Lower Costs, More Cures Act of 2021
Bill: S.2164 | Sponsor: Sen. Crapo, Mike (R-ID)
Policy area: Health

Summary:
Lower Costs, More Cures Act of 2021
This bill establishes and modifies several programs and requirements to address prescription drug prices, particularly in relation to Medicare and Medicaid.
Among other changes, the bill

To provide for certain reforms with respect to the Medicare program 
 under title XVIII of the Social Security Act, 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.

    This Act may be cited as the ``Lower Costs, More Cures Act of 
2021''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
               TITLE I--MEDICARE AND MEDICAID PROVISIONS

                 Subtitle A--Medicare Part B Provisions

Sec. 101. Improvements to Medicare site-of-service transparency.
Sec. 102. Requiring manufacturers of certain single-dose container or 
                            single-use package drugs payable under part 
                            B of the Medicare program to provide 
                            refunds with respect to discarded amounts 
                            of such drugs.
Sec. 103. Providing for variation in payment for certain drugs covered 
                            under part B of the Medicare program.
Sec. 104. Establishment of maximum add-on payment for drugs and 
                            biologicals.
Sec. 105. Treatment of drug administration services furnished by 
                            certain excepted off-campus outpatient 
                            departments of a provider.
Sec. 106. Payment for biosimilar biological products during initial 
                            period.
Sec. 107. Credit under the Medicare Merit-Based Incentive Payment 
                            System for completion of a clinical medical 
                            education program on biosimilar biological 
                            products.
Sec. 108. GAO study and report on average sales price.
                 Subtitle B--Medicare Part D Provisions

Sec. 111. Medicare part D benefit redesign.
Sec. 112. Allowing the offering of additional prescription drug plans 
                            under Medicare part D.
Sec. 113. Allowing certain enrollees of prescription drug plans and MA-
                            PD plans under the Medicare program to 
                            spread out cost-sharing under certain 
                            circumstances.
Sec. 114. Continuation of Part D Senior Savings Model.
Sec. 115. Requiring prescription drug plans and MA-PD plans to report 
                            potential fraud, waste, and abuse to the 
                            Secretary of HHS.
Sec. 116. Establishment of pharmacy quality measures under Medicare 
                            part D.
                    Subtitle C--Medicaid Provisions

Sec. 121. Price reporting clarifications for gene therapy outcomes-
                            based agreements.
Sec. 122. Anti-kickback statute and physician self-referral safe 
                            harbors.
Sec. 123. GAO study and report on use of outcomes-based agreements.
              TITLE II--DRUG PRICE TRANSPARENCY PROVISIONS

Sec. 201. Reporting on explanation for drug price increases.
Sec. 202. Public disclosure of drug discounts.
Sec. 203. Making prescription drug marketing sample information 
                            reported by manufacturers available to 
                            certain individuals and entities.
Sec. 204. Sense of the Senate regarding the need to expand commercially 
                            available drug pricing comparison 
                            platforms.
                      TITLE III--REVENUE PROVISION

Sec. 301. Inclusion of insulin and other treatments for chronic 
                            conditions as preventive care.
                   TITLE IV--MISCELLANEOUS PROVISIONS

Sec. 401. Improving coordination between the Food and Drug 
                            Administration and the Centers for Medicare 
                            & Medicaid Services.
Sec. 402. Patient consultation in Medicare national and local coverage 
                            determinations in order to mitigate 
                            barriers to inclusion of such perspectives.
Sec. 403. MedPAC report on shifting coverage of certain Medicare part B 
                            drugs to Medicare part D.
Sec. 404. Authority to require that direct-to-consumer advertisements 
                            for prescription drugs and biological 
                            products include truthful and non-
                            misleading pricing information.
Sec. 405. Chief Pharmaceutical Negotiator at the Office of the United 
                            States Trade Representative.

               TITLE I--MEDICARE AND MEDICAID PROVISIONS

                 Subtitle A--Medicare Part B Provisions

SEC. 101. IMPROVEMENTS TO MEDICARE SITE-OF-SERVICE TRANSPARENCY.

    Section 1834(t) of the Social Security Act (42 U.S.C. 1395m(t)) is 
amended--
            (1) in paragraph (1)--
                    (A) in the heading, by striking ``In general'' and 
                inserting ``Site payment'';
                    (B) in the matter preceding subparagraph (A)--
                            (i) by striking ``or to'' and inserting ``, 
                        to'';
                            (ii) by inserting ``, or to a physician for 
                        services furnished in a physician's office'' 
                        after ``surgical center under this title''; and
                            (iii) by inserting ``(or 2022 with respect 
                        to a physician for services furnished in a 
                        physician's office)'' after ``2018''; and
                    (C) in subparagraph (A)--
                            (i) by striking ``and the'' and inserting 
                        ``, the''; and
                            (ii) by inserting ``, and the physician fee 
                        schedule under section 1848 (with respect to 
                        the practice expense component of such payment 
                        amount)'' after ``such section'';
            (2) by redesignating paragraphs (2) through (4) as 
        paragraphs (3) through (5), respectively; and
            (3) by inserting after paragraph (1) the following new 
        paragraph:
            ``(2) Physician payment.--Beginning in 2022, the Secretary 
        shall expand the information included on the internet website 
        described in paragraph (1) to include--
                    ``(A) the amount paid to a physician under section 
                1848 for an item or service for the settings described 
                in paragraph (1); and
                    ``(B) the estimated amount of beneficiary liability 
                applicable to the item or service.''.

SEC. 102. REQUIRING MANUFACTURERS OF CERTAIN SINGLE-DOSE CONTAINER OR 
              SINGLE-USE PACKAGE DRUGS PAYABLE UNDER PART B OF THE 
              MEDICARE PROGRAM TO PROVIDE REFUNDS WITH RESPECT TO 
              DISCARDED AMOUNTS OF SUCH DRUGS.

    Section 1847A of the Social Security Act (42 U.S.C. 1395-3a) is 
amended--
            (1) by redesignating subsection (h) as subsection (i); and
            (2) by inserting after subsection (g) the following new 
        subsection:
    ``(h) Refund for Certain Discarded Single-Dose Container or Single-
Use Package Drugs.--
            ``(1) Secretarial provision of information.--
                    ``(A) In general.--For each calendar quarter 
                beginning on or after July 1, 2022, the Secretary 
                shall, with respect to a refundable single-dose 
                container or single-use package drug (as defined in 
                paragraph (8)), report to each manufacturer (as defined 
                in subsection (c)(6)(A)) of such refundable single-dose 
                container or single-use package drug the following for 
                the calendar quarter:
                            ``(i) Subject to subparagraph (C), 
                        information on the total number of units of the 
                        billing and payment code of such drug, if any, 
                        that were discarded during such quarter, as 
                        determined using a mechanism such as the JW 
                        modifier used as of the date of enactment of 
                        this subsection (or any such successor modifier 
                        that includes such data as determined 
                        appropriate by the Secretary).
                            ``(ii) The refund amount that the 
                        manufacturer is liable for pursuant to 
                        paragraph (3).
                    ``(B) Determination of discarded amounts.--For 
                purposes of subparagraph (A)(i), with respect to a 
                refundable single-dose container or single-use package 
                drug furnished during a quarter, the amount of such 
                drug that was discarded shall be determined based on 
                the amount of such drug that was unused and discarded 
                for each drug on the date of service.
                    ``(C) Exclusion of units of packaged drugs.--The 
                total number of units of the billing and payment code 
                of a refundable single-dose container or single-use 
                package drug of a manufacturer furnished during a 
                calendar quarter for purposes of subparagraph (A)(i), 
                and the determination of the estimated total allowed 
                charges for the drug in the quarter for purposes of 
                paragraph (3)(A)(ii), shall not include such units that 
                are packaged into the payment amount for an item or 
                service and are not separately payable.
            ``(2) Manufacturer requirement.--For each calendar quarter 
        beginning on or after July 1, 2022, the manufacturer of a 
        refundable single-dose container or single-use package drug 
        shall, for such drug, provide to the Secretary a refund that is 
        equal to the amount specified in paragraph (3) for such drug 
        for such quarter.
            ``(3) Refund amount.--
                    ``(A) In general.--The amount of the refund 
                specified in this paragraph is, with respect to a 
                refundable single-dose container or single-use package 
                drug of a manufacturer assigned to a billing and 
                payment code for a calendar quarter beginning on or 
                after July 1, 2022, an amount equal to the estimated 
                amount (if any) by which--
                            ``(i) the product of--
                                    ``(I) the total number of units of 
                                the billing and payment code for such 
                                drug that were discarded during such 
                                quarter (as determined under paragraph 
                                (1)); and
                                    ``(II)(aa) in the case of a 
                                refundable single-dose container or 
                                single-use package drug that is a 
                                single source drug or biological, the 
                                amount determined for such drug under 
                                subsection (b)(4); or
                                    ``(bb) in the case of a refundable 
                                single-dose container or single-use 
                                package drug that is a biosimilar 
                                biological product, the average sales 
                                price determined under subsection 
                                (b)(8)(A); exceeds
                            ``(ii) an amount equal to the applicable 
                        percentage (as defined in subparagraph (B)) of 
                        the estimated total allowed charges for such 
                        drug during the quarter.
                    ``(B) Applicable percentage defined.--
                            ``(i) In general.--For purposes of 
                        subparagraph (A)(ii), the term `applicable 
                        percentage' means--
                                    ``(I) subject to subclause (II), 10 
                                percent; and
                                    ``(II) if applicable, in the case 
                                of a refundable single-dose container 
                                or single-use package drug described in 
                                clause (ii), a percentage specified by 
                                the Secretary pursuant to such clause.
                            ``(ii) Treatment of drugs that have unique 
                        circumstances.--In the case of a refundable 
                        single-dose container or single-use package 
                        drug that has unique circumstances involving 
                        similar loss of product as that described in 
                        paragraph (8)(B), the Secretary, through notice 
                        and comment rulemaking, may increase the 
                        applicable percentage otherwise applicable 
                        under clause (i)(I) as determined appropriate 
                        by the Secretary.
            ``(4) Frequency.--Amounts required to be refunded pursuant 
        to paragraph (2) shall be paid in regular intervals (as 
        determined appropriate by the Secretary).
            ``(5) Refund deposits.--Amounts paid as refunds pursuant to 
        paragraph (2) shall be deposited into the Federal Supplementary 
        Medical Insurance Trust Fund established under section 1841.
            ``(6) Enforcement.--
                    ``(A) Audits.--
                            ``(i) Manufacturer audits.--Each 
                        manufacturer of a refundable single-dose 
                        container or single-use package drug that is 
                        required to provide a refund under this 
                        subsection shall be subject to periodic audit 
                        with respect to such drug and such refunds by 
                        the Secretary.
                            ``(ii) Provider audits.--The Secretary 
                        shall conduct periodic audits of claims 
                        submitted under this part with respect to 
                        refundable single-dose container or single-use 
                        package drugs in accordance with the authority 
                        under section 1833(e) to ensure compliance with 
                        the requirements applicable under this 
                        subsection.
                    ``(B) Civil money penalty.--
                            ``(i) In general.--The Secretary shall 
                        impose a civil money penalty on a manufacturer 
                        of a refundable single-dose container or 
                        single-use package drug who has failed to 
                        comply with the requirement under paragraph (2) 
                        for such drug for a calendar quarter in an 
                        amount equal to the sum of--
                                    ``(I) the amount that the 
                                manufacturer would have paid under such 
                                paragraph with respect to such drug for 
                                such quarter; and
                                    ``(II) 25 percent of such amount.
                            ``(ii) Application.--The provisions of 
                        section 1128A (other than subsections (a) and 
                        (b)) shall apply to a civil money penalty under 
                        this subparagraph in the same manner as such 
                        provisions apply to a penalty or proceeding 
                        under section 1128A(a).
            ``(7) Implementation.--The Secretary shall implement this 
        subsection through notice and comment rulemaking.
            ``(8) Definition of refundable single-dose container or 
        single-use package drug.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), in this subsection, the term 
                `refundable single-dose container or single-use package 
                drug' means a single source drug or biological (as 
                defined in section 1847A(c)(6)(D)) or a biosimilar 
                biological product (as defined in section 
                1847A(c)(6)(H)) for which payment is established under 
                this part and that is furnished from a single-dose 
                container or single-use package.
                    ``(B) Exclusions.--The term `refundable single-dose 
                container or single-use package drug' does not 
                include--
                            ``(i) a drug or biological that is either a 
                        radiopharmaceutical or an imaging agent;
                            ``(ii) a drug or biological for which 
                        dosage and administration instructions approved 
                        by the Commissioner of Food and Drugs require 
                        filtration during the drug preparation process, 
                        prior to dilution and administration, and 
                        require that any unused portion of such drug 
                        after the filtration process be discarded after 
                        the completion of such filtration process; or
                            ``(iii) a drug or biological approved by 
                        the Food and Drug Administration on or after 
                        the date of enactment of this subsection and 
                        with respect to which payment has been made 
                        under this part for less than 18 months.''.

SEC. 103. PROVIDING FOR VARIATION IN PAYMENT FOR CERTAIN DRUGS COVERED 
              UNDER PART B OF THE MEDICARE PROGRAM.

    (a) In General.--Section 1847A(b) of the Social Security Act (42 
U.S.C. 1395w-3a(b)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A), by inserting after ``or 
                106 percent'' the following: ``(or, for a multiple 
                source drug (other than autologous cellular 
                immunotherapy) furnished on or after January 1, 2022, 
                the applicable percent specified in paragraph (9)(A) 
                for the drug and quarter involved)''; and
                    (B) in subparagraph (B) of paragraph (1), by 
                inserting after ``106 percent'' the following: ``(or, 
                for a single source drug or biological (other than 
                autologous cellular immunotherapy) furnished on or 
                after January 1, 2022, the applicable percent specified 
                in paragraph (9)(A) for the drug or biological and 
                quarter involved)''; and
            (2) by adding at the end the following new paragraph:
            ``(9) Application of variable percentages based on 
        percentile ranking of per beneficiary allowed charges.--
                    ``(A) Applicable percent to be applied.--
                            ``(i) In general.--Subject to clause (ii), 
                        with respect to a drug or biological furnished 
                        in a calendar quarter beginning on or after 
                        January 1, 2022, if the Secretary determines 
                        that the percentile rank of a drug or 
                        biological under subparagraph (B)(i)(III), with 
                        respect to per beneficiary allowed charges for 
                        all such drugs or biologicals, is--
                                    ``(I) at least equal to the 85th 
                                percentile, the applicable percent for 
                                the drug for such quarter under this 
                                subparagraph is 104 percent;
                                    ``(II) at least equal to the 70th 
                                percentile, but less than the 85th 
                                percentile, such applicable percent is 
                                106 percent;
                                    ``(III) at least equal to the 50th 
                                percentile, but less than the 70th 
                                percentile, such applicable percent is 
                                108 percent; or
                                    ``(IV) less than the 50th 
                                percentile, such applicable percent is 
                                110 percent.
                            ``(ii) Cases where data not sufficiently 
                        available to compute per beneficiary allowed 
                        charges.--Subject to clause (iii), in the case 
                        of a drug or biological furnished for which the 
                        amount of payment is determined under 
                        subparagraph (A) or (B) of paragraph (1) and 
                        not under subsection (c)(4), for calendar 
                        quarters during a period in which data are not 
                        sufficiently available to compute a per 
                        beneficiary allowed charges for the drug or 
                        biological, the applicable percent is 106 
                        percent.
                    ``(B) Determination of percentile rank of per 
                beneficiary allowed charges of drugs.--
                            ``(i) In general.--With respect to a 
                        calendar quarter beginning on or after January 
                        1, 2022, for drugs and biologicals for which 
                        the amount of payment is determined under 
                        subparagraph (A) or (B) of paragraph (1), 
                        except for drugs or biologicals for which data 
                        are not sufficiently available, the Secretary 
                        shall--
                                    ``(I) compute the per beneficiary 
                                allowed charges (as defined in 
                                subparagraph (C)) for each such drug or 
                                biological;
                                    ``(II) adjust such per beneficiary 
                                allowed charges for the quarter, to the 
                                extent provided under subparagraph (D); 
                                and
                                    ``(III) arrange such adjusted per 
                                beneficiary allowed charges for all 
                                such drugs or biologicals from high to 
                                low and rank such drugs or biologicals 
                                by percentile of such per beneficiary 
                                allowed charges.
                            ``(ii) Frequency.--The Secretary shall make 
                        the computations under clause (i)(I) every 6 
                        months (or, if necessary, as determined by the 
                        Secretary, every 9 or 12 months) and such 
                        computations shall apply to succeeding calendar 
                        quarters until a new computation has been made.
                            ``(iii) Applicable data period.--For 
                        purposes of this paragraph, the term 
                        `applicable data period' means the most recent 
                        period for which the data necessary for making 
                        the computations under clause (i) are 
                        available, as determined by the Secretary.
                    ``(C) Per beneficiary allowed charges defined.--In 
                this paragraph, the term `per beneficiary allowed 
                charges' means, with respect to a drug or biological 
                for which the amount of payment is determined under 
                subparagraph (A) or (B) of paragraph (1)--
                            ``(i) the allowed charges for the drug or 
                        biological for which payment is so made for the 
                        applicable data period, as estimated by the 
                        Secretary; divided by
                            ``(ii) the number of individuals for whom 
                        any payment for the drug or biological was made 
                        under paragraph (1) for the applicable data 
                        period, as estimated by the Secretary.
                    ``(D) Adjustment to reflect changes in average 
                sales price.--In applying this paragraph for a 
                particular calendar quarter, the Secretary shall adjust 
                the per beneficiary allowed charges for a drug or 
                biological by multiplying such per beneficiary allowed 
                charges under subparagraph (C) for the applicable data 
                period by the ratio of--
                            ``(i) the average sales price for the drug 
                        or biological for the most recent calendar 
                        quarter used under subsection (c)(5)(B); to
                            ``(ii) the average sales price for the drug 
                        or biological for the calendar quarter (or the 
                        weighted average for the quarters involved) 
                        included in the applicable data period.''.
    (b) Application of Judicial Review Provisions.--Section 1847A(i) of 
the Social Security Act (42 U.S.C. 1395w-3a(i)), as redesignated by 
section 102, is amended--
            (1) by striking ``and'' at the end of paragraph (4);
            (2) by striking the period at the end of paragraph (5) and 
        inserting ``; and''; and
            (3) by adding at the end the following new paragraph:
            ``(6) the determination of per beneficiary allowed charges 
        of drugs or biologicals and ranking of such charges under 
        subsection (b)(9).''.

SEC. 104. ESTABLISHMENT OF MAXIMUM ADD-ON PAYMENT FOR DRUGS AND 
              BIOLOGICALS.

