117 S2164 IS: Lower Costs, More Cures Act of 2021
U.S. Senate
2021-06-22
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EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.This Act may be cited as the Lower Costs, More Cures Act of 2021
.2.The table of contents for this Act is as follows:Sec. 1. Short title.Sec. 2. Table of contents.TITLE I—Medicare and Medicaid ProvisionsSubtitle A—Medicare Part B Provisions Sec. 101. Improvements to Medicare site-of-service transparency.Sec. 102. Requiring manufacturers of certain single-dose container or single-use package drugs payable under part B of the Medicare program to provide refunds with respect to discarded amounts of such drugs.Sec. 103. Providing for variation in payment for certain drugs covered under part B of the Medicare program.Sec. 104. Establishment of maximum add-on payment for drugs and biologicals.Sec. 105. Treatment of drug administration services furnished by certain excepted off-campus outpatient departments of a provider.Sec. 106. Payment for biosimilar biological products during initial period.Sec. 107. Credit under the Medicare Merit-Based Incentive Payment System for completion of a clinical medical education program on biosimilar biological products.Sec. 108. GAO study and report on average sales price.Subtitle B—Medicare Part D ProvisionsSec. 111. Medicare part D benefit redesign.Sec. 112. Allowing the offering of additional prescription drug plans under Medicare part D.Sec. 113. Allowing certain enrollees of prescription drug plans and MA–PD plans under the Medicare program to spread out cost-sharing under certain circumstances.Sec. 114. Continuation of Part D Senior Savings Model.Sec. 115. Requiring prescription drug plans and MA–PD plans to report potential fraud, waste, and abuse to the Secretary of HHS.Sec. 116. Establishment of pharmacy quality measures under Medicare part D.Subtitle C—Medicaid provisionsSec. 121. Price reporting clarifications for gene therapy outcomes-based agreements.Sec. 122. Anti-kickback statute and physician self-referral safe harbors.Sec. 123. GAO study and report on use of outcomes-based agreements.TITLE II—Drug Price Transparency ProvisionsSec. 201. Reporting on explanation for drug price increases.Sec. 202. Public disclosure of drug discounts.Sec. 203. Making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities.Sec. 204. Sense of the Senate regarding the need to expand commercially available drug pricing comparison platforms.TITLE III—Revenue ProvisionSec. 301. Inclusion of insulin and other treatments for chronic conditions as preventive care.TITLE IV—Miscellaneous ProvisionsSec. 401. Improving coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services.Sec. 402. Patient consultation in Medicare national and local coverage determinations in order to mitigate barriers to inclusion of such perspectives.Sec. 403. MedPAC report on shifting coverage of certain Medicare part B drugs to Medicare part D.Sec. 404. Authority to require that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information.Sec. 405. Chief Pharmaceutical Negotiator at the Office of the United States Trade Representative.<enum>I</enum><header>Medicare and Medicaid Provisions</header><subtitle id="H843DDA9F8CFA4FBB8D15CBB110973998"><enum>A</enum><header>Medicare Part B Provisions </header><section id="H01F577DBB25B43DC978F2525CEDD817F"><enum>101.</enum><header>Improvements to Medicare site-of-service transparency</header><text display-inline="no-display-inline">Section 1834(t) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(t)</external-xref>) is amended—</text><paragraph id="HE9AA188A17CE4FA78DD9D74D2739E787"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text><subparagraph id="H4634A8996EAD4D518B269B3F4D98F84F"><enum>(A)</enum><text>in the heading, by striking <quote><header-in-text level="paragraph" style="OLC">In general</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Site payment</header-in-text></quote>;</text></subparagraph><subparagraph id="HCA923E90EDD849B2974AF13916926B7D"><enum>(B)</enum><text>in the matter preceding subparagraph (A)—</text><clause id="HBC724FFCBE8444D49BF02B64A056BA05"><enum>(i)</enum><text>by striking <quote>or to</quote> and inserting <quote>, to</quote>;</text></clause><clause id="HE2454118A91043F58B4676315C767D25"><enum>(ii)</enum><text>by inserting <quote>, or to a physician for services furnished in a physician’s office</quote> after <quote>surgical center under this title</quote>; and</text></clause><clause id="H03765D45F73D44518786F563737A7D0E"><enum>(iii)</enum><text>by inserting <quote>(or 2022 with respect to a physician for services furnished in a physician’s office)</quote> after <quote>2018</quote>; and</text></clause></subparagraph><subparagraph id="H1D99B595C5EC4C569B8CC30C7DF0D041"><enum>(C)</enum><text>in subparagraph (A)—</text><clause id="HAD91CEC9D3C94D6C8A9835855FF649AB"><enum>(i)</enum><text>by striking <quote>and the</quote> and inserting <quote>, the</quote>; and</text></clause><clause id="H64EF3E67F038481B868D5D898966E137"><enum>(ii)</enum><text>by inserting <quote>, and the physician fee schedule under section 1848 (with respect to the practice expense component of such payment amount)</quote> after <quote>such section</quote>;</text></clause></subparagraph></paragraph><paragraph id="H6D782172CD51449889C6D96FE8604ECF"><enum>(2)</enum><text>by redesignating paragraphs (2) through (4) as paragraphs (3) through (5), respectively; and</text></paragraph><paragraph id="H9BC9F7D10A9841A8AF1F4A98944599FE"><enum>(3)</enum><text>by inserting after paragraph (1) the following new paragraph:</text><quoted-block style="OLC" id="HB81BBDD0049F45A4B3422C374921253B"><paragraph id="H63FB7D9DF55540A7A976455DE08A6249"><enum>(2)</enum><header>Physician payment</header><text>Beginning in 2022, the Secretary shall expand the information included on the internet website described in paragraph (1) to include—</text><subparagraph id="H8337E67BDE5A4F1BB52663CFF266FCA0"><enum>(A)</enum><text>the amount paid to a physician under section 1848 for an item or service for the settings described in paragraph (1); and</text></subparagraph><subparagraph id="H1638C804F3E743EE8C46F752C1CB60FC"><enum>(B)</enum><text>the estimated amount of beneficiary liability applicable to the item or service.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="H4FCCD7B53DEC4613B2AA06ED97D906AD"><enum>102.</enum><header>Requiring manufacturers of certain single-dose container or single-use package drugs payable under part B of the Medicare program to provide refunds with respect to discarded amounts of such drugs</header><text display-inline="no-display-inline">Section 1847A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395-3a">42 U.S.C. 1395–3a</external-xref>) is amended—</text><paragraph id="id44c6f004c92c4671949a6c5f904b3eeb"><enum>(1)</enum><text>by redesignating subsection (h) as subsection (i); and</text></paragraph><paragraph id="id5c3b4edb032d4653973a9c13b5046566"><enum>(2)</enum><text>by inserting after subsection (g) the following new subsection: </text><quoted-block style="OLC" display-inline="no-display-inline" id="H3873F9A125484D04BE7ADCD2075894DC"><subsection id="H1AAA600B2A4B4A91A32A2529A737544B"><enum>(h)</enum><header>Refund for certain discarded single-Dose container or single-Use package drugs</header><paragraph id="HFB84ABEF10AC42E49CC3CE7BFCBAEF4B"><enum>(1)</enum><header>Secretarial provision of information</header><subparagraph id="H8C0BD872D3D2496A8262D78B337A0E70"><enum>(A)</enum><header>In general</header><text>For each calendar quarter beginning on or after July 1, 2022, the Secretary shall, with respect to a refundable single-dose container or single-use package drug (as defined in paragraph (8)), report to each manufacturer (as defined in subsection (c)(6)(A)) of such refundable single-dose container or single-use package drug the following for the calendar quarter:</text><clause id="H36C402161E294975A92BD554DC1F57B6"><enum>(i)</enum><text>Subject to subparagraph (C), information on the total number of units of the billing and payment code of such drug, if any, that were discarded during such quarter, as determined using a mechanism such as the JW modifier used as of the date of enactment of this subsection (or any such successor modifier that includes such data as determined appropriate by the Secretary).</text></clause><clause id="H94D70F00215A4CCFB6329E8D48C5F0AB"><enum>(ii)</enum><text>The refund amount that the manufacturer is liable for pursuant to paragraph (3).</text></clause></subparagraph><subparagraph id="H83BB5D5B5B6A40CCB98E19C428A54DB6"><enum>(B)</enum><header>Determination of discarded amounts</header><text>For purposes of subparagraph (A)(i), with respect to a refundable single-dose container or single-use package drug furnished during a quarter, the amount of such drug that was discarded shall be determined based on the amount of such drug that was unused and discarded for each drug on the date of service.</text></subparagraph><subparagraph id="H812D002F2EDB4C3DBE1583AA2EE4B6DB"><enum>(C)</enum><header>Exclusion of units of packaged drugs</header><text>The total number of units of the billing and payment code of a refundable single-dose container or single-use package drug of a manufacturer furnished during a calendar quarter for purposes of subparagraph (A)(i), and the determination of the estimated total allowed charges for the drug in the quarter for purposes of paragraph (3)(A)(ii), shall not include such units that are packaged into the payment amount for an item or service and are not separately payable.</text></subparagraph></paragraph><paragraph id="H00DC55E7A7A640FD949AC0A41BCA38F6"><enum>(2)</enum><header>Manufacturer requirement</header><text>For each calendar quarter beginning on or after July 1, 2022, the manufacturer of a refundable single-dose container or single-use package drug shall, for such drug, provide to the Secretary a refund that is equal to the amount specified in paragraph (3) for such drug for such quarter.</text></paragraph><paragraph id="H84B08478FF6B492483CC305C93C60D78"><enum>(3)</enum><header>Refund amount</header><subparagraph id="H4CF4F9B6443541DD999C3B88B05ACC57"><enum>(A)</enum><header>In general</header><text>The amount of the refund specified in this paragraph is, with respect to a refundable single-dose container or single-use package drug of a manufacturer assigned to a billing and payment code for a calendar quarter beginning on or after July 1, 2022, an amount equal to the estimated amount (if any) by which—</text><clause id="H0FBD00F85E124B32B98D90BD6C26A057"><enum>(i)</enum><text>the product of—</text><subclause id="HBD2EC55094034D56B9A9A008379E934F"><enum>(I)</enum><text>the total number of units of the billing and payment code for such drug that were discarded during such quarter (as determined under paragraph (1)); and</text></subclause><subclause id="H366BFD08CEE64F27AF359D4C24526190"><enum>(II)</enum><item commented="no" display-inline="yes-display-inline" id="HBE513A7FDD824CB7AF581CE541A2BA74"><enum>(aa)</enum><text>in the case of a refundable single-dose container or single-use package drug that is a single source drug or biological, the amount determined for such drug under subsection (b)(4); or</text></item><item id="H63B0F4790D774CA7802ABBECDCD07784" indent="up1"><enum>(bb)</enum><text>in the case of a refundable single-dose container or single-use package drug that is a biosimilar biological product, the average sales price determined under subsection (b)(8)(A); exceeds</text></item></subclause></clause><clause id="H605234BAD8284F349D9974B010B9ED72"><enum>(ii)</enum><text>an amount equal to the applicable percentage (as defined in subparagraph (B)) of the estimated total allowed charges for such drug during the quarter.</text></clause></subparagraph><subparagraph id="H4727E3814CD44231B08412D269E08CB6"><enum>(B)</enum><header>Applicable percentage defined</header><clause id="H4BDD1B5808BE4BFBAD3431C9543DA262"><enum>(i)</enum><header>In general</header><text>For purposes of subparagraph (A)(ii), the term <term>applicable percentage</term> means—</text><subclause id="HDA1EC6FC4FA043EB8B726DA61962D06C"><enum>(I)</enum><text>subject to subclause (II), 10 percent; and</text></subclause><subclause id="H5A4BFCC6D6BF4056911D1F4A3F05195B"><enum>(II)</enum><text>if applicable, in the case of a refundable single-dose container or single-use package drug described in clause (ii), a percentage specified by the Secretary pursuant to such clause.</text></subclause></clause><clause commented="no" id="HDA13C4A0A99E4D6EBC2E9C4C02C12631"><enum>(ii)</enum><header>Treatment of drugs that have unique circumstances</header><text display-inline="yes-display-inline">In the case of a refundable single-dose container or single-use package drug that has unique circumstances involving similar loss of product as that described in paragraph (8)(B), the Secretary, through notice and comment rulemaking, may increase the applicable percentage otherwise applicable under clause (i)(I) as determined appropriate by the Secretary.</text></clause></subparagraph></paragraph><paragraph id="H1EA6CE2512BA45E1BB5060F2FD7017A7"><enum>(4)</enum><header>Frequency</header><text>Amounts required to be refunded pursuant to paragraph (2) shall be paid in regular intervals (as determined appropriate by the Secretary).</text></paragraph><paragraph id="HF28BE54770324741BB90C4CCFE520A4B"><enum>(5)</enum><header>Refund deposits</header><text>Amounts paid as refunds pursuant to paragraph (2) shall be deposited into the Federal Supplementary Medical Insurance Trust Fund established under section 1841.</text></paragraph><paragraph id="H9685C9AC249847DAAF26E187E2834A3A"><enum>(6)</enum><header>Enforcement</header><subparagraph id="H455439DE0C2C4DB3BF962B618971D0FF"><enum>(A)</enum><header>Audits</header><clause id="HCE7C544555DC413194BEB50B636A2534"><enum>(i)</enum><header>Manufacturer audits</header><text>Each manufacturer of a refundable single-dose container or single-use package drug that is required to provide a refund under this subsection shall be subject to periodic audit with respect to such drug and such refunds by the Secretary.</text></clause><clause id="H27E0F93528DF42A796D5E98779B5B657"><enum>(ii)</enum><header>Provider audits</header><text>The Secretary shall conduct periodic audits of claims submitted under this part with respect to refundable single-dose container or single-use package drugs in accordance with the authority under section 1833(e) to ensure compliance with the requirements applicable under this subsection.</text></clause></subparagraph><subparagraph id="H6A2E18513013447E8DA0F196A5F53548"><enum>(B)</enum><header>Civil money penalty</header><clause id="H3EC369496D764EA281186881EA730357"><enum>(i)</enum><header>In general</header><text>The Secretary shall impose a civil money penalty on a manufacturer of a refundable single-dose container or single-use package drug who has failed to comply with the requirement under paragraph (2) for such drug for a calendar quarter in an amount equal to the sum of—</text><subclause id="HBA5553CFE91A47CE92E28571C9141874"><enum>(I)</enum><text>the amount that the manufacturer would have paid under such paragraph with respect to such drug for such quarter; and</text></subclause><subclause id="H9AC7732E2C9A466397C1084CB143B3DB"><enum>(II)</enum><text>25 percent of such amount.</text></subclause></clause><clause id="H7E2B458540614AAB89BAA4B2F2A502B9"><enum>(ii)</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 subparagraph in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).</text></clause></subparagraph></paragraph><paragraph id="H3E39001B38E4465595EF7E3D19ACBD92"><enum>(7)</enum><header>Implementation</header><text>The Secretary shall implement this subsection through notice and comment rulemaking.</text></paragraph><paragraph id="H0A00C0D3C16A49AC8EBBFFA4C316F089"><enum>(8)</enum><header>Definition of refundable single-dose container or single-use package drug</header><subparagraph id="H0FBA948D346B4EB6BB1CB3E4038ADEDB"><enum>(A)</enum><header>In general</header><text>Except as provided in subparagraph (B), in this subsection, the term <term>refundable single-dose container or single-use package drug</term> means a single source drug or biological (as defined in section 1847A(c)(6)(D)) or a biosimilar biological product (as defined in section 1847A(c)(6)(H)) for which payment is established under this part and that is furnished from a single-dose container or single-use package.</text></subparagraph><subparagraph commented="no" id="H8FE3F6EE09B2401F91ECE7A2CA4D0A90"><enum>(B)</enum><header>Exclusions</header><text>The term <term>refundable single-dose container or single-use package drug</term> does not include—</text><clause commented="no" id="H20AD00ED5F6C480F8622A116B8D96190"><enum>(i)</enum><text>a drug or biological that is either a radiopharmaceutical or an imaging agent;</text></clause><clause commented="no" id="H5C7F7286545949B391D4EBDF1AD33A77"><enum>(ii)</enum><text>a drug or biological for which dosage and administration instructions approved by the Commissioner of Food and Drugs require filtration during the drug preparation process, prior to dilution and administration, and require that any unused portion of such drug after the filtration process be discarded after the completion of such filtration process; or</text></clause><clause commented="no" id="H2EDFA2674B3B4C0BABBC9C36C892593B"><enum>(iii)</enum><text>a drug or biological approved by the Food and Drug Administration on or after the date of enactment of this subsection and with respect to which payment has been made under this part for less than 18 months.</text></clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="H214A140256D04393A4772F7873BE74AB"><enum>103.</enum><header>Providing for variation in payment for certain drugs covered under part B of the Medicare program</header><subsection id="H52926043673F4FA3BE728EF7611E20E8"><enum>(a)</enum><header>In general</header><text>Section 1847A(b) of the Social Security Act (42 U.S.C. 1395w–3a(b)) is amended—</text><paragraph id="HFE97CC95D11142148200AD00A0CC653F"><enum>(1)</enum><text>in paragraph (1)—</text><subparagraph id="HFCE77F5AF8734527B152D131213ED1EF"><enum>(A)</enum><text>in subparagraph (A), by inserting after <quote>or 106 percent</quote> the following: <quote>(or, for a multiple source drug (other than autologous cellular immunotherapy) furnished on or after January 1, 2022, the applicable percent specified in paragraph (9)(A) for the drug and quarter involved)</quote>; and</text></subparagraph><subparagraph id="H016258DA11134AFBAE21E85A800AC6A1"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (B) of paragraph (1), by inserting after <quote>106 percent</quote> the following: <quote>(or, for a single source drug or biological (other than autologous cellular immunotherapy) furnished on or after January 1, 2022, the applicable percent specified in paragraph (9)(A) for the drug or biological and quarter involved)</quote>; and</text></subparagraph></paragraph><paragraph id="H890EAE0760D94EA8B248BDA1CCF440F1"><enum>(2)</enum><text>by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H7B7820AC62954513B4FAF81AA3136CC6"><paragraph id="HBED3B6226DA443B9A51F54401DB98750"><enum>(9)</enum><header>Application of variable percentages based on percentile ranking of per beneficiary allowed charges</header><subparagraph id="H7A6D5752CBDB4FEDACB6E7E4695259F3"><enum>(A)</enum><header>Applicable percent to be applied</header><clause id="H3A3EA227596B4D5285D2008B5B792419"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to clause (ii), with respect to a drug or biological furnished in a calendar quarter beginning on or after January 1, 2022, if the Secretary determines that the percentile rank of a drug or biological under subparagraph (B)(i)(III), with respect to per beneficiary allowed charges for all such drugs or biologicals, is—</text><subclause id="H46F922ACF6AA41099FDF37485F275A43"><enum>(I)</enum><text>at least equal to the 85th percentile, the applicable percent for the drug for such quarter under this subparagraph is 104 percent;</text></subclause><subclause id="HCE7B188BA07E4E61A28001969FEA3822"><enum>(II)</enum><text display-inline="yes-display-inline">at least equal to the 70th percentile, but less than the 85th percentile, such applicable percent is 106 percent;</text></subclause><subclause display-inline="no-display-inline" id="H0B3E1455A70445719CD696662AD37937"><enum>(III)</enum><text display-inline="yes-display-inline">at least equal to the 50th percentile, but less than the 70th percentile, such applicable percent is 108 percent; or</text></subclause><subclause display-inline="no-display-inline" id="H7A1F36A94F894823B2926075B6B2D45C"><enum>(IV)</enum><text display-inline="yes-display-inline">less than the 50th percentile, such applicable percent is 110 percent.