Title: Elijah E. Cummings Lower Drug Costs Now Act
Policy area: Health

Summary:
Elijah E. Cummings Lower Drug Costs Now Act
This bill establishes several programs and requirements relating to the prices of prescription drugs.
In particular, the bill requires the Department of Health and Human Services (HHS) to negotiate prices for certain drugs (current law prohibits HHS from doing so). Specifically, HHS must negotiate maximum prices for single-source, brand-name drugs that lack certain generics and that are among either the 125 drugs that account for the greatest national spending or the 125 drugs that account for the greatest Medicare spending. HHS must negotiate the prices of at least 25 such drugs for 2024 and of at least 50 such drugs thereafter and must also negotiate prices for certain newly approved drugs and for insulin products. The negotiated prices must be offered under Medicare and may also be offered under private health insurance unless the insurer opts out.
The negotiated maximum price may not exceed (1) 120% of the average price in Australia, Canada, France, Germany, Japan, and the United Kingdom; or (2) if such information is not available, 85% of the U.S. average manufacturer price. Drug manufacturers that fail to comply with the bill's negotiation requirements are subject to civil and tax penalties.
The bill also makes a series of additional changes to Medicare prescription drug coverage and pricing, including by (1) requiring drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services for covered drugs that cost $100 or more and for which the average manufacturer price increases faster than inflation, and (2) capping annual out-of-pocket spending under the Medicare prescription drug benefit.
The bill also requires drug manufacturers to report specified information for certain high-cost drugs, and it provides funds for opioid epidemic initiatives and biomedical research.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3 Introduced in House (IH)]

<DOC>






117th CONGRESS
  1st Session
                                 H. R. 3

  To establish a fair price negotiation program, protect the Medicare 
program from excessive price increases, and establish an out-of-pocket 
     maximum for Medicare part D enrollees, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 22, 2021

    Mr. Pallone (for himself, Mr. Neal, and Mr. Scott of Virginia) 
 introduced the following bill; which was referred to the Committee on 
  Energy and Commerce, and in addition to the Committees on Ways and 
    Means, Education and Labor, Oversight and Reform, and Veterans' 
Affairs, for a period to be subsequently determined by the Speaker, in 
   each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
  To establish a fair price negotiation program, protect the Medicare 
program from excessive price increases, and establish an out-of-pocket 
     maximum for Medicare part D enrollees, and for other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Elijah E. Cummings 
Lower Drug Costs Now Act''.
    (b) Table of Contents.--The table of contents is as follows:

Sec. 1. Short title; table of contents.
      TITLE I--LOWERING PRICES THROUGH FAIR DRUG PRICE NEGOTIATION

Sec. 101. Providing for lower prices for certain high-priced single 
                            source drugs.
Sec. 102. Selected drug manufacturer excise tax imposed during 
                            noncompliance periods.
Sec. 103. Fair Price Negotiation Implementation Fund.
             TITLE II--PRESCRIPTION DRUG INFLATION REBATES

Sec. 201. Medicare part B rebate by manufacturers.
Sec. 202. Medicare part D rebate by manufacturers.
Sec. 203. Provision regarding inflation rebates for group health plans 
                            and group health insurance coverage.
Sec. 204. Annual report on drug costs in group health plans and group 
                            health insurance coverage.
Sec. 205. Collection of data.
   TITLE III--PART D IMPROVEMENTS AND MAXIMUM OUT-OF-POCKET CAP FOR 
                         MEDICARE BENEFICIARIES

Sec. 301. Medicare part D benefit redesign.
Sec. 302. Allowing certain enrollees of prescription drug plans and MA-
                            PD plans under Medicare program to spread 
                            out cost-sharing under certain 
                            circumstances.
Sec. 303. Establishment of pharmacy quality measures under Medicare 
                            part D.
                   TITLE IV--DRUG PRICE TRANSPARENCY

Sec. 401. Drug price transparency.
            TITLE V--NIH, FDA, AND OVERDOSE EPIDEMIC FUNDING

              Subtitle A--Biomedical Innovation Expansion

Sec. 501. NIH Innovation Initiatives.
Sec. 502. NIH clinical trial.
Sec. 503. Innovation Network.
             Subtitle B--Investing in Safety and Innovation

Sec. 511. Food and Drug Administration.
Sec. 512. Study on high-risk, high-reward drugs.
                 Subtitle C--Overdose Epidemic Response

Sec. 521. Overdose Epidemic Response Fund.
Sec. 522. Substance Abuse and Mental Health Services Administration.
Sec. 523. Centers for Disease Control and Prevention.
Sec. 524. Food and Drug Administration.
Sec. 525. National Institutes of Health.
Sec. 526. Health Resources and Services Administration.
Sec. 527. Administration for Children and Families.

      TITLE I--LOWERING PRICES THROUGH FAIR DRUG PRICE NEGOTIATION

SEC. 101. PROVIDING FOR LOWER PRICES FOR CERTAIN HIGH-PRICED SINGLE 
              SOURCE DRUGS.

    (a) Program To Lower Prices for Certain High-Priced Single Source 
Drugs.--Title XI of the Social Security Act (42 U.S.C. 1301 et seq.) is 
amended by adding at the end the following new part:

 ``PART E--FAIR PRICE NEGOTIATION PROGRAM TO LOWER PRICES FOR CERTAIN 
                    HIGH-PRICED SINGLE SOURCE DRUGS

``SEC. 1191. ESTABLISHMENT OF PROGRAM.

    ``(a) In General.--The Secretary shall establish a Fair Price 
Negotiation Program (in this part referred to as the `program'). Under 
the program, with respect to each price applicability period, the 
Secretary shall--
            ``(1) publish a list of selected drugs in accordance with 
        section 1192;
            ``(2) enter into agreements with manufacturers of selected 
        drugs with respect to such period, in accordance with section 
        1193;
            ``(3) negotiate and, if applicable, renegotiate maximum 
        fair prices for such selected drugs, in accordance with section 
        1194; and
            ``(4) carry out the administrative duties described in 
        section 1196.
    ``(b) Definitions Relating to Timing.--For purposes of this part:
            ``(1) Initial price applicability year.--The term `initial 
        price applicability year' means a plan year (beginning with 
        plan year 2024) or, if agreed to in an agreement under section 
        1193 by the Secretary and manufacturer involved, a period of 
        more than one plan year (beginning on or after January 1, 
        2024).
            ``(2) Price applicability period.--The term `price 
        applicability period' means, with respect to a drug, the period 
        beginning with the initial price applicability year with 
        respect to which such drug is a selected drug and ending with 
        the last plan year during which the drug is a selected drug.
            ``(3) Selected drug publication date.--The term `selected 
        drug publication date' means, with respect to each initial 
        price applicability year, April 15 of the plan year that begins 
        2 years prior to such year.
            ``(4) Voluntary negotiation period.--The term `voluntary 
        negotiation period' means, with respect to an initial price 
        applicability year with respect to a selected drug, the 
        period--
                    ``(A) beginning on the sooner of--
                            ``(i) the date on which the manufacturer of 
                        the drug and the Secretary enter into an 
                        agreement under section 1193 with respect to 
                        such drug; or
                            ``(ii) June 15 following the selected drug 
                        publication date with respect to such selected 
                        drug; and
                    ``(B) ending on March 31 of the year that begins 
                one year prior to the initial price applicability year.
    ``(c) Other Definitions.--For purposes of this part:
            ``(1) Fair price eligible individual.--The term `fair price 
        eligible individual' means, with respect to a selected drug--
                    ``(A) in the case such drug is furnished or 
                dispensed to the individual at a pharmacy or by a mail 
                order service--
                            ``(i) an individual who is enrolled under a 
                        prescription drug plan under part D of title 
                        XVIII or an MA-PD plan under part C of such 
                        title if coverage is provided under such plan 
                        for such selected drug; and
                            ``(ii) an individual who is enrolled under 
                        a group health plan or health insurance 
                        coverage offered in the group or individual 
                        market (as such terms are defined in section 
                        2791 of the Public Health Service Act) with 
                        respect to which there is in effect an 
                        agreement with the Secretary under section 1197 
                        with respect to such selected drug as so 
                        furnished or dispensed; and
                    ``(B) in the case such drug is furnished or 
                administered to the individual by a hospital, 
                physician, or other provider of services or supplier--
                            ``(i) an individual who is entitled to 
                        benefits under part A of title XVIII or 
                        enrolled under part B of such title if such 
                        selected drug is covered under the respective 
                        part; and
                            ``(ii) an individual who is enrolled under 
                        a group health plan or health insurance 
                        coverage offered in the group or individual 
                        market (as such terms are defined in section 
                        2791 of the Public Health Service Act) with 
                        respect to which there is in effect an 
                        agreement with the Secretary under section 1197 
                        with respect to such selected drug as so 
                        furnished or administered.
            ``(2) Maximum fair price.--The term `maximum fair price' 
        means, with respect to a plan year during a price applicability 
        period and with respect to a selected drug (as defined in 
        section 1192(c)) with respect to such period, the price 
        published pursuant to section 1195 in the Federal Register for 
        such drug and year.
            ``(3) Average international market price defined.--
                    ``(A) In general.--The terms `average international 
                market price' and `AIM price' mean, with respect to a 
                drug, the average price (which shall be the net average 
                price, if practicable, and volume-weighted, if 
                practicable) for a unit (as defined in paragraph (4)) 
                of the drug for sales of such drug (calculated across 
                different dosage forms and strengths of the drug and 
                not based on the specific formulation or package size 
                or package type), as computed (as of the date of 
                publication of such drug as a selected drug under 
                section 1192(a)) in all countries described in clause 
                (ii) of subparagraph (B) that are applicable countries 
                (as described in clause (i) of such subparagraph) with 
                respect to such drug.
                    ``(B) Applicable countries.--
                            ``(i) In general.--For purposes of 
                        subparagraph (A), a country described in clause 
                        (ii) is an applicable country described in this 
                        clause with respect to a drug if there is 
                        available an average price for any unit for the 
                        drug for sales of such drug in such country.
                            ``(ii) Countries described.--For purposes 
                        of this paragraph, the following are countries 
                        described in this clause:
                                    ``(I) Australia.
                                    ``(II) Canada.
                                    ``(III) France.
                                    ``(IV) Germany.
                                    ``(V) Japan.
                                    ``(VI) The United Kingdom.
            ``(4) Unit.--The term `unit' means, with respect to a drug, 
        the lowest identifiable quantity (such as a capsule or tablet, 
        milligram of molecules, or grams) of the drug that is 
        dispensed.

``SEC. 1192. SELECTION OF NEGOTIATION-ELIGIBLE DRUGS AS SELECTED DRUGS.

    ``(a) In General.--Not later than the selected drug publication 
date with respect to an initial price applicability year, subject to 
subsection (h), the Secretary shall select and publish in the Federal 
Register a list of--
            ``(1)(A) with respect to an initial price applicability 
        year during 2024, at least 25 negotiation-eligible drugs 
        described in subparagraphs (A) and (B), but not subparagraph 
        (C), of subsection (d)(1) (or, with respect to an initial price 
        applicability year during such period beginning after 2024, the 
        maximum number (if such number is less than 25) of such 
        negotiation-eligible drugs for the year) with respect to such 
        year; and
            ``(B) with respect to an initial price applicability year 
        during 2025 or a subsequent year, at least 50 negotiation-
        eligible drugs described in subparagraphs (A) and (B), but not 
        subparagraph (C), of subsection (d)(1) (or, with respect to an 
        initial price applicability year during such period, the 
        maximum number (if such number is less than 50) of such 
        negotiation-eligible drugs for the year) with respect to such 
        year;
            ``(2) all negotiation-eligible drugs described in 
        subparagraph (C) of such subsection with respect to such year; 
        and
            ``(3) all new-entrant negotiation-eligible drugs (as 
        defined in subsection (g)(1)) with respect to such year.
Each drug published on the list pursuant to the previous sentence shall 
be subject to the negotiation process under section 1194 for the 
voluntary negotiation period with respect to such initial price 
applicability year (and the renegotiation process under such section as 
applicable for any subsequent year during the applicable price 
applicability period). In applying this subsection, any negotiation-
eligible drug that is selected under this subsection for an initial 
price applicability year shall not count toward the required minimum 
amount of drugs to be selected under paragraph (1) for any subsequent 
year, including such a drug so selected that is subject to 
renegotiation under section 1194.
    ``(b) Selection of Drugs.--In carrying out subsection (a)(1) the 
Secretary shall select for inclusion on the published list described in 
subsection (a) with respect to a price applicability period, the 
negotiation-eligible drugs that the Secretary projects will result in 
the greatest savings to the Federal Government or fair price eligible 
individuals during the price applicability period. In making this 
projection of savings for drugs for which there is an AIM price for a 
price applicability period, the savings shall be projected across 
different dosage forms and strengths of the drugs and not based on the 
specific formulation or package size or package type of the drugs, 
taking into consideration both the volume of drugs for which payment is 
made, to the extent such data is available, and the amount by which the 
net price for the drugs exceeds the AIM price for the drugs.
    ``(c) Selected Drug.--For purposes of this part, each drug included 
on the list published under subsection (a) with respect to an initial 
price applicability year shall be referred to as a `selected drug' with 
respect to such year and each subsequent plan year beginning before the 
first plan year beginning after the date on which the Secretary 
determines two or more drug products--
            ``(1) are approved or licensed (as applicable)--
                    ``(A) under section 505(j) of the Federal Food, 
                Drug, and Cosmetic Act using such drug as the listed 
                drug; or
                    ``(B) under section 351(k) of the Public Health 
                Service Act using such drug as the reference product; 
                and
            ``(2) continue to be marketed.
    ``(d) Negotiation-Eligible Drug.--
            ``(1) In general.--For purposes of this part, the term 
        `negotiation-eligible drug' means, with respect to the selected 
        drug publication date with respect to an initial price 
        applicability year, a qualifying single source drug, as defined 
        in subsection (e), that meets any of the following criteria:
                    ``(A) Covered part d drugs.--The drug is among the 
                125 covered part D drugs (as defined in section 1860D-
                2(e)) for which there was an estimated greatest net 
                spending under parts C and D of title XVIII, as 
                determined by the Secretary, during the most recent 
                plan year prior to such drug publication date for which 
                data are available.
                    ``(B) Other drugs.--The drug is among the 125 drugs 
                for which there was an estimated greatest net spending 
                in the United States (including the 50 States, the 
                District of Columbia, and the territories of the United 
                States), as determined by the Secretary, during the 
                most recent plan year prior to such drug publication 
                date for which data are available.
                    ``(C) Insulin.--The drug is a qualifying single 
                source drug described in subsection (e)(3).
            ``(2) Clarification.--In determining whether a qualifying 
        single source drug satisfies any of the criteria described in 
        paragraph (1), the Secretary shall, to the extent practicable, 
        use data that is aggregated across dosage forms and strengths 
        of the drug and not based on the specific formulation or 
        package size or package type of the drug.
            ``(3) Publication.--Not later than the selected drug 
        publication date with respect to an initial price applicability 
        year, the Secretary shall publish in the Federal Register a 
        list of negotiation-eligible drugs with respect to such 
        selected drug publication date.
    ``(e) Qualifying Single Source Drug.--For purposes of this part, 
the term `qualifying single source drug' means any of the following:
            ``(1) Drug products.--A drug that--
                    ``(A) is approved under section 505(c) of the 
                Federal Food, Drug, and Cosmetic Act and continues to 
                be marketed pursuant to such approval; and
                    ``(B) is not the listed drug for any drug that is 
                approved and continues to be marketed under section 
                505(j) of such Act.
            ``(2) Biological products.--A biological product that--
                    ``(A) is licensed under section 351(a) of the 
                Public Health Service Act, including any product that 
                has been deemed to be licensed under section 351 of 
                such Act pursuant to section 7002(e)(4) of the 
                Biologics Price Competition and Innovation Act of 2009, 
                and continues to be marketed under section 351 of such 
                Act; and
                    ``(B) is not the reference product for any 
                biological product that is licensed and continues to be 
                marketed under section 351(k) of such Act.
            ``(3) Insulin product.--Notwithstanding paragraphs (1) and 
        (2), any insulin product that is approved under subsection (c) 
        or (j) of section 505 of the Federal Food, Drug, and Cosmetic 
        Act or licensed under subsection (a) or (k) of section 351 of 
        the Public Health Service Act and continues to be marketed 
        under such section 505 or 351, including any insulin product 
        that has been deemed to be licensed under section 351(a) of the 
        Public Health Service Act pursuant to section 7002(e)(4) of the 
        Biologics Price Competition and Innovation Act of 2009 and 
        continues to be marketed pursuant to such licensure.
For purposes of applying paragraphs (1) and (2), a drug or biological 
product that is marketed by the same sponsor or manufacturer (or an 
affiliate thereof or a cross-licensed producer or distributor) as the 
listed drug or reference product described in such respective paragraph 
shall not be taken into consideration.
    ``(f) Information on International Drug Prices.--For purposes of 
determining which negotiation-eligible drugs to select under subsection 
(a) and, in the case of such drugs that are selected drugs, to 
determine the maximum fair price for such a drug and whether such 
maximum fair price should be renegotiated under section 1194, the 
Secretary shall use data relating to the AIM price with respect to such 
drug as available or provided to the Secretary and shall on an ongoing 
basis request from manufacturers of selected drugs information on the 
AIM price of such a drug.
    ``(g) New-Entrant Negotiation-Eligible Drugs.--
            ``(1) In general.--For purposes of this part, the term 
        `new-entrant negotiation-eligible drug' means, with respect to 
        the selected drug publication date with respect to an initial 
        price applicability year, a qualifying single source drug--
                    ``(A) that is first approved or licensed, as 
                described in paragraph (1), (2), or (3) of subsection 
                (e), as applicable, during the year preceding such 
                selected drug publication date; and
                    ``(B) that the Secretary determines under paragraph 
                (2) is likely to be included as a negotiation-eligible 
                drug with respect to the subsequent selected drug 
                publication date.
            ``(2) Determination.--In the case of a qualifying single 
        source drug that meets the criteria described in subparagraph 
        (A) of paragraph (1), with respect to an initial price 
        applicability year, if the wholesale acquisition cost at which 
        such drug is first marketed in the United States is equal to or 
        greater than the median household income (as determined 
        according to the most recent data collected by the United 
        States Census Bureau), the Secretary shall determine before the 
        selected drug publication date with respect to the initial 
        price applicability year, if the drug is likely to be included 
        as a negotiation-eligible drug with respect to the subsequent 
        selected drug publication date, based on the projected spending 
        under title XVIII or in the United States on such drug. For 
        purposes of this paragraph the term `United States' includes 
        the 50 States, the District of Columbia, and the territories of 
        the United States.
    ``(h) Conflict of Interest.--
            ``(1) In general.--In the case the Inspector General of the 
        Department of Health and Human Services determines the 
        Secretary has a conflict, with respect to a matter described in 
        paragraph (2), the individual described in paragraph (3) shall 
        carry out the duties of the Secretary under this part, with 
        respect to a negotiation-eligible drug, that would otherwise be 
        such a conflict.
            ``(2) Matter described.--A matter described in this 
        paragraph is--
                    ``(A) a financial interest (as described in section 
                2635.402 of title 5, Code of Federal Regulations, as in 
                effect on the date of the enactment of this section, 
                (except for an interest described in subsection 
                (b)(2)(iv) of such section)) on the date of the 
                selected drug publication date, with respect the price 
                applicability year (as applicable);
                    ``(B) a personal or business relationship (as 
                described in section 2635.502 of such title) on the 
                date of the selected drug publication date, with 
                respect the price applicability year;
                    ``(C) employment by a manufacturer of a 
                negotiation-eligible drug during the preceding 10-year 
                period beginning on the date of the selected drug 
                publication date, with respect to each price 
                applicability year; and
                    ``(D) any other matter the General Counsel 
                determines appropriate.
            ``(3) Individual described.--An individual described in 
        this paragraph is--
                    ``(A) the highest-ranking officer or employee of 
                the Department of Health and Human Services (as 
                determined by the organizational chart of the 
                Department) that does not have a conflict under this 
                subsection; and
                    ``(B) is nominated by the President and confirmed 
                by the Senate with respect to the position.

``SEC. 1193. MANUFACTURER AGREEMENTS.

