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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3 Placed on Calendar Senate (PCS)]

<DOC>

                                                       Calendar No. 521
116th CONGRESS
  2d Session
                                 H. R. 3

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           December 16, 2019

                                Received

                            August 13, 2020

                          Read the first time

                           September 8, 2020

            Read the second time and placed on the calendar

_______________________________________________________________________

                                 AN ACT

 
  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--MEDICARE PARTS B AND D PRESCRIPTION DRUG INFLATION REBATES

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

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

Sec. 401. Drug price transparency.
  TITLE V--PROGRAM IMPROVEMENTS FOR MEDICARE LOW-INCOME BENEFICIARIES

Sec. 501. Dissemination to Medicare part D subsidy eligible individuals 
                            of information comparing premiums of 
                            certain prescription drug plans.
Sec. 502. Providing for intelligent assignment of certain subsidy 
                            eligible individuals auto-enrolled under 
                            Medicare prescription drug plans and MA-PD 
                            plans.
Sec. 503. Expanding eligibility for low-income subsidies under part D 
                            of the Medicare program.
Sec. 504. Automatic eligibility of certain low-income territorial 
                            residents for premium and cost-sharing 
                            subsidies under the Medicare program; 
                            Sunset of enhanced allotment program.
Sec. 505. Automatic qualification of certain Medicaid beneficiaries for 
                            premium and cost-sharing subsidies under 
                            part D of the Medicare program.
Sec. 506. Providing for certain rules regarding the treatment of 
                            eligible retirement plans in determining 
                            the eligibility of individuals for premium 
                            and cost-sharing subsidies under part D of 
                            the Medicare program.
Sec. 507. Reducing cost-sharing and other program improvements for low-
                            income beneficiaries.
TITLE VI--PROVIDING FOR DENTAL, VISION, AND HEARING COVERAGE UNDER THE 
                            MEDICARE PROGRAM

Sec. 601. Dental and oral health care.
Sec. 602. Providing coverage for hearing care under the Medicare 
                            program.
Sec. 603. Providing coverage for vision care under the Medicare 
                            program.
                TITLE VII--NIH, FDA, AND OPIOIDS FUNDING

              Subtitle A--Biomedical Innovation Expansion

Sec. 701. NIH Innovation Initiatives.
Sec. 702. NIH clinical trial.
Sec. 703. Innovation Network.
             Subtitle B--Investing in Safety and Innovation

Sec. 711. Food and Drug Administration.
Sec. 712. Study on high-risk, high-reward drugs.
                  Subtitle C--Opioid Epidemic Response

Sec. 721. Opioid Epidemic Response Fund.
Sec. 722. Substance Abuse and Mental Health Services Administration.
Sec. 723. Centers for Disease Control and Prevention.
Sec. 724. Food and Drug Administration.
Sec. 725. National Institutes of Health.
Sec. 726. Health Resources and Services Administration.
Sec. 727. Administration for Children and Families.
  Subtitle D--Reducing Administrative Costs and Burdens in Health Care

Sec. 731. Reducing administrative costs and burdens in health care.
                       TITLE VIII--MISCELLANEOUS

Sec. 801. Guaranteed issue of certain Medigap policies.
Sec. 802. Reporting requirements for PDP sponsors regarding point-of-
                            sale rejections under Medicare part D.
Sec. 803. Providing access to annual Medicare notifications in multiple 
                            languages.
Sec. 804. Temporary increase in Medicare part B payment for certain 
                            biosimilar biological products.
Sec. 805. Waiving medicare coinsurance for colorectal cancer screening 
                            tests.
Sec. 806. Medicare coverage of certain lymphedema compression treatment 
                            items.
Sec. 807. Physician fee update.
Sec. 808. Additional community health center funding.
Sec. 809. Grants to improve trauma support services and mental health 
                            care for children and youth in educational 
                            settings.
Sec. 810. Pathway to Health Careers Act.
Sec. 811. Home Visiting to Reduce Maternal Mortality and Morbidity Act.
Sec. 812. Addition of new measures based on access to biosimilar 
                            biological products to the 5-star rating 
                            system under medicare advantage.
Sec. 813. Sense of Congress regarding the impact of the high cost of 
                            prescription drugs on communities of color 
                            and persons living in rural or sparsely 
                            populated areas of the United States.
Sec. 814. Regulations requiring direct-to-consumer advertisements for 
                            prescription drugs and biological products 
                            to include truthful and not misleading 
                            pricing information.
Sec. 815. Improving transparency and preventing the use of abusive 
                            spread pricing and related practices in 
                            Medicaid.
Sec. 816. Graduate medical education improvements in rural and 
                            underserved communities.

      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 2023) or, if agreed to in an agreement under section 
        1193 by the Secretary and manufacturer involved, a period of 
        more than one plan year (beginning on or after January 1, 
        2023).
            ``(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 2023, at least 25 negotiation-eligible drugs 
        described in subparagraphs (A) and (B), but not subparagraph 
        (C), of subsection (d)(1) (or, with respect to an initial price 
        applicability year during such period beginning after 2023, the 
        maximum number (if such number is less than 25) of such 
        negotiation-eligible drugs for the year) with respect to such 
        year; and
            ``(B) with respect to an initial price applicability year 
        during 2024 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 
                (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, 2025, the National Academy of Medicine shall conduct a study, and 
submit to Congress a report, on recommendations for improvements to the 
program under this part, including the determination of the limits 
applied under section 1194(c).
    ``(c) MedPAC Study.--Not later than December 31, 2025, the Medicare 
Payment Advisory Commission shall conduct a study, and submit to 
Congress a report, on the program under this part with respect to the 
Medicare program under title XVIII, including with respect to the 
effect of the program on individuals entitled to benefits or enrolled 
under such title.
    ``(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, 2025, the Comptroller 
General of the United States shall conduct a study of, and submit to 
Congress a report on, the implementation of the Fair Price Negotiation 
Program under this part.''.
    (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 A of title XXVII of the Public 
                Health Service Act is amended by inserting after 
                section 2729 the following new section:

``SEC. 2729A. 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. 716. 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 716''.
                            (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. 716. 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. 9816. 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 9816,'' 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. 9816. 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, 2020;
            (3) $600,000,000 shall become available on October 1, 2021;
            (4) $600,000,000 shall become available on October 1, 2022; 
        and
            (5) $600,000,000 shall become available on October 1, 2023.
    (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--MEDICARE PARTS B AND D 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:
    ``(x) 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, 2021, the 
                Secretary shall, for each part B rebatable drug, report 
                to each manufacturer of such part B rebatable drug the 
                following for such calendar quarter:
                            ``(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, 2021, the 
                manufacturer of a part B rebatable drug shall, for such 
                drug, not later than 30 days after the date of receipt 
                from the Secretary of the information described in 
                subparagraph (A) for such calendar quarter, provide to 
                the Secretary a rebate that is equal to the amount 
                specified in paragraph (3) for such drug for such 
                calendar quarter.
            ``(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 2022, shall be the dollar amount 
                        specified under such subparagraph for 2021, 
                        increased by the percentage increase in the 
                        consumer price index for all urban consumers 
                        (United States city average) for the 12 month 
                        period ending with June of the previous year; 
                        and
                            ``(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, 
                2021' under such paragraph were a reference to the 
                later of the 6th full calendar quarter after the day on 
                which the drug was first marketed or July 1, 2021.
                    ``(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 (CC)'' and inserting 
                        ``(CC)''; and
                            (iii) by inserting before the semicolon at 
                        the end the following: ``, and (DD) with 
                        respect to a part B rebatable drug (as defined 
                        in paragraph (2) of section 1834(x)) for which 
                        the payment amount for a calendar quarter under 
                        paragraph (3)(A)(ii)(I) of such section for 
                        such quarter exceeds the inflation-adjusted 
                        payment under paragraph (3)(A)(ii)(II) of such 
                        section for such quarter, the amounts paid 
                        shall be the difference between (i) the payment 
                        amount under paragraph (3)(A)(ii)(I) of such 
                        section for such drug, and (ii) 20 percent of 
                        the inflation-adjusted payment amount under 
                        paragraph (3)(A)(ii)(II) of such section for 
                        such drug'';
                    (B) by adding at the end of the flush left matter 
                following paragraph (9), the following:
``For purposes of applying paragraph (1)(DD), subsections (i)(9) and 
(t)(8)(F), and section 1834(x)(5), the Secretary shall make such 
estimates and use such data as the Secretary determines appropriate, 
and notwithstanding any other provision of law, may do so by program 
instruction or otherwise.'';
            (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(x)) for which payment under this 
subsection is not packaged into a payment for a covered OPD service (as 
defined in subsection (t)(1)(B)) (or group of services) furnished on or 
after July 1, 2021, under the system under this subsection, in lieu of 
calculation of coinsurance and the amount of payment otherwise 
applicable under this subsection, the provisions of section 1834(x)(5), 
paragraph (1)(DD) of subsection (a), and the flush left matter 
following paragraph (9) of subsection (a), shall, as determined 
appropriate by the Secretary, apply under this subsection in the same 
manner as such provisions of section 1834(x)(5) and subsection (a) 
apply under such section and subsection.''; 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(x)) for which payment under this part is 
                not packaged into a payment for a service furnished on 
                or after July 1, 2021, under the system under this 
                subsection, in lieu of calculation of coinsurance and 
                the amount of payment otherwise applicable under this 
                subsection, the provisions of section 1834(x)(5), 
                paragraph (1)(DD) of subsection (a), and the flush left 
                matter following paragraph (9) of subsection (a), 
                shall, as determined appropriate by the Secretary, 
                apply under this subsection in the same manner as such 
                provisions of section 1834(x)(5) and subsection (a) 
                apply under such section and subsection.''.
    (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(x)'' 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(x)'' 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(x)''.

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, 2022, and ending on December 
                31, 2022, there were extenuating circumstances.
            ``(3) Applicable year.--For purposes of this section the 
        term `applicable year' means a year beginning with 2022.
    ``(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 2023, shall be the dollar amount 
                        specified under such subparagraph for 2022, 
                        increased by the percentage increase in the 
                        consumer price index for all urban consumers 
                        (United States city average) for the 12-month 
                        period beginning with January of 2022; and
                            ``(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(x)'' and inserting ``section 1927, section 
        1834(x), 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(x)'' and inserting ``, section 1834(x), 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(x)'' and inserting ``, section 1834(x), 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, 2021, the Secretary of 
Labor, in consultation with the Secretary of Health and Human Services 
and the Secretary of the Treasury, shall submit to Congress a report 
on--
            (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(x) of the 
        Social Security Act, as added by section 201, and section 
        1860D-14B of such Act, as added by section 202, with respect to 
        prescription drugs that are furnished or dispensed under part B 
        of title XVIII of such Act and part D of such title, 
        respectively; 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, 2022, 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, 2021, the 
Secretary of Labor shall, in consultation with the Secretary of Health 
and Human Services and the Secretary of the Treasury, submit to 
Congress a report, with respect to a period (as determined by the 
Secretary of Labor), on--
            (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(x) of the 
        Social Security Act, as added by section 201, and section 
        1860D-14B of such Act, as added by section 202, with respect to 
        prescription drugs that are furnished or dispensed under part B 
        of title XVIII of such Act and part D of such title, 
        respectively, through increased prices charged with respect to 
        drugs that are furnished or dispensed to participants and 
        beneficiaries of group health plans and health insurance 
        coverage offered in the group market during such period.
    (b) Annual Report.--Not later than December 31 of each year 
following 2021, the Secretary of Labor shall, in consultation with the 
Secretary of Health and Human Services and the Secretary of the 
Treasury, submit to Congress a report updating the information and 
analysis included in the report required under subsection (a), 
reflecting, in part, new price and cost information and data for the 
12-month period after the period on which the prior year's report was 
based.

SEC. 205. COLLECTION OF DATA.

    (a) Manufacturers of Prescription Drugs.--Manufacturers of 
prescription drugs shall submit to the Secretary of Health and Human 
Services, Secretary of Labor, and the Secretary of the Treasury 
appropriate data as necessary for the Secretaries to obtain information 
needed to provide the reports under sections 203 and 204.
    (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, 
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 2022 
                and for costs above the annual deductible specified in 
                paragraph (1) and up to the annual out-of-pocket 
                threshold specified in paragraph (4)(B) for 2022 and 
                each subsequent year'' after ``paragraph (3)'';
                    (B) in subparagraph (C)--
                            (i) in clause (i), in the matter preceding 
                        subclause (I), by inserting ``for a year 
                        preceding 2022,'' after ``paragraph (4),''; and
                            (ii) in clause (ii)(III), by striking ``and 
                        each subsequent year'' and inserting ``and 
                        2021''; and
                    (C) in subparagraph (D)--
                            (i) in clause (i)--
                                    (I) in the matter preceding 
                                subclause (I), by inserting ``for a 
                                year preceding 2022,'' after 
                                ``paragraph (4),''; and
                                    (II) in subclause (I)(bb), by 
                                striking ``a year after 2018'' and 
                                inserting ``each of years 2018 through 
                                2021''; and
                            (ii) in clause (ii)(V), by striking ``2019 
                        and each subsequent year'' and inserting ``each 
                        of years 2019 through 2021'';
            (2) in paragraph (3)(A)--
                    (A) in the matter preceding clause (i), by 
                inserting ``for a year preceding 2022,'' after ``and 
                (4),''; and
                    (B) in clause (ii), by striking ``for a subsequent 
                year'' and inserting ``for each of years 2007 through 
                2021''; 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 2022, 
                                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 2022 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 2021''; 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 2022, 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 
                2022, for amounts''; and
                    (D) in subparagraph (E), by striking ``In 
                applying'' and inserting ``For each of years 2011 
                through 2021, 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 2021, 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, 
2021, 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, 2022.
                    ``(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 2022.--In order for 
                        an agreement with a manufacturer to be in 
                        effect under this section with respect to the 
                        period beginning on January 1, 2022, and ending 
                        on December 31, 2022, the manufacturer shall 
                        enter into such agreement not later than 30 
                        days after the date of the establishment of a 
                        model agreement under subsection (a).
                            ``(ii) 2023 and subsequent years.--In order 
                        for an agreement with a manufacturer to be in 
                        effect under this section with respect to plan 
                        year 2023 or a subsequent plan year, the 
                        manufacturer shall enter into such agreement 
                        (or such agreement shall be renewed under 
                        paragraph (4)(A)) not later than January 30 of 
                        the preceding year.
            ``(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, 2022, 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, 2022, 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 2022 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 2022 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 2022, 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 
                        2022 or the annual out-of-pocket threshold 
                        specified in subsection (b)(4)(B) for the year 
                        for 2022 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 
                2022, 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 2022, 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 2022, 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 2022, the elimination''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (C), by striking ``The 
                        continuation'' and inserting ``For a year 
                        preceding 2022, 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 2022, 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 2022 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 2022'' 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 2021, the Medicare coverage 
                gap discount program under section 1860D-14A; and
                    ``(B) for 2022 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 2021, an agreement described 
                in subsection (b) of section 1860D-14A with the 
                Secretary; and
                    ``(B) for 2022 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 2021, a contract with a 
                third party that the Secretary has entered into a 
                contract with under subsection (d)(3) of section 1860D-
                14A; and
                    ``(B) for 2022 and each subsequent year, a contract 
                with a third party that the Secretary has entered into 
                a contract with under subsection (d)(3) of section 
                1860D-14C.''; 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, 2022, and 
paragraphs (1)(B), (2)(B), and (3)(B) of such subsection shall apply to 
covered part D drugs dispensed under this part on or after January 1, 
2022.''.
            (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 2022 and subsequent plan years.

SEC. 302. ALLOWING CERTAIN ENROLLEES OF PRESCRIPTION DRUGS 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 2022 and 
                subsequent plan years, a prescription drug plan or an 
                MA-PD plan shall, in the case of a part D eligible 
                individual enrolled with such plan for such plan year 
                who is not a subsidy eligible individual (as defined in 
                section 1860D-14(a)(3)) and with respect to whom the 
                plan projects that the dispensing of the first fill of 
                a covered part D drug to such individual will result in 
                the individual incurring costs that are equal to or 
                above the annual out-of-pocket threshold specified in 
                paragraph (4)(B) for such plan year, provide such 
                individual with the option to make the coinsurance 
                payment required under subparagraph (A) (for the 
                portion of such costs that are not above such annual 
                out-of-pocket threshold) in the form of periodic 
                installments over the remainder of such plan year.''.

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, 2021, or such earlier 
                date specified by the Secretary if the Secretary 
                determines there are sufficient measures established or 
                approved under subparagraph (B) to meet the requirement 
                under subparagraph (A).''.

                   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. 1150C. 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, 2019; 
                        or
                            ``(ii) 25 percent or more within a 36-month 
                        period beginning on or after January 1, 2019;
                    ``(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, 2021; 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, 2021; or
                            ``(ii) 25 percent or more within a 36-month 
                        period that begins and ends during the 5-year 
                        period preceding January 1, 2021.
            ``(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, 2019, and 
                ending on the day that is 60 days after the date of the 
                enactment of this section, not later than 90 days after 
                such date of enactment;
                    ``(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, 2021.
    ``(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 Pubic 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. 1150D. 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 1150C;
            ``(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 
        1150C; 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--PROGRAM IMPROVEMENTS FOR MEDICARE LOW-INCOME BENEFICIARIES

SEC. 501. DISSEMINATION TO MEDICARE PART D SUBSIDY ELIGIBLE INDIVIDUALS 
              OF INFORMATION COMPARING PREMIUMS OF CERTAIN PRESCRIPTION 
              DRUG PLANS.

    Section 1860D-1(c)(3) of the Social Security Act (42 U.S.C. 1395w-
101(c)(3)) is amended by adding at the end the following new 
subparagraph:
                    ``(C) Information on premiums for subsidy eligible 
                individuals.--
                            ``(i) In general.--For plan year 2022 and 
                        each subsequent plan year, the Secretary shall 
                        disseminate to each subsidy eligible individual 
                        (as defined in section 1860D-14(a)(3)) 
                        information under this paragraph comparing 
                        premiums that would apply to such individual 
                        for prescription drug coverage under LIS 
                        benchmark plans, including, in the case of an 
                        individual enrolled in a prescription drug plan 
                        under this part, information that compares the 
                        premium that would apply if such individual 
                        were to remain enrolled in such plan to 
                        premiums that would apply if the individual 
                        were to enroll in other LIS benchmark plans.
                            ``(ii) LIS benchmark plan.--For purposes of 
                        clause (i), the term `LIS benchmark plan' 
                        means, with respect to an individual, a 
                        prescription drug plan under this part that is 
                        offered in the region in which the individual 
                        resides and--
                                    ``(I) that provides for a premium 
                                that is not more than the low-income 
                                benchmark premium amount (as defined in 
                                section 1860D-14(b)(2)) for such 
                                region; or
                                    ``(II) with respect to which the 
                                premium would be waived as de minimis 
                                pursuant to section 1860D-14(a)(5) for 
                                such individual.''.

SEC. 502. PROVIDING FOR INTELLIGENT ASSIGNMENT OF CERTAIN SUBSIDY 
              ELIGIBLE INDIVIDUALS AUTO-ENROLLED UNDER MEDICARE 
              PRESCRIPTION DRUG PLANS AND MA-PD PLANS.

