[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6833 Placed on Calendar Senate (PCS)]

<DOC>





                                                       Calendar No. 389
117th CONGRESS
  2d Session
                                H. R. 6833


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

               April 4 (legislative day, March 31), 2022

                                Received

                              May 24, 2022

                           Read the first time

                              May 25, 2022

            Read the second time and placed on the calendar

_______________________________________________________________________

                                 AN ACT


 
  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 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 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 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 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, before an enrolled individual has 
                incurred, during a 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).''.
    (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 section 
through sub-regulatory guidance, program instruction, or otherwise.

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)--
                            (i) in subparagraph (A), by striking ``and 
                        (D)'' and inserting ``and (D) and paragraph 
                        (8)'';
                            (ii) in subparagraph (B), by striking ``and 
                        (D)'' and inserting ``and (D) and paragraph 
                        (8)'';
                            (iii) in subparagraph (C)(i), by striking 
                        ``paragraph (4)'' and inserting ``paragraphs 
                        (4) and (8)''; and
                            (iv) in subparagraph (D)(i), by striking 
                        ``paragraph (4)'' and inserting ``paragraphs 
                        (4) and (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, with respect to an individual, 
                the following shall apply with respect to any insulin 
                product (as defined in subparagraph (B)) that is 
                covered under the prescription drug plan or MA-PD plan 
                in which the individual is enrolled:
                            ``(i) No application of deductible.--The 
                        deductible under paragraph (1) shall not apply 
                        with respect to such insulin product.
                            ``(ii) Application of cost-sharing.--
                                    ``(I) In general.--The coverage 
                                provides benefits for such insulin 
                                product, 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 for a 
                                one-month supply that is equal to the 
                                applicable copayment amount.
                                    ``(II) 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 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 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 for a one-month supply of 
                an insulin product (as defined in subparagraph (B) of 
                section 1860D-2(b)(8)) dispensed to the individual may 
                not exceed the applicable copayment amount (as defined 
                in subparagraph (A)(ii)(II) of such section) 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 (B), by adding at the end the 
                following new sentence: ``For plan year 2023 and 
                subsequent plan years, the annual deductible applicable 
                under such section, including as reduced under the 
                preceding sentence, shall not apply with respect to an 
                insulin product (as defined in subparagraph (B) of 
                section 1860D-2(b)(8)) dispensed to the individual.'';
                    (B) 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 for a one-month 
                supply of an insulin product (as defined in 
                subparagraph (B) of section 1860D-2(b)(8)) dispensed to 
                the individual may not exceed the applicable copayment 
                amount (as defined in subparagraph (A)(ii)(II) of such 
                section) for the product under the prescription drug 
                plan or MA-PD plan in which the individual is 
                enrolled.''; and
                    (C) in subparagraph (E), by adding at the end the 
                following new sentence: ``For plan year 2023 and 
                subsequent plan years, the amount of the copayment or 
                coinsurance applicable under the preceding sentence for 
                a one-month supply of an insulin product (as defined in 
                subparagraph (B) of section 1860D-2(b)(8)) dispensed to 
                the individual may not exceed the applicable copayment 
                amount (as defined in subparagraph (A)(ii)(II) of such 
                section) for the product under the prescription drug 
                plan or MA-PD plan in which the individual is 
                enrolled.''
    (c) Implementation.--Notwithstanding any other provision of law, 
the Secretary of Health and Human Services shall implement this section 
for plan years 2023 and 2024 by program instruction or otherwise.

SEC. 4. ONE YEAR-EXTENSION ON MORATORIUM ON IMPLEMENTATION OF RULE 
              RELATING TO ELIMINATING THE ANTI-KICKBACK STATUTE SAFE 
              HARBOR PROTECTION FOR PRESCRIPTION DRUG REBATES.

    Section 90006 of the Infrastructure Investment and Jobs Act (P.L. 
117-58) is amended by striking ``January 1, 2026'' and inserting 
``January 1, 2027''.

SEC. 5. MEDICARE IMPROVEMENT FUND.

    Section 1898(b)(1) of the Social Security Act (42 U.S.C. 
1395iii(b)(1)), as amended by section 313 of division P of the 
Consolidated Appropriations Act, 2022, is amended by striking 
``$5,000,000'' and inserting ``$9,046,500,000''.

            Passed the House of Representatives March 31, 2022.

            Attest:

                                             CHERYL L. JOHNSON,

                                                                 Clerk.
                                                       Calendar No. 389

117th CONGRESS

  2d Session

                               H. R. 6833

_______________________________________________________________________

                                 AN ACT

  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.

_______________________________________________________________________

                              May 25, 2022

            Read the second time and placed on the calendar