    ``(a) In General.--For purposes of section 1191(a)(2), the 
Secretary shall enter into agreements with manufacturers of selected 
drugs with respect to a price applicability period, by not later than 
June 15 following the selected drug publication date with respect to 
such selected drug, under which--
            ``(1) during the voluntary negotiation period for the 
        initial price applicability year for the selected drug, the 
        Secretary and manufacturer, in accordance with section 1194, 
        negotiate to determine (and, by not later than the last date of 
        such period and in accordance with subsection (c), agree to) a 
        maximum fair price for such selected drug of the manufacturer 
        in order to provide access to such price--
                    ``(A) to fair price eligible individuals who with 
                respect to such drug are described in subparagraph (A) 
                of section 1191(c)(1) and are furnished or dispensed 
                such drug during, subject to subparagraph (2), the 
                price applicability period; and
                    ``(B) to hospitals, physicians, and other providers 
                of services and suppliers with respect to fair price 
                eligible individuals who with respect to such drug are 
                described in subparagraph (B) of such section and are 
                furnished or administered such drug during, subject to 
                subparagraph (2), the price applicability period;
            ``(2) the Secretary and the manufacturer shall, in 
        accordance with a process and during a period specified by the 
        Secretary pursuant to rulemaking, renegotiate (and, by not 
        later than the last date of such period and in accordance with 
        subsection (c), agree to) the maximum fair price for such drug 
        if the Secretary determines that there is a material change in 
        any of the factors described in section 1194(d) relating to the 
        drug, including changes in the AIM price for such drug, in 
        order to provide access to such maximum fair price (as so 
        renegotiated)--
                    ``(A) to fair price eligible individuals who with 
                respect to such drug are described in subparagraph (A) 
                of section 1191(c)(1) and are furnished or dispensed 
                such drug during any year during the price 
                applicability period (beginning after such 
                renegotiation) with respect to such selected drug; and
                    ``(B) to hospitals, physicians, and other providers 
                of services and suppliers with respect to fair price 
                eligible individuals who with respect to such drug are 
                described in subparagraph (B) of such section and are 
                furnished or administered such drug during any year 
                described in subparagraph (A);
            ``(3) the maximum fair price (including as renegotiated 
        pursuant to paragraph (2)), with respect to such a selected 
        drug, shall be provided to fair price eligible individuals, who 
        with respect to such drug are described in subparagraph (A) of 
        section 1191(c)(1), at the pharmacy or by a mail order service 
        at the point-of-sale of such drug;
            ``(4) the manufacturer, subject to subsection (d), submits 
        to the Secretary, in a form and manner specified by the 
        Secretary--
                    ``(A) for the voluntary negotiation period for the 
                price applicability period (and, if applicable, before 
                any period of renegotiation specified pursuant to 
                paragraph (2)) with respect to such drug all 
                information that the Secretary requires to carry out 
                the negotiation (or renegotiation process) under this 
                part, including information described in section 
                1192(f) and section 1194(d)(1); and
                    ``(B) on an ongoing basis, information on changes 
                in prices for such drug that would affect the AIM price 
                for such drug or otherwise provide a basis for 
                renegotiation of the maximum fair price for such drug 
                pursuant to paragraph (2);
            ``(5) the manufacturer agrees that in the case the selected 
        drug of a manufacturer is a drug described in subsection (c), 
        the manufacturer will, in accordance with such subsection, make 
        any payment required under such subsection with respect to such 
        drug; and
            ``(6) the manufacturer complies with requirements imposed 
        by the Secretary for purposes of administering the program, 
        including with respect to the duties described in section 1196.
    ``(b) Agreement in Effect Until Drug Is No Longer a Selected 
Drug.--An agreement entered into under this section shall be effective, 
with respect to a drug, until such drug is no longer considered a 
selected drug under section 1192(c).
    ``(c) Special Rule for Certain Selected Drugs Without AIM Price.--
            ``(1) In general.--In the case of a selected drug for which 
        there is no AIM price available with respect to the initial 
        price applicability year for such drug and for which an AIM 
        price becomes available beginning with respect to a subsequent 
        plan year during the price applicability period for such drug, 
        if the Secretary determines that the amount described in 
        paragraph (2)(A) for a unit of such drug is greater than the 
        amount described in paragraph (2)(B) for a unit of such drug, 
        then by not later than one year after the date of such 
        determination, the manufacturer of such selected drug shall pay 
        to the Treasury an amount equal to the product of--
                    ``(A) the difference between such amount described 
                in paragraph (2)(A) for a unit of such drug and such 
                amount described in paragraph (2)(B) for a unit of such 
                drug; and
                    ``(B) the number of units of such drug sold in the 
                United States, including the 50 States, the District of 
                Columbia, and the territories of the United States, 
                during the period described in paragraph (2)(B).
            ``(2) Amounts described.--
                    ``(A) Weighted average price before aim price 
                available.--For purposes of paragraph (1), the amount 
                described in this subparagraph for a selected drug 
                described in such paragraph, is the amount equal to the 
                weighted average manufacturer price (as defined in 
                section 1927(k)(1)) for such dosage strength and form 
                for the drug during the period beginning with the first 
                plan year for which the drug is included on the list of 
                negotiation-eligible drugs published under section 
                1192(d) and ending with the last plan year during the 
                price applicability period for such drug with respect 
                to which there is no AIM price available for such drug.
                    ``(B) Amount multiplier after aim price 
                available.--For purposes of paragraph (1), the amount 
                described in this subparagraph for a selected drug 
                described in such paragraph, is the amount equal to 200 
                percent of the AIM price for such drug with respect to 
                the first plan year during the price applicability 
                period for such drug with respect to which there is an 
                AIM price available for such drug.
    ``(d) Confidentiality of Information.--Information submitted to the 
Secretary under this part by a manufacturer of a selected drug that is 
proprietary information of such manufacturer (as determined by the 
Secretary) may be used only by the Secretary or disclosed to and used 
by the Comptroller General of the United States or the Medicare Payment 
Advisory Commission for purposes of carrying out this part.
    ``(e) Regulations.--
            ``(1) In general.--The Secretary shall, pursuant to 
        rulemaking, specify, in accordance with paragraph (2), the 
        information that must be submitted under subsection (a)(4).
            ``(2) Information specified.--Information described in 
        paragraph (1), with respect to a selected drug, shall include 
        information on sales of the drug (by the manufacturer of the 
        drug or by another entity under license or other agreement with 
        the manufacturer, with respect to the sales of such drug, 
        regardless of the name under which the drug is sold) in any 
        foreign country that is part of the AIM price. The Secretary 
        shall verify, to the extent practicable, such sales from 
        appropriate officials of the government of the foreign country 
        involved.
    ``(f) Compliance With Requirements for Administration of Program.--
Each manufacturer with an agreement in effect under this section shall 
comply with requirements imposed by the Secretary or a third party with 
a contract under section 1196(c)(1), as applicable, for purposes of 
administering the program.

``SEC. 1194. NEGOTIATION AND RENEGOTIATION PROCESS.

    ``(a) In General.--For purposes of this part, under an agreement 
under section 1193 between the Secretary and a manufacturer of a 
selected drug, with respect to the period for which such agreement is 
in effect and in accordance with subsections (b) and (c), the Secretary 
and the manufacturer--
            ``(1) shall during the voluntary negotiation period with 
        respect to the initial price applicability year for such drug, 
        in accordance with this section, negotiate a maximum fair price 
        for such drug for the purpose described in section 1193(a)(1); 
        and
            ``(2) as applicable pursuant to section 1193(a)(2) and in 
        accordance with the process specified pursuant to such section, 
        renegotiate such maximum fair price for such drug for the 
        purpose described in such section.
    ``(b) Negotiating Methodology and Objective.--
            ``(1) In general.--The Secretary shall develop and use a 
        consistent methodology for negotiations under subsection (a) 
        that, in accordance with paragraph (2) and subject to paragraph 
        (3), achieves the lowest maximum fair price for each selected 
        drug while appropriately rewarding innovation.
            ``(2) Prioritizing factors.--In considering the factors 
        described in subsection (d) in negotiating (and, as applicable, 
        renegotiating) the maximum fair price for a selected drug, the 
        Secretary shall, to the extent practicable, consider all of the 
        available factors listed but shall prioritize the following 
        factors:
                    ``(A) Research and development costs.--The factor 
                described in paragraph (1)(A) of subsection (d).
                    ``(B) Market data.--The factor described in 
                paragraph (1)(B) of such subsection.
                    ``(C) Unit costs of production and distribution.--
                The factor described in paragraph (1)(C) of such 
                subsection.
                    ``(D) Comparison to existing therapeutic 
                alternatives.--The factor described in paragraph (2)(A) 
                of such subsection.
            ``(3) Requirement.--
                    ``(A) In general.--In negotiating the maximum fair 
                price of a selected drug, with respect to an initial 
                price applicability year for the selected drug, and, as 
                applicable, in renegotiating the maximum fair price for 
                such drug, with respect to a subsequent year during the 
                price applicability period for such drug, in the case 
                that the manufacturer of the selected drug offers under 
                the negotiation or renegotiation, as applicable, a 
                price for such drug that is not more than the target 
                price described in subparagraph (B) for such drug for 
                the respective year, the Secretary shall agree under 
                such negotiation or renegotiation, respectively, to 
                such offered price as the maximum fair price.
                    ``(B) Target price.--
                            ``(i) In general.--Subject to clause (ii), 
                        the target price described in this subparagraph 
                        for a selected drug with respect to a year, is 
                        the average price (which shall be the net 
                        average price, if practicable, and volume-
                        weighted, if practicable) for a unit of such 
                        drug for sales of such drug, as computed 
                        (across different dosage forms and strengths of 
                        the drug and not based on the specific 
                        formulation or package size or package type of 
                        the drug) in the applicable country described 
                        in section 1191(c)(3)(B) with respect to such 
                        drug that, with respect to such year, has the 
                        lowest average price for such drug as compared 
                        to the average prices (as so computed) of such 
                        drug with respect to such year in the other 
                        applicable countries described in such section 
                        with respect to such drug.
                            ``(ii) Selected drugs without aim price.--
                        In applying this paragraph in the case of 
                        negotiating the maximum fair price of a 
                        selected drug for which there is no AIM price 
                        available with respect to the initial price 
                        applicability year for such drug, or, as 
                        applicable, renegotiating the maximum fair 
                        price for such drug with respect to a 
                        subsequent year during the price applicability 
                        period for such drug before the first plan year 
                        for which there is an AIM price available for 
                        such drug, the target price described in this 
                        subparagraph for such drug and respective year 
                        is the amount that is 80 percent of the average 
                        manufacturer price (as defined in section 
                        1927(k)(1)) for such drug and year.
            ``(4) Annual report.--After the completion of each 
        voluntary negotiation period, the Secretary shall submit to 
        Congress a report on the maximum fair prices negotiated (or, as 
        applicable, renegotiated) for such period. Such report shall 
        include information on how such prices so negotiated (or 
        renegotiated) meet the requirements of this part, including the 
        requirements of this subsection.
    ``(c) Limitation.--
            ``(1) In general.--Subject to paragraph (2), the maximum 
        fair price negotiated (including as renegotiated) under this 
        section for a selected drug, with respect to each plan year 
        during a price applicability period for such drug, shall not 
        exceed 120 percent of the AIM price applicable to such drug 
        with respect to such year.
            ``(2) Selected drugs without aim price.--In the case of a 
        selected drug for which there is no AIM price available with 
        respect to the initial price applicability year for such drug, 
        for each plan year during the price applicability period before 
        the first plan year for which there is an AIM price available 
        for such drug, the maximum fair price negotiated (including as 
        renegotiated) under this section for the selected drug shall 
        not exceed the amount equal to 85 percent of the average 
        manufacturer price for the drug with respect to such year.
    ``(d) Considerations.--For purposes of negotiating and, as 
applicable, renegotiating (including for purposes of determining 
whether to renegotiate) the maximum fair price of a selected drug under 
this part with the manufacturer of the drug, the Secretary, consistent 
with subsection (b)(2), shall take into consideration the factors 
described in paragraphs (1), (2), (3), and (5), and may take into 
consideration the factor described in paragraph (4):
            ``(1) Manufacturer-specific information.--The following 
        information, including as submitted by the manufacturer:
                    ``(A) Research and development costs of the 
                manufacturer for the drug and the extent to which the 
                manufacturer has recouped research and development 
                costs.
                    ``(B) Market data for the drug, including the 
                distribution of sales across different programs and 
                purchasers and projected future revenues for the drug.
                    ``(C) Unit costs of production and distribution of 
                the drug.
                    ``(D) Prior Federal financial support for novel 
                therapeutic discovery and development with respect to 
                the drug.
                    ``(E) Data on patents and on existing and pending 
                exclusivity for the drug.
                    ``(F) National sales data for the drug.
                    ``(G) Information on clinical trials for the drug 
                in the United States or in applicable countries 
                described in section 1191(c)(3)(B).
            ``(2) Information on alternative products.--The following 
        information:
                    ``(A) The extent to which the drug represents a 
                therapeutic advance as compared to existing therapeutic 
                alternatives and, to the extent such information is 
                available, the costs of such existing therapeutic 
                alternatives.
                    ``(B) Information on approval by the Food and Drug 
                Administration of alternative drug products.
                    ``(C) Information on comparative effectiveness 
                analysis for such products, taking into consideration 
                the effects of such products on specific populations, 
                such as individuals with disabilities, the elderly, 
                terminally ill, children, and other patient 
                populations.
        In considering information described in subparagraph (C), the 
        Secretary shall not use evidence or findings from comparative 
        clinical effectiveness research in a manner that treats 
        extending the life of an elderly, disabled, or terminally ill 
        individual as of lower value than extending the life of an 
        individual who is younger, nondisabled, or not terminally ill. 
        Nothing in the previous sentence shall affect the application 
        or consideration of an AIM price for a selected drug.
            ``(3) Foreign sales information.--To the extent available 
        on a timely basis, including as provided by a manufacturer of 
        the selected drug or otherwise, information on sales of the 
        selected drug in each of the countries described in section 
        1191(c)(3)(B).
            ``(4) VA drug pricing information.--Information disclosed 
        to the Secretary pursuant to subsection (f).
            ``(5) Additional information.--Information submitted to the 
        Secretary, in accordance with a process specified by the 
        Secretary, by other parties that are affected by the 
        establishment of a maximum fair price for the selected drug.
    ``(e) Request for Information.--For purposes of negotiating and, as 
applicable, renegotiating (including for purposes of determining 
whether to renegotiate) the maximum fair price of a selected drug under 
this part with the manufacturer of the drug, with respect to a price 
applicability period, and other relevant data for purposes of this 
section--
            ``(1) the Secretary shall, not later than the selected drug 
        publication date with respect to the initial price 
        applicability year of such period, request drug pricing 
        information from the manufacturer of such selected drug, 
        including information described in subsection (d)(1); and
            ``(2) by not later than October 1 following the selected 
        drug publication date, the manufacturer of such selected drug 
        shall submit to the Secretary such requested information in 
        such form and manner as the Secretary may require.
The Secretary shall request, from the manufacturer or others, such 
additional information as may be needed to carry out the negotiation 
and renegotiation process under this section.
    ``(f) Disclosure of Information.--For purposes of this part, the 
Secretary of Veterans Affairs may disclose to the Secretary of Health 
and Human Services the price of any negotiation-eligible drug that is 
purchased pursuant to section 8126 of title 38, United States Code.

``SEC. 1195. PUBLICATION OF MAXIMUM FAIR PRICES.

    ``(a) In General.--With respect to an initial price applicability 
year and selected drug with respect to such year, not later than April 
1 of the plan year prior to such initial price applicability year, the 
Secretary shall publish in the Federal Register the maximum fair price 
for such drug negotiated under this part with the manufacturer of such 
drug.
    ``(b) Updates.--
            ``(1) Subsequent year maximum fair prices.--For a selected 
        drug, for each plan year subsequent to the initial price 
        applicability year for such drug with respect to which an 
        agreement for such drug is in effect under section 1193, the 
        Secretary shall publish in the Federal Register--
                    ``(A) subject to subparagraph (B), the amount equal 
                to the maximum fair price published for such drug for 
                the previous year, increased by the annual percentage 
                increase in the consumer price index for all urban 
                consumers (all items; U.S. city average) as of 
                September of such previous year; or
                    ``(B) in the case the maximum fair price for such 
                drug was renegotiated, for the first year for which 
                such price as so renegotiated applies, such 
                renegotiated maximum fair price.
            ``(2) Prices negotiated after deadline.--In the case of a 
        selected drug with respect to an initial price applicability 
        year for which the maximum fair price is determined under this 
        part after the date of publication under this section, the 
        Secretary shall publish such maximum fair price in the Federal 
        Register by not later than 30 days after the date such maximum 
        price is so determined.

``SEC. 1196. ADMINISTRATIVE DUTIES; COORDINATION PROVISIONS.

    ``(a) Administrative Duties.--
            ``(1) In general.--For purposes of section 1191, the 
        administrative duties described in this section are the 
        following:
                    ``(A) The establishment of procedures (including 
                through agreements with manufacturers under this part, 
                contracts with prescription drug plans under part D of 
                title XVIII and MA-PD plans under part C of such title, 
                and agreements under section 1197 with group health 
                plans and health insurance issuers of health insurance 
                coverage offered in the individual or group market) 
                under which the maximum fair price for a selected drug 
                is provided to fair price eligible individuals, who 
                with respect to such drug are described in subparagraph 
                (A) of section 1191(c)(1), at pharmacies or by mail 
                order service at the point-of-sale of the drug for the 
                applicable price period for such drug and providing 
                that such maximum fair price is used for determining 
                cost-sharing under such plans or coverage for the 
                selected drug.
                    ``(B) The establishment of procedures (including 
                through agreements with manufacturers under this part 
                and contracts with hospitals, physicians, and other 
                providers of services and suppliers and agreements 
                under section 1197 with group health plans and health 
                insurance issuers of health insurance coverage offered 
                in the individual or group market) under which, in the 
                case of a selected drug furnished or administered by 
                such a hospital, physician, or other provider of 
                services or supplier to fair price eligible individuals 
                (who with respect to such drug are described in 
                subparagraph (B) of section 1191(c)(1)), the maximum 
                fair price for the selected drug is provided to such 
                hospitals, physicians, and other providers of services 
                and suppliers (as applicable) with respect to such 
                individuals and providing that such maximum fair price 
                is used for determining cost-sharing under the 
                respective part, plan, or coverage for the selected 
                drug.
                    ``(C) The establishment of procedures (including 
                through agreements and contracts described in 
                subparagraphs (A) and (B)) to ensure that, not later 
                than 90 days after the dispensing of a selected drug to 
                a fair price eligible individual by a pharmacy or mail 
                order service, the pharmacy or mail order service is 
                reimbursed for an amount equal to the difference 
                between--
                            ``(i) the lesser of--
                                    ``(I) the wholesale acquisition 
                                cost of the drug;
                                    ``(II) the national average drug 
                                acquisition cost of the drug; and
                                    ``(III) any other similar 
                                determination of pharmacy acquisition 
                                costs of the drug, as determined by the 
                                Secretary; and
                            ``(ii) the maximum fair price for the drug.
                    ``(D) The establishment of procedures to ensure 
                that the maximum fair price for a selected drug is 
                applied before--
                            ``(i) any coverage or financial assistance 
                        under other health benefit plans or programs 
                        that provide coverage or financial assistance 
                        for the purchase or provision of prescription 
                        drug coverage on behalf of fair price eligible 
                        individuals as the Secretary may specify; and
                            ``(ii) any other discounts.
                    ``(E) The establishment of procedures to enter into 
                appropriate agreements and protocols for the ongoing 
                computation of AIM prices for selected drugs, 
                including, to the extent possible, to compute the AIM 
                price for selected drugs and including by providing 
                that the manufacturer of such a selected drug should 
                provide information for such computation not later than 
                3 months after the first date of the voluntary 
                negotiation period for such selected drug.
                    ``(F) The establishment of procedures to compute 
                and apply the maximum fair price across different 
                strengths and dosage forms of a selected drug and not 
                based on the specific formulation or package size or 
                package type of the drug.
                    ``(G) The establishment of procedures to negotiate 
                and apply the maximum fair price in a manner that does 
                not include any dispensing or similar fee.
                    ``(H) The establishment of procedures to carry out 
                the provisions of this part, as applicable, with 
                respect to--
                            ``(i) fair price eligible individuals who 
                        are enrolled under a prescription drug plan 
                        under part D of title XVIII or an MA-PD plan 
                        under part C of such title;
                            ``(ii) fair price eligible individuals who 
                        are enrolled under a group health plan or 
                        health insurance coverage offered by a health 
                        insurance issuer in the individual or group 
                        market with respect to which there is an 
                        agreement in effect under section 1197; and
                            ``(iii) fair price eligible individuals who 
                        are entitled to benefits under part A of title 
                        XVIII or enrolled under part B of such title.
                    ``(I) The establishment of a negotiation process 
                and renegotiation process in accordance with section 
                1194, including a process for acquiring information 
                described in subsection (d) of such section and 
                determining amounts described in subsection (b) of such 
                section.
                    ``(J) The provision of a reasonable dispute 
                resolution mechanism to resolve disagreements between 
                manufacturers, fair price eligible individuals, and the 
                third party with a contract under subsection (c)(1).
            ``(2) Monitoring compliance.--
                    ``(A) In general.--The Secretary shall monitor 
                compliance by a manufacturer with the terms of an 
                agreement under section 1193, including by establishing 
                a mechanism through which violations of such terms may 
                be reported.
                    ``(B) Notification.--If a third party with a 
                contract under subsection (c)(1) determines that the 
                manufacturer is not in compliance with such agreement, 
                the third party shall notify the Secretary of such 
                noncompliance for appropriate enforcement under section 
                4192 of the Internal Revenue Code of 1986 or section 
                1198, as applicable.
    ``(b) Collection of Data.--
            ``(1) From prescription drug plans and ma-pd plans.--The 
        Secretary may collect appropriate data from prescription drug 
        plans under part D of title XVIII and MA-PD plans under part C 
        of such title in a timeframe that allows for maximum fair 
        prices to be provided under this part for selected drugs.
            ``(2) From health plans.--The Secretary may collect 
        appropriate data from group health plans or health insurance 
        issuers offering group or individual health insurance coverage 
        in a timeframe that allows for maximum fair prices to be 
        provided under this part for selected drugs.
            ``(3) Coordination of data collection.--To the extent 
        feasible, as determined by the Secretary, the Secretary shall 
        ensure that data collected pursuant to this subsection is 
        coordinated with, and not duplicative of, other Federal data 
        collection efforts.
    ``(c) Contract With Third Parties.--
            ``(1) In general.--The Secretary may enter into a contract 
        with 1 or more third parties to administer the requirements 
        established by the Secretary in order to carry out this part. 
        At a minimum, the contract with a third party under the 
        preceding sentence shall require that the third party--
                    ``(A) receive and transmit information between the 
                Secretary, manufacturers, and other individuals or 
                entities the Secretary determines appropriate;
                    ``(B) receive, distribute, or facilitate the 
                distribution of funds of manufacturers to appropriate 
                individuals or entities in order to meet the 
                obligations of manufacturers under agreements under 
                this part;
                    ``(C) provide adequate and timely information to 
                manufacturers, consistent with the agreement with the 
                manufacturer under this part, as necessary for the 
                manufacturer to fulfill its obligations under this 
                part; and
                    ``(D) permit manufacturers to conduct periodic 
                audits, directly or through contracts, of the data and 
                information used by the third party to determine 
                discounts for applicable drugs of the manufacturer 
                under the program.
            ``(2) Performance requirements.--The Secretary shall 
        establish performance requirements for a third party with a 
        contract under paragraph (1) and safeguards to protect the 
        independence and integrity of the activities carried out by the 
        third party under the program under this part.