    (a) In General.--Section 1860D-1(b)(1) of the Social Security Act 
(42 U.S.C. 1395w-101(b)(1)) is amended--
            (1) in subparagraph (C)--
                    (A) by inserting after ``PDP region'' the 
                following: ``or through use of an intelligent 
                assignment process that is designed to maximize the 
                access of such individual to necessary prescription 
                drugs while minimizing costs to such individual and to 
                the program under this part to the greatest extent 
                possible. In the case the Secretary enrolls such 
                individuals through use of an intelligent assignment 
                process, such process shall take into account the 
                extent to which prescription drugs necessary for the 
                individual are covered in the case of a PDP sponsor of 
                a prescription drug plan that uses a formulary, the use 
                of prior authorization or other restrictions on access 
                to coverage of such prescription drugs by such a 
                sponsor, and the overall quality of a prescription drug 
                plan as measured by quality ratings established by the 
                Secretary''; and
                    (B) by striking ``Nothing in the previous 
                sentence'' and inserting ``Nothing in this 
                subparagraph''; and
            (2) in subparagraph (D)--
                    (A) by inserting after ``PDP region'' the 
                following: ``or through use of an intelligent 
                assignment process that is designed to maximize the 
                access of such individual to necessary prescription 
                drugs while minimizing costs to such individual and to 
                the program under this part to the greatest extent 
                possible. In the case the Secretary enrolls such 
                individuals through use of an intelligent assignment 
                process, such process shall take into account the 
                extent to which prescription drugs necessary for the 
                individual are covered in the case of a PDP sponsor of 
                a prescription drug plan that uses a formulary, the use 
                of prior authorization or other restrictions on access 
                to coverage of such prescription drugs by such a 
                sponsor, and the overall quality of a prescription drug 
                plan as measured by quality ratings established by the 
                Secretary''; and
                    (B) by striking ``Nothing in the previous 
                sentence'' and inserting ``Nothing in this 
                subparagraph''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
apply with respect to plan years beginning with plan year 2022.

SEC. 503. EXPANDING ELIGIBILITY FOR LOW-INCOME SUBSIDIES UNDER PART D 
              OF THE MEDICARE PROGRAM.

    Section 1860D-14(a) of the Social Security Act (42 U.S.C. 1395w-
114(a)), as amended by section 301(d), is further amended--
            (1) in the subsection heading, by striking ``Individuals'' 
        and all that follows through ``Line'' and inserting ``Certain 
        Individuals'';
            (2) in paragraph (1)--
                    (A) by striking the paragraph heading and inserting 
                ``Individuals with certain low incomes''; and
                    (B) in the matter preceding subparagraph (A), by 
                inserting ``(or, with respect to a plan year beginning 
                on or after January 1, 2022, 150 percent)'' after ``135 
                percent''; and
            (3) in paragraph (2)--
                    (A) by striking the paragraph heading and inserting 
                ``Other low-income individuals''; and
                    (B) in the matter preceding subparagraph (A), by 
                striking ``In the case of a subsidy'' and inserting 
                ``With respect to a plan year beginning before January 
                1, 2022, in the case of a subsidy''.

SEC. 504. AUTOMATIC ELIGIBILITY OF CERTAIN LOW-INCOME TERRITORIAL 
              RESIDENTS FOR PREMIUM AND COST-SHARING SUBSIDIES UNDER 
              THE MEDICARE PROGRAM; SUNSET OF ENHANCED ALLOTMENT 
              PROGRAM.

    (a) Automatic Eligibility of Certain Low-Income Territorial 
Residents for Premium and Cost-Sharing Subsidies Under the Medicare 
Program.--
            (1) In general.--Section 1860D-14(a)(3) of the Social 
        Security Act (42 U.S.C. 1395w-114(a)(3)) is amended--
                    (A) in subparagraph (B)(v)--
                            (i) in subclause (I), by striking ``and'' 
                        at the end;
                            (ii) in subclause (II), by striking the 
                        period and inserting ``; and''; and
                            (iii) by inserting after subclause (II) the 
                        following new subclause:
                                    ``(III) with respect to plan years 
                                beginning on or after January 1, 2024, 
                                shall provide that any part D eligible 
                                individual who is enrolled for medical 
                                assistance under the State Medicaid 
                                plan of a territory (as defined in 
                                section 1935(f)) under title XIX (or a 
                                waiver of such a plan) shall be treated 
                                as a subsidy eligible individual 
                                described in paragraph (1).''; and
                    (B) in subparagraph (F), by adding at the end the 
                following new sentence: ``The previous sentence shall 
                not apply with respect to eligibility determinations 
                for premium and cost-sharing subsidies under this 
                section made on or after January 1, 2024.''.
            (2) Conforming amendment.--Section 1860D-31(j)(2)(D) of the 
        Social Security Act (42 U.S.C. 1395w-141(j)(2)(D)) is amended 
        by adding at the end the following new sentence: ``The previous 
        sentence shall not apply with respect to amounts made available 
        to a State under this paragraph on or after January 1, 2024.''.
    (b) Sunset of Enhanced Allotment Program.--
            (1) In general.--Section 1935(e) of the Social Security Act 
        (42 U.S.C. 1396u-5(e)) is amended--
                    (A) in paragraph (1)(A), by inserting after ``such 
                State'' the following: ``before January 1, 2021''; and
                    (B) in paragraph (3)--
                            (i) in subparagraph (A), in the matter 
                        preceding clause (i), by inserting after ``a 
                        year'' the following: ``(before 2024)''; and
                            (ii) in subparagraph (B)(iii), by striking 
                        ``a subsequent year'' and inserting ``each of 
                        fiscal years 2008 through 2023''.
            (2) Territory defined.--Section 1935 of the Social Security 
        Act (42 U.S.C. 1396u-5) is amended by adding at the end the 
        following new subsection:
    ``(f) Territory Defined.--In this section, the term `territory' 
means Puerto Rico, the Virgin Islands, Guam, the Northern Mariana 
Islands, and American Samoa.''.

SEC. 505. AUTOMATIC QUALIFICATION OF CERTAIN MEDICAID BENEFICIARIES FOR 
              PREMIUM AND COST-SHARING SUBSIDIES UNDER PART D OF THE 
              MEDICARE PROGRAM.

    Clause (v) of section 1860D-14(a)(3)(B) of the Social Security Act 
(42 U.S.C. 1395w-114(a)(3)(B)), as amended by section 504, is further 
amended--
            (1) in subclause (II), by striking ``and'' at the end;
            (2) in subclause (III), by striking the period and 
        inserting ``; and''; and
            (3) by inserting after subclause (III) the following new 
        subclause:
                                    ``(IV) with respect to plan years 
                                beginning on or after January 1, 2024, 
                                shall, notwithstanding the preceding 
                                clauses of this subparagraph, provide 
                                that any part D eligible individual not 
                                described in subclause (I), (II), or 
                                (III) who is enrolled, as of the day 
                                before the date on which such 
                                individual attains the age of 65, for 
                                medical assistance under a State plan 
                                under title XIX (or a waiver of such 
                                plan) pursuant to clause (i)(VIII) or 
                                (ii)(XX) of section 1902(a)(10)(A), and 
                                who has income below 200 percent of the 
                                poverty line applicable to a family of 
                                the size involved, shall be treated as 
                                a subsidy eligible individual described 
                                in paragraph (1) for a limited period 
                                of time, as specified by the 
                                Secretary.''.

SEC. 506. PROVIDING FOR CERTAIN RULES REGARDING THE TREATMENT OF 
              ELIGIBLE RETIREMENT PLANS IN DETERMINING THE ELIGIBILITY 
              OF INDIVIDUALS FOR PREMIUM AND COST-SHARING SUBSIDIES 
              UNDER PART D OF THE MEDICARE PROGRAM.

    Section 1860D-14(a)(3)(C)(i) of the Social Security Act (42 U.S.C. 
1395w-114(a)(3)(C)(i)) is amended, by striking ``except that support 
and maintenance furnished in kind shall not be counted as income; and'' 
and inserting ``except that--
                                    ``(I) support and maintenance 
                                furnished in kind shall not be counted 
                                as income; and
                                    ``(II) for plan years beginning on 
                                or after January 1, 2024, any 
                                distribution or withdrawal from an 
                                eligible retirement plan (as defined in 
                                subparagraph (B) of section 402(c)(8) 
                                of the Internal Revenue Code of 1986, 
                                but excluding any defined benefit plan 
                                described in clause (iv) or (v) of such 
                                subparagraph and any qualified trust 
                                (as defined in subparagraph (A) of such 
                                section) which is part of such a 
                                defined benefit plan) shall be counted 
                                as income; and''.

SEC. 507. REDUCING COST-SHARING AND OTHER PROGRAM IMPROVEMENTS FOR LOW-
              INCOME BENEFICIARIES.

    (a) Increase in Income Eligibility to 150 Percent of FPL for 
Qualified Medicare Beneficiaries.--
            (1) In general.--Section 1905(p)(2)(A) of the Social 
        Security Act (42 U.S.C. 1396d(p)(2)(A)) is amended by striking 
        ``shall be at least the percent provided under subparagraph (B) 
        (but not more than 100 percent) of the official poverty line'' 
        and all that follows through the period at the end and 
        inserting the following: ``shall be--
                            ``(i) before January 1, 2022, at least the 
                        percent provided under subparagraph (B) (but 
                        not more than 100 percent) of the official 
                        poverty line (as defined by the Office of 
                        Management and Budget, and revised annually in 
                        accordance with section 673(2) of the Omnibus 
                        Budget Reconciliation Act of 1981) applicable 
                        to a family of the size involved; and
                            ``(ii) on or after January 1, 2022, equal 
                        to 150 percent of the official poverty line (as 
                        so defined and revised) applicable to a family 
                        of the size involved.''.
            (2) Not counting in-kind support and maintenance as 
        income.--Section 1905(p)(2)(D) of the Social Security Act (42 
        U.S.C. 1396d(p)(2)(D)) is amended by adding at the end the 
        following new clause:
                            ``(iii) In determining income under this 
                        subsection, support and maintenance furnished 
                        in kind, as described in section 1612(a)(2)(A), 
                        shall not be counted as income.''.
            (3) Conforming amendments.--
                    (A) Section 1902(a)(10)(E) of the Social Security 
                Act (42 U.S.C. 1396a(a)(10)(E)) is amended--
                            (i) in clause (iii), by striking ``for 
                        making medical'' and inserting ``before January 
                        1, 2022, for making medical''; and
                            (ii) in clause (iv), by striking ``subject 
                        to sections'' and inserting ``before January 1, 
                        2022, subject to sections''.
                    (B) Section 1933 of the Social Security Act (42 
                U.S.C. 1396u-3) is amended--
                            (i) in subsection (a), by striking ``A 
                        State plan'' and inserting ``Subject to 
                        subsection (h), a State plan''; and
                            (ii) by adding at the end the following new 
                        subsection:
    ``(h) Sunset.--The provisions of this section shall have no force 
or effect after December 31, 2021.''.
    (b) 100 Percent FMAP.--Section 1905 of the Social Security Act (42 
U.S.C. 1396d) is amended by adding at the end the following new 
subsection:
    ``(gg) Increased FMAP for Expanded Medicare Cost-Sharing 
Populations.--
            ``(1) In general.--Notwithstanding subsection (b), with 
        respect to expenditures described in paragraph (2) the Federal 
        medical assistance percentage shall be equal to 100 percent.
            ``(2) Expenditures described.--The expenditures described 
        in this paragraph are expenditures made on or after January 1, 
        2022, for medical assistance for medicare cost-sharing provided 
        to any individual under clause (i) or (ii) of section 
        1902(a)(10)(E) who would not have been eligible for medicare 
        cost-sharing under any such clause under the income or resource 
        eligibility standards in effect on October 1, 2018.''.

TITLE VI--PROVIDING FOR DENTAL, VISION, AND HEARING COVERAGE UNDER THE 
                            MEDICARE PROGRAM

SEC. 601. DENTAL AND ORAL HEALTH CARE.

    (a) Coverage.--Section 1861(s)(2) of the Social Security Act (42 
U.S.C. 1395x(s)(2)) is amended--
            (1) in subparagraph (GG), by striking ``and'' after the 
        semicolon at the end;
            (2) in subparagraph (HH), by striking the period at the end 
        and adding ``; and''; and
            (3) by adding at the end the following new subparagraph:
            ``(II) dental and oral health services (as defined in 
        subsection (kkk));''.
    (b) Dental and Oral Health Services Defined.--Section 1861 of the 
Social Security Act (42 U.S.C. 1395x) is amended by adding at the end 
the following new subsection:
    ``(kkk) Dental and Oral Health Services.--
            ``(1) In general.--The term `dental and oral health 
        services' means items and services (other than such items and 
        services for which payment may be made under part A as 
        inpatient hospital services) that are furnished during 2025 or 
        a subsequent year, for which coverage was not provided under 
        part B as of the date of the enactment of this subsection, and 
        that are--
                    ``(A) the preventive and screening services 
                described in paragraph (2) furnished by a doctor of 
                dental surgery or of dental medicine (as described in 
                subsection (r)(2)) or an oral health professional (as 
                defined in paragraph (4)); or
                    ``(B) the basic treatments specified for such year 
                by the Secretary pursuant to paragraph (3)(A) and the 
                major treatments specified for such year by the 
                Secretary pursuant to paragraph (3)(B) furnished by 
                such a doctor or such a professional.
            ``(2) Preventive and screening services.--The preventive 
        and screening services described in this paragraph are the 
        following:
                    ``(A) Oral exams.
                    ``(B) Dental cleanings.
                    ``(C) Dental x-rays performed in the office of a 
                doctor or professional described in paragraph (1)(A).
                    ``(D) Fluoride treatments.
            ``(3) Basic and major treatments.--For 2025 and each 
        subsequent year, the Secretary shall specify--
                    ``(A) basic treatments (which may include basic 
                tooth restorations, basic periodontic services, tooth 
                extractions, and oral disease management services); and
                    ``(B) major treatments (which may include major 
                tooth restorations, major periodontic services, 
                bridges, crowns, and root canals);
        that shall be included as dental and oral health services for 
        such year.
            ``(4) Oral health professional.--The term `oral health 
        professional' means, with respect to dental and oral health 
        services, a health professional who is licensed to furnish such 
        services, acting within the scope of such license, by the State 
        in which such services are furnished.''.
    (c) Payment; Coinsurance; and Limitations.--
            (1) In general.--Section 1833(a)(1) of the Social Security 
        Act (42 U.S.C. 1395l(a)(1)) is amended--
                    (A) in subparagraph (N), by inserting ``and dental 
                and oral health services (as defined in section 
                1861(kkk))'' after ``section 1861(hhh)(1))'';
                    (B) by striking ``and'' before ``(CC)''; and
                    (C) by inserting before the semicolon at the end 
                the following: ``, and (DD) with respect to dental and 
                oral health services (as defined in section 1861(kkk)), 
                the amount paid shall be the payment amount specified 
                under section 1834(x)''.
            (2) Payment and limits specified.--Section 1834 of the 
        Social Security Act (42 U.S.C. 1395m) is amended by adding at 
        the end the following new subsection:
    ``(x) Payment and Limits for Dental and Oral Health Services.--
            ``(1) In general.--The payment amount under this part for 
        dental and oral health services (as defined in section 
        1861(kkk)) shall be, subject to paragraph (3), the applicable 
        percent (specified in paragraph (2)) of the lesser of the 
        actual charge for the services or the amount determined under 
        the payment basis determined under section 1848. In determining 
        such amounts determined under such payment basis, the Secretary 
        shall consider payment rates paid to dentists for comparable 
        services under State plans under title XIX, under the TRICARE 
        program under chapter 55 of title 10 of the United States Code, 
        and by other health care payers, such as Medicare Advantage 
        plans under part C.
            ``(2) Applicable percent.--For purposes of paragraph (1), 
        the applicable percent specified in this paragraph is, with 
        respect to dental and oral health services (as defined in 
        section 1861(kkk)) furnished in a year--
                    ``(A) that are preventive and screening services 
                described in paragraph (2) or basic treatments 
                specified for such year pursuant to paragraph (3)(A) of 
                such section, 80 percent; and
                    ``(B) that are major treatments specified for such 
                year pursuant to paragraph (3)(B) of such section--
                            ``(i) in the case such services are 
                        furnished during 2025, 10 percent;
                            ``(ii) in the case such services are 
                        furnished during 2026 or a subsequent year 
                        before 2029, the applicable percent specified 
                        under this subparagraph for the previous year, 
                        increased by 10 percentage points; and
                            ``(iii) in the case such services are 
                        furnished during 2029 or a subsequent year, 50 
                        percent.
            ``(3) Limitations.--With respect to dental and oral health 
        services that are--
                    ``(A) preventive and screening oral exams, payment 
                may be made under this part for not more than two such 
                exams during a 12-month period;
                    ``(B) dental cleanings, payment may be made under 
                this part for not more than two such cleanings during a 
                12-month period; and
                    ``(C) not described in subparagraph (A) or (B), 
                payment may be made under this part only at such 
                frequencies and under such circumstances determined 
                appropriate by the Secretary.''.
    (d) Payment Under Physician Fee Schedule.--
            (1) In general.--Section 1848(j)(3) of the Social Security 
        Act (42 U.S.C. 1395w-4(j)(3)) is amended by inserting 
        ``(2)(II),'' before ``(3)''.
            (2) Exclusion from mips.--Section 1848(q)(1)(C)(ii) of the 
        Social Security Act (42 U.S.C. 1395w-4(q)(1)(C)(ii)) is 
        amended--
                    (A) in subclause (II), by striking ``or'' at the 
                end;
                    (B) in subclause (III), by striking the period at 
                the end and inserting ``; or''; and
                    (C) by adding at the end the following new 
                subclause:
                                    ``(IV) with respect to 2025 and 
                                each subsequent year, is a doctor of 
                                dental surgery or of dental medicine 
                                (as described in section 1861(r)(2)) or 
                                is an oral health professional (as 
                                defined in section 1861(kkk)(4)).''.
            (3) Inclusion of oral health professionals as certain 
        practitioners.--Section 1842(b)(18)(C) of the Social Security 
        Act (42 U.S.C. 1395u(b)(18)(C)) is amended by adding at the end 
        the following new clause:
            ``(vii) With respect to 2025 and each subsequent year, an 
        oral health professional (as defined in section 
        1861(kkk)(4)).''.
    (e) Dentures.--
            (1) In general.--Section 1861(s)(8) of the Social Security 
        Act (42 U.S.C. 1395x(s)(8)) is amended--
                    (A) by striking ``(other than dental)''; and
                    (B) by inserting ``and excluding dental, except for 
                a full or partial set of dentures furnished on or after 
                January 1, 2025'' after ``colostomy care''.
            (2) Special payment rules.--
                    (A) Limitations.--Section 1834(h) of the Social 
                Security Act (42 U.S.C. 1395m(h)) is amended by adding 
                at the end the following new paragraph:
            ``(6) Special payment rule for dentures.--Payment may be 
        made under this part with respect to an individual for 
        dentures--
                    ``(A) not more than once during any 5-year period 
                (except in the case that a doctor or professional 
                described in section 1861(kkk)(1)(A) determines such 
                dentures do not fit the individual); and
                    ``(B) only to the extent that such dentures are 
                furnished pursuant to a written order of such a doctor 
                or professional.''.
                    (B) Application of competitive acquisition.--
                            (i) In general.--Section 1834(h)(1)(H) of 
                        the Social Security Act (42 U.S.C. 
                        1395m(h)(1)(H)) is amended--
                                    (I) in the subparagraph heading, by 
                                inserting ``, dentures'' after 
                                ``orthotics'';
                                    (II) by inserting ``, of dentures 
                                described in paragraph (2)(D) of such 
                                section,'' after ``2011,''; and
                                    (III) in clause (i), by inserting 
                                ``, such dentures'' after 
                                ``orthotics''.
                            (ii) Conforming amendment.--Section 
                        1847(a)(2) of the Social Security Act (42 
                        U.S.C. 1395w-3(a)(2)) is amended by adding at 
                        the end the following new subparagraph:
                    ``(D) Dentures.--Dentures described in section 
                1861(s)(8) for which payment would otherwise be made 
                under section 1834(h).''.
                            (iii) Exemption of certain items from 
                        competitive acquisition.--Section 1847(a)(7) of 
                        the Social Security Act (42 U.S.C. 1395w-
                        3(a)(7)) is amended by adding at the end the 
                        following new subparagraph:
                    ``(C) Certain dentures.--Those items and services 
                described in paragraph (2)(D) if furnished by a 
                physician or other practitioner (as defined by the 
                Secretary) to the physician's or practitioner's own 
                patients as part of the physician's or practitioner's 
                professional service.''.
    (f) Exclusion Modifications.--Section 1862(a) of the Social 
Security Act (42 U.S.C. 1395y(a)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (O), by striking ``and'' at the 
                end;
                    (B) in subparagraph (P), by striking the semicolon 
                at the end and inserting ``, and''; and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(Q) in the case of dental and oral health services (as 
        defined in section 1861(kkk)) that are preventive and screening 
        services described in paragraph (2) of such section, which are 
        furnished more frequently than provided under section 
        1834(x)(3) and under circumstances other than circumstances 
        determined appropriate under such section;''; and
            (2) in paragraph (12), by inserting before the semicolon at 
        the end the following: ``and except that payment may be made 
        under part B for dental and oral health services that are 
        covered under section 1861(s)(2)(II)''.
    (g) Certain Non-application.--
            (1) In general.--Paragraphs (1) and (4) of section 1839(a) 
        of the Social Security Act (42 U.S.C. 1395r(a)) are amended by 
        adding at the end of each such paragraphs the following: ``In 
        applying this paragraph there shall not be taken into account 
        benefits and administrative costs attributable to the 
        amendments made by section 601 (other than subsection (g)) of 
        the Elijah E. Cummings Lower Drug Costs Now Act and the 
        Government contribution under section 1844(a)(4)''.
            (2) Payment.--Section 1844(a) of such Act (42 U.S.C. 
        1395w(a)) is amended--
                    (A) in paragraph (3), by striking the period at the 
                end and inserting ``; plus''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(4) a Government contribution equal to the amount that is 
        estimated to be payable for benefits and related administrative 
        costs incurred that are attributable to the amendments made by 
        section 601 (other than subsection (g)) of the Elijah E. 
        Cummings Lower Drug Costs Now Act.''.
    (h) Implementation Funding.--
            (1) In general.--The Secretary of Health and Human Services 
        (in this subsection referred to as the ``Secretary'') shall 
        provide for the transfer from the Federal Supplementary Medical 
        Insurance Trust Fund under section 1841 of the Social Security 
        Act (42 U.S.C. 1395t) to the Centers for Medicare & Medicaid 
        Services Program Management Account of--
                    (A) $20,000,000 for each of fiscal years 2020 
                through 2025 for purposes of implementing the 
                amendments made by this section; and
                    (B) such sums as determined appropriate by the 
                Secretary for each subsequent fiscal year for purposes 
                of administering the provisions of such amendments.
            (2) Availability and additional use of funds.--Funds 
        transferred pursuant to paragraph (1) shall remain available 
        until expended and may be used, in addition to the purpose 
        specified in paragraph (1)(A), to implement the amendments made 
        by sections 602 and 603.

