpractice Reform</header><section id="H602D6973413F42AE86E52840DF72AD8A"><enum>381.</enum><header>Definitions</header><text display-inline="no-display-inline">In this Act:</text><paragraph id="HA66A9AE4FC49427A867DA6D3A558F493"><enum>(1)</enum><header>Alternative dispute resolution system; ADR</header><text>The term <term>alternative dispute resolution system</term> or <term>ADR</term> 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.</text></paragraph><paragraph id="H9CA201C00DCF47F28C741FCA7C4D1068"><enum>(2)</enum><header>Claimant</header><text>The term <term>claimant</term> 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.</text></paragraph><paragraph id="H2D942851BB1B44B098ABEEE1FA46A9D9"><enum>(3)</enum><header>Collateral source benefits</header><text>The term <term>collateral source benefits</term> 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—</text><subparagraph id="H3624D128EA3D4E3A96D4B6706D2230D5"><enum>(A)</enum><text>any State or Federal health, sickness, income-disability, accident, or workers’ compensation law;</text></subparagraph><subparagraph id="H1A82FEBADA42475EBB9ECEB2C96940F6"><enum>(B)</enum><text>any health, sickness, income-disability, or accident insurance that provides health benefits or income-disability coverage;</text></subparagraph><subparagraph id="H7991AA50C9EE481191D1E642AFBBD6BE"><enum>(C)</enum><text>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</text></subparagraph><subparagraph id="H9BA8703D457F4966B4B3633A65711A95"><enum>(D)</enum><text>any other publicly or privately funded program.</text></subparagraph></paragraph><paragraph id="HFE2524FC663744258E9C422CC0852D4C"><enum>(4)</enum><header>Contingent fee</header><text>The term <term>contingent fee</term> includes all compensation to any person or persons which is payable only if a recovery is effected on behalf of one or more claimants.</text></paragraph><paragraph id="H0918F180810A48C2A4D66F4C314A7A5F"><enum>(5)</enum><header>Economic damages</header><text>The term <term>economic damages</term> 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.</text></paragraph><paragraph id="H0FABB460F6E14F47B63A7E7DFEA085D7"><enum>(6)</enum><header>Future damages</header><text>The term <term>future damages</term> 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).</text></paragraph><paragraph id="HC475D6CCEB974E3C8F9AC3790FBB8F79"><enum>(7)</enum><header>Health care lawsuit</header><text>The term <term>health care lawsuit</term> 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.</text></paragraph><paragraph id="HDDBD625CDA7D4B5CBE06F7B946995758"><enum>(8)</enum><header>Health care liability action</header><text>The term <term>health care liability action</term> 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.</text></paragraph><paragraph id="HE900FE082043418B8603B0E76DCD9B5D"><enum>(9)</enum><header>Health care liability claim</header><text>The term <term>health care liability claim</term> 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.</text></paragraph><paragraph id="HD46D02D7D932454A9A32803713382EF2"><enum>(10)</enum><header>Health care provider</header><text>The term <term>health care provider</term> 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.</text></paragraph><paragraph id="HA0499D74369E4934AF98D5507F276499"><enum>(11)</enum><header>Health care services</header><text display-inline="yes-display-inline">The term <term>health care services</term> 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.</text></paragraph><paragraph id="H0AA1F235372542CF9C3C6299EDB3997E"><enum>(12)</enum><header>Medical product</header><text>The term <term>medical product</term> means a drug, device, or biological product intended for humans, and the terms <term>drug</term>, <term>device</term>, and <term>biological product</term> have the meanings given such terms in sections 201(g)(1) and 201(h) of the Federal Food, Drug and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321(g)(1)</external-xref> and (h)) and section 351(a) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(a)</external-xref>), respectively, including any component or raw material used therein, but excluding health care services.</text></paragraph><paragraph id="HFEDC8ACAA1EB4F0381D24F8B67335099"><enum>(13)</enum><header>Noneconomic damages</header><text>The term <term>noneconomic damages</term> 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.</text></paragraph><paragraph id="H15C95B94C8D04089B84761FA3E9F8161"><enum>(14)</enum><header>Recovery</header><text>The term <term>recovery</term> 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.</text></paragraph><paragraph id="H25A37D3D62C54F4B9B0B3A5122235EBC"><enum>(15)</enum><header>Representative</header><text>The term <term>representative</term> 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.</text></paragraph><paragraph id="H1CDBA44BCF5E45CD897BA3141F9302E9"><enum>(16)</enum><header>State</header><text>The term <term>State</term> 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.</text></paragraph></section><section id="H82D38E56C3054D5FA021F18C71B2802A"><enum>382.</enum><header>Encouraging speedy resolution of claims</header><subsection id="HA70BFC13370F461D832A96A0D921F417"><enum>(a)</enum><header>Statute of limitations</header><paragraph id="HEB91D738F42C4D70B33BC17A3FE34628"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided in paragraph (2), the time for the commencement of a health care lawsuit shall be, whichever occurs first of the following:</text><subparagraph id="HB3924CAB2CBE4DA799E6FEFF2DC9C045"><enum>(A)</enum><text>Three years after the date of the occurrence of the breach or tort.</text></subparagraph><subparagraph id="H53DBF5E5B94E4911B81C91C5BC2FB9AB"><enum>(B)</enum><text>Three years after the date the medical or health care treatment that is the subject of the claim is completed.</text></subparagraph><subparagraph id="H143CA4599EFB4FBC9DCA527A94CF510C"><enum>(C)</enum><text>One year after the claimant discovers, or through the use of reasonable diligence should have discovered, the injury. </text></subparagraph></paragraph><paragraph id="H16A703DD8A444705B93802B1CA25C8A8"><enum>(2)</enum><header>Tolling</header><text display-inline="yes-display-inline">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—</text><subparagraph id="HFC668DE4BF4F40ED968AF487F808F660"><enum>(A)</enum><text>upon proof of fraud; </text></subparagraph><subparagraph id="H2CBDCB26EBA14A8CA702D75A309ED18A"><enum>(B)</enum><text>intentional concealment; or </text></subparagraph><subparagraph id="HC6D5D51E593A487BBFA494CCC2A19665"><enum>(C)</enum><text>the presence of a foreign body, which has no therapeutic or diagnostic purpose or effect, in the person of the injured person.</text></subparagraph></paragraph><paragraph id="HF5DF34794FB34F14B2748BBA0C912ABE"><enum>(3)</enum><header>Actions by a minor</header><text display-inline="yes-display-inline">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.</text></paragraph></subsection><subsection id="HEF7E775FA2764EA58482938593A49AD6"><enum>(b)</enum><header>State flexibility</header><text>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—</text><paragraph id="HC3D3EA47BA4244DBAC4E87DD78D301C2"><enum>(1)</enum><text>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;</text></paragraph><paragraph id="HDA02EBDDF69243D5BF7DA2702E931822"><enum>(2)</enum><text>that specifies a different time period for the filing of lawsuits by a minor;</text></paragraph><paragraph id="H7018F668DADD4FE18CE2D3814E69E56B"><enum>(3)</enum><text>that triggers the time period based on the date of the alleged negligence; or</text></paragraph><paragraph id="H57FED345E27A47E49BEE9C3CAEAE9A21"><enum>(4)</enum><text>establishes a statute of repose for the filing of a health care lawsuit.</text></paragraph></subsection></section><section id="HABBEAC9D622E41F08D16334A40D868FE"><enum>383.</enum><header>Compensating patient injury</header><subsection id="H82660DE0E86E461A8CCC630DDCF5B7F1"><enum>(a)</enum><header>Unlimited amount of damages for actual economic losses in health care lawsuits</header><text>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).</text></subsection><subsection id="H17966C98B74642B4BCCA002E06AC2041"><enum>(b)</enum><header>Additional noneconomic damages</header><text>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.</text></subsection><subsection id="H912532639D0F42DEB76D071E727298A0"><enum>(c)</enum><header>No discount of award for noneconomic damages</header><text>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.</text></subsection><subsection id="H95B8059576794C86BD91A9A5CAAF3C00"><enum>(d)</enum><header>Fair share rule</header><text>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.</text></subsection><subsection id="HF1528485D11E444A89606E039E918A1B"><enum>(e)</enum><header>State flexibility</header><text>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.</text></subsection></section><section id="H0850C3EACF0C4F83ADB930D2E7F12F80"><enum>384.</enum><header>Maximizing patient recovery</header><subsection id="H13998F5E0F364058A2A2CDE28856E38A"><enum>(a)</enum><header>Court supervision of share of damages actually paid to claimants</header><text>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:</text><paragraph id="H7B4EFEDC3DDD4414B96CECED160CB86C"><enum>(1)</enum><text>Forty percent of the first $50,000 recovered by the claimant(s).</text></paragraph><paragraph id="HCDD67F9C3F2348F9A4CFFC07CE26E5C4"><enum>(2)</enum><text>Thirty-three and one-third percent of the next $50,000 recovered by the claimant(s).</text></paragraph><paragraph id="H0C59B8C062F347F79425FCA33B27AFC8"><enum>(3)</enum><text>Twenty-five percent of the next $500,000 recovered by the claimant(s).</text></paragraph><paragraph id="H5C9B9DBA27DF4890B2E9D07898D41C21"><enum>(4)</enum><text>Fifteen percent of any amount by which the recovery by the claimant(s) is in excess of $600,000.</text></paragraph></subsection><subsection id="H9D81028737FA4B2C8AA341BD115C1EC3"><enum>(b)</enum><header>Applicability</header><text>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.</text></subsection><subsection id="H2E3EFD8AD8284D25BF10089409806E59"><enum>(c)</enum><header>State flexibility</header><text>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.</text></subsection></section><section id="HB88514ACAD364594A9F19FB7DAE744BE"><enum>385.</enum><header>Authorization of payment of future damages to claimants in health care lawsuits</header><subsection id="H36348CB0A9CF4603B35D380BD1144972"><enum>(a)</enum><header>In general</header><text>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.</text></subsection><subsection id="H61A104B911DC4380B1049A397B3DBA43"><enum>(b)</enum><header>Applicability</header><text>This section applies to all actions which have not been first set for trial or retrial before the effective date of this Act.</text></subsection><subsection id="HB6C4C30B4857472B95F39C612D648735"><enum>(c)</enum><header>State Flexibility</header><text>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.</text></subsection></section><section id="H3D8B4F5D09F8404591FC27DAE5E0EF07"><enum>386.</enum><header>Product liability for health care providers</header><text display-inline="no-display-inline">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.</text></section><section id="H3A064BA4343C4D94B6DD36A3D0895C78"><enum>387.</enum><header>Effect on other laws</header><subsection id="HF5BE961727C64483983EEF9CAF102618"><enum>(a)</enum><header>Vaccine injury</header><paragraph id="H324E21005D984749870E684FF411DA1B"><enum>(1)</enum><text>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—</text><subparagraph id="HAB7B085CC5B84209AA33CC823902CF36"><enum>(A)</enum><text>this Act does not affect the application of the rule of law to such an action; and</text></subparagraph><subparagraph id="HEB7F372B528E46C980C32DEE09C1B100"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><paragraph id="HFA3297F63C384B5CB2E33AAF7DF646DB"><enum>(2)</enum><text>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.</text></paragraph></subsection><subsection id="HB377351FA7184367BF022C38FBC15A66"><enum>(b)</enum><header>Other Federal law</header><text>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.</text></subsection></section><section id="H429E8888A4B44B549DFE6FC72CEBA0B8"><enum>388.</enum><header>Limitation on expert witness testimony</header><subsection id="H1C83DD704D104C49A4C1CB61195A5B12"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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—</text><paragraph id="H5C3E27C2AF4E4C18A1EA09061B69BD86"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text></paragraph><paragraph id="H7234DF089C57493885CD6A22519FD782"><enum>(2)</enum><text display-inline="yes-display-inline">that the defendant acted with less than or failed to act with ordinary and reasonable care in accordance with the recognized standard; and</text></paragraph><paragraph id="H5771F7BCCA8D4F55B439F3B48E1DC6A8"><enum>(3)</enum><text display-inline="yes-display-inline">that as a proximate result of the defendant’s negligent act or omission, the claimant suffered injuries which would not otherwise have occurred,</text></paragraph><continuation-text continuation-text-level="subsection">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. </continuation-text></subsection><subsection id="H2A30207C248F4F62927FB4275BA50DAA"><enum>(b)</enum><header>Applicability</header><text display-inline="yes-display-inline">The requirements set forth in subsection (a) shall also apply to expert witnesses testifying for the defendant as rebuttal witnesses.</text></subsection><subsection id="H3F77E7D80B3446A69CE0BA8B836647AE"><enum>(c)</enum><header>Waiver authority</header><text display-inline="yes-display-inline">The court may waive the requirements in this subsection if it determines that the appropriate witnesses otherwise would not be available.</text></subsection></section><section id="H01CBF4413C934692B8237FC1BABEB434" display-inline="no-display-inline" section-type="subsequent-section"><enum>389.</enum><header>Expert witness qualifications</header><subsection id="HB9F263A1B7E0498298B8AD87F57802B7"><enum>(a)</enum><header>In general</header><text>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:</text><paragraph id="H10EECF319819429D9F84F1E3BE8DD0F2"><enum>(1)</enum><text>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.</text></paragraph><paragraph id="H8C009D0FE2D94DE7B4502BC8510ABD09"><enum>(2)</enum><text>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:</text><subparagraph id="H8BA97C39DCB14051BF3C0EF629194F3E"><enum>(A)</enum><text>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.</text></subparagraph><subparagraph id="H1B45FB258A464150BD90D8D4A97CCFAE"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><paragraph id="HC7A8DA32B41B433089C9045A26370412"><enum>(3)</enum><text>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:</text><subparagraph id="HFD8CE6FA90FA4E8FBD2FE09942927FA9"><enum>(A)</enum><text>Active clinical practice as a general practitioner.</text></subparagraph><subparagraph id="H90D036D353D5422D842FA8ED589340BD"><enum>(B)</enum><text>Instruction of students in an accredited health professional school or accredited residency or clinical research program in the same health profession as the defendant.</text></subparagraph></paragraph></subsection><subsection id="H263925B7884040C9978CDB56BAEBEDD2"><enum>(b)</enum><header>Lawsuits against entities</header><text>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.</text></subsection><subsection id="HB3CE89B0D3D946FC9E816E424CC55D42"><enum>(c)</enum><header>Power of court</header><text>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.</text></subsection><subsection id="H81FB9BDFF91147608302FF1C06EF2C05"><enum>(d)</enum><header>Limitation</header><text>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.</text></subsection><subsection id="HC1DA599F2A9A48F2B7312481ACB0DB87"><enum>(e)</enum><header>State flexibility</header><text>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.</text></subsection></section><section id="HDE007336125444D58893E32D521FD1B2"><enum>390.</enum><header>Communications following unanticipated outcome</header><subsection id="H3E7A0EB61ABC4646A8EDFCF044F1FFEB"><enum>(a)</enum><header>Provider communications</header><text>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.</text></subsection><subsection id="HEB1A49CA93FA4534BEE1563CD3CC6067"><enum>(b)</enum><header>State flexibility</header><text>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.</text></subsection></section><section id="HD23BF6AD296448C78C9E82B9182A581D"><enum>391.</enum><header>Affidavit of merit</header><subsection id="H401FF07F01A24BC99BD8512B892695E5"><enum>(a)</enum><header>Required filing</header><text>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:</text><paragraph id="HE2E020E4176A4EEBB0814E29ECEB94BD"><enum>(1)</enum><text>The applicable standard of practice or care.</text></paragraph><paragraph id="HEAE559C9FD654AB0A224505DA35EDA16"><enum>(2)</enum><text>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.</text></paragraph><paragraph id="HB82D00DE04C142068A8CA1509D12E28E"><enum>(3)</enum><text>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.</text></paragraph><paragraph id="H789725314752484A9CAA3E2EBE721452"><enum>(4)</enum><text>The manner in which the breach of the standard of practice or care was the proximate cause of the injury alleged in the notice.</text></paragraph><paragraph id="H25CFA14A128A4CD28644CE44389C0E82"><enum>(5)</enum><text>A listing of the medical records reviewed.</text></paragraph></subsection><subsection id="H62DD5CEA7D8E4CFAAAAEFF1EE15BBD18"><enum>(b)</enum><header>Filing extension</header><text>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).</text></subsection><subsection id="H00D0927B402143C0A2CB6EE6532C6A22"><enum>(c)</enum><header>State flexibility</header><text>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.</text></subsection></section><section id="H34668AE72DC4476C9CAD2C9E540B2927"><enum>392.</enum><header>Notice of intent to commence lawsuit</header><subsection id="H25478566B81E45EDBDD3531EC143C42B"><enum>(a)</enum><header>Advance notice</header><text>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.</text></subsection><subsection id="HB4F1BB43AAF44829A53E24EFB357FC9B"><enum>(b)</enum><header>Exceptions</header><text>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.</text></subsection><subsection id="H71DA5266B95C4C9A8EC6C3EF82606BCE"><enum>(c)</enum><header>State flexibility</header><text>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.</text></subsection></section><section id="HE312FC8180614D0BB6666FA08081E871"><enum>393.</enum><header>Limitation on liability for volunteer health care professionals</header><subsection id="HB38E154F5256458890E26C768AB9E954"><enum>(a)</enum><header>In general</header><text>Title II of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/202">42 U.S.C. 202 et seq.</external-xref>) is amended by inserting after section 224 the following:</text><quoted-block id="H26DD802E4D7D4B5585A2F110F8D81287" style="OLC"><section id="HD9CB8331F25440FDADA061E7475EA0EC"><enum>224A.</enum><header>Limitation on liability for volunteer health care professionals</header><subsection id="H36D4678E390C435197836012339C1872"><enum>(a)</enum><header>Limitation on liability</header><text>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—</text><paragraph id="HBB3EAB092601459680A5E4E8A132872B"><enum>(1)</enum><text>occurs in the course of furnishing qualified charity care (as such term is defined in <external-xref legal-doc="usc" parsable-cite="usc/26/199B">section 199B</external-xref> of the Internal Revenue Code of 1986); and</text></paragraph><paragraph id="H1AA5EA3A5FCB4DA2A15BC0A3198B9307"><enum>(2)</enum><text>was not grossly negligent.</text></paragraph></subsection><subsection id="HE044B631C5E64A7793E8C91480FD99DD"><enum>(b)</enum><header>Preemption</header><text>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.