</text></subclause></clause><clause commented="no" id="HFCD450C84A514457A73C0371A7115A15"><enum>(ii)</enum><header>Cases where data not sufficiently available to compute per beneficiary allowed charges</header><text display-inline="yes-display-inline">Subject to clause (iii), in the case of a drug or biological furnished for which the amount of payment is determined under subparagraph (A) or (B) of paragraph (1) and not under subsection (c)(4), for calendar quarters during a period in which data are not sufficiently available to compute a per beneficiary allowed charges for the drug or biological, the applicable percent is 106 percent.</text></clause></subparagraph><subparagraph id="H36A9D7C6EE614A3C8679781797618B52"><enum>(B)</enum><header>Determination of percentile rank of per beneficiary allowed charges of drugs</header><clause id="H0FE3F8A7F5A145F699FD0D559847F877"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">With respect to a calendar quarter beginning on or after January 1, 2022, for drugs and biologicals for which the amount of payment is determined under subparagraph (A) or (B) of paragraph (1), except for drugs or biologicals for which data are not sufficiently available, the Secretary shall—</text><subclause id="H26719D7F07B040188FDF2E7F8533C3D8"><enum>(I)</enum><text>compute the per beneficiary allowed charges (as defined in <internal-xref idref="HE908821171B943069C2822D902D6696C" legis-path="(9)(C)">subparagraph (C)</internal-xref>) for each such drug or biological;</text></subclause><subclause commented="no" id="H3897B224BD2A47A191F794968DB92E51"><enum>(II)</enum><text>adjust such per beneficiary allowed charges for the quarter, to the extent provided under subparagraph (D); and</text></subclause><subclause id="H3ABF4D8D6698427DAD27051167262524"><enum>(III)</enum><text display-inline="yes-display-inline">arrange such adjusted per beneficiary allowed charges for all such drugs or biologicals from high to low and rank such drugs or biologicals by percentile of such per beneficiary allowed charges.</text></subclause></clause><clause id="H2A10815C1C9240E5B6F672BB56860A01"><enum>(ii)</enum><header>Frequency</header><text>The Secretary shall make the computations under clause (i)(I) every 6 months (or, if necessary, as determined by the Secretary, every 9 or 12 months) and such computations shall apply to succeeding calendar quarters until a new computation has been made.</text></clause><clause commented="no" id="HBFCC7CBB1CF741CB84708811F0C9463A"><enum>(iii)</enum><header>Applicable data period</header><text>For purposes of this paragraph, the term <term>applicable data period</term> means the most recent period for which the data necessary for making the computations under <internal-xref idref="H0FE3F8A7F5A145F699FD0D559847F877" legis-path="(9)(B)(i)">clause (i)</internal-xref> are available, as determined by the Secretary.</text></clause></subparagraph><subparagraph id="HE908821171B943069C2822D902D6696C"><enum>(C)</enum><header>Per beneficiary allowed charges defined</header><text display-inline="yes-display-inline">In this paragraph, the term <term>per beneficiary allowed charges</term> means, with respect to a drug or biological for which the amount of payment is determined under subparagraph (A) or (B) of paragraph (1)—</text><clause id="HC980A27DF5154480AFB465AD368795DA"><enum>(i)</enum><text display-inline="yes-display-inline">the allowed charges for the drug or biological for which payment is so made for the applicable data period, as estimated by the Secretary; divided by</text></clause><clause id="HD1CDFF7319914F38B351E292994C0CBB"><enum>(ii)</enum><text display-inline="yes-display-inline">the number of individuals for whom any payment for the drug or biological was made under paragraph (1) for the applicable data period, as estimated by the Secretary.</text></clause></subparagraph><subparagraph commented="no" id="HEEC63E4CD52B45558C7D0FB976C45124"><enum>(D)</enum><header>Adjustment to reflect changes in average sales price</header><text>In applying this paragraph for a particular calendar quarter, the Secretary shall adjust the per beneficiary allowed charges for a drug or biological by multiplying such per beneficiary allowed charges under subparagraph (C) for the applicable data period by the ratio of—</text><clause commented="no" id="H36D06C59E2E7421C9CA22E0F8CAEC35B"><enum>(i)</enum><text>the average sales price for the drug or biological for the most recent calendar quarter used under subsection (c)(5)(B); to</text></clause><clause commented="no" id="HE274838CF2564A46B243F984DA77FECD"><enum>(ii)</enum><text display-inline="yes-display-inline">the average sales price for the drug or biological for the calendar quarter (or the weighted average for the quarters involved) included in the applicable data period.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HFE44F074F9584F28A27B7197AE2732AB"><enum>(b)</enum><header>Application of judicial review provisions</header><text>Section 1847A(i) of the Social Security Act (42 U.S.C. 1395w–3a(i)), as redesignated by section 102, is amended—</text><paragraph id="H665B63F9E2514BA38D5EECF606589FDD"><enum>(1)</enum><text>by striking <quote>and</quote> at the end of paragraph (4);</text></paragraph><paragraph id="H34776AD2F27D45AA872A15D051EC4A06"><enum>(2)</enum><text>by striking the period at the end of paragraph (5) and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="H18FA34983D074BF3865CE907B1D11E2A"><enum>(3)</enum><text>by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H62C9948F89C947139A7F85A08D529C22"><paragraph id="H8046E57A28464416B25F0249FE0EC402"><enum>(6)</enum><text display-inline="yes-display-inline">the determination of per beneficiary allowed charges of drugs or biologicals and ranking of such charges under subsection (b)(9).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section id="H8FA8E4F4558B469F821408EF81F871CC"><enum>104.</enum><header>Establishment of maximum add-on payment for drugs and biologicals</header><subsection id="H9286BFEB45E2468B98DEA4A24795F313"><enum>(a)</enum><header>In general</header><text>Section 1847A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-3a">42 U.S.C. 1395w–3a</external-xref>), as amended by section 103, is amended—</text><paragraph id="H37FAD84BD67C41EA97A0E8140E862727"><enum>(1)</enum><text>in subsection (b)—</text><subparagraph id="H2A44116F373D4B268A224D1273F504E5"><enum>(A)</enum><text>in paragraph (1), in the matter preceding subparagraph (A), by striking <quote>paragraph (7)</quote> and inserting <quote>paragraphs (7) and (10)</quote>; and</text></subparagraph><subparagraph id="H197AFC528F704853BCAE2CB7DA1C07A9"><enum>(B)</enum><text>by adding at the end the following new paragraph:</text><quoted-block style="OLC" id="H22D4540168354275A15186F442D1E1FD"><paragraph id="H38B8569E2D3C4294AD41B4E39232AFB1"><enum>(10)</enum><header>Maximum add-on payment amount</header><subparagraph id="HF96FC1189DAB4D0FBD5D2C25DE32ED91"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">In determining the payment amount under the provisions of subparagraph (A), (B), or (C) of paragraph (1) of this subsection, subsection (c)(4)(A)(ii), or subsection (d)(3)(C) for a drug or biological furnished on or after January 1, 2022, if the applicable add-on payment (as defined in subparagraph (B)) for each drug or biological on a claim for a date of service exceeds the maximum add-on payment amount specified under subparagraph (C) for the drug or biological, then the payment amount otherwise determined for the drug or biological under those provisions, as applicable, shall be reduced by the amount of such excess.</text></subparagraph><subparagraph id="H2061A287CD21421EA5BDE1A3FE0589D5"><enum>(B)</enum><header>Applicable add-on payment defined</header><text>In this paragraph, the term <term>applicable add-on payment</term> means the following amounts, determined without regard to the application of subparagraph (A):</text><clause id="H3F5EDD89B1FF4BB8A1F1A998D7D0C33D"><enum>(i)</enum><text>In the case of a multiple source drug, an amount equal to the difference between—</text><subclause id="H767B05A05EC748C0ACB1C61394E47CEF"><enum>(I)</enum><text>the amount that would otherwise be applied under paragraph (1)(A); and</text></subclause><subclause id="H7C0A662A548944FAA006760E05381E6A"><enum>(II)</enum><text>the amount that would be applied under such paragraph if <quote>100 percent</quote> were substituted for the applicable percent (as defined in paragraph (9)) for such drug.</text></subclause></clause><clause id="H5E02DF2FF1B6470BA73323BE7ABEC5F6"><enum>(ii)</enum><text>In the case of a single source drug or biological, an amount equal to the difference between—</text><subclause id="HB93EDEAE36BA4E20BBF1EB96B8E88A1D"><enum>(I)</enum><text>the amount that would otherwise be applied under paragraph (1)(B); and</text></subclause><subclause id="H4354263D366748208D06953CFD3A4488"><enum>(II)</enum><text>the amount that would be applied under such paragraph if <quote>100 percent</quote> were substituted for the applicable percent (as defined in paragraph (9)) for such drug or biological.</text></subclause></clause><clause id="H5DD89021C4E941E893584EE0841B68F5"><enum>(iii)</enum><text>In the case of a biosimilar biological product, the amount otherwise determined under paragraph (8)(B).</text></clause><clause id="H0612D15FB36449A2A375FF868B1F7360"><enum>(iv)</enum><text>In the case of a drug or biological during the initial period described in subsection (c)(4)(A), an amount equal to the difference between—</text><subclause id="H9E93892749DC470EBD6ADC6E587362E8"><enum>(I)</enum><text>the amount that would otherwise be applied under subsection (c)(4)(A)(ii); and</text></subclause><subclause id="H8CE5FBB0AEA44EEE901969D5852F5771"><enum>(II)</enum><text>the amount that would be applied under such subsection if <quote>100 percent</quote> were substituted, as applicable, for—</text><item id="H55308141A537488589F4F2936F6F6477"><enum>(aa)</enum><text><quote>103 percent</quote> in subclause (I) of such subsection; or</text></item><item id="HD38856F9F2654AACBC7C0DAF6F59D6DD"><enum>(bb)</enum><text>any percent in excess of 100 percent applied under subclause (II) of such subsection.</text></item></subclause></clause><clause id="HE7FEA04FC2CD4E3D8CA87F2DDAE7421E"><enum>(v)</enum><text>In the case of a drug or biological to which subsection (d)(3)(C) applies, an amount equal to the difference between—</text><subclause id="H0C58255F1D5A4BE7AD603D03E97B7BDA"><enum>(I)</enum><text>the amount that would otherwise be applied under such subsection; and</text></subclause><subclause id="H80BB6CDC7E344908B910776864070F1C"><enum>(II)</enum><text>the amount that would be applied under such subsection if <quote>100 percent</quote> were substituted, as applicable, for—</text><item id="HCC65A7FB086E431E9486FB8C897B354A"><enum>(aa)</enum><text>any percent in excess of 100 percent applied under clause (i) of such subsection; or</text></item><item id="H77D1332443FA4C2D8776894D65E0A868"><enum>(bb)</enum><text><quote>103 percent</quote> in clause (ii) of such subsection.</text></item></subclause></clause></subparagraph><subparagraph id="HD6440FD8D6164AFE9CDEB4FF9886C440"><enum>(C)</enum><header>Maximum add-on payment amount specified</header><text>For purposes of subparagraph (A), the maximum add-on payment amount specified in this subparagraph is—</text><clause id="H2764264182D947A0B2283B3C9441EC18"><enum>(i)</enum><text display-inline="yes-display-inline">with respect to a drug or biological (other than autologous or allogeneric cellular immunotherapy)—</text><subclause id="H31F3F542065A4A42826B1C68EA71F925"><enum>(I)</enum><text>for each of 2022 through 2029, $1,000; and</text></subclause><subclause id="HE43E0CD2E4E84DF1A5F119F71F784C57"><enum>(II)</enum><text>for a subsequent year, the amount specified in this subparagraph for the preceding year increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) for the 12-month period ending with June of the previous year; or</text></subclause></clause><clause id="H240F7B9A8EA64E1382FEBAA732F150C4"><enum>(ii)</enum><text display-inline="yes-display-inline">with respect to a drug or biological consisting of autologous or allogeneric cellular immunotherapy—</text><subclause id="H0E4E5AD8B7CD4117A91E8349AAE98A87"><enum>(I)</enum><text>for each of 2022 through 2029, $2,000; and</text></subclause><subclause id="H05ACF73C3B6C4346AC03BA7419832FAF"><enum>(II)</enum><text>for a subsequent year, the amount specified in this subparagraph for the preceding year increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) for the 12-month period ending with June of the previous year.</text></subclause></clause><continuation-text continuation-text-level="subparagraph">Any amount determined under this subparagraph that is not a multiple of $10 shall be rounded to the nearest multiple of $10.</continuation-text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H7654E9BC6C524657B905162C67B9A921"><enum>(2)</enum><text>in subsection (c)(4)(A)(ii), by striking <quote>in the case</quote> and inserting <quote>subject to subsection (b)(10), in the case</quote>.</text></paragraph></subsection><subsection id="HEB96A164FB6B4505B5A69C2588357516"><enum>(b)</enum><header>Conforming amendments relating to separately payable drugs</header><paragraph id="H2F42C50AD5A546FD97DC4152F6F5F7EB"><enum>(1)</enum><header>OPPS</header><text>Section 1833(t)(14) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(t)(14)</external-xref>) is amended—</text><subparagraph id="H2B53AD50622948908C7EBDADC9DFD41C"><enum>(A)</enum><text>in subparagraph (A)(iii)(II), by inserting <quote>, subject to subparagraph (I)</quote> after <quote>are not available</quote>; and</text></subparagraph><subparagraph id="H1E3921772C7F461F9D0D0153C7E35DD9"><enum>(B)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="HC98479B0D2A142878530CF02F01CA82E"><subparagraph id="H5688817ABDC347BD9D80351D80939856"><enum>(I)</enum><header>Application of maximum add-on payment for separately payable drugs and biologicals</header><text>In establishing the amount of payment under subparagraph (A) for a specified covered outpatient drug that is furnished as part of a covered OPD service (or group of services) on or after January 1, 2022, if such payment is determined based on the average price for the year established under section 1847A pursuant to clause (iii)(II) of such subparagraph, the provisions of subsection (b)(10) of section 1847A shall apply to the amount of payment so established in the same manner as such provisions apply to the amount of payment under section 1847A.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HC92880FDE3B44DF681FB2CC74A847E32"><enum>(2)</enum><header>ASC</header><text>Section 1833(i)(2)(D) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(i)(2)(D)</external-xref>) is amended—</text><subparagraph id="HA2D9C14668EC412EB5B1CB9FF340ECD7"><enum>(A)</enum><text>by moving clause (v) 6 ems to the left;</text></subparagraph><subparagraph id="H297EC8D6CEA34AFABA62E6AB441A461E"><enum>(B)</enum><text>by redesignating clause (vi) as clause (vii); and</text></subparagraph><subparagraph id="HF4FEF7D53B9A490CA567F9421980E833"><enum>(C)</enum><text>by inserting after clause (v) the following new clause:</text><quoted-block style="OLC" id="HB4D3924F24BC41C1A5826B9399D79AEB"><clause id="H541DB0AFB4F24E468084D3CB7A923465"><enum>(vi)</enum><text>If there is a separate payment under the system described in clause (i) for a drug or biological furnished on or after January 1, 2022, the provisions of subsection (t)(14)(I) shall apply to the establishment of the amount of payment for the drug or biological under such system in the same manner in which such provisions apply to the establishment of the amount of payment under subsection (t)(14)(A).</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection></section><section id="H16796F40D2FB4063AED6E4E84861F746"><enum>105.</enum><header>Treatment of drug administration services furnished by certain excepted off-campus outpatient departments of a provider</header><text display-inline="no-display-inline">Section 1833(t)(16) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(t)(16)</external-xref>) is amended by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="H0872CCFA69934BF5A858E96015116553"><subparagraph id="H807853C115704BE79457D537D424BF1F"><enum>(G)</enum><header>Special payment rule for drug administration services furnished by an excepted department of a provider</header><clause id="H1D973D2689C246CDBB0C6709B458E3D9"><enum>(i)</enum><header>In general</header><text>In the case of a covered OPD service that is a drug administration service (as defined by the Secretary) furnished by a department of a provider described in clause (ii) or (iv) of paragraph (21)(B), the payment amount for such service furnished on or after January 1, 2022, shall be the same payment amount (as determined in paragraph (21)(C)) that would apply if the drug administration service was furnished by an off-campus outpatient department of a provider (as defined in paragraph (21)(B)).</text></clause><clause id="HBB1FE42D7CF44B9691BB4E448866BDCF"><enum>(ii)</enum><header>Application without regard to budget neutrality</header><text>The reductions made under this subparagraph—</text><subclause id="HFCCA509832AC4C95B5BA93596E956D34"><enum>(I)</enum><text>shall not be considered an adjustment under paragraph (2)(E); and</text></subclause><subclause id="HC7C58A607A6248E4821E9028E6D22F13"><enum>(II)</enum><text>shall not be implemented in a budget neutral manner.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H82DEDA5BEFB34E0E9166DBE919A5216F"><enum>106.</enum><header>Payment for biosimilar biological products during initial period</header><text display-inline="no-display-inline">Section 1847A(c)(4) of the Social Security Act (42 U.S.C. 1395w–3a(c)(4)) is amended—</text><paragraph id="H9E9133AB19EC4B34A7BE5FE2991A8C04"><enum>(1)</enum><text>in each of subparagraphs (A) and (B), by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively, and moving such subclauses 2 ems to the right;</text></paragraph><paragraph id="H2A7BF4142FBC438DAB42EE764B103F1A"><enum>(2)</enum><text>by redesignating subparagraphs (A) and (B) as clauses (i) and (ii) and moving such clauses 2 ems to the right;</text></paragraph><paragraph id="HF5C5464E88184E4186B882CFFDDB9910"><enum>(3)</enum><text>by striking <quote><header-in-text level="paragraph" style="OLC">unavailable</header-in-text>.—In the case</quote> and inserting “<header-in-text level="paragraph" style="OLC">unavailable</header-in-text>.