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136 STAT. 1902 PUBLIC LAW 117–169—AUG. 16, 2022 SEC. 11406. APPROPRIATE COST-SHARING FOR COVERED INSULIN PRODUCTS UNDER MEDICARE PART D. (a) IN GENERAL.—Section 1860D–2 of the Social Security Act (42 U.S.C. 1395w–102), as amended by sections 11201, 11202, and 11401, is amended— (1) in subsection (b)— (A) in paragraph (1)(A), by striking ‘‘paragraph (8)’’ and inserting ‘‘paragraphs (8) and (9)’’; (B) in paragraph (2)— (i) in subparagraph (A), by striking ‘‘paragraph (8)’’ and inserting ‘‘paragraphs (8) and (9)’’; (ii) in subparagraph (C)(i), in the matter preceding subclause (I), by striking ‘‘and (8)’’ and inserting ‘‘, (8), and (9)’’; and (iii) in subparagraph (D)(i), in the matter preceding subclause (I), by striking ‘‘and (8)’’ and inserting ‘‘, (8), and (9)’’; (C) in paragraph (3)(A), in the matter preceding clause (i), by striking ‘‘and (8)’’ and inserting ‘‘(8), and (9)’’; (D) in paragraph (4)(A)(i), by striking ‘‘paragraph (8)’’ and inserting ‘‘paragraphs (8) and (9)’’; and (E) by adding at the end the following new paragraph: ‘‘(9) TREATMENT OF COST-SHARING FOR COVERED INSULIN PRODUCTS.— ‘‘(A) NO APPLICATION OF DEDUCTIBLE.—For plan year 2023 and subsequent plan years, the deductible under para- graph (1) shall not apply with respect to any covered insulin product. ‘‘(B) APPLICATION OF COST-SHARING.— ‘‘(i) PLAN YEARS 2023 AND 2024.—For plan years 2023 and 2024, the coverage provides benefits for any covered insulin product, regardless of whether an indi- vidual has reached the initial coverage limit under paragraph (3) or the out-of-pocket threshold under paragraph (4), with cost-sharing for a month’s supply that does not exceed the applicable copayment amount. ‘‘(ii) PLAN YEAR 2025 AND SUBSEQUENT PLAN YEARS.—For a plan year beginning on or after January 1, 2025, the coverage provides benefits for any covered insulin product, prior to an individual reaching the out-of-pocket threshold under paragraph (4), with cost- sharing for a month’s supply that does not exceed the applicable copayment amount. ‘‘(C) COVERED INSULIN PRODUCT.—In this paragraph, the term ‘covered insulin product’ means an insulin product that is a covered part D drug covered under the prescription drug plan or MA–PD plan that is approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of the Public Health Service Act and marketed pursuant to such approval or licensure, including any covered insulin product that has been deemed to be licensed under section 351 of the Public Health Service Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 and marketed pursuant to such section. ‘‘(D) APPLICABLE COPAYMENT AMOUNT.—In this para- graph, the term ‘applicable copayment amount’ means, with Definition. Definition. Time periods. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00086 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw