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 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ensuring Access to 

5 Lower-Cost Medicines for Seniors Act of 2023’’. 


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1 SEC. 2. REQUIREMENTS FOR PDP SPONSORS OF PRESCRIP2 TION DRUG PLANS UNDER PART D OF THE 

3 MEDICARE PROGRAM THAT USE 

4 FORMULARIES. 

5 Section 1860D–4(b)(3) of the Social Security Act (42 

6 U.S.C. 1395w–104(b)(3)) is amended by adding at the 

7 end the following new subparagraph: 

8 ‘‘(J) REQUIRED INCLUSION OF CERTAIN

9 GENERIC DRUGS AND BIOSIMILAR BIOLOGICAL

10 PRODUCTS.— 

11 ‘‘(i) IN GENERAL.—With respect to a 

12 plan year beginning on or after January 1, 

13 2024, the formulary shall include in a pre14 ferred position relative to the reference 

15 drug— 

16 ‘‘(I) each covered generic drug 

17 for which the wholesale acquisition 

18 cost is less than the wholesale acquisi19 tion cost of the reference drug of such 

20 covered generic drug; and 

21 ‘‘(II) at least two covered bio22 similar biological products for which 

23 the wholesale acquisition cost is less 

24 than the wholesale acquisition cost of 

25 the reference biological product of 


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•HR 5461 IH

1 such covered biosimilar biological 

2 product. 

3 ‘‘(ii) PROHIBITION ON CERTAIN LIM4 ITS ON ACCESS.—The PDP sponsor offer5 ing the prescription drug plan may not im6 pose limits on access to a covered generic 

7 drug required to be included on the for8 mulary under clause (i)(I) or a covered 

9 biosimilar biological product required to be 

10 included on the formulary under clause 

11 (i)(II), including through utilization man12 agement techniques such as prior author13 ization, or step therapy, that are more re14 strictive than any such limits imposed on 

15 access to the reference drug of such cov16 ered generic drug or reference biological 

17 product of such covered biosimilar biologi18 cal product, respectively, or that otherwise 

19 have the effect of limiting the availability 

20 to enrollees of such covered generic drug or 

21 covered biosimilar biological product rel22 ative to such reference drug or reference 

23 biological product over such covered ge24 neric drug or covered biosimilar biological 

25 product, respectively. 


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•HR 5461 IH

1 ‘‘(iii) DEFINITIONS.—In this subpara2 graph and subparagraph (J): 

3 ‘‘(I) COVERED BIOSIMILAR BIO4 LOGICAL PRODUCT.—The term ‘cov5 ered biosimilar biological product’ 

6 means a covered part D drug that is 

7 a biosimilar biological product (as de8 fined in section 1847A(c)(6)(H)). 

9 ‘‘(II) COVERED GENERIC

10 DRUG.—The term ‘covered generic 

11 drug’ means a covered part D drug 

12 that is a drug described in section 

13 1860D–2(e)(1)(A) and approved 

14 under section 505(j) of the Federal 

15 Food, Drug, and Cosmetic Act. 

16 ‘‘(III) PREFERRED POSITION.— 

17 The term ‘preferred position’ means a 

18 product is placed on a more favorable 

19 formulary tier and has lower patient 

20 out-of-pocket costs than the cor21 responding reference drug or ref22 erence biological product. 

23 ‘‘(IV) REFERENCE BIOLOGICAL

24 PRODUCT.—The term ‘reference bioVerDate Sep 11 2014 00:58 Sep 16, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5461.IH H5461

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1 logical product’ has the meaning given 

2 such term in section 1847A(c)(6)(I). 

3 ‘‘(V) REFERENCE DRUG.—The 

4 term ‘reference drug’ means, with re5 spect to a covered generic drug, the 

6 listed drug (as described in clause (i) 

7 of section 505(j)(2)(A) of the Federal 

8 Food, Drug, and Cosmetic Act) that 

9 is referred to in the abbreviated appli10 cation for such covered generic drug 

11 under such section. 

12 ‘‘(VI) WHOLESALE ACQUISITION

13 COST.—The term ‘wholesale acquisi14 tion cost’ has the meaning given such 

15 term in section 1847A(c)(6)(B).’’. 

Æ 


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