    (a) In General.--Section 1847A of the Social Security Act (42 
U.S.C. 1395w-3a), as amended by section 103, is amended--
            (1) in subsection (b)--
                    (A) in paragraph (1), in the matter preceding 
                subparagraph (A), by striking ``paragraph (7)'' and 
                inserting ``paragraphs (7) and (10)''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(10) Maximum add-on payment amount.--
                    ``(A) In general.--In determining the payment 
                amount under the provisions of subparagraph (A), (B), 
                or (C) of paragraph (1) of this subsection, subsection 
                (c)(4)(A)(ii), or subsection (d)(3)(C) for a drug or 
                biological furnished on or after January 1, 2022, if 
                the applicable add-on payment (as defined in 
                subparagraph (B)) for each drug or biological on a 
                claim for a date of service exceeds the maximum add-on 
                payment amount specified under subparagraph (C) for the 
                drug or biological, then the payment amount otherwise 
                determined for the drug or biological under those 
                provisions, as applicable, shall be reduced by the 
                amount of such excess.
                    ``(B) Applicable add-on payment defined.--In this 
                paragraph, the term `applicable add-on payment' means 
                the following amounts, determined without regard to the 
                application of subparagraph (A):
                            ``(i) In the case of a multiple source 
                        drug, an amount equal to the difference 
                        between--
                                    ``(I) the amount that would 
                                otherwise be applied under paragraph 
                                (1)(A); and
                                    ``(II) the amount that would be 
                                applied under such paragraph if `100 
                                percent' were substituted for the 
                                applicable percent (as defined in 
                                paragraph (9)) for such drug.
                            ``(ii) In the case of a single source drug 
                        or biological, an amount equal to the 
                        difference between--
                                    ``(I) the amount that would 
                                otherwise be applied under paragraph 
                                (1)(B); and
                                    ``(II) the amount that would be 
                                applied under such paragraph if `100 
                                percent' were substituted for the 
                                applicable percent (as defined in 
                                paragraph (9)) for such drug or 
                                biological.
                            ``(iii) In the case of a biosimilar 
                        biological product, the amount otherwise 
                        determined under paragraph (8)(B).
                            ``(iv) In the case of a drug or biological 
                        during the initial period described in 
                        subsection (c)(4)(A), an amount equal to the 
                        difference between--
                                    ``(I) the amount that would 
                                otherwise be applied under subsection 
                                (c)(4)(A)(ii); and
                                    ``(II) the amount that would be 
                                applied under such subsection if `100 
                                percent' were substituted, as 
                                applicable, for--
                                            ``(aa) `103 percent' in 
                                        subclause (I) of such 
                                        subsection; or
                                            ``(bb) any percent in 
                                        excess of 100 percent applied 
                                        under subclause (II) of such 
                                        subsection.
                            ``(v) In the case of a drug or biological 
                        to which subsection (d)(3)(C) applies, an 
                        amount equal to the difference between--
                                    ``(I) the amount that would 
                                otherwise be applied under such 
                                subsection; and
                                    ``(II) the amount that would be 
                                applied under such subsection if `100 
                                percent' were substituted, as 
                                applicable, for--
                                            ``(aa) any percent in 
                                        excess of 100 percent applied 
                                        under clause (i) of such 
                                        subsection; or
                                            ``(bb) `103 percent' in 
                                        clause (ii) of such subsection.
                    ``(C) Maximum add-on payment amount specified.--For 
                purposes of subparagraph (A), the maximum add-on 
                payment amount specified in this subparagraph is--
                            ``(i) with respect to a drug or biological 
                        (other than autologous or allogeneric cellular 
                        immunotherapy)--
                                    ``(I) for each of 2022 through 
                                2029, $1,000; and
                                    ``(II) for a subsequent year, the 
                                amount specified in this subparagraph 
                                for the preceding year increased by the 
                                percentage increase in the consumer 
                                price index for all urban consumers 
                                (all items; United States city average) 
                                for the 12-month period ending with 
                                June of the previous year; or
                            ``(ii) with respect to a drug or biological 
                        consisting of autologous or allogeneric 
                        cellular immunotherapy--
                                    ``(I) for each of 2022 through 
                                2029, $2,000; and
                                    ``(II) for a subsequent year, the 
                                amount specified in this subparagraph 
                                for the preceding year increased by the 
                                percentage increase in the consumer 
                                price index for all urban consumers 
                                (all items; United States city average) 
                                for the 12-month period ending with 
                                June of the previous year.
                Any amount determined under this subparagraph that is 
                not a multiple of $10 shall be rounded to the nearest 
                multiple of $10.''; and
            (2) in subsection (c)(4)(A)(ii), by striking ``in the 
        case'' and inserting ``subject to subsection (b)(10), in the 
        case''.
    (b) Conforming Amendments Relating to Separately Payable Drugs.--
            (1) OPPS.--Section 1833(t)(14) of the Social Security Act 
        (42 U.S.C. 1395l(t)(14)) is amended--
                    (A) in subparagraph (A)(iii)(II), by inserting ``, 
                subject to subparagraph (I)'' after ``are not 
                available''; and
                    (B) by adding at the end the following new 
                subparagraph:
                    ``(I) Application of maximum add-on payment for 
                separately payable drugs and biologicals.--In 
                establishing the amount of payment under subparagraph 
                (A) for a specified covered outpatient drug that is 
                furnished as part of a covered OPD service (or group of 
                services) on or after January 1, 2022, if such payment 
                is determined based on the average price for the year 
                established under section 1847A pursuant to clause 
                (iii)(II) of such subparagraph, the provisions of 
                subsection (b)(10) of section 1847A shall apply to the 
                amount of payment so established in the same manner as 
                such provisions apply to the amount of payment under 
                section 1847A.''.
            (2) ASC.--Section 1833(i)(2)(D) of the Social Security Act 
        (42 U.S.C. 1395l(i)(2)(D)) is amended--
                    (A) by moving clause (v) 6 ems to the left;
                    (B) by redesignating clause (vi) as clause (vii); 
                and
                    (C) by inserting after clause (v) the following new 
                clause:
                            ``(vi) If there is a separate payment under 
                        the system described in clause (i) for a drug 
                        or biological furnished on or after January 1, 
                        2022, the provisions of subsection (t)(14)(I) 
                        shall apply to the establishment of the amount 
                        of payment for the drug or biological under 
                        such system in the same manner in which such 
                        provisions apply to the establishment of the 
                        amount of payment under subsection 
                        (t)(14)(A).''.

SEC. 105. TREATMENT OF DRUG ADMINISTRATION SERVICES FURNISHED BY 
              CERTAIN EXCEPTED OFF-CAMPUS OUTPATIENT DEPARTMENTS OF A 
              PROVIDER.

    Section 1833(t)(16) of the Social Security Act (42 U.S.C. 
1395l(t)(16)) is amended by adding at the end the following new 
subparagraph:
                    ``(G) Special payment rule for drug administration 
                services furnished by an excepted department of a 
                provider.--
                            ``(i) In general.--In the case of a covered 
                        OPD service that is a drug administration 
                        service (as defined by the Secretary) furnished 
                        by a department of a provider described in 
                        clause (ii) or (iv) of paragraph (21)(B), the 
                        payment amount for such service furnished on or 
                        after January 1, 2022, shall be the same 
                        payment amount (as determined in paragraph 
                        (21)(C)) that would apply if the drug 
                        administration service was furnished by an off-
                        campus outpatient department of a provider (as 
                        defined in paragraph (21)(B)).
                            ``(ii) Application without regard to budget 
                        neutrality.--The reductions made under this 
                        subparagraph--
                                    ``(I) shall not be considered an 
                                adjustment under paragraph (2)(E); and
                                    ``(II) shall not be implemented in 
                                a budget neutral manner.''.

SEC. 106. PAYMENT FOR BIOSIMILAR BIOLOGICAL PRODUCTS DURING INITIAL 
              PERIOD.

    Section 1847A(c)(4) of the Social Security Act (42 U.S.C. 1395w-
3a(c)(4)) is amended--
            (1) in each of subparagraphs (A) and (B), by redesignating 
        clauses (i) and (ii) as subclauses (I) and (II), respectively, 
        and moving such subclauses 2 ems to the right;
            (2) by redesignating subparagraphs (A) and (B) as clauses 
        (i) and (ii) and moving such clauses 2 ems to the right;
            (3) by striking ``unavailable.--In the case'' and inserting 
        ``unavailable.--
                    ``(A) In general.--Subject to subparagraph (B), in 
                the case''; and
            (4) by adding at the end the following new subparagraph:
                    ``(B) Limitation on payment amount for biosimilar 
                biological products during initial period.--In the case 
                of a biosimilar biological product furnished on or 
                after January 1, 2022, in lieu of applying subparagraph 
                (A) during the initial period described in such 
                subparagraph with respect to the biosimilar biological 
                product, the amount payable under this section for the 
                biosimilar biological product is the lesser of the 
                following:
                            ``(i) The amount determined under clause 
                        (ii) of such subparagraph for the biosimilar 
                        biological product.
                            ``(ii) The amount determined under 
                        subsection (b)(1)(B) for the reference 
                        biological product.''.

SEC. 107. CREDIT UNDER THE MEDICARE MERIT-BASED INCENTIVE PAYMENT 
              SYSTEM FOR COMPLETION OF A CLINICAL MEDICAL EDUCATION 
              PROGRAM ON BIOSIMILAR BIOLOGICAL PRODUCTS.

    Section 1848(q)(5)(C) of the Social Security Act (42 U.S.C. 1395w-
4(q)(5)(C)) is amended by adding at the end the following new clause:
                            ``(iv) Clinical medical education program 
                        on biosimilar biological products.--Completion 
                        of a clinical medical education program 
                        developed or improved under section 352A(b) of 
                        the Public Health Service Act by a MIPS 
                        eligible professional during a performance 
                        period shall earn such eligible professional 
                        one-half of the highest potential score for the 
                        performance category described in paragraph 
                        (2)(A)(iii) for such performance period. A MIPS 
                        eligible professional may only count the 
                        completion of such a program for purposes of 
                        such category one time during the eligible 
                        professional's lifetime.''.

SEC. 108. GAO STUDY AND REPORT ON AVERAGE SALES PRICE.

    (a) Study.--
            (1) In general.--The Comptroller General of the United 
        States (in this section referred to as the ``Comptroller 
        General'') shall conduct a study on spending for applicable 
        drugs under part B of title XVIII of the Social Security Act.
            (2) Applicable drugs defined.--In this section, the term 
        ``applicable drugs'' means drugs and biologicals--
                    (A) for which reimbursement under such part B is 
                based on the average sales price of the drug or 
                biological; and
                    (B) that account for the largest percentage of 
                total spending on drugs and biologicals under such part 
                B (as determined by the Comptroller General, but in no 
                case less than 25 drugs or biologicals).
            (3) Requirements.--The study under paragraph (1) shall 
        include an analysis of the following:
                    (A) The extent to which each applicable drug is 
                paid for--
                            (i) under such part B for Medicare 
                        beneficiaries; or
                            (ii) by private payers in the commercial 
                        market.
                    (B) Any change in Medicare spending or Medicare 
                beneficiary cost-sharing that would occur if the 
                average sales price of an applicable drug was based 
                solely on payments by private payers in the commercial 
                market.
                    (C) The extent to which drug manufacturers provide 
                rebates, discounts, or other price concessions to 
                private payers in the commercial market for applicable 
                drugs, which the manufacturer includes in its average 
                sales price calculation, for--
                            (i) formulary placement;
                            (ii) utilization management considerations; 
                        or
                            (iii) other purposes.
                    (D) Barriers to drug manufacturers providing such 
                price concessions for applicable drugs.
                    (E) Other areas determined appropriate by the 
                Comptroller General.
    (b) Report.--Not later than 2 years after the date of the enactment 
of this Act, the Comptroller General shall submit to Congress a report 
on the study conducted under subsection (a), together with 
recommendations for such legislation and administrative action as the 
Secretary determines appropriate.

                 Subtitle B--Medicare Part D Provisions

SEC. 111. 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)--
                            (i) 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)'';
                            (ii) in clause (i), by inserting after ``25 
                        percent'' the following: ``(or, for 2022 and 
                        each subsequent year, 15 percent)''; and
                            (iii) in clause (ii), by inserting ``(or, 
                        for 2022 and each subsequent year, 15 
                        percent)'' after ``25 percent'';
                    (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 indenting 
                                appropriately;
                                    (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)--
                                    (I) by striking ``clause (i)(I)'' 
                                and inserting ``clause (i)(I)(aa)''; 
                                and
                                    (II) by adding at the end the 
                                following new sentence: ``The Secretary 
                                shall continue to calculate the dollar 
                                amounts specified in clause (i)(I)(aa), 
                                including with the adjustment under 
                                this clause, after 2021 for purposes of 
                                section 1860D-14(a)(1)(D)(iii).'';
                    (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 
                                $3,100; 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 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--
            (1) by striking ``equal to 80 percent'' and inserting 
        ``equal to--
                    ``(A) for a year preceding 2022, 80 percent'';
            (2) in subparagraph (A), as added by paragraph (1), by 
        striking the period at the end and inserting ``; and''; and
            (3) by adding at the end the following new subparagraph:
                    ``(B) for 2022 and each subsequent year, the sum 
                of--
                            ``(i) an amount equal to 20 percent of the 
                        allowable reinsurance costs (as specified in 
                        paragraph (2)) attributable to that portion of 
                        gross covered prescription drug costs as 
                        specified in paragraph (3) incurred in the 
                        coverage year after such individual has 
                        incurred costs that exceed the annual out-of-
                        pocket threshold specified in section 1860D-
                        2(b)(4)(B) with respect to applicable drugs (as 
                        defined in section 1860D-14B(g)(2)); and
                            ``(ii) an amount equal to 30 percent of the 
                        allowable reinsurance costs (as specified in 
                        paragraph (2)) attributable to that portion of 
                        gross covered prescription drug costs as 
                        specified in paragraph (3) incurred in the 
                        coverage year after such individual has 
                        incurred costs that exceed the annual out-of-
                        pocket threshold specified in section 1860D-
                        2(b)(4)(B) with respect to covered part D drugs 
                        that are not applicable drugs (as so 
                        defined).''.
    (c) Manufacturer Discount Program.--
            (1) In general.--Part D of title XVIII of the Social 
        Security Act is amended by inserting after section 1860D-14A 
        (42 U.S.C. 1495w-114) the following new section:

