[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5461 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 5461
To amend title XVIII of the Social Security Act to require PDP sponsors
of a prescription drug plan under part D of the Medicare program that
use a formulary to include certain generic drugs and biosimilar
biological products on such formulary, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 14, 2023
Ms. Kuster (for herself, Mrs. Miller-Meeks, Ms. Matsui, and Mr. Dunn of
Florida) 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 require PDP sponsors
of a prescription drug plan under part D of the Medicare program that
use a formulary to include certain generic drugs and biosimilar
biological products on such formulary, and for other purposes.
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 ``Ensuring Access to Lower-Cost
Medicines for Seniors Act of 2023''.
SEC. 2. REQUIREMENTS FOR PDP SPONSORS OF PRESCRIPTION DRUG PLANS UNDER
PART D OF THE MEDICARE PROGRAM THAT USE FORMULARIES.
Section 1860D-4(b)(3) of the Social Security Act (42 U.S.C. 1395w-
104(b)(3)) is amended by adding at the end the following new
subparagraph:
``(J) Required inclusion of certain generic drugs
and biosimilar biological products.--
``(i) In general.--With respect to a plan
year beginning on or after January 1, 2024, the
formulary shall include in a preferred position
relative to the reference drug--
``(I) each covered generic drug for
which the wholesale acquisition cost is
less than the wholesale acquisition
cost of the reference drug of such
covered generic drug; and
``(II) at least two covered
biosimilar biological products for
which the wholesale acquisition cost is
less than the wholesale acquisition
cost of the reference biological
product of such covered biosimilar
biological product.
``(ii) Prohibition on certain limits on
access.--The PDP sponsor offering the
prescription drug plan may not impose limits on
access to a covered generic drug required to be
included on the formulary under clause (i)(I)
or a covered biosimilar biological product
required to be included on the formulary under
clause (i)(II), including through utilization
management techniques such as prior
authorization, or step therapy, that are more
restrictive than any such limits imposed on
access to the reference drug of such covered
generic drug or reference biological product of
such covered biosimilar biological product,
respectively, or that otherwise have the effect
of limiting the availability to enrollees of
such covered generic drug or covered biosimilar
biological product relative to such reference
drug or reference biological product over such
covered generic drug or covered biosimilar
biological product, respectively.
``(iii) Definitions.--In this subparagraph
and subparagraph (J):
``(I) Covered biosimilar biological
product.--The term `covered biosimilar
biological product' means a covered
part D drug that is a biosimilar
biological product (as defined in
section 1847A(c)(6)(H)).
``(II) Covered generic drug.--The
term `covered generic drug' means a
covered part D drug that is a drug
described in section 1860D-2(e)(1)(A)
and approved under section 505(j) of
the Federal Food, Drug, and Cosmetic
Act.
``(III) Preferred position.--The
term `preferred position' means a
product is placed on a more favorable
formulary tier and has lower patient
out-of-pocket costs than the
corresponding reference drug or
reference biological product.
``(IV) Reference biological
product.--The term `reference
biological product' has the meaning
given such term in section
1847A(c)(6)(I).
``(V) Reference drug.--The term
`reference drug' means, with respect to
a covered generic drug, the listed drug
(as described in clause (i) of section
505(j)(2)(A) of the Federal Food, Drug,
and Cosmetic Act) that is referred to
in the abbreviated application for such
covered generic drug under such
section.
``(VI) Wholesale acquisition
cost.--The term `wholesale acquisition
cost' has the meaning given such term
in section 1847A(c)(6)(B).''.
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