Treatment of cost-sharing for covered insulin products
(A) No application of deductible
(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.
(B)(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.
(B)(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 355 of title 21 or licensed under section 351 of the Public Health Service Act [ 42 U.S.C. 262 ] 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 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 subchapter 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.
(D)(i)#
during plan years 2023, 2024, and 2025, $35; and
(D)(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 subchapter 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.
(D)(ii)(I)#
(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.