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[Discussion Draft]
[Discussion Draft]
December 6, 2019
116th CONGRESS 1st Session
Rules Committee Print 116–41
Text of H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act
Offered by M_. ______
[Showing the text of H.R. 3, as ordered reported by the Committee on Energy and Commerce, the Committee on Ways and Means, and the Committee on Education and Labor, with modifications.]
1.Short title; table of contents
(a)This Act may be cited as the Elijah E. Cummings Lower Drug Costs Now Act
.
(b)The table of contents is as follows:
Sec. 1. Short title; table of contents.
Title I—Lowering Prices Through Fair Drug Price Negotiation
Sec. 101. Providing for lower prices for certain high-priced single source drugs.
Sec. 102. Selected drug manufacturer excise tax imposed during noncompliance periods.
Sec. 103. Fair Drug Price Negotiation Implementation Fund.
Title II—Medicare Parts B and D Prescription Drug Inflation Rebates
Sec. 201. Medicare part B rebate by manufacturers.
Sec. 202. Medicare part D rebate by manufacturers.
Sec. 203. Provision regarding inflation rebates for group health plans and group health insurance coverage.
Sec. 204. Annual report on drug costs in group health plans and group health insurance coverage.
Sec. 205. Collection of data.
Title III—Part D Improvements and Maximum Out-of-Pocket Cap for Medicare Beneficiaries
Sec. 301. Medicare part D benefit redesign.
Sec. 302. Allowing certain enrollees of prescription drugs plans and MA–PD plans under Medicare program to spread out cost-sharing under certain circumstances.
Sec. 303. Establishment of pharmacy quality measures under Medicare part D.
Title IV—Drug Price Transparency
Sec. 401. Drug price transparency.
Title V—Program improvements for Medicare low-income beneficiaries
Sec. 501. Dissemination to Medicare part D subsidy eligible individuals of information comparing premiums of certain prescription drug plans.
Sec. 502. Providing for intelligent assignment of certain subsidy eligible individuals auto-enrolled under Medicare prescription drug plans and MA–PD plans.
Sec. 503. Expanding eligibility for low-income subsidies under part D of the Medicare program.
Sec. 504. Automatic eligibility of certain low-income territorial residents for premium and cost-sharing subsidies under the Medicare program; Sunset of enhanced allotment program.
Sec. 505. Automatic qualification of certain Medicaid beneficiaries for premium and cost-sharing subsidies under part D of the Medicare program.
Sec. 506. Providing for certain rules regarding the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost-sharing subsidies under part D of the Medicare program.
Sec. 507. Reducing cost-sharing and other program improvements for low-income beneficiaries.
Title VI—Providing for Dental, Vision, and Hearing Coverage under the Medicare program
Sec. 601. Dental and oral health care.
Sec. 602. Providing coverage for hearing care under the Medicare program.
Sec. 603. Providing coverage for vision care under the Medicare program.
Title VII—NIH, FDA, and Opioids Funding
Subtitle A—Biomedical Innovation Expansion
Sec. 701. NIH Innovation Initiatives.
Sec. 702. NIH clinical trial.
Subtitle B—Investing in Safety and Innovation
Sec. 711. Food and Drug Administration.
Subtitle C—Opioid Epidemic Response
Sec. 721. Opioid Epidemic Response Fund.
Sec. 722. Substance Abuse and Mental Health Services Administration.
Sec. 723. Centers for Disease Control and Prevention.
Sec. 724. Food and Drug Administration.
Sec. 725. National Institutes of Health.
Sec. 726. Health Resources and Services Administration.
Sec. 727. Administration for Children and Families.
Title VIII—Miscellaneous
Sec. 801. Guaranteed issue of certain Medigap policies.
Sec. 802. Reporting requirements for PDP sponsors regarding point-of-sale rejections under Medicare part D.
Sec. 803. Providing access to annual Medicare notifications in multiple languages.
Sec. 804. Temporary increase in Medicare part B payment for certain biosimilar biological products.
Sec. 805. Waiving medicare coinsurance for colorectal cancer screening tests.
Sec. 806. Medicare coverage of certain lymphedema compression treatment items.
Sec. 807. Physician fee update.
Sec. 808. Additional community health center funding.
Sec. 809. Grants to improve trauma support services and mental health care for children and youth in educational settings.
Sec. 810. Pathway to Health Careers Act.
Sec. 811. Home Visiting to Reduce Maternal Mortality and Morbidity Act.
<enum>I</enum><header>Lowering Prices Through Fair Drug Price Negotiation</header>
<section id="HB32E409DEF084D128D5983B8A2F96AC0"><enum>101.</enum><header>Providing for lower prices for certain high-priced single source drugs</header>
<subsection id="H2127DCF8B1624537A9389E6688512547"><enum>(a)</enum><header>Program To lower prices for certain high-Priced single source drugs</header><text display-inline="yes-display-inline">Title XI of the Social Security Act (42 U.S.C. 1301 et seq.) is amended by adding at the end the following new part:</text>
<quoted-block display-inline="no-display-inline" id="H688D4C56FD964A06ACA985E5C6227F18" style="OLC">
<part id="H5C09E3CCD1BE42F78E414C74EB457AE9"><enum>E</enum><header>Fair Price Negotiation Program to Lower Prices for Certain High-Priced Single Source Drugs</header>
<section id="H86B9E745B33D42E6A00C9A047E352878"><enum>1191.</enum><header>Establishment of program</header>
<subsection id="H4210F8D3DBE3475AB4E9433D4B683851"><enum>(a)</enum><header>In general</header><text>The Secretary shall establish a Fair Price Negotiation Program (in this part referred to as the <quote>program</quote>). Under the program, with respect to each price applicability period, the Secretary shall—</text>
<paragraph id="HDAD0072995E146E1A2DA97F7326DA44E"><enum>(1)</enum><text>publish a list of selected drugs in accordance with section 1192;</text></paragraph>
<paragraph id="H320FE552A04B4578ABBD2F393CB5CE1F"><enum>(2)</enum><text display-inline="yes-display-inline">enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193;</text></paragraph>
<paragraph id="H3C5ADE21BA114107919B9FC319A00769"><enum>(3)</enum><text>negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and</text></paragraph>
<paragraph id="H587B847984224DB1AB8CFA830DF2D503"><enum>(4)</enum><text display-inline="yes-display-inline">carry out the administrative duties described in section 1196.</text></paragraph></subsection>
<subsection id="H08A005B69D0C457FA9B45764008E4282"><enum>(b)</enum><header>Definitions relating to timing</header><text>For purposes of this part:</text>
<paragraph id="H330A9C11D4434EA7B7156F9A0A5EE9E3"><enum>(1)</enum><header>Initial price applicability year</header><text display-inline="yes-display-inline">The term <term>initial price applicability year</term> means a plan year (beginning with plan year 2023) or, if agreed to in an agreement under section 1193 by the Secretary and manufacturer involved, a period of more than one plan year (beginning on or after January 1, 2023).</text></paragraph>
<paragraph id="H5A6DFBB8826746A9B94D867B9EC511E7"><enum>(2)</enum><header>Price applicability period</header><text display-inline="yes-display-inline">The term <term>price applicability period</term> means, with respect to a drug, the period beginning with the initial price applicability year with respect to which such drug is a selected drug and ending with the last plan year during which the drug is a selected drug.</text></paragraph>
<paragraph id="H5F97E356AC5048D9896DEFB76E063671"><enum>(3)</enum><header>Selected drug publication date</header><text>The term <term>selected drug publication date</term> means, with respect to each initial price applicability year, April 15 of the plan year that begins 2 years prior to such year.</text></paragraph>
<paragraph id="H9251671EF96B47AFBE332D23F020B741"><enum>(4)</enum><header>Voluntary negotiation period</header><text display-inline="yes-display-inline">The term <term>voluntary negotiation period</term> means, with respect to an initial price applicability year with respect to a selected drug, the period—</text>
<subparagraph id="H716D9A8694A744D6AE480C50EA89F73D"><enum>(A)</enum><text>beginning on the sooner of—</text>
<clause id="HDC7AB2262BD140E4887F26D0792EFA9B"><enum>(i)</enum><text>the date on which the manufacturer of the drug and the Secretary enter into an agreement under section 1193 with respect to such drug; or</text></clause>
<clause id="H1B2976362DE0401CB4CE51458DC061E3"><enum>(ii)</enum><text>June 15 following the selected drug publication date with respect to such selected drug; and</text></clause></subparagraph>
<subparagraph id="H2E279BB07D9A4834BF999FEC7D680F22"><enum>(B)</enum><text>ending on March 31 of the year that begins one year prior to the initial price applicability year.</text></subparagraph></paragraph></subsection>
<subsection id="HAE39263AB44742A0A9FCA1665FE98553"><enum>(c)</enum><header>Other definitions</header><text display-inline="yes-display-inline">For purposes of this part:</text>
<paragraph id="HBFE083DC2F2146E0BDEC1A9BA258F8FD"><enum>(1)</enum><header>Fair price eligible individual</header><text display-inline="yes-display-inline">The term <term>fair price eligible individual</term> means, with respect to a selected drug—</text>
<subparagraph id="H65875D2A22FC4ABC81F2441025DD268E"><enum>(A)</enum><text display-inline="yes-display-inline">in the case such drug is furnished or dispensed to the individual at a pharmacy or by a mail order service—</text>
<clause id="HEA9878E0EED4457F8D9C7C94C0023129"><enum>(i)</enum><text>an individual who is enrolled under a prescription drug plan under part D of title XVIII or an MA–PD plan under part C of such title if coverage is provided under such plan for such selected drug; and</text></clause>
<clause id="H85EF00332BFD43B397DEADF4CA57C5AF"><enum>(ii)</enum><text display-inline="yes-display-inline">an individual who is enrolled under a group health plan or health insurance coverage offered in the group or individual market (as such terms are defined in section 2791 of the Public Health Service Act) with respect to which there is in effect an agreement with the Secretary under section 1197 with respect to such selected drug as so furnished or dispensed; and</text></clause></subparagraph>
<subparagraph id="H8A85B2689A554E36B0863D4EC43F820A"><enum>(B)</enum><text>in the case such drug is furnished or administered to the individual by a hospital, physician, or other provider of services or supplier—</text>
<clause id="HCA3E4CF10B894ECE807220B6E0E9DF53"><enum>(i)</enum><text>an individual who is entitled to benefits under part A of title XVIII or enrolled under part B of such title if such selected drug is covered under the respective part; and</text></clause>
<clause id="H9E650B1D300940D98EB4A7D9938D4A57"><enum>(ii)</enum><text>an individual who is enrolled under a group health plan or health insurance coverage offered in the group or individual market (as such terms are defined in section 2791 of the Public Health Service Act) with respect to which there is in effect an agreement with the Secretary under section 1197 with respect to such selected drug as so furnished or administered.</text></clause></subparagraph></paragraph>
<paragraph id="HCB5551E76F754691901C8F574D5C0DA0"><enum>(2)</enum><header>Maximum fair price</header><text display-inline="yes-display-inline">The term <term>maximum fair price</term> means, with respect to a plan year during a price applicability period and with respect to a selected drug (as defined in section 1192(c)) with respect to such period, the price published pursuant to section 1195 in the Federal Register for such drug and year.</text></paragraph>
<paragraph id="HA6B3298681694C878BB72E03B0F88BC6"><enum>(3)</enum><header>Average international market price defined</header>
<subparagraph id="H8758DCDDA5294BDD839EC322783D4AC6"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The terms <term>average international market price</term> and <term>AIM price</term> mean, with respect to a drug, the average price (which shall be the net average price, if practicable, and volume-weighted, if practicable) for a unit (as defined in paragraph (4)) of the drug for sales of such drug (calculated across different dosage forms and strengths of the drug and not based on the specific formulation or package size or package type), as computed (as of the date of publication of such drug as a selected drug under section 1192(a)) in all countries described in clause (ii) of subparagraph (B) that are applicable countries (as described in clause (i) of such subparagraph) with respect to such drug.</text></subparagraph>
<subparagraph id="HF5D8111A38054CD48EDBE532B2470CA6"><enum>(B)</enum><header>Applicable countries</header>
<clause id="H4383938A3A2D49CBA78914878F97F8CC"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of subparagraph (A), a country described in clause (ii) is an applicable country described in this clause with respect to a drug if there is available an average price for any unit for the drug for sales of such drug in such country.</text></clause>
<clause id="HBD919AD05EF947A3AAC4209FB3F868DB"><enum>(ii)</enum><header>Countries described</header><text>For purposes of this paragraph, the following are countries described in this clause:</text>
<subclause id="H2B888FA91E234053BF74476E19271984"><enum>(I)</enum><text>Australia.</text></subclause>
<subclause id="H43BC4CB580D14192A6F56DD35BAF528F"><enum>(II)</enum><text>Canada.</text></subclause>
<subclause id="H9C741DCCC3964B3282BDA7672A6541B7"><enum>(III)</enum><text>France.</text></subclause>
<subclause id="H688C79C8169846D39852903954293EA5"><enum>(IV)</enum><text>Germany.</text></subclause>
<subclause id="H3C0D2BB657B4479A911C44D77E51C11D"><enum>(V)</enum><text>Japan.</text></subclause>
<subclause id="HB1D7D599CE5B44889C16B67D008B6E44"><enum>(VI)</enum><text>The United Kingdom.</text></subclause></clause></subparagraph></paragraph>
<paragraph id="H75634B75E4DF478D91B4E7C9E35A6B5D"><enum>(4)</enum><header>Unit</header><text>The term <term>unit</term> means, with respect to a drug, the lowest identifiable quantity (such as a capsule or tablet, milligram of molecules, or grams) of the drug that is dispensed.</text></paragraph></subsection></section>
<section id="HDE25A89EF23E421880B0FC52A6218329"><enum>1192.</enum><header>Selection of negotiation-eligible drugs as selected drugs</header>
<subsection id="H67E01AE9A0D9482B9B396807790C0B49"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than the selected drug publication date with respect to an initial price applicability year, the Secretary shall select and publish in the Federal Register a list of—</text>
<paragraph commented="no" id="H981CAA9302A34233BAADD88FACEC47DC"><enum>(1)</enum>
<subparagraph id="H49E4002652D945A9BC66C947C2D169C8" display-inline="yes-display-inline"><enum>(A)</enum><text>with respect to an initial price applicability year during the period beginning with 2023 and ending with 2027, at least 25 negotiation-eligible drugs described in subparagraphs (A) and (B), but not subparagraph (C), of subsection (d)(1) (or, with respect to an initial price applicability year during such period beginning after 2023, the maximum number (if such number is less than 25) of such negotiation-eligible drugs for the year) with respect to such year;</text></subparagraph>
<subparagraph id="H6041DBB7F3D4412485ED12C2B42969B0" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">with respect to an initial price applicability year during the period beginning with 2028 and ending with 2032, at least 30 negotiation-eligible drugs described in subparagraphs (A) and (B), but not subparagraph (C), of subsection (d)(1) (or, with respect to an initial price applicability year during such period, the maximum number (if such number is less than 30) of such negotiation-eligible drugs for the year) with respect to such year; and</text></subparagraph>
<subparagraph id="HE4F0E5390F414D329368BE69C3A71957" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">with respect to an initial price applicability year beginning after 2032, at least 35 negotiation-eligible drugs described in subparagraphs (A) and (B), but not subparagraph (C), of subsection (d)(1) (or, with respect to an initial price applicability year during such period, the maximum number (if such number is less than 35) of such negotiation-eligible drugs for the year) with respect to such year;</text></subparagraph></paragraph>
<paragraph id="H851A2368076E4B81B68A1C430910D8E2"><enum>(2)</enum><text>all negotiation-eligible drugs described in subparagraph (C) of such subsection with respect to such year; and</text></paragraph>
<paragraph id="H14EB224E4BCF408BAB2150C727106AE0"><enum>(3)</enum><text>all new-entrant negotiation-eligible drugs (as defined in subsection (g)(1)) with respect to such year.</text></paragraph><continuation-text continuation-text-level="subsection">Each drug published on the list pursuant to the previous sentence shall be subject to the negotiation process under section 1194 for the voluntary negotiation period with respect to such initial price applicability year (and the renegotiation process under such section as applicable for any subsequent year during the applicable price applicability period). In applying this subsection, any negotiation-eligible drug that is selected under this subsection for an initial price applicability year shall not count toward the required minimum amount of drugs to be selected under paragraph (1) for any subsequent year, including such a drug so selected that is subject to renegotiation under section 1194.</continuation-text></subsection>
<subsection id="H16BD2A6B9C52464985DE477D6B7F3DDD"><enum>(b)</enum><header>Selection of drugs</header><text>In carrying out subsection (a)(1) the Secretary shall select for inclusion on the published list described in subsection (a) with respect to a price applicability period, the negotiation-eligible drugs that the Secretary projects will result in the greatest savings to the Federal Government or fair price eligible individuals during the price applicability period. In making this projection of savings for drugs for which there is an AIM price for a price applicability period, the savings shall be projected across different dosage forms and strengths of the drugs and not based on the specific formulation or package size or package type of the drugs, taking into consideration both the volume of drugs for which payment is made, to the extent such data is available, and the amount by which the net price for the drugs exceeds the AIM price for the drugs.</text></subsection>
<subsection id="HEF737932741B4986AA571D008688AE23"><enum>(c)</enum><header>Selected drug</header><text display-inline="yes-display-inline">For purposes of this part, each drug included on the list published under subsection (a) with respect to an initial price applicability year shall be referred to as a <quote>selected drug</quote> with respect to such year and each subsequent plan year beginning before the first plan year beginning after the date on which the Secretary determines two or more drug products—</text>
<paragraph id="H792FD66A7DDA4D9B9A4CD7B9EE3F69C1"><enum>(1)</enum><text>are approved or licensed (as applicable)—</text>
<subparagraph id="H56E438DE8DEE49E5B53122046F2B64D9"><enum>(A)</enum><text>under section 505(j) of the Federal Food, Drug, and Cosmetic Act using such drug as the listed drug; or</text></subparagraph>
<subparagraph id="H71EADDE4833D409F9445BCCF89AC41DA"><enum>(B)</enum><text>under section 351(k) of the Public Health Service Act using such drug as the reference product; and</text></subparagraph></paragraph>
<paragraph id="H71391423E55C4B42BF92338D5A4F5B2C"><enum>(2)</enum><text>continue to be marketed.</text></paragraph></subsection>
<subsection id="H41667EE8DFF24A30B619A5DB5F9F7E30"><enum>(d)</enum><header>Negotiation-Eligible drug</header>
<paragraph id="HF93B612A71704947A685254AD876DC66"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of this part, the term <term>negotiation-eligible drug</term> means, with respect to the selected drug publication date with respect to an initial price applicability year, a qualifying single source drug, as defined in subsection (e), that meets any of the following criteria:</text>
<subparagraph id="HFA1AEC768EC649C8A3CC7F497B770290"><enum>(A)</enum><header>Covered part D drugs</header><text display-inline="yes-display-inline">The drug is among the 125 covered part D drugs (as defined in section 1860D–2(e)) for which there was an estimated greatest net spending under parts C and D of title XVIII, as determined by the Secretary, during the most recent plan year prior to such drug publication date for which data are available.</text></subparagraph>
<subparagraph id="HF99F6D2B82A5457CAD28B422866ABBA5"><enum>(B)</enum><header>Other drugs</header><text display-inline="yes-display-inline">The drug is among the 125 drugs for which there was an estimated greatest net spending in the United States (including the 50 States, the District of Columbia, and the territories of the United States), as determined by the Secretary, during the most recent plan year prior to such drug publication date for which data are available.</text></subparagraph>
<subparagraph commented="no" id="H97271BF3E716475398083ADE6CBD2DE0"><enum>(C)</enum><header>Insulin</header><text>The drug is a qualifying single source drug described in subsection (e)(3).</text></subparagraph></paragraph>
<paragraph id="HAFEC089B35CE4961BA3ADC474DAF059D"><enum>(2)</enum><header>Clarification</header><text display-inline="yes-display-inline">In determining whether a qualifying single source drug satisfies any of the criteria described in paragraph (1), the Secretary shall, to the extent practicable, use data that is aggregated across dosage forms and strengths of the drug and not based on the specific formulation or package size or package type of the drug.</text></paragraph>
<paragraph id="HA101E74A8193456CA3B20BFA72F96CD8"><enum>(3)</enum><header>Publication</header><text display-inline="yes-display-inline">Not later than the selected drug publication date with respect to an initial price applicability year, the Secretary shall publish in the Federal Register a list of negotiation-eligible drugs with respect to such selected drug publication date.</text></paragraph></subsection>
<subsection commented="no" id="HC878B049C6D5411087A63300A3E02945"><enum>(e)</enum><header>Qualifying single source drug</header><text display-inline="yes-display-inline">For purposes of this part, the term <term>qualifying single source drug</term> means any of the following:</text>
<paragraph commented="no" id="H65F871FB6A304536A929C81022BD628F"><enum>(1)</enum><header>Drug products</header><text>A drug that—</text>
<subparagraph commented="no" id="H1A9F4DFCBA934A08AA28FFF6F24430B7"><enum>(A)</enum><text>is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act and continues to be marketed pursuant to such approval; and</text></subparagraph>
<subparagraph commented="no" id="HA4B42C1ED4824AB89540AC426688E559"><enum>(B)</enum><text>is not the listed drug for any drug that is approved and continues to be marketed under section 505(j) of such Act.</text></subparagraph></paragraph>
<paragraph commented="no" id="H5AFBE31786B5431D8F7104E192DBDCB2"><enum>(2)</enum><header>Biological products</header><text>A biological product that—</text>
<subparagraph commented="no" id="H389E8852820D4A739355A9F50969277E"><enum>(A)</enum><text display-inline="yes-display-inline">is licensed under section 351(a) of the Public Health Service Act, including any product that has been deemed to be licensed under section 351 of such Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009, and continues to be marketed under section 351 of such Act; and</text></subparagraph>
<subparagraph commented="no" id="H6D9316EACAD0437894B42E982CD365A8"><enum>(B)</enum><text display-inline="yes-display-inline">is not the reference product for any biological product that is licensed and continues to be marketed under section 351(k) of such Act.</text></subparagraph></paragraph>
<paragraph commented="no" id="HC40A32FD262B47CEAD7E8687B7F36E4A"><enum>(3)</enum><header>Insulin product</header><text display-inline="yes-display-inline">Notwithstanding paragraphs (1) and (2), any insulin product that is approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under subsection (a) or (k) of section 351 of the Public Health Service Act and continues to be marketed under such section 505 or 351, including any insulin product that has been deemed to be licensed under section 351(a) of the Public Health Service Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 and continues to be marketed pursuant to such licensure.</text></paragraph><continuation-text commented="no" continuation-text-level="subsection">For purposes of applying paragraphs (1) and (2), a drug or biological product that is marketed by the same sponsor or manufacturer (or an affiliate thereof or a cross-licensed producer or distributor) as the listed drug or reference product described in such respective paragraph shall not be taken into consideration.</continuation-text></subsection>
<subsection commented="no" id="HE1971BD064884E4BA18FB8800138FF3D"><enum>(f)</enum><header>Information on international drug prices</header><text display-inline="yes-display-inline">For purposes of determining which negotiation-eligible drugs to select under subsection (a) and, in the case of such drugs that are selected drugs, to determine the maximum fair price for such a drug and whether such maximum fair price should be renegotiated under section 1194, the Secretary shall use data relating to the AIM price with respect to such drug as available or provided to the Secretary and shall on an ongoing basis request from manufacturers of selected drugs information on the AIM price of such a drug.</text></subsection>
<subsection id="H1770C4EBFAD448C691928927CE72D190"><enum>(g)</enum><header>New-entrant negotiation-eligible drugs</header>
<paragraph id="H7653CBF77EB14BAE936927D3FDEDD68B"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of this part, the term <quote>new-entrant negotiation-eligible drug</quote> means, with respect to the selected drug publication date with respect to an initial price applicability year, a qualifying single source drug—</text>
<subparagraph id="HB821010355AF46F4BC619747DAB6886B"><enum>(A)</enum><text display-inline="yes-display-inline">that is first approved or licensed, as described in paragraph (1), (2), or (3) of subsection (e), as applicable, during the year preceding such selected drug publication date; and</text></subparagraph>
<subparagraph id="HEAC39CF82B9D46A99A5A21A772B340BB"><enum>(B)</enum><text>that the Secretary determines under paragraph (2) is likely to be included as a negotiation-eligible drug with respect to the subsequent selected drug publication date.</text></subparagraph></paragraph>
<paragraph id="HD4921820D3FF494380ED64118CBA2272"><enum>(2)</enum><header>Determination</header><text display-inline="yes-display-inline">In the case of a qualifying single source drug that meets the criteria described in subparagraph (A) of paragraph (1), with respect to an initial price applicability year, if the wholesale acquisition cost at which such drug is first marketed in the United States is equal to or greater than the median household income (as determined according to the most recent data collected by the United States Census Bureau), the Secretary shall determine before the selected drug publication date with respect to the initial price applicability year, if the drug is likely to be included as a negotiation-eligible drug with respect to the subsequent selected drug publication date, based on the projected spending under title XVIII or in the United States on such drug. For purposes of this paragraph the term <quote>United States</quote> includes the 50 States, the District of Columbia, and the territories of the United States. </text></paragraph></subsection></section>
<section id="HA4461FBE010844F990DA4069581BE514"><enum>1193.</enum><header>Manufacturer agreements</header>
<subsection id="H3596FFCA112948B3BE71F45930A06491"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of section 1191(a)(2), the Secretary shall enter into agreements with manufacturers of selected drugs with respect to a price applicability period, by not later than June 15 following the selected drug publication date with respect to such selected drug, under which—</text>
<paragraph id="H491F2D5BFB59472589AB82595110AABE"><enum>(1)</enum><text>during the voluntary negotiation period for the initial price applicability year for the selected drug, the Secretary and manufacturer, in accordance with section 1194, negotiate to determine (and, by not later than the last date of such period and in accordance with subsection (c), agree to) a maximum fair price for such selected drug of the manufacturer in order to provide access to such price—</text>
<subparagraph id="HC685A53DA3C947B39F9F74EBDA227617"><enum>(A)</enum><text>to fair price eligible individuals who with respect to such drug are described in subparagraph (A) of section 1191(c)(1) and are furnished or dispensed such drug during, subject to subparagraph (2), the price applicability period; and</text></subparagraph>
<subparagraph id="H84F75E0D30594864821A84FE3C0D8D29"><enum>(B)</enum><text display-inline="yes-display-inline">to hospitals, physicians, and other providers of services and suppliers with respect to fair price eligible individuals who with respect to such drug are described in subparagraph (B) of such section and are furnished or administered such drug during, subject to subparagraph (2), the price applicability period;</text></subparagraph></paragraph>
<paragraph id="HA20D2049863849D8954ABC5A5B8463E9"><enum>(2)</enum><text display-inline="yes-display-inline">the Secretary and the manufacturer shall, in accordance with a process and during a period specified by the Secretary pursuant to rulemaking, renegotiate (and, by not later than the last date of such period and in accordance with subsection (c), agree to) the maximum fair price for such drug if the Secretary determines that there is a material change in any of the factors described in section 1194(d) relating to the drug, including changes in the AIM price for such drug, in order to provide access to such maximum fair price (as so renegotiated)—</text>
<subparagraph id="H8FD15D0EEEAF4DE7B8B58ED0512F95BC"><enum>(A)</enum><text display-inline="yes-display-inline">to fair price eligible individuals who with respect to such drug are described in subparagraph (A) of section 1191(c)(1) and are furnished or dispensed such drug during any year during the price applicability period (beginning after such renegotiation) with respect to such selected drug; and</text></subparagraph>
<subparagraph id="H1017D515EA1542D58C958A657BA72E12"><enum>(B)</enum><text display-inline="yes-display-inline">to hospitals, physicians, and other providers of services and suppliers with respect to fair price eligible individuals who with respect to such drug are described in subparagraph (B) of such section and are furnished or administered such drug during any year described in subparagraph (A);</text></subparagraph></paragraph>
<paragraph id="HA369A045462940AEAC37B8BFFC0EB9DC"><enum>(3)</enum><text display-inline="yes-display-inline">the maximum fair price (including as renegotiated pursuant to paragraph (2)), with respect to such a selected drug, shall be provided to fair price eligible individuals, who with respect to such drug are described in subparagraph (A) of section 1191(c)(1), at the pharmacy or by a mail order service at the point-of-sale of such drug;</text></paragraph>
<paragraph id="HC7FAB0CA703D47BFADF0F4EB9520B357"><enum>(4)</enum><text display-inline="yes-display-inline">the manufacturer, subject to subsection (d), submits to the Secretary, in a form and manner specified by the Secretary—</text>
<subparagraph id="HB599F87E07ED41729FE902706DA5C0FD"><enum>(A)</enum><text>for the voluntary negotiation period for the price applicability period (and, if applicable, before any period of renegotiation specified pursuant to paragraph (2)) with respect to such drug all information that the Secretary requires to carry out the negotiation (or renegotiation process) under this part, including information described in section 1192(f) and section 1194(d)(1); and</text></subparagraph>
<subparagraph id="H615C8FCA393F447CBB0606C01B40CD11"><enum>(B)</enum><text>on an ongoing basis, information on changes in prices for such drug that would affect the AIM price for such drug or otherwise provide a basis for renegotiation of the maximum fair price for such drug pursuant to paragraph (2);</text></subparagraph></paragraph>
<paragraph id="HB30EFBBDBD0D4DA2A49B7E6A1E8373C0"><enum>(5)</enum><text>the manufacturer agrees that in the case the selected drug of a manufacturer is a drug described in subsection (c), the manufacturer will, in accordance with such subsection, make any payment required under such subsection with respect to such drug; and</text></paragraph>
<paragraph id="H0237DB5B241F4E6ABB67E78A4CF2970B"><enum>(6)</enum><text display-inline="yes-display-inline">the manufacturer complies with requirements imposed by the Secretary for purposes of administering the program, including with respect to the duties described in section 1196.</text></paragraph></subsection>
<subsection id="H7820EA7D700A40CC8E2EDBCEB75F4FE1"><enum>(b)</enum><header>Agreement in effect until drug is no longer a selected drug</header><text display-inline="yes-display-inline">An agreement entered into under this section shall be effective, with respect to a drug, until such drug is no longer considered a selected drug under section 1192(c).</text></subsection>
<subsection id="H6E1B3FCB4E054FDA954A7905661F3499"><enum>(c)</enum><header>Special rule for certain selected drugs without AIM price</header>
<paragraph id="H3F638024AFB646B18C4AEF4B24FB21B6"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">In the case of a selected drug for which there is no AIM price available with respect to the initial price applicability year for such drug and for which an AIM price becomes available beginning with respect to a subsequent plan year during the price applicability period for such drug, if the Secretary determines that the amount described in paragraph (2)(A) for a unit of such drug is greater than the amount described in paragraph (2)(B) for a unit of such drug, then by not later than one year after the date of such determination, the manufacturer of such selected drug shall pay to the Treasury an amount equal to the product of—</text>
<subparagraph id="H35105FF08E4A425EA4CDA6BAFD47E985"><enum>(A)</enum><text display-inline="yes-display-inline">the difference between such amount described in paragraph (2)(A) for a unit of such drug and such amount described in paragraph (2)(B) for a unit of such drug; and</text></subparagraph>
<subparagraph id="H515BE782C2204FB6B2EF380D8B2A960A"><enum>(B)</enum><text display-inline="yes-display-inline">the number of units of such drug sold in the United States, including the 50 States, the District of Columbia, and the territories of the United States, during the period described in paragraph (2)(B).</text></subparagraph></paragraph>
<paragraph id="HA8052DD3D3F94FCD9E75576CB15DDB91"><enum>(2)</enum><header>Amounts described</header>
<subparagraph id="H28112713191F4A1EABA3CD43920962C4"><enum>(A)</enum><header>Weighted average price before AIM price available</header><text display-inline="yes-display-inline">For purposes of paragraph (1), the amount described in this subparagraph for a selected drug described in such paragraph, is the amount equal to the weighted average manufacturer price (as defined in section 1927(k)(1)) for such dosage strength and form for the drug during the period beginning with the first plan year for which the drug is included on the list of negotiation-eligible drugs published under section 1192(d) and ending with the last plan year during the price applicability period for such drug with respect to which there is no AIM price available for such drug.</text></subparagraph>
<subparagraph id="H0A2F4CD78DD346BFB8E0D6BBD9374620"><enum>(B)</enum><header>Amount multiplier after AIM price available</header><text display-inline="yes-display-inline">For purposes of paragraph (1), the amount described in this subparagraph for a selected drug described in such paragraph, is the amount equal to 200 percent of the AIM price for such drug with respect to the first plan year during the price applicability period for such drug with respect to which there is an AIM price available for such drug.</text></subparagraph></paragraph></subsection>
<subsection id="HA3DE5FF75A8D4CB79D1D43800E2410F1"><enum>(d)</enum><header>Confidentiality of information</header><text>Information submitted to the Secretary under this part by a manufacturer of a selected drug that is proprietary information of such manufacturer (as determined by the Secretary) may be used only by the Secretary or disclosed to and used by the Comptroller General of the United States or the Medicare Payment Advisory Commission for purposes of carrying out this part.</text></subsection>
<subsection id="H7DA9F158635C438E8661634D94722805"><enum>(e)</enum><header>Regulations</header>
<paragraph id="HBA94FA304F804401B55263BBFD0D1758"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall, pursuant to rulemaking, specify, in accordance with paragraph (2), the information that must be submitted under subsection (a)(4).</text></paragraph>
<paragraph id="HB212A5FB893F4178AED14F1BBF6C6A46"><enum>(2)</enum><header>Information specified</header><text>Information described in paragraph (1), with respect to a selected drug, shall include information on sales of the drug (by the manufacturer of the drug or by another entity under license or other agreement with the manufacturer, with respect to the sales of such drug, regardless of the name under which the drug is sold) in any foreign country that is part of the AIM price. The Secretary shall verify, to the extent practicable, such sales from appropriate officials of the government of the foreign country involved.</text></paragraph></subsection>
<subsection commented="no" id="H246EE9599EBC44D480927CF3069EA884"><enum>(f)</enum><header>Compliance with requirements for administration of program</header><text display-inline="yes-display-inline">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 section 1196(c)(1), as applicable, for purposes of administering the program.</text></subsection></section>
<section id="H3217532B54804A68875AFC68DDC04C24"><enum>1194.</enum><header>Negotiation and renegotiation process</header>
<subsection id="H8C50B7DEAB624F17B4E8FFC6D8C129E4"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of this part, under an agreement under section 1193 between the Secretary and a manufacturer of a selected drug, with respect to the period for which such agreement is in effect and in accordance with subsections (b) and (c), the Secretary and the manufacturer—</text>
<paragraph id="HD67773AF95E844BA82EF6A6512D38C89"><enum>(1)</enum><text>shall during the voluntary negotiation period with respect to the initial price applicability year for such drug, in accordance with this section, negotiate a maximum fair price for such drug for the purpose described in section 1193(a)(1); and</text></paragraph>
<paragraph id="H721DFB981B9044988C7C4A23331AAD01"><enum>(2)</enum><text display-inline="yes-display-inline">as applicable pursuant to section 1193(a)(2) and in accordance with the process specified pursuant to such section, renegotiate such maximum fair price for such drug for the purpose described in such section.</text></paragraph></subsection>
<subsection id="H0DBE322AF7734AB192F09E235C561C14"><enum>(b)</enum><header>Negotiating methodology and objective</header>
<paragraph id="HAB127CEA308F40ACAB8AC5C1F8099944"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall develop and use a consistent methodology for negotiations under subsection (a) that, in accordance with paragraph (2) and subject to paragraph (3), achieves the lowest maximum fair price for each selected drug while appropriately rewarding innovation.</text></paragraph>
<paragraph id="HDCA96C170C1941E583FB63608B517D2C"><enum>(2)</enum><header>Prioritizing factors</header><text display-inline="yes-display-inline">In considering the factors described in subsection (d) in negotiating (and, as applicable, renegotiating) the maximum fair price for a selected drug, the Secretary shall, to the extent practicable, consider all of the available factors listed but shall prioritize the following factors:</text>
<subparagraph id="HF3D403A2FBEB4100A4C154760786056D"><enum>(A)</enum><header>Research and development costs</header><text>The factor described in paragraph (1)(A) of subsection (d).</text></subparagraph>
<subparagraph id="H15D99CB827C04C02AF50D81ABECB8202"><enum>(B)</enum><header>Market data</header><text display-inline="yes-display-inline">The factor described in paragraph (1)(B) of such subsection.</text></subparagraph>
<subparagraph id="H30CA4BA010E548D4843D0FCE7DC43F0C"><enum>(C)</enum><header>Unit costs of production and distribution</header><text display-inline="yes-display-inline">The factor described in paragraph (1)(C) of such subsection.</text></subparagraph>
<subparagraph id="HD63A872EE8514DFD9D68009F81C50E14"><enum>(D)</enum><header>Comparison to existing therapeutic alternatives</header><text display-inline="yes-display-inline">The factor described in paragraph (2)(A) of such subsection.</text></subparagraph></paragraph>
<paragraph commented="no" id="H3CF051A8BD204EC0AC6D94438EA35A2A"><enum>(3)</enum><header>Requirement</header>
<subparagraph id="HA80759C4B83D4C9685F101BFB985E71F"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">In negotiating the maximum fair price of a selected drug, with respect to an initial price applicability year for the selected drug, and, as applicable, in renegotiating the maximum fair price for such drug, with respect to a subsequent year during the price applicability period for such drug, in the case that the manufacturer of the selected drug offers under the negotiation or renegotiation, as applicable, a price for such drug that is not more than the target price described in subparagraph (B) for such drug for the respective year, the Secretary shall agree under such negotiation or renegotiation, respectively, to such offered price as the maximum fair price.</text></subparagraph>
<subparagraph id="H56BA69EDEFF44748B3A1FA056DB29DBA"><enum>(B)</enum><header>Target price</header>
<clause id="HC31196637C3746E2BBBAFAA3E57432C2"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to clause (ii), the target price described in this subparagraph for a selected drug with respect to a year, is the average price (which shall be the net average price, if practicable, and volume-weighted, if practicable) for a unit of such drug for sales of such drug, as computed (across different dosage forms and strengths of the drug and not based on the specific formulation or package size or package type of the drug) in the applicable country described in section 1191(c)(3)(B) with respect to such drug that, with respect to such year, has the lowest average price for such drug as compared to the average prices (as so computed) of such drug with respect to such year in the other applicable countries described in such section with respect to such drug.</text></clause>
<clause id="H5B7287C0EAC84D2EBF1D81317FD2EC0B"><enum>(ii)</enum><header>Selected drugs without AIM price</header><text display-inline="yes-display-inline">In applying this paragraph in the case of negotiating the maximum fair price of a selected drug for which there is no AIM price available with respect to the initial price applicability year for such drug, or, as applicable, renegotiating the maximum fair price for such drug with respect to a subsequent year during the price applicability period for such drug before the first plan year for which there is an AIM price available for such drug, the target price described in this subparagraph for such drug and respective year is the amount that is 80 percent of the average manufacturer price (as defined in section 1927(k)(1)) for such drug and year.</text></clause></subparagraph></paragraph>
<paragraph id="HE8D76A9309444BF684DC6676CCCC2425"><enum>(4)</enum><header>Annual report</header><text>After the completion of each voluntary negotiation period, the Secretary shall submit to Congress a report on the maximum fair prices negotiated (or, as applicable, renegotiated) for such period. Such report shall include information on how such prices so negotiated (or renegotiated) meet the requirements of this part, including the requirements of this subsection.</text></paragraph></subsection>
<subsection id="H9116DC43E3724569A480CBCEDFFC853C"><enum>(c)</enum><header>Limitation</header>
<paragraph id="H111D44AA81AF4133B44BB5F2C199D9A0"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to paragraph (2), the maximum fair price negotiated (including as renegotiated) under this section for a selected drug, with respect to each plan year during a price applicability period for such drug, shall not exceed 120 percent of the AIM price applicable to such drug with respect to such year.</text></paragraph>
<paragraph id="H581E333B86B54B68BED388620D610F45"><enum>(2)</enum><header>Selected drugs without AIM price</header><text>In the case of a selected drug for which there is no AIM price available with respect to the initial price applicability year for such drug, for each plan year during the price applicability period before the first plan year for which there is an AIM price available for such drug, the maximum fair price negotiated (including as renegotiated) under this section for the selected drug shall not exceed the amount equal to 85 percent of the average manufacturer price for the drug with respect to such year.</text></paragraph></subsection>
<subsection id="H8D2CFA4F650E45D8BE3A808A37396331"><enum>(d)</enum><header>Considerations</header><text>For purposes of negotiating and, as applicable, renegotiating (including for purposes of determining whether to renegotiate) the maximum fair price of a selected drug under this part with the manufacturer of the drug, the Secretary, consistent with subsection (b)(2), shall take into consideration the factors described in paragraphs (1), (2), (3), and (5), and may take into consideration the factor described in paragraph (4):</text>
<paragraph id="HC73D8F232C0A4621A6E15B9556275119"><enum>(1)</enum><header>Manufacturer-specific information</header><text display-inline="yes-display-inline">The following information, including as submitted by the manufacturer:</text>
<subparagraph id="H4AA3680F2F5042A8B3DD9F42B93A8F1D"><enum>(A)</enum><text display-inline="yes-display-inline">Research and development costs of the manufacturer for the drug and the extent to which the manufacturer has recouped research and development costs.</text></subparagraph>
<subparagraph id="HFD61725913BB4AD2816ADFC65069B888"><enum>(B)</enum><text>Market data for the drug, including the distribution of sales across different programs and purchasers and projected future revenues for the drug.</text></subparagraph>
<subparagraph id="HFBAA46532AC64B0685F3791D1ABE9F3C"><enum>(C)</enum><text>Unit costs of production and distribution of the drug.</text></subparagraph>
<subparagraph id="H5B88FBDD4D174948A1BFD28EBD75AC00"><enum>(D)</enum><text>Prior Federal financial support for novel therapeutic discovery and development with respect to the drug.</text></subparagraph>
<subparagraph id="H9E2A63D3FAC540BDB531C6D5E9A74E9D"><enum>(E)</enum><text>Data on patents and on existing and pending exclusivity for the drug.</text></subparagraph>
<subparagraph id="H83487AC4B9684003B31115AAF0870AD8"><enum>(F)</enum><text>National sales data for the drug.</text></subparagraph>
<subparagraph id="H0F97BA3DCE054697B1615982619F09CF"><enum>(G)</enum><text display-inline="yes-display-inline">Information on clinical trials for the drug in the United States or in applicable countries described in section 1191(c)(3)(B).</text></subparagraph></paragraph>
<paragraph id="H02983A6B1F9E4FB2AB2FD26B2278B8D5"><enum>(2)</enum><header>Information on alternative products</header><text>The following information:</text>
<subparagraph id="HBB62ECF363744EF58FC02C801EF7EE1C"><enum>(A)</enum><text display-inline="yes-display-inline">The extent to which the drug represents a therapeutic advance as compared to existing therapeutic alternatives and, to the extent such information is available, the costs of such existing therapeutic alternatives.</text></subparagraph>
<subparagraph id="HE8AA654D6F554530B6DA7D61167B5D71"><enum>(B)</enum><text>Information on approval by the Food and Drug Administration of alternative drug products.</text></subparagraph>
<subparagraph id="H4EEB5DCA0C594A798000F294A09B19F0"><enum>(C)</enum><text display-inline="yes-display-inline">Information on comparative effectiveness analysis for such products, taking into consideration the effects of such products on specific populations, such as individuals with disabilities, the elderly, terminally ill, children, and other patient populations. </text></subparagraph><continuation-text continuation-text-level="paragraph">In considering information described in subparagraph (C), the Secretary shall not use evidence or findings from comparative clinical effectiveness research in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill. Nothing in the previous sentence shall affect the application or consideration of an AIM price for a selected drug.</continuation-text></paragraph>
<paragraph id="H2960C2430E384BDFB6E7A15D7633486F"><enum>(3)</enum><header>Foreign sales information</header><text>To the extent available on a timely basis, including as provided by a manufacturer of the selected drug or otherwise, information on sales of the selected drug in each of the countries described in section 1191(c)(3)(B).</text></paragraph>
<paragraph id="HADB95E2C9C9046A8A2A0D77B758975DF"><enum>(4)</enum><header>VA drug pricing information</header><text>Information disclosed to the Secretary pursuant to subsection (f).</text></paragraph>
<paragraph commented="no" id="H1B713965B91341A5ABF4CBBF57986902"><enum>(5)</enum><header>Additional information</header><text>Information submitted to the Secretary, in accordance with a process specified by the Secretary, by other parties that are affected by the establishment of a maximum fair price for the selected drug.</text></paragraph></subsection>
<subsection commented="no" id="HFA24FD749A3246D8A2415C754B7512F4"><enum>(e)</enum><header>Request for information</header><text display-inline="yes-display-inline">For purposes of negotiating and, as applicable, renegotiating (including for purposes of determining whether to renegotiate) the maximum fair price of a selected drug under this part with the manufacturer of the drug, with respect to a price applicability period, and other relevant data for purposes of this section—</text>
<paragraph commented="no" id="HAC6784D612F24FF2B9293FBE7EC6C054"><enum>(1)</enum><text>the Secretary shall, not later than the selected drug publication date with respect to the initial price applicability year of such period, request drug pricing information from the manufacturer of such selected drug, including information described in subsection (d)(1); and</text></paragraph>
<paragraph commented="no" id="HB93CFAADE86F4473A6CE1BA56E94A107"><enum>(2)</enum><text display-inline="yes-display-inline">by not later than October 1 following the selected drug publication date, the manufacturer of such selected drug shall submit to the Secretary such requested information in such form and manner as the Secretary may require.</text></paragraph><continuation-text continuation-text-level="subsection">The Secretary shall request, from the manufacturer or others, such additional information as may be needed to carry out the negotiation and renegotiation process under this section.</continuation-text></subsection>
<subsection id="H88D43C1E81F144CFAF3C394C37770ABA"><enum>(f)</enum><header>Disclosure of information</header><text display-inline="yes-display-inline">For purposes of this part, the Secretary of Veterans Affairs may disclose to the Secretary of Health and Human Services the price of any negotiation-eligible drug that is purchased pursuant to section 8126 of title 38, United States Code.</text></subsection></section>
<section id="HFBFE5E1067E849D6BC84797F256CEF52"><enum>1195.</enum><header>Publication of maximum fair prices</header>
<subsection id="HD57060C24E2A487AB2751C26FA7F99D0"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">With respect to an initial price applicability year and selected drug with respect to such year, not later than April 1 of the plan year prior to such initial price applicability year, the Secretary shall publish in the Federal Register the maximum fair price for such drug negotiated under this part with the manufacturer of such drug.</text></subsection>
<subsection id="H405A69BB9CD1407EA19C006C713550C5"><enum>(b)</enum><header>Updates</header>
<paragraph id="HB6F1B472FAA649D78BE84E20291977E8"><enum>(1)</enum><header>Subsequent year maximum fair prices</header><text display-inline="yes-display-inline">For a selected drug, for each plan year subsequent to the initial price applicability year for such drug with respect to which an agreement for such drug is in effect under section 1193, the Secretary shall publish in the Federal Register—</text>
<subparagraph id="H77D73E334EF9480D872D9F40DDD13696"><enum>(A)</enum><text>subject to subparagraph (B), the amount equal to the maximum fair price published for such drug for the previous year, increased by the annual percentage increase in the consumer price index for all urban consumers (all items; U.S. city average) as of September of such previous year; or</text></subparagraph>
<subparagraph id="HD6155DA9342848CC95929B63AB46C6F5"><enum>(B)</enum><text>in the case the maximum fair price for such drug was renegotiated, for the first year for which such price as so renegotiated applies, such renegotiated maximum fair price.</text></subparagraph></paragraph>