SEC. 602. PROVIDING COVERAGE FOR HEARING CARE UNDER THE MEDICARE 
              PROGRAM.

    (a) Provision of Aural Rehabilitation and Treatment Services by 
Qualified Audiologists.--Section 1861(ll)(3) of the Social Security Act 
(42 U.S.C. 1395x(ll)(3)) is amended by inserting ``(and, beginning 
January 1, 2023, such aural rehabilitation and treatment services)'' 
after ``assessment services''.
    (b) Coverage of Hearing Aids.--
            (1) Inclusion of hearing aids as prosthetic devices.--
        Section 1861(s)(8) of the Social Security Act (42 U.S.C. 
        1395x(s)(8)) is amended by inserting ``, and including hearing 
        aids furnished on or after January 1, 2023, to individuals 
        diagnosed with profound or severe hearing loss'' before the 
        semicolon at the end.
            (2) Payment limitations for hearing aids.--Section 1834(h) 
        of the Social Security Act (42 U.S.C. 1395m(h)), as amended by 
        section 601(e)(2)(A), is further amended by adding at the end 
        the following new paragraph:
            ``(7) Limitations for hearing aids.--Payment may be made 
        under this part with respect to an individual, with respect to 
        hearing aids furnished on or after January 1, 2023--
                    ``(A) not more than once during a 5-year period;
                    ``(B) only for types of such hearing aids that are 
                not over-the-counter hearing aids (as defined in 
                section 520(q)(1) of the Federal Food, Drug, and 
                Cosmetic Act) and that are determined appropriate by 
                the Secretary; and
                    ``(C) only if furnished pursuant to a written order 
                of a physician or qualified audiologist (as defined in 
                section 1861(ll)(4)(B)).''.
            (3) Application of competitive acquisition.--
                    (A) In general.--Section 1834(h)(1)(H) of the 
                Social Security Act (42 U.S.C. 1395m(h)(1)(H)), as 
                amended by section 601(e)(2)(B)(i), is further 
                amended--
                            (i) in the header, by inserting ``, hearing 
                        aids'' after ``dentures'';
                            (ii) by inserting ``, of hearing aids 
                        described in paragraph (2)(E) of such 
                        section,'' after ``paragraph (2)(D) of such 
                        section''; and
                            (iii) in clause (i), by inserting ``, such 
                        hearing aids'' after ``such dentures''.
                    (B) Conforming amendment.--
                            (i) In general.--Section 1847(a)(2) of the 
                        Social Security Act (42 U.S.C. 1395w-3(a)(2)), 
                        as amended by section 601(e)(2)(B)(ii), is 
                        further amended by adding at the end the 
                        following new subparagraph:
                    ``(E) Hearing aids.--Hearing aids described in 
                section 1861(s)(8) for which payment would otherwise be 
                made under section 1834(h).''.
                            (ii) Exemption of certain items from 
                        competitive acquisition.--Section 1847(a)(7) of 
                        the Social Security Act (42 U.S.C. 1395w-
                        3(a)(7)), as amended by section 
                        601(e)(2)(B)(iii), is further amended by adding 
                        at the end the following new subparagraph:
                    ``(D) Certain hearing aids.--Those items and 
                services described in paragraph (2)(E) if furnished by 
                a physician or other practitioner (as defined by the 
                Secretary) to the physician's or practitioner's own 
                patients as part of the physician's or practitioner's 
                professional service.''.
            (4) Inclusion of audiologists as certain practitioners to 
        receive payment on an assignment-related basis.--Section 
        1842(b)(18)(C) of the Social Security Act (42 U.S.C. 
        1395u(b)(18)(C)), as amended by section 601(d)(4), is further 
        amended by adding at the end the following new clause:
                            ``(viii) With respect to 2023 and each 
                        subsequent year, a qualified audiologist (as 
                        defined in section 1861(ll)(4)(B)).''.
    (c) Exclusion Modification.--Section 1862(a)(7) of the Social 
Security Act (42 U.S.C. 1395y(a)(7)) is amended by inserting ``(except 
such hearing aids or examinations therefor as described in and 
otherwise allowed under section 1861(s)(8))'' after ``hearing aids or 
examinations therefor''.
    (d) Certain Non-application.--
            (1) In general.--The last sentence of section 1839(a)(1) of 
        the Social Security Act (42 U.S.C. 1395r(a)(1)), as added by 
        section 601(g)(1), is amended by striking ``section 601 (other 
        than subsection (g))'' and inserting ``sections 601 (other than 
        subsection (g)), 602 (other than subsection (d))''.
            (2) Payment.--Paragraph (4) of section 1844(a) of such Act 
        (42 U.S.C. 1395w(a)), as added by section 601(g)(2), is amended 
        by striking ``section 601 (other than subsection (g))'' and 
        inserting ``sections 601 (other than subsection (g)), 602 
        (other than subsection (d))''.
    (e) Report; Regulations.--
            (1) Report.--Not later than the date that is 3 years after 
        the date of the enactment of this Act, the Inspector General of 
        the Department of Health and Human Services shall conduct a 
        study to assess (and submit to the Secretary of Health and 
        Human Services a report on) any program integrity or 
        overutilization risks with respect to allowing qualified 
        audiologists (as defined in paragraph (4)(B) of 1861(ll) of the 
        Social Security Act (42 U.S.C. 1395x(ll))) to furnish audiology 
        services (as defined in paragraph (3) of such section) to 
        individuals entitled to benefits under part A of title XVIII of 
        such Act (42 U.S.C. 1395c et seq.) and enrolled for benefits 
        under part B of such title (42 U.S.C.1395j et seq.) without 
        such individuals being referred by a physician (as defined in 
        section 1861(r) of such Act (42 U.S.C. 1395x(r))) or 
        practitioner (as described in section 602.32 of title 42, Code 
        of Federal Regulations) to such qualified audiologists. In 
        conducting such study, the Inspector General may take into 
        account experiences with audiologists furnishing audiology 
        services to enrollees in other Federal programs, including in a 
        health benefit plan under chapter 89 of title 5, United States 
        Code or in health care benefits under the TRICARE program under 
        chapter 55 of title 10 of the United States Code or under 
        chapter 17 of title 38 of such Code.
            (2) Regulations.--The Secretary of Health and Human 
        Services may promulgate regulations to allow qualified 
        audiologists (as so defined) to furnish audiology services (as 
        so defined) without a referral from a physician or 
        practitioner, consistent with the findings submitted to the 
        Secretary pursuant to paragraph (1)(B).
    (f) Implementation Funding.--
            (1) In general.--The Secretary of Health and Human Services 
        (in this subsection referred to as the ``Secretary'') shall 
        provide for the transfer from the Federal Supplementary Medical 
        Insurance Trust Fund under section 1841 of the Social Security 
        Act (42 U.S.C. 1395t) to the Centers for Medicare & Medicaid 
        Services Program Management Account of--
                    (A) $20,000,000 for each of fiscal years 2020 
                through 2024 for purposes of implementing the 
                amendments made by this section; and
                    (B) such sums as determined appropriate by the 
                Secretary for each subsequent fiscal year for purposes 
                of administering the provisions of such amendments.
            (2) Availability and additional use of funds.--Funds 
        transferred pursuant to paragraph (1) shall remain available 
        until expended and may be used, in addition to the purpose 
        specified in paragraph (1)(A), to implement the amendments made 
        by sections 601 and 603.

SEC. 603. PROVIDING COVERAGE FOR VISION CARE UNDER THE MEDICARE 
              PROGRAM.

    (a) Coverage.--Section 1861(s)(2) of the Social Security Act (42 
U.S.C. 1395x(s)(2)), as amended by section 601(a), is further amended--
            (1) in subparagraph (HH), by striking ``and'' after the 
        semicolon at the end;
            (2) in subparagraph (II), by striking the period at the end 
        and adding ``; and''; and
            (3) by adding at the end the following new subparagraph:
            ``(JJ) vision services (as defined in subsection (lll));''.
    (b) Vision Services Defined.--Section 1861 of the Social Security 
Act (42 U.S.C. 1395x), as amended by section 601(b), is further amended 
by adding at the end the following new subsection:
    ``(lll) Vision Services.--The term `vision services' means--
            ``(1) routine eye examinations to determine the refractive 
        state of the eyes, including procedures performed during the 
        course of such examination; and
            ``(2) contact lens fitting services;
furnished on or after January 1, 2023, by or under the direct 
supervision of an optometrist or ophthalmologist who is legally 
authorized to furnish such examinations, procedures, or fitting 
services (as applicable) under State law (or the State regulatory 
mechanism provided by State law) of the State in which the 
examinations, procedures, or fitting services are furnished.''.
    (c) Payment Limitations.--Section 1834 of the Social Security Act 
(42 U.S.C. 1395m), as amended by section 601(c)(2), is further amended 
by adding at the end the following new subsection:
    ``(y) Limitation for Vision Services.--With respect to vision 
services (as defined in section 1861(lll)) and an individual, payment 
may be made under this part for only 1 routine eye examination 
described in paragraph (1) of such section and 1 contact lens fitting 
service described in paragraph (2) of such section during a 2-year 
period.''.
    (d) Payment Under Physician Fee Schedule.--Section 1848(j)(3) of 
the Social Security Act (42 U.S.C. 1395w-4(j)(3)), as amended by 
section 601(d)(1), is further amended by inserting ``(2)(JJ),'' before 
``(3)''.
    (e) Coverage of Conventional Eyeglasses and Contact Lenses.--
Section 1861(s)(8) of the Social Security Act (42 U.S.C. 1395x(s)(8)), 
as amended by section 602(b)(1), is further amended by striking ``, and 
including one pair of conventional eyeglasses or contact lenses 
furnished subsequent to each cataract surgery with insertion of an 
intraocular lens'' and inserting ``, including one pair of conventional 
eyeglasses or contact lenses furnished subsequent to each cataract 
surgery with insertion of an intraocular lens, if furnished before 
January 1, 2023, including conventional eyeglasses or contact lenses, 
whether or not furnished subsequent to such a surgery, if furnished on 
or after January 1, 2024''.
    (f) Special Payment Rules for Eyeglasses and Contact Lenses.--
            (1) Limitations.--Section 1834(h) of the Social Security 
        Act (42 U.S.C. 1395m(h)), as amended by section 601(e)(2)(A) 
        and section 602(b)(2), is further amended by adding at the end 
        the following new paragraph:
            ``(8) Payment limitations for eyeglasses and contact 
        lenses.--
                    ``(A) In general.--With respect to eyeglasses and 
                contact lenses furnished to an individual on or after 
                January 1, 2023, subject to subparagraph (B), payment 
                may be made under this part only--
                            ``(i) during a 2-year period, for either 1 
                        pair of eyeglasses (including lenses and 
                        frames) or not more than a 2-year supply of 
                        contact lenses that is provided in not more 
                        than 180-day increments;
                            ``(ii) with respect to amounts attributable 
                        to the lenses and frames of such a pair of 
                        eyeglasses or amounts attributable to such a 2-
                        year supply of contact lenses, in an amount not 
                        greater than--
                                    ``(I) for a pair of eyeglasses 
                                furnished in, or a 2-year supply of 
                                contact lenses beginning in, 2023--
                                            ``(aa) $85 for the lenses 
                                        of such pair of eyeglasses and 
                                        $85 for the frames of such pair 
                                        of eyeglasses; or
                                            ``(bb) $85 for such 2-year 
                                        supply of contact lenses; and
                                    ``(II) for the lenses and frames of 
                                a pair of eyeglasses furnished in, or a 
                                2-year supply of contact lenses 
                                beginning in, a subsequent year, the 
                                dollar amounts specified under this 
                                subparagraph for the previous year, 
                                increased by the percentage change in 
                                the consumer price index for all urban 
                                consumers (United States city average) 
                                for the 12-month period ending with 
                                June of the previous year;
                            ``(iii) for types of eyeglass lenses, and 
                        for types of contact lenses, as determined 
                        appropriate by the Secretary;
                            ``(iv) if furnished pursuant to a written 
                        order of a physician described in section 
                        1861(lll); and
                            ``(v) if during the 2-year period described 
                        in clause (i), the individual did not already 
                        receive (as described in subparagraph (B)) one 
                        pair of conventional eyeglasses or contact 
                        lenses subsequent to a cataract surgery with 
                        insertion of an intraocular lens furnished 
                        during such period.
                    ``(B) Exception.--With respect to a 2-year period 
                described in subparagraph (A)(i), in the case of an 
                individual who receives cataract surgery with insertion 
                of an intraocular lens, notwithstanding subparagraph 
                (A), payment may be made under this part for one pair 
                of conventional eyeglasses or contact lenses furnished 
                subsequent to such cataract surgery during such 
                period.''.
            (2) Application of competitive acquisition.--
                    (A) In general.--Section 1834(h)(1)(H) of the 
                Social Security Act (42 U.S.C. 1395m(h)(1)(H)), as 
                amended by section 601(e)(2)(B)(i) and section 
                602(b)(3)(A), is further amended--
                            (i) in the header by inserting ``, 
                        eyeglasses, and contact lenses'' after 
                        ``hearing aids'';
                            (ii) by inserting ``and of eyeglasses and 
                        contact lenses described in paragraph (2)(F) of 
                        such section,'' after ``paragraph (2)(E) of 
                        such section,''; and
                            (iii) in clause (i), by inserting ``, or 
                        such eyeglasses and contact lenses'' after 
                        ``such hearing aids''.
                    (B) Conforming amendment.--
                            (i) In general.--Section 1847(a)(2) of the 
                        Social Security Act (42 U.S.C. 1395w-3(a)(2)), 
                        as amended by section 601(e)(2)(B)(ii) and 
                        section 602(b)(3)(B)(i), is further amended by 
                        adding at the end the following new 
                        subparagraph:
                    ``(F) Eyeglasses and contact lenses.--Eyeglasses 
                and contact lenses described in section 1861(s)(8) for 
                which payment would otherwise be made under section 
                1834(h).''.
                            (ii) Exemption of certain items from 
                        competitive acquisition.--Section 1847(a)(7) of 
                        the Social Security Act (42 U.S.C. 1395w-
                        3(a)(7)), as amended by section 
                        601(e)(2)(B)(iii) and section 602(b)(3)(B)(ii), 
                        is further amended by adding at the end the 
                        following new subparagraph:
                    ``(E) Certain eyeglasses and contact lenses.--Those 
                items and services described in paragraph (2)(F) if 
                furnished by a physician or other practitioner (as 
                defined by the Secretary) to the physician's or 
                practitioner's own patients as part of the physician's 
                or practitioner's professional service.''.
    (g) Exclusion Modifications.--Section 1862(a) of the Social 
Security Act (42 U.S.C. 1395y(a)), as amended by section 601(f), is 
further amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (P), by striking ``and'' at the 
                end;
                    (B) in subparagraph (Q), by striking the semicolon 
                at the end and inserting ``, and''; and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(R) in the case of vision services (as defined in section 
        1861(lll)) that are routine eye examinations and contact lens 
        fitting services (as described in paragraph (1) or (2), 
        respectively, of such section), which are furnished more 
        frequently than once during a 2-year period;''; and
            (2) in paragraph (7)--
                    (A) by inserting ``(other than such an examination 
                that is a vision service that is covered under section 
                1861(s)(2)(JJ))'' after ``eye examinations''; and
                    (B) by inserting ``(other than such a procedure 
                that is a vision service that is covered under section 
                1861(s)(2)(JJ))'' after ``refractive state of the 
                eyes''.
    (h) Certain Non-application.--
            (1) In general.--The last sentence of section 1839(a)(1) of 
        the Social Security Act (42 U.S.C. 1395r(a)(1)), as added by 
        section 601(g)(1) and amended by section 602(d)(1), is further 
        amended by inserting ``, and 603 (other than subsection (h))'' 
        after ``602 (other than subsection (d))''.
            (2) Payment.--Paragraph (4) of section 1844(a) of such Act 
        (42 U.S.C. 1395w(a)), as added by section 601(g)(2) and amended 
        by section 602(d)(2), is further amended by inserting ``, and 
        603 (other than subsection (h))'' after ``602 (other than 
        subsection (d))''.
    (i) Implementation Funding.--
            (1) In general.--The Secretary of Health and Human Services 
        (in this subsection referred to as the ``Secretary'') shall 
        provide for the transfer from the Federal Supplementary Medical 
        Insurance Trust Fund under section 1841 of the Social Security 
        Act (42 U.S.C. 1395t) to the Centers for Medicare & Medicaid 
        Services Program Management Account of--
                    (A) $20,000,000 for each of fiscal years 2020 
                through 2024 for purposes of implementing the 
                amendments made by this section; and
                    (B) such sums as determined appropriate by the 
                Secretary for each subsequent fiscal year for purposes 
                of administering the provisions of such amendments.
            (2) Availability and additional use of funds.--Funds 
        transferred pursuant to paragraph (1) shall remain available 
        until expended and may be used, in addition to the purpose 
        specified in paragraph (1)(A), to implement the amendments made 
        by sections 601 and 602.

