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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5391 Introduced in House (IH)]

<DOC>

118th CONGRESS
  1st Session
                                H. R. 5391

To amend title XVIII of the Social Security Act to provide for a rebate 
by manufacturers for selected drugs and biological products subject to 
                    maximum fair price negotiation.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           September 12, 2023

Mr. Burgess (for himself and Mr. Murphy) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL

 
To amend title XVIII of the Social Security Act to provide for a rebate 
by manufacturers for selected drugs and biological products subject to 
                    maximum fair price negotiation.

    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 ``Protecting Patient Access to Cancer 
and Complex Therapies Act''.

SEC. 2. REBATE BY MANUFACTURERS FOR SELECTED DRUGS AND BIOLOGICAL 
              PRODUCTS SUBJECT TO MAXIMUM FAIR PRICE NEGOTIATION.

    (a) Maintaining Payments Under Part B Based on ASP+6.--Section 
1847A(b)(1)(B) of the Social Security Act (42 U.S.C. 1395w-3a(b)(1)(B)) 
is amended by striking ``or in the case of such a drug or biological 
product that is a selected drug'' and all that follows through the 
semiocolon and inserting a semicolon.
    (b) Rebate by Manufacturers for Selected Drugs and Biological 
Products Subject to Maximum Fair Price Negotiation.--
            (1) In general.--Section 1847A of the Social Security Act 
        (42 U.S.C. 1395w-3a) is amended--
                    (A) by redesignating subsection (j) as subsection 
                (k); and
                    (B) by inserting after subsection (i) the following 
                new subsection:
    ``(j) Rebate by Manufacturers for Selected Drugs and Biological 
Products Subject to Maximum Fair Price Negotiation.--
            ``(1) Requirements.--
                    ``(A) Secretarial provision of information.--Not 
                later than 6 months after the end of each calendar 
                quarter beginning on or after the first day of the 
                initial price applicability period (as defined in 
                section 1191(b)(2)), the Secretary shall, for each 
                selected drug (as defined in section 1192(c)) of each 
                manufacturer with an agreement under section 1193 for 
                which a maximum fair price is in effect and for which 
                payment may be made under this part, report to each 
                manufacturer of such selected drug the following for 
                such calendar quarter during such price applicability 
                period:
                            ``(i) Information on the total number of 
                        units of the billing and payment code for such 
                        selected drug furnished under this part during 
                        such calendar quarter.
                            ``(ii) Information on the sum of--
                                    ``(I) the amount (if any) by 
                                which--
                                            ``(aa) the ASP+6 payment 
                                        amount (as defined in paragraph 
                                        (5)) for such drug and calendar 
                                        quarter, less the ASP+6 
                                        coinsurance amount for such 
                                        drug and calendar quarter; 
                                        exceeds
                                            ``(bb) the MFP+6 payment 
                                        amount (as so defined) for such 
                                        drug and calendar quarter, less 
                                        the MFP+6 coinsurance amount 
                                        for such drug and calendar 
                                        quarter; and
                                    ``(II) the amount (if any) by 
                                which--
                                            ``(aa) the ASP+6 
                                        coinsurance amount (as defined 
                                        in paragraph (5)) for such drug 
                                        and calendar quarter; exceeds
                                            ``(bb) the MFP+6 
                                        coinsurance amount (as so 
                                        defined) for such drug and 
                                        calendar quarter.
                            ``(iii) The rebate amount specified under 
                        subparagraph (B) for such drug and calendar 
                        quarter.
                    ``(B) Manufacturer requirement.--For each calendar 
                quarter beginning on or after the first day of the 
                initial price applicability period (as defined in 
                section 1191(b)(2)), the manufacturer of a selected 
                drug shall, for such drug, not later than 30 days after 
                the date of receipt from the Secretary of the 
                information described in subparagraph (A) for such 
                calendar quarter, provide to the Secretary a rebate 
                that is equal to the amount specified in subparagraph 
                (A)(ii) multiplied by the number of units specified in 
                subparagraph (A)(i) for such drug for such calendar 
                quarter. The rebate required under this subparagraph 
                shall be in addition to any other rebates required 
                under this title or title XIX, including the payments 
                required under subsections (h) and (i).
            ``(2) Calculation of beneficiary coinsurance based on 
        mfp+6.--
                    ``(A) In general.--Subject to subparagraph (B), in 
                the case of a selected drug with respect to which a 
                rebate is paid under this subsection--
                            ``(i) the amount of any coinsurance 
                        applicable under this part to an individual to 
                        whom such drug is furnished during a calendar 
                        quarter shall be equal to the MFP+6 coinsurance 
                        amount; and
                            ``(ii) the amount of such coinsurance for 
                        such calendar quarter shall be applied as a 
                        percent, as determined by the Secretary, to the 
                        payment amount that would otherwise apply under 
                        subsection (b)(1)(B).
                    ``(B) Clarification regarding application of 
                inflation rebate.--If a rebate is required under 
                subsection (i) with respect to a selected drug for a 
                calendar quarter, the lesser of the amount of 
                coinsurance computed under subparagraph (A) or the 
                coinsurance computed under subsection (i)(5) shall 
                apply for such drug and calendar quarter.
            ``(3) Rebate deposits.--Amounts paid as rebates under 
        paragraph (1)(B) shall be deposited into the Federal 
        Supplementary Medical Insurance Trust Fund established under 
        section 1841.
            ``(4) Civil money penalty.--The civil money penalty 
        established under paragraph (7) of subsection (i) shall apply 
        to the failure to comply with this subsection in the same 
        manner as such penalty applies to failures to comply with the 
        requirements under paragraph (1)(B) of subsection (i).
            ``(5) Definitions.--In this subsection, with respect to a 
        selected drug for a calendar quarter during a price 
        applicability period:
                    ``(A) ASP+6 coinsurance amount.--The `ASP+6 
                coinsurance amount' is equal to 20 percent of the ASP+6 
                payment amount.
                    ``(B) ASP+6 payment amount.--The `ASP+6 payment 
                amount' is equal to 106 percent of the amount 
                determined under paragraph (4) of subsection (b) for 
                such drug during such calendar quarter.
                    ``(C) MFP+6 coinsurance amount.--The `MFP+6 
                coinsurance amount' is equal to 20 percent of the MFP+6 
                payment amount.
                    ``(D) MFP+6 payment amount.--The `MFP+6 payment 
                amount' is equal to 106 percent of the maximum fair 
                price (as defined in section 1191(c)(2)) applicable for 
                such drug during such calendar quarter.
            ``(6) Clarification.--Nothing in part E of title XI or this 
        subsection shall be construed to require a manufacturer to 
        provide selected drugs at maximum fair prices other than 
        through the rebate required under this subsection.''.
            (2) Amounts payable; cost-sharing.--Section 1833(a)(1) of 
        the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended--
                    (A) in subparagraph (G), by striking ``subsection 
                (i)(9)'' and inserting ``paragraphs (9) and (10) of 
                subsection (i)'';
                    (B) in subparagraph (S), by striking ``subparagraph 
                (EE)'' and inserting ``subparagraphs (EE) and (II)'';
                    (C) by striking ``and (HH)'' and inserting 
                ``(HH)''; and
                    (D) by inserting before the semicolon at the end 
                the following: ``, and (II) with respect to a selected 
                drug (as defined in section 1192(c)) that is subject to 
                a rebate under section 1847A(j), the amounts paid shall 
                be equal to the percent of the payment amount otherwise 
                determined under section 1847A(b)(1)(B) that equals the 
                difference between (i) 100 percent, and (ii) the 