``SEC. 1197. VOLUNTARY PARTICIPATION BY OTHER HEALTH PLANS.

    ``(a) Agreement To Participate Under Program.--
            ``(1) In general.--Subject to paragraph (2), under the 
        program under this part the Secretary shall be treated as 
        having in effect an agreement with a group health plan or 
        health insurance issuer offering group or individual health 
        insurance coverage (as such terms are defined in section 2791 
        of the Public Health Service Act), with respect to a price 
        applicability period and a selected drug with respect to such 
        period--
                    ``(A) with respect to such selected drug furnished 
                or dispensed at a pharmacy or by mail order service if 
                coverage is provided under such plan or coverage during 
                such period for such selected drug as so furnished or 
                dispensed; and
                    ``(B) with respect to such selected drug furnished 
                or administered by a hospital, physician, or other 
                provider of services or supplier if coverage is 
                provided under such plan or coverage during such period 
                for such selected drug as so furnished or administered.
            ``(2) Opting out of agreement.--The Secretary shall not be 
        treated as having in effect an agreement under the program 
        under this part with a group health plan or health insurance 
        issuer offering group or individual health insurance coverage 
        with respect to a price applicability period and a selected 
        drug with respect to such period if such a plan or issuer 
        affirmatively elects, through a process specified by the 
        Secretary, not to participate under the program with respect to 
        such period and drug.
    ``(b) Publication of Election.--With respect to each price 
applicability period and each selected drug with respect to such 
period, the Secretary and the Secretary of Labor and the Secretary of 
the Treasury, as applicable, shall make public a list of each group 
health plan and each health insurance issuer offering group or 
individual health insurance coverage, with respect to which coverage is 
provided under such plan or coverage for such drug, that has elected 
under subsection (a) not to participate under the program with respect 
to such period and drug.

``SEC. 1198. CIVIL MONETARY PENALTY.

    ``(a) Violations Relating to Offering of Maximum Fair Price.--Any 
manufacturer of a selected drug that has entered into an agreement 
under section 1193, with respect to a plan year during the price 
applicability period for such drug, that does not provide access to a 
price that is not more than the maximum fair price (or a lesser price) 
for such drug for such year--
            ``(1) to a fair price eligible individual who with respect 
        to such drug is described in subparagraph (A) of section 
        1191(c)(1) and who is furnished or dispensed such drug during 
        such year; or
            ``(2) to a hospital, physician, or other provider of 
        services or supplier with respect to fair price eligible 
        individuals who with respect to such drug is described in 
        subparagraph (B) of such section and is furnished or 
        administered such drug by such hospital, physician, or provider 
        or supplier during such year;
shall be subject to a civil monetary penalty equal to ten times the 
amount equal to the difference between the price for such drug made 
available for such year by such manufacturer with respect to such 
individual or hospital, physician, provider, or supplier and the 
maximum fair price for such drug for such year.
    ``(b) Violations of Certain Terms of Agreement.--Any manufacturer 
of a selected drug that has entered into an agreement under section 
1193, with respect to a plan year during the price applicability period 
for such drug, that is in violation of a requirement imposed pursuant 
to section 1193(a)(6) shall be subject to a civil monetary penalty of 
not more than $1,000,000 for each such violation.
    ``(c) Application.--The provisions of section 1128A (other than 
subsections (a) and (b)) shall apply to a civil monetary penalty under 
this section in the same manner as such provisions apply to a penalty 
or proceeding under section 1128A(a).

``SEC. 1199. MISCELLANEOUS PROVISIONS.

    ``(a) Paperwork Reduction Act.--Chapter 35 of title 44, United 
States Code, shall not apply to data collected under this part.
    ``(b) National Academy of Medicine Study.--Not later than December 
31, 2027, the National Academy of Medicine shall conduct a study, and 
submit to Congress a report, on recommendations for improvements to the 
program under this part, including the determination of the limits 
applied under section 1194(c).
    ``(c) MedPAC Study.--Not later than December 31, 2027, the Medicare 
Payment Advisory Commission shall conduct a study, and submit to 
Congress a report, on the program under this part with respect to the 
Medicare program under title XVIII, including with respect to the 
effect of the program on individuals entitled to benefits or enrolled 
under such title.
    ``(d) Limitation on Judicial Review.--The following shall not be 
subject to judicial review:
            ``(1) The selection of drugs for publication under section 
        1192(a).
            ``(2) The determination of whether a drug is a negotiation-
        eligible drug under section 1192(d).
            ``(3) The determination of the maximum fair price of a 
        selected drug under section 1194.
            ``(4) The determination of units of a drug for purposes of 
        section 1191(c)(3).
    ``(e) Coordination.--In carrying out this part with respect to 
group health plans or health insurance coverage offered in the group 
market that are subject to oversight by the Secretary of Labor or the 
Secretary of the Treasury, the Secretary of Health and Human Services 
shall coordinate with such respective Secretary.
    ``(f) Data Sharing.--The Secretary shall share with the Secretary 
of the Treasury such information as is necessary to determine the tax 
imposed by section 4192 of the Internal Revenue Code of 1986.
    ``(g) GAO Study.--Not later than December 31, 2027, the Comptroller 
General of the United States shall conduct a study of, and submit to 
Congress a report on, the implementation of the Fair Price Negotiation 
Program under this part.''.
    (b) Application of Maximum Fair Prices and Conforming Amendments.--
            (1) Under medicare.--
                    (A) Application to payments under part b.--Section 
                1847A(b)(1)(B) of the Social Security Act (42 U.S.C. 
                1395w-3a(b)(1)(B)) is amended by inserting ``or in the 
                case of such a drug or biological that is a selected 
                drug (as defined in section 1192(c)), with respect to a 
                price applicability period (as defined in section 
                1191(b)(2)), 106 percent of the maximum fair price (as 
                defined in section 1191(c)(2)) applicable for such drug 
                and a plan year during such period'' after ``paragraph 
                (4)''.
                    (B) Exception to part d non-interference.--Section 
                1860D-11(i) of the Social Security Act (42 U.S.C. 
                1395w-111(i)) is amended by inserting ``, except as 
                provided under part E of title XI'' after ``the 
                Secretary''.
                    (C) Application as negotiated price under part d.--
                Section 1860D-2(d)(1) of the Social Security Act (42 
                U.S.C. 1395w-102(d)(1)) is amended--
                            (i) in subparagraph (B), by inserting ``, 
                        subject to subparagraph (D),'' after 
                        ``negotiated prices''; and
                            (ii) by adding at the end the following new 
                        subparagraph:
                    ``(D) Application of maximum fair price for 
                selected drugs.--In applying this section, in the case 
                of a covered part D drug that is a selected drug (as 
                defined in section 1192(c)), with respect to a price 
                applicability period (as defined in section 
                1191(b)(2)), the negotiated prices used for payment (as 
                described in this subsection) shall be the maximum fair 
                price (as defined in section 1191(c)(2)) for such drug 
                and for each plan year during such period.''.
                    (D) Information from prescription drug plans and 
                ma-pd plans required.--
                            (i) Prescription drug plans.--Section 
                        1860D-12(b) of the Social Security Act (42 
                        U.S.C. 1395w-112(b)) is amended by adding at 
                        the end the following new paragraph:
            ``(8) Provision of information related to maximum fair 
        prices.--Each contract entered into with a PDP sponsor under 
        this part with respect to a prescription drug plan offered by 
        such sponsor shall require the sponsor to provide information 
        to the Secretary as requested by the Secretary in accordance 
        with section 1196(b).''.
                            (ii) MA-PD plans.--Section 1857(f)(3) of 
                        the Social Security Act (42 U.S.C. 1395w-
                        27(f)(3)) is amended by adding at the end the 
                        following new subparagraph:
                    ``(E) Provision of information related to maximum 
                fair prices.--Section 1860D-12(b)(8).''.
            (2) Under group health plans and health insurance 
        coverage.--
                    (A) PHSA.--Part D of title XXVII of the Public 
                Health Service Act (42 U.S.C. 300gg-111 et seq.) is 
                amended by adding at the end the following new section:

``SEC. 2799A-11. FAIR PRICE NEGOTIATION PROGRAM AND APPLICATION OF 
              MAXIMUM FAIR PRICES.

    ``(a) In General.--In the case of a group health plan or health 
insurance issuer offering group or individual health insurance coverage 
that is treated under section 1197 of the Social Security Act as having 
in effect an agreement with the Secretary under the Fair Price 
Negotiation Program under part E of title XI of such Act, with respect 
to a price applicability period (as defined in section 1191(b) of such 
Act) and a selected drug (as defined in section 1192(c) of such Act) 
with respect to such period with respect to which coverage is provided 
under such plan or coverage--
            ``(1) the provisions of such part shall apply--
                    ``(A) if coverage of such selected drug is provided 
                under such plan or coverage if the drug is furnished or 
                dispensed at a pharmacy or by a mail order service, to 
                the plans or coverage offered by such plan or issuer, 
                and to the individuals enrolled under such plans or 
                coverage, during such period, with respect to such 
                selected drug, in the same manner as such provisions 
                apply to prescription drug plans and MA-PD plans, and 
                to individuals enrolled under such prescription drug 
                plans and MA-PD plans during such period; and
                    ``(B) if coverage of such selected drug is provided 
                under such plan or coverage if the drug is furnished or 
                administered by a hospital, physician, or other 
                provider of services or supplier, to the plans or 
                coverage offered by such plan or issuers, to the 
                individuals enrolled under such plans or coverage, and 
                to hospitals, physicians, and other providers of 
                services and suppliers during such period, with respect 
                to such drug in the same manner as such provisions 
                apply to the Secretary, to individuals entitled to 
                benefits under part A of title XVIII or enrolled under 
                part B of such title, and to hospitals, physicians, and 
                other providers and suppliers participating under title 
                XVIII during such period;
            ``(2) the plan or issuer shall apply any cost-sharing 
        responsibilities under such plan or coverage, with respect to 
        such selected drug, by substituting an amount not more than the 
        maximum fair price negotiated under such part E of title XI for 
        such drug in lieu of the drug price upon which the cost-sharing 
        would have otherwise applied, and such cost-sharing 
        responsibilities with respect to such selected drug may not 
        exceed such maximum fair price; and
            ``(3) the Secretary shall apply the provisions of such part 
        E to such plan, issuer, and coverage, such individuals so 
        enrolled in such plans and coverage, and such hospitals, 
        physicians, and other providers and suppliers participating in 
        such plans and coverage.
    ``(b) Notification Regarding Nonparticipation in Fair Price 
Negotiation Program.--A group health plan or a health insurance issuer 
offering group or individual health insurance coverage shall publicly 
disclose in a manner and in accordance with a process specified by the 
Secretary any election made under section 1197 of the Social Security 
Act by the plan or issuer to not participate in the Fair Price 
Negotiation Program under part E of title XI of such Act with respect 
to a selected drug (as defined in section 1192(c) of such Act) for 
which coverage is provided under such plan or coverage before the 
beginning of the plan year for which such election was made.''.
                    (B) ERISA.--
                            (i) In general.--Subpart B of part 7 of 
                        subtitle B of title I of the Employee 
                        Retirement Income Security Act of 1974 (29 
                        U.S.C. 1181 et seq.) is amended by adding at 
                        the end the following new section:

``SEC. 726. FAIR PRICE NEGOTIATION PROGRAM AND APPLICATION OF MAXIMUM 
              FAIR PRICES.

    ``(a) In General.--In the case of a group health plan or health 
insurance issuer offering group health insurance coverage that is 
treated under section 1197 of the Social Security Act as having in 
effect an agreement with the Secretary under the Fair Price Negotiation 
Program under part E of title XI of such Act, with respect to a price 
applicability period (as defined in section 1191(b) of such Act) and a 
selected drug (as defined in section 1192(c) of such Act) with respect 
to such period with respect to which coverage is provided under such 
plan or coverage--
            ``(1) the provisions of such part shall apply, as 
        applicable--
                    ``(A) if coverage of such selected drug is provided 
                under such plan or coverage if the drug is furnished or 
                dispensed at a pharmacy or by a mail order service, to 
                the plans or coverage offered by such plan or issuer, 
                and to the individuals enrolled under such plans or 
                coverage, during such period, with respect to such 
                selected drug, in the same manner as such provisions 
                apply to prescription drug plans and MA-PD plans, and 
                to individuals enrolled under such prescription drug 
                plans and MA-PD plans during such period; and
                    ``(B) if coverage of such selected drug is provided 
                under such plan or coverage if the drug is furnished or 
                administered by a hospital, physician, or other 
                provider of services or supplier, to the plans or 
                coverage offered by such plan or issuers, to the 
                individuals enrolled under such plans or coverage, and 
                to hospitals, physicians, and other providers of 
                services and suppliers during such period, with respect 
                to such drug in the same manner as such provisions 
                apply to the Secretary, to individuals entitled to 
                benefits under part A of title XVIII or enrolled under 
                part B of such title, and to hospitals, physicians, and 
                other providers and suppliers participating under title 
                XVIII during such period;
            ``(2) the plan or issuer shall apply any cost-sharing 
        responsibilities under such plan or coverage, with respect to 
        such selected drug, by substituting an amount not more than the 
        maximum fair price negotiated under such part E of title XI for 
        such drug in lieu of the drug price upon which the cost-sharing 
        would have otherwise applied, and such cost-sharing 
        responsibilities with respect to such selected drug may not 
        exceed such maximum fair price; and
            ``(3) the Secretary shall apply the provisions of such part 
        E to such plan, issuer, and coverage, and such individuals so 
        enrolled in such plans.
    ``(b) Notification Regarding Nonparticipation in Fair Price 
Negotiation Program.--A group health plan or a health insurance issuer 
offering group health insurance coverage shall publicly disclose in a 
manner and in accordance with a process specified by the Secretary any 
election made under section 1197 of the Social Security Act by the plan 
or issuer to not participate in the Fair Price Negotiation Program 
under part E of title XI of such Act with respect to a selected drug 
(as defined in section 1192(c) of such Act) for which coverage is 
provided under such plan or coverage before the beginning of the plan 
year for which such election was made.''.
                            (ii) Application to retiree and certain 
                        small group health plans.--Section 732(a) of 
                        the Employee Retirement Income Security Act of 
                        1974 (29 U.S.C. 1191a(a)) is amended by 
                        striking ``section 711'' and inserting 
                        ``sections 711 and 726''.
                            (iii) Clerical amendment.--The table of 
                        sections for subpart B of part 7 of subtitle B 
                        of title I of the Employee Retirement Income 
                        Security Act of 1974 is amended by adding at 
                        the end the following:

``Sec. 726. Fair Price Negotiation Program and application of maximum 
                            fair prices.''.
                    (C) IRC.--
                            (i) In general.--Subchapter B of chapter 
                        100 of the Internal Revenue Code of 1986 is 
                        amended by adding at the end the following new 
                        section:

``SEC. 9826. FAIR PRICE NEGOTIATION PROGRAM AND APPLICATION OF MAXIMUM 
              FAIR PRICES.

    ``(a) In General.--In the case of a group health plan that is 
treated under section 1197 of the Social Security Act as having in 
effect an agreement with the Secretary under the Fair Price Negotiation 
Program under part E of title XI of such Act, with respect to a price 
applicability period (as defined in section 1191(b) of such Act) and a 
selected drug (as defined in section 1192(c) of such Act) with respect 
to such period with respect to which coverage is provided under such 
plan--
            ``(1) the provisions of such part shall apply, as 
        applicable--
                    ``(A) if coverage of such selected drug is provided 
                under such plan if the drug is furnished or dispensed 
                at a pharmacy or by a mail order service, to the plan, 
                and to the individuals enrolled under such plan during 
                such period, with respect to such selected drug, in the 
                same manner as such provisions apply to prescription 
                drug plans and MA-PD plans, and to individuals enrolled 
                under such prescription drug plans and MA-PD plans 
                during such period; and
                    ``(B) if coverage of such selected drug is provided 
                under such plan if the drug is furnished or 
                administered by a hospital, physician, or other 
                provider of services or supplier, to the plan, to the 
                individuals enrolled under such plan, and to hospitals, 
                physicians, and other providers of services and 
                suppliers during such period, with respect to such drug 
                in the same manner as such provisions apply to the 
                Secretary, to individuals entitled to benefits under 
                part A of title XVIII or enrolled under part B of such 
                title, and to hospitals, physicians, and other 
                providers and suppliers participating under title XVIII 
                during such period;
            ``(2) the plan shall apply any cost-sharing 
        responsibilities under such plan, with respect to such selected 
        drug, by substituting an amount not more than the maximum fair 
        price negotiated under such part E of title XI for such drug in 
        lieu of the drug price upon which the cost-sharing would have 
        otherwise applied, and such cost-sharing responsibilities with 
        respect to such selected drug may not exceed such maximum fair 
        price; and
            ``(3) the Secretary shall apply the provisions of such part 
        E to such plan and such individuals so enrolled in such plan.
    ``(b) Notification Regarding Nonparticipation in Fair Price 
Negotiation Program.--A group health plan shall publicly disclose in a 
manner and in accordance with a process specified by the Secretary any 
election made under section 1197 of the Social Security Act by the plan 
to not participate in the Fair Price Negotiation Program under part E 
of title XI of such Act with respect to a selected drug (as defined in 
section 1192(c) of such Act) for which coverage is provided under such 
plan before the beginning of the plan year for which such election was 
made.''.
                            (ii) Application to retiree and certain 
                        small group health plans.--Section 9831(a)(2) 
                        of the Internal Revenue Code of 1986 is amended 
                        by inserting ``other than with respect to 
                        section 9826,'' before ``any group health 
                        plan''.
                            (iii) Clerical amendment.--The table of 
                        sections for subchapter B of chapter 100 of 
                        such Code is amended by adding at the end the 
                        following new item:

``Sec. 9826. Fair Price Negotiation Program and application of maximum 
                            fair prices.''.
            (3) Fair price negotiation program prices included in best 
        price and amp.--Section 1927 of the Social Security Act (42 
        U.S.C. 1396r-8) is amended--
                    (A) in subsection (c)(1)(C)(ii)--
                            (i) in subclause (III), by striking at the 
                        end ``; and'';
                            (ii) in subclause (IV), by striking at the 
                        end the period and inserting ``; and''; and
                            (iii) by adding at the end the following 
                        new subclause:
                                    ``(V) in the case of a rebate 
                                period and a covered outpatient drug 
                                that is a selected drug (as defined in 
                                section 1192(c)) during such rebate 
                                period, shall be inclusive of the price 
                                for such drug made available from the 
                                manufacturer during the rebate period 
                                by reason of application of part E of 
                                title XI to any wholesaler, retailer, 
                                provider, health maintenance 
                                organization, nonprofit entity, or 
                                governmental entity within the United 
                                States.''; and
                    (B) in subsection (k)(1)(B), by adding at the end 
                the following new clause:
                            ``(iii) Clarification.--Notwithstanding 
                        clause (i), in the case of a rebate period and 
                        a covered outpatient drug that is a selected 
                        drug (as defined in section 1192(c)) during 
                        such rebate period, any reduction in price paid 
                        during the rebate period to the manufacturer 
                        for the drug by a wholesaler or retail 
                        community pharmacy described in subparagraph 
                        (A) by reason of application of part E of title 
                        XI shall be included in the average 
                        manufacturer price for the covered outpatient 
                        drug.''.
            (4) FEHBP.--Section 8902 of title 5, United States Code, is 
        amended by adding at the end the following:
    ``(p) A contract may not be made or a plan approved under this 
chapter with any carrier that has affirmatively elected, pursuant to 
section 1197 of the Social Security Act, not to participate in the Fair 
Price Negotiation Program established under section 1191 of such Act 
for any selected drug (as that term is defined in section 1192(c) of 
such Act).''.
            (5) Option of secretary of veterans affairs to purchase 
        covered drugs at maximum fair prices.--Section 8126 of title 
        38, United States Code, is amended--
                    (A) in subsection (a)(2), by inserting ``, subject 
                to subsection (j),'' after ``may not exceed'';
                    (B) in subsection (d), in the matter preceding 
                paragraph (1), by inserting ``, subject to subsection 
                (j)'' after ``for the procurement of the drug''; and
                    (C) by adding at the end the following new 
                subsection:
    ``(j)(1) In the case of a covered drug that is a selected drug, for 
any year during the price applicability period for such drug, if the 
Secretary determines that the maximum fair price of such drug for such 
year is less than the price for such drug otherwise in effect pursuant 
to this section (including after application of any reduction under 
subsection (a)(2) and any discount under subsection (c)), at the option 
of the Secretary, in lieu of the maximum price (determined after 
application of the reduction under subsection (a)(2) and any discount 
under subsection (c), as applicable) that would be permitted to be 
charged during such year for such drug pursuant to this section without 
application of this subsection, the maximum price permitted to be 
charged during such year for such drug pursuant to this section shall 
be such maximum fair price for such drug and year.
    ``(2) For purposes of this subsection:
            ``(A) The term `maximum fair price' means, with respect to 
        a selected drug and year during the price applicability period 
        for such drug, the maximum fair price (as defined in section 
        1191(c)(2) of the Social Security Act) for such drug and year.
            ``(B) The term `negotiation eligible drug' has the meaning 
        given such term in section 1192(d)(1) of the Social Security 
        Act.
            ``(C) The term `price applicability period' has, with 
        respect to a selected drug, the meaning given such term in 
        section 1191(b)(2) of such Act.
            ``(D) The term `selected drug' means, with respect to a 
        year, a drug that is a selected drug under section 1192(c) of 
        such Act for such year.''.