                TITLE VII--NIH, FDA, AND OPIOIDS FUNDING

              Subtitle A--Biomedical Innovation Expansion

SEC. 701. 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 2021, $255,400,000.
                            ``(ii) For fiscal year 2022, $260,400,000.
                            ``(iii) For fiscal year 2023, $163,400,000.
                            ``(iv) For fiscal year 2024, $547,000,000.
                            ``(v) For fiscal year 2025, $848,000,000.
                            ``(vi) For fiscal year 2026, $842,400,000.
                            ``(vii) For fiscal year 2027, 
                        $1,089,600,000.
                            ``(viii) For fiscal year 2028, 
                        $1,115,600,000.
                            ``(ix) For fiscal year 2029, 
                        $1,170,600,000.
                            ``(x) For fiscal year 2030, $1,207,600,000.
                    ``(B) Supplemental funding for certain projects.--
                Of the total amounts made available under subparagraph 
                (A) for each of fiscal years 2021 through 2030, a total 
                amount not to exceed the following shall be made 
                available for the following categories of NIH 
                Innovation Projects:
                            ``(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 2021 
                                and 2022, $50,000,000.
                                    ``(II) For fiscal year 2024, 
                                $100,000,000.
                                    ``(III) For each of fiscal years 
                                2025 and 2026, $300,000,000.
                                    ``(IV) For each of fiscal years 
                                2027 through 2029, $317,000,000.
                                    ``(V) For fiscal year 2030, 
                                $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 2021 
                                and 2022, $50,000,000.
                                    ``(II) For fiscal year 2024, 
                                $128,000,000.
                                    ``(III) For fiscal year 2025, 
                                $209,000,000.
                                    ``(IV) For fiscal year 2026, 
                                $100,000,000.
                                    ``(V) For fiscal year 2027, 
                                $325,000,000.
                                    ``(VI) For fiscal year 2028, 
                                $350,000,000.
                                    ``(VII) For fiscal year 2029, 
                                $400,000,000.
                                    ``(VIII) For fiscal year 2030, 
                                $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 2021 through 2030.
                    ``(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 2021 
                                through 2024, $100,000,000.
                                    ``(II) For each of fiscal years 
                                2025 and 2026, $120,000,000.
                                    ``(III) For each of fiscal years 
                                2027 through 2029, $125,000,000.
                                    ``(IV) For fiscal year 2030, 
                                $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 2021, 
                                $40,000,000.
                                    ``(II) For fiscal year 2022, 
                                $45,000,000.
                                    ``(III) For fiscal year 2023, 
                                $48,000,000.
                                    ``(IV) For each of fiscal years 
                                2024 and 2025, $52,400,000.
                                    ``(V) For fiscal year 2026, 
                                $55,800,000.
                                    ``(VI) For fiscal year 2027, 
                                $56,000,000.
                                    ``(VII) For fiscal year 2028, 
                                $57,000,000.
                                    ``(VIII) For each of fiscal years 
                                2029 and 2030, $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)''; and
                    (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 2021 through 2030 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 ``2030''.
    (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, 2030''.

SEC. 702. 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 or section 351 of this Act 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, $680,000,000 for each of fiscal years 2021 through 
        2025, 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. 703. INNOVATION NETWORK.

    Part A of title IV of the Public Health Service Act (42 U.S.C. 281 
et seq.), as amended by section 702, 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 2021 through 2025, to be available until expended.''.

             Subtitle B--Investing in Safety and Innovation

SEC. 711. 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 2020, $417,500,000.
                            ``(ii) For each of fiscal years 2021 and 
                        2022, $157,500,000.
                            ``(iii) For each of fiscal years 2023 
                        through 2025, $152,500,000.
                            ``(iv) For each of fiscal years 2026 
                        through 2029, $202,500,000.
                    ``(B) Supplemental funding for certain 
                activities.--Of the total amounts made available under 
                subparagraph (A) for each of fiscal years 2026 through 
                2029, a total amount not to exceed $50,000,000 for each 
                such fiscal year, shall be made available for the 
                activities under subtitles A through F (including the 
                amendments made by such subtitles) of title III of this 
                Act and section 1014 of the Federal Food, Drug, and 
                Cosmetic Act, as added by section 3073 of this Act.
                    ``(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 2020, 
                                $180,000,000.
                                    ``(II) For each of fiscal years 
                                2021 through 2029, $60,000.
                            ``(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 2020 
                        through 2029, $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 2020, 
                                $50,000,000.
                                    ``(II) For each of fiscal years 
                                2021 through 2029, $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 2020 through 2029, $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 2020 through 2029, $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 2020, 
                                $112,500,000.
                                    ``(II) For each of fiscal years 
                                2021 through 2029, $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 2020 
                                through 2022, $10,000,000.
                                    ``(II) For each of fiscal years 
                                2023 through 2029, $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 2020 
                        through 2029, $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 2020 through 2029, $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 ``2030''.
    (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. 712. 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--Opioid Epidemic Response

SEC. 721. OPIOID 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 opioid and 
substance use disorder epidemic. Such funds shall be in addition to any 
funds which are otherwise available to carry out such programs and 
activities.
    (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 $1,980,000,000 for each of 
        fiscal years 2021 through 2025.
            (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 2021 through 2025, 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 722, $1,500,000,000 for each of fiscal 
        years 2021 through 2025.
            (2) CDC.--For the Centers for Disease Control and 
        Prevention to carry out programs and activities pursuant to 
        section 723, $120,000,000 for each of fiscal years 2021 through 
        2025.
            (3) FDA.--For the Food and Drug Administration to carry out 
        programs and activities pursuant to section 724, $10,000,000 
        for each of fiscal years 2021 through 2025.
            (4) NIH.--For the National Institutes of Health to carry 
        out programs and activities pursuant to section 725, 
        $240,000,000 for each of fiscal years 2021 through 2025.
            (5) HRSA.--For the Health Resources and Services 
        Administration to carry out programs and activities pursuant to 
        section 726, $90,000,000 for each of fiscal years 2021 through 
        2025.
            (6) ACF.--For the Administration for Children and Families 
        to carry out programs and activities pursuant to section 727, 
        $20,000,000 for each of fiscal years 2021 through 2025.
    (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 2021 through 2025 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 2022 through 2026, the Secretary of Health and 
        Human Services shall submit to the Committee on Health, 
        Education, Labor, and Pensions and the Committee on 
        Appropriations of the Senate and the Committee on Energy and 
        Commerce, the Committee on Appropriations, and the Committee on 
        Education and Labor of the House of Representatives, a report 
        including--
                    (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. 722. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.

    (a) In General.--The entirety of the funds made available pursuant 
to section 721(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 
731(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. 723. CENTERS FOR DISEASE CONTROL AND PREVENTION.

    (a) Addressing Opioid Use Disorder.--The entirety of the funds made 
available pursuant to section 721(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 
721(c)(2) for carrying out this section, not more than 20 percent may 
be used for intramural purposes.

SEC. 724. FOOD AND DRUG ADMINISTRATION.

    The entirety of the funds made available pursuant to section 
721(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. 725. NATIONAL INSTITUTES OF HEALTH.

    The entirety of the funds made available pursuant to section 
721(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. 726. HEALTH RESOURCES AND SERVICES ADMINISTRATION.

    The entirety of the funds made available pursuant to section 
721(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. 727. ADMINISTRATION FOR CHILDREN AND FAMILIES.

    Of the funds made available pursuant to section 721(c)(6) for each 
of fiscal years 2021 through 2025, $20,000,000 for each such fiscal 
year shall be for the Secretary of Health and Human Services to carry 
out title I of the Child Abuse Prevention and Treatment Act (42 U.S.C. 
5101 et seq.).

  Subtitle D--Reducing Administrative Costs and Burdens in Health Care

SEC. 731. REDUCING ADMINISTRATIVE COSTS AND BURDENS IN HEALTH CARE.

    Title II of the Public Health Service Act (42 U.S.C. 202 et seq.) 
is amended by adding at the end the following:

   ``PART E--REDUCING ADMINISTRATIVE COSTS AND BURDENS IN HEALTH CARE

``SEC. 281. ELIMINATING UNNECESSARY ADMINISTRATIVE BURDENS AND COSTS.

    ``(a) Reducing Administrative Burdens and Costs.--The Secretary, in 
consultation with providers of health services, health care suppliers 
of services, health care payers, health professional societies, health 
vendors and developers, health care standard development organizations 
and operating rule entities, health care quality organizations, health 
care accreditation organizations, public health entities, States, 
patients, and other appropriate entities, shall, in accordance with 
subsection (b)--
            ``(1) establish a goal of reducing unnecessary costs and 
        administrative burdens across the health care system, including 
        the Medicare program under title XVIII of the Social Security 
        Act, the Medicaid program under title XIX of such Act, and the 
        private health insurance market, by at least half over a period 
        of 10 years from the date of enactment of this section;
            ``(2) develop strategies and benchmarks for meeting the 
        goal established under paragraph (1);
            ``(3) develop recommendations for meeting the goal 
        established under paragraph (1); and
            ``(4) take action to reduce unnecessary costs and 
        administrative burdens based on recommendations identified in 
        this subsection.
    ``(b) Strategies, Recommendations, and Actions.--
            ``(1) In general.--To achieve the goal established under 
        subsection (a)(1), the Secretary, in consultation with the 
        entities described in such subsection, shall not later than 1 
        year after the date of enactment of this section, develop 
        strategies and recommendations and take actions to meet such 
        goal in accordance with this subsection. No strategies, 
        recommendation, or action shall undermine the quality of 
        patient care or patient health outcomes.
            ``(2) Strategies.--The strategies developed under paragraph 
        (1) shall address unnecessary costs and administrative burdens. 
        Such strategies shall include broad public comment and shall 
        prioritize--
                    ``(A) recommendations identified as a result of 
                efforts undertaken to implement section 3001;
                    ``(B) recommendations and best practices identified 
                as a result of efforts undertaken under this part;
                    ``(C) a review of regulations, rules, and 
                requirements of the Department of Health and Human 
                Services that could be modified or eliminated to reduce 
                unnecessary costs and administrative burden imposed on 
                patients, providers, payers, and other stakeholders 
                across the health care system; and
                    ``(D) feedback from stakeholders in rural or 
                frontier areas on how to reduce unnecessary costs and 
                administrative burdens on the health care system in 
                those areas.
            ``(3) Recommendations.--The recommendations developed under 
        paragraph (1) shall include--
                    ``(A) actions that improve the standardization and 
                automation of administrative transactions;
                    ``(B) actions that integrate clinical and 
                administrative functions;
                    ``(C) actions that improve patient care and reduce 
                unnecessary costs and administrative burdens borne by 
                patients, their families, and other caretakers;
                    ``(D) actions that advance the development and 
                adoption of open application programming interfaces and 
                other emerging technologies to increase transparency 
                and interoperability, empower patients, and facilitate 
                better integration of clinical and administrative 
                functions;
                    ``(E) actions to be taken by the Secretary and 
                actions that need to be taken by other entities; and
                    ``(F) other areas, as the Secretary determines 
                appropriate, to reduce unnecessary costs and 
                administrative burdens required of health care 
                providers.
            ``(4) Consistency.--Any improvements in electronic 
        processes proposed by the Secretary under this section should 
        leverage existing information technology definitions under 
        Federal Law. Specifically, any electronic processes should not 
        be construed to include a facsimile, a proprietary payer portal 
        that does not meet standards specified by the Secretary, or an 
        electronic form image.
            ``(5) Actions.--The Secretary shall take action to achieve 
        the goal established under subsection (a)(1), and, not later 
        than 1 year after the date of enactment of this section, and 
        biennially thereafter, submit to Congress and make publically 
        available, a report describing the actions taken by the 
        Secretary pursuant to goals, strategies, and recommendations 
        described in this subsection.
            ``(6) FACA.--The Federal Advisory Committee Act (5 U.S.C. 
        App.) shall not apply to the development of the goal, 
        strategies, recommendations, or actions described in this 
        section.
            ``(7) Rule of construction.--Nothing in this subsection 
        shall be construed to authorize, or be used by, the Federal 
        Government to inhibit or otherwise restrain efforts made to 
        reduce waste, fraud, and abuse across the health care system.

``SEC. 282. GRANTS TO STATES TO DEVELOP AND IMPLEMENT RECOMMENDATIONS 
              TO ACCELERATE STATE INNOVATION TO REDUCE HEALTH CARE 
              ADMINISTRATIVE COSTS.

    ``(a) Grants.--
            ``(1) In general.--Not later than 6 months after the date 
        of enactment of this section, the Secretary shall award grants 
        to at least 15 States, and one coordinating entity designated 
        as provided for under subsection (e), to enable such States to 
        establish and administer private-public multi-stakeholder 
        commissions for the purpose of reducing health care 
        administrative costs and burden within and across States. Not 
        less than 3 of such grants shall be awarded to States that are 
        primarily rural, frontier, or a combination thereof, in nature.
            ``(2) Entities.--For purposes of this section, the term 
        `State' means a State, a State designated entity, or a multi-
        State collaborative (as defined by the Secretary).
            ``(3) Priority.--In awarding grants under this section, the 
        Secretary shall give priority to applications submitted by 
        States that propose to carry out a pilot program or support the 
        adoption of electronic health care transactions and operating 
        rules.
    ``(b) Application.--
            ``(1) In general.--To be eligible to receive a grant under 
        subsection (a) a State shall submit to the Secretary an 
        application in such a manner and containing such information as 
        the Secretary may reasonably require, including the information 
        described in paragraph (2).
            ``(2) Required information.--In addition to any additional 
        information required by the Secretary under this subsection, an 
        application shall include a description of--
                    ``(A) the size and composition of the commission to 
                be established under the grant, including the 
                stakeholders represented and the degree to which the 
                commission reflects important geographic and population 
                characteristics of the State;
                    ``(B) the relationship of the commission to the 
                State official responsible for coordinating and 
                implementing the recommendations resulting from the 
                commission, and the role and responsibilities of the 
                State with respect to the commission, including any 
                participation, review, oversight, implementation or 
                other related functions;
                    ``(C) the history and experience of the State in 
                addressing health care administrative costs, and any 
                experience similar to the purpose of the commission to 
                improve health care administrative processes and the 
                exchange of health care administrative data;
                    ``(D) the resources and expertise that will be made 
                available to the commission by commission members or 
                other possible sources, and how Federal funds will be 
                used to leverage and complement these resources;
                    ``(E) the governance structure and procedures that 
                the commission will follow to make, implement, and 
                pilot recommendations;
                    ``(F) the proposed objectives relating to the 
                simplification of administrative transactions and 
                operating rules, increased standardization, and the 
                efficiency and effectiveness of the transmission of 
                health information;
                    ``(G) potential cost savings and other improvements 
                in meeting the objectives described in subparagraph 
                (F); and
                    ``(H) the method or methods by which the 
                recommendations described in subsection (c) will be 
                reviewed, tested, adopted, implemented, and updated as 
                needed.
    ``(c) Multi-Stakeholder Commission.--
            ``(1) In general.--Not later than 90 days after the date on 
        which a grant is awarded to a State under this section, the 
        State official described in subsection (b)(2)(B), the State 
        insurance commissioner, or other appropriate State official 
        shall convene a multi-stakeholder commission, in accordance 
        with this subsection.
            ``(2) Membership.--The commission convened under paragraph 
        (1) shall include representatives from health plans, health 
        care providers, health vendors, relevant State agencies, health 
        care standard development organizations, and operating rule 
        entities, relevant professional and trade associations, 
        patients, and other entities determined appropriate by the 
        State.
            ``(3) Recommendations.--Not later than one year after the 
        date on which a grant is awarded to a State under this section, 
        the commission shall make recommendations and plans, consistent 
        with the application submitted by the State under subsection 
        (b), and intended to meet the objectives defined in the 
        application. Such recommendations shall comply with, and build 
        upon, all relevant Federal requirements and regulations, and 
        may include--
                    ``(A) common, uniform specifications, best 
                practices, and conventions, for the efficient, 
                effective exchange of administrative transactions 
                adopted pursuant to the Health Insurance Portability 
                and Accountability Act of 1996 (Public Law 104-191);
                    ``(B) the development of streamlined business 
                processes for the exchange and use of health care 
                administrative data; and
                    ``(C) specifications, incentives, requirements, 
                tools, mechanisms, and resources to improve--
                            ``(i) the access, exchange, and use of 
                        health care administrative information through 
                        electronic means;
                            ``(ii) the implementation of utilization 
                        management protocols; and
                            ``(iii) compliance with Federal and State 
                        laws.
    ``(d) Use of Funds for Implementation.--A State may use amounts 
received under a grant under this section for one or more of the 
following:
            ``(1) The development, implementation, and best use of 
        shared data infrastructure that supports the electronic 
        transmission of administrative data.
            ``(2) The development and provision of training and 
        educational materials, forums, and activities as well as 
        technical assistance to effectively implement, use, and benefit 
        from electronic health care transactions and operating rules.
            ``(3) To accelerate the early adoption and implementation 
        of administrative transactions and operating rules designated 
        by the Secretary and that have been adopted pursuant to the 
        Health Insurance Portability and Accountability Act of 1996 
        (Public Law 104-191), including transactions and operating 
        rules described in section 1173(a)(2) of the Social Security 
        Act.
            ``(4) To accelerate the early adoption and implementation 
        of additional or updated administrative transactions, operating 
        rules, and related data exchange standards that are being 
        considered for adoption under the Health Insurance Portability 
        and Accountability Act of 1996 or are adopted pursuant to such 
        Act, or as designated by the Secretary, including the 
        electronic claim attachment.
            ``(5) To conduct pilot projects to test approaches to 
        implement and use the electronic health care transactions and 
        operating rules in practice under a variety of different 
        settings. With respect to the electronic attachment 
        transaction, priority shall be given to pilot projects that 
        test and evaluate methods and mechanisms to most effectively 
        incorporate patient health data from electronic health records 
        and other electronic sources with the electronic attachment 
        transaction.
            ``(6) To assess barriers to the adoption, implementation, 
        and effective use of electronic health care transactions and 
        operating rules, as well as to explore, identify, and plan 
        options, approaches, and resources to address barriers and make 
        improvements.
            ``(7) The facilitation of public and private initiatives to 
        reduce administrative costs and accelerate the adoption, 
        implementation, and effective use of electronic health care 
        transactions and operating rules for State programs.
            ``(8) Developing, testing, implementing, and assessing 
        additional data exchange specifications, operating rules, 
        incentives, requirements, tools, mechanisms, and resources to 
        accelerate the adoption and effective use of the transactions 
        and operating rules.
            ``(9) Ongoing needs assessments and planning related to the 
        development and implementation of administrative simplification 
        initiatives.
    ``(e) Coordinating Entity.--
            ``(1) Functions.--Not later than 6 months after the date of 
        enactment of this section, the Secretary shall designate a 
        coordinating entity under this subsection for the purpose of--
                    ``(A) providing technical assistance to States 
                relating to the simplification of administrative 
                transactions and operating rules, increased 
                standardization, and the efficiency and effectiveness 
                of the transmission of health care information;
                    ``(B) evaluating pilot projects and other efforts 
                conducted under this section for impact and best 
                practices to inform broader national use;
                    ``(C) using consistent evaluation methodologies to 
                compare return on investment across efforts conducted 
                under this section;
                    ``(D) compiling, synthesizing, disseminating, and 
                adopting lessons learned to promote the adoption of 
                electronic health care transactions and operating rules 
                across the health care system; and
                    ``(E) making recommendations to the Secretary and 
                the National Committee on Vital and Health Statistics 
                regarding the national adoption of efforts conducted 
                under this section.
            ``(2) Eligibility.--The entity designated under paragraph 
        (1) shall be a qualified nonprofit entity that--
                    ``(A) focuses its mission on administrative 
                simplification;
                    ``(B) has demonstrated experience using a multi-
                stakeholder and consensus-based process for the 
                development of common, uniform specifications, 
                operating rules, best practices, and conventions, for 
                the efficient, effective exchange of administrative 
                transactions that includes representation by or 
                participation from health plans, health care providers, 
                vendors, States, relevant Federal agencies, and other 
                health care standard development organizations;
                    ``(C) has demonstrated experience providing 
                technical assistance to health plans, health care 
                providers, vendors, and States relating to the 
                simplification of administrative transactions and 
                operating rules, increased standardization, and the 
                efficiency and effectiveness of the transmission of 
                health care information;
                    ``(D) has demonstrated experience evaluating and 
                measuring the adoption and return on investment of 
                administrative transactions and operating rules;
                    ``(E) has demonstrated experience gathering, 
                synthesizing, and adopting common, uniform 
                specifications, operating rules, best practices, and 
                conventions for national use based on lessons learned 
                to promote the adoption of electronic health care 
                transactions and operating rules across the health care 
                system;
                    ``(F) has a public set of guiding principles that 
                ensure processes are open and transparent, and supports 
                nondiscrimination and conflict of interest policies 
                that demonstrate a commitment to open, fair, and 
                nondiscriminatory practices;
                    ``(G) builds on the transaction standards issued 
                under Health Insurance Portability and Accountability 
                Act of 1996; and
                    ``(H) allows for public review and updates of 
                common, uniform specifications, operating rules, best 
                practices, and conventions to support administrative 
                simplification.
    ``(f) Period and Amount.--A grant awarded to a State under this 
section shall be for a period of 5 years and shall not exceed 
$50,000,000 for such 5-year period. A grant awarded to the coordinating 
entity designated by the Secretary under subsection (e) shall be for a 
period of 5 years and shall not exceed $15,000,000 for such 5-year 
period.
    ``(g) Reports.--
            ``(1) States.--Not later than 1 year after receiving a 
        grant under this section, and biennially thereafter, a State 
        shall submit to the Secretary a report on the outcomes 
        experienced by the State under the grant.
            ``(2) Coordinating entity.--Not later than 1 year after 
        receiving a grant under this section, and at least biennially 
        thereafter, the coordinating entity shall submit to the 
        Secretary and the National Committee on Vital and Health 
        Statistics a report of evaluations conducted under the grant 
        under this section and recommendations regarding the national 
        adoption of efforts conducted under this section.
            ``(3) Secretary.--Not later than 6 months after the date on 
        which the States and coordinating entity submit the report 
        required under paragraphs (1) and (2), the Secretary, in 
        consultation with National Committee on Vital and Health 
        Statistics, shall submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report on the 
        outcomes achieved under the grants under this section.
            ``(4) GAO.--Not later than 6 months after the date on which 
        the Secretary submits the final report under paragraph (3), the 
        Comptroller General of the United States shall conduct a study, 
        and submit to the Committee on Health, Education, Labor, and 
        Pensions of the Senate and the Committee on Energy and Commerce 
        of the House of Representatives, a report on the outcomes of 
        the activities carried out under this section which shall 
        contain a list of best practices and recommendations to States 
        concerning administrative simplification.
    ``(h) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $250,000,000 for the 5-fiscal-
year period beginning with fiscal year 2020.''.