<paragraph id="HDEF79B7E05B041B8ACECF682CAAAD663"><enum>(2)</enum><header>Prices negotiated after deadline</header><text>In the case of a selected drug with respect to an initial price applicability year for which the maximum fair price is determined under this part after the date of publication under this section, the Secretary shall publish such maximum fair price in the Federal Register by not later than 30 days after the date such maximum price is so determined.</text></paragraph></subsection></section>
<section id="H3B2BAA5C73B74EBD93100364AB0B3805"><enum>1196.</enum><header>Administrative duties; coordination provisions</header>
<subsection id="HB5ADF899A22047C5B879973F74FBDE67"><enum>(a)</enum><header>Administrative duties</header>
<paragraph id="HC32D920E372E4991B3FEE8C6FCE1FB44"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of section 1191, the administrative duties described in this section are the following:</text>
<subparagraph id="H550DFD65ED974134A0D259F6782590E1"><enum>(A)</enum><text display-inline="yes-display-inline">The establishment of procedures (including through agreements with manufacturers under this part, contracts with prescription drug plans under part D of title XVIII and MA–PD plans under part C of such title, and agreements under section 1197 with group health plans and health insurance issuers of health insurance coverage offered in the individual or group market) under which the maximum fair price for a selected drug is provided to fair price eligible individuals, who with respect to such drug are described in subparagraph (A) of section 1191(c)(1), at pharmacies or by mail order service at the point-of-sale of the drug for the applicable price period for such drug and providing that such maximum fair price is used for determining cost-sharing under such plans or coverage for the selected drug.</text></subparagraph>
<subparagraph id="H375E09FFE9A949678C03FEDDCBD6CF4B"><enum>(B)</enum><text display-inline="yes-display-inline">The establishment of procedures (including through agreements with manufacturers under this part and contracts with hospitals, physicians, and other providers of services and suppliers and agreements under section 1197 with group health plans and health insurance issuers of health insurance coverage offered in the individual or group market) under which, in the case of a selected drug furnished or administered by such a hospital, physician, or other provider of services or supplier to fair price eligible individuals (who with respect to such drug are described in subparagraph (B) of section 1191(c)(1)), the maximum fair price for the selected drug is provided to such hospitals, physicians, and other providers of services and suppliers (as applicable) with respect to such individuals and providing that such maximum fair price is used for determining cost-sharing under the respective part, plan, or coverage for the selected drug.</text></subparagraph>
<subparagraph id="H43893BDA8D254647AA8D25B0D24FFCFD"><enum>(C)</enum><text>The establishment of procedures (including through agreements and contracts described in subparagraphs (A) and (B)) to ensure that, not later than 90 days after the dispensing of a selected drug to a fair price eligible individual 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="H36D3281EF7194E8687765933205AD8EC"><enum>(i)</enum><text display-inline="yes-display-inline">the lesser of—</text>
<subclause id="H9C2E80AD6B6545D384A0D9589D7BDCB1"><enum>(I)</enum><text>the wholesale acquisition cost of the drug;</text></subclause>
<subclause id="H4FC3001AA31641B49D85857F1FA2DFC7"><enum>(II)</enum><text>the national average drug acquisition cost of the drug; and</text></subclause>
<subclause id="H2329A4AB7A874DD89B316325E20D3F43"><enum>(III)</enum><text>any other similar determination of pharmacy acquisition costs of the drug, as determined by the Secretary; and</text></subclause></clause>
<clause id="H3F0CEE118AB041AF818F0EA2ECC6A038"><enum>(ii)</enum><text>the maximum fair price for the drug.</text></clause></subparagraph>
<subparagraph commented="no" id="H91E7CBACAEC045DBB698EA637585F54A"><enum>(D)</enum><text>The establishment of procedures to ensure that the maximum fair price for a selected drug is applied before—</text>
<clause id="H7269EA547E044D069FEA7041AAB0E82D"><enum>(i)</enum><text>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 fair price eligible individuals as the Secretary may specify; and</text></clause>
<clause id="H66ACB9EF76514835908F40CAC4B5AD62"><enum>(ii)</enum><text>any other discounts.</text></clause></subparagraph>
<subparagraph id="H392DF5FABE924EFC9A20018C38128C1F"><enum>(E)</enum><text display-inline="yes-display-inline">The establishment of procedures to enter into appropriate agreements and protocols for the ongoing computation of AIM prices for selected drugs, including, to the extent possible, to compute the AIM price for selected drugs and including by providing that the manufacturer of such a selected drug should provide information for such computation not later than 3 months after the first date of the voluntary negotiation period for such selected drug.</text></subparagraph>
<subparagraph id="HCB2FEA562AD345C8814D8877DEEAC48D"><enum>(F)</enum><text display-inline="yes-display-inline">The establishment of procedures to compute and apply the maximum fair price across different strengths and dosage forms of a selected drug and not based on the specific formulation or package size or package type of the drug.</text></subparagraph>
<subparagraph id="HF55DCA2344D64195B1E9F6D4601EAD98"><enum>(G)</enum><text>The establishment of procedures to negotiate and apply the maximum fair price in a manner that does not include any dispensing or similar fee.</text></subparagraph>
<subparagraph id="HBC618EBB7BFA405A989F8B0BC0DE1F6F"><enum>(H)</enum><text>The establishment of procedures to carry out the provisions of this part, as applicable, with respect to—</text>
<clause id="H45E551328DB040CCA5DA4F43B1750E3A"><enum>(i)</enum><text>fair price eligible individuals who are enrolled under a prescription drug plan under part D of title XVIII or an MA–PD plan under part C of such title; </text></clause>
<clause commented="no" id="H994AC57094F64D4AA207B15FBFFFE665"><enum>(ii)</enum><text>fair price eligible individuals who are enrolled under a group health plan or health insurance coverage offered by a health insurance issuer in the individual or group market with respect to which there is an agreement in effect under section 1197; and</text></clause>
<clause id="HC51E5126162F490EA5D72C59286ACA61"><enum>(iii)</enum><text>fair price eligible individuals who are entitled to benefits under part A of title XVIII or enrolled under part B of such title.</text></clause></subparagraph>
<subparagraph id="H5DE89C39C1B443108FF4DBA32E741294"><enum>(I)</enum><text>The establishment of a negotiation process and renegotiation process in accordance with section 1194, including a process for acquiring information described in subsection (d) of such section and determining amounts described in subsection (b) of such section.</text></subparagraph>
<subparagraph commented="no" id="HB47C6D2F9AB345039E6AD07CC8A072DC"><enum>(J)</enum><text>The provision of a reasonable dispute resolution mechanism to resolve disagreements between manufacturers, fair price eligible individuals, and the third party with a contract under subsection (c)(1).</text></subparagraph></paragraph>
<paragraph id="HF15B2DA384594738A57ADD0B273C5BCA"><enum>(2)</enum><header>Monitoring compliance</header>
<subparagraph id="H9480DD97160B4D06B27BCFF6F4088973"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall monitor compliance by a manufacturer with the terms of an agreement under section 1193, including by establishing a mechanism through which violations of such terms may be reported.</text></subparagraph>
<subparagraph commented="no" id="HA6F58B31DB5F422292A7C1252EB39E63"><enum>(B)</enum><header>Notification</header><text>If a third party with a contract under subsection (c)(1) 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 section 4192 of the Internal Revenue Code of 1986 or section 1198, as applicable.</text></subparagraph></paragraph></subsection>
<subsection id="H5B12A8A9E46249868E6F002A70D607E8"><enum>(b)</enum><header>Collection of data</header>
<paragraph id="HAEF70B44924744CFBC86938A1EDA3BC7"><enum>(1)</enum><header>From prescription drug plans and MA–PD plans</header><text display-inline="yes-display-inline">The Secretary may collect appropriate data from prescription drug plans under part D of title XVIII and MA–PD plans under part C of such title in a timeframe that allows for maximum fair prices to be provided under this part for selected drugs.</text></paragraph>
<paragraph id="HF40B93CEE3064B599E8331B4DDBC05FA"><enum>(2)</enum><header>From health plans</header><text display-inline="yes-display-inline">The Secretary may collect appropriate data from group health plans or health insurance issuers offering group or individual health insurance coverage in a timeframe that allows for maximum fair prices to be provided under this part for selected drugs.</text></paragraph>
<paragraph id="HDA64F451AEEA4162A73AB3064B9A7185"><enum>(3)</enum><header>Coordination of data collection</header><text>To the extent feasible, as determined by the Secretary, the Secretary shall ensure that data collected pursuant to this subsection is coordinated with, and not duplicative of, other Federal data collection efforts.</text></paragraph></subsection>
<subsection commented="no" id="HFEFBA237CA1546CC8CBD10D4744021A0"><enum>(c)</enum><header>Contract with third parties</header>
<paragraph commented="no" id="H93E373A491554DC2AB8437F37C8C0281"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary may enter into a contract with 1 or more third parties to administer the requirements established by the Secretary in order to carry out this part. At a minimum, the contract with a third party under the preceding sentence shall require that the third party—</text>
<subparagraph commented="no" id="H5A6A3ACE253949DCA65FC3439D4A53C5"><enum>(A)</enum><text>receive and transmit information between the Secretary, manufacturers, and other individuals or entities the Secretary determines appropriate;</text></subparagraph>
<subparagraph commented="no" id="H4106FD317FDE48D19D84EFEF8C5A7DCF"><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 part;</text></subparagraph>
<subparagraph commented="no" id="H5AA3BD184E1146B288EC72FB772478A2"><enum>(C)</enum><text>provide adequate and timely information to manufacturers, consistent with the agreement with the manufacturer under this part, as necessary for the manufacturer to fulfill its obligations under this part; and</text></subparagraph>
<subparagraph commented="no" id="H651A6896A57E4103A543FAB14273C60F"><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 commented="no" id="HCD87147F51E54C90A2E2CEC7044C3730"><enum>(2)</enum><header>Performance requirements</header><text>The Secretary shall establish performance requirements for a third party with a contract under paragraph (1) and safeguards to protect the independence and integrity of the activities carried out by the third party under the program under this part.</text></paragraph></subsection></section>
<section commented="no" id="H8D95FA2E78254819B534810C79F3B47E"><enum>1197.</enum><header>Voluntary participation by other health plans</header>
<subsection id="H1B4E29BE75774A95A2298B73557A5A78" commented="no"><enum>(a)</enum><header>Agreement to participate under program</header><text/>
<paragraph id="H54132802209C458FAEAE934D46A68098" commented="no"><enum>(1)</enum><header>In general</header><text>Subject to paragraph (2), under the program under this part the Secretary shall be treated as having in effect an agreement with a group health plan or health insurance issuer offering group or individual health insurance coverage (as such terms are defined in section 2791 of the Public Health Service Act), with respect to a price applicability period and a selected drug with respect to such period—</text>
<subparagraph id="H490F1EA5946F4D2E98A7166825ED854F" commented="no"><enum>(A)</enum><text>with respect to such selected drug furnished or dispensed at a pharmacy or by mail order service if coverage is provided under such plan or coverage during such period for such selected drug as so furnished or dispensed; and</text></subparagraph>
<subparagraph id="H6553024F8862429892EC200015D38D34" commented="no"><enum>(B)</enum><text>with respect to such selected drug furnished or administered by a hospital, physician, or other provider of services or supplier if coverage is provided under such plan or coverage during such period for such selected drug as so furnished or administered.</text></subparagraph></paragraph>
<paragraph id="HE502879CA1BD42F6AD1CAD4AE69B1196" commented="no"><enum>(2)</enum><header>Opting out of agreement</header><text>The Secretary shall not be treated as having in effect an agreement under the program under this part with a group health plan or health insurance issuer offering group or individual health insurance coverage with respect to a price applicability period and a selected drug with respect to such period if such a plan or issuer affirmatively elects, through a process specified by the Secretary, not to participate under the program with respect to such period and drug.</text></paragraph></subsection>
<subsection id="H9AB157BBA47A436DBEFE37323A710A19"><enum>(b)</enum><header>Publication of election</header><text display-inline="yes-display-inline">With respect to each price applicability period and each selected drug with respect to such period, the Secretary and the Secretary of Labor and the Secretary of the Treasury, as applicable, shall make public a list of each group health plan and each health insurance issuer offering group or individual health insurance coverage, with respect to which coverage is provided under such plan or coverage for such drug, that has elected under subsection (a) not to participate under the program with respect to such period and drug.</text></subsection></section>
<section id="HF1AD0B6BE8134E50BEEA1DB230DEA759"><enum>1198.</enum><header>Civil monetary penalty</header>
<subsection id="HE814788449B742389DAD8D3C0CC30CDE"><enum>(a)</enum><header>Violations relating To offering of maximum fair price</header><text display-inline="yes-display-inline">Any manufacturer of a selected drug that has entered into an agreement under section 1193, with respect to a plan year during the price applicability period for such drug, that does not provide access to a price that is not more than the maximum fair price (or a lesser price) for such drug for such year—</text>
<paragraph id="H2FFB25F70AC04BDF8229E1F227CF2A97"><enum>(1)</enum><text>to a fair price eligible individual who with respect to such drug is described in subparagraph (A) of section 1191(c)(1) and who is furnished or dispensed such drug during such year; or</text></paragraph>
<paragraph id="HA6F527B54536472E956F97DF40D217B4"><enum>(2)</enum><text>to a hospital, physician, or other provider of services or supplier with respect to fair price eligible individuals who with respect to such drug is described in subparagraph (B) of such section and is furnished or administered such drug by such hospital, physician, or provider or supplier during such year;</text></paragraph><continuation-text continuation-text-level="subsection">shall be subject to a civil monetary penalty equal to ten times the amount equal to the difference between the price for such drug made available for such year by such manufacturer with respect to such individual or hospital, physician, provider, or supplier and the maximum fair price for such drug for such year.</continuation-text></subsection>
<subsection commented="no" id="HDC607BC470F24387892D89FF4040105A"><enum>(b)</enum><header>Violations of certain terms of agreement</header><text display-inline="yes-display-inline">Any manufacturer of a selected drug that has entered into an agreement under section 1193, with respect to a plan year during the price applicability period for such drug, that is in violation of a requirement imposed pursuant to section 1193(a)(6) shall be subject to a civil monetary penalty of not more than $1,000,000 for each such violation. </text></subsection>
<subsection id="H6991E12A35A04C4DBB044B528A0DCF47"><enum>(c)</enum><header>Application</header><text>The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil monetary penalty under this section in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).</text></subsection></section>
<section id="H733535E28482414E93AB7A6D0E22022E"><enum>1199.</enum><header>Miscellaneous provisions</header>
<subsection id="H7E3CA33D6FAC48F788C552E2F52BF120"><enum>(a)</enum><header>Paperwork Reduction Act</header><text display-inline="yes-display-inline">Chapter 35 of title 44, United States Code, shall not apply to data collected under this part.</text></subsection>
<subsection id="H630C96FFE5B747D8BF20651E09AEEBA9"><enum>(b)</enum><header>National Academy of Medicine study</header><text>Not later than December 31, 2025, the National Academy of Medicine shall conduct a study, and submit to Congress a report, on recommendations for improvements to the program under this part, including the determination of the limits applied under section 1194(c).</text></subsection>
<subsection id="H510352B6BC6F4AAF94FD44E9F4A5EE58"><enum>(c)</enum><header>MedPAC study</header><text display-inline="yes-display-inline">Not later than December 31, 2025, the Medicare Payment Advisory Commission shall conduct a study, and submit to Congress a report, on the program under this part with respect to the Medicare program under title XVIII, including with respect to the effect of the program on individuals entitled to benefits or enrolled under such title.</text></subsection>
<subsection id="H6778041A266C4865B7B90316DBD0ED0C"><enum>(d)</enum><header>Limitation on judicial review</header><text>The following shall not be subject to judicial review:</text>
<paragraph id="HC014FBB17E0C4A639EAAB486E3D68DBB"><enum>(1)</enum><text>The selection of drugs for publication under section 1192(a).</text></paragraph>
<paragraph id="HFA75D4E37B084963ABF83C597D51BF31"><enum>(2)</enum><text>The determination of whether a drug is a negotiation-eligible drug under section 1192(d).</text></paragraph>
<paragraph id="HDA7C3606FE0A43B4BC65320FEE698749"><enum>(3)</enum><text>The determination of the maximum fair price of a selected drug under section 1194.</text></paragraph>
<paragraph id="HFC8B46B8FBA14CBF86A06AA1F4FA7BAC"><enum>(4)</enum><text>The determination of units of a drug for purposes of section 1191(c)(3).</text></paragraph></subsection>
<subsection id="H674DFB2460EA4DED844D9845042A8454"><enum>(e)</enum><header>Coordination</header><text>In carrying out this part with respect to group health plans or health insurance coverage offered in the group market that are subject to oversight by the Secretary of Labor or the Secretary of the Treasury, the Secretary of Health and Human Services shall coordinate with such respective Secretary.</text></subsection>
<subsection commented="no" id="HFC5042335FB043B9B21548BDC607FF9D"><enum>(f)</enum><header>Data sharing</header><text display-inline="yes-display-inline">The Secretary shall share with the Secretary of the Treasury such information as is necessary to determine the tax imposed by section 4192 of the Internal Revenue Code of 1986.</text></subsection>
<subsection id="H29BCD5EAF561442ABFD04303713DA86B"><enum>(g)</enum><header>GAO study</header><text>Not later than December 31, 2025, the Comptroller General of the United States shall conduct a study of, and submit to Congress a report on, the implementation of the Fair Price Negotiation Program under this part.</text></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HEE7B2BB93C4C403698FABF5DC550C535"><enum>(b)</enum><header>Application of maximum fair prices and conforming amendments</header>
<paragraph id="H4078CE2F372C430C9E1A0FCD0FCA4996"><enum>(1)</enum><header>Under Medicare</header><text display-inline="yes-display-inline"/>
<subparagraph id="HC8DAA60866724ED4A58AB5F666F53473"><enum>(A)</enum><header>Application to payments under part B</header><text display-inline="yes-display-inline">Section 1847A(b)(1)(B) of the Social Security Act (42 U.S.C. 1395w–3a(b)(1)(B)) is amended by inserting <quote>or in the case of such a drug or biological that is a selected drug (as defined in section 1192(c)), with respect to a price applicability period (as defined in section 1191(b)(2)), 106 percent of the maximum fair price (as defined in section 1191(c)(2) applicable for such drug and a plan year during such period</quote> after <quote>paragraph (4)</quote>.</text></subparagraph>
<subparagraph id="HB2FCB9B1DE9D4382BCD593A48A317805"><enum>(B)</enum><header>Exception to part D non-interference</header><text display-inline="yes-display-inline">Section 1860D–11(i) of the Social Security Act (42 U.S.C. 1395w–111(i)) is amended by inserting <quote>, except as provided under part E of title XI</quote> after <quote>the Secretary</quote>.</text></subparagraph>
<subparagraph id="HADD19846A0164C76B30C871101B7A23E"><enum>(C)</enum><header>Application as negotiated price under part D</header><text display-inline="yes-display-inline">Section 1860D–2(d)(1) of the Social Security Act (42 U.S.C. 1395w–102(d)(1)) is amended—</text>
<clause id="HE03E1EB94185477BAA3B1B1AA04B07A0"><enum>(i)</enum><text>in subparagraph (B), by inserting <quote>, subject to subparagraph (D),</quote> after <quote>negotiated prices</quote>; and</text></clause>
<clause id="HD87AEF422C6442B0A51D615607A4E82B"><enum>(ii)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="HFB3235A4CD0A4103B826E5DA5452B2D8" style="OLC">
<subparagraph id="H1D48A0ADD9624B0DB65380E1594CA3CC"><enum>(D)</enum><header>Application of maximum fair price for selected drugs</header><text display-inline="yes-display-inline">In applying this section, in the case of a covered part D drug that is a selected drug (as defined in section 1192(c)), with respect to a price applicability period (as defined in section 1191(b)(2)), the negotiated prices used for payment (as described in this subsection) shall be the maximum fair price (as defined in section 1191(c)(2)) for such drug and for each plan year during such period.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph>
<subparagraph id="HCDD91709FDAE47AC9B4B88C7DBC043F7"><enum>(D)</enum><header>Information from prescription drug plans and MA–PD plans required</header>
<clause id="HBAD7189ED0A04B058894961C3EA6F556"><enum>(i)</enum><header>Prescription drug plans</header><text display-inline="yes-display-inline">Section 1860D–12(b) of the Social Security Act (42 U.S.C. 1395w–112(b)) is amended by adding at the end the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="HF251903A08BC4701A3DC1A4097E26BF3" style="OLC">
<paragraph id="H5E9F745361B54D4E95D3C17D36E59C05"><enum>(8)</enum><header>Provision of information related to maximum fair prices</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 the sponsor to provide information to the Secretary as requested by the Secretary in accordance with section 1196(b).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></clause>
<clause id="H058EA84432B14234A6527004816AE29F"><enum>(ii)</enum><header>MA–PD plans</header><text display-inline="yes-display-inline">Section 1857(f)(3) of the Social Security Act (42 U.S.C. 1395w–27(f)(3)) is amended by adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="H3127F7A7EA854DC9ABBB4B357BAAC1C8" style="OLC">
<subparagraph id="H3E9572A6E28B45FCAAA308EB1C4830F5"><enum>(E)</enum><header>Provision of information related to maximum fair prices</header><text display-inline="yes-display-inline">Section 1860D–12(b)(8).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph>
<paragraph id="H43F079C601864BC6A3B0A27E80DFB934"><enum>(2)</enum><header>Under group health plans and health insurance coverage</header>
<subparagraph id="H7B2C4F2FF53F4AC281DDB31C203D2D27"><enum>(A)</enum><header>PHSA</header><text display-inline="yes-display-inline">Part A of title XXVII of the Public Health Service Act is amended by inserting after section 2729 the following new section:</text>
<quoted-block display-inline="no-display-inline" id="H9D3907C45410441A8F6A519C1E5BF2E7" style="OLC">
<section id="HFDD10606A9B74BF0B6D12F127E5061C9"><enum>2729A.</enum><header>Fair Price Negotiation Program and application of maximum fair prices</header>
<subsection id="HD69C3076E5974E55B9B34AF96BE86A80"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">In the case of a group health plan or health insurance issuer offering group or individual health insurance coverage that is treated under section 1197 of the Social Security Act as having in effect an agreement with the Secretary under the Fair Price Negotiation Program under part E of title XI of such Act, with respect to a price applicability period (as defined in section 1191(b) of such Act) and a selected drug (as defined in section 1192(c) of such Act) with respect to such period with respect to which coverage is provided under such plan or coverage—</text>
<paragraph commented="no" id="HB33D7F630945436282C93DA78B4CA374"><enum>(1)</enum><text>the provisions of such part shall apply—</text>
<subparagraph id="HA02B6600E1D045038102D369E8250B1F"><enum>(A)</enum><text>if coverage of such selected drug is provided under such plan or coverage if the drug is furnished or dispensed at a pharmacy or by a mail order service, to the plans or coverage offered by such plan or issuer, and to the individuals enrolled under such plans or coverage, during such period, with respect to such selected drug, in the same manner as such provisions apply to prescription drug plans and MA–PD plans, and to individuals enrolled under such prescription drug plans and MA–PD plans during such period; and</text></subparagraph>
<subparagraph id="HD7F7B6C588D14461989181E529C9199D"><enum>(B)</enum><text>if coverage of such selected drug is provided under such plan or coverage if the drug is furnished or administered by a hospital, physician, or other provider of services or supplier, to the plans or coverage offered by such plan or issuers, to the individuals enrolled under such plans or coverage, and to hospitals, physicians, and other providers of services and suppliers during such period, with respect to such drug in the same manner as such provisions apply to the Secretary, to individuals entitled to benefits under part A of title XVIII or enrolled under part B of such title, and to hospitals, physicians, and other providers and suppliers participating under title XVIII during such period;</text></subparagraph></paragraph>
<paragraph id="HB1866412EB694BE89C117F98812C1DCA"><enum>(2)</enum><text display-inline="yes-display-inline">the plan or issuer shall apply any cost-sharing responsibilities under such plan or coverage, with respect to such selected drug, by substituting an amount not more than the maximum fair price negotiated under such part E of title XI for such drug in lieu of the drug price upon which the cost-sharing would have otherwise applied, and such cost-sharing responsibilities with respect to such selected drug may not exceed such maximum fair price; and</text></paragraph>
<paragraph commented="no" id="H5579485AA00340B79A2021480AE1BCCE"><enum>(3)</enum><text display-inline="yes-display-inline">the Secretary shall apply the provisions of such part E to such plan, issuer, and coverage, such individuals so enrolled in such plans and coverage, and such hospitals, physicians, and other providers and suppliers participating in such plans and coverage.</text></paragraph></subsection>
<subsection id="H2AE6381277364133A7690DB0071BB9E8"><enum>(b)</enum><header>Notification regarding nonparticipation in Fair Drug Price Negotiation Program</header><text>A group health plan or a health insurance issuer offering group or individual health insurance coverage shall publicly disclose in a manner and in accordance with a process specified by the Secretary any election made under section 1197 of the Social Security Act by the plan or issuer to not participate in the Fair Drug Price Negotiation Program under part E of title XI of such Act with respect to a selected drug (as defined in section 1192(c) of such Act) for which coverage is provided under such plan or coverage before the beginning of the plan year for which such election was made.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph>
<subparagraph id="HC3A76B6510204A7D8A4B814C52400E46"><enum>(B)</enum><header>ERISA</header>
<clause id="H52D670CC6C004CB9A244269E13041A96"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1181 et. seq.) is amended by adding at the end the following new section:</text>
<quoted-block display-inline="no-display-inline" id="H974FD52EF0CB4AD5B3551E92B74C4DE8" style="OLC">
<section id="HB030AC2EB84B4AD2902183C0B5E7CDB8"><enum>716.</enum><header>Fair Price Negotiation Program and application of maximum fair prices</header>
<subsection id="H008C742CD8C041159AF780111E72B1B5"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">In the case of a group health plan or health insurance issuer offering group health insurance coverage that is treated under section 1197 of the Social Security Act as having in effect an agreement with the Secretary under the Fair Price Negotiation Program under part E of title XI of such Act, with respect to a price applicability period (as defined in section 1191(b) of such Act) and a selected drug (as defined in section 1192(c) of such Act) with respect to such period with respect to which coverage is provided under such plan or coverage—</text>
<paragraph commented="no" id="H0B986E9F64164F09A38FA72356ACF3C5"><enum>(1)</enum><text>the provisions of such part shall apply, as applicable—</text>
<subparagraph id="HCD69AC1F43D94CCE9867E2175BA33569"><enum>(A)</enum><text display-inline="yes-display-inline">if coverage of such selected drug is provided under such plan or coverage if the drug is furnished or dispensed at a pharmacy or by a mail order service, to the plans or coverage offered by such plan or issuer, and to the individuals enrolled under such plans or coverage, during such period, with respect to such selected drug, in the same manner as such provisions apply to prescription drug plans and MA–PD plans, and to individuals enrolled under such prescription drug plans and MA–PD plans during such period; and</text></subparagraph>
<subparagraph id="HE4427D6D8AC14488B0CCA5F6EA05A7A9"><enum>(B)</enum><text>if coverage of such selected drug is provided under such plan or coverage if the drug is furnished or administered by a hospital, physician, or other provider of services or supplier, to the plans or coverage offered by such plan or issuers, to the individuals enrolled under such plans or coverage, and to hospitals, physicians, and other providers of services and suppliers during such period, with respect to such drug in the same manner as such provisions apply to the Secretary, to individuals entitled to benefits under part A of title XVIII or enrolled under part B of such title, and to hospitals, physicians, and other providers and suppliers participating under title XVIII during such period;</text></subparagraph></paragraph>
<paragraph id="H414CCC6C18D54637AE821FE9450BF7C5"><enum>(2)</enum><text display-inline="yes-display-inline">the plan or issuer shall apply any cost-sharing responsibilities under such plan or coverage, with respect to such selected drug, by substituting an amount not more than the maximum fair price negotiated under such part E of title XI for such drug in lieu of the drug price upon which the cost-sharing would have otherwise applied, and such cost-sharing responsibilities with respect to such selected drug may not exceed such maximum fair price; and</text></paragraph>
<paragraph commented="no" id="H406F0F9627B1470FBF845953CF6AD8B7"><enum>(3)</enum><text>the Secretary shall apply the provisions of such part E to such plan, issuer, and coverage, and such individuals so enrolled in such plans.</text></paragraph></subsection>
<subsection id="H5D915AE1A15F4745B52107AEDDA715A8"><enum>(b)</enum><header>Notification regarding nonparticipation in Fair Drug Price Negotiation Program</header><text display-inline="yes-display-inline">A group health plan or a health insurance issuer offering group health insurance coverage shall publicly disclose in a manner and in accordance with a process specified by the Secretary any election made under section 1197 of the Social Security Act by the plan or issuer to not participate in the Fair Drug Price Negotiation Program under part E of title XI of such Act with respect to a selected drug (as defined in section 1192(c) of such Act) for which coverage is provided under such plan or coverage before the beginning of the plan year for which such election was made.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></clause>
<clause id="HB3B7A99AB0A541EFAA55BCAFD1B72593"><enum>(ii)</enum><header>Application to retiree and certain small group health plans</header><text display-inline="yes-display-inline">Section 732(a) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1191a(a)) is amended by striking <quote>section 711</quote> and inserting <quote>sections 711 and 716</quote>. </text></clause>
<clause id="HBBD2C8BC5BAE4719908C9835F1F39087"><enum>(iii)</enum><header>Clerical amendment</header><text>The table of sections for subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H0812656FCC884AED872F3E639162B834" style="OLC">
<toc regeneration="no-regeneration">
<toc-entry level="section">Sec. 716. Fair Price Negotiation Program and application of maximum fair prices.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph>
<subparagraph id="H4E09C6A9B9B341F1B29BDA4B431F2F01"><enum>(C)</enum><header>IRC</header>
<clause id="H8E26B6565571423895F886CC749D28E4"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section:</text>
<quoted-block display-inline="no-display-inline" id="H74CB7CFB7E424C588F75E7AE8119F119" style="OLC">
<section id="HC54C90DAECCC48EF9A47BADE401618FD"><enum>9816.</enum><header>Fair Price Negotiation Program and application of maximum fair prices</header>
<subsection id="H193B6AE3799641FEA31E20C9DCE0F257"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">In the case of a group health plan that is treated under section 1197 of the Social Security Act as having in effect an agreement with the Secretary under the Fair Price Negotiation Program under part E of title XI of such Act, with respect to a price applicability period (as defined in section 1191(b) of such Act) and a selected drug (as defined in section 1192(c) of such Act) with respect to such period with respect to which coverage is provided under such plan—</text>
<paragraph id="HE050353DD7044CCABEA06B0D8D45260A" commented="no" display-inline="no-display-inline"><enum>(1)</enum><text>the provisions of such part shall apply, as applicable—</text>
<subparagraph id="H0FD24886BBB344C8AAA858E746B0F570"><enum>(A)</enum><text>if coverage of such selected drug is provided under such plan if the drug is furnished or dispensed at a pharmacy or by a mail order service, to the plan, and to the individuals enrolled under such plan during such period, with respect to such selected drug, in the same manner as such provisions apply to prescription drug plans and MA–PD plans, and to individuals enrolled under such prescription drug plans and MA–PD plans during such period; and</text></subparagraph>
<subparagraph id="H1EB79C62F293436AA5929054A537AA05"><enum>(B)</enum><text>if coverage of such selected drug is provided under such plan if the drug is furnished or administered by a hospital, physician, or other provider of services or supplier, to the plan, to the individuals enrolled under such plan, and to hospitals, physicians, and other providers of services and suppliers during such period, with respect to such drug in the same manner as such provisions apply to the Secretary, to individuals entitled to benefits under part A of title XVIII or enrolled under part B of such title, and to hospitals, physicians, and other providers and suppliers participating under title XVIII during such period;</text></subparagraph></paragraph>
<paragraph id="HFA7E088A06E1458083387D76326DFB77"><enum>(2)</enum><text display-inline="yes-display-inline">the plan shall apply any cost-sharing responsibilities under such plan, with respect to such selected drug, by substituting an amount not more than the maximum fair price negotiated under such part E of title XI for such drug in lieu of the drug price upon which the cost-sharing would have otherwise applied, and such cost-sharing responsibilities with respect to such selected drug may not exceed such maximum fair price; and</text></paragraph>
<paragraph commented="no" id="HC469A9D36C96401380D65A780CFAD315"><enum>(3)</enum><text>the Secretary shall apply the provisions of such part E to such plan and such individuals so enrolled in such plan.</text></paragraph></subsection>
<subsection id="HFB833082F1CE47C7ADC4B1025237ABBE"><enum>(b)</enum><header>Notification regarding nonparticipation in Fair Drug Price Negotiation Program</header><text display-inline="yes-display-inline">A group health plan shall publicly disclose in a manner and in accordance with a process specified by the Secretary any election made under section 1197 of the Social Security Act by the plan to not participate in the Fair Drug Price Negotiation Program under part E of title XI of such Act with respect to a selected drug (as defined in section 1192(c) of such Act) for which coverage is provided under such plan before the beginning of the plan year for which such election was made.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></clause>
<clause id="H165F1FE11190434A907B5A8D10C4E36C" display-inline="no-display-inline"><enum>(ii)</enum><header>Application to retiree and certain small group health plans</header><text display-inline="yes-display-inline">Section 9831(a)(2) of the Internal Revenue Code of 1986 is amended by inserting <quote>other than with respect to section 9816,</quote> before <quote>any group health plan</quote>. </text></clause>
<clause id="H163E78C76F6643DE994287F1E08F6708"><enum>(iii)</enum><header>Clerical amendment</header><text>The table of sections for subchapter B of chapter 100 of such Code is amended by adding at the end the following new item:</text>
<quoted-block display-inline="no-display-inline" id="H59FEAB1D3029405780C7B90B64404569" style="OLC">
<toc regeneration="no-regeneration">
<toc-entry level="section">Sec. 9816. Fair Price Negotiation Program and application of maximum fair prices.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph>
<paragraph id="H05CDFA49B3BF4D1CA4247A293B95E07E"><enum>(3)</enum><header>Fair price negotiation program prices included in best price and AMP</header><text display-inline="yes-display-inline">Section 1927 of the Social Security Act (42 U.S.C. 1396r–8) is amended—</text>
<subparagraph id="HB31070BF48814D588DD9D32C165DE0FC"><enum>(A)</enum><text>in subsection (c)(1)(C)(ii)—</text>
<clause id="H81A9EF8AB0C4406C8F919988188A83DC"><enum>(i)</enum><text>in subclause (III), by striking at the end <quote>; and</quote>;</text></clause>
<clause id="H5DAB7BBB4ED0446BAD657E3A9F5FC0BB"><enum>(ii)</enum><text>in subclause (IV), by striking at the end the period and inserting <quote>; and</quote>; and</text></clause>
<clause id="H72E8F5B0B9204A6E9512CF4719E94B8B"><enum>(iii)</enum><text>by adding at the end the following new subclause:</text>
<quoted-block style="OLC" id="H9CC25D54C54446B3B4E7EFCF48E28691" display-inline="no-display-inline">
<subclause id="H6A54F545467B41ECAF45028378333F7F"><enum>(V)</enum><text display-inline="yes-display-inline">in the case of a rebate period and a covered outpatient drug that is a selected drug (as defined in section 1192(c)) during such rebate period, shall be inclusive of the price for such drug made available from the manufacturer during the rebate period by reason of application of part E of title XI to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or governmental entity within the United States.</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph>
<subparagraph id="H493E3BF5348E47ADB3B0F39B2C223A49"><enum>(B)</enum><text>in subsection (k)(1)(B), by adding at the end the following new clause:</text>
<quoted-block style="OLC" id="H6378004040FC4A04BAEDA75E3B6D6B79" display-inline="no-display-inline">
<clause id="HC2D010D0098D45418A16604CE7969FE2"><enum>(iii)</enum><header>Clarification</header><text display-inline="yes-display-inline">Notwithstanding clause (i), in the case of a rebate period and a covered outpatient drug that is a selected drug (as defined in section 1192(c)) during such rebate period, any reduction in price paid during the rebate period to the manufacturer for the drug by a wholesaler or retail community pharmacy described in subparagraph (A) by reason of application of part E of title XI shall be included in the average manufacturer price for the covered outpatient drug.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection></section>
<section id="HCE30F6018CDC4E36B2E72B31A136829B" section-type="subsequent-section"><enum>102.</enum><header>Selected drug manufacturer excise tax imposed during noncompliance periods</header>
<subsection id="HEEBC57DED5F84B87AB105A496B5925CA"><enum>(a)</enum><header>In general</header><text>Subchapter E of chapter 32 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section:</text>
<quoted-block act-name="" id="H82C0A8395E1146899E553D8320BEDCD9" style="OLC">
<section id="H41C5C3B6FE7C4E7EB4F40A39721DF402"><enum>4192.</enum><header>Selected drugs during noncompliance periods</header>
<subsection display-inline="no-display-inline" id="H6320B239636A4FCFBE4B4E1DFA1D4FE4"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">There is hereby imposed on the sale by the manufacturer, producer, or importer of any selected drug during a day described in subsection (b) a tax in an amount such that the applicable percentage is equal to the ratio of—</text>
<paragraph id="HD9983DCBBFCF4ACA8EB94C67098FEB6A"><enum>(1)</enum><text>such tax, divided by</text></paragraph>
<paragraph id="H02BB2ADFF3D24B5AB968A7624A64B984"><enum>(2)</enum><text>the sum of such tax and the price for which so sold.</text></paragraph></subsection>
<subsection commented="no" display-inline="no-display-inline" id="HCDA64C2DA48147119FB7B3D4856D099C"><enum>(b)</enum><header>Noncompliance periods</header><text display-inline="yes-display-inline">A day is described in this subsection with respect to a selected drug if it is a day during one of the following periods:</text>
<paragraph id="HE3A5068D705845419461FF277F10939E"><enum>(1)</enum><text>The period beginning on the June 16th immediately following the selected drug publication date and ending on the first date during which the manufacturer of the drug has in place an agreement described in subsection (a) of section 1193 of the Social Security Act with respect to such drug.</text></paragraph>
<paragraph id="H9FCF7FC8023A4218810EE5068A124F07"><enum>(2)</enum><text>The period beginning on the April 1st immediately following the June 16th described in paragraph (1) and ending on the first date during which the manufacturer of the drug has agreed to a maximum fair price under such agreement.</text></paragraph>
<paragraph id="HB6348C95A18E4C9494C021126902B1B4"><enum>(3)</enum><text display-inline="yes-display-inline">In the case of a selected drug with respect to which the Secretary of Health and Human Services has specified a renegotiation period under such agreement, the period beginning on the first date after the last date of such renegotiation period and ending on the first date during which the manufacturer of the drug has agreed to a renegotiated maximum fair price under such agreement.</text></paragraph>
<paragraph id="H58E54D7D1CBA4A1EBEF2CBA9AAC087E8"><enum>(4)</enum><text display-inline="yes-display-inline">With respect to information that is required to be submitted to the Secretary of Health and Human Services under such agreement, the period beginning on the date on which such Secretary certifies that such information is overdue and ending on the date that such information is so submitted.</text></paragraph>
<paragraph id="H6142FB35C2EA4589A481D1CC3E60DEC2"><enum>(5)</enum><text display-inline="yes-display-inline">In the case of a selected drug with respect to which a payment is due under subsection (c) of such section 1193, the period beginning on the date on which the Secretary of Health and Human Services certifies that such payment is overdue and ending on the date that such payment is made in full.</text></paragraph></subsection>
<subsection commented="no" id="H95CB27F677974FE88E9BAEF852A5C17C"><enum>(c)</enum><header>Applicable percentage</header><text>For purposes of this section, the term <term>applicable percentage</term> means—</text>
<paragraph commented="no" id="H3C1399502E6044FEAED93E9FAE83519F"><enum>(1)</enum><text>in the case of sales of a selected drug during the first 90 days described in subsection (b) with respect to such drug, 65 percent,</text></paragraph>
<paragraph commented="no" id="HBF3BA49264A94EAABF22A0235F6EAA70"><enum>(2)</enum><text>in the case of sales of such drug during the 91st day through the 180th day described in subsection (b) with respect to such drug, 75 percent,</text></paragraph>
<paragraph id="H5DD00A632DA24ECA91D6AAA9300C4A68"><enum>(3)</enum><text>in the case of sales of such drug during the 181st day through the 270th day described in subsection (b) with respect to such drug, 85 percent, and</text></paragraph>
<paragraph id="H6EE3E5E667C44305B25AF0D9AAD2E929"><enum>(4)</enum><text>in the case of sales of such drug during any subsequent day, 95 percent.</text></paragraph></subsection>
<subsection id="H82665D727A8947B692A420523C90D93D"><enum>(d)</enum><header>Selected drug</header><text>For purposes of this section—</text>
<paragraph id="HDCD51272DBE04584994B89870FDE655C"><enum>(1)</enum><header>In general</header><text>The term <quote>selected drug</quote> means any selected drug (within the meaning of section 1192 of the Social Security Act) which is manufactured or produced in the United States or entered into the United States for consumption, use, or warehousing.</text></paragraph>
<paragraph id="HA104310E6AE547B7884B47C7F554308C"><enum>(2)</enum><header>United States</header><text>The term <quote>United States</quote> has the meaning given such term by section 4612(a)(4).</text></paragraph>
<paragraph id="H5FD35A078821410393E15437803E0F9A"><enum>(3)</enum><header>Coordination with rules for possessions of the United States</header><text>Rules similar to the rules of paragraphs (2) and (4) of section 4132(c) shall apply for purposes of this section.</text></paragraph></subsection>
<subsection id="HD144EB86AED743B59A0B6B2A9EABD1B7"><enum>(e)</enum><header>Other definitions</header><text display-inline="yes-display-inline">For purposes of this section, the terms <term>selected drug publication date</term> and <term>maximum fair price</term> have the meaning given such terms in section 1191 of the Social Security Act.</text></subsection>
<subsection commented="no" id="HA0C6AD70E77E47E4A7C92B9FA6DAB5F0"><enum>(f)</enum><header>Anti-Abuse rule</header><text display-inline="yes-display-inline">In the case of a sale which was timed for the purpose of avoiding the tax imposed by this section, the Secretary may treat such sale as occurring during a day described in subsection (b).</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HE9BED496C06D4551A46260DC9A688126"><enum>(b)</enum><header>No deduction for excise tax payments</header><text display-inline="yes-display-inline">Section 275 of the Internal Revenue Code of 1986 is amended by adding <quote>or by section 4192</quote> before the period at the end of subsection (a)(6).</text></subsection>
<subsection id="H34B5D4F9A9FA44BD8E9257F63CC99C7E"><enum>(c)</enum><header>Conforming amendments</header>
<paragraph id="H27F0B386A7974D46BB1CDE8C6DD04927"><enum>(1)</enum><text display-inline="yes-display-inline">Section 4221(a) of the Internal Revenue Code of 1986 is amended by inserting <quote>or 4192</quote> after <quote>section 4191</quote>.</text></paragraph>
<paragraph id="H432AE5399E474F0AB2223959D4274C58"><enum>(2)</enum><text display-inline="yes-display-inline">Section 6416(b)(2) of such Code is amended by inserting <quote>or 4192</quote> after <quote>section 4191</quote>.</text></paragraph></subsection>
<subsection id="H7887FDEEB6A143C18D6F963F3D422347"><enum>(d)</enum><header>Clerical amendments</header>
<paragraph id="H8923E87DB7684D64BA4652131056527D"><enum>(1)</enum><text>The heading of subchapter E of chapter 32 of the Internal Revenue Code of 1986 is amended by striking <quote><header-in-text level="subchapter" style="OLC">Medical devices</header-in-text></quote> and inserting <quote><header-in-text level="subchapter" style="OLC">Other medical products</header-in-text></quote>.</text></paragraph>
<paragraph id="H4D1C3E12F9FF417ABF6B6467C8DC550B"><enum>(2)</enum><text>The table of subchapters for chapter 32 of such Code is amended by striking the item relating to subchapter E and inserting the following new item:</text>
<quoted-block display-inline="no-display-inline" id="H7073B36FC5D947F5B14D87C83A0F0A8B" style="OLC">
<toc>
<toc-entry bold="off" level="subchapter">Subchapter E. Other medical products</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H5EEF86C5188A4CC8B6CE23CCF0ED251D"><enum>(3)</enum><text>The table of sections for subchapter E of chapter 32 of such Code is amended by adding at the end the following new item:</text>
<quoted-block id="HF8BD890DC37D45EEAEBE1328C60BD427" style="OLC">
<toc>
<toc-entry idref="H41C5C3B6FE7C4E7EB4F40A39721DF402" level="section">Sec. 4192. Selected drugs during noncompliance periods.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="H97379676FC664C90AF675C9AF2FF8341"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall apply to sales after the date of the enactment of this Act.</text></subsection></section>
<section id="HEE92D1B6903945EDBF32A8A664F21EBC"><enum>103.</enum><header>Fair Drug Price Negotiation Implementation Fund</header>
<subsection id="H432451408F34410BA47AFC8CC5371993"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">There is hereby established a Fair Drug Price Negotiation Implementation Fund (referred to in this section as the <quote>Fund</quote>). The Secretary of Health and Human Services may obligate and expend amounts in the Fund to carry out this title and titles II and III (and the amendments made by such titles).</text></subsection>
<subsection id="H33BD0A6388874159B30E0160370AAC33"><enum>(b)</enum><header>Funding</header><text>There is authorized to be appropriated, and there is hereby appropriated, out of any monies in the Treasury not otherwise appropriated, to the Fund $3,000,000,000, to remain available until expended, of which—</text>
<paragraph id="H966458A6632842BCA0B6A6E1DDE7435E"><enum>(1)</enum><text display-inline="yes-display-inline">$600,000,000 shall become available on the date of the enactment of this Act;</text></paragraph>
<paragraph id="HEDA10853D5F54513BB5911343C45DA42"><enum>(2)</enum><text>$600,000,000 shall become available on October 1, 2020;</text></paragraph>
<paragraph id="HB806F00BCE49487AA00FC32D35EAC3B2"><enum>(3)</enum><text>$600,000,000 shall become available on October 1, 2021;</text></paragraph>
<paragraph id="H98D90AA9EEFF4A8F9C17C47A9AE77919"><enum>(4)</enum><text>$600,000,000 shall become available on October 1, 2022; and</text></paragraph>
<paragraph id="H1609006F51164E73BA3295E5AF9D61AF"><enum>(5)</enum><text>$600,000,000 shall become available on October 1, 2023.</text></paragraph></subsection>
<subsection id="H14592B31FA7D402BB954BFE5078D8037"><enum>(c)</enum><header>Supplement not supplant</header><text display-inline="yes-display-inline">Any amounts appropriated pursuant to this section shall be in addition to any other amounts otherwise appropriated pursuant to any other provision of law.</text></subsection></section>
<enum>II</enum><header>Medicare Parts B and D Prescription Drug Inflation Rebates</header>
<section id="HBA9A3098A69149AEBF501820A17ADED5"><enum>201.</enum><header>Medicare part B rebate by manufacturers</header>
<subsection id="H74140ECC96204E5CBB7E7EA15172EECA"><enum>(a)</enum><header>In general</header><text>Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="HA4A8FE421AE04368A95D6BBA9CDAE8B0" style="OLC">
<subsection id="H938E651D494849238C30F136B1BE0E3D"><enum>(x)</enum><header>Rebate by manufacturers for single source drugs with prices increasing faster than inflation</header>
<paragraph id="HA03D88A62A0A46D9B6422DDA28FF772F"><enum>(1)</enum><header>Requirements</header>
<subparagraph display-inline="no-display-inline" id="HCD25BD0EA3B947E691AACEF0F003E1F2"><enum>(A)</enum><header>Secretarial provision of information</header><text display-inline="yes-display-inline">Not later than 6 months after the end of each calendar quarter beginning on or after July 1, 2021, the Secretary shall, for each part B rebatable drug, report to each manufacturer of such part B rebatable drug the following for such calendar quarter:</text>
<clause id="HBCCA2F1F1B55458F976E82E15775FBA8"><enum>(i)</enum><text>Information on the total number of units of the billing and payment code described in subparagraph (A)(i) of paragraph (3) with respect to such drug and calendar quarter.</text></clause>
<clause id="H95A17107055F40DEB9A99E1AC69BE4E1"><enum>(ii)</enum><text>Information on the amount (if any) of the excess average sales price increase described in subparagraph (A)(ii) of such paragraph for such drug and calendar quarter.</text></clause>
<clause id="HD5FA606CEED54762BCD702DBCB4266FF"><enum>(iii)</enum><text>The rebate amount specified under such paragraph for such part B rebatable drug and calendar quarter.</text></clause></subparagraph>