—</text><quoted-block style="OLC" display-inline="no-display-inline" id="HE9932BC8675F49E19F4C9321A87F51F1"><subparagraph id="H97A309835D8D4AA6A394B85A02231266"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (B), in the case</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="H1AF18A118694451581C10101267E2DA0"><enum>(4)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H851BBBFC3BCA4B3698DD1F17775750E9"><subparagraph id="HB69C5C8131AC43789D11D9BE2368C697"><enum>(B)</enum><header>Limitation on payment amount for biosimilar biological products during initial period</header><text>In the case of a biosimilar biological product furnished on or after January 1, 2022, in lieu of applying subparagraph (A) during the initial period described in such subparagraph with respect to the biosimilar biological product, the amount payable under this section for the biosimilar biological product is the lesser of the following:</text><clause commented="no" id="HDF0CE3C45FF14DB5831C0767362D447F"><enum>(i)</enum><text>The amount determined under clause (ii) of such subparagraph for the biosimilar biological product.</text></clause><clause commented="no" display-inline="no-display-inline" id="H269A536120F942C484CF5733A41B3AC2"><enum>(ii)</enum><text>The amount determined under subsection (b)(1)(B) for the reference biological product.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="id83748AF233F9424889455FE80288C230"><enum>107.</enum><header>Credit under the Medicare Merit-Based Incentive Payment System for completion of a clinical medical education program on biosimilar biological products</header><text display-inline="no-display-inline">Section 1848(q)(5)(C) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-4">42 U.S.C. 1395w–4(q)(5)(C)</external-xref>) is amended by adding at the end the following new clause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H3C41C766A3B949D09034776F70B0F7E5"><clause id="HA70BBBFAA0C54E5BADF287BD4C128E6F"><enum>(iv)</enum><header>Clinical medical education program on biosimilar biological products</header><text display-inline="yes-display-inline">Completion of a clinical medical education program developed or improved under section 352A(b) of the Public Health Service Act by a MIPS eligible professional during a performance period shall earn such eligible professional one-half of the highest potential score for the performance category described in paragraph (2)(A)(iii) for such performance period. A MIPS eligible professional may only count the completion of such a program for purposes of such category one time during the eligible professional’s lifetime.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="HBFDB858259E74D7E847837E9856A8723"><enum>108.</enum><header>GAO study and report on average sales price</header><subsection id="HF5BD281CDB174B6EAE2B87A553B865F5"><enum>(a)</enum><header>Study</header><paragraph id="H954B4CB2530C4A879AECB71CCB6B31A6"><enum>(1)</enum><header>In general</header><text>The Comptroller General of the United States (in this section referred to as the <quote>Comptroller General</quote>) shall conduct a study on spending for applicable drugs under part B of title XVIII of the Social Security Act.</text></paragraph><paragraph id="HEFCDF2D96215447CA5D86039E1D8B371"><enum>(2)</enum><header>Applicable drugs defined</header><text>In this section, the term <term>applicable drugs</term> means drugs and biologicals—</text><subparagraph id="H547D7ADA69024764822D11FB035F66FD"><enum>(A)</enum><text>for which reimbursement under such part B is based on the average sales price of the drug or biological; and</text></subparagraph><subparagraph id="H90FE11ACD5AA4B668A16A6D71D9F9BF4"><enum>(B)</enum><text>that account for the largest percentage of total spending on drugs and biologicals under such part B (as determined by the Comptroller General, but in no case less than 25 drugs or biologicals).</text></subparagraph></paragraph><paragraph id="HA6A4A22249004E58B35268A69796DED6"><enum>(3)</enum><header>Requirements</header><text>The study under paragraph (1) shall include an analysis of the following:</text><subparagraph id="H5CFB71E658B84DEC90834BE79489290C"><enum>(A)</enum><text>The extent to which each applicable drug is paid for—</text><clause id="H3F4850DD7A70499FB5E35E1F851F02C1"><enum>(i)</enum><text>under such part B for Medicare beneficiaries; or</text></clause><clause id="H9E9DDF56AECD47D5BFE6CAB7858A3562"><enum>(ii)</enum><text>by private payers in the commercial market.</text></clause></subparagraph><subparagraph id="HB70FF5A5AF0A48AF8CC493B4083DA8F6"><enum>(B)</enum><text>Any change in Medicare spending or Medicare beneficiary cost-sharing that would occur if the average sales price of an applicable drug was based solely on payments by private payers in the commercial market.</text></subparagraph><subparagraph id="HAC336377A20B4B4EA4D6140ED581739A"><enum>(C)</enum><text>The extent to which drug manufacturers provide rebates, discounts, or other price concessions to private payers in the commercial market for applicable drugs, which the manufacturer includes in its average sales price calculation, for—</text><clause id="H0F0BBC202B7243D888BA4E167ECDD91D"><enum>(i)</enum><text>formulary placement;</text></clause><clause id="H1DCCB6E912A14C278DC4019DFD294621"><enum>(ii)</enum><text>utilization management considerations; or</text></clause><clause id="HAE59C3C503364E3C990E689E3B8EFFDE"><enum>(iii)</enum><text>other purposes.</text></clause></subparagraph><subparagraph id="HB9EEC18BD4CE43CC880A4B64AF30370A"><enum>(D)</enum><text>Barriers to drug manufacturers providing such price concessions for applicable drugs.</text></subparagraph><subparagraph id="H51770AFA3B864537970B2410DE9AD0AB"><enum>(E)</enum><text>Other areas determined appropriate by the Comptroller General.</text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H8C52FD581D36495D8F717CD9986433D2"><enum>(b)</enum><header>Report</header><text>Not later than 2 years after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report on the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Secretary determines appropriate.</text></subsection></section></subtitle><subtitle id="H66821CED3D454B53AF1BC76C9911F0D0"><enum>B</enum><header>Medicare Part D Provisions</header><section commented="no" id="HF612B44E0B8244789F1678F3568D4629"><enum>111.</enum><header>Medicare part D benefit redesign</header><subsection commented="no" id="HCE625EB0661D48FBB5576BCB86EFB3D0"><enum>(a)</enum><header>Benefit structure redesign</header><text>Section 1860D–2(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(b)</external-xref>) is amended—</text><paragraph commented="no" id="H25099531DD3943EE916911E1C0A59DC0"><enum>(1)</enum><text>in paragraph (2)—</text><subparagraph commented="no" id="H34790E4DD47A4B78816E788E35EA6F73"><enum>(A)</enum><text>in subparagraph (A)—</text><clause id="H5C57FEE380E34D39953FD3864B2B589F"><enum>(i)</enum><text>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></clause><clause id="H7AC2C3F807DB49E6ACBCDC6D93CA8BD3"><enum>(ii)</enum><text>in clause (i), by inserting after <quote>25 percent</quote> the following: <quote>(or, for 2022 and each subsequent year, 15 percent)</quote>; and</text></clause><clause id="idDB4A7BE3BFE14D7681C2B12B538F209E"><enum>(iii)</enum><text>in clause (ii), by inserting <quote>(or, for 2022 and each subsequent year, 15 percent)</quote> after <quote>25 percent</quote>;</text></clause></subparagraph><subparagraph commented="no" id="H98DF6E52434349FEAAAB6D380B85A3D9"><enum>(B)</enum><text>in subparagraph (C)—</text><clause commented="no" id="HB9FF5186425A40AE90D6EDB722D5655F"><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 commented="no" id="H4535217CF4AD455F850DD14622647DD4"><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 commented="no" id="H803A95A4C70C43F3A98CE51024EDA683"><enum>(C)</enum><text>in subparagraph (D)—</text><clause commented="no" id="H661B7A87C84D4B958A7D0AC6E28F5100"><enum>(i)</enum><text>in clause (i)—</text><subclause commented="no" id="HEBD41BB53C174B1BB6EDD1CE9C952320"><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 commented="no" id="HA48C1D9990D44EFBBD51BD23E4BCE84B"><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 commented="no" id="HF2FAB892F6544062990437079C38DAB4"><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 commented="no" id="HA5B85C6A421B4E61B6B33B7E21AA9583"><enum>(2)</enum><text>in paragraph (3)(A)—</text><subparagraph commented="no" id="HBAAA15CD04CB4DE9A37AC97092C77C83"><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 commented="no" id="H22B8F494A1994B788591F701BE88A3B9"><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 commented="no" id="HCFC6A9B96C234997BA345F4999E843EC"><enum>(3)</enum><text>in paragraph (4)—</text><subparagraph commented="no" id="H49A5F1C77BB24906A4CAC99A0CBBB402"><enum>(A)</enum><text>in subparagraph (A)—</text><clause commented="no" id="H07B908861CEF46369002B7E19E40820B"><enum>(i)</enum><text>in clause (i)—</text><subclause commented="no" id="H110C148EBAD74ACEBD66422DE48CF941"><enum>(I)</enum><text>by redesignating subclauses (I) and (II) as items (aa) and (bb), respectively, and indenting appropriately;</text></subclause><subclause commented="no" id="HF4A2BE1FC03B4636ABD118E7AD058AC3"><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</text><quoted-block style="OLC" display-inline="yes-display-inline" id="HCB93E0E4F9B844BF9743F70C5C8AC725"><text>is equal to—</text><subclause id="HCF3676EDD3BB42D2A6F501DD733E1A22"><enum>(I)</enum><text display-inline="yes-display-inline">for a year preceding 2022, the greater of—</text></subclause><after-quoted-block>;</after-quoted-block></quoted-block></subclause><subclause commented="no" id="H2A3CE05665D7422882BF256B097436E8"><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 commented="no" id="H79225326F73A418F955ADCF12088F22F"><enum>(IV)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" id="H1999406D0B88445C9B1744D19D89ECEB"><subclause commented="no" id="H625D11D815D940CB80EB09A74DE66660"><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 commented="no" id="H72C12A2B501240E1B62CFF8F3FE52079"><enum>(ii)</enum><text>in clause (ii)—</text><subclause commented="no" id="H94A122427BFA419B8484D64F024E0E89"><enum>(I)</enum><text>by striking <quote>clause (i)(I)</quote> and inserting <quote>clause (i)(I)(aa)</quote>; and</text></subclause><subclause commented="no" id="H92AAD2FF2A9848E39E0591EE0DDED798"><enum>(II)</enum><text>by adding at the end the following new sentence: <quote>The Secretary shall continue to calculate the dollar amounts specified in clause (i)(I)(aa), including with the adjustment under this clause, after 2021 for purposes of section 1860D–14(a)(1)(D)(iii).</quote>;</text></subclause></clause></subparagraph><subparagraph commented="no" id="H19CEE3BB8EE243A0B3EB391B972D3B22"><enum>(B)</enum><text>in subparagraph (B)—</text><clause commented="no" id="H30666DCD20C34653937C1D92A5FD4BAA"><enum>(i)</enum><text>in clause (i)—</text><subclause commented="no" id="H425DFA71DEFA4BFF81BD7C36967BFABC"><enum>(I)</enum><text>in subclause (V), by striking <quote>or</quote> at the end;</text></subclause><subclause commented="no" id="H00105BDDF80143A4B824E16B775B2A85"><enum>(II)</enum><text>in subclause (VI)—</text><item commented="no" id="HF6FFB811BAE04F89A75DBA063AA0A435"><enum>(aa)</enum><text>by striking <quote>for a subsequent year</quote> and inserting <quote>for 2021</quote>; and</text></item><item commented="no" id="H642F994C3E5F4FE09CA7D7547491754D"><enum>(bb)</enum><text>by striking the period at the end and inserting a semicolon; and</text></item></subclause><subclause commented="no" id="HAFE07BF8C01846DE9EC3BDB0EB72CCDA"><enum>(III)</enum><text>by adding at the end the following new subclauses:</text><quoted-block style="OLC" id="HE3F23DF04E964652BA49D642A8406E4E"><subclause commented="no" id="H36394755A101484CB345A92B94346699"><enum>(VII)</enum><text>for 2022, is equal to $3,100; or</text></subclause><subclause commented="no" id="H8828D602AC3444F3A4C21C25F9B4697B"><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 commented="no" id="H919FF72F91754BBC911E60910CEDF871"><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="H84B5893408CE4D31902E2181460DAE00"><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="HB4DD67C3AB0A46BEAF192EB139771CA1"><enum>(D)</enum><text>in subparagraph (E), by striking <quote>In applying</quote> and inserting <quote>For each of 2011 through 2021, in applying</quote>.</text></subparagraph></paragraph></subsection><subsection commented="no" id="H99C6412FE4764D43A502696984CBA1BC"><enum>(b)</enum><header>Decreasing reinsurance payment amount</header><text>Section 1860D–15(b)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-115">42 U.S.C. 1395w–115(b)(1)</external-xref>) is amended—</text><paragraph commented="no" id="HEF87941A6BD141A5BEE5ACC06C572F69"><enum>(1)</enum><text>by striking <quote>equal to 80 percent</quote> and inserting</text><quoted-block style="OLC" display-inline="yes-display-inline" id="H55B8BFFFA16B4818A772B079D83EC8D6"><text>equal to—</text><subparagraph id="HECFF220FBD6C49BDB33D4E911D420D5F"><enum>(A)</enum><text display-inline="yes-display-inline">for a year preceding 2022, 80 percent</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph commented="no" id="H5C34AAC3D86342FEAA69CCC7F5FB7A5E"><enum>(2)</enum><text>in subparagraph (A), as added by paragraph (1), by striking the period at the end and inserting <quote>; and</quote>; and</text></paragraph><paragraph commented="no" id="H766FF05B91654AD6A9CC27628F9DC165"><enum>(3)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="H6EA4227955C645038106E25916A7F523"><subparagraph commented="no" id="HB38CBDA8517A496A9A1DD9CB4B198628"><enum>(B)</enum><text>for 2022 and each subsequent year, the sum of—</text><clause commented="no" id="HD128F53303634152BCBDD7E904B71EF6"><enum>(i)</enum><text>an amount equal to 20 percent of the allowable reinsurance costs (as specified in paragraph (2)) attributable to that portion of gross covered prescription drug costs as specified in paragraph (3) incurred in the coverage year after such individual has incurred costs that exceed the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B) with respect to applicable drugs (as defined in section 1860D–14B(g)(2)); and</text></clause><clause commented="no" id="HD4217EE48DE74389848D9533EEE01085"><enum>(ii)</enum><text>an amount equal to 30 percent of the allowable reinsurance costs (as specified in paragraph (2)) attributable to that portion of gross covered prescription drug costs as specified in paragraph (3) incurred in the coverage year after such individual has incurred costs that exceed the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B) with respect to covered part D drugs that are not applicable drugs (as so defined).</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" id="H5B0AC3D890034AAA9D6C346FE9F819E7"><enum>(c)</enum><header>Manufacturer discount program</header><paragraph commented="no" id="H13178F28A82347B48DC11AB2AC1EE77A"><enum>(1)</enum><header>In general</header><text>Part D of title XVIII of the Social Security Act is amended by inserting after section 1860D–14A (<external-xref legal-doc="usc" parsable-cite="usc/42/1495w-114">42 U.S.C. 1495w–114</external-xref>) the following new section:</text><quoted-block style="OLC" id="H7615109A7A084D8EB407BA150A715112"><section commented="no" id="H8BBB7D99FB1C4E85A75C0EAB8C27C0C5"><enum>1860D–14B.</enum><header>Manufacturer discount program</header><subsection commented="no" id="H261381F0B6874B06B558CC4D8945D4F7"><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, 2023, in consultation with manufacturers, and allow for comment on such model agreement.</text></subsection><subsection commented="no" id="HF340F65ACA7947D993CDF91D7643216C"><enum>(b)</enum><header>Terms of agreement</header><paragraph commented="no" id="H2A746DBF516C46D7BC9BBD477F10EB2F"><enum>(1)</enum><header>In general</header><subparagraph commented="no" id="H7C27D188032B4F8586EDB5759960DAC3"><enum>(A)</enum><header>Agreement</header><text display-inline="yes-display-inline">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="HB264E3A47ACA4C139A9A71F008F67224"><enum>(B)</enum><header>Provision of discounted prices at the point-of-sale</header><text>The discounted prices described in subparagraph (A) shall be provided to the applicable beneficiary at the pharmacy or by the mail order service at the point-of-sale of an applicable drug.</text></subparagraph></paragraph><paragraph commented="no" id="HF3B3B1F5FA55466DBE41B3A642EC19AE"><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="H75829B768F924F58ABB691E7BC517489"><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 commented="no" id="H463D07287CA44346904430679AE73E32"><enum>(4)</enum><header>Length of agreement</header><subparagraph commented="no" id="H3A91EBB2A2664E0BAE17C7B702C0F976"><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 commented="no" id="H1D60CDD3337C4FA998EAB5028397B2A5"><enum>(B)</enum><header>Termination</header><clause commented="no" id="H9AA4126304A54090AB4A969764967C2B"><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 commented="no" id="H483E0F7862C140DFB97434AA4A213630"><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="H2892B3D16BD64F0CB044664AA9FCBC92"><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="HF4E306D027794721A9B65B47DBBE9A5A"><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="H9F8F6C62FA90408785F81405B15264AB"><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="H06D62CD0B89248B69986E9F35250425E"><enum>(iv)</enum><header>Notice to third party</header><text>The Secretary shall provide notice of such termination to a third party with a contract under subsection (d)(3) within not less than 30 days before the effective date of such termination.</text></clause></subparagraph></paragraph><paragraph commented="no" id="HF70204CDA63E4096AD7FC7B157EB3116"><enum>(5)</enum><header>Effective date of agreement</header><text>An agreement under this section shall take effect on a date determined appropriate by the Secretary, which may be at the start of a calendar quarter.</text></paragraph></subsection><subsection commented="no" id="HB2AA8839F6B5405183BDDCA588085E73"><enum>(c)</enum><header>Duties described</header><text>The duties described in this subsection are the following:</text><paragraph commented="no" id="HCC64C044BB91421293AF480510BA3782"><enum>(1)</enum><header>Administration of program</header><text>Administering the program, including—</text><subparagraph commented="no" id="H150C5A6D4CBE4083B19D6160D93ACB69"><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="H37101D64B04D401E90025434699C81A2"><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="HFC8F3D6D32CC42CBA1786AC4913AFB16"><enum>(C)</enum><text>the establishment of procedures to ensure that, not later than the applicable number of calendar days after the dispensing of an applicable drug by a pharmacy or mail order service, the pharmacy or mail order service is reimbursed for an amount equal to the difference between—</text><clause id="H7DF817CA4F39442881074EE8BC77B0E0"><enum>(i)</enum><text>the negotiated price of the applicable drug; and</text></clause><clause commented="no" id="H46AE00DC3F2F4EC19BA050D122B47C9E"><enum>(ii)</enum><text>the discounted price of the applicable drug;</text></clause></subparagraph><subparagraph commented="no" id="H1DD3419282704DA1BB242C609E0D0C79"><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="H4A6EAACC28A1431AA15B07EA1DE4C3E1"><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 commented="no" id="H661E6246581E465488679A01586B3F3E"><enum>(2)</enum><header>Monitoring compliance</header><subparagraph commented="no" id="H632EED0B8DF142458B3BA34CB4DD4E1D"><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 commented="no" id="H3E4B2D8B1D604E838247320BA94AD0B4"><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 commented="no" id="HA0BA7619B26C4CAEB4FE41512CBC4FB5"><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 commented="no" id="HFBCB00BCDEAD4697AF0A6C2EE87E35C7"><enum>(d)</enum><header>Administration</header><paragraph commented="no" id="H3F573AEB3EC7451D8D0D222441A4BCC0"><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="HED400A763BB2486FAC18DDB0CDEECCFC"><enum>(2)</enum><header>Limitation</header><text>In providing for the implementation of this section, the Secretary shall not receive or distribute any funds of a manufacturer under the program.