APPROPRIATE COST-SHARING FOR COVERED INSULIN PRODUCTS UNDER MEDICARE PART D.

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 paragraph (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 individual 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 paragraph, the term ‘applicable copayment amount’ means, with 136 STAT. 1903 respect to a covered insulin product under a prescription drug plan or an MA–PD plan dispensed—“(i) during plan years 2023, 2024, and 2025, $35; and “(ii) during plan year 2026 and each subsequent plan year, the lesser of—“(I) $35; “(II) an amount equal to 25 percent of the maximum fair price established for the covered insulin product in accordance with part E of title XI; or “(III) an amount equal to 25 percent of the negotiated price of the covered insulin product under the prescription drug plan or MA–PD plan. “(E) Special rule for first 3 months of 2023.—With respect to a month’s supply of a covered insulin product dispensed during the period beginning on January 1, 2023, and ending on March 31, 2023, a PDP sponsor offering a prescription drug plan or an MA organization offering an MA–PD plan shall reimburse an enrollee within 30 days for any cost-sharing paid by such enrollee that exceeds the cost-sharing applied by the prescription drug plan or MA–PD plan under subparagraph (B)(i) at the point-of-sale for such month’s supply.” ; and (2) in subsection (c), by adding at the end the following new paragraph:“(6) Treatment of cost-sharing for covered insulin products.—The coverage is provided in accordance with subsection (b)(9).” . (b) Conforming Amendments to Cost-sharing for Low-income Individuals.—Section 1860D–14(a) of the Social Security Act (42 U.S.C. 1395w–114(a)), as amended by sections 11201, 11401, and 11404, is amended—(1) in paragraph (1)—(A) in subparagraph (D)(iii), by adding at the end the following new sentence: “For plan year 2023 and subsequent plan years, the copayment amount applicable under the preceding sentence to a month’s supply of a covered insulin product (as defined in section 1860D–2(b)(9)(C)) dispensed to the individual may not exceed the applicable copayment amount for the product under the prescription drug plan or MA–PD plan in which the individual is enrolled.”; and (B) in subparagraph (E), by inserting the following before the period at the end: “or under section 1860D–2(b)(9) in the case of a covered insulin product (as defined in subparagraph (C) of such section)”; and (2) in paragraph (2)—(A) in subparagraph (B), by striking “section 1860D–2(b)(8)” and inserting “paragraphs (8) and (9) of section 1860D–2(b)”; (B) in subparagraph (D), by adding at the end the following new sentence: “For plan year 2023, the amount of the coinsurance applicable under the preceding sentence to a month’s supply of a covered insulin product (as defined in section 1860D–2(b)(9)(C)) dispensed to the individual may not exceed the applicable copayment amount for the 136 STAT. 1904 product under the prescription drug plan or MA–PD plan in which the individual is enrolled.”; and (C) in subparagraph (E), by adding at the end the following new sentence: “For plan year 2023, the amount of the copayment or coinsurance applicable under the preceding sentence to a month’s supply of a covered insulin product (as defined in section 1860D–2(b)(9)(C)) dispensed to the individual may not exceed the applicable copayment amount for the product under the prescription drug plan or MA–PD plan in which the individual is enrolled.”. (c) Temporary Retrospective Subsidy.—Section 1860D–15(h) of the Social Security Act (42 U.S.C. 1395w–115(h)), as added by section 11401(c), is amended—(1) in the subsection heading, by inserting “and Insulin” after “Practices”; and (2) in paragraph (1), by striking “section 1860D–2(b)(8)” and inserting “paragraph (8) or (9) of section 1860D–2(b)”. (d) Implementation for 2023 Through 2025.—The Secretary shall implement this section for plan years 2023, 2024, and 2025 by program instruction or other forms of program guidance. (e) Funding.—In addition to amounts otherwise available, there is appropriated to the Centers for Medicare & Medicaid Services, out of any money in the Treasury not otherwise appropriated, $1,500,000 for fiscal year 2022, to remain available until expended, to carry out the provisions of, including the amendments made by, this section.