Affordable Insulin Now Act

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6255 Introduced in House (IH)]

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119th CONGRESS
  1st Session
                                H. R. 6255

  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

                           November 21, 2025

 Ms. Craig (for herself, Mrs. McBath, Mr. Horsford, Mr. Landsman, and
 Ms. Schrier) 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 Workforce, 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,
2026, 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,
2026, 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,
2026, 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).''.
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