</text></paragraph><paragraph commented="no" id="H03D5CA7975E246CCAEF9632CED091DC6"><enum>(3)</enum><header>Contract with third parties</header><text>The Secretary shall enter into a contract with one 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="HE7C7B93616874D6AB294A067121DD3DC"><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="H2A642B7DBAEC4D32975A48CF0F15EAFB"><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="HD66EB86A952E484CB4C41DBD158AE653"><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="H47B3EBBB0C76490AB8BA1D254920C7A7"><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="HA116E3FEBCD543B99150575D7AF6E548"><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="H3621C5FFCBA54CD9A592805A5E90520D"><enum>(5)</enum><header>Administration</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/44/35">Chapter 35</external-xref> of title 44, United States Code, shall not apply to the program under this section.</text></paragraph></subsection><subsection commented="no" id="HDE85DD78DFD9461E99B95DC8F7B02FD2"><enum>(e)</enum><header>Enforcement</header><paragraph commented="no" id="H22898EC2E3114627A3E8B18F87224427"><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 commented="no" id="H2C1C320470354006A8881DFF062A379B"><enum>(2)</enum><header>Civil money penalty</header><subparagraph commented="no" id="H1CC94742CF964210AAB02D21AF929032"><enum>(A)</enum><header>In general</header><text>The Secretary shall impose a civil money penalty on a manufacturer that fails to provide applicable beneficiaries discounts for applicable drugs of the manufacturer in accordance with such agreement for each such failure in an amount the Secretary determines is commensurate with the sum of—</text><clause commented="no" id="H20DA405BA54C45B38C25101FEC35FF45"><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 commented="no" id="HD1D2CA777E2B419599FA259D61FD0239"><enum>(ii)</enum><text>25 percent of such amount.</text></clause></subparagraph><subparagraph commented="no" id="H331F874347314FB8ABB01427F288680C"><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="H07082D4D597F46B6A46C0C067102A2EB"><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 on the formulary of the prescription drug plan or MA–PD plan that the applicable beneficiary is enrolled in.</text></subsection><subsection commented="no" id="H543E9C29534540F697F018F2F9A40BD7"><enum>(g)</enum><header>Definitions</header><text>In this section:</text><paragraph commented="no" id="HC7D0CBB2DB0848AE94D66D4A846B6D12"><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 commented="no" id="HE95026ACCB884D399850CFAC11310201"><enum>(A)</enum><text>is enrolled in a prescription drug plan or an MA–PD plan;</text></subparagraph><subparagraph commented="no" id="H2B901EA904E346ED814D1459DAD7BBEA"><enum>(B)</enum><text>is not enrolled in a qualified retiree prescription drug plan; and</text></subparagraph><subparagraph commented="no" id="H37A7259E784E4CB7BAE83D1DD37B2470"><enum>(C)</enum><text>has incurred costs for covered part D drugs in the year that are equal to or exceed the annual deductible specified in section 1860D–2(b)(1) for such year.</text></subparagraph></paragraph><paragraph commented="no" id="HCC7F959FA1374FDDA1E4FFAE4234A1A1"><enum>(2)</enum><header>Applicable drug</header><text>The term <term>applicable drug</term> means, with respect to an applicable beneficiary, a covered part D drug—</text><subparagraph commented="no" id="H03FEE57EBFDD49A69393E94F86CE58E3"><enum>(A)</enum><text>approved under a new drug application under section 505(c) of the Federal Food, Drug, and Cosmetic Act or, in the case of a biologic product, licensed under section 351 of the Public Health Service Act (including a product licensed under subsection (k) of such section); and</text></subparagraph><subparagraph commented="no" id="HFE0095DD48FF49419EE7C5290900F3EA"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H91A41DCA89684DF3A1416566C9124128"><enum>(i)</enum><text>if the PDP sponsor of the prescription drug plan or the MA organization offering the MA–PD plan uses a formulary, which is on the formulary of the prescription drug plan or MA–PD plan that the applicable beneficiary is enrolled in;</text></clause><clause commented="no" id="HE8DD6DD3B9E34A5C9A26FA01F84ED2E0" indent="up1"><enum>(ii)</enum><text>if the PDP sponsor of the prescription drug plan or the MA organization offering the MA–PD plan does not use a formulary, for which benefits are available under the prescription drug plan or MA–PD plan that the applicable beneficiary is enrolled in; or</text></clause><clause commented="no" id="H6CBD4E87DC224F7ABB94A0A992EAD757" indent="up1"><enum>(iii)</enum><text>is provided through an exception or appeal.</text></clause></subparagraph></paragraph><paragraph commented="no" id="H881D4535ABBF460FB1CAD90A7F554F28"><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="H3FAEB1FBD6CD4817B230ACB351444E4F"><enum>(A)</enum><text>with respect to claims for reimbursement submitted electronically, 14 days; and</text></subparagraph><subparagraph commented="no" id="H03D83FB6EDF3474C8C331800B7D2CAA7"><enum>(B)</enum><text>with respect to claims for reimbursement submitted otherwise, 30 days.</text></subparagraph></paragraph><paragraph commented="no" id="HC12787ECF44E4E7BBE588B29BF489593"><enum>(4)</enum><header>Discounted price</header><subparagraph commented="no" id="H2C5F4B504C264F6BBB5741439D6296D6"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The term <term>discounted price</term> means, with respect to an applicable drug of a manufacturer furnished during a year to an applicable beneficiary, 90 percent of the negotiated price of such drug.</text></subparagraph><subparagraph commented="no" id="HA86E024490C54D348A3BC530214B49D7"><enum>(B)</enum><header>Clarification</header><text>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" id="H92941E9AC45043F39FF3EF00673084B4"><enum>(C)</enum><header>Special case for claims spanning deductible</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 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></subparagraph></paragraph><paragraph commented="no" id="H2227B4B7F8504B0AA5E70355CA2B9639"><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="HEB6ECFB587D347D792EA133735E43B4B"><enum>(6)</enum><header>Negotiated price</header><text>The term <term>negotiated price</term> has the meaning given such term in section 1860D–2(d)(1)(B), except that such negotiated price shall not include any dispensing fee for an applicable drug.</text></paragraph><paragraph commented="no" id="H4209EE82DA314E75AF24ECCD421311AF"><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 11860D–22(a)(2).</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph commented="no" id="H6994EDA48DE94665A26242D3C8C6616E"><enum>(2)</enum><header>Sunset of Medicare coverage gap discount program</header><text>Section 1860D–14A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395-114a">42 U.S.C. 1395–114a</external-xref>) is amended—</text><subparagraph commented="no" id="H0E0EF23E76D947F2B013728F37A1B351"><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 commented="no" id="HA9A729B4B58F43F6AFC2A56BD9EDFBED"><enum>(B)</enum><text>by adding at the end the following new subsection:</text><quoted-block style="OLC" id="H07FCCBD73991458EAD6B34AD1ABD306E"><subsection commented="no" id="H4B164DBFEE37440F8F6E3930F3FDF945"><enum>(h)</enum><header>Sunset of program</header><paragraph commented="no" id="HEB72D6D0452B4255B08DC1387D71BED8"><enum>(1)</enum><header>In general</header><text>The program shall not apply 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 commented="no" id="HBEC5B5687F0141BBA14019689A8A5288"><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="HB83F16D7E9CE4E6EA13A1B4B506B05EF"><enum>(3)</enum><header>Inclusion of actuarial value of manufacturer discounts in bids</header><text>Section 1860D–11 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-111">42 U.S.C. 1395w–111</external-xref>) is amended—</text><subparagraph commented="no" id="H02B66927A8184F30B582B8F14D040F37"><enum>(A)</enum><text>in subsection (b)(2)(C)(iii)—</text><clause commented="no" id="H78FFFA9F9F59445389334B9DF503BE3C"><enum>(i)</enum><text>by striking <quote>assumptions regarding the reinsurance</quote> and inserting</text><quoted-block style="OLC" display-inline="yes-display-inline" id="H579141FE277C44F7A0CB3FAA431B0EFD"><text>assumptions regarding—</text><subclause id="HC3644588B788463F8FB16B8C9AE032DC"><enum>(I)</enum><text display-inline="yes-display-inline">the reinsurance</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause commented="no" id="HDE623D21C53C446A90FF7710A4B83006"><enum>(ii)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HCC9AF2F485E0446EB124768471B626C1"><subclause commented="no" id="H3ABF3EE3C73547908EA534445DFDE0A0"><enum>(II)</enum><text display-inline="yes-display-inline">for 2022 and each subsequent year, the manufacturer discounts provided under section 1860D– 14B subtracted from the actuarial value to produce such bid; and</text></subclause><after-quoted-block>; and </after-quoted-block></quoted-block></clause></subparagraph><subparagraph commented="no" id="H87D51383F7A0481389FFE8175D56789F"><enum>(B)</enum><text>in subsection (c)(1)(C)—</text><clause commented="no" id="H0FDE3622E7044C22942EFEFA762B47BC"><enum>(i)</enum><text>by striking <quote>an actuarial valuation of the reinsurance</quote> and inserting</text><quoted-block style="OLC" display-inline="yes-display-inline" id="H639C4093AFEA4104AD18E757823CBD98"><text>an actuarial valuation of—</text><clause id="HD2444223BB544CFE8001C4F211C3B9FB"><enum>(i)</enum><text display-inline="yes-display-inline">the reinsurance</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause><clause commented="no" id="H7865CB6C930D480DA9CF750D1425EB15"><enum>(ii)</enum><text>in clause (i), as added by clause (i) of this subparagraph, by adding <quote>and</quote> at the end; and</text></clause><clause commented="no" id="HB7EEDDDA49C848A2899727FC47000D36"><enum>(iii)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" id="H277A1B24375E472FAB9A779C96B67E70"><clause commented="no" id="H98496B7C14DC444AA473717A50F32B67"><enum>(ii)</enum><text>for 2022 and each subsequent year, the manufacturer discounts provided under section 1860D–14B;</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph commented="no" id="id8FBC933BDF884868BD7D93E30FA2687F"><enum>(4)</enum><header>Clarification regarding exclusion of manufacturer discounts from TrOOP</header><text>Section 1860D–2(b)(4) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(b)(4)</external-xref>) is amended—</text><subparagraph id="id7215AA4973D14DF48F791739CB4E6C1B"><enum>(A)</enum><text>in subparagraph (C), by inserting <quote>and subject to subparagraph (F)</quote> after <quote>subparagraph (E)</quote>; and</text></subparagraph><subparagraph id="id481A6DF047544633981949AF550754F8"><enum>(B)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id186D9BC671634D2A9BB5E56B3A8294AC"><subparagraph id="idCDA7744395BF4D61A8B5151E50821F9E"><enum>(F)</enum><header>Clarification regarding exclusion of manufacturer discounts</header><text>In applying subparagraph (A), incurred costs shall not include any manufacturer discounts provided under section 1860D–14B.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection><subsection commented="no" id="HE6A39FD06FD94A2895A8007ACC3D6583"><enum>(d)</enum><header>Determination of allowable reinsurance costs</header><text>Section 1860D–15(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-115">42 U.S.C. 1395w–115(b)</external-xref>) is amended—</text><paragraph commented="no" id="HE193DFF5D30F4A0196ED6F5898E27CB3"><enum>(1)</enum><text>in paragraph (2)—</text><subparagraph commented="no" id="HF760DF2B0F2B4EEEBC109B088CF4B1F2"><enum>(A)</enum><text>by striking <quote><header-in-text level="paragraph" style="OLC">Costs.—</header-in-text>For purposes</quote> and inserting</text><quoted-block style="OLC" display-inline="yes-display-inline" id="H6B40938BE7314E199C4C173BA8829F68"><text><header-in-text level="paragraph" style="OLC">Costs.—</header-in-text></text><subparagraph commented="no" id="HFBA477AF7B114AD6B71CC3FB88F5AE6B"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to subparagraph (B), for purposes</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" id="H37E2C55AAA7E46038D69E49BCF25EB86"><enum>(B)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="HC35E617F088847E88B4E24F44A271215"><subparagraph commented="no" id="H92BAFD60C6E74F6D98F15AF1D78CA49E"><enum>(B)</enum><header>Inclusion of manufacturer discounts on applicable drugs</header><text>For purposes of applying subparagraph (A), the term <term>allowable reinsurance costs</term> shall include the portion of the negotiated price (as defined in section 1860D–14B(g)(6)) of an applicable drug (as defined in section 1860D–14(g)(2)) that was paid by a manufacturer under the manufacturer discount program under section 1860D–14B.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" id="HE879F1A926E84A0E8B45DD198AC1F799"><enum>(2)</enum><text>in paragraph (3)—</text><subparagraph commented="no" id="HB2A14279405443AFA68778CECB479DD0"><enum>(A)</enum><text>in the first sentence, by striking <quote>For purposes</quote> and inserting <quote>Subject to paragraph (2)(B), for purposes</quote>; and</text></subparagraph><subparagraph commented="no" id="H4FA9510276D945A08E38C3B7D4421441"><enum>(B)</enum><text>in the second sentence, by inserting <quote>or, in the case of an applicable drug, by a manufacturer</quote> after <quote>by the individual or under the plan</quote>.</text></subparagraph></paragraph></subsection><subsection commented="no" id="H3D54674C5DE545EC854151963E3DA993"><enum>(e)</enum><header>Updating risk adjustment methodologies To account for part D modernization redesign</header><text>Section 1860D–15(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-115">42 U.S.C. 1395w–115(c)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" id="H2C8296BCAFD047B1A80D4C00ECF30A3C"><paragraph commented="no" id="H6CA21997C34E4DE4A86A950F47F10724"><enum>(3)</enum><header>Updating risk adjustment methodologies to account for part D modernization redesign</header><text display-inline="yes-display-inline">The Secretary shall update the risk adjustment model used to adjust bid amounts pursuant to this subsection as appropriate to take into account changes in benefits under this part pursuant to the amendments made by section 121 of the Lower Costs, More Cures Act of 2019.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection commented="no" id="HB5E666A3A08E4532AFBB908158D850B6"><enum>(f)</enum><header>Conditions for coverage of drugs under this part</header><text>Section 1860D–43 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-153">42 U.S.C. 1395w–153</external-xref>) is amended—</text><paragraph commented="no" id="HFE3B830973864C728C886D4527A1C949"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph commented="no" id="H11F4CC7FD2B44F1D911FA7D1BD004BBE"><enum>(A)</enum><text>in paragraph (2), by striking <quote>and</quote> at the end;</text></subparagraph><subparagraph commented="no" id="H88DDF5F03DCF40AA960911A20B04953F"><enum>(B)</enum><text>in paragraph (3), by striking the period at the end and inserting a semicolon; and</text></subparagraph><subparagraph commented="no" id="H5CE2485CF08F402499E753E3A1D7BFE3"><enum>(C)</enum><text>by adding at the end the following new paragraphs:</text><quoted-block style="OLC" id="H953C126D6EF3460985C309064CE6B04E"><paragraph commented="no" id="H3DBEC2E498C14159AA25C46431FED638"><enum>(4)</enum><text>participate in the manufacturer discount program under section 1860D–14B;</text></paragraph><paragraph commented="no" id="H91D4619F33634326881AE17EB2684A77"><enum>(5)</enum><text>have entered into and have in effect an agreement described in subsection (b) of such section 1860D–14B with the Secretary; and</text></paragraph><paragraph commented="no" id="H8D03AC71540C48F898BFCBDC93BD11AA"><enum>(6)</enum><text>have entered into and have in effect, under terms and conditions specified by the Secretary, a contract with a third party that the Secretary has entered into a contract with under subsection (d)(3) of such section 1860D–14B.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" id="HDFFCB1EAF32E4E1FBDBF95754E5F9575"><enum>(2)</enum><text>by striking subsection (b) and inserting the following:</text><quoted-block style="OLC" id="HEDBBAA648D194F7CB150066D19CBEEA4"><subsection commented="no" id="HEEA9A8EFD2C84468979C4BF35D496BA3"><enum>(b)</enum><header>Effective date</header><text>Paragraphs (1) through (3) of subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011, and before January 1, 2022, and paragraphs (4) through (6) of such subsection shall apply to covered part D drugs dispensed on or after January 1, 2022.</text></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph commented="no" id="HC4E29EE6E0464B1C8E9A067254F7E857"><enum>(3)</enum><text>in subsection (c), by striking paragraph (2) and inserting the following:</text><quoted-block style="OLC" id="H23D44A9A830948539211ADFE1D77BAE2"><paragraph commented="no" id="H92E9F66613F545DEBB597FAC9E6C2DB5"><enum>(2)</enum><text>the Secretary determines that in the period beginning on January 1, 2011, and ending on December 31, 2011 (with respect to paragraphs (1) through (3) of subsection (a)), or the period beginning on January 1, 2022, and ending December 31, 2022 (with respect to paragraphs (4) through (6) of such subsection), there were extenuating circumstances.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H04ECAE6CD2D24379B18ED1BD8C522315"><enum>(g)</enum><header>Conforming amendments</header><paragraph id="H64DDBB8DC7364056A944A74135E2320D"><enum>(1)</enum><text display-inline="yes-display-inline">Section 1860D–2 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102</external-xref>) is amended—</text><subparagraph id="H2A936BC199D34C4980CB0F5460B165AA"><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="H880E4DE85AF94FAA8AC92AF8D1974AF0"><enum>(B)</enum><text>in subsection (c)(1)(C)—</text><clause id="HE2C0D5D01FF94D7DAAFD2193AAF42EEF"><enum>(i)</enum><text display-inline="yes-display-inline">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="H6A08F6E147C541E4B36B73F7928AA15B"><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="HFC229E43C19342F1962BF91433F84D89"><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="HA69A9461507B48BD9A61B3A2D8D2FF64"><enum>(2)</enum><text>Section 1860D–4(a)(4)(B)(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104(a)(4)(B)(i)</external-xref>) is amended by striking <quote>the initial</quote> and inserting <quote>for a year preceding 2022, the initial</quote>.</text></paragraph><paragraph id="H4B18970A06F64C0E8BAA7BE10A05F1B6"><enum>(3)</enum><text>Section 1860D–14(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-114">42 U.S.C. 1395w–114(a)</external-xref>) is amended—</text><subparagraph id="H6A1394E50C7C4825B2597533B3DE916A"><enum>(A)</enum><text>in paragraph (1)—</text><clause id="HD3473EFAC181485C93328451C620B50C"><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="HCC39C9855F5842A6BC165DE2A2903FAF"><enum>(ii)</enum><text display-inline="yes-display-inline">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="HCA5A60CA48724E20AC8390ED9B4516CB"><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="HC1E1608F39FB45BC9D95ACAE72F9094B"><enum>(B)</enum><text>in paragraph (2)—</text><clause id="H7038459594F341A4B8F789025F22A9FE"><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="H2809183B5A314B50B8923CB9EAB52D08"><enum>(ii)</enum><text>in subparagraph (E)—</text><subclause id="H1F36214621D945D09100BD1FC5301B23"><enum>(I)</enum><text>by inserting <quote>for a year preceding 2022,</quote> after <quote>subsection (c)</quote>; and</text></subclause><subclause id="HCEE2833239BF49BCAF2FFE66F51CD742"><enum>(II)</enum><text>by striking <quote>1860D– 2(b)(4)(A)(i)(I)</quote> and inserting <quote>1860D–2(b)(4)(A)(i)(I)(aa)</quote>.