Title: Affordable Insulin Now Act
Policy area: Health

Summary:
Affordable Insulin Now Act
This bill limits cost-sharing for insulin under private health insurance and the Medicare prescription drug benefit.
Specifically, the bill caps cost-sharing under private health insurance for a month's supply of selected insulin products at $35 or 25% of a plan's negotiated price (after any price concessions), whichever is less, beginning in 2023.
The bill caps cost-sharing under the Medicare prescription drug benefit for a month's supply of covered insulin products at (1) $35 between October 1, 2022, and January 1, 2024; and (2) $35 or 25% of a plan's negotiated price, whichever is less, beginning in 2024. The bill provides funds for FY2022 for the Centers for Medicare & Medicaid Services (CMS) to implement the bill.
Currently, the CMS is testing a voluntary model under the Medicare prescription drug benefit (the Part D Senior Savings Model) in which the copayment for a month's supply of insulin is capped at $35 through participating plans. The model is set to expire on December 31, 2025.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3700 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  2d Session
                                S. 3700

 To provide for appropriate cost-sharing for insulin products covered 
            under Medicare part D and private health plans.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 17, 2022

   Mr. Warnock (for himself, Mr. Schumer, Mr. Durbin, Mr. Wyden, Mr. 
Bennet, Mr. Blumenthal, Ms. Baldwin, Mr. Kelly, Ms. Stabenow, Mr. Reed, 
Mr. Van Hollen, Ms. Hirono, Ms. Klobuchar, Mr. Murphy, Ms. Hassan, Mrs. 
 Shaheen, Mr. Booker, Mr. King, Ms. Smith, and Mr. Padilla) introduced 
the following bill; which was read twice and referred to the Committee 
                               on Finance

_______________________________________________________________________

                                 A BILL


 
 To provide for appropriate cost-sharing for insulin products covered 
            under Medicare part D and private health plans.

    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''.

SEC. 2. APPROPRIATE COST-SHARING FOR INSULIN PRODUCTS COVERED UNDER 
              MEDICARE PART D AND PRIVATE HEALTH PLANS.

    (a) Medicare Part D.--
            (1) In general.--Section 1860D-2 of the Social Security Act 
        (42 U.S.C. 1395w-102) is amended--
                    (A) in subsection (b)--
                            (i) in paragraph (1)(A), in the matter 
                        preceding clause (i), by striking ``The 
                        coverage'' and inserting ``Subject to paragraph 
                        (8), the coverage'';
                            (ii) in paragraph (2)--
                                    (I) in subparagraph (A), in the 
                                matter preceding clause (i), by 
                                striking ``and (D)'' and inserting 
                                ``and (D) and paragraph (8)'';
                                    (II) in subparagraph (C)(i), in the 
                                matter preceding subclause (I), by 
                                striking ``paragraph (4)'' and 
                                inserting ``paragraphs (4) and (8)''; 
                                and
                                    (III) in subparagraph (D)(i), in 
                                the matter preceding subclause (I), by 
                                striking ``paragraph (4)'' and 
                                inserting ``paragraphs (4) and (8)'';
                            (iii) in paragraph (3)(A), in the matter 
                        preceding clause (i), by striking ``and (4)'' 
                        and inserting ``(4), and (8)'';
                            (iv) in paragraph (4)(A)(i), in the matter 
                        preceding subclause (I), by striking ``The 
                        coverage'' and inserting ``Subject to paragraph 
                        (8), the coverage''; and
                            (v) by adding at the end the following new 
                        paragraph:
            ``(8) Treatment of cost-sharing for covered insulin 
        products.--
                    ``(A) In general.--For the portion of plan year 
                2022 beginning on October 1, 2022, and ending on 
                December 31, 2022, and for plan year 2023 and 
                subsequent plan years, the following rules shall apply 
                with respect to cost-sharing for a month's supply of 
                any covered insulin product (as defined in subparagraph 
                (B)) that is covered under the prescription drug plan 
                or MA-PD plan:
                            ``(i) No application of deductible.--The 
                        deductible under paragraph (1) shall not apply 
                        with respect to any such covered insulin 
                        product.
                            ``(ii) Maximum cost-sharing.--
                                    ``(I) In general.--The coverage 
                                shall provide benefits for such any 
                                covered insulin product, regardless of 
                                whether an individual has reached the 
                                initial coverage limit under paragraph 
                                (3) or the annual out-of-pocket 
                                threshold under paragraph (4), with 
                                cost-sharing for a month's supply that 
                                does not exceed the maximum cost-
                                sharing amount.
                                    ``(II) Maximum cost-sharing 
                                amount.--For purposes of subclause (I), 
                                the term `maximum cost-sharing amount' 
                                means, with respect to a covered 
                                insulin product under a prescription 
                                drug plan or an MA-PD plan dispensed--
                                            ``(aa) on or after October 
                                        1, 2022, and before January 1, 
                                        2024, $35; and
                                            ``(bb) during plan year 
                                        2024 or subsequent plan year, 
                                        the lesser of--

                                                    ``(AA) $35; or

                                                    ``(BB) an amount 
                                                equal to 25 percent of 
                                                the negotiated price of 
                                                the covered insulin 
                                                product under the 
                                                prescription drug plan 
                                                or MA-PD plan.