<subparagraph id="H7A3307393A424532BA6C4C3524C1105D"><enum>(B)</enum><header>Manufacturer requirement</header><text display-inline="yes-display-inline">For each calendar quarter beginning on or after July 1, 2021, the manufacturer of a part B rebatable drug shall, for such drug, not later than 30 days after the date of receipt from the Secretary of the information described in subparagraph (A) for such calendar quarter, provide to the Secretary a rebate that is equal to the amount specified in paragraph (3) for such drug for such calendar quarter.</text></subparagraph></paragraph>
<paragraph commented="no" id="H03AAB0BE8C4147B0AF12F48014C42E74"><enum>(2)</enum><header>Part B rebatable drug defined</header>
<subparagraph id="HA4369EE7D44C450788F5029C7776DDA8"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">In this subsection, the term <term>part B rebatable drug</term> means a single source drug or biological (as defined in subparagraph (D) of section 1847A(c)(6)), including a biosimilar biological product (as defined in subparagraph (H) of such section), paid for under this part, except such term shall not include such a drug or biological—</text>
<clause commented="no" id="H1E06314ADFEF42A6962DBC48A2B1BFA6"><enum>(i)</enum><text display-inline="yes-display-inline">if the average total allowed charges for a year per individual that uses such a drug or biological, as determined by the Secretary, are less than, subject to subparagraph (B), $100; or</text></clause>
<clause id="HD1FF945A536D4B2788DFCF7508B18A00"><enum>(ii)</enum><text>that is a vaccine described in subparagraph (A) or (B) of section 1861(s)(10).</text></clause></subparagraph>
<subparagraph commented="no" id="H443DA4E60F44407590D8B730A0689D8B"><enum>(B)</enum><header>Increase</header><text>The dollar amount applied under subparagraph (A)(i)—</text>
<clause commented="no" id="H84C4D7E39DC7494B9BF7081E84336398"><enum>(i)</enum><text display-inline="yes-display-inline">for 2022, shall be the dollar amount specified under such subparagraph for 2021, increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12 month period ending with June of the previous year; and</text></clause>
<clause commented="no" id="HBA12655751B54017A1A79CFCE9155A51"><enum>(ii)</enum><text display-inline="yes-display-inline">for a subsequent year, shall be the dollar amount specified in this clause (or clause (i)) for the previous year, increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12 month period ending with June of the previous year.</text></clause><continuation-text commented="no" continuation-text-level="subparagraph">Any dollar amount specified under this subparagraph that is not a multiple of $10 shall be rounded to the nearest multiple of $10.</continuation-text></subparagraph></paragraph>
<paragraph commented="no" id="HA3B08B67237A4F32B3974DD5571FDC82"><enum>(3)</enum><header>Rebate amount</header>
<subparagraph commented="no" id="H787D8EA45B0C48B3ACE0BF4D92C15461"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of paragraph (1), the amount specified in this paragraph for a part B rebatable drug assigned to a billing and payment code for a calendar quarter is, subject to paragraph (4), the amount equal to the product of—</text>
<clause commented="no" id="HD0EA2ED3396B4008A9AEFD2D6E034541"><enum>(i)</enum><text display-inline="yes-display-inline">subject to subparagraphs (B) and (G), the total number of units of the billing and payment code for such part B rebatable drug furnished under this part during the calendar quarter; and</text></clause>
<clause commented="no" id="H677BB0EDC49847E48D24B6433EA7C009"><enum>(ii)</enum><text>the amount (if any) by which—</text>
<subclause commented="no" id="HAF6235715BF943DCAAA02EED71A0B33A"><enum>(I)</enum><text display-inline="yes-display-inline">the payment amount under subparagraph (B) or (C) of section 1847A(b)(1), as applicable, for such part B rebatable drug during the calendar quarter; exceeds</text></subclause>
<subclause commented="no" id="HF5869B71950F469AA7EB999578D4FF20"><enum>(II)</enum><text display-inline="yes-display-inline">the inflation-adjusted payment amount determined under subparagraph (C) for such part B rebatable drug during the calendar quarter.</text></subclause></clause></subparagraph>
<subparagraph commented="no" id="H26BE995A35304969979266EBB6116F69"><enum>(B)</enum><header>Excluded units</header><text display-inline="yes-display-inline">For purposes of subparagraph (A)(i), the total number of units of the billing and payment code for each part B rebatable drug furnished during a calendar quarter shall not include—</text>
<clause display-inline="no-display-inline" id="HB2555685728244DEB941455A7FC0878D"><enum>(i)</enum><text display-inline="yes-display-inline">units packaged into the payment for a procedure or service under section 1833(t) or under section 1833(i) (instead of separately payable under such respective section);</text></clause>
<clause id="H22E5694903734AC9BF8274EA9E46C02B"><enum>(ii)</enum><text display-inline="yes-display-inline">units included under the single payment system for renal dialysis services under section 1881(b)(14); or</text></clause>
<clause id="H549DECDBB5284508A45A60E474F52C05"><enum>(iii)</enum><text>units of a part B rebatable drug of a manufacturer furnished to an individual, if such manufacturer, with respect to the furnishing of such units of such drug, provides for discounts under section 340B of the Public Health Service Act or for rebates under section 1927.</text></clause></subparagraph>
<subparagraph id="HB35C82ABCCED45CA89AEFFB308919BDF"><enum>(C)</enum><header>Determination of inflation-adjusted payment amount</header><text display-inline="yes-display-inline">The inflation-adjusted payment amount determined under this subparagraph for a part B rebatable drug for a calendar quarter is—</text>
<clause id="HA846FEC539C24472B823B7EBA2C00693"><enum>(i)</enum><text display-inline="yes-display-inline">the payment amount for the billing and payment code for such drug in the payment amount benchmark quarter (as defined in subparagraph (D)); increased by</text></clause>
<clause id="H1BBDFFB6022A4E31AD5D544F34175C10"><enum>(ii)</enum><text>the percentage by which the rebate period CPI–U (as defined in subparagraph (F)) for the calendar quarter exceeds the benchmark period CPI–U (as defined in subparagraph (E)).</text></clause></subparagraph>
<subparagraph id="HAF8F21D642D94095815A939F7A1D1238"><enum>(D)</enum><header>Payment amount benchmark quarter</header><text display-inline="yes-display-inline">The term <term>payment amount benchmark quarter</term> means the calendar quarter beginning January 1, 2016.</text></subparagraph>
<subparagraph id="HC9BB29ECA3134041A7E7A96E3E516303"><enum>(E)</enum><header>Benchmark period CPI–U</header><text display-inline="yes-display-inline">The term <term>benchmark period CPI–U</term> means the consumer price index for all urban consumers (United States city average) for July 2015.</text></subparagraph>
<subparagraph id="H8C2F94BE973F4FAEA965E584AEC8385A"><enum>(F)</enum><header>Rebate period CPI–U</header><text display-inline="yes-display-inline">The term <term>rebate period CPI–U</term> means, with respect to a calendar quarter described in subparagraph (C), the greater of the benchmark period CPI–U and the consumer price index for all urban consumers (United States city average) for the first month of the calendar quarter that is two calendar quarters prior to such described calendar quarter.</text></subparagraph>
<subparagraph id="H149984E19CD54D6FBF251BE772B93319"><enum>(G)</enum><header>Counting units</header>
<clause id="H28005A05D289449E986191E2BB7610FF"><enum>(i)</enum><header>Cut-off period to count units</header><text display-inline="yes-display-inline">For purposes of subparagraph (A)(i), subject to clause (ii), to count the total number of billing units for a part B rebatable drug for a quarter, the Secretary may use a cut-off period in order to exclude from such total number of billing units for such quarter claims for services furnished during such quarter that were not processed at an appropriate time prior to the end of the cut-off period.</text></clause>
<clause id="HCBF763F839274341A3F7DE4BB5CDB382"><enum>(ii)</enum><header>Counting units for claims processed after cut-off period</header><text>If the Secretary uses a cut-off period pursuant to clause (i), in the case of units of a part B rebatable drug furnished during a quarter but pursuant to application of such cut-off period excluded for purposes of subparagraph (A)(i) from the total number of billing units for the drug for such quarter, the Secretary shall count such units of such drug so furnished in the total number of billing units for such drug for a subsequent quarter, as the Secretary determines appropriate.</text></clause></subparagraph></paragraph>
<paragraph id="H3610E90C2E7D49C88CDB5662458EA28B"><enum>(4)</enum><header>Special treatment of certain drugs and exemption</header>
<subparagraph id="H07243A1D1B4D4EF5B030C1D7AEEF11C4"><enum>(A)</enum><header>Subsequently approved drugs</header><text display-inline="yes-display-inline">Subject to subparagraph (B), in the case of a part B rebatable drug first approved or licensed by the Food and Drug Administration after July 1, 2015, clause (i) of paragraph (3)(C) shall be applied as if the term <term>payment amount benchmark quarter</term> were defined under paragraph (3)(D) as the third full calendar quarter after the day on which the drug was first marketed and clause (ii) of paragraph (3)(C) shall be applied as if the term <term>benchmark period CPI–U</term> were defined under paragraph (3)(E) as if the reference to <quote>July 2015</quote> under such paragraph were a reference to <quote>the first month of the first full calendar quarter after the day on which the drug was first marketed</quote>.</text></subparagraph>
<subparagraph commented="no" id="HB1E83381C4354649AECE9752257FF985"><enum>(B)</enum><header>Timeline for provision of rebates for subsequently approved drugs</header><text display-inline="yes-display-inline">In the case of a part B rebatable drug first approved or licensed by the Food and Drug Administration after July 1, 2015, paragraph (1)(B) shall be applied as if the reference to <quote>July 1, 2021</quote> under such paragraph were a reference to the later of the 6th full calendar quarter after the day on which the drug was first marketed or July 1, 2021.</text></subparagraph>
<subparagraph id="H31F704D902794D83B641187C8B5069ED"><enum>(C)</enum><header>Exemption for shortages</header><text>The Secretary may reduce or waive the rebate amount under paragraph (1)(B) with respect to a part B rebatable drug that is described as currently in shortage on the shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act or in the case of other exigent circumstances, as determined by the Secretary.</text></subparagraph>
<subparagraph id="HF088AD14D34D4F8B9A29FDAB7FA07240"><enum>(D)</enum><header>Selected drugs</header><text display-inline="yes-display-inline">In the case of a part B rebatable drug that is a selected drug (as defined in section 1192(c)) for a price applicability period (as defined in section 1191(b)(2))—</text>
<clause id="HC94AA6248E2C4DAAAA2101B0D68C6AD5"><enum>(i)</enum><text>for calendar quarters during such period for which a maximum fair price (as defined in section 1191(c)(2)) for such drug has been determined and is applied under part E of title XI, the rebate amount under paragraph (1)(B) shall be waived; and </text></clause>
<clause id="HCDD612F172444578A27E83D72313DF46"><enum>(ii)</enum><text>in the case such drug is determined (pursuant to such section 1192(c)) to no longer be a selected drug, for each applicable year beginning after the price applicability period with respect to such drug, clause (i) of paragraph (3)(C) shall be applied as if the term <term>payment amount benchmark quarter</term> were defined under paragraph (3)(D) as the calendar quarter beginning January 1 of the last year beginning during such price applicability period with respect to such selected drug and clause (ii) of paragraph (3)(C) shall be applied as if the term <term>benchmark period CPI–U</term> were defined under paragraph (3)(E) as if the reference to <quote>July 2015</quote> under such paragraph were a reference to the July of the year preceding such last year.</text></clause></subparagraph></paragraph>
<paragraph commented="no" id="HAC6B007CEF4048A0B26DA12F7092A073"><enum>(5)</enum><header>Application to beneficiary coinsurance</header><text display-inline="yes-display-inline">In the case of a part B rebatable drug, if the payment amount for a quarter exceeds the inflation adjusted payment for such quarter—</text>
<subparagraph id="H9BDDEF78002F4083A90ECFE21E53F3CD"><enum>(A)</enum><text>in computing the amount of any coinsurance applicable under this title to an individual with respect to such drug, the computation of such coinsurance shall be based on the inflation-adjusted payment amount determined under paragraph (3)(C) for such part B rebatable drug; and</text></subparagraph>
<subparagraph id="H57B0391D97DB4E1B89C7A7DF7CE213AF"><enum>(B)</enum><text>the amount of such coinsurance is equal to 20 percent of such inflation-adjusted payment amount so determined.</text></subparagraph></paragraph>
<paragraph id="H125631FBA0DB4499A99D137605A73694"><enum>(6)</enum><header>Rebate deposits</header><text>Amounts paid as rebates under paragraph (1)(B) shall be deposited into the Federal Supplementary Medical Insurance Trust Fund established under section 1841.</text></paragraph>
<paragraph id="HD5E2EAFB1C234128AD17574AAB58ED0F"><enum>(7)</enum><header>Civil money penalty</header><text display-inline="yes-display-inline">If a manufacturer of a part B rebatable drug has failed to comply with the requirements under paragraph (1)(B) for such drug for a calendar quarter, the manufacturer shall be subject to, in accordance with a process established by the Secretary pursuant to regulations, a civil money penalty in an amount equal to at least 125 percent of the amount specified in paragraph (3) for such drug for such calendar quarter. The provisions of section 1128A (other than subsections (a) (with respect to amounts of penalties or additional assessments) 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></paragraph>
<paragraph id="H160D015E551441A49012175CD9DB9C7D"><enum>(8)</enum><header>Study and report</header>
<subparagraph id="H262D2BFE51054C5996396EADF8D801F5"><enum>(A)</enum><header>Study</header><text display-inline="yes-display-inline">The Secretary shall conduct a study of the feasibility of and operational issues involved with the following:</text>
<clause id="H3C144ADDB05D43E29B629B179423B943"><enum>(i)</enum><text>Including multiple source drugs (as defined in section 1847A(c)(6)(C)) in the rebate system under this subsection.</text></clause>
<clause id="H361233A40F094DDCB8835C8FE1A3F931"><enum>(ii)</enum><text>Including drugs and biologicals paid for under MA plans under part C in the rebate system under this subsection.</text></clause>
<clause id="H65C7BD2FE543468C8A2DF7DC73D3A417"><enum>(iii)</enum><text>Including drugs excluded under paragraph (2)(A) and units of the billing and payment code of the drugs excluded under paragraph (3)(B) in the rebate system under this subsection.</text></clause></subparagraph>
<subparagraph id="H5FBF3A785C1D4100BEBDB83DBB4811E9"><enum>(B)</enum><header>Report</header><text>Not later than 3 years after the date of the enactment of this subsection, the Secretary shall submit to Congress a report on the study conducted under subparagraph (A).</text></subparagraph></paragraph>
<paragraph id="HE4D38D8EEB2E4E2383C15002337FE3CC"><enum>(9)</enum><header>Application to multiple source drugs</header><text>The Secretary may, based on the report submitted under paragraph (8) and pursuant to rulemaking, apply the provisions of this subsection to multiple source drugs (as defined in section 1847A(c)(6)(C)), including, for purposes of determining the rebate amount under paragraph (3), by calculating manufacturer-specific average sales prices for the benchmark period and the rebate period.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HBF3921C1A2524231BEDC5C0E4B653CE5"><enum>(b)</enum><header>Amounts payable; cost-Sharing</header><text display-inline="yes-display-inline">Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended—</text>
<paragraph id="H830932E607E34F6980ABEBE8BBFE2EE0"><enum>(1)</enum><text>in subsection (a)—</text>
<subparagraph id="H72EEF2E1A24448CD800B5AC9116A4B29"><enum>(A)</enum><text>in paragraph (1)—</text>
<clause id="HA6269449C30D467BA1B77D1AB363DA7D"><enum>(i)</enum><text>in subparagraph (S), by striking <quote>with respect to</quote> and inserting <quote>subject to subparagraph (DD), with respect to</quote>;</text></clause>
<clause id="H82A8E95E22FC48C1AA18C32AF6D55B7C"><enum>(ii)</enum><text>by striking <quote>and (CC)</quote> and inserting <quote>(CC)</quote>; and</text></clause>
<clause id="HF8D76FB91305481BB397414DB657EFE8"><enum>(iii)</enum><text>by inserting before the semicolon at the end the following: <quote>, and (DD) with respect to a part B rebatable drug (as defined in paragraph (2) of section 1834(x)) for which the payment amount for a calendar quarter under paragraph (3)(A)(ii)(I) of such section for such quarter exceeds the inflation-adjusted payment under paragraph (3)(A)(ii)(II) of such section for such quarter, the amounts paid shall be the difference between (i) the payment amount under paragraph (3)(A)(ii)(I) of such section for such drug, and (ii) 20 percent of the inflation-adjusted payment amount under paragraph (3)(A)(ii)(II) of such section for such drug</quote>;</text></clause></subparagraph>
<subparagraph id="H052C0C3FF5CB468F97842DCC3745B244"><enum>(B)</enum><text>by adding at the end of the flush left matter following paragraph (9), the following:</text>
<quoted-block display-inline="no-display-inline" id="H3280953EDD9C43E8A969B781E13D93C5" style="OLC">
<quoted-block-continuation-text quoted-block-continuation-text-level="subsection">For purposes of applying paragraph (1)(DD), subsections (i)(9) and (t)(8)(F), and section 1834(x)(5), the Secretary shall make such estimates and use such data as the Secretary determines appropriate, and notwithstanding any other provision of law, may do so by program instruction or otherwise.</quoted-block-continuation-text><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H8B2595E6E709403DB9B90A99AFF0ED68"><enum>(2)</enum><text>in subsection (i), by adding at the end the following new paragraph:</text>
<quoted-block style="OLC" id="H4F68B5BB5BA74B8F96B253204166CCA9" display-inline="no-display-inline">
<paragraph id="H68AA3E84E85C4866A69CEE4119F2F50D" indent="up1"><enum>(9)</enum><text display-inline="yes-display-inline">In the case of a part B rebatable drug (as defined in paragraph (2) of section 1834(x)) for which payment under this subsection is not packaged into a payment for a covered OPD service (as defined in subsection (t)(1)(B)) (or group of services) furnished on or after July 1, 2021, under the system under this subsection, in lieu of calculation of coinsurance and the amount of payment otherwise applicable under this subsection, the provisions of section 1834(x)(5), paragraph (1)(DD) of subsection (a), and the flush left matter following paragraph (9) of subsection (a), shall, as determined appropriate by the Secretary, apply under this subsection in the same manner as such provisions of section 1834(x)(5) and subsection (a) apply under such section and subsection.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph>
<paragraph id="H7240C3CCF8EB45B2B67F2BCFB82BDD8F"><enum>(3)</enum><text>in subsection (t)(8), by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" id="H5EC70E3726E8408E8C67AF09B3DF2AD7" display-inline="no-display-inline">
<subparagraph id="H39D6BA6ECDF743619DB269618390BE5E"><enum>(F)</enum><header>Part B rebatable drugs</header><text display-inline="yes-display-inline">In the case of a part B rebatable drug (as defined in paragraph (2) of section 1834(x)) for which payment under this part is not packaged into a payment for a service furnished on or after July 1, 2021, under the system under this subsection, in lieu of calculation of coinsurance and the amount of payment otherwise applicable under this subsection, the provisions of section 1834(x)(5), paragraph (1)(DD) of subsection (a), and the flush left matter following paragraph (9) of subsection (a), shall, as determined appropriate by the Secretary, apply under this subsection in the same manner as such provisions of section 1834(x)(5) and subsection (a) apply under such section and subsection.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="HB14BD6EA5B74484CBC7782D4E5B5690C"><enum>(c)</enum><header>Conforming amendments</header>
<paragraph id="HD04C9A272DC243708825D0A109C1AA11"><enum>(1)</enum><header>To part B ASP calculation</header><text display-inline="yes-display-inline">Section 1847A(c)(3) of the Social Security Act (42 U.S.C. 1395w–3a(c)(3)) is amended by inserting <quote>or section 1834(x)</quote> after <quote>section 1927</quote>.</text></paragraph>
<paragraph id="H86C408EA87A64E0E9CAB4BBBE42F7EF1" commented="no"><enum>(2)</enum><header>Excluding parts B drug inflation rebate from best price</header><text display-inline="yes-display-inline">Section 1927(c)(1)(C)(ii)(I) of the Social Security Act (42 U.S.C. 1396r–8(c)(1)(C)(ii)(I)) is amended by inserting <quote>or section 1834(x)</quote> after <quote>this section</quote>.</text></paragraph></subsection></section>
<section id="H3E26E583605F491A9765F88B357E94DB" section-type="subsequent-section"><enum>202.</enum><header>Medicare part D rebate by manufacturers</header>
<subsection id="H7BD894230EAC4B5085042B3094A7C104"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Part D of title XVIII of the Social Security Act is amended by inserting after section 1860D–14A (42 U.S.C. 1395w–114a) the following new section:</text>
<quoted-block display-inline="no-display-inline" id="H19E4C6E88A4740148395E4EBCB7B2ADA" style="OLC">
<section id="H0957C9AB409644EB8F91E6EEB5B97C63"><enum>1860D–14B.</enum><header>Manufacturer rebate for certain drugs with prices increasing faster than inflation</header>
<subsection id="HC852CA6305FE4647909974A67E3F79AE"><enum>(a)</enum><header>In general</header>
<paragraph id="H17F35D572E374969B541C939507CA217"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to the provisions of this section, in order for coverage to be available under this part for a part D rebatable drug (as defined in subsection (h)(1)) of a manufacturer (as defined in section 1927(k)(5)) dispensed during an applicable year, the manufacturer must have entered into and have in effect an agreement described in subsection (b).</text></paragraph>
<paragraph id="H68AB4AD0EAB4434BB5A99CDD8724212A"><enum>(2)</enum><header> Authorizing Coverage for Drugs Not Covered Under Agreements</header><text display-inline="yes-display-inline">Paragraph (1) shall not apply to the dispensing of a covered part D drug if—</text>
<subparagraph id="H2CE60B0F80D545EBAC502997C986FA63"><enum>(A)</enum><text>the Secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part; or</text></subparagraph>
<subparagraph id="HC7EDCF3DB94F493D9BC88230529B7591"><enum>(B)</enum><text>the Secretary determines that in the period beginning on January 1, 2022, and ending on December 31, 2022, there were extenuating circumstances. </text></subparagraph></paragraph>
<paragraph id="H73F8EC9ED02A4E95AC36E6FF4DE50FB4"><enum>(3)</enum><header>Applicable year</header><text>For purposes of this section the term <term>applicable year</term> means a year beginning with 2022.</text></paragraph></subsection>
<subsection id="H1620EDF12D4740FA9B86C0A90E99E2E2"><enum>(b)</enum><header>Agreements</header>
<paragraph id="HAF78A2C019C9486AA2CE4B053E460C75"><enum>(1)</enum><header>Terms of agreement</header><text display-inline="yes-display-inline">An agreement described in this subsection, with respect to a manufacturer of a part D rebatable drug, is an agreement under which the following shall apply:</text>
<subparagraph display-inline="no-display-inline" id="H3276A0715EC24D7F903BA5C1E39C9F4B"><enum>(A)</enum><header>Secretarial provision of information</header><text display-inline="yes-display-inline">Not later than 9 months after the end of each applicable year with respect to which the agreement is in effect, the Secretary, for each part D rebatable drug of the manufacturer, shall report to the manufacturer the following for such year:</text>
<clause id="H28A729EBCD03490399FDE13A2A10A6B5"><enum>(i)</enum><text>Information on the total number of units (as defined in subsection (h)(2)) for each dosage form and strength with respect to such part D rebatable drug and year.</text></clause>
<clause id="HA0150C0E84E54D48BC598293E8F1A467"><enum>(ii)</enum><text>Information on the amount (if any) of the excess average manufacturer price increase described in subsection (c)(1)(B) for each dosage form and strength with respect to such drug and year.</text></clause>
<clause id="H2C4CC7D4251E4E978C77D4226F2CE1F1"><enum>(iii)</enum><text display-inline="yes-display-inline">The rebate amount specified under subsection (c) for each dosage form and strength with respect to such drug and year.</text></clause></subparagraph>
<subparagraph id="H35B6CBD09575457088403B0FFE03D209"><enum>(B)</enum><header>Manufacturer requirements</header><text display-inline="yes-display-inline">For each applicable year with respect to which the agreement is in effect, the manufacturer of the part D rebatable drug, for each dosage form and strength with respect to such drug, not later than 30 days after the date of receipt from the Secretary of the information described in subparagraph (A) for such year, shall provide to the Secretary a rebate that is equal to the amount specified in subsection (c) for such dosage form and strength with respect to such drug for such year.</text></subparagraph></paragraph>
<paragraph id="H2AACF88DD0C34C6E9C9DD3206BAD417D"><enum>(2)</enum><header>Length of agreement</header>
<subparagraph id="HF2D61A7713994207BBED1374AC55B75A"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">An agreement under this section, with respect to a part D rebatable drug, shall be effective for an initial period of not less than one year and shall be automatically renewed for a period of not less than one year unless terminated under subparagraph (B).</text></subparagraph>
<subparagraph id="HA5C7C5EC1FA3479690826F7880E239AB"><enum>(B)</enum><header>Termination</header>
<clause id="HF9650E9C5CA94D059D192A315B0DBACB"><enum>(i)</enum><header>By Secretary</header><text display-inline="yes-display-inline">The Secretary may provide for termination of an agreement under this section for 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 of such termination. The Secretary shall provide, upon request, a manufacturer with a hearing concerning such a termination, but such hearing shall not delay the effective date of the termination.</text></clause>
<clause id="H3BB10B375516457EA63D521AC5A3420C"><enum>(ii)</enum><header>By a manufacturer</header><text display-inline="yes-display-inline">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="H08F4DCD6B3F349CC83F76ECD8C6AC0D6"><enum>(I)</enum><text>if the termination occurs before January 30 of the plan year, as of the day after the end of the plan year; and</text></subclause>
<subclause id="H305B7EE91F4C4CF2A2E7A11C0EC422EE"><enum>(II)</enum><text>if the termination occurs on or after January 30 of the plan year, as of the day after the end of the succeeding plan year.</text></subclause></clause></subparagraph>
<subparagraph id="H80AFCB46F3144DA98DCBF5BAB58352EE"><enum>(C)</enum><header>Effectiveness of termination</header><text display-inline="yes-display-inline">Any termination under this paragraph shall not affect rebates due under the agreement under this section before the effective date of its termination.</text></subparagraph>
<subparagraph id="H086165C8C87A4796A0CA9DE9B3A70D15"><enum>(D)</enum><header>Delay before reentry</header><text>In the case of any agreement under this section with a manufacturer that is terminated in a plan year, the Secretary may not enter into another such agreement with the manufacturer (or a successor manufacturer) before the subsequent plan year, unless the Secretary finds good cause for an earlier reinstatement of such an agreement.</text></subparagraph></paragraph></subsection>
<subsection commented="no" id="H7A0F4EC5F00F4D668118A7EB3A5F50F1"><enum>(c)</enum><header>Rebate amount</header>
<paragraph commented="no" id="H7B4AE2B6FA5C460D867F0978663179C5"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of this section, the amount specified in this subsection for a dosage form and strength with respect to a part D rebatable drug and applicable year is, subject to subparagraphs (B) and (C) of paragraph (5), the amount equal to the product of—</text>
<subparagraph commented="no" id="H30ED7F24964E4EBAAEEEC0915855A54C"><enum>(A)</enum><text display-inline="yes-display-inline">the total number of units of such dosage form and strength with respect to such part D rebatable drug and year; and</text></subparagraph>
<subparagraph commented="no" id="H6EA07D228BD949AA9E38964B4A3A12C0"><enum>(B)</enum><text>the amount (if any) by which—</text>
<clause commented="no" id="H4FAE6A5710D84687AC2B91D40ECE49B9"><enum>(i)</enum><text display-inline="yes-display-inline">the annual manufacturer price (as determined in paragraph (2)) paid for such dosage form and strength with respect to such part D rebatable drug for the year; exceeds</text></clause>
<clause commented="no" id="H247860A2ADDF469EB7B50EEA28A16679"><enum>(ii)</enum><text display-inline="yes-display-inline">the inflation-adjusted payment amount determined under paragraph (3) for such dosage form and strength with respect to such part D rebatable drug for the year.</text></clause></subparagraph></paragraph>
<paragraph id="H3984E6850FE2427AA81675830AAF1C41"><enum>(2)</enum><header>Determination of annual manufacturer price</header><text display-inline="yes-display-inline">The annual manufacturer price determined under this paragraph for a dosage form and strength, with respect to a part D rebatable drug and an applicable year, is the sum of the products of—</text>
<subparagraph id="H564FC1207B9B4185B505EEA0FE1839CD"><enum>(A)</enum><text>the average manufacturer price (as defined in subsection (h)(6)) of such dosage form and strength, as calculated for a unit of such drug, with respect to each of the calendar quarters of such year; and</text></subparagraph>
<subparagraph id="H24E07575EDE940BBA1F3C8D6A53D05CE"><enum>(B)</enum><text>the ratio of—</text>
<clause id="HFFB834776B3E42A5BBF0B38A10906D24"><enum>(i)</enum><text>the total number of units of such dosage form and strength dispensed during each such calendar quarter of such year; to</text></clause>
<clause id="HCA026B9DF4804B0EBAE7F5E43E5E71A5"><enum>(ii)</enum><text>the total number of units of such dosage form and strength dispensed during such year.</text></clause></subparagraph></paragraph>
<paragraph id="HE3680AF506064718A8C88125A2D615E6"><enum>(3)</enum><header>Determination of inflation-adjusted payment amount</header><text display-inline="yes-display-inline">The inflation-adjusted payment amount determined under this paragraph for a dosage form and strength with respect to a part D rebatable drug for an applicable year, subject to subparagraphs (A) and (D) of paragraph (5), is—</text>
<subparagraph id="H09EC10374DED41D78D7A2F7D70315C16"><enum>(A)</enum><text display-inline="yes-display-inline">the benchmark year manufacturer price determined under paragraph (4) for such dosage form and strength with respect to such drug and an applicable year; increased by</text></subparagraph>
<subparagraph id="H555BB71B595A4F19AFC67580E0C0D6E0"><enum>(B)</enum><text>the percentage by which the applicable year CPI–U (as defined in subsection (h)(5)) for the applicable year exceeds the benchmark period CPI–U (as defined in subsection (h)(4)).</text></subparagraph></paragraph>
<paragraph id="H77D5904FCCCC47E19B449DCD53259F08"><enum>(4)</enum><header>Determination of benchmark year manufacturer price</header><text display-inline="yes-display-inline">The benchmark year manufacturer price determined under this paragraph for a dosage form and strength, with respect to a part D rebatable drug and an applicable year, is the sum of the products of—</text>
<subparagraph id="HF99F2CE207664AF89C4A549430293F24"><enum>(A)</enum><text>the average manufacturer price (as defined in subsection (h)(6)) of such dosage form and strength, as calculated for a unit of such drug, with respect to each calendar quarter of the payment amount benchmark year (as defined in subsection (h)(3)); and</text></subparagraph>
<subparagraph id="HAF8DF87455C94AF9B71040585C8D9F7E"><enum>(B)</enum><text>the ratio of—</text>
<clause id="HF3B488183683409AABFAC9D44477EE0B"><enum>(i)</enum><text>the total number of units of such dosage form and strength dispensed during such calendar quarter of the payment amount benchmark year; to</text></clause>
<clause id="H44CBD1D1CD20423DAF2BA547D4E5A8D8"><enum>(ii)</enum><text>the total number of units of such dosage form and strength dispensed during the payment amount benchmark year.</text></clause></subparagraph></paragraph>
<paragraph id="H0567D8DBEC084C63BC1BBFA1C6215FAA"><enum>(5)</enum><header>Special treatment of certain drugs and exemption</header>
<subparagraph commented="no" id="H6771743A3C244260A445CA04187D023D"><enum>(A)</enum><header>Subsequently approved drugs</header><text display-inline="yes-display-inline">In the case of a part D rebatable drug first approved or licensed by the Food and Drug Administration after January 1, 2016, subparagraphs (A) and (B) of paragraph (4) shall be applied as if the term <term>payment amount benchmark year</term> were defined under subsection (h)(3) as the first calendar year beginning after the day on which the drug was first marketed by any manufacturer and subparagraph (B) of paragraph (3) shall be applied as if the term <term>benchmark period CPI–U</term> were defined under subsection (h)(4) as if the reference to <quote>January 2016</quote> under such subsection were a reference to <quote>January of the first year beginning after the date on which the drug was first marketed by any manufacturer</quote>.</text></subparagraph>
<subparagraph id="H3B124C5DA4F9473783C0385766708478"><enum>(B)</enum><header>Exemption for shortages</header><text>The Secretary may reduce or waive the rebate under paragraph (1) with respect to a part D rebatable drug that is described as currently in shortage on the shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act or in the case of other exigent circumstances, as determined by the Secretary.</text></subparagraph>
<subparagraph commented="no" id="HC76ADF80C90B4634884CB8E303CFD33E"><enum>(C)</enum><header>Treatment of new formulations</header>
<clause commented="no" id="HC75473FC3CBF4C6A8B1C4ACC52360CDD"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">In the case of a part D rebatable drug that is a line extension of a part D rebatable drug that is an oral solid dosage form, the Secretary shall establish a formula for determining the amount specified in this subsection with respect to such part D rebatable drug and an applicable year with consideration of the original part D rebatable drug.</text></clause>
<clause commented="no" id="H286F88CB1E2548B98145749EA7B35D8F"><enum>(ii)</enum><header>Line extension defined</header><text>In this subparagraph, the term <term>line extension</term> means, with respect to a part D rebatable drug, a new formulation of the drug (as determined by the Secretary), such as an extended release formulation, but does not include an abuse-deterrent formulation of the drug (as determined by the Secretary), regardless of whether such abuse-deterrent formulation is an extended release formulation.</text></clause></subparagraph>
<subparagraph id="HF79269105C514E808AD7F2F29723E5D4"><enum>(D)</enum><header>Selected drugs</header><text>In the case of a part D rebatable drug that is a selected drug (as defined in section 1192(c)) for a price applicability period (as defined in section 1191(b)(2))—</text>
<clause id="H52EECB0DAF284B5DAE2D8DB5E9D83234"><enum>(i)</enum><text>for plan years during such period for which a maximum fair price (as defined in section 1191(c)(2)) for such drug has been determined and is applied under part E of title XI, the rebate under subsection (b)(1)(B) shall be waived; and</text></clause>
<clause id="H8BFF0D608C7649B98D61189A56858166"><enum>(ii)</enum><text display-inline="yes-display-inline">in the case such drug is determined (pursuant to such section 1192(c)) to no longer be a selected drug, for each applicable year beginning after the price applicability period with respect to such drug, subparagraphs (A) and (B) of paragraph (4) shall be applied as if the term <term>payment amount benchmark year</term> were defined under subsection (h)(3) as the last year beginning during such price applicability period with respect to such selected drug and subparagraph (B) of paragraph (3) shall be applied as if the term <term>benchmark period CPI–U</term> were defined under subsection (h)(4) as if the reference to <quote>January 2016</quote> under such subsection were a reference to January of the last year beginning during such price applicability period with respect to such drug.</text></clause></subparagraph></paragraph></subsection>
<subsection id="HD29106A07B3848A98B70BF2915954FF9"><enum>(d)</enum><header>Rebate deposits</header><text display-inline="yes-display-inline">Amounts paid as rebates under subsection (c) shall be deposited into the Medicare Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund established under section 1841.</text></subsection>
<subsection id="H5DB64C6671B24C049EBC2BB682AC0018"><enum>(e)</enum><header>Information</header><text display-inline="yes-display-inline">For purposes of carrying out this section, the Secretary shall use information submitted by manufacturers under section 1927(b)(3).</text></subsection>
<subsection id="H036D958A1A0A4CDCAF73EC0FBEA8B2E6"><enum>(f)</enum><header>Civil money penalty</header><text display-inline="yes-display-inline">In the case of a manufacturer of a part D rebatable drug with an agreement in effect under this section who has failed to comply with the terms of the agreement under subsection (b)(1)(B) with respect to such drug for an applicable year, the Secretary may impose a civil money penalty on such manufacturer in an amount equal to 125 percent of the amount specified in subsection (c) for such drug for such year. The provisions of section 1128A (other than subsections (a) (with respect to amounts of penalties or additional assessments) and (b)) shall apply to a civil money penalty under this subsection in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).</text></subsection>
<subsection id="HC82C84B217564725888420F7A80EA460"><enum>(g)</enum><header>Judicial review</header><text>There shall be no judicial review of the following:</text>
<paragraph id="H0B83D6A54ADE4D149652A58DBB5CCDA1"><enum>(1)</enum><text>The determination of units under this section.</text></paragraph>
<paragraph id="H1D5EB1746127412F93C65756268CD5A8"><enum>(2)</enum><text>The determination of whether a drug is a part D rebatable drug under this section.</text></paragraph>
<paragraph id="H7491E9482B2F4FB2BF33D6DE0D1DD8B5"><enum>(3)</enum><text>The calculation of the rebate amount under this section.</text></paragraph></subsection>
<subsection id="H5CB966D9D6D244058930BB78F52FA8F8"><enum>(h)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph commented="no" id="H75F5E0E0BAE643339C381F10C65CE450"><enum>(1)</enum><header>Part D rebatable drug defined</header>
<subparagraph id="H54F6E1AB02EF4C8291FD5633392D303E"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The term <term>part D rebatable drug</term> means a drug or biological that would (without application of this section) be a covered part D drug, except such term shall, with respect to an applicable year, not include such a drug or biological if the average annual total cost under this part for such year per individual who uses such a drug or biological, as determined by the Secretary, is less than, subject to subparagraph (B), $100, as determined by the Secretary using the most recent data available or, if data is not available, as estimated by the Secretary.</text></subparagraph>
<subparagraph commented="no" id="HF8635440EBD244139F5FF29BBE6492DA"><enum>(B)</enum><header>Increase</header><text>The dollar amount applied under subparagraph (A)—</text>
<clause commented="no" id="HC1BAF3526089466A95457D2CE162D933"><enum>(i)</enum><text display-inline="yes-display-inline">for 2023, shall be the dollar amount specified under such subparagraph for 2022, increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period beginning with January of 2022; and</text></clause>
<clause commented="no" id="H43C2078072B644A7A907C2535392F2BD"><enum>(ii)</enum><text display-inline="yes-display-inline">for a subsequent year, shall be the dollar amount specified in this subparagraph for the previous year, increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period beginning with January of the previous year.</text></clause><continuation-text commented="no" continuation-text-level="subparagraph">Any dollar amount specified under this subparagraph that is not a multiple of $10 shall be rounded to the nearest multiple of $10.</continuation-text></subparagraph></paragraph>
<paragraph id="HF409C29421C4418990ED12C8EB64F518"><enum>(2)</enum><header>Unit defined</header><text display-inline="yes-display-inline">The term <term>unit</term> means, with respect to a part D rebatable drug, the lowest identifiable quantity (such as a capsule or tablet, milligram of molecules, or grams) of the part D rebatable drug that is dispensed to individuals under this part.</text></paragraph>
<paragraph id="HC79254A4457547FEAA9244F7369C6EAF"><enum>(3)</enum><header>Payment amount benchmark year</header><text display-inline="yes-display-inline">The term <term>payment amount benchmark year</term> means the year beginning January 1, 2016.</text></paragraph>
<paragraph id="HD7010EE35CB64667A056B3D792DE605F"><enum>(4)</enum><header>Benchmark period CPI–U</header><text display-inline="yes-display-inline">The term <term>benchmark period CPI–U</term> means the consumer price index for all urban consumers (United States city average) for January 2016.</text></paragraph>
<paragraph id="HF052BDEDDAF247819628A8D9AD1EE4D8"><enum>(5)</enum><header>Applicable year CPI–U</header><text display-inline="yes-display-inline">The term <term>applicable year CPI–U</term> means, with respect to an applicable year, the consumer price index for all urban consumers (United States city average) for January of such year.</text></paragraph>
<paragraph id="HC831CB23E864455CAD6F2C9660A6B49B"><enum>(6)</enum><header>Average manufacturer price</header><text display-inline="yes-display-inline">The term <term>average manufacturer price</term> has the meaning, with respect to a part D rebatable drug of a manufacturer, given such term in section 1927(k)(1), with respect to a covered outpatient drug of a manufacturer for a rebate period under section 1927. </text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HBED66D69D15C404197E8F4FE33894271"><enum>(b)</enum><header>Conforming amendments</header>
<paragraph id="HF149FD48E66A49169449E5103844426E"><enum>(1)</enum><header>To part B ASP calculation</header><text display-inline="yes-display-inline">Section 1847A(c)(3) of the Social Security Act (42 U.S.C. 1395w–3a(c)(3)), as amended by section 201(c)(1), is further amended by striking <quote>section 1927 or section 1834(x)</quote> and inserting <quote>section 1927, section 1834(x), or section 1860D–14B</quote>.</text></paragraph>
<paragraph id="H0869EDDD5C214B99A522609DE6EA4393" commented="no"><enum>(2)</enum><header>Excluding part D drug inflation rebate from best price</header><text display-inline="yes-display-inline">Section 1927(c)(1)(C)(ii)(I) of the Social Security Act (42 U.S.C. 1396r–8(c)(1)(C)(ii)(I)), as amended by section 201(c)(2), is further amended by striking <quote>or section 1834(x)</quote> and inserting <quote>, section 1834(x), or section 1860D–14B</quote>.</text></paragraph></subsection></section>
<section id="H7E270D1BE6724210ACC0886B7F265CDE"><enum>203.</enum><header>Provision regarding inflation rebates for group health plans and group health insurance coverage</header><text display-inline="no-display-inline">Not later than December 31, 2021, the Secretary of Labor, in consultation with the Secretary of Health and Human Services and the Secretary of the Treasury, shall submit to Congress a report on—</text>
<paragraph id="H099FBFFB17934CACA2308B4E7C9BC7B6"><enum>(1)</enum><text>potential models for an agreement process with manufacturers of prescription drugs under which such manufacturers provide for inflation rebates with respect to such drugs that are furnished or dispensed to participants and beneficiaries of group health plans and health insurance coverage offered in the group market in a manner similar to how manufacturers provide for rebates under section 1834(x) of the Social Security Act, as added by section 201, and section 1860D–14B of such Act, as added by section 202, with respect to prescription drugs that are furnished or dispensed under part B of title XVIII of such Act and part D of such title, respectively;</text></paragraph>
<paragraph id="HB6964E3C5ADF47CBAA947C085E9F8491"><enum>(2)</enum><text display-inline="yes-display-inline">potential models for enforcement mechanisms with respect to such an agreement process that ensure that such inflation rebates are proportionally distributed, with respect to costs, to group health plans and health insurance issuers offering health insurance coverage in the group market, to participants and beneficiaries of such plans and coverage, or to both; and</text></paragraph>
<paragraph id="HAF77D0AC9AB14BA1B1B6411205815955"><enum>(3)</enum><text>for each potential model under paragraphs (1) and (2) any additional statutory authority needed to implement such model.</text></paragraph></section>
<section id="H2654811F09A143B288454ABC7CD11392"><enum>204.</enum><header>Annual report on drug costs in group health plans and group health insurance coverage</header>
<subsection id="HBF677F5C3BAB4990A5033CA0FEE9BE3B"><enum>(a)</enum><header>Initial report</header><text>Not later than December 31, 2021, the Secretary of Labor shall, in consultation with the Secretary of Health and Human Services and the Secretary of the Treasury, submit to Congress a report, with respect to a period (as determined by the Secretary of Labor), on—</text>
<paragraph id="HB6E10AF97B9A445CA3F1DF36C4F0224F"><enum>(1)</enum><text>whether the prices of prescription drugs that are furnished or dispensed to participants and beneficiaries of group health plans and health insurance coverage offered in the group market during such period have increased at a percentage that exceeds the percentage by which the consumer price index for all urban consumers (United States city average) increased for such period; and</text></paragraph>
<paragraph id="H051A8E0E0F434546A0EF3703B6928257"><enum>(2)</enum><text display-inline="yes-display-inline">whether there are mechanisms by which manufacturers of prescription drugs have attempted to recover rebate payments required of such manufacturers under section 1834(x) of the Social Security Act, as added by section 201, and section 1860D–14B of such Act, as added by section 202, with respect to prescription drugs that are furnished or dispensed under part B of title XVIII of such Act and part D of such title, respectively, through increased prices charged with respect to drugs that are furnished or dispensed to participants and beneficiaries of group health plans and health insurance coverage offered in the group market during such period.</text></paragraph></subsection>
<subsection id="HBB779E1F067C4EF48F886E11095EC017"><enum>(b)</enum><header>Annual report</header><text>Not later than December 31 of each year following 2021, the Secretary of Labor shall, in consultation with the Secretary of Health and Human Services and the Secretary of the Treasury, submit to Congress a report updating the information and analysis included in the report required under subsection (a), reflecting, in part, new price and cost information and data for the 12-month period after the period on which the prior year’s report was based.</text></subsection></section>
<section id="H3B268922F7734130A343599FA654DDD6"><enum>205.</enum><header>Collection of data</header>
<subsection id="H913C0571A014490AA363BC89BF44BF4D"><enum>(a)</enum><header>Manufacturers of prescription drugs</header><text>Manufacturers of prescription drugs shall submit to the Secretary of Health and Human Services, Secretary of Labor, and the Secretary of the Treasury appropriate data as necessary for the Secretaries to obtain information needed to provide the reports under sections 203 and 204.</text></subsection>
<subsection id="H25B44BD8021A4CC5A44692440CC2392A"><enum>(b)</enum><header>Group health plans and health insurance issuers offering health insurance coverage in the group market</header><text>Group health plans and health insurance issuers offering health insurance coverage in the group market shall submit to the Secretary of Health and Human Services, Secretary of Labor, and the Secretary of the Treasury appropriate data as necessary for the Secretaries to obtain information needed to provide the reports under sections 203 and 204.</text></subsection></section>
<enum>III</enum><header>Part D Improvements and Maximum Out-of-Pocket Cap for Medicare Beneficiaries</header>
<section id="H59D446969A7743E0BC01E62832AF15EB"><enum>301.</enum><header>Medicare part D benefit redesign</header>
<subsection id="H4D4905C17BA44B3CAE9A9FA383CFC488"><enum>(a)</enum><header>Benefit structure redesign</header><text>Section 1860D–2(b) of the Social Security Act (42 U.S.C. 1395w–102(b)) is amended—</text>
<paragraph id="H48947F311E864A068989A1A8E19472C8"><enum>(1)</enum><text>in paragraph (2)—</text>
<subparagraph id="H3B12B3B15F804230A103327157BC37D9"><enum>(A)</enum><text>in subparagraph (A), in the matter preceding clause (i), by inserting <quote>for a year preceding 2022 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 2022 and each subsequent year</quote> after <quote>paragraph (3)</quote>;</text></subparagraph>
<subparagraph id="H8A27CDFB7AC848EB9F8784FB17E6865F"><enum>(B)</enum><text>in subparagraph (C)—</text>
<clause id="H1762B8756E8F44DD9ADD017F40947BA2"><enum>(i)</enum><text>in clause (i), in the matter preceding subclause (I), by inserting <quote>for a year preceding 2022, </quote> after <quote>paragraph (4),</quote>; and</text></clause>
<clause id="HCB5940003DEF402DAF4AE7D80DE0D2FE"><enum>(ii)</enum><text>in clause (ii)(III), by striking <quote>and each subsequent year</quote> and inserting <quote>and 2021</quote>; and</text></clause></subparagraph>
<subparagraph id="HBF39DC6B313C47BB84378A85A86102FD"><enum>(C)</enum><text>in subparagraph (D)—</text>
<clause id="HFD2CD5A335D744F1B1F8B7214D1ABE6E"><enum>(i)</enum><text>in clause (i)—</text>
<subclause id="HC2BED671027740D9AE89995955992D37"><enum>(I)</enum><text>in the matter preceding subclause (I), by inserting <quote>for a year preceding 2022, </quote> after <quote>paragraph (4),</quote>; and</text></subclause>
<subclause id="H54B4D370808643FCBF8FF16D3ABD8420"><enum>(II)</enum><text>in subclause (I)(bb), by striking <quote>a year after 2018</quote> and inserting <quote>each of years 2018 through 2021</quote>; and</text></subclause></clause>
<clause id="H9CB5356063FA47A785450B2AC76CB353"><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 2021</quote>;</text></clause></subparagraph></paragraph>
<paragraph id="H8491DEC8A4E847E78074724D4D9F4550"><enum>(2)</enum><text>in paragraph (3)(A)—</text>
<subparagraph id="HDFAC73A6A12247A58AE310CAE32CDF89"><enum>(A)</enum><text>in the matter preceding clause (i), by inserting <quote>for a year preceding 2022,</quote> after <quote>and (4),</quote>; and</text></subparagraph>
<subparagraph id="HBD8D8339CB1342FA8891142B3C389034"><enum>(B)</enum><text>in clause (ii), by striking <quote>for a subsequent year</quote> and inserting <quote>for each of years 2007 through 2021</quote>; and</text></subparagraph></paragraph>
<paragraph id="H22E069635FF24296A374E57B08FDDD70"><enum>(3)</enum><text>in paragraph (4)—</text>
<subparagraph id="H484F69AFE4194202B0229936893894C8"><enum>(A)</enum><text>in subparagraph (A)—</text>
<clause id="H8F729BE98BDB4F5D90E305DBA53D5023"><enum>(i)</enum><text>in clause (i)—</text>
<subclause id="HA7B26C4069A447DE8877DBDC95983F0E"><enum>(I)</enum><text>by redesignating subclauses (I) and (II) as items (aa) and (bb), respectively, and moving the margin of each such redesignated item 2 ems to the right;</text></subclause>
<subclause id="HC4AFA3AF8737436D859A4D8F335F79E7"><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 display-inline="no-display-inline" id="HBA6CF84EA64146DBBE54956318647AB6" style="OLC">
<subclause id="H26F597BF3FBD464A867F62B699C89D1A"><enum>(I)</enum><text>for a year preceding 2022, the greater of—</text></subclause><after-quoted-block>;</after-quoted-block></quoted-block></subclause>
<subclause id="HD529F0BFF1A3476B859AB91B1434E31E"><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="H1B4F7C444E1146E192F22A56484479A4"><enum>(IV)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HF6B9E81363244F19BB77C8D01481F358" style="OLC">
<subclause id="H819CB43CAAEF47C0AA54898B800D8CCB"><enum>(II)</enum><text>for 2022 and each succeeding year, $0.</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause>
<clause id="HAFC9B4FA29AA448DB8959F2B009699BF"><enum>(ii)</enum><text display-inline="yes-display-inline">in clause (ii), by striking <quote>clause (i)(I)</quote> and inserting <quote>clause (i)(I)(aa)</quote>;</text></clause></subparagraph>
<subparagraph id="H1E5272B2F9184F398424B4210E1C933C"><enum>(B)</enum><text>in subparagraph (B)—</text>
<clause id="H265641A4BA4944FABEDC50AAA22DE6B8"><enum>(i)</enum><text>in clause (i)—</text>