</text></subclause></clause></subparagraph></paragraph><paragraph id="H852E78D0A8394CCC9942138AA7A9F6C0"><enum>(4)</enum><text>Section 1860D–21(d)(7) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-131">42 U.S.C. 1395w–131(d)(7)</external-xref>) is amended by striking <quote>section 1860D–2(b)(4)(B)(i)</quote> and inserting <quote>section 1860D–2(b)(4)(C)(i)</quote>.</text></paragraph><paragraph id="H1FCF90F1CD6D44E78DFBE87AF50C2625"><enum>(5)</enum><text>Section 1860D–22(a)(2)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-132">42 U.S.C. 1395w–132(a)(2)(A)</external-xref>) is amended—</text><subparagraph id="H39B2D717BA6B4F20A9121D99C691A17A"><enum>(A)</enum><text>by striking <quote>the value of any discount</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="yes-display-inline" id="H1C3E013CECC747EF959FC70A642E9401"><text>the value of—</text><clause commented="no" id="H8028FD5E7D1A42F18634C76D74016B4E"><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="H2494496484314140A195B8AF738625B2"><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="H764B9065D533437680417B019D6FB0E2"><enum>(C)</enum><text>by adding at the end the following new clause:</text><quoted-block style="OLC" id="HA1D4A48F080A45A28DE0BCF2D82E1D81"><clause commented="no" id="HD115926F6D294C82B96D8F3B54712139"><enum>(ii)</enum><text>for 2022 and each subsequent year, any discount provided pursuant to section 1860D–14B.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H9C3219B1B64D4F9C9F144F7371051BA0"><enum>(6)</enum><text>Section 1860D–41(a)(6) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-151">42 U.S.C. 1395w–151(a)(6)</external-xref>) is amended—</text><subparagraph id="H675E23E0138A469F8D37984A02A9DBF7"><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="H93AD54A9E0FF4F50A3FC6C6EBA02A89E"><enum>(B)</enum><text>by inserting <quote>for such year</quote> before the period.</text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HDE1B5F3D12C44696BAC4BE1C3FE928AC"><enum>(h)</enum><header>Effective date</header><text>The amendments made by this section shall apply to plan year 2022 and subsequent plan years.</text></subsection></section><section id="HB9EB5FD0154C4587810793CBCACB91C4"><enum>112.</enum><header>Allowing the offering of additional prescription drug plans under Medicare part D</header><subsection id="H54789D28E851491D9AAFC30F2ABE9A38"><enum>(a)</enum><header>Rescinding and issuance of new guidance</header><text display-inline="yes-display-inline">Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall—</text><paragraph id="HF113C8B0F0634383BA717D1D8EEB9010"><enum>(1)</enum><text>rescind sections of any sub-regulatory guidance that limit the number of prescription drug plans in each PDP region that may be offered by a PDP sponsor under part D of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-101">42 U.S.C. 1395w–101 et seq.</external-xref>); and</text></paragraph><paragraph id="H3D64541A5C0041F2B8C5FDC2091C2699"><enum>(2)</enum><text>issue new guidance specifying that a PDP sponsor may offer up to 4 (or a greater number if determined appropriate by the Secretary) prescription drug plans in each PDP region, except in cases where the PDP sponsor may offer up to 2 additional plans in a PDP region pursuant to section 1860D–11(d)(4) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-111">42 U.S.C. 1395w–111(d)(4)</external-xref>), as added by subsection (b).</text></paragraph></subsection><subsection id="HD9695D5368114D3AADAB44EDFD7BA4B5"><enum>(b)</enum><header>Offering of additional plans</header><text>Section 1860D–11(d) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-111">42 U.S.C. 1395w–111(d)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H817342CB27954F82982ACFA8C1BCFBAF"><paragraph id="H8F9534924F3648C1A5F5B4ED131438DD"><enum>(4)</enum><header>Offering of additional plans</header><subparagraph id="H45AD4230F1444ECDABFDAF58CBD59727"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">For plan year 2022 and each subsequent plan year, a PDP sponsor may offer up to 2 additional prescription drug plans in a PDP region (in addition to any limit established by the Secretary under this part) provided that the PDP sponsor complies with subparagraph (B) with respect to at least one such prescription drug plan.</text></subparagraph><subparagraph id="H0CED1EA6D0E6478A9094482DF06F6760"><enum>(B)</enum><header>Requirements</header><text display-inline="yes-display-inline">In order to be eligible to offer up to 2 additional plans in a PDP region pursuant to subparagraph (A), a PDP sponsor must ensure that, with respect to at least one such prescription drug plan, the sponsor or any entity that provides pharmacy benefits management services under a contract with any such sponsor or plan does not receive direct or indirect remuneration, as defined in section 423.308 of title 42, Code of Federal Regulations (or any successor regulation), unless at least 25 percent of the aggregate reductions in price or other remuneration received by the PDP sponsor or entity from drug manufacturers with respect to the plan and plan year—</text><clause id="HC70A744611BB4111B50EDF93618B19E9"><enum>(i)</enum><text display-inline="yes-display-inline">are reflected at the point-of-sale to the enrollee; or</text></clause><clause id="HCEBDFABBA16E4B4596339D1E1C075849"><enum>(ii)</enum><text display-inline="yes-display-inline">are used to reduce total beneficiary cost-sharing estimated by the PDP sponsor for prescription drug coverage under the plan in the annual bid submitted by the PDP sponsor under section 1860D–11(b).</text></clause></subparagraph><subparagraph id="HB585264BBF37434F9B1A125E0D694F4A"><enum>(C)</enum><header>Definition of reductions in price</header><text display-inline="yes-display-inline">For purposes of subparagraph (B), the term <term>reductions in price</term> refers only to collectible amounts, as determined by the Secretary, which excludes amounts which after adjudication and reconciliation with pharmacies and manufacturers are duplicate in nature, contrary to other contractual clauses, or otherwise ineligible (such as due to beneficiary disenrollment or coordination of benefits).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HBD8B963875984B20B5F5588A93478E7B"><enum>(c)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">Nothing in the provisions of, or amendments made by, this section shall be construed as limiting the ability of the Secretary to increase any limit otherwise applicable on the number of prescription drug plans that a PDP sponsor may offer, at the discretion of the PDP sponsor, in a PDP region under part D of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-101">42 U.S.C. 1395w–101 et seq.</external-xref>).</text></subsection></section><section section-type="subsequent-section" id="HEE70AC5AB8B149EEB2E6A5242B928EB5"><enum>113.</enum><header>Allowing certain enrollees of prescription drug plans and MA–PD plans under the Medicare program to spread out cost-sharing under certain circumstances</header><subsection id="HB303B3DDACC9449CBC71BD19E681C037"><enum>(a)</enum><header>Standard prescription drug coverage</header><text display-inline="yes-display-inline">Section 1860D–2(b)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(b)(2)</external-xref>), as amended by section 111, is amended—</text><paragraph id="HAF90143064914EF180CE42AC1329067C"><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="HDD487BF8FE96413A813D1ED6E2BEC01E"><enum>(2)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H28B3DA05CF864F65B683377B57E91225"><subparagraph id="HD24EBD471BCD46C0AA1D65DD19F7CF8F"><enum>(E)</enum><header>Enrollee option regarding spreading cost-sharing</header><clause id="H579A479F6E4C470CA8FB73512F391826"><enum>(i)</enum><header>In general</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 with respect to whom the plan projects that the dispensing of a covered part D drug to such individual will result in the individual incurring costs within a 30-day period that are equal to a significant percentage (as specified by the Secretary pursuant to such regulation) of 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 such costs in the form of equal monthly installments over the remainder of such plan year.</text></clause><clause id="HF4D391D7A179462D8AADB27793F778E2"><enum>(ii)</enum><header>Significant percentage limitations</header><text>In specifying a significant percentage pursuant to the regulation established by the Secretary under clause (i), the Secretary shall not specify a percentage that is less than 30 percent or greater than 100 percent.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H1989101DDA5B474097538B401A92154E"><enum>(b)</enum><header>Alternative prescription drug coverage</header><text display-inline="yes-display-inline">Section 1860D–2(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(c)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HE15EF8D2D81F45FDBA92EF421E50EB1B"><paragraph id="H2E71475163B346479F0BEE5958942A53"><enum>(4)</enum><header>Same enrollee option regarding spreading cost-sharing</header><text display-inline="yes-display-inline">For plan year 2022 and subsequent plan years, the coverage provides the enrollee option regarding spreading cost-sharing described in and required under subsection (b)(2)(E).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section display-inline="no-display-inline" commented="no" id="idDA515F8C16A340D78753F5415068C769"><enum>114.</enum><header>Continuation of Part D Senior Savings Model</header><text display-inline="no-display-inline">Section 1115A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1315a">42 U.S.C. 1315a</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idBB864FC6FB7C4417A31671928CB7ED81"><subsection display-inline="no-display-inline" commented="no" id="id9002947C94674AC7AD9B0B889B14549F"><enum>(h)</enum><header>Part D Senior Savings Model</header><text>Notwithstanding any other provision of law, the Secretary shall provide for the continued implementation on a permanent basis of the Part D Senior Savings Model under this section, under the same parameters under which such model was implemented for plan year 2021.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H087F75AE29DB412C9E46CA9CFC339CE7"><enum>115.</enum><header>Requiring prescription drug plans and MA–PD plans to report potential fraud, waste, and abuse to the Secretary of HHS</header><text display-inline="no-display-inline">Section 1860D–4 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HAEFE647E352E475EA15351DB035C5B00"><subsection id="HDF08E661E1AF458FAFA784ABA57C511A"><enum>(p)</enum><header>Reporting potential fraud, waste, and abuse</header><text>Beginning January 1, 2022, the PDP sponsor of a prescription drug plan shall report to the Secretary, as specified by the Secretary—</text><paragraph id="H0D28F2148C3B4C4D96D5272B7D424C1D"><enum>(1)</enum><text>any substantiated or suspicious activities (as defined by the Secretary) with respect to the program under this part as it relates to fraud, waste, and abuse; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC95BC99A4DCB4225B11F267A761B87D4"><enum>(2)</enum><text>any steps made by the PDP sponsor after identifying such activities to take corrective actions.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H06F93A0A25514EB28674D4165F0CA1F9"><enum>116.</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 (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104(c)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HC90854040BC5470C9C8AE14DF625E2B1"><paragraph id="HD58A66095C494997B9A57E74F9593F3E"><enum>(8)</enum><header>Application of pharmacy quality measures</header><subparagraph id="H38D3CC8ED38C44A0843C5F7313389D91"><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="H2E1AB209AE694C08A6FC900C1B94A866"><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 commented="no" display-inline="no-display-inline" id="H947F865B000447B1880CDD6FF7D600DE"><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, 2023, 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></section></subtitle><subtitle id="idA989D05B43974F33AE78D758922807CB" style="OLC"><enum>C</enum><header>Medicaid provisions</header><section id="id4E6772C345F745FBB1C2E9B14E42C8DA"><enum>121.</enum><header>Price reporting clarifications for gene therapy outcomes-based agreements</header><subsection id="idBA37EE75F52C47C4AB7209C3726FA3EA"><enum>(a)</enum><header>Quarterly price reporting obligation</header><text>Section 1927(b)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(b)(3)</external-xref>) is amended by adding at the end the following new subparagraph:</text><quoted-block id="idF92F0E61CD8A41F994F5028D5637CE7D" style="OLC" act-name=""><subparagraph id="id464CEFA3509846C180B104530195720B"><enum>(E)</enum><header>Outcomes-based agreements</header><clause id="id59AB2C10933A433389DBA3B50F09CC5D"><enum>(i)</enum><header>In general</header><text>Beginning January 1, 2022, in the case of a covered outpatient drug that is a single course transformative therapy (as defined in subsection (k)(12)) and is sold under an outcomes-based agreement (as defined in subsection (k)(13)) during a rebate period, the manufacturer of such drug shall report (in addition to any other information required under this paragraph) the pricing structure for such drug based on pre-defined outcomes or measures specified in such outcomes-based agreement.</text></clause><clause id="id90139379B1A346719FB67796EFBECB28" commented="no"><enum>(ii)</enum><header>Access to outcomes-based agreements for State plans</header><text>As a condition of excluding a refund, rebate, reimbursement, free item, withholding, or repayment made under an outcomes-based agreement with respect to a covered outpatient drug from the best price or average manufacturer price of the drug for a rebate period (as described in subsection (c)(1)(C)(i)(VII) or (k)(1)(B)(i)(VI), as applicable), the manufacturer shall—</text><subclause id="id5E53861FFAA04A1595152FC255C9AEB1" commented="no"><enum>(I)</enum><text>make available to each State plan the opportunity to enter into an outcomes-based agreement for such drug and rebate period; and</text></subclause><subclause id="id1B9AE19B298E416D962893433B95D8D3" commented="no"><enum>(II)</enum><text>certify to the Secretary that the manufacturer has made such opportunity so available to each State plan.</text></subclause></clause><clause id="id8EB57821E3D6484C93A0559A82879E86"><enum>(iii)</enum><header>Rules of construction</header><text>Nothing in this subparagraph shall be construed as— </text><subclause id="idE8A91AF9F2C14D7D99CC4824652B987D"><enum>(I)</enum><text>requiring a manufacturer to execute an outcomes-based agreement with a State for a covered outpatient drug that is a single course transformative therapy (as defined in subsection (k)(12)); ; </text></subclause><subclause id="id0822A0D9989047E99F9E7F38B9DA51A0"><enum>(II)</enum><text>precluding the execution of a rebate agreement under this section for such a drug; or</text></subclause><subclause id="idc4bf5135592a42f981a1d83cee7b5430"><enum>(III)</enum><text>limiting States’ ability to join together for a multi-State contract with a single manufacturer to establish an outcomes-based agreement for such a drug.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="id983CB851A7524B799BC5592470B127CE"><enum>(b)</enum><header>Definition of best price</header><text>Section 1927(c)(1)(C) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396-8">42 U.S.C. 1396–8(c)(1)(C)</external-xref>) is amended—</text><paragraph id="idAC8243C9424B450CA1492B12937A86A9"><enum>(1)</enum><text>in clause (i)—</text><subparagraph id="id0E56ABB3CBB54153945F364704FFF717"><enum>(A)</enum><text>in subclause (V), by striking <quote>and</quote>;</text></subparagraph><subparagraph id="idF0A6BF91E880454B8237336D0C0091CC"><enum>(B)</enum><text>in subclause (VI), by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph id="idE33311890BC448A3B5089EA5D8278035"><enum>(C)</enum><text>by adding at the end the following new subclause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idF4CFA3665ED248E588FD0DBA5A17E902"><subclause id="id7717D2F222D2435DB98FE86F8E0345C5"><enum>(VII)</enum><text>subject to subsection (b)(3)(E)(ii), with respect to a covered outpatient drug that is a single course transformative therapy (as defined in subsection (k)(12)) and is sold under an outcomes-based agreement (as defined in subsection (k)(13)) during the rebate period, any prices resulting from—</text><item id="idB671A47A9BA5415883978EB8ECF0A1F8"><enum>(aa)</enum><text>a refund, rebate, reimbursement, or free goods from the manufacturer or third party on behalf of the manufacturer; or</text></item><item id="id939D9297445D4295A89A2A6E2827F3FE"><enum>(bb)</enum><text>the withholding or reduction of a payment to the manufacturer or third party on behalf of the manufacturer,</text></item><continuation-text continuation-text-level="subclause">that is triggered by a patient who fails to achieve outcomes or measures defined under the terms of such outcomes-based agreement during the period for which such agreement is effective.</continuation-text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="id0D11BE701A79482E97D7A393101A4FFC"><enum>(2)</enum><text>in clause (ii)—</text><subparagraph id="id0B5FB468009C4EB6BFD94BE8F605B43B"><enum>(A)</enum><text>in subclause (I), by striking the semicolon at the end and inserting <quote>, except any price adjustment described in clause (i)(VII);</quote>;</text></subparagraph><subparagraph id="id342635D772994B1AB379390A37C7D1EB"><enum>(B)</enum><text>in subclause (III), by striking <quote>and</quote>; </text></subparagraph><subparagraph id="id838990D07D39449490C0481400F4FC12"><enum>(C)</enum><text>in subclause (IV)—</text><clause id="idB8BE0D70F3B5405191E892A631D33435"><enum>(i)</enum><text>by moving the left margin of such subclause 2 ems to the right; and</text></clause><clause id="idBEA50DAF61BD4262A3B929965753AECF"><enum>(ii)</enum><text>by striking the period at the end and inserting <quote>; and</quote>; and</text></clause></subparagraph><subparagraph id="id35940B649C574FD9A59BD7ED0F307C32"><enum>(D)</enum><text>by adding at the end the following new subclause:</text><quoted-block id="idF0CB4B2E20774D559B909E64AE7DF9E9" style="OLC" act-name=""><subclause id="id1B0715787CE44F59AE40410CB6E3B219"><enum>(V)</enum><text>in the case of a covered outpatient drug that is a single course transformative therapy (as defined in subsection (k)(12)) and is sold under an outcomes-based agreement (as defined in subsection (k)(13)) that provides that payment for such drug is made in installments over the course of such agreement, shall be determined as if the aggregate price per the terms of the agreement was paid in full in the first installment during the rebate period.