II 118th CONGRESS 1st Session S. 954 IN THE SENATE OF THE UNITED STATES March 23, 2023 Mr. Warnock (for himself and Mr. Kennedy ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To provide for appropriate cost-sharing for insulin products covered under private health plans, and to establish a program to support health care providers and pharmacies in providing discounted insulin products to uninsured individuals.

1. Short title This Act may be cited as the Affordable Insulin Now Act of 2023 . 2. Appropriate cost-sharing for insulin products covered under private health plans (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–11. Requirements with respect to cost-sharing for certain insulin products (a) In general For plan years beginning on or after January 1, 2024, 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 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) Definitions In this section: (1) Selected insulin products 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. (2) Insulin defined The term insulin means insulin that is licensed under subsection (a) or (k) of section 351 and continues to be marketed under such section. (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 coverage 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. . (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 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. . (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), a health plan described in paragraph (1) shall provide coverage of selected insulin products, in accordance with section 2799A–11 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–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). . (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: 726. Requirements with respect to cost-sharing for certain insulin products (a) In general For plan years beginning on or after January 1, 2024, 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 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) Definitions In this section: (1) Selected insulin products 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. (2) Insulin defined 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. (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 coverage 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. . (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 725 the following: Sec. 726. 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 new section: 9826. Requirements with respect to cost-sharing for certain insulin products (a) In general For plan years beginning on or after January 1, 2024, 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 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) Definitions In this section: (1) Selected insulin products 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. (2) Insulin defined 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. (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. . (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. 9826. Requirements with respect to cost-sharing for certain insulin products. . (f) Implementation 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. 3. Reimbursement for insulin furnished to uninsured individuals (a) In general The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall establish a program under which the Secretary enters into agreements with qualifying entities for purposes of furnishing insulin products to uninsured individuals. (b) Payment The Secretary shall pay to each qualifying entity with an agreement in effect under this section, with respect to each 30-day supply of insulin products furnished to an uninsured individual by such entity on or after January 1, 2024, an amount equal to the difference between the out-of-pocket cost to the individual for a 30-day supply of such insulin products and $35. (c) Definitions In this section: (1) Insulin product The term insulin product has the meaning given the term insulin in section 2799A–11 of the Public Health Service Act, as added by section 2. (2) Qualifying entity The term qualifying entity means a health care provider or pharmacy that— (A) agrees, with respect to an insulin product furnished by such provider or pharmacy to an uninsured individual after January 1, 2024, for which payment is made by the Secretary under this section, not to hold such individual liable for any payment amount for such product; and (B) meets such other standards and requirements as may be determined appropriate by the Secretary. (3) Specified health plan The term specified health plan means a Federal health care program (as defined in section 1128B of the Social Security Act ( 42 U.S.C. 1320a–7b )), the health program established under chapter 89 of title 5, United States Code, a group health plan (as defined in section 2791 of the Public Health Service Act ( 42 U.S.C. 300gg–91 ), and group or individual health insurance coverage (as defined in such section 2791). (4) Uninsured individual The term uninsured individual means, with respect to an individual and an insulin product, an individual who does not have benefits available for such product (or for another insulin product of the same dosage form (such as vial, pump, or inhaler dosage forms) and type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra-long-acting, and premixed)) under a specified health plan. 4. Sense of Congress It is the sense of Congress that subsequent legislation should be enacted by Congress that provides for an offset for any costs to the Federal Government resulting from the enactment of this Act.