<subclause id="H26A0B5B694A04A259131834C56B015E8"><enum>(I)</enum><text>in subclause (V), by striking <quote>or</quote> at the end;</text></subclause>
<subclause id="H9B1A0F645CD84C3DB181327392E39C72"><enum>(II)</enum><text>in subclause (VI)—</text>
<item id="H8EECA566D2854AAE8A079D85AAD4BDDA"><enum>(aa)</enum><text>by striking <quote>for a subsequent year</quote> and inserting <quote>for 2021</quote>; and</text></item>
<item id="HDBDE69A24C9C43BF9865039AADA4B937"><enum>(bb)</enum><text>by striking the period at the end and inserting a semicolon; and</text></item></subclause>
<subclause id="HF152283F19C14DEFAC47440AAD259FEE"><enum>(III)</enum><text>by adding at the end the following new subclauses:</text>
<quoted-block display-inline="no-display-inline" id="HCA10FD7E38534DD0ADE7ED64D97BBD80" style="OLC">
<subclause id="HAB291E77D09D4B4D93E7BB575E7179A6"><enum>(VII)</enum><text>for 2022, is equal to $2,000; or</text></subclause>
<subclause id="H0D27596C4A8040449365A7A4AF1692E8"><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="H6CA81F451E3A4F4C958186089B5447F3"><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="H06C3733AB7B24BE49EECC50573747C3B"><enum>(C)</enum><text>in subparagraph (C)(i), by striking <quote>and for amounts</quote> and inserting <quote>and, for a year preceding 2022, for amounts</quote>; and</text></subparagraph>
<subparagraph commented="no" id="HFECE73D3BF1E47F3821FEA7573AAC8B5"><enum>(D)</enum><text>in subparagraph (E), by striking <quote>In applying</quote> and inserting <quote>For each of years 2011 through 2021, in applying</quote>.</text></subparagraph></paragraph></subsection>
<subsection id="H4AC75F18AFD8432FA982BAF45E9AD9E3"><enum>(b)</enum><header>Decreasing reinsurance payment amount</header><text display-inline="yes-display-inline">Section 1860D–15(b)(1) of the Social Security Act (42 U.S.C. 1395w–115(b)(1)) is amended by inserting after <quote>80 percent</quote> the following: <quote>(or, with respect to a coverage year after 2021, 20 percent)</quote>.</text></subsection>
<subsection id="H4EEE06C14A294752A4E9854C8660C7DA"><enum>(c)</enum><header>Manufacturer discount program</header>
<paragraph id="H25F1994A0BD441319841C2B41C8C846E"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Part D of title XVIII of the Social Security Act (42 U.S.C. 1395w–101 et seq.), as amended by section 202, is further amended by inserting after section 1860D–14B the following new section:</text>
<quoted-block display-inline="no-display-inline" id="HE35455A053214889AC509EF5CCEFA088" style="OLC">
<section id="HEB38B24D69054936A773409AFC331B28"><enum>1860D–14C.</enum><header>Manufacturer discount program</header>
<subsection id="H43155080295E4FA9B126348634F9BEE6"><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, 2021, in consultation with manufacturers, and allow for comment on such model agreement.</text></subsection>
<subsection id="H4D0B783F1F6342A79245186B9C0648FC"><enum>(b)</enum><header>Terms of agreement</header>
<paragraph commented="no" id="H05FF480AC30646B2A3DFF825D0E77CF2"><enum>(1)</enum><header>In general</header>
<subparagraph commented="no" id="H45264310C10341F79AAAE32FEF0BAD4C"><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, 2022.</text></subparagraph>
<subparagraph commented="no" id="H26FC38EE8BBB4035B49D8BCB199158F2"><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>
<subparagraph commented="no" id="H1AA474E17AE247909C17FB3CBA174F4E"><enum>(C)</enum><header>Timing of agreement</header>
<clause commented="no" id="H4C65F99BE667407D99C5B4EC640909DF"><enum>(i)</enum><header>Special rule for 2022</header><text display-inline="yes-display-inline">In order for an agreement with a manufacturer to be in effect under this section with respect to the period beginning on January 1, 2022, and ending on December 31, 2022, the manufacturer shall enter into such agreement not later than 30 days after the date of the establishment of a model agreement under subsection (a).</text></clause>
<clause commented="no" id="H043EBE15836945529339C12FC990F4DA"><enum>(ii)</enum><header>2023 and subsequent years</header><text display-inline="yes-display-inline">In order for an agreement with a manufacturer to be in effect under this section with respect to plan year 2023 or a subsequent plan year, the manufacturer shall enter into such agreement (or such agreement shall be renewed under paragraph (4)(A)) not later than January 30 of the preceding year.</text></clause></subparagraph></paragraph>
<paragraph commented="no" id="H049B2196AA2C4B329AAC28CD518A48D2"><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 commented="no" id="HD9A74E29B6604703A33CCDFA89CE0E5A"><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="H3262763817F64CBE8DD4306D3A4CEB82"><enum>(4)</enum><header>Length of agreement</header>
<subparagraph commented="no" id="H5A979321504F438E88DBFCA9AC1D2A20"><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="HCBAED2FEAE744D9A970CDF3F790B7B03"><enum>(B)</enum><header>Termination</header>
<clause id="H6B25C485CAD14D9C94828E99D8F44206"><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="H7968C30A28D8456C86E13280EADC393E"><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 commented="no" id="H82847E06CD994F25A98A2C97EE5588DF"><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 commented="no" id="HA8BD19F1AB974C62B2474D7427326683"><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 commented="no" id="H2286873AC7C34836A4ECCB41A6C8FEAD"><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 commented="no" id="H0FCC9F61C32F4D6AAD8BDB5C87987427"><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></subsection>
<subsection id="HDF7DBBE151384F6BAAF128CC8942047D"><enum>(c)</enum><header>Duties described</header><text>The duties described in this subsection are the following:</text>
<paragraph commented="no" id="HDDF06A1696CC4E5890D6C8436878B594"><enum>(1)</enum><header>Administration of program</header><text>Administering the program, including—</text>
<subparagraph commented="no" id="H9CFA5A4034FC4DF288E2B0F226AB0993"><enum>(A)</enum><text>the determination of the amount of the discounted price of an applicable drug of a manufacturer;</text></subparagraph>
<subparagraph commented="no" id="HE3B1FC5D5DFE454A9974E714ABB500FC"><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 commented="no" id="H450D93C0BE504D328FDFC1B3A64CB43D"><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 commented="no" id="H9AE02FAFB80D47D691C3A42367A88B11"><enum>(i)</enum><text>the negotiated price of the applicable drug; and</text></clause>
<clause commented="no" id="H2FBAF78D5C604422B076BB2305A9F33F"><enum>(ii)</enum><text>the discounted price of the applicable drug;</text></clause></subparagraph>
<subparagraph commented="no" id="HB3132308352E4812A1EEEC991A171C2C"><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 commented="no" id="H4745E91FD79846458C1C0404DDC41099"><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="HB5DBF872CDF2480D995DBBBB1C83416E"><enum>(2)</enum><header>Monitoring compliance</header>
<subparagraph id="H450B47DF56B4473BAEDBB99890717D63"><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="H3A9A18C0EEF54DFD991D10A575B15E94"><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="HCCC805D03F2C42D7BFBD7CCFC60BEA62"><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="H0AA4C0B7FB3242468C834B81129E368C"><enum>(d)</enum><header>Administration</header>
<paragraph id="HDD3A61DD41934ED69113959D46D9BD29"><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 commented="no" id="HEC6D1436D15B4E74A87918FEB75AF499"><enum>(2)</enum><header>Limitation</header><text display-inline="yes-display-inline">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="HA5DE2AFBA6DA42FC99D8421C765DB6DA"><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 commented="no" id="HB021B74743454C99BA4C7FC1C2EFD29D"><enum>(A)</enum><text>receive and transmit information between the Secretary, manufacturers, and other individuals or entities the Secretary determines appropriate;</text></subparagraph>
<subparagraph commented="no" id="HE6053D53DE0748DB9D3C7D5EE2371D75"><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 commented="no" id="H19A693E9000F43CDB311BEC1278B67C8"><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 commented="no" id="HD75367CCB7CF4B6092BE2D43BEEDAF83"><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 commented="no" id="H7CA5C37C95884CF580E060FEB248853B"><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 commented="no" id="HA327C4B53C2B4BACA1B0F5F74D1242CA"><enum>(5)</enum><header>Implementation</header><text>Notwithstanding any other provision of law, the Secretary may implement the program under this section by program instruction or otherwise.</text></paragraph>
<paragraph commented="no" id="H2F728E0851D94136BFAF3860FEFCBB2C"><enum>(6)</enum><header>Administration</header><text>Chapter 35 of title 44, United States Code, shall not apply to the program under this section.</text></paragraph></subsection>
<subsection id="HD8329B188CFE4025AEB73BFC92D3B755"><enum>(e)</enum><header>Enforcement</header>
<paragraph id="HD4185090A3F84BDF85E737852000FD31"><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="HEFC9FBC5F09D4BA08C8963BB44011F96"><enum>(2)</enum><header>Civil money penalty</header>
<subparagraph id="H3D6B0879258742C18BA23D996834677E"><enum>(A)</enum><header>In general</header><text>The Secretary may 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 equal to the sum of—</text>
<clause id="H7AFE852AB51F4908813E51E89A3E2BB6"><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="HD0AE8E75C04A4830AA81287CA3BCCFC1"><enum>(ii)</enum><text>25 percent of such amount.</text></clause></subparagraph>
<subparagraph commented="no" id="H34CA5A17F3C5431FA202ACB000FD1CE3"><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 commented="no" id="H54632EAD59324F0C8A7EFA8FFF4B8232"><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="H3BFA8D44BB5B4F489DF3878BA90F50DF"><enum>(g)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="H70E1D11F7B75435ABE27E01EB68F6919"><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="HB523CCD6464049F8B954CCACDD075A5C"><enum>(A)</enum><text>is enrolled in a prescription drug plan or an MA–PD plan;</text></subparagraph>
<subparagraph id="HB42337C917634A28A59A01F209739D10"><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="HFE0B8A8388FB43A0BEA4CB12AB0C9FAC"><enum>(C)</enum><text display-inline="yes-display-inline">has incurred costs, as determined in accordance with section 1860D–2(b)(4)(C), for covered part D drugs in the year that are equal to or exceed the annual deductible with respect to such individual for such year, as specified in section 1860D–2(b)(1), section 1860D–14(a)(1)(B), or section 1860D–14(a)(2)(B), as applicable.</text></subparagraph></paragraph>
<paragraph id="HDC52FAE2CC004E498201B9472C43623E"><enum>(2)</enum><header>Applicable drug</header><text>The term <term>applicable drug</term>, with respect to an applicable beneficiary—</text>
<subparagraph id="H7904BAC0A2954DC68C5EA416F2D4D0D2"><enum>(A)</enum><text>means a covered part D drug—</text>
<clause id="H051AFECED1EA4530A0C80627E32CC734"><enum>(i)</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; and</text></clause>
<clause id="HF16F3A2EDCC64EC1B2B30122459477EF"><enum>(ii)</enum>
<subclause commented="no" display-inline="yes-display-inline" id="H2A82CB8B0CCB44F693B931E2705D1195"><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></subclause>
<subclause id="H68CA9172E6394E27975830A61256F0C0" 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></subclause>
<subclause id="H00187460895242058978C55625515FA3" indent="up1"><enum>(III)</enum><text>is provided through an exception or appeal; and</text></subclause></clause></subparagraph>
<subparagraph id="H42131D26AD144B0BBA5C50695F15BB12"><enum>(B)</enum><text>does not include a selected drug (as defined in section 1192(c)) during a price applicability period (as defined in section 1191(b)(2)) with respect to such drug.</text></subparagraph></paragraph>
<paragraph commented="no" id="H93C57A45272148A7BB12CA2F7A46B448"><enum>(3)</enum><header>Applicable number of calendar days</header><text>The term <term>applicable number of calendar days</term> means—</text>
<subparagraph commented="no" id="H80E7AD3634E340E38050900377C30E9B"><enum>(A)</enum><text>with respect to claims for reimbursement submitted electronically, 14 days; and</text></subparagraph>
<subparagraph commented="no" id="H3CA2C64026C14E26B474C37B35E9F431"><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="H4595F97AD1FD40CB83109BF92A1B1EBE"><enum>(4)</enum><header display-inline="yes-display-inline">Discounted price</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HBD93688C6878443E9903067AB9B4CD43"><enum>(A)</enum><header>In general</header><text>The term <term>discounted price</term> means, with respect to an applicable drug of a manufacturer furnished during a year to an applicable beneficiary—</text>
<clause commented="no" id="H2981DBFAA78B4684BB6DC223BD6FA4BE"><enum>(i)</enum><text display-inline="yes-display-inline">who has not incurred costs, as determined in accordance with section 1860D–2(b)(4)(C), 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)(i) for the year, 90 percent of the negotiated price of such drug; and</text></clause>
<clause commented="no" id="HACBAD2B6D1444020BEA5EEA1100D01B5"><enum>(ii)</enum><text>who has incurred such costs, as so determined, in the year that are equal to or exceed such threshold for the year, 70 percent of the negotiated price of such drug.</text></clause></subparagraph>
<subparagraph commented="no" display-inline="no-display-inline" id="HC0D13189E8EE46D2BA3BDD867D2008B5"><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="H9A79C789EA3649A482CC0E100CF29205"><enum>(C)</enum><header>Special case for certain claims</header>
<clause commented="no" id="H54D13C0BFFF74B079F8CBF5A5B56B714"><enum>(i)</enum><header>Claims spanning deductible</header><text>In the case where the entire amount of the negotiated price of an individual claim for an applicable drug with respect to an applicable beneficiary does not fall at or above the annual deductible specified in section 1860D–2(b)(1) for the year, the manufacturer of the applicable drug shall provide the discounted price under this section on only the portion of the negotiated price of the applicable drug that falls at or above such annual deductible.</text></clause>
<clause commented="no" id="H76077DD629024234B169F180DDFFA30C"><enum>(ii)</enum><header>Claims spanning out-of-pocket threshold</header><text display-inline="yes-display-inline">In the case where the entire amount of the negotiated price of an individual claim for an applicable drug with respect to an applicable beneficiary does not fall entirely below or entirely above the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B)(i) for the year, the manufacturer of the applicable drug shall provide the discounted price—</text>
<subclause commented="no" id="H9EF04A7BCDC24A44AB1FC47308733700"><enum>(I)</enum><text>in accordance with subparagraph (A)(i) on the portion of the negotiated price of the applicable drug that falls below such threshold; and</text></subclause>
<subclause commented="no" id="H4BDFE07C5A3745B6A932D0C50D419090"><enum>(II)</enum><text>in accordance with subparagraph (A)(ii) on the portion of such price of such drug that falls at or above such threshold.</text></subclause></clause></subparagraph></paragraph>
<paragraph commented="no" id="H3BBC46CA4ED7465A967796AB09062048"><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 commented="no" id="HAF7F2BEED2AF49CBB051730FF18287A8"><enum>(6)</enum><header>Negotiated price</header><text display-inline="yes-display-inline">The term <term>negotiated price</term> has the meaning given such term in section 423.100 of title 42, Code of Federal Regulations (or any successor regulation), except that, with respect to an applicable drug, such negotiated price shall not include any dispensing fee for the applicable drug.</text></paragraph>
<paragraph commented="no" id="HFA3C9B1529D44F41B646C9DDBEF811EF"><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="HED8A4F3085D54B27ADBADA9C256252B6"><enum>(2)</enum><header>Sunset of Medicare coverage gap discount program</header><text>Section 1860D–14A of the Social Security Act (42 U.S.C. 1395–114a) is amended—</text>
<subparagraph id="H0C8CE71A18EE499593559113ED77DCD6"><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="HD713F250ED644BD88D2F06CA8FB6CDCC"><enum>(B)</enum><text>by adding at the end the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="H32E895A362DF4AB6969E4F227C4933DE" style="OLC">
<subsection id="HCB8D9A8727F84FC490FFFCBC0CB8C8B0"><enum>(h)</enum><header>Sunset of program</header>
<paragraph id="HA9DA50A394C24144A870D9FDF7A3FC7A"><enum>(1)</enum><header>In general</header><text>The program shall not apply with respect to applicable drugs dispensed on or after January 1, 2022, and, subject to paragraph (2), agreements under this section shall be terminated as of such date.</text></paragraph>
<paragraph id="H31800BB652B84D9FB671CE3DF7A8105E"><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, 2022, with respect to applicable drugs dispensed prior to such date.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph commented="no" id="HF8A07C1EADDA4E068C95EC4C08AE817D"><enum>(3)</enum><header>Inclusion of actuarial value of manufacturer discounts in bids</header><text>Section 1860D–11 of the Social Security Act (42 U.S.C. 1395w–111) is amended—</text>
<subparagraph commented="no" id="HDB654DA18FF24544BF79C0301722BEEE"><enum>(A)</enum><text>in subsection (b)(2)(C)(iii)—</text>
<clause commented="no" id="H4E72209EE9BE4A519097C0DB6B14CBEB"><enum>(i)</enum><text>by striking <quote>assumptions regarding the reinsurance</quote> and inserting “assumptions regarding—</text>
<quoted-block display-inline="no-display-inline" id="H8F7052A63A4C49198B18E008BF8E7AA9" style="OLC">
<subclause commented="no" id="H986D02D4231D4B8FBDF04242662857F8"><enum>(I)</enum><text>the reinsurance</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></clause>
<clause commented="no" id="H5CF13491007049D3B5FF45FCBE5F2FC1"><enum>(ii)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HBB2BA131030543879298846DEE9C1EA5" style="OLC">
<subclause commented="no" id="H004FC4FEA28E4F9FBD45F702F628AB85"><enum>(II)</enum><text display-inline="yes-display-inline">for 2022 and each subsequent year, the manufacturer discounts provided under section 1860D–14C subtracted from the actuarial value to produce such bid; and</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph>
<subparagraph commented="no" id="H65C97E5CCE44454AB9302510915B8DFA"><enum>(B)</enum><text>in subsection (c)(1)(C)—</text>
<clause commented="no" id="H3B410CC10FAE46F1B9D785C78BBB2FC4"><enum>(i)</enum><text>by striking <quote>an actuarial valuation of the reinsurance</quote> and inserting “an actuarial valuation of—</text>
<quoted-block display-inline="no-display-inline" id="HD0177148A4AD4E5BA33C69B735FFE06F" style="OLC">
<clause commented="no" id="H4ADB66079EC347C7AAA6013A03705824"><enum>(i)</enum><text>the reinsurance</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause>
<clause commented="no" id="H4A4205800F9A4856972ACBA360A1B218"><enum>(ii)</enum><text>in clause (i), as inserted by clause (i) of this subparagraph, by adding <quote>and</quote> at the end; and</text></clause>
<clause commented="no" id="HA89ECDBD421C4733B1E36007C07FC30D"><enum>(iii)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HBCA31777FF224877996193E82668F7C4" style="OLC">
<clause commented="no" id="H2C736377A5B74CAC800A7AD79EA556E2"><enum>(ii)</enum><text>for 2022 and each subsequent year, the manufacturer discounts provided under section 1860D–14C;</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph></subsection>
<subsection id="H79E91B5B5EE14781945AA302BEF9980F"><enum>(d)</enum><header>Conforming amendments</header>
<paragraph id="HDA2D0F4A86984126AEF23F11BA9118E7"><enum>(1)</enum><text>Section 1860D–2 of the Social Security Act (42 U.S.C. 1395w–102) is amended—</text>
<subparagraph id="H9613A8DCDA5C41C1884A7B33EF31E1A6"><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 2022, an increase in the initial</quote>;</text></subparagraph>
<subparagraph id="HCB47C32C297A476881C41FEF72F467A2"><enum>(B)</enum><text>in subsection (c)(1)(C)—</text>
<clause id="H1A67F65506014815A19A5471C3624E59"><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="H2B5A4E9EDD5F474799882DBBFADFFA6C"><enum>(ii)</enum><text>by inserting <quote>for a year preceding 2022 or the annual out-of-pocket threshold specified in subsection (b)(4)(B) for the year for 2022 and each subsequent year</quote> after <quote>subsection (b)(3) for the year</quote> each place it appears; and</text></clause></subparagraph>
<subparagraph id="H5F8ED5FA45FB465D8E6A4659FCDE941E"><enum>(C)</enum><text>in subsection (d)(1)(A), by striking <quote>or an initial</quote> and inserting <quote>or, for a year preceding 2022, an initial</quote>.</text></subparagraph></paragraph>
<paragraph id="HF6CA7C18C2B54CF1A70F3628D32FD62B"><enum>(2)</enum><text>Section 1860D–4(a)(4)(B)(i) of the Social Security Act (42 U.S.C. 1395w–104(a)(4)(B)(i)) is amended by striking <quote>the initial</quote> and inserting <quote>for a year preceding 2022, the initial</quote>.</text></paragraph>
<paragraph id="H13AA8D763DCC4286A556D8D1C4938B71"><enum>(3)</enum><text>Section 1860D–14(a) of the Social Security Act (42 U.S.C. 1395w–114(a)) is amended—</text>
<subparagraph id="H503AF7151D4B434F9F8BB059CA5C1460"><enum>(A)</enum><text>in paragraph (1)—</text>
<clause id="HEC42724EDB5D41FA92237F10091444F6"><enum>(i)</enum><text>in subparagraph (C), by striking <quote>The continuation</quote> and inserting <quote>For a year preceding 2022, the continuation</quote>;</text></clause>
<clause id="HB45BE62959D145EB90AF95C212397E3C"><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="H55FF47CA624143809679F77796D4FB16"><enum>(iii)</enum><text>in subparagraph (E), by striking <quote>The elimination</quote> and inserting <quote>For a year preceding 2022, the elimination</quote>; and</text></clause></subparagraph>
<subparagraph id="HBB312757773C46FEA6911439D06A0E44"><enum>(B)</enum><text>in paragraph (2)—</text>
<clause id="HD94417388DC747F3BE02A11BCBB5C88F"><enum>(i)</enum><text>in subparagraph (C), by striking <quote>The continuation</quote> and inserting <quote>For a year preceding 2022, the continuation</quote>; and</text></clause>
<clause id="HCDEFD3513E5A419B92F0708BA13B4913"><enum>(ii)</enum><text>in subparagraph (E), by striking <quote>1860D–2(b)(4)(A)(i)(I)</quote> and inserting <quote>1860D–2(b)(4)(A)(i)(I)(aa)</quote>.</text></clause></subparagraph></paragraph>
<paragraph commented="no" display-inline="no-display-inline" id="HA30DCBFE66E746D48949A351E12E3A4F"><enum>(4)</enum><text display-inline="yes-display-inline">Section 1860D–21(d)(7) of the Social Security Act (42 U.S.C. 1395w–131(d)(7)) is amended by striking <quote>section 1860D–2(b)(4)(B)(i)</quote> and inserting <quote>section 1860D–2(b)(4)(C)(i)</quote>.</text></paragraph>
<paragraph id="H4CD03BCE02914FEF99639BD407E32F5C"><enum>(5)</enum><text display-inline="yes-display-inline">Section 1860D–22(a)(2)(A) of the Social Security Act (42 U.S.C. 1395w–132(a)(2)(A)) is amended—</text>
<subparagraph id="H767C68434375431BA947749C13AEA743"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>the value of any discount</quote> and inserting the following:</text>
<quoted-block display-inline="yes-display-inline" id="H971CB1854AE84F25A0BA8E3EA45230E8" style="OLC"><text>the value of—</text>
<clause id="HB3B5CDC694B94645BE6C48AE726A1CAA"><enum>(i)</enum><text display-inline="yes-display-inline">for years prior to 2022, any discount</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph>
<subparagraph id="HF382387074B4427F83A3304C0C93B23E"><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="HD2A6CB67A7774939895BCC22CDD79CCC"><enum>(C)</enum><text>by adding at the end the following new clause:</text>
<quoted-block display-inline="no-display-inline" id="HB2F12A2F777F484C8354DF10074EA6A9" style="OLC">
<clause commented="no" id="H393A0086F0ED435C91C30109DD751637"><enum>(ii)</enum><text>for 2022 and each subsequent year, any discount provided pursuant to section 1860D–14C.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="HD951012CD786490A8D9510D784871424"><enum>(6)</enum><text>Section 1860D–41(a)(6) of the Social Security Act (42 U.S.C. 1395w–151(a)(6)) is amended—</text>
<subparagraph id="HD6760F12516B4DFD8E5A7EBBDE034AFB"><enum>(A)</enum><text>by inserting <quote>for a year before 2022</quote> after <quote>1860D–2(b)(3)</quote>; and</text></subparagraph>
<subparagraph id="HF9DE97CC81C441CC85C8CF76BAD03F16"><enum>(B)</enum><text>by inserting <quote>for such year</quote> before the period.</text></subparagraph></paragraph>
<paragraph commented="no" display-inline="no-display-inline" id="H729107522D6B406CB7DD265E8A279EBF"><enum>(7)</enum><text display-inline="yes-display-inline">Section 1860D–43 of the Social Security Act (42 U.S.C. 1395w–153) is amended—</text>
<subparagraph id="H4C9128B1AF4746A28F3BC0B626D699BD"><enum>(A)</enum><text>in subsection (a)—</text>
<clause id="HF4612EB5A36D4E50A5DA80D1CFE229EC"><enum>(i)</enum><text>by striking paragraph (1) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H002BE0D97C4945A28DE2B0190958EE05" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H1F552ACF17D64AED80E6007DE17DCB06"><enum>(1)</enum><text>participate in—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H9E0ED5603B4C45BC8B3663A023F5EF26"><enum>(A)</enum><text>for 2011 through 2021, the Medicare coverage gap discount program under section 1860D–14A; and</text></subparagraph>
<subparagraph commented="no" display-inline="no-display-inline" id="HD2E65144A02544DEACAEB07AF1FB5998"><enum>(B)</enum><text>for 2022 and each subsequent year, the manufacturer discount program under section 1860D–14C;</text></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></clause>
<clause id="H412A4E959BD946648800F7FA7AF5CD3D"><enum>(ii)</enum><text>by striking paragraph (2) and inserting the following:</text>
<quoted-block style="OLC" id="H9C231AE208924BA59D750881C8D42A67" display-inline="no-display-inline">
<paragraph id="H8FDC71129EFE448592F546BC9EA43130"><enum>(2)</enum><text display-inline="yes-display-inline">have entered into and have in effect—</text>
<subparagraph id="HAD5AF78CF6FC4400BC67429E6977DCB0"><enum>(A)</enum><text>for 2011 through 2021, an agreement described in subsection (b) of section 1860D–14A with the Secretary; and</text></subparagraph>
<subparagraph id="H287EF9B2AAF347C1B10534A7EFC8B774"><enum>(B)</enum><text>for 2022 and each subsequent year, an agreement described in subsection (b) of section 1860D–14C with the Secretary; and</text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause>
<clause id="H5F6E1A6E344044D2BDC0A46895D84FC8"><enum>(iii)</enum><text>by striking paragraph (3) and inserting the following:</text>
<quoted-block style="OLC" id="H8B025AD57970423CB7492CD83EF7B5BC" display-inline="no-display-inline">
<paragraph id="H15832C43715B46B7A53D71479570630B"><enum>(3)</enum><text display-inline="yes-display-inline">have entered into and have in effect, under terms and conditions specified by the Secretary—</text>
<subparagraph id="H21B00CE60F3E4549A019F4B6DE9C73B4"><enum>(A)</enum><text display-inline="yes-display-inline">for 2011 through 2021, a contract with a third party that the Secretary has entered into a contract with under subsection (d)(3) of section 1860D–14A; and</text></subparagraph>
<subparagraph id="HDF5B95722FE34437B88041CBF1DC2DFC"><enum>(B)</enum><text display-inline="yes-display-inline">for 2022 and each subsequent year, a contract with a third party that the Secretary has entered into a contract with under subsection (d)(3) of section 1860D–14C.</text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph>
<subparagraph id="HFE0E9C207197406D81E5A60C6BCFB8E0"><enum>(B)</enum><text>by striking subsection (b) and inserting the following:</text>
<quoted-block style="OLC" id="H6D637D96D6A9408FBBB7235B4B9D8C2C" display-inline="no-display-inline">
<subsection id="HC67B8617EAF4484A88AEEFB92FF08C57"><enum>(b)</enum><header>Effective date</header><text display-inline="yes-display-inline">Paragraphs (1)(A), (2)(A), and (3)(A) of subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011, and before January 1, 2022, and paragraphs (1)(B), (2)(B), and (3)(B) of such subsection shall apply to covered part D drugs dispensed under this part on or after January 1, 2022.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H2FE1CA54C2894EDEA97C6D48A57121B7"><enum>(8)</enum><text display-inline="yes-display-inline">Section 1927 of the Social Security Act (42 U.S.C. 1396r–8) is amended—</text>
<subparagraph id="H62DA65C80DBE4EC5B82EE2D3450F3A91"><enum>(A)</enum><text display-inline="yes-display-inline">in subsection (c)(1)(C)(i)(VI), by inserting before the period at the end the following: <quote>or under the manufacturer discount program under section 1860D–14C</quote>; and</text></subparagraph>
<subparagraph id="HFB3FF489D91A43D4877893766611C745"><enum>(B)</enum><text display-inline="yes-display-inline">in subsection (k)(1)(B)(i)(V), by inserting before the period at the end the following: <quote>or under section 1860D–14C</quote>.</text> </subparagraph></paragraph></subsection>
<subsection id="HAF27058D2C6B4B10A56961D0B5D3E0BD"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall apply with respect to plan year 2022 and subsequent plan years.</text></subsection></section>
<section id="H0F7CA3DF33B34D6181CF2881344CA4B5" section-type="subsequent-section"><enum>302.</enum><header>Allowing certain enrollees of prescription drugs plans and MA–PD plans under Medicare program to spread out cost-sharing under certain circumstances</header><text display-inline="no-display-inline">Section 1860D–2(b)(2) of the Social Security Act (42 U.S.C. 1395w–102(b)(2)), as amended by section 301, is further amended—</text>
<paragraph id="HDEF59AAE3BD541B581AFADDDFEA0DC4F"><enum>(1)</enum><text>in subparagraph (A), by striking <quote>Subject to subparagraphs (C) and (D)</quote> and inserting <quote>Subject to subparagraphs (C), (D), and (E)</quote>; and</text></paragraph>
<paragraph id="HB78A2D40E8D647A59941D82538DD8848"><enum>(2)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" id="H88151702953D494D9E9A8952B315F361" display-inline="no-display-inline">
<subparagraph id="H88FDF8EA96FC4C14A3740263FA963AA7"><enum>(E)</enum><header>Enrollee option regarding spreading cost-sharing</header><text display-inline="yes-display-inline">The Secretary shall establish by regulation a process under which, with respect to plan year 2022 and subsequent plan years, a prescription drug plan or an MA–PD plan shall, in the case of a part D eligible individual enrolled with such plan for such plan year who is not a subsidy eligible individual (as defined in section 1860D–14(a)(3)) and with respect to whom the plan projects that the dispensing of the first fill of a covered part D drug to such individual will result in the individual incurring costs that are equal to or above the annual out-of-pocket threshold specified in paragraph (4)(B) for such plan year, provide such individual with the option to make the coinsurance payment required under subparagraph (A) (for the portion of such costs that are not above such annual out-of-pocket threshold) in the form of periodic installments over the remainder of such plan year.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section>
<section id="H10CE6BD8A3F74850B1DA462B14301239"><enum>303.</enum><header>Establishment of pharmacy quality measures under Medicare part D</header><text display-inline="no-display-inline">Section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–104(c)) is amended—</text>
<paragraph id="H223590DDEF2F4789A2071FD7866E7386"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating the paragraph (6), as added by section 50354 of division E of the Bipartisan Budget Act of 2018 (Public Law 115–123), as paragraph (7); and</text></paragraph>
<paragraph id="HF987ADD8D6304C3AA9A4CDB6D2BA9AFE"><enum>(2)</enum><text>by adding at the end the following new paragraph:</text>
<quoted-block id="HE29BD723E7B84A66999A31E5A365C578" style="OLC">
<paragraph id="HF855C3B2C5034F00933589FBF3C73F38"><enum>(8)</enum><header>Application of pharmacy quality measures</header>
<subparagraph id="H57D459CDEE2342BAB427728872002A93"><enum>(A)</enum><header>In general</header><text>A PDP sponsor that implements incentive payments to a pharmacy or price concessions paid by a pharmacy based on quality measures shall use measures established or approved by the Secretary under subparagraph (B) with respect to payment for covered part D drugs dispensed by such pharmacy.</text></subparagraph>
<subparagraph id="H8ACE79AD3B4347A88C41E2725CA498F5"><enum>(B)</enum><header>Standard pharmacy quality measures</header><text>The Secretary shall establish or approve standard quality measures from a consensus and evidence-based organization for payments described in subparagraph (A). Such measures shall focus on patient health outcomes and be based on proven criteria measuring pharmacy performance.</text></subparagraph>
<subparagraph id="HC63B01C9FACD4891BCD66CF1C129C357"><enum>(C)</enum><header>Effective date</header><text>The requirement under subparagraph (A) shall take effect for plan years beginning on or after January 1, 2021, or such earlier date specified by the Secretary if the Secretary determines there are sufficient measures established or approved under subparagraph (B) to meet the requirement under subparagraph (A).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section>
<enum>IV</enum><header>Drug Price Transparency</header>
<section id="HABFD4A9BA244445191AAD6CDBF1637C6" section-type="subsequent-section"><enum>401.</enum><header>Drug price transparency</header><text display-inline="no-display-inline">Part A of title XI of the Social Security Act is amended by adding at the end the following new sections:</text>
<quoted-block display-inline="no-display-inline" id="HA23712450EF54FBBBF2B764F7AE716FF" style="OLC">
<section id="HA7761F68B1C342A0A078FEC0E996EA26"><enum>1150C.</enum><header>Reporting on drug prices</header>
<subsection id="H733D5254555243C28545B76FF2602EE6"><enum>(a)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="HC00F90451D1C4209BF404CB097D64393"><enum>(1)</enum><header>Manufacturer</header><text>The term <term>manufacturer</term> means the person—</text>
<subparagraph id="HB4CD679E73644C59A0346008233663DD"><enum>(A)</enum><text>that holds the application for a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of the Public Health Service Act; or</text></subparagraph>
<subparagraph id="H0AE64BCF04E9427391A5D81CFB383A8D"><enum>(B)</enum><text display-inline="yes-display-inline">who is responsible for setting the wholesale acquisition cost for the drug.</text></subparagraph></paragraph>
<paragraph id="H59436BBC6D37443CA2923DE54928170C"><enum>(2)</enum><header>Qualifying drug</header><text>The term <term>qualifying drug</term> means any drug that is approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under subsection (a) or (k) of section 351 of the Public Health Service Act—</text>
<subparagraph id="H50EF309E158442F693506308B35F84FC"><enum>(A)</enum><text display-inline="yes-display-inline">that has a wholesale acquisition cost of $100 or more, adjusted for inflation occurring after the date of enactment of this section, for a month’s supply or a typical course of treatment that lasts less than a month, and is—</text>
<clause id="H8380256CA0AC4334AFCD292C479699B1"><enum>(i)</enum><text>subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act; and</text></clause>
<clause id="H2B527712846740A3A1766D2C745A2732"><enum>(ii)</enum><text>not a preventative vaccine; and</text></clause></subparagraph>
<subparagraph id="HBE61743481B24B528E8C109E8F21E811"><enum>(B)</enum><text>for which, during the previous calendar year, at least 1 dollar of the total amount of sales were for individuals enrolled under the Medicare program under title XVIII or under a State Medicaid plan under title XIX or under a waiver of such plan.</text></subparagraph></paragraph>
<paragraph id="H6A2B09960FE3402283188EA7A33048CA"><enum>(3)</enum><header>Wholesale acquisition cost</header><text>The term <term>wholesale acquisition cost</term> has the meaning given that term in section 1847A(c)(6)(B).</text></paragraph></subsection>
<subsection id="HBC7CB69A19374F319ACF1AC4209E71FA"><enum>(b)</enum><header>Report</header>
<paragraph id="H9C633CD77FE14B18AF37030ABFB6A6DB"><enum>(1)</enum><header>Report required</header><text>The manufacturer of a qualifying drug shall submit a report to the Secretary if, with respect to the qualifying drug—</text>
<subparagraph id="H23EA02DBF16E42B4882AD2527DE8EC27"><enum>(A)</enum><text>there is an increase in the price of the qualifying drug that results in an increase in the wholesale acquisition cost of that drug that is equal to—</text>
<clause id="HF443516AB0DA48788200226C39DFB2B5"><enum>(i)</enum><text display-inline="yes-display-inline">10 percent or more within a 12-month period beginning on or after January 1, 2019; or</text></clause>
<clause id="HF5D2387DEA8C4167B6704BC8A558994E"><enum>(ii)</enum><text display-inline="yes-display-inline">25 percent or more within a 36-month period beginning on or after January 1, 2019; </text></clause></subparagraph>
<subparagraph id="HD57C5E40C0C344369724E13B473D5DB5"><enum>(B)</enum><text display-inline="yes-display-inline">the estimated price of the qualifying drug or spending per individual or per user of such drug (as estimated by the Secretary) for the applicable year (or per course of treatment in such applicable year as determined by the Secretary) is at least $26,000 beginning on or after January 1, 2021; or</text></subparagraph>
<subparagraph id="HEDABDD3981C54195B1BACA9463D93A9D"><enum>(C)</enum><text display-inline="yes-display-inline">there was an increase in the price of the qualifying drug that resulted in an increase in the wholesale acquisition cost of that drug that is equal to—</text>
<clause id="H25AB215482AA4992BA47F152B834F431"><enum>(i)</enum><text>10 percent or more within a 12-month period that begins and ends during the 5-year period preceding January 1, 2021; or</text></clause>
<clause id="H0980FB4767F941D39813629E2C6C0CDD"><enum>(ii)</enum><text>25 percent or more within a 36-month period that begins and ends during the 5-year period preceding January 1, 2021. </text></clause></subparagraph></paragraph>
<paragraph id="HA1A96EAA0C6D4B4C832D2B71A5B4F325"><enum>(2)</enum><header>Report deadline</header><text>Each report described in paragraph (1) shall be submitted to the Secretary—</text>
<subparagraph id="HCC6DE9FC5F0E4116B54D22B63843CDAA"><enum>(A)</enum><text display-inline="yes-display-inline">in the case of a report with respect to an increase in the price of a qualifying drug that occurs during the period beginning on January 1, 2019, and ending on the day that is 60 days after the date of the enactment of this section, not later than 90 days after such date of enactment; </text></subparagraph>
<subparagraph id="HF9B1085784B740C08DF3BD579035C1BE"><enum>(B)</enum><text display-inline="yes-display-inline">in the case of a report with respect to an increase in the price of a qualifying drug that occurs after the period described in subparagraph (A), not later than 30 days prior to the planned effective date of such price increase for such qualifying drug; </text></subparagraph>
<subparagraph id="H784331F44B7243FEAB75440749D93D3B"><enum>(C)</enum><text display-inline="yes-display-inline">in the case of a report with respect to a qualifying drug that meets the criteria under paragraph (1)(B), not later than 30 days after such drug meets such criteria; and</text></subparagraph>
<subparagraph id="HAEA82F53D281470791C91C5982C7D69A"><enum>(D)</enum><text>in the case of a report with respect to an increase in the price of a qualifying drug that occurs during a 12-month or 36-month period described in paragraph (1)(C), not later than April 1, 2021.</text></subparagraph></paragraph></subsection>
<subsection id="H3CA85D3F8BD1435D96ABC3ABFAFBCFB2"><enum>(c)</enum><header>Contents</header><text display-inline="yes-display-inline">A report under subsection (b), consistent with the standard for disclosures described in section 213.3(d) of title 12, Code of Federal Regulations (as in effect on the date of enactment of this section), shall, at a minimum, include—</text>
<paragraph id="H0A89645DFE484FE9A82D49EB716B7CE9"><enum>(1)</enum><text>with respect to the qualifying drug—</text>
<subparagraph id="H77B0ECE6AEA74BF68C9CC48D142FC2AC"><enum>(A)</enum><text display-inline="yes-display-inline">the percentage by which the manufacturer will raise the wholesale acquisition cost of the drug within the 12-month period or 36-month period as described in subsection (b)(1)(A)(i), (b)(1)(A)(ii), (b)(1)(C)(i), or (b)(1)(C)(ii), as applicable, and the effective date of such price increase or the cost associated with a qualifying drug if such drug meets the criteria under subsection (b)(1)(B) and the effective date at which such drug meets such criteria;</text></subparagraph>
<subparagraph id="HE9D5812FACC2421ABB2273D62D083C4A"><enum>(B)</enum><text>an explanation for, and description of, each price increase for such drug that will occur during the 12-month period or the 36-month period described in subsection (b)(1)(A)(i), (b)(1)(A)(ii), (b)(1)(C)(i), or (b)(1)(C)(ii), as applicable;</text></subparagraph>
<subparagraph id="H22E20366236D483D85670B5B7B28D1DB"><enum>(C)</enum><text display-inline="yes-display-inline">an explanation for, and description of, the cost associated with a qualifying drug if such drug meets the criteria under subsection (b)(1)(B), as applicable;</text></subparagraph>
<subparagraph id="HFC19ECC9528E420A8EA5D9A49E2CD32F"><enum>(D)</enum><text display-inline="yes-display-inline">if known and different from the manufacturer of the qualifying drug, the identity of—</text>
<clause id="HFF2A6C7C3B954D20AF57CC499219EFA7"><enum>(i)</enum><text>the sponsor or sponsors of any investigational new drug applications under section 505(i) of the Federal Food, Drug, and Cosmetic Act for clinical investigations with respect to such drug, for which the full reports are submitted as part of the application—</text>
<subclause id="HF256F2745B1A4DCA993DF16E769D0D2C"><enum>(I)</enum><text>for approval of the drug under section 505 of such Act; or</text></subclause>
<subclause id="HCF7AAB62FB2444BCB555A37A5B4C3AFE"><enum>(II)</enum><text>for licensure of the drug under section 351 of the Pubic Health Service Act; and</text></subclause></clause>
<clause id="H9887C0B7C5A04F03B3BB7332B088D0CF"><enum>(ii)</enum><text>the sponsor of an application for the drug approved under such section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of the Public Health Service Act;</text></clause></subparagraph>
<subparagraph id="H617B3BD60D33466A94100150F01020B1"><enum>(E)</enum><text>a description of the history of the manufacturer’s price increases for the drug since the approval of the application for the drug under section 505 of the Federal Food, Drug, and Cosmetic Act or the issuance of the license for the drug under section 351 of the Public Health Service Act, or since the manufacturer acquired such approved application or license, if applicable;</text></subparagraph>
<subparagraph id="HF29A9E786541419DB6C689A33F33C3DE"><enum>(F)</enum><text>the current wholesale acquisition cost of the drug;</text></subparagraph>
<subparagraph commented="no" id="H41F21D6F27C44CF0938C3CA3AF146B0E"><enum>(G)</enum><text>the total expenditures of the manufacturer on—</text>
<clause commented="no" id="H4CB54354A5924FBFA6249A462DF9F67F"><enum>(i)</enum><text>materials and manufacturing for such drug; </text></clause>
<clause commented="no" id="HBAE2EF63917F41888CE86F2DCC004DDA"><enum>(ii)</enum><text>acquiring patents and licensing for such drug; and</text></clause>
<clause id="H26E34EA50D5D4E1EA1E648A758769014"><enum>(iii)</enum><text display-inline="yes-display-inline">purchasing or acquiring such drug from another manufacturer, if applicable;</text></clause></subparagraph>
<subparagraph id="HF0A4CBC8CB584E4683574FCAC528ECB0"><enum>(H)</enum><text>the percentage of total expenditures of the manufacturer on research and development for such drug that was derived from Federal funds;</text></subparagraph>
<subparagraph id="HC390E31E70ED4FDFAD8AAF172BBA256B"><enum>(I)</enum><text display-inline="yes-display-inline">the total expenditures of the manufacturer on research and development for such drug that is necessary to demonstrate that it meets applicable statutory standards for approval under section 505 of the Federal Food, Drug, and Cosmetic Act or licensure under section 351 of the Public Health Service Act, as applicable;</text></subparagraph>
<subparagraph id="H094AC2AD6091443099818069FF2DFC0A"><enum>(J)</enum><text display-inline="yes-display-inline">the total expenditures of the manufacturer on pursuing new or expanded indications or dosage changes for such drug under section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act;</text></subparagraph>
<subparagraph id="HDA15848F93C64A3B8AB4ECEC13AD0572"><enum>(K)</enum><text display-inline="yes-display-inline">the total expenditures of the manufacturer on carrying out postmarket requirements related to such drug, including under section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act;</text></subparagraph>
<subparagraph id="H67F9BB2928CD49E2945D51930282AA9A"><enum>(L)</enum><text>the total revenue and the net profit generated from the qualifying drug for each calendar year since the approval of the application for the drug under section 505 of the Federal Food, Drug, and Cosmetic Act or the issuance of the license for the drug under section 351 of the Public Health Service Act, or since the manufacturer acquired such approved application or license; and</text></subparagraph>
<subparagraph id="HD4790E06594F473EAEACA9688A5BD3B4"><enum>(M)</enum><text>the total costs associated with marketing and advertising for the qualifying drug;</text></subparagraph></paragraph>
<paragraph id="H6F6399314A144BEF98FC30202E822E5B"><enum>(2)</enum><text>with respect to the manufacturer—</text>
<subparagraph id="H11EE04F260A54B009F724D51EEE20EE2"><enum>(A)</enum><text display-inline="yes-display-inline">the total revenue and the net profit of the manufacturer for each of the 12-month period described in subsection (b)(1)(A)(i) or (b)(1)(C)(i) or the 36-month period described in subsection (b)(1)(A)(ii) or (b)(1)(C)(ii), as applicable;</text></subparagraph>
<subparagraph id="H0A610D51C437456992E1FCBDB2C8B233"><enum>(B)</enum><text display-inline="yes-display-inline">all stock-based performance metrics used by the manufacturer to determine executive compensation for each of the 12-month periods described in subsection (b)(1)(A)(i) or (b)(1)(C)(i) or the 36-month periods described in subsection (b)(1)(A)(ii) or (b)(1)(C)(ii), as applicable; and</text></subparagraph>
<subparagraph id="HA7918A470A6D4FCB95C20AD248C556B2"><enum>(C)</enum><text>any additional information the manufacturer chooses to provide related to drug pricing decisions, such as total expenditures on—</text>
<clause id="H63B6058536EF43CB8F11FE81EE4F0294"><enum>(i)</enum><text>drug research and development; or</text></clause>
<clause id="H514E28C5D5414CECA17F2CB03ABDD729"><enum>(ii)</enum><text>clinical trials, including on drugs that failed to receive approval by the Food and Drug Administration; and</text></clause></subparagraph></paragraph>
<paragraph id="HC9966136C98043B3ACA62E308790A658"><enum>(3)</enum><text display-inline="yes-display-inline">such other related information as the Secretary considers appropriate and as specified by the Secretary.</text></paragraph></subsection>
<subsection id="H09A54462A61E4ED2A9E5FF895574A3F2"><enum>(d)</enum><header>Information provided</header><text display-inline="yes-display-inline">The manufacturer of a qualifying drug that is required to submit a report under subsection (b), shall ensure that such report and any explanation for, and description of, each price increase described in subsection (c)(1) shall be truthful, not misleading, and accurate.</text></subsection>
<subsection id="H502D54A44432406CBE19CEB5FEB247BA"><enum>(e)</enum><header>Civil monetary penalty</header><text display-inline="yes-display-inline">Any manufacturer of a qualifying drug that fails to submit a report for the drug as required by this section, following notification by the Secretary to the manufacturer that the manufacturer is not in compliance with this section, shall be subject to a civil monetary penalty of $75,000 for each day on which the violation continues.</text></subsection>
<subsection id="H121473D92F3143F092ED580AAAE08B02"><enum>(f)</enum><header>False information</header><text display-inline="yes-display-inline">Any manufacturer that submits a report for a drug as required by this section that knowingly provides false information in such report is subject to a civil monetary penalty in an amount not to exceed $100,000 for each item of false information. </text></subsection>
<subsection id="HB3D60B141F4A4B15BFDFEBF84244A94E"><enum>(g)</enum><header>Public posting</header>
<paragraph id="HCDE8CF78436F4B96A50EFD1CC08EBC0B"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to paragraph (4), the Secretary shall post each report submitted under subsection (b) on the public website of the Department of Health and Human Services the day the price increase of a qualifying drug is scheduled to go into effect.</text></paragraph>
<paragraph id="H25F6145813F94A86AB9E36A25AF1D29E"><enum>(2)</enum><header>Format</header><text display-inline="yes-display-inline">In developing the format in which reports will be publicly posted under paragraph (1), the Secretary shall consult with stakeholders, including beneficiary groups, and shall seek feedback from consumer advocates and readability experts on the format and presentation of the content of such reports to ensure that such reports are—</text>
<subparagraph id="H9E940B7D801E4BF487D2E81DA36FD8E0"><enum>(A)</enum><text>user-friendly to the public; and</text></subparagraph>
<subparagraph id="H9DC2BC47D66D493897B65789EE3A5AAD"><enum>(B)</enum><text>written in plain language that consumers can readily understand.</text></subparagraph></paragraph>
<paragraph id="H04DA7550E6E64F8ABDF2AF071483E7DA"><enum>(3)</enum><header>List</header><text display-inline="yes-display-inline">In addition to the reports submitted under subsection (b), the Secretary shall also post a list of each qualifying drug with respect to which the manufacturer was required to submit such a report in the preceding year and whether such manufacturer was required to submit such report based on a qualifying price increase or whether such drug meets the criteria under subsection (b)(1)(B).</text></paragraph>
<paragraph id="HE688A129D2DD4691B80E0D4646345353"><enum>(4)</enum><header>Protected information</header><text display-inline="yes-display-inline">In carrying out this section, the Secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets.</text></paragraph></subsection></section>
<section id="H16F27AF9B0BF4A74B8FF860E23F96DE7"><enum>1150D.</enum><header>Annual report to Congress</header>
<subsection id="HF10DFAFA9B944347B0117CC2C3278F83"><enum>(a)</enum><header>In General</header><text display-inline="yes-display-inline">Subject to subsection (b), the Secretary shall submit to the Committees on Energy and Commerce and Ways and Means of the House of Representatives and the Committees on Health, Education, Labor, and Pensions and Finance of the Senate, and post on the public website of the Department of Health and Human Services in a way that is user-friendly to the public and written in plain language that consumers can readily understand, an annual report—</text>
<paragraph id="H07E536B7F2A84605BF0307A9104CEAB7"><enum>(1)</enum><text display-inline="yes-display-inline">summarizing the information reported pursuant to section 1150C;</text></paragraph>
<paragraph id="H8ED3BAE682DA4122B85C0D8CF472B02F"><enum>(2)</enum><text display-inline="yes-display-inline">including copies of the reports and supporting detailed economic analyses submitted pursuant to such section;</text></paragraph>
<paragraph id="HA103AB23FB7D498ABF0B44A6E1B40511"><enum>(3)</enum><text display-inline="yes-display-inline">detailing the costs and expenditures incurred by the Department of Health and Human Services in carrying out section 1150C; and</text></paragraph>
<paragraph id="H1507830C1D214FA087A45CD729570F78"><enum>(4)</enum><text display-inline="yes-display-inline">explaining how the Department of Health and Human Services is improving consumer and provider information about drug value and drug price transparency.</text></paragraph></subsection>
<subsection id="H4103D81D771A4CB99490790F0F03CD9F"><enum>(b)</enum><header>Protected information</header><text display-inline="yes-display-inline">In carrying out this section, the Secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section>
<enum>V</enum><header>Program improvements for Medicare low-income beneficiaries</header>
501.Dissemination to Medicare part D subsidy eligible individuals of information comparing premiums of certain prescription drug plansSection 1860D–1(c)(3) of the Social Security Act (42 U.S.C. 1395w–101(c)(3)) is amended by adding at the end the following new subparagraph:
(C)Information on premiums for subsidy eligible individuals
(i)For plan year 2022 and each subsequent plan year, the Secretary shall disseminate to each subsidy eligible individual (as defined in section 1860D–14(a)(3)) information under this paragraph comparing premiums that would apply to such individual for prescription drug coverage under LIS benchmark plans, including, in the case of an individual enrolled in a prescription drug plan under this part, information that compares the premium that would apply if such individual were to remain enrolled in such plan to premiums that would apply if the individual were to enroll in other LIS benchmark plans.