</text></subclause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection><subsection id="idBB5D6011A1F3404B904210CCC825BAF2"><enum>(c)</enum><header>Definition of average manufacturer price</header><text>Section 1927(k)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(k)(1)</external-xref>) is amended—</text><paragraph id="idAA8315BEAD6E4A4FAC1C381062ACAFD9"><enum>(1)</enum><text>in subparagraph (B)(i)—</text><subparagraph id="idF8443F6B3FCE433FA0DA27B8DF1CF228"><enum>(A)</enum><text>in subclause (IV), by striking at the end <quote>and</quote>;</text></subparagraph><subparagraph id="id555C5255B1D247CEA344BB9E468A1CFE"><enum>(B)</enum><text>in subclause (V), by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph id="idD04212DA60BA43E498B10CF210AB0ED3"><enum>(C)</enum><text>by adding at the end the following new subclause:</text><quoted-block id="id99FE8CA34021401A90B4F70AECEB42FC" style="OLC" act-name=""><subclause id="id8007C6A3A3D64EF3991578A5C0711767"><enum>(VI)</enum><text>subject to subsection (b)(3)(E)(ii), with respect to a covered outpatient drug that is a single course transformative therapy (as defined in paragraph (12)) and is sold under an outcomes-based agreement (as defined in paragraph (13)) during the rebate period—</text><item id="id89b98ebb519f497583048f95996bd760"><enum>(aa)</enum><text>a refund, rebate, reimbursement, or free goods from the manufacturer or third party on behalf of the manufacturer; or</text></item><item id="id415280bd6f974b36a0935ea9a561afa8"><enum>(bb)</enum><text>the withholding or reduction of a payment to the manufacturer or third party on behalf of the manufacturer,</text></item><continuation-text continuation-text-level="subclause">that is triggered by a patient who fails to achieve outcomes or measures defined under the terms of such outcomes-based agreement during the period for which such agreement is effective.</continuation-text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="idD7511F7A0F4646D3B3EC34DEF26455EA"><enum>(2)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id7609004c2dd14cf2837d662474197754"><subparagraph id="id3e2439dac0d349bdabb2756b9b07f689"><enum>(D)</enum><header>Special rule for certain outcomes-based agreements</header><text>For the purpose of subparagraph (A), in determining the average price paid to the manufacturer for a covered outpatient drug that is a single course transformative therapy (as defined in paragraph (12)) and is sold under an outcomes-based agreement (as defined in paragraph (13)) that provides that payment for such drug is made in installments over the course of such agreement, such price shall be determined as if the aggregate price per the terms of the agreement was paid in full in the first installment during the rebate period.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="id71C754CD7AA64B7AA5F8B50AB7CCE64F"><enum>(d)</enum><header>Other definitions</header><text>Section 1927(k) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(k)</external-xref>) is amended by adding at the end the following paragraphs: </text><quoted-block style="OLC" display-inline="no-display-inline" id="ida39a03ee3c3a4489b2382d62579baa3a"><paragraph id="id61387e6ae0b04a5c92901c3353db9b93"><enum>(12)</enum><header>Single course transformative therapy</header><text>The term <term>single course transformative therapy</term> means a treatment that consists of the administration of a covered outpatient drug that—</text><subparagraph id="id378d69a61791413da1e867fd8d6b4bd6"><enum>(A)</enum><text>is a form of gene therapy, as defined by the Commissioner of Food and Drugs, that is—</text><clause id="idbda3aa1a33d046ce94a52b46bc2f0df6"><enum>(i)</enum><text>designated under section 526 of the Federal Food, Drug, and Cosmetics Act; and</text></clause><clause id="id952a2325f6dd4f039128f81069a7aa99"><enum>(ii)</enum><text>licensed under subsection (a) or (k) of section 351 of the Public Health Service Act for a serious or life-threatening rare disease or condition;</text></clause></subparagraph><subparagraph id="idf9b2358216a846b4ab8538d35a04c434"><enum>(B)</enum><text>if administered in accordance with the <quote>Indications and Usage</quote> section of its label, is expected to result in—</text><clause id="id852482dcbd754c2194a6ed53ba9d72a6"><enum>(i)</enum><text>the cure of such disease or condition;</text></clause><clause id="id6e42f27aec274c699a67bf949216bd04"><enum>(ii)</enum><text>a reduction in the symptoms of such disease or condition to the extent that it is expected to—</text><subclause id="idbe4b17c8697a4e328f694bb526ac90f6"><enum>(I)</enum><text>extend life expectancy for those individuals with such disease or condition;</text></subclause><subclause id="id06382428036949db920dad8d9b1099fd"><enum>(II)</enum><text>prevent, eliminate, or halt progression of comorbidities related to such disease or condition in such individuals; or</text></subclause><subclause id="idf2fc3a25329841b5a7633e9c8e2cf646"><enum>(III)</enum><text>allow such individuals to achieve or maintain maximum functional capacity in performing daily activities; or</text></subclause></clause><clause id="id1abcb62ef4bd49d1a5a58dea9edbd677"><enum>(iii)</enum><text>prevention or elimination of episodes, illnesses, injuries, or disabilities related to such disease or condition; and</text></clause></subparagraph><subparagraph id="id9de869035adf4d5fa0a5970fb2027588"><enum>(C)</enum><text>is expected to achieve a result described in subparagraph (B), which may be achieved over an extended period of time, following a single prescribed course of treatment.</text></subparagraph></paragraph><paragraph id="idb0b8b6c6d4c44de5926506bfcab1b001"><enum>(13)</enum><header>Outcomes-based agreement</header><text>The term <term>outcomes-based agreement</term> means a written contract between a manufacturer and purchaser in which the aggregate price over the course of the contract of the covered outpatient drug is based on the achievement of pre-defined outcomes or measures and adjusted accordingly.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="idC87CB8B635C440AF918783DAAF308381"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall take effect on January 1, 2022.</text></subsection></section><section id="idbe658344324441208e060dea253602da"><enum>122.</enum><header>Anti-kickback statute and physician self-referral safe harbors</header><subsection id="idf531c43b4cd842849c00e8843571c4e6"><enum>(a)</enum><header>Exclusion from antikickback prohibition</header><text>Section 1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)) is amended—</text><paragraph id="id40545fb04fe8432890495b6b078b6c0f"><enum>(1)</enum><text>in subclause (J)—</text><subparagraph id="idc635d8193b9a4641b660c930f5783499"><enum>(A)</enum><text>by moving the left margin of such subparagraph 2 ems to the left; and</text></subparagraph><subparagraph id="idfecd1837e5074e84a8b592cc7cf465cb"><enum>(B)</enum><text>by striking <quote>and</quote> after the semicolon at the end;</text></subparagraph></paragraph><paragraph id="idbc97138b89924c65b5fc3595d9e62554"><enum>(2)</enum><text>in subclause (K)—</text><subparagraph id="id9c7fe9e1b06e4e9aa9ae0b8877d627b1"><enum>(A)</enum><text>by moving the left margin of such subparagraph 2 ems to the left; and</text></subparagraph><subparagraph id="id59a2b06042394aa082566917307a499d"><enum>(B)</enum><text>by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph></paragraph><paragraph id="id081224d72442411b8f98a72ed77f5512"><enum>(3)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block id="id2A9BED27AF4845FDB29994517846B3A9" style="OLC" act-name=""><subparagraph indent="up1" id="idA24459CDEE364B92801035872E500C34"><enum>(L)</enum><text>any remuneration provided by a manufacturer or third party on behalf of a manufacturer to a plan under an outcomes-based agreement (as defined in section 1927(k)(13)) in the event a patient fails to achieve outcomes or measures defined in such agreement following the administration of a covered outpatient drug that is a single course transformative therapy (as defined in section 1927(k)(12).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="ideb8ba0c0632c433f88f5b7993f3e1165"><enum>(b)</enum><header>Exclusion from physician self-referral prohibition</header><text>Section 1877(h)(1)(C) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395nn">42 U.S.C. 1395nn(h)(1)(C)</external-xref>) is amended by adding at the end the following new clause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="ide69c0bde1f3f48e6add4836dd2f8ecd4"><clause id="id5d4cb09f2b9d45d3a6241d338c9bc333" indent="up1"><enum>(iv)</enum><text>Any amounts paid under an outcomes-based agreement (as defined in section 1927(k)(13)).</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="idfa7d4040dd69469eaa20d74f6e06cea1"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall take effect on January 1, 2022.</text></subsection></section><section id="id2203d83df2c24bb592530472402204c3"><enum>123.</enum><header>GAO study and report on use of outcomes-based agreements</header><subsection id="ideeb27ef1349a476c86d07e15beb6f6ca"><enum>(a)</enum><header>Study</header><text>The Comptroller General of the United States shall conduct a study on the extent to which outcomes-based agreements (as defined in section 1927(k)(13) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(k)(13)</external-xref>) for rare disease gene therapies facilitate patient access to such therapies, improve patient outcomes, lower overall health system costs, and lower costs for patients in Federal health care programs. In conducting such study, the Comptroller General shall—</text><paragraph id="id86fcc3e191264d6b90114ebb05828384"><enum>(1)</enum><text>study the impact of this subtitle on–</text><subparagraph id="id31b50f8678e242b79be268f83d8d1cc8"><enum>(A)</enum><text>mitigating socioeconomic disparities in accessing rare disease gene therapies through its requirement that State Medicaid programs have access to the same outcomes-based agreement remedy terms that are available in the commercial market for the gene therapy; and</text></subparagraph><subparagraph id="id999b6c075ae14b24b1e4621e1c5a696b"><enum>(B)</enum><text>the Medicaid Drug Rebate Program, the 340B Drug Pricing Program, and the Medicare Part B program, including compliance with such programs; and</text></subparagraph></paragraph><paragraph id="idb469bab3086746c7a15be026a18f69a4"><enum>(2)</enum><text>with respect to rare disease gene therapies sold under an outcomes-based agreement (as so defined), conduct an audit of manufacturers offering State Medicaid programs the same remedy terms for non-responding patients as offered to commercial insurance plans during a particular rebate period, as described in subsections (c)(1)(C)(i)(VII) and (k)(1)(B)(i)(VI) of section 1927 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8</external-xref>), as added by this subtitle.</text></paragraph></subsection><subsection id="id5ee0220cd4ed4d06bd1d7ae3b10b0fe4" commented="no" display-inline="no-display-inline"><enum>(b)</enum><header>Report</header><text>Not later than June 30, 2027, the Comptroller General of the United States shall submit to Congress a report containing the results of the study conducted under subsection (a).</text></subsection></section></subtitle><enum>II</enum><header>Drug Price Transparency Provisions</header><section section-type="subsequent-section" id="H26004FAAF5204390861417B3DD3D3EF4"><enum>201.</enum><header>Reporting on explanation for drug price increases</header><subsection id="HB845495816C7431A94C9D66C2DABCAA7"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Title XI of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1301">42 U.S.C. 1301 et seq.</external-xref>) is amended by inserting after section 1128K the following new section:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id9FA6D5E9018C467F86168949780B8752"><section id="id0E20F25E825B4D8394EE69EB216F7C0A"><enum>1128L.</enum><header>Drug price reporting</header><subsection id="HF1405333585E4744AE139B5F10383A6E"><enum>(a)</enum><header>Definitions</header><text>In this section:</text><paragraph id="H283C40DB42724023A752B9BBA07D4533"><enum>(1)</enum><header>Manufacturer</header><text>The term <term>manufacturer</term> means the person—</text><subparagraph id="H96962F701FCC4564A1B5A966428276C4"><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="HACC8B4B803714203B1892A46820CDDF8"><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="H95065306F92F4543883E3900BFE54E1F"><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 this Act—</text><subparagraph id="H86AEC3E3CC63435BB969FC7648272232"><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="H6255C1636E264A5B82800C78EF9CFEB8"><enum>(i)</enum><text>subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act;</text></clause><clause id="H1D6E6734C719409E99A926B6BA44CE5A"><enum>(ii)</enum><text display-inline="yes-display-inline">administered or otherwise dispensed to treat a disease or condition affecting more than 200,000 persons in the United States; and</text></clause><clause id="H3D0DDE15221F4846A8D93C802A333B46"><enum>(iii)</enum><text>not a vaccine; and</text></clause></subparagraph><subparagraph id="H4CE12040BA9048DEA0D085406918C373"><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="HFD3B3BB69060433D900C9536470F126C"><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="H37BD9FB3EC0B40CD951776813086D1F6"><enum>(b)</enum><header>Report</header><paragraph id="HDE499DFC77914DE38C89A002BB8A5016"><enum>(1)</enum><header>Report required</header><text>The manufacturer of a qualifying drug shall submit a report to the Secretary—</text><subparagraph id="H928010D0DA4C4890810391632C5A4178"><enum>(A)</enum><text>for each increase in the price of a qualifying drug that results in an increase in the wholesale acquisition cost of that drug that is equal to—</text><clause id="H5FA03ED940714A918A80DD9E9031835E"><enum>(i)</enum><text display-inline="yes-display-inline">10 percent or more within a single calendar year beginning on or after January 1, 2021; or</text></clause><clause id="HBEF7446B25FF4DEEA556F4499376DC7F"><enum>(ii)</enum><text display-inline="yes-display-inline">25 percent or more within three consecutive calendar years for which the first such calendar year begins on or after January 1, 2021; and</text></clause></subparagraph><subparagraph id="HF90FAF9268F147FF99F080520BF942ED"><enum>(B)</enum><text display-inline="yes-display-inline">in the case that the qualifying drug is first covered under title XVIII with respect to an applicable year, if the estimated cost or spending under such title per individual or per user of such drug (as estimated by the Secretary) for such applicable year (or per course of treatment in such applicable year, as defined by the Secretary) is at least $26,000.</text></subparagraph></paragraph><paragraph id="HCE27990BB6CD40F8979878A6B7349226"><enum>(2)</enum><header>Report deadline</header><text>Each report described in paragraph (1) shall be submitted to the Secretary—</text><subparagraph id="HD0F80297D2234BA889302BF9126A36FF"><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, 2021, and ending on the day that is 60 days after the date of enactment of this section, not later than 90 days after such date of enactment;</text></subparagraph><subparagraph id="HF15E64E4E7984730B38F928664E7F847"><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; and</text></subparagraph><subparagraph id="H196C2F21657241AAB7D696EFEB59F7A2"><enum>(C)</enum><text>in the case of a report with respect to a qualifying drug that meets the criteria described in paragraph (1)(B), not later than 30 days after such drug meets such criteria.</text></subparagraph></paragraph></subsection><subsection id="H82A622F31CB644BBB6DDF0B287B5A010"><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="H1732C958BF654BEAA929B6A0C26A64D8"><enum>(1)</enum><text>with respect to the qualifying drug—</text><subparagraph id="H77E2D80C18B74CA9A1BBF4FF568E27A7"><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 calendar year or three consecutive calendar years as described in subsection (b)(1)(A) or (b)(1)(B), if applicable, and the effective date of such price increase;</text></subparagraph><subparagraph id="HF219522D7A214826BFF28057FB647BF4"><enum>(B)</enum><text>an explanation for, and description of, each price increase for such drug that will occur during the calendar year period described in subsection (b)(1)(A) or the three consecutive calendar year period described in subsection (b)(1)(B), as applicable;</text></subparagraph><subparagraph id="H01C1004A570948BFBBFEA57C24B02AA9"><enum>(C)</enum><text display-inline="yes-display-inline">if known and different from the manufacturer of the qualifying drug, the identity of—</text><clause id="H015CC0A2A9904CD5B90BEC2600DB86D3"><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="HD332D49C0A254F40A166D19E3CC72AC6"><enum>(I)</enum><text>for approval of the drug under section 505 of such Act; or</text></subclause><subclause id="HFFE14218806E4BF1BBFA14F739CDFAB9"><enum>(II)</enum><text>for licensure of the drug under section 351 of the Public Health Service Act; and</text></subclause></clause><clause id="H2119FA87B2B04034A46B9B111306996B"><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="H348B6F558F67422996D14D4AE398C362"><enum>(D)</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="H92B7347DC2B54FEDBE6E0AC3D036D20D"><enum>(E)</enum><text>the current wholesale acquisition cost of the drug;</text></subparagraph><subparagraph commented="no" id="HD81E03B88FFF4EDCA95AE72F8A54B149"><enum>(F)</enum><text>the total expenditures of the manufacturer on—</text><clause commented="no" id="H979B0B93167E42F890EFE6233ADF4FA1"><enum>(i)</enum><text>materials and manufacturing for such drug; and</text></clause><clause commented="no" id="H1F39FBADF8B543828A3FB28FEC2FD7C6"><enum>(ii)</enum><text>acquiring patents and licensing for such drug;</text></clause></subparagraph><subparagraph id="H81140BB6432F4ADBAA494D0C46903679"><enum>(G)</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="H80C930CAA6E042B2B0961D6926C95843"><enum>(H)</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="H970893368C844ECBB9FD80A547800553"><enum>(I)</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="H4286E9CE7E1C4538B65202D5EA5D01FB"><enum>(J)</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="H089D51DB50584438AD0A1617A75C053B"><enum>(K)</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="H2CBC0DFACF734761A0F097AF5F811B03"><enum>(L)</enum><text>the total costs associated with marketing and advertising for the qualifying drug;</text></subparagraph></paragraph><paragraph id="HEC73EED18831478196EDD8A1C8D86F78"><enum>(2)</enum><text>with respect to the manufacturer—</text><subparagraph id="HAFF2A1CA5CFB4BA5BFCB9850E65FFCEA"><enum>(A)</enum><text display-inline="yes-display-inline">the total revenue and the net profit of the manufacturer for each of the 1-year period described in subsection (b)(1)(A) or the 3-year period described in subsection (b)(1)(B), as applicable;</text></subparagraph><subparagraph id="H5F00519559BC42E088BFBDF315575E48"><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 1-year period described in subsection (b)(1)(A) or the 3-year period described in subsection (b)(1)(B), as applicable; and</text></subparagraph><subparagraph id="HACE66CC6E7AB4DCF8046EED1158A7549"><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="HAA1162BAE49940E0B16E0F16011D26A7"><enum>(i)</enum><text>drug research and development; or</text></clause><clause id="HDFB455F949394F85BE298135326AD4C6"><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="HB69269FE8E954ABB881C7E1CB3877F66"><enum>(3)</enum><text display-inline="yes-display-inline">such other related information as the Secretary considers appropriate and as specified by the Secretary through notice-and-comment rulemaking.</text></paragraph></subsection><subsection id="H2C464A9C21C34553BFCC0E3616FBD57B"><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)(B) shall be truthful, not misleading, and accurate.</text></subsection><subsection id="HD7210EDD188948C1928FDE1E4B5101C7"><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="H7919579F0FEB43F8AC34D8DF50709264"><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 $75,000 for each item of false information.</text></subsection><subsection id="H4EBFF7A37F2945179781AA232091AAF2"><enum>(g)</enum><header>Public posting</header><paragraph id="H76EA8A33EDA546218234B08F5AD6349B"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to paragraph (3), 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="HF7683E82F90445C08E84A86E4D5963A2"><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="H05C3A9AAAD9D4FD8A9E9E97836A94BD8"><enum>(A)</enum><text>user-friendly to the public; and</text></subparagraph><subparagraph id="HF99D6D7C88214367878DEFB07909372E"><enum>(B)</enum><text>written in plain language that consumers can readily understand.