; and (C) by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and adjusting the margins accordingly. 302. Permitted mid-year changes in Medicare part D plan formularies for certain biosimilar biological products and the reference product of such biosimilars (a) In general Section 1860D–4(b) of the Social Security Act (42 5 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 2024, 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, 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 clause (i), 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 subregulatory guidance, program instruction, or otherwise.