                       TITLE VIII--MISCELLANEOUS

SEC. 801. GUARANTEED ISSUE OF CERTAIN MEDIGAP POLICIES.

    (a) Guaranteed Issue of Medigap Policies to All Medigap-Eligible 
Medicare Beneficiaries.--
            (1) In general.--Section 1882(s) of the Social Security Act 
        (42 U.S.C. 1395ss(s)) is amended--
                    (A) in paragraph (2)(A), by striking ``65 years of 
                age or older and is enrolled for benefits under part 
                B'' and inserting ``entitled to, or enrolled for, 
                benefits under part A and enrolled for benefits under 
                part B'';
                    (B) in paragraph (2)(D), by striking ``who is 65 
                years of age or older as of the date of issuance and'';
                    (C) in paragraph (3)(B)(ii), by striking ``is 65 
                years of age or older and''; and
                    (D) in paragraph (3)(B)(vi), by striking ``at age 
                65''.
            (2) Additional enrollment period for certain individuals.--
                    (A) One-time enrollment period.--
                            (i) In general.--In the case of a specified 
                        individual, the Secretary shall establish a 
                        one-time enrollment period described in clause 
                        (iii) during which such an individual may 
                        enroll in any medicare supplemental policy of 
                        the individual's choosing.
                            (ii) Application.--The provisions of--
                                    (I) paragraph (2) of section 
                                1882(s) of the Social Security Act (42 
                                U.S.C. 1395ss(s)) shall apply with 
                                respect to a specified individual who 
                                is described in subclause (I) of 
                                subparagraph (B)(iii) as if references 
                                in such paragraph (2) to the 6 month 
                                period described in subparagraph (A) of 
                                such paragraph were references to the 
                                one-time enrollment period established 
                                under clause (i); and
                                    (II) paragraph (3) of such section 
                                shall apply with respect to a specified 
                                individual who is described in 
                                subclause (II) of subparagraph (B)(iii) 
                                as if references in such paragraph (3) 
                                to the period specified in subparagraph 
                                (E) of such paragraph were references 
                                to the one-time enrollment period 
                                established under clause (i).
                            (iii) Period.--The enrollment period 
                        established under clause (i) shall be the 6-
                        month period beginning on January 1, 2024.
                    (B) Specified individual.--For purposes of this 
                paragraph, the term ``specified individual'' means an 
                individual who--
                            (i) is entitled to hospital insurance 
                        benefits under part A of title XVIII of the 
                        Social Security Act (42 U.S.C. 1395c et seq.) 
                        pursuant to section 226(b) or section 226A of 
                        such Act (42 U.S.C. 426(b); 426-1);
                            (ii) is enrolled for benefits under part B 
                        of such Act (42 U.S.C. 1395j et seq.); and
                            (iii)(I) would not, but for the amendments 
                        made by subparagraphs (A) and (B) of paragraph 
                        (1) and the provisions of this paragraph (if 
                        such provisions applied to such individual), be 
                        eligible for the guaranteed issue of a medicare 
                        supplemental policy under paragraph (2) of 
                        section 1882(s) of such Act (42 U.S.C. 
                        1395ss(s)); or
                            (II) would not, but for the amendments made 
                        by subparagraphs (C) and (D) of paragraph (1) 
                        and the provisions of this paragraph (if such 
                        provisions applied to such individual), be 
                        eligible for the guaranteed issue of a medicare 
                        supplemental policy under paragraph (3) of such 
                        section.
                    (C) Outreach plan.--
                            (i) In general.--The Secretary shall 
                        develop an outreach plan to notify specified 
                        individuals of the one-time enrollment period 
                        established under subparagraph (A).
                            (ii) Consultation.--In implementing the 
                        outreach plan developed under clause (i), the 
                        Secretary shall consult with consumer 
                        advocates, brokers, insurers, the National 
                        Association of Insurance Commissioners, and 
                        State Health Insurance Assistance Programs.
            (3) Effective date.--The amendments made by paragraph (1) 
        shall apply to medicare supplemental policies effective on or 
        after January 1, 2024.
    (b) Guaranteed Issue of Medigap Policies for Medicare Advantage 
Enrollees.--
            (1) In general.--Section 1882(s)(3) of the Social Security 
        Act (42 U.S.C. 1395ss(s)(3)), as amended by subsection (a), is 
        further amended--
                    (A) in subparagraph (B), by adding at the end the 
                following new clause:
            ``(vii) The individual--
                    ``(I) was enrolled in a Medicare Advantage plan 
                under part C for not less than 12 months;
                    ``(II) subsequently disenrolled from such plan;
                    ``(III) elects to receive benefits under this title 
                through the original Medicare fee-for-service program 
                under parts A and B; and
                    ``(IV) has not previously elected to receive 
                benefits under this title through the original Medicare 
                fee-for-service program pursuant to disenrollment from 
                a Medicare Advantage plan under part C.'';
                    (B) by striking subparagraph (C)(iii) and inserting 
                the following:
    ``(iii) Subject to subsection (v)(1), for purposes of an individual 
described in clause (vi) or (vii) of subparagraph (B), a medicare 
supplemental policy described in this subparagraph shall include any 
medicare supplemental policy.''; and
                    (C) in subparagraph (E)--
                            (i) in clause (iv), by striking ``and'' at 
                        the end;
                            (ii) in clause (v), by striking the period 
                        at the end and inserting ``; and''; and
                            (iii) by adding at the end the following 
                        new clause--
            ``(vi) in the case of an individual described in 
        subparagraph (B)(vii), the annual, coordinated election period 
        (as defined in section 1851(e)(3)(B)) or a continuous open 
        enrollment period (as defined in section 1851(e)(2)) during 
        which the individual disenrolls from a Medicare Advantage plan 
        under part C.''.
            (2) Effective date.--The amendments made by paragraph (1) 
        shall apply to medicare supplemental policies effective on or 
        after January 1, 2024.

SEC. 802. REPORTING REQUIREMENTS FOR PDP SPONSORS REGARDING POINT-OF-
              SALE REJECTIONS UNDER MEDICARE PART D.

    Section 1860D-4(g) of the Social Security Act (42 U.S.C. 1395w-
104(g)) is amended by adding at the end the following new paragraph:
            ``(3) Reporting requirements regarding point-of-sale 
        rejections.--
                    ``(A) In general.--With respect to a plan year 
                beginning on or after January 1, 2020, a PDP sponsor 
                offering a prescription drug plan shall submit to the 
                Secretary, in a form and manner specified by the 
                Secretary, information on point-of-sale rejections made 
                during a period of time occurring in such plan year (as 
                specified by the Secretary), including each of the 
                following:
                            ``(i) The reason for each point-of-sale 
                        rejection.
                            ``(ii) Identifying information for each 
                        drug with respect to which a point-of-sale 
                        rejection was made.
                            ``(iii) With respect to applicable types of 
                        point-of-sale rejections (as specified by the 
                        Secretary), each of the following:
                                    ``(I) Whether such a rejection was 
                                consistent with the formulary of the 
                                plan (as approved by the Secretary).
                                    ``(II) Whether a coverage 
                                determination or appeal of a coverage 
                                determination was requested for the 
                                drug with respect to which such a 
                                rejection was made.
                                    ``(III) The outcome of any such 
                                coverage determination or appeal of a 
                                coverage determination.
                                    ``(IV) The length of time between 
                                when such a rejection was made and when 
                                the drug with respect to which such 
                                rejection was made is dispensed, as 
                                applicable.
                    ``(B) Public availability of information.--The 
                Secretary shall make publicly available on the public 
                website of the Centers for Medicare & Medicaid Services 
                information submitted under subparagraph (A).
                    ``(C) Use of information.--The Secretary may use 
                information submitted under subparagraph (A), as 
                determined appropriate, in developing measures for the 
                5-star rating system under section 1853(o)(4).
                    ``(D) Implementation.--Notwithstanding any other 
                provision of law, the Secretary may implement this 
                paragraph through program instruction or otherwise.
                    ``(E) Funding.--The are authorized to be 
                appropriated to the Secretary from the Federal 
                Supplementary Medical Insurance Trust Fund under 
                section 1841 such sums as may be necessary to implement 
                this paragraph.''.

SEC. 803. PROVIDING ACCESS TO ANNUAL MEDICARE NOTIFICATIONS IN MULTIPLE 
              LANGUAGES.

    (a) In General.--Section 1804 of the Social Security Act (42 U.S.C. 
1395b-2) is amended by adding at the end the following new subsection:
    ``(e) The notice provided under subsection (a) shall be translated 
into languages in addition to English and Spanish. In carrying out the 
previous sentence, the Secretary shall prioritize translation of the 
notice into languages in which documents provided by the Commissioner 
of Social Security are translated and language that are the most 
frequently requested for translation for purposes of applying for old-
age insurance benefits under title II.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply to notices distributed prior to each Medicare open enrollment 
period beginning after January 1, 2020.

SEC. 804. TEMPORARY INCREASE IN MEDICARE PART B PAYMENT FOR CERTAIN 
              BIOSIMILAR BIOLOGICAL PRODUCTS.

    Section 1847A(b)(8) of the Social Security Act (42 U.S.C. 1395w-
3a(b)(8)) is amended--
            (1) by redesignating subparagraphs (A) and (B) as clauses 
        (i) and (ii), respectively, and moving the margin of each such 
        redesignated clause 2 ems to the right;
            (2) by striking ``product.--The amount'' and inserting the 
        following: ``product.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                amount''; and
            (3) by adding at the end the following new subparagraph:
                    ``(B) Temporary payment increase.--
                            ``(i) In general.--In the case of a 
                        qualifying biosimilar biological product that 
                        is furnished during the applicable 5-year 
                        period for such product, the amount specified 
                        in this paragraph for such product with respect 
                        to such period is the sum determined under 
                        subparagraph (A), except that clause (ii) of 
                        such subparagraph shall be applied by 
                        substituting `8 percent' for `6 percent'.
                            ``(ii) Applicable 5-year period.--For 
                        purposes of clause (i), the applicable 5-year 
                        period for a biosimilar biological product is--
                                    ``(I) in the case of such a product 
                                for which payment was made under this 
                                paragraph as of December 31, 2019, the 
                                5-year period beginning on January 1, 
                                2020; and
                                    ``(II) in the case of such a 
                                product for which payment is first made 
                                under this paragraph during a calendar 
                                quarter during the period beginning 
                                January 1, 2020, and ending December 
                                31, 2024, the 5-year period beginning 
                                on the first day of such calendar 
                                quarter during which such payment is 
                                first made.
                            ``(iii) Qualifying biosimilar biological 
                        product defined.--For purposes of this 
                        subparagraph, the term `qualifying biosimilar 
                        biological product' means a biosimilar 
                        biological product described in paragraph 
                        (1)(C) with respect to which--
                                    ``(I) in the case of a product 
                                described in clause (ii)(I), the 
                                average sales price is not more than 
                                the average sales price for the 
                                reference biological product; and
                                    ``(II) in the case of a product 
                                described in clause (ii)(II), the 
                                wholesale acquisition cost is not more 
                                than the wholesale acquisition cost for 
                                the reference biological product.''.

SEC. 805. WAIVING MEDICARE COINSURANCE FOR COLORECTAL CANCER SCREENING 
              TESTS.

    Section 1833(a) of the Social Security Act (42 U.S.C. 1395l(a)) is 
amended--
            (1) in the second sentence, by striking ``section 1834(0)'' 
        and inserting ``section 1834(o)'';
            (2) by moving such second sentence 2 ems to the left; and
            (3) by inserting the following third sentence following 
        such second sentence: ``For services furnished on or after 
        January 1, 2021, paragraph (1)(Y) shall apply with respect to a 
        colorectal cancer screening test regardless of the code that is 
        billed for the establishment of a diagnosis as a result of the 
        test, or for the removal of tissue or other matter or other 
        procedure that is furnished in connection with, as a result of, 
        and in the same clinical encounter as the screening test.''.

SEC. 806. MEDICARE COVERAGE OF CERTAIN LYMPHEDEMA COMPRESSION TREATMENT 
              ITEMS.

    (a) Coverage.--
            (1) In general.--Section 1861 of the Social Security Act 
        (42 U.S.C. 1395x), as amended by section 601 and section 603, 
        is further amended--
                    (A) in subsection (s)(2)--
                            (i) in subparagraph (II), by striking 
                        ``and'' after the semicolon at the end;
                            (ii) in subparagraph (JJ), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by adding at the end the following 
                        new subparagraph:
            ``(KK) lymphedema compression treatment items (as defined 
        in subsection (mmm));''; and
                    (B) by adding at the end the following new 
                subsection:
    ``(mmm) Lymphedema Compression Treatment Items.--The term 
`lymphedema compression treatment items' means compression garments, 
devices, bandaging systems, components, and supplies, including 
multilayer compression bandaging systems, standard fit gradient 
compression garments, and other compression garments, devices, 
bandaging systems, components, or supplies (as determined by the 
Secretary), that are--
            ``(1) furnished on or after January 1, 2022, to an 
        individual with a diagnosis of lymphedema for the treatment of 
        such condition;
            ``(2) primarily and customarily used in the medical 
        treatment of lymphedema, as determined by the Secretary; and
            ``(3) prescribed by a physician (or a physician assistant, 
        nurse practitioner, or a clinical nurse specialist (as those 
        terms are defined in section 1861(aa)(5)) to the extent 
        authorized under State law).''.
            (2) Payment.--
                    (A) In general.--Section 1833(a)(1) of the Social 
                Security Act (42 U.S.C. 1395l(a)(1)), as amended by 
                section 601(c)(1), is further amended--
                            (i) by striking ``and'' before ``(DD)''; 
                        and
                            (ii) by inserting before the semicolon at 
                        the end the following: ``, and (EE) with 
                        respect to lymphedema compression treatment 
                        items (as defined in section 1861(mmm)), the 
                        amount paid shall be equal to 80 percent of the 
                        lesser of the actual charge or the amount 
                        determined under the payment basis determined 
                        under section 1834(z)''.
                    (B) Payment basis and limitations.--Section 1834 of 
                the Social Security Act (42 U.S.C. 1395m), as amended 
                by sections 601(c)(2) and 603(c), is further amended by 
                adding at the end the following new subsection:
    ``(z) Payment for Lymphedema Compression Treatment Items.--
            ``(1) In general.--The Secretary shall determine an 
        appropriate payment basis for lymphedema compression treatment 
        items (as defined in section 1861(mmm)). In making such a 
        determination, the Secretary may take into account payment 
        rates for such items under State plans (or waivers of such 
        plans) under title XIX, the Veterans Health Administration, and 
        group health plans and health insurance coverage (as such terms 
        are defined in section 2791 of the Public Health Service Act), 
        and such other information as the Secretary determines 
        appropriate.
            ``(2) Frequency limitation.--No payment may be made under 
        this part for lymphedema compression treatment items furnished 
        other than at such frequency as the Secretary may establish.
            ``(3) Application of competitive acquisition.--In the case 
        of lymphedema compression treatment items that are included in 
        a competitive acquisition program in a competitive acquisition 
        area under section 1847(a)--
                    ``(A) the payment basis under this subsection for 
                such items furnished in such area shall be the payment 
                basis determined under such competitive acquisition 
                program; and
                    ``(B) the Secretary may use information on the 
                payment determined under such competitive acquisition 
                programs to adjust the payment amount otherwise 
                determined under this subsection for an area that is 
                not a competitive acquisition area under section 1847, 
                and in the case of such adjustment, paragraphs (8) and 
                (9) of section 1842(b) shall not be applied.''.
            (3) Conforming amendments.--
                    (A) Exclusions.--Section 1862(a)(1) of the Social 
                Security Act (42 U.S.C. 1395y(a)(1)), as amended by 
                section 601(f) and section 603(g), is further amended--
                            (i) in subparagraph (Q), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (R), by striking the 
                        semicolon and inserting ``, and''; and
                            (iii) by adding at the end the following 
                        new subparagraph:
            ``(S) in the case of lymphedema compression treatment items 
        (as defined in section 1861(mmm)), which are furnished more 
        frequently than is established pursuant to section 
        1834(z)(2);''.
                    (B) Application of competitive acquisition.--
                            (i) In general.--Section 1847(a)(2) of the 
                        Social Security Act (42 U.S.C. 1395w-3(a)(2)), 
                        as amended by sections 601(e)(2)(B)(ii), 
                        602(b)(3)(B)(i), and 603(f)(2)(B), is further 
                        amended by adding at the end the following new 
                        subparagraph:
                    ``(G) Lymphedema compression treatment items.--
                Lymphedema compression treatment items (as defined in 
                section 1861(mmm)) for which payment would otherwise be 
                made under section 1834(z).''.
    (b) Inclusion in Requirements for Suppliers of Medical Equipment 
and Supplies.--Section 1834(j)(5) of the Social Security Act (42 U.S.C. 
1395m(j)(5)) is amended--
            (1) by redesignating subparagraphs (E) and (F) as 
        subparagraphs (F) and (G), respectively; and
            (2) by inserting after subparagraph (D) the following new 
        subparagraph:
                    ``(E) lymphedema compression treatment items (as 
                defined in section 1861(mmm));''.
    (c) Study and Report on Implementation.--
            (1) Study.--The Secretary of Health and Human Services (in 
        this section referred to as the ``Secretary'') shall conduct a 
        study on the implementation of Medicare coverage of certain 
        lymphedema compression treatment items under the amendments 
        made by this Act. Such study shall include an evaluation of the 
        following:
                    (A) Medicare beneficiary utilization of items and 
                services under parts A and B of title XVIII of the 
                Social Security Act as a result of the implementation 
                of such amendments.
                    (B) Whether the Secretary has determined, pursuant 
                to section 1861(mmm) of the Social Security Act, as 
                added by subsection (a)(1), that lymphedema compression 
                treatment items other than compression bandaging 
                systems and standard fit gradient compression garments 
                are covered under such section.
            (2) Report.--Not later than January 1, 2024, the Secretary 
        shall submit to Congress and make available to the public a 
        report on the study conducted under paragraph (1).

