S 694 — PLASMA Act

Summary

Preserving Life-saving Access to Specialty Medicines in America Act or the PLASMA ActThis bill phases-in certain price adjustments for plasma-derived products under the Medicare prescription drug benefit's Manufacturer Discount Program.Current law requires manufacturers of covered drugs under the Medicare prescription drug benefit to provide a 10% discount for covered drugs during the initial coverage phase (i.e., before a beneficiary reaches the out-of-pocket spending threshold) and a 20% discount during the catastrophic coverage phase (i.e., after a beneficiary reaches the out-of-pocket spending threshold). The bill phases-in discounts for plasma-derived products over several years, starting with a 1% discount in 2026 for both the initial and catastrophic coverage phases, and ending with a 10% discount beginning in 2030 for the initial coverage phase and a 20% discount beginning in 2032 for the catastrophic coverage phase.

Bill Text

• Introduced Introduced in Senate Current html February 24, 2025

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill amends the Social Security Act to implement a phase-in for discounts on plasma-derived products under the manufacturer discount program.

• 42 U.S.C. 1395w-114c(g)(4)

  and (C) → , (C), and (D)

  This change includes an additional subparagraph (D) to the existing regulations.

• 42 U.S.C. 1395w-114c(g)(4)

  subparagraph (D) → subparagraph (E)

  This change renumbers the existing subparagraphs that follow.

• 42 U.S.C. 1395w-114c(g)(4)

  (D) Phase-in for plasma-derived products.-- (i) In general.--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.

  This addition creates a new policy for phased discounts on plasma-derived products.

• 42 U.S.C. 1395w-114c(g)(4)

  (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.

  This defines what constitutes a plasma-derived product within the statute.

• 42 U.S.C. 1395w-114c(g)(4)

  (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 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.

  This specifies the percentage discounts applicable to plasma-derived products based on beneficiaries' costs.

• 42 U.S.C. 1395w-114c(g)(4)

  (iv) Limitations.--This subparagraph shall not apply with respect to the following: (I) Certain drugs dispensed to lis beneficiaries.--An applicable drug described in subparagraph (B)(i). (II) Specified small manufacturers.--An applicable drug described in subparagraph (C)(i).

  This outlines limitations on the application of the phase-in for certain drugs and manufacturers.

Action History

1. February 24, 2025

   Introduced in Senate

2. February 24, 2025

   Read twice and referred to the Committee on Finance.

Sponsors

• Thomas Tillis · Primary
• Mark Kelly · Cosponsor
• Ted Budd · Cosponsor
• Alex Padilla · Cosponsor

Subjects