Us Congress 2025 2025-2026 Regular Session

Us Congress House Bill HB1476 Introduced / Bill

Filed 03/17/2025

                    I 
119THCONGRESS 
1
STSESSION H. R. 1476 
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 
FEBRUARY21, 2025 
Mr. H
UDSON(for himself, Mr. DAVISof North Carolina, Mr. MURPHY, and 
Mr. P
ETERS) 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-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Preserving Life-saving 4
Access to Specialty Medicines in America Act’’ or the 5
‘‘PLASMA Act’’. 6
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SEC. 2. PHASE-IN FOR PLASMA-DERIVED PRODUCTS UNDER 1
MANUFACTURER DISCOUNT PROGRAM. 2
Section 1860D–14C(g)(4) of the Social Security Act 3
(42 U.S.C. 1395w–114c(g)(4)) is amended— 4
(1) in subparagraph (A), in the matter pre-5
ceding clause (i), by striking ‘‘and (C)’’ and insert-6
ing ‘‘, (C), and (D)’’; 7
(2) by redesignating subparagraphs (D) and 8
(E) as subparagraphs (E) and (F), respectively; and 9
(3) by inserting after subparagraph (C) the fol-10
lowing: 11
‘‘(D) P
HASE-IN FOR PLASMA -DERIVED 12
PRODUCTS.— 13
‘‘(i) I
N GENERAL.—For 2026 and 14
subsequent years, subject to clause (iv), in 15
the case of an applicable drug of a manu-16
facturer that is a plasma-derived product 17
(as defined in clause (ii)), and that is mar-18
keted as of August 16, 2022, and dis-19
pensed for an applicable beneficiary, the 20
term ‘discounted price’ means the specified 21
plasma-derived product percent (as defined 22
in clause (iii)) of the negotiated price of 23
the applicable drug of the manufacturer. 24
‘‘(ii) P
LASMA-DERIVED PRODUCT.—In 25
this subparagraph, the term ‘plasma-de-26
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rived product’ means an applicable drug 1
that is a biological product that is derived 2
from human whole blood or plasma. 3
‘‘(iii) S
PECIFIED PLASMA -DERIVED 4
PRODUCT PERCENT .—In this subpara-5
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 a plasma-derived product dispensed 10
for an applicable beneficiary who has 11
not incurred costs, as determined in 12
accordance with section 1860D– 13
2(b)(4)(C), for covered part D drugs 14
in the year that are equal to or exceed 15
the annual out-of-pocket threshold 16
specified in section 1860D– 17
2(b)(4)(B)(i) for the year— 18
‘‘(aa) for 2026, 99 percent; 19
‘‘(bb) for 2027, 98 percent; 20
‘‘(cc) for 2028, 95 percent; 21
‘‘(dd) for 2029, 92 percent; 22
and 23
‘‘(ee) for 2030 and each 24
subsequent year, 90 percent; and 25
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‘‘(II) for an applicable drug that 1
is a plasma-derived product dispensed 2
for an applicable beneficiary who has 3
incurred costs, as determined in ac-4
cordance with section 1860D– 5
2(b)(4)(C), for covered part D drugs 6
in the year that are equal to or exceed 7
the annual out-of-pocket threshold 8
specified in section 1860D– 9
2(b)(4)(B)(i) for the year— 10
‘‘(aa) for 2026, 99 percent; 11
‘‘(bb) for 2027, 98 percent; 12
‘‘(cc) for 2028, 95 percent; 13
‘‘(dd) for 2029, 92 percent; 14
‘‘(ee) for 2030, 90 percent; 15
‘‘(ff) for 2031, 85 percent; 16
and 17
‘‘(gg) for 2032 and each 18
subsequent year, 80 percent. 19
‘‘(iv) L
IMITATIONS.—This subpara-20
graph shall not apply with respect to the 21
following: 22
‘‘(I) C
ERTAIN DRUGS DISPENSED 23
TO LIS BENEFICIARIES.—An applica-24
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ble drug described in subparagraph 1
(B)(i). 2
‘‘(II) S
PECIFIED SMALL MANU -3
FACTURERS.—An applicable drug de-4
scribed in subparagraph (C)(i).’’. 5
Æ 
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