SEC. 807. PHYSICIAN FEE UPDATE.

    Section 1848(d)(19) of the Social Security Act (42 U.S.C. 1395w-
4(d)(19)) is amended to read as follows:
            ``(19) Update for 2020 through 2025.--The update to the 
        single conversion factor established in paragraph (1)(C)--
                    ``(A) for each of 2020 through 2022 shall be 0.5 
                percent; and
                    ``(B) for each of 2023 through 2025 shall be 0.0 
                percent.''.

SEC. 808. ADDITIONAL COMMUNITY HEALTH CENTER FUNDING.

    Section 10503 of the Patient Protection and Affordable Care Act (42 
U.S.C. 254b-2) is amended by striking subsection (c) and inserting the 
following:
    ``(c) Additional Enhanced Funding; Capital Projects.--There is 
authorized to be appropriated, and there is appropriated, out of any 
monies in the Treasury not otherwise appropriated, to the CHC Fund--
            ``(1) to be transferred to the Secretary of Health and 
        Human Services to provide additional enhanced funding for the 
        community health center program under section 330 of the Public 
        Health Service Act, $1,000,000,000 for each of fiscal years 
        2021 through 2025; and
            ``(2) to be transferred to the Secretary of Health and 
        Human Services for capital projects of the community health 
        center program under section 330 of the Public Health Service 
        Act, $5,000,000,000 for the period of fiscal years 2021 through 
        2025.''.

SEC. 809. GRANTS TO IMPROVE TRAUMA SUPPORT SERVICES AND MENTAL HEALTH 
              CARE FOR CHILDREN AND YOUTH IN EDUCATIONAL SETTINGS.

    (a) Grants, Contracts, and Cooperative Agreements Authorized.--The 
Secretary, in coordination with the Assistant Secretary for Mental 
Health and Substance Use, is authorized to award grants to, or enter 
into contracts or cooperative agreements with, State educational 
agencies, local educational agencies, Indian Tribes (as defined in 
section 4 of the Indian Self-Determination and Education Assistance 
Act) or their tribal educational agencies, a school operated by the 
Bureau of Indian Education, a Regional Corporation, or a Native 
Hawaiian educational organization, for the purpose of increasing 
student access to evidence-based trauma support services and mental 
health care by developing innovative initiatives, activities, or 
programs to link local school systems with local trauma-informed 
support and mental health systems, including those under the Indian 
Health Service.
    (b) Duration.--With respect to a grant, contract, or cooperative 
agreement awarded or entered into under this section, the period during 
which payments under such grant, contract, or agreement are made to the 
recipient may not exceed 4 years.
    (c) Use of Funds.--An entity that receives a grant, contract, or 
cooperative agreement under this section shall use amounts made 
available through such grant, contract, or cooperative agreement for 
evidence-based activities, which shall include any of the following:
            (1) Collaborative efforts between school-based service 
        systems and trauma-informed support and mental health service 
        systems to provide, develop, or improve prevention, screening, 
        referral, and treatment and support services to students, such 
        as providing trauma screenings to identify students in need of 
        specialized support.
            (2) To implement schoolwide positive behavioral 
        interventions and supports, or other trauma-informed models of 
        support.
            (3) To provide professional development to teachers, 
        teacher assistants, school leaders, specialized instructional 
        support personnel, and mental health professionals that--
                    (A) fosters safe and stable learning environments 
                that prevent and mitigate the effects of trauma, 
                including through social and emotional learning;
                    (B) improves school capacity to identify, refer, 
                and provide services to students in need of trauma 
                support or behavioral health services; or
                    (C) reflects the best practices for trauma-informed 
                identification, referral, and support developed by the 
                Interagency Task Force on Trauma-Informed Care.
            (4) Services at a full-service community school that 
        focuses on trauma-informed supports, which may include a full-
        time site coordinator, or other activities consistent with 
        section 4625 of the Elementary and Secondary Education Act of 
        1965 (20 U.S.C. 7275).
            (5) Engaging families and communities in efforts to 
        increase awareness of child and youth trauma, which may include 
        sharing best practices with law enforcement regarding trauma-
        informed care and working with mental health professionals to 
        provide interventions, as well as longer term coordinated care 
        within the community for children and youth who have 
        experienced trauma and their families.
            (6) To provide technical assistance to school systems and 
        mental health agencies.
            (7) To evaluate the effectiveness of the program carried 
        out under this section in increasing student access to 
        evidence-based trauma support services and mental health care.
            (8) To establish partnerships with or provide subgrants to 
        Head Start agencies (including Early Head Start agencies), 
        public and private preschool programs, child care programs 
        (including home-based providers), or other entities described 
        in subsection (a), to include such entities described in this 
        paragraph in the evidence-based trauma initiatives, activities, 
        support services, and mental health systems established under 
        this section in order to provide, develop, or improve 
        prevention, screening, referral, and treatment and support 
        services to young children and their families.
    (d) Applications.--To be eligible to receive a grant, contract, or 
cooperative agreement under this section, an entity described in 
subsection (a) shall submit an application to the Secretary at such 
time, in such manner, and containing such information as the Secretary 
may reasonably require, which shall include the following:
            (1) A description of the innovative initiatives, 
        activities, or programs to be funded under the grant, contract, 
        or cooperative agreement, including how such program will 
        increase access to evidence-based trauma support services and 
        mental health care for students, and, as applicable, the 
        families of such students.
            (2) A description of how the program will provide 
        linguistically appropriate and culturally competent services.
            (3) A description of how the program will support students 
        and the school in improving the school climate in order to 
        support an environment conducive to learning.
            (4) An assurance that--
                    (A) persons providing services under the grant, 
                contract, or cooperative agreement are adequately 
                trained to provide such services; and
                    (B) teachers, school leaders, administrators, 
                specialized instructional support personnel, 
                representatives of local Indian Tribes or tribal 
                organizations as appropriate, other school personnel, 
                and parents or guardians of students participating in 
                services under this section will be engaged and 
                involved in the design and implementation of the 
                services.
            (5) A description of how the applicant will support and 
        integrate existing school-based services with the program in 
        order to provide mental health services for students, as 
        appropriate.
            (6) A description of the entities in the community with 
        which the applicant will partner or to which the applicant will 
        provide subgrants in accordance with subsection (c)(8).
    (e) Interagency Agreements.--
            (1) Local interagency agreements.--To ensure the provision 
        of the services described in subsection (c), a recipient of a 
        grant, contract, or cooperative agreement under this section, 
        or their designee, shall establish a local interagency 
        agreement among local educational agencies, agencies 
        responsible for early childhood education programs, Head Start 
        agencies (including Early Head Start agencies), juvenile 
        justice authorities, mental health agencies, child welfare 
        agencies, and other relevant agencies, authorities, or entities 
        in the community that will be involved in the provision of such 
        services.
            (2) Contents.--In ensuring the provision of the services 
        described in subsection (c), the local interagency agreement 
        shall specify with respect to each agency, authority, or entity 
        that is a party to such agreement--
                    (A) the financial responsibility for the services;
                    (B) the conditions and terms of responsibility for 
                the services, including quality, accountability, and 
                coordination of the services; and
                    (C) the conditions and terms of reimbursement among 
                such agencies, authorities, or entities, including 
                procedures for dispute resolution.
    (f) Evaluation.--The Secretary shall reserve not more than 3 
percent of the funds made available under subsection (l) for each 
fiscal year to--
            (1) conduct a rigorous, independent evaluation of the 
        activities funded under this section; and
            (2) disseminate and promote the utilization of evidence-
        based practices regarding trauma support services and mental 
        health care.
    (g) Distribution of Awards.--The Secretary shall ensure that 
grants, contracts, and cooperative agreements awarded or entered into 
under this section are equitably distributed among the geographical 
regions of the United States and among tribal, urban, suburban, and 
rural populations.
    (h) Rule of Construction.--Nothing in this section shall be 
construed--
            (1) to prohibit an entity involved with a program carried 
        out under this section from reporting a crime that is committed 
        by a student to appropriate authorities; or
            (2) to prevent Federal, State, and tribal law enforcement 
        and judicial authorities from exercising their responsibilities 
        with regard to the application of Federal, tribal, and State 
        law to crimes committed by a student.
    (i) Supplement, Not Supplant.--Any services provided through 
programs carried out under this section shall supplement, and not 
supplant, existing mental health services, including any special 
education and related services provided under the Individuals with 
Disabilities Education Act (20 U.S.C. 1400 et seq.).
    (j) Consultation With Indian Tribes.--In carrying out subsection 
(a), the Secretary shall, in a timely manner, meaningfully consult with 
Indian Tribes and their representatives to ensure notice of 
eligibility.
    (k) Definitions.--In this section:
            (1) Elementary school.--The term ``elementary school'' has 
        the meaning given such term in section 8101 of the Elementary 
        and Secondary Education Act of 1965 (20 U.S.C. 7801).
            (2) Evidence-based.--The term ``evidence-based'' has the 
        meaning given such term in section 8101(21)(A)(i) of the 
        Elementary and Secondary Education Act of 1965 (20 U.S.C. 
        7801(21)(A)(i)).
            (3) Native hawaiian educational organization.--The term 
        ``Native Hawaiian educational organization'' has the meaning 
        given such term in section 6207 of the Elementary and Secondary 
        Education Act of 1965 (20 U.S.C. 7517).
            (4) Local educational agency.--The term ``local educational 
        agency'' has the meaning given such term in section 8101 of the 
        Elementary and Secondary Education Act of 1965 (20 U.S.C. 
        7801).
            (5) Regional corporation.--The term ``Regional 
        Corporation'' has the meaning given the term in section 3 of 
        the Alaska Native Claims Settlement Act (43 U.S.C. 1602).
            (6) School.--The term ``school'' means a public elementary 
        school or public secondary school.
            (7) School leader.--The term ``school leader'' has the 
        meaning given such term in section 8101 of the Elementary and 
        Secondary Education Act of 1965 (20 U.S.C. 7801).
            (8) Secondary school.--The term ``secondary school'' has 
        the meaning given such term in section 8101 of the Elementary 
        and Secondary Education Act of 1965 (20 U.S.C. 7801).
            (9) Secretary.--The term ``Secretary'' means the Secretary 
        of Education.
            (10) Specialized instructional support personnel.--The term 
        ``specialized instructional support personnel'' has the meaning 
        given such term in section 8101 of the Elementary and Secondary 
        Education Act of 1965 (20 U.S.C. 7801).
            (11) State educational agency.--The term ``State 
        educational agency'' has the meaning given such term in section 
        8101 of the Elementary and Secondary Education Act of 1965 (20 
        U.S.C. 7801).
    (l) Authorization of Appropriations.--There is authorized to be 
appropriated, and there is appropriated, out of any money in the 
Treasury not otherwise appropriated, to carry out this section, 
$20,000,000 for each of fiscal years 2021 through 2025.

SEC. 810. PATHWAY TO HEALTH CAREERS ACT.

    (a) Short Title.--This section may be cited as the ``Pathways to 
Health Careers Act''.
    (b) Extension Through Fiscal Year 2020 of Funding for Demonstration 
Projects to Address Health Professions Workforce Needs.--
            (1) In general.--Section 2008(c)(1) of the Social Security 
        Act (42 U.S.C. 1397g(c)(1)) is amended by striking ``2019.'' 
        and inserting ``2020, and to provide technical assistance and 
        cover administrative costs associated with implementing the 
        successor to this section $15,000,000 for fiscal year 2020.''.
            (2) Availability of other funds.--Upon the date of the 
        enactment of this section--
                    (A) amounts expended pursuant to section 1501 of 
                division B of Public Law 116-59, or any other prior law 
                making amounts available for fiscal year 2020 for 
                activities authorized by section 2008 of the Social 
                Security Act, shall be charged to the appropriation 
                made by subsection (c)(1) of such section 2008 for 
                fiscal year 2020 (not including the amount for 
                technical assistance and administrative costs); and
                    (B) if such enactment occurs on or before November 
                21, 2019, the availability of funds appropriated in, 
                and the authority provided under, such section 1501 
                shall terminate.
    (c) Career Pathways Through Health Profession Opportunity Grants.--
Effective October 1, 2020, section 2008 of the Social Security Act (42 
U.S.C. 1397g) is amended to read as follows:

``SEC. 2008. CAREER PATHWAYS THROUGH HEALTH PROFESSION OPPORTUNITY 
              GRANTS.

