HR2636-119

1. Short title This Act may be cited as the Making Insulin Affordable for All Children Act.

2. Appropriate cost-sharing for individuals 26 years of age or younger for insulin products covered under private health plans Part D of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–111 et seq.) is amended by adding at the end the following: For plan years beginning on or after January 1, 2026, a group health plan or health insurance issuer offering group or individual health insurance coverage shall, with respect to enrolled individuals 26 years of age or younger, provide coverage of selected insulin products, and with respect to such products, shall not— apply any deductible; or impose any cost-sharing in excess of the lesser of, per 30-day supply— $35; or 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 coverage, including price concessions received by or on behalf of third-party entities providing services to the plan or coverage, such as pharmacy benefit management services. In this section: The term selected insulin products means at least one of each dosage form (such as vial, pump, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin (as defined below), when available, as selected by the group health plan or health insurance issuer. The term insulin means insulin that is licensed under subsection (a) or (k) of section 351 and continues to be marketed under such section, including any insulin product that has been deemed to be licensed under section 351(a) 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. Subsection (a) shall not be construed to require coverage of, or prevent a group health plan or health insurance coverage from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products or insulin products for an individual not described in subsection (a), to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law. Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage. 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: The exemption of coverage of selected insulin products (as defined in section 2799A–11(b) of the Public Health Service Act) from the application of any deductible pursuant to section 2799A–11(a)(1) of such Act, section 726(a)(1) of the Employee Retirement Income Security Act of 1974, or section 9826(a)(1) of the Internal Revenue Code of 1986 shall not be considered when determining the actuarial value of a qualified health plan under this subsection. 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: Notwithstanding paragraph (1)(B)(i), a health plan described in paragraph (1) shall provide coverage of selected insulin products, with respect to an enrolled individual who is 26 years of age or younger, in accordance with section 2799A–11 of the Public Health Service Act, before the 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. For purposes of subparagraph (A)— the term selected insulin products has the meaning given such term in section 2799A–11(b) of the Public Health Service Act; and the requirements of section 2799A–11 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). Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et seq.) is amended by adding at the end the following: For plan years beginning on or after January 1, 2026, a group health plan or health insurance issuer offering group health insurance coverage shall, with respect to enrolled individuals 26 years of age or younger, provide coverage of selected insulin products, and with respect to such products, shall not— apply any deductible; or impose any cost-sharing in excess of the lesser of, per 30-day supply— $35; or 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 coverage, including price concessions received by or on behalf of third-party entities providing services to the plan or coverage, such as pharmacy benefit management services. In this section: The term selected insulin products means at least one of each dosage form (such as vial, pump, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin (as defined below), when available, as selected by the group health plan or health insurance issuer. The term insulin means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) and continues to be marketed under such section, including any insulin product that has been deemed to be licensed under section 351(a) of such Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111–148) and continues to be marketed pursuant to such licensure. Subsection (a) shall not be construed to require coverage of, or prevent a group health plan or health insurance coverage from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products or insulin products for an individual not described in subsection (a), to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law. Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage. The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1001 et seq.) is amended by inserting after the item relating to section 725 the following: Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section: For plan years beginning on or after January 1, 2026, a group health plan shall, with respect to enrolled individuals 26 years of age or younger, provide coverage of selected insulin products, and with respect to such products, shall not— apply any deductible; or impose any cost-sharing in excess of the lesser of, per 30-day supply— $35; or 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, including price concessions received by or on behalf of third-party entities providing services to the plan, such as pharmacy benefit management services. In this section: The term selected insulin products means at least one of each dosage form (such as vial, pump, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin (as defined below), when available, as selected by the group health plan. The term insulin means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) and continues to be marketed under such section, including any insulin product that has been deemed to be licensed under section 351(a) of such Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111–148) and continues to be marketed pursuant to such licensure. Subsection (a) shall not be construed to require coverage of, or prevent a group health plan from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products or insulin products for an individual not described in subsection (a), to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law. Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan. The table of sections for subchapter B of chapter 100 of such Code is amended by adding at the end the following new item: The Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury may implement the provisions of, including the amendments made by, this subsection through sub-regulatory guidance, program instruction or otherwise. 