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

    ``(a) Establishment.--The Secretary shall establish a manufacturer 
discount program (in this section referred to as the `program'). Under 
the program, the Secretary shall enter into agreements described in 
subsection (b) with manufacturers and provide for the performance of 
the duties described in subsection (c). The Secretary shall establish a 
model agreement for use under the program by not later than January 1, 
2023, in consultation with manufacturers, and allow for comment on such 
model agreement.
    ``(b) Terms of Agreement.--
            ``(1) In general.--
                    ``(A) Agreement.--An agreement under this section 
                shall require the manufacturer to provide applicable 
                beneficiaries access to discounted prices for 
                applicable drugs of the manufacturer that are dispensed 
                on or after January 1, 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.
            ``(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.
            ``(5) Effective date of agreement.--An agreement under this 
        section shall take effect on a date determined appropriate by 
        the Secretary, which may be at the start of a calendar quarter.
    ``(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 one or more third parties to 
        administer the requirements established by the Secretary in 
        order to carry out this section. At a minimum, the contract 
        with a third party under the preceding sentence shall require 
        that the third party--
                    ``(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) 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 shall impose a 
                civil money penalty on a manufacturer that fails to 
                provide applicable beneficiaries discounts for 
                applicable drugs of the manufacturer in accordance with 
                such agreement for each such failure in an amount the 
                Secretary determines is commensurate with the sum of--
                            ``(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 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 for covered part D drugs 
                in the year that are equal to or exceed the annual 
                deductible specified in section 1860D-2(b)(1) for such 
                year.
            ``(2) Applicable drug.--The term `applicable drug' means, 
        with respect to an applicable beneficiary, a covered part D 
        drug--
                    ``(A) approved under a new drug application under 
                section 505(c) of the Federal Food, Drug, and Cosmetic 
                Act or, in the case of a biologic product, licensed 
                under section 351 of the Public Health Service Act 
                (including a product licensed under subsection (k) of 
                such section); and
                    ``(B)(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.
            ``(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 furnished during a year to an applicable 
                beneficiary, 90 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 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 at or above the annual 
                deductible specified in section 1860D-2(b)(1) for the 
                year, the manufacturer of the applicable drug shall 
                provide the discounted price under this section on only 
                the portion of the negotiated price of the applicable 
                drug that falls at or above such annual deductible.
            ``(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 1860D-2(d)(1)(B), except 
        that such negotiated price shall not include any dispensing fee 
        for an applicable drug.
            ``(7) Qualified retiree prescription drug plan.--The term 
        `qualified retiree prescription drug plan' has the meaning 
        given such term in section 11860D-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 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- 14B 
                                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 added 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-14B;''.
            (4) Clarification regarding exclusion of manufacturer 
        discounts from troop.--Section 1860D-2(b)(4) of the Social 
        Security Act (42 U.S.C. 1395w-102(b)(4)) is amended--
                    (A) in subparagraph (C), by inserting ``and subject 
                to subparagraph (F)'' after ``subparagraph (E)''; and
                    (B) by adding at the end the following new 
                subparagraph:
                    ``(F) Clarification regarding exclusion of 
                manufacturer discounts.--In applying subparagraph (A), 
                incurred costs shall not include any manufacturer 
                discounts provided under section 1860D-14B.''.
    (d) Determination of Allowable Reinsurance Costs.--Section 1860D-
15(b) of the Social Security Act (42 U.S.C. 1395w-115(b)) is amended--
            (1) in paragraph (2)--
                    (A) by striking ``Costs.--For purposes'' and 
                inserting ``Costs.--
                    ``(A) In general.--Subject to subparagraph (B), for 
                purposes''; and
                    (B) by adding at the end the following new 
                subparagraph:
                    ``(B) Inclusion of manufacturer discounts on 
                applicable drugs.--For purposes of applying 
                subparagraph (A), the term `allowable reinsurance 
                costs' shall include the portion of the negotiated 
                price (as defined in section 1860D-14B(g)(6)) of an 
                applicable drug (as defined in section 1860D-14(g)(2)) 
                that was paid by a manufacturer under the manufacturer 
                discount program under section 1860D-14B.''; and
            (2) in paragraph (3)--
                    (A) in the first sentence, by striking ``For 
                purposes'' and inserting ``Subject to paragraph (2)(B), 
                for purposes''; and
                    (B) in the second sentence, by inserting ``or, in 
                the case of an applicable drug, by a manufacturer'' 
                after ``by the individual or under the plan''.
    (e) Updating Risk Adjustment Methodologies To Account for Part D 
Modernization Redesign.--Section 1860D-15(c) of the Social Security Act 
(42 U.S.C. 1395w-115(c)) is amended by adding at the end the following 
new paragraph:
            ``(3) Updating risk adjustment methodologies to account for 
        part d modernization redesign.--The Secretary shall update the 
        risk adjustment model used to adjust bid amounts pursuant to 
        this subsection as appropriate to take into account changes in 
        benefits under this part pursuant to the amendments made by 
        section 121 of the Lower Costs, More Cures Act of 2019.''.
    (f) Conditions for Coverage of Drugs Under This Part.--Section 
1860D-43 of the Social Security Act (42 U.S.C. 1395w-153) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (2), by striking ``and'' at the 
                end;
                    (B) in paragraph (3), by striking the period at the 
                end and inserting a semicolon; and
                    (C) by adding at the end the following new 
                paragraphs:
            ``(4) participate in the manufacturer discount program 
        under section 1860D-14B;
            ``(5) have entered into and have in effect an agreement 
        described in subsection (b) of such section 1860D-14B with the 
        Secretary; and
            ``(6) have entered into and have in effect, under terms and 
        conditions specified by the Secretary, a contract with a third 
        party that the Secretary has entered into a contract with under 
        subsection (d)(3) of such section 1860D-14B.'';
            (2) by striking subsection (b) and inserting the following:
    ``(b) Effective Date.--Paragraphs (1) through (3) of subsection (a) 
shall apply to covered part D drugs dispensed under this part on or 
after January 1, 2011, and before January 1, 2022, and paragraphs (4) 
through (6) of such subsection shall apply to covered part D drugs 
dispensed on or after January 1, 2022.''; and
            (3) in subsection (c), by striking paragraph (2) and 
        inserting the following:
            ``(2) the Secretary determines that in the period beginning 
        on January 1, 2011, and ending on December 31, 2011 (with 
        respect to paragraphs (1) through (3) of subsection (a)), or 
        the period beginning on January 1, 2022, and ending December 
        31, 2022 (with respect to paragraphs (4) through (6) of such 
        subsection), there were extenuating circumstances.''.
    (g) 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)--
                                    (I) by inserting ``for a year 
                                preceding 2022,'' after ``subsection 
                                (c)''; and
                                    (II) 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-14B.''.
            (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.
    (h) Effective Date.--The amendments made by this section shall 
apply to plan year 2022 and subsequent plan years.

SEC. 112. ALLOWING THE OFFERING OF ADDITIONAL PRESCRIPTION DRUG PLANS 
              UNDER MEDICARE PART D.

    (a) Rescinding and Issuance of New Guidance.--Not later than one 
year after the date of the enactment of this Act, the Secretary of 
Health and Human Services (in this section referred to as the 
``Secretary'') shall--
            (1) rescind sections of any sub-regulatory guidance that 
        limit the number of prescription drug plans in each PDP region 
        that may be offered by a PDP sponsor under part D of title 
        XVIII of the Social Security Act (42 U.S.C. 1395w-101 et seq.); 
        and
            (2) issue new guidance specifying that a PDP sponsor may 
        offer up to 4 (or a greater number if determined appropriate by 
        the Secretary) prescription drug plans in each PDP region, 
        except in cases where the PDP sponsor may offer up to 2 
        additional plans in a PDP region pursuant to section 1860D-
        11(d)(4) of the Social Security Act (42 U.S.C. 1395w-
        111(d)(4)), as added by subsection (b).
    (b) Offering of Additional Plans.--Section 1860D-11(d) of the 
Social Security Act (42 U.S.C. 1395w-111(d)) is amended by adding at 
the end the following new paragraph:
            ``(4) Offering of additional plans.--
                    ``(A) In general.--For plan year 2022 and each 
                subsequent plan year, a PDP sponsor may offer up to 2 
                additional prescription drug plans in a PDP region (in 
                addition to any limit established by the Secretary 
                under this part) provided that the PDP sponsor complies 
                with subparagraph (B) with respect to at least one such 
                prescription drug plan.
                    ``(B) Requirements.--In order to be eligible to 
                offer up to 2 additional plans in a PDP region pursuant 
                to subparagraph (A), a PDP sponsor must ensure that, 
                with respect to at least one such prescription drug 
                plan, the sponsor or any entity that provides pharmacy 
                benefits management services under a contract with any 
                such sponsor or plan does not receive direct or 
                indirect remuneration, as defined in section 423.308 of 
                title 42, Code of Federal Regulations (or any successor 
                regulation), unless at least 25 percent of the 
                aggregate reductions in price or other remuneration 
                received by the PDP sponsor or entity from drug 
                manufacturers with respect to the plan and plan year--
                            ``(i) are reflected at the point-of-sale to 
                        the enrollee; or
                            ``(ii) are used to reduce total beneficiary 
                        cost-sharing estimated by the PDP sponsor for 
                        prescription drug coverage under the plan in 
                        the annual bid submitted by the PDP sponsor 
                        under section 1860D-11(b).
                    ``(C) Definition of reductions in price.--For 
                purposes of subparagraph (B), the term `reductions in 
                price' refers only to collectible amounts, as 
                determined by the Secretary, which excludes amounts 
                which after adjudication and reconciliation with 
                pharmacies and manufacturers are duplicate in nature, 
                contrary to other contractual clauses, or otherwise 
                ineligible (such as due to beneficiary disenrollment or 
                coordination of benefits).''.
    (c) Rule of Construction.--Nothing in the provisions of, or 
amendments made by, this section shall be construed as limiting the 
ability of the Secretary to increase any limit otherwise applicable on 
the number of prescription drug plans that a PDP sponsor may offer, at 
the discretion of the PDP sponsor, in a PDP region under part D of 
title XVIII of the Social Security Act (42 U.S.C. 1395w-101 et seq.).