</text></subparagraph></paragraph><paragraph id="H59B19C18857B45B48986DC5BB9321E1F"><enum>(3)</enum><header>Protected information</header><text display-inline="yes-display-inline">Nothing in this section shall be construed to authorize the public disclosure of information submitted by a manufacturer that is prohibited from disclosure by applicable laws concerning the protection of trade secrets, commercial information, and other information covered under such laws.</text></paragraph></subsection><subsection id="H83829DDC6F984EF5943BC145EC79F86C"><enum>(h)</enum><header>Annual report to Congress</header><paragraph id="H8F54079D32EF43D594DD0F2CA9F511F4"><enum>(1)</enum><header>In General</header><text display-inline="yes-display-inline">Subject to paragraph (2), the Secretary shall submit to Congress, 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><subparagraph id="HCDA607C8472243B3843A5AAED95AEB7D"><enum>(A)</enum><text display-inline="yes-display-inline">summarizing the information reported pursuant to this section;</text></subparagraph><subparagraph id="H4E090158CB7F4030A13F4A4153201303"><enum>(B)</enum><text display-inline="yes-display-inline">including copies of the reports and supporting detailed economic analyses submitted pursuant to this section;</text></subparagraph><subparagraph id="HE24E4B85A00A4EB3BB167115A8D5736F"><enum>(C)</enum><text display-inline="yes-display-inline">detailing the costs and expenditures incurred by the Department of Health and Human Services in carrying out this section; and</text></subparagraph><subparagraph id="H6016F020906A49EB8168406E7FE8235A"><enum>(D)</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></subparagraph></paragraph><paragraph id="H3D627B45B6F5450DA84B1545C125FB95"><enum>(2)</enum><header>Protected information</header><text display-inline="yes-display-inline">Nothing in this subsection shall be construed to authorize the public disclosure of information submitted by a manufacturer that is prohibited from disclosure by applicable laws concerning the protection of trade secrets, commercial information, and other information covered under such laws.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HE6E8D94161694F87A4B9D0FF9AF398AF"><enum>(b)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendment made by subsection (a) shall take effect on the date of enactment of this Act.</text></subsection></section><section id="HD5AF316FA44344B796C63CC2AEB37E23"><enum>202.</enum><header>Public disclosure of drug discounts</header><text display-inline="no-display-inline">Section 1150A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-23">42 U.S.C. 1320b–23</external-xref>) is amended—</text><paragraph id="H8CB2CD42A21A4A2281088A1EBBA39A6C"><enum>(1)</enum><text>in subsection (c), in the matter preceding paragraph (1), by inserting <quote>(other than as permitted under subsection (e))</quote> after <quote>disclosed by the Secretary</quote>; and</text></paragraph><paragraph id="H081566F6DCFE470997365F428C41B1A1"><enum>(2)</enum><text>by adding at the end the following new subsection:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HAD2E69AD916943838D3DC653CFDF1094"><subsection id="HE114C0683CF34736A3B50BA860699A25"><enum>(e)</enum><header>Public availability of certain information</header><paragraph id="H4534D2285D3C4E87A7FF2E11FE4276A4"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">In order to allow the comparison of PBMs’ ability to negotiate rebates, discounts, direct and indirect remuneration fees, administrative fees, and price concessions and the amount of such rebates, discounts, direct and indirect remuneration fees, administrative fees, and price concessions that are passed through to plan sponsors, beginning January 1, 2022, the Secretary shall make available on the internet website of the Department of Health and Human Services the information with respect to the second preceding calendar year provided to the Secretary on generic dispensing rates (as described in paragraph (1) of subsection (b)) and information provided to the Secretary under paragraphs (2) and (3) of such subsection that, as determined by the Secretary, is with respect to each PBM.</text></paragraph><paragraph id="H2A6B4B4662BB495B8541748B0DFCDAF3"><enum>(2)</enum><header>Availability of data</header><text>In carrying out paragraph (1), the Secretary shall ensure the following:</text><subparagraph id="HB3C9B1A9C20B4012A89577D43BF577B2"><enum>(A)</enum><header>Confidentiality</header><text display-inline="yes-display-inline">The information described in such paragraph is displayed in a manner that prevents the disclosure of information, with respect to an individual drug or an individual plan, on rebates, discounts, direct and indirect remuneration fees, administrative fees, and price concessions.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0B48AF851913461B9FEE90B287BD524B"><enum>(B)</enum><header>Class of drug</header><text>The information described in such paragraph is made available by class of drug, using an existing classification system, but only if the class contains such number of drugs, as specified by the Secretary (but not fewer than three drugs), to ensure confidentiality of proprietary information or other information that is prevented to be disclosed under subparagraph (A).</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section commented="no" id="H850CCFBD10F741CDB4B57481EA4CEBF2"><enum>203.</enum><header>Making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities</header><subsection commented="no" id="HBA21A8E1A3E44A689DF96A75FC08817F"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1128H of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320a-7i">42 U.S.C. 1320a–7i</external-xref>) is amended—</text><paragraph commented="no" id="HCA87D3829773419E9283135540FDA2E2"><enum>(1)</enum><text>by redesignating subsection (b) as subsection (e); and</text></paragraph><paragraph commented="no" id="H8CBABD7161DA431FABD1E6173A1BB269"><enum>(2)</enum><text>by inserting after subsection (a) the following new subsections:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H6DD07C6732B544538A5EAB59738B8D43"><subsection commented="no" id="H140890D66E184AEA8EEA020E14EBEDEF"><enum>(b)</enum><header>Data sharing agreements</header><paragraph commented="no" id="HA0C7F76245DD449A96702360E96CD953"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall enter into agreements with the specified data sharing individuals and entities described in paragraph (2) under which—</text><subparagraph commented="no" id="H241643DEC8E7490FB2BE260091E6C86A"><enum>(A)</enum><text>upon request of such an individual or entity, as applicable, the Secretary makes available to such individual or entity the information submitted under subsection (a) by manufacturers and authorized distributors of record; and</text></subparagraph><subparagraph commented="no" id="H8F5E78951FF645778EB7494BB61C9E11"><enum>(B)</enum><text>such individual or entity agrees to not disclose publicly or to another individual or entity any information that identifies a particular practitioner or health care facility.</text></subparagraph></paragraph><paragraph commented="no" id="H59E1EFD199B94453AE68B348BE1790C3"><enum>(2)</enum><header>Specified data sharing individuals and entities</header><text>For purposes of paragraph (1), the specified data sharing individuals and entities described in this paragraph are the following:</text><subparagraph commented="no" id="H39266B59550D4FE1A5FEB431BF1CB0A7"><enum>(A)</enum><header>Oversight agencies</header><text>Health oversight agencies (as defined in section 164.501 of title 45, Code of Federal Regulations), including the Centers for Medicare & Medicaid Services, the Office of the Inspector General of the Department of Health and Human Services, the Government Accountability Office, the Congressional Budget Office, the Medicare Payment Advisory Commission, and the Medicaid and CHIP Payment and Access Commission.</text></subparagraph><subparagraph commented="no" id="H985D9F8418C74986BA63C88BEB3E0574"><enum>(B)</enum><header>Researchers</header><text>Individuals who conduct scientific research (as defined in section 164.501 of title 45, Code of Federal Regulations) in relevant areas as determined by the Secretary.</text></subparagraph><subparagraph commented="no" id="HA51FEE894FFC4B0793EDAF1477D8CFE9"><enum>(C)</enum><header>Payers</header><text>Private and public health care payers, including group health plans, health insurance coverage offered by health insurance issuers, Federal health programs, and State health programs.</text></subparagraph></paragraph><paragraph commented="no" id="HF86E55C123854E0EBDAC7276D20AB716"><enum>(3)</enum><header>Exemption from Freedom of Information Act</header><text display-inline="yes-display-inline">Except as described in paragraph (1), the Secretary may not be compelled to disclose the information submitted under subsection (a) to any individual or entity. For purposes of section 552 of title 5, United States Code (commonly referred to as the Freedom of Information Act), this paragraph shall be considered a statute described in subsection (b)(3)(B) of such section.</text></paragraph></subsection><subsection commented="no" id="H58D6F81B9F314C75AF8BEF8ABDAFBB80"><enum>(c)</enum><header>Penalties</header><paragraph commented="no" id="H2B38D5B8D5224DF7BCC78A95698E2CE8"><enum>(1)</enum><header>Data sharing agreements</header><text display-inline="yes-display-inline">Subject to paragraph (3), any specified data sharing individual or entity described in subsection (b)(2) that violates the terms of a data sharing agreement the individual or entity has with the Secretary under subsection (b)(1) shall be subject to a civil money penalty of not less than $1,000, but not more than $10,000, for each such violation. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of section 1128A are imposed and collected under that section.</text></paragraph><paragraph commented="no" id="H50A0A7C9755349A5B6A944C13358842A"><enum>(2)</enum><header>Failure to report</header><text display-inline="yes-display-inline">Subject to paragraph (3), any manufacturer or authorized distributor of record of an applicable drug under subsection (a) that fails to submit information required under such subsection in a timely manner in accordance with rules or regulations promulgated to carry out such subsection shall be subject to a civil money penalty of not less than $1,000, but not more than $10,000, for each such failure. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of section 1128A are imposed and collected under that section.</text></paragraph><paragraph commented="no" id="H8718BF55F6F9479885444FC0D527468D"><enum>(3)</enum><header>Limitation</header><text>The total amount of civil money penalties imposed under paragraph (1) or (2) with respect to a year and an individual or entity described in paragraph (1) or a manufacturer or distributor described in paragraph (2), respectively, shall not exceed $150,000.</text></paragraph></subsection><subsection commented="no" id="H5CFC2B51374047AEA38B47EF4251A471"><enum>(d)</enum><header>Drug sample distribution information</header><paragraph commented="no" id="HEF66E728F25F492C8DB1874E80B91500"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than January 1 of each year (beginning with 2022), the Secretary shall maintain a list containing information related to the distribution of samples of applicable drugs. Such list shall provide the following information with respect to the preceding year:</text><subparagraph commented="no" id="H682D63D2D6224915951FAC2CBE1D7099"><enum>(A)</enum><text>The name of the manufacturer or authorized distributor of record of an applicable drug for which samples were requested or distributed under this section.</text></subparagraph><subparagraph commented="no" id="HD0AB5CB75DF84CDF902947471CF3FCD7"><enum>(B)</enum><text>The quantity and class of drug samples requested.</text></subparagraph><subparagraph commented="no" id="H0F78E217655C489C96A591EE56644655"><enum>(C)</enum><text>The quantity and class of drug samples distributed.</text></subparagraph></paragraph><paragraph commented="no" id="H02EF4430377E41A79C1B29E6B2886F98"><enum>(2)</enum><header>Public availability</header><text display-inline="yes-display-inline">The Secretary shall make the information in such list available to the public on the internet website of the Food and Drug Administration.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" id="H0FE41CC3091148738D34D401D492EA4C"><enum>(b)</enum><header>FDA maintenance of information</header><text display-inline="yes-display-inline">The Food and Drug Administration shall maintain information available to affected reporting companies to ensure their ability to fully comply with the requirements of section 1128H of the Social Security Act.</text></subsection><subsection commented="no" id="HEE8FA72DF83A44968334B04A4513CBD8"><enum>(c)</enum><header>Prohibition on distribution of samples of opioids</header><text>Section 503(d) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353(d)</external-xref>) is amended—</text><paragraph commented="no" id="HE3C403E30BEE4AB49EB5591AEFDD465D"><enum>(1)</enum><text>by moving the margin of paragraph (4) 2 ems to the left; and</text></paragraph><paragraph commented="no" id="H20AF44B127614BBEB39C6BF984A6B593"><enum>(2)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H82B38CBB66FE481D9874B70A9373CC9E"><paragraph commented="no" id="H86655EA85A6249AA8A9693EE9370ACD1" indent="up1"><enum>(5)</enum><text display-inline="yes-display-inline">No person may distribute a drug sample of a drug that is—</text><subparagraph commented="no" id="H862755D800434E0BA10DA97EB958C208"><enum>(A)</enum><text>an applicable drug (as defined in section 1128H(e) of the Social Security Act);</text></subparagraph><subparagraph commented="no" id="H0684D76848D04C24B5FB3B0073677D3B"><enum>(B)</enum><text display-inline="yes-display-inline">a controlled substance (as defined in section 102 of the Controlled Substances Act) for which the findings required under section 202(b)(2) of such Act have been made; and</text></subparagraph><subparagraph commented="no" id="HA274BE093E9B4321B23E03CD1B547F3A"><enum>(C)</enum><text>approved under section 505 for use in the management or treatment of pain (other than for the management or treatment of a substance use disorder).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HD1295069F09E40B79453DA390D4E0AC5"><enum>(d)</enum><header>MedPAC report</header><text display-inline="yes-display-inline">Not later than 3 years after the date of the enactment of this Act, the Medicare Payment Advisory Commission shall conduct a study on the impact of drug samples on provider prescribing practices and health care costs and may, as the Commission deems appropriate, make recommendations on such study.</text></subsection></section><section id="HCB6AD4CC2FA3412188495F5D88C84D7A"><enum>204.</enum><header>Sense of the Senate regarding the need to expand commercially available drug pricing comparison platforms</header><text display-inline="no-display-inline">It is the sense of the Senate that—</text><paragraph id="H592EF85E40A54146B7CA12A21E922590"><enum>(1)</enum><text>commercially available drug pricing comparison platforms can, at no cost, help patients find the lowest price for their medications at their local pharmacy;</text></paragraph><paragraph id="H95E1E3C60D674AA78F38EA1EB4102005"><enum>(2)</enum><text>such platforms should be integrated, to the maximum extent possible, in the health care delivery ecosystem; and</text></paragraph><paragraph id="H1A82B65AA9534B4799AB86336B2268AF"><enum>(3)</enum><text>pharmacy benefit managers should work to disclose generic and brand name drug prices to such platforms to ensure that—</text><subparagraph id="HD745FC1D3C9140E1AAD4EB963B6213C5"><enum>(A)</enum><text>patients can benefit from the lowest possible price available to them; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF728A903717946B4AB6B6764B051E396"><enum>(B)</enum><text>overall drug prices can be reduced as more educated purchasing decisions are made based on price transparency.</text></subparagraph></paragraph></section><enum>III</enum><header>Revenue Provision</header><section id="id8711A537C6104CB094A50B4EA155F33B" section-type="subsequent-section"><enum>301.</enum><header>Inclusion of insulin and other treatments for chronic conditions as preventive care</header><subsection id="id8064C59E806C4B9E8D8930CBD9841383"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Subparagraph (C) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)(2)</external-xref> of the Internal Revenue Code of 1986 is amended—</text><paragraph id="id00382DD973C84AF5B043B261115411EA"><enum>(1)</enum><text>by striking <quote><header-in-text style="OLC" level="subparagraph">deductible</header-in-text>.—A plan</quote> and inserting “<header-in-text level="subparagraph" style="OLC">deductible</header-in-text>.—</text><quoted-block style="OLC" display-inline="no-display-inline" id="id202C9F8279124B17996CF4CB15417DD6"><clause id="id599B06DED4ED4812A5CF3AEA273092E7"><enum>(i)</enum><header>In general</header><text>A plan</text></clause><after-quoted-block>, and</after-quoted-block></quoted-block></paragraph><paragraph id="id0E760031544D400984BAADFBB96778F6"><enum>(2)</enum><text>by adding at the end the following new clause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idA57AE4ADE5484EEAA495FF1B5DDBD02A"><clause id="idF1F873FC9AD74B38836596864E1D95E2"><enum>(ii)</enum><header>Special rule</header><text>The term <term>preventive care</term> includes such drugs (including insulin), devices, supplies, and medical services or screenings prescribed for the prevention or avoidance of a disease or condition, or the regular treatment and maintenance of a chronic disease or condition, as are determined by the Secretary, in consultation with the Secretary of Health and Human Services, to be—</text><subclause id="id14A8D64108E44756A9A82D5869A5F690"><enum>(I)</enum><text>low in cost,</text></subclause><subclause id="id38174126A8984982B0ACE1BF4645E1A8"><enum>(II)</enum><text>supported by medical evidence to have a high cost efficiency in preventing exacerbation of a chronic condition or the development of a secondary condition, and</text></subclause><subclause id="idD0E4D991B3AA4474B450ED40C306AF62"><enum>(III)</enum><text>likely (as documented by clinical evidence), when prescribed for a class of individuals, to prevent exacerbation of the chronic condition of such individuals or the development of a secondary condition requiring significantly higher cost treatments.</text></subclause></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="idAAC399667FA145B4B4AC6EEFC51119AC"><enum>(b)</enum><header>Effective date</header><paragraph id="idA47BA908445743B9A17A8571E2E1121C"><enum>(1)</enum><header>In general</header><text>The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></paragraph><paragraph id="id1DAB696FEBE44253AC2EB8FB07D5B45A"><enum>(2)</enum><header>Treasury guidance in effect on date of enactment</header><subparagraph id="id863AEC0CCD2846F7B98C3F32404292B5"><enum>(A)</enum><header>In general</header><text>No inference shall be drawn by reason of the amendments made by this Act with respect to the effectiveness of the provisions of Internal Revenue Service Notice 2019-45 on the date of the enactment of this Act, and such notice shall continue to apply as in effect on July 17, 2019, unless amended by the Secretary of the Treasury (or the Secretary's delegate) pursuant to the amendments made by this Act or pursuant to subparagraph (B).