SEC. 102. SELECTED DRUG MANUFACTURER EXCISE TAX IMPOSED DURING 
              NONCOMPLIANCE PERIODS.

    (a) In General.--Subchapter E of chapter 32 of the Internal Revenue 
Code of 1986 is amended by adding at the end the following new section:

``SEC. 4192. SELECTED DRUGS DURING NONCOMPLIANCE PERIODS.

    ``(a) In General.--There is hereby imposed on the sale by the 
manufacturer, producer, or importer of any selected drug during a day 
described in subsection (b) a tax in an amount such that the applicable 
percentage is equal to the ratio of--
            ``(1) such tax, divided by
            ``(2) the sum of such tax and the price for which so sold.
    ``(b) Noncompliance Periods.--A day is described in this subsection 
with respect to a selected drug if it is a day during one of the 
following periods:
            ``(1) The period beginning on the June 16th immediately 
        following the selected drug publication date and ending on the 
        first date during which the manufacturer of the drug has in 
        place an agreement described in subsection (a) of section 1193 
        of the Social Security Act with respect to such drug.
            ``(2) The period beginning on the April 1st immediately 
        following the June 16th described in paragraph (1) and ending 
        on the first date during which the manufacturer of the drug has 
        agreed to a maximum fair price under such agreement.
            ``(3) In the case of a selected drug with respect to which 
        the Secretary of Health and Human Services has specified a 
        renegotiation period under such agreement, the period beginning 
        on the first date after the last date of such renegotiation 
        period and ending on the first date during which the 
        manufacturer of the drug has agreed to a renegotiated maximum 
        fair price under such agreement.
            ``(4) With respect to information that is required to be 
        submitted to the Secretary of Health and Human Services under 
        such agreement, the period beginning on the date on which such 
        Secretary certifies that such information is overdue and ending 
        on the date that such information is so submitted.
            ``(5) In the case of a selected drug with respect to which 
        a payment is due under subsection (c) of such section 1193, the 
        period beginning on the date on which the Secretary of Health 
        and Human Services certifies that such payment is overdue and 
        ending on the date that such payment is made in full.
    ``(c) Applicable Percentage.--For purposes of this section, the 
term `applicable percentage' means--
            ``(1) in the case of sales of a selected drug during the 
        first 90 days described in subsection (b) with respect to such 
        drug, 65 percent,
            ``(2) in the case of sales of such drug during the 91st day 
        through the 180th day described in subsection (b) with respect 
        to such drug, 75 percent,
            ``(3) in the case of sales of such drug during the 181st 
        day through the 270th day described in subsection (b) with 
        respect to such drug, 85 percent, and
            ``(4) in the case of sales of such drug during any 
        subsequent day, 95 percent.
    ``(d) Selected Drug.--For purposes of this section--
            ``(1) In general.--The term `selected drug' means any 
        selected drug (within the meaning of section 1192 of the Social 
        Security Act) which is manufactured or produced in the United 
        States or entered into the United States for consumption, use, 
        or warehousing.
            ``(2) United states.--The term `United States' has the 
        meaning given such term by section 4612(a)(4).
            ``(3) Coordination with rules for possessions of the united 
        states.--Rules similar to the rules of paragraphs (2) and (4) 
        of section 4132(c) shall apply for purposes of this section.
    ``(e) Other Definitions.--For purposes of this section, the terms 
`selected drug publication date' and `maximum fair price' have the 
meaning given such terms in section 1191 of the Social Security Act.
    ``(f) Anti-Abuse Rule.--In the case of a sale which was timed for 
the purpose of avoiding the tax imposed by this section, the Secretary 
may treat such sale as occurring during a day described in subsection 
(b).''.
    (b) No Deduction for Excise Tax Payments.--Section 275 of the 
Internal Revenue Code of 1986 is amended by adding ``or by section 
4192'' before the period at the end of subsection (a)(6).
    (c) Conforming Amendments.--
            (1) Section 4221(a) of the Internal Revenue Code of 1986 is 
        amended by inserting ``or 4192'' after ``section 4191''.
            (2) Section 6416(b)(2) of such Code is amended by inserting 
        ``or 4192'' after ``section 4191''.
    (d) Clerical Amendments.--
            (1) The heading of subchapter E of chapter 32 of the 
        Internal Revenue Code of 1986 is amended by striking ``Medical 
        Devices'' and inserting ``Other Medical Products''.
            (2) The table of subchapters for chapter 32 of such Code is 
        amended by striking the item relating to subchapter E and 
        inserting the following new item:

               ``subchapter e. other medical products''.

            (3) The table of sections for subchapter E of chapter 32 of 
        such Code is amended by adding at the end the following new 
        item:

``Sec. 4192. Selected drugs during noncompliance periods.''.
    (e) Effective Date.--The amendments made by this section shall 
apply to sales after the date of the enactment of this Act.

SEC. 103. FAIR PRICE NEGOTIATION IMPLEMENTATION FUND.

    (a) In General.--There is hereby established a Fair Price 
Negotiation Implementation Fund (referred to in this section as the 
``Fund''). The Secretary of Health and Human Services may obligate and 
expend amounts in the Fund to carry out this title and titles II and 
III (and the amendments made by such titles).
    (b) Funding.--There is authorized to be appropriated, and there is 
hereby appropriated, out of any monies in the Treasury not otherwise 
appropriated, to the Fund $3,000,000,000, to remain available until 
expended, of which--
            (1) $600,000,000 shall become available on the date of the 
        enactment of this Act;
            (2) $600,000,000 shall become available on October 1, 2022;
            (3) $600,000,000 shall become available on October 1, 2023;
            (4) $600,000,000 shall become available on October 1, 2024; 
        and
            (5) $600,000,000 shall become available on October 1, 2025.
    (c) Supplement Not Supplant.--Any amounts appropriated pursuant to 
this section shall be in addition to any other amounts otherwise 
appropriated pursuant to any other provision of law.

             TITLE II--PRESCRIPTION DRUG INFLATION REBATES

SEC. 201. MEDICARE PART B REBATE BY MANUFACTURERS.

    (a) In General.--Section 1834 of the Social Security Act (42 U.S.C. 
1395m) is amended by adding at the end the following new subsection:
    ``(z) Rebate by Manufacturers for Single Source Drugs With Prices 
Increasing Faster Than Inflation.--
            ``(1) Requirements.--
                    ``(A) Secretarial provision of information.--Not 
                later than 6 months after the end of each calendar 
                quarter beginning on or after July 1, 2023, the 
                Secretary shall, for each part B rebatable drug, report 
                to each manufacturer of such part B rebatable drug the 
                following for such calendar quarter:
                            ``(i) Information on the total number of 
                        units of the billing and payment code described 
                        in subparagraph (A)(i) of paragraph (3) with 
                        respect to such drug and calendar quarter.
                            ``(ii) Information on the amount (if any) 
                        of the excess average sales price increase 
                        described in subparagraph (A)(ii) of such 
                        paragraph for such drug and calendar quarter.
                            ``(iii) The rebate amount specified under 
                        such paragraph for such part B rebatable drug 
                        and calendar quarter.
                    ``(B) Manufacturer requirement.--For each calendar 
                quarter beginning on or after July 1, 2023, the 
                manufacturer of a part B rebatable drug shall, for such 
                drug, not later than 30 days after the date of receipt 
                from the Secretary of the information described in 
                subparagraph (A) for such calendar quarter, provide to 
                the Secretary a rebate that is equal to the amount 
                specified in paragraph (3) for such drug for such 
                calendar quarter.
            ``(2) Part b rebatable drug defined.--
                    ``(A) In general.--In this subsection, the term 
                `part B rebatable drug' means a single source drug or 
                biological (as defined in subparagraph (D) of section 
                1847A(c)(6)), including a biosimilar biological product 
                (as defined in subparagraph (H) of such section), paid 
                for under this part, except such term shall not include 
                such a drug or biological--
                            ``(i) if the average total allowed charges 
                        for a year per individual that uses such a drug 
                        or biological, as determined by the Secretary, 
                        are less than, subject to subparagraph (B), 
                        $100; or
                            ``(ii) that is a vaccine described in 
                        subparagraph (A) or (B) of section 1861(s)(10).
                    ``(B) Increase.--The dollar amount applied under 
                subparagraph (A)(i)--
                            ``(i) for 2024, shall be the dollar amount 
                        specified under such subparagraph for 2023, 
                        increased by the percentage increase in the 
                        consumer price index for all urban consumers 
                        (United States city average) for the 12-month 
                        period ending with June of the previous year; 
                        and
                            ``(ii) for a subsequent year, shall be the 
                        dollar amount specified in this clause (or 
                        clause (i)) for the previous year, increased by 
                        the percentage increase in the consumer price 
                        index for all urban consumers (United States 
                        city average) for the 12-month period ending 
                        with June of the previous year.
                Any dollar amount specified under this subparagraph 
                that is not a multiple of $10 shall be rounded to the 
                nearest multiple of $10.
            ``(3) Rebate amount.--
                    ``(A) In general.--For purposes of paragraph (1), 
                the amount specified in this paragraph for a part B 
                rebatable drug assigned to a billing and payment code 
                for a calendar quarter is, subject to paragraph (4), 
                the amount equal to the product of--
                            ``(i) subject to subparagraphs (B) and (G), 
                        the total number of units of the billing and 
                        payment code for such part B rebatable drug 
                        furnished under this part during the calendar 
                        quarter; and
                            ``(ii) the amount (if any) by which--
                                    ``(I) the payment amount under 
                                subparagraph (B) or (C) of section 
                                1847A(b)(1), as applicable, for such 
                                part B rebatable drug during the 
                                calendar quarter; exceeds
                                    ``(II) the inflation-adjusted 
                                payment amount determined under 
                                subparagraph (C) for such part B 
                                rebatable drug during the calendar 
                                quarter.
                    ``(B) Excluded units.--For purposes of subparagraph 
                (A)(i), the total number of units of the billing and 
                payment code for each part B rebatable drug furnished 
                during a calendar quarter shall not include--
                            ``(i) units packaged into the payment for a 
                        procedure or service under section 1833(t) or 
                        under section 1833(i) (instead of separately 
                        payable under such respective section);
                            ``(ii) units included under the single 
                        payment system for renal dialysis services 
                        under section 1881(b)(14); or
                            ``(iii) units of a part B rebatable drug of 
                        a manufacturer furnished to an individual, if 
                        such manufacturer, with respect to the 
                        furnishing of such units of such drug, provides 
                        for discounts under section 340B of the Public 
                        Health Service Act or for rebates under section 
                        1927.
                    ``(C) Determination of inflation-adjusted payment 
                amount.--The inflation-adjusted payment amount 
                determined under this subparagraph for a part B 
                rebatable drug for a calendar quarter is--
                            ``(i) the payment amount for the billing 
                        and payment code for such drug in the payment 
                        amount benchmark quarter (as defined in 
                        subparagraph (D)); increased by
                            ``(ii) the percentage by which the rebate 
                        period CPI-U (as defined in subparagraph (F)) 
                        for the calendar quarter exceeds the benchmark 
                        period CPI-U (as defined in subparagraph (E)).
                    ``(D) Payment amount benchmark quarter.--The term 
                `payment amount benchmark quarter' means the calendar 
                quarter beginning January 1, 2016.
                    ``(E) Benchmark period cpi-u.--The term `benchmark 
                period CPI-U' means the consumer price index for all 
                urban consumers (United States city average) for July 
                2015.
                    ``(F) Rebate period cpi-u.--The term `rebate period 
                CPI-U' means, with respect to a calendar quarter 
                described in subparagraph (C), the greater of the 
                benchmark period CPI-U and the consumer price index for 
                all urban consumers (United States city average) for 
                the first month of the calendar quarter that is two 
                calendar quarters prior to such described calendar 
                quarter.
                    ``(G) Counting units.--
                            ``(i) Cut-off period to count units.--For 
                        purposes of subparagraph (A)(i), subject to 
                        clause (ii), to count the total number of 
                        billing units for a part B rebatable drug for a 
                        quarter, the Secretary may use a cut-off period 
                        in order to exclude from such total number of 
                        billing units for such quarter claims for 
                        services furnished during such quarter that 
                        were not processed at an appropriate time prior 
                        to the end of the cut-off period.
                            ``(ii) Counting units for claims processed 
                        after cut-off period.--If the Secretary uses a 
                        cut-off period pursuant to clause (i), in the 
                        case of units of a part B rebatable drug 
                        furnished during a quarter but pursuant to 
                        application of such cut-off period excluded for 
                        purposes of subparagraph (A)(i) from the total 
                        number of billing units for the drug for such 
                        quarter, the Secretary shall count such units 
                        of such drug so furnished in the total number 
                        of billing units for such drug for a subsequent 
                        quarter, as the Secretary determines 
                        appropriate.
            ``(4) Special treatment of certain drugs and exemption.--
                    ``(A) Subsequently approved drugs.--Subject to 
                subparagraph (B), in the case of a part B rebatable 
                drug first approved or licensed by the Food and Drug 
                Administration after July 1, 2015, clause (i) of 
                paragraph (3)(C) shall be applied as if the term 
                `payment amount benchmark quarter' were defined under 
                paragraph (3)(D) as the third full calendar quarter 
                after the day on which the drug was first marketed and 
                clause (ii) of paragraph (3)(C) shall be applied as if 
                the term `benchmark period CPI-U' were defined under 
                paragraph (3)(E) as if the reference to `July 2015' 
                under such paragraph were a reference to `the first 
                month of the first full calendar quarter after the day 
                on which the drug was first marketed'.
                    ``(B) Timeline for provision of rebates for 
                subsequently approved drugs.--In the case of a part B 
                rebatable drug first approved or licensed by the Food 
                and Drug Administration after July 1, 2015, paragraph 
                (1)(B) shall be applied as if the reference to `July 1, 
                2023' under such paragraph were a reference to the 
                later of the 6th full calendar quarter after the day on 
                which the drug was first marketed or July 1, 2023.
                    ``(C) Exemption for shortages.--The Secretary may 
                reduce or waive the rebate amount under paragraph 
                (1)(B) with respect to a part B rebatable drug that is 
                described as currently in shortage on the shortage list 
                in effect under section 506E of the Federal Food, Drug, 
                and Cosmetic Act or in the case of other exigent 
                circumstances, as determined by the Secretary.
                    ``(D) Selected drugs.--In the case of a part B 
                rebatable drug that is a selected drug (as defined in 
                section 1192(c)) for a price applicability period (as 
                defined in section 1191(b)(2))--
                            ``(i) for calendar quarters during such 
                        period for which a maximum fair price (as 
                        defined in section 1191(c)(2)) for such drug 
                        has been determined and is applied under part E 
                        of title XI, the rebate amount under paragraph 
                        (1)(B) shall be waived; and
                            ``(ii) in the case such drug is determined 
                        (pursuant to such section 1192(c)) to no longer 
                        be a selected drug, for each applicable year 
                        beginning after the price applicability period 
                        with respect to such drug, clause (i) of 
                        paragraph (3)(C) shall be applied as if the 
                        term `payment amount benchmark quarter' were 
                        defined under paragraph (3)(D) as the calendar 
                        quarter beginning January 1 of the last year 
                        beginning during such price applicability 
                        period with respect to such selected drug and 
                        clause (ii) of paragraph (3)(C) shall be 
                        applied as if the term `benchmark period CPI-U' 
                        were defined under paragraph (3)(E) as if the 
                        reference to `July 2015' under such paragraph 
                        were a reference to the July of the year 
                        preceding such last year.
            ``(5) Application to beneficiary coinsurance.--In the case 
        of a part B rebatable drug, if the payment amount for a quarter 
        exceeds the inflation adjusted payment for such quarter--
                    ``(A) in computing the amount of any coinsurance 
                applicable under this title to an individual with 
                respect to such drug, the computation of such 
                coinsurance shall be based on the inflation-adjusted 
                payment amount determined under paragraph (3)(C) for 
                such part B rebatable drug; and
                    ``(B) the amount of such coinsurance is equal to 20 
                percent of such inflation-adjusted payment amount so 
                determined.
            ``(6) Rebate deposits.--Amounts paid as rebates under 
        paragraph (1)(B) shall be deposited into the Federal 
        Supplementary Medical Insurance Trust Fund established under 
        section 1841.
            ``(7) Civil money penalty.--If a manufacturer of a part B 
        rebatable drug has failed to comply with the requirements under 
        paragraph (1)(B) for such drug for a calendar quarter, the 
        manufacturer shall be subject to, in accordance with a process 
        established by the Secretary pursuant to regulations, a civil 
        money penalty in an amount equal to at least 125 percent of the 
        amount specified in paragraph (3) for such drug for such 
        calendar quarter. The provisions of section 1128A (other than 
        subsections (a) (with respect to amounts of penalties or 
        additional assessments) and (b)) shall apply to a civil money 
        penalty under this paragraph in the same manner as such 
        provisions apply to a penalty or proceeding under section 
        1128A(a).
            ``(8) Study and report.--
                    ``(A) Study.--The Secretary shall conduct a study 
                of the feasibility of and operational issues involved 
                with the following:
                            ``(i) Including multiple source drugs (as 
                        defined in section 1847A(c)(6)(C)) in the 
                        rebate system under this subsection.
                            ``(ii) Including drugs and biologicals paid 
                        for under MA plans under part C in the rebate 
                        system under this subsection.
                            ``(iii) Including drugs excluded under 
                        paragraph (2)(A) and units of the billing and 
                        payment code of the drugs excluded under 
                        paragraph (3)(B) in the rebate system under 
                        this subsection.
                    ``(B) Report.--Not later than 3 years after the 
                date of the enactment of this subsection, the Secretary 
                shall submit to Congress a report on the study 
                conducted under subparagraph (A).
            ``(9) Application to multiple source drugs.--The Secretary 
        may, based on the report submitted under paragraph (8) and 
        pursuant to rulemaking, apply the provisions of this subsection 
        to multiple source drugs (as defined in section 
        1847A(c)(6)(C)), including, for purposes of determining the 
        rebate amount under paragraph (3), by calculating manufacturer-
        specific average sales prices for the benchmark period and the 
        rebate period.''.
    (b) Amounts Payable; Cost-Sharing.--Section 1833 of the Social 
Security Act (42 U.S.C. 1395l) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (S), by striking ``with 
                        respect to'' and inserting ``subject to 
                        subparagraph (DD), with respect to'';
                            (ii) by striking ``and (DD)'' and inserting 
                        ``(EE)''; and
                            (iii) by inserting before the semicolon at 
                        the end the following: ``, and (EE) with 
                        respect to a part B rebatable drug (as defined 
                        in paragraph (2) of section 1834(z)) for which 
                        the payment amount for a calendar quarter under 
                        paragraph (3)(A)(ii)(I) of such section for 
                        such quarter exceeds the inflation-adjusted 
                        payment under paragraph (3)(A)(ii)(II) of such 
                        section for such quarter, the amounts paid 
                        shall be the difference between (i) the payment 
                        amount under paragraph (3)(A)(ii)(I) of such 
                        section for such drug, and (ii) 20 percent of 
                        the inflation-adjusted payment amount under 
                        paragraph (3)(A)(ii)(II) of such section for 
                        such drug''; and
                    (B) by adding at the end of the flush left matter 
                following paragraph (9), the following:
``For purposes of applying paragraph (1)(EE), subsections (i)(9) and 
(t)(8)(F), and section 1834(z)(5), the Secretary shall make such 
estimates and use such data as the Secretary determines appropriate, 
and notwithstanding any other provision of law, may do so by program 
instruction or otherwise.'';
            (2) in subsection (i), by adding at the end the following 
        new paragraph:
    ``(9) In the case of a part B rebatable drug (as defined in 
paragraph (2) of section 1834(z)) for which payment under this 
subsection is not packaged into a payment for a covered OPD service (as 
defined in subsection (t)(1)(B)) (or group of services) furnished on or 
after July 1, 2023, under the system under this subsection, in lieu of 
calculation of coinsurance and the amount of payment otherwise 
applicable under this subsection, the provisions of section 1834(z)(5), 
paragraph (1)(EE) of subsection (a), and the flush left matter 
following paragraph (9) of subsection (a), shall, as determined 
appropriate by the Secretary, apply under this subsection in the same 
manner as such provisions of section 1834(z)(5) and subsection (a) 
apply under such section and subsection.''; and
            (3) in subsection (t)(8), by adding at the end the 
        following new subparagraph:
                    ``(F) Part b rebatable drugs.--In the case of a 
                part B rebatable drug (as defined in paragraph (2) of 
                section 1834(z)) for which payment under this part is 
                not packaged into a payment for a service furnished on 
                or after July 1, 2023, under the system under this 
                subsection, in lieu of calculation of coinsurance and 
                the amount of payment otherwise applicable under this 
                subsection, the provisions of section 1834(z)(5), 
                paragraph (1)(EE) of subsection (a), and the flush left 
                matter following paragraph (9) of subsection (a), 
                shall, as determined appropriate by the Secretary, 
                apply under this subsection in the same manner as such 
                provisions of section 1834(z)(5) and subsection (a) 
                apply under such section and subsection.''.
    (c) Conforming Amendments.--
            (1) To part b asp calculation.--Section 1847A(c)(3) of the 
        Social Security Act (42 U.S.C. 1395w-3a(c)(3)) is amended by 
        inserting ``or section 1834(z)'' after ``section 1927''.
            (2) Excluding parts b drug inflation rebate from best 
        price.--Section 1927(c)(1)(C)(ii)(I) of the Social Security Act 
        (42 U.S.C. 1396r-8(c)(1)(C)(ii)(I)) is amended by inserting 
        ``or section 1834(z)'' after ``this section''.
            (3) Coordination with medicaid rebate information 
        disclosure.--Section 1927(b)(3)(D)(i) of the Social Security 
        Act (42 U.S.C. 1396r-8(b)(3)(D)(i)) is amended by striking ``or 
        to carry out section 1847B'' and inserting ``to carry out 
        section 1847B or section 1834(z)''.