</text></subsection><subsection id="H4479437523E94E4A94557C7B84159C46"><enum>(c)</enum><header>Definitions</header><text>In this section:</text><paragraph id="HA6167F845CAC412AB9C870034CE60976"><enum>(1)</enum><header>Physician</header><text>The term <term>physician</term> has the meaning given such term by section 1861(r) of the Social Security Act.</text></paragraph><paragraph id="H4703B5E31F8F47F595C02AB973A3BFCA"><enum>(2)</enum><header>Attending medical personnel</header><text>The term <term>attending medical personnel</term> means an individual who is licensed to directly support a physician in furnishing medical services.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H56B74FCDB9994F3EBA9D65F3ED95C3D6"><enum>(b)</enum><header>Effective date</header><text>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.</text></subsection></section><section id="HF7F6D32F750943358D9E3D44A4400DDB"><enum>394.</enum><header>Rules of construction</header><subsection id="H2A1D02CAD86343B893EEA73E1B09CFB5"><enum>(a)</enum><header>Health care lawsuits</header><text>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 <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/28/171">chapter 171</external-xref> of title 28, United States Code, to the extent that such chapter—</text><paragraph id="H0DD1E69217D744EAA985929CF35B9613"><enum>(1)</enum><text>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</text></paragraph><paragraph id="H35522FA523C641F9A2706870CDF07286"><enum>(2)</enum><text>prohibits the introduction of evidence regarding collateral source benefits, or mandates or permits subrogation or a lien on collateral source benefits.</text></paragraph></subsection><subsection id="HC0978CE47ADE4A538870B58B0CA43DD0"><enum>(b)</enum><header>Protection of States’ rights and other laws</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="H0366247BC6DE404DAD38E7C590CDA407"><enum>(c)</enum><header>State Flexibility</header><text>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.</text></subsection></section><section id="H92262B8A2B354C238214F1EB47A1E3EB"><enum>395.</enum><header>Effective date</header><text display-inline="no-display-inline">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.</text></section></subtitle><enum>IV</enum><header>Medicare and Medicaid Reforms</header><subtitle id="HC2436807D29F42BC8BC06AEDFBA6BD0E"><enum>A</enum><header>Medicaid Reforms</header><section id="H18AF595E631E43B4BCAA3360AEFAEA72"><enum>401.</enum><header>Medicaid payment reform</header><subsection id="H1C2D75E7A45841C39AC9C67898659970"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Title XIX of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396">42 U.S.C. 1396 et seq.</external-xref>) is amended by inserting after section 1903 the following section:</text><quoted-block display-inline="no-display-inline" id="H8F87335FD48647BEA7A6DFA626674878" style="OLC"><section id="H756ADB8A928D4199A894A160D64AD03F"><enum>1903A.</enum><header>Reformed payment to States</header><subsection id="H62BC80476D304FE285DCD482BB967E89"><enum>(a)</enum><header>Reformed payment system</header><paragraph id="H1C59B4F3C30A440F8183A4CD48F65FED"><enum>(1)</enum><header>In general</header><text>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:</text><subparagraph id="H5DFA8BF6D6734DB396F6C58B8ADBDEB0"><enum>(A)</enum><header>Adjusted aggregate beneficiary-based amount</header><text>The aggregate beneficiary-based amount specified in <internal-xref idref="H8F0FC6E7AF7C4F879BCBE62B84286297" legis-path="1903A.(b)">subsection (b)</internal-xref> for the quarter and the State, adjusted under <internal-xref idref="H7EF7BE376973460A8F5C20882CD1F25F" legis-path="1903A.(e)">subsection (e)</internal-xref>.</text></subparagraph><subparagraph id="H692376BDECE747F983D0CD332BA08B80"><enum>(B)</enum><header>Chronic care quality bonus</header><text display-inline="yes-display-inline">The amount (if any) of the chronic care quality bonus payment specified in <internal-xref idref="HBEE941292C8D450E9EF1B7C9C07ADF08" legis-path="1903A.(f)">subsection (f)</internal-xref> for the quarter for the State.</text></subparagraph></paragraph><paragraph id="H873179194E4B457887C8E70F52A10FF6"><enum>(2)</enum><header>Requirement of State share</header><subparagraph id="HFC052F35A543443EB2D539668EFA0E78"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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 <internal-xref idref="H1C59B4F3C30A440F8183A4CD48F65FED" legis-path="1903A.(a)(1)">paragraph (1)</internal-xref>, Federal funds would have been payable under this title.</text></subparagraph><subparagraph id="H199061B61D944061BCB6AD5829F6B255"><enum>(B)</enum><header>State share</header><text>The State share for a State for a quarter in a fiscal year is equal to the product of—</text><clause id="H998AFAB4509E40D597CA9E40EC6AD378"><enum>(i)</enum><text>the aggregate beneficiary-based amount specified in <internal-xref idref="H8F0FC6E7AF7C4F879BCBE62B84286297" legis-path="1903A.(b)">subsection (b)</internal-xref> for the quarter and the State; and</text></clause><clause id="HA38F7BE0A0644A2DAABA8670716226DF"><enum>(ii)</enum><text>the ratio of—</text><subclause id="HF90713FD127542E3AD039383B2E476A1"><enum>(I)</enum><text>the State percentage described in subparagraph (D)(ii) for such State and fiscal year; to</text></subclause><subclause id="H04807E80121C4A719AB8BF96D38E4D54"><enum>(II)</enum><text display-inline="yes-display-inline">the Federal percentage described in subparagraph (D)(i) for such State and fiscal year.</text></subclause></clause></subparagraph><subparagraph id="HA4D08CA396A247AFA4B5F90265C20CE7"><enum>(C)</enum><header>Nonpayment for failure to pay state share</header><clause id="H5625750346D54F6FABEA0EF17EF744B6"><enum>(i)</enum><header>In general</header><text>If a State fails to expend the amount required under <internal-xref idref="HFC052F35A543443EB2D539668EFA0E78" legis-path="1903A.(a)(2)(A)">subparagraph (A)</internal-xref> for a quarter in a fiscal year, the amount payable to the State under <internal-xref idref="H1C59B4F3C30A440F8183A4CD48F65FED" legis-path="1903A.(a)(1)">paragraph (1)</internal-xref> shall be reduced by the product of the amount by which the State payment is less than the State share and the ratio of—</text><subclause id="HE5EE6E10B3EC49D5A32C7CE203B0E6FF"><enum>(I)</enum><text display-inline="yes-display-inline">the Federal percentage described in subparagraph (D)(i) for such State and fiscal year; to</text></subclause><subclause id="HDFA9EC8CEA244883A423C68651D4B319"><enum>(II)</enum><text>the State percentage described in subparagraph (D)(ii) for such State and fiscal year.</text></subclause></clause><clause id="H2E356D029E8B4EC48674876E030DFB7F"><enum>(ii)</enum><header>Grace period</header><text display-inline="yes-display-inline">A State shall not be considered to have failed to provide payment of its required State share for a quarter under <internal-xref idref="HFC052F35A543443EB2D539668EFA0E78" legis-path="1903A.(a)(2)(A)">subparagraph (A)</internal-xref> 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.</text></clause></subparagraph><subparagraph id="HF956C204B9E84656892B2B0D1717FE7B"><enum>(D)</enum><header>Federal and State percentages</header><text>In this paragraph, with respect to a State and a fiscal year:</text><clause commented="no" id="H78607A75DED94381A4331DA497A7F9D1"><enum>(i)</enum><header>Federal percentage</header><text>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.</text></clause><clause id="H1F9A33FED19847F9B477F7200F5A8245"><enum>(ii)</enum><header>State percentage</header><text display-inline="yes-display-inline">The State percentage described in this clause is 100 percent minus the Federal percentage described in <internal-xref idref="H78607A75DED94381A4331DA497A7F9D1" legis-path="1903A.(a)(2)(D)(i)">clause (i)</internal-xref>.</text></clause></subparagraph><subparagraph id="H2945F018BB7B481A9E721D330C5B01E9"><enum>(E)</enum><header>Rules for crediting toward State share</header><clause id="HC19B52B0DC6C4D1EA73F9E488DB28314"><enum>(i)</enum><header>General limitation to matchable expenditures</header><text>A payment for expenditures shall not be counted toward the State share under <internal-xref idref="HFC052F35A543443EB2D539668EFA0E78" legis-path="1903A.(a)(2)(A)">subparagraph (A)</internal-xref> unless Federal payments may be used for such expenditures consistent with paragraph (3)(B).</text></clause><clause id="HC02467855C6241FCA151FCAB94E1B408"><enum>(ii)</enum><header>Further limitations on allowable expenditures</header><text>A payment for expenditures shall not be counted towards the State share under <internal-xref idref="HFC052F35A543443EB2D539668EFA0E78" legis-path="1903A.(a)(2)(A)">subparagraph (A)</internal-xref> if the expenditure is for any of the following:</text><subclause id="HE722176BD9DF48C3A330B976A51E90CD"><enum>(I)</enum><header>Abortion</header><text>Expenditures for an abortion.</text></subclause><subclause id="HE9EC13F94E9B420791EEDDFF315DE715"><enum>(II)</enum><header>Intergovernmental transfers</header><text>An expenditure that is attributable to an intergovernmental transfer.</text></subclause><subclause id="H1BF92369860241C7B925C3AA8639862F"><enum>(III)</enum><header>Certified public expenditures</header><text>An expenditure that is attributable to certified public expenditures.</text></subclause></clause><clause id="H84113555374745079A6DDC8E5699AFCB"><enum>(iii)</enum><header>Crediting fraud and abuse recoveries</header><text display-inline="yes-display-inline">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 <internal-xref idref="HFC052F35A543443EB2D539668EFA0E78" legis-path="1903A.(a)(2)(A)">subparagraph (A)</internal-xref>.</text></clause></subparagraph><subparagraph id="HB7000BE787D1480DA8BCF0A14A39A0D1"><enum>(F)</enum><header>Construction</header><text display-inline="yes-display-inline">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.</text></subparagraph><subparagraph id="HC74AA24A0C5B412FAE9FD4186E5F5070"><enum>(G)</enum><header>Determination based upon submitted claims</header><text>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.</text></subparagraph></paragraph><paragraph id="H5F7094806424495FAD63820F1FAFE87B"><enum>(3)</enum><header>Use of Federal payments</header><subparagraph id="HD4DFB7DCFBC14CEAA351218D6DB10679"><enum>(A)</enum><header>Application of Medicaid limitations</header><text>A State may only use Federal payments received under <internal-xref idref="H62BC80476D304FE285DCD482BB967E89" legis-path="1903A.(a)">subsection (a)</internal-xref> for expenditures for which Federal funds would have been payable under this title but for this section.</text></subparagraph><subparagraph id="H24C8CA59AF6547C4A6512047C1841A75"><enum>(B)</enum><header>Limitation for certain eligibles</header><clause id="HEBA702A4D4FF4EEAB4515E29F22C0AE1"><enum>(i)</enum><header>Application of 100 percent federal poverty line limit on eligibility</header><text>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.</text></clause><clause id="HF08AF7C7BEB74B50B2CB14ABC2BE98F5"><enum>(ii)</enum><header>Determination of income using modified adjusted gross income without any 5 percent increase</header><text display-inline="yes-display-inline">In determining income for purposes of clause (i) under section 1902(e)(14) (relating to modified adjusted gross income), the following rules shall apply:</text><subclause id="H0775EB5B24A64B35B4C9D4A9687CFC06"><enum>(I)</enum><header>Application of spend down</header><text display-inline="yes-display-inline">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).<italic></italic></text></subclause><subclause id="H492C0C8F259E41E3BA4BE9EB3E13DDE3"><enum>(II)</enum><header>Disregard of 5 percent increase</header><text>Subparagraph (I) of section 1902(e)(14) (relating to a 5 percent reduction) shall not apply.</text></subclause></clause><clause id="HAC551546C41F43258F32CEEF1D6F9ADD"><enum>(iii)</enum><header>Exception</header><text>Clause (i) shall not apply to an individual who is—</text><subclause id="HC4FA251CE50C4E4987E6F88473377E08"><enum>(I)</enum><text>a woman described in clause (i) of section 1903(v)(4)(A);</text></subclause><subclause id="HFE226FCD20F9424C9DB4B23ABC688FB9"><enum>(II)</enum><text>a child who is an individual described in clause (i) of section 1905(a);</text></subclause><subclause id="H83A4FDABD57142D8B575D04DEFF06B49"><enum>(III)</enum><text>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</text></subclause><subclause id="HC2CC54CAEF2F49BEB9E3F5A94F51D9CA"><enum>(IV)</enum><text display-inline="yes-display-inline">described in section 1902(e)(14)(D) (relating to modified adjusted gross income).</text></subclause></clause><clause id="H99F543034FC54A4A8A64EF8D7A09A926"><enum>(iv)</enum><header>Clarification related to community spouse</header><text>Nothing in this subparagraph shall supersede the application of section 1924 (related to community spouse income and assets).</text></clause></subparagraph></paragraph><paragraph id="HBC93BB7911514152A9A8A48D90EFB7D5"><enum>(4)</enum><header>Exceptions for pass-through payments</header><subparagraph id="H0A66286FAEB54954BB85A57EB6E8C872"><enum>(A)</enum><header>In general</header><text><internal-xref idref="H1C59B4F3C30A440F8183A4CD48F65FED" legis-path="1903A.(a)(1)">Paragraph (1)</internal-xref> shall not apply, and amounts shall continue to be payable under this title (and not under <internal-xref idref="H62BC80476D304FE285DCD482BB967E89" legis-path="1903A.(a)">subsection (a)</internal-xref>), in the case of the following payments (and related administrative costs and expenditures):</text><clause id="HB150AF80C4164488A6E345A80ED9157B"><enum>(i)</enum><header>Payments to territories</header><text>Payments to a State other than the 50 States and the District of Columbia.</text></clause><clause id="H19C7274716A14E118FAA1D47177BFE18"><enum>(ii)</enum><header>Medicare cost-sharing</header><text>Payments attributable to Medicare cost-sharing under section 1905(p).</text></clause><clause id="HC1A2B8EE34F240AB82768F67C997FB95"><enum>(iii)</enum><header>Pediatric vaccines</header><text>Payments attributable to section 1928.</text></clause><clause commented="no" id="HA5A5435EF4BD458FA67EA6FCBBEDEDF0"><enum>(iv)</enum><header>Emergency services for certain individuals</header><text>Payments for treatment of emergency medical conditions attributable to the application of section 1903(v)(2).</text></clause><clause id="H1A3D65B29CD646C99153FEF2F24A8C05"><enum>(v)</enum><header>Indian health care facilities</header><text>Payments for medical assistance described in the third sentence of section 1905(b).</text></clause><clause id="HC87FD3CDEA4847158ADAFF24AF031155"><enum>(vi)</enum><header>Employer-sponsored insurance (ESI)</header><text>Payments for medical assistance attributable to payments to employers for employer-sponsored health benefits coverage.</text></clause><clause commented="no" id="HA38B5E1505BF452994A3CBE9156BA4B5"><enum>(vii)</enum><header>Other populations with limited benefit coverage</header><text>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.</text></clause></subparagraph><subparagraph id="HC07B522014844CA9B49AE4E8DCEFC561"><enum>(B)</enum><header>Certain expenses</header><text><internal-xref idref="H1C59B4F3C30A440F8183A4CD48F65FED" legis-path="1903A.(a)(1)">Paragraph (1)</internal-xref> shall not apply, and amounts shall continue to be payable under this title (and not under <internal-xref idref="H62BC80476D304FE285DCD482BB967E89" legis-path="1903A.(a)">subsection (a)</internal-xref>), in the case of the following:</text><clause id="H4980501FDDF7441CAEE604A104060745"><enum>(i)</enum><header>Administration of medicare prescription drug benefit</header><text>Expenditures described in section 1935(b) (relating to administration of the Medicare prescription drug benefit).</text></clause><clause id="H3DC7ACF81C4C444B86044358B2373DFB"><enum>(ii)</enum><header>Payments for HIT bonuses</header><text display-inline="yes-display-inline">Payments under section 1903(a)(3)(F) (relating to payments to encourage the adoption and use of certified EHR technology).</text></clause><clause id="H8EBC1DD71C3A4511A982C9521DBE96F7"><enum>(iii)</enum><header>Payments for design, development, and installation of MMIS and eligibility systems</header><text display-inline="yes-display-inline">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).</text></clause></subparagraph></paragraph><paragraph id="H52433BB3E5EA4A14BE0017BF039FC1E7"><enum>(5)</enum><header>Payment of amounts</header><subparagraph id="H00977189D29C4CBDB327417C64744670"><enum>(A)</enum><header>In general</header><text>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.</text></subparagraph><subparagraph id="HC154A678D0A34390909380DEA2E3D0B6"><enum>(B)</enum><header>Information and forms</header><clause id="H13E6ACCD4F694189AD7F48F7BC291476"><enum>(i)</enum><header>Submission</header><text>As a condition of receiving payment under <internal-xref idref="H62BC80476D304FE285DCD482BB967E89" legis-path="1903A.(a)">subsection (a)</internal-xref>, 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).</text></clause><clause id="H07039D6AE3A6484398626725C3EAD76D"><enum>(ii)</enum><header>Uniform reporting</header><text>The Secretary shall develop such forms as may be needed to assure a system of uniform reporting of such information across States.</text></clause></subparagraph><subparagraph id="H4856134B03FF4AEE91859E631E1345FF"><enum>(C)</enum><header>Required reporting of information on medical loss ratios for managed care</header><text>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.</text></subparagraph></paragraph></subsection><subsection id="H8F0FC6E7AF7C4F879BCBE62B84286297"><enum>(b)</enum><header>Aggregate beneficiary-Based amount</header><paragraph id="H3A92EE14056C4E7C90487DEC41808C7F"><enum>(1)</enum><header>In general</header><text>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 <internal-xref idref="H5B41BB8C9F6F452C9E3EED96D91DCB50" legis-path="1903A.(b)(2)">paragraph (2)</internal-xref>, of the following:</text><subparagraph id="H14AFF88F0FA240B99645B44669B091F0"><enum>(A)</enum><header>Beneficiary-based quarterly amount</header><text>The beneficiary-based quarterly amount for such category computed under <internal-xref idref="H640250343D774766A72694E490AEF489" legis-path="1903A.(c)">subsection (c)</internal-xref> for such State for such quarter.</text></subparagraph><subparagraph id="HD5E4C4A310A4407D8EF3A901CCE7AA7D"><enum>(B)</enum><header>Number of individuals in category</header><text>Subject to <internal-xref idref="H881933506D4C4DB0A76A470AE21D858C" legis-path="1903A.(d)">subsection (d)</internal-xref>, the average number of Medicaid beneficiaries enrolled in such category in the State in such quarter.</text></subparagraph></paragraph><paragraph id="H5B41BB8C9F6F452C9E3EED96D91DCB50"><enum>(2)</enum><header>Categories</header><text display-inline="yes-display-inline">The categories specified in this paragraph are the following:</text><subparagraph id="HC9655124920640279C64AA338E043A0F"><enum>(A)</enum><header>Elderly</header><text display-inline="yes-display-inline">A category of Medicaid beneficiaries who are 65 years of age or older.</text></subparagraph><subparagraph id="HCA397849198744BF825F5DA4D36D9299"><enum>(B)</enum><header>Blind or disabled</header><text display-inline="yes-display-inline">A category of Medicaid beneficiaries not described in <internal-xref idref="HC9655124920640279C64AA338E043A0F" legis-path="1903A.(b)(2)(A)">subparagraph (A) </internal-xref>who are described in section 1937(a)(2)(B)(ii).</text></subparagraph><subparagraph id="H02C0E7C371FE4606A9CAB686280E265C"><enum>(C)</enum><header>Children</header><text display-inline="yes-display-inline">A category of Medicaid beneficiaries not described in subparagraph (B) who are under 21 years of age.</text></subparagraph><subparagraph id="HDAB23C98818F445FBFE8906A959A125E"><enum>(D)</enum><header>Other adults</header><text display-inline="yes-display-inline">A category of any Medicaid beneficiaries who are not described in a previous subparagraph of this paragraph.