I 

118TH CONGRESS 

1ST SESSION H. R. 5372 

To amend Title XVIII of the Social Security Act to facilitate midyear 

formulary changes for biosimilars. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 8, 2023 

Mr. JOYCE of Pennsylvania (for himself 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 facilitate 

midyear formulary changes for biosimilars. 

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 ‘‘Expanding Seniors’ 

5 Access to Lower Cost Medicines Act of 2023’’. 


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1 SEC. 2. FACILITATING MIDYEAR FORMULARY CHANGES 

2 FOR BIOSIMILARS. 

3 (a) IN GENERAL.—Section 1860D–4(b) of the Social 

4 Security Act (42 U.S.C. 1395w–104(b)) is amended by 

5 adding at the end the following new paragraph: 

6 ‘‘(5) MID-YEAR CHANGES IN FORMULARIES

7 PERMITTED FOR CERTAIN BIOSIMILAR BIOLOGICAL

8 PRODUCTS AND THE REFERENCE PRODUCT OF SUCH

9 BIOSIMILARS.—If a PDP sponsor of a prescription 

10 drug plan uses a formulary (including the use of 

11 tiered cost-sharing), the following shall apply: 

12 ‘‘(A) IN GENERAL.—For plan year 2025, 

13 and subsequent plan years, in the case of a cov14 ered part D drug that is the reference biological 

15 product (as defined in section 1847A(c)(6)(I)) 

16 with respect to a biosimilar biological product 

17 (as defined in section 1847A(c)(6)(H)), the 

18 PDP sponsor may, with respect to a formulary, 

19 at any time after the first 60 days of the plan 

20 year, subject to paragraph (3)(E), change the 

21 preferred or tiered cost-sharing status of such 

22 reference biological product if such PDP spon23 sor adds, before or at the same time, to such 

24 formulary such biosimilar biological product at 

25 the same or a higher preferred status, or to the 

26 same or lower cost-sharing tier, as that of such 


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1 reference biological product immediately prior 

2 to such change. 

3 ‘‘(B) REQUEST FOR APPROVAL OF

4 CHANGE.—Prior to making a change described 

5 in subparagraph (A), the PDP sponsor shall 

6 submit to the Secretary a request to make such 

7 change. If the Secretary approves the request 

8 or has not provided a decision to the PDP 

9 sponsor regarding such request within 30 days 

10 of receiving such request, such PDP sponsor 

11 may make such change.’’. 

12 (b) ADMINISTRATION.— 

13 (1) IMPLEMENTATION.—Notwithstanding any 

14 other provision of law, the Secretary of Health and 

15 Human Services may implement the amendment 

16 made by subsection (a) by program instruction or 

17 otherwise. 

18 (2) NON-APPLICATION OF THE PAPERWORK RE19 DUCTION ACT.—Chapter 35 of title 44, United 

20 States Code (commonly referred to as the ‘‘Paper21 work Reduction Act of 1995’’), shall not apply to the 

22 implementation of the amendment made by sub23 section (a). 

Æ 


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