Requirements with respect to cost-sharing for certain insulin products

(a) In general 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: 2799A–12. Requirements with respect to cost-sharing for certain insulin products (a) In general For plan years beginning on or after January 1, 2027, 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, 2027, at least one of each dosage form (such as vial, pen, or inhaler dosage forms) 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 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. (d) Rule of construction Subsection (a) shall not be construed to 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 products that are not selected insulin products, to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law. (e) Application of cost-Sharing towards deductibles and out-of-Pocket maximums 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. (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 pharmacy benefit management services, any prior authorization or other 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 2799A–12(b) of the Public Health Service Act) from the application of any deductible pursuant to section 2799A–12(a)(1) of such Act, section 727(a)(1) of the Employee Retirement Income Security Act of 1974, or section 9827(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.. (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, 2027, a health plan described in paragraph (1) shall provide coverage of selected insulin products, in accordance with section 2799A–12 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 2799A–12(b) of the Public Health Service Act; and (ii) the requirements of section 2799A–12 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) ERISA (1) In general 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: 727. Requirements with respect to cost-sharing for certain insulin products (a) In general For plan years beginning on or after January 1, 2027, a group health plan or health insurance issuer offering group 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, 2027, at least one of each dosage form (such as vial, pen, or inhaler dosage forms) 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 of the Public Health Service Act (42 U.S.C. 262) 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. (d) Rule of construction Subsection (a) shall not be construed to 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 products that are not selected insulin products, to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law. (e) Application of cost-Sharing towards deductibles and out-of-Pocket maximums 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. (f) Other requirements A group health plan or health insurance issuer offering group health insurance coverage shall not impose, directly or through an entity providing pharmacy benefit management services, any prior authorization or other 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.. (2) Clerical amendment 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 726 the following: Sec. 727. Requirements with respect to cost-sharing for certain insulin products.. (e) Internal Revenue Code (1) In general Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following: 9827. Requirements with respect to cost-sharing for certain insulin products (a) In general For plan years beginning on or after January 1, 2027, a group health plan 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, including price concessions received by or on behalf of third-party entities providing services to the plan, 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, 2027, at least one of each dosage form (such as vial, pen, or inhaler dosage forms) 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. (2) Insulin 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 pursuant to such licensure. (c) Out-of-Network providers Nothing in this section requires a plan 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 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. (d) Rule of construction 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, to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law. (e) Application of cost-Sharing towards deductibles and out-of-Pocket maximums 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. (f) Other requirements A group health plan shall not impose, directly or through an entity providing pharmacy benefit management services, any prior authorization or other 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.. (2) Clerical amendment The table of sections for subchapter B of chapter 100 of such Code is amended by adding at the end the following new item: Sec. 9827. Requirements with respect to cost-sharing for certain insulin products..