SEC. 113. ALLOWING CERTAIN ENROLLEES OF PRESCRIPTION DRUG PLANS AND MA-
              PD PLANS UNDER THE MEDICARE PROGRAM TO SPREAD OUT COST-
              SHARING UNDER CERTAIN CIRCUMSTANCES.

    (a) Standard Prescription Drug Coverage.--Section 1860D-2(b)(2) of 
the Social Security Act (42 U.S.C. 1395w-102(b)(2)), as amended by 
section 111, is 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.--
                            ``(i) In general.--The Secretary shall 
                        establish by regulation a process under which, 
                        with respect to plan year 2022 and subsequent 
                        plan years, a prescription drug plan or an MA-
                        PD plan shall, in the case of a part D eligible 
                        individual enrolled with such plan for such 
                        plan year with respect to whom the plan 
                        projects that the dispensing of a covered part 
                        D drug to such individual will result in the 
                        individual incurring costs within a 30-day 
                        period that are equal to a significant 
                        percentage (as specified by the Secretary 
                        pursuant to such regulation) of the annual out-
                        of-pocket threshold specified in paragraph 
                        (4)(B) for such plan year, provide such 
                        individual with the option to make the 
                        coinsurance payment required under subparagraph 
                        (A) for such costs in the form of equal monthly 
                        installments over the remainder of such plan 
                        year.
                            ``(ii) Significant percentage 
                        limitations.--In specifying a significant 
                        percentage pursuant to the regulation 
                        established by the Secretary under clause (i), 
                        the Secretary shall not specify a percentage 
                        that is less than 30 percent or greater than 
                        100 percent.''.
    (b) Alternative Prescription Drug Coverage.--Section 1860D-2(c) of 
the Social Security Act (42 U.S.C. 1395w-102(c)) is amended by adding 
at the end the following new paragraph:
            ``(4) Same enrollee option regarding spreading cost-
        sharing.--For plan year 2022 and subsequent plan years, the 
        coverage provides the enrollee option regarding spreading cost-
        sharing described in and required under subsection 
        (b)(2)(E).''.

SEC. 114. CONTINUATION OF PART D SENIOR SAVINGS MODEL.

    Section 1115A of the Social Security Act (42 U.S.C. 1315a) is 
amended by adding at the end the following new subsection:
    ``(h) Part D Senior Savings Model.--Notwithstanding any other 
provision of law, the Secretary shall provide for the continued 
implementation on a permanent basis of the Part D Senior Savings Model 
under this section, under the same parameters under which such model 
was implemented for plan year 2021.''.

SEC. 115. REQUIRING PRESCRIPTION DRUG PLANS AND MA-PD PLANS TO REPORT 
              POTENTIAL FRAUD, WASTE, AND ABUSE TO THE SECRETARY OF 
              HHS.

    Section 1860D-4 of the Social Security Act (42 U.S.C. 1395w-104) is 
amended by adding at the end the following new subsection:
    ``(p) Reporting Potential Fraud, Waste, and Abuse.--Beginning 
January 1, 2022, the PDP sponsor of a prescription drug plan shall 
report to the Secretary, as specified by the Secretary--
            ``(1) any substantiated or suspicious activities (as 
        defined by the Secretary) with respect to the program under 
        this part as it relates to fraud, waste, and abuse; and
            ``(2) any steps made by the PDP sponsor after identifying 
        such activities to take corrective actions.''.

SEC. 116. 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 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, 2023, or such earlier 
                date specified by the Secretary if the Secretary 
                determines there are sufficient measures established or 
                approved under subparagraph (B) to meet the requirement 
                under subparagraph (A).''.

                    Subtitle C--Medicaid Provisions

SEC. 121. PRICE REPORTING CLARIFICATIONS FOR GENE THERAPY OUTCOMES-
              BASED AGREEMENTS.

    (a) Quarterly Price Reporting Obligation.--Section 1927(b)(3) of 
the Social Security Act (42 U.S.C. 1396r-8(b)(3)) is amended by adding 
at the end the following new subparagraph:
                    ``(E) Outcomes-based agreements.--
                            ``(i) In general.--Beginning January 1, 
                        2022, in the case of a covered outpatient drug 
                        that is a single course transformative therapy 
                        (as defined in subsection (k)(12)) and is sold 
                        under an outcomes-based agreement (as defined 
                        in subsection (k)(13)) during a rebate period, 
                        the manufacturer of such drug shall report (in 
                        addition to any other information required 
                        under this paragraph) the pricing structure for 
                        such drug based on pre-defined outcomes or 
                        measures specified in such outcomes-based 
                        agreement.
                            ``(ii) Access to outcomes-based agreements 
                        for state plans.--As a condition of excluding a 
                        refund, rebate, reimbursement, free item, 
                        withholding, or repayment made under an 
                        outcomes-based agreement with respect to a 
                        covered outpatient drug from the best price or 
                        average manufacturer price of the drug for a 
                        rebate period (as described in subsection 
                        (c)(1)(C)(i)(VII) or (k)(1)(B)(i)(VI), as 
                        applicable), the manufacturer shall--
                                    ``(I) make available to each State 
                                plan the opportunity to enter into an 
                                outcomes-based agreement for such drug 
                                and rebate period; and
                                    ``(II) certify to the Secretary 
                                that the manufacturer has made such 
                                opportunity so available to each State 
                                plan.
                            ``(iii) Rules of construction.--Nothing in 
                        this subparagraph shall be construed as--
                                    ``(I) requiring a manufacturer to 
                                execute an outcomes-based agreement 
                                with a State for a covered outpatient 
                                drug that is a single course 
                                transformative therapy (as defined in 
                                subsection (k)(12)); ;
                                    ``(II) precluding the execution of 
                                a rebate agreement under this section 
                                for such a drug; or
                                    ``(III) limiting States' ability to 
                                join together for a multi-State 
                                contract with a single manufacturer to 
                                establish an outcomes-based agreement 
                                for such a drug.''.
    (b) Definition of Best Price.--Section 1927(c)(1)(C) of the Social 
Security Act (42 U.S.C. 1396-8(c)(1)(C)) is amended--
            (1) in clause (i)--
                    (A) in subclause (V), by striking ``and'';
                    (B) in subclause (VI), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by adding at the end the following new 
                subclause:
                                    ``(VII) subject to subsection 
                                (b)(3)(E)(ii), with respect to a 
                                covered outpatient drug that is a 
                                single course transformative therapy 
                                (as defined in subsection (k)(12)) and 
                                is sold under an outcomes-based 
                                agreement (as defined in subsection 
                                (k)(13)) during the rebate period, any 
                                prices resulting from--
                                            ``(aa) a refund, rebate, 
                                        reimbursement, or free goods 
                                        from the manufacturer or third 
                                        party on behalf of the 
                                        manufacturer; or
                                            ``(bb) the withholding or 
                                        reduction of a payment to the 
                                        manufacturer or third party on 
                                        behalf of the manufacturer,
                                that is triggered by a patient who 
                                fails to achieve outcomes or measures 
                                defined under the terms of such 
                                outcomes-based agreement during the 
                                period for which such agreement is 
                                effective.''; and
            (2) in clause (ii)--
                    (A) in subclause (I), by striking the semicolon at 
                the end and inserting ``, except any price adjustment 
                described in clause (i)(VII);'';
                    (B) in subclause (III), by striking ``and'';
                    (C) in subclause (IV)--
                            (i) by moving the left margin of such 
                        subclause 2 ems to the right; and
                            (ii) by striking the period at the end and 
                        inserting ``; and''; and
                    (D) by adding at the end the following new 
                subclause:
                                    ``(V) in the case of a covered 
                                outpatient drug that is a single course 
                                transformative therapy (as defined in 
                                subsection (k)(12)) and is sold under 
                                an outcomes-based agreement (as defined 
                                in subsection (k)(13)) that provides 
                                that payment for such drug is made in 
                                installments over the course of such 
                                agreement, shall be determined as if 
                                the aggregate price per the terms of 
                                the agreement was paid in full in the 
                                first installment during the rebate 
                                period.''.
    (c) Definition of Average Manufacturer Price.--Section 1927(k)(1) 
of the Social Security Act (42 U.S.C. 1396r-8(k)(1)) is amended--
            (1) in subparagraph (B)(i)--
                    (A) in subclause (IV), by striking at the end 
                ``and'';
                    (B) in subclause (V), by striking the period at the 
                end and inserting ``; and''; and
                    (C) by adding at the end the following new 
                subclause:
                                    ``(VI) subject to subsection 
                                (b)(3)(E)(ii), with respect to a 
                                covered outpatient drug that is a 
                                single course transformative therapy 
                                (as defined in paragraph (12)) and is 
                                sold under an outcomes-based agreement 
                                (as defined in paragraph (13)) during 
                                the rebate period--
                                            ``(aa) a refund, rebate, 
                                        reimbursement, or free goods 
                                        from the manufacturer or third 
                                        party on behalf of the 
                                        manufacturer; or
                                            ``(bb) the withholding or 
                                        reduction of a payment to the 
                                        manufacturer or third party on 
                                        behalf of the manufacturer,
                                that is triggered by a patient who 
                                fails to achieve outcomes or measures 
                                defined under the terms of such 
                                outcomes-based agreement during the 
                                period for which such agreement is 
                                effective.''; and
            (2) by adding at the end the following new subparagraph:
                    ``(D) Special rule for certain outcomes-based 
                agreements.--For the purpose of subparagraph (A), in 
                determining the average price paid to the manufacturer 
                for a covered outpatient drug that is a single course 
                transformative therapy (as defined in paragraph (12)) 
                and is sold under an outcomes-based agreement (as 
                defined in paragraph (13)) that provides that payment 
                for such drug is made in installments over the course 
                of such agreement, such price shall be determined as if 
                the aggregate price per the terms of the agreement was 
                paid in full in the first installment during the rebate 
                period.''.
    (d) Other Definitions.--Section 1927(k) of the Social Security Act 
(42 U.S.C. 1396r-8(k)) is amended by adding at the end the following 
paragraphs:
            ``(12) Single course transformative therapy.--The term 
        `single course transformative therapy' means a treatment that 
        consists of the administration of a covered outpatient drug 
        that--
                    ``(A) is a form of gene therapy, as defined by the 
                Commissioner of Food and Drugs, that is--
                            ``(i) designated under section 526 of the 
                        Federal Food, Drug, and Cosmetics Act; and
                            ``(ii) licensed under subsection (a) or (k) 
                        of section 351 of the Public Health Service Act 
                        for a serious or life-threatening rare disease 
                        or condition;
                    ``(B) if administered in accordance with the 
                `Indications and Usage' section of its label, is 
                expected to result in--
                            ``(i) the cure of such disease or 
                        condition;
                            ``(ii) a reduction in the symptoms of such 
                        disease or condition to the extent that it is 
                        expected to--
                                    ``(I) extend life expectancy for 
                                those individuals with such disease or 
                                condition;
                                    ``(II) prevent, eliminate, or halt 
                                progression of comorbidities related to 
                                such disease or condition in such 
                                individuals; or
                                    ``(III) allow such individuals to 
                                achieve or maintain maximum functional 
                                capacity in performing daily 
                                activities; or
                            ``(iii) prevention or elimination of 
                        episodes, illnesses, injuries, or disabilities 
                        related to such disease or condition; and
                    ``(C) is expected to achieve a result described in 
                subparagraph (B), which may be achieved over an 
                extended period of time, following a single prescribed 
                course of treatment.
            ``(13) Outcomes-based agreement.--The term `outcomes-based 
        agreement' means a written contract between a manufacturer and 
        purchaser in which the aggregate price over the course of the 
        contract of the covered outpatient drug is based on the 
        achievement of pre-defined outcomes or measures and adjusted 
        accordingly.''.
    (e) Effective Date.--The amendments made by this section shall take 
effect on January 1, 2022.

