[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1476 Introduced in House (IH)]
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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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