(ii)For purposes of clause (i), the term LIS benchmark plan means, with respect to an individual, a prescription drug plan under this part that is offered in the region in which the individual resides and—
(I)that provides for a premium that is not more than the low-income benchmark premium amount (as defined in section 1860D–14(b)(2)) for such region; or
(II)with respect to which the premium would be waived as de minimis pursuant to section 1860D–14(a)(5) for such individual..
502.Providing for intelligent assignment of certain subsidy eligible individuals auto-enrolled under Medicare prescription drug plans and MA–PD plans
(a)Section 1860D–1(b)(1) of the Social Security Act (42 U.S.C. 1395w–101(b)(1)) is amended—
(1)in subparagraph (C)—
(A)by inserting after PDP region
the following: or through use of an intelligent assignment process that is designed to maximize the access of such individual to necessary prescription drugs while minimizing costs to such individual and to the program under this part to the greatest extent possible. In the case the Secretary enrolls such individuals through use of an intelligent assignment process, such process shall take into account the extent to which prescription drugs necessary for the individual are covered in the case of a PDP sponsor of a prescription drug plan that uses a formulary, the use of prior authorization or other restrictions on access to coverage of such prescription drugs by such a sponsor, and the overall quality of a prescription drug plan as measured by quality ratings established by the Secretary
; and
(B)by striking Nothing in the previous sentence
and inserting Nothing in this subparagraph
; and
(2)in subparagraph (D)—
(A)by inserting after PDP region
the following: or through use of an intelligent assignment process that is designed to maximize the access of such individual to necessary prescription drugs while minimizing costs to such individual and to the program under this part to the greatest extent possible. In the case the Secretary enrolls such individuals through use of an intelligent assignment process, such process shall take into account the extent to which prescription drugs necessary for the individual are covered in the case of a PDP sponsor of a prescription drug plan that uses a formulary, the use of prior authorization or other restrictions on access to coverage of such prescription drugs by such a sponsor, and the overall quality of a prescription drug plan as measured by quality ratings established by the Secretary
; and
(B)by striking Nothing in the previous sentence
and inserting Nothing in this subparagraph
.
(b)The amendments made by subsection (a) shall apply with respect to plan years beginning with plan year 2022.
503.Expanding eligibility for low-income subsidies under part D of the Medicare programSection 1860D–14(a) of the Social Security Act (42 U.S.C. 1395w–114(a)), as amended by section 301(d), is further amended—
(1)in the subsection heading, by striking individuals
and all that follows through line
and inserting certain individuals
;
(2)in paragraph (1)—
(A)by striking the paragraph heading and inserting Individuals with certain low incomes
; and
(B)in the matter preceding subparagraph (A), by inserting (or, with respect to a plan year beginning on or after January 1, 2024, 150 percent)
after 135 percent
; and
(3)in paragraph (2)—
(A)by striking the paragraph heading and inserting Other low-income individuals
; and
(B)in the matter preceding subparagraph (A), by striking In the case of a subsidy
and inserting With respect to a plan year beginning before January 1, 2024, in the case of a subsidy
.
504.Automatic eligibility of certain low-income territorial residents for premium and cost-sharing subsidies under the Medicare program; Sunset of enhanced allotment program
(a)Automatic eligibility of certain low-Income territorial residents for premium and cost-Sharing subsidies under the Medicare program
(1)Section 1860D–14(a)(3) of the Social Security Act (42 U.S.C. 1395w–114(a)(3)) is amended—
(A)in subparagraph (B)(v)—
(i)in subclause (I), by striking and
at the end;
(ii)in subclause (II), by striking the period and inserting ; and
; and
(iii)by inserting after subclause (II) the following new subclause:
(III)with respect to plan years beginning on or after January 1, 2024, shall provide that any part D eligible individual who is enrolled for medical assistance under the State Medicaid plan of a territory (as defined in section 1935(f)) under title XIX (or a waiver of such a plan) shall be treated as a subsidy eligible individual described in paragraph (1).; and
(B)in subparagraph (F), by adding at the end the following new sentence: The previous sentence shall not apply with respect to eligibility determinations for premium and cost-sharing subsidies under this section made on or after January 1, 2024.
.
(2)Section 1860D–31(j)(2)(D) of the Social Security Act (42 U.S.C. 1395w–141(j)(2)(D)) is amended by adding at the end the following new sentence: The previous sentence shall not apply with respect to amounts made available to a State under this paragraph on or after January 1, 2024.
.
(b)Sunset of enhanced allotment program
(1)Section 1935(e) of the Social Security Act (42 U.S.C. 1396u–5(e)) is amended—
(A)in paragraph (1)(A), by inserting after such State
the following: before January 1, 2021
; and
(B)in paragraph (3)—
(i)in subparagraph (A), in the matter preceding clause (i), by inserting after a year
the following: (before 2024)
; and
(ii)in subparagraph (B)(iii), by striking a subsequent year
and inserting each of fiscal years 2008 through 2023
.
(2)Section 1935 of the Social Security Act (42 U.S.C. 1396u–5) is amended by adding at the end the following new subsection:
(f)In this section, the term territory means Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa..
505.Automatic qualification of certain Medicaid beneficiaries for premium and cost-sharing subsidies under part D of the Medicare programClause (v) of section 1860D–14(a)(3)(B) of the Social Security Act (42 U.S.C. 1395w–114(a)(3)(B)), as amended by section 504, is further amended—
(1)in subclause (II), by striking and
at the end;
(2)in subclause (III), by striking the period and inserting ; and
; and
(3)by inserting after subclause (III) the following new subclause:
(IV)with respect to plan years beginning on or after January 1, 2024, shall, notwithstanding the preceding clauses of this subparagraph, provide that any part D eligible individual not described in subclause (I), (II), or (III) who is enrolled, as of the day before the date on which such individual attains the age of 65, for medical assistance under a State plan under title XIX (or a waiver of such plan) pursuant to clause (i)(VIII) or (ii)(XX) of section 1902(a)(10)(A), and who has income below 200 percent of the poverty line applicable to a family of the size involved, shall be treated as a subsidy eligible individual described in paragraph (1) for a limited period of time, as specified by the Secretary..
506.Providing for certain rules regarding the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost-sharing subsidies under part D of the Medicare programSection 1860D–14(a)(3)(C)(i) of the Social Security Act (42 U.S.C. 1395w–114(a)(3)(C)(i)) is amended, by striking except that support and maintenance furnished in kind shall not be counted as income; and
and inserting
except that—
(I)support and maintenance furnished in kind shall not be counted as income; and
(II)for plan years beginning on or after January 1, 2024, any distribution or withdrawal from an eligible retirement plan (as defined in subparagraph (B) of section 402(c)(8) of the Internal Revenue Code of 1986, but excluding any defined benefit plan described in clause (iv) or (v) of such subparagraph and any qualified trust (as defined in subparagraph (A) of such section) which is part of such a defined benefit plan) shall be counted as income; and.
507.Reducing cost-sharing and other program improvements for low-income beneficiaries
(a)Increase in income eligibility to 150 percent of FPL for qualified Medicare beneficiaries
(1)Section 1905(p)(2)(A) of the Social Security Act (42 U.S.C. 1396d(p)(2)(A)) is amended by striking shall be at least the percent provided under subparagraph (B) (but not more than 100 percent) of the official poverty line
and all that follows through the period at the end and inserting the following:
shall be—
(i)before January 1, 2024, at least the percent provided under subparagraph (B) (but not more than 100 percent) of the official poverty line (as defined by the Office of Management and Budget, and revised annually in accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981) applicable to a family of the size involved; and
(ii)on or after January 1, 2024, equal to 150 percent of the official poverty line (as so defined and revised) applicable to a family of the size involved..
(2)Not counting in-kind support and maintenance as incomeSection 1905(p)(2)(D) of the Social Security Act (42 U.S.C. 1396d(p)(2)(D)) is amended by adding at the end the following new clause:
(iii)In determining income under this subsection, support and maintenance furnished in kind shall not be counted as income..
(3)
(A)Section 1902(a)(10)(E) of the Social Security Act (42 U.S.C. 1396a(a)(10)(E)) is amended—
(i)in clause (iii), by striking for making medical
and inserting before January 1, 2024, for making medical
; and
(ii)in clause (iv), by striking subject to sections
and inserting before January 1, 2024, subject to sections
.
(B)Section 1933 of the Social Security Act (42 U.S.C. 1396u–3) is amended—
(i)in subsection (a), by striking A State plan
and inserting Subject to subsection (h), a State plan
; and
(ii)by adding at the end the following new subsection:
(h)The provisions of this section shall have no force or effect after December 31, 2023..
(b)Section 1905 of the Social Security Act (42 U.S.C. 1396d) is amended by adding at the end the following new subsection:
(gg)Increased FMAP for expanded medicare cost-Sharing populations
(1)Notwithstanding subsection (b), with respect to expenditures described in paragraph (2) the Federal medical assistance percentage shall be equal to 100 percent.
(2)The expenditures described in this paragraph are expenditures made on or after January 1, 2024, for medical assistance for medicare cost-sharing provided to any individual under clause (i) or (ii) of section 1902(a)(10)(E) who would not have been eligible for medicare cost-sharing under any such clause under the income or resource eligibility standards in effect on October 1, 2018..
<enum>VI</enum><header>Providing for Dental, Vision, and Hearing Coverage under the Medicare program</header>
<section id="H9237F46156924EE0B4AE8B90CB5C02CA"><enum>601.</enum><header>Dental and oral health care</header>
<subsection id="H1591961E973442AFBB68D0F735A5C26A"><enum>(a)</enum><header>Coverage</header><text>Section 1861(s)(2) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (42 U.S.C. 1395x(s)(2)) is amended—</text>
<paragraph id="HB2EC4BD90ED14FE4BD11353DEE2F2BEE"><enum>(1)</enum><text>in subparagraph (GG), by striking <quote>and</quote> after the semicolon at the end;</text></paragraph>
<paragraph id="H8A5E384FEE9C4AFCB8CF1FF0BE85D15C"><enum>(2)</enum><text>in subparagraph (HH), by striking the period at the end and adding <quote>; and</quote>; and</text></paragraph>
<paragraph id="H95A69FD8549A439FBF4E1515E14456D0"><enum>(3)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="H51C812EC4FD448E686937CB90E8DB846" style="OLC">
<subparagraph id="H3783F75ED49448D6A8A80B88460BB19D" indent="up1"><enum>(II)</enum><text>dental and oral health services (as defined in subsection (kkk));</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="HBE6D86E5306C42EC8D87840353DC4D1A"><enum>(b)</enum><header>Dental and oral health services defined</header><text>Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended by adding at the end the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="H19B83F5693A54B8EADD3605AEF019CB1" style="OLC">
<subsection id="H503C6415C6BD433F8E2CDF1722042525"><enum>(kkk)</enum><header>Dental and oral health services</header>
<paragraph id="H09AC1EFBCA04488E8E98B5D8FD3542FE"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The term <term>dental and oral health services</term> means items and services (other than such items and services for which payment may be made under part A as inpatient hospital services) that are furnished during 2025 or a subsequent year, for which coverage was not provided under part B as of the date of the enactment of this subsection, and that are—</text>
<subparagraph id="H34711ABB8D024D95A28C9EDFEC1B5EA5"><enum>(A)</enum><text>the preventive and screening services described in paragraph (2) furnished by a doctor of dental surgery or of dental medicine (as described in subsection (r)(2)) or an oral health professional (as defined in paragraph (4)); or</text></subparagraph>
<subparagraph id="H6490DAADC4D74E54BA14E4AF3BE38F5E"><enum>(B)</enum><text>the basic treatments specified for such year by the Secretary pursuant to paragraph (3)(A) and the major treatments specified for such year by the Secretary pursuant to paragraph (3)(B) furnished by such a doctor or such a professional.</text></subparagraph></paragraph>
<paragraph id="H1C6D54D07581493DB10036FFFBE9B000"><enum>(2)</enum><header>Preventive and screening services</header><text>The preventive and screening services described in this paragraph are the following:</text>
<subparagraph id="HDEB8EA1F25B04756B628383AFADC870E"><enum>(A)</enum><text>Oral exams.</text></subparagraph>
<subparagraph id="HAF19DAF8025B4080B379CBFFD1F6FBEB"><enum>(B)</enum><text>Dental cleanings.</text></subparagraph>
<subparagraph id="HB65D905FB40448FFB68E3A7957CF07AA"><enum>(C)</enum><text>Dental x-rays performed in the office of a doctor or professional described in paragraph (1)(A).</text></subparagraph>
<subparagraph id="H499AB8A3E92D46AF9E7D1072A7292E6B"><enum>(D)</enum><text>Fluoride treatments.</text></subparagraph></paragraph>
<paragraph id="H634CB61A8F3C4C2A8C150B0FF4656110"><enum>(3)</enum><header>Basic and major treatments</header><text>For 2025 and each subsequent year, the Secretary shall specify—</text>
<subparagraph id="H51796289B02144C3B9713F2F31435B50"><enum>(A)</enum><text>basic treatments (which may include basic tooth restorations, basic periodontic services, tooth extractions, and oral disease management services); and</text></subparagraph>
<subparagraph id="HA9197B15194F46FBB9C1CB28990F59E8"><enum>(B)</enum><text>major treatments (which may include major tooth restorations, major periodontic services, bridges, crowns, and root canals);</text></subparagraph><continuation-text continuation-text-level="paragraph">that shall be included as dental and oral health services for such year.</continuation-text></paragraph>
<paragraph id="H202C7B89B0C044D79BDA6BDFE3E46392"><enum>(4)</enum><header>Oral health professional</header><text>The term <term>oral health professional</term> means, with respect to dental and oral health services, a health professional who is licensed to furnish such services, acting within the scope of such license, by the State in which such services are furnished.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="H6F97C92D24DD45BB9FD791A31809E11B"><enum>(c)</enum><header>Payment; coinsurance; and limitations</header>
<paragraph id="H7AB3A8332E1F463C88C477CBE318763D"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended—</text>
<subparagraph id="HFDFBFEDC8DCB4DEDA07D019D0E24AE04"><enum>(A)</enum><text>in subparagraph (N), by inserting <quote>and dental and oral health services (as defined in section 1861(kkk))</quote> after <quote>section 1861(hhh)(1))</quote>; </text> </subparagraph>
<subparagraph id="H40348AA173A5470DB634BD3FD74FC30B"><enum>(B)</enum><text>by striking <quote>and</quote> before <quote>(CC)</quote>; and</text></subparagraph>
<subparagraph id="H4A80FC41807C4D7884FC988A11B5C048"><enum>(C)</enum><text>by inserting before the semicolon at the end the following: <quote>, and (DD) with respect to dental and oral health services (as defined in section 1861(kkk)), the amount paid shall be the payment amount specified under section 1834(x)</quote>.</text></subparagraph></paragraph>
<paragraph id="H3F4DF1101A0844CBB04FC2998A7DE624"><enum>(2)</enum><header>Payment and limits specified</header><text>Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="H15B26CDFEC8340478FC67CFE2CA87B93" style="OLC">
<subsection id="H008FCA8A35AC4FB6A5978ACA1C49A421"><enum>(x)</enum><header>Payment and limits for dental and oral health services</header>
<paragraph id="HB2A344BD0A284574BBDF5CD17CBE6A6D"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The payment amount under this part for dental and oral health services (as defined in section 1861(kkk)) shall be, subject to paragraph (3), the applicable percent (specified in paragraph (2)) of the lesser of the actual charge for the services or the amount determined under the payment basis determined under section 1848. In determining such amounts determined under such payment basis, the Secretary shall consider payment rates paid to dentists for comparable services under State plans under title XIX, under the TRICARE program under chapter 55 of title 10 of the United States Code, and by other health care payers, such as Medicare Advantage plans under part C.</text></paragraph>
<paragraph id="HD783A123A0454B84A3C491E1F2B4E3F3"><enum>(2)</enum><header>Applicable percent</header><text display-inline="yes-display-inline">For purposes of paragraph (1), the applicable percent specified in this paragraph is, with respect to dental and oral health services (as defined in section 1861(kkk)) furnished in a year—</text>
<subparagraph id="HFA88DA9E8B0B4AA49040C331AB5959C4"><enum>(A)</enum><text>that are preventive and screening services described in paragraph (2) or basic treatments specified for such year pursuant to paragraph (3)(A) of such section, 80 percent; and</text></subparagraph>
<subparagraph id="H1FCBB54FEC834522A507DD5DEF43E556"><enum>(B)</enum><text>that are major treatments specified for such year pursuant to paragraph (3)(B) of such section—</text>
<clause id="HF6418516D1E8427F9355071B924D42B9"><enum>(i)</enum><text>in the case such services are furnished during 2025, 10 percent;</text></clause>
<clause id="H599BFC46D0A842D69C50FCF0573B7E9A"><enum>(ii)</enum><text display-inline="yes-display-inline">in the case such services are furnished during 2026 or a subsequent year before 2029, the applicable percent specified under this subparagraph for the previous year, increased by 10 percentage points; and</text></clause>
<clause id="H043766B6D04B40E08C8D04E79CA64CA9"><enum>(iii)</enum><text display-inline="yes-display-inline">in the case such services are furnished during 2029 or a subsequent year, 50 percent.</text></clause></subparagraph></paragraph>
<paragraph id="HBED1211CA55548B4A2F0E6BDED70597E"><enum>(3)</enum><header>Limitations</header><text>With respect to dental and oral health services that are—</text>
<subparagraph id="HD16ED5931D3A4DA59FD64887B2CAB9F4"><enum>(A)</enum><text display-inline="yes-display-inline">preventive and screening oral exams, payment may be made under this part for not more than two such exams during a 12-month period;</text></subparagraph>
<subparagraph id="H35D46EC613644D74A536A446F756C558"><enum>(B)</enum><text>dental cleanings, payment may be made under this part for not more than two such cleanings during a 12-month period; and</text></subparagraph>
<subparagraph id="H6DE7FCDA04AC4E979E5322668025826A"><enum>(C)</enum><text>not described in subparagraph (A) or (B), payment may be made under this part only at such frequencies and under such circumstances determined appropriate by the Secretary.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="HF78906CF6F85465FA7792E05EF677FAF"><enum>(d)</enum><header>Payment under physician fee schedule</header>
<paragraph id="H20BAC2757AD943F7888EF1D8D3625B05"><enum>(1)</enum><header>In general</header><text>Section 1848(j)(3) of the Social Security Act (42 U.S.C. 1395w–4(j)(3)) is amended by inserting <quote>(2)(II),</quote> before <quote>(3)</quote>.</text></paragraph>
<paragraph id="H4E7EF8FA60494BACAFA49255D6A22FFD"><enum>(2)</enum><header>Exclusion from MIPS</header><text display-inline="yes-display-inline">Section 1848(q)(1)(C)(ii) of the Social Security Act (42 U.S.C. 1395w–4(q)(1)(C)(ii)) is amended—</text>
<subparagraph id="HC7D89E76A2E64C62B1C4F5E5B5532FFA"><enum>(A)</enum><text>in subclause (II), by striking <quote>or</quote> at the end;</text></subparagraph>
<subparagraph id="H4613E0039239427E89F2EF8378200F6F"><enum>(B)</enum><text>in subclause (III), by striking the period at the end and inserting <quote>; or</quote>; and</text></subparagraph>
<subparagraph id="HDCBC2BA0DA9849019F27196E90C9494A"><enum>(C)</enum><text>by adding at the end the following new subclause:</text>
<quoted-block display-inline="no-display-inline" id="HB85BDD8380C14688A0372781389A316C" style="OLC">
<subclause id="HAFC0FBA62F1E481CB60B321F35AAD86F"><enum>(IV)</enum><text display-inline="yes-display-inline">with respect to 2025 and each subsequent year, is a doctor of dental surgery or of dental medicine (as described in section 1861(r)(2)) or is an oral health professional (as defined in section 1861(kkk)(4)).</text></subclause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="HA1D14A6BC1C24CF29F6149922B7DE88A"><enum>(3)</enum><header>Inclusion of oral health professionals as certain practitioners</header><text display-inline="yes-display-inline">Section 1842(b)(18)(C) of the Social Security Act (42 U.S.C. 1395u(b)(18)(C)) is amended by adding at the end the following new clause:</text>
<quoted-block display-inline="no-display-inline" id="HB3E10CE7AFAE42FA88C42CD2D280F998" style="OLC">
<clause id="HC957B29F7C7E4B378372EC3D7594C198" indent="up2"><enum>(vii)</enum><text display-inline="yes-display-inline">With respect to 2025 and each subsequent year, an oral health professional (as defined in section 1861(kkk)(4)).</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection commented="no" display-inline="no-display-inline" id="H670301F0C19E4FF986C9A562E4305E21"><enum>(e)</enum><header>Dentures</header>
<paragraph id="H218E8D38EBCE4976B099CC557CF82BA3"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1861(s)(8) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (42 U.S.C. 1395x(s)(8)) is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H581D1155B7C94D719B171CBB1CF4D570"><enum>(A)</enum><text>by striking <quote>(other than dental)</quote>; and</text></subparagraph>
<subparagraph id="H92B1E68614C249AEBCB2A2E628D448FC"><enum>(B)</enum><text>by inserting <quote>and excluding dental, except for a full or partial set of dentures furnished on or after January 1, 2025</quote> after <quote>colostomy care</quote>.</text></subparagraph></paragraph>
<paragraph commented="no" display-inline="no-display-inline" id="H7BDF212B243647378B233C65903F5FFA"><enum>(2)</enum><header>Special payment rules</header>
<subparagraph id="HCFB9990868BB4A4D910DFF8F99C5A75A"><enum>(A)</enum><header>Limitations</header><text>Section 1834(h) of the Social Security Act (42 U.S.C. 1395m(h)) is amended by adding at the end the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="H683EF92B95F04AACA4CFAF444C5D7D7A" style="OLC">
<paragraph id="H2BE28C9F123D45559427DAF01C445A99"><enum>(6)</enum><header>Special payment rule for dentures</header><text display-inline="yes-display-inline">Payment may be made under this part with respect to an individual for dentures—</text>
<subparagraph id="H2DEE72888DC94580BE8875B95EAB7079"><enum>(A)</enum><text>not more than once during any 5-year period (except in the case that a doctor or professional described in section 1861(kkk)(1)(A) determines such dentures do not fit the individual); and</text></subparagraph>
<subparagraph id="H62A7FB0EE9DD429282C159AB66F1366F"><enum>(B)</enum><text display-inline="yes-display-inline">only to the extent that such dentures are furnished pursuant to a written order of such a doctor or professional.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph>
<subparagraph id="HB5414FF03B2740B0BACA31BD71CCF59B"><enum>(B)</enum><header>Application of competitive acquisition</header>
<clause id="HEB46BF43D9BB4204B61377C4954E8E33"><enum>(i)</enum><header>In general</header><text>Section 1834(h)(1)(H) of the Social Security Act (42 U.S.C. 1395m(h)(1)(H)) is amended—</text>
<subclause id="H7A1B61F188F84C31B58246CB6A486CBE"><enum>(I)</enum><text>in the subparagraph heading, by inserting <quote><header-in-text level="subparagraph" style="OLC">, dentures</header-in-text></quote> after <quote><header-in-text level="subparagraph" style="OLC">orthotics</header-in-text></quote>;</text></subclause>
<subclause id="H860A75FA66D341528779F746D828A01D"><enum>(II)</enum><text>by inserting <quote>, of dentures described in paragraph (2)(D) of such section,</quote> after <quote>2011,</quote>; and</text></subclause>
<subclause id="HFFA233DF519E4DBFA596D2C8654CC118"><enum>(III)</enum><text>in clause (i), by inserting <quote>, such dentures</quote> after <quote>orthotics</quote>.</text></subclause></clause>
<clause id="HA7374202D56D41518D79F44C86B72051"><enum>(ii)</enum><header>Conforming amendment</header><text>Section 1847(a)(2) of the Social Security Act (42 U.S.C. 1395w–3(a)(2)) is amended by adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="H823952EEB8DC4956BED45940505DF375" style="OLC">
<subparagraph id="H391CE317B4914A40BA9354357815E6F0"><enum>(D)</enum><header>Dentures</header><text display-inline="yes-display-inline">Dentures described in section 1861(s)(8) for which payment would otherwise be made under section 1834(h).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause>
<clause id="H906CB3AC3137469B8941F4AAED0DD91A"><enum>(iii)</enum><header>Exemption of certain items from competitive acquisition</header><text>Section 1847(a)(7) of the Social Security Act (42 U.S.C. 1395w–3(a)(7)) is amended by adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="H691B12DF73414596BC377F6627561B6B" style="OLC">
<subparagraph id="H383377F30A794B128C3D7DD7E3BDA892"><enum>(C)</enum><header>Certain dentures</header><text display-inline="yes-display-inline">Those items and services described in paragraph (2)(D) if furnished by a physician or other practitioner (as defined by the Secretary) to the physician’s or practitioner’s own patients as part of the physician’s or practitioner’s professional service.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph></subsection>
<subsection id="HBD86D45256DE4089983B938EFF9B81DB"><enum>(f)</enum><header>Exclusion modifications</header><text>Section 1862(a) of the Social Security Act (42 U.S.C. 1395y(a)) is amended—</text>
<paragraph id="H9D8ECEB6FF764B459D4AFD8BC988A0AA"><enum>(1)</enum><text>in paragraph (1)—</text>
<subparagraph id="HB66600A9C3C94C8F99973BBD6F1F5C67"><enum>(A)</enum><text>in subparagraph (O), by striking <quote>and</quote> at the end;</text></subparagraph>
<subparagraph id="H008F9FA7BB7B4D43AD5FB66D1B3C6BC5"><enum>(B)</enum><text>in subparagraph (P), by striking the semicolon at the end and inserting <quote>, and</quote>; and</text></subparagraph>
<subparagraph id="H30C25F5EE12B4B449674AC397A6F5871"><enum>(C)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="H3DB9DF3816014733955D640B1432B62A" style="OLC">
<subparagraph id="HD42BA62221824B75940FAA45DCB812F7" indent="up1"><enum>(Q)</enum><text display-inline="yes-display-inline">in the case of dental and oral health services (as defined in section 1861(kkk)) that are preventive and screening services described in paragraph (2) of such section, which are furnished more frequently than provided under section 1834(x)(3) and under circumstances other than circumstances determined appropriate under such section;</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H3D5E96F662A840789BFFF82D0127E40B"><enum>(2)</enum><text>in paragraph (12), by inserting before the semicolon at the end the following: <quote>and except that payment may be made under part B for dental and oral health services that are covered under section 1861(s)(2)(II)</quote>.</text></paragraph></subsection>
<subsection id="H78DC15BB85F84D848F827BA2074F625B"><enum>(g)</enum><header>Certain non-application</header>
<paragraph id="H78C88A2B62F44413AB42F480752796D9"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Paragraphs (1) and (4) of section 1839(a) of the Social Security Act (42 U.S.C. 1395r(a)) are amended by adding at the end of each such paragraphs the following: <quote>In applying this paragraph there shall not be taken into account benefits and administrative costs attributable to the amendments made by section 601 (other than subsection (g)) of the Elijah E. Cummings Lower Drug Costs Now Act and the Government contribution under section 1844(a)(4)</quote>. </text></paragraph>
<paragraph id="HE7F43FB5801A4DD09EAA382033DBDB15"><enum>(2)</enum><header>Payment</header><text>Section 1844(a) of such Act (42 U.S.C. 1395w(a)) is amended—</text>
<subparagraph id="H2BD4710B57DF47DFB1BF30C4D2F85ED7"><enum>(A)</enum><text>in paragraph (3), by striking the period at the end and inserting <quote>; plus</quote>; and</text></subparagraph>
<subparagraph id="H8050A560085F4BE1A68F9EAC09F554BF"><enum>(B)</enum><text>by adding at the end the following new paragraph: </text>
<quoted-block style="OLC" id="HB7D50AD0B41C426A87AF512D0DE148F4" display-inline="no-display-inline">
<paragraph id="H35E6D8D7F0AF4D9282F931C67EC58FE8"><enum>(4)</enum><text display-inline="yes-display-inline">a Government contribution equal to the amount that is estimated to be payable for benefits and related administrative costs incurred that are attributable to the amendments made by section 601 (other than subsection (g)) of the Elijah E. Cummings Lower Drug Costs Now Act.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection>
<subsection id="H6D6DB7E7AB314BC5BB6D65B6DB06D5FF" display-inline="no-display-inline"><enum>(h)</enum><header>Implementation funding</header>
<paragraph id="H06E209184DF341D5A94056968693A6EE"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services (in this subsection referred to as the <quote>Secretary</quote>) shall provide for the transfer from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act (42 U.S.C. 1395t) to the Centers for Medicare & Medicaid Services Program Management Account of—</text>
<subparagraph id="H8588A21F2CEE4B0A81CE78C16B2708E8"><enum>(A)</enum><text>$20,000,000 for each of fiscal years 2020 through 2025 for purposes of implementing the amendments made by this section; and</text></subparagraph>
<subparagraph id="HA741784C005446AEA09954F701B5408F"><enum>(B)</enum><text>such sums as determined appropriate by the Secretary for each subsequent fiscal year for purposes of administering the provisions of such amendments.</text></subparagraph></paragraph>
<paragraph id="H644C10CB188547CEAB21A5E4859BCD74"><enum>(2)</enum><header>Availability and additional use of funds</header><text>Funds transferred pursuant to paragraph (1) shall remain available until expended and may be used, in addition to the purpose specified in paragraph (1)(A), to implement the amendments made by sections 602 and 603.</text></paragraph></subsection> </section>
<section id="H12F05E2571F443BC9EBDDC3A142DAF5F" display-inline="no-display-inline" section-type="subsequent-section"><enum>602.</enum><header>Providing coverage for hearing care under the Medicare program</header>
<subsection id="H070FB02D340A4441BD0B6F74D11BB065"><enum>(a)</enum><header>Provision of aural rehabilitation and treatment services by qualified audiologists</header><text display-inline="yes-display-inline">Section 1861(ll)(3) of the Social Security Act (42 U.S.C. 1395x(ll)(3)) is amended by inserting <quote>(and, beginning January 1, 2024, such aural rehabilitation and treatment services)</quote> after <quote>assessment services</quote>. </text></subsection>
<subsection commented="no" display-inline="no-display-inline" id="H2125484A919B4B9C93CE22DFD45336AC"><enum>(b)</enum><header>Coverage of hearing aids</header>
<paragraph id="H7A2A06D3371A4C2D8D47B6902ACC6854"><enum>(1)</enum><header>Inclusion of hearing aids as prosthetic devices</header><text>Section 1861(s)(8) of the Social Security Act (42 U.S.C. 1395x(s)(8)) is amended by inserting <quote>, and including hearing aids furnished on or after January 1, 2024, to individuals diagnosed with profound or severe hearing loss</quote> before the semicolon at the end.</text></paragraph>
<paragraph id="H2D36E85C035C47258D6A3D14C21F590E"><enum>(2)</enum><header>Payment limitations for hearing aids</header><text>Section 1834(h) of the Social Security Act (42 U.S.C. 1395m(h)), as amended by section 601(e)(2)(A), is further amended by adding at the end the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="H9153F4CE144E4671B330529CEB4A0F02" style="OLC">
<paragraph id="H6E8FA0637421470E925E91DCC48297AC"><enum>(7)</enum><header>Limitations for hearing aids</header><text display-inline="yes-display-inline">Payment may be made under this part with respect to an individual, with respect to hearing aids furnished on or after January 1, 2024—</text>
<subparagraph id="H37A356F7201C423485C2F94881111F0D"><enum>(A)</enum><text>not more than once during a 5-year period;</text></subparagraph>
<subparagraph id="H3BD37134661342B1B6EF79594EE1045F"><enum>(B)</enum><text>only for types of such hearing aids that are not over-the-counter hearing aids (as defined in section 520(q)(1) of the Federal Food, Drug, and Cosmetic Act) and that are determined appropriate by the Secretary; and</text></subparagraph>
<subparagraph id="H9EC5615CA925432FB3A90148A417B27B"><enum>(C)</enum><text display-inline="yes-display-inline">only if furnished pursuant to a written order of a physician or qualified audiologist (as defined in section 1861(ll)(4)(B)).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H82CC1D59A93644F78FBED5417D0F2CF3" display-inline="no-display-inline"><enum>(3)</enum><header>Application of competitive acquisition</header>
<subparagraph id="HC3701017B94E42E1A71BA079FE7B34C8"><enum>(A)</enum><header>In general</header><text>Section 1834(h)(1)(H) of the Social Security Act (42 U.S.C. 1395m(h)(1)(H)), as amended by section 601(e)(2)(B)(i), is further amended—</text>
<clause id="HC062A47E25184B2186022A7F422E82DD"><enum>(i)</enum><text>in the header, by inserting <quote><header-in-text level="subparagraph" style="OLC">, hearing aids</header-in-text></quote> after <quote><header-in-text level="subparagraph" style="OLC">dentures</header-in-text></quote>;</text></clause>
<clause id="H29D4736ADD574C91AF9EDFDA696BAF1B"><enum>(ii)</enum><text>by inserting <quote>, of hearing aids described in paragraph (2)(E) of such section,</quote> after <quote>paragraph (2)(D) of such section</quote>; and</text></clause>
<clause id="HC212EC68B9BA4FCB91B71562BE191E81"><enum>(iii)</enum><text>in clause (i), by inserting <quote>, such hearing aids</quote> after <quote>such dentures</quote>.</text></clause></subparagraph>
<subparagraph id="H56D99E84B6D740B5B09754841584FA8D"><enum>(B)</enum><header>Conforming amendment</header>
<clause id="H19624CE73FDF4C209DE3207DE76C4622"><enum>(i)</enum><header>In general</header><text>Section 1847(a)(2) of the Social Security Act (42 U.S.C. 1395w–3(a)(2)), as amended by section 601(e)(2)(B)(ii), is further amended by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H256BA0FDB0EC4B4A94DDE338DB6A8679">
<subparagraph id="HE5C125DA831F4DBFA973711535406596"><enum>(E)</enum><header>Hearing aids</header><text display-inline="yes-display-inline">Hearing aids described in section 1861(s)(8) for which payment would otherwise be made under section 1834(h).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause>
<clause id="H33CC5262D4104B6A8A7FDB2593A0EE73"><enum>(ii)</enum><header>Exemption of certain items from competitive acquisition</header><text>Section 1847(a)(7) of the Social Security Act (42 U.S.C. 1395w–3(a)(7)), as amended by section 601(e)(2)(B)(iii), is further amended by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H978D2AECE5EC4B72B408B29B8373B55F">
<subparagraph id="HC36539ACBD8E40F69E93035F1ACD1EB4"><enum>(D)</enum><header>Certain hearing aids</header><text display-inline="yes-display-inline">Those items and services described in paragraph (2)(E) if furnished by a physician or other practitioner (as defined by the Secretary) to the physician’s or practitioner’s own patients as part of the physician’s or practitioner’s professional service.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph>
<paragraph id="H8F026470D468477FAFDE85791CD51DD5"><enum>(4)</enum><header>Inclusion of audiologists as certain practitioners to receive payment on an assignment-related basis</header><text display-inline="yes-display-inline">Section 1842(b)(18)(C) of the Social Security Act (42 U.S.C. 1395u(b)(18)(C)), as amended by section 601(d)(4), is further amended by adding at the end the following new clause:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H77D8BAF81D3046A58C82C018BEA74439">
<clause id="H4118D8BD34A74D2FA957B71A8F0AE42C"><enum>(viii)</enum><text display-inline="yes-display-inline">With respect to 2024 and each subsequent year, a qualified audiologist (as defined in section 1861(ll)(4)(B)).</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="HE4FE647B38714F14999811A53392C71E"><enum>(c)</enum><header>Exclusion modification</header><text>Section 1862(a)(7) of the Social Security Act (42 U.S.C. 1395y(a)(7)) is amended by inserting <quote>(except such hearing aids or examinations therefor as described in and otherwise allowed under section 1861(s)(8))</quote> after <quote>hearing aids or examinations therefor</quote>.</text></subsection>
<subsection id="HB457FD6726B04C37BAD28021D02C9753"><enum>(d)</enum><header>Certain non-application</header>
<paragraph id="HDD497AC1FFA446CB8484EB25CF3795A8"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The last sentence of section 1839(a)(1) of the Social Security Act (42 U.S.C. 1395r(a)(1)), as added by section 601(g)(1), is amended by striking <quote>section 601 (other than subsection (g))</quote> and inserting <quote>sections 601 (other than subsection (g)), 602 (other than subsection (d))</quote>.</text></paragraph>
<paragraph id="H03E0598074014938ABC575AE45B10C3E"><enum>(2)</enum><header>Payment</header><text display-inline="yes-display-inline">Paragraph (4) of section 1844(a) of such Act (42 U.S.C. 1395w(a)), as added by section 601(g)(2), is amended by striking <quote>section 601 (other than subsection (g))</quote> and inserting <quote>sections 601 (other than subsection (g)), 602 (other than subsection (d))</quote>.</text></paragraph></subsection>
<subsection id="H8D9C92E2BB6247FD865F44FA5E931F5E"><enum>(e)</enum><header>Report; regulations</header>
<paragraph id="H5CEB6157F45943C6990819CEBF30E0BA"><enum>(1)</enum><header>Report</header><text display-inline="yes-display-inline">Not later than the date that is 3 years after the date of the enactment of this Act, the Inspector General of the Department of Health and Human Services shall conduct a study to assess (and submit to the Secretary of Health and Human Services a report on) any program integrity or overutilization risks with respect to allowing qualified audiologists (as defined in paragraph (4)(B) of 1861(ll) of the Social Security Act (42 U.S.C. 1395x(ll))) to furnish audiology services (as defined in paragraph (3) of such section) to individuals entitled to benefits under part A of title XVIII of such Act (42 U.S.C. 1395c et seq.) and enrolled for benefits under part B of such title (42 U.S.C.1395j et seq.) without such individuals being referred by a physician (as defined in section 1861(r) of such Act (42 U.S.C. 1395x(r))) or practitioner (as described in section 602.32 of title 42, Code of Federal Regulations) to such qualified audiologists. In conducting such study, the Inspector General may take into account experiences with audiologists furnishing audiology services to enrollees in other Federal programs, including in a health benefit plan under chapter 89 of title 5, United States Code or in health care benefits under the TRICARE program under chapter 55 of title 10 of the United States Code or under chapter 17 of title 38 of such Code.</text> </paragraph>
<paragraph id="H2F6B699524FB4669BE5DBDBA33D74B62"><enum>(2)</enum><header>Regulations</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services may promulgate regulations to allow qualified audiologists (as so defined) to furnish audiology services (as so defined) without a referral from a physician or practitioner, consistent with the findings submitted to the Secretary pursuant to paragraph (1)(B).</text></paragraph></subsection>
<subsection id="HE0CAD81E7DE1444E9A16F919FCFFB8B0" display-inline="no-display-inline"><enum>(f)</enum><header>Implementation funding</header>
<paragraph id="HA9DDF48134EF496887A7B2AEA3CF6DFC"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services (in this subsection referred to as the <quote>Secretary</quote>) shall provide for the transfer from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act (42 U.S.C. 1395t) to the Centers for Medicare & Medicaid Services Program Management Account of—</text>
<subparagraph id="H0F4BF5DCC11A4DB0B880547F17247315"><enum>(A)</enum><text>$20,000,000 for each of fiscal years 2020 through 2024 for purposes of implementing the amendments made by this section; and</text></subparagraph>
<subparagraph id="H986AA667876C40BF86829C0595C5D1D8"><enum>(B)</enum><text>such sums as determined appropriate by the Secretary for each subsequent fiscal year for purposes of administering the provisions of such amendments.</text></subparagraph></paragraph>
<paragraph id="H4C86A626202B4CF3A112F9A3B71E1BE8"><enum>(2)</enum><header>Availability and additional use of funds</header><text>Funds transferred pursuant to paragraph (1) shall remain available until expended and may be used, in addition to the purpose specified in paragraph (1)(A), to implement the amendments made by sections 601 and 603.</text></paragraph></subsection> </section>
<section id="H5C6ACAFB91BA4A1495AE4116E89CC844"><enum>603.</enum><header>Providing coverage for vision care under the Medicare program</header>
<subsection id="H0EDE5EEAB8A34E8FB94CAF489F9CA32B"><enum>(a)</enum><header>Coverage</header><text>Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)), as amended by section 601(a), is further amended—</text>
<paragraph id="H4124A47F7DBF464B818FCF248CEB1522"><enum>(1)</enum><text>in subparagraph (HH), by striking <quote>and</quote> after the semicolon at the end;</text></paragraph>
<paragraph id="H059BF76B749D45A486875C5E7897829C"><enum>(2)</enum><text>in subparagraph (II), by striking the period at the end and adding <quote>; and</quote>; and</text></paragraph>
<paragraph id="H831C8C28A988444EAF269A4714BBAF07"><enum>(3)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="H694C5ECC61D8425F8279E7795744359C" style="OLC">
<subparagraph id="HA9C94585562C44AB89CFD6CE579CA670" indent="up1"><enum>(JJ)</enum><text display-inline="yes-display-inline">vision services (as defined in subsection (lll));</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="HF7BF60C41F6748BA9F4A64B2AFF65428"><enum>(b)</enum><header>Vision services defined</header><text>Section 1861 of the Social Security Act (42 U.S.C. 1395x), as amended by section 601(b), is further amended by adding at the end the following new subsection:</text>
<quoted-block style="OLC" id="H83CBD9A92A664B2191AD2C74D9551608" display-inline="no-display-inline">
<subsection id="H19EDCAC7EBD644C69A9F4D30BE3314A1"><enum>(lll)</enum><header>Vision services</header><text display-inline="yes-display-inline">The term <term>vision services</term> means—</text>
<paragraph id="H56558F7EDE93468E81DB1097F07BD61A"><enum>(1)</enum><text display-inline="yes-display-inline">routine eye examinations to determine the refractive state of the eyes, including procedures performed during the course of such examination; and</text></paragraph>
<paragraph id="H340A393B7A904F8882E8B82B9D632691" commented="no"><enum>(2)</enum><text>contact lens fitting services;</text></paragraph><continuation-text continuation-text-level="subsection">furnished on or after January 1, 2024, by or under the direct supervision of an optometrist or ophthalmologist who is legally authorized to furnish such examinations, procedures, or fitting services (as applicable) under State law (or the State regulatory mechanism provided by State law) of the State in which the examinations, procedures, or fitting services are furnished.</continuation-text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HE9725B70D12B4A3E9291EA64BD7A2062" commented="no"><enum>(c)</enum><header>Payment limitations</header><text>Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by section 601(c)(2), is further amended by adding at the end the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="HB97F55696A0549CC9A2AF731DF8BA246" style="OLC">
<subsection id="H24D1E9ABF20B4D0588B7AE95B97E7293" commented="no"><enum>(y)</enum><header>Limitation for vision services</header><text display-inline="yes-display-inline">With respect to vision services (as defined in section 1861(lll)) and an individual, payment may be made under this part for only 1 routine eye examination described in paragraph (1) of such section and 1 contact lens fitting service described in paragraph (2) of such section during a 2-year period.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection display-inline="no-display-inline" id="HEE071C951DB541F7B2D363EED9EF5FC6"><enum>(d)</enum><header>Payment under physician fee schedule</header><text display-inline="yes-display-inline">Section 1848(j)(3) of the Social Security Act (42 U.S.C. 1395w–4(j)(3)), as amended by section 601(d)(1), is further amended by inserting <quote>(2)(JJ),</quote> before <quote>(3)</quote>.</text> </subsection>
<subsection id="H01471EA99D8242BD917C9E18626F2777"><enum>(e)</enum><header>Coverage of conventional eyeglasses and contact lenses</header><text>Section 1861(s)(8) of the Social Security Act (42 U.S.C. 1395x(s)(8)), as amended by section 602(b)(1), is further amended by striking <quote>, and including one pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens</quote> and inserting <quote>, including one pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens, if furnished before January 1, 2024, including conventional eyeglasses or contact lenses, whether or not furnished subsequent to such a surgery, if furnished on or after January 1, 2024</quote>. </text></subsection>
<subsection commented="no" display-inline="no-display-inline" id="HA5FB6D2E8E1541DFB711A69AAEBE1F0A"><enum>(f)</enum><header>Special payment rules for eyeglasses and contact lenses</header>
<paragraph id="HC7671C2609904A7782B789617BE4FBF3"><enum>(1)</enum><header>Limitations</header><text display-inline="yes-display-inline">Section 1834(h) of the Social Security Act (42 U.S.C. 1395m(h)), as amended by section 601(e)(2)(A) and section 602(b)(2), is further amended by adding at the end the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="H88C8A14982574FECA167A564A560A63F" style="OLC">
<paragraph id="H0A4DB45984E84F6BA0D14ED65F04FF34"><enum>(8)</enum><header>Payment limitations for eyeglasses and contact lenses</header>
<subparagraph id="H887673F8B3234CC79E79BBA4D2ADC833"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">With respect to eyeglasses and contact lenses furnished to an individual on or after January 1, 2024, subject to subparagraph (B), payment may be made under this part only—</text>
<clause id="HCBF1B4BA914B461C83E2B66F338D9D52"><enum>(i)</enum><text display-inline="yes-display-inline">during a 2-year period, for either 1 pair of eyeglasses (including lenses and frames) or not more than a 2-year supply of contact lenses that is provided in not more than 180-day increments;</text></clause>
<clause id="HFE6C1E24473D4ECCB4B4591CC43FDD78"><enum>(ii)</enum><text display-inline="yes-display-inline">with respect to amounts attributable to the lenses and frames of such a pair of eyeglasses or amounts attributable to such a 2-year supply of contact lenses, in an amount not greater than—</text>
<subclause id="HBF18B69E4D1C44B0A04F415D2BB3EF63"><enum>(I)</enum><text display-inline="yes-display-inline">for a pair of eyeglasses furnished in, or a 2-year supply of contact lenses beginning in, 2024—</text>
<item id="H1D34CE955FD7470FBFE44F9B73D1479D"><enum>(aa)</enum><text>$85 for the lenses of such pair of eyeglasses and $85 for the frames of such pair of eyeglasses; or</text></item>
<item id="H17DBCE7781634DC6A39451E1EFF81F5D"><enum>(bb)</enum><text>$85 for such 2-year supply of contact lenses; and</text></item></subclause>
<subclause id="HB67452CFB50D48649CFFFC0F9749F09D"><enum>(II)</enum><text display-inline="yes-display-inline">for the lenses and frames of a pair of eyeglasses furnished in, or a 2-year supply of contact lenses beginning in, a subsequent year, the dollar amounts specified under this subparagraph for the previous year, increased by the percentage change in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year;</text></subclause></clause>
<clause id="H143B3BC556DA4DD7ABEFE51966310C31"><enum>(iii)</enum><text display-inline="yes-display-inline">for types of eyeglass lenses, and for types of contact lenses, as determined appropriate by the Secretary;</text></clause>
<clause id="H3BA08697788D46DCADD5F0592C6CD0D3"><enum>(iv)</enum><text display-inline="yes-display-inline">if furnished pursuant to a written order of a physician described in section 1861(lll); and</text></clause>
<clause id="H89FF4296984544D5ABD3507D57D7BB1D"><enum>(v)</enum><text display-inline="yes-display-inline">if during the 2-year period described in clause (i), the individual did not already receive (as described in subparagraph (B)) one pair of conventional eyeglasses or contact lenses subsequent to a cataract surgery with insertion of an intraocular lens furnished during such period.</text></clause></subparagraph>
<subparagraph id="HEB226617420244DF9CE5199C75DBFBEF"><enum>(B)</enum><header>Exception</header><text display-inline="yes-display-inline">With respect to a 2-year period described in subparagraph (A)(i), in the case of an individual who receives cataract surgery with insertion of an intraocular lens, notwithstanding subparagraph (A), payment may be made under this part for one pair of conventional eyeglasses or contact lenses furnished subsequent to such cataract surgery during such period.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H0516600C31E94714B56EE9BAA94E60E1"><enum>(2)</enum><header>Application of competitive acquisition</header>
<subparagraph id="HB0E30CA152F04C03B4505B3CBC69640C"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1834(h)(1)(H) of the Social Security Act (42 U.S.C. 1395m(h)(1)(H)), as amended by section 601(e)(2)(B)(i) and section 602(b)(3)(A), is further amended—</text>
<clause id="H6EC481F622E7443F9EE2933E38B14210"><enum>(i)</enum><text display-inline="yes-display-inline">in the header by inserting <quote><header-in-text level="subparagraph" style="OLC">, eyeglasses, and contact lenses</header-in-text></quote> after <quote><header-in-text level="subparagraph" style="OLC">hearing aids</header-in-text></quote>;</text></clause>
<clause id="HB709A79AFC4A435AA4E40F1D0524EA00"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting <quote>and of eyeglasses and contact lenses described in paragraph (2)(F) of such section,</quote> after <quote>paragraph (2)(E) of such section,</quote>; and</text></clause>
