H.R. 8143

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8143 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 8143

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.

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IN THE HOUSE OF REPRESENTATIVES

March 27, 2026

Ms. Matsui (for herself, Mrs. Miller-Meeks, and Mr. Auchincloss) 
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

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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 2026.''

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, 2027, 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 bio-
similar 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 lim-its 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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