(e) EFFECTIVE DATE.—The amendments made by 
this section shall apply with respect to plan years begin-
ning on or after January 1, 2027. 
SEC. 302. REQUIREMENTS WITH RESPECT TO COST-SHAR-
ING FOR INSULIN PRODUCTS. 
(a) PHSA.—Part D of title XXVII of the Public 
Health Service Act (42 U.S.C. 300gg–111 et seq.), as 
amended by sections 101 and 301, is further amended by 
adding at the end the following new section: 
‘‘SEC. 2799A–13. REQUIREMENTS WITH RESPECT TO COST- 
SHARING FOR CERTAIN INSULIN PRODUCTS. 
‘‘(a) IN GENERAL.—For plan years beginning on or 
after January 1, 2027, a group health plan or health in-
surance issuer offering group or individual health insur-
ance 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 prod-
uct 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- 
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party entities providing services to the plan or 
coverage, such as pharmacy benefit manage-
ment 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 Bio-
logics 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 prod-
ucts described in this section that are delivered by an out- 
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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 insu-
lin 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 prod-
ucts, to the extent that such coverage is not otherwise re-
quired 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) ERISA.— 
(1) IN GENERAL.—Subpart B of part 7 of sub-
title B of title I of the Employee Retirement Income 
Security Act of 1974 (29 U.S.C. 1185 et seq.), as 
amended by sections 101 and 301, is further amend-
ed by adding at the end the following new section: 
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‘‘SEC. 728. REQUIREMENTS WITH RESPECT TO COST-SHAR-
ING FOR CERTAIN INSULIN PRODUCTS. 
‘‘(a) IN GENERAL.—For plan years beginning on or 
after January 1, 2027, a group health plan or health in-
surance 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 prod-
uct 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 manage-
ment 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 
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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 prod-
ucts 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 insu-
lin 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 
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(a) on, insulin products that are not selected insulin prod-
ucts, to the extent that such coverage is not otherwise re-
quired 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 con-
tents in section 1 of such Act is amended by insert-
ing after the item relating to section 727 (as in-
serted by section 301) the following new item: 
‘‘Sec. 728. Requirements with respect to cost-sharing for certain insulin prod-
ucts.’’. 
(c) IRC.— 
(1) IN
GENERAL.—Subchapter B of chapter 
100 of the Internal Revenue Code of 1986, as 
amended by sections 101 and 301, is further amend-
ed by adding at the end the following new section: 
‘‘SEC. 9828. REQUIREMENTS WITH RESPECT TO COST-SHAR-
ING FOR CERTAIN INSULIN PRODUCTS. 
‘‘(a) IN GENERAL.—For plan years beginning on or 
after January 1, 2027, a group health plan shall provide 
coverage of selected insulin products, and with respect to 
such products, shall not— 
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‘‘(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 prod-
uct 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 phar-
macy 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 
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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 pro-
vider, 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 pro-
vider. 
‘‘(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 lev-
els specified in subsection (a) on, insulin products that are 
not selected insulin products, to the extent that such cov-
erage 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) 
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shall be counted toward any deductible or out-of-pocket 
maximum that applies under the plan.’’. 
(2) CLERICAL AMENDMENT.—The table of sec-
tions for subchapter B of chapter 100 of the Inter-
nal Revenue Code of 1986, as amended by sections 
101 and 301, is further amended by adding at the 
end the following new item: 
‘‘Sec. 9828. Requirements with respect to cost-sharing for certain insulin prod-
ucts.’’. 
(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 INSU-
LIN COVERAGE.—The exemption of coverage of 
selected insulin products (as defined in section 
2799A–13(b) of the Public Health Service Act) 
from the application of any deductible pursuant 
to section 2799A–13(a)(1) of such Act, section 
728(a)(1) of the Employee Retirement Income 
Security Act of 1974, or section 9828(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 sub-
section.’’. 
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(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 
new paragraph: 
‘‘(4) COVERAGE
OF
CERTAIN
INSULIN
PROD-
UCTS.— 
‘‘(A) IN GENERAL.—Notwithstanding para-
graph (1)(B)(i), a health plan described in 
paragraph (1) shall provide coverage of selected 
insulin products, in accordance with section 
2799A–13 of the Public Health Service Act, for 
a plan year before an enrolled individual has in-
curred 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 prod-
ucts’ has the meaning given such term in 
section 2799A–13(b) of the Public Health 
Service Act; and 
‘‘(ii) the requirements of section 
2799A–13 of such Act shall be applied by 
deeming each reference in such section to 
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‘individual health insurance coverage’ to be 
a reference to a plan described in para-
graph (1).’’. 
Æ 
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