SEC. 122. ANTI-KICKBACK STATUTE AND PHYSICIAN SELF-REFERRAL SAFE 
              HARBORS.

    (a) Exclusion From Antikickback Prohibition.--Section 1128B(b)(3) 
of the Social Security Act (42 U.S.C. 1320a-7b(b)(3)) is amended--
            (1) in subclause (J)--
                    (A) by moving the left margin of such subparagraph 
                2 ems to the left; and
                    (B) by striking ``and'' after the semicolon at the 
                end;
            (2) in subclause (K)--
                    (A) by moving the left margin of such subparagraph 
                2 ems to the left; and
                    (B) by striking the period at the end and inserting 
                ``; and''; and
            (3) by adding at the end the following new subparagraph:
            ``(L) any remuneration provided by a manufacturer or third 
        party on behalf of a manufacturer to a plan under an outcomes-
        based agreement (as defined in section 1927(k)(13)) in the 
        event a patient fails to achieve outcomes or measures defined 
        in such agreement following the administration of a covered 
        outpatient drug that is a single course transformative therapy 
        (as defined in section 1927(k)(12).''.
    (b) Exclusion From Physician Self-referral Prohibition.--Section 
1877(h)(1)(C) of the Social Security Act (42 U.S.C. 1395nn(h)(1)(C)) is 
amended by adding at the end the following new clause:
                    ``(iv) Any amounts paid under an outcomes-based 
                agreement (as defined in section 1927(k)(13)).''.
    (c) Effective Date.--The amendments made by this section shall take 
effect on January 1, 2022.

SEC. 123. GAO STUDY AND REPORT ON USE OF OUTCOMES-BASED AGREEMENTS.

    (a) Study.--The Comptroller General of the United States shall 
conduct a study on the extent to which outcomes-based agreements (as 
defined in section 1927(k)(13) of the Social Security Act (42 U.S.C. 
1396r-8(k)(13)) for rare disease gene therapies facilitate patient 
access to such therapies, improve patient outcomes, lower overall 
health system costs, and lower costs for patients in Federal health 
care programs. In conducting such study, the Comptroller General 
shall--
            (1) study the impact of this subtitle on-
                    (A) mitigating socioeconomic disparities in 
                accessing rare disease gene therapies through its 
                requirement that State Medicaid programs have access to 
                the same outcomes-based agreement remedy terms that are 
                available in the commercial market for the gene 
                therapy; and
                    (B) the Medicaid Drug Rebate Program, the 340B Drug 
                Pricing Program, and the Medicare Part B program, 
                including compliance with such programs; and
            (2) with respect to rare disease gene therapies sold under 
        an outcomes-based agreement (as so defined), conduct an audit 
        of manufacturers offering State Medicaid programs the same 
        remedy terms for non-responding patients as offered to 
        commercial insurance plans during a particular rebate period, 
        as described in subsections (c)(1)(C)(i)(VII) and 
        (k)(1)(B)(i)(VI) of section 1927 of the Social Security Act (42 
        U.S.C. 1396r-8), as added by this subtitle.
    (b) Report.--Not later than June 30, 2027, the Comptroller General 
of the United States shall submit to Congress a report containing the 
results of the study conducted under subsection (a).

              TITLE II--DRUG PRICE TRANSPARENCY PROVISIONS

SEC. 201. REPORTING ON EXPLANATION FOR DRUG PRICE INCREASES.

    (a) In General.--Title XI of the Social Security Act (42 U.S.C. 
1301 et seq.) is amended by inserting after section 1128K the following 
new section:

``SEC. 1128L. DRUG PRICE REPORTING.

    ``(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 this 
        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;
                            ``(ii) administered or otherwise dispensed 
                        to treat a disease or condition affecting more 
                        than 200,000 persons in the United States; and
                            ``(iii) not a 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--
                    ``(A) for each increase in the price of a 
                qualifying drug that results in an increase in the 
                wholesale acquisition cost of that drug that is equal 
                to--
                            ``(i) 10 percent or more within a single 
                        calendar year beginning on or after January 1, 
                        2021; or
                            ``(ii) 25 percent or more within three 
                        consecutive calendar years for which the first 
                        such calendar year begins on or after January 
                        1, 2021; and
                    ``(B) in the case that the qualifying drug is first 
                covered under title XVIII with respect to an applicable 
                year, if the estimated cost or spending under such 
                title per individual or per user of such drug (as 
                estimated by the Secretary) for such applicable year 
                (or per course of treatment in such applicable year, as 
                defined by the Secretary) is at least $26,000.
            ``(2) Report deadline.--Each report described in paragraph 
        (1) shall be submitted to the Secretary--
                    ``(A) in the case of a report with respect to an 
                increase in the price of a qualifying drug that occurs 
                during the period beginning on January 1, 2021, and 
                ending on the day that is 60 days after the date of 
                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; and
                    ``(C) in the case of a report with respect to a 
                qualifying drug that meets the criteria described in 
                paragraph (1)(B), not later than 30 days after such 
                drug meets such criteria.
    ``(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 calendar year or three consecutive calendar years 
                as described in subsection (b)(1)(A) or (b)(1)(B), if 
                applicable, and the effective date of such price 
                increase;
                    ``(B) an explanation for, and description of, each 
                price increase for such drug that will occur during the 
                calendar year period described in subsection (b)(1)(A) 
                or the three consecutive calendar year period described 
                in subsection (b)(1)(B), as applicable;
                    ``(C) if known and different from the manufacturer 
                of the qualifying drug, the identity of--
                            ``(i) the sponsor or sponsors of any 
                        investigational new drug applications under 
                        section 505(i) of the Federal Food, Drug, and 
                        Cosmetic Act for clinical investigations with 
                        respect to such drug, for which the full 
                        reports are submitted as part of the 
                        application--
                                    ``(I) for approval of the drug 
                                under section 505 of such Act; or
                                    ``(II) for licensure of the drug 
                                under section 351 of the Public Health 
                                Service Act; and
                            ``(ii) the sponsor of an application for 
                        the drug approved under such section 505 of the 
                        Federal Food, Drug, and Cosmetic Act or 
                        licensed under section 351 of the Public Health 
                        Service Act;
                    ``(D) 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;
                    ``(E) the current wholesale acquisition cost of the 
                drug;
                    ``(F) the total expenditures of the manufacturer 
                on--
                            ``(i) materials and manufacturing for such 
                        drug; and
                            ``(ii) acquiring patents and licensing for 
                        such drug;
                    ``(G) the percentage of total expenditures of the 
                manufacturer on research and development for such drug 
                that was derived from Federal funds;
                    ``(H) 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;
                    ``(I) 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;
                    ``(J) 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;
                    ``(K) 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
                    ``(L) 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 1-year period described in 
                subsection (b)(1)(A) or the 3-year period described in 
                subsection (b)(1)(B), as applicable;
                    ``(B) all stock-based performance metrics used by 
                the manufacturer to determine executive compensation 
                for each of the 1-year period described in subsection 
                (b)(1)(A) or the 3-year period described in subsection 
                (b)(1)(B), as applicable; and
                    ``(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 through 
        notice-and-comment rulemaking.
    ``(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)(B) 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 $75,000 for each item of false information.
    ``(g) Public Posting.--
            ``(1) In general.--Subject to paragraph (3), the Secretary 
        shall post each report submitted under subsection (b) on the 
        public website of the Department of Health and Human Services 
        the day the price increase of a qualifying drug is scheduled to 
        go into effect.
            ``(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) Protected information.--Nothing in this section shall 
        be construed to authorize the public disclosure of information 
        submitted by a manufacturer that is prohibited from disclosure 
        by applicable laws concerning the protection of trade secrets, 
        commercial information, and other information covered under 
        such laws.
    ``(h) Annual Report to Congress.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall submit to Congress, and post on the public website of the 
        Department of Health and Human Services in a way that is user-
        friendly to the public and written in plain language that 
        consumers can readily understand, an annual report--
                    ``(A) summarizing the information reported pursuant 
                to this section;
                    ``(B) including copies of the reports and 
                supporting detailed economic analyses submitted 
                pursuant to this section;
                    ``(C) detailing the costs and expenditures incurred 
                by the Department of Health and Human Services in 
                carrying out this section; and
                    ``(D) explaining how the Department of Health and 
                Human Services is improving consumer and provider 
                information about drug value and drug price 
                transparency.
            ``(2) Protected information.--Nothing in this subsection 
        shall be construed to authorize the public disclosure of 
        information submitted by a manufacturer that is prohibited from 
        disclosure by applicable laws concerning the protection of 
        trade secrets, commercial information, and other information 
        covered under such laws.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect on the date of enactment of this Act.

SEC. 202. PUBLIC DISCLOSURE OF DRUG DISCOUNTS.

    Section 1150A of the Social Security Act (42 U.S.C. 1320b-23) is 
amended--
            (1) in subsection (c), in the matter preceding paragraph 
        (1), by inserting ``(other than as permitted under subsection 
        (e))'' after ``disclosed by the Secretary''; and
            (2) by adding at the end the following new subsection:
    ``(e) Public Availability of Certain Information.--
            ``(1) In general.--In order to allow the comparison of 
        PBMs' ability to negotiate rebates, discounts, direct and 
        indirect remuneration fees, administrative fees, and price 
        concessions and the amount of such rebates, discounts, direct 
        and indirect remuneration fees, administrative fees, and price 
        concessions that are passed through to plan sponsors, beginning 
        January 1, 2022, the Secretary shall make available on the 
        internet website of the Department of Health and Human Services 
        the information with respect to the second preceding calendar 
        year provided to the Secretary on generic dispensing rates (as 
        described in paragraph (1) of subsection (b)) and information 
        provided to the Secretary under paragraphs (2) and (3) of such 
        subsection that, as determined by the Secretary, is with 
        respect to each PBM.
            ``(2) Availability of data.--In carrying out paragraph (1), 
        the Secretary shall ensure the following:
                    ``(A) Confidentiality.--The information described 
                in such paragraph is displayed in a manner that 
                prevents the disclosure of information, with respect to 
                an individual drug or an individual plan, on rebates, 
                discounts, direct and indirect remuneration fees, 
                administrative fees, and price concessions.
                    ``(B) Class of drug.--The information described in 
                such paragraph is made available by class of drug, 
                using an existing classification system, but only if 
                the class contains such number of drugs, as specified 
                by the Secretary (but not fewer than three drugs), to 
                ensure confidentiality of proprietary information or 
                other information that is prevented to be disclosed 
                under subparagraph (A).''.

SEC. 203. MAKING PRESCRIPTION DRUG MARKETING SAMPLE INFORMATION 
              REPORTED BY MANUFACTURERS AVAILABLE TO CERTAIN 
              INDIVIDUALS AND ENTITIES.

    (a) In General.--Section 1128H of the Social Security Act (42 
U.S.C. 1320a-7i) is amended--
            (1) by redesignating subsection (b) as subsection (e); and
            (2) by inserting after subsection (a) the following new 
        subsections:
    ``(b) Data Sharing Agreements.--
            ``(1) In general.--The Secretary shall enter into 
        agreements with the specified data sharing individuals and 
        entities described in paragraph (2) under which--
                    ``(A) upon request of such an individual or entity, 
                as applicable, the Secretary makes available to such 
                individual or entity the information submitted under 
                subsection (a) by manufacturers and authorized 
                distributors of record; and
                    ``(B) such individual or entity agrees to not 
                disclose publicly or to another individual or entity 
                any information that identifies a particular 
                practitioner or health care facility.
            ``(2) Specified data sharing individuals and entities.--For 
        purposes of paragraph (1), the specified data sharing 
        individuals and entities described in this paragraph are the 
        following:
                    ``(A) Oversight agencies.--Health oversight 
                agencies (as defined in section 164.501 of title 45, 
                Code of Federal Regulations), including the Centers for 
                Medicare & Medicaid Services, the Office of the 
                Inspector General of the Department of Health and Human 
                Services, the Government Accountability Office, the 
                Congressional Budget Office, the Medicare Payment 
                Advisory Commission, and the Medicaid and CHIP Payment 
                and Access Commission.
                    ``(B) Researchers.--Individuals who conduct 
                scientific research (as defined in section 164.501 of 
                title 45, Code of Federal Regulations) in relevant 
                areas as determined by the Secretary.
                    ``(C) Payers.--Private and public health care 
                payers, including group health plans, health insurance 
                coverage offered by health insurance issuers, Federal 
                health programs, and State health programs.
            ``(3) Exemption from freedom of information act.--Except as 
        described in paragraph (1), the Secretary may not be compelled 
        to disclose the information submitted under subsection (a) to 
        any individual or entity. For purposes of section 552 of title 
        5, United States Code (commonly referred to as the Freedom of 
        Information Act), this paragraph shall be considered a statute 
        described in subsection (b)(3)(B) of such section.
    ``(c) Penalties.--
            ``(1) Data sharing agreements.--Subject to paragraph (3), 
        any specified data sharing individual or entity described in 
        subsection (b)(2) that violates the terms of a data sharing 
        agreement the individual or entity has with the Secretary under 
        subsection (b)(1) shall be subject to a civil money penalty of 
        not less than $1,000, but not more than $10,000, for each such 
        violation. Such penalty shall be imposed and collected in the 
        same manner as civil money penalties under subsection (a) of 
        section 1128A are imposed and collected under that section.
            ``(2) Failure to report.--Subject to paragraph (3), any 
        manufacturer or authorized distributor of record of an 
        applicable drug under subsection (a) that fails to submit 
        information required under such subsection in a timely manner 
        in accordance with rules or regulations promulgated to carry 
        out such subsection shall be subject to a civil money penalty 
        of not less than $1,000, but not more than $10,000, for each 
        such failure. Such penalty shall be imposed and collected in 
        the same manner as civil money penalties under subsection (a) 
        of section 1128A are imposed and collected under that section.
            ``(3) Limitation.--The total amount of civil money 
        penalties imposed under paragraph (1) or (2) with respect to a 
        year and an individual or entity described in paragraph (1) or 
        a manufacturer or distributor described in paragraph (2), 
        respectively, shall not exceed $150,000.
    ``(d) Drug Sample Distribution Information.--
            ``(1) In general.--Not later than January 1 of each year 
        (beginning with 2022), the Secretary shall maintain a list 
        containing information related to the distribution of samples 
        of applicable drugs. Such list shall provide the following 
        information with respect to the preceding year:
                    ``(A) The name of the manufacturer or authorized 
                distributor of record of an applicable drug for which 
                samples were requested or distributed under this 
                section.
                    ``(B) The quantity and class of drug samples 
                requested.
                    ``(C) The quantity and class of drug samples 
                distributed.
            ``(2) Public availability.--The Secretary shall make the 
        information in such list available to the public on the 
        internet website of the Food and Drug Administration.''.
    (b) FDA Maintenance of Information.--The Food and Drug 
Administration shall maintain information available to affected 
reporting companies to ensure their ability to fully comply with the 
requirements of section 1128H of the Social Security Act.
    (c) Prohibition on Distribution of Samples of Opioids.--Section 
503(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(d)) 
is amended--
            (1) by moving the margin of paragraph (4) 2 ems to the 
        left; and
            (2) by adding at the end the following:
    ``(5) No person may distribute a drug sample of a drug that is--
            ``(A) an applicable drug (as defined in section 1128H(e) of 
        the Social Security Act);
            ``(B) a controlled substance (as defined in section 102 of 
        the Controlled Substances Act) for which the findings required 
        under section 202(b)(2) of such Act have been made; and
            ``(C) approved under section 505 for use in the management 
        or treatment of pain (other than for the management or 
        treatment of a substance use disorder).''.
    (d) MedPAC Report.--Not later than 3 years after the date of the 
enactment of this Act, the Medicare Payment Advisory Commission shall 
conduct a study on the impact of drug samples on provider prescribing 
practices and health care costs and may, as the Commission deems 
appropriate, make recommendations on such study.

SEC. 204. SENSE OF THE SENATE REGARDING THE NEED TO EXPAND COMMERCIALLY 
              AVAILABLE DRUG PRICING COMPARISON PLATFORMS.

    It is the sense of the Senate that--
            (1) commercially available drug pricing comparison 
        platforms can, at no cost, help patients find the lowest price 
        for their medications at their local pharmacy;
            (2) such platforms should be integrated, to the maximum 
        extent possible, in the health care delivery ecosystem; and
            (3) pharmacy benefit managers should work to disclose 
        generic and brand name drug prices to such platforms to ensure 
        that--
                    (A) patients can benefit from the lowest possible 
                price available to them; and
                    (B) overall drug prices can be reduced as more 
                educated purchasing decisions are made based on price 
                transparency.

                      TITLE III--REVENUE PROVISION

SEC. 301. INCLUSION OF INSULIN AND OTHER TREATMENTS FOR CHRONIC 
              CONDITIONS AS PREVENTIVE CARE.

    (a) In General.--Subparagraph (C) of section 223(c)(2) of the 
Internal Revenue Code of 1986 is amended--
            (1) by striking ``deductible.--A plan'' and inserting 
        ``deductible.--
                            ``(i) In general.--A plan'', and
            (2) by adding at the end the following new clause:
                            ``(ii) Special rule.--The term `preventive 
                        care' includes such drugs (including insulin), 
                        devices, supplies, and medical services or 
                        screenings prescribed for the prevention or 
                        avoidance of a disease or condition, or the 
                        regular treatment and maintenance of a chronic 
                        disease or condition, as are determined by the 
                        Secretary, in consultation with the Secretary 
                        of Health and Human Services, to be--
                                    ``(I) low in cost,
                                    ``(II) supported by medical 
                                evidence to have a high cost efficiency 
                                in preventing exacerbation of a chronic 
                                condition or the development of a 
                                secondary condition, and
                                    ``(III) likely (as documented by 
                                clinical evidence), when prescribed for 
                                a class of individuals, to prevent 
                                exacerbation of the chronic condition 
                                of such individuals or the development 
                                of a secondary condition requiring 
                                significantly higher cost 
                                treatments.''.
    (b) Effective Date.--
            (1) In general.--The amendments made by this section shall 
        apply to taxable years beginning after the date of the 
        enactment of this Act.
            (2) Treasury guidance in effect on date of enactment.--
                    (A) In general.--No inference shall be drawn by 
                reason of the amendments made by this Act with respect 
                to the effectiveness of the provisions of Internal 
                Revenue Service Notice 2019-45 on the date of the 
                enactment of this Act, and such notice shall continue 
                to apply as in effect on July 17, 2019, unless amended 
                by the Secretary of the Treasury (or the Secretary's 
                delegate) pursuant to the amendments made by this Act 
                or pursuant to subparagraph (B).
                    (B) Continued publication and update of list.--
                            (i) In general.--The Secretary of the 
                        Treasury (or the Secretary's delegate) may 
                        publish, and update from time to time as such 
                        Secretary (or delegate) deems appropriate, a 
                        list of the drugs, devices, supplies, and 
                        services identified under section 
                        223(c)(2)(C)(ii) of the Internal Revenue Code 
                        of 1986, in consultation with the Secretary of 
                        Health and Human Services (or such Secretary's 
                        delegate), as preventive care.
                            (ii) Inclusion of certain diabetic 
                        supplies.--As soon as practicable after the 
                        date of the enactment of this Act, the list in 
                        effect under Internal Revenue Service Notice 
                        2019-45 shall be amended to include insulin 
                        delivery devices and related supplies, and 
                        continuous glucose monitoring systems and 
                        related supplies.

                   TITLE IV--MISCELLANEOUS PROVISIONS

SEC. 401. IMPROVING COORDINATION BETWEEN THE FOOD AND DRUG 
              ADMINISTRATION AND THE CENTERS FOR MEDICARE & MEDICAID 
              SERVICES.

