[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.
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