SEC. 202. MEDICARE PART D REBATE BY MANUFACTURERS.

    (a) In General.--Part D of title XVIII of the Social Security Act 
is amended by inserting after section 1860D-14A (42 U.S.C. 1395w-114a) 
the following new section:

``SEC. 1860D-14B. MANUFACTURER REBATE FOR CERTAIN DRUGS WITH PRICES 
              INCREASING FASTER THAN INFLATION.

    ``(a) In General.--
            ``(1) In general.--Subject to the provisions of this 
        section, in order for coverage to be available under this part 
        for a part D rebatable drug (as defined in subsection (h)(1)) 
        of a manufacturer (as defined in section 1927(k)(5)) dispensed 
        during an applicable year, the manufacturer must have entered 
        into and have in effect an agreement described in subsection 
        (b).
            ``(2)  Authorizing coverage for drugs not covered under 
        agreements.--Paragraph (1) shall not apply to the dispensing of 
        a covered part D drug if--
                    ``(A) the Secretary has made a determination that 
                the availability of the drug is essential to the health 
                of beneficiaries under this part; or
                    ``(B) the Secretary determines that in the period 
                beginning on January 1, 2023, and ending on December 
                31, 2023, there were extenuating circumstances.
            ``(3) Applicable year.--For purposes of this section the 
        term `applicable year' means a year beginning with 2023.
    ``(b) Agreements.--
            ``(1) Terms of agreement.--An agreement described in this 
        subsection, with respect to a manufacturer of a part D 
        rebatable drug, is an agreement under which the following shall 
        apply:
                    ``(A) Secretarial provision of information.--Not 
                later than 9 months after the end of each applicable 
                year with respect to which the agreement is in effect, 
                the Secretary, for each part D rebatable drug of the 
                manufacturer, shall report to the manufacturer the 
                following for such year:
                            ``(i) Information on the total number of 
                        units (as defined in subsection (h)(2)) for 
                        each dosage form and strength with respect to 
                        such part D rebatable drug and year.
                            ``(ii) Information on the amount (if any) 
                        of the excess average manufacturer price 
                        increase described in subsection (c)(1)(B) for 
                        each dosage form and strength with respect to 
                        such drug and year.
                            ``(iii) The rebate amount specified under 
                        subsection (c) for each dosage form and 
                        strength with respect to such drug and year.
                    ``(B) Manufacturer requirements.--For each 
                applicable year with respect to which the agreement is 
                in effect, the manufacturer of the part D rebatable 
                drug, for each dosage form and strength with respect to 
                such drug, not later than 30 days after the date of 
                receipt from the Secretary of the information described 
                in subparagraph (A) for such year, shall provide to the 
                Secretary a rebate that is equal to the amount 
                specified in subsection (c) for such dosage form and 
                strength with respect to such drug for such year.
            ``(2) Length of agreement.--
                    ``(A) In general.--An agreement under this section, 
                with respect to a part D rebatable drug, shall be 
                effective for an initial period of not less than one 
                year and shall be automatically renewed for a period of 
                not less than one year unless terminated under 
                subparagraph (B).
                    ``(B) Termination.--
                            ``(i) By secretary.--The Secretary may 
                        provide for termination of an agreement under 
                        this section for violation of the requirements 
                        of the agreement or other good cause shown. 
                        Such termination shall not be effective earlier 
                        than 30 days after the date of notice of such 
                        termination. The Secretary shall provide, upon 
                        request, a manufacturer with a hearing 
                        concerning such a termination, but such hearing 
                        shall not delay the effective date of the 
                        termination.
                            ``(ii) By a manufacturer.--A manufacturer 
                        may terminate an agreement under this section 
                        for any reason. Any such termination shall be 
                        effective, with respect to a plan year--
                                    ``(I) if the termination occurs 
                                before January 30 of the plan year, as 
                                of the day after the end of the plan 
                                year; and
                                    ``(II) if the termination occurs on 
                                or after January 30 of the plan year, 
                                as of the day after the end of the 
                                succeeding plan year.
                    ``(C) Effectiveness of termination.--Any 
                termination under this paragraph shall not affect 
                rebates due under the agreement under this section 
                before the effective date of its termination.
                    ``(D) Delay before reentry.--In the case of any 
                agreement under this section with a manufacturer that 
                is terminated in a plan year, the Secretary may not 
                enter into another such agreement with the manufacturer 
                (or a successor manufacturer) before the subsequent 
                plan year, unless the Secretary finds good cause for an 
                earlier reinstatement of such an agreement.
    ``(c) Rebate Amount.--
            ``(1) In general.--For purposes of this section, the amount 
        specified in this subsection for a dosage form and strength 
        with respect to a part D rebatable drug and applicable year is, 
        subject to subparagraphs (B) and (C) of paragraph (5), the 
        amount equal to the product of--
                    ``(A) the total number of units of such dosage form 
                and strength with respect to such part D rebatable drug 
                and year; and
                    ``(B) the amount (if any) by which--
                            ``(i) the annual manufacturer price (as 
                        determined in paragraph (2)) paid for such 
                        dosage form and strength with respect to such 
                        part D rebatable drug for the year; exceeds
                            ``(ii) the inflation-adjusted payment 
                        amount determined under paragraph (3) for such 
                        dosage form and strength with respect to such 
                        part D rebatable drug for the year.
            ``(2) Determination of annual manufacturer price.--The 
        annual manufacturer price determined under this paragraph for a 
        dosage form and strength, with respect to a part D rebatable 
        drug and an applicable year, is the sum of the products of--
                    ``(A) the average manufacturer price (as defined in 
                subsection (h)(6)) of such dosage form and strength, as 
                calculated for a unit of such drug, with respect to 
                each of the calendar quarters of such year; and
                    ``(B) the ratio of--
                            ``(i) the total number of units of such 
                        dosage form and strength dispensed during each 
                        such calendar quarter of such year; to
                            ``(ii) the total number of units of such 
                        dosage form and strength dispensed during such 
                        year.
            ``(3) Determination of inflation-adjusted payment amount.--
        The inflation-adjusted payment amount determined under this 
        paragraph for a dosage form and strength with respect to a part 
        D rebatable drug for an applicable year, subject to 
        subparagraphs (A) and (D) of paragraph (5), is--
                    ``(A) the benchmark year manufacturer price 
                determined under paragraph (4) for such dosage form and 
                strength with respect to such drug and an applicable 
                year; increased by
                    ``(B) the percentage by which the applicable year 
                CPI-U (as defined in subsection (h)(5)) for the 
                applicable year exceeds the benchmark period CPI-U (as 
                defined in subsection (h)(4)).
            ``(4) Determination of benchmark year manufacturer price.--
        The benchmark year manufacturer price determined under this 
        paragraph for a dosage form and strength, with respect to a 
        part D rebatable drug and an applicable year, is the sum of the 
        products of--
                    ``(A) the average manufacturer price (as defined in 
                subsection (h)(6)) of such dosage form and strength, as 
                calculated for a unit of such drug, with respect to 
                each of the calendar quarters of the payment amount 
                benchmark year (as defined in subsection (h)(3)); and
                    ``(B) the ratio of--
                            ``(i) the total number of units of such 
                        dosage form and strength dispensed during each 
                        such calendar quarter of such payment amount 
                        benchmark year; to
                            ``(ii) the total number of units of such 
                        dosage form and strength dispensed during such 
                        payment amount benchmark year.
            ``(5) Special treatment of certain drugs and exemption.--
                    ``(A) Subsequently approved drugs.--In the case of 
                a part D rebatable drug first approved or licensed by 
                the Food and Drug Administration after January 1, 2016, 
                subparagraphs (A) and (B) of paragraph (4) shall be 
                applied as if the term `payment amount benchmark year' 
                were defined under subsection (h)(3) as the first 
                calendar year beginning after the day on which the drug 
                was first marketed by any manufacturer and subparagraph 
                (B) of paragraph (3) shall be applied as if the term 
                `benchmark period CPI-U' were defined under subsection 
                (h)(4) as if the reference to `January 2016' under such 
                subsection were a reference to `January of the first 
                year beginning after the date on which the drug was 
                first marketed by any manufacturer'.
                    ``(B) Exemption for shortages.--The Secretary may 
                reduce or waive the rebate under paragraph (1) with 
                respect to a part D rebatable drug that is described as 
                currently in shortage on the shortage list in effect 
                under section 506E of the Federal Food, Drug, and 
                Cosmetic Act or in the case of other exigent 
                circumstances, as determined by the Secretary.
                    ``(C) Treatment of new formulations.--
                            ``(i) In general.--In the case of a part D 
                        rebatable drug that is a line extension of a 
                        part D rebatable drug that is an oral solid 
                        dosage form, the Secretary shall establish a 
                        formula for determining the amount specified in 
                        this subsection with respect to such part D 
                        rebatable drug and an applicable year with 
                        consideration of the original part D rebatable 
                        drug.
                            ``(ii) Line extension defined.--In this 
                        subparagraph, the term `line extension' means, 
                        with respect to a part D rebatable drug, a new 
                        formulation of the drug (as determined by the 
                        Secretary), such as an extended release 
                        formulation, but does not include an abuse-
                        deterrent formulation of the drug (as 
                        determined by the Secretary), regardless of 
                        whether such abuse-deterrent formulation is an 
                        extended release formulation.
                    ``(D) Selected drugs.--In the case of a part D 
                rebatable drug that is a selected drug (as defined in 
                section 1192(c)) for a price applicability period (as 
                defined in section 1191(b)(2))--
                            ``(i) for plan years during such period for 
                        which a maximum fair price (as defined in 
                        section 1191(c)(2)) for such drug has been 
                        determined and is applied under part E of title 
                        XI, the rebate under subsection (b)(1)(B) shall 
                        be waived; and
                            ``(ii) in the case such drug is determined 
                        (pursuant to such section 1192(c)) to no longer 
                        be a selected drug, for each applicable year 
                        beginning after the price applicability period 
                        with respect to such drug, subparagraphs (A) 
                        and (B) of paragraph (4) shall be applied as if 
                        the term `payment amount benchmark year' were 
                        defined under subsection (h)(3) as the last 
                        year beginning during such price applicability 
                        period with respect to such selected drug and 
                        subparagraph (B) of paragraph (3) shall be 
                        applied as if the term `benchmark period CPI-U' 
                        were defined under subsection (h)(4) as if the 
                        reference to `January 2016' under such 
                        subsection were a reference to January of the 
                        last year beginning during such price 
                        applicability period with respect to such drug.
    ``(d) Rebate Deposits.--Amounts paid as rebates under subsection 
(c) shall be deposited into the Medicare Prescription Drug Account in 
the Federal Supplementary Medical Insurance Trust Fund established 
under section 1841.
    ``(e) Information.--For purposes of carrying out this section, the 
Secretary shall use information submitted by manufacturers under 
section 1927(b)(3).
    ``(f) Civil Money Penalty.--In the case of a manufacturer of a part 
D rebatable drug with an agreement in effect under this section who has 
failed to comply with the terms of the agreement under subsection 
(b)(1)(B) with respect to such drug for an applicable year, the 
Secretary may impose a civil money penalty on such manufacturer in an 
amount equal to 125 percent of the amount specified in subsection (c) 
for such drug for such year. The provisions of section 1128A (other 
than subsections (a) (with respect to amounts of penalties or 
additional assessments) and (b)) shall apply to a civil money penalty 
under this subsection in the same manner as such provisions apply to a 
penalty or proceeding under section 1128A(a).
    ``(g) Judicial Review.--There shall be no judicial review of the 
following:
            ``(1) The determination of units under this section.
            ``(2) The determination of whether a drug is a part D 
        rebatable drug under this section.
            ``(3) The calculation of the rebate amount under this 
        section.
    ``(h) Definitions.--In this section:
            ``(1) Part d rebatable drug defined.--
                    ``(A) In general.--The term `part D rebatable drug' 
                means a drug or biological that would (without 
                application of this section) be a covered part D drug, 
                except such term shall, with respect to an applicable 
                year, not include such a drug or biological if the 
                average annual total cost under this part for such year 
                per individual who uses such a drug or biological, as 
                determined by the Secretary, is less than, subject to 
                subparagraph (B), $100, as determined by the Secretary 
                using the most recent data available or, if data is not 
                available, as estimated by the Secretary.
                    ``(B) Increase.--The dollar amount applied under 
                subparagraph (A)--
                            ``(i) for 2024, shall be the dollar amount 
                        specified under such subparagraph for 2023, 
                        increased by the percentage increase in the 
                        consumer price index for all urban consumers 
                        (United States city average) for the 12-month 
                        period beginning with January of 2023; and
                            ``(ii) for a subsequent year, shall be the 
                        dollar amount specified in this subparagraph 
                        for the previous year, increased by the 
                        percentage increase in the consumer price index 
                        for all urban consumers (United States city 
                        average) for the 12-month period beginning with 
                        January of the previous year.
                Any dollar amount specified under this subparagraph 
                that is not a multiple of $10 shall be rounded to the 
                nearest multiple of $10.
            ``(2) Unit defined.--The term `unit' means, with respect to 
        a part D rebatable drug, the lowest identifiable quantity (such 
        as a capsule or tablet, milligram of molecules, or grams) of 
        the part D rebatable drug that is dispensed to individuals 
        under this part.
            ``(3) Payment amount benchmark year.--The term `payment 
        amount benchmark year' means the year beginning January 1, 
        2016.
            ``(4) Benchmark period cpi-u.--The term `benchmark period 
        CPI-U' means the consumer price index for all urban consumers 
        (United States city average) for January 2016.
            ``(5) Applicable year cpi-u.--The term `applicable year 
        CPI-U' means, with respect to an applicable year, the consumer 
        price index for all urban consumers (United States city 
        average) for January of such year.
            ``(6) Average manufacturer price.--The term `average 
        manufacturer price' has the meaning, with respect to a part D 
        rebatable drug of a manufacturer, given such term in section 
        1927(k)(1), with respect to a covered outpatient drug of a 
        manufacturer for a rebate period under section 1927.''.
    (b) Conforming Amendments.--
            (1) To part b asp calculation.--Section 1847A(c)(3) of the 
        Social Security Act (42 U.S.C. 1395w-3a(c)(3)), as amended by 
        section 201(c)(1), is further amended by striking ``section 
        1927 or section 1834(z)'' and inserting ``section 1927, section 
        1834(z), or section 1860D-14B''.
            (2) Excluding part d drug inflation rebate from best 
        price.--Section 1927(c)(1)(C)(ii)(I) of the Social Security Act 
        (42 U.S.C. 1396r-8(c)(1)(C)(ii)(I)), as amended by section 
        201(c)(2), is further amended by striking ``or section 
        1834(z)'' and inserting ``, section 1834(z), or section 1860D-
        14B''.
            (3) Coordination with medicaid rebate information 
        disclosure.--Section 1927(b)(3)(D)(i) of the Social Security 
        Act (42 U.S.C. 1396r-8(b)(3)(D)(i)), as amended by section 
        201(c)(3), is further amended by striking ``or section 
        1834(z)'' and inserting ``, section 1834(z), or section 1860D-
        14B''.

SEC. 203. PROVISION REGARDING INFLATION REBATES FOR GROUP HEALTH PLANS 
              AND GROUP HEALTH INSURANCE COVERAGE.

    (a) In General.--Not later than December 31, 2023, the Secretary of 
Labor, in consultation with the Secretary of Health and Human Services 
and the Secretary of the Treasury, shall submit to Congress a report 
on--
            (1) potential models for an agreement process with 
        manufacturers of prescription drugs under which such 
        manufacturers provide for inflation rebates with respect to 
        such drugs that are furnished or dispensed to participants and 
        beneficiaries of group health plans and health insurance 
        coverage offered in the group market in a manner similar to how 
        manufacturers provide for rebates under section 1834(z) of the 
        Social Security Act, as added by section 201, and section 
        1860D-14B of such Act, as added by section 202, with respect to 
        prescription drugs that are furnished or dispensed under part B 
        of title XVIII of such Act and part D of such title, 
        respectively; and
            (2) potential models for enforcement mechanisms with 
        respect to such an agreement process that ensure that such 
        inflation rebates are proportionally distributed, with respect 
        to costs, to group health plans and health insurance issuers 
        offering health insurance coverage in the group market, to 
        participants and beneficiaries of such plans and coverage, or 
        to both.
    (b) Regulations.--Not later than December 31, 2024, the Secretary 
of Labor shall, in consultation with the Secretary of Health and Human 
Services and the Secretary of the Treasury, promulgate regulations to 
implement a model described in subsection (a)(1) and a model described 
in subsection (a)(2), if the Secretary determines that--
            (1) the prices of a sufficient number (as determined by the 
        Secretary) of drugs described in subsection (a)(1) have 
        increased over a period of time (as determined by the 
        Secretary) at a percentage that exceeds the percentage by which 
        the consumer price index for all urban consumers (United States 
        city average) has increased over such period; and
            (2) such model described in subsection (a)(1) and such 
        model described in subsection (a)(2) are feasible.

SEC. 204. ANNUAL REPORT ON DRUG COSTS IN GROUP HEALTH PLANS AND GROUP 
              HEALTH INSURANCE COVERAGE.

    (a) Initial Report.--Not later than December 31, 2023, the 
Secretary of Labor shall, in consultation with the Secretary of Health 
and Human Services and the Secretary of the Treasury, submit to 
Congress a report, with respect to a period (as determined by the 
Secretary of Labor), on--
            (1) whether the prices of prescription drugs that are 
        furnished or dispensed to participants and beneficiaries of 
        group health plans and health insurance coverage offered in the 
        group market during such period have increased at a percentage 
        that exceeds the percentage by which the consumer price index 
        for all urban consumers (United States city average) increased 
        for such period; and
            (2) whether there are mechanisms by which manufacturers of 
        prescription drugs have attempted to recover rebate payments 
        required of such manufacturers under section 1834(z) of the 
        Social Security Act, as added by section 201, and section 
        1860D-14B of such Act, as added by section 202, with respect to 
        prescription drugs that are furnished or dispensed under part B 
        of title XVIII of such Act and part D of such title, 
        respectively, through increased prices charged with respect to 
        drugs that are furnished or dispensed to participants and 
        beneficiaries of group health plans and health insurance 
        coverage offered in the group market during such period.
    (b) Annual Report.--Not later than December 31 of each year 
following 2023, the Secretary of Labor shall, in consultation with the 
Secretary of Health and Human Services and the Secretary of the 
Treasury, submit to Congress a report updating the information and 
analysis included in the report required under subsection (a), 
reflecting, in part, new price and cost information and data for the 
12-month period after the period on which the prior year's report was 
based.

SEC. 205. COLLECTION OF DATA.

    (a) Manufacturers of Prescription Drugs.--Manufacturers of 
prescription drugs shall submit to the Secretary of Health and Human 
Services, the Secretary of Labor, and the Secretary of the Treasury 
appropriate data as necessary for the Secretaries to obtain information 
needed to provide the reports under sections 203 and 204.
    (b) Group Health Plans and Health Insurance Issuers Offering Health 
Insurance Coverage in the Group Market.--Group health plans and health 
insurance issuers offering health insurance coverage in the group 
market shall submit to the Secretary of Health and Human Services, the 
Secretary of Labor, and the Secretary of the Treasury appropriate data 
as necessary for the Secretaries to obtain information needed to 
provide the reports under sections 203 and 204.

   TITLE III--PART D IMPROVEMENTS AND MAXIMUM OUT-OF-POCKET CAP FOR 
                         MEDICARE BENEFICIARIES

SEC. 301. MEDICARE PART D BENEFIT REDESIGN.