    ``(a) Application Requirements.--An eligible entity desiring a 
grant under this section for a project shall submit to the Secretary an 
application for the grant, that includes the following:
            ``(1) A description of how the applicant will use a career 
        pathways approach to train eligible individuals for health 
        professions that pay well or will put eligible individuals on a 
        career path to an occupation that pays well, under the project.
            ``(2) A description of the adult basic education and 
        literacy activities, work readiness activities, training 
        activities, and case management and career coaching services 
        that the applicant will use to assist eligible individuals to 
        gain work experience, connection to employers, and job 
        placement, and a description of the plan for recruiting, 
        hiring, and training staff to provide the case management, 
        mentoring, and career coaching services, under the project 
        directly or through local governmental, apprenticeship, 
        educational, or charitable institutions.
            ``(3) In the case of an application for a grant under this 
        section for a demonstration project described in subsection 
        (c)(2)(B)(i)(I)--
                    ``(A) a demonstration that the State in which the 
                demonstration project is to be conducted has in effect 
                policies or laws that permit certain allied health and 
                behavioral health care credentials to be awarded to 
                people with certain arrest or conviction records (which 
                policies or laws shall include appeals processes, 
                waivers, certificates, and other opportunities to 
                demonstrate rehabilitation to obtain credentials, 
                licensure, and approval to work in the proposed health 
                careers), and a plan described in the application that 
                will use a career pathway to assist participants with 
                such a record in acquiring credentials, licensing, and 
                employment in the specified careers;
                    ``(B) a discussion of how the project or future 
                strategic hiring decisions will demonstrate the 
                experience and expertise of the project in working with 
                job seekers who have arrest or conviction records or 
                employers with experience working with people with 
                arrest or conviction records;
                    ``(C) an identification of promising innovations or 
                best practices that can be used to provide the 
                training;
                    ``(D) a proof of concept or demonstration that the 
                applicant has done sufficient research on workforce 
                shortage or in-demand jobs for which people with 
                certain types of arrest or conviction records can be 
                hired;
                    ``(E) a plan for recruiting students who are 
                eligible individuals into the project; and
                    ``(F) a plan for providing post-employment support 
                and ongoing training as part of a career pathway under 
                the project.
            ``(4) In the case of an application for a grant under this 
        section for a demonstration project described in subsection 
        (c)(2)(B)(i)(II)--
                    ``(A) a description of the partnerships, strategic 
                staff hiring decisions, tailored program activities, or 
                other programmatic elements of the project, such as 
                training plans for doulas and other community health 
                workers and training plans for midwives and other 
                allied health professions, that are designed to support 
                a career pathway in pregnancy, birth, or post-partum 
                services; and
                    ``(B) a demonstration that the State in which the 
                demonstration project is to be conducted recognizes 
                doulas or midwives, as the case may be.
            ``(5) A demonstration that the applicant has experience 
        working with low-income populations, or a description of the 
        plan of the applicant to work with a partner organization that 
        has the experience.
            ``(6) A plan for providing post-employment support and 
        ongoing training as part of a career pathway under the project.
            ``(7) A description of the support services that the 
        applicant will provide under the project, including a plan for 
        how child care and transportation support services will be 
        guaranteed and, if the applicant will provide a cash stipend or 
        wage supplement, how the stipend or supplement would be 
        calculated and distributed.
            ``(8) A certification by the applicant that the project 
        development included--
                    ``(A) consultation with a local workforce 
                development board established under section 107 of the 
                Workforce Innovation and Opportunity Act;
                    ``(B) consideration of apprenticeship and pre-
                apprenticeship models registered under the Act of 
                August 16, 1937 (also known as the `National 
                Apprenticeship Act');
                    ``(C) consideration of career pathway programs in 
                the State in which the project is to be conducted; and
                    ``(D) a review of the State plan under section 102 
                or 103 of the Workforce Innovation and Opportunity Act.
            ``(9) A description of the availability and relevance of 
        recent labor market information and other pertinent evidence of 
        in-demand jobs or worker shortages.
            ``(10) A certification that the applicant will directly 
        provide or contract for the training services described in the 
        application.
            ``(11) A commitment by the applicant that, if the grant is 
        made to the applicant, the applicant will--
                    ``(A) during the planning period for the project, 
                provide the Secretary with any information needed by 
                the Secretary to establish adequate data reporting and 
                administrative structure for the project;
                    ``(B) hire a person to direct the project not later 
                than the end of the planning period applicable to the 
                project;
                    ``(C) accept all technical assistance offered by 
                the Secretary with respect to the grant;
                    ``(D) participate in such in-person grantee 
                conferences as are regularly scheduled by the 
                Secretary;
                    ``(E) provide all data required by the Secretary 
                under subsection (g); and
                    ``(F) notify the local disabled veterans' outreach 
                program specialists under section 4103A of title 38, 
                United States Code, and the local veterans' employment 
                representatives under section 4104 of such title, of 
                the grantee's outreach plan for advertising training 
                opportunities to potential participants in the project.
    ``(b) Preferences in Considering Applications.--In considering 
applications for a grant under this section, the Secretary shall give 
preference to--
            ``(1) applications submitted by applicants to whom a grant 
        was made under this section or any predecessor to this section;
            ``(2) applications submitted by applicants who have 
        business and community partners in each of the following 
        categories:
                    ``(A) State and local government agencies and 
                social service providers, including a State or local 
                entity that administers a State program funded under 
                part A of this title;
                    ``(B) institutions of higher education, 
                apprenticeship programs, and local workforce 
                development boards established under section 107 of the 
                Workforce Innovation and Opportunity Act; and
                    ``(C) health care employers, health care industry 
                or sector partnerships, labor unions, and labor-
                management partnerships;
            ``(3) applications that include opportunities for mentoring 
        or peer support, and make career coaching available, as part of 
        the case management plan;
            ``(4) applications which describe a project that will serve 
        a rural area in which--
                    ``(A) the community in which the individuals to be 
                enrolled in the project reside is located;
                    ``(B) the project will be conducted; or
                    ``(C) an employer partnership that has committed to 
                hiring individuals who successfully complete all 
                activities under the project is located;
            ``(5) applications that include a commitment to providing 
        project participants with a cash stipend or wage supplement; 
        and
            ``(6) applications which have an emergency cash fund to 
        assist project participants financially in emergency 
        situations.
    ``(c) Grants.--
            ``(1) Competitive grants.--
                    ``(A) Grant authority.--
                            ``(i) In general.--The Secretary, in 
                        consultation with the Secretary of Labor and 
                        the Secretary of Education, may make a grant in 
                        accordance with this paragraph to an eligible 
                        entity whose application for the grant is 
                        approved by the Secretary, to conduct a project 
                        designed to train low-income individuals for 
                        allied health professions, health information 
                        technology, physicians assistants, nursing 
                        assistants, registered nurse, advanced practice 
                        nurse, and other professions considered part of 
                        a health care career pathway model.
                            ``(ii) Guarantee of grantees in each state 
                        and the district of columbia.--For each grant 
                        cycle, the Secretary shall award a grant under 
                        this paragraph to at least 2 eligible entities 
                        in each State that is not a territory, to the 
                        extent there are a sufficient number of 
                        applications submitted by the entities that 
                        meet the requirements applicable with respect 
                        to such a grant. If, for a grant cycle, there 
                        are fewer than 2 such eligible entities in a 
                        State, the Secretary shall include that 
                        information in the report required by 
                        subsection (g)(2) that covers the fiscal year.
                    ``(B) Guarantee of grants for indian populations.--
                From the amount reserved under subsection (i)(2)(B) for 
                each fiscal year, the Secretary shall award a grant 
                under this paragraph to at least 10 eligible entities 
                that are an Indian tribe, a tribal organization, or a 
                tribal college or university, to the extent there are a 
                sufficient number of applications submitted by the 
                entities that meet the requirements applicable with 
                respect to such a grant.
                    ``(C) Guarantee of grantees in the territories.--
                From the amount reserved under subsection (i)(2)(C) for 
                each fiscal year, the Secretary shall award a grant 
                under this paragraph to at least 2 eligible entities 
                that are located in a territory, to the extent there 
                are a sufficient number of applications submitted by 
                the entities that meet the requirements applicable with 
                respect to such a grant.
            ``(2) Grants for demonstration projects.--
                    ``(A) Grant authority.--The Secretary, in 
                consultation with the Secretary of Labor and the 
                Secretary of Education (and, with respect to 
                demonstration projects of the type described in 
                subparagraph (B)(i)(I), the Attorney General) shall 
                make a grant in accordance with this subsection to an 
                eligible entity whose application for the grant is 
                approved by the Secretary, to conduct a demonstration 
                project that meets the requirements of subparagraph 
                (B).
                    ``(B) Requirements.--The requirements of this 
                subparagraph are the following:
                            ``(i) Type of project.--The demonstration 
                        project shall be of 1 of the following types:
                                    ``(I) Individuals with arrest or 
                                conviction records demonstration.--The 
                                demonstration project shall be of a 
                                type designed to provide education and 
                                training for eligible individuals with 
                                arrest or conviction records to enter 
                                and follow a career pathway in the 
                                health professions through occupations 
                                that pay well and are expected to 
                                experience a labor shortage or be in 
                                high demand.
                                    ``(II) Pregnancy and childbirth 
                                career pathway demonstration.--The 
                                demonstration project shall be of a 
                                type designed to provide education and 
                                training for eligible individuals to 
                                enter and follow a career pathway in 
                                the field of pregnancy, childbirth, or 
                                post-partum, in a State that recognizes 
                                doulas or midwives and that provides 
                                payment for services provided by doulas 
                                or midwives, as the case may be, under 
                                private or public health insurance 
                                plans.
                            ``(ii) Duration.--The demonstration project 
                        shall be conducted for not less than 5 years.
                    ``(C) Minimum allocation of funds for each type of 
                demonstration project.--
                            ``(i) Individuals with arrest or conviction 
                        records demonstrations.--Not less than 25 
                        percent of the amounts made available for 
                        grants under this paragraph shall be used to 
                        make grants for demonstration projects of the 
                        type described in subparagraph (B)(i)(I).
                            ``(ii) Pregnancy and childbirth career 
                        pathway demonstrations.--Not less than 25 
                        percent of the amounts made available for 
                        grants under this paragraph shall be used to 
                        make grants for demonstration projects of the 
                        type described in subparagraph (B)(i)(II).
            ``(3) Grant cycle.--The grant cycle under this section 
        shall be not less than 5 years, with a planning period of not 
        more than the 1st 12 months of the grant cycle. During the 
        planning period, the amount of the grant shall be in such 
        lesser amount as the Secretary determines appropriate.
    ``(d) Use of Grant.--
            ``(1) In general.--An entity to which a grant is made under 
        this section shall use the grant in accordance with the 
        approved application for the grant.
            ``(2) Support to be provided.--
                    ``(A) Required support.--A project for which a 
                grant is made under this section shall include the 
                following:
                            ``(i) An assessment for adult basic skill 
                        competency, and provision of adult basic skills 
                        education if necessary for lower-skilled 
                        eligible individuals to enroll in the project 
                        and go on to enter and complete post-secondary 
                        training, through means including the 
                        following:
                                    ``(I) Establishing a network of 
                                partners that offer pre-training 
                                activities for project participants who 
                                need to improve basic academic skills 
                                or English language proficiency before 
                                entering a health occupational training 
                                career pathway program.
                                    ``(II) Offering resources to enable 
                                project participants to continue 
                                advancing adult basic skill proficiency 
                                while enrolled in a career pathway 
                                program.
                                    ``(III) Embedding adult basic skill 
                                maintenance as part of ongoing post-
                                graduation career coaching and 
                                mentoring.
                            ``(ii) A guarantee that child care is an 
                        available and affordable support service for 
                        project participants through means such as the 
                        following:
                                    ``(I) Referral to, and assistance 
                                with, enrollment in a subsidized child 
                                care program.
                                    ``(II) Direct payment to a child 
                                care provider if a slot in a subsidized 
                                child care program is not available or 
                                reasonably accessible.
                                    ``(III) Payment of co-payments or 
                                associated fees for child care.
                            ``(iii) Case management plans that include 
                        career coaching (with the option to offer 
                        appropriate peer support and mentoring 
                        opportunities to help develop soft skills and 
                        social capital), which may be offered on an 
                        ongoing basis before, during, and after initial 
                        training as part of a career pathway model.
                            ``(iv) A plan to provide project 
                        participants with transportation through means 
                        such as the following:
                                    ``(I) Referral to, and assistance 
                                with enrollment in, a subsidized 
                                transportation program.
                                    ``(II) If a subsidized 
                                transportation program is not 
                                reasonably available, direct payments 
                                to subsidize transportation costs.
                        For purposes of this clause, the term 
                        `transportation' includes public transit, or 
                        gasoline for a personal vehicle if public 
                        transit is not reasonably accessible or 
                        available.
                            ``(v) In the case of a demonstration 
                        project of the type described in subsection 
                        (c)(2)(B)(i)(I), access to legal assistance for 
                        project participants for the purpose of 
                        addressing arrest or conviction records and 
                        associated workforce barriers.
                    ``(B) Allowed support.--The goods and services 
                provided under a project for which a grant is made 
                under this section may include the following:
                            ``(i) A cash stipend that is at least 
                        monthly.
                            ``(ii) A reserve fund for financial 
                        assistance to project participants in emergency 
                        situations.
                            ``(iii) Tuition, and training materials 
                        such as books, software, uniforms, shoes, and 
                        hair nets.
                            ``(iv) In-kind resource donations such as 
                        interview clothing and conference attendance 
                        fees.
                            ``(v) Assistance with accessing and 
                        completing high school equivalency or adult 
                        basic education courses as necessary to achieve 
                        success in the project and make progress toward 
                        career goals.
                            ``(vi) Assistance with programs and 
                        activities, including legal assistance, deemed 
                        necessary to address arrest or conviction 
                        records as an employment barrier.
                            ``(vii) Other support services as deemed 
                        necessary for family well-being, success in the 
                        project, and progress toward career goals.
                    ``(C) Treatment of support for purposes of means-
                tested programs.--Any goods or services provided to an 
                eligible individual participating in a project for 
                which a grant is made under this section shall not be 
                considered income, and shall not be taken into account 
                for purposes of determining the eligibility of the 
                individual for, or amount of benefits to be provided to 
                the individual, under any means-tested program.
            ``(3) Training.--The number of hours of training provided 
        to an eligible individual under a project for which a grant is 
        made under this section, for a recognized postsecondary 
        credential, including an industry-recognized credential, which 
        is awarded in recognition of attainment of measurable technical 
        or occupational skills necessary to gain employment or advance 
        within an occupation (including a certificate awarded by a 
        local workforce development board established under section 107 
        of the Workforce Innovation and Opportunity Act), shall be--
                    ``(A) not less than the number of hours of training 
                required for certification in that level of skill by 
                the State in which the project is conducted; or
                    ``(B) if there is no such requirement, such number 
                of hours of training as the Secretary finds is 
                necessary to achieve that skill level.
            ``(4) Income limitation.--An entity to which a grant is 
        made under this section shall not use the grant to provide 
        support to a person who is not an eligible individual.
            ``(5) Inclusion of tanf recipients.--In the case of a 
        project for which a grant is made under this section that is 
        conducted in a State that has a program funded under part A of 
        title IV, at least 10 percent of the eligible individuals to 
        whom support is provided under the project shall meet the 
        income eligibility requirements under that State program, 
        without regard to whether the individuals receive benefits or 
        services directly under that State program.
            ``(6) Prohibition.--An entity to which a grant is made 
        under this section shall not use the grant for purposes of 
        entertainment, except that case management and career coaching 
        services may include celebrations of specific career-based 
        milestones such as completing a semester, graduation, or job 
        placement.
    ``(e) Technical Assistance.--
            ``(1) In general.--The Secretary shall provide technical 
        assistance--
                    ``(A) to assist eligible entities in applying for 
                grants under this section;
                    ``(B) that is tailored to meet the needs of 
                grantees at each stage of the administration of 
                projects for which grants are made under this section;
                    ``(C) that is tailored to meet the specific needs 
                of Indian tribes, tribal organizations, and tribal 
                colleges and universities;
                    ``(D) that is tailored to meet the specific needs 
                of the territories;
                    ``(E) that is tailored to meet the specific needs 
                of eligible entities in carrying out demonstration 
                projects for which a grant is made under this section; 
                and
                    ``(F) to facilitate the exchange of information 
                among eligible entities regarding best practices and 
                promising practices used in the projects.
            ``(2) Continuation of peer technical assistance 
        conferences.--The Secretary shall continue to hold peer 
        technical assistance conferences for entities to which a grant 
        is made under this section or was made under the immediate 
        predecessor of this section.
    ``(f) Evaluation of Demonstration Projects.--
            ``(1) In general.--The Secretary shall, by grant, contract, 
        or interagency agreement, conduct rigorous and well-designed 
        evaluations of the demonstration projects for which a grant is 
        made under this section.
            ``(2) Requirement applicable to individuals with arrest or 
        conviction records demonstration.--In the case of a project of 
        the type described in subsection (c)(2)(B)(i)(I), the 
        evaluation shall include identification of successful 
        activities for creating opportunities for developing and 
        sustaining, particularly with respect to low-income individuals 
        with arrest or conviction records, a health professions 
        workforce that has accessible entry points, that meets high 
        standards for education, training, certification, and 
        professional development, and that provides increased wages and 
        affordable benefits, including health care coverage, that are 
        responsive to the needs of the workforce.
            ``(3) Requirement applicable to pregnancy and childbirth 
        career pathway demonstration.--In the case of a project of the 
        type described in subsection (c)(2)(B)(i)(II), the evaluation 
        shall include identification of successful activities for 
        creating opportunities for developing and sustaining, 
        particularly with respect to low-income individuals and other 
        entry-level workers, a career pathway that has accessible entry 
        points, that meets high standards for education, training, 
        certification, and professional development, and that provides 
        increased wages and affordable benefits, including health care 
        coverage, that are responsive to the needs of the birth, 
        pregnancy, and post-partum workforce.
            ``(4) Rule of interpretation.--Evaluations conducted 
        pursuant to this subsection may include a randomized controlled 
        trial, but this subsection shall not be interpreted to require 
        an evaluation to include such a trial.
    ``(g) Reports.--
            ``(1) To the secretary.--An eligible entity awarded a grant 
        to conduct a project under this section shall submit interim 
        reports to the Secretary on the activities carried out under 
        the project, and, on the conclusion of the project, a final 
        report on the activities. Each such report shall include data 
        on participant outcomes related to earnings, employment in 
        health professions, graduation rate, graduation timeliness, 
        credential attainment, participant demographics, and other data 
        specified by the Secretary.
            ``(2) To the congress.--During each Congress, the Secretary 
        shall submit to the Committee on Ways and Means of the House of 
        Representatives and the Committee on Finance of the Senate a 
        report--
                    ``(A) on the demographics of the participants in 
                the projects for which a grant is made under this 
                section;
                    ``(B) on the rate of which project participants 
                completed all activities under the projects;
                    ``(C) on the employment credentials acquired by 
                project participants;
                    ``(D) on the employment of project participants on 
                completion of activities under the projects, and the 
                earnings of project participants at entry into 
                employment;
                    ``(E) on best practices and promising practices 
                used in the projects;
                    ``(F) on the nature of any technical assistance 
                provided to grantees under this section;
                    ``(G) on, with respect to the period since the 
                period covered in the most recent prior report 
                submitted under this paragraph--
                            ``(i) the number of applications submitted 
                        under this section, with a separate statement 
                        of the number of applications referred to in 
                        subsection (b)(5);
                            ``(ii) the number of applications that were 
                        approved, with a separate statement of the 
                        number of such applications referred to in 
                        subsection (b)(5); and
                            ``(iii) a description of how grants were 
                        made in any case described in the last sentence 
                        of subsection (c)(1)(A)(ii); and
                    ``(H) that includes an assessment of the 
                effectiveness of the projects with respect to 
                addressing health professions workforce shortages or 
                in-demand jobs.
    ``(h) Definitions.--In this section:
            ``(1) Allied health profession.--The term `allied health 
        profession' has the meaning given in section 799B(5) of the 
        Public Health Service Act.
            ``(2) Career pathway.--The term `career pathway' has the 
        meaning given that term in section 3(7) of the Workforce 
        Innovation and Opportunity Act.
            ``(3) Doula.--The term `doula' means an individual who--
                    ``(A) is certified by an organization that has been 
                established for not less than 5 years and that requires 
                the completion of continuing education to maintain the 
                certification, to provide non-medical advice, 
                information, emotional support, and physical comfort to 
                an individual during the individual's pregnancy, 
                childbirth, and post-partum period; and
                    ``(B) maintains the certification by completing the 
                required continuing education.
            ``(4) Eligible entity.--The term `eligible entity' means 
        any of the following entities that demonstrates in an 
        application submitted under this section that the entity has 
        the capacity to fully develop and administer the project 
        described in the application:
                    ``(A) A local workforce development board 
                established under section 107 of the Workforce 
                Innovation and Opportunity Act.
                    ``(B) A State or territory, a political subdivision 
                of a State or territory, or an agency of a State, 
                territory, or such a political subdivision, including a 
                State or local entity that administers a State program 
                funded under part A of this title.
                    ``(C) An Indian tribe, a tribal organization, or a 
                tribal college or university.
                    ``(D) An institution of higher education (as 
                defined in the Higher Education Act of 1965).
                    ``(E) A hospital (as defined in section 1861(e)).
                    ``(F) A high-quality skilled nursing facility.
                    ``(G) A Federally qualified health center (as 
                defined in section 1861(aa)(4)).
                    ``(H) A nonprofit organization described in section 
                501(c)(3) of the Internal Revenue Code of 1986, a labor 
                organization, or an entity with shared labor-management 
                oversight, that has a demonstrated history of providing 
                health profession training to eligible individuals.
                    ``(I) In the case of a demonstration project of the 
                type provided for in subsection (c)(2)(B)(i)(II) of 
                this section, an entity recognized by a State, Indian 
                tribe, or tribal organization as qualified to train 
                doulas or midwives, if midwives or doulas, as the case 
                may be, are permitted to practice in the State 
                involved.
                    ``(J) An opioid treatment program (as defined in 
                section 1861(jjj)(2)), and other high quality 
                comprehensive addiction care providers.
            ``(5) Eligible individual.--The term `eligible individual' 
        means an individual whose family income does not exceed 200 
        percent of the Federal poverty level.
            ``(6) Federal poverty level.--The term `Federal poverty 
        level' means the poverty line (as defined in section 673(2) of 
        the Omnibus Budget Reconciliation Act of 1981, including any 
        revision required by such section applicable to a family of the 
        size involved).
            ``(7) Indian tribe; tribal organization.--The terms `Indian 
        tribe' and `tribal organization' have the meaning given the 
        terms in section 4 of the Indian Self-Determination and 
        Education Assistance Act (25 U.S.C. 450b).
            ``(8) Institution of higher education.--The term 
        `institution of higher education' has the meaning given the 
        term in section 101 or 102(a)(1)(B) of the Higher Education Act 
        of 1965.
            ``(9) Territory.--The term `territory' means the 
        Commonwealth of Puerto Rico, the United States Virgin Islands, 
        Guam, the Northern Mariana Islands, and American Samoa.
            ``(10) Tribal college or university.--The term `tribal 
        college or university' has the meaning given the term in 
        section 316(b) of the Higher Education Act of 1965.
    ``(i) Funding.--
            ``(1) In general.--Out of any funds in the Treasury of the 
        United States not otherwise appropriated, there are 
        appropriated to the Secretary to carry out this section 
        $425,000,000 for each of fiscal years 2021 through 2025.
            ``(2) Allocation of funds.--Of the amount appropriated for 
        a fiscal year under paragraph (1) of this subsection--
                    ``(A) 75 percent shall be available for grants 
                under subsection (c)(1)(A);
                    ``(B) 4 percent shall be reserved for grants under 
                subsection (c)(1)(B);
                    ``(C) 5 percent shall be reserved for grants under 
                subsection (c)(1)(C);
                    ``(D) 6 percent shall be available for 
                demonstration project grants under subsection (c)(2);
                    ``(E) 6 percent, plus all amounts referred to in 
                subparagraphs (A) through (D) of this paragraph that 
                remain unused after all grant awards are made for the 
                fiscal year, shall be available for the provision of 
                technical assistance and associated staffing; and
                    ``(F) 4 percent shall be available for studying the 
                effects of the demonstration and non-demonstration 
                projects for which a grant is made under this section, 
                and for associated staffing, for the purpose of 
                supporting the rigorous evaluation of the demonstration 
                projects, and supporting the continued study of the 
                short-, medium-, and long-term effects of all such 
                projects, including the effectiveness of new or added 
                elements of the non-demonstration projects.
    ``(j) Nonapplicability of Preceding Sections of This Subtitle.--
            ``(1) In general.--Except as provided in paragraph (2), the 
        preceding sections of this subtitle shall not apply to a grant 
        awarded under this section.
            ``(2) Exception for certain limitations on use of grants.--
        Section 2005(a) (other than paragraphs (2), (3), (5), (6), and 
        (8)) shall apply to a grant awarded under this section to the 
        same extent and in the same manner as such section applies to 
        payments to States under this subtitle.''.

SEC. 811. HOME VISITING TO REDUCE MATERNAL MORTALITY AND MORBIDITY ACT.

    (a) Short Title.--This section may be cited as the ``Home Visiting 
to Reduce Maternal Mortality and Morbidity Act''.
    (b) Increase in Tribal Set-aside Percentage.--
            (1) In general.--Section 511(j)(2)(A) of the Social 
        Security Act (42 U.S.C. 711(j)(2)(A)) is amended by striking 
        ``3'' and inserting ``6''.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall take effect on October 1, 2020.
    (c) Increase in Funding.--Section 511(j)(1) of such Act (42 U.S.C. 
711(j)(1)) is amended--
            (1) by striking ``and'' at the end of subparagraph (G); and
            (2) by striking subparagraph (H) and inserting the 
        following:
                    ``(H) $400,000,000 for each of fiscal years 2017 
                through 2020;
                    ``(I) $600,000,000 for fiscal year 2021; and
                    ``(J) $800,000,000 for fiscal year 2022.''.
    (d) Use of Additional Funds.--Section 511(c) of such Act (42 U.S.C. 
711(c)) is amended by adding at the end the following:
            ``(6) Use of certain funds to provide additional resources 
        to address high rates of maternal mortality and morbidity, 
        support unmet needs identified by the needs assessment, or 
        increase allocations to states and territories based on 
        relative population or poverty.--The Secretary shall ensure 
        that any amounts exceeding $400,000,000 that are used for 
        grants under this subsection for a fiscal year are used to--
                    ``(A) provide additional funding priority to 
                States, tribes, and territories to address high rates 
                of maternal mortality and morbidity;
                    ``(B) address unmet needs identified by a needs 
                assessment conducted under subsection (b); or
                    ``(C) increase the amounts allocated under this 
                section to States and to Puerto Rico, Guam, the Virgin 
                Islands, the Northern Mariana Islands, and American 
                Samoa, based on the proportion of children who have not 
                attained 5 years of age and are living in poverty.''.

SEC. 812. ADDITION OF NEW MEASURES BASED ON ACCESS TO BIOSIMILAR 
              BIOLOGICAL PRODUCTS TO THE 5-STAR RATING SYSTEM UNDER 
              MEDICARE ADVANTAGE.