</text></subparagraph></paragraph></subsection><subsection id="H640250343D774766A72694E490AEF489"><enum>(c)</enum><header>Computation of per beneficiary, per category quarterly amount</header><paragraph id="H2EDACBE7AF0A4A859C4C19CE2E6D3CDC"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">For a State, for each category of beneficiary for a quarter—</text><subparagraph id="H345ED54C87B94CDEB9CD2049E90DA289"><enum>(A)</enum><header>First reform year</header><text>For quarters in the first reform year (as defined in subsection (k)(2)), the beneficiary-based quarterly amount is equal to <fraction>1/4</fraction> of the base average per beneficiary Federal payments for such State for such category determined under <internal-xref idref="HDAECBC3DD01C4B85AF243571D500015B" legis-path="1903A.(c)(2)">paragraph (2)</internal-xref>, increased by a factor that reflects the sum of the following:</text><clause id="HCB1159DEE9184E2CB209F1C9670B8F4F"><enum>(i)</enum><header>Historical medical care component of CPI through previous reform year</header><text>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 <internal-xref idref="HB273B275580B4A0FBA076248D6FBC773" legis-path="1903A.(c)(6)">paragraph (6)</internal-xref>) to the midpoint of the fiscal year preceding the first reform year.</text></clause><clause id="H20C8132117564216BC69A7B1F58EE069"><enum>(ii)</enum><header>Projected medical care component of CPI for the first reform year</header><text display-inline="yes-display-inline">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.</text></clause></subparagraph><subparagraph id="HCC588B02FC2A42DC99EE5DF4BA050CEE"><enum>(B)</enum><header>Second and third reform years</header><text display-inline="yes-display-inline">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 <internal-xref idref="H2E8C78F90543440DB584B824F59B892C" legis-path="1903A.(c)(1)(E)">subparagraph (E))</internal-xref> for such category and reform year.</text></subparagraph><subparagraph id="HAC220B8FE27F45A896EF78496706A7C9"><enum>(C)</enum><header>Fourth through tenth reform years</header><text display-inline="yes-display-inline">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—</text><clause id="H1416C222BF344ACABCB67A7C4F4A63CF"><enum>(i)</enum><text display-inline="yes-display-inline">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</text></clause><clause id="H0BDB17FD85DA4AC2AC074E6FA9D5DB18"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text></clause></subparagraph><subparagraph id="H992E40745C574C788967491D06E838C8"><enum>(D)</enum><header>Eleventh reform year and subsequent reform years</header><text display-inline="yes-display-inline">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.</text></subparagraph><subparagraph id="H2E8C78F90543440DB584B824F59B892C"><enum>(E)</enum><header>Annual percentage increase beginning with second reform year</header><text display-inline="yes-display-inline">For purposes of this subsection, the term <term>per beneficiary percentage increase</term> means, for a reform year, the sum of—</text><clause id="H21489B3C0D774899B971417950818148"><enum>(i)</enum><text>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</text></clause><clause id="HD4E99865D4104D7289C65F98D516EFCA"><enum>(ii)</enum><text>one percentage point.</text></clause></subparagraph></paragraph><paragraph id="HDAECBC3DD01C4B85AF243571D500015B"><enum>(2)</enum><header>Base per beneficiary, per category amount for each State</header><subparagraph id="H98BFCB15992E460B8288EAA60B7841B6"><enum>(A)</enum><header>Average per category</header><clause id="H08BFA6A4A9544EDD81231B6A548330CD"><enum>(i)</enum><header>In general</header><text>The Secretary shall determine, consistent with this paragraph and <internal-xref idref="H27D21FD807F94D9EAF920DE375891F24" legis-path="1903A.(c)(3)">paragraph (3)</internal-xref>, 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 <internal-xref idref="H5B41BB8C9F6F452C9E3EED96D91DCB50" legis-path="1903A.(b)(2)">subsection (b)(2)</internal-xref> for the base fiscal year for each of the 50 States and the District of Columbia.</text></clause><clause commented="no" id="H5D2C3511BC3F49F3ACA9D1CDDB79BB9C"><enum>(ii)</enum><header>Best available data</header><text>The determination under <internal-xref idref="H08BFA6A4A9544EDD81231B6A548330CD" legis-path="1903A.(c)(2)(A)(i)">clause (i)</internal-xref> shall initially be estimated by the Secretary, based upon the best available data at the time the determination is made.</text></clause><clause id="H1335E8C8171B47BE8CFB19B80F25A17D"><enum>(iii)</enum><header>Updates</header><text>The determination under <internal-xref idref="H08BFA6A4A9544EDD81231B6A548330CD" legis-path="1903A.(c)(2)(A)(i)">clause (i)</internal-xref> shall be updated by the Secretary on an annual basis based upon improved data. The Secretary shall adjust the amounts under <internal-xref idref="H5DFA8BF6D6734DB396F6C58B8ADBDEB0" legis-path="1903A.(a)(1)(A)">subsection (a)(1)(A)</internal-xref> to reflect changes in the amounts so determined based on such updates.</text></clause></subparagraph><subparagraph id="H516569D86686476AAB32E1102F4153A5"><enum>(B)</enum><header>Exclusion of pass-through payments</header><text>In computing base per beneficiary, per category amounts under <internal-xref idref="H08BFA6A4A9544EDD81231B6A548330CD" legis-path="1903A.(c)(2)(A)(i)">subparagraph (A)(i)</internal-xref> the Secretary shall exclude payments described in <internal-xref idref="HBC93BB7911514152A9A8A48D90EFB7D5" legis-path="1903A.(a)(4)">subsection (a)(4)</internal-xref>.</text></subparagraph><subparagraph id="H319C241DB58D49DD9E9DC069AAEB7371"><enum>(C)</enum><header>Standardization</header><clause id="H91149C941F724C9EAC6966D40B073CD0"><enum>(i)</enum><header>In general</header><text>In computing each such amount, the Secretary shall standardize the amount in order to remove the variation attributable to the following:</text><subclause id="H3E3ADF071273411B9221FAE836A02E50"><enum>(I)</enum><header>Risk factors</header><text display-inline="yes-display-inline">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.</text></subclause><subclause id="HB71BC7B7C84A4C30A2E2ED4BC76E4EA0"><enum>(II)</enum><header>Geographic</header><text display-inline="yes-display-inline">Variations in costs on a county-by-county basis.</text></subclause></clause><clause id="H412BFA35C1DA429484E2FE68ACE7A3EF"><enum>(ii)</enum><header>Method of standardization</header><subclause id="H205F7A3795A34484AD4169D48076BFD2"><enum>(I)</enum><header>Consultation in development of risk standardization</header><text display-inline="yes-display-inline">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.</text></subclause><subclause id="HE3107BE2B86446CABB640815DC842E44"><enum>(II)</enum><header>Method for risk standardization</header><text display-inline="yes-display-inline">In carrying out <internal-xref idref="H3E3ADF071273411B9221FAE836A02E50" legis-path="1903A.(c)(2)(C)(i)(I)">clause (i)(I)</internal-xref>, 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.</text></subclause><subclause id="HF4ADC06724C4495A95EB6B62A03373E3"><enum>(III)</enum><header>Method for geographic standardization</header><text>The Secretary shall apply the standardization under <internal-xref idref="HB71BC7B7C84A4C30A2E2ED4BC76E4EA0" legis-path="1903A.(c)(2)(C)(i)(II)">clause (i)(II)</internal-xref> in a manner similar to that applied under section 1853(c)(4)(A)(iii).</text></subclause></clause><clause id="H624A6D897A31410DBD51BB7E9FDF8FA4"><enum>(iii)</enum><header>Application on a national, budget neutral basis</header><text>The standardization under <internal-xref idref="H91149C941F724C9EAC6966D40B073CD0" legis-path="1903A.(c)(2)(C)(i)">clause (i)</internal-xref> 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 <internal-xref idref="H62BC80476D304FE285DCD482BB967E89" legis-path="1903A.(a)">subsection (a)</internal-xref>.</text></clause><clause id="HF0E733BD630546569CA337F3CB89FC36"><enum>(iv)</enum><header>Response to new risk</header><text>Subject to <internal-xref idref="H624A6D897A31410DBD51BB7E9FDF8FA4" legis-path="1903A.(c)(2)(C)(iii)">clause (iii)</internal-xref>, the Secretary may adjust the standardization under <internal-xref idref="H91149C941F724C9EAC6966D40B073CD0" legis-path="1903A.(c)(2)(C)(i)">clause (i)</internal-xref> to respond promptly to new instances of communicable diseases and other public health hazards.</text></clause><clause id="H42E5AFE0099144F5B754F3361CF7180B"><enum>(v)</enum><header>Reference to application of risk adjustment</header><text>For rules related to the application of risk adjustment to amounts under subsection (a)(1)(A), see subsection (e).</text></clause></subparagraph><subparagraph id="HEA07661B69D54B01889C4DAC1A705B2F"><enum>(D)</enum><header>Adjustment for temporary FMAP increases</header><text display-inline="yes-display-inline">In computing each base per beneficiary, per category amounts under <internal-xref idref="H08BFA6A4A9544EDD81231B6A548330CD" legis-path="1903A.(c)(2)(A)(i)">subparagraph (A)(i)</internal-xref> 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:</text><clause id="HD2809A2CF2B249FB8D4A87D7A31A4046"><enum>(i)</enum><header>PPACA disaster FMAP</header><text>Section 1905(aa).</text></clause><clause id="HC019691AD1084B769D001E9EA0AB9621"><enum>(ii)</enum><header>ARRA</header><text>Section 5001 of the American Recovery and Reinvestment Act of 2009 (<external-xref legal-doc="usc" parsable-cite="usc/42/1396d">42 U.S.C. 1396d</external-xref> note).</text></clause><clause commented="no" id="H66AAEF254C0048768E842413EA92F72E"><enum>(iii)</enum><header>Extraordinary employer pension contribution</header><text display-inline="yes-display-inline">Section 614 of the Children's Health Insurance Program Reauthorization Act of 2009 (<external-xref legal-doc="usc" parsable-cite="usc/42/1396d">42 U.S.C. 1396d</external-xref> note).</text></clause></subparagraph></paragraph><paragraph id="H27D21FD807F94D9EAF920DE375891F24"><enum>(3)</enum><header>Allocation of nonmedical assistance payments</header><text display-inline="yes-display-inline">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)—</text><subparagraph id="H684BAED210D746FC986804569DD7C06A"><enum>(A)</enum><text>among different categories of beneficiaries; and</text></subparagraph><subparagraph id="H63FDC114977A4F88A13CBC0B8D94864C"><enum>(B)</enum><text>between payments included under <internal-xref idref="H1C59B4F3C30A440F8183A4CD48F65FED" legis-path="1903A.(a)(1)">subsection (a)(1)</internal-xref> and payments described in <internal-xref idref="HBC93BB7911514152A9A8A48D90EFB7D5" legis-path="1903A.(a)(4)">subsection (a)(4).</internal-xref></text></subparagraph></paragraph><paragraph commented="no" id="H54CA2D70F2EA445E8B2FCE21BD78526C"><enum>(4)</enum><header>Transition to a corridor around the national average</header><subparagraph commented="no" id="H8D1005E301A2479E9845918FE172191E"><enum>(A)</enum><header>Determination of national average base per beneficiary, per category amount</header><text display-inline="yes-display-inline">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 <internal-xref idref="HDAECBC3DD01C4B85AF243571D500015B" legis-path="1903A.(c)(2)">paragraph (2)</internal-xref>, weighted by the average number of beneficiaries in each such category and State as determined by the Secretary consistent with <internal-xref idref="H881933506D4C4DB0A76A470AE21D858C" legis-path="1903A.(d)">subsection (d)</internal-xref> for the base fiscal year.</text></subparagraph><subparagraph commented="no" id="H59A612A03492470EA0D12F698294818B"><enum>(B)</enum><header>Transition adjustment</header><clause id="H2799F46FD1B043EE81F1BA2C9B111A89"><enum>(i)</enum><header>High per beneficiary states</header><text display-inline="yes-display-inline">In the case of a high per beneficiary State (as defined in <internal-xref idref="HA2FE696EE4964F9494129D1AD546AE9E" legis-path="1903A.(c)(4)(B)(iii)(I)">clause (iii)(I)</internal-xref>) 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—</text><subclause id="HBD13181BAF3D4E60930D7B3563736349"><enum>(I)</enum><text display-inline="yes-display-inline">the product of the State-specific factor for such reform year (as defined in <internal-xref idref="H0B3B928DECF74DB283657B68E8B7D334" legis-path="1903A.(c)(4)(B)(iv)">clause (iv)</internal-xref>) 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</text></subclause><subclause id="H82CC5070FCBC4785BAA42EE67550CD15"><enum>(II)</enum><text>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.</text></subclause></clause><clause display-inline="no-display-inline" id="H964CA3F2E06146199C46399500F39DB6"><enum>(ii)</enum><header>Low per beneficiary states</header><text display-inline="yes-display-inline">In the case of a low per beneficiary State (as defined in <internal-xref idref="H91CB89030AC847099945575880DAD709" legis-path="1903A.(c)(4)(B)(iii)(II)">clause (iii)(II)</internal-xref>) 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—</text><subclause id="H13CC7A5B4D48429B9AB24BC955653FE1"><enum>(I)</enum><text display-inline="yes-display-inline">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</text></subclause><subclause id="H0DE1375F64534C948DA3F593C513E0DB"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text></subclause></clause><clause id="H08FBEB55BEA6443FAFD468CDA61DA6BF"><enum>(iii)</enum><header>High and low per beneficiary States defined</header><text>In this subparagraph:</text><subclause id="HA2FE696EE4964F9494129D1AD546AE9E"><enum>(I)</enum><header>High per beneficiary State</header><text>The term <term>high per beneficiary State</term> 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.</text></subclause><subclause id="H91CB89030AC847099945575880DAD709"><enum>(II)</enum><header>Low per beneficiary State</header><text display-inline="yes-display-inline">The term <term>low per beneficiary State</term> 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.</text></subclause></clause><clause id="H0B3B928DECF74DB283657B68E8B7D334"><enum>(iv)</enum><header>State-specific factor</header><text>In this subparagraph, the term <term>State-specific factor</term> means—</text><subclause id="H628E577A370D48B48536458EBEF45D9D"><enum>(I)</enum><text>for the fourth reform year, <fraction>7/8</fraction>; and</text></subclause><subclause id="H6955A28DFCB54933852FC08C58755137"><enum>(II)</enum><text>for a subsequent reform year, the State-specific factor under this clause for the previous reform year minus <fraction>1/8.</fraction></text></subclause></clause></subparagraph><subparagraph commented="no" id="H8818AEABACE64387BF3C8128F4E66B94"><enum>(C)</enum><header>No additional expenditures</header><clause id="HCCC1BACBB76B48CCBFD5D154E7D0D1EB"><enum>(i)</enum><header>Determination of increase in Federal expenditures</header><text display-inline="yes-display-inline">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—</text><subclause id="H4D175E602B7541EDBE2D2EEA0DFDA849"><enum>(I)</enum><text>to the category for the reform year will result in an aggregate increase in the aggregate Federal expenditures under <internal-xref idref="H62BC80476D304FE285DCD482BB967E89" legis-path="1903A.(a)">subsection (a)</internal-xref>; and</text></subclause><subclause id="H93301E0B07FC4D098FA1A6BC8B537506"><enum>(II)</enum><text display-inline="yes-display-inline">to all the categories for the reform year will result in a net aggregate increase in the aggregate Federal expenditures under <internal-xref idref="H62BC80476D304FE285DCD482BB967E89" legis-path="1903A.(a)">subsection (a)</internal-xref>.</text></subclause></clause><clause id="H931D115937B04FD9930D091CEEF40A46"><enum>(ii)</enum><header>Adjustment</header><text>If the Secretary determines under <internal-xref idref="H93301E0B07FC4D098FA1A6BC8B537506" legis-path="1903A.(c)(4)(C)(i)(II)">clause (i)(II)</internal-xref> 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 <internal-xref idref="H8D1005E301A2479E9845918FE172191E" legis-path="1903A.(c)(4)(A)">subparagraph (A)</internal-xref> for each of the categories determined under <internal-xref idref="H4D175E602B7541EDBE2D2EEA0DFDA849" legis-path="1903A.(c)(4)(C)(i)(I)">clause (i)(I)</internal-xref> 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 <internal-xref idref="H93301E0B07FC4D098FA1A6BC8B537506" legis-path="1903A.(c)(4)(C)(i)(II)">clause (i)(II)</internal-xref> for the reform year.</text></clause></subparagraph></paragraph><paragraph id="HED87CD69D56644118BEBF6D3DD86C059"><enum>(5)</enum><header>Reports on per beneficiary rates; appeals</header><subparagraph id="H4774115F673A4326ABA9C244A39C16C2"><enum>(A)</enum><header>Report to states</header><text display-inline="yes-display-inline">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—</text><clause id="HEE1D8BA460514D06B496DF9A111CC880"><enum>(i)</enum><text>the base per beneficiary, per category amounts under paragraph (2) for such State; and</text></clause><clause id="H8C97F95523F445758D5676D718871D7A"><enum>(ii)</enum><text>the national average base per beneficiary, per category amounts under <internal-xref idref="H8D1005E301A2479E9845918FE172191E" legis-path="1903A.(c)(4)(A)">paragraph (4)(A)</internal-xref>.</text></clause></subparagraph><subparagraph id="H36899F6DE3A442AF8EE31FD36F4447F4"><enum>(B)</enum><header>Opportunity to appeal</header><text>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 <internal-xref idref="HEE1D8BA460514D06B496DF9A111CC880" legis-path="1903A.(c)(5)(A)(i)">subparagraph (A)(i)</internal-xref>, the State may file with the Secretary, in a form and manner specified by the Secretary, an appeal of such determination.</text></subparagraph><subparagraph id="H5C2C799E4438486FA09A6F5CCB2D6605"><enum>(C)</enum><header>Determination on appeal</header><text>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 <internal-xref idref="HEE1D8BA460514D06B496DF9A111CC880" legis-path="1903A.(c)(5)(A)(i)">subparagraph (A)(i)</internal-xref> shall become final.</text></subparagraph></paragraph><paragraph id="HB273B275580B4A0FBA076248D6FBC773"><enum>(6)</enum><header>Base fiscal year defined</header><text>In this section, the term <term>base fiscal year</term> 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.</text></paragraph></subsection><subsection id="H881933506D4C4DB0A76A470AE21D858C"><enum>(d)</enum><header>Not counting individuals To account for excluded payments</header><text display-inline="yes-display-inline">Under rules specified by the Secretary, individuals shall not be counted as Medicaid beneficiaries for purposes of <internal-xref idref="HD5E4C4A310A4407D8EF3A901CCE7AA7D" legis-path="1903A.(b)(1)(B)">subsection (b)(1)(B)</internal-xref> and <internal-xref idref="H98BFCB15992E460B8288EAA60B7841B6" legis-path="1903A.(c)(2)(A)">subsection (c)(2)(A)</internal-xref> to the extent that such individuals—</text><paragraph id="H574860B50FFA4D168FC575F14770C363"><enum>(1)</enum><text>are receiving medical assistance for which payments described under <internal-xref idref="H0A66286FAEB54954BB85A57EB6E8C872" legis-path="1903A.(a)(4)(A)">subsection (a)(4)(A)</internal-xref> are made; or</text></paragraph><paragraph id="H04A1E3FD6D794AC098372069DA6376FD"><enum>(2)</enum><text>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.</text></paragraph></subsection><subsection id="H7EF7BE376973460A8F5C20882CD1F25F"><enum>(e)</enum><header>Risk Adjustment</header><paragraph id="HE2DBAE6FDC53477EBA57B4B1EB6B7249"><enum>(1)</enum><header>In general</header><text>The amount under <internal-xref idref="H5DFA8BF6D6734DB396F6C58B8ADBDEB0" legis-path="1903A.(a)(1)(A)">subsection (a)(1)(A)</internal-xref> shall be adjusted under this subsection in an appropriate manner, specified by the Secretary and consistent with <internal-xref idref="H8657C88B36354A669FA2DC1043AAF98F" legis-path="1903A.(e)(2)">paragraph (2)</internal-xref>, to take into account—</text><subparagraph id="H11D8E1645A324DC3B212528C92A6C35A"><enum>(A)</enum><text>the factors described in subsection (c)(2)(C)(i)(I) within a category of beneficiaries; and</text></subparagraph><subparagraph id="HA03D93265C764D439AD584510A40D785"><enum>(B)</enum><text>variations in costs on a county-by-county basis for medical assistance and administrative expenses.