118 HR 6465 IH: Preserving Life-saving Access to Specialty Medicines in America Act U.S. House of Representatives 2023-11-21 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I118th CONGRESS1st SessionH. R. 6465IN THE HOUSE OF REPRESENTATIVESNovember 21, 2023Mr. 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 concernedA BILLTo 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

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-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 as 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, the percent specified under subparagraph (B)(iii)(I) for such year; and(II)for an applicable drug that is as 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, the percent specified under subparagraph (B)(iii)(II) for such year..