Expanding Seniors' Access to Lower Cost Medicines Act of 2023

“(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.”