</text></subparagraph></paragraph><paragraph id="H8657C88B36354A669FA2DC1043AAF98F"><enum>(2)</enum><header>Method of adjustment</header><subparagraph id="H6B0CB35F72D54FBDAE579F903223030E"><enum>(A)</enum><header>In general</header><text>The adjustments under <internal-xref idref="HE2DBAE6FDC53477EBA57B4B1EB6B7249" legis-path="1903A.(e)(1)">paragraph (1)</internal-xref> shall be made in a manner similar to the manner in which similar adjustments are made under <internal-xref idref="H319C241DB58D49DD9E9DC069AAEB7371" legis-path="1903A.(c)(2)(C)">subsection (c)(2)(C)</internal-xref> and consistent with the requirements of clause (iii) of such subsection and subparagraph (B).</text></subparagraph><subparagraph id="H1095527EB7C54F2396B68D81C7FCEA02"><enum>(B)</enum><header>Biannual update of risk adjustment methodology</header><text>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.</text></subparagraph></paragraph></subsection><subsection id="HBEE941292C8D450E9EF1B7C9C07ADF08"><enum>(f)</enum><header>Chronic care quality bonus payments</header><paragraph id="H03A9029594E3481489B37A9FF019C7CA"><enum>(1)</enum><header>Determination of bonus payments</header><text display-inline="yes-display-inline">If the Secretary determines that, based on the reports under <internal-xref idref="HC762182BCD8A4BF7936AF86F29FFA711" legis-path="1903A.(f)(5)">paragraph (5)</internal-xref>, with respect to categories of chronic disease for which chronic care performance targets had been established under <internal-xref idref="HF4C5CFD6357E4405965BC0B998E9A65F" legis-path="1903A.(f)(3)">paragraph (3)</internal-xref> for each category of Medicaid beneficiaries specified under <internal-xref idref="H5B41BB8C9F6F452C9E3EED96D91DCB50" legis-path="1903A.(b)(2)">subsection (b)(2)</internal-xref> 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 <internal-xref idref="H9A3E10492E9344548A0E8E26E9839842" legis-path="1903A.(f)(6)">paragraph (6)</internal-xref> 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 <internal-xref idref="H5F7094806424495FAD63820F1FAFE87B" legis-path="1903A.(a)(3)">subsection (a)(3)</internal-xref>.</text></paragraph><paragraph id="H152A2D4F3FCD492191569A44DACE8077"><enum>(2)</enum><header>Identification of categories of chronic disease</header><text>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.</text></paragraph><paragraph id="HF4C5CFD6357E4405965BC0B998E9A65F"><enum>(3)</enum><header>Adoption of quality measurement system and identification of performance targets</header><subparagraph id="HB581B7C535414730B16BC83A10787006"><enum>(A)</enum><header>System and data</header><text>With respect to the categories of chronic disease under <internal-xref idref="H152A2D4F3FCD492191569A44DACE8077" legis-path="1903A.(f)(2)">paragraph (2)</internal-xref>, the Secretary shall adopt a quality measurement system that uses data described in <internal-xref idref="H855E44A28B304DD4B28C27B5DBF09FD2" legis-path="1903A.(f)(4)">paragraph (4)</internal-xref> 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.</text></subparagraph><subparagraph id="HA58C82F8CB3F459E95A9BB39E387AB33"><enum>(B)</enum><header>Targets</header><text>Using such system and data, the Secretary shall establish for each reform year the chronic care performance targets for purposes of the payments under <internal-xref idref="H03A9029594E3481489B37A9FF019C7CA" legis-path="1903A.(f)(1)">paragraph (1)</internal-xref>. 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.</text></subparagraph></paragraph><paragraph id="H855E44A28B304DD4B28C27B5DBF09FD2"><enum>(4)</enum><header>Data to be used</header><text>The data to be used under <internal-xref idref="HF4C5CFD6357E4405965BC0B998E9A65F" legis-path="1903A.(f)(3)">paragraph (3)</internal-xref> shall include—</text><subparagraph id="H50450380488C4B68B2D0A9E4CBEB66B3"><enum>(A)</enum><text>data collected through methods such as—</text><clause id="H9E28A2849629486CB517759ECA89C70C"><enum>(i)</enum><text display-inline="yes-display-inline">the <quote>Healthcare Effectiveness Data and Information Set</quote> (also known as <quote>HEDIS</quote>) (or an appropriate successor performance measurement tool);</text></clause><clause id="HF0BC885FEB9C49D9949EA29340FF761E"><enum>(ii)</enum><text display-inline="yes-display-inline">the <quote>Consumer Assessment of Healthcare Providers and Systems</quote> (also known as <quote>CAHPS</quote>) (or an appropriate successor performance measurement tool); and</text></clause><clause id="H3876D5C5B7E64690A10D817C732A9566"><enum>(iii)</enum><text display-inline="yes-display-inline">the <quote>Health Outcomes Survey</quote> (also known as <quote>HOS</quote>) (or an appropriate successor performance measurement tool); and</text></clause></subparagraph><subparagraph id="H9487D7BEA13B4DAF96B5FF3C64EBB40A"><enum>(B)</enum><text>other data collected by the State.</text></subparagraph></paragraph><paragraph id="HC762182BCD8A4BF7936AF86F29FFA711"><enum>(5)</enum><header>Reports</header><subparagraph id="H65ED4B105CEC445AA942EC3786EF8ABB"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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 <internal-xref idref="H855E44A28B304DD4B28C27B5DBF09FD2" legis-path="1903A.(f)(4)">paragraph (4)</internal-xref> that permit the Secretary to monitor the State’s performance relative to the chronic care performance targets established under <internal-xref idref="HF4C5CFD6357E4405965BC0B998E9A65F" legis-path="1903A.(f)(3)">paragraph (3)</internal-xref>.</text></subparagraph><subparagraph id="H2279044317354C678D988368F3B0CA84"><enum>(B)</enum><header>Review and verification</header><text>The Secretary may review the data collected by the State under <internal-xref idref="H65ED4B105CEC445AA942EC3786EF8ABB" legis-path="1903A.(f)(5)(A)">subparagraph (A)</internal-xref> to verify the State’s analysis of such data with respect to the performance targets under <internal-xref idref="HF4C5CFD6357E4405965BC0B998E9A65F" legis-path="1903A.(f)(3)">paragraph (3)</internal-xref>.</text></subparagraph></paragraph><paragraph commented="no" id="H9A3E10492E9344548A0E8E26E9839842"><enum>(6)</enum><header>Amount of bonus payments</header><subparagraph id="H09D432DB6137434281E9624FF43025E1"><enum>(A)</enum><header>In general</header><text>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 <internal-xref idref="HF4C5CFD6357E4405965BC0B998E9A65F" legis-path="1903A.(f)(3)">paragraph (3)</internal-xref> for a reform year for such category, performs—</text><clause id="H72B4C7EE321B48F19C573E745A69CBB4"><enum>(i)</enum><text>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;</text></clause><clause id="HDA4EAEA5A10C4A988594BBC6DDCBFEF3"><enum>(ii)</enum><text display-inline="yes-display-inline">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;</text></clause><clause id="H919AB495ADE04C71A19F3B9C99BE453F"><enum>(iii)</enum><text display-inline="yes-display-inline">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;</text></clause><clause id="H94B78A171579467B95EBAE9C73D06BC7"><enum>(iv)</enum><text display-inline="yes-display-inline">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</text></clause><clause id="HA1480F7EC2984FC2934C5F1ACF5015EF"><enum>(v)</enum><text display-inline="yes-display-inline">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.</text></clause></subparagraph><subparagraph id="HB95AEB1CB388476685A0C407DDE7AD92"><enum>(B)</enum><header>Aggregate annual limit for each category of Medicaid beneficiaries</header><clause id="H6DDD52CC46544BD9AC96279FA02A5CA3"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></clause><clause id="H29B5B18B9D4944449F3017DB8CA1CB34"><enum>(ii)</enum><header>Limit</header><text>The limit specified in this clause—</text><subclause id="H5A5921FCD356400E80C72C7475C0AA2E"><enum>(I)</enum><text>for the second reform year is equal to $250,000,000; or</text></subclause><subclause id="H1E01BF19F055451CB0F1006C55CF1257"><enum>(II)</enum><text display-inline="yes-display-inline">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).</text></subclause></clause></subparagraph><subparagraph id="HA45EDA2ACB4D446B97E440CFC84745D9"><enum>(C)</enum><header>Limitation and proration of bonuses based on application of aggregate limit</header><clause id="HCA000F26A3534F9CAF7BC220B3107E85"><enum>(i)</enum><header>No bonus for third or subsequent tiers unless aggregate limit not reached on first two tiers</header><text display-inline="yes-display-inline">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.</text></clause><clause id="HC4289D68173041CC9595B266D3E4571C"><enum>(ii)</enum><header>Proration for first two tiers</header><text>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.</text></clause><clause id="HE52251A7F9F542C2B80043EB979BD77B"><enum>(iii)</enum><header>Proration for next three tiers</header><text display-inline="yes-display-inline">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.</text></clause></subparagraph></paragraph></subsection><subsection id="HD353A5A2A35A4C2CAADBE7D1D2A03113"><enum>(g)</enum><header>State option for receiving Medicare payments for full-Benefit dual eligible individuals</header><paragraph id="H0AB0858422B24029BAAB7A32B5DC7333"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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 <internal-xref idref="HE3588E1ADAF84330A343496C8C21EEEE" legis-path="1903A.(g)(3)">paragraph (3)</internal-xref>. 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—</text><subparagraph id="H3D2AA2E74021461F914293705E99A6DB"><enum>(A)</enum><text>the medical assistance to which such eligible individuals would otherwise be entitled under this title; and</text></subparagraph><subparagraph id="H507A072040B54406A39AC790F137187C"><enum>(B)</enum><text>any items and services which such eligible individuals would otherwise receive under title XVIII.</text></subparagraph></paragraph><paragraph id="H9416F4E86D9940919199E22B8C8AC1F9"><enum>(2)</enum><header>Provider payment requirement</header><subparagraph commented="no" id="H2749DA723ECB4E9298D5EDEAB3E95422"><enum>(A)</enum><header>In general</header><text>A State electing the option under this subsection shall provide payment to health care providers for the items and services described under <internal-xref idref="H507A072040B54406A39AC790F137187C" legis-path="1903A.(g)(1)(B)">paragraph (1)(B)</internal-xref> 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.</text></subparagraph><subparagraph id="HF07FFCD649454A22A3CADD87464A7292"><enum>(B)</enum><header>Flexibility in payment methods</header><text>Nothing in <internal-xref idref="H2749DA723ECB4E9298D5EDEAB3E95422" legis-path="1903A.(g)(2)(A)">subparagraph (A)</internal-xref> 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.</text></subparagraph></paragraph><paragraph id="HE3588E1ADAF84330A343496C8C21EEEE"><enum>(3)</enum><header>Payments to States in lieu of Medicare payments</header><text>With respect to a full-benefit dual eligible individual, in the case of a State that elects the option under <internal-xref idref="H0AB0858422B24029BAAB7A32B5DC7333" legis-path="1903A.(g)(1)">paragraph (1)</internal-xref> for quarters in a reform year—</text><subparagraph id="H3639FAF050AD4F9BB548B0CCF6E8A40B"><enum>(A)</enum><text>the Secretary shall not make any payment under title XVIII for items and services furnished to such individual for such quarters; and</text></subparagraph><subparagraph id="H6CA8BF21E04446A098F9756F6D011CF7"><enum>(B)</enum><text>the Secretary shall pay to the State, in addition to the amounts paid to such State under <internal-xref idref="H62BC80476D304FE285DCD482BB967E89" legis-path="1903A.(a)">subsection (a)</internal-xref>, 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.</text></subparagraph></paragraph><paragraph id="H75B909C0359B4BBAA4ECC6AC8FFB5973"><enum>(4)</enum><header>Full-benefit dual eligible individual defined</header><text display-inline="yes-display-inline">In this subsection, the term <term>full-benefit dual eligible individual</term> means an individual who meets the requirements of section 1935(c)(6)(A)(ii).</text></paragraph></subsection><subsection id="H0F3B967927264001BF5EA1614DF38F74"><enum>(h)</enum><header>Audits</header><text>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.</text></subsection><subsection id="HC5548E3B0478486F905366C357316D3A"><enum>(i)</enum><header>Treatment of waivers</header><paragraph id="H44F9E903513548FA995F5C1553A1FA4F"><enum>(1)</enum><header>No impact on current waivers</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="HA003EA7F1AFF4D8CB5DB1F6BF37E11FB"><enum>(2)</enum><header>Application of budget neutrality to subsequent waivers and renewals taking section into account</header><text display-inline="yes-display-inline">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.</text></paragraph></subsection><subsection id="HCFE2798653764AAF82FC88C8230A317E"><enum>(j)</enum><header>Report to Congress</header><text>Not later than January 1 of the second reform year, the Secretary shall submit to Congress a report on the implementation of this section.</text></subsection><subsection id="H5B8D6D5C7DA2415B87BAEA2C8CAAB251"><enum>(k)</enum><header>Definitions</header><text>In this section:</text><paragraph id="H82963A70152E42B1AD8F3C3A51804A1C"><enum>(1)</enum><header>Implementation date</header><text display-inline="yes-display-inline">The term <term>implementation date</term> means—<italic></italic></text><subparagraph id="HFBA4E1AAC8FD460C85D75B5E774C15E2"><enum>(A)</enum><text display-inline="yes-display-inline">July 1, 2025, if this section is enacted on or before July 1, 2024; or</text></subparagraph><subparagraph id="HD9324818514F43BEAAAAC1F8F5BF0E22"><enum>(B)</enum><text display-inline="yes-display-inline">July 1, 2026, if this section is enacted after July 1, 2024.</text></subparagraph></paragraph><paragraph id="H540A4871DB7C4C3F8A81303CE1FA473A"><enum>(2)</enum><header>Reform years</header><subparagraph id="HD499F0F4BF0746648ED9BEA79DAC84B8"><enum>(A)</enum><text>The term <term>reform year</term> means a fiscal year beginning with the first reform year.</text></subparagraph><subparagraph id="H2ACD1489754C48B3875AC4A4A3ECBF0F"><enum>(B)</enum><text>The term <term>first reform year</term> means the fiscal year in which the implementation date occurs.</text></subparagraph><subparagraph id="HB6AD36B7BEF1461AB8CB3613867AA3BB"><enum>(C)</enum><text>The terms <term>second</term>, <term>third</term>, and successive similar terms mean, with respect to a reform year, the second, third, or successive reform year, respectively, succeeding the first reform year.</text></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H582ADB0B2CAE45D4AE8C0B4FA606B030"><enum>(b)</enum><header>Conforming amendments</header><paragraph id="HC5F0E19C7B934DA48901BF5319B7C299"><enum>(1)</enum><header>Continued application of clawback provisions</header><subparagraph id="H286E2240C2CB44419A5BAADF7141F395"><enum>(A)</enum><header>Continued application</header><text>Subsections (a) and (c)(1)(C) of section 1935 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396u-5">42 U.S.C. 1396u–5</external-xref>) are each amended by inserting <quote>or 1903A(a)</quote> after <quote>1903(a)</quote>.</text></subparagraph><subparagraph id="H0C4696D79A6847A7B173414BD6548021"><enum>(B)</enum><header>Technical amendment</header><text>Section 1935(d)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396u-5">42 U.S.C. 1396u–5(d)(1)</external-xref>) is amended by inserting <quote>except as provided in section 1903A(g)</quote> after <quote>any other provision of this title</quote>.</text></subparagraph></paragraph><paragraph id="H3E9B3D538C0949E185297CE3B2D453FF"><enum>(2)</enum><header>Payment rules under section 1903</header><subparagraph id="H69893E5294F846BAB687FF6D60A470C6"><enum>(A)</enum><text>Section 1903(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396b">42 U.S.C. 1396b(a)</external-xref>) is amended, in the matter before paragraph (1), by inserting <quote>and section 1903A</quote> after <quote>except as otherwise provided in this section</quote>.</text></subparagraph><subparagraph commented="no" id="H321DDA667C714E4F86D4DEDB41A8CE95"><enum>(B)</enum><text display-inline="yes-display-inline">Section 1903(d) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396b">42 U.S.C. 1396b(d)</external-xref>) is amended—</text><clause commented="no" id="H99F7EBD8744842218FBA37F0E7F01325"><enum>(i)</enum><text>in paragraph (1), by inserting <quote>and under section 1903A</quote> after <quote>subsections (a) and (b)</quote>;</text></clause><clause commented="no" id="H0CE21A297EAB4D74A33FCBCA30F90549"><enum>(ii)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text><subclause commented="no" id="HDC5C48C0577A491393ED58267D1C0C92"><enum>(I)</enum><text>in subparagraph (A), by inserting <quote>or section 1903A</quote> after <quote>was made under this section</quote>; and</text></subclause><subclause commented="no" id="HD107AA39B8DA4825B506043077E00D47"><enum>(II)</enum><text display-inline="yes-display-inline">in subparagraph (B), by inserting <quote>or section 1903A</quote> after <quote>under subsection (a)</quote>;</text></subclause></clause><clause commented="no" id="H997B9875998141FC9B6E0B1EC32F43C7"><enum>(iii)</enum><text>in paragraph (4)—</text><subclause id="HC44F5183BA6A4A1A9F4EA04A6F9DD3CF"><enum>(I)</enum><text>by striking <quote>under this subsection</quote> and inserting <quote>, with respect to this section or section 1903A, under this subsection</quote>; and</text></subclause><subclause id="H1AAC715BC75B4256988195AA567F5780"><enum>(II)</enum><text>by striking <quote>under this section</quote> and inserting <quote>under the respective section</quote>; and</text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="H945106C752424C20B41AB9FF061B5007"><enum>(iv)</enum><text>in paragraph (5), by inserting <quote>or section 1903A</quote> after <quote>overpayment under this section</quote>.</text></clause></subparagraph></paragraph><paragraph id="H825A0D37932946C4A83DBB66EA727D0B"><enum>(3)</enum><header>Conforming waiver authority</header><text>Section 1115(a)(2)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1315">42 U.S.C. 1315(a)(2)(A)</external-xref>) is amended by striking <quote>or 1903</quote> and inserting <quote>1903, or 1903A</quote>.</text></paragraph><paragraph id="HB52CD86854674AFC87B26D9EBB1B392C"><enum>(4)</enum><header>Report on additional conforming amendments needed</header><text>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.</text></paragraph></subsection></section><section id="H07CD012728D3463F997E9E8E30AD2BF3" commented="no" display-inline="no-display-inline" section-type="subsequent-section"><enum>402.</enum><header>Income limitations for refundable credits for coverage under a qualified health plan</header><subsection id="H70CAB891B2DC4AD8A4672C827BC6EA33" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Subparagraphs (A) and (B) of <external-xref legal-doc="usc" parsable-cite="usc/26/36B">section 36B(c)(1)</external-xref> of the Internal Revenue Code of 1986 are amended by inserting after <quote>100 percent</quote> each place such term appears the following: <quote>(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)</quote>. </text></subsection><subsection id="H4C76FFDE1BD84B84ABA9553BB8829EC5" commented="no"><enum>(b)</enum><header>Effective date</header><text>The amendments made by this section shall apply with respect to taxable years beginning after the date of the enactment of this Act.</text></subsection></section><section id="H0DD39CCB8A5B44E09D55A9B1BA44303B"><enum>403.</enum><header>Medicaid eligibility determinations</header><subsection id="HB4EF2D6ACA704E799CE7A924CCCFD047"><enum>(a)</enum><header>State flexibility To use contractors To make eligibility determinations on behalf of State</header><text display-inline="yes-display-inline">Section 1902(a)(5) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)(5)</external-xref>) is amended by inserting before the semicolon at the end the following: <quote>, 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</quote>.