H.R. 1476

119 HR 1476 IH: Preserving Life-saving Access to Specialty Medicines in America Act
 U.S. House of Representatives
 2025-02-21
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 I  119th CONGRESS  1st Session  H. R. 1476  IN THE HOUSE OF REPRESENTATIVES   February 21, 2025   Mr. Hudson  (for himself,  Mr. Davis of North Carolina ,  Mr. Murphy , and  Mr. Peters ) 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.
Short title
This Act may be cited as the   Preserving Life-saving Access to Specialty Medicines in America Act   or the   PLASMA Act  .
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 preceding clause (i), by striking  and (C)  and inserting  , (C), and (D) ;
(2)
by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively; and
(3)
by inserting after subparagraph (C) the following:
(D)
Phase-in for plasma-derived products
(i)
In general
For 2026 and subsequent years, subject to clause (iv), in the case of an applicable drug of a manufacturer that is a plasma-derived product (as defined in  clause (ii) ), and that is marketed as of August 16, 2022, 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-derived product  means an applicable drug that is a biological product that is derived from human whole blood or plasma.
(iii)
Specified plasma-derived product percent
In this subparagraph, the term  specified plasma-derived product percent  means, with respect to a year—
(I)
for an applicable drug that is a plasma-derived product dispensed for an applicable beneficiary who has not incurred costs, as determined 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—
(aa)
for 2026, 99 percent;
(bb)
for 2027, 98 percent;
(cc)
for 2028, 95 percent;
(dd)
for 2029, 92 percent; and
(ee)
for 2030 and each subsequent year, 90 percent; and
(II)
for an applicable drug that is a plasma-derived product dispensed for an applicable beneficiary who has incurred costs, as determined 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—
(aa)
for 2026, 99 percent;
(bb)
for 2027, 98 percent;
(cc)
for 2028, 95 percent;
(dd)
for 2029, 92 percent;
(ee)
for 2030, 90 percent;
(ff)
for 2031, 85 percent; and
(gg)
for 2032 and each subsequent year, 80 percent.
(iv)
Limitations
This subparagraph shall not apply with respect to the following:
(I)
Certain drugs dispensed to LIS beneficiaries
An applicable drug described in subparagraph (B)(i).
(II)
Specified small manufacturers
An applicable drug described in subparagraph (C)(i).
 .