Section 1 Short title
This Act may be cited as the “Preserving Life-saving Access to Specialty Medicines in America Act” or the “PLASMA Act”.
Preserving Life-saving Access to Specialty Medicines in America Act
A BILL
To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program.
Sec. 2 Phase-in for plasma-derived products under manufacturer discount program
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:
“(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.
“(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).”