    (a) Benefit Structure Redesign.--Section 1860D-2(b) of the Social 
Security Act (42 U.S.C. 1395w-102(b)) is amended--
            (1) in paragraph (2)--
                    (A) in subparagraph (A), in the matter preceding 
                clause (i), by inserting ``for a year preceding 2024 
                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 2024 and 
                each subsequent year'' after ``paragraph (3)'';
                    (B) in subparagraph (C)--
                            (i) in clause (i), in the matter preceding 
                        subclause (I), by inserting ``for a year 
                        preceding 2024,'' after ``paragraph (4),''; and
                            (ii) in clause (ii)(III), by striking ``and 
                        each subsequent year'' and inserting ``through 
                        2023''; and
                    (C) in subparagraph (D)--
                            (i) in clause (i)--
                                    (I) in the matter preceding 
                                subclause (I), by inserting ``for a 
                                year preceding 2024,'' after 
                                ``paragraph (4),''; and
                                    (II) in subclause (I)(bb), by 
                                striking ``a year after 2018'' and 
                                inserting ``each of years 2018 through 
                                2023''; and
                            (ii) in clause (ii)(V), by striking ``2019 
                        and each subsequent year'' and inserting ``each 
                        of years 2019 through 2023'';
            (2) in paragraph (3)(A)--
                    (A) in the matter preceding clause (i), by 
                inserting ``for a year preceding 2024,'' after ``and 
                (4),''; and
                    (B) in clause (ii), by striking ``for a subsequent 
                year'' and inserting ``for each of years 2007 through 
                2023''; and
            (3) in paragraph (4)--
                    (A) in subparagraph (A)--
                            (i) in clause (i)--
                                    (I) by redesignating subclauses (I) 
                                and (II) as items (aa) and (bb), 
                                respectively, and moving the margin of 
                                each such redesignated item 2 ems to 
                                the right;
                                    (II) in the matter preceding item 
                                (aa), as redesignated by subclause (I), 
                                by striking ``is equal to the greater 
                                of--'' and inserting ``is equal to--
                                    ``(I) for a year preceding 2024, 
                                the greater of--'';
                                    (III) by striking the period at the 
                                end of item (bb), as redesignated by 
                                subclause (I), and inserting ``; and''; 
                                and
                                    (IV) by adding at the end the 
                                following:
                                    ``(II) for 2024 and each succeeding 
                                year, $0.''; and
                            (ii) in clause (ii), by striking ``clause 
                        (i)(I)'' and inserting ``clause (i)(I)(aa)'';
                    (B) in subparagraph (B)--
                            (i) in clause (i)--
                                    (I) in subclause (V), by striking 
                                ``or'' at the end;
                                    (II) in subclause (VI)--
                                            (aa) by striking ``for a 
                                        subsequent year'' and inserting 
                                        ``for each of years 2021 
                                        through 2023''; and
                                            (bb) by striking the period 
                                        at the end and inserting a 
                                        semicolon; and
                                    (III) by adding at the end the 
                                following new subclauses:
                                    ``(VII) for 2024, is equal to 
                                $2,000; or
                                    ``(VIII) for a subsequent year, is 
                                equal to the amount specified in this 
                                subparagraph for the previous year, 
                                increased by the annual percentage 
                                increase described in paragraph (6) for 
                                the year involved.''; and
                            (ii) in clause (ii), by striking ``clause 
                        (i)(II)'' and inserting ``clause (i)'';
                    (C) in subparagraph (C)(i), by striking ``and for 
                amounts'' and inserting ``and, for a year preceding 
                2024, for amounts''; and
                    (D) in subparagraph (E), by striking ``In 
                applying'' and inserting ``For each of years 2011 
                through 2023, in applying''.
    (b) Decreasing Reinsurance Payment Amount.--Section 1860D-15(b)(1) 
of the Social Security Act (42 U.S.C. 1395w-115(b)(1)) is amended by 
inserting after ``80 percent'' the following: ``(or, with respect to a 
coverage year after 2023, 20 percent)''.
    (c) Manufacturer Discount Program.--
            (1) In general.--Part D of title XVIII of the Social 
        Security Act (42 U.S.C. 1395w-101 et seq.), as amended by 
        section 202, is further amended by inserting after section 
        1860D-14B the following new section:

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

    ``(a) Establishment.--The Secretary shall establish a manufacturer 
discount program (in this section referred to as the `program'). Under 
the program, the Secretary shall enter into agreements described in 
subsection (b) with manufacturers and provide for the performance of 
the duties described in subsection (c). The Secretary shall establish a 
model agreement for use under the program by not later than January 1, 
2023, in consultation with manufacturers, and allow for comment on such 
model agreement.
    ``(b) Terms of Agreement.--
            ``(1) In general.--
                    ``(A) Agreement.--An agreement under this section 
                shall require the manufacturer to provide applicable 
                beneficiaries access to discounted prices for 
                applicable drugs of the manufacturer that are dispensed 
                on or after January 1, 2024.
                    ``(B) Provision of discounted prices at the point-
                of-sale.--The discounted prices described in 
                subparagraph (A) shall be provided to the applicable 
                beneficiary at the pharmacy or by the mail order 
                service at the point-of-sale of an applicable drug.
                    ``(C) Timing of agreement.--
                            ``(i) Special rule for 2024.--In order for 
                        an agreement with a manufacturer to be in 
                        effect under this section with respect to the 
                        period beginning on January 1, 2024, and ending 
                        on December 31, 2024, the manufacturer shall 
                        enter into such agreement not later than 30 
                        days after the date of the establishment of a 
                        model agreement under subsection (a).
                            ``(ii) 2025 and subsequent years.--In order 
                        for an agreement with a manufacturer to be in 
                        effect under this section with respect to plan 
                        year 2025 or a subsequent plan year, the 
                        manufacturer shall enter into such agreement 
                        (or such agreement shall be renewed under 
                        paragraph (4)(A)) not later than January 30 of 
                        the preceding year.
            ``(2) Provision of appropriate data.--Each manufacturer 
        with an agreement in effect under this section shall collect 
        and have available appropriate data, as determined by the 
        Secretary, to ensure that it can demonstrate to the Secretary 
        compliance with the requirements under the program.
            ``(3) Compliance with requirements for administration of 
        program.--Each manufacturer with an agreement in effect under 
        this section shall comply with requirements imposed by the 
        Secretary or a third party with a contract under subsection 
        (d)(3), as applicable, for purposes of administering the 
        program, including any determination under subparagraph (A) of 
        subsection (c)(1) or procedures established under such 
        subsection (c)(1).
            ``(4) Length of agreement.--
                    ``(A) In general.--An agreement under this section 
                shall be effective for an initial period of not less 
                than 12 months and shall be automatically renewed for a 
                period of not less than 1 year unless terminated under 
                subparagraph (B).
                    ``(B) Termination.--
                            ``(i) By the secretary.--The Secretary may 
                        provide for termination of an agreement under 
                        this section for a knowing and willful 
                        violation of the requirements of the agreement 
                        or other good cause shown. Such termination 
                        shall not be effective earlier than 30 days 
                        after the date of notice to the manufacturer of 
                        such termination. The Secretary shall provide, 
                        upon request, a manufacturer with a hearing 
                        concerning such a termination, and such hearing 
                        shall take place prior to the effective date of 
                        the termination with sufficient time for such 
                        effective date to be repealed if the Secretary 
                        determines appropriate.
                            ``(ii) By a manufacturer.--A manufacturer 
                        may terminate an agreement under this section 
                        for any reason. Any such termination shall be 
                        effective, with respect to a plan year--
                                    ``(I) if the termination occurs 
                                before January 30 of a plan year, as of 
                                the day after the end of the plan year; 
                                and
                                    ``(II) if the termination occurs on 
                                or after January 30 of a plan year, as 
                                of the day after the end of the 
                                succeeding plan year.
                            ``(iii) Effectiveness of termination.--Any 
                        termination under this subparagraph shall not 
                        affect discounts for applicable drugs of the 
                        manufacturer that are due under the agreement 
                        before the effective date of its termination.
                            ``(iv) Notice to third party.--The 
                        Secretary shall provide notice of such 
                        termination to a third party with a contract 
                        under subsection (d)(3) within not less than 30 
                        days before the effective date of such 
                        termination.
    ``(c) Duties Described.--The duties described in this subsection 
are the following:
            ``(1) Administration of program.--Administering the 
        program, including--
                    ``(A) the determination of the amount of the 
                discounted price of an applicable drug of a 
                manufacturer;
                    ``(B) the establishment of procedures under which 
                discounted prices are provided to applicable 
                beneficiaries at pharmacies or by mail order service at 
                the point-of-sale of an applicable drug;
                    ``(C) the establishment of procedures to ensure 
                that, not later than the applicable number of calendar 
                days after the dispensing of an applicable drug by a 
                pharmacy or mail order service, the pharmacy or mail 
                order service is reimbursed for an amount equal to the 
                difference between--
                            ``(i) the negotiated price of the 
                        applicable drug; and
                            ``(ii) the discounted price of the 
                        applicable drug;
                    ``(D) the establishment of procedures to ensure 
                that the discounted price for an applicable drug under 
                this section is applied before any coverage or 
                financial assistance under other health benefit plans 
                or programs that provide coverage or financial 
                assistance for the purchase or provision of 
                prescription drug coverage on behalf of applicable 
                beneficiaries as the Secretary may specify; and
                    ``(E) providing a reasonable dispute resolution 
                mechanism to resolve disagreements between 
                manufacturers, applicable beneficiaries, and the third 
                party with a contract under subsection (d)(3).
            ``(2) Monitoring compliance.--
                    ``(A) In general.--The Secretary shall monitor 
                compliance by a manufacturer with the terms of an 
                agreement under this section.
                    ``(B) Notification.--If a third party with a 
                contract under subsection (d)(3) determines that the 
                manufacturer is not in compliance with such agreement, 
                the third party shall notify the Secretary of such 
                noncompliance for appropriate enforcement under 
                subsection (e).
            ``(3) Collection of data from prescription drug plans and 
        ma-pd plans.--The Secretary may collect appropriate data from 
        prescription drug plans and MA-PD plans in a timeframe that 
        allows for discounted prices to be provided for applicable 
        drugs under this section.
    ``(d) Administration.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall provide for the implementation of this section, including 
        the performance of the duties described in subsection (c).
            ``(2) Limitation.--In providing for the implementation of 
        this section, the Secretary shall not receive or distribute any 
        funds of a manufacturer under the program.
            ``(3) Contract with third parties.--The Secretary shall 
        enter into a contract with 1 or more third parties to 
        administer the requirements established by the Secretary in 
        order to carry out this section. At a minimum, the contract 
        with a third party under the preceding sentence shall require 
        that the third party--
                    ``(A) receive and transmit information between the 
                Secretary, manufacturers, and other individuals or 
                entities the Secretary determines appropriate;
                    ``(B) receive, distribute, or facilitate the 
                distribution of funds of manufacturers to appropriate 
                individuals or entities in order to meet the 
                obligations of manufacturers under agreements under 
                this section;
                    ``(C) provide adequate and timely information to 
                manufacturers, consistent with the agreement with the 
                manufacturer under this section, as necessary for the 
                manufacturer to fulfill its obligations under this 
                section; and
                    ``(D) permit manufacturers to conduct periodic 
                audits, directly or through contracts, of the data and 
                information used by the third party to determine 
                discounts for applicable drugs of the manufacturer 
                under the program.
            ``(4) Performance requirements.--The Secretary shall 
        establish performance requirements for a third party with a 
        contract under paragraph (3) and safeguards to protect the 
        independence and integrity of the activities carried out by the 
        third party under the program under this section.
            ``(5) Implementation.--Notwithstanding any other provision 
        of law, the Secretary may implement the program under this 
        section by program instruction or otherwise.
            ``(6) Administration.--Chapter 35 of title 44, United 
        States Code, shall not apply to the program under this section.
    ``(e) Enforcement.--
            ``(1) Audits.--Each manufacturer with an agreement in 
        effect under this section shall be subject to periodic audit by 
        the Secretary.
            ``(2) Civil money penalty.--
                    ``(A) In general.--The Secretary may impose a civil 
                money penalty on a manufacturer that fails to provide 
                applicable beneficiaries discounts for applicable drugs 
                of the manufacturer in accordance with such agreement 
                for each such failure in an amount the Secretary 
                determines is equal to the sum of--
                            ``(i) the amount that the manufacturer 
                        would have paid with respect to such discounts 
                        under the agreement, which will then be used to 
                        pay the discounts which the manufacturer had 
                        failed to provide; and
                            ``(ii) 25 percent of such amount.
                    ``(B) Application.--The provisions of section 1128A 
                (other than subsections (a) and (b)) shall apply to a 
                civil money penalty under this paragraph in the same 
                manner as such provisions apply to a penalty or 
                proceeding under section 1128A(a).
    ``(f) Clarification Regarding Availability of Other Covered Part D 
Drugs.--Nothing in this section shall prevent an applicable beneficiary 
from purchasing a covered part D drug that is not an applicable drug 
(including a generic drug or a drug that is not on the formulary of the 
prescription drug plan or MA-PD plan that the applicable beneficiary is 
enrolled in).
    ``(g) Definitions.--In this section:
            ``(1) Applicable beneficiary.--The term `applicable 
        beneficiary' means an individual who, on the date of dispensing 
        a covered part D drug--
                    ``(A) is enrolled in a prescription drug plan or an 
                MA-PD plan;
                    ``(B) is not enrolled in a qualified retiree 
                prescription drug plan; and
                    ``(C) has incurred costs, as determined in 
                accordance with section 1860D-2(b)(4)(C), for covered 
                part D drugs in the year that exceed the annual 
                deductible with respect to such individual for such 
                year, as specified in section 1860D-2(b)(1), section 
                1860D-14(a)(1)(B), or section 1860D-14(a)(2)(B), as 
                applicable.
            ``(2) Applicable drug.--The term `applicable drug', with 
        respect to an applicable beneficiary--
                    ``(A) means a covered part D drug--
                            ``(i) approved under a new drug application 
                        under section 505(c) of the Federal Food, Drug, 
                        and Cosmetic Act or, in the case of a biologic 
                        product, licensed under section 351 of the 
                        Public Health Service Act; and
                            ``(ii)(I) if the PDP sponsor of the 
                        prescription drug plan or the MA organization 
                        offering the MA-PD plan uses a formulary, which 
                        is on the formulary of the prescription drug 
                        plan or MA-PD plan that the applicable 
                        beneficiary is enrolled in;
                            ``(II) if the PDP sponsor of the 
                        prescription drug plan or the MA organization 
                        offering the MA-PD plan does not use a 
                        formulary, for which benefits are available 
                        under the prescription drug plan or MA-PD plan 
                        that the applicable beneficiary is enrolled in; 
                        or
                            ``(III) is provided through an exception or 
                        appeal; and
                    ``(B) does not include a selected drug (as defined 
                in section 1192(c)) during a price applicability period 
                (as defined in section 1191(b)(2)) with respect to such 
                drug.
            ``(3) Applicable number of calendar days.--The term 
        `applicable number of calendar days' means--
                    ``(A) with respect to claims for reimbursement 
                submitted electronically, 14 days; and
                    ``(B) with respect to claims for reimbursement 
                submitted otherwise, 30 days.
            ``(4) Discounted price.--
                    ``(A) In general.--The term `discounted price' 
                means, with respect to an applicable drug of a 
                manufacturer dispensed during a year to an applicable 
                beneficiary--
                            ``(i) who has not incurred costs, as 
                        determined in accordance with section 1860D-
                        2(b)(4)(C), for covered part D drugs in the 
                        year that are equal to or exceed the annual 
                        out-of-pocket threshold specified in section 
                        1860D-2(b)(4)(B)(i) for the year, 90 percent of 
                        the negotiated price of such drug; and
                            ``(ii) who has incurred such costs, as so 
                        determined, in the year that are equal to or 
                        exceed such threshold for the year, 70 percent 
                        of the negotiated price of such drug.
                    ``(B) Clarification.--Nothing in this section shall 
                be construed as affecting the responsibility of an 
                applicable beneficiary for payment of a dispensing fee 
                for an applicable drug.
                    ``(C) Special case for certain claims.--
                            ``(i) Claims spanning deductible.--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 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 above 
                        such annual deductible.
                            ``(ii) Claims spanning out-of-pocket 
                        threshold.--In the case where the entire amount 
                        of the negotiated price of an individual claim 
                        for an applicable drug with respect to an 
                        applicable beneficiary does not fall entirely 
                        below or entirely above the annual out-of-
                        pocket threshold specified in section 1860D-
                        2(b)(4)(B)(i) for the year, the manufacturer of 
                        the applicable drug shall provide the 
                        discounted price--
                                    ``(I) in accordance with 
                                subparagraph (A)(i) on the portion of 
                                the negotiated price of the applicable 
                                drug that falls below such threshold; 
                                and
                                    ``(II) in accordance with 
                                subparagraph (A)(ii) on the portion of 
                                such price of such drug that falls at 
                                or above such threshold.
            ``(5) Manufacturer.--The term `manufacturer' means any 
        entity which is engaged in the production, preparation, 
        propagation, compounding, conversion, or processing of 
        prescription drug products, either directly or indirectly by 
        extraction from substances of natural origin, or independently 
        by means of chemical synthesis, or by a combination of 
        extraction and chemical synthesis. Such term does not include a 
        wholesale distributor of drugs or a retail pharmacy licensed 
        under State law.
            ``(6) Negotiated price.--The term `negotiated price' has 
        the meaning given such term in section 423.100 of title 42, 
        Code of Federal Regulations (or any successor regulation), 
        except that, with respect to an applicable drug, such 
        negotiated price shall not include any dispensing fee for the 
        applicable drug.
            ``(7) Qualified retiree prescription drug plan.--The term 
        `qualified retiree prescription drug plan' has the meaning 
        given such term in section 1860D-22(a)(2).''.
            (2) Sunset of medicare coverage gap discount program.--
        Section 1860D-14A of the Social Security Act (42 U.S.C. 1395-
        114a) is amended--
                    (A) in subsection (a), in the first sentence, by 
                striking ``The Secretary'' and inserting ``Subject to 
                subsection (h), the Secretary''; and
                    (B) by adding at the end the following new 
                subsection:
    ``(h) Sunset of Program.--
            ``(1) In general.--The program shall not apply with respect 
        to applicable drugs dispensed on or after January 1, 2024, and, 
        subject to paragraph (2), agreements under this section shall 
        be terminated as of such date.
            ``(2) Continued application for applicable drugs dispensed 
        prior to sunset.--The provisions of this section (including all 
        responsibilities and duties) shall continue to apply after 
        January 1, 2024, with respect to applicable drugs dispensed 
        prior to such date.''.
            (3) Inclusion of actuarial value of manufacturer discounts 
        in bids.--Section 1860D-11 of the Social Security Act (42 
        U.S.C. 1395w-111) is amended--
                    (A) in subsection (b)(2)(C)(iii)--
                            (i) by striking ``assumptions regarding the 
                        reinsurance'' and inserting ``assumptions 
                        regarding--
                                    ``(I) the reinsurance''; and
                            (ii) by adding at the end the following:
                                    ``(II) for 2024 and each subsequent 
                                year, the manufacturer discounts 
                                provided under section 1860D-14C 
                                subtracted from the actuarial value to 
                                produce such bid; and''; and
                    (B) in subsection (c)(1)(C)--
                            (i) by striking ``an actuarial valuation of 
                        the reinsurance'' and inserting ``an actuarial 
                        valuation of--
                            ``(i) the reinsurance'';
                            (ii) in clause (i), as inserted by clause 
                        (i) of this subparagraph, by adding ``and'' at 
                        the end; and
                            (iii) by adding at the end the following:
                            ``(ii) for 2024 and each subsequent year, 
                        the manufacturer discounts provided under 
                        section 1860D-14C;''.
    (d) Conforming Amendments.--
            (1) Section 1860D-2 of the Social Security Act (42 U.S.C. 
        1395w-102) is amended--
                    (A) in subsection (a)(2)(A)(i)(I), by striking ``, 
                or an increase in the initial'' and inserting ``or, for 
                a year preceding 2024, an increase in the initial'';
                    (B) in subsection (c)(1)(C)--
                            (i) in the subparagraph heading, by 
                        striking ``at initial coverage limit''; and
                            (ii) by inserting ``for a year preceding 
                        2024 or the annual out-of-pocket threshold 
                        specified in subsection (b)(4)(B) for the year 
                        for 2024 and each subsequent year'' after 
                        ``subsection (b)(3) for the year'' each place 
                        it appears; and
                    (C) in subsection (d)(1)(A), by striking ``or an 
                initial'' and inserting ``or, for a year preceding 
                2024, an initial''.
            (2) Section 1860D-4(a)(4)(B)(i) of the Social Security Act 
        (42 U.S.C. 1395w-104(a)(4)(B)(i)) is amended by striking ``the 
        initial'' and inserting ``for a year preceding 2024, the 
        initial''.
            (3) Section 1860D-14(a) of the Social Security Act (42 
        U.S.C. 1395w-114(a)) is amended--
                    (A) in paragraph (1)--
                            (i) in subparagraph (C), by striking ``The 
                        continuation'' and inserting ``For a year 
                        preceding 2024, the continuation'';
                            (ii) in subparagraph (D)(iii), by striking 
                        ``1860D-2(b)(4)(A)(i)(I)'' and inserting 
                        ``1860D-2(b)(4)(A)(i)(I)(aa)''; and
                            (iii) in subparagraph (E), by striking 
                        ``The elimination'' and inserting ``For a year 
                        preceding 2024, the elimination''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (C), by striking ``The 
                        continuation'' and inserting ``For a year 
                        preceding 2024, the continuation''; and
                            (ii) in subparagraph (E), by striking 
                        ``1860D-2(b)(4)(A)(i)(I)'' and inserting 
                        ``1860D-2(b)(4)(A)(i)(I)(aa)''.
            (4) Section 1860D-21(d)(7) of the Social Security Act (42 
        U.S.C. 1395w-131(d)(7)) is amended by striking ``section 1860D-
        2(b)(4)(B)(i)'' and inserting ``section 1860D-2(b)(4)(C)(i)''.
            (5) Section 1860D-22(a)(2)(A) of the Social Security Act 
        (42 U.S.C. 1395w-132(a)(2)(A)) is amended--
                    (A) by striking ``the value of any discount'' and 
                inserting the following: ``the value of--
                            ``(i) for years prior to 2024, any 
                        discount'';
                    (B) in clause (i), as inserted by subparagraph (A) 
                of this paragraph, by striking the period at the end 
                and inserting ``; and''; and
                    (C) by adding at the end the following new clause:
                            ``(ii) for 2024 and each subsequent year, 
                        any discount provided pursuant to section 
                        1860D-14C.''.
            (6) Section 1860D-41(a)(6) of the Social Security Act (42 
        U.S.C. 1395w-151(a)(6)) is amended--
                    (A) by inserting ``for a year before 2024'' after 
                ``1860D-2(b)(3)''; and
                    (B) by inserting ``for such year'' before the 
                period.
            (7) Section 1860D-43 of the Social Security Act (42 U.S.C. 
        1395w-153) is amended--
                    (A) in subsection (a)--
                            (i) by striking paragraph (1) and inserting 
                        the following:
            ``(1) participate in--
                    ``(A) for 2011 through 2023, the Medicare coverage 
                gap discount program under section 1860D-14A; and
                    ``(B) for 2024 and each subsequent year, the 
                manufacturer discount program under section 1860D-
                14C;'';
                            (ii) by striking paragraph (2) and 
                        inserting the following:
            ``(2) have entered into and have in effect--
                    ``(A) for 2011 through 2023, an agreement described 
                in subsection (b) of section 1860D-14A with the 
                Secretary; and
                    ``(B) for 2024 and each subsequent year, an 
                agreement described in subsection (b) of section 1860D-
                14C with the Secretary; and''; and
                            (iii) by striking paragraph (3) and 
                        inserting the following:
            ``(3) have entered into and have in effect, under terms and 
        conditions specified by the Secretary--
                    ``(A) for 2011 through 2023, a contract with a 
                third party that the Secretary has entered into a 
                contract with under subsection (d)(3) of section 1860D-
                14A; and
                    ``(B) for 2024 and each subsequent year, a contract 
                with a third party that the Secretary has entered into 
                a contract with under subsection (d)(3) of section 
                1860D-14C.''; and
                    (B) by striking subsection (b) and inserting the 
                following:
    ``(b) Effective Date.--Paragraphs (1)(A), (2)(A), and (3)(A) of 
subsection (a) shall apply to covered part D drugs dispensed under this 
part on or after January 1, 2011, and before January 1, 2024, and 
paragraphs (1)(B), (2)(B), and (3)(B) of such subsection shall apply to 
covered part D drugs dispensed under this part on or after January 1, 
2024.''.
            (8) Section 1927 of the Social Security Act (42 U.S.C. 
        1396r-8) is amended--
                    (A) in subsection (c)(1)(C)(i)(VI), by inserting 
                before the period at the end the following: ``or under 
                the manufacturer discount program under section 1860D-
                14C''; and
                    (B) in subsection (k)(1)(B)(i)(V), by inserting 
                before the period at the end the following: ``or under 
                section 1860D-14C''.
    (e) Effective Date.--The amendments made by this section shall 
apply with respect to plan year 2024 and subsequent plan years.

