118 HR 5372 IH: Expanding Seniors' Access to Lower Cost Medicines Act of 2023 U.S. House of Representatives 2023-09-08 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I118th CONGRESS1st SessionH. R. 5372IN THE HOUSE OF REPRESENTATIVESSeptember 8, 2023Mr. 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 concernedA BILLTo amend Title XVIII of the Social Security Act to facilitate midyear formulary changes for biosimilars.

1.

Short title

This Act may be cited as the Expanding Seniors' Access to Lower Cost Medicines Act of 2023.

2.

Facilitating midyear formulary changes for biosimilars

(a)

In general

Section 1860D–4(b) of the Social Security Act (42 U.S.C. 1395w–104(b)) is amended by adding at the end the following new paragraph:(5)

Mid-year changes in formularies permitted for certain biosimilar biological products and the reference product of such biosimilars

If a PDP sponsor of a prescription drug plan uses a formulary (including the use of tiered cost-sharing), the following shall apply:(A)

In general

For plan year 2025, and subsequent plan years, in the case of a covered part D drug that is the reference biological product (as defined in section 1847A(c)(6)(I)) with respect to a biosimilar biological product (as defined in section 1847A(c)(6)(H)), the PDP sponsor may, with respect to a formulary, at any time after the first 60 days of the plan year, subject to paragraph (3)(E), change the preferred or tiered cost-sharing status of such reference biological product if such PDP sponsor adds, before or at the same time, to such formulary such biosimilar biological product at the same or a higher preferred status, or to the same or lower cost-sharing tier, as that of such reference biological product immediately prior to such change.(B)

Request for approval of change

Prior to making a change described in subparagraph (A), the PDP sponsor shall submit to the Secretary a request to make such change. If the Secretary approves the request or has not provided a decision to the PDP sponsor regarding such request within 30 days of receiving such request, such PDP sponsor may make such change..(b)

Administration

(1)

Implementation

Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendment made by subsection (a) by program instruction or otherwise.(2)

Non-application of the Paperwork Reduction Act

Chapter 35 of title 44, United States Code (commonly referred to as the Paperwork Reduction Act of 1995), shall not apply to the implementation of the amendment made by subsection (a).