Bill Details
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AI Summary This summary was generated by AI from the bill text. AI can get information wrong.
This bill would change how Medicare’s Part D drug discount program applies to plasma-derived medicines, which are drugs made from human blood plasma. Starting in 2026, it would phase in the required discount for these products instead of applying the full rule right away. The goal is to give this group of specialty medicines a slower, more gradual change in pricing under Medicare. The bill applies only to certain plasma-derived products that were already on the market as of August 16, 2022, and it sets different discount levels depending on a patient’s out-of-pocket spending during the year.
- For beneficiaries who have not yet reached the yearly out-of-pocket threshold, the required discount would be set at 99% in 2026, 98% in 2027, 95% in 2028, 92% in 2029, and 90% in 2030 and later years.
- For beneficiaries who have reached the out-of-pocket threshold, the required discount would follow the same early path, then drop further to 85% in 2031 and 80% in 2032 and later years.
- The bill defines “plasma-derived products” as biological products made from human whole blood or plasma.
- It would not apply to certain drugs for low-income subsidy beneficiaries or to drugs made by 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]
[H.R. 1476 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1476
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 HOUSE OF REPRESENTATIVES
February 21, 2025
Mr. Hudson (for himself, Mr. Davis of North Carolina, Mr. Murphy, and
Mr. Peters) introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
Ways and Means, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
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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