SEC. 302. ALLOWING CERTAIN ENROLLEES OF PRESCRIPTION DRUG PLANS AND MA-
              PD PLANS UNDER MEDICARE PROGRAM TO SPREAD OUT COST-
              SHARING UNDER CERTAIN CIRCUMSTANCES.

    Section 1860D-2(b)(2) of the Social Security Act (42 U.S.C. 1395w-
102(b)(2)), as amended by section 301, is further amended--
            (1) in subparagraph (A), by striking ``Subject to 
        subparagraphs (C) and (D)'' and inserting ``Subject to 
        subparagraphs (C), (D), and (E)''; and
            (2) by adding at the end the following new subparagraph:
                    ``(E) Enrollee option regarding spreading cost-
                sharing.--The Secretary shall establish by regulation a 
                process under which, with respect to plan year 2024 and 
                subsequent plan years, a prescription drug plan or an 
                MA-PD plan shall, in the case of a part D eligible 
                individual enrolled with such plan for such plan year 
                who is not a subsidy eligible individual (as defined in 
                section 1860D-14(a)(3)) and with respect to whom the 
                plan projects that the dispensing of the first fill of 
                a covered part D drug to such individual will result in 
                the individual incurring costs that are equal to or 
                above the annual out-of-pocket threshold specified in 
                paragraph (4)(B) for such plan year, provide such 
                individual with the option to make the coinsurance 
                payment required under subparagraph (A) (for the 
                portion of such costs that are not above such annual 
                out-of-pocket threshold) in the form of periodic 
                installments over the remainder of such plan year.''.

SEC. 303. ESTABLISHMENT OF PHARMACY QUALITY MEASURES UNDER MEDICARE 
              PART D.

    Section 1860D-4(c) of the Social Security Act (42 U.S.C. 1395w-
104(c)) is amended--
            (1) by redesignating the paragraph (6), as added by section 
        50354 of division E of the Bipartisan Budget Act of 2018 
        (Public Law 115-123), as paragraph (7); and
            (2) by adding at the end the following new paragraph:
            ``(8) Application of pharmacy quality measures.--
                    ``(A) In general.--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.
                    ``(B) Standard pharmacy quality measures.--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.
                    ``(C) Effective date.--The requirement under 
                subparagraph (A) shall take effect for plan years 
                beginning on or after January 1, 2024, 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).''.

                   TITLE IV--DRUG PRICE TRANSPARENCY

SEC. 401. DRUG PRICE TRANSPARENCY.

    Part A of title XI of the Social Security Act is amended by adding 
at the end the following new sections:

``SEC. 1150D. REPORTING ON DRUG PRICES.

    ``(a) Definitions.--In this section:
            ``(1) Manufacturer.--The term `manufacturer' means the 
        person--
                    ``(A) 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
                    ``(B) who is responsible for setting the wholesale 
                acquisition cost for the drug.
            ``(2) Qualifying drug.--The term `qualifying drug' means 
        any drug that is approved under subsection (c) or (j) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act or 
        licensed under subsection (a) or (k) of section 351 of the 
        Public Health Service Act--
                    ``(A) 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--
                            ``(i) subject to section 503(b)(1) of the 
                        Federal Food, Drug, and Cosmetic Act; and
                            ``(ii) not a preventative vaccine; and
                    ``(B) 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.
            ``(3) Wholesale acquisition cost.--The term `wholesale 
        acquisition cost' has the meaning given that term in section 
        1847A(c)(6)(B).
    ``(b) Report.--
            ``(1) Report required.--The manufacturer of a qualifying 
        drug shall submit a report to the Secretary if, with respect to 
        the qualifying drug--
                    ``(A) there is an increase in the price of the 
                qualifying drug that results in an increase in the 
                wholesale acquisition cost of that drug that is equal 
                to--
                            ``(i) 10 percent or more within a 12-month 
                        period beginning on or after January 1, 2021; 
                        or
                            ``(ii) 25 percent or more within a 36-month 
                        period beginning on or after January 1, 2021;
                    ``(B) the estimated price of the qualifying drug or 
                spending per individual or per user of such drug (as 
                estimated by the Secretary) for the applicable year (or 
                per course of treatment in such applicable year as 
                determined by the Secretary) is at least $26,000 
                beginning on or after January 1, 2023; or
                    ``(C) there was an increase in the price of the 
                qualifying drug that resulted in an increase in the 
                wholesale acquisition cost of that drug that is equal 
                to--
                            ``(i) 10 percent or more within a 12-month 
                        period that begins and ends during the 5-year 
                        period preceding January 1, 2023; or
                            ``(ii) 25 percent or more within a 36-month 
                        period that begins and ends during the 5-year 
                        period preceding January 1, 2023.
            ``(2) Report deadline.--Each report described in paragraph 
        (1) shall be submitted to the Secretary--
                    ``(A) 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 the 
                enactment of this section, not later than 90 days after 
                such date of enactment;
                    ``(B) 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;
                    ``(C) in the case of a report with respect to a 
                qualifying drug that meets the criteria under paragraph 
                (1)(B), not later than 30 days after such drug meets 
                such criteria; and
                    ``(D) in the case of a report with respect to an 
                increase in the price of a qualifying drug that occurs 
                during a 12-month or 36-month period described in 
                paragraph (1)(C), not later than April 1, 2023.
    ``(c) Contents.--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--
            ``(1) with respect to the qualifying drug--
                    ``(A) the percentage by which the manufacturer will 
                raise the wholesale acquisition cost of the drug within 
                the 12-month period or 36-month period as described in 
                subsection (b)(1)(A)(i), (b)(1)(A)(ii), (b)(1)(C)(i), 
                or (b)(1)(C)(ii), as applicable, and the effective date 
                of such price increase or the cost associated with a 
                qualifying drug if such drug meets the criteria under 
                subsection (b)(1)(B) and the effective date at which 
                such drug meets such criteria;
                    ``(B) an explanation for, and description of, each 
                price increase for such drug that will occur during the 
                12-month period or the 36-month period described in 
                subsection (b)(1)(A)(i), (b)(1)(A)(ii), (b)(1)(C)(i), 
                or (b)(1)(C)(ii), as applicable;
                    ``(C) an explanation for, and description of, the 
                cost associated with a qualifying drug if such drug 
                meets the criteria under subsection (b)(1)(B), as 
                applicable;
                    ``(D) if known and different from the manufacturer 
                of the qualifying drug, the identity of--
                            ``(i) 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--
                                    ``(I) for approval of the drug 
                                under section 505 of such Act; or
                                    ``(II) for licensure of the drug 
                                under section 351 of the Public Health 
                                Service Act; and
                            ``(ii) 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;
                    ``(E) 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;
                    ``(F) the current wholesale acquisition cost of the 
                drug;
                    ``(G) the total expenditures of the manufacturer 
                on--
                            ``(i) materials and manufacturing for such 
                        drug;
                            ``(ii) acquiring patents and licensing for 
                        such drug; and
                            ``(iii) purchasing or acquiring such drug 
                        from another manufacturer, if applicable;
                    ``(H) the percentage of total expenditures of the 
                manufacturer on research and development for such drug 
                that was derived from Federal funds;
                    ``(I) 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;
                    ``(J) 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;
                    ``(K) 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;
                    ``(L) 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
                    ``(M) the total costs associated with marketing and 
                advertising for the qualifying drug;
            ``(2) with respect to the manufacturer--
                    ``(A) the total revenue and the net profit of the 
                manufacturer for each of the 12-month period described 
                in subsection (b)(1)(A)(i) or (b)(1)(C)(i) or the 36-
                month period described in subsection (b)(1)(A)(ii) or 
                (b)(1)(C)(ii), as applicable;
                    ``(B) all stock-based performance metrics used by 
                the manufacturer to determine executive compensation 
                for each of the 12-month periods described in 
                subsection (b)(1)(A)(i) or (b)(1)(C)(i) or the 36-month 
                periods described in subsection (b)(1)(A)(ii) or 
                (b)(1)(C)(ii), as applicable; and
                    ``(C) any additional information the manufacturer 
                chooses to provide related to drug pricing decisions, 
                such as total expenditures on--
                            ``(i) drug research and development; or
                            ``(ii) clinical trials, including on drugs 
                        that failed to receive approval by the Food and 
                        Drug Administration; and
            ``(3) such other related information as the Secretary 
        considers appropriate and as specified by the Secretary.
    ``(d) Information Provided.--The manufacturer of a qualifying drug 
that is required to submit a report under subsection (b), shall ensure 
that such report and any explanation for, and description of, each 
price increase described in subsection (c)(1) shall be truthful, not 
misleading, and accurate.
    ``(e) Civil Monetary Penalty.--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.
    ``(f) False Information.--Any manufacturer that submits a report 
for a drug as required by this section that knowingly provides false 
information in such report is subject to a civil monetary penalty in an 
amount not to exceed $100,000 for each item of false information.
    ``(g) Public Posting.--
            ``(1) In general.--Subject to paragraph (4), the Secretary 
        shall post each report submitted under subsection (b) on the 
        public website of the Department of Health and Human Services 
        the day the price increase of a qualifying drug is scheduled to 
        go into effect.
            ``(2) Format.--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--
                    ``(A) user-friendly to the public; and
                    ``(B) written in plain language that consumers can 
                readily understand.
            ``(3) List.--In addition to the reports submitted under 
        subsection (b), the Secretary shall also post a list of each 
        qualifying drug with respect to which the manufacturer was 
        required to submit such a report in the preceding year and 
        whether such manufacturer was required to submit such report 
        based on a qualifying price increase or whether such drug meets 
        the criteria under subsection (b)(1)(B).
            ``(4) Protected information.--In carrying out this section, 
        the Secretary shall enforce applicable law concerning the 
        protection of confidential commercial information and trade 
        secrets.

``SEC. 1150E. ANNUAL REPORT TO CONGRESS.

    ``(a) In General.--Subject to subsection (b), the Secretary shall 
submit to the Committees on Energy and Commerce and Ways and Means of 
the House of Representatives and the Committees on Health, Education, 
Labor, and Pensions and Finance of the Senate, and post on the public 
website of the Department of Health and Human Services in a way that is 
user-friendly to the public and written in plain language that 
consumers can readily understand, an annual report--
            ``(1) summarizing the information reported pursuant to 
        section 1150D;
            ``(2) including copies of the reports and supporting 
        detailed economic analyses submitted pursuant to such section;
            ``(3) detailing the costs and expenditures incurred by the 
        Department of Health and Human Services in carrying out section 
        1150D; and
            ``(4) explaining how the Department of Health and Human 
        Services is improving consumer and provider information about 
        drug value and drug price transparency.
    ``(b) Protected Information.--In carrying out this section, the 
Secretary shall enforce applicable law concerning the protection of 
confidential commercial information and trade secrets.''.

            TITLE V--NIH, FDA, AND OVERDOSE EPIDEMIC FUNDING

              Subtitle A--Biomedical Innovation Expansion

SEC. 501. NIH INNOVATION INITIATIVES.

    (a) NIH Innovation Account.--
            (1) In general.--Section 1001(b) of the 21st Century Cures 
        Act (Public Law 114-255) is amended by adding at the end the 
        following:
            ``(5) Supplemental funding and additional activities.--
                    ``(A) In general.--In addition to the funds made 
                available under paragraph (2), there are authorized to 
                be appropriated, and are hereby appropriated, to the 
                Account, out of any monies in the Treasury not 
                otherwise appropriated, to be available until expended 
                without further appropriation, the following:
                            ``(i) For fiscal year 2022, $255,400,000.
                            ``(ii) For fiscal year 2023, $160,400,000.
                            ``(iii) For fiscal year 2024, $414,600,000.
                            ``(iv) For fiscal year 2025, $547,000,000.
                            ``(v) For fiscal year 2026, $948,000,000.
                            ``(vi) For fiscal year 2027, $842,400,000.
                            ``(vii) For fiscal year 2028, 
                        $1,089,600,000.
                            ``(viii) For fiscal year 2029, 
                        $1,115,600,000.
                            ``(ix) For fiscal year 2030, 
                        $1,170,600,000.
                            ``(x) For fiscal year 2031, $956,400,000.
                    ``(B) Supplemental funding for certain projects.--
                Of the total amounts made available under subparagraph 
                (A) for each of fiscal years 2022 through 2031, a total 
                amount not to exceed the following shall be made 
                available for the following categories of NIH 
                Innovation Projects:
                            ``(i) For projects described in paragraph 
                        (4)(A), an amount not to exceed a total of 
                        $2,070,600,000 as follows:
                                    ``(I) For each of fiscal years 2022 
                                and 2024, $50,000,000.
                                    ``(II) For fiscal year 2025, 
                                $100,000,000.
                                    ``(III) For each of fiscal years 
                                2026 and 2027, $300,000,000.
                                    ``(IV) For each of fiscal years 
                                2028 through 2030, $317,000,000.
                                    ``(V) For fiscal year 2031, 
                                $319,600,000.
                            ``(ii) For projects described in paragraph 
                        (4)(B), an amount not to exceed a total of 
                        $2,041,900,000 as follows:
                                    ``(I) For each of fiscal years 2022 
                                and 2024, $50,000,000.
                                    ``(II) For fiscal year 2025, 
                                $128,000,000.
                                    ``(III) For fiscal year 2026, 
                                $209,000,000.
                                    ``(IV) For fiscal year 2027, 
                                $100,000,000.
                                    ``(V) For fiscal year 2028, 
                                $325,000,000.
                                    ``(VI) For fiscal year 2029, 
                                $350,000,000.
                                    ``(VII) For fiscal year 2030, 
                                $400,000,000.
                                    ``(VIII) For fiscal year 2031, 
                                $429,900,000.
                            ``(iii) For projects described in paragraph 
                        (4)(C), an amount not to exceed a total of 
                        $1,558,400,000 as follows:
                                    ``(I) For each of fiscal years 2024 
                                and 2025, $151,200,000.
                                    ``(II) For each of fiscal years 
                                2026 through 2030, $251,200,000.
                            ``(iv) For projects described in paragraph 
                        (4)(D), an amount not to exceed $15,400,000 for 
                        each of fiscal years 2022 through 2031.
                    ``(C) Additional nih innovation projects.--In 
                addition to funding NIH Innovation Projects pursuant to 
                subparagraph (B), of the total amounts made available 
                under subparagraph (A), a total amount not to exceed 
                the following shall be made available for the following 
                categories of NIH Innovation Projects:
                            ``(i) To support research related to 
                        combating antimicrobial resistance and 
                        antibiotic resistant bacteria, including 
                        research into new treatments, diagnostics, and 
                        vaccines, research, in consultation with the 
                        Centers for Disease Control and Prevention, 
                        into stewardship, and the development of 
                        strategies, in coordination with the Biomedical 
                        Advanced Research and Development Authority 
                        under section 319L of the Public Health Service 
                        Act, to support commercialization of new 
                        antibiotics, not to exceed a total of 
                        $1,144,500,000, as follows:
                                    ``(I) For each of fiscal years 2022 
                                through 2025, $100,000,000.
                                    ``(II) For each of fiscal years 
                                2026 and 2027, $120,000,000.
                                    ``(III) For each of fiscal years 
                                2028 through 2030, $125,000,000.
                                    ``(IV) For fiscal year 2031, 
                                $129,500,000.
                            ``(ii) To support research and research 
                        activities related to rare diseases or 
                        conditions, including studies or analyses that 
                        help to better understand the natural history 
                        of a rare disease or condition and 
                        translational studies related to rare diseases 
                        or conditions, not to exceed a total of 
                        $530,600,000, as follows:
                                    ``(I) For fiscal year 2022, 
                                $40,000,000.
                                    ``(II) For fiscal year 2023, 
                                $45,000,000.
                                    ``(III) For fiscal year 2024, 
                                $48,000,000.
                                    ``(IV) For each of fiscal years 
                                2025 and 2026, $52,400,000.
                                    ``(V) For fiscal year 2027, 
                                $55,800,000.
                                    ``(VI) For fiscal year 2028, 
                                $56,000,000.
                                    ``(VII) For fiscal year 2029, 
                                $57,000,000.
                                    ``(VIII) For each of fiscal years 
                                2030 and 2031, $62,000,000.''.
            (2) Conforming amendments.--Section 1001 of the 21st 
        Century Cures Act (Public Law 114-255) is amended--
                    (A) in subsection (a), by striking ``subsection 
                (b)(4)'' and inserting ``subsections (b)(4) and 
                (b)(5)'';
                    (B) in subsection (b)(1), by striking ``paragraph 
                (4)'' and inserting ``paragraphs (4) and (5)'';
                    (C) in subsection (c)(2)(A)(ii), by inserting ``or 
                pursuant to subsection (b)(5)'' after ``subsection 
                (b)(3)''; and
                    (D) in subsection (d), by inserting ``or pursuant 
                to subsection (b)(5)'' after ``subsection (b)(3)''.
    (b) Workplan.--Section 1001(c)(1) of the 21st Century Cures Act 
(Public Law 114-255) is amended by adding at the end the following:
                    ``(D) Updates.--The Director of NIH shall, after 
                seeking recommendations in accordance with the process 
                described in subparagraph (C), update the work plan 
                submitted under this subsection for each of fiscal 
                years 2022 through 2031 to reflect the amendments made 
                to this section by the Elijah E. Cummings Lower Drug 
                Costs Now Act.''.
    (c) Annual Reports.--Section 1001(c)(2)(A) of the 21st Century 
Cures Act (Public Law 114-255) is amended by striking ``2027'' and 
inserting ``2031''.
    (d) Sunset.--Section 1001(e) of the 21st Century Cures Act (Public 
Law 114-255) is amended by striking ``September 30, 2026'' and 
inserting ``September 30, 2031''.

SEC. 502. NIH CLINICAL TRIAL.

    Part A of title IV of the Public Health Service Act (42 U.S.C. 281 
et seq.) is amended by adding at the end the following:

``SEC. 404O. CLINICAL TRIAL ACCELERATION PILOT INITIATIVE.

