What This Bill Does
This bill requires health insurance plans and insurance companies to limit what patients pay for insulin medications. Starting in 2024, plans must cover certain insulin products with low or no upfront costs (called cost-sharing). The bill changes rules under three major health insurance laws.
##
Who It Affects
- People with group health insurance through employers
- People with individual health insurance (bought on their own)
- Health insurance companies
- Self-insured group health plans
- Pharmacy benefit managers (companies that manage prescription drug benefits)
##
Key Provisions
- Health insurance plans must provide coverage of selected insulin products with no upfront costs before meeting a deductible (the amount you pay before insurance kicks in) starting on or after January 1, 2024 (Sec. 2)
- For a 30-day supply of selected insulin products, patients pay whichever is lower: $35 or 25 percent of the negotiated price (the price insurance companies agree to pay) after accounting for any discounts or rebates the insurance company receives (Sec. 2)
- "Selected insulin products" means at least one type of each insulin form (like vials, pumps, or inhalers) in each category (like fast-acting or long-acting), when available, as chosen by the insurance plan (Sec. 2)
- Plans with a network of providers (approved doctors and pharmacies) do not have to cover insulin from doctors or pharmacies outside their network, and can charge higher costs for out-of-network insulin (Sec. 2)
- Any money patients pay for insulin counts toward their deductible or annual out-of-pocket maximum (the most they have to pay in a year) (Sec. 2)
##
What Changes
If this becomes law, people who take insulin will pay no more than $35 for a 30-day supply (or 25 percent of the negotiated price, whichever is lower) instead of potentially paying much higher amounts. Insurance plans must cover at least one form of each type of insulin. The requirement applies to employer-sponsored insurance, individual insurance purchased directly, and self-insured plans.
##
Important Definitions
- **Selected insulin products**: At least one of each type and form of insulin (vial, pump, inhaler, rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, or premixed), when available, chosen by the insurance plan
- **Insulin**: Medications that are approved by federal authorities and continue to be sold, including newer insulin products approved under biosimilar rules (a process for approving drugs similar to existing medications)
- **Cost-sharing**: The amount patients must pay out of their own pockets for health care (like copays or coinsurance)
- **Negotiated price**: The price that an insurance plan agrees to pay for a medication after haggling with drug makers or pharmacy benefit managers
- **Out-of-network provider**: A doctor, pharmacy, or other health provider that does not have a contract with a patient's insurance plan
##
Effective Date
Plan years beginning on or after January 1, 2024
I
118TH CONGRESS
1ST SESSION H. R. 1488
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
MARCH 9, 2023
Ms. CRAIG (for herself, Mr. KILDEE, and Mrs. MCBATH) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committees on Ways and Means, and Edu-
cation and the Workforce, for a period to be subsequently determined by
the Speaker, in each case for consideration of such provisions as fall with-
in 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 in-
sulin products, and for other purposes.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Affordable Insulin Now
4
Act’’.
5
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•HR 1488 IH
SEC. 2. REQUIREMENTS WITH RESPECT TO COST-SHARING
1
FOR INSULIN PRODUCTS.
2
(a) PHSA.—Part D of title XXVII of the Public
3
Health Service Act (42 U.S.C. 300gg–111 et seq.) is
4
amended by adding at the end the following new section:
5
‘‘SEC. 2799A–11. REQUIREMENTS WITH RESPECT TO COST-
6
SHARING FOR CERTAIN INSULIN PRODUCTS.
7
‘‘(a) IN GENERAL.—For plan years beginning on or
8
after January 1, 2024, a group health plan or health in-
9
surance issuer offering group or individual health insur-
10
ance coverage shall provide coverage of selected insulin
11
products, and with respect to such products, shall not—
12
‘‘(1) apply any deductible; or
13
‘‘(2) impose any cost-sharing in excess of the
14
lesser of, per 30-day supply—
15
‘‘(A) $35; or
16
‘‘(B) the amount equal to 25 percent of
17
the negotiated price of the selected insulin prod-
18
uct net of all price concessions received by or on
19
behalf of the plan or coverage, including price
20
concessions received by or on behalf of third-
21
party entities providing services to the plan or
22
coverage, such as pharmacy benefit manage-
23
ment services.
