I 
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 Com-
mittee 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 Representa-
tives 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’’. 
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SEC. 2. REQUIREMENTS FOR PDP SPONSORS OF PRESCRIP-
TION 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 pre-
ferred position relative to the reference 
drug— 
‘‘(I) each covered generic drug 
for which the wholesale acquisition 
cost is less than the wholesale acquisi-
tion 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 
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such 
covered 
biosimilar 
biological 
product. 
‘‘(ii) PROHIBITION ON CERTAIN LIM-
ITS ON ACCESS.—The PDP sponsor offer-
ing the prescription drug plan may not im-
pose limits on access to a covered generic 
drug required to be included on the for-
mulary under clause (i)(I) or a covered 
biosimilar biological product required to be 
included on the formulary under clause 
(i)(II), including through utilization man-
agement techniques such as prior author-
ization, or step therapy, that are more re-
strictive than any such limits imposed on 
access to the reference drug of such cov-
ered generic drug or reference biological 
product of such covered biosimilar biologi-
cal product, respectively, or that otherwise 
have the effect of limiting the availability 
to enrollees of such covered generic drug or 
covered biosimilar biological product rel-
ative to such reference drug or reference 
biological product over such covered ge-
neric drug or covered biosimilar biological 
product, respectively. 
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‘‘(iii) DEFINITIONS.—In this subpara-
graph and subparagraph (J): 
‘‘(I) COVERED
BIOSIMILAR
BIO-
LOGICAL
PRODUCT.—The term ‘cov-
ered biosimilar biological product’ 
means a covered part D drug that is 
a biosimilar biological product (as de-
fined 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 cor-
responding reference drug or ref-
erence biological product. 
‘‘(IV) REFERENCE
BIOLOGICAL 
PRODUCT.—The term ‘reference bio-
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logical product’ has the meaning given 
such term in section 1847A(c)(6)(I). 
‘‘(V) REFERENCE
DRUG.—The 
term ‘reference drug’ means, with re-
spect 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 appli-
cation for such covered generic drug 
under such section. 
‘‘(VI) WHOLESALE ACQUISITION 
COST.—The term ‘wholesale acquisi-
tion cost’ has the meaning given such 
term in section 1847A(c)(6)(B).’’. 
Æ 
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