<clause id="H92C428D386444B0D8782FEFFE0FC532B"><enum>(iii)</enum><text display-inline="yes-display-inline">in clause (i), by inserting <quote>, or such eyeglasses and contact lenses</quote> after <quote>such hearing aids</quote>.</text></clause></subparagraph>
<subparagraph id="HA2E41E95D50041DA8D60E1291A70681C"><enum>(B)</enum><header>Conforming amendment</header>
<clause id="HA3F2D59C89B84AF2AF1F88E98B5D0A0F"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1847(a)(2) of the Social Security Act (42 U.S.C. 1395w–3(a)(2)), as amended by section 601(e)(2)(B)(ii) and section 602(b)(3)(B)(i), is further amended by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="HC32A0ED957684DEA80DCCEEAAE167AF5">
<subparagraph id="HE5BC0C8C5C0941B1B670530E24AE7690"><enum>(F)</enum><header>Eyeglasses and contact lenses</header><text display-inline="yes-display-inline">Eyeglasses and contact lenses described in section 1861(s)(8) for which payment would otherwise be made under section 1834(h).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause>
<clause id="HBBCD9A61001F4F53850FBC79696CAD5A"><enum>(ii)</enum><header>Exemption of certain items from competitive acquisition</header><text display-inline="yes-display-inline">Section 1847(a)(7) of the Social Security Act (42 U.S.C. 1395w–3(a)(7)), as amended by section 601(e)(2)(B)(iii) and section 602(b)(3)(B)(ii), is further amended by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" id="HCAF52F82BF064C95852FA6CB5310B301" display-inline="no-display-inline">
<subparagraph id="HCDA4F2837CD243569379274FF6D62E22"><enum>(E)</enum><header>Certain eyeglasses and contact lenses</header><text display-inline="yes-display-inline">Those items and services described in paragraph (2)(F) if furnished by a physician or other practitioner (as defined by the Secretary) to the physician’s or practitioner’s own patients as part of the physician’s or practitioner’s professional service.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph></subsection>
<subsection id="H725C6486F9A04506BDD77DB505B5E242"><enum>(g)</enum><header>Exclusion modifications</header><text>Section 1862(a) of the Social Security Act (42 U.S.C. 1395y(a)), as amended by section 601(f), is further amended—</text>
<paragraph id="HC5C004112C834C5CA71114605FA35010"><enum>(1)</enum><text>in paragraph (1)—</text>
<subparagraph id="H0ACCA1C3A5DF4C0FABECE3B2444AF1D0"><enum>(A)</enum><text>in subparagraph (P), by striking <quote>and</quote> at the end;</text></subparagraph>
<subparagraph id="H7DDEF561801F46999EE91D42B912ECC2"><enum>(B)</enum><text>in subparagraph (Q), by striking the semicolon at the end and inserting <quote>, and</quote>; and</text></subparagraph>
<subparagraph id="HD8E29459E47249A3B3C96323E58C4F68"><enum>(C)</enum><text>by adding at the end the following new subparagraph: </text>
<quoted-block style="OLC" id="H8C917FD0187E4EA7A61CE51177F8D267" display-inline="no-display-inline">
<subparagraph id="HA006DA3B059A4672908857D6A14AD675" indent="up1"><enum>(R)</enum><text display-inline="yes-display-inline">in the case of vision services (as defined in section 1861(lll)) that are routine eye examinations and contact lens fitting services (as described in paragraph (1) or (2), respectively, of such section), which are furnished more frequently than once during a 2-year period;</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H90C48057364A467CAC3871AAAEDF3F2E"><enum>(2)</enum><text>in paragraph (7)—</text>
<subparagraph id="H48A3255396394C818FE7CC152B0E190D"><enum>(A)</enum><text>by inserting <quote>(other than such an examination that is a vision service that is covered under section 1861(s)(2)(JJ))</quote> after <quote>eye examinations</quote>; and</text></subparagraph>
<subparagraph id="HB194E7C815DB453497D72A471434A7F5"><enum>(B)</enum><text>by inserting <quote>(other than such a procedure that is a vision service that is covered under section 1861(s)(2)(JJ))</quote> after <quote>refractive state of the eyes</quote>. </text></subparagraph></paragraph></subsection>
<subsection id="H1C442F42E91E4BECA647109136B141FD"><enum>(h)</enum><header>Certain non-application</header>
<paragraph id="H3D1418CF04764279AF35DF1A870F09EA"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The last sentence of section 1839(a)(1) of the Social Security Act (42 U.S.C. 1395r(a)(1)), as added by section 601(g)(1) and amended by section 602(d)(1), is further amended by inserting <quote>, and 603 (other than subsection (h))</quote> after <quote>602 (other than subsection (d))</quote>.</text></paragraph>
<paragraph id="H7158AD3C85984163BC3000CBEA566452"><enum>(2)</enum><header>Payment</header><text display-inline="yes-display-inline">Paragraph (4) of section 1844(a) of such Act (42 U.S.C. 1395w(a)), as added by section 601(g)(2) and amended by section 602(d)(2), is further amended by inserting <quote>, and 603 (other than subsection (h))</quote> after <quote>602 (other than subsection (d))</quote>.</text></paragraph></subsection>
<subsection id="H971788580C0244E79A6D468171F4F403" display-inline="no-display-inline"><enum>(i)</enum><header>Implementation funding</header>
<paragraph id="H22E1C7281095469485F61AF76C55D270"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services (in this subsection referred to as the <quote>Secretary</quote>) shall provide for the transfer from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act (42 U.S.C. 1395t) to the Centers for Medicare & Medicaid Services Program Management Account of—</text>
<subparagraph id="HEC08BA6D6CED46828D97160B34E90501"><enum>(A)</enum><text>$20,000,000 for each of fiscal years 2020 through 2024 for purposes of implementing the amendments made by this section; and</text></subparagraph>
<subparagraph id="HD8B9E5D1F1B54DC08B77A75CC8CB13D9"><enum>(B)</enum><text>such sums as determined appropriate by the Secretary for each subsequent fiscal year for purposes of administering the provisions of such amendments.</text></subparagraph></paragraph>
<paragraph id="H71944778B0084C12AECF59741192044A"><enum>(2)</enum><header>Availability and additional use of funds</header><text>Funds transferred pursuant to paragraph (1) shall remain available until expended and may be used, in addition to the purpose specified in paragraph (1)(A), to implement the amendments made by sections 601 and 602.</text></paragraph> </subsection> </section>
<enum>VII</enum><header>NIH, FDA, and Opioids Funding</header>
<subtitle id="H625308C78C93456B8B5C3128DBBB24FC"><enum>A</enum><header>Biomedical Innovation Expansion</header>
<section id="H33EA040830B4491397146172DC291B2A"><enum>701.</enum><header>NIH Innovation Initiatives</header>
<subsection id="HA423FF65FDF44B0DBE449C3F1C7830EF"><enum>(a)</enum><header>NIH Innovation account</header>
<paragraph id="HB2F3AFE894314540BBC45A2202751F5A"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1001(b) of the 21st Century Cures Act (Public Law 114–255) is amended by adding at the end the following: </text>
<quoted-block style="OLC" id="H60D8B959B5CC4028BEE09E25FE096B75" display-inline="no-display-inline">
<paragraph id="H1FC468E28AE34BC09CCF2C9A2FB28AE7"><enum>(5)</enum><header>Supplemental funding and additional activities</header>
<subparagraph id="H7E8D8BE3A9D2444ABD74E40926079D1F"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">In addition to the funds made available under paragraph (2), there are authorized to be appropriated, and are hereby appropriated, to the Account, out of any monies in the Treasury not otherwise appropriated, to be available until expended without further appropriation, the following:</text>
<clause id="HAC7668B964CA4978B8658A2645EBB9FF"><enum>(i)</enum><text display-inline="yes-display-inline">For fiscal year 2021, $255,400,000.</text></clause>
<clause id="H386F6A5EA8B0405E9EEF6E3D60C0EFCF"><enum>(ii)</enum><text display-inline="yes-display-inline">For fiscal year 2022, $260,400,000.</text></clause>
<clause id="H287575CC65C74D1596FD032BA58CE27A"><enum>(iii)</enum><text display-inline="yes-display-inline">For fiscal year 2023, $163,400,000.</text></clause>
<clause id="HE499E8C61E5A40D0B5255A7F3E0867D1"><enum>(iv)</enum><text display-inline="yes-display-inline">For fiscal year 2024, $547,000,000.</text></clause>
<clause id="HA87B93404D15468BBFD77262E8A5FE58"><enum>(v)</enum><text display-inline="yes-display-inline">For fiscal year 2025, $848,000,000.</text></clause>
<clause id="HA109B662C95A448C9BCCD4668FFA1437"><enum>(vi)</enum><text display-inline="yes-display-inline">For fiscal year 2026, $842,400,000.</text></clause>
<clause id="HC67BD53799C646A0BB4C731035979749"><enum>(vii)</enum><text display-inline="yes-display-inline">For fiscal year 2027, $1,089,600,000.</text></clause>
<clause id="H60A1F7D6DFB64BE2B08A0CA72615F234"><enum>(viii)</enum><text display-inline="yes-display-inline">For fiscal year 2028, $1,115,600,000.</text></clause>
<clause id="H24518E54044248CFB2E7B3534E50AD63"><enum>(ix)</enum><text display-inline="yes-display-inline">For fiscal year 2029, $1,170,600,000.</text></clause>
<clause id="H1987E84754B64336A43ADFE85427B7FE"><enum>(x)</enum><text display-inline="yes-display-inline">For fiscal year 2030, $1,207,600,000.</text></clause></subparagraph>
<subparagraph id="H449713C92F5B44A783645C0188051C3C"><enum>(B)</enum><header>Supplemental funding for certain projects</header><text display-inline="yes-display-inline">Of the total amounts made available under subparagraph (A) for each of fiscal years 2021 through 2030, a total amount not to exceed the following shall be made available for the following categories of NIH Innovation Projects:</text>
<clause id="H50737CC9918E468BBD3904B774F8FE95"><enum>(i)</enum><text display-inline="yes-display-inline">For projects described in paragraph (4)(A), an amount not to exceed a total of $2,070,600,000 as follows:</text>
<subclause id="H4B5B20707317402CAB768F6698E4CA03"><enum>(I)</enum><text display-inline="yes-display-inline">For each of fiscal years 2021 and 2022, $50,000,000.</text></subclause>
<subclause id="H97F30C3A310948CDB1A38CDE5E3732CB"><enum>(II)</enum><text display-inline="yes-display-inline">For fiscal year 2024, $100,000,000.</text></subclause>
<subclause id="H3B7F3B9D838F400B96AE8DA137BB2337"><enum>(III)</enum><text display-inline="yes-display-inline">For each of fiscal years 2025 and 2026, $300,000,000.</text></subclause>
<subclause id="H7E7401F56B724B378E46ADDB21109CA3"><enum>(IV)</enum><text>For each of fiscal years 2027 through 2029, $317,000,000.</text></subclause>
<subclause id="H7E29C9E4E637400BAAF1F43626FDDD90"><enum>(V)</enum><text display-inline="yes-display-inline">For fiscal year 2030, $319,600,000.</text></subclause></clause>
<clause id="H0F0B7EE41F4744029598768562BDE1B8"><enum>(ii)</enum><text display-inline="yes-display-inline">For projects described in paragraph (4)(B), an amount not to exceed a total of $2,041,900,000 as follows:</text>
<subclause id="H74A2E4618C754825969753E80622B584"><enum>(I)</enum><text display-inline="yes-display-inline">For each of fiscal years 2021 and 2022, $50,000,000.</text></subclause>
<subclause id="HAE4BD070D6AC4AA6A0DCF4F8386EB86B"><enum>(II)</enum><text display-inline="yes-display-inline">For fiscal year 2024, $128,000,000.</text></subclause>
<subclause id="H5964B581C33742A087C9B1A7FE52A2FC"><enum>(III)</enum><text display-inline="yes-display-inline">For fiscal year 2025, $209,000,000.</text></subclause>
<subclause id="H6EF3B0A215F242D5A8EFD4350A3BCA59"><enum>(IV)</enum><text display-inline="yes-display-inline">For fiscal year 2026, $100,000,000.</text></subclause>
<subclause id="HD19FA7A25C174A0DB9D6882C342F2D4A"><enum>(V)</enum><text display-inline="yes-display-inline">For fiscal year 2027, $325,000,000.</text></subclause>
<subclause id="H6A834E65DE224CC6A28C8A0EDDC51378"><enum>(VI)</enum><text display-inline="yes-display-inline">For fiscal year 2028, $350,000,000.</text></subclause>
<subclause id="H93592EF69FDB49B29540A7412B8370FA"><enum>(VII)</enum><text display-inline="yes-display-inline">For fiscal year 2029, $400,000,000.</text></subclause>
<subclause id="H0E77CDD339464D628ED94E9E9795569B"><enum>(VIII)</enum><text display-inline="yes-display-inline">For fiscal year 2030, $429,900,000.</text></subclause></clause>
<clause id="H160856B92F8A4A7887912AA747A64346"><enum>(iii)</enum><text display-inline="yes-display-inline">For projects described in paragraph (4)(C), an amount not to exceed a total of $1,558,400,000 as follows:</text>
<subclause id="H6BBD464090F5478CBE72453C08B170BC"><enum>(I)</enum><text>For each of fiscal years 2024 and 2025, $151,200,000.</text></subclause>
<subclause id="H9AE7F51A2EFD4963B184B2A43AB82631"><enum>(II)</enum><text>For each of fiscal years 2026 through 2030, $251,200,000.</text></subclause></clause>
<clause id="H236ED4403065447C81F9A05D2F1B2A1A"><enum>(iv)</enum><text display-inline="yes-display-inline">For projects described in paragraph (4)(D), an amount not to exceed $15,400,000 for each of fiscal years 2021 through 2030.</text></clause></subparagraph>
<subparagraph id="H6C8FE20F1803401F9111B775AB150FBD"><enum>(C)</enum><header>Additional NIH Innovation Projects</header><text display-inline="yes-display-inline">In addition to funding NIH Innovation Projects pursuant to subparagraph (B), of the total amounts made available under subparagraph (A), a total amount not to exceed the following shall be made available for the following categories of NIH Innovation Projects:</text>
<clause id="HE2DF781A15C14738B1B2A7C4BC418DEC"><enum>(i)</enum><text display-inline="yes-display-inline">To support research related to combating antimicrobial resistance and antibiotic resistant bacteria, including research into new treatments, diagnostics, and vaccines, research, in consultation with the Centers for Disease Control and Prevention, into stewardship, and the development of strategies, in coordination with the Biomedical Advanced Research and Development Authority under section 319L of the Public Health Service Act, to support commercialization of new antibiotics, not to exceed a total of 1,144,500,000, as follows:</text>
<subclause id="H20BE81D52C634E3DBE29719EF025C0A4"><enum>(I)</enum><text>For each of fiscal years 2021 through 2024, $100,000,000.</text></subclause>
<subclause id="H30C561D1F1384584BCEC9E34F02F9D4D"><enum>(II)</enum><text>For each of fiscal years 2025 and 2026, $120,000,000.</text></subclause>
<subclause id="H5846F2806861459DBAE3B9B3ECA6AB4E"><enum>(III)</enum><text>For each of fiscal years 2027 through 2029, $125,000,000.</text></subclause>
<subclause id="H4CA2CEAF6651401790EF1185806397B1"><enum>(IV)</enum><text>For fiscal year 2030, $129,500,000.</text></subclause></clause>
<clause id="H12264FE06276422087DFCE5F1CC64E30"><enum>(ii)</enum><text display-inline="yes-display-inline">To support research and research activities related to rare diseases or conditions, including studies or analyses that help to better understand the natural history of a rare disease or condition and translational studies related to rare diseases or conditions, not to exceed a total of $530,600,000, as follows:</text>
<subclause id="H68BD7DFF456E4762A0A77DD18DD1566F"><enum>(I)</enum><text>For fiscal year 2021, $40,000,000.</text></subclause>
<subclause id="HA1746C78A05F4C42932313E9ECB88164"><enum>(II)</enum><text>For fiscal year 2022, $45,000,000.</text></subclause>
<subclause id="H00D77F1B7C9C4172B19FCA40F078D95F"><enum>(III)</enum><text>For fiscal year 2023, $48,000,000.</text></subclause>
<subclause id="H52C6438F270044BE92C7CC3E0F37FDA3"><enum>(IV)</enum><text>For each of fiscal years 2024 and 2025, $52,400,000.</text></subclause>
<subclause id="H86D5413A57104AB3BF8BCE1DEDB851F7"><enum>(V)</enum><text>For fiscal year 2026, $55,800,000.</text></subclause>
<subclause id="H06BF443FE5DF4FB6B08BB023B991BBFD"><enum>(VI)</enum><text>For fiscal year 2027, $56,000,000.</text></subclause>
<subclause id="HAF15105CDC0E4258BA004CDA7F94B875"><enum>(VII)</enum><text>For fiscal year 2028, $57,000,000.</text></subclause>
<subclause id="HCADD98B4A72B46748F6A231E94EFC729"><enum>(VIII)</enum><text>For each of fiscal years 2029 and 2030, $62,000,000.</text></subclause></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H982857A23F2747F59852CBC03989027D"><enum>(2)</enum><header>Conforming amendments</header><text display-inline="yes-display-inline">Section 1001 of the 21st Century Cures Act (Public Law 114–255) is amended—</text>
<subparagraph id="H65D0674378474C1B9F018375935844B5"><enum>(A)</enum><text>in subsection (a), by striking <quote>subsection (b)(4)</quote> and inserting <quote>subsections (b)(4) and (b)(5)</quote>; </text></subparagraph>
<subparagraph id="H935B96D774BA49F6B0E8B177C1D4DE3D"><enum>(B)</enum><text display-inline="yes-display-inline">in subsection (b)(1), by striking <quote>paragraph (4)</quote> and inserting <quote>paragraphs (4) and (5)</quote>; and</text></subparagraph>
<subparagraph id="H344BE65BA096427B900E980D5C9BE252"><enum>(C)</enum><text display-inline="yes-display-inline">in subsection (c)(2)(A)(ii), by inserting <quote>or pursuant to subsection (b)(5)</quote> after <quote>subsection (b)(3)</quote>; and</text> </subparagraph>
<subparagraph id="HEB49F7691023422EA894AC7DCBF22ADA"><enum>(D)</enum><text display-inline="yes-display-inline">in subsection (d), by inserting <quote>or pursuant to subsection (b)(5)</quote> after <quote>subsection (b)(3)</quote>. </text></subparagraph></paragraph></subsection>
<subsection id="H1FCE45CC86744F39A8832B5477356752"><enum>(b)</enum><header>Workplan</header><text display-inline="yes-display-inline">Section 1001(c)(1) of the 21st Century Cures Act (Public Law 114–255) is amended by adding at the end the following: </text>
<quoted-block style="OLC" id="H582035D3882C47929886B30CB12157A7" display-inline="no-display-inline">
<subparagraph id="HB3F06876A95E47AB8269D58EC1B91713"><enum>(D)</enum><header>Updates</header><text display-inline="yes-display-inline">The Director of NIH shall , after seeking recommendations in accordance with the process described in subparagraph (C), update the work plan submitted under this subsection for each of fiscal years 2021 through 2030 to reflect the amendments made to this section by the Elijah E. Cummings Lower Drug Costs Now Act.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HB076E2078AC2425893A1BE43EBEC45CC"><enum>(c)</enum><header>Annual reports</header><text display-inline="yes-display-inline">Section 1001(c)(2)(A) of the 21st Century Cures Act (Public Law 114–255) is amended by striking <quote>2027</quote> and inserting <quote>2030</quote>.</text></subsection>
<subsection id="H4DD2E3AECD304A3DBA6AA0DF0AC609F2"><enum>(d)</enum><header>Sunset</header><text display-inline="yes-display-inline">Section 1001(e) of the 21st Century Cures Act (Public Law 114–255) is amended by striking <quote>September 30, 2026</quote> and inserting <quote>September 30, 2030</quote>.</text></subsection></section>
<section id="H4FAECCF7F7264F269BF4FCBE9302B86F"><enum>702.</enum><header>NIH clinical trial</header><text display-inline="no-display-inline">Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following:</text>
<quoted-block id="H66CD7AE9F6A14C81A4D14A134E8E235A" style="OLC">
<section id="HC1AC55C4EC224E179FF0A08696150E6C"><enum>404O.</enum><header>Clinical Trial Acceleration Pilot Initiative</header>
<subsection id="HEE02D3CB9E6A4D40AF6280A472AEB56A"><enum>(a)</enum><header>Establishment of pilot program</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of the National Institutes of Health, shall, not later than 2 years after the date of enactment of this Act, establish and implement a pilot program to award multi-year contracts to eligible entities to support phase II clinical trials and phase III clinical trials—</text>
<paragraph id="H6F72CAD2788F4D6792AC9244EC78425F"><enum>(1)</enum><text>to promote innovation in treatments and technologies supporting the advanced research and development and production of high need cures; and</text></paragraph>
<paragraph id="HAA8F023179A64111B497624E7E4D9565"><enum>(2)</enum><text>to provide support for the development of medical products and therapies.</text></paragraph></subsection>
<subsection id="HFF1A3597B1DC4BCF8C87214F931EAFC6"><enum>(b)</enum><header>Eligible entities</header><text>To be eligible to receive assistance under the pilot program established under subsection (a), an entity shall—</text>
<paragraph id="HC73DFA77407547CCB416BF3D2D53FBF2"><enum>(1)</enum><text display-inline="yes-display-inline">be seeking to market a medical product or therapy that is the subject of clinical trial or trials to be supported using such assistance;</text></paragraph>
<paragraph id="H6A996EB6FADA43A1A043519AF3787AA0"><enum>(2)</enum><text>be a public or private entity, which may include a private or public research institution, a contract research organization, an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)), a medical center, a biotechnology company, or an academic research institution; and</text></paragraph>
<paragraph id="H9ABF1B25DA50424C88951BEC7429124F"><enum>(3)</enum><text>comply with requirements of the Federal Food, Drug, and Cosmetic Act or section 351 of this Act at all stages of development, manufacturing, review, approval, and safety surveillance of a medical product.</text></paragraph></subsection>
<subsection id="HB0876C1AEB034B7F8C5718A4CE2FB346"><enum>(c)</enum><header>Duties</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of National Institutes of Health, shall—</text>
<paragraph id="HAD8DB4FC5CD444A4B3901167839064BD"><enum>(1)</enum><text>in establishing the pilot program under subsection (a), consult with—</text>
<subparagraph id="H6666B05232E34B16A2B2C0AA2921807D"><enum>(A)</enum><text>the Director of the National Center for Advancing Translational Sciences and the other national research institutes in considering their requests for new or expanded clinical trial support efforts; and</text></subparagraph>
<subparagraph id="H95C547385A854011A5075C5EE9EBAE18"><enum>(B)</enum><text display-inline="yes-display-inline">the Commissioner of Food and Drugs and any other head of a Federal agency as the Secretary determines to be appropriate to ensure coordination and efficiently advance clinical trial activities;</text></subparagraph></paragraph>
<paragraph id="H1B9EB277A9EF4B3183EC5E17F3261C4F"><enum>(2)</enum><text display-inline="yes-display-inline">in implementing the pilot program under subsection (a), consider consulting with patients and patient advocates; and</text></paragraph>
<paragraph id="H2E821FD7043B4D6AA54AB792182D9C10"><enum>(3)</enum><text>in awarding contracts under the pilot program under subsection (a), consider—</text>
<subparagraph id="H13436319CC4F4FFBB2D197DFC1530729"><enum>(A)</enum><text display-inline="yes-display-inline">the expected health impacts of the clinical trial or trials to be supported under the contract; and</text></subparagraph>
<subparagraph id="H26F504C6C4B84355B601FE53F19246C2"><enum>(B)</enum><text display-inline="yes-display-inline">the the degree to which the medical product or therapy that is the subject of such clinical trial or trials is a high need cure.</text></subparagraph></paragraph></subsection>
<subsection id="HF325F58B78D942D389B6F773FE51C5C8"><enum>(d)</enum><header>Exclusion</header><text display-inline="yes-display-inline">A contract may not be awarded under the pilot program under subsection (a) if the drug that is the subject of the clinical trial or trials to be supported under the contract is a drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act as a drug for a rare disease or condition.</text></subsection>
<subsection id="H5176711B5CC74E64B21A02074CB15B45"><enum>(e)</enum><header>NIH Clinical Trial Accelerator Account</header>
<paragraph id="HF86A7908C0C34AE7ABAEFDB0A80E371C"><enum>(1)</enum><header>Establishment</header><text>There is established in the Treasury an account, to be known as the <quote>NIH Clinical Trial Accelerator Account</quote> (referred to in this section as the <quote>Account</quote>), for purposes of carrying out this section.</text></paragraph>
<paragraph id="H6B0FEDFB9F854387B13016C507A11218" commented="no"><enum>(2)</enum><header>Transfer of direct spending savings</header><text display-inline="yes-display-inline">There shall be transferred to the Account from the general fund of the Treasury, $500,000,000 for each of fiscal years 2021 through 2025, to be available until expended without further appropriation.</text></paragraph>
<paragraph id="H5B83D45C15504EB589E0A301FFE174CA"><enum>(3)</enum><header>Work plan</header><text display-inline="yes-display-inline">Not later than 180 days after the date of enactment of this Act, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a work plan that includes the proposed implementation of this section and the proposed allocation of funds in the Account.</text></paragraph></subsection>
<subsection id="H98DF02CCEE1C4636962EB1FCE92644E9"><enum>(f)</enum><header>Reports to Congress</header><text>Not later than October 1 of each fiscal year, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on—</text>
<paragraph id="H30113CB0D4CE4ABB865B356A5226D6E0"><enum>(1)</enum><text>the implementation of this section; </text></paragraph>
<paragraph id="H35309577FDEC4D719F8E4212A31A2BC4"><enum>(2)</enum><text>any available results on phase II clinical trials and phase III clinical trials supported under this section during such fiscal year; and</text></paragraph>
<paragraph id="H91ABDF9E60534BD9B1E60AD4BD321FDE"><enum>(3)</enum><text display-inline="yes-display-inline">the extent to which Federal funds are obligated to support such clinical trials, including the specific amount of such support and awards pursuant to an allocation from the Account under subsection (e).</text></paragraph></subsection>
<subsection id="HAA0DCD5FD26E4D4D881643C8C6FBE848"><enum>(g)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph id="H23D78F68A92A498CA5484D9B0DB42980"><enum>(1)</enum><header>Phase II clinical trial</header><text>The term <quote>phase II clinical trial</quote> means a phase II clinical investigation, as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations).</text></paragraph>
<paragraph id="H9ED25EB8B1E843A798537FAEEEAB2859"><enum>(2)</enum><header>Phase III clinical trials</header><text>The term <quote>phase III clinical trial</quote> means a phase III clinical investigation, as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations).</text></paragraph>
<paragraph id="HAD3A23060E4B415790697E381F93F576"><enum>(3)</enum><header>High need cure</header><text>The term <quote>high need cure</quote> has the meaning given such term in section 480(a)(3).</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> </subtitle>
<subtitle id="H6C4ADE29A9614F3285DE6799F14541F6"><enum>B</enum><header>Investing in Safety and Innovation</header>
<section id="H2C135465A1704A48BF13AB5D72651893" commented="no"><enum>711.</enum><header>Food and Drug Administration</header>
<subsection id="HACC5DF97614445EFB72C4D389472B8D0" commented="no"><enum>(a)</enum><header>FDA Innovation account</header>
<paragraph id="H88DDC86109F14C288774EB03C2BF7CD1"><enum>(1)</enum><header>In general</header><text>Section 1002(b) of the 21st Century Cures Act (Public Law 114–255) is amended—</text>
<subparagraph id="H601FF4A6285342BC98DE70B73A5A62DE"><enum>(A)</enum><text>in paragraph (1), by striking <quote>paragraph (4)</quote> and inserting <quote>paragraphs (4) and (5)</quote>; and</text></subparagraph>
<subparagraph id="H174CF6CDA2774CD0B85ABA2484530717"><enum>(B)</enum><text>by adding at the end the following new paragraph: </text>
<quoted-block style="OLC" id="H9E3EA2BE5E9E4A7595BB1C918CABFB1E" display-inline="no-display-inline">
<paragraph id="H27FBCA3E59A24913A809712116565D0F"><enum>(5)</enum><header>Supplemental funding and additional activities</header>
<subparagraph id="H0AAC05B635804C7BB8AD09DB029B985C"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">In addition to the funds made available under paragraph (2), there are authorized to be appropriated, and are hereby appropriated, to the Account, out of any monies in the Treasury not otherwise appropriated, to be available until expended without further appropriation, the following:</text>
<clause id="H7224C7BC235841BABD9D4920F0E2474E"><enum>(i)</enum><text>For fiscal year 2020, $417,500,000.</text></clause>
<clause id="HCE8987B572D24B26BC3DB28634FFECD4"><enum>(ii)</enum><text>For each of fiscal years 2021 and 2022, $157,500,000.</text></clause>
<clause id="HB0ABA65C63CD42979D2E2452E712DF26"><enum>(iii)</enum><text>For each of fiscal years 2023 through 2025, $152,500,000.</text></clause>
<clause id="HFFFB3A2DE9454B059105C2C4E0094F99"><enum>(iv)</enum><text>For each of fiscal years 2026 through 2029, $202,500,000.</text></clause></subparagraph>
<subparagraph id="HCB513261DCE6475986F19B64A66A6C15"><enum>(B)</enum><header>Supplemental funding for certain activities</header><text display-inline="yes-display-inline">Of the total amounts made available under subparagraph (A) for each of fiscal years 2026 through 2029, a total amount not to exceed $50,000,000 for each such fiscal year, shall be made available for the activities under subtitles A through F (including the amendments made by such subtitles) of title III of this Act and section 1014 of the Federal Food, Drug, and Cosmetic Act, as added by section 3073 of this Act.</text></subparagraph>
<subparagraph id="H31FC2047D6EB4009B2ECA3F181A35F62"><enum>(C)</enum><header>Additional FDA activities</header><text display-inline="yes-display-inline">In addition to funding activities pursuant to subparagraph (B), of the total amounts made available under subparagraph (A), a total amount not to exceed the following shall be made available for the following categories of activities:</text>
<clause id="H85F982E80C024CA0B212F659E83D106F"><enum>(i)</enum><text display-inline="yes-display-inline">For modernization of the technical infrastructure of the Food and Drug Administration, including enhancements such as interoperability across the agency, and additional capabilities to develop an advanced information technology infrastructure to support the agency’s regulatory mission:</text>
<subclause id="H3653762C2B324B0BA8ECDF941F45289B"><enum>(I)</enum><text display-inline="yes-display-inline">For fiscal year 2020, $180,000,000.</text></subclause>
<subclause id="H42BC87961E084084ADA1768ABAE2FB45"><enum>(II)</enum><text display-inline="yes-display-inline">For each of fiscal years 2021 through 2029, $60,000.</text></subclause></clause>
<clause id="HD3E8B416D09142118A665BCD867C0CBC"><enum>(ii)</enum><text display-inline="yes-display-inline">For support for continuous manufacturing of drugs and biological products, including complex biological products such as regenerative medicine therapies, through grants to institutions of higher education and nonprofit organizations and other appropriate mechanisms, for each of fiscal years 2020 through 2029, $20,000,000.</text></clause>
<clause id="H8ABF05646EE94084B3C307898BA2F696"><enum>(iii)</enum><text display-inline="yes-display-inline">For support for the Commissioner of Food and Drugs to engage experts, such as through the formation and operation of public-private partnerships or other appropriate collaborative efforts, to advance the development and delivery of individualized human gene therapy products:</text>
<subclause id="H85B002AAC0F44D48859CAC0760DEEB0C"><enum>(I)</enum><text display-inline="yes-display-inline">For fiscal year 2020, $50,000,000.</text></subclause>
<subclause id="H03E21E2ED7784495BA6591392D18D1C2"><enum>(II)</enum><text display-inline="yes-display-inline">For each of fiscal years 2021 through 2029, $10,000,000.</text></subclause></clause>
<clause id="H615E258E06A24248909812457812FAA9"><enum>(iv)</enum><text display-inline="yes-display-inline">For support for inspections, enforcement, and quality surveillance activities across the Food and Drug Administration, including foreign and domestic inspections across products, for each of fiscal years 2020 through 2029, $20,000,000.</text></clause>
<clause id="HEC6B1E84C2F641E49F7405AA3B09B8BD"><enum>(v)</enum><text display-inline="yes-display-inline">For support for activities of the Food and Drug Administration related to customs and border protection to provide improvements to technologies, inspection capacity, and sites of import (including international mail facilities) in which the Food and Drug Administration operates, for each of fiscal years 2020 through 2029, $10,000,000.</text></clause>
<clause id="H76CF25A8169441E18E25791BB3BB6E7B"><enum>(vi)</enum><text display-inline="yes-display-inline">To further advance the development of a coordinated postmarket surveillance system for all medical products, including drugs, biological products, and devices, linked to electronic health records in furtherance of the Food and Drug Administration’s postmarket surveillance capabilities:</text>
<subclause id="HE1A100CF72E0480E933F5385287119AC"><enum>(I)</enum><text display-inline="yes-display-inline">For fiscal year 2020, $112,500,000.</text></subclause>
<subclause id="H0932C9B8DAAC4E2797AD86DF1AD1663D"><enum>(II)</enum><text display-inline="yes-display-inline">For each of fiscal years 2021 through 2029, $12,500,000.</text></subclause></clause>
<clause id="H4592E9D5EA214F63BB359EE5EDD579EA"><enum>(vii)</enum><text display-inline="yes-display-inline">For support for Food and Drug Administration activities to keep pace with the projected product development of regenerative therapies, including cellular and somatic cell gene therapy products:</text>
<subclause id="H74AC47DB6A8E4D2395A031CDF105CE05"><enum>(I)</enum><text display-inline="yes-display-inline">For each of fiscal years 2020 through 2022, $10,000,000.</text></subclause>
<subclause id="H4DB50FBA0B0B4174820A21E6696CD59E"><enum>(II)</enum><text display-inline="yes-display-inline">For each of fiscal years 2023 through 2029, $5,000,000.</text></subclause></clause>
<clause id="H7A3EB15EB30A4D7493ACA217894786F2"><enum>(viii)</enum><text display-inline="yes-display-inline">For carrying out section 714A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d–3a; relating to hiring authority for scientific, technical, and professional personnel), for each of fiscal years 2020 through 2029, $2,500,000.</text></clause>
<clause id="HC9380864BA0D4D69ADFE9ED4AD7401C7"><enum>(ix)</enum><text display-inline="yes-display-inline">For the Food and Drug Administration to support improvements to the technological infrastructure for reporting and analysis of adverse events associated with the use of drugs and biological products, for each of fiscal years 2020 through 2029, $12,500,000.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H68532BBD9FC146F5AEBDDB562329D300"><enum>(2)</enum><header>Conforming amendments</header><text display-inline="yes-display-inline">Section 1002 of the 21st Century Cures Act (Public Law 114–255) is amended—</text>
<subparagraph id="H7B00546623F5431F9C1FBCD6D096697A"><enum>(A)</enum><text>in subsection (a), by inserting before the period at the end the following: <quote>or pursuant to subparagraph (A) of subsection (b)(5) to carry out the activities described in subparagraphs (B) and (C) of such subsection</quote>; and</text></subparagraph>
<subparagraph id="HF9017379E011446287CD9560724BE8BE"><enum>(B)</enum><text>in subsection (d)—</text>
<clause id="H98C59033C1574F64AEED988E5DBE14BF"><enum>(i)</enum><text display-inline="yes-display-inline">by inserting <quote>or pursuant to subparagraph (A) of subsection (b)(5)</quote> after <quote>subsection (b)(3)</quote>; and</text></clause>
<clause id="H9387444F2F0F44B9B99C4DDA683EADD4"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>subsection (b)(4)</quote> and inserting <quote>subsections (b)(4) and (b)(5)</quote>.</text></clause></subparagraph></paragraph></subsection>
<subsection id="HEB1DB5439C3947699F5801A958967B43"><enum>(b)</enum><header>Annual Report</header><text display-inline="yes-display-inline">Section 1002(c)(2)(A) of the 21st Century Cures Act (Public Law 114–255) is amended, in the matter preceding clause (i), by striking <quote>2026</quote> and inserting <quote>2030</quote>.</text></subsection>
<subsection id="HB9372D8A69E24BEFA6D81BEA9C4D74D7"><enum>(c)</enum><header>Sunset</header><text display-inline="yes-display-inline">Section 1002(e) of the 21st Century Cures Act (Public Law 114–255) is amended by striking <quote>September 30, 2025</quote> and inserting <quote>September 30, 2030</quote>.</text></subsection></section></subtitle>
<subtitle id="HCB1FFFE91A144FB5B75CC56FF32E253C"><enum>C</enum><header>Opioid Epidemic Response</header>
<section id="H59496B3A16EB449FAC4878DB0BC4763F"><enum>721.</enum><header>Opioid Epidemic Response Fund</header>
<subsection id="HFCEECB27F62542BEA4BED12F41EFEE23"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall use any funds made available pursuant to subsection (b) to carry out the programs and activities described in subsection (c) to address the opioid and substance use disorder epidemic. Such funds shall be in addition to any funds which are otherwise available to carry out such programs and activities.</text></subsection>
<subsection id="H76935C23CD3047BC9A5998F8212AB9C9"><enum>(b)</enum><header>Opioid Epidemic Response Fund</header>
<paragraph id="H55699B149796434CBD414AF84F157F16"><enum>(1)</enum><header>Establishment of account</header><text display-inline="yes-display-inline">There is established in the Treasury an account, to be known as the Opioid Epidemic Response Fund (referred to in this section as the <quote>Fund</quote>), for purposes of funding the programs and activities described in subsection (c).</text></paragraph>
<paragraph id="H4573C6246EAC414AA9AF934B79E1C418"><enum>(2)</enum><header>Funding</header><text display-inline="yes-display-inline">There is authorized to be appropriated, and there is appropriated, to the Fund, out of any monies in the Treasury not otherwise appropriated $1,980,000,000 for each of fiscal years 2021 through 2025.</text></paragraph>
<paragraph id="H0917C57E686F4A6A8CFCF5F620A1F22B"><enum>(3)</enum><header>Availability</header><text display-inline="yes-display-inline">Amounts made available by paragraph (2) shall be made available to the agencies specified in subsection (c) in accordance with such subsection. Amounts made available to an agency pursuant to the preceding sentence for a fiscal year shall remain available until expended.</text></paragraph></subsection>
<subsection id="HEAFAD47DA9C04019B1C561E7ADE76A51"><enum>(c)</enum><header>Programs and activities</header><text display-inline="yes-display-inline">Of the total amount in the Fund for each of fiscal years 2021 through 2025, such amount shall be allocated as follows:</text>
<paragraph id="H6191648C7227420382B8C1B79DC55220"><enum>(1)</enum><header>SAMHSA</header><text display-inline="yes-display-inline">For the Substance Abuse and Mental Health Services Administration to carry out programs and activities pursuant to section 732, $1,500,000,000 for each of fiscal years 2021 through 2025.</text></paragraph>
<paragraph id="H971B3812523C42A3A5E23061B0F2859A"><enum>(2)</enum><header>CDC</header><text display-inline="yes-display-inline">For the Centers for Disease Control and Prevention to carry out programs and activities pursuant to section 733, $120,000,000 for each of fiscal years 2021 through 2025.</text></paragraph>
<paragraph id="HBC863456A2D84CC7B0661BEB19266C41"><enum>(3)</enum><header>FDA</header><text display-inline="yes-display-inline">For the Food and Drug Administration to carry out programs and activities pursuant to section 734, $10,000,000 for each of fiscal years 2021 through 2025.</text></paragraph>
<paragraph id="HC106D37E69134470A6140CF50AE2A446"><enum>(4)</enum><header>NIH</header><text display-inline="yes-display-inline">For the National Institutes of Health to carry out programs and activities pursuant to section 735, $240,000,000 for each of fiscal years 2021 through 2025.</text></paragraph>
<paragraph id="H7F5F289B5D19479C989A8FFF724B47AD"><enum>(5)</enum><header>HRSA</header><text display-inline="yes-display-inline">For the Health Resources and Services Administration to carry out programs and activities pursuant to section 736, $90,000,000 for each of fiscal years 2021 through 2025.</text></paragraph>
<paragraph commented="no" id="HBF04DB35E40440618A754B62268E5A53"><enum>(6)</enum><header>ACF</header><text display-inline="yes-display-inline">For the Administration for Children and Families to carry out programs and activities pursuant to section 737, $20,000,000 for each of fiscal years 2021 through 2025.</text></paragraph></subsection>
<subsection commented="no" id="H8635C14CA8974CF19DF7E78D4B94D4B0"><enum>(d)</enum><header>Accountability and oversight</header>
<paragraph commented="no" id="H3B1A6604074E48CEB6118825722D0004"><enum>(1)</enum><header>Work plan</header>
<subparagraph commented="no" id="H78FE8EA7761E4CCE865D151C3BC7DE26"><enum>(A)</enum><header>In general</header><text>Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce, the Committee on Appropriations, and the Committee on Education and Labor of the House of Representatives, a work plan including the proposed allocation of funds made available pursuant to subsection (b) for each of fiscal years 2021 through 2025 and the contents described in subparagraph (B).</text></subparagraph>
<subparagraph commented="no" id="HBCCF3EFE2E294F4A897220F0AE6B926E"><enum>(B)</enum><header>Contents</header><text>The work plan submitted under subparagraph (A) shall include—</text>
<clause commented="no" id="H4A45DEFC21244F94A8A024730E4ED546"><enum>(i)</enum><text>the amount of money to be obligated or expended out of the Fund in each fiscal year for each program and activity described in subsection (c); and</text></clause>
<clause commented="no" id="H5690362AD82A4B2184BB99AAF4DC0588"><enum>(ii)</enum><text>a description and justification of each such program and activity.</text></clause></subparagraph></paragraph>
<paragraph id="H574137D8D8774DF68F91CA476BA84E9D" commented="no"><enum>(2)</enum><header>Annual reports</header><text>Not later than October 1 of each of fiscal years 2022 through 2026, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce, the Committee on Appropriations, and the Committee on Education and Labor of the House of Representatives, a report including—</text>
<subparagraph id="HFF20C2546AA94ECB8E2D8C92D7F11349" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">the amount of money obligated or expended out of the Fund in the prior fiscal year for each program and activity described in subsection (c);</text></subparagraph>
<subparagraph id="HDFD4B796B41E40AF9F4A69854B8EAE41" commented="no"><enum>(B)</enum><text>a description of all programs and activities using funds made available pursuant to subsection (b); and</text></subparagraph>
<subparagraph id="H3B7EDD6858264DE488717C656212C383" commented="no"><enum>(C)</enum><text>how the programs and activities are responding to the opioid and substance use disorder epidemic.</text></subparagraph></paragraph></subsection>
<subsection commented="no" id="H39955673562542FB957BDC9F40B2998D"><enum>(e)</enum><header>Limitations</header><text display-inline="yes-display-inline">Notwithstanding any authority in this subtitle or any appropriations Act, any funds made available pursuant to subsection (b) may not be used for any purpose other than the programs and activities described in subsection (c).</text></subsection></section>
<section commented="no" id="H8207A96819184D778AD7715D8FF7B121"><enum>722.</enum><header>Substance Abuse and Mental Health Services Administration</header>
<subsection id="H43777500444849E3B1D30C190A4E0101"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The entirety of the funds made available pursuant to section 731(c)(1) shall be for the Assistant Secretary for Mental Health and Substance Use to continue to award the State Opioid Response Grants funded by the heading <quote>Substance Abuse And Mental Health Services Administration—Substance Abuse Treatment</quote> in title II of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2018 (Public Law 115–141). Subject to subsections (b) and (c), such grants shall be awarded in the same manner and subject to the same conditions as were applicable to such grants for fiscal year 2018.</text></subsection>
<subsection id="HBFEE150B16274232A2CE8FEC9F2419FF"><enum>(b)</enum><header>Requirement that treatment be evidence-based</header><text display-inline="yes-display-inline">As a condition on receipt of a grant pursuant to subsection (a), a grantee shall agree that—</text>
<paragraph id="HA9FA59F6FF7D40AB8AA015CCD0FF0F16"><enum>(1)</enum><text>treatments, practices, or interventions funded through the grant will be evidence-based; and</text></paragraph>
<paragraph id="H003ED30620E841658203B9C844B6E77E"><enum>(2)</enum><text>such treatments, practices, and interventions will include medication-assisted treatment for individuals diagnosed with opioid use disorder, using drugs only if the drugs have been approved or licensed by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262).</text></paragraph></subsection>
<subsection id="H4A2EC159ED8C43BCBF809D4D07BFDD19"><enum>(c)</enum><header>Reservations</header><text display-inline="yes-display-inline">Of the amount made available pursuant to section 731(c)(1) for a fiscal year—</text>
<paragraph id="H8FC6E853B2F6443D95E10CD59BCA90AC"><enum>(1)</enum><text>not less than $75,000,000 shall be reserved to make grants under subsection (a) to Indian Tribes or Tribal organizations; and</text></paragraph>
<paragraph id="H1A96AF31AFDE463EA906FAF6E2B83798"><enum>(2)</enum><text display-inline="yes-display-inline">not less than $50,000,000 shall be reserved to make grants under subsection (a) to political subdivisions of States, such as counties, cities, or towns.</text></paragraph></subsection></section>
<section commented="no" id="HE9D1608C7F224BE288BC05AB1AEB1936"><enum>723.</enum><header>Centers for Disease Control and Prevention</header>
<subsection commented="no" id="H254086E1AF3548B3AAB323B1D96548E6"><enum>(a)</enum><header>Addressing opioid use disorder</header><text display-inline="yes-display-inline">The entirety of the funds made available pursuant to section 731(c)(2) shall be for the Director of the Centers for Disease Control and Prevention, pursuant to applicable authorities in the Public Health Service Act (42 U.S.C. 201 et seq.), to continue and expand programs of the Centers for Disease Control and Prevention to address opioid and substance use disorder, including by—</text>
<paragraph commented="no" id="H2A21120316344C77B4877BD918B11081"><enum>(1)</enum><text display-inline="yes-display-inline">improving the timeliness and quality of data on the opioid use disorder epidemic, including improvement of—</text>
<subparagraph id="H15D3F539E4D44966AABB7B28BD060B2E"><enum>(A)</enum><text>data on fatal and nonfatal overdoses;</text></subparagraph>
<subparagraph id="HA6AE77E6E68B4492ACC85DC061D175C0"><enum>(B)</enum><text>syndromic surveillance;</text></subparagraph>
<subparagraph id="H4EEC24E7BEC74D70907223E12A5C4CFB"><enum>(C)</enum><text>data on long-term sequelae (including neonatal abstinence syndrome); and</text></subparagraph>
<subparagraph id="H9B0CBBD3147048BDB9E5482DC29B03FB"><enum>(D)</enum><text>cause of death reporting related to substance abuse or opioid overdose;</text></subparagraph></paragraph>
<paragraph commented="no" id="H44CEA9484C0B46F88E98EE38A8740CA6"><enum>(2)</enum><text>expanding and strengthening evidence-based prevention and education strategies;</text></paragraph>
<paragraph id="H65F2A9F2995E49EBB30DBB2C92F0991E"><enum>(3)</enum><text>supporting responsible prescribing practices, including through development and dissemination of prescriber guidelines;</text></paragraph>
<paragraph id="H889EBF9B97BA446FBD7972E772D6A136"><enum>(4)</enum><text>improving access to and use of effective prevention, treatment, and recovery support, including through grants and the provision of technical assistance to States and localities;</text></paragraph>
<paragraph id="H38DDA0D4FCA147A789A5E460C2953372"><enum>(5)</enum><text>strengthening partnerships with first responders, including to protect their safety;</text></paragraph>
<paragraph id="HEED346BC7CEE40E1B63FBDC32E268AC4"><enum>(6)</enum><text>considering the needs of vulnerable populations;</text></paragraph>
<paragraph id="H993D0E58D46F4973BA6849BAF238F40F"><enum>(7)</enum><text display-inline="yes-display-inline">addressing infectious diseases linked to the opioid crisis;</text></paragraph>
<paragraph id="H4525E8F714CA4A0D9E4363A3053327E6"><enum>(8)</enum><text display-inline="yes-display-inline">strengthening prescription drug monitoring programs; and</text></paragraph>
<paragraph id="H72F0652D3F344FCD879D8926F0FCD49C"><enum>(9)</enum><text display-inline="yes-display-inline">providing financial and technical assistance to State and local health department efforts to treat and prevent substance use disorder.</text></paragraph></subsection>
<subsection id="HD036C486D1FE47069188DB11E2BD8E2F"><enum>(b)</enum><header>Limitation</header><text display-inline="yes-display-inline">Of the funds made available pursuant to section 731(c)(2) for carrying out this section, not more than 20 percent may be used for intramural purposes.</text></subsection></section>
<section commented="no" id="H597A3C169EE54E2CAB4088F5951CD9D2"><enum>724.</enum><header>Food and Drug Administration</header><text display-inline="no-display-inline">The entirety of the funds made available pursuant to section 731(c)(3) shall be for the Commissioner of Food and Drugs, pursuant to applicable authorities in the Public Health Service Act (42 U.S.C. 201 et seq.) or the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and other applicable law, to support widespread innovation in non-opioid and non-addictive medical products for pain treatment, access to opioid addiction treatments, appropriate use of approved opioids, and efforts to reduce illicit importation of opioids. Such support may include the following:</text>
<paragraph id="HB241DEA07DF84398BDC913B86FCC99A1"><enum>(1)</enum><text>Facilitating the development of non-opioid and non-addictive pain treatments.</text></paragraph>
<paragraph id="H2ACD81E3BBDC4DB988066EEFCDF93520"><enum>(2)</enum><text>Advancing guidance documents for sponsors of non-opioid pain products.</text></paragraph>
<paragraph id="HDE2817C10EE64039A7138F8902610A1C"><enum>(3)</enum><text>Developing evidence to inform the potential for nonprescription overdose therapies.</text></paragraph>
<paragraph id="H45D6043C203440D2A17E93CC36582E4E"><enum>(4)</enum><text>Examining expanded labeling indications for medication-assisted treatment.</text></paragraph>
<paragraph id="H3289E7D4D3D1472A947BFF02E9C51B81"><enum>(5)</enum><text display-inline="yes-display-inline">Conducting public education and outreach, including public workshops or public meetings, regarding the benefits of medication-assisted treatment, including all drugs approved by the Food and Drug Administration, and device treatment options approved or cleared by the Food and Drug Administration.</text></paragraph>
<paragraph id="HF0511BB284B241B79792D054D87B82B9"><enum>(6)</enum><text>Exploring the expansion and possible mandatory nature of prescriber education regarding pain management and appropriate opioid prescribing through authorities under section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1).</text></paragraph>
<paragraph id="H60DA958B56674FBDB36DA2E7AD0E3C6C"><enum>(7)</enum><text>Examining options to limit the duration of opioid prescriptions for acute pain, including through packaging options.</text></paragraph>