</text></subsection><subsection id="HAE4BE8A9BA3A48999B6F918A1E960E41"><enum>(b)</enum><header>Frequency of eligibility redeterminations</header><text display-inline="yes-display-inline">Section 1902(e)(14) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(e)(14)</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" id="H4F392FE7E7284636A82CBC9D0BD3A66D" display-inline="no-display-inline"><subparagraph id="H6F496B6D73934939AB14F3D246EDC27A"><enum>(L)</enum><header>Frequency of eligibility redeterminations</header><text display-inline="yes-display-inline">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).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="H69BA5E9FA2824D82AD099FD325F44C38"><enum>404.</enum><header>Lowering safe harbor threshold with respect to State taxes on health care providers</header><text display-inline="no-display-inline"> Section 1903(w)(4)(C)(ii) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396b">42 U.S.C. 1396b(w)(4)(C)(ii)</external-xref>) is amended—</text><paragraph id="H97B3FE9CB8F54F67B77D654CD77948AD"><enum>(1)</enum><text>by striking <quote>of fiscal years beginning</quote> and inserting </text><quoted-block style="OLC" id="HCB02B8F14CC74EDD9F8E203FDC1F7DF9" display-inline="yes-display-inline"><text>of fiscal years—</text><subclause id="HCFF91150C33C46F8BC6B592E54B946DF" indent="up2"><enum>(I)</enum><text display-inline="yes-display-inline">beginning</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="HF4C030E41DFC4020A8D4DE903DE864C7"><enum>(2)</enum><text>by striking <quote>it appears.</quote> and inserting the following: </text><quoted-block style="OLC" id="HC9FAA6A8049F4BD28D27539197D73054" display-inline="yes-display-inline"><text>it appears;</text><subclause id="H650C7A072D764867995D68B004545314" indent="up2"><enum>(II)</enum><text display-inline="yes-display-inline">beginning on or after January 1, 2025, and before January 1, 2034, <quote>4 percent</quote> shall be substituted for <quote>6 percent</quote> each place it appears;</text></subclause><subclause id="H880CE350BB994FE6A06EE9C20CBB45C7" indent="up2"><enum>(III)</enum><text>beginning on or after January 1, 2034, and before January 1, 2039, <quote>3 percent</quote> shall be substituted for <quote>6 percent</quote> each place it appears;</text></subclause><subclause id="HC305A03DE5074BFEB8B36A427F44E415" indent="up2"><enum>(IV)</enum><text>beginning on or after January 1, 2039, and before January 1, 2044, <quote>2 percent</quote> shall be substituted for <quote>6 percent</quote> each place it appears;</text></subclause><subclause id="H1E57591B0FF342ECB4600400E9DBF938" indent="up2"><enum>(V)</enum><text>beginning on or after January 1, 2044, and before January 1, 2049, <quote>1 percent</quote> shall be substituted for <quote>6 percent</quote> each place it appears; and</text></subclause><subclause id="HA7FF04633F5C4DE1A50AAAE15ECD1D9A" indent="up2"><enum>(VI)</enum><text>beginning on or after January 1, 2049, <quote>0 percent</quote> shall be substituted for <quote>6 percent</quote> each place it appears. </text></subclause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="HDA47B6281D8344BFA229BF240A69C7AD"><enum>405.</enum><header>Providing for State approval and implementation of specified waivers under the Medicaid program</header><text display-inline="no-display-inline">Section 1115 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1315">42 U.S.C. 1315</external-xref>) is amended—</text><paragraph id="H844C5CC093C14C9A9B2035195D95957E"><enum>(1)</enum><text>in subsection (d)—</text><subparagraph id="H31C0732AB54C4B799D674628B011164A"><enum>(A)</enum><text>in paragraph (1), by striking <quote>An application</quote> and inserting <quote>Subject to paragraph (4), an application</quote>; and</text></subparagraph><subparagraph id="HE3D252E76C70461585E6FF3C41ADBDB4"><enum>(B)</enum><text>by adding at the end the following new paragraph:</text><quoted-block style="OLC" id="H697A7973827F4F14847C5CDA3A1EDACA" display-inline="no-display-inline"><paragraph id="H8A43BCACD1C84D1095F751D32EB2A189"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H11E23FB1A2ED434B998F3648D401820D"><enum>(A)</enum><text>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).</text></subparagraph><subparagraph id="H54EE894DD2D8403DB655BFB370389D7F" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">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—</text><clause id="H4BE6B4C4EDF94A36A9CEDF6441D02CB3"><enum>(i)</enum><text>individuals enrolled under such plan (or such waiver) may elect to participate in such project with respect to a year; and</text></clause><clause id="H315B1DCD4E6744A9B8B5E1DB41C8B216" commented="no"><enum>(ii)</enum><text>such individuals who elect to so participate are furnished with primary care services (as described in <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)(1)(D)(ii)(I)</external-xref> of the Internal Revenue Code of 1986) through a direct primary care service arrangement (as defined in such section).</text></clause></subparagraph><subparagraph id="H2E41CE4A79EE4C38876B5CA196FF080B" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">For purposes of a State’s approval or renewal of an experimental, pilot, or demonstration project under subparagraph (A), each reference to <quote>the Secretary</quote> in subsection (a) shall be deemed to be a reference to <quote>the State</quote>.</text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H405BF282078E40D2BD82CCF877057900"><enum>(2)</enum><text>in subsection (e), by inserting <quote>(other than such a project that is described in paragraph (4)(B))</quote> before the period at the end.</text></paragraph></section><section id="H35076EB5966549BAAE237B5A6D2BAB19"><enum>406.</enum><header>Deduction for qualified charity care</header><subsection id="HB3077E0FEAD74D22AE66A737C9DC49E2"><enum>(a)</enum><header>In general</header><text>Part VI of subchapter B of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/1">chapter 1</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new section:</text><quoted-block id="H0961453C5F534323AFF4E18BD92A7073" style="OLC"><section id="H90AE7EA8483B486B9B002EEAE78B9AA7"><enum>199B.</enum><header>Qualified charity care</header><subsection id="H84485AC33ACE46F3856A3397C6D12487"><enum>(a)</enum><header>In general</header><text>There shall be allowed as a deduction for the taxable year an amount equal to—</text><paragraph id="H8BCF23C4B6C0402EBB85ADECEB29B568"><enum>(1)</enum><text>in the case of a direct primary care physician, an amount equal to the sum of—</text><subparagraph id="H4B9900E1FACC412B88A00024B6C15DD8"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="H012D8AC2FEA84F7FA1E28417FF83F472"><enum>(B)</enum><text>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</text></subparagraph></paragraph><paragraph id="H6876CCFD92444182A157B5632041C74B"><enum>(2)</enum><text>in the case of any other individual, the unreimbursed Medicare-based value of qualified charity care furnished by such taxpayer during such year.</text></paragraph></subsection><subsection id="HA38EFC8A671C46A0B9DBB1E49CB978FC"><enum>(b)</enum><header>Definitions</header><text>For purposes of this section:</text><paragraph id="HD06BF5ADA26A4CE189047E8BF019D705"><enum>(1)</enum><header>Unreimbursed medicare-based value</header><text>The term <term>unreimbursed Medicare-based value</term> 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.</text></paragraph><paragraph id="HFC2680ECC1D24C40866A2B2C1ED9D409"><enum>(2)</enum><header>Qualified charity care</header><text>The term <term>qualified charity care</term> means physicians’ services that are furnished—</text><subparagraph id="H92DB923AA2B24AA496458D28A92698CB"><enum>(A)</enum><text>without expectation of reimbursement, and</text></subparagraph><subparagraph id="HDA0D998392E84E89A3F8CFD68EA0EAD0"><enum>(B)</enum><text>to an individual enrolled—</text><clause id="H7CF9F712C61141B6A085431BB26B9229"><enum>(i)</enum><text>under a State plan under title XIX of the Social Security Act (or a waiver of such plan), or</text></clause><clause id="H79A7CB9850D94B829916299516610EC9"><enum>(ii)</enum><text>under a State child health plan under title XXI of the Social Security Act (or a waiver of such plan).</text></clause></subparagraph></paragraph><paragraph id="HF1B65B0623BF4B3285743E9A9AB847BF"><enum>(3)</enum><header>Direct primary care physician</header><text>The term <term>direct primary care physician</term> means a physician (as defined in section 1861(r) of the Social Security Act) who provides primary care—</text><subparagraph id="HAB214CC81C054BCFBF04A73995EA7C57"><enum>(A)</enum><text>to individuals who have paid a periodic subscription fee, and</text></subparagraph><subparagraph id="H9310B466F9064D39BB70FD35F98520F1"><enum>(B)</enum><text>in exchange for a fee that is published on a publicly available website of such physician.</text></subparagraph></paragraph><paragraph id="HF7D1E45A841B46DBBF2DCEEA68CF6005"><enum>(4)</enum><header>Physicians’ services</header><text>The term <term>physicians</term> services’ has the meaning given such term by section 1861(q) of the Social Security Act.</text></paragraph></subsection><subsection id="H1C9A04256CB34996B8AF5D99B2002B5F"><enum>(c)</enum><header>Limitation</header><text>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.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H8422B650D4C944C69F43846A9098F548"><enum>(b)</enum><header>Clerical amendment</header><text>The table of sections for part VI of subchapter B of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/1">chapter 1</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new item:</text><quoted-block id="H67868D21A09F45E3BE2CBADF5CA8F99E"><toc><toc-entry level="section">Sec. 199B. Qualified charity care.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section></subtitle><subtitle id="HBF18837FAA594A1C91236C55F988FBE7"><enum>B</enum><header>Medicare Reforms</header><section id="H6BBC1197A7214193BC3D1647ACF9105F"><enum>411.</enum><header>Off-campus provider-based department Medicare site neutral payment</header><subsection id="HE2E38AEAFF7C46EF89A70510BCDD0AD7"><enum>(a)</enum><header>In general</header><text>Section 1834 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block id="H573AF39325D44DAD90C055C521E1FD7B" style="OLC"><subsection id="H7FC8C3EBFCC8479DBF2CAE49B22D3052"><enum>(x)</enum><header>Off-Campus provider-Based department Medicare site neutral payment</header><paragraph id="H834915F9DADA4E21AA7396D86B92FC4E"><enum>(1)</enum><header>In general</header><text>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.</text></paragraph><paragraph id="HA9D1F18CA6774FA7A445AF49E2598525"><enum>(2)</enum><header>Off-campus provider-based department</header><text>For purposes of this subsection, the term <term>off-campus provider-based department</term> has such meaning as specified by the Secretary.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H300FD4BB8E6B4174B9A1B56D66ABB21C"><enum>(b)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall apply with respect to items and services furnished on or after January 1, 2025.</text></subsection></section><section id="H24C3262944014A56A39E321A50AD324B"><enum>412.</enum><header>Eliminating FEHBP eligibility for annuitants</header><text display-inline="no-display-inline">Section 8905(b) of title 5, United States Code, is amended—</text><paragraph id="H6C97DE37451741DDA075B21C7FA89867"><enum>(1)</enum><text>in the matter preceding paragraph (1), by striking <quote>An</quote> and inserting <quote>Consistent with the last sentence of this subsection, an</quote>; and</text></paragraph><paragraph id="H0205136980B34F8CAE6ACCA21F6E9FEB"><enum>(2)</enum><text>by adding at the end the following: <quote>. An individual who is entitled to benefits under part A of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395c">42 U.S.C. 1395c et seq.</external-xref>) by reason of section 226 or 226A of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/426">42 U.S.C. 426</external-xref>, 426–1), or otherwise eligible to enroll under such part pursuant to section 1818 or 1818A of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395i-2">42 U.S.C. 1395i–2</external-xref>, 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.</quote>.</text></paragraph></section><section id="HCE6E76001F1D4C6A892812D8F60EF287"><enum>413.</enum><header>Elimination of Medicare eligibility for certain individuals</header><subsection id="HEA6D4C2B96554BE6B48779D1196BB659"><enum>(a)</enum><header>Enrollment prohibition</header><paragraph id="HDB78BD473C42424C9362C10D882D879F"><enum>(1)</enum><header>Part B</header><text>Section 1836 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395o">42 U.S.C. 1395o</external-xref>) is amended by striking the period at the end and inserting <quote>, 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.</quote>.</text></paragraph><paragraph id="H9BABF9FD536D432AA4F86CFE23CBAFAB"><enum>(2)</enum><header>Part D</header><text>Section 1860D–1(a)(3)(A) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-101">42 U.S.C. 1395w–101(a)(3)(A)</external-xref>) is amended by striking the period at the end and inserting <quote>, excluding an individual who, upon attaining age 65, has earned $10,000,000 or more in lifetime wages.</quote>. </text></paragraph></subsection><subsection id="H3D0C8175303D4C0FB6DA40CEDA63AE3C"><enum>(b)</enum><header>Medigap</header><text>Section 1882 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ss">42 U.S.C. 1395ss</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block style="OLC" id="HFC4B8F2A7E7E411AA1B10F0241DAEB3C" display-inline="no-display-inline"><subsection id="H126C8E0C551445329137DDF39D51C36D"><enum>(aa)</enum><header>Additional limitation on newly eligible beneficiaries</header><paragraph id="H2177F42A4758484B9F96EF0335185187"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="HD94D0696879E45E185E551CB8D292BF0"><enum>(2)</enum><header>Targeted newly eligible Medicare beneficiary</header><text>For purposes of this subsection, the term <term>targeted newly eligible Medicare beneficiary</term> means an individual who, upon attaining the age of 65, has earned $10,000,000 or more in lifetime wages. </text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="H2721A450EA664729B7E2FA4B3FC7C657"><enum>414.</enum><header>Medicare part D tax deduction</header><subsection id="HEFA73456F39F4D9DBDBB0A4829AFDA2A"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/139A">Section 139A</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following: <quote>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.</quote>.</text></subsection><subsection id="H15D5B3AD37BD4476A54D1FC0ABB64ED0"><enum>(b)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendment made by this section shall apply to taxable years beginning after December 31, 2022. </text></subsection></section><section id="H76D5F4C83F29419AB2193ED8415CDE0E"><enum>415.</enum><header>Repeal of net investment income tax</header><subsection id="H07586FDF767142409FB88D04535D6730"><enum>(a)</enum><header>In general</header><text>Subtitle A of the Internal Revenue Code of 1986 is amended by striking chapter 2A.</text></subsection><subsection id="H64CF0A694BC84928A0D94AE56A882B0C"><enum>(b)</enum><header>Effective date</header><text>The amendment made by this section shall apply to taxable years beginning after December 31, 2024.</text></subsection></section><section id="H54EC85C97F44412CB14E3ACD77D6A46A"><enum>416.</enum><header>Medicare coverage of bad debt</header><text display-inline="no-display-inline">Section 1861(v)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395(v)(1)</external-xref>) is amended—</text><paragraph id="H660FE24B1C5B4B90AC478E94424ED456"><enum>(1)</enum><text>in subparagraph (T)—</text><subparagraph id="H3F203F9F716F483688AC958C560C57A7"><enum>(A)</enum><text display-inline="yes-display-inline">in clause (iv), by striking <quote>and</quote> at the end;</text></subparagraph><subparagraph id="HDECF23B33EA149FDB554A373EE980681"><enum>(B)</enum><text>in clause (v)—</text><clause id="H7B5073DC2EE94A4EA55E1EF8B64BB943"><enum>(i)</enum><text>by striking <quote>during fiscal year</quote> and inserting <quote>during fiscal years</quote>; </text></clause><clause id="H94520A4C155E4E7EA65B07C9D62D3CA7"><enum>(ii)</enum><text>by striking <quote>or a subsequent fiscal year</quote> and inserting <quote>through 2024</quote>; and</text></clause><clause id="HD5950051A1354BFEA0DFD9D2584D298B"><enum>(iii)</enum><text>by striking the period at the end and inserting <quote>, and</quote>; and</text></clause></subparagraph><subparagraph id="H8102170FF4D84A57BD76A249065DC055"><enum>(C)</enum><text>by adding at the end the following new clause:</text><quoted-block style="OLC" id="H94310CFEA6D242B7AA80113B67D325D5" display-inline="no-display-inline"><clause id="H9455498AA8F9408E9FBE11878A2C818C" indent="up2"><enum>(vi)</enum><text display-inline="yes-display-inline">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.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H27C16998FB8248C5BBFC122C730F9D09"><enum>(2)</enum><text>in subparagraph (V)—</text><subparagraph id="H2A1E8CEFC68F43A8A21818386045B420"><enum>(A)</enum><text>in clause (i)—</text><clause id="HA77F2988D1004BC3823C9BA40FDE5099"><enum>(i)</enum><text display-inline="yes-display-inline">in subclause (III), by striking <quote>and</quote> at the end;</text></clause><clause id="HB6D071454339443991C71D87FFEEC582"><enum>(ii)</enum><text>in subclause (IV)—</text><subclause id="H5084925D9C6B46CD8A65E435E5711AEE"><enum>(I)</enum><text>by striking <quote>during fiscal year</quote> and inserting <quote>during fiscal years 2017 through 2024</quote>; and</text></subclause><subclause id="HACAB956BAE24474EBD85E702B74A4A18"><enum>(II)</enum><text>by striking the period at the end and inserting <quote>; and</quote>; and</text></subclause></clause><clause id="H547E2A81E11B4F0A905BD3713BD24B84"><enum>(iii)</enum><text>by adding at the end the following new subclause:</text><quoted-block style="OLC" id="HAF58235910B1437092FC975DAB982892" display-inline="no-display-inline"><clause id="HA92D4CE7EC5F4D25AE5A050B7C3F7600" indent="up1"><enum>(V)</enum><text display-inline="yes-display-inline">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.</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="HA9057B73778B42189B816A8058C5748B"><enum>(B)</enum><text>in clause (ii)—</text><clause id="HF67A3D04F5B1432EB894DFDCE0D76616"><enum>(i)</enum><text>in subclause (III), by striking <quote>and</quote> at the end; and</text></clause><clause id="H3D58D822AC744A2C95DADB8E23B1FBE3"><enum>(ii)</enum><text>in subclause (IV)—</text><subclause id="H827CE5A8B1BA4B3A8BC9117EDFA796AD"><enum>(I)</enum><text>by striking <quote>a subsequent fiscal year</quote> and inserting <quote>fiscal years 2015 through 2024</quote>;</text></subclause><subclause id="H5165080D68314D86802A5E7391601F6A"><enum>(II)</enum><text>by striking the period at the end and inserting <quote>; and</quote>; and</text></subclause><subclause id="H41A58EBB1D904E94B40CA972A56EB020"><enum>(III)</enum><text>by adding at the end the following new subclause:</text><quoted-block style="OLC" id="H24C0DCFD7E564D569367E75A72D41339" display-inline="no-display-inline"><subclause id="H1B7D4F5821F443EDB2D3150EFA273114" indent="up2"><enum>(V)</enum><text display-inline="yes-display-inline">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.</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause></subparagraph></paragraph><paragraph id="HB5BFB1C36B8E4F55A348303605A0F645"><enum>(3)</enum><text>in subparagraph (W)(i)—</text><subparagraph id="HED0CF4E5D9074FE0A2F4B460C5348B40"><enum>(A)</enum><text>in subclause (II), by striking <quote>and</quote> at the end;</text></subparagraph><subparagraph id="H5A46C88656404E8D99B0A7527CF5E68F"><enum>(B)</enum><text>in subclause (III)—</text><clause id="HFE04A1DEA93643BDBD2CD7689724021B"><enum>(i)</enum><text>by striking <quote>during a subsequent fiscal year</quote> and inserting <quote>during fiscal years 2015 through 2024</quote>; and</text></clause><clause id="H91497B44911B423DB97C1F957B851FA6"><enum>(ii)</enum><text>by striking the period at the end and inserting <quote>; and</quote>; and</text></clause></subparagraph><subparagraph id="H1CF459EDBB444A2E9BC75336F657F9C1"><enum>(C)</enum><text>by adding at the end the following new subclause:</text><quoted-block style="OLC" id="H6E83E725AF9B401E8C364F561E2B26AA" display-inline="no-display-inline"><subclause id="H2934D2C7D0824161AD4D50DC689E07EB" indent="up3"><enum>(IV)</enum><text display-inline="yes-display-inline">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.