24
‘‘(b) DEFINITIONS.—In this section:
25
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•HR 1488 IH
‘‘(1) SELECTED INSULIN PRODUCTS.—The term
1
‘selected insulin products’ means at least one of each
2
dosage form (such as vial, pump, or inhaler dosage
3
forms) of each different type (such as rapid-acting,
4
short-acting, intermediate-acting, long-acting, ultra
5
long-acting, and premixed) of insulin (as defined
6
below), when available, as selected by the group
7
health plan or health insurance issuer.
8
‘‘(2) INSULIN
DEFINED.—The term ‘insulin’
9
means insulin that is licensed under subsection (a)
10
or (k) of section 351 and continues to be marketed
11
under such section, including any insulin product
12
that has been deemed to be licensed under section
13
351(a) pursuant to section 7002(e)(4) of the Bio-
14
logics Price Competition and Innovation Act of 2009
15
and continues to be marketed pursuant to such li-
16
censure.
17
‘‘(c) OUT-OF-NETWORK
PROVIDERS.—Nothing in
18
this section requires a plan or issuer that has a network
19
of providers to provide benefits for selected insulin prod-
20
ucts described in this section that are delivered by an out-
21
of-network provider, or precludes a plan or issuer that has
22
a network of providers from imposing higher cost-sharing
23
than the levels specified in subsection (a) for selected insu-
24
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•HR 1488 IH
lin products described in this section that are delivered
1
by an out-of-network provider.
2
‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall
3
not be construed to require coverage of, or prevent a group
4
health plan or health insurance coverage from imposing
5
cost-sharing other than the levels specified in subsection
6
(a) on, insulin products that are not selected insulin prod-
7
ucts, to the extent that such coverage is not otherwise re-
8
quired and such cost-sharing is otherwise permitted under
9
Federal and applicable State law.
10
‘‘(e) APPLICATION
OF
COST-SHARING
TOWARDS
11
DEDUCTIBLES
AND OUT-OF-POCKET MAXIMUMS.—Any
12
cost-sharing payments made pursuant to subsection (a)(2)
13
shall be counted toward any deductible or out-of-pocket
14
maximum that applies under the plan or coverage.’’.
15
(b) IRC.—
16
(1) IN
GENERAL.—Subchapter B of chapter
17
100 of the Internal Revenue Code of 1986 is amend-
18
ed by adding at the end the following new section:
19
‘‘SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHAR-
20
ING FOR CERTAIN INSULIN PRODUCTS.
21
‘‘(a) IN GENERAL.—For plan years beginning on or
22
after January 1, 2024, a group health plan shall provide
23
coverage of selected insulin products, and with respect to
24
such products, shall not—
25
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•HR 1488 IH
‘‘(1) apply any deductible; or
1
‘‘(2) impose any cost-sharing in excess of the
2
lesser of, per 30-day supply—
3
‘‘(A) $35; or
4
‘‘(B) the amount equal to 25 percent of
5
the negotiated price of the selected insulin prod-
6
uct net of all price concessions received by or on
7
behalf of the plan, including price concessions
8
received by or on behalf of third-party entities
9
providing services to the plan, such as phar-
10
macy benefit management services.
11
‘‘(b) DEFINITIONS.—In this section:
12
‘‘(1) SELECTED INSULIN PRODUCTS.—The term
13
‘selected insulin products’ means at least one of each
14
dosage form (such as vial, pump, or inhaler dosage
15
forms) of each different type (such as rapid-acting,
16
short-acting, intermediate-acting, long-acting, ultra
17
long-acting, and premixed) of insulin (as defined
18
below), when available, as selected by the group
19
health plan.
