[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4189 Introduced in Senate (IS)]
<DOC>
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, and Mrs. Britt) 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 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,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(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''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Sense of Congress.
TITLE I--COMMERCIAL MARKET PATIENT PROTECTIONS
Sec. 101. Requirements with respect to cost-sharing for certain insulin
products.
Sec. 102. Application to retiree and certain small group plans.
Sec. 103. Administration.
TITLE II--PHARMACY BENEFIT MANAGER TRANSPARENCY AND REBATE REFORM
Sec. 201. Full rebate on insulin pass-through to plan.
TITLE III--BIOSIMILAR BIOLOGICAL PRODUCT AND GENERIC DRUG COMPETITION
AND AFFORDABILITY
Sec. 301. Ensuring timely access to generics.
Sec. 302. Expediting competitive biosimilar competition.
Sec. 303. Insulin competition report.
TITLE IV--PROGRAMS FOR PROVIDING AFFORDABLE INSULIN TO UNINSURED
INDIVIDUALS
Sec. 401. Pilot program for providing affordable insulin to uninsured
individuals.
Sec. 402. GAO study on uninsured individuals who use insulin.
Sec. 403. Insulin resource center and hotline for uninsured
individuals.
SEC. 2. SENSE OF CONGRESS.
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.
TITLE I--COMMERCIAL MARKET PATIENT PROTECTIONS
SEC. 101. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN INSULIN
PRODUCTS.
(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:
``SEC. 2799A-12. 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 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 requirements in excess of,
per 30-day supply--
``(A) for any applicable plan year beginning before
January 1, 2028, $35; or
``(B) for any plan year beginning on or after
January 1, 2028, the lesser of--
``(i) $35; or
``(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.
``(b) Definitions.--In this section:
``(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.
``(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.
``(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 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.
``(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.
``(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.''.
(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:
``(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.''.
(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:
``(4) Coverage of certain insulin products.--
``(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.
``(B) Terminology.--For purposes of subparagraph
(A)--
``(i) the term `selected insulin products'
has the meaning given such term in section
2799A-12(b) of the Public Health Service Act;
and
``(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).''.
(d) ERISA.--
(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:
``SEC. 727. 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 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 requirements in excess of,
per 30-day supply--
``(A) for any applicable plan year beginning before
January 1, 2028, $35; or
``(B) for any plan year beginning on or after
January 1, 2028, the lesser of--
``(i) $35; or
``(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.
``(b) Definitions.--In this section:
``(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.
``(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.
``(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 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.
``(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.
``(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.''.
(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:
``Sec. 727. Requirements with respect to cost-sharing for certain
insulin products.''.
(e) Internal Revenue Code.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986 is amended by adding at the end
the following:
``SEC. 9827. 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 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 requirements in excess of,
per 30-day supply--
``(A) for any applicable plan year beginning before
January 1, 2028, $35; or
``(B) for any plan year beginning on or after
January 1, 2028, the lesser of--
``(i) $35; or
``(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.
``(b) Definitions.--In this section:
``(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.
``(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.
``(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.
``(f) Other Requirements.--A group health plan 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.''.
(2) 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. 9827. Requirements with respect to cost-sharing for certain
insulin products.''.
SEC. 102. APPLICATION TO RETIREE AND CERTAIN SMALL GROUP PLANS.
(a) ERISA.--Section 732(a) of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1191a(a)) is amended by striking
``section 711'' and inserting ``sections 711 and 727''.
(b) IRC.--The Internal Revenue Code of 1986 is amended--
(1) in section 9831(a), by adding at the end the following
flush text:
``Paragraph (2) shall not apply to the requirements under sections 9811
and 9827.''; and
(2) in section 4980D(d)(1), by striking ``section 9811''
and inserting ``section 9811 or 9827''.
SEC. 103. ADMINISTRATION.
(a) Implementation.--Notwithstanding any other provision of law,
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 title for plan years that begin
on or after January 1, 2027, and end not later than January 1, 2030, by
subregulatory guidance, program instruction, or otherwise.
(b) Non-Application of the Paperwork Reduction Act.--Chapter 35 of
title 44, United States Code (commonly referred to as the ``Paperwork
Reduction Act of 1995''), shall not apply to the provisions of,
including the amendments made by, this title.
TITLE II--PHARMACY BENEFIT MANAGER TRANSPARENCY AND REBATE REFORM
SEC. 201. FULL REBATE ON INSULIN PASS-THROUGH TO PLAN.
(a) PHSA.--Part D of title XXVII of the Public Health Service Act
(42 U.S.C. 300gg-111 et seq.), as amended by section 101, is further
amended by adding at the end the following:
``SEC. 2799A-13. FULL REBATE ON INSULIN PASS-THROUGH TO PLAN.
``(a) In General.--A pharmacy benefits manager, a third-party
administrator of a group health plan, a health insurance issuer
offering group health insurance coverage, or an entity providing
pharmacy benefits management services under such health plan or health
insurance coverage shall remit 100 per