</text></subclause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></section></subtitle><subtitle id="H9B1B7965701040D3A696B4DB5799C657"><enum>C</enum><header>Medicare Choice and Competition</header><section id="HE47DD6462D3046E28512FB46A7395736"><enum>421.</enum><header>Competitive bidding and premiums under unified Medicare</header><subsection id="H154A6C960AE043F29DA5AA5219576C6C"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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:</text><quoted-block display-inline="no-display-inline" id="H761522305C9A4192A806F79793C52CD6" style="OLC"><subpart id="H474A6BE2682D440BBD6306618E958570"><enum>3</enum><header>Competitive bidding and premiums</header><section id="H80524121B2784259B06EE0DF694F21D2"><enum>1860E–31.</enum><header>Application of competitive bidding in enrollment</header><subsection id="H699C3861B1594EFEA76F00A6771E54B1"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="HA669B5B7F29F4C549ECCB90A9D0C0412"><enum>(b)</enum><header>Enrollment options</header><text display-inline="yes-display-inline">For purposes of subsection (a), the Secretary shall make the following options available to individuals for enrollment under this title:</text><paragraph id="H214BAF281AD54BB38999167CD2EA94A3"><enum>(1)</enum><text>Traditional fee-for-service coverage.</text></paragraph><paragraph id="H766B975154C24D5CAB5204A00A16E036"><enum>(2)</enum><text>provider-led risk-bearing plans (also known as ACOs).</text></paragraph><paragraph id="HDEEB01D8855F454BB8B6963B9E48418E"><enum>(3)</enum><text>Medicare Advantage plans.</text></paragraph></subsection><subsection id="HD589B6D7D0174F2A96E5FC7A6152874C"><enum>(c)</enum><header>Medicare advantage plan actuarial value requirement</header><text>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.</text></subsection><subsection id="HC28A05CAEE8C4326B3878067CE3067BB"><enum>(d)</enum><header>MA direct deposit of certain rebates</header><text>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.</text></subsection><subsection id="HABF8513A9D404A18A39F6961DDABA950"><enum>(e)</enum><header>Enrollment in prescription drug coverage</header><text>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.</text></subsection><subsection id="H54C1DA86B3744BBEA28080F9F333AC86"><enum>(f)</enum><header>Supplemental benefits</header><paragraph id="HBF46DBC162384A83A179575E9C038A66"><enum>(1)</enum><header>MA plans</header><text display-inline="yes-display-inline">An MA plan is allowed to offer two different packages of supplemental benefits (these packages are available only to individuals who select such plans).</text></paragraph><paragraph id="H9BAF6D87105D4AFD91FD3BCEC16D3875"><enum>(2)</enum><header>A<enum-in-header>CO</enum-in-header>s</header><text display-inline="yes-display-inline">ACOs may limit supplemental options for their enrollees to Medigap plans with contractual ties.</text></paragraph><paragraph id="H4B6630DA617F479181F3F1E88D638305"><enum>(3)</enum><header>Fee-for-service</header><text>Fee-for-service individuals may select supplemental coverage from Medigap policies.</text></paragraph></subsection></section><section id="H8BF14135728947DD8145488AA3C560FA"><enum>1860E–32.</enum><header>Competition</header><subsection id="HD6CBE00B54D847C28A6B5550FFECD7D4"><enum>(a)</enum><header>Bid areas</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="H92E2CEF8A1E546B1B65DE18C2F8E6749"><enum>(b)</enum><header>Premiums</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="H14AEDC6738154DC9B0CEF626C147B32B"><enum>(c)</enum><header>Beneficiary responsibility</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="H72764B14DDB443AFB159E01A295B9631"><enum>(d)</enum><header>Transition</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="H445A02D8C16941A99C42E373FC17569A"><enum>(e)</enum><header>Multiyear contracts</header><text>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).</text></subsection></section></subpart><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HA5685F6418D04ABFA6D48137678E9A5B"><enum>(b)</enum><header>Conforming amendments</header><paragraph id="H287EC03D622E4CB0AA784F14F57B4A87"><enum>(1)</enum><text>Section 1853(a)(1)(A) of the Social Security Act is amended by striking <quote>and section 1859(e)(4)</quote> and inserting <quote>, section 1859(e)(4), and subpart 3 of part E</quote>.</text></paragraph><paragraph id="HCCBFD6E1E0764938A6AAD75C6918D4BA"><enum>(2)</enum><text>Section 1853(j) of such Act is amended by inserting <quote>and subpart 3 of part E</quote> after <quote>subsection (o)</quote>.</text></paragraph><paragraph id="HCF5E3BB0B2D5492C8D22142F706D6F7A"><enum>(3)</enum><text>Section 1854 of such Act is amended—</text><subparagraph id="H030AEDCB7BB24A309BC50964D6C9CB46"><enum>(A)</enum><text>in subsection (a), after the heading, by inserting <quote>Subject to subpart 3 of part E:</quote>;</text></subparagraph><subparagraph id="H7C1BAE6402064E7EB59CB49ED49B9E30"><enum>(B)</enum><text>in subsection (b), after the heading, by inserting <quote>Subject to subpart 3 of part E:</quote>;</text></subparagraph><subparagraph id="H05787BFF9D6444B391C92FF7A25D6844"><enum>(C)</enum><text>in subsection (d), after the heading, by inserting <quote>Subject to subpart 3 of part E:</quote>; and</text></subparagraph><subparagraph id="H793E2C8ED0FC4E78877AF1D48E714E75"><enum>(D)</enum><text>in subsection (e), after the heading, by inserting <quote>Subject to subpart 3 of part E:</quote>.</text></subparagraph></paragraph></subsection></section><section id="HE4FD0CCD72D54DE0A5AFFF4352D77E54"><enum>422.</enum><header>New unified eligibility and enrollment rules</header><subsection id="H4EB40DA473F74E4584225CAA50D64473"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Title XVIII of the Social Security Act is amended—</text><paragraph id="HF80BB21AD0584CA092C205F38572B2F9"><enum>(1)</enum><text>by redesignating part E as part F; and</text></paragraph><paragraph id="H24F20F50CC724950A5CC3D2EAE46AA8C"><enum>(2)</enum><text>by inserting after part D the following new part:</text><quoted-block display-inline="no-display-inline" id="HEECD5A186F954C648081EB1536C1D90A" style="OLC"><part id="HEBADA4BF995E4D84BB316A41D11D004F"><enum>E</enum><header>Medicare with Choice and Competition</header><subpart id="H0B79F69C8C3C4CE28E466564BAF5946A"><enum>1</enum><header>Opt-Out and auto-Enrollment</header><section id="HC9D5995D29D44822BF72FB760B3AC040"><enum>1860E–11.</enum><header>Part A opt-out and MA auto-enrollment</header><subsection id="H4F84EC506BD54DC28EB36EAB3CF855D9"><enum>(a)</enum><header>Permitting individuals To opt out of part A coverage without losing social security benefits</header><paragraph id="H0847A84DC1A44305ADA7C0FDB8953835"><enum>(1)</enum><header>In general</header><text>The Secretary shall establish—</text><subparagraph id="HF5CE57FB052248488F15363EF16839E9"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="H6A32E96C6AB14008B39F382075DD5855"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text></subparagraph><continuation-text continuation-text-level="paragraph">The process under subparagraph (B) shall be coordinated with the enrollment process under section 1837 for part B. </continuation-text></paragraph><paragraph id="H2ED863ECC00C42BBA7FBC5AF26FEC2B2"><enum>(2)</enum><header>Application of late enrollment penalty</header><text display-inline="yes-display-inline">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).</text></paragraph><paragraph id="H5EA82E8AAF094815A2372271DDFC5205"><enum>(3)</enum><header>No impact on title II benefits</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="H3F6E0FC46EDD4A118CF3A50613B33985"><enum>(4)</enum><header>Deemed opt-out</header><subparagraph id="HD916C371E88442AA8020866C146C4E12"><enum>(A)</enum><text>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).</text></subparagraph><subparagraph id="H070228ADB06C47529F75C906A27137D5"><enum>(B)</enum><text>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.</text></subparagraph></paragraph></subsection><subsection id="H3CEC093E8B82406BB17279810B1D683A"><enum>(b)</enum><header>Special open enrollment period without late enrollment penalty for current part A only or part B only enrollees</header><text>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.</text></subsection><subsection id="H6D1F43EF6FAC4B69AFBF2DA6D8C1CCF1"><enum>(c)</enum><header>Auto enrollment of dual eligible individuals under Medicare Advantage plans</header><paragraph id="H70461CA81DA54F72BE18B378EFBEBC47"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="H511277BD9AA146F6A496E1C91D6FB8B5"><enum>(2)</enum><header>Right to disenroll</header><text>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.</text></paragraph></subsection></section><section id="H47D3F8FA52BB4E0CA80D79662F76C1CA"><enum>1860E–12.</enum><header>Coordination with part D</header><subsection id="H4786C0B3A7704F17BC5489409A03DF18"><enum>(a)</enum><header>Deemed enrollment under part D</header><paragraph id="H26E5E1905F3148089F8DB06F59E2026E"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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—</text><subparagraph id="H2158A923392C4A05AC737660A9AC2194"><enum>(A)</enum><text>failed to enroll in such a prescription drug plan during the applicable enrollment or coverage election period under section 1860D–1(b); and</text></subparagraph><subparagraph id="H3601A3ED3EEA4786920E59B004866B7C"><enum>(B)</enum><text>failed to elect not to enroll in such a prescription drug plan during an applicable opt-out period described in paragraph (2).</text></subparagraph><continuation-text continuation-text-level="paragraph">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). </continuation-text></paragraph><paragraph id="H6CEA568C14C140568C06A7533E985F80"><enum>(2)</enum><header>Opt-out periods</header><text display-inline="yes-display-inline">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.</text></paragraph><paragraph id="H3AE613B946094AC786EBDA243F771D6B"><enum>(3)</enum><header>Late enrollment penalties</header><text>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.</text></paragraph><paragraph id="HE2A897724853449788211828713A33C7"><enum>(4)</enum><header>No late enrollment penalty for current fee-for-service beneficiaries without drug coverage</header><text display-inline="yes-display-inline">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.</text></paragraph></subsection><subsection id="HEC3C9EDD26B6428D922726CC2F9494D8"><enum>(b)</enum><header>Reference to required prescription drug coverage under part C</header><text>For provision requiring coverage under MA plans to include prescription drug coverage, see section 1860E–26.</text></subsection></section></subpart></part><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HC40A4CCB28914D73B2E18DBD201A7C03"><enum>(b)</enum><header>Limitation on Medicaid benefits for full-Benefit dual eligible individuals</header><text>Section 1902 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block display-inline="no-display-inline" id="H45A59738B74C4F43A187BF9BAE6B3F2C" style="OLC"><subsection id="H005A980D451F449D9EFA9977B1451860"><enum>(ll)</enum><header>Limitation on benefits for full-Benefit dual eligible individuals</header><text display-inline="yes-display-inline">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.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HC9156FB8BA494575B0A95107D4281FE4"><enum>(c)</enum><header>Medicaid maintenance of effort and alternatives</header><text>Title XIX of the Social Security Act is amended by inserting after section 1943 the following new section:</text><quoted-block display-inline="no-display-inline" id="HA8E8E2F55C57429288C8A39FBC2CB923" style="traditional"><section id="H504164C27BF04F178B530F2AB24AD9A8"><enum>1944.</enum><header>Maintenance of effort options for full-benefit dual eligible individuals</header><subsection commented="no" display-inline="yes-display-inline" id="HF0E7D4858B2849CEB86B2418D9CCF747"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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).</text></subsection><subsection id="H8207E2662E0D40F191569D3E73A8F6E3"><enum>(b)</enum><header>Maintenance of effort options described</header><text display-inline="yes-display-inline">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:</text><paragraph id="HCD833D0166BD48D5B4A45B2F1E31192E"><enum>(1)</enum><header>Enrollment of dual eligibles in comprehensive Medicaid managed care plan</header><subparagraph id="H0DEF32D0AA63416B9362B76372A40984"><enum>(A)</enum><header>In general</header><text>The State enrolls all such individuals in a comprehensive Medicaid managed care plan offered by a managed care entity under section 1932.</text></subparagraph><subparagraph id="HD9F5D3C0CE01428CA800106D8AC5797F"><enum>(B)</enum><header>Payment of subsidy amount to State</header><text display-inline="yes-display-inline">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.</text></subparagraph><subparagraph id="HDF55E575BA394F13AF50B5CA93BB3E21"><enum>(C)</enum><header>Relation to part D rules</header><text display-inline="yes-display-inline">In the case of a State that has elected the option under this paragraph, notwithstanding any other provision of law—</text><clause id="H4520110DB2FA4AECA64EE30018567338"><enum>(i)</enum><text>the coverage provided under this option shall be in lieu of any coverage that may otherwise be provided under part D; and</text></clause><clause id="H8DA45ABB6AEE46209A5BC6912111BCC9"><enum>(ii)</enum><text>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.</text></clause></subparagraph></paragraph><paragraph id="HA58F3802F3724515A1092E53EBEFFBD5"><enum>(2)</enum><header>Other innovative alternatives</header><subparagraph id="H22FE1439A9F4430EAC73E56DBA42BEA3"><enum>(A)</enum><header>In general</header><text>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.</text></subparagraph><subparagraph id="H93D2475F1A18449CA9052AA49BD8A4D4"><enum>(B)</enum><header>Process for review</header><text>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—</text><clause id="HD38C75F44B7A4C5B983DD1DEDB09917C"><enum>(i)</enum><text>there would be no increased cost to the Federal Government if it were approved; and</text></clause><clause id="H629AF33F918849A286E352DA42260E08"><enum>(ii)</enum><text>there would be no reduction in the quality of care provided to such individuals if the proposal were approved.</text></clause></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H18F57FB9675941AA963558A491285515"><enum>(d)</enum><header>Conforming amendments</header><paragraph id="HC8048F23E5A64D6DBEBE056E999476DB"><enum>(1)</enum><header>Section <enum-in-header>226</enum-in-header></header><text display-inline="yes-display-inline">Section 226 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/426">42 U.S.C. 426</external-xref>) is amended—</text><subparagraph id="HE96A76376CE34C5F95684CC46C4475F7"><enum>(A)</enum><text>in subsection (a), in the matter preceding paragraph (1), by inserting <quote>, subject to section 1860E–11(a)</quote> after <quote>individual who</quote>;</text></subparagraph><subparagraph id="H2212594B28BE43A9850B27831D244BED"><enum>(B)</enum><text>in subsection (b), in the matter preceding paragraph (1), by inserting <quote>, subject to section 1860E–11(a)</quote> after <quote>individual who</quote>; and</text></subparagraph><subparagraph id="H4AAA6F1D7E9D4AE9937FD312FC3B59AF"><enum>(C)</enum><text>in subsection (c), in the matter preceding paragraph (1), by inserting <quote>, subject to section 1860E–11(a)</quote> after <quote>subsection (a)</quote>.</text></subparagraph></paragraph><paragraph id="H1EF38E86CEB94D15A7B1D8886EA0261B"><enum>(2)</enum><header>Section <enum-in-header>226A</enum-in-header></header><text display-inline="yes-display-inline">Section 226A(a) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/426-1">42 U.S.C. 426–1(a)</external-xref>) is amended, in the matter preceding paragraph (1), by inserting <quote>and subject to section 1860E–11(a)</quote> after <quote>or title XVIII</quote>.</text></paragraph><paragraph id="HB17022394F2242E79F60798C0787EDE7"><enum>(3)</enum><header>Section <enum-in-header>1932</enum-in-header></header><text>Section 1932(a)(2)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396u-2">42 U.S.C. 1396u–2(a)(2)(B)</external-xref>) is amended by striking <quote>A State</quote> and inserting <quote>Except in the case of a State that has elected the maintenance of effort option described in section 1944(b)(2), a State</quote>.</text></paragraph></subsection></section><section id="H8A2C4E9C5F394D75A8DEB8C167D96ACE"><enum>423.</enum><header>New benefit structure under unified Medicare</header><subsection id="H9B9C5A9CA3A54BD0891D91955C53EB4C"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Part E of title XVIII of the Social Security Act, as added by section 251, is amended by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="H6FF0379DF6174B6A97EE3251E0432B9E" style="OLC"><subpart id="HB8F3833111F1485D91E720372A2FF28D"><enum>2</enum><header>Out-of-Pocket limit</header><section id="H08EB308FCEDA40CFA72C370F57D003A1"><enum>1860E–21.</enum><header>Out-of-pocket limit</header><subsection commented="no" display-inline="no-display-inline" id="HE7C880BCA31944CFA3B008E5792E488B"><enum>(a)</enum><header>In general</header><text>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—</text><paragraph id="H6436DAE0F9E54ED2B231A3CB809EBB22"><enum>(1)</enum><text>the enrollee shall not be responsible for additional out-of-pocket cost-sharing incurred during that year; and</text></paragraph><paragraph id="H8F2FC434AF40445DAA462B1D1A82CF05"><enum>(2)</enum><text display-inline="yes-display-inline">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—</text><subparagraph id="H89BA7E7030934346B24532A364AC26AB"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="H564EF3389D294C9B92EEBB590E57F4D9"><enum>(B)</enum><text display-inline="yes-display-inline">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).</text></subparagraph></paragraph></subsection><subsection commented="no" id="H9AEC8B8AB9794C199E02ABBBB3808C5D"><enum>(b)</enum><header>Catastrophic limit</header><text display-inline="yes-display-inline">The amount of the catastrophic limit under this subsection for a year shall be the dollar amount in effect under <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)(2)(A)(ii)</external-xref> of the Internal Revenue Code of 1986 for self-only coverage for taxable years beginning in such year.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H3CB5A6D2EB8E4C4A856210F8F856AD9D"><enum>(c)</enum><header>Out-of-Pocket cost-Sharing defined</header><text display-inline="yes-display-inline">In this section, the term <term>out-of-pocket cost-sharing</term> means, with respect to an individual, the amount of costs incurred by the individual that are attributable to—</text><paragraph id="HF75AB04980F34C719D7F3FFA62332EF4"><enum>(1)</enum><text>deductibles and coinsurance imposed under part A or part B; and</text></paragraph><paragraph id="HA30A1BB5F1B948C682EA148B071E848C"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text></paragraph></subsection></section></subpart><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H4A175550BD7043468A45833DB731E7B2"><enum>(b)</enum><header>Application of out-of-Pocket limit to MA–PD plans</header><paragraph id="HC9CD0A66923E428190D44C8D5DBBC701"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1852(a)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-22">42 U.S.C. 1395w–22(a)(1)(B)</external-xref>) is amended—</text><subparagraph id="H1FB2687F9CF9476EBEE78FF7F5A89DD5"><enum>(A)</enum><text>in clause (i), by striking <quote>clause (iii)</quote> and inserting <quote>clauses (iii) and (vi)</quote>; and</text></subparagraph><subparagraph id="H8B772BB50C3741ECA1278E48C9A20BA6"><enum>(B)</enum><text>by adding at the end the following new clause:</text><quoted-block display-inline="no-display-inline" id="H400A3F30FE0746388AB48BBD52AA2762" style="OLC"><clause id="H906915F7A39B49B9B878459B2D13FD3C"><enum>(vi)</enum><header>Out-of-pocket limit</header><text display-inline="yes-display-inline">The provisions of section 1860E–21—</text><subclause id="HDE79E492A068470E998E705660C2FBBC"><enum>(I)</enum><text>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</text></subclause><subclause id="HA1CFA98E758B41B2ACF43119BF904D18"><enum>(II)</enum><text>as applied under subclause (I), may not be waived by application of this subparagraph.