<paragraph id="H4B69123F48414BB886C3AD17D26BAB1F"><enum>(8)</enum><text display-inline="yes-display-inline">Increasing staff and infrastructure capacity to inspect and analyze packages at international mail facilities and pursue criminal investigations.</text></paragraph></section>
<section commented="no" id="H7B5F5E2C36FF4FA7B8FA4FD136EDFA6E"><enum>725.</enum><header>National Institutes of Health</header><text display-inline="no-display-inline">The entirety of the funds made available pursuant to section 731(c)(4) shall be for the Director of the National Institutes of Health, pursuant to applicable authorities in the Public Health Service Act (42 U.S.C. 201 et seq.), to carry out activities related to—</text>
<paragraph commented="no" id="H1BB801E471D04C9C8172A3CCC01B34F2"><enum>(1)</enum><text display-inline="yes-display-inline">accelerating research for addressing the opioid use disorder epidemic, including developing non-opioid medications and interventions, including non-addictive medications, to manage pain, as well as developing medications and interventions to treat and to prevent substance use disorders;</text></paragraph>
<paragraph commented="no" id="HB5EEAFA6B48B48ACB0620D7E0E5545A9"><enum>(2)</enum><text>conducting and supporting research on which treatments (in terms of pain management as well as treating and preventing substance use disorders) are optimal for which patients; and</text></paragraph>
<paragraph commented="no" id="H6162BC52C5F941699EF65529AA49AB67"><enum>(3)</enum><text>conducting and supporting research on creating longer-lasting or faster-acting antidotes for opioid overdose, particularly in response to the prevalence of fentanyl and carfentanyl overdoses.</text></paragraph></section>
<section commented="no" id="HFB63BCAC2F144003835C17F89E04D4E4"><enum>726.</enum><header>Health Resources and Services Administration</header><text display-inline="no-display-inline">The entirety of the funds made available pursuant to section 731(c)(5) shall be for the Administrator of the Health Resources and Services Administration, pursuant to applicable authorities in titles III, VII, and VIII of the Public Health Service Act (42 U.S.C. 241 et seq.), to carry out activities that increase the availability and capacity of the behavioral health workforce. Such activities shall include providing loan repayment assistance for substance use disorder treatment providers.</text></section>
<section commented="no" id="H541A29D5C70C47228AE1CC9BC70AA7A4"><enum>727.</enum><header>Administration for Children and Families</header><text display-inline="no-display-inline">Of the funds made available pursuant to section 731(c)(6) for each of fiscal years 2021 through 2025, $20,000,000 for each such fiscal year shall be for the Secretary of Health and Human Services to carry out title I of the Child Abuse Prevention and Treatment Act (42 U.S.C. 5101 et seq.).</text></section></subtitle>
<enum>VIII</enum><header>Miscellaneous</header>
<section id="H43B0B4DBB3114AEFB58C88E9C34ADFC9"><enum>801.</enum><header>Guaranteed issue of certain Medigap policies</header>
<subsection commented="no" display-inline="no-display-inline" id="H53518F98DE5948369861E70F470B44C3"><enum>(a)</enum><header display-inline="yes-display-inline">Guaranteed issue of Medigap policies to all Medigap-Eligible Medicare beneficiaries</header>
<paragraph commented="no" display-inline="no-display-inline" id="H4F7E023333454053BF657AD3F2F9CC99"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 1882(s) of the Social Security Act (42 U.S.C. 1395ss(s)) is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H41ECF9EB11884A1B8C850E2330FCB7C5"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (2)(A), by striking <quote>65 years of age or older and is enrolled for benefits under part B</quote> and inserting <quote>entitled to, or enrolled for, benefits under part A and enrolled for benefits under part B</quote>;</text></subparagraph>
<subparagraph commented="no" display-inline="no-display-inline" id="H13B6C647427049639F82172795DE3CA4"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)(D), by striking <quote>who is 65 years of age or older as of the date of issuance and</quote>;</text></subparagraph>
<subparagraph id="HE341850EBB7040B08DC9B5FA16D59ABF"><enum>(C)</enum><text>in paragraph (3)(B)(ii), by striking <quote>is 65 years of age or older and</quote>; and</text></subparagraph>
<subparagraph commented="no" display-inline="no-display-inline" id="HD591A83BD22E404EB23F064F0B3275F4"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (3)(B)(vi), by striking <quote>at age 65</quote>.</text></subparagraph></paragraph>
<paragraph commented="no" display-inline="no-display-inline" id="H100D654650F84E5BB958096F9F64B953"><enum>(2)</enum><header display-inline="yes-display-inline">Additional enrollment period for certain individuals</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HAAA035B268574424854E198BF6CFB472"><enum>(A)</enum><header display-inline="yes-display-inline">One-time enrollment period</header>
<clause commented="no" display-inline="no-display-inline" id="HA89619BF44A74BCC95CF0E1BE2DFAF0E"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In the case of a specified individual, the Secretary shall establish a one-time enrollment period described in clause (iii) during which such an individual may enroll in any medicare supplemental policy of the individual’s choosing.</text></clause>
<clause id="HD457C13979764506B2B665237AFC44A6"><enum>(ii)</enum><header>Application</header><text display-inline="yes-display-inline">The provisions of—</text>
<subclause id="HEE45553DA565465788C4777EC92ECCDA"><enum>(I)</enum><text>paragraph (2) of section 1882(s) of the Social Security Act (42 U.S.C. 1395ss(s)) shall apply with respect to a specified individual who is described in subclause (I) of subparagraph (B)(iii) as if references in such paragraph (2) to the 6 month period described in subparagraph (A) of such paragraph were references to the one-time enrollment period established under clause (i); and</text></subclause>
<subclause id="H7BE99642EF834F2095A0D8A3E64AB139"><enum>(II)</enum><text>paragraph (3) of such section shall apply with respect to a specified individual who is described in subclause (II) of subparagraph (B)(iii) as if references in such paragraph (3) to the period specified in subparagraph (E) of such paragraph were references to the one-time enrollment period established under clause (i).</text></subclause></clause>
<clause commented="no" display-inline="no-display-inline" id="H1D7193D9B3A64380AA77E7218A2DBC7A"><enum>(iii)</enum><header display-inline="yes-display-inline">Period</header><text display-inline="yes-display-inline">The enrollment period established under clause (i) shall be the 6-month period beginning on January 1, 2024.</text></clause></subparagraph>
<subparagraph commented="no" display-inline="no-display-inline" id="H4608E5883DE34E978B74524C88F71838"><enum>(B)</enum><header display-inline="yes-display-inline">Specified individual</header><text display-inline="yes-display-inline">For purposes of this paragraph, the term <quote>specified individual</quote> means an individual who—</text>
<clause commented="no" display-inline="no-display-inline" id="H1C15D0C5881C4F6DAA690CBB9DE9F82A"><enum>(i)</enum><text display-inline="yes-display-inline">is entitled to hospital insurance benefits under part A of title XVIII of the Social Security Act (42 U.S.C. 1395c et seq.) pursuant to section 226(b) or section 226A of such Act (42 U.S.C. 426(b); 426–1);</text></clause>
<clause commented="no" display-inline="no-display-inline" id="H5015CD06C22546EEAEAD7B87276722F1"><enum>(ii)</enum><text display-inline="yes-display-inline">is enrolled for benefits under part B of such Act (42 U.S.C. 1395j et seq.); and</text></clause>
<clause commented="no" display-inline="no-display-inline" id="H7E86C73527044C6882F886C0CCECB08F"><enum>(iii)</enum>
<subclause id="H02AB52440CBA44CFA00BFD24C2772577" display-inline="yes-display-inline"><enum>(I)</enum><text>would not, but for the amendments made by subparagraphs (A) and (B) of paragraph (1) and the provisions of this paragraph (if such provisions applied to such individual), be eligible for the guaranteed issue of a medicare supplemental policy under paragraph (2) of section 1882(s) of such Act (42 U.S.C. 1395ss(s)); or</text></subclause>
<subclause id="H74FEF1620BB748EEADEF0EEFC867ADC2" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">would not, but for the amendments made by subparagraphs (C) and (D) of paragraph (1) and the provisions of this paragraph (if such provisions applied to such individual), be eligible for the guaranteed issue of a medicare supplemental policy under paragraph (3) of such section.</text></subclause></clause></subparagraph>
<subparagraph commented="no" display-inline="no-display-inline" id="H6970167DCE064F35809E51DC4754CAA4"><enum>(C)</enum><header display-inline="yes-display-inline">Outreach plan</header>
<clause id="HBF133D00DA1742F8989E249D9CE76812"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall develop an outreach plan to notify specified individuals of the one-time enrollment period established under subparagraph (A).</text></clause>
<clause id="HBD57B48652B3490CBF6984ACE7FBB9F7"><enum>(ii)</enum><header>Consultation</header><text display-inline="yes-display-inline">In implementing the outreach plan developed under clause (i), the Secretary shall consult with consumer advocates, brokers, insurers, the National Association of Insurance Commissioners, and State Health Insurance Assistance Programs.</text></clause></subparagraph></paragraph>
<paragraph id="H3CFC1816ED394065A062E5057983C2A2" commented="no" display-inline="no-display-inline"><enum>(3)</enum><header display-inline="yes-display-inline">Effective date</header><text display-inline="yes-display-inline">The amendments made by paragraph (1) shall apply to medicare supplemental policies effective on or after January 1, 2024.</text></paragraph> </subsection>
<subsection commented="no" display-inline="no-display-inline" id="H85DA1CBBF9444CC78DDFA313B5F41060"><enum>(b)</enum><header display-inline="yes-display-inline">Guaranteed issue of Medigap policies for Medicare Advantage enrollees</header>
<paragraph commented="no" display-inline="no-display-inline" id="H45B79C9A92A94BC5A06932D2C2CC5E9A"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 1882(s)(3) of the Social Security Act (42 U.S.C. 1395ss(s)(3)), as amended by subsection (a), is further amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HF0E25E3334A0425DAE4384F2979972A8"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (B), by adding at the end the following new clause:</text>
<quoted-block act-name="" display-inline="no-display-inline" id="HF2A3BB3A4D6743859159F5AF3C5BFDB9" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="H571C27DAC8D740E5B3E6E5B411E65CEA" indent="up2"><enum>(vii)</enum><text display-inline="yes-display-inline">The individual—</text>
<subclause id="H2B7CE62531A04EA5862D90B386464DE6"><enum>(I)</enum><text>was enrolled in a Medicare Advantage plan under part C for not less than 12 months;</text></subclause>
<subclause id="H4A65A694505D42F4B159022FC028CE85"><enum>(II)</enum><text>subsequently disenrolled from such plan;</text></subclause>
<subclause id="H88AE84BBD4974EC38C81F5018C0F9686"><enum>(III)</enum><text>elects to receive benefits under this title through the original Medicare fee-for-service program under parts A and B; and</text></subclause>
<subclause id="H9D9CC5E265514CA4BC3D2A6882E02D91" commented="no"><enum>(IV)</enum><text display-inline="yes-display-inline">has not previously elected to receive benefits under this title through the original Medicare fee-for-service program pursuant to disenrollment from a Medicare Advantage plan under part C.</text></subclause></clause><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph>
<subparagraph commented="no" display-inline="no-display-inline" id="H3A070E538A9C47A4B1F257A7F569DE07"><enum>(B)</enum><text display-inline="yes-display-inline">by striking subparagraph (C)(iii) and inserting the following:</text>
<quoted-block act-name="" display-inline="no-display-inline" id="HBD53C2D5288248EEBBED7881652EBD52" style="traditional">
<clause commented="no" display-inline="no-display-inline" id="H3440ACE1086B4F619692B0651FEC795F" indent="up3"><enum>(iii)</enum><text display-inline="yes-display-inline">Subject to subsection (v)(1), for purposes of an individual described in clause (vi) or (vii) of subparagraph (B), a medicare supplemental policy described in this subparagraph shall include any medicare supplemental policy.</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph>
<subparagraph commented="no" display-inline="no-display-inline" id="HE113D2B8FAEF46A7A047E1AE3D6B9C24"><enum>(C)</enum><text display-inline="yes-display-inline">in subparagraph (E)—</text>
<clause commented="no" display-inline="no-display-inline" id="H5679D3C5938249B1B287184DD2546D88"><enum>(i)</enum><text display-inline="yes-display-inline">in clause (iv), by striking <quote>and</quote> at the end;</text></clause>
<clause commented="no" display-inline="no-display-inline" id="H6FA941FA56A847549FAF85496978871E"><enum>(ii)</enum><text display-inline="yes-display-inline">in clause (v), by striking the period at the end and inserting <quote>; and</quote>; and</text></clause>
<clause commented="no" display-inline="no-display-inline" id="H65A3C699C9B041D08FBF00F13C30C168"><enum>(iii)</enum><text display-inline="yes-display-inline">by adding at the end the following new clause—</text>
<quoted-block act-name="" display-inline="no-display-inline" id="HE9B591E9B1C940CDBA584A0C673FD917" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="H8CF04347723F427294435BF01A88EDF8" indent="up2"><enum>(vi)</enum><text display-inline="yes-display-inline">in the case of an individual described in subparagraph (B)(vii), the annual, coordinated election period (as defined in section 1851(e)(3)(B)) or a continuous open enrollment period (as defined in section 1851(e)(2)) during which the individual disenrolls from a Medicare Advantage plan under part C.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph>
<paragraph commented="no" display-inline="no-display-inline" id="HECA33A87644A40079D0FA01AFAA39135"><enum>(2)</enum><header display-inline="yes-display-inline">Effective date</header><text display-inline="yes-display-inline">The amendments made by paragraph (1) shall apply to medicare supplemental policies effective on or after January 1, 2024.</text></paragraph></subsection></section>
<section id="H65A618222173497DB1852DBD9F7B25A2" commented="no"><enum>802.</enum><header>Reporting requirements for PDP sponsors regarding point-of-sale rejections under Medicare part D</header><text display-inline="no-display-inline">Section 1860D–4(g) of the Social Security Act (42 U.S.C. 1395w–104(g)) is amended by adding at the end the following new paragraph:</text>
<quoted-block style="OLC" id="H915E40BC60314B9EA811D0331DB6E64F" display-inline="no-display-inline">
<paragraph id="H021D7185C8D346F9865CD04BBA815B2D" commented="no"><enum>(3)</enum><header>Reporting requirements regarding point-Of-Sale rejections</header>
<subparagraph id="H181A892E3C0D4DBAABF73AD4145D23A9"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">With respect to a plan year beginning on or after January 1, 2020, a PDP sponsor offering a prescription drug plan shall submit to the Secretary, in a form and manner specified by the Secretary, information on point-of-sale rejections made during a period of time occurring in such plan year (as specified by the Secretary), including each of the following:</text>
<clause id="HFABCEBC039984F6EAEF01B0F36BA2EEC"><enum>(i)</enum><text>The reason for each point-of-sale rejection.</text></clause>
<clause id="H467249C001E7448C8453A2EEEE22934B"><enum>(ii)</enum><text>Identifying information for each drug with respect to which a point-of-sale rejection was made.</text></clause>
<clause id="HDEA37FD68B1546D29A8CABC2F4C56467"><enum>(iii)</enum><text>With respect to applicable types of point-of-sale rejections (as specified by the Secretary), each of the following:</text>
<subclause id="H39C235BDEC0D46B0875EC83BDAD066CA"><enum>(I)</enum><text>Whether such a rejection was consistent with the formulary of the plan (as approved by the Secretary).</text></subclause>
<subclause id="HA10BDEE6C3D14C64A112FF150FA4CC60"><enum>(II)</enum><text>Whether a coverage determination or appeal of a coverage determination was requested for the drug with respect to which such a rejection was made.</text></subclause>
<subclause id="H604AB5AF3E914FF7A638CF189F9EB35F"><enum>(III)</enum><text>The outcome of any such coverage determination or appeal of a coverage determination.</text></subclause>
<subclause id="HE5386079EB074C0196FFD5F75229B96A"><enum>(IV)</enum><text>The length of time between when such a rejection was made and when the drug with respect to which such rejection was made is dispensed, as applicable.</text></subclause></clause></subparagraph>
<subparagraph id="H610D579A1F6645AF8E9F90B75B122BA0"><enum>(B)</enum><header>Public availability of information</header><text>The Secretary shall make publicly available on the public website of the Centers for Medicare & Medicaid Services information submitted under subparagraph (A).</text></subparagraph>
<subparagraph id="H1EAF3FF36755487CB53CE9BB0B728BF2"><enum>(C)</enum><header>Use of information</header><text display-inline="yes-display-inline">The Secretary may use information submitted under subparagraph (A), as determined appropriate, in developing measures for the 5-star rating system under section 1853(o)(4).</text></subparagraph>
<subparagraph id="H45445A648F07427983ADF58E9A22BFF2"><enum>(D)</enum><header>Implementation</header><text>Notwithstanding any other provision of law, the Secretary may implement this paragraph through program instruction or otherwise.</text></subparagraph>
<subparagraph id="H1BA9A46CCB2F40D59F43B42D3678F15B"><enum>(E)</enum><header>Funding</header><text>The are authorized to be appropriated to the Secretary from the Federal Supplementary Medical Insurance Trust Fund under section 1841 such sums as may be necessary to implement this paragraph.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </section>
<section id="HC06AEA5711304E3A89D4B48EC9168DB8"><enum>803.</enum><header>Providing access to annual Medicare notifications in multiple languages</header>
<subsection id="HFF7CDF98FBE748E28C1F6CB277BD1741"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1804 of the Social Security Act (42 U.S.C. 1395b–2) is amended by adding at the end the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="HEA43C51D7C124B65943C17CAD4ED2F48" style="OLC">
<subsection id="H5DE94E21210343E1951FBE15217FF4CB"><enum>(e)</enum><text display-inline="yes-display-inline">The notice provided under subsection (a) shall be translated into languages in addition to English and Spanish. In carrying out the previous sentence, the Secretary shall prioritize translation of the notice into languages in which documents provided by the Commissioner of Social Security are translated and language that are the most frequently requested for translation for purposes of applying for old-age insurance benefits under title II.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection>
<subsection id="H7950D3B153B840748CC1641533FD4E16"><enum>(b)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall apply to notices distributed prior to each Medicare open enrollment period beginning after January 1, 2020.</text></subsection></section>
<section id="HA2A46A77F907408DAC58D460649926B5"><enum>804.</enum><header>Temporary increase in Medicare part B payment for certain biosimilar biological products</header><text display-inline="no-display-inline">Section 1847A(b)(8) of the Social Security Act (42 U.S.C. 1395w–3a(b)(8)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H30DB1A6F9A194169AF36BD6A57EE7487"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and moving the margin of each such redesignated clause 2 ems to the right;</text></paragraph>
<paragraph id="H044893E771A84675829E02652FF67C09"><enum>(2)</enum><text>by striking <quote><header-in-text level="paragraph" style="OLC">product</header-in-text>.—The amount</quote> and inserting the following: “<header-in-text level="paragraph" style="OLC">product</header-in-text>.—</text>
<quoted-block display-inline="no-display-inline" id="H6FC10BE82EB7442AA3B1FEE318F2AC3D" style="OLC">
<subparagraph id="HAB18CFCBD63D4A82890F3FD6BF633CF8"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (B), the amount</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph>
<paragraph id="H2F4772CE13A84EC9A1A73429C1A24D09"><enum>(3)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="HE47D14852E8B4500B074656E25970904" style="OLC">
<subparagraph id="H323ABDD55D1A4FAE998A7A34D6079B12"><enum>(B)</enum><header>Temporary payment increase</header>
<clause id="H5AFD5CD6C0564B478288ABED36192E13"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">In the case of a qualifying biosimilar biological product that is furnished during the applicable 5-year period for such product, the amount specified in this paragraph for such product with respect to such period is the sum determined under subparagraph (A), except that clause (ii) of such subparagraph shall be applied by substituting <quote>8 percent</quote> for <quote>6 percent</quote>.</text></clause>
<clause id="H745D81752E36495DAFFC43BD86297D25"><enum>(ii)</enum><header>Applicable 5-year period</header><text>For purposes of clause (i), the applicable 5-year period for a biosimilar biological product is—</text>
<subclause id="H6077E0BC3E6C4C68B82C9B477830D18F"><enum>(I)</enum><text>in the case of such a product for which payment was made under this paragraph as of December 31, 2019, the 5-year period beginning on January 1, 2020; and</text></subclause>
<subclause commented="no" display-inline="no-display-inline" id="HD8D20798624041309F9522CDB6AF8DF8"><enum>(II)</enum><text display-inline="yes-display-inline">in the case of such a product for which payment is first made under this paragraph during a calendar quarter during the period beginning January 1, 2020, and ending December 31, 2024, the 5-year period beginning on the first day of such calendar quarter during which such payment is first made.</text></subclause></clause>
<clause id="H672E94CBD58B41E88CA60851FDFC4289"><enum>(iii)</enum><header>Qualifying biosimilar biological product defined</header><text display-inline="yes-display-inline">For purposes of this subparagraph, the term <term>qualifying biosimilar biological product</term> means a biosimilar biological product described in paragraph (1)(C) with respect to which—</text>
<subclause id="H7173B902F7CF48B1B4D732F94F45B6AE"><enum>(I)</enum><text>in the case of a product described in clause (ii)(I), the average sales price is not more than the average sales price for the reference biological product; and</text></subclause>
<subclause id="H1AFED47678954628BD11ACEF10271E05"><enum>(II)</enum><text display-inline="yes-display-inline">in the case of a product described in clause (ii)(II), the wholesale acquisition cost is not more than the wholesale acquisition cost for the reference biological product.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section>
<section id="H0BB4E6482E7945299E2B2953D807AB1B"><enum>805.</enum><header>Waiving medicare coinsurance for colorectal cancer screening tests</header> <text display-inline="no-display-inline">Section 1833(a) of the Social Security Act (42 U.S.C. 1395l(a)) is amended—</text>
<paragraph id="H8203E3FD83E9493C9AE87A0E5B531D59"><enum>(1)</enum><text display-inline="yes-display-inline">in the second sentence, by striking <quote>section 1834(0)</quote> and inserting <quote>section 1834(o)</quote>;</text></paragraph>
<paragraph id="HC6E6F38ABC5B408681D26A05B722E14E"><enum>(2)</enum><text display-inline="yes-display-inline">by moving such second sentence 2 ems to the left; and</text></paragraph>
<paragraph id="HA2C1C0FDD7C341A8817C6C300CD6EA92"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting the following third sentence following such second sentence: <quote>For services furnished on or after January 1, 2021, paragraph (1)(Y) shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test.</quote>.</text></paragraph></section>
<section id="H046F53E3795243438A6C009B35BC09AD"><enum>806.</enum><header>Medicare coverage of certain lymphedema compression treatment items</header>
<subsection id="HFAE9CF871D9046C39F486300A893DFE6"><enum>(a)</enum><header>Coverage</header>
<paragraph id="HE825C7D6FEF3489492E09492820F272D"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1861 of the Social Security Act (42 U.S.C. 1395x), as amended by section 601 and section 603, is further amended—</text>
<subparagraph id="H8F0F8E2A3B5F44799849E64C45A81AC4"><enum>(A)</enum><text>in subsection (s)(2)—</text>
<clause id="H3018C9EE8B18400FBCB883D1E608660C"><enum>(i)</enum><text>in subparagraph (II), by striking <quote>and</quote> after the semicolon at the end;</text></clause>
<clause id="H96540AD663D642B0B953EDFC229BEA02"><enum>(ii)</enum><text>in subparagraph (JJ), by striking the period at the end and inserting <quote>; and</quote>; and</text></clause>
<clause id="H3A22AF0A445F4E9A9567AC2BEC0CFB2B"><enum>(iii)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="H5C48CE5A8DEA46878FDE8C0C70D0A9EE" style="OLC">
<subparagraph id="HBA3BE1C7EAF94B648EC34E6657326E41" indent="up1"><enum>(KK)</enum><text display-inline="yes-display-inline">lymphedema compression treatment items (as defined in subsection (mmm));</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </clause></subparagraph>
<subparagraph id="H09461CED30CA4202BAE211222DD4FA7E"><enum>(B)</enum><text>by adding at the end the following new subsection:</text>
<quoted-block style="OLC" id="H780AC3DFDDE24809BFD6E72717CBE02D" display-inline="no-display-inline">
<subsection id="H14279E93ACA347EFA654628E5FEE337E"><enum>(mmm)</enum><header>Lymphedema compression treatment items</header><text display-inline="yes-display-inline">The term <term>lymphedema compression treatment items</term> means compression garments, devices, bandaging systems, components, and supplies, including multilayer compression bandaging systems, standard fit gradient compression garments, and other compression garments, devices, bandaging systems, components, or supplies (as determined by the Secretary), that are—</text>
<paragraph id="H67E93098BCB5470386C60D15E1190FD4"><enum>(1)</enum><text display-inline="yes-display-inline">furnished on or after January 1, 2022, to an individual with a diagnosis of lymphedema for the treatment of such condition;</text></paragraph>
<paragraph id="HBA59CE3444594A5884BC6F05A39ECB5E"><enum>(2)</enum><text>primarily and customarily used in the medical treatment of lymphedema, as determined by the Secretary; and</text></paragraph>
<paragraph id="HA1735D71418A4A5A801A939C6A0FB36C"><enum>(3)</enum><text>prescribed by a physician (or a physician assistant, nurse practitioner, or a clinical nurse specialist (as those terms are defined in section 1861(aa)(5)) to the extent authorized under State law).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H624217022C6443E4BA33FE7B4B86D677"><enum>(2)</enum><header>Payment</header>
<subparagraph id="H6C7FE0EAB5504E40932F5E6210D56F5F"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)), as amended by section 601(c)(1), is further amended—</text>
<clause id="H2B411ED9DA454C9B980F25561B6A2889"><enum>(i)</enum><text>by striking <quote>and</quote> before <quote>(DD)</quote>; and</text></clause>
<clause id="H00EB846251A24CF7ADE65B6AEA7D6002"><enum>(ii)</enum><text>by inserting before the semicolon at the end the following: <quote>, and (EE) with respect to lymphedema compression treatment items (as defined in section 1861(mmm)), the amount paid shall be equal to 80 percent of the lesser of the actual charge or the amount determined under the payment basis determined under section 1834(z)</quote>.</text></clause></subparagraph>
<subparagraph id="HC4AA23269E774493981BE38D2B9CBCC7"><enum>(B)</enum><header>Payment basis and limitations</header><text>Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by sections 601(c)(2) and 603(c), is further amended by adding at the end the following new subsection:</text>
<quoted-block style="OLC" id="H2B1DAC86F93448668DA0DE8937724A10" display-inline="no-display-inline">
<subsection id="H95FF55C26631454DA38D9FA9282CF56F"><enum>(z)</enum><header>Payment for lymphedema compression treatment items</header>
<paragraph id="H4074841AF0CF47769AAB691CB65FC4D5"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall determine an appropriate payment basis for lymphedema compression treatment items (as defined in section 1861(mmm)). In making such a determination, the Secretary may take into account payment rates for such items under State plans (or waivers of such plans) under title XIX, the Veterans Health Administration, and group health plans and health insurance coverage (as such terms are defined in section 2791 of the Public Health Service Act), and such other information as the Secretary determines appropriate.</text></paragraph>
<paragraph id="H5643DCE799ED4F9293224991930F5F24"><enum>(2)</enum><header>Frequency limitation</header><text>No payment may be made under this part for lymphedema compression treatment items furnished other than at such frequency as the Secretary may establish.</text></paragraph>
<paragraph id="H6F09F3706E61459C98A740B07DCFE2BC"><enum>(3)</enum><header>Application of competitive acquisition</header><text>In the case of lymphedema compression treatment items that are included in a competitive acquisition program in a competitive acquisition area under section 1847(a)—</text>
<subparagraph id="H2968FDDD8DE041E19F9DEC0B6C8CFF23"><enum>(A)</enum><text display-inline="yes-display-inline">the payment basis under this subsection for such items furnished in such area shall be the payment basis determined under such competitive acquisition program; and</text></subparagraph>
<subparagraph id="HDB3E333BDED041F1A79828BD1EFF4913"><enum>(B)</enum><text display-inline="yes-display-inline">the Secretary may use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise determined under this subsection for an area that is not a competitive acquisition area under section 1847, and in the case of such adjustment, paragraphs (8) and (9) of section 1842(b) shall not be applied.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subparagraph></paragraph>
<paragraph id="H6CC244F38B8640319BFE3AD0D20C0685"><enum>(3)</enum><header>Conforming amendments</header>
<subparagraph id="H1BD85981896B454BB104CED329623D1A"><enum>(A)</enum><header>Exclusions</header><text>Section 1862(a)(1) of the Social Security Act (42 U.S.C. 1395y(a)(1)), as amended by section 601(f) and section 603(g), is further amended—</text>
<clause id="H4AB69DFF55454FDB92FB1733E9807628"><enum>(i)</enum><text>in subparagraph (Q), by striking <quote>and</quote> at the end;</text></clause>
<clause id="HF182FF15C2654F0D88A7F1841EE8F90D"><enum>(ii)</enum><text>in subparagraph (R), by striking the semicolon and inserting <quote>, and</quote>; and</text></clause>
<clause id="H87753E55091A405A892A4EDB82B4ECAA"><enum>(iii)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="HAF4BBBDE25804AC297C9EF636870D10C" style="OLC">
<subparagraph id="H2DF4B65B598244AE8CD60C4F3692C1B2" indent="up1"><enum>(S)</enum><text>in the case of lymphedema compression treatment items (as defined in section 1861(mmm)), which are furnished more frequently than is established pursuant to section 1834(z)(2);</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph>
<subparagraph id="H45FA8930448D4E28A6D08CA8078144CF"><enum>(B)</enum><header>Application of competitive acquisition</header>
<clause id="H4A76D4810C4849C689A9544A05233CAE"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1847(a)(2) of the Social Security Act (42 U.S.C. 1395w–3(a)(2)), as amended by sections 601(e)(2)(B)(ii), 602(b)(3)(B)(i), and 603(f)(2)(B), is further amended by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" id="H4F025DDA811A4C7590C9CFF6E78AF704" display-inline="no-display-inline">
<subparagraph id="HC5379BB6BB384537A338789EA234D640"><enum>(G)</enum><header>Lymphedema compression treatment items</header><text display-inline="yes-display-inline">Lymphedema compression treatment items (as defined in section 1861(mmm)) for which payment would otherwise be made under section 1834(z). </text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph></subsection>
<subsection id="HCD36D85F4C4247748D3444CEE8BD99FC"><enum>(b)</enum><header>Inclusion in requirements for suppliers of medical equipment and supplies</header><text>Section 1834(j)(5) of the Social Security Act (42 U.S.C. 1395m(j)(5)) is amended—</text>
<paragraph id="H530B2E5A0E574E43A32A1E83C6E6A32A"><enum>(1)</enum><text>by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and</text></paragraph>
<paragraph id="H42AD335B8A3B44E6BF7D125D810EAE42"><enum>(2)</enum><text>by inserting after subparagraph (D) the following new subparagraph:</text>
<quoted-block style="OLC" id="HC3E3B80BFF7046288DBCD09AF9C7AE22" display-inline="no-display-inline">
<subparagraph id="H3B5203955CB8426587C32997A75963AC"><enum>(E)</enum><text display-inline="yes-display-inline">lymphedema compression treatment items (as defined in section 1861(mmm));</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection>
<subsection id="H6B232231208C4B7B985D3DB7B972A2F4"><enum>(c)</enum><header>Study and report on implementation</header>
<paragraph id="HA59D076184C54BE887E1CA6F696BEA14"><enum>(1)</enum><header>Study</header><text>The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall conduct a study on the implementation of Medicare coverage of certain lymphedema compression treatment items under the amendments made by this Act. Such study shall include an evaluation of the following:</text>
<subparagraph id="H4454E7F760AE4259AD05B33FCD454CD4"><enum>(A)</enum><text>Medicare beneficiary utilization of items and services under parts A and B of title XVIII of the Social Security Act as a result of the implementation of such amendments.</text></subparagraph>
<subparagraph id="HFA9069EDF43441CDAD1E70B0C6591EF9"><enum>(B)</enum><text display-inline="yes-display-inline">Whether the Secretary has determined, pursuant to section 1861(mmm) of the Social Security Act, as added by subsection (a)(1), that lymphedema compression treatment items other than compression bandaging systems and standard fit gradient compression garments are covered under such section.</text></subparagraph></paragraph>
<paragraph id="HF053B0482F344279BC29F3E5BB497B5D"><enum>(2)</enum><header>Report</header><text>Not later than January 1, 2024, the Secretary shall submit to Congress and make available to the public a report on the study conducted under paragraph (1).</text></paragraph></subsection></section>
<section id="HB58904FA95A045F2B76376B199B264ED" commented="no"><enum>807.</enum><header>Physician fee update</header><text display-inline="no-display-inline">Section 1848(d)(19) of the Social Security Act (42 U.S.C. 1395w–4(d)(19)) is amended to read as follows:</text>
<quoted-block style="OLC" id="H4951B2CE1F2C460D9B4605098C2FF6DF" display-inline="no-display-inline">
<paragraph id="HBDA427CF8F1F4C2DB345B07AE6B4D038" commented="no"><enum>(19)</enum><header>Update for 2020 through 2025</header><text display-inline="yes-display-inline">The update to the single conversion factor established in paragraph (1)(C)—</text>
<subparagraph id="H587C10AE6DAD42E68A15EB70787577F8" commented="no"><enum>(A)</enum><text>for 2020 and 2021 shall be 0.5 percent; and</text></subparagraph>
<subparagraph id="HDDA7D56A0D4B443DABE51B42B8CA87DE" commented="no"><enum>(B)</enum><text>for 2022 and each subsequent year through 2025 shall be 0.0 percent.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="H4AAA5279C3B5428A8B7DE8D6D4532FD9" section-type="subsequent-section"><enum>808.</enum><header>Additional community health center funding</header><text display-inline="no-display-inline">Section 10503 of the Patient Protection and Affordable Care Act (42 U.S.C. 254b–2) is amended by striking subsection (c) and inserting the following:</text>
<quoted-block style="OLC" id="H5F1A293815124FD88887265C3C327360" display-inline="no-display-inline">
<subsection id="H5DF4B5A821084EBB821EE6C5C435147D"><enum>(c)</enum><header>Additional enhanced funding; capital projects</header><text display-inline="yes-display-inline">There is authorized to be appropriated, and there is appropriated, out of any monies in the Treasury not otherwise appropriated, to the CHC Fund—</text>
<paragraph id="H37C0A3D85F454D53B8F607E669518FC9"><enum>(1)</enum><text display-inline="yes-display-inline">to be transferred to the Secretary of Health and Human Services to provide additional enhanced funding for the community health center program under section 330 of the Public Health Service Act, $1,000,000,000 for each of fiscal years 2021 through 2025; and</text></paragraph>
<paragraph id="H8BB9E8BC79A94A4D927971E54F4C2FAE"><enum>(2)</enum><text display-inline="yes-display-inline">to be transferred to the Secretary of Health and Human Services for capital projects of the community health center program under section 330 of the Public Health Service Act, $5,000,000,000 for the period of fiscal years 2021 through 2025.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </section>
<section id="H245C2B4DC3C14274AA441C5A76A0E5B8"><enum>809.</enum><header>Grants to improve trauma support services and mental health care for children and youth in educational settings</header>
<subsection id="HA445337DC4CB4D789A24A09D650CA786"><enum>(a)</enum><header>Grants, contracts, and cooperative agreements authorized</header><text>The Secretary, in coordination with the Assistant Secretary for Mental Health and Substance Use, is authorized to award grants to, or enter into contracts or cooperative agreements with, State educational agencies, local educational agencies, Indian Tribes (as defined in section 4 of the Indian Self-Determination and Education Assistance Act) or their tribal educational agencies, a school operated by the Bureau of Indian Education, a Regional Corporation, or a Native Hawaiian educational organization, for the purpose of increasing student access to evidence-based trauma support services and mental health care by developing innovative initiatives, activities, or programs to link local school systems with local trauma-informed support and mental health systems, including those under the Indian Health Service.</text> </subsection>
<subsection id="HE5517F6D798C41ADB41F80105FCE89EE"><enum>(b)</enum><header>Duration</header><text>With respect to a grant, contract, or cooperative agreement awarded or entered into under this section, the period during which payments under such grant, contract, or agreement are made to the recipient may not exceed 4 years.</text> </subsection>
<subsection id="HF6B21D9E22BC4564A393D0DFD7377074"><enum>(c)</enum><header>Use of funds</header><text>An entity that receives a grant, contract, or cooperative agreement under this section shall use amounts made available through such grant, contract, or cooperative agreement for evidence-based activities, which shall include any of the following:</text>
<paragraph id="H1B6556FE36BB4558B7D5240DA3FFBFF5"><enum>(1)</enum><text>Collaborative efforts between school-based service systems and trauma-informed support and mental health service systems to provide, develop, or improve prevention, screening, referral, and treatment and support services to students, such as providing trauma screenings to identify students in need of specialized support.</text> </paragraph>
<paragraph id="H9BBB7C94B43F4707BEC819809662ACF6"><enum>(2)</enum><text>To implement schoolwide positive behavioral interventions and supports, or other trauma-informed models of support.</text> </paragraph>
<paragraph id="H1E41D00FEF98428C86CDF04E131929EB"><enum>(3)</enum><text>To provide professional development to teachers, teacher assistants, school leaders, specialized instructional support personnel, and mental health professionals that—</text>
<subparagraph id="H6D853B1309C4420E903D6A8819C88CFB"><enum>(A)</enum><text>fosters safe and stable learning environments that prevent and mitigate the effects of trauma, including through social and emotional learning;</text> </subparagraph>
<subparagraph id="H8709CE924CE74FD58B7360D332E54B12"><enum>(B)</enum><text>improves school capacity to identify, refer, and provide services to students in need of trauma support or behavioral health services; or</text> </subparagraph>
<subparagraph id="HC88974741AF84967B96B2F37488F2B47"><enum>(C)</enum><text display-inline="yes-display-inline">reflects the best practices for trauma-informed identification, referral, and support developed by the Interagency Task Force on Trauma-Informed Care.</text> </subparagraph></paragraph>
<paragraph id="HC771BB2809564B3B934FCFCF6B67C7D5"><enum>(4)</enum><text>Services at a full-service community school that focuses on trauma-informed supports, which may include a full-time site coordinator, or other activities consistent with section 4625 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7275).</text> </paragraph>
<paragraph id="HA151096D391D4EAC9E33B77D6E4C81F1"><enum>(5)</enum><text>Engaging families and communities in efforts to increase awareness of child and youth trauma, which may include sharing best practices with law enforcement regarding trauma-informed care and working with mental health professionals to provide interventions, as well as longer term coordinated care within the community for children and youth who have experienced trauma and their families.</text> </paragraph>
<paragraph id="H72ECDE510AA84D868511EFC92B406E2F"><enum>(6)</enum><text>To provide technical assistance to school systems and mental health agencies.</text> </paragraph>
<paragraph id="H97C9C689585A4BE1B1B9413DE2EB88BF"><enum>(7)</enum><text>To evaluate the effectiveness of the program carried out under this section in increasing student access to evidence-based trauma support services and mental health care.</text> </paragraph>
<paragraph id="H32F2579EA8DC4AF0934B95C1AA049F77"><enum>(8)</enum><text>To establish partnerships with or provide subgrants to Head Start agencies (including Early Head Start agencies), public and private preschool programs, child care programs (including home-based providers), or other entities described in subsection (a), to include such entities described in this paragraph in the evidence-based trauma initiatives, activities, support services, and mental health systems established under this section in order to provide, develop, or improve prevention, screening, referral, and treatment and support services to young children and their families.</text> </paragraph></subsection>
<subsection id="HDA4116C257F640438B6F34D48AE9D464"><enum>(d)</enum><header>Applications</header><text>To be eligible to receive a grant, contract, or cooperative agreement under this section, an entity described in subsection (a) shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, which shall include the following:</text>
<paragraph id="H85782211E26744FFB60A0056C903379A"><enum>(1)</enum><text>A description of the innovative initiatives, activities, or programs to be funded under the grant, contract, or cooperative agreement, including how such program will increase access to evidence-based trauma support services and mental health care for students, and, as applicable, the families of such students.</text> </paragraph>
<paragraph id="HD72F0FF96445402EA7A33ECA626B1DD1"><enum>(2)</enum><text>A description of how the program will provide linguistically appropriate and culturally competent services.</text> </paragraph>
<paragraph id="H34413E11FE0F4F609F8D9A9D776F0B9F"><enum>(3)</enum><text>A description of how the program will support students and the school in improving the school climate in order to support an environment conducive to learning.</text> </paragraph>
<paragraph id="H676E1ACA9C77477FA2C04865987B9715"><enum>(4)</enum><text>An assurance that—</text>
<subparagraph id="HB32D70BCB3EB44BC9D0C2346219E0E57"><enum>(A)</enum><text>persons providing services under the grant, contract, or cooperative agreement are adequately trained to provide such services; and</text> </subparagraph>
<subparagraph id="HC14AC8E4F7C54688A3455BF7BC42A8AD"><enum>(B)</enum><text>teachers, school leaders, administrators, specialized instructional support personnel, representatives of local Indian Tribes or tribal organizations as appropriate, other school personnel, and parents or guardians of students participating in services under this section will be engaged and involved in the design and implementation of the services.</text> </subparagraph></paragraph>
<paragraph id="H6BA1F598CF474E8C8BDF27398FA44D16"><enum>(5)</enum><text>A description of how the applicant will support and integrate existing school-based services with the program in order to provide mental health services for students, as appropriate.</text> </paragraph>
<paragraph id="HE2F715B56DAA49EBA756B5AAFB2BFE62"><enum>(6)</enum><text>A description of the entities in the community with which the applicant will partner or to which the applicant will provide subgrants in accordance with subsection (c)(8).</text> </paragraph></subsection>
<subsection id="HBE6760BC5F5B4C00B2B2686446E45766"><enum>(e)</enum><header>Interagency agreements</header>
<paragraph id="H97E5F2A766BC4E5DB875CB28F0DE5E01"><enum>(1)</enum><header>Local interagency agreements</header><text>To ensure the provision of the services described in subsection (c), a recipient of a grant, contract, or cooperative agreement under this section, or their designee, shall establish a local interagency agreement among local educational agencies, agencies responsible for early childhood education programs, Head Start agencies (including Early Head Start agencies), juvenile justice authorities, mental health agencies, child welfare agencies, and other relevant agencies, authorities, or entities in the community that will be involved in the provision of such services.</text> </paragraph>
<paragraph id="H6A579868508248D0817937182966C69A"><enum>(2)</enum><header>Contents</header><text>In ensuring the provision of the services described in subsection (c), the local interagency agreement shall specify with respect to each agency, authority, or entity that is a party to such agreement—</text>
<subparagraph id="H6038A5531A9948BD8B9571DFB3173890"><enum>(A)</enum><text>the financial responsibility for the services;</text> </subparagraph>
<subparagraph id="H235B15073AF948B59D78CAD845A9B057"><enum>(B)</enum><text>the conditions and terms of responsibility for the services, including quality, accountability, and coordination of the services; and</text> </subparagraph>
<subparagraph id="HB77A21F55AEB4BED843AD76E56EE0315"><enum>(C)</enum><text>the conditions and terms of reimbursement among such agencies, authorities, or entities, including procedures for dispute resolution.</text> </subparagraph></paragraph></subsection>
<subsection id="HC8859427936C4A8BA0729F2390A4D1C2"><enum>(f)</enum><header>Evaluation</header><text>The Secretary shall reserve not more than 3 percent of the funds made available under subsection (l) for each fiscal year to—</text>
<paragraph id="H58F09F131D304E4483A710E82B0343B4"><enum>(1)</enum><text>conduct a rigorous, independent evaluation of the activities funded under this section; and</text> </paragraph>
<paragraph id="H2DA93E5BFD704069BF8A2183C60296DA"><enum>(2)</enum><text>disseminate and promote the utilization of evidence-based practices regarding trauma support services and mental health care.</text> </paragraph></subsection>
<subsection id="HCC80BC06880E4164A0BFFE441CB65D1D"><enum>(g)</enum><header>Distribution of awards</header><text>The Secretary shall ensure that grants, contracts, and cooperative agreements awarded or entered into under this section are equitably distributed among the geographical regions of the United States and among tribal, urban, suburban, and rural populations.</text> </subsection>
<subsection id="H990D8F844F2A47EAB06C3E3F61ED974F"><enum>(h)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed—</text>
<paragraph id="HA23A85CE8DDE4356943B5E8C50995F34"><enum>(1)</enum><text>to prohibit an entity involved with a program carried out under this section from reporting a crime that is committed by a student to appropriate authorities; or</text> </paragraph>
<paragraph id="HA1A7C327ECC34FA8A8A4255844D8EE3B"><enum>(2)</enum><text>to prevent Federal, State, and tribal law enforcement and judicial authorities from exercising their responsibilities with regard to the application of Federal, tribal, and State law to crimes committed by a student.</text> </paragraph></subsection>
<subsection id="H279832CED3AB41BEB96E4BE33FA1EC09"><enum>(i)</enum><header>Supplement, not supplant</header><text>Any services provided through programs carried out under this section shall supplement, and not supplant, existing mental health services, including any special education and related services provided under the Individuals with Disabilities Education Act (20 U.S.C. 1400 et seq.).</text> </subsection>
<subsection id="HA13FD1A46C96484E83486B34DE99D100"><enum>(j)</enum><header>Consultation with Indian tribes</header><text>In carrying out subsection (a), the Secretary shall, in a timely manner, meaningfully consult with Indian Tribes and their representatives to ensure notice of eligibility.</text> </subsection>
<subsection id="H84A5A181CCFA46828BC5D59726B0364D"><enum>(k)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="HEA01E8FCBA9B4AED95ABF0599333FEC3"><enum>(1)</enum><header>Elementary school</header><text>The term <term>elementary school</term> has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).</text> </paragraph>
<paragraph id="H56CF9B832BC4426AA6D7A1C3E6D0F291"><enum>(2)</enum><header>Evidence-based</header><text>The term <term>evidence-based</term> has the meaning given such term in section 8101(21)(A)(i) of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801(21)(A)(i)).</text> </paragraph>
<paragraph id="H6178455A4BD442DA9E44FC8F0714CF23"><enum>(3)</enum><header>Native hawaiian educational organization</header><text>The term <term>Native Hawaiian educational organization</term> has the meaning given such term in section 6207 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7517).</text> </paragraph>
<paragraph id="HEFBD620C57724A35940C807D66E4A2BA"><enum>(4)</enum><header>Local educational agency</header><text>The term <term>local educational agency</term> has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).</text> </paragraph>
<paragraph id="H94B5ECF1D03C49C59DB082A9B656EBD4"><enum>(5)</enum><header>Regional corporation</header><text>The term <term>Regional Corporation</term> has the meaning given the term in section 3 of the Alaska Native Claims Settlement Act (43 U.S.C. 1602).</text> </paragraph>
<paragraph id="H24695BE9CB044127A92C371C56F9BBCA"><enum>(6)</enum><header>School</header><text>The term <term>school</term> means a public elementary school or public secondary school.</text> </paragraph>
<paragraph id="HE87484E04A2040CF831427D7B3B54065"><enum>(7)</enum><header>School leader</header><text>The term <term>school leader</term> has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).</text> </paragraph>
<paragraph id="HFC772202DEA94B25BFE95EB4413B14E4"><enum>(8)</enum><header>Secondary school</header><text>The term <term>secondary school</term> has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).</text> </paragraph>
