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