Affordable Insulin Now Act of 2023

Subjects: Health


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 954 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                 S. 954

 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.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Affordable Insulin Now Act of 
2023''.

SEC. 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:

``SEC. 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:

``SEC. 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:

``SEC. 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.

SEC. 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.

SEC. 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.
                                 &lt;all&gt;
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