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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5372 Introduced in House (IH)]

<DOC>

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.

    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 ``Expanding Seniors' Access to Lower 
Cost Medicines Act of 2023''.

SEC. 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).
                                 <all>
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