HR6465-118

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— 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 by inserting after subparagraph (C) the following: 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. 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. In this subparagraph, the term specified plasma-derived product percent means, with respect to a year— 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 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. (D)Phase-in for plasma-derived products(i)In generalIn 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 productIn 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 percentIn 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..