</text></subclause><continuation-text continuation-text-level="clause">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.</continuation-text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H7B3EEDD4306A490EB9AAEDCFA7EE8B6D"><enum>(2)</enum><header>Exempting MA–PD plans offering alternative prescription drug coverage from part D deductible and out-of-pocket limit requirements</header><text>Section 1860D–2(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(c)</external-xref>) is amended—</text><subparagraph id="H99436948C2484FA2AD688358419E1AE5"><enum>(A)</enum><text>in paragraph (2), by striking <quote>The deductible</quote> and inserting <quote>In the case of a prescription drug plan, the deductible</quote>; and</text></subparagraph><subparagraph id="HD0F52E1FA9664B3EB18272B52EE72D3E"><enum>(B)</enum><text>in paragraph (3), by striking <quote>The coverage provides</quote> and inserting <quote>In the case of a prescription drug plan, the coverage provides</quote>.</text></subparagraph></paragraph></subsection><subsection id="H731C33C468B244A3801D701B5226215E"><enum>(c)</enum><header>Prescription drug plans required To report enrollees’ out-of-Pocket cost-Sharing</header><text>Section 1860D–12(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112(b)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block display-inline="no-display-inline" id="H89715CA0ABCA4589B1D72E99B388A3ED" style="OLC"><paragraph id="H5E6477D233C942A18E90279DBD7EFFD0"><enum>(7)</enum><header>Out-of-pocket cost-sharing reports</header><text display-inline="yes-display-inline">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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HA8F4D1043275465E8B921576CE0B14AB"><enum>(d)</enum><header>Conforming amendments</header><paragraph id="H8BA53D4DF286400CAF7406A2F44A4337"><enum>(1)</enum><text>Section 1813 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395e">42 U.S.C. 1395e</external-xref>) is amended—</text><subparagraph id="H858ACC51E1264E1EA5B7A4281C12126B"><enum>(A)</enum><text>in subsection (a), by inserting <quote>Subject to subpart 2 of part E:</quote> before paragraph (1); and</text></subparagraph><subparagraph id="HC32EB93D7F424FD58C49DD4C1BF445A5"><enum>(B)</enum><text display-inline="yes-display-inline">in subsection (b), by inserting <quote>Subject to subpart 2 of part E:</quote> before paragraph (1).</text></subparagraph></paragraph><paragraph id="HA9C36E965ED144A89BBD9892E4B7CA4F"><enum>(2)</enum><text>Section 1833 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l</external-xref>) is amended—</text><subparagraph id="HDC6769712A3843809939AF2C858C2ECB"><enum>(A)</enum><text>in subsection (a), in the matter preceding paragraph (1), by inserting <quote>and subpart 2 of part E</quote> after <quote>succeeding provisions of this section</quote>;</text></subparagraph><subparagraph id="HF95B3CCB263248DDB8F0E932A1B069C6"><enum>(B)</enum><text>in subsection (b), in the first sentence, by striking <quote>Before applying</quote> and inserting <quote>Subject to subpart 2 of part E, before applying</quote>;</text></subparagraph><subparagraph id="HBCCC0535548B4E1EB9B494EF0344A061"><enum>(C)</enum><text>in subsection (c)(1), in the matter preceding subparagraph (A), by inserting <quote>subject to subpart 2 of part E,</quote> after <quote>this part,</quote>;</text></subparagraph><subparagraph id="H8BE6670A40524AA6883A6C019BD967DD"><enum>(D)</enum><text>in subsection (f), by striking <quote>In establishing</quote> and inserting <quote>Subject to subpart 2 of part E, in establishing</quote>; and</text></subparagraph><subparagraph id="HD72B943B61964223BE77FE56137A1CDB"><enum>(E)</enum><text>in subsection (g)(1), by inserting <quote>and subpart 2 of part E</quote> and <quote>paragraphs (4) and (5)</quote>.</text></subparagraph></paragraph><paragraph id="H8AEF092AC73F4ACEB81EEB932B6C5323"><enum>(3)</enum><text>Section 1882(a)(2) of such Act is amended by striking <quote>No medicare</quote> and inserting <quote>Subject to section 1860E–24(c), no medicare</quote>.</text></paragraph></subsection></section><section id="H428AF5D6AED6422C9120BF1D600D017E"><enum>424.</enum><header>Late enrollment penalty not to apply for months of any health coverage</header><subsection id="HCB8BF47A46A34DCCA005B0872294630C"><enum>(a)</enum><header>In general</header><text>Section 1839(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395r">42 U.S.C. 1395r</external-xref>) is amended in the second sentence, by inserting before the period at the end the following: <quote>or months during which the individual has any other health coverage</quote>.</text></subsection><subsection id="HEFD84A216A6347539AB860F4FE222B41"><enum>(b)</enum><header>Effective date</header><text>The amendment made by paragraph (1) shall apply for months of coverage beginning after the date of the enactment of this Act.</text></subsection></section><section id="H987DD38F471047EC85AF5C44394C615D"><enum>425.</enum><header>Medigap reform</header><text display-inline="no-display-inline">Notwithstanding any provision of section 1882 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ss">42 U.S.C. 1395ss</external-xref>), 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.</text></section><section id="H39DF5B5989A948D29E302EB6F9533C22"><enum>426.</enum><header>ACO revision</header><subsection id="H529F1256A4CB463AA759302EC7E158FB"><enum>(a)</enum><header>Enrollment</header><text>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.</text></subsection><subsection id="H431F574A77B746D88612F72C00F7B814"><enum>(b)</enum><header>Direction of payment</header><text>An ACO may direct that any payments under such title be made to a centralized entity rather than to an individual provider or supplier.</text></subsection><subsection id="H7CA21FC08F1540D0937D6F5B1DD7B727"><enum>(c)</enum><header>Bids</header><text>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.</text></subsection></section><section id="HA598DB641B5644F0AAE3FD2596C851CC"><enum>427.</enum><header>Primary care options</header><subsection id="HA1B18A60AA7E405EB823B85CBB655C6C"><enum>(a)</enum><header>Selection of primary care physician</header><text display-inline="yes-display-inline">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.</text></subsection><subsection id="HE3676E00B9064EAD824D4037928F2CD3"><enum>(b)</enum><header>Payment to physician</header><text>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.</text></subsection></section><section id="H739355DA2B324F86A6CA3A56E970FC07"><enum>428.</enum><header>General provisions; effective date</header><text display-inline="no-display-inline">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:</text><quoted-block display-inline="no-display-inline" id="H48099AAA5B1F4B1982843165249FC91F" style="OLC"><subpart id="H13DBEDF5E1DD4B08AD99898D7FBD48D7"><enum>5.</enum><header>General provisions</header><section id="HDA1F8AA2B887495FB8103C6628295A6F"><enum>1860E–51.</enum><header>Applicability; definitions</header><subsection display-inline="no-display-inline" id="HFAD4E0BE9AF241DF90B162F691B67062"><enum>(a)</enum><header>In general</header><text>The provisions of this Act are superseded to the extent inconsistent with the provisions of this part.</text></subsection><subsection id="HF3385AF6A7154C83BC13C7D38D0A4AB8"><enum>(b)</enum><header>Terminology</header><text display-inline="yes-display-inline">For purposes of this part:</text><paragraph id="HEF6E1C9E1DD1423C874B299C65E8E720"><enum>(1)</enum><header>Medicare enrollee</header><subparagraph id="H502A76EA103C4C90856863CC3E5BBBA5"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The term <term>Medicare enrollee</term> means—</text><clause id="HEC447DCC661F4D368EAAA849F1C7CED8"><enum>(i)</enum><text>an individual entitled to (or enrolled for benefits) under part A and enrolled under part B; and</text></clause><clause commented="no" id="HFDC1DCFCE1944C7B8132A31B1C2EC167"><enum>(ii)</enum><text>except as otherwise specified, an individual described in section 1860E–11(a)(3).</text></clause></subparagraph><subparagraph id="HA9BA886C14794A649188450ADE329F1F"><enum>(B)</enum><header>Treatment</header><text>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.</text></subparagraph></paragraph><paragraph id="H5CC20144F159444196D177834C3CB731"><enum>(2)</enum><header>Medicare fee-for-service</header><text display-inline="yes-display-inline">The term <term>Medicare fee-for-service</term> 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.</text></paragraph><paragraph id="H80AC4F79349D4A86B179BAB4F74F05B4"><enum>(3)</enum><header>Medicare fee-for-service enrollee</header><text display-inline="yes-display-inline">The term <term>Medicare fee-for-service enrollee</term> means a Medicare enrollee who is not enrolled under a Medicare Advantage plan under part C.</text></paragraph></subsection></section><section id="HE33D49C4FAC244B290EB88B2A3391AE5"><enum>1860E–61.</enum><header>General effective date</header><text display-inline="no-display-inline">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 <quote>general effective date</quote>).</text></section></subpart><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle><subtitle id="H6A2E61DAB3124D5CA7DD3B43F263B6BE"><enum>D</enum><header>Telehealth Improvements and Expansion</header><section id="H7DC7DAECF41043C5B3692B46791F3DBF"><enum>431.</enum><header>Expansion of coverage of telehealth services</header><subsection id="H2E42BD0879C54B18995826614B2CA34F"><enum>(a)</enum><header>Covered services</header><text display-inline="yes-display-inline">Section 1834(m)(4)(F)(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(4)(F)(i)</external-xref>) is amended—</text><paragraph id="H273D948CACE441BC8386E24D540FE68C"><enum>(1)</enum><text>by striking <quote>and office</quote> and inserting <quote>office</quote>; and</text></paragraph><paragraph id="HF51B6265A5174FD8ABC73B9B5B8C77F6"><enum>(2)</enum><text>by inserting: <quote>respiratory services, audiology services (as defined in section 1861(ll)), outpatient therapy services (including physical therapy, occupational therapy, and speech-language pathology services)</quote> after <quote>the Secretary)),</quote>.</text></paragraph></subsection><subsection id="H670C49A9A2C64089895835B6277827F9"><enum>(b)</enum><header>Providers</header><text>Subsection (m) of section 1834 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m</external-xref>) is amended—</text><paragraph id="HAC40FD16BC91444E89ED895586B29BE3"><enum>(1)</enum><text>in paragraph (1), by striking <quote>or a practitioner (described in section 1842(b)(18)(C))</quote> and inserting <quote>, a practitioner (described in section 1842(b)(18)(C)), or an applicable professional (as defined in paragraph (4)(G))</quote>;</text></paragraph><paragraph id="H81BF2ABED0CB4861AAAC0BD223F305EB"><enum>(2)</enum><text>by striking <quote>physician or practitioner</quote> each time it appears in such subsection and inserting <quote>physician, practitioner, or applicable professional</quote>;</text></paragraph><paragraph id="HABC233132E1A4131A7FE64EAD0312A25"><enum>(3)</enum><text>in paragraph (3)(A)—</text><subparagraph id="HAFC6394BC8E7468D9A226117B83C0483"><enum>(A)</enum><text>in the heading, by striking <quote><header-in-text level="subparagraph" style="OLC">Physician and practitioner</header-in-text></quote> and inserting <quote><header-in-text level="subparagraph" style="OLC">Physician, practitioner, and applicable professional</header-in-text></quote>; and</text></subparagraph><subparagraph id="H837761D15536439BA8566533F6F61B73"><enum>(B)</enum><text>by striking <quote>physicians or practitioners</quote> and inserting <quote>physicians, practitioners, or applicable professionals</quote>; and</text></subparagraph></paragraph><paragraph id="H27752B9691C04351B41F9CAAF77B9488"><enum>(4)</enum><text>in paragraph (4), by adding at the end the following new subparagraph:</text><quoted-block id="HB0C86564F8C047F58E0D9BF8620923A6" style="OLC"><subparagraph id="H56B3DA7A86914C669EEF44B3C3310677"><enum>(G)</enum><header>Applicable professional</header><text>The term <term>applicable professional</term> 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—</text><clause id="H4652499EA0D843088800301BB42464CC"><enum>(i)</enum><text>respiratory therapist;</text></clause><clause id="HFBDD5B2482204AA5AB6D9B439D00D3E6"><enum>(ii)</enum><text>audiologist;</text></clause><clause id="HA1EF46C0ADB946D688849839C19F9D8F"><enum>(iii)</enum><text>occupational therapist;</text></clause><clause id="HF2FFCE6837E9487BA83E70CB0AC683CA"><enum>(iv)</enum><text>physical therapist; or</text></clause><clause id="HE638D98E01804AF6A76F06F7FC7ED4A2"><enum>(v)</enum><text>speech language pathologist.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HC4519E5A1C344A85B47CE4810388B17B"><enum>(c)</enum><header>Home-Based monitoring services for congestive heart failure and chronic obstructive pulmonary disease</header><paragraph id="H429D54A300994295825D6C882B51724B"><enum>(1)</enum><header>Coverage of remote patient monitoring services for certain chronic health conditions</header><text>Section 1861(s)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(s)(2)</external-xref>) is amended—</text><subparagraph id="H990C6CA34DB84100B750CC81999ED329"><enum>(A)</enum><text>in subparagraph (GG), by striking <quote>and</quote> at the end;</text></subparagraph><subparagraph id="H31BA5753E8764ADD9931514CA93FFE81"><enum>(B)</enum><text>in subparagraph (HH), by inserting <quote>and</quote> at the end; and</text></subparagraph><subparagraph id="H08E9A19247C142FA896A3156F82D317D"><enum>(C)</enum><text>by inserting after subparagraph (HH) the following new subparagraph:</text><quoted-block id="H9795335AFF5F4CC48E82313E368ED1CC" style="OLC"><subparagraph id="H0AC0D5FD19EA4CBEA7E3F030FD7807D4"><enum>(II)</enum><text>applicable remote patient monitoring services (as defined in paragraph (1)(A) of subsection (iii));</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H6BDEC86936584EA5BA422A96442D865F"><enum>(2)</enum><header>Services described</header><text>Section 1861 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block id="HFD3CEDDBD0004063951F26D712BE486B" style="OLC"><subsection id="H88D44F0101DA4B55A6B9E34817B1433F"><enum>(kkk)</enum><header>Remote Patient Monitoring Services for Chronic Health Conditions</header><paragraph id="HED689436CC3349FB9F0685DF79DFD616"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HA20028E4644742CC8515F4667CD2FAE3"><enum>(A)</enum><text>The term <term>applicable remote patient monitoring services</term> 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.</text></subparagraph><subparagraph id="H737A9CABC2D84927AECF49701E010BCD" indent="up1"><enum>(B)</enum><text>The term <term>remote patient monitoring services</term> means services furnished through remote patient monitoring technology (as defined in subparagraph (C)).</text></subparagraph><subparagraph id="H9CD1B222408346FBBC223713ABE2ED22" indent="up1"><enum>(C)</enum><text>The term <term>remote patient monitoring technology</term> 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.</text></subparagraph></paragraph><paragraph id="H25634EEC9D7546DE8FFF54BA2C4D1EEA"><enum>(2)</enum><text>For purposes of paragraph (1), the term <term>covered chronic health condition</term> 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)).</text></paragraph><paragraph id="H685A5B1C08B94659BB5E8C5F3320A245"><enum>(3)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HF73E0A9CB6D74289B9FB1D23CE52BCE2"><enum>(A)</enum><text>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).</text></subparagraph><subparagraph id="HE4DFEDC071724DDFA9BB3B52FCE5869E" indent="up1"><enum>(B)</enum><text>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.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HBA7DD2A220DC4B0F8302D3F288AAE282"><enum>(3)</enum><header>Payment under the physician fee schedule</header><text>Section 1848 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-4">42 U.S.C. 1395w–4</external-xref>) is amended—</text><subparagraph id="HA81508087BA045A798F6EF0017D49DD6"><enum>(A)</enum><text>in subsection (c)—</text><clause id="HBC16A75D4B294C9F94EB2531613481D1"><enum>(i)</enum><text>in paragraph (2)(B)—</text><subclause id="H91D32DBEB3564A669079720B52C9290D"><enum>(I)</enum><text>in clause (ii)(II), by striking <quote>and (v)</quote> and inserting <quote>(v), and (vii)</quote>; and</text></subclause><subclause id="H0177CA7368174E33BA06F7CC21890DAF"><enum>(II)</enum><text>by adding at the end the following new clause:</text><quoted-block id="HF48D1A5DEFE14B1C87699F1482433B5B" style="OLC"><clause id="H2A857F53AD4C4CF7B88D9022BFB336E2"><enum>(vii)</enum><header>Budgetary treatment of certain services</header><text>The additional expenditures attributable to services described in section 1861(s)(2)(II) shall not be taken into account in applying clause (ii)(II).</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause><clause id="HBCBF3560820A45E792635AC69B3CD4A6"><enum>(ii)</enum><text>by adding at the end the following new paragraph:</text><quoted-block id="H415F1903EB2848BCB52340ED05C35C26" style="OLC"><paragraph id="HB22359496AF844A59001B1CD72D80337"><enum>(7)</enum><header>Treatment of applicable remote patient monitoring services</header><subparagraph id="H9A6E901168DC48FEAA1C3B18C8D89377"><enum>(A)</enum><text>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—</text><clause id="H973D6D8ADEC741E3A24B03C365DC8DB7"><enum>(i)</enum><text>physician or practitioner resources, including physician or practitioner time and the level of intensity of services provided, based on—</text><subclause id="HA6C249D5F2714F4CB3B06ABA2D1E68F7"><enum>(I)</enum><text>the frequency of evaluation necessary to manage the individual being furnished the services;</text></subclause><subclause id="HB834DCAD8726481AA3359D70EB1C33CA"><enum>(II)</enum><text>the complexity of the evaluation, including the information that must be obtained, reviewed, and analyzed; and</text></subclause><subclause id="HA700E1CEE0A4470DA1F79AA7760B4515"><enum>(III)</enum><text>the number of possible diagnoses and the number of management options that must be considered;</text></subclause></clause><clause id="H700D4457CE1E47C986702DFE808FE620"><enum>(ii)</enum><text>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</text></clause><clause id="H946A6082A46B4F5688CADFA89F2EB61E"><enum>(iii)</enum><text>malpractice expense resources.</text></clause></subparagraph><subparagraph id="H572C130AD1684104A0C07C020828F009"><enum>(B)</enum><text>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.</text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="HF7C1876BE2344D149BBA2B79B3462235"><enum>(B)</enum><text>in subsection (j)(3), by inserting <quote>(2)(II),</quote> after <quote>health risk assessment),</quote>.</text></subparagraph></paragraph></subsection></section><section id="H02CFE40A8C3646A58E4A32C59D50CC3D"><enum>432.