119-S694

Bill is currently in: Senate
Path to Law
House Senate President

119th CONGRESS

1st Session

S. 694

1. Short title
2. Phase-in for plasma-derived products under 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) Phase-in for plasma-derived products - by inserting after subparagraph (C) the following:

(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 ), 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 ) 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 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) 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).