<paragraph id="HC83664B79F0447A2B61D4A90E6E4A5B5"><enum>(9)</enum><header>Secretary</header><text>The term <term>Secretary</term> means the Secretary of Education.</text> </paragraph>
<paragraph id="H65FC58F4C3F94E10A6C943B979143C75"><enum>(10)</enum><header>Specialized instructional support personnel</header><text>The term <term>specialized instructional support personnel</term> has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).</text> </paragraph>
<paragraph id="HFE3F706C459A4234A3C3AEF5229444C9"><enum>(11)</enum><header>State educational agency</header><text>The term <term>State educational agency</term> has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).</text> </paragraph></subsection>
<subsection id="HA22D53A796A54AFAB46B0963598D9F75"><enum>(l)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">There is authorized to be appropriated, and there is appropriated, out of any money in the Treasury not otherwise appropriated, to carry out this section, $20,000,000 for each of fiscal years 2021 through 2025.</text> </subsection></section>
<section id="H63F94F3C2E7441B5AB65311331E61DF8"><enum>810.</enum><header>Pathway to Health Careers Act</header>
<subsection id="H0762177AB5604DACBBE539D81FDB5A2E"><enum>(a)</enum><header>Short title</header><text>This section may be cited as the <quote>Pathways to Health Careers Act</quote>.</text></subsection>
<subsection id="H14920B6B72694707A488028A46FD6F3F"><enum>(b)</enum><header>Extension through fiscal year <enum-in-header>2020</enum-in-header> of funding for demonstration projects to address health professions workforce needs</header>
<paragraph id="HF018604258034CB6A7917A70CC772A0C"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 2008(c)(1) of the Social Security Act (42 U.S.C. 1397g(c)(1)) is amended by striking <quote>2019.</quote> and inserting <quote>2020, and to provide technical assistance and cover administrative costs associated with implementing the successor to this section $15,000,000 for fiscal year 2020.</quote>.</text></paragraph>
<paragraph id="H1F338CD21FA5471EA0DE3D3EFCCE7D5E"><enum>(2)</enum><header>Availability of other funds</header><text display-inline="yes-display-inline">Upon the date of the enactment of this section—</text>
<subparagraph id="H61D3D97EFC524F3CA0553EB9267E8D3A"><enum>(A)</enum><text>amounts expended pursuant to section 1501 of division B of Public Law 116–59, or any other prior law making amounts available for fiscal year 2020 for activities authorized by section 2008 of the Social Security Act, shall be charged to the appropriation made by subsection (c)(1) of such section 2008 for fiscal year 2020 (not including the amount for technical assistance and administrative costs); and</text></subparagraph>
<subparagraph id="HFCB37A9B6E6C49D7AB6C2D317B5CF4E1" commented="no"><enum>(B)</enum><text>if such enactment occurs on or before November 21, 2019, the availability of funds appropriated in, and the authority provided under, such section 1501 shall terminate.</text></subparagraph></paragraph></subsection>
<subsection id="H6A771D944E6942C6BFC4946C76662C9A"><enum>(c)</enum><header>Career pathways through health profession opportunity grants</header><text>Effective October 1, 2020, section 2008 of the Social Security Act (42 U.S.C. 1397g) is amended to read as follows:</text>
<quoted-block style="OLC" id="HBFB7A1DB7D854B55ACAC3D8D91B32F44" display-inline="no-display-inline">
<section id="HE5CE093234EF4A96B071E433B3989BC4"><enum>2008.</enum><header>Career pathways through health profession opportunity grants</header>
<subsection id="HBA0FA70CD478480E8FA36DD2011C847E"><enum>(a)</enum><header>Application requirements</header><text>An eligible entity desiring a grant under this section for a project shall submit to the Secretary an application for the grant, that includes the following:</text>
<paragraph id="H0CB12BADC0484B4A845D52C61468C948"><enum>(1)</enum><text display-inline="yes-display-inline">A description of how the applicant will use a career pathways approach to train eligible individuals for health professions that pay well or will put eligible individuals on a career path to an occupation that pays well, under the project.</text></paragraph>
<paragraph id="H2F349E3CACDB4A78B8F3218DBA564464"><enum>(2)</enum><text display-inline="yes-display-inline">A description of the adult basic education and literacy activities, work readiness activities, training activities, and case management and career coaching services that the applicant will use to assist eligible individuals to gain work experience, connection to employers, and job placement, and a description of the plan for recruiting, hiring, and training staff to provide the case management, mentoring, and career coaching services, under the project directly or through local governmental, apprenticeship, educational, or charitable institutions.</text></paragraph>
<paragraph id="HBE664501118543BD82BDEC838902AEA1"><enum>(3)</enum><text display-inline="yes-display-inline">In the case of an application for a grant under this section for a demonstration project described in subsection (c)(2)(B)(i)(I)—</text>
<subparagraph id="HFC9819B1C3BE42549C158E585DDA2C14"><enum>(A)</enum><text display-inline="yes-display-inline">a demonstration that the State in which the demonstration project is to be conducted has in effect policies or laws that permit certain allied health and behavioral health care credentials to be awarded to people with certain arrest or conviction records (which policies or laws shall include appeals processes, waivers, certificates, and other opportunities to demonstrate rehabilitation to obtain credentials, licensure, and approval to work in the proposed health careers), and a plan described in the application that will use a career pathway to assist participants with such a record in acquiring credentials, licensing, and employment in the specified careers;</text></subparagraph>
<subparagraph id="H77DF1189333A4C8983D5848659234F1E"><enum>(B)</enum><text>a discussion of how the project or future strategic hiring decisions will demonstrate the experience and expertise of the project in working with job seekers who have arrest or conviction records or employers with experience working with people with arrest or conviction records;</text></subparagraph>
<subparagraph id="H1B99C2DA03D74F9CA8B5DB0223A9E9DB"><enum>(C)</enum><text display-inline="yes-display-inline">an identification of promising innovations or best practices that can be used to provide the training;</text></subparagraph>
<subparagraph id="HECFA8B41A4D44D06BBB0B727236AF9E1"><enum>(D)</enum><text>a proof of concept or demonstration that the applicant has done sufficient research on workforce shortage or in-demand jobs for which people with certain types of arrest or conviction records can be hired;</text></subparagraph>
<subparagraph id="H7295C223821E45628E4B6C79D4D61193"><enum>(E)</enum><text>a plan for recruiting students who are eligible individuals into the project; and</text></subparagraph>
<subparagraph id="H780A1F19DECD46BE9A02B43E3538588E" display-inline="no-display-inline"><enum>(F)</enum><text>a plan for providing post-employment support and ongoing training as part of a career pathway under the project.</text></subparagraph></paragraph>
<paragraph id="HA50852BA5DC741C787B405CB83ECD2BA"><enum>(4)</enum><text display-inline="yes-display-inline">In the case of an application for a grant under this section for a demonstration project described in subsection (c)(2)(B)(i)(II)—</text>
<subparagraph id="H1884EAE908F7429EAC228A6629F25AB0"><enum>(A)</enum><text display-inline="yes-display-inline">a description of the partnerships, strategic staff hiring decisions, tailored program activities, or other programmatic elements of the project, such as training plans for doulas and other community health workers and training plans for midwives and other allied health professions, that are designed to support a career pathway in pregnancy, birth, or post-partum services; and</text></subparagraph>
<subparagraph id="H3DFFA3A7380B446EB70BE5DBA344201E"><enum>(B)</enum><text display-inline="yes-display-inline">a demonstration that the State in which the demonstration project is to be conducted recognizes doulas or midwives, as the case may be.</text></subparagraph></paragraph>
<paragraph id="H27576B4EC5384F82A0553C38E88F3FF4"><enum>(5)</enum><text>A demonstration that the applicant has experience working with low-income populations, or a description of the plan of the applicant to work with a partner organization that has the experience.</text></paragraph>
<paragraph id="H139CB9777339499D807CB4C7BF3BDA49"><enum>(6)</enum><text>A plan for providing post-employment support and ongoing training as part of a career pathway under the project.</text></paragraph>
<paragraph id="HF0DD0F55BA98429EA80C0BADC0A25EAC"><enum>(7)</enum><text>A description of the support services that the applicant will provide under the project, including a plan for how child care and transportation support services will be guaranteed and, if the applicant will provide a cash stipend or wage supplement, how the stipend or supplement would be calculated and distributed.</text></paragraph>
<paragraph id="H2654F93EC37845249228AAB769658F76"><enum>(8)</enum><text display-inline="yes-display-inline">A certification by the applicant that the project development included—</text>
<subparagraph id="HA3072F46BDE94E43A9FD3961040B7B61"><enum>(A)</enum><text>consultation with a local workforce development board established under section 107 of the Workforce Innovation and Opportunity Act;</text></subparagraph>
<subparagraph id="H50AB66E74526492A9E84798A0D86E592"><enum>(B)</enum><text>consideration of apprenticeship and pre-apprenticeship models registered under the Act of August 16, 1937 (also known as the <quote>National Apprenticeship Act</quote>);</text></subparagraph>
<subparagraph id="H0BBEC7E7A95A4589852B498E6324C652"><enum>(C)</enum><text display-inline="yes-display-inline">consideration of career pathway programs in the State in which the project is to be conducted; and</text></subparagraph>
<subparagraph id="HB26EEF398D494CCA8C82D6603962BEB5"><enum>(D)</enum><text display-inline="yes-display-inline">a review of the State plan under section 102 or 103 of the Workforce Innovation and Opportunity Act.</text></subparagraph></paragraph>
<paragraph id="H40CBFF16A7CD4CA98963E7FBCEA053DB"><enum>(9)</enum><text>A description of the availability and relevance of recent labor market information and other pertinent evidence of in-demand jobs or worker shortages.</text></paragraph>
<paragraph id="HEDEEBBEC8EDE43C08BB38C9649226484"><enum>(10)</enum><text>A certification that the applicant will directly provide or contract for the training services described in the application.</text></paragraph>
<paragraph id="HEB4C274F5D62497FB93EE3715039A8F7"><enum>(11)</enum><text>A commitment by the applicant that, if the grant is made to the applicant, the applicant will—</text>
<subparagraph id="H3E1923B18981453B883962DCA2716E79"><enum>(A)</enum><text display-inline="yes-display-inline">during the planning period for the project, provide the Secretary with any information needed by the Secretary to establish adequate data reporting and administrative structure for the project;</text></subparagraph>
<subparagraph id="H52E7A3F4CC51466681B8ACD255C27212"><enum>(B)</enum><text>hire a person to direct the project not later than the end of the planning period applicable to the project;</text></subparagraph>
<subparagraph id="H00C45A79C01345D3A5CEA3F6AA42B623"><enum>(C)</enum><text>accept all technical assistance offered by the Secretary with respect to the grant;</text></subparagraph>
<subparagraph id="H1F0A8CDDFB9D4F84AFD83940C86A964E"><enum>(D)</enum><text>participate in such in-person grantee conferences as are regularly scheduled by the Secretary;</text></subparagraph>
<subparagraph id="HC4F33FFDE52C41D8812B92327AD41355"><enum>(E)</enum><text display-inline="yes-display-inline">provide all data required by the Secretary under subsection (g); and</text></subparagraph>
<subparagraph id="H8E183F7CEEB84DCA8B6F750BBA8294B5"><enum>(F)</enum><text display-inline="yes-display-inline">notify the local disabled veterans’ outreach program specialists under section 4103A of title 38, United States Code, and the local veterans’ employment representatives under section 4104 of such title, of the grantee’s outreach plan for advertising training opportunities to potential participants in the project.</text></subparagraph></paragraph></subsection>
<subsection id="H2064F2C59064434D8AC8EC0F963EFBF6"><enum>(b)</enum><header>Preferences in considering applications</header><text display-inline="yes-display-inline">In considering applications for a grant under this section, the Secretary shall give preference to—</text>
<paragraph id="H1CAA784BDB3D44FB9E70AFE90450A674"><enum>(1)</enum><text display-inline="yes-display-inline">applications submitted by applicants to whom a grant was made under this section or any predecessor to this section;</text></paragraph>
<paragraph id="HE81A6D42F2054E52ABF1A92E0A583EB8"><enum>(2)</enum><text>applications submitted by applicants who have business and community partners in each of the following categories:</text>
<subparagraph id="H9232B3D7A70C43409A66D94CD7E5332C"><enum>(A)</enum><text display-inline="yes-display-inline">State and local government agencies and social service providers, including a State or local entity that administers a State program funded under part A of this title;</text></subparagraph>
<subparagraph id="H2B54772AAD3F477DA189CD5B55881C33"><enum>(B)</enum><text display-inline="yes-display-inline">institutions of higher education, apprenticeship programs, and local workforce development boards established under section 107 of the Workforce Innovation and Opportunity Act; and</text></subparagraph>
<subparagraph id="H473D733F944F4B298DA8C2DFD6E48DC5"><enum>(C)</enum><text display-inline="yes-display-inline">health care employers, health care industry or sector partnerships, labor unions, and labor-management partnerships;</text></subparagraph></paragraph>
<paragraph id="H35C7D9F2D2414A52AEEEC3D5C7CDD35B"><enum>(3)</enum><text display-inline="yes-display-inline">applications that include opportunities for mentoring or peer support, and make career coaching available, as part of the case management plan;</text></paragraph>
<paragraph id="H100C7FB9A49847AC9C7306C10B6F83B4"><enum>(4)</enum><text>applications which describe a project that will serve a rural area in which—</text>
<subparagraph id="HFCAB789B72944763A20E5254EE1F3147"><enum>(A)</enum><text>the community in which the individuals to be enrolled in the project reside is located;</text></subparagraph>
<subparagraph id="H47CCAB165D754440AB313F1082D5B99F"><enum>(B)</enum><text>the project will be conducted; or</text></subparagraph>
<subparagraph id="HF68CACC5AC254748AF1910E8FE284C4B"><enum>(C)</enum><text>an employer partnership that has committed to hiring individuals who successfully complete all activities under the project is located;</text></subparagraph></paragraph>
<paragraph id="H6FD4D24671EA4BF89E86F84C889D1A9D"><enum>(5)</enum><text>applications that include a commitment to providing project participants with a cash stipend or wage supplement; and</text></paragraph>
<paragraph id="HCB66E4C6FB9C4D1A9C671D16F3394E8D"><enum>(6)</enum><text>applications which have an emergency cash fund to assist project participants financially in emergency situations.</text></paragraph></subsection>
<subsection id="HC8A6F9CB92B54D80BF1FE26EBAA1D815"><enum>(c)</enum><header>Grants</header>
<paragraph id="H631E6F9C52F04959A626DDEBB0A4058D"><enum>(1)</enum><header>Competitive grants</header>
<subparagraph id="H2D579D478BBE4CA4A7B8CBE4AC1C8F93"><enum>(A)</enum><header>Grant authority</header>
<clause id="H4BCD7AF913E5425C9438B96AFD740F60"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary, in consultation with the Secretary of Labor and the Secretary of Education, may make a grant in accordance with this paragraph to an eligible entity whose application for the grant is approved by the Secretary, to conduct a project designed to train low-income individuals for allied health professions, health information technology, physicians assistants, nursing assistants, registered nurse, advanced practice nurse, and other professions considered part of a health care career pathway model.</text></clause>
<clause id="H1C59A58BE73D44E396FB2299D25E6249"><enum>(ii)</enum><header>Guarantee of grantees in each state and the district of columbia</header><text display-inline="yes-display-inline">For each grant cycle, the Secretary shall award a grant under this paragraph to at least 2 eligible entities in each State that is not a territory, to the extent there are a sufficient number of applications submitted by the entities that meet the requirements applicable with respect to such a grant. If, for a grant cycle, there are fewer than 2 such eligible entities in a State, the Secretary shall include that information in the report required by subsection (g)(2) that covers the fiscal year.</text></clause></subparagraph>
<subparagraph id="HE972DD891C7540E5BB938B894AB78523"><enum>(B)</enum><header>Guarantee of grants for indian populations</header><text display-inline="yes-display-inline">From the amount reserved under subsection (i)(2)(B) for each fiscal year, the Secretary shall award a grant under this paragraph to at least 10 eligible entities that are an Indian tribe, a tribal organization, or a tribal college or university, to the extent there are a sufficient number of applications submitted by the entities that meet the requirements applicable with respect to such a grant.</text></subparagraph>
<subparagraph id="HF33C6C62E1584B7C858EEC46EC9A7FCA" display-inline="no-display-inline"><enum>(C)</enum><header>Guarantee of grantees in the territories</header><text display-inline="yes-display-inline">From the amount reserved under subsection (i)(2)(C) for each fiscal year, the Secretary shall award a grant under this paragraph to at least 2 eligible entities that are located in a territory, to the extent there are a sufficient number of applications submitted by the entities that meet the requirements applicable with respect to such a grant.</text></subparagraph></paragraph>
<paragraph id="H20986871BA4B49A6B8D59072B833929F"><enum>(2)</enum><header>Grants for demonstration projects</header>
<subparagraph id="HA818C47ED4D7497C83B18C684CA58059"><enum>(A)</enum><header>Grant authority</header><text display-inline="yes-display-inline">The Secretary, in consultation with the Secretary of Labor and the Secretary of Education (and, with respect to demonstration projects of the type described in subparagraph (B)(i)(I), the Attorney General) shall make a grant in accordance with this subsection to an eligible entity whose application for the grant is approved by the Secretary, to conduct a demonstration project that meets the requirements of subparagraph (B).</text></subparagraph>
<subparagraph id="H2C109D38736F40DDA94BAD4610B69B2E"><enum>(B)</enum><header>Requirements</header><text>The requirements of this subparagraph are the following:</text>
<clause id="H9E160FE3989E46BBB7B16D994D8C1764"><enum>(i)</enum><header>Type of project</header><text>The demonstration project shall be of 1 of the following types:</text>
<subclause id="H12ED5E9F6BF94286B1C4A01025CC206E"><enum>(I)</enum><header>Individuals with arrest or conviction records demonstration</header><text display-inline="yes-display-inline">The demonstration project shall be of a type designed to provide education and training for eligible individuals with arrest or conviction records to enter and follow a career pathway in the health professions through occupations that pay well and are expected to experience a labor shortage or be in high demand.</text></subclause>
<subclause id="HADBEEF907FCF4C58821D596D8DBE36C9"><enum>(II)</enum><header>Pregnancy and childbirth career pathway demonstration</header><text display-inline="yes-display-inline">The demonstration project shall be of a type designed to provide education and training for eligible individuals to enter and follow a career pathway in the field of pregnancy, childbirth, or post-partum, in a State that recognizes doulas or midwives and that provides payment for services provided by doulas or midwives, as the case may be, under private or public health insurance plans.</text></subclause></clause>
<clause id="H8728DBE43FD6431EBEB47C1A90DEEA62"><enum>(ii)</enum><header>Duration</header><text>The demonstration project shall be conducted for not less than 5 years.</text></clause></subparagraph>
<subparagraph id="H0CA948B3761F4607B2E69632A1749CD3" display-inline="no-display-inline"><enum>(C)</enum><header>Minimum allocation of funds for each type of demonstration project</header>
<clause id="H1C370EA726834BC997311979B5CDDDEC"><enum>(i)</enum><header>Individuals with arrest or conviction records demonstrations</header><text>Not less than 25 percent of the amounts made available for grants under this paragraph shall be used to make grants for demonstration projects of the type described in subparagraph (B)(i)(I).</text></clause>
<clause id="H24C5F181CCB74916B0372573CCD5452D"><enum>(ii)</enum><header>Pregnancy and childbirth career pathway demonstrations</header><text>Not less than 25 percent of the amounts made available for grants under this paragraph shall be used to make grants for demonstration projects of the type described in subparagraph (B)(i)(II).</text></clause></subparagraph></paragraph>
<paragraph id="HEC830C1D36984219B46ED7867EEC5966"><enum>(3)</enum><header>Grant cycle</header><text display-inline="yes-display-inline">The grant cycle under this section shall be not less than 5 years, with a planning period of not more than the 1st 12 months of the grant cycle. During the planning period, the amount of the grant shall be in such lesser amount as the Secretary determines appropriate.</text></paragraph></subsection>
<subsection id="HC2E83B3F245B4713802F9C07199676FD"><enum>(d)</enum><header>Use of grant</header>
<paragraph id="HA022BDD3F03F418A8ABAA2B584E4131D"><enum>(1)</enum><header>In general</header><text>An entity to which a grant is made under this section shall use the grant in accordance with the approved application for the grant.</text></paragraph>
<paragraph id="H7B346C41E6834300A23674C7EC2FB923"><enum>(2)</enum><header>Support to be provided</header>
<subparagraph id="HC50AAA4E9532452E9B9EEDEA70FB2EBD"><enum>(A)</enum><header>Required support</header><text display-inline="yes-display-inline">A project for which a grant is made under this section shall include the following:</text>
<clause id="H7CEDB5305E1E4FA8991A1E4BD7312BBA"><enum>(i)</enum><text>An assessment for adult basic skill competency, and provision of adult basic skills education if necessary for lower-skilled eligible individuals to enroll in the project and go on to enter and complete post-secondary training, through means including the following:</text>
<subclause id="H4A16887227F44F89BBB8FFF34D1CFE24"><enum>(I)</enum><text>Establishing a network of partners that offer pre-training activities for project participants who need to improve basic academic skills or English language proficiency before entering a health occupational training career pathway program.</text></subclause>
<subclause id="HF41331E97B2548CB8BDA5D472868576C"><enum>(II)</enum><text>Offering resources to enable project participants to continue advancing adult basic skill proficiency while enrolled in a career pathway program.</text></subclause>
<subclause id="H7CDB29981C3B4720A87FA5B61C27F3EA"><enum>(III)</enum><text>Embedding adult basic skill maintenance as part of ongoing post-graduation career coaching and mentoring.</text></subclause></clause>
<clause id="HF3775076FEA7470DAF1F7DBDB2AD7B54"><enum>(ii)</enum><text>A guarantee that child care is an available and affordable support service for project participants through means such as the following;</text>
<subclause id="HFBDEFCE34EA748A89D26317C1D4E50EE"><enum>(I)</enum><text>Referral to, and assistance with, enrollment in a subsidized child care program.</text></subclause>
<subclause id="HD510059DFC594564BD6C5BCC1E2EEF05"><enum>(II)</enum><text>Direct payment to a child care provider if a slot in a subsidized child care program is not available or reasonably accessible.</text></subclause>
<subclause id="H874E9F6D06EF4F2C92D0E594BBFC43D1"><enum>(III)</enum><text>Payment of co-payments or associated fees for child care.</text></subclause></clause>
<clause id="H1DF0A992952144F08BE379BCE77D74CF"><enum>(iii)</enum><text>Case management plans that include career coaching (with the option to offer appropriate peer support and mentoring opportunities to help develop soft skills and social capital), which may be offered on an ongoing basis before, during, and after initial training as part of a career pathway model.</text></clause>
<clause id="H2C74B3387E394A2B8FA82E3E6034253F"><enum>(iv)</enum><text>A plan to provide project participants with transportation through means such as the following:</text>
<subclause id="HC8546536C539487B85A1D5E21325B998"><enum>(I)</enum><text>Referral to, and assistance with enrollment in, a subsidized transportation program.</text></subclause>
<subclause id="H56AA07C95AF441ECBD7A3CDFA59F2CC8"><enum>(II)</enum><text>If a subsidized transportation program is not reasonably available, direct payments to subsidize transportation costs.</text></subclause><continuation-text continuation-text-level="clause">For purposes of this clause, the term <term>transportation</term> includes public transit, or gasoline for a personal vehicle if public transit is not reasonably accessible or available.</continuation-text></clause>
<clause id="H820F9B284CEB4DC2B37F3D6BF3EB341F"><enum>(v)</enum><text display-inline="yes-display-inline">In the case of a demonstration project of the type described in subsection (c)(2)(B)(i)(I), access to legal assistance for project participants for the purpose of addressing arrest or conviction records and associated workforce barriers.</text></clause></subparagraph>
<subparagraph id="H0EBAE6A7A9274D2DB64A42F9C7177F79"><enum>(B)</enum><header>Allowed support</header><text>The goods and services provided under a project for which a grant is made under this section may include the following:</text>
<clause id="H417BE9D05C8B489FA995FC7636928534"><enum>(i)</enum><text>A cash stipend that is at least monthly.</text></clause>
<clause id="HCAD25B5E2AB548688A2BAC9C301CE243"><enum>(ii)</enum><text>A reserve fund for financial assistance to project participants in emergency situations.</text></clause>
<clause id="H45D14D3C03F745D49C6F6E9E1991EE6E"><enum>(iii)</enum><text>Tuition, and training materials such as books, software, uniforms, shoes, and hair nets.</text></clause>
<clause id="H5D6B307DE82C464E862C951F58455210"><enum>(iv)</enum><text>In-kind resource donations such as interview clothing and conference attendance fees.</text></clause>
<clause id="HDFB5D5EC1BA04E5E9001125D1415C61F"><enum>(v)</enum><text display-inline="yes-display-inline">Assistance with accessing and completing high school equivalency or adult basic education courses as necessary to achieve success in the project and make progress toward career goals.</text></clause>
<clause id="H16E9E7B044A74701A365F5529222826E"><enum>(vi)</enum><text display-inline="yes-display-inline">Assistance with programs and activities, including legal assistance, deemed necessary to address arrest or conviction records as an employment barrier.</text></clause>
<clause id="H398963555984471CB05D89BE94D53D3F"><enum>(vii)</enum><text>Other support services as deemed necessary for family well-being, success in the project, and progress toward career goals.</text></clause></subparagraph>
<subparagraph id="H19E8F95B3BC64DF7B8F0D8181A192E6E"><enum>(C)</enum><header>Treatment of support for purposes of means-tested programs</header><text display-inline="yes-display-inline">Any goods or services provided to an eligible individual participating in a project for which a grant is made under this section shall not be considered income, and shall not be taken into account for purposes of determining the eligibility of the individual for, or amount of benefits to be provided to the individual, under any means-tested program.</text></subparagraph></paragraph>
<paragraph id="H5B8C959B181540EDAC6D68372505E79E"><enum>(3)</enum><header>Training</header><text display-inline="yes-display-inline">The number of hours of training provided to an eligible individual under a project for which a grant is made under this section, for a recognized postsecondary credential, including an industry-recognized credential, which is awarded in recognition of attainment of measurable technical or occupational skills necessary to gain employment or advance within an occupation (including a certificate awarded by a local workforce development board established under section 107 of the Workforce Innovation and Opportunity Act), shall be—</text>
<subparagraph id="H2A1FB334552F457D9299A6258FB0E498"><enum>(A)</enum><text>not less than the number of hours of training required for certification in that level of skill by the State in which the project is conducted; or</text></subparagraph>
<subparagraph id="H895A3C12FAD74C51A21EA27E2A47B1EE"><enum>(B)</enum><text>if there is no such requirement, such number of hours of training as the Secretary finds is necessary to achieve that skill level.</text></subparagraph></paragraph>
<paragraph id="H8EE385E3DB124DCDA8EFDF50A6F85702" display-inline="no-display-inline"><enum>(4)</enum><header>Income limitation</header><text display-inline="yes-display-inline">An entity to which a grant is made under this section shall not use the grant to provide support to a person who is not an eligible individual.</text></paragraph>
<paragraph id="HF3539E934A9A42ECA2963E801029DA63"><enum>(5)</enum><header>Inclusion of TANF recipients</header><text display-inline="yes-display-inline">In the case of a project for which a grant is made under this section that is conducted in a State that has a program funded under part A of title IV, at least 10 percent of the eligible individuals to whom support is provided under the project shall meet the income eligibility requirements under that State program, without regard to whether the individuals receive benefits or services directly under that State program.</text></paragraph>
<paragraph id="H18A65DB15FBF4F1C8B2E23BA62B1B057"><enum>(6)</enum><header>Prohibition</header><text display-inline="yes-display-inline">An entity to which a grant is made under this section shall not use the grant for purposes of entertainment, except that case management and career coaching services may include celebrations of specific career-based milestones such as completing a semester, graduation, or job placement.</text></paragraph></subsection>
<subsection id="H23D55C978D0046D385B1DB2A0ED90FAF"><enum>(e)</enum><header>Technical assistance</header>
<paragraph id="H2BA4C6703DE44F65AD3522FEA4946584"><enum>(1)</enum><header>In general</header><text>The Secretary shall provide technical assistance—</text>
<subparagraph id="H429A25DF82284DEAB985C4CB6CA34A89"><enum>(A)</enum><text>to assist eligible entities in applying for grants under this section;</text></subparagraph>
<subparagraph id="HE65917FCE2B8414485DA6AED2C41667B"><enum>(B)</enum><text>that is tailored to meet the needs of grantees at each stage of the administration of projects for which grants are made under this section;</text></subparagraph>
<subparagraph id="HF48971FBC93848BD8484903842597807"><enum>(C)</enum><text>that is tailored to meet the specific needs of Indian tribes, tribal organizations, and tribal colleges and universities;</text></subparagraph>
<subparagraph id="H4968EA1DD82A4C8C8DD2265E2181EE5D"><enum>(D)</enum><text>that is tailored to meet the specific needs of the territories;</text></subparagraph>
<subparagraph id="HBF5448A4525242359BEAD832A8FCEA39"><enum>(E)</enum><text>that is tailored to meet the specific needs of eligible entities in carrying out demonstration projects for which a grant is made under this section; and</text></subparagraph>
<subparagraph id="HC14E4219480948F0B84387FDADE6544A"><enum>(F)</enum><text display-inline="yes-display-inline">to facilitate the exchange of information among eligible entities regarding best practices and promising practices used in the projects.</text></subparagraph></paragraph>
<paragraph id="H0CEA205829134432BAA19B7FD714FC33"><enum>(2)</enum><header>Continuation of peer technical assistance conferences</header><text>The Secretary shall continue to hold peer technical assistance conferences for entities to which a grant is made under this section or was made under the immediate predecessor of this section.</text></paragraph></subsection>
<subsection id="HBB4BBBEF1E3B4B7EAC62D21722E1DA9A" display-inline="no-display-inline"><enum>(f)</enum><header>Evaluation of demonstration projects</header>
<paragraph id="HE0A0D6787C8F4613A9055A21C932ED04"><enum>(1)</enum><header>In general</header><text>The Secretary shall, by grant, contract, or interagency agreement, conduct rigorous and well-designed evaluations of the demonstration projects for which a grant is made under this section.</text></paragraph>
<paragraph id="H2464367EA9F44D969E77D1CE011359CF"><enum>(2)</enum><header>Requirement applicable to individuals with arrest or conviction records demonstration</header><text>In the case of a project of the type described in subsection (c)(2)(B)(i)(I), the evaluation shall include identification of successful activities for creating opportunities for developing and sustaining, particularly with respect to low-income individuals with arrest or conviction records, a health professions workforce that has accessible entry points, that meets high standards for education, training, certification, and professional development, and that provides increased wages and affordable benefits, including health care coverage, that are responsive to the needs of the workforce.</text></paragraph>
<paragraph id="HE4DF6EA3F4844A40B8D7666E29B60F5D"><enum>(3)</enum><header>Requirement applicable to pregnancy and childbirth career pathway demonstration</header><text display-inline="yes-display-inline">In the case of a project of the type described in subsection (c)(2)(B)(i)(II), the evaluation shall include identification of successful activities for creating opportunities for developing and sustaining, particularly with respect to low-income individuals and other entry-level workers, a career pathway that has accessible entry points, that meets high standards for education, training, certification, and professional development, and that provides increased wages and affordable benefits, including health care coverage, that are responsive to the needs of the birth, pregnancy, and post-partum workforce.</text></paragraph>
<paragraph id="H2E79C3BA4D394822B013C2E761271D32"><enum>(4)</enum><header>Rule of interpretation</header><text display-inline="yes-display-inline">Evaluations conducted pursuant to this subsection may include a randomized controlled trial, but this subsection shall not be interpreted to require an evaluation to include such a trial.</text></paragraph></subsection>
<subsection id="H694C7799C0E64B1A83729C36B5CBF5ED"><enum>(g)</enum><header>Reports</header>
<paragraph id="HE1B893EFEDF24DBB96953533A33CAF72"><enum>(1)</enum><header>To the Secretary</header><text display-inline="yes-display-inline">An eligible entity awarded a grant to conduct a project under this section shall submit interim reports to the Secretary on the activities carried out under the project, and, on the conclusion of the project, a final report on the activities. Each such report shall include data on participant outcomes related to earnings, employment in health professions, graduation rate, graduation timeliness, credential attainment, participant demographics, and other data specified by the Secretary.</text></paragraph>
<paragraph id="H5749B54E72544A8CA6490AE30947303A"><enum>(2)</enum><header>To the Congress</header><text display-inline="yes-display-inline">During each Congress, the Secretary shall submit to the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate a report—</text>
<subparagraph id="H797CAE6DFBEC4842A94945B6218FA1AB"><enum>(A)</enum><text display-inline="yes-display-inline">on the demographics of the participants in the projects for which a grant is made under this section;</text></subparagraph>
<subparagraph id="HEBFE4AA0907E46A7B1EF73966D817B3D"><enum>(B)</enum><text>on the rate of which project participants completed all activities under the projects;</text></subparagraph>
<subparagraph id="H9AA8D80E758B4DCB8CCDEA59305538F3"><enum>(C)</enum><text>on the employment credentials acquired by project participants;</text></subparagraph>
<subparagraph id="H2203C60E22CB4E529AEE4A0047042571"><enum>(D)</enum><text>on the employment of project participants on completion of activities under the projects, and the earnings of project participants at entry into employment;</text></subparagraph>
<subparagraph id="H5519AD68C0604B7FA232DC1418B09DB7"><enum>(E)</enum><text>on best practices and promising practices used in the projects;</text></subparagraph>
<subparagraph id="HDC7E2DB355C14E96B6BCD807324E802D"><enum>(F)</enum><text>on the nature of any technical assistance provided to grantees under this section;</text></subparagraph>
<subparagraph id="H9032F2757C6E4E688B9501B7EEC29012"><enum>(G)</enum><text display-inline="yes-display-inline">on, with respect to the period since the period covered in the most recent prior report submitted under this paragraph—</text>
<clause id="HEB01673EE90E4CC39440CA90E9F4F9BE"><enum>(i)</enum><text>the number of applications submitted under this section, with a separate statement of the number of applications referred to in subsection (b)(5);</text></clause>
<clause id="H8BF30E2B1CC6405D8483FBC6F75AE992"><enum>(ii)</enum><text display-inline="yes-display-inline">the number of applications that were approved, with a separate statement of the number of such applications referred to in subsection (b)(5); and</text></clause>
<clause id="H33793B4EB7834F699958D2FE89B839CA"><enum>(iii)</enum><text>a description of how grants were made in any case described in the last sentence of subsection (c)(1)(A)(ii); and</text></clause></subparagraph>
<subparagraph id="HF3FF70A279A842EFBBA32DEF6424E877"><enum>(H)</enum><text display-inline="yes-display-inline">that includes an assessment of the effectiveness of the projects with respect to addressing health professions workforce shortages or in-demand jobs.</text></subparagraph></paragraph></subsection>
<subsection id="H59C65CD834624D74B319AD4AD524FCB6"><enum>(h)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="HB4A4B9DC40A941F7BF3806617CAB5F1C"><enum>(1)</enum><header>Allied health profession</header><text display-inline="yes-display-inline">The term <quote>allied health profession</quote> has the meaning given in section 799B(5) of the Public Health Service Act.</text></paragraph>
<paragraph id="H2FADA9011D1A4513A12005945F1F9114"><enum>(2)</enum><header>Career pathway</header><text>The term <term>career pathway</term> has the meaning given that term in section 3(7) of the Workforce Innovation and Opportunity Act.</text></paragraph>
<paragraph id="H77719EF174E141028863C94546B1DFB9"><enum>(3)</enum><header>Doula</header><text display-inline="yes-display-inline">The term <term>doula</term> means an individual who—</text>
<subparagraph id="H27A66499B3384F909A857892B55DF533"><enum>(A)</enum><text>is certified by an organization that has been established for not less than 5 years and that requires the completion of continuing education to maintain the certification, to provide non-medical advice, information, emotional support, and physical comfort to an individual during the individual’s pregnancy, childbirth, and post-partum period; and</text></subparagraph>
<subparagraph id="H140FFD65DBD34BD7B619EC7217EF0BBE"><enum>(B)</enum><text>maintains the certification by completing the required continuing education.</text></subparagraph></paragraph>
<paragraph id="H80D6AE05B327472BB613C4DF47D9B29D"><enum>(4)</enum><header>Eligible entity</header><text display-inline="yes-display-inline">The term <term>eligible entity</term> means any of the following entities that demonstrates in an application submitted under this section that the entity has the capacity to fully develop and administer the project described in the application:</text>
<subparagraph id="H67C1520EE2B7484B82D0E536C0FBBD6A"><enum>(A)</enum><text>A local workforce development board established under section 107 of the Workforce Innovation and Opportunity Act.</text></subparagraph>
<subparagraph id="HFA167D73A2A948C3896E1303C5B2802A"><enum>(B)</enum><text display-inline="yes-display-inline">A State or territory, a political subdivision of a State or territory, or an agency of a State, territory, or such a political subdivision, including a State or local entity that administers a State program funded under part A of this title.</text></subparagraph>
<subparagraph id="H4E93590AC1734316863B14DBFCA1B7B7"><enum>(C)</enum><text display-inline="yes-display-inline">An Indian tribe, a tribal organization, or a tribal college or university.</text></subparagraph>
<subparagraph id="H734F1EA11C184CEBBC4C3DD184E4A73E"><enum>(D)</enum><text>An institution of higher education (as defined in the Higher Education Act of 1965).</text></subparagraph>
<subparagraph id="H36FA6A88B8744C1DA0CF2FFCD0B9544F"><enum>(E)</enum><text>A hospital (as defined in section 1861(e)).</text></subparagraph>
<subparagraph id="H0DE83A1B477E478490E85C2F0759F0FB"><enum>(F)</enum><text display-inline="yes-display-inline">A high-quality skilled nursing facility.</text></subparagraph>
<subparagraph id="H2717D7530C7E4148A0C0C816AD820565"><enum>(G)</enum><text>A Federally qualified health center (as defined in section 1861(aa)(4)).</text></subparagraph>
<subparagraph id="HA586085E2977465EA0B6C5ADDEA381DC"><enum>(H)</enum><text display-inline="yes-display-inline">A nonprofit organization described in section 501(c)(3) of the Internal Revenue Code of 1986, a labor organization, or an entity with shared labor-management oversight, that has a demonstrated history of providing health profession training to eligible individuals.</text></subparagraph>
<subparagraph id="H8454F678297145928E1771619026F338"><enum>(I)</enum><text display-inline="yes-display-inline">In the case of a demonstration project of the type provided for in subsection (c)(2)(B)(i)(II) of this section, an entity recognized by a State, Indian tribe, or tribal organization as qualified to train doulas or midwives, if midwives or doulas, as the case may be, are permitted to practice in the State involved.</text></subparagraph>
<subparagraph id="H49034FC2D3C5456A8612EBE73FDD8604"><enum>(J)</enum><text display-inline="yes-display-inline">An opioid treatment program (as defined in section 1861(jjj)(2)), and other high quality comprehensive addiction care providers.</text></subparagraph></paragraph>
<paragraph id="HABB4735CAC6949F09E1DD148244A41F2"><enum>(5)</enum><header>Eligible individual</header><text display-inline="yes-display-inline">The term <term>eligible individual</term> means an individual whose family income does not exceed 200 percent of the Federal poverty level.</text></paragraph>
<paragraph id="H040AD64055A44748BA971A2C237BE802"><enum>(6)</enum><header>Federal poverty level</header><text display-inline="yes-display-inline">The term <term>Federal poverty level</term> means the poverty line (as defined in section 673(2) of the Omnibus Budget Reconciliation Act of 1981, including any revision required by such section applicable to a family of the size involved).</text></paragraph>
<paragraph id="H6EE28BB5E2FE4E3284BC13897DEBC6DB"><enum>(7)</enum><header>Indian tribe; tribal organization</header><text>The terms <term>Indian tribe</term> and <term>tribal organization</term> have the meaning given the terms in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b).</text></paragraph>
<paragraph id="H2FCB657A21B649BE98C003023861EDA6"><enum>(8)</enum><header>Institution of higher education</header><text display-inline="yes-display-inline">The term <term>institution of higher education</term> has the meaning given the term in section 101 or 102(a)(1)(B) of the Higher Education Act of 1965.</text></paragraph>
<paragraph id="H4DFD59F74A85456D8B104345640F5608"><enum>(9)</enum><header>Territory</header><text display-inline="yes-display-inline">The term <term>territory</term> means the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa.</text></paragraph>
<paragraph id="H2E3386F9A76E433AA4E546C7974C5797"><enum>(10)</enum><header>Tribal college or university</header><text>The term <term>tribal college or university</term> has the meaning given the term in section 316(b) of the Higher Education Act of 1965.</text></paragraph></subsection>
<subsection id="HE9710DACF80F47AEB26ECF699FFF75DC"><enum>(i)</enum><header>Funding</header>
<paragraph id="H3786204A3C5D49F4A352C0E42E8D4FC4"><enum>(1)</enum><header>In general</header><text>Out of any funds in the Treasury of the United States not otherwise appropriated, there are appropriated to the Secretary to carry out this section $425,000,000 for each of fiscal years 2021 through 2025.</text></paragraph>
<paragraph id="H1A99071CFB9F405D8A7A18CB054F4914"><enum>(2)</enum><header>Allocation of funds</header><text>Of the amount appropriated for a fiscal year under paragraph (1) of this subsection—</text>
<subparagraph id="HA878371BA46C44B19E8B029C3459D8F4"><enum>(A)</enum><text>75 percent shall be available for grants under subsection (c)(1)(A);</text></subparagraph>
<subparagraph id="H42C56502D79B489C9BBAF9648816E07D"><enum>(B)</enum><text>4 percent shall be reserved for grants under subsection (c)(1)(B);</text></subparagraph>
<subparagraph id="H92F75E83CC5247FF95A10CEEBB10E691"><enum>(C)</enum><text>5 percent shall be reserved for grants under subsection (c)(1)(C);</text></subparagraph>
<subparagraph id="H61891F8873FF4D7EBC79291B99B57916"><enum>(D)</enum><text display-inline="yes-display-inline">6 percent shall be available for demonstration project grants under subsection (c)(2);</text></subparagraph>
<subparagraph id="HE46A3F232BA346BE822B199D944234CD"><enum>(E)</enum><text>6 percent, plus all amounts referred to in subparagraphs (A) through (D) of this paragraph that remain unused after all grant awards are made for the fiscal year, shall be available for the provision of technical assistance and associated staffing; and</text></subparagraph>
<subparagraph id="H6EA458E4A7344709AA3E1B5A104F1D58"><enum>(F)</enum><text display-inline="yes-display-inline">4 percent shall be available for studying the effects of the demonstration and non-demonstration projects for which a grant is made under this section, and for associated staffing, for the purpose of supporting the rigorous evaluation of the demonstration projects, and supporting the continued study of the short-, medium-, and long-term effects of all such projects, including the effectiveness of new or added elements of the non-demonstration projects.</text></subparagraph></paragraph></subsection>
<subsection id="H404C7A95885D41C78F1D3612FCA9A7DC"><enum>(j)</enum><header>Nonapplicability of preceding sections of this subtitle</header>
<paragraph id="H02D79BBCA7FE4A69AAA78EE93389BF76"><enum>(1)</enum><header>In general</header><text>Except as provided in paragraph (2), the preceding sections of this subtitle shall not apply to a grant awarded under this section.</text></paragraph>
<paragraph id="HE03BBFBA2D0C4E6295929F5D337E1CF2"><enum>(2)</enum><header>Exception for certain limitations on use of grants</header><text>Section 2005(a) (other than paragraphs (2), (3), (5), (6), and (8)) shall apply to a grant awarded under this section to the same extent and in the same manner as such section applies to payments to States under this subtitle.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section>
<section id="H90BFB4D7FFA84E7A9B7DA27BEE0FFCCC"><enum>811.</enum><header>Home Visiting to Reduce Maternal Mortality and Morbidity Act</header>
<subsection id="H48434AA172AD4336BEE1308BBF7D648F"><enum>(a)</enum><header>Short title</header><text>This section may be cited as the <quote>Home Visiting to Reduce Maternal Mortality and Morbidity Act</quote>.</text></subsection>
<subsection id="H29E4759C0D2B49978F40B5DE00871C13"><enum>(b)</enum><header>Increase in tribal set-aside percentage</header>
<paragraph id="H87DDFA38006548A7A0C846CDADF97267"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 511(j)(2)(A) of the Social Security Act (42 U.S.C. 711(j)(2)(A)) is amended by striking <quote>3</quote> and inserting <quote>6</quote>.</text></paragraph>
<paragraph id="H025C84D6AA934D4B9F74CAB2596DBE1F"><enum>(2)</enum><header>Effective date</header><text>The amendment made by paragraph (1) shall take effect on October 1, 2020.</text></paragraph></subsection>
<subsection id="HDFA3FE22A6404F34BCCFB7188B8CC4E7"><enum>(c)</enum><header>Increase in funding</header><text>Section 511(j)(1) of such Act (42 U.S.C. 711(j)(1)) is amended—</text>
<paragraph id="H6A42B9C97BE84A0A885D0C6AF52BBF0D"><enum>(1)</enum><text>by striking <quote>and</quote> at the end of subparagraph (G); and</text></paragraph>
<paragraph id="H9D363CDC67A8452EA2B277D2E51D2320"><enum>(2)</enum><text>by striking subparagraph (H) and inserting the following:</text>
<quoted-block style="OLC" id="H16449C6AC3F44E9480913928EAEF375C" display-inline="no-display-inline">
<subparagraph id="H9A3FE80EA369463596351B7DF0AF038A"><enum>(H)</enum><text display-inline="yes-display-inline">$400,000,000 for each of fiscal years 2017 through 2020;</text></subparagraph>
<subparagraph id="H93FEA4A07FBD4B798657298F15CE0E00"><enum>(I)</enum><text>$600,000,000 for fiscal year 2021; and</text></subparagraph>
<subparagraph id="H9AFCC521408045C5A61C5FC237D098C4"><enum>(J)</enum><text>$800,000,000 for fiscal year 2022.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="H955459D43A9745E192F24D6EE5CE7446"><enum>(d)</enum><header>Use of additional funds</header><text>Section 511(c) of such Act (42 U.S.C. 711(c)) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="HAAD6752B890C4700955436A7A067AC06" display-inline="no-display-inline">
<paragraph id="HDC35643065BD4DA8AC4F040A42BF403E"><enum>(6)</enum><header>Use of certain funds to provide additional resources to address high rates of maternal mortality and morbidity, support unmet needs identified by the needs assessment, or increase allocations to States and territories based on relative population or poverty</header><text display-inline="yes-display-inline">The Secretary shall ensure that any amounts exceeding $400,000,000 that are used for grants under this subsection for a fiscal year are used to—</text>
<subparagraph id="H5E62132C2F2E434E8ABD43F769F19097"><enum>(A)</enum><text display-inline="yes-display-inline">provide additional funding priority to States, tribes, and territories to address high rates of maternal mortality and morbidity;</text></subparagraph>
<subparagraph id="HC574E93F4E4C41F0A5F31EE1B21B5795"><enum>(B)</enum><text>address unmet needs identified by a needs assessment conducted under subsection (b); or</text></subparagraph>
<subparagraph id="HAAD84B0D8BEB41039F78D30BF7E44CE4"><enum>(C)</enum><text display-inline="yes-display-inline">increase the amounts allocated under this section to States and to Puerto Rico, Guam, the Virgin Islands, the Northern Mariana Islands, and American Samoa, based on the proportion of children who have not attained 5 years of age and are living in poverty.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section>