    ``(a) Establishment of Pilot Program.--The Secretary, acting 
through the Director of the National Institutes of Health, shall, not 
later than 2 years after the date of enactment of this Act, establish 
and implement a pilot program to award multi-year contracts to eligible 
entities to support phase II clinical trials and phase III clinical 
trials--
            ``(1) to promote innovation in treatments and technologies 
        supporting the advanced research and development and production 
        of high need cures; and
            ``(2) to provide support for the development of medical 
        products and therapies.
    ``(b) Eligible Entities.--To be eligible to receive assistance 
under the pilot program established under subsection (a), an entity 
shall--
            ``(1) be seeking to market a medical product or therapy 
        that is the subject of clinical trial or trials to be supported 
        using such assistance;
            ``(2) be a public or private entity, which may include a 
        private or public research institution, a contract research 
        organization, an institution of higher education (as defined in 
        section 101 of the Higher Education Act of 1965 (20 U.S.C. 
        1001)), a medical center, a biotechnology company, or an 
        academic research institution; and
            ``(3) comply with requirements of the Federal Food, Drug, 
        and Cosmetic Act and section 351 of this Act, as applicable, at 
        all stages of development, manufacturing, review, approval, and 
        safety surveillance of a medical product.
    ``(c) Duties.--The Secretary, acting through the Director of 
National Institutes of Health, shall--
            ``(1) in establishing the pilot program under subsection 
        (a), consult with--
                    ``(A) the Director of the National Center for 
                Advancing Translational Sciences and the other national 
                research institutes in considering their requests for 
                new or expanded clinical trial support efforts; and
                    ``(B) the Commissioner of Food and Drugs and any 
                other head of a Federal agency as the Secretary 
                determines to be appropriate to ensure coordination and 
                efficiently advance clinical trial activities;
            ``(2) in implementing the pilot program under subsection 
        (a), consider consulting with patients and patient advocates; 
        and
            ``(3) in awarding contracts under the pilot program under 
        subsection (a), consider--
                    ``(A) the expected health impacts of the clinical 
                trial or trials to be supported under the contract; and
                    ``(B) the degree to which the medical product or 
                therapy that is the subject of such clinical trial or 
                trials is a high need cure.
    ``(d) Exclusion.--A contract may not be awarded under the pilot 
program under subsection (a) if the drug that is the subject of the 
clinical trial or trials to be supported under the contract is a drug 
designated under section 526 of the Federal Food, Drug, and Cosmetic 
Act as a drug for a rare disease or condition.
    ``(e) NIH Clinical Trial Accelerator Account.--
            ``(1) Establishment.--There is established in the Treasury 
        an account, to be known as the `NIH Clinical Trial Accelerator 
        Account' (referred to in this section as the `Account'), for 
        purposes of carrying out this section.
            ``(2) Transfer of direct spending savings.--There shall be 
        transferred to the Account from the general fund of the 
        Treasury, $400,000,000 for each of fiscal years 2022 through 
        2026, to be available until expended without further 
        appropriation.
            ``(3) Work plan.--Not later than 180 days after the date of 
        enactment of this Act, the Secretary shall submit to the 
        Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions of the Senate a work plan that includes the 
        proposed implementation of this section and the proposed 
        allocation of funds in the Account.
    ``(f) Reports to Congress.--Not later than October 1 of each fiscal 
year, the Secretary shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report on--
            ``(1) the implementation of this section;
            ``(2) any available results on phase II clinical trials and 
        phase III clinical trials supported under this section during 
        such fiscal year; and
            ``(3) the extent to which Federal funds are obligated to 
        support such clinical trials, including the specific amount of 
        such support and awards pursuant to an allocation from the 
        Account under subsection (e).
    ``(g) Definitions.--In this section:
            ``(1) Phase ii clinical trial.--The term `phase II clinical 
        trial' means a phase II clinical investigation, as described in 
        section 312.21 of title 21, Code of Federal Regulations (or any 
        successor regulations).
            ``(2) Phase iii clinical trials.--The term `phase III 
        clinical trial' means a phase III clinical investigation, as 
        described in section 312.21 of title 21, Code of Federal 
        Regulations (or any successor regulations).
            ``(3) High need cure.--The term `high need cure' has the 
        meaning given such term in section 480(a)(3).''.

SEC. 503. INNOVATION NETWORK.

    Part A of title IV of the Public Health Service Act (42 U.S.C. 281 
et seq.), as amended by section 502, is further amended by adding at 
the end the following:

``SEC. 404P. INNOVATION NETWORK.

    ``(a) Funds.--The Director of NIH shall award grants or contracts 
to eligible entities to develop, expand, and enhance the 
commercialization of biomedical products.
    ``(b) Eligible Entity.--In this section, the term `eligible entity' 
means an entity receiving funding under--
            ``(1) the Small Business Innovation Research program of the 
        National Institutes of Health; or
            ``(2) the Small Business Technology Transfer program of the 
        National Institutes of Health.
    ``(c) Use of Funds.--An eligible entity shall use the funds 
received through such grant or contract to support--
            ``(1) the Commercialization Readiness Pilot program of the 
        National Institutes of Health;
            ``(2) the Innovation Corps program of the National 
        Institutes of Health;
            ``(3) the Commercialization Accelerator program of the 
        National Institutes of Health;
            ``(4) the Commercialization Assistance program of the 
        National Institutes of Health; and
            ``(5) such other programs and activities as the Director of 
        NIH determines to be appropriate, to support the 
        commercialization stage of research, later stage research and 
        development, technology transfer, and commercialization 
        technical assistance.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $100,000,000 for each of fiscal 
years 2022 through 2026, to be available until expended.''.

             Subtitle B--Investing in Safety and Innovation

SEC. 511. FOOD AND DRUG ADMINISTRATION.

    (a) FDA Innovation Account.--
            (1) In general.--Section 1002(b) of the 21st Century Cures 
        Act (Public Law 114-255) is amended--
                    (A) in paragraph (1), by striking ``paragraph (4)'' 
                and inserting ``paragraphs (4) and (5)''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(5) Supplemental funding and additional activities.--
                    ``(A) In general.--In addition to the funds made 
                available under paragraph (2), there are authorized to 
                be appropriated, and are hereby appropriated, to the 
                Account, out of any monies in the Treasury not 
                otherwise appropriated, to be available until expended 
                without further appropriation, the following:
                            ``(i) For fiscal year 2022, $417,500,000.
                            ``(ii) For each of fiscal years 2023 and 
                        2024, $157,500,000.
                            ``(iii) For each of fiscal years 2025 
                        through 2027, $152,500,000.
                            ``(iv) For each of fiscal years 2028 
                        through 2031, $202,500,000.
                    ``(B) Supplemental funding for certain 
                activities.--Of the total amounts made available under 
                subparagraph (A) for each of fiscal years 2028 through 
                2031, a total amount not to exceed $50,000,000 for each 
                such fiscal year, shall be made available for the 
                activities under subtitles A through F (including the 
                amendments made by such subtitles) of title III of this 
                Act and section 1014 (relating to Intercenter 
                Institutes) of the Federal Food, Drug, and Cosmetic 
                Act.
                    ``(C) Additional fda activities.--In addition to 
                funding activities pursuant to subparagraph (B), of the 
                total amounts made available under subparagraph (A), a 
                total amount not to exceed the following shall be made 
                available for the following categories of activities:
                            ``(i) For modernization of the technical 
                        infrastructure of the Food and Drug 
                        Administration, including enhancements such as 
                        interoperability across the agency, and 
                        additional capabilities to develop an advanced 
                        information technology infrastructure to 
                        support the agency's regulatory mission:
                                    ``(I) For fiscal year 2022, 
                                $180,000,000.
                                    ``(II) For each of fiscal years 
                                2023 through 2031, $60,000,000.
                            ``(ii) For support for continuous 
                        manufacturing of drugs and biological products, 
                        including complex biological products such as 
                        regenerative medicine therapies, through grants 
                        to institutions of higher education and 
                        nonprofit organizations and other appropriate 
                        mechanisms, for each of fiscal years 2022 
                        through 2031, $20,000,000.
                            ``(iii) For support for the Commissioner of 
                        Food and Drugs to engage experts, such as 
                        through the formation and operation of public-
                        private partnerships or other appropriate 
                        collaborative efforts, to advance the 
                        development and delivery of individualized 
                        human gene therapy products:
                                    ``(I) For fiscal year 2022, 
                                $50,000,000.
                                    ``(II) For each of fiscal years 
                                2023 through 2031, $10,000,000.
                            ``(iv) For support for inspections, 
                        enforcement, and quality surveillance 
                        activities across the Food and Drug 
                        Administration, including foreign and domestic 
                        inspections across products, for each of fiscal 
                        years 2022 through 2031, $20,000,000.
                            ``(v) For support for activities of the 
                        Food and Drug Administration related to customs 
                        and border protection to provide improvements 
                        to technologies, inspection capacity, and sites 
                        of import (including international mail 
                        facilities) in which the Food and Drug 
                        Administration operates, for each of fiscal 
                        years 2022 through 2031, $10,000,000.
                            ``(vi) To further advance the development 
                        of a coordinated postmarket surveillance system 
                        for all medical products, including drugs, 
                        biological products, and devices, linked to 
                        electronic health records in furtherance of the 
                        Food and Drug Administration's postmarket 
                        surveillance capabilities:
                                    ``(I) For fiscal year 2022, 
                                $112,500,000.
                                    ``(II) For each of fiscal years 
                                2023 through 2031, $12,500,000.
                            ``(vii) For support for Food and Drug 
                        Administration activities to keep pace with the 
                        projected product development of regenerative 
                        therapies, including cellular and somatic cell 
                        gene therapy products:
                                    ``(I) For each of fiscal years 2022 
                                through 2024, $10,000,000.
                                    ``(II) For each of fiscal years 
                                2025 through 2031, $5,000,000.
                            ``(viii) For carrying out section 714A of 
                        the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 379d-3a; relating to hiring authority 
                        for scientific, technical, and professional 
                        personnel), for each of fiscal years 2022 
                        through 2031, $2,500,000.
                            ``(ix) For the Food and Drug Administration 
                        to support improvements to the technological 
                        infrastructure for reporting and analysis of 
                        adverse events associated with the use of drugs 
                        and biological products, for each of fiscal 
                        years 2022 through 2031, $12,500,000.''.
            (2) Conforming amendments.--Section 1002 of the 21st 
        Century Cures Act (Public Law 114-255) is amended--
                    (A) in subsection (a), by inserting before the 
                period at the end the following: ``or pursuant to 
                subparagraph (A) of subsection (b)(5) to carry out the 
                activities described in subparagraphs (B) and (C) of 
                such subsection''; and
                    (B) in subsection (d)--
                            (i) by inserting ``or pursuant to 
                        subparagraph (A) of subsection (b)(5)'' after 
                        ``subsection (b)(3)''; and
                            (ii) by striking ``subsection (b)(4)'' and 
                        inserting ``subsections (b)(4) and (b)(5)''.
    (b) Annual Report.--Section 1002(c)(2)(A) of the 21st Century Cures 
Act (Public Law 114-255) is amended, in the matter preceding clause 
(i), by striking ``2026'' and inserting ``2032''.
    (c) Sunset.--Section 1002(e) of the 21st Century Cures Act (Public 
Law 114-255) is amended by striking ``September 30, 2025'' and 
inserting ``September 30, 2030''.

SEC. 512. STUDY ON HIGH-RISK, HIGH-REWARD DRUGS.

    (a) In General.--Not later than 180 days after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
conduct a study to identify--
            (1) diseases or conditions that lack a treatment approved 
        by the Food and Drug Administration and instances in which 
        development of a treatment for such diseases or conditions 
        could fill an unmet medical need for the treatment of a serious 
        or life-threatening disease or condition or a rare disease or 
        condition; and
            (2) appropriate incentives that would lead to the 
        development, approval, and marketing of such treatments.
    (b) Report to Congress; Recommendations.--Not later than one year 
after the date of enactment of this Act, the Secretary shall submit to 
the Congress a report that includes--
            (1) findings from the study under subsection (a); and
            (2) recommendations regarding legislation necessary to 
        create appropriate incentives identified pursuant to subsection 
        (a)(2).

                 Subtitle C--Overdose Epidemic Response

SEC. 521. OVERDOSE EPIDEMIC RESPONSE FUND.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall use any funds 
made available pursuant to subsection (b) to carry out the programs and 
activities described in subsection (c) to address the overdose and 
substance use disorder epidemic. Such funds shall be in addition to any 
funds which are otherwise available to carry out such programs and 
activities.
    (b) Opioid Epidemic Response Fund.--
            (1) Establishment of account.--There is established in the 
        Treasury an account, to be known as the Opioid Epidemic 
        Response Fund (referred to in this section as the ``Fund''), 
        for purposes of funding the programs and activities described 
        in subsection (c).
            (2) Funding.--There is authorized to be appropriated, and 
        there is appropriated, to the Fund, out of any monies in the 
        Treasury not otherwise appropriated $2,000,000,000 for each of 
        fiscal years 2022 through 2026.
            (3) Availability.--Amounts made available by paragraph (2) 
        shall be made available to the agencies specified in subsection 
        (c) in accordance with such subsection. Amounts made available 
        to an agency pursuant to the preceding sentence for a fiscal 
        year shall remain available until expended.
    (c) Programs and Activities.--Of the total amount in the Fund for 
each of fiscal years 2022 through 2026, such amount shall be allocated 
as follows:
            (1) SAMHSA.--For the Substance Abuse and Mental Health 
        Services Administration to carry out programs and activities 
        pursuant to section 522, $1,500,000,000 for each of fiscal 
        years 2022 through 2026.
            (2) CDC.--For the Centers for Disease Control and 
        Prevention to carry out programs and activities pursuant to 
        section 523, $120,000,000 for each of fiscal years 2022 through 
        2026.
            (3) FDA.--For the Food and Drug Administration to carry out 
        programs and activities pursuant to section 524, $10,000,000 
        for each of fiscal years 2022 through 2026.
            (4) NIH.--For the National Institutes of Health to carry 
        out programs and activities pursuant to section 525, 
        $240,000,000 for each of fiscal years 2022 through 2026.
            (5) HRSA.--For the Health Resources and Services 
        Administration to carry out programs and activities pursuant to 
        section 526, $90,000,000 for each of fiscal years 2022 through 
        2026.
            (6) ACF.--For the Administration for Children and Families 
        to carry out programs and activities pursuant to section 527, 
        $40,000,000 for each of fiscal years 2022 through 2026.
    (d) Accountability and Oversight.--
            (1) Work plan.--
                    (A) In general.--Not later than 180 days after the 
                date of enactment of this Act, the Secretary of Health 
                and Human Services shall submit to the Committee on 
                Health, Education, Labor, and Pensions and the 
                Committee on Appropriations of the Senate and the 
                Committee on Energy and Commerce, the Committee on 
                Appropriations, and the Committee on Education and 
                Labor of the House of Representatives, a work plan 
                including the proposed allocation of funds made 
                available pursuant to subsection (b) for each of fiscal 
                years 2022 through 2026 and the contents described in 
                subparagraph (B).
                    (B) Contents.--The work plan submitted under 
                subparagraph (A) shall include--
                            (i) the amount of money to be obligated or 
                        expended out of the Fund in each fiscal year 
                        for each program and activity described in 
                        subsection (c); and
                            (ii) a description and justification of 
                        each such program and activity.
            (2) Annual reports.--Not later than October 1 of each of 
        fiscal years 2023 through 2027, the Secretary of Health and 
        Human Services shall submit to the Committee on Health, 
        Education, Labor, and Pensions and the Committee on 
        Appropriations of the Senate and the Committee on Energy and 
        Commerce, the Committee on Appropriations, and the Committee on 
        Education and Labor of the House of Representatives, a report 
        including--
                    (A) the amount of money obligated or expended out 
                of the Fund in the prior fiscal year for each program 
                and activity described in subsection (c);
                    (B) a description of all programs and activities 
                using funds made available pursuant to subsection (b); 
                and
                    (C) how the programs and activities are responding 
                to the opioid and substance use disorder epidemic.
    (e) Limitations.--Notwithstanding any authority in this subtitle or 
any appropriations Act, any funds made available pursuant to subsection 
(b) may not be used for any purpose other than the programs and 
activities described in subsection (c).

SEC. 522. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.

    (a) In General.--The entirety of the funds made available pursuant 
to section 521(c)(1) shall be for the Assistant Secretary for Mental 
Health and Substance Use to continue to award the State Opioid Response 
Grants funded by the heading ``Substance Abuse And Mental Health 
Services Administration--Substance Abuse Treatment'' in title II of the 
Departments of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 2018 (Public Law 115-141). Subject 
to subsections (b) and (c), such grants shall be awarded in the same 
manner and subject to the same conditions as were applicable to such 
grants for fiscal year 2018.
    (b) Requirement That Treatment Be Evidence-Based.--As a condition 
on receipt of a grant pursuant to subsection (a), a grantee shall agree 
that--
            (1) treatments, practices, or interventions funded through 
        the grant will be evidence-based; and
            (2) such treatments, practices, and interventions will 
        include medication-assisted treatment for individuals diagnosed 
        with opioid use disorder, using drugs only if the drugs have 
        been approved or licensed by the Food and Drug Administration 
        under section 505 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355) or section 351 of the Public Health Service Act 
        (42 U.S.C. 262).
    (c) Reservations.--Of the amount made available pursuant to section 
521(c)(1) for a fiscal year--
            (1) not less than $75,000,000 shall be reserved to make 
        grants under subsection (a) to Indian Tribes or Tribal 
        organizations; and
            (2) not less than $50,000,000 shall be reserved to make 
        grants under subsection (a) to political subdivisions of 
        States, such as counties, cities, or towns.

SEC. 523. CENTERS FOR DISEASE CONTROL AND PREVENTION.

    (a) Addressing Opioid Use Disorder.--The entirety of the funds made 
available pursuant to section 521(c)(2) shall be for the Director of 
the Centers for Disease Control and Prevention, pursuant to applicable 
authorities in the Public Health Service Act (42 U.S.C. 201 et seq.), 
to continue and expand programs of the Centers for Disease Control and 
Prevention to address opioid and substance use disorder, including by--
            (1) improving the timeliness and quality of data on the 
        opioid use disorder epidemic, including improvement of--
                    (A) data on fatal and nonfatal overdoses;
                    (B) syndromic surveillance;
                    (C) data on long-term sequelae (including neonatal 
                abstinence syndrome); and
                    (D) cause of death reporting related to substance 
                abuse or opioid overdose;
            (2) expanding and strengthening evidence-based prevention 
        and education strategies;
            (3) supporting responsible prescribing practices, including 
        through development and dissemination of prescriber guidelines;
            (4) improving access to and use of effective prevention, 
        treatment, and recovery support, including through grants and 
        the provision of technical assistance to States and localities;
            (5) strengthening partnerships with first responders, 
        including to protect their safety;
            (6) considering the needs of vulnerable populations;
            (7) addressing infectious diseases linked to the opioid 
        crisis;
            (8) strengthening prescription drug monitoring programs; 
        and
            (9) providing financial and technical assistance to State 
        and local health department efforts to treat and prevent 
        substance use disorder.
    (b) Limitation.--Of the funds made available pursuant to section 
521(c)(2) for carrying out this section, not more than 20 percent may 
be used for intramural purposes.

SEC. 524. FOOD AND DRUG ADMINISTRATION.

    The entirety of the funds made available pursuant to section 
521(c)(3) shall be for the Commissioner of Food and Drugs, pursuant to 
applicable authorities in the Public Health Service Act (42 U.S.C. 201 
et seq.) or the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.) and other applicable law, to support widespread innovation in 
non-opioid and non-addictive medical products for pain treatment, 
access to opioid addiction treatments, appropriate use of approved 
opioids, and efforts to reduce illicit importation of opioids. Such 
support may include the following:
            (1) Facilitating the development of non-opioid and non-
        addictive pain treatments.
            (2) Advancing guidance documents for sponsors of non-opioid 
        pain products.
            (3) Developing evidence to inform the potential for 
        nonprescription overdose therapies.
            (4) Examining expanded labeling indications for medication-
        assisted treatment.
            (5) Conducting public education and outreach, including 
        public workshops or public meetings, regarding the benefits of 
        medication-assisted treatment, including all drugs approved by 
        the Food and Drug Administration, and device treatment options 
        approved or cleared by the Food and Drug Administration.
            (6) Exploring the expansion and possible mandatory nature 
        of prescriber education regarding pain management and 
        appropriate opioid prescribing through authorities under 
        section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355-1).
            (7) Examining options to limit the duration of opioid 
        prescriptions for acute pain, including through packaging 
        options.
            (8) Increasing staff and infrastructure capacity to inspect 
        and analyze packages at international mail facilities and 
        pursue criminal investigations.

SEC. 525. NATIONAL INSTITUTES OF HEALTH.

    The entirety of the funds made available pursuant to section 
521(c)(4) shall be for the Director of the National Institutes of 
Health, pursuant to applicable authorities in the Public Health Service 
Act (42 U.S.C. 201 et seq.), to carry out activities related to--
            (1) accelerating research for addressing the opioid use 
        disorder epidemic, including developing non-opioid medications 
        and interventions, including non-addictive medications, to 
        manage pain, as well as developing medications and 
        interventions to treat and to prevent substance use disorders;
            (2) conducting and supporting research on which treatments 
        (in terms of pain management as well as treating and preventing 
        substance use disorders) are optimal for which patients; and
            (3) conducting and supporting research on creating longer-
        lasting or faster-acting antidotes for opioid overdose, 
        particularly in response to the prevalence of fentanyl and 
        carfentanyl overdoses.

SEC. 526. HEALTH RESOURCES AND SERVICES ADMINISTRATION.

    The entirety of the funds made available pursuant to section 
521(c)(5) shall be for the Administrator of the Health Resources and 
Services Administration, pursuant to applicable authorities in titles 
III, VII, and VIII of the Public Health Service Act (42 U.S.C. 241 et 
seq.), to carry out activities that increase the availability and 
capacity of the behavioral health workforce. Such activities shall 
include providing loan repayment assistance for substance use disorder 
treatment providers.

SEC. 527. ADMINISTRATION FOR CHILDREN AND FAMILIES.

    Of the funds made available pursuant to section 521(c)(6) for each 
of fiscal years 2022 through 2026, $40,000,000 for each such fiscal 
year shall be for the Secretary of Health and Human Services to carry 
out title I of the Child Abuse Prevention and Treatment Act (42 U.S.C. 
5101 et seq.).
                                 <all>