[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6833 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 6833

  To amend title XXVII of the Public Health Service Act, the Internal 
 Revenue Code of 1986, and the Employee Retirement Income Security Act 
  of 1974 to establish requirements with respect to cost-sharing for 
           certain insulin products, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 25, 2022

  Ms. Craig (for herself, Mr. Kildee, and Mrs. McBath) introduced the 
   following bill; which was referred to the Committee on Energy and 
  Commerce, and in addition to the Committees on Ways and Means, and 
Education and Labor, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
  To amend title XXVII of the Public Health Service Act, the Internal 
 Revenue Code of 1986, and the Employee Retirement Income Security Act 
  of 1974 to establish requirements with respect to cost-sharing for 
           certain insulin products, and for other purposes.

    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. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR INSULIN PRODUCTS.

    (a) PHSA.--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 new section:

``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.''.
    (b) IRC.--
            (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, 
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.''.
            (2) Clerical amendment.--The table of sections for 
        subchapter B of chapter 100 of the Internal Revenue Code of 
        1986 is amended by adding at the end the following new item:

``Sec. 9826. Requirements with respect to cost-sharing for certain 
                            insulin products.''.
    (c) 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, 
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.''.
            (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.''.
    (d) 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.''.
    (e) 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, for a plan year before an enrolled 
                individual has incurred 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).''.

SEC. 3. APPROPRIATE COST-SHARING FOR CERTAIN INSULIN PRODUCTS UNDER 
              MEDICARE PART D.

    (a) In General.--Section 1860D-2 of the Social Security Act (42 
U.S.C. 1395w-102) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (1)(A), by striking ``The 
                coverage'' and inserting ``Subject to paragraph (8), 
                the coverage'';
                    (B) in paragraph (2)(A), by striking ``and (D)'' 
                and inserting ``and (D) and paragraph (8)'';
                    (C) in paragraph (3)(A), by striking ``and (4)'' 
                and inserting ``(4), and (8)'';
                    (D) in paragraph (4)(A)(i), by striking ``The 
                coverage'' and inserting ``Subject to paragraph (8), 
                the coverage''; and
                    (E) by adding at the end the following new 
                paragraph:
            ``(8) Treatment of cost-sharing for certain insulin 
        products.--
                    ``(A) In general.--For plan years beginning on or 
                after January 1, 2023, the following shall apply with 
                respect to insulin products (as defined in subparagraph 
                (B)):
                            ``(i) No application of deductible.--The 
                        deductible under paragraph (1) shall not apply 
                        with respect to such insulin products.
                            ``(ii) Application of cost-sharing.--
                                    ``(I) Plan year 2023.--For plan 
                                year 2023, the coverage provides 
                                benefits for such insulin products, 
                                regardless of whether an individual has 
                                reached the initial coverage limit 
                                under paragraph (3) or the out-of-
                                pocket threshold under paragraph (4), 
                                with cost-sharing that is equal to the 
                                applicable copayment amount.
                                    ``(II) Plan year 2024 and 
                                subsequent plan years.--For plan year 
                                2024 and subsequent plan years, the 
                                coverage provides benefits for such 
                                insulin products, prior to an 
                                individual reaching the out-of-pocket 
                                threshold under paragraph (4), with 
                                cost-sharing that is equal to the 
                                applicable copayment amount.
                                    ``(III) Applicable copayment 
                                amount.--For purposes of this clause, 
                                the term `applicable copayment amount' 
                                means, with respect to an insulin 
                                product under a prescription drug plan 
                                or an MA-PD plan, an amount that is not 
                                more than $35.
                    ``(B) Insulin product.--For purposes of this 
                paragraph, the term `insulin product' means 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 
                marketed pursuant to such approval or licensure, 
                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 marketed pursuant to such section.''; and
            (2) 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).''.
    (b) 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--
            (1) in paragraph (1)--
                    (A) in subparagraph (D)(iii), by adding at the end 
                the following new sentence: ``For plan year 2023 and 
                subsequent plan years, the copayment amount applicable 
                under the preceding sentence to an insulin product (as 
                defined in section 1860D-2(b)(8)(B)) furnished to the 
                individual may not exceed the applicable copayment 
                amount for the product under the prescription drug plan 
                or MA-PD plan in which the individual is enrolled.''; 
                and
                    (B) in subparagraph (E), by inserting the following 
                before the period at the end ``or under section 1860D-
                2(b)(8) in the case of an insulin product (as defined 
                in subparagraph (B) of such section)''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (D), by adding at the end the 
                following new sentence: ``For plan year 2023 and 
                subsequent plan years, the amount of the coinsurance 
                applicable under the preceding sentence to an insulin 
                product (as defined in section 1860D-2(b)(8)(B)) 
                furnished to the individual may not exceed the 
                applicable copayment amount for the product under the 
                prescription drug plan or MA-PD plan in which the 
                individual is enrolled.''; and
                    (B) in subparagraph (E), by adding at the end the 
                following new sentence: ``For plan year 2023, the 
                amount of the copayment or coinsurance applicable under 
                the preceding sentence to an insulin product (as 
                defined in section 1860D-2(b)(8)(B)) furnished to the 
                individual may not exceed the applicable copayment 
                amount for the product under the prescription drug plan 
                or MA-PD plan in which the individual is enrolled.''
    (c) Implementation.--The Secretary shall implement this section for 
plan years 2023 and 2024 by program instruction or otherwise.
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