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 manu-
facturer discount program. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Preserving Life-saving 
Access to Specialty Medicines in America Act’’ or the 
‘‘PLASMA Act’’. 
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SEC. 2. PHASE-IN FOR PLASMA-DERIVED PRODUCTS UNDER 
MANUFACTURER DISCOUNT PROGRAM. 
Section 1860D–14C(g)(4) of the Social Security Act 
(42 U.S.C. 1395w–114c(g)(4)) is amended— 
(1) in subparagraph (A), in the matter pre-
ceding clause (i), by striking ‘‘and (C)’’ and insert-
ing ‘‘, (C), and (D)’’; 
(2) by redesignating subparagraphs (D) and 
(E) as subparagraphs (E) and (F), respectively; and 
(3) by inserting after subparagraph (C) the fol-
lowing: 
‘‘(D) PHASE-IN
FOR
PLASMA-DERIVED 
PRODUCTS.— 
‘‘(i) IN GENERAL.—In the case of an 
applicable drug that is a plasma-derived 
product (as defined in clause (ii)), and that 
is marketed as of the date of enactment of 
this subparagraph and dispensed for an 
applicable beneficiary, the term ‘discounted 
price’ means the specified plasma-derived 
product percent (as defined in clause (iii)) 
of the negotiated price of the applicable 
drug of the manufacturer. 
‘‘(ii) PLASMA-DERIVED PRODUCT.—In 
this subparagraph, the term ‘plasma-de-
rived product’ means an applicable drug 
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that is a biological product that is derived 
from human whole blood or plasma. 
‘‘(iii) 
SPECIFIED
PLASMA-DERIVED 
PRODUCT
PERCENT.—In this subpara-
graph, the term ‘specified plasma-derived 
product percent’ means, with respect to a 
year— 
‘‘(I) for an applicable drug that 
is as a plasma-derived product dis-
pensed for an applicable beneficiary 
who has not incurred costs, as deter-
mined in accordance with section 
1860D–2(b)(4)(C), for covered part D 
drugs in the year that are equal to or 
exceed 
the 
annual 
out-of-pocket 
threshold specified in section 1860D– 
2(b)(4)(B)(i) for the year, the percent 
specified 
under 
subparagraph 
(B)(iii)(I) for such year; and 
‘‘(II) for an applicable drug that 
is as a plasma-derived product dis-
pensed for an applicable beneficiary 
who has incurred costs, as determined 
in accordance with section 1860D– 
2(b)(4)(C), for covered part D drugs 
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in the year that are equal to or exceed 
the annual out-of-pocket threshold 
specified 
in 
section 
1860D– 
2(b)(4)(B)(i) for the year, the percent 
specified 
under 
subparagraph 
(B)(iii)(II) for such year.’’. 
Æ 
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