H.R. 1476
119th CONGRESS 1st Session
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 · February 21, 2025 · Sponsor: Mr. Hudson
Table of contents
SEC. 1. Short title
- This Act may be cited as the or the .
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—
- in subparagraph (A), in the matter preceding clause (i), by striking
and (C)and inserting, (C), and (D); - by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively; and
- (D) Phase-in for plasma-derived products
- (i) 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 ), and that is marketed as of August 16, 2022, and dispensed for an applicable beneficiary, the term
discounted pricemeans the specified plasma-derived product percent (as defined in ) of the negotiated price of the applicable drug of the manufacturer. - (ii) In this subparagraph, the term
plasma-derived productmeans an applicable drug that is a biological product that is derived from human whole blood or plasma. - (iii) In this subparagraph, the term
specified plasma-derived product percentmeans, with respect to a year— - 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—
- for 2026, 99 percent;
- for 2027, 98 percent;
- for 2028, 95 percent;
- for 2029, 92 percent; and
- for 2030 and each subsequent year, 90 percent; and
- 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—
- for 2026, 99 percent;
- for 2027, 98 percent;
- for 2028, 95 percent;
- for 2029, 92 percent;
- for 2030, 90 percent;
- for 2031, 85 percent; and
- for 2032 and each subsequent year, 80 percent.
- (iv) This subparagraph shall not apply with respect to the following:
- An applicable drug described in subparagraph (B)(i).
- An applicable drug described in subparagraph (C)(i).
- (i) 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 ), and that is marketed as of August 16, 2022, and dispensed for an applicable beneficiary, the term
- (D) Phase-in for plasma-derived products
- by inserting after subparagraph (C) the following:
- in subparagraph (A), in the matter preceding clause (i), by striking