2799A–11.Requirements with respect to cost-sharing for certain insulin products(a)In generalFor plan years beginning on or after January 1, 2026, a group health plan or health insurance issuer offering group or individual health insurance coverage shall, with respect to enrolled individuals 26 years of age or younger, provide coverage of selected insulin products, and with respect to such products, shall not—(1)apply any deductible; or(2)impose any cost-sharing in excess of the lesser of, per 30-day supply—(A)$35; or(B)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 coverage, including price concessions received by or on behalf of third-party entities providing services to the plan or coverage, such as pharmacy benefit management services.(b)DefinitionsIn this section:(1)Selected insulin productsThe term selected insulin products means at least one of each dosage form (such as vial, pump, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin (as defined below), when available, as selected by the group health plan or health insurance issuer.(2)Insulin definedThe term insulin means insulin that is licensed under subsection (a) or (k) of section 351 and continues to be marketed under such section, including any insulin product that has been deemed to be licensed under section 351(a) 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)Rule of constructionSubsection (a) shall not be construed to require coverage of, or prevent a group health plan or health insurance coverage from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products or insulin products for an individual not described in subsection (a), to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law.(d)Application of cost-Sharing towards deductibles and out-of-Pocket maximumsAny cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage.. (D)Special rule relating to insulin coverageThe exemption of coverage of selected insulin products (as defined in section 2799A–11(b) of the Public Health Service Act) from the application of any deductible pursuant to section 2799A–11(a)(1) of such Act, section 726(a)(1) of the Employee Retirement Income Security Act of 1974, or section 9826(a)(1) of the Internal Revenue Code of 1986 shall not be considered when determining the actuarial value of a qualified health plan under this subsection.. (4)Coverage of certain insulin products(A)In generalNotwithstanding paragraph (1)(B)(i), a health plan described in paragraph (1) shall provide coverage of selected insulin products, with respect to an enrolled individual who is 26 years of age or younger, in accordance with section 2799A–11 of the Public Health Service Act, before the 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)TerminologyFor purposes of subparagraph (A)—(i)the term selected insulin products has the meaning given such term in section 2799A–11(b) of the Public Health Service Act; and(ii)the requirements of section 2799A–11 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). . 726.Requirements with respect to cost-sharing for certain insulin products(a)In generalFor plan years beginning on or after January 1, 2026, a group health plan or health insurance issuer offering group health insurance coverage shall, with respect to enrolled individuals 26 years of age or younger, provide coverage of selected insulin products, and with respect to such products, shall not—(1)apply any deductible; or(2)impose any cost-sharing in excess of the lesser of, per 30-day supply—(A)$35; or(B)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 coverage, including price concessions received by or on behalf of third-party entities providing services to the plan or coverage, such as pharmacy benefit management services.(b)DefinitionsIn this section:(1)Selected insulin productsThe term selected insulin products means at least one of each dosage form (such as vial, pump, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin (as defined below), when available, as selected by the group health plan or health insurance issuer.(2)Insulin definedThe term insulin means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) and continues to be marketed under such section, including any insulin product that has been deemed to be licensed under section 351(a) of such Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111–148) and continues to be marketed pursuant to such licensure. (c)Rule of constructionSubsection (a) shall not be construed to require coverage of, or prevent a group health plan or health insurance coverage from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products or insulin products for an individual not described in subsection (a), to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law.(d)Application of cost-Sharing towards deductibles and out-of-Pocket maximumsAny cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage.. Sec. 726. Requirements with respect to cost-sharing for certain insulin products.. 9826.Requirements with respect to cost-sharing for certain insulin products(a)In generalFor plan years beginning on or after January 1, 2026, a group health plan shall, with respect to enrolled individuals 26 years of age or younger, provide coverage of selected insulin products, and with respect to such products, shall not—(1)apply any deductible; or(2)impose any cost-sharing in excess of the lesser of, per 30-day supply—(A)$35; or(B)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, including price concessions received by or on behalf of third-party entities providing services to the plan, such as pharmacy benefit management services.(b)DefinitionsIn this section:(1)Selected insulin productsThe term selected insulin products means at least one of each dosage form (such as vial, pump, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin (as defined below), when available, as selected by the group health plan.(2)Insulin definedThe term insulin means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) and continues to be marketed under such section, including any insulin product that has been deemed to be licensed under section 351(a) of such Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111–148) and continues to be marketed pursuant to such licensure. (c)Rule of constructionSubsection (a) shall not be construed to require coverage of, or prevent a group health plan from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products or insulin products for an individual not described in subsection (a), to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law.(d)Application of cost-Sharing towards deductibles and out-of-Pocket maximumsAny cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan.. Sec. 9826. Requirements with respect to cost-sharing for certain insulin products..