</text></subparagraph><subparagraph id="idF4C59E2AE3B34566845AAE594F7F1BBA"><enum>(B)</enum><header>Continued publication and update of list</header><clause id="id26965F0005E341E89B877EB9DD4BCDE3"><enum>(i)</enum><header>In general</header><text>The Secretary of the Treasury (or the Secretary's delegate) may publish, and update from time to time as such Secretary (or delegate) deems appropriate, a list of the drugs, devices, supplies, and services identified under <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)(2)(C)(ii)</external-xref> of the Internal Revenue Code of 1986, in consultation with the Secretary of Health and Human Services (or such Secretary's delegate), as preventive care.</text></clause><clause id="id866C5AF9ABBD4098ABBC2B438AEC7C71" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><header>Inclusion of certain diabetic supplies</header><text>As soon as practicable after the date of the enactment of this Act, the list in effect under Internal Revenue Service Notice 2019-45 shall be amended to include insulin delivery devices and related supplies, and continuous glucose monitoring systems and related supplies.</text></clause></subparagraph></paragraph></subsection></section><enum>IV</enum><header>Miscellaneous Provisions</header><section id="H2B87E0D89AD94433849F3B6E2D1A5414"><enum>401.</enum><header>Improving coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services</header><subsection id="HF1AD32D90AC643C9A750E0C1B5203B96"><enum>(a)</enum><header>In general</header><paragraph id="H53B2D2887E1B40548B3ECAA851BF3543"><enum>(1)</enum><header>Public meeting</header><subparagraph id="HD119248676C748D8BD083CE3D2AE6993"><enum>(A)</enum><header>In general</header><text>Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall convene a public meeting for the purposes of discussing and providing input on improvements to coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services in preparing for the availability of novel medical products described in subsection (c) on the market in the United States.</text></subparagraph><subparagraph id="H1C2D612D85D34B6F993B48ED4D17C1C8"><enum>(B)</enum><header>Attendees</header><text>The public meeting shall include—</text><clause id="H8160E0BEB22245228ECE561BD54F97C9"><enum>(i)</enum><text>representatives of relevant Federal agencies, including representatives from each of the medical product centers within the Food and Drug Administration and representatives from the coding, coverage, and payment offices within the Centers for Medicare & Medicaid Services;</text></clause><clause id="HC858817D299E4F5BB239C53399E6F259"><enum>(ii)</enum><text>stakeholders with expertise in the research and development of novel medical products, including manufacturers of such products;</text></clause><clause id="H7B786CCC14ED497ABA207FDD4AB70C98"><enum>(iii)</enum><text>representatives of commercial health insurance payers;</text></clause><clause id="HD5A3246A43D64BC49CB57525BA12F565"><enum>(iv)</enum><text>stakeholders with expertise in the administration and use of novel medical products, including physicians; and</text></clause><clause id="HD78F039A48DD4A919FC72A0F61D04BCA"><enum>(v)</enum><text>stakeholders representing patients and with expertise in the utilization of patient experience data in medical product development.</text></clause></subparagraph><subparagraph id="H39CC050E5A8D447886D494B01D9AE2F4"><enum>(C)</enum><header>Topics</header><text>The public meeting shall include a discussion of—</text><clause id="H49F01C011EE64D93B389EEEF22448F19"><enum>(i)</enum><text>the status of the drug and medical device development pipeline related to the availability of novel medical products;</text></clause><clause id="H8CC3CEC1641A4C0A97D8DAC4E0BF06FF"><enum>(ii)</enum><text>the anticipated expertise necessary to review the safety and effectiveness of such products at the Food and Drug Administration and current gaps in such expertise, if any;</text></clause><clause id="H898EAFB13F2741E8B5F1EF6B7AD28B8C"><enum>(iii)</enum><text>the expertise necessary to make coding, coverage, and payment decisions with respect to such products within the Centers for Medicare & Medicaid Services, and current gaps in such expertise, if any;</text></clause><clause id="H39A146B5D07C4A71BB7381DECBC9AC62"><enum>(iv)</enum><text>trends in the differences in the data necessary to determine the safety and effectiveness of a novel medical product and the data necessary to determine whether a novel medical product meets the reasonable and necessary requirements for coverage and payment under title XVIII of the Social Security Act pursuant to section 1862(a)(1)(A) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C. 1395y(a)(1)(A)</external-xref>);</text></clause><clause id="HE8D3010699DF4FD1B68589C6BCBAB246"><enum>(v)</enum><text>the availability of information for sponsors of such novel medical products to meet each of those requirements; and</text></clause><clause id="H3B6DEF159CE54D9A81F196608D13B93C"><enum>(vi)</enum><text>the coordination of information related to significant clinical improvement over existing therapies for patients between the Food and Drug Administration and the Centers for Medicare & Medicaid Services with respect to novel medical products.</text></clause></subparagraph><subparagraph id="H48E4C8650958473E85406E88291F5D5A"><enum>(D)</enum><header>Trade secrets and confidential information</header><text>No information discussed as a part of the public meeting under this paragraph shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code.</text></subparagraph></paragraph><paragraph id="HC38AA37E573E44B39B374094382D2137"><enum>(2)</enum><header>Improving transparency of criteria for Medicare coverage</header><subparagraph id="H63E468A39192425DAB52692736C598D0"><enum>(A)</enum><header>Draft guidance</header><text>Not later than 18 months after the public meeting under paragraph (1), the Secretary shall update the final guidance titled <quote>National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development</quote> to address any opportunities to improve the availability and coordination of information as described in clauses (iv) through (vi) of paragraph (1)(C).</text></subparagraph><subparagraph id="H0B4B5C9FDCA54DF593D0A932A31BB69A"><enum>(B)</enum><header>Final guidance</header><text>Not later than 12 months after issuing draft guidance under subparagraph (A), the Secretary shall finalize the updated guidance to address any such opportunities.</text></subparagraph></paragraph></subsection><subsection id="H680B64710D99417C8EBEEDE90A3EBC27"><enum>(b)</enum><header>Report on coding, coverage, and payment processes under medicare for novel medical products</header><text>Not later than 12 months after the date of the enactment of this Act, the Secretary shall publish a report on the internet website of the Department of Health and Human Services regarding processes under the Medicare program under title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395 et seq.</external-xref>) with respect to the coding, coverage, and payment of novel medical products described in subsection (c). Such report shall include the following:</text><paragraph id="H2085346758F642C28085004CDCD0A53D"><enum>(1)</enum><text>A description of challenges in the coding, coverage, and payment processes under the Medicare program for novel medical products.</text></paragraph><paragraph id="H0D76DD29E32F411B98BC66BEB35D8703"><enum>(2)</enum><text>Recommendations to—</text><subparagraph id="H43C63AB85A9F4108A6129A8D981E6142"><enum>(A)</enum><text>incorporate patient experience data (such as the impact of a disease or condition on the lives of patients and patient treatment preferences) into the coverage and payment processes within the Centers for Medicare & Medicaid Services;</text></subparagraph><subparagraph id="H9D42EFD2637943F29A1BE68AD90E0489"><enum>(B)</enum><text>decrease the length of time to make national and local coverage determinations under the Medicare program (as those terms are defined in subparagraph (A) and (B), respectively, of section 1862(l)(6) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C. 1395y(l)(6)</external-xref>));</text></subparagraph><subparagraph id="H5631283C279D4A03A0A0422FA2F7B5B7"><enum>(C)</enum><text>streamline the coverage process under the Medicare program and incorporate input from relevant stakeholders into such coverage determinations; and</text></subparagraph><subparagraph id="H06F37512200C46E9AE7897B8EE3CACE3"><enum>(D)</enum><text>identify potential mechanisms to incorporate novel payment designs similar to those in development in commercial insurance plans and State plans under title XIX of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396">42 U.S.C. 1396 et seq.</external-xref>) into the Medicare program.</text></subparagraph></paragraph></subsection><subsection id="H64A6818014CC4DA482157998B5BB07F9"><enum>(c)</enum><header>Novel medical products described</header><text>For purposes of this section, a novel medical product described in this subsection is a medical product, including a drug, biological (including gene and cell therapy), or medical device, that has been designated as a breakthrough therapy under section 506(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356">21 U.S.C. 356(a)</external-xref>), a breakthrough device under section 515B of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e-3">21 U.S.C. 360e–3</external-xref>), or a regenerative advanced therapy under section 506(g) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356">21 U.S.C. 356(g)</external-xref>).</text></subsection></section><section id="H69A86532F112411F87A7D71006E5C53C"><enum>402.</enum><header>Patient consultation in Medicare national and local coverage determinations in order to mitigate barriers to inclusion of such perspectives</header><text display-inline="no-display-inline">Section 1862(l) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C. 1395y(l)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H9414A42A19FE4D06B7017D9825E757C4"><paragraph id="H76D49837BB1246209C2CCF0667E7A9F8"><enum>(7)</enum><header>Patient consultation in national and local coverage determinations</header><text>The Secretary may consult with patients and organizations representing patients in making national and local coverage determinations.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H7C5FECEFBD65455DA65271441DB5F3CB"><enum>403.</enum><header>MedPAC report on shifting coverage of certain Medicare part B drugs to Medicare part D</header><subsection id="H1BA2D45F57EA41A1A94769E12CC0D78C"><enum>(a)</enum><header>Study</header><text>The Medicare Payment Advisory Commission (in this section referred to as the <quote>Commission</quote>) shall conduct a study on shifting coverage of certain drugs and biologicals for which payment is currently made under part B of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395j">42 U.S.C. 1395j et seq.</external-xref>) to part D of such title (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-21">42 U.S.C. 1395w–21 et seq.</external-xref>). Such study shall include an analysis of—</text><paragraph id="H2FF3D2A149FA4AB9B977385A3B1C90EF"><enum>(1)</enum><text>differences in program structures and payment methods for drugs and biologicals covered under such parts B and D, including effects of such a shift on program spending, beneficiary cost-sharing liability, and utilization management techniques for such drugs and biologicals; and</text></paragraph><paragraph id="HBB8F2DA0394C418CB99C756C41D5753F"><enum>(2)</enum><text>the feasibility and policy implications of shifting coverage of drugs and biologicals for which payment is currently made under such part B to such part D.</text></paragraph></subsection><subsection id="HDB740C84937C4BB8B93ECD61AED49254"><enum>(b)</enum><header>Report</header><paragraph id="H7EBA59C9159C4166BB5372D6241C785E"><enum>(1)</enum><header>In general</header><text>Not later than June 30, 2023, the Commission shall submit to Congress a report containing the results of the study conducted under subsection (a).</text></paragraph><paragraph id="HAA73D7C238194379A6281284E24F42A7"><enum>(2)</enum><header>Contents</header><text>The report under paragraph (1) shall include information, and recommendations as the Commission deems appropriate, regarding—</text><subparagraph id="HF0FF357A7610486593FE3E3C0F6A78B9"><enum>(A)</enum><text>formulary design under such part D;</text></subparagraph><subparagraph id="H066730FF15054D37A30408A4070CB37E"><enum>(B)</enum><text>the ability of the benefit structure under such part D to control total spending on drugs and biologicals for which payment is currently made under such part B;</text></subparagraph><subparagraph id="HAF4CC252803140F8AC69923818EC8E7B"><enum>(C)</enum><text>changes to the bid process under such part D, if any, that may be necessary to integrate coverage of such drugs and biologicals into such part D;</text></subparagraph><subparagraph id="HAB2D3478AD734392B9FC5E33FD32D371"><enum>(D)</enum><text>any other changes to the program that Congress should consider in determining whether to shift coverage of such drugs and biologicals from such part B to such part D; and</text></subparagraph><subparagraph id="H71E49768BF9F490CA6FD15D15CAE006C"><enum>(E)</enum><text>the feasibility and policy implications of creating a methodology to preserve the healthcare provider’s ability to take title of the drug, including a methodology under which—</text><clause id="H5930953903914E3A9B92EC12983101BB"><enum>(i)</enum><text>prescription drug plans negotiate reimbursement rates and other arrangements with drug manufacturers on behalf of a wholesaler;</text></clause><clause id="HC15BCDCD27AF4CE89216923BBB34A031"><enum>(ii)</enum><text>wholesalers purchase the drugs from the manufacturers at the negotiated rate and ship them through distributors to physicians to administer to patients;</text></clause><clause id="H002AC7CD0B9541AF95AF6466A1ADAB45"><enum>(iii)</enum><text>physicians and hospitals purchase the drug from the wholesaler via the distributor;</text></clause><clause id="HA9CBDF78EADF4F01B8984700A0C5CBE4"><enum>(iv)</enum><text>after administering the drug, the physician submits a claim to the MAC for their drug administration fee;</text></clause><clause id="HF57DF33C87A94366993F9B8CB0E7A744"><enum>(v)</enum><text>to be reimbursed for the purchase of the drug from the distributor, the physician furnishes the claim for the drug itself to the wholesaler and the wholesaler would refund the cost of the drug to the physician; and</text></clause><clause id="H821FC6069D604B539A29F5C08F7CEBEA"><enum>(vi)</enum><text>the wholesaler passes this claim to the PDP to receive reimbursement.</text></clause></subparagraph></paragraph></subsection></section><section id="H3E218A16DDEA459ABE3372EEB7A71054"><enum>404.</enum><header>Authority to require that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information</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 section:</text><quoted-block style="OLC" id="HD580499B7D754FEC97572AB0DC48E423"><section id="H0A1AF74C027A49E6BD0FB829E61F0692"><enum>1150D.</enum><header>Authority to require that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information</header><subsection id="HF6C9C213481D4B8ABF58D1C341362698"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary may require that each direct-to-consumer advertisement for a prescription drug or biological product for which payment is available under title XVIII or XIX includes an internet website address that provides an appropriate disclosure of truthful and non-misleading pricing information with respect to the drug or product.</text></subsection><subsection id="HFB9B8D9126F44BC1BF2BCC884CA167E8"><enum>(b)</enum><header>Determination by CMS</header><text>The Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall determine the components of the requirement under subsection (a), such as the forms of advertising, the manner of disclosure, the price point listing, and the price information for disclosure.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="HB3825ACEDFFE4FA98D7EA19572E166FE"><enum>405.</enum><header>Chief Pharmaceutical Negotiator at the Office of the United States Trade Representative</header><subsection id="H317C993B6C1D47B0AC9225698F856D87"><enum>(a)</enum><header>In general</header><text>Section 141 of the Trade Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/19/2171">19 U.S.C. 2171</external-xref>) is amended—</text><paragraph id="H7D94F7B693844641A917365A369970BC"><enum>(1)</enum><text>in subsection (b)(2)—</text><subparagraph id="HAF76975964684ECBA14E29E2837B993B"><enum>(A)</enum><text>by striking <quote>and one Chief Innovation and Intellectual Property Negotiator</quote> and inserting <quote>one Chief Innovation and Intellectual Property Negotiator, and one Chief Pharmaceutical Negotiator</quote>;</text></subparagraph><subparagraph id="HB15EE925E71A4C2EBF3AD332E5FB503B"><enum>(B)</enum><text>by striking <quote>or the Chief Innovation and Intellectual Property Negotiator</quote> and inserting <quote>the Chief Innovation and Intellectual Property Negotiator, or the Chief Pharmaceutical Negotiator</quote>; and</text></subparagraph><subparagraph id="H5164A5E8BAEF438CB4E49EFA5AD38AB8"><enum>(C)</enum><text>by striking <quote>and the Chief Innovation and Intellectual Property Negotiator</quote> and inserting <quote>the Chief Innovation and Intellectual Property Negotiator, and the Chief Pharmaceutical Negotiator</quote>; and</text></subparagraph></paragraph><paragraph id="H3B08A9561BAC469B812D452BB7D0D820"><enum>(2)</enum><text>in subsection (c), by adding at the end the following new paragraph:</text><quoted-block style="OLC" id="H885EC8344BF4456685953C8F122FFF40"><paragraph id="H58F2156374B54151BDA3D025568C1698"><enum>(7)</enum><text>The principal function of the Chief Pharmaceutical Negotiator shall be to conduct trade negotiations and to enforce trade agreements relating to United States pharmaceutical products and services. The Chief Pharmaceutical Negotiator shall be a vigorous advocate on behalf of United States pharmaceutical interests. The Chief Pharmaceutical Negotiator shall perform such other functions as the United States Trade Representative may direct.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H8319BAA3BD934298A04245EED3EC5969"><enum>(b)</enum><header>Compensation</header><text>Section 5314 of title 5, United States Code, is amended by striking <quote>Chief Innovation and Intellectual Property Negotiator, Office of the United States Trade Representative.</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HCDD54C7D82FB4A889658589B0D850859"><list level="paragraph"><list-item>Chief Innovation and Intellectual Property Negotiator, Office of the United States Trade Representative.</list-item><list-item>Chief Pharmaceutical Negotiator, Office of the United States Trade Representative.</list-item></list><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HE358B2157FA34D62A81D903E8E69BA4C"><enum>(c)</enum><header>Report required</header><text>Not later than the date that is one year after the appointment of the first Chief Pharmaceutical Negotiator pursuant to paragraph (2) of section 141(b) of the Trade Act of 1974, as amended by subsection (a), and annually thereafter, the United States Trade Representative shall submit to the Committee on Finance of the Senate and the Committee on Ways and Means of the House of Representatives a report describing in detail—</text><paragraph id="HF55C5FC83E164DDD9B26783E910B5704"><enum>(1)</enum><text>enforcement actions taken by the United States Trade Representative during the 1-year period preceding the submission of the report to ensure the protection of United States pharmaceutical products and services; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC5BA72A671674AC4934F2211109B034B"><enum>(2)</enum><text>other actions taken by the United States Trade Representative to advance United States pharmaceutical products and services.</text></paragraph></subsection></section>