119-hr4299

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4299 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 4299

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

 July 7, 2025

Mr. Murphy (for himself, Mr. Gray, and Mr. Dunn of Florida) 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 
semicolon 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,''.
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