H.R. 1476 — PLASMA Act

This section provides the short title of the Act as the “Preserving Life-saving Access to Specialty Medicines in America Act” or the “PLASMA Act.”

This section establishes a phase-in for plasma-derived products under the Medicare Part D manufacturer discount program for 2026 and subsequent years. As background, the manufacturer discount program requires drug manufacturers to provide discounts on covered Part D drugs for beneficiaries who have reached the annual out-of-pocket threshold. For applicable drugs that are plasma-derived products, defined as biological products derived from human whole blood or plasma and marketed as of August 16, 2022, the section sets the discounted price at a specified percentage of the negotiated price rather than the full discount otherwise required. The specified plasma-derived product percent is set at: (1) 99 percent for 2026, 98 percent for 2027, 95 percent for 2028, 92 percent for 2029, and 90 percent for 2030 and each subsequent year for beneficiaries who have not yet reached the annual out-of-pocket threshold; and (2) 99 percent for 2026, 98 percent for 2027, 95 percent for 2028, 92 percent for 2029, 90 percent for 2030, 85 percent for 2031, and 80 percent for 2032 and each subsequent year for beneficiaries who have reached the threshold. Thus, the required manufacturer discount for these products phases down over time from near-full price to 90 percent or 80 percent of negotiated price, depending on beneficiary cost-sharing status. The section also excludes from this phase-in: (1) certain drugs dispensed to low-income subsidy beneficiaries under 42 U.S.C. 1395w–114c(g)(4)(B)(i), and (2) drugs from specified small manufacturers under 42 U.S.C. 1395w–114c(g)(4)(C)(i).