                    ``(B) Covered insulin product.--For purposes of 
                this paragraph, the term `covered insulin product' 
                means a covered part D drug that is an insulin product 
                that is approved under section 505 of the Federal Food, 
                Drug, and Cosmetic Act or licensed under section 351 of 
                the Public Health Service Act and continues to be 
                marketed, including any insulin product that has been 
                deemed to be licensed under section 351 of the Public 
                Health Service Act pursuant to section 7002(e)(4) of 
                the Biologics Price Competition and Innovation Act of 
                2009 and continues to be marketed.''; and
                    (B) in subsection (c), by adding at the end the 
                following new paragraph:
            ``(4) Treatment of cost-sharing for insulin products.--The 
        coverage is provided in accordance with subsection (b)(8).''.
            (2) Conforming amendments to cost-sharing for low-income 
        individuals.--Section 1860D-14(a) of the Social Security Act 
        (42 U.S.C. 1395w-114(a)) is amended--
                    (A) in paragraph (1)--
                            (i) in subparagraph (D)(iii), by adding at 
                        the end the following new sentence: ``For the 
                        portion of plan year 2022 beginning on October 
                        1, 2022, and ending on December 31, 2022, and 
                        for plan year 2023 and subsequent plan years, 
                        the copayment amount applicable under the 
                        preceding sentence to a month's supply of a 
                        covered insulin product (as described in 
                        section 1860D-2(b)(8)) dispensed to the 
                        individual may not exceed the applicable 
                        copayment or coinsurance amount for the product 
                        under the prescription drug plan or MA-PD plan 
                        in which the individual is enrolled.''; and
                            (ii) in subparagraph (E), by inserting the 
                        following before the period at the end: ``or 
                        under section 1860D-2(b)(8) in the case of a 
                        covered insulin product (as described in such 
                        section)''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (D), by adding at the 
                        end the following new sentence: ``For the 
                        portion of plan year 2022 beginning on October 
                        1, 2022, and ending on December 31, 2022, and 
                        for plan year 2023 and subsequent plan years, 
                        the amount of the coinsurance applicable under 
                        the preceding sentence to a month's supply of a 
                        covered insulin product (as described in 
                        section 1860D-2(b)(8)) dispensed to the 
                        individual may not exceed the applicable 
                        copayment or coinsurance amount for the product 
                        under the prescription drug plan or MA-PD plan 
                        in which the individual is enrolled.''; and
                            (ii) in subparagraph (E), by adding at the 
                        end the following new sentence: ``For the 
                        portion of plan year 2022 beginning on October 
                        1, 2022, and ending on December 31, 2022, and 
                        for plan year 2023 and subsequent plan years, 
                        the amount of the copayment or coinsurance 
                        applicable under the preceding sentence to a 
                        month's supply of a covered insulin product (as 
                        described in section 1860D-2(b)(8)) dispensed 
                        to the individual may not exceed the applicable 
                        copayment or coinsurance amount for the product 
                        under the prescription drug plan or MA-PD plan 
                        in which the individual is enrolled.''.
            (3) Implementation.--Notwithstanding any other provision of 
        law, the Secretary of Health and Human Services may implement 
        the provisions of, including the amendments made by, this 
        subsection for plan years 2022, 2023, and 2024 by program 
        instruction or otherwise.
            (4) Funding.--In addition to amounts otherwise available, 
        there is appropriated to the Centers for Medicare & Medicaid 
        Services, out of any money in the Treasury not otherwise 
        appropriated, $1,500,000 for fiscal year 2022, to remain 
        available until expended, to carry out the provisions of, 
        including the amendments made by, this subsection.
    (b) Private Health Plans.--
            (1) 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, 
2023, 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, 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) 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) 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.''.
            (3) 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).''.
            (4) ERISA.--
                    (A) 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, 
2023, 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, 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) 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) 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.''.
            (5) Internal revenue code.--
                    (A) 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, 
2023, 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, 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) 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.''.
                    (B) 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.''.
            (6) 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.
                                 <all>