    (a) In General.--Section 1853(o)(4) of the Social Security Act (42 
U.S.C. 1395w-23(o)(4)) is amended by adding at the end the following 
new subparagraph:
                    ``(E) Addition of new measures based on access to 
                biosimilar biological products.--
                            ``(i) In general.--For 2021 and subsequent 
                        years, the Secretary shall add a new set of 
                        measures to the 5-star rating system based on 
                        access to biosimilar biological products 
                        covered under part B and, in the case of MA-PD 
                        plans, such products that are covered part D 
                        drugs. Such measures shall assess the impact a 
                        plan's benefit structure may have on enrollees' 
                        utilization of or ability to access biosimilar 
                        biological products, including in comparison to 
                        the reference biological product, and shall 
                        include measures, as applicable, with respect 
                        to the following:
                                    ``(I) Coverage.--Assessing whether 
                                a biosimilar biological product is on 
                                the plan formulary in lieu of or in 
                                addition to the reference biological 
                                product.
                                    ``(II) Preferencing.--Assessing 
                                tier placement or cost-sharing for a 
                                biosimilar biological product relative 
                                to the reference biological product.
                                    ``(III) Utilization management 
                                tools.--Assessing whether and how 
                                utilization management tools are used 
                                with respect to a biosimilar biological 
                                product relative to the reference 
                                biological product.
                                    ``(IV) Utilization.--Assessing the 
                                percentage of enrollees prescribed the 
                                biosimilar biological product when the 
                                reference biological product is also 
                                available.
                            ``(ii) Definitions.--In this subparagraph, 
                        the terms `biosimilar biological product' and 
                        `reference biological product' have the meaning 
                        given those terms in section 1847A(c)(6).
                            ``(iii) Protecting patient interests.--In 
                        developing such measures, the Secretary shall 
                        ensure that each measure developed to address 
                        coverage, preferencing, or utilization 
                        management is constructed such that patients 
                        retain equal access to appropriate therapeutic 
                        options without undue administrative burden.''.
    (b) Clarification Regarding Application to Prescription Drug 
Plans.--To the extent the Secretary of Health and Human Services 
applies the 5-star rating system under section 1853(o)(4) of the Social 
Security Act (42 U.S.C. 1395w-23(o)(4)), or a similar system, to 
prescription drug plans under part D of title XVIII of such Act, the 
provisions of subparagraph (E) of such section, as added by subsection 
(a) of this section, shall apply under the system with respect to such 
plans in the same manner as such provisions apply to the 5-star rating 
system under such section 1853(o)(4).

SEC. 813. SENSE OF CONGRESS REGARDING THE IMPACT OF THE HIGH COST OF 
              PRESCRIPTION DRUGS ON COMMUNITIES OF COLOR AND PERSONS 
              LIVING IN RURAL OR SPARSELY POPULATED AREAS OF THE UNITED 
              STATES.

    It is the sense of the Congress that--
            (1) the United States has the highest drug prices in the 
        world and for millions of Americans the cost of prescription 
        drugs is increasing as a barrier to proper disease treatment, 
        especially for communities of color and for persons living in 
        rural or sparsely populated areas of the nation;
            (2) the Patient Protection and Affordable Care Act (Public 
        Law 111-148) substantially reduced the number of uninsured 
        Americans, but over 28 million Americans remain without 
        insurance and approximately 55 percent of uninsured Americans 
        under the age of 65 are persons of color;
            (3) without health insurance, paying retail prices for 
        medications is invariably burdensome or financially impossible;
            (4) the median net worth of Caucasian households in 2016 
        was 9.7 times higher than African-American households and 8.3 
        times higher than Hispanic households, which contributes to 
        disparities in negative health consequences, including for 
        example the underuse of insulin among insured adults with 
        diabetes; and
            (5) due to the high cost of prescription drugs to 
        communities of color and for persons living in rural or 
        sparsely populated areas of the nation, this Act should 
        positively impact such communities and persons (and the 
        Secretaries of Health and Human Services, Labor, and Treasury 
        should monitor such impact).

SEC. 814. REGULATIONS REQUIRING DIRECT-TO-CONSUMER ADVERTISEMENTS FOR 
              PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS TO INCLUDE 
              TRUTHFUL AND NOT MISLEADING PRICING INFORMATION.

    (a) In General.--Not later than the date that is one year after the 
date of the enactment of the Elijah E. Cummings Lower Drug Costs Now 
Act, the Secretary of Health and Human Services, acting through the 
Administrator of the Centers for Medicare & Medicaid Services (referred 
to in this section as the ``Administrator''), shall promulgate final 
regulations requiring each direct-to-consumer advertisement on 
television (including broadcast, cable, streaming, and satellite 
television) for a prescription drug or biological product for which 
payment is available under title XVIII or XIX of the Social Security 
Act to include a textual statement, which shall be truthful and not 
misleading, indicating the list price, as determined on the first day 
of the quarter during which the advertisement is being aired or 
otherwise broadcast, for a typical 30-day regimen or typical course of 
treatment (whichever is most appropriate).
    (b) Determinations.--In promulgating final regulations under 
subsection (a), the Administrator shall determine--
            (1) whether such regulations should apply with respect to 
        additional forms of advertising;
            (2) the manner and format of textual statements described 
        in such subsection;
            (3) appropriate enforcement mechanisms; and
            (4) whether such textual statements should include any 
        other price information, as appropriate.

SEC. 815. IMPROVING TRANSPARENCY AND PREVENTING THE USE OF ABUSIVE 
              SPREAD PRICING AND RELATED PRACTICES IN MEDICAID.

    (a) Pass-through Pricing Required.--
            (1) In general.--Section 1927(e) of the Social Security Act 
        (42 U.S.C. 1396r-8(e)) is amended by adding at the end the 
        following:
            ``(6) Pass-through pricing required.--A contract between 
        the State and a pharmacy benefit manager (referred to in this 
        paragraph as a `PBM'), or a contract between the State and a 
        managed care entity or other specified entity (as such terms 
        are defined in section 1903(m)(9)(D)) that includes provisions 
        making the entity responsible for coverage of covered 
        outpatient drugs dispensed to individuals enrolled with the 
        entity, shall require that payment for such drugs and related 
        administrative services (as applicable), including payments 
        made by a PBM on behalf of the State or entity, is based on a 
        pass-through pricing model under which--
                    ``(A) any payment made by the entity or the PBM (as 
                applicable) for such a drug--
                            ``(i) is limited to--
                                    ``(I) ingredient cost; and
                                    ``(II) a professional dispensing 
                                fee that is not less than the 
                                professional dispensing fee that the 
                                State plan or waiver would pay if the 
                                plan or waiver was making the payment 
                                directly;
                            ``(ii) is passed through in its entirety by 
                        the entity or PBM to the pharmacy that 
                        dispenses the drug; and
                            ``(iii) is made in a manner that is 
                        consistent with section 1902(a)(30)(A) and 
                        sections 447.512, 447.514, and 447.518 of title 
                        42, Code of Federal Regulations (or any 
                        successor regulation) as if such requirements 
                        applied directly to the entity or the PBM;
                    ``(B) payment to the entity or the PBM (as 
                applicable) for administrative services performed by 
                the entity or PBM is limited to a reasonable 
                administrative fee that covers the reasonable cost of 
                providing such services;
                    ``(C) the entity or the PBM (as applicable) shall 
                make available to the State, and the Secretary upon 
                request, all costs and payments related to covered 
                outpatient drugs and accompanying administrative 
                services incurred, received, or made by the entity or 
                the PBM, including ingredient costs, professional 
                dispensing fees, administrative fees, post-sale and 
                post-in-voice fees. Discounts, or related adjustments 
                such as direct and indirect remuneration fees, and any 
                and all remuneration; and
                    ``(D) any form of spread pricing whereby any amount 
                charged or claimed by the entity or the PBM (as 
                applicable) that is in excess of the amount paid to the 
                pharmacies on behalf of the entity, including any post-
                sale or post-invoice fees, discounts, or related 
                adjustments such as direct and indirect remuneration 
                fees or assessments (after allowing for a reasonable 
                administrative fee as described in subparagraph (B)), 
                is not allowable for purposes of claiming Federal 
                matching payments under this title.''.
            (2) Conforming amendment.--Clause (xiii) of section 
        1903(m)(2)(A) of such Act (42 U.S.C. 1396b(m)(2)(A)) is 
        amended--
                    (A) by striking ``and (III)'' and inserting 
                ``(III)''; and
                    (B) by inserting before the period at the end the 
                following: ``, and (IV) pharmacy benefit management 
                services provided by the entity, or provided by a 
                pharmacy benefit manager on behalf of the entity under 
                a contract or other arrangement between the entity and 
                the pharmacy benefit manager, shall comply with the 
                requirements of section 1927(e)(6)''.
            (3) Effective date.--The amendments made by this subsection 
        apply to contracts between States and managed care entities, 
        other specified entities, or pharmacy benefits managers that 
        are entered into or renewed on or after the date that is 18 
        months after the date of enactment of this Act.
    (b) Survey of Retail Prices.--
            (1) In general.--Section 1927(f) of the Social Security Act 
        (42 U.S.C. 1396r-8(f)) is amended--
                    (A) by striking ``and'' after the semicolon at the 
                end of paragraph (1)(A)(i) and all that precedes it 
                through ``(1)'' and inserting the following:
            ``(1) Survey of retail prices.--The Secretary shall conduct 
        a survey of retail community drug prices, to include at least 
        the national average drug acquisition cost, as follows:
                    ``(A) Use of vendor.--The Secretary may contract 
                services for--
                            ``(i) with respect to retail community 
                        pharmacies, the determination on a monthly 
                        basis of retail survey prices of the national 
                        average drug acquisition cost for covered 
                        outpatient drugs for such pharmacies, net of 
                        all discounts and rebates (to the extent any 
                        information with respect to such discounts and 
                        rebates is available), the average 
                        reimbursement received for such drugs by such 
                        pharmacies from all sources of payment, 
                        including third parties, and, to the extent 
                        available, the usual and customary charges to 
                        consumers for such drugs; and'';
                    (B) by adding at the end of paragraph (1) the 
                following:
                    ``(F) Survey reporting.--In order to meet the 
                requirement of section 1902(a)(54), a State shall 
                require that any retail community pharmacy in the State 
                that receives any payment, administrative fee, 
                discount, or rebate related to the dispensing of 
                covered outpatient drugs to individuals receiving 
                benefits under this title, regardless of whether such 
                payment, fee, discount, or rebate is received from the 
                State or a managed care entity directly or from a 
                pharmacy benefit manager or another entity that has a 
                contract with the State or a managed care entity, shall 
                respond to surveys of retail prices conducted under 
                this subsection.
                    ``(G) Survey information.--Information on retail 
                community prices obtained under this paragraph shall be 
                made publicly available and shall include at least the 
                following:
                            ``(i) The monthly response rate of the 
                        survey including a list of pharmacies not in 
                        compliance with subparagraph (F).
                            ``(ii) The sampling frame and number of 
                        pharmacies sampled monthly.
                            ``(iii) Characteristics of reporting 
                        pharmacies, including type (such as independent 
                        or chain), geographic or regional location, and 
                        dispensing volume.
                            ``(iv) Reporting of a separate national 
                        average drug acquisition cost for each drug for 
                        independent retail pharmacies and chain 
                        operated pharmacies.
                            ``(v) Information on price concessions 
                        including on and off invoice discounts, 
                        rebates, and other price concessions.
                            ``(vi) Information on average professional 
                        dispensing fees paid.
                    ``(H) Penalties.--
                            ``(i) Failure to provide timely 
                        information.--A retail community pharmacy that 
                        fails to respond to a survey conducted under 
                        this subsection on a timely basis may be 
                        subject to a civil monetary penalty in the 
                        amount of $10,000 for each day in which such 
                        information has not been provided.
                            ``(ii) False information.--A retail 
                        community pharmacy that knowingly provides 
                        false information in response to a survey 
                        conducted under this subsection may be subject 
                        to a civil money penalty in an amount not to 
                        exceed $100,000 for each item of false 
                        information.
                            ``(iii) Other penalties.--Any civil money 
                        penalties imposed under this subparagraph shall 
                        be in addition to other penalties as may be 
                        prescribed by law. The provisions of section 
                        1128A (other than subsections (a) and (b)) 
                        shall apply to a civil money penalty under this 
                        subparagraph in the same manner as such 
                        provisions apply to a penalty or proceedings 
                        under section 1128A(a).
                    ``(I) Report on specialty pharmacies.--
                            ``(i) In general.--Not later than 1 year 
                        after the effective date of this subparagraph, 
                        the Secretary shall submit a report to Congress 
                        examining specialty drug coverage and 
                        reimbursement under this title.
                            ``(ii) Content of report.--Such report 
                        shall include a description of how State 
                        Medicaid programs define specialty drugs, how 
                        much State Medicaid programs pay for specialty 
                        drugs, how States and managed care plans 
                        determine payment for specialty drugs, the 
                        settings in which specialty drugs are dispensed 
                        (such as retail community pharmacies or 
                        specialty pharmacies), whether acquisition 
                        costs for specialty drugs are captured in the 
                        national average drug acquisition cost survey, 
                        and recommendations as to whether specialty 
                        pharmacies should be included in the survey of 
                        retail prices to ensure national average drug 
                        acquisition costs capture drugs sold at 
                        specialty pharmacies and how such specialty 
                        pharmacies should be defined.'';
                    (C) in paragraph (2)--
                            (i) in subparagraph (A), by inserting ``, 
                        including payments rates under Medicaid managed 
                        care plans,'' after ``under this title''; and
                            (ii) in subparagraph (B), by inserting 
                        ``and the basis for such dispensing fees'' 
                        before the semicolon; and
                    (D) in paragraph (4), by inserting ``, and 
                $5,000,000 for fiscal year 2020 and each fiscal year 
                thereafter,'' after ``2010''.
            (2) Effective date.--The amendments made by this subsection 
        take effect on the 1st day of the 1st quarter that begins on or 
        after the date that is 18 months after the date of enactment of 
        this Act.
    (c) Manufacturer Reporting of Wholesale Acquisition Cost.--Section 
1927(b)(3) of such Act (42 U.S.C. 1396r-8(b)(3)) is amended--
            (1) in subparagraph (A)(i)--
                    (A) in subclause (I), by striking ``and'' after the 
                semicolon;
                    (B) in subclause (II), by adding ``and'' after the 
                semicolon;
                    (C) by moving the left margins of subclause (I) and 
                (II) 2 ems to the right; and
                    (D) by adding at the end the following:
                                    ``(III) in the case of rebate 
                                periods that begin on or after the date 
                                of enactment of this subclause, on the 
                                wholesale acquisition cost (as defined 
                                in section 1847A(c)(6)(B)) for covered 
                                outpatient drugs for the rebate period 
                                under the agreement (including for all 
                                such drugs that are sold under a new 
                                drug application approved under section 
                                505(c) of the Federal Food, Drug, and 
                                Cosmetic Act);''; and
            (2) in subparagraph (D)--
                    (A) in the matter preceding clause (i), by 
                inserting ``and clause (vii) of this subparagraph'' 
                after ``1847A'';
                    (B) in clause (v), by striking ``and'' after the 
                comma;
                    (C) in clause (vi), by striking the period and 
                inserting ``, and''; and
                    (D) by inserting after clause (vi) the following:
                            ``(vii) to the Secretary to disclose 
                        (through a website accessible to the public) 
                        the most recently reported wholesale 
                        acquisition cost (as defined in section 
                        1847A(c)(6)(B)) for each covered outpatient 
                        drug (including for all such drugs that are 
                        sold under a new drug application approved 
                        under section 505(c) of the Federal Food, Drug, 
                        and Cosmetic Act), as reported under 
                        subparagraph (A)(i)(III).''.

SEC. 816. GRADUATE MEDICAL EDUCATION IMPROVEMENTS IN RURAL AND 
              UNDERSERVED COMMUNITIES.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding at the end the following new 
section:

``SEC. 399V-7. GRADUATE MEDICAL EDUCATION IMPROVEMENTS IN RURAL AND 
              UNDERSERVED COMMUNITIES.

    ``(a) Rural and Underserved Community GME Grant Program.--Not later 
than 1 year after the date of the enactment of this Act, the Secretary 
of Health and Human Services (in this section referred to as the 
`Secretary'), acting through the Administrator of the Health Resources 
and Services Administration, shall establish a rural and underserved 
community graduate medical education grant program under which the 
Secretary shall award grants to specified hospitals (as defined in 
subsection (b)) that have not established an approved medical residency 
training program (as defined for purposes of section 1886(h) of the 
Social Security Act (42 U.S.C. 1395ww(h))) in order to encourage such 
hospitals to establish such a program, or to establish an affiliation 
with a hospital that has established such a program in order to host 
residents under such program.
    ``(b) Use of Funds.--Grants awarded under subsection (a) may be 
used by a specified hospital for any initial costs associated with 
establishing such a program or such an affiliation, including costs 
associated with faculty development, administration, infrastructure, 
supplies, and legal and consultant services.
    ``(c) Specified Hospital Defined.--For purposes of subsection (a), 
the term `specified hospital' means a hospital or critical access 
hospital (as such terms are defined in section 1861 of the Social 
Security Act (42 U.S.C. 1395x)) that--
            ``(1) is--
                    ``(A) located in a rural area (as defined in 
                section 1886(d)(2)(D) of such Act (42 U.S.C. 
                1395ww(d)(2)(D))); or
                    ``(B) treated as being located in a rural area 
                pursuant to section 1886(d)(8)(E) of such Act (42 
                U.S.C. 1395ww(d)(8)(E)); and
            ``(2) is located in a medically underserved area (as 
        defined in section 330I(a) of the Public Health Service Act (42 
        U.S.C. 254c-14(a))).
    ``(d) Critical Access Hospital Grant Program.--Not later than 1 
year after the date of the enactment of this Act, the Secretary, acting 
through the Administrator of the Health Resources and Services 
Administration, shall establish a grant program under which the 
Secretary awards grants to critical access hospitals (as defined in 
section 1861 of the Social Security Act (42 U.S.C. 1395x)) that do not 
have in effect an affiliation with a hospital with an approved medical 
residency training program to host residents of such program in order 
to assist such critical access hospitals in setting up such 
affiliations in order to host such residents.
    ``(e) Limitation on Grant Amounts.--No hospital may receive an 
aggregate amount of grants under this section in excess of $250,000.
    ``(f) Reports.--
            ``(1) HHS.--Not later than 5 years after the date of the 
        enactment of this Act, the Secretary of Health and Human 
        Services 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 
        graduate medical residency training programs of hospitals that 
        received a grant under subsection (a) or (d). Such report shall 
        include the following:
                    ``(A) The number of hospitals that applied for a 
                grant under this section.
                    ``(B) The number of hospitals that were awarded 
                such a grant.
                    ``(C) The number of residency positions created by 
                hospitals receiving such a grant.
                    ``(D) An estimate of the number of such positions 
                such hospitals will create after the date of the 
                submission of such report.
                    ``(E) A description of any challenges faced by 
                hospitals in applying for such a grant or using funds 
                awarded under such a grant.
            ``(2) GAO.--Not later than 10 years after the date of the 
        enactment of this Act, the Comptroller General of the United 
        States shall submit to Congress a report containing an analysis 
        of--
                    ``(A) the number of residents who trained at a 
                hospital or critical access hospital that received a 
                grant under subsection (a) or (d); and
                    ``(B) whether such residents continued to practice 
                medicine in a rural area (as defined in section 
                1886(d)(2)(D) of the Social Security Act (42 U.S.C. 
                1395ww(d)(2)(D))) or in a medically underserved area 
                (as defined in section 330I(a) of the Public Health 
                Service Act (42 U.S.C. 254c-14(a))) after completing 
                such training.
    ``(g) Funding.--There are authorized to be appropriated such sums 
as are necessary for purposes of making grants under this section for 
each of fiscal years 2020 through 2029.''.

            Passed the House of Representatives December 12, 2019.

            Attest:

                                             CHERYL L. JOHNSON,

                                                                 Clerk.
                                                       Calendar No. 521

116th CONGRESS

  2d Session

                                H. R. 3

_______________________________________________________________________

                                 AN ACT

  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.

_______________________________________________________________________

                           September 8, 2020

            Read the second time and placed on the calendar
```