What This Bill Does
This bill limits the amount people pay out-of-pocket for insulin medicine. It makes changes to how Medicare Part D (prescription drug coverage for seniors) handles insulin costs and creates new rules for private health insurance plans that cover insulin.
##
Who It Affects
People who take insulin and have Medicare Part D coverage
People with private health insurance through their job or the individual market
Group health plans and health insurance companies
##
Key Provisions
* Starting in plan year 2024, health insurance plans must cover selected insulin products (meaning at least one option of each type of insulin available, such as rapid-acting, long-acting, or premixed) without requiring people to pay a deductible (upfront amount before insurance kicks in) (Sec. 3(a), Sec. 3(d), Sec. 3(e))
* For each 30-day supply of selected insulin products, a person cannot be charged more than the lesser of: $25 or 25 percent of the negotiated price after all discounts (Sec. 3(a))
* Insurance plans cannot require prior authorization (advance approval from the insurance company) or step therapy protocols (trying cheaper medicines first) for selected insulin products, unless medically necessary and approved by the Secretary (Sec. 3(a))
* For Medicare Part D in 2024 and 2025, the amount people pay out-of-pocket for insulin is capped at $25 per 30-day supply (Sec. 2)
* Any payments people make for insulin count toward their deductible and out-of-pocket maximum limits (Sec. 3(a))
##
What Changes
If this becomes law, starting in 2024, people will pay no more than $25 per 30-day supply for certain insulin products under their health insurance or Medicare Part D. Insurance companies cannot deny insulin coverage without a medical reason. Plans do not have to cover insulin types that are not "selected insulin products," meaning they can still manage costs for other options.
##
Important Definitions
"Selected insulin products" means at least one type of each different insulin form (such as vials, pumps, or inhalers) and each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed), when available, chosen by the insurance plan.
"Insulin" means any insulin medicine approved by the government and still being sold legally.
"Cost-sharing" means the amount patients pay directly, such as copays (fixed amounts per prescription) or coinsurance (a percentage of the cost).
##
Effective Date
Plan years beginning on or after January 1, 2024
II
118TH CONGRESS
1ST SESSION
S. 146
To reduce the price of insulin for patients.
IN THE SENATE OF THE UNITED STATES
JANUARY 30, 2023
Mr. HAWLEY introduced the following bill; which was read twice and referred
to the Committee on Health, Education, Labor, and Pensions
A BILL
To reduce the price of insulin for patients.
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 ‘‘Cap Insulin Prices
4
Act’’.
5
SEC. 2. REDUCTION IN COST-SHARING FOR COVERED INSU-
6
LIN PRODUCTS UNDER MEDICARE PART D.
7
Section 1860D–2(b)(9)(D) of the Social Security Act
8
(42 U.S.C. 1395w–102(b)(9)(D)) is amended—
9
(1) by redesignating clause (ii) as clause (iii);
10
(2) in clause (i)—
11
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•S 146 IS
(A) by striking ‘‘plan years 2023, 2024,
1
and 2025’’ and inserting ‘‘plan year 2023’’; and
2
(B) by striking ‘‘and’’ after the semicolon
3
at the end;
4
(3) by inserting after clause (i) the following
5
new clause:
6
‘‘(ii) during plan years 2024 and
7
2025, $25; and’’; and
8
(4) in clause (iii)(I), as redesignated by para-
9
graph (1) of this section, by striking ‘‘$35’’ and in-
10
serting ‘‘$25’’.
11
SEC. 3. REQUIREMENTS WITH RESPECT TO COST-SHARING
12
FOR INSULIN PRODUCTS.
13
(a) IN GENERAL.—Part D of title XXVII of the Pub-
14
lic Health Service Act (42 U.S.C. 300gg–111 et seq.) is
15
amended by adding at the end the following:
16
‘‘SEC. 2799A–11. REQUIREMENTS WITH RESPECT TO COST-
17
SHARING FOR CERTAIN INSULIN PRODUCTS.
18
‘‘(a) IN GENERAL.—For plan years beginning on or
19
after January 1, 2024, a group health plan or health in-
20
surance issuer offering group or individual health insur-
21
ance coverage shall provide coverage of selected insulin
22
products, and with respect to such products, shall not—
23
‘‘(1) apply any deductible;
24
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•S 146 IS
‘‘(2) impose any cost-sharing requirement in ex-
1
cess of the lesser of, per 30-day supply—
2
‘‘(A) $25; or
3
‘‘(B) the amount equal to 25 percent of
4
the negotiated price of the selected insulin prod-
5
uct net of all price concessions received by or on
6
behalf of the plan or coverage, including price
7
concessions received by or on behalf of third-
8
party entities providing services to the plan or
9
coverage, such as pharmacy benefit manage-
10
ment services; or
11
‘‘(3) impose any utilization management prac-
12
tices such as prior authorization, step therapy proto-
13
cols, or other similar conditions on such products,
14
except as clinically justified and as specified by the
15
Secretary.
