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This bill would slowly change how certain plasma-derived medicines are priced in Medicare drug coverage. These medicines are made from human blood or plasma and are used for important, often life-saving treatments. Starting in 2026, the bill would set a stepped-in discount formula instead of applying the full discount right away, giving drug makers and the program time to adjust. The goal is to protect access to these specialty medicines while easing the financial impact of the manufacturer discount program.
- It applies only to plasma-derived biological products that were already on the market as of August 16, 2022.
- For patients who have not yet reached the yearly out-of-pocket spending limit, the required discounted price would gradually move from 99% of the negotiated price in 2026 down to 90% in 2030 and later.
- For patients who have already reached that out-of-pocket limit, the phase-in is slower at first but goes further over time, falling to 85% in 2031 and 80% in 2032 and later.
- The new rule would not apply to certain low-income subsidy drugs or to products from certain small manufacturers.
Official Summaries
Preserving Life-saving Access to Specialty Medicines in America Act or the PLASMA Act
This 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.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 694 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 694
To amend title XVIII of the Social Security Act to provide a phase-in
for plasma-derived products under the manufacturer discount program.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 24, 2025
Mr. Tillis (for himself and Mr. Kelly) introduced the following bill;
which was read twice and referred to the Committee on Finance
_______________________________________________________________________
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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''.
SEC. 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) 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).''.
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