20
‘‘(2) INSULIN
DEFINED.—The term ‘insulin’
21
means insulin that is licensed under subsection (a)
22
or (k) of section 351 of the Public Health Service
23
Act (42 U.S.C. 262) and continues to be marketed
24
under such section, including any insulin product
25
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•HR 1488 IH
that has been deemed to be licensed under section
1
351(a) of such Act pursuant to section 7002(e)(4)
2
of the Biologics Price Competition and Innovation
3
Act of 2009 (Public Law 111–148) and continues to
4
be marketed pursuant to such licensure.
5
‘‘(c) OUT-OF-NETWORK
PROVIDERS.—Nothing in
6
this section requires a plan that has a network of providers
7
to provide benefits for selected insulin products described
8
in this section that are delivered by an out-of-network pro-
9
vider, or precludes a plan that has a network of providers
10
from imposing higher cost-sharing than the levels specified
11
in subsection (a) for selected insulin products described
12
in this section that are delivered by an out-of-network pro-
13
vider.
14
‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall
15
not be construed to require coverage of, or prevent a group
16
health plan from imposing cost-sharing other than the lev-
17
els specified in subsection (a) on, insulin products that are
18
not selected insulin products, to the extent that such cov-
19
erage is not otherwise required and such cost-sharing is
20
otherwise permitted under Federal and applicable State
21
law.
22
‘‘(e) APPLICATION
OF
COST-SHARING
TOWARDS
23
DEDUCTIBLES
AND OUT-OF-POCKET MAXIMUMS.—Any
24
cost-sharing payments made pursuant to subsection (a)(2)
25
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7
•HR 1488 IH
shall be counted toward any deductible or out-of-pocket
1
maximum that applies under the plan.’’.
2
(2) CLERICAL AMENDMENT.—The table of sec-
3
tions for subchapter B of chapter 100 of the Inter-
4
nal Revenue Code of 1986 is amended by adding at
5
the end the following new item:
6
‘‘Sec. 9826. Requirements with respect to cost-sharing for certain insulin prod-
ucts.’’.
(c) ERISA.—
7
(1) IN GENERAL.—Subpart B of part 7 of sub-
8
title B of title I of the Employee Retirement Income
9
Security Act of 1974 (29 U.S.C. 1185 et seq.) is
10
amended by adding at the end the following:
11
‘‘SEC. 726. REQUIREMENTS WITH RESPECT TO COST-SHAR-
12
ING FOR CERTAIN INSULIN PRODUCTS.
13
‘‘(a) IN GENERAL.—For plan years beginning on or
14
after January 1, 2024, a group health plan or health in-
15
surance issuer offering group health insurance coverage
16
shall provide coverage of selected insulin products, and
17
with respect to such products, shall not—
18
‘‘(1) apply any deductible; or
19
‘‘(2) impose any cost-sharing in excess of the
20
lesser of, per 30-day supply—
21
‘‘(A) $35; or
22
‘‘(B) the amount equal to 25 percent of
23
the negotiated price of the selected insulin prod-
24
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8
•HR 1488 IH
uct net of all price concessions received by or on
1
behalf of the plan or coverage, including price
2
concessions received by or on behalf of third-
3
party entities providing services to the plan or
4
coverage, such as pharmacy benefit manage-
5
ment services.
6
‘‘(b) DEFINITIONS.—In this section:
7
‘‘(1) SELECTED INSULIN PRODUCTS.—The term
8
‘selected insulin products’ means at least one of each
9
dosage form (such as vial, pump, or inhaler dosage
10
forms) of each different type (such as rapid-acting,
11
short-acting, intermediate-acting, long-acting, ultra
12
long-acting, and premixed) of insulin (as defined
13
below), when available, as selected by the group
14
health plan or health insurance issuer.
15
‘‘(2) INSULIN
DEFINED.—The term ‘insulin’
16
means insulin that is licensed under subsection (a)
17
or (k) of section 351 of the Public Health Service
18
Act (42 U.S.C. 262) and continues to be marketed
19
under such section, including any insulin product
20
that has been deemed to be licensed under section
21
351(a) of such Act pursuant to section 7002(e)(4)
22
of the Biologics Price Competition and Innovation
23
Act of 2009 (Public Law 111–148) and continues to
24
be marketed pursuant to such licensure.