16
‘‘(b) DEFINITIONS.—In this section:
17
‘‘(1) SELECTED INSULIN PRODUCTS.—The term
18
‘selected insulin products’ means at least one of each
19
dosage form (such as vial, pump, or inhaler dosage
20
forms) of each different type (such as rapid-acting,
21
short-acting, intermediate-acting, long-acting, ultra
22
long-acting, and premixed) of insulin (as defined
23
below), when available, as selected by the group
24
health plan or health insurance issuer.
25
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•S 146 IS
‘‘(2) INSULIN
DEFINED.—The term ‘insulin’
1
means insulin that is licensed under subsection (a)
2
or (k) of section 351 and continues to be marketed
3
under such section.
4
‘‘(c) OUT-OF-NETWORK
PROVIDERS.—Nothing in
5
this section requires a plan or issuer that has a network
6
of providers to provide benefits for selected insulin prod-
7
ucts described in this section that are delivered by an out-
8
of-network provider, or precludes a plan or issuer that has
9
a network of providers from imposing higher cost-sharing
10
than the levels specified in subsection (a) for selected insu-
11
lin products described in this section that are delivered
12
by an out-of-network provider.
13
‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall
14
not be construed to require coverage of, or prevent a group
15
health plan or health insurance coverage from imposing
16
cost-sharing other than the levels specified in subsection
17
(a) on, insulin products that are not selected insulin prod-
18
ucts, to the extent that such coverage is not otherwise re-
19
quired and such cost-sharing is otherwise permitted under
20
Federal and applicable State law.
21
‘‘(e) APPLICATION
OF
COST-SHARING
TOWARDS
22
DEDUCTIBLES
AND OUT-OF-POCKET MAXIMUMS.—Any
23
cost-sharing payments made pursuant to subsection (a)(2)
24
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•S 146 IS
shall be counted toward any deductible or out-of-pocket
1
maximum that applies under the plan or coverage.’’.
2
(b) 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.—For plan years beginning on
8
or after January 1, 2024, the exemption of cov-
9
erage of selected insulin products (as defined in
10
section 2799A–11(b) of the Public Health Serv-
11
ice Act) from the application of any deductible
12
pursuant to section 2799A–11(a)(1) of such
13
Act, section 726(a)(1) of the Employee Retire-
14
ment Income Security Act of 1974, or section
15
9826(a)(1) of the Internal Revenue Code of
16
1986 shall not be considered when determining
17
the actuarial value of a qualified health plan
18
under this subsection.’’.
19
(c) COVERAGE
OF CERTAIN INSULIN PRODUCTS
20
UNDER CATASTROPHIC PLANS.—Section 1302(e) of the
21
Patient Protection and Affordable Care Act (42 U.S.C.
22
18022(e)) is amended by adding at the end the following:
23
‘‘(4) COVERAGE
OF
CERTAIN
INSULIN
PROD-
24
UCTS.—
25
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6
•S 146 IS
‘‘(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 reference in such section to
18
‘individual health insurance coverage’ to be
19
a reference to a plan described in para-
20
graph (1).’’.
21
(d) ERISA.—
22
(1) IN GENERAL.—Subpart B of part 7 of sub-
23
title B of title I of the Employee Retirement Income
24
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7
•S 146 IS
Security Act of 1974 (29 U.S.C. 1185 et seq.) is
1
amended by adding at the end the following:
2
‘‘SEC. 726. REQUIREMENTS WITH RESPECT TO COST-SHAR-
3
ING FOR CERTAIN INSULIN PRODUCTS.
4
‘‘(a) IN GENERAL.—For plan years beginning on or
5
after January 1, 2024, a group health plan or health in-
6
surance issuer offering group health insurance coverage
7
shall provide coverage of selected insulin products, and
8
with respect to such products, shall not—
9
‘‘(1) apply any deductible;
10
‘‘(2) impose any cost-sharing requirement in ex-
11
cess of the lesser of, per 30-day supply—
12
‘‘(A) $25; or
13
‘‘(B) the amount equal to 25 percent of
14
the negotiated price of the selected insulin prod-
15
uct net of all price concessions received by or on
16
behalf of the plan or coverage, including price
17
concessions received by or on behalf of third-
18
party entities providing services to the plan or
19
coverage, such as pharmacy benefit manage-
20
ment services; or
21
‘‘(3) impose any utilization management prac-
22
tices such as prior authorization, step therapy proto-
23
cols, or other similar conditions on such products,
24
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8
•S 146 IS
except as clinically justified and as specified by the
1
Secretary.
2
‘‘(b) DEFINITIONS.—In this section:
3
‘‘(1) SELECTED INSULIN PRODUCTS.—The term
4
‘selected insulin products’ means at least one of each
5
dosage form (such as vial, pump, or inhaler dosage
6
forms) of each different type (such as rapid-acting,
7
short-acting, intermediate-acting, long-acting, ultra
8
long-acting, and premixed) of insulin (as defined
9
below), when available, as selected by the group
10
health plan or health insurance issuer.
11
‘‘(2) INSULIN
DEFINED.—The term ‘insulin’
12
means insulin that is licensed under subsection (a)
13
or (k) of section 351 of the Public Health Service
14
Act (42 U.S.C. 262) and continues to be marketed
15
under such section.
16
‘‘(c) OUT-OF-NETWORK
PROVIDERS.—Nothing in
17
this section requires a plan or issuer that has a network
18
of providers to provide benefits for selected insulin prod-
19
ucts described in this section that are delivered by an out-
20
of-network provider, or precludes a plan or issuer that has
21
a network of providers from imposing higher cost-sharing
22
than the levels specified in subsection (a) for selected insu-
23
lin products described in this section that are delivered
24
by an out-of-network provider.
25
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•S 146 IS
‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall
1
not be construed to require coverage of, or prevent a group
2
health plan or health insurance coverage from imposing
3
cost-sharing other than the levels specified in subsection
4
(a) on, insulin products that are not selected insulin prod-
5
ucts, to the extent that such coverage is not otherwise re-
6
quired and such cost-sharing is otherwise permitted under
7
Federal and applicable State law.
8
‘‘(e) APPLICATION
OF
COST-SHARING
TOWARDS
9
DEDUCTIBLES
AND OUT-OF-POCKET MAXIMUMS.—Any
10
cost-sharing payments made pursuant to subsection (a)(2)
11
shall be counted toward any deductible or out-of-pocket
12
maximum that applies under the plan or coverage.’’.
13
(2) CLERICAL AMENDMENT.—The table of con-
14
tents in section 1 of the Employee Retirement In-
15
come Security Act of 1974 (29 U.S.C. 1001 et seq.)
16
is amended by inserting after the item relating to
17
section 725 the following:
18
‘‘Sec. 726 Requirements with respect to cost-sharing for certain insulin prod-
ucts.’’.
(e) INTERNAL REVENUE CODE.—
19
(1) IN
GENERAL.—Subchapter B of chapter
20
100 of the Internal Revenue Code of 1986 is amend-
21
ed by adding at the end the following new section:
22
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•S 146 IS
‘‘SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHAR-
1
ING FOR CERTAIN INSULIN PRODUCTS.
2
‘‘(a) IN GENERAL.—For plan years beginning on or
3
after January 1, 2024, a group health plan shall provide
4
coverage of selected insulin products, and with respect to
5
such products, shall not—
6
‘‘(1) apply any deductible;
7
‘‘(2) impose any cost-sharing requirement in ex-
8
cess of the lesser of, per 30-day supply—
9
‘‘(A) $25; or
10
‘‘(B) the amount equal to 25 percent of
11
the negotiated price of the selected insulin prod-
12
uct net of all price concessions received by or on
13
behalf of the plan, including price concessions
14
received by or on behalf of third-party entities
15
providing services to the plan, such as phar-
16
macy benefit management services; or
17
‘‘(3) impose any utilization management prac-
18
tices such as prior authorization, step therapy proto-
19
cols, or other similar conditions on such products,
20
except as clinically justified and as specified by the
21
Secretary.
22
‘‘(b) DEFINITIONS.—In this section:
23
‘‘(1) SELECTED INSULIN PRODUCTS.—The term
24
‘selected insulin products’ means at least one of each
25
dosage form (such as vial, pump, or inhaler dosage
26
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•S 146 IS
forms) of each different type (such as rapid-acting,
1
short-acting, intermediate-acting, long-acting, ultra
2
long-acting, and premixed) of insulin (as defined
3
below), when available, as selected by the group
4
health plan.
5
‘‘(2) INSULIN
DEFINED.—The term ‘insulin’
6
means insulin that is licensed under subsection (a)
7
or (k) of section 351 of the Public Health Service
8
Act (42 U.S.C. 262) and continues to be marketed
9
under such section.
10
‘‘(c) OUT-OF-NETWORK
PROVIDERS.—Nothing in
11
this section requires a plan that has a network of providers
12
to provide benefits for selected insulin products described
13
in this section that are delivered by an out-of-network pro-
14
vider, or precludes a plan that has a network of providers
15
from imposing higher cost-sharing than the levels specified
16
in subsection (a) for selected insulin products described
17
in this section that are delivered by an out-of-network pro-
18
vider.
19
‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall
20
not be construed to require coverage of, or prevent a group
21
health plan from imposing cost-sharing other than the lev-
22
els specified in subsection (a) on, insulin products that are
23
not selected insulin products, to the extent that such cov-
24
erage is not otherwise required and such cost-sharing is
25
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•S 146 IS
otherwise permitted under Federal and applicable State
1
law.
2
‘‘(e) APPLICATION
OF
COST-SHARING
TOWARDS
3
DEDUCTIBLES
AND OUT-OF-POCKET MAXIMUMS.—Any
4
cost-sharing payments made pursuant to subsection (a)(2)
5
shall be counted toward any deductible or out-of-pocket
6
maximum that applies under the plan.’’.
7
(2) CLERICAL AMENDMENT.—The table of sec-
8
tions for s
[Text truncated for display. Full text available on Congress.gov.]