    (a) In General.--
            (1) Public meeting.--
                    (A) In general.--Not later than 12 months after the 
                date of the enactment of this Act, the Secretary of 
                Health and Human Services (referred to in this section 
                as the ``Secretary'') shall convene a public meeting 
                for the purposes of discussing and providing input on 
                improvements to coordination between the Food and Drug 
                Administration and the Centers for Medicare & Medicaid 
                Services in preparing for the availability of novel 
                medical products described in subsection (c) on the 
                market in the United States.
                    (B) Attendees.--The public meeting shall include--
                            (i) representatives of relevant Federal 
                        agencies, including representatives from each 
                        of the medical product centers within the Food 
                        and Drug Administration and representatives 
                        from the coding, coverage, and payment offices 
                        within the Centers for Medicare & Medicaid 
                        Services;
                            (ii) stakeholders with expertise in the 
                        research and development of novel medical 
                        products, including manufacturers of such 
                        products;
                            (iii) representatives of commercial health 
                        insurance payers;
                            (iv) stakeholders with expertise in the 
                        administration and use of novel medical 
                        products, including physicians; and
                            (v) stakeholders representing patients and 
                        with expertise in the utilization of patient 
                        experience data in medical product development.
                    (C) Topics.--The public meeting shall include a 
                discussion of--
                            (i) the status of the drug and medical 
                        device development pipeline related to the 
                        availability of novel medical products;
                            (ii) the anticipated expertise necessary to 
                        review the safety and effectiveness of such 
                        products at the Food and Drug Administration 
                        and current gaps in such expertise, if any;
                            (iii) the expertise necessary to make 
                        coding, coverage, and payment decisions with 
                        respect to such products within the Centers for 
                        Medicare & Medicaid Services, and current gaps 
                        in such expertise, if any;
                            (iv) trends in the differences in the data 
                        necessary to determine the safety and 
                        effectiveness of a novel medical product and 
                        the data necessary to determine whether a novel 
                        medical product meets the reasonable and 
                        necessary requirements for coverage and payment 
                        under title XVIII of the Social Security Act 
                        pursuant to section 1862(a)(1)(A) of such Act 
                        (42 U.S.C. 1395y(a)(1)(A));
                            (v) the availability of information for 
                        sponsors of such novel medical products to meet 
                        each of those requirements; and
                            (vi) the coordination of information 
                        related to significant clinical improvement 
                        over existing therapies for patients between 
                        the Food and Drug Administration and the 
                        Centers for Medicare & Medicaid Services with 
                        respect to novel medical products.
                    (D) Trade secrets and confidential information.--No 
                information discussed as a part of the public meeting 
                under this paragraph shall be construed as authorizing 
                the Secretary to disclose any information that is a 
                trade secret or confidential information subject to 
                section 552(b)(4) of title 5, United States Code.
            (2) Improving transparency of criteria for medicare 
        coverage.--
                    (A) Draft guidance.--Not later than 18 months after 
                the public meeting under paragraph (1), the Secretary 
                shall update the final guidance titled ``National 
                Coverage Determinations with Data Collection as a 
                Condition of Coverage: Coverage with Evidence 
                Development'' to address any opportunities to improve 
                the availability and coordination of information as 
                described in clauses (iv) through (vi) of paragraph 
                (1)(C).
                    (B) Final guidance.--Not later than 12 months after 
                issuing draft guidance under subparagraph (A), the 
                Secretary shall finalize the updated guidance to 
                address any such opportunities.
    (b) Report on Coding, Coverage, and Payment Processes Under 
Medicare for Novel Medical Products.--Not later than 12 months after 
the date of the enactment of this Act, the Secretary shall publish a 
report on the internet website of the Department of Health and Human 
Services regarding processes under the Medicare program under title 
XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) with respect 
to the coding, coverage, and payment of novel medical products 
described in subsection (c). Such report shall include the following:
            (1) A description of challenges in the coding, coverage, 
        and payment processes under the Medicare program for novel 
        medical products.
            (2) Recommendations to--
                    (A) incorporate patient experience data (such as 
                the impact of a disease or condition on the lives of 
                patients and patient treatment preferences) into the 
                coverage and payment processes within the Centers for 
                Medicare & Medicaid Services;
                    (B) decrease the length of time to make national 
                and local coverage determinations under the Medicare 
                program (as those terms are defined in subparagraph (A) 
                and (B), respectively, of section 1862(l)(6) of the 
                Social Security Act (42 U.S.C. 1395y(l)(6)));
                    (C) streamline the coverage process under the 
                Medicare program and incorporate input from relevant 
                stakeholders into such coverage determinations; and
                    (D) identify potential mechanisms to incorporate 
                novel payment designs similar to those in development 
                in commercial insurance plans and State plans under 
                title XIX of such Act (42 U.S.C. 1396 et seq.) into the 
                Medicare program.
    (c) Novel Medical Products Described.--For purposes of this 
section, a novel medical product described in this subsection is a 
medical product, including a drug, biological (including gene and cell 
therapy), or medical device, that has been designated as a breakthrough 
therapy under section 506(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356(a)), a breakthrough device under section 515B of 
such Act (21 U.S.C. 360e-3), or a regenerative advanced therapy under 
section 506(g) of such Act (21 U.S.C. 356(g)).

SEC. 402. PATIENT CONSULTATION IN MEDICARE NATIONAL AND LOCAL COVERAGE 
              DETERMINATIONS IN ORDER TO MITIGATE BARRIERS TO INCLUSION 
              OF SUCH PERSPECTIVES.

    Section 1862(l) of the Social Security Act (42 U.S.C. 1395y(l)) is 
amended by adding at the end the following new paragraph:
            ``(7) Patient consultation in national and local coverage 
        determinations.--The Secretary may consult with patients and 
        organizations representing patients in making national and 
        local coverage determinations.''.

SEC. 403. MEDPAC REPORT ON SHIFTING COVERAGE OF CERTAIN MEDICARE PART B 
              DRUGS TO MEDICARE PART D.

    (a) Study.--The Medicare Payment Advisory Commission (in this 
section referred to as the ``Commission'') shall conduct a study on 
shifting coverage of certain drugs and biologicals for which payment is 
currently made under part B of title XVIII of the Social Security Act 
(42 U.S.C. 1395j et seq.) to part D of such title (42 U.S.C. 1395w-21 
et seq.). Such study shall include an analysis of--
            (1) differences in program structures and payment methods 
        for drugs and biologicals covered under such parts B and D, 
        including effects of such a shift on program spending, 
        beneficiary cost-sharing liability, and utilization management 
        techniques for such drugs and biologicals; and
            (2) the feasibility and policy implications of shifting 
        coverage of drugs and biologicals for which payment is 
        currently made under such part B to such part D.
    (b) Report.--
            (1) In general.--Not later than June 30, 2023, the 
        Commission shall submit to Congress a report containing the 
        results of the study conducted under subsection (a).
            (2) Contents.--The report under paragraph (1) shall include 
        information, and recommendations as the Commission deems 
        appropriate, regarding--
                    (A) formulary design under such part D;
                    (B) the ability of the benefit structure under such 
                part D to control total spending on drugs and 
                biologicals for which payment is currently made under 
                such part B;
                    (C) changes to the bid process under such part D, 
                if any, that may be necessary to integrate coverage of 
                such drugs and biologicals into such part D;
                    (D) any other changes to the program that Congress 
                should consider in determining whether to shift 
                coverage of such drugs and biologicals from such part B 
                to such part D; and
                    (E) the feasibility and policy implications of 
                creating a methodology to preserve the healthcare 
                provider's ability to take title of the drug, including 
                a methodology under which--
                            (i) prescription drug plans negotiate 
                        reimbursement rates and other arrangements with 
                        drug manufacturers on behalf of a wholesaler;
                            (ii) wholesalers purchase the drugs from 
                        the manufacturers at the negotiated rate and 
                        ship them through distributors to physicians to 
                        administer to patients;
                            (iii) physicians and hospitals purchase the 
                        drug from the wholesaler via the distributor;
                            (iv) after administering the drug, the 
                        physician submits a claim to the MAC for their 
                        drug administration fee;
                            (v) to be reimbursed for the purchase of 
                        the drug from the distributor, the physician 
                        furnishes the claim for the drug itself to the 
                        wholesaler and the wholesaler would refund the 
                        cost of the drug to the physician; and
                            (vi) the wholesaler passes this claim to 
                        the PDP to receive reimbursement.

SEC. 404. AUTHORITY TO REQUIRE THAT DIRECT-TO-CONSUMER ADVERTISEMENTS 
              FOR PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS INCLUDE 
              TRUTHFUL AND NON-MISLEADING PRICING INFORMATION.

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

``SEC. 1150D. AUTHORITY TO REQUIRE THAT DIRECT-TO-CONSUMER 
              ADVERTISEMENTS FOR PRESCRIPTION DRUGS AND BIOLOGICAL 
              PRODUCTS INCLUDE TRUTHFUL AND NON-MISLEADING PRICING 
              INFORMATION.

    ``(a) In General.--The Secretary may require that each direct-to-
consumer advertisement for a prescription drug or biological product 
for which payment is available under title XVIII or XIX includes an 
internet website address that provides an appropriate disclosure of 
truthful and non-misleading pricing information with respect to the 
drug or product.
    ``(b) Determination by CMS.--The Secretary, acting through the 
Administrator of the Centers for Medicare & Medicaid Services, shall 
determine the components of the requirement under subsection (a), such 
as the forms of advertising, the manner of disclosure, the price point 
listing, and the price information for disclosure.''.

SEC. 405. CHIEF PHARMACEUTICAL NEGOTIATOR AT THE OFFICE OF THE UNITED 
              STATES TRADE REPRESENTATIVE.

    (a) In General.--Section 141 of the Trade Act of 1974 (19 U.S.C. 
2171) is amended--
            (1) in subsection (b)(2)--
                    (A) by striking ``and one Chief Innovation and 
                Intellectual Property Negotiator'' and inserting ``one 
                Chief Innovation and Intellectual Property Negotiator, 
                and one Chief Pharmaceutical Negotiator'';
                    (B) by striking ``or the Chief Innovation and 
                Intellectual Property Negotiator'' and inserting ``the 
                Chief Innovation and Intellectual Property Negotiator, 
                or the Chief Pharmaceutical Negotiator''; and
                    (C) by striking ``and the Chief Innovation and 
                Intellectual Property Negotiator'' and inserting ``the 
                Chief Innovation and Intellectual Property Negotiator, 
                and the Chief Pharmaceutical Negotiator''; and
            (2) in subsection (c), by adding at the end the following 
        new paragraph:
            ``(7) The principal function of the Chief Pharmaceutical 
        Negotiator shall be to conduct trade negotiations and to 
        enforce trade agreements relating to United States 
        pharmaceutical products and services. The Chief Pharmaceutical 
        Negotiator shall be a vigorous advocate on behalf of United 
        States pharmaceutical interests. The Chief Pharmaceutical 
        Negotiator shall perform such other functions as the United 
        States Trade Representative may direct.''.
    (b) Compensation.--Section 5314 of title 5, United States Code, is 
amended by striking ``Chief Innovation and Intellectual Property 
Negotiator, Office of the United States Trade Representative.'' and 
inserting the following:
            ``Chief Innovation and Intellectual Property Negotiator, 
        Office of the United States Trade Representative.
            ``Chief Pharmaceutical Negotiator, Office of the United 
        States Trade Representative.''.
    (c) Report Required.--Not later than the date that is one year 
after the appointment of the first Chief Pharmaceutical Negotiator 
pursuant to paragraph (2) of section 141(b) of the Trade Act of 1974, 
as amended by subsection (a), and annually thereafter, the United 
States Trade Representative shall submit to the Committee on Finance of 
the Senate and the Committee on Ways and Means of the House of 
Representatives a report describing in detail--
            (1) enforcement actions taken by the United States Trade 
        Representative during the 1-year period preceding the 
        submission of the report to ensure the protection of United 
        States pharmaceutical products and services; and
            (2) other actions taken by the United States Trade 
        Representative to advance United States pharmaceutical products 
        and services.
                                 <all>