25
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9
•HR 1488 IH
‘‘(c) OUT-OF-NETWORK
PROVIDERS.—Nothing in
1
this section requires a plan or issuer that has a network
2
of providers to provide benefits for selected insulin prod-
3
ucts described in this section that are delivered by an out-
4
of-network provider, or precludes a plan or issuer that has
5
a network of providers from imposing higher cost-sharing
6
than the levels specified in subsection (a) for selected insu-
7
lin products described in this section that are delivered
8
by an out-of-network provider.
9
‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall
10
not be construed to require coverage of, or prevent a group
11
health plan or health insurance coverage from imposing
12
cost-sharing other than the levels specified in subsection
13
(a) on, insulin products that are not selected insulin prod-
14
ucts, to the extent that such coverage is not otherwise re-
15
quired and such cost-sharing is otherwise permitted under
16
Federal and applicable State law.
17
‘‘(e) APPLICATION
OF
COST-SHARING
TOWARDS
18
DEDUCTIBLES
AND OUT-OF-POCKET MAXIMUMS.—Any
19
cost-sharing payments made pursuant to subsection (a)(2)
20
shall be counted toward any deductible or out-of-pocket
21
maximum that applies under the plan or coverage.’’.
22
(2) CLERICAL AMENDMENT.—The table of con-
23
tents in section 1 of the Employee Retirement In-
24
come Security Act of 1974 (29 U.S.C. 1001 et seq.)
25
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10
•HR 1488 IH
is amended by inserting after the item relating to
1
section 725 the following:
2
‘‘Sec. 726. Requirements with respect to cost-sharing for certain insulin prod-
ucts.’’.
(d) NO EFFECT ON OTHER COST-SHARING.—Section
3
1302(d)(2) of the Patient Protection and Affordable Care
4
Act (42 U.S.C. 18022(d)(2)) is amended by adding at the
5
end the following new subparagraph:
6
‘‘(D) SPECIAL RULE RELATING TO INSU-
7
LIN COVERAGE.—The exemption of coverage of
8
selected insulin products (as defined in section
9
2799A–11(b) of the Public Health Service Act)
10
from the application of any deductible pursuant
11
to section 2799A–11(a)(1) of such Act, section
12
726(a)(1) of the Employee Retirement Income
13
Security Act of 1974, or section 9826(a)(1) of
14
the Internal Revenue Code of 1986 shall not be
15
considered when determining the actuarial value
16
of a qualified health plan under this sub-
17
section.’’.
18
(e) COVERAGE
OF CERTAIN INSULIN PRODUCTS
19
UNDER CATASTROPHIC PLANS.—Section 1302(e) of the
20
Patient Protection and Affordable Care Act (42 U.S.C.
21
18022(e)) is amended by adding at the end the following:
22
‘‘(4) COVERAGE
OF
CERTAIN
INSULIN
PROD-
23
UCTS.—
24
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•HR 1488 IH
‘‘(A) IN GENERAL.—Notwithstanding para-
1
graph (1)(B)(i), a health plan described in
2
paragraph (1) shall provide coverage of selected
3
insulin products, in accordance with section
4
2799A–11 of the Public Health Service Act, for
5
a plan year before an enrolled individual has in-
6
curred cost-sharing expenses in an amount
7
equal to the annual limitation in effect under
8
subsection (c)(1) for the plan year.
9
‘‘(B) TERMINOLOGY.—For purposes of
10
subparagraph (A)—
11
‘‘(i) the term ‘selected insulin prod-
12
ucts’ has the meaning given such term in
13
section 2799A–11(b) of the Public Health
14
Service Act; and
15
‘‘(ii) the requirements of section
16
2799A–11 of such Act shall be applied by
17
deeming each refe
[Text truncated for display. Full text available on Congress.gov.]