2799A–11. Requirements with respect to cost-sharing for certain insulin products For plan years beginning on or after January 1, 2026, a group health plan or health insurance issuer offering group or individual health insurance coverage shall, with respect to enrolled individuals 26 years of age or younger, provide coverage of selected insulin products, and with respect to such products, shall not— apply any deductible; or impose any cost-sharing in excess of the lesser of, per 30-day supply— $35; or 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 coverage, including price concessions received by or on behalf of third-party entities providing services to the plan or coverage, such as pharmacy benefit management services. In this section: The term selected insulin products means at least one of each dosage form (such as vial, pump, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin (as defined below), when available, as selected by the group health plan or health insurance issuer. The term insulin means insulin that is licensed under subsection (a) or (k) of section 351 and continues to be marketed under such section, including any insulin product that has been deemed to be licensed under section 351(a) 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. Subsection (a) shall not be construed to require coverage of, or prevent a group health plan or health insurance coverage from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products or insulin products for an individual not described in subsection (a), to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law. Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage.

726. Requirements with respect to cost-sharing for certain insulin products For plan years beginning on or after January 1, 2026, a group health plan or health insurance issuer offering group health insurance coverage shall, with respect to enrolled individuals 26 years of age or younger, provide coverage of selected insulin products, and with respect to such products, shall not— apply any deductible; or impose any cost-sharing in excess of the lesser of, per 30-day supply— $35; or 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 coverage, including price concessions received by or on behalf of third-party entities providing services to the plan or coverage, such as pharmacy benefit management services. In this section: The term selected insulin products means at least one of each dosage form (such as vial, pump, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin (as defined below), when available, as selected by the group health plan or health insurance issuer. The term insulin means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) and continues to be marketed under such section, including any insulin product that has been deemed to be licensed under section 351(a) of such Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111–148) and continues to be marketed pursuant to such licensure. Subsection (a) shall not be construed to require coverage of, or prevent a group health plan or health insurance coverage from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products or insulin products for an individual not described in subsection (a), to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law. Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage.

9826. Requirements with respect to cost-sharing for certain insulin products For plan years beginning on or after January 1, 2026, a group health plan shall, with respect to enrolled individuals 26 years of age or younger, provide coverage of selected insulin products, and with respect to such products, shall not— apply any deductible; or impose any cost-sharing in excess of the lesser of, per 30-day supply— $35; or 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, including price concessions received by or on behalf of third-party entities providing services to the plan, such as pharmacy benefit management services. In this section: The term selected insulin products means at least one of each dosage form (such as vial, pump, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin (as defined below), when available, as selected by the group health plan. The term insulin means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) and continues to be marketed under such section, including any insulin product that has been deemed to be licensed under section 351(a) of such Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111–148) and continues to be marketed pursuant to such licensure. Subsection (a) shall not be construed to require coverage of, or prevent a group health plan from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products or insulin products for an individual not described in subsection (a), to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law. Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan.