I 

118TH CONGRESS 

1ST SESSION H. R. 6465 

To amend title XVIII of the Social Security Act to provide a phase-in 

for plasma-derived products under the manufacturer discount program. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 21, 2023 

Mr. HUDSON (for himself, Mr. MURPHY, Mr. DAVIS of North Carolina, and 

Mr. NICKEL) 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 

a phase-in for plasma-derived products under the manufacturer discount program. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Preserving Life-saving 

5 Access to Specialty Medicines in America Act’’ or the 

6 ‘‘PLASMA Act’’. 


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1 SEC. 2. PHASE-IN FOR PLASMA-DERIVED PRODUCTS UNDER 

2 MANUFACTURER DISCOUNT PROGRAM. 

3 Section 1860D–14C(g)(4) of the Social Security Act 

4 (42 U.S.C. 1395w–114c(g)(4)) is amended— 

5 (1) in subparagraph (A), in the matter pre6 ceding clause (i), by striking ‘‘and (C)’’ and insert7 ing ‘‘, (C), and (D)’’; 

8 (2) by redesignating subparagraphs (D) and 

9 (E) as subparagraphs (E) and (F), respectively; and 

10 (3) by inserting after subparagraph (C) the fol11 lowing: 

12 ‘‘(D) PHASE-IN FOR PLASMA-DERIVED

13 PRODUCTS.— 

14 ‘‘(i) IN GENERAL.—In the case of an 

15 applicable drug that is a plasma-derived 

16 product (as defined in clause (ii)), and that 

17 is marketed as of the date of enactment of 

18 this subparagraph and dispensed for an 

19 applicable beneficiary, the term ‘discounted 

20 price’ means the specified plasma-derived 

21 product percent (as defined in clause (iii)) 

22 of the negotiated price of the applicable 

23 drug of the manufacturer. 

24 ‘‘(ii) PLASMA-DERIVED PRODUCT.—In 

25 this subparagraph, the term ‘plasma-de26 rived product’ means an applicable drug 


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1 that is a biological product that is derived 

2 from human whole blood or plasma. 

3 ‘‘(iii) SPECIFIED PLASMA-DERIVED

4 PRODUCT PERCENT.—In this subpara5 graph, the term ‘specified plasma-derived 

6 product percent’ means, with respect to a 

7 year— 

8 ‘‘(I) for an applicable drug that 

9 is as a plasma-derived product dis10 pensed for an applicable beneficiary 

11 who has not incurred costs, as deter12 mined in accordance with section 

13 1860D–2(b)(4)(C), for covered part D 

14 drugs in the year that are equal to or 

15 exceed the annual out-of-pocket 

16 threshold specified in section 1860D– 

17 2(b)(4)(B)(i) for the year, the percent 

18 specified under subparagraph 

19 (B)(iii)(I) for such year; and 

20 ‘‘(II) for an applicable drug that 

21 is as a plasma-derived product dis22 pensed for an applicable beneficiary 

23 who has incurred costs, as determined 

24 in accordance with section 1860D– 

25 2(b)(4)(C), for covered part D drugs 


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1 in the year that are equal to or exceed 

2 the annual out-of-pocket threshold 

3 specified in section 1860D– 

4 2(b)(4)(B)(i) for the year, the percent 

5 specified under subparagraph 

6 (B)(iii)(II) for such year.’’. 

Æ 


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