</enum><header>Expanding the use of telehealth through the waiver of certain requirements</header><subsection id="H15722F915E804FCBACAFB552BBA87929"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1834(m) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)</external-xref>) is amended—</text><paragraph id="H88A6376DD5124D16930EB3474BE21212"><enum>(1)</enum><text>in paragraph (4)(C)(i), by striking <quote>and (7)</quote> and inserting <quote>(7), and (8)</quote>; and</text></paragraph><paragraph id="H31B95D757E384409B64D0865DE464A1B"><enum>(2)</enum><text>by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="H0AF97EEAB389404BAF9717EFAB640F2D" style="OLC"><paragraph id="HFA5868B70BA14E86810097F4FED3B5C3"><enum>(8)</enum><header>Authority to waive requirements and limitations if certain conditions met</header><subparagraph id="H21C3137F96FA4575BC6B5242960D87A5"><enum>(A)</enum><header>In general</header><text>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—</text><clause id="HFE5AD705D72C46DD8F7A8C8AE9CE54AB"><enum>(i)</enum><text>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</text></clause><clause id="H1F55395FC801496E9BE6D90731AB8870"><enum>(ii)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/42/254e">42 U.S.C. 254e(a)(1)(A)</external-xref>)).</text></clause></subparagraph><subparagraph id="HD100EB2793B6489DACF59384BD363158"><enum>(B)</enum><header>Restrictions described</header><text>For purposes of this paragraph, restrictions applicable to payment for telehealth services under paragraph (1) are—</text><clause id="HDAAB7FFE8DA64E17847E7DD877DA2CAC"><enum>(i)</enum><text>requirements relating to qualifications for an originating site under paragraph (4)(C)(ii);</text></clause><clause id="HA48C955997D4494DA1585B7E7F1CBA67"><enum>(ii)</enum><text>any geographic limitations under paragraph (4)(C)(i) (other than applicable State law requirements, including State licensure requirements);</text></clause><clause id="H93C049256019435AAB361481E810A619"><enum>(iii)</enum><text>any limitation on the type of technology used to furnish telehealth services;</text></clause><clause id="HD8D343D7CA39473E8EEF8EC4337A2240"><enum>(iv)</enum><text>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);</text></clause><clause id="H5B40EE82E4ED4A7EAC4B6EA05EA77ABB"><enum>(v)</enum><text>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</text></clause><clause id="H0E197C786FB442CA8C6A9BECD30916D7"><enum>(vi)</enum><text>any other limitation relating to the furnishing of telehealth services under this title identified by the Secretary.</text></clause></subparagraph><subparagraph id="H6EF95A5C1C364CFFBF23209EED7FF8F1"><enum>(C)</enum><header>Public comment</header><text>The Secretary shall establish a process by which stakeholders may (on at least an annual basis) provide public comment for waivers under this paragraph.</text></subparagraph><subparagraph id="HCE34CD2C4FE84C9B9358E4F122B5357B"><enum>(D)</enum><header>Periodic review of waivers</header><text>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).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HBCA4AF0C6E434B039FB2E8D4C2EA14B1"><enum>(b)</enum><header>Posting of information</header><text>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—</text><paragraph id="H3E12C2A1CC6340BC904709DF1B2A8D21"><enum>(1)</enum><text>the number of Medicare beneficiaries receiving telehealth services by reason of each waiver under such section;</text></paragraph><paragraph id="H329F7680F748472AA1EB110E6DCACDE9"><enum>(2)</enum><text>the impact of such waivers on expenditures and utilization under title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395 et seq.</external-xref>); and</text></paragraph><paragraph id="HA030094CA7A64E8BAD7168091DF6A6FC"><enum>(3)</enum><text>other outcomes, as determined appropriate by the Secretary.</text></paragraph></subsection></section><section id="H159B7CB0F05B43039BCECF4E3E8C614C"><enum>433.</enum><header>Expanding the use of telehealth for mental health services</header><subsection id="HFCE5D00491B8406B80B7715EA40CEAA2"><enum>(a)</enum><header>In general</header><text>Section 1834(m) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)</external-xref>), as amended by the preceding sections, is amended—</text><paragraph id="H4F15118208394FC38B972461E1BBAABC"><enum>(1)</enum><text>in paragraph (4)(C)(i), by striking <quote>and (8)</quote> and inserting <quote>(8), and (9)</quote>; and</text></paragraph><paragraph id="H63A726A45EBD48499776E6DD971F6AB1"><enum>(2)</enum><text>by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="HBDCCE5A7A9EF4C72800F2DDC8258C92A" style="OLC"><paragraph id="H5FD6158B05CB424EAB4E1AA3CEA4BF3A"><enum>(9)</enum><header>Treatment of mental health services furnished through telehealth</header><text>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).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H3EEF7EF1EE9F47D4BD6C5A771C2F1AFE"><enum>(b)</enum><header>Inclusion of the home as an originating site</header><text>Section 1834(m)(4)(C)(ii)(X) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(4)(C)(ii)(X)</external-xref>) is amended by striking <quote>paragraph (7)</quote> and inserting <quote>paragraphs (7) and (9)</quote>.</text></subsection><subsection id="HEAC4F5B0732F4E59B48681B113BF0D72"><enum>(c)</enum><header>Additional services</header><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m</external-xref>) for authorized payment under paragraph (1) of such section.</text></subsection></section><section id="H2CC8047ED1264A9CA86EA7F6F903C352"><enum>434.</enum><header>Use of telehealth in emergency medical care</header><subsection id="H1691639A517044D7AF8C8753829450C9"><enum>(a)</enum><header>In general</header><text>Section 1834(m) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)</external-xref>), as amended by the preceding sections, is amended—</text><paragraph id="H802E3C84F8E34790B485DF6AEF2DEDF3"><enum>(1)</enum><text>in paragraph (4)(C)(i), by striking <quote>and (9)</quote> and inserting <quote>(9), and (10)</quote>; and</text></paragraph><paragraph id="HD3BBBAEAF9804B2D8E8D4ABFE02C99DF"><enum>(2)</enum><text>by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="H27F9BCF3229140BB92C1CD86A57A5788" style="OLC"><paragraph id="H7C3349C2A06B4752AFF4C877FA15F8F0"><enum>(10)</enum><header>Treatment of emergency medical care furnished through telehealth</header><text>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).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HC8CB880CAA8D410387DC3030939383A6"><enum>(b)</enum><header>Additional services</header><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m</external-xref>) for authorized payment under paragraph (1) of such section.</text></subsection></section><section id="H9EFC9E65B1C944088DA8A149356C140F"><enum>435.</enum><header>Improvements to the process for adding telehealth services</header><text display-inline="no-display-inline">The Secretary shall undertake a review of the process established pursuant to section 1834(m)(4)(F)(ii) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(4)(F)(ii)</external-xref>), and based on the results of such review—</text><paragraph id="H73E1C3545406447291364070BA0A9E25"><enum>(1)</enum><text>implement revisions to the process so that the criteria to add services prioritizes, as appropriate, improved access to care through telehealth services; and</text></paragraph><paragraph id="HD5D8EFCDB35D4064A67C3C449370B059"><enum>(2)</enum><text>provide clarification on what requests to add telehealth services under such process should include.</text></paragraph></section><section id="H85DBD6C132C74847852DD1EB56DBDD6F"><enum>436.</enum><header>Rural health clinics and Federally qualified health centers</header><subsection id="HF81A9A7FAC2A487A8107D18B16E43350"><enum>(a)</enum><header>Expansion of originating sites</header><text>Section 1834(m)(4)(C) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(4)(C)</external-xref>), as amended by the preceding sections, is amended—</text><paragraph id="HB08DD36BE3D3409EA4E7AF0A6EC1A876"><enum>(1)</enum><text>in clause (i), by striking <quote>and (10)</quote> and inserting <quote>and (10), and subject to clause (iii),</quote>; and</text></paragraph><paragraph id="H3ABE7154A8084E6AA333E76DE0FFA242"><enum>(2)</enum><text>by adding at the end the following new clause:</text><quoted-block display-inline="no-display-inline" id="H43701606C739493B9E50A739B01B5CFB" style="OLC"><clause id="HF201718FD2974CFBB60ED6D42423E461"><enum>(iii)</enum><header>Rural health clinics and Federally qualified health centers</header><text>The term <term>originating site</term> 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.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HEBB9106BD8CF43FA843219F81D520319"><enum>(b)</enum><header>Expansion of distant sites</header><text>Section 1834(m) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)</external-xref>) is amended—</text><paragraph id="H89BAC952D70E4C1097C52BEEB0B00CE5"><enum>(1)</enum><text>in the first sentence of paragraph (1)—</text><subparagraph id="HF5FD86A26EEA4E8393F35EEEE52F73CC"><enum>(A)</enum><text>by striking <quote>or a practitioner (described in section 1842(b)(18)(C))</quote> and inserting <quote>, a practitioner (described in section 1842(b)(18)(C)), a Federally qualified health center, or a rural health clinic</quote>; and</text></subparagraph><subparagraph id="H5F21F93DA5F64ED99C6B6D66F095D20D"><enum>(B)</enum><text>by striking <quote>or practitioner</quote> and inserting <quote>, practitioner, Federally qualified health center, or rural health clinic</quote>;</text></subparagraph></paragraph><paragraph id="HFFE1A36C5107465481937C3AD124422D"><enum>(2)</enum><text>in paragraph (2)(A)—</text><subparagraph id="H088FBDF9C8A04FA0A5C8D01DBDA9F067"><enum>(A)</enum><text>by inserting <quote>or to a Federally qualified health center or rural health clinic that serves as a distant site</quote> after <quote>a distant site</quote>; and</text></subparagraph><subparagraph commented="no" id="HC36561F1EC884066966584B5BC65883C"><enum>(B)</enum><text>by striking <quote>such physician or practitioner</quote> and inserting <quote>such physician, practitioner, Federally qualified health center, or rural health clinic</quote>; and</text></subparagraph></paragraph><paragraph id="H0563852D17A9469193ADE0DADF5051BC"><enum>(3)</enum><text>in paragraph (4)—</text><subparagraph id="H91C22CDB9C024C1FBE1F634C4E56E29E"><enum>(A)</enum><text>in subparagraph (A), by inserting <quote>and includes a Federally qualified health center or rural health clinic that furnishes a telehealth service to an eligible individual</quote> before the period at the end; and</text></subparagraph><subparagraph commented="no" id="HAA3D764A78E549A9ACB5E45FC3E7719C"><enum>(B)</enum><text>in subparagraph (F), by adding at the end the following new clause:</text><quoted-block display-inline="no-display-inline" id="HCA061F05040C47C2923D46AAEFDC9D5F" style="OLC"><clause commented="no" id="HAB8E70CEBC4A44A9A70433CF98A692E6"><enum>(iii)</enum><header>Inclusion of rural health clinic services and Federally qualified health center services furnished using telehealth</header><text>For purposes of this subparagraph, the term <term>telehealth services</term> 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.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection><subsection id="HA6C7FB1666DF415496859E88820EC85E"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply to services furnished on or after January 1, 2023.</text></subsection></section><section id="H4D789E573D0940A0B8B93ED25C0E4A70"><enum>437.</enum><header>Native American health facilities</header><subsection id="HE6A7D90AD5154164A4AD8B9C53181697"><enum>(a)</enum><header>In general</header><text>Section 1834(m)(4)(C) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(4)(C)</external-xref>), as amended by the preceding sections, is amended—</text><paragraph id="H5B70F2BF741F48D4A967ED80C152907F"><enum>(1)</enum><text>in clause (i), by striking <quote>clause (iii)</quote> and inserting <quote>clauses (iii) and (iv)</quote>; and</text></paragraph><paragraph id="H8109F785616941DAAA8321A704F8AE6D"><enum>(2)</enum><text>by adding at the end the following new clause:</text><quoted-block display-inline="no-display-inline" id="H1808818C89A34572BBAC8B3105BABE7C" style="OLC"><clause id="H0C8EC24A15264D1280E6452F105570C8"><enum>(iv)</enum><header>Native American health facilities</header><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/25/1603">25 U.S.C. 1603</external-xref>)) or a tribal organization (as that term is defined in section 4 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5304">25 U.S.C. 5304</external-xref>)), or a facility of the Native Hawaiian health care systems authorized under the Native Hawaiian Health Care Improvement Act (<external-xref legal-doc="usc" parsable-cite="usc/42/11701">42 U.S.C. 11701 et seq.</external-xref>).</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H427E60BB2F4F46C6A8B4CA29BBAB1499"><enum>(b)</enum><header>No originating site facility fee for new sites</header><text>Section 1834(m)(2)(B)(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(2)(B)(i)</external-xref>) is amended, in the matter preceding subclause (I), by inserting <quote>(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)</quote> after <quote>the originating site</quote>.</text></subsection><subsection id="HB947CF045BAC4689931267A5C098FFB0"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply to services furnished on or after January 1, 2025.</text></subsection></section><section id="HD263AA17F18A44DFA977C21EF2A88B88"><enum>438.</enum><header>Waiver of telehealth restrictions during national emergencies</header><text display-inline="no-display-inline">Section 1135(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-5">42 U.S.C. 1320b–5(b)</external-xref>) is amended—</text><paragraph id="H250A226E721041288EC3EA00BAB1EA4E"><enum>(1)</enum><text>in paragraph (6), by striking <quote>and</quote> after the semicolon;</text></paragraph><paragraph id="H65A5694CCEA147228E3B272967C21CF2"><enum>(2)</enum><text>in paragraph (7), by striking the period at the end and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="HD958412DD2B944C6AE6530D195290769"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block display-inline="no-display-inline" id="HC003DA5D7D7848009747C9A512AD688B" style="OLC"><paragraph id="H96B3AA198BA54F3F9512AB381F47CF18"><enum>(8)</enum><text>requirements for payment for telehealth services under section 1834(m).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="HE4562988AEEC441CA617C011DB319F17"><enum>439.</enum><header>Use of telehealth in recertification for hospice care</header><subsection id="H47ADAAF2803F49E6A94F7A1E338F10B2"><enum>(a)</enum><header>In general</header><text>Section 1814(a)(7)(D)(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395f">42 U.S.C. 1395f(a)(7)(D)(i)</external-xref>) is amended by inserting <quote>(including through use of telehealth, notwithstanding the requirements in section 1834(m)(4)(C))</quote> after <quote>face-to-face encounter</quote>.</text></subsection><subsection id="HDFC05B8FA4FA41CB84317C95B46F7B31"><enum>(b)</enum><header>GAO report</header><text>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—</text><paragraph id="H6A4B9162288A4497998096E94D3D151D"><enum>(1)</enum><text>the number and percentage of beneficiaries recertified for the Medicare hospice benefit at 180 days and for subsequent benefit periods;</text></paragraph><paragraph id="HE6E6FC96293E4C75B283E9CC304FFB93"><enum>(2)</enum><text>the appropriateness for hospice care of the patients recertified through the use of telehealth; and</text></paragraph><paragraph id="HB99F1BEB98F84B90A8E83A4B971288AD"><enum>(3)</enum><text>any other factors determined appropriate by the Comptroller General.</text></paragraph></subsection></section><section id="H2054B7E17A5E4AAB909787213D1844B7"><enum>440.</enum><header>Clarification for fraud and abuse laws regarding technologies provided to beneficiaries</header><text display-inline="no-display-inline">Section 1128A(i)(6) of the Social Security Act (42 U.S.C. 1320a–7a(i)(6)) is amended—</text><paragraph id="HBC729585B851473299F7C64D6C42412C"><enum>(1)</enum><text>in subparagraph (I), by striking <quote>; or</quote> and inserting a semicolon;</text></paragraph><paragraph id="H68BA176A5FCE42D99CCCC1E6D2299585"><enum>(2)</enum><text>in subparagraph (J), by striking the period at the end and inserting <quote>; or</quote>; and</text></paragraph><paragraph id="HC27AEA586D16479A9F1A45BF6185EA30"><enum>(3)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block display-inline="no-display-inline" id="H416C62B43D294A8F8A679E72AB035B6B" style="OLC"><subparagraph id="H8BA21A2B91014838BEF07613353102CE"><enum>(K)</enum><text>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—</text><clause id="HD51B798D95B342E3B2EAF3590EB361C6"><enum>(i)</enum><text>the technologies are not offered as part of any advertisement or solicitation; and</text></clause><clause id="HDFA712A91C7B494CA2093018457CDE92"><enum>(ii)</enum><text>the provision of the technologies meets any other requirements set forth in regulations promulgated by the Secretary.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="H78E7B9BEC32F4EDEBA660E73B7C68959"><enum>441.</enum><header>Study and report on increasing access to telehealth services in the home</header><subsection id="HF0BB3AFAE23B40D9A226E260CA6A356B"><enum>(a)</enum><header>MedPAC study</header><text>The Medicare Payment Advisory Commission (in this section referred to as the <quote>Commission</quote>) shall conduct a study on increasing access under the Medicare program under title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395 et seq.</external-xref>) to telehealth services in the home. Such study shall include an analysis of the following:</text><paragraph id="H1AC7895ED31743E483D9C63ABF49B87B"><enum>(1)</enum><text>How different payers allow the home to be an originating site for telehealth services.</text></paragraph><paragraph id="HD140C10A97844BB7A64C140EEB653687"><enum>(2)</enum><text>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.</text></paragraph></subsection><subsection id="H80EAEE4149654A609820B531D24E91B2"><enum>(b)</enum><header>Report</header><text>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.</text></subsection></section><section id="H239823DDEA6944AB8CC45D2EA147EB69"><enum>442.</enum><header>Analysis of telehealth waivers in alternative payment models</header><text display-inline="no-display-inline">The second sentence of section 1115A(g) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1315a">42 U.S.C. 1315a(g)</external-xref>) is amended by inserting <quote>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,</quote> after <quote>subsection (c),</quote>.</text></section><section id="H6B4D7F02D0E4408E8B38EAD5CDB08FD5"><enum>443.</enum><header>Model to allow additional health professionals to furnish telehealth services</header><text display-inline="no-display-inline">Section 1115A(b)(2)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1315a">42 U.S.C. 1315a(b)(2)(B)</external-xref>) is amended by adding at the end the following new clause:</text><quoted-block display-inline="no-display-inline" id="H777BF0461D394A48833B13A407D1EFE1" style="OLC"><clause id="HC8D6D583BE424E5BBFAA9C45FE312EF6"><enum>(xxviii)</enum><text display-inline="yes-display-inline">Allowing health professionals who are not otherwise eligible under section 1834(m) to furnish telehealth services to furnish such services.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="HCE134B5D664649519000FF56164C28EB"><enum>444.</enum><header>Testing of models to examine the use of telehealth under the Medicare program</header><text display-inline="no-display-inline">Section 1115A(b)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1315a">42 U.S.C. 1315a(b)(2)</external-xref>) is amended by adding at the end the following new subparagraph:</text><quoted-block display-inline="no-display-inline" id="H48EEBA035EEE4DFEB38A1D2C15C8A7AB" style="OLC"><subparagraph id="H52AF8A4A841448C0A8DF9C502265696A"><enum>(D)</enum><header>Testing models to examine use of telehealth under Medicare</header><text>The Secretary shall consider testing under this subsection models to examine the use of telehealth under title XVIII.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle>