[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4189 Reported in Senate (RS)]
<DOC>
Calendar No. 552
119th CONGRESS
2d Session
S. 4189
To reduce the price of insulin and provide for patient protections with
respect to the cost of insulin.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 25, 2026
Mrs. Shaheen (for herself, Ms. Collins, Mr. Warnock, Mr. Kennedy, Ms.
Rosen, Mr. Tuberville, Mr. King, Ms. Murkowski, Mr. Kelly, Mr.
Grassley, Ms. Baldwin, Mrs. Britt, Mr. Coons, Mr. Wicker, Mr. Kaine,
Mrs. Capito, Ms. Blunt Rochester, Mr. Justice, Ms. Ernst, Mr.
Hickenlooper, Mr. Cramer, Ms. Alsobrooks, Mrs. Hyde-Smith, Ms. Cortez
Masto, Mr. Banks, Mr. Booker, Mr. McCormick, Ms. Slotkin, and Mr.
Warner) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
August 7, 2026
Reported by Mr. Cassidy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To reduce the price of insulin and provide for patient protections with
respect to the cost of insulin.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE; TABLE OF CONTENTS.</DELETED>
<DELETED> (a) Short Title.--This Act may be cited as the ``Improving
Needed Safeguards for Users of Lifesaving Insulin Now Act of 2026'' or
the ``INSULIN Act of 2026''.</DELETED>
<DELETED> (b) Table of Contents.--The table of contents for this Act
is as follows:</DELETED>
<DELETED>Sec. 1. Short title; table of contents.
<DELETED>Sec. 2. Sense of Congress.
<DELETED>TITLE I--COMMERCIAL MARKET PATIENT PROTECTIONS
<DELETED>Sec. 101. Requirements with respect to cost-sharing for
certain insulin products.
<DELETED>Sec. 102. Application to retiree and certain small group
plans.
<DELETED>Sec. 103. Administration.
<DELETED>TITLE II--PHARMACY BENEFIT MANAGER TRANSPARENCY AND REBATE
REFORM
<DELETED>Sec. 201. Full rebate on insulin pass-through to plan.
<DELETED>TITLE III--BIOSIMILAR BIOLOGICAL PRODUCT AND GENERIC DRUG
COMPETITION AND AFFORDABILITY
<DELETED>Sec. 301. Ensuring timely access to generics.
<DELETED>Sec. 302. Expediting competitive biosimilar competition.
<DELETED>Sec. 303. Insulin competition report.
<DELETED>TITLE IV--PROGRAMS FOR PROVIDING AFFORDABLE INSULIN TO
UNINSURED INDIVIDUALS
<DELETED>Sec. 401. Pilot program for providing affordable insulin to
uninsured individuals.
<DELETED>Sec. 402. GAO study on uninsured individuals who use insulin.
<DELETED>Sec. 403. Insulin resource center and hotline for uninsured
individuals.
<DELETED>SEC. 2. SENSE OF CONGRESS.</DELETED>
<DELETED> It is the sense of Congress that Congress should enact
subsequent legislation that provides for an offset for any costs to the
Federal Government resulting from the enactment of this Act.</DELETED>
<DELETED>TITLE I--COMMERCIAL MARKET PATIENT PROTECTIONS</DELETED>
<DELETED>SEC. 101. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR
CERTAIN INSULIN PRODUCTS.</DELETED>
<DELETED> (a) 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:</DELETED>
<DELETED>``SEC. 2799A-12. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR
CERTAIN INSULIN PRODUCTS.</DELETED>
<DELETED> ``(a) In General.--For plan years beginning on or after
January 1, 2027, 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--</DELETED>
<DELETED> ``(1) apply any deductible; or</DELETED>
<DELETED> ``(2) impose any cost-sharing requirements in
excess of, per 30-day supply--</DELETED>
<DELETED> ``(A) for any applicable plan year
beginning before January 1, 2028, $35; or</DELETED>
<DELETED> ``(B) for any plan year beginning on or
after January 1, 2028, the lesser of--</DELETED>
<DELETED> ``(i) $35; or</DELETED>
<DELETED> ``(ii) 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 issuer,
including price concessions received by or on
behalf of third-party entities providing
services to the plan or issuer, such as
pharmacy benefit management services or third
party administrators.</DELETED>
<DELETED> ``(b) Definitions.--In this section:</DELETED>
<DELETED> ``(1) Selected insulin products.--The term
`selected insulin products' means, for any plan year beginning
on or after January 1, 2027, at least one of each dosage form
(such as vial, pen, or inhaler dosage forms) of each different
type (such as rapid-acting, short-acting, intermediate-acting,
long-acting, and pre-mixed) of insulin, when such form is
licensed and marketed, as selected by the group health plan or
health insurance issuer.</DELETED>
<DELETED> ``(2) Insulin.--The term `insulin' means insulin
that is licensed under subsection (a) or (k) of section 351 and
continues to be marketed pursuant to such licensure.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(d) Rule of Construction.--Subsection (a) shall not be
construed to require coverage of, or prevent a group health plan or
health insurance issuer 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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(f) Other Requirements.--A group health plan or health
insurance issuer offering group or individual health insurance coverage
shall not impose, directly or through an entity providing pharmacy
benefit management services, any prior authorization or other medical
management requirement, or other similar conditions, on selected
insulin products, except as clinically justified for safety reasons, to
ensure reasonable quantity limits and as specified by the
Secretary.''.</DELETED>
<DELETED> (b) 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:</DELETED>
<DELETED> ``(D) Special rule relating to insulin
coverage.--For plans years beginning on or after
January 1, 2028, the exemption of coverage of selected
insulin products (as defined in section 2799A-12(b) of
the Public Health Service Act) from the application of
any deductible pursuant to section 2799A-12(a)(1) of
such Act, section 727(a)(1) of the Employee Retirement
Income Security Act of 1974, or section 9827(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.''.</DELETED>
<DELETED> (c) 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:</DELETED>
<DELETED> ``(4) Coverage of certain insulin products.--
</DELETED>
<DELETED> ``(A) In general.--Notwithstanding
paragraph (1)(B)(i), for plan years beginning on or
after January 1, 2027, a health plan described in
paragraph (1) shall provide coverage of selected
insulin products, in accordance with section 2799A-12
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.</DELETED>
<DELETED> ``(B) Terminology.--For purposes of
subparagraph (A)--</DELETED>
<DELETED> ``(i) the term `selected insulin
products' has the meaning given such term in
section 2799A-12(b) of the Public Health
Service Act; and</DELETED>
<DELETED> ``(ii) the requirements of section
2799A-12 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).''.</DELETED>
<DELETED> (d) ERISA.--</DELETED>
<DELETED> (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:</DELETED>
<DELETED>``SEC. 727. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR
CERTAIN INSULIN PRODUCTS.</DELETED>
<DELETED> ``(a) In General.--For plan years beginning on or after
January 1, 2027, 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--</DELETED>
<DELETED> ``(1) apply any deductible; or</DELETED>
<DELETED> ``(2) impose any cost-sharing requirements in
excess of, per 30-day supply--</DELETED>
<DELETED> ``(A) for any applicable plan year
beginning before January 1, 2028, $35; or</DELETED>
<DELETED> ``(B) for any plan year beginning on or
after January 1, 2028, the lesser of--</DELETED>
<DELETED> ``(i) $35; or</DELETED>
<DELETED> ``(ii) 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 issuer,
including price concessions received by or on
behalf of third-party entities providing
services to the plan or issuer, such as
pharmacy benefit management services or third
party administrators.</DELETED>
<DELETED> ``(b) Definitions.--In this section:</DELETED>
<DELETED> ``(1) Selected insulin products.--The term
`selected insulin products' means, for any plan year beginning
on or after January 1, 2027, at least one of each dosage form
(such as vial, pen, or inhaler dosage forms) of each different
type (such as rapid-acting, short-acting, intermediate-acting,
long-acting, and pre-mixed) of insulin, when such form is
licensed and marketed, as selected by the group health plan or
health insurance issuer.</DELETED>
<DELETED> ``(2) Insulin.--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 pursuant to such licensure.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(d) Rule of Construction.--Subsection (a) shall not be
construed to require coverage of, or prevent a group health plan or
health insurance issuer 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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(f) Other Requirements.--A group health plan or health
insurance issuer offering group health insurance coverage shall not
impose, directly or through an entity providing pharmacy benefit
management services, any prior authorization or other medical
management requirement, or other similar conditions, on selected
insulin products, except as clinically justified for safety reasons, to
ensure reasonable quantity limits and as specified by the
Secretary.''.</DELETED>
<DELETED> (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 726 the following:</DELETED>
<DELETED>``Sec. 727. Requirements with respect to cost-sharing for
certain insulin products.''.
<DELETED> (e) Internal Revenue Code.--</DELETED>
<DELETED> (1) In general.--Subchapter B of chapter 100 of
the Internal Revenue Code of 1986 is amended by adding at the
end the following:</DELETED>
<DELETED>``SEC. 9827. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR
CERTAIN INSULIN PRODUCTS.</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(1) apply any deductible; or</DELETED>
<DELETED> ``(2) impose any cost-sharing requirements in
excess of, per 30-day supply--</DELETED>
<DELETED> ``(A) for any applicable plan year
beginning before January 1, 2028, $35; or</DELETED>
<DELETED> ``(B) for any plan year beginning on or
after January 1, 2028, the lesser of--</DELETED>
<DELETED> ``(i) $35; or</DELETED>
<DELETED> ``(ii) 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 or third party
administrators.</DELETED>
<DELETED> ``(b) Definitions.--In this section:</DELETED>
<DELETED> ``(1) Selected insulin products.--The term
`selected insulin products' means, for any plan year beginning
on or after January 1, 2027, at least one of each dosage form
(such as vial, pen, or inhaler dosage forms) of each different
type (such as rapid-acting, short-acting, intermediate-acting,
long-acting, and pre-mixed) of insulin, when such form is
licensed and marketed, as selected by the group health
plan.</DELETED>
<DELETED> ``(2) Insulin.--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 pursuant to such licensure.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(e) Appl