HR1476-119

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: 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. 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 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. 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). (D)Phase-in for plasma-derived products (i)In generalFor 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 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 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)LimitationsThis subparagraph shall not apply with respect to the following: (I)Certain drugs dispensed to LIS beneficiariesAn applicable drug described in subparagraph (B)(i). (II)Specified small manufacturersAn applicable drug described in subparagraph (C)(i)..