                percent applied under section 1847A(j)(2)(A)(ii)''.
            (3) ASC conforming amendments.--Section 1833(i) of the 
        Social Security Act (42 U.S.C. 1395l(i)) is amended by adding 
        at the end the following new paragraph:
            ``(11) In the case of a selected drug (as defined in 
        section 1192(c)), subject to a rebate under section 1847A(j) 
        for which payment under this subsection is not packaged into a 
        payment for a service furnished on or after the initial price 
        applicability year for the selected drug under the revised 
        payment system under this subsection, in lieu of calculation of 
        coinsurance and the amount of payment otherwise applicable 
        under this subsection, the provisions of section 1847(j)(2) and 
        paragraph (1)(II) of subsection (a), shall, as determined 
        appropriate by the Secretary, apply under this subsection in 
        the same manner as such provisions of section 1847A(j)(2) and 
        subsection (a) apply under such section and subsection.''.
            (4) Opps conforming amendment.--Section 1833(t)(8) of the 
        Social Security Act (42 U.S.C. 1395l(t)(8)) is amended by 
        adding at the end the following new subparagraph:
                    ``(G) Selected drugs subject to rebate.--In the 
                case of a selected drug (as defined in section 
                1192(c)), subject to a rebate under section 1847A(j) 
                for which payment under this subsection is not packaged 
                into a payment for a covered OPD service (or group of 
                services) furnished on or after the initial price 
                applicability year for the selected drug, and the 
                payment for such drug is the same as the amount for a 
                calendar quarter under section 1847A(b)(1)(B), under 
                the system under this subsection, in lieu of the 
                calculation of the copayment amount and the amount 
                otherwise applicable under this subsection (other than 
                the application of the limitation described in 
                subparagraph (C)), the provisions of section 
                1847A(j)(2) and paragraph (1)(II) of subsection (a), 
                shall, as determined by the Secretary apply under this 
                section in the same manner as such provisions of 
                section 1847A(j)(2) and subsection (a) apply under such 
                section and subsection.''.
            (5) Exclusion of selected drug mfp rebates from asp 
        calculation.--Section 1847A(c)(3) of the Social Security Act 
        (42 U.S.C. 1395w-3a(c)(3)) is amended by striking ``subsection 
        (i)'' and inserting ``subsection (i), subsection (j)''.
            (6) Coordination with medicaid rebate information 
        disclosures.--Section 1927(b)(3)(D)(i) of the Social Security 
        Act (42 U.S.C. 1396r-8(b)(3)(D)(i)) is amended by striking 
        ``and the rebate'' and inserting ``and the rebates''.
            (7) Provision of rebates.--Section 1193(a) of the Social 
        Security Act (42 U.S.C. 1320f-2(a)) is amended--
                    (A) in paragraph (1), by striking subparagraph (B) 
                and inserting the following:
                    ``(B) by paying rebates in accordance with section 
                1847A(j);'';
                    (B) in paragraph (2), by striking subparagraph (B) 
                and inserting the following:
                    ``(B) by paying rebates in accordance with section 
                1847A(j);''; and
                    (C) in paragraph (3), by striking subparagraph (B) 
                and inserting the following:
                    ``(B) by paying rebates in accordance with section 
                1847A(j);''.
    (c) Conforming Amendments.--
            (1) Section 1847A(i)(5) of the Social Security Act (42 
        U.S.C. 1395w-3a(i)(5)) is amended, in the matter preceding 
        subparagraph (A)--
                    (A) by striking ``In the case'' and inserting 
                ``Subsection to subsection (j)(2)(B), in the case''; 
                and
                    (B) by striking ``(or, in the case of a part B 
                rebatable drug that is a selected drug (as defined in 
                section 1192(c)), the payment amount described in 
                subsection (b)(1)(B) for such drug)''; and
            (2) Section 1833(a)(1)(EE) of the Social Security Act (42 
        U.S.C. 1395l(a)(1)(EE)) is amended--
                    (A) by striking ``(or, in the case of a part B 
                rebatable drug that is a selected drug (as defined in 
                section 1192(c) for which, the payment amount described 
                in section 1847A(b)(1)(B)) for such drug for such 
                quarter''; and
                    (B) by striking ``or section 1847A(b)(1)(B), as 
                applicable,''.
                                 <all>
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