Requirements with respect to cost-sharing for certain insulin products

(a) In general Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11 et seq.) is amended by adding at the end the following: 2729A. Requirements with respect to cost-sharing for certain insulin products (a) In general For plan years beginning on or after January 1, 2028, a group health plan or health insurance issuer offering group or individual health insurance coverage shall provide coverage of selected insulin products, and with respect to such products, shall not— (1) apply any deductible; or (2) impose any cost-sharing requirements in excess of, per 30-day supply— (A) for any applicable plan year beginning before January 1, 2028, $35; or (B) for any plan year beginning on or after January 1, 2028, the lesser of— (i) $35; or (ii) the amount equal to 25 percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan or issuer, including price concessions received by or on behalf of third-party entities providing services to the plan or issuer, such as pharmacy benefit management services or third party administrators. (b) Definitions In this section: (1) Selected insulin products The term selected insulin products means, for any plan year beginning on or after January 1, 2028, at least one of each dosage form and delivery device (such as vial, pen, inhaler dosage forms, or such other delivery devices approved by the Secretary) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, and pre-mixed) of insulin, when such form is licensed and marketed, as selected by the group health plan or health insurance issuer. (2) Insulin The term insulin means insulin that is licensed under subsection (a) or (k) of section 351, including insulin deemed to be licensed under section 351 pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009, and continues to be marketed pursuant to such licensure. (c) Out-of-Network providers Nothing in this section requires a plan or issuer that has a network of providers to provide benefits for selected insulin products described in this section that are delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing higher cost-sharing than the levels specified in subsection (a) for selected insulin products described in this section that are delivered by an out-of-network provider if permitted under applicable law. (d) Rules of construction Subsection (a) shall not be construed to— (1) require coverage of, or prevent a group health plan or health insurance issuer from imposing cost-sharing other than the levels specified in subsection (a) on, insulin that is not a selected insulin product, to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law; or (2) permit a group health plan or health insurance issuer to pay any amount in excess of the amount specified under section (a)(2) to an entity providing pharmaceutical benefit management services, a provider, or a pharmaceutical manufacturer with respect to the provision of selected insulin products. (e) Application of patient protections The provisions of this title shall apply to selected insulin product benefits described in subsection (a) as though such benefits were required to be provided under section 2707(a). (f) Other requirements A group health plan or health insurance issuer offering group or individual health insurance coverage shall not impose, directly or through an entity providing services to the plan or coverage, any prior authorization or medical management requirement, or other similar conditions, on selected insulin products, except as clinically justified for safety reasons, to ensure reasonable quantity limits, and as specified by the Secretary.. (b) No effect on other cost-Sharing Section 1302(d)(2) of the Patient Protection and Affordable Care Act (42 U.S.C. 18022(d)(2)) is amended by adding at the end the following new subparagraph: (D) Special rule relating to insulin coverage For plans years beginning on or after January 1, 2028, the exemption of coverage of selected insulin products (as defined in section 2729A of the Public Health Service Act) from the application of any deductible pursuant to section 2729(a)(1) of such Act, shall not be treated as increasing the actuarial value of a plan when determining the actuarial value of a qualified health plan under this subsection.. (c) Coverage of certain insulin products under catastrophic plans Section 1302(e) of the Patient Protection and Affordable Care Act (42 U.S.C. 18022(e)) is amended by adding at the end the following: (4) Coverage of certain insulin products (A) In general Notwithstanding paragraph (1)(B)(i), for plan years beginning on or after January 1, 2028, a health plan described in paragraph (1) shall provide coverage of selected insulin products, in accordance with section 2729A of the Public Health Service Act, before an enrolled individual has incurred, during the plan year, cost-sharing expenses in an amount equal to the annual limitation in effect under subsection (c)(1) for the plan year. (B) Terminology For purposes of subparagraph (A)— (i) the term selected insulin products has the meaning given such term in section 2729A(b) of the Public Health Service Act; and (ii) the requirements of section 2729A of such Act shall be applied by deeming each reference in such section to individual health insurance coverage to be a reference to a plan described in paragraph (1).. (d) Conforming amendments (1) ERISA Section 715(a)(1) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185d(a)(1)) is amended by inserting and the INSULIN Act of 2026 after Affordable Care Act. (2) IRC Section 9815(a)(1) of the Internal Revenue Code of 1986 is amended by inserting and the INSULIN Act of 2026 after Affordable Care Act.