[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) 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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED>``Sec. 9827. Requirements with respect to cost-sharing for
certain insulin products.''.
<DELETED>SEC. 102. APPLICATION TO RETIREE AND CERTAIN SMALL GROUP
PLANS.</DELETED>
<DELETED> (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''.</DELETED>
<DELETED> (b) IRC.--The Internal Revenue Code of 1986 is amended--
</DELETED>
<DELETED> (1) in section 9831(a), by adding at the end the
following flush text:</DELETED>
<DELETED>``Paragraph (2) shall not apply to the requirements under
sections 9811 and 9827.''; and</DELETED>
<DELETED> (2) in section 4980D(d)(1), by striking ``section
9811'' and inserting ``section 9811 or 9827''.</DELETED>
<DELETED>SEC. 103. ADMINISTRATION.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED>TITLE II--PHARMACY BENEFIT MANAGER TRANSPARENCY AND REBATE
REFORM</DELETED>
<DELETED>SEC. 201. FULL REBATE ON INSULIN PASS-THROUGH TO
PLAN.</DELETED>
<DELETED> (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:</DELETED>
<DELETED>``SEC. 2799A-13. FULL REBATE ON INSULIN PASS-THROUGH TO
PLAN.</DELETED>
<DELETED> ``(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 percent of rebates, fees,
alternative discounts, and all other remuneration received from a
pharmaceutical manufacturer, distributor or any other third party, that
are related to utilization of insulin under such health plan or health
insurance coverage, to the group health plan.</DELETED>
<DELETED> ``(b) Form and Manner of Remittance.--Such rebates, fees,
alternative discounts, and other remuneration shall be--</DELETED>
<DELETED> ``(1) remitted to the group health plan in a
timely fashion after the period for which such rebates, fees,
or other remuneration is calculated, and in no case later than
90 days after the end of such period;</DELETED>
<DELETED> ``(2) fully disclosed and enumerated to the group
health plan sponsor; and</DELETED>
<DELETED> ``(3) available for audit by the plan sponsor, or
a third-party designated by a plan sponsor no less than once
per plan year.''.</DELETED>
<DELETED> (b) 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.), as amended by section 101, is
further amended by adding at the end the following:</DELETED>
<DELETED>``SEC. 728. FULL REBATE ON INSULIN PASS-THROUGH TO
PLAN.</DELETED>
<DELETED> ``(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 percent of rebates, fees,
alternative discounts, and all other remuneration received from a
pharmaceutical manufacturer, distributor or any other third party, that
are related to utilization of insulin under such health plan or health
insurance coverage, to the group health plan.</DELETED>
<DELETED> ``(b) Form and Manner of Remittance.--Such rebates, fees,
alternative discounts, and other remuneration shall be--</DELETED>
<DELETED> ``(1) remitted to the group health plan in a
timely fashion after the period for which such rebates, fees,
or other remuneration is calculated, and in no case later than
90 days after the end of such period;</DELETED>
<DELETED> ``(2) fully disclosed and enumerated to the group
health plan sponsor; and</DELETED>
<DELETED> ``(3) available for audit by the plan sponsor, or
a third-party designated by a plan sponsor no less than once
per plan year.''.</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.), as amended by section 101, is
further amended by inserting after the item relating to section
727 the following:</DELETED>
<DELETED>``Sec. 728. Full rebate on insulin pass-through to plan.''.
<DELETED> (c) Internal Revenue Code.--</DELETED>
<DELETED> (1) In general.--Subchapter B of chapter 100 of
the Internal Revenue Code of 1986, as amended by section 101,
is further amended by adding at the end the following new
section:</DELETED>
<DELETED>``SEC. 9828. FULL REBATE ON INSULIN PASS-THROUGH TO
PLAN.</DELETED>
<DELETED> ``(a) In General.--A pharmacy benefits manager, a third-
party administrator of a group health plan, or an entity providing
pharmacy benefits management services under such health plan shall
remit 100 percent of rebates, fees, alternative discounts, and all
other remuneration received from a pharmaceutical manufacturer,
distributor or any other third party, that are related to utilization
of insulin under such health plan, to the group health plan.</DELETED>
<DELETED> ``(b) Form and Manner of Remittance.--Such rebates, fees,
alternative discounts, and other remuneration shall be--</DELETED>
<DELETED> ``(1) remitted to the group health plan in a
timely fashion after the period for which such rebates, fees,
or other remuneration is calculated, and in no case later than
90 days after the end of such period;</DELETED>
<DELETED> ``(2) fully disclosed and enumerated to the group
health plan sponsor; and</DELETED>
<DELETED> ``(3) available for audit by the plan sponsor, or
a third-party designated by a plan sponsor no less than once
per plan year.''.</DELETED>
<DELETED> (2) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of such Code, as amended by section
101, is further amended by adding at the end the following new
item:</DELETED>
<DELETED>``Sec. 9828. Full rebate on insulin pass-through to plan.''.
<DELETED>TITLE III--BIOSIMILAR BIOLOGICAL PRODUCT AND GENERIC DRUG
COMPETITION AND AFFORDABILITY</DELETED>
<DELETED>SEC. 301. ENSURING TIMELY ACCESS TO GENERICS.</DELETED>
<DELETED> Section 505(q) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(q)) is amended--</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) in subparagraph (A)(i), by inserting
``, 10.31,'' after ``10.30'';</DELETED>
<DELETED> (B) in subparagraph (E)--</DELETED>
<DELETED> (i) by striking ``application
and'' and inserting ``application
or'';</DELETED>
<DELETED> (ii) by striking ``If the
Secretary'' and inserting the
following:</DELETED>
<DELETED> ``(i) In general.--If the
Secretary''; and</DELETED>
<DELETED> (iii) by striking the second
sentence and inserting the following:</DELETED>
<DELETED> ``(ii) Primary purpose of
delaying.--</DELETED>
<DELETED> ``(I) In general.--In
determining whether a petition was
submitted with the primary purpose of
delaying an application, the Secretary
may consider the following
factors:</DELETED>
<DELETED> ``(aa) Whether the
petition was submitted in
accordance with paragraph
(2)(B), based on when the
petitioner knew or reasonably
should have known the relevant
information relied upon to form
the basis of such
petition.</DELETED>
<DELETED> ``(bb) Whether the
petitioner has submitted
multiple or serial petitions or
supplements to petitions
raising issues that reasonably
could have been known to the
petitioner at the time of
submission of the earlier
petition or
petitions.</DELETED>
<DELETED> ``(cc) Whether the
petition was submitted close in
time to a known, first date
upon which an application under
subsection (b)(2) or (j) of
this section or section 351(k)
of the Public Health Service
Act could be
approved.</DELETED>
<DELETED> ``(dd) Whether the
petition was submitted without
relevant data or information in
support of the scientific
positions forming the basis of
such petition.</DELETED>
<DELETED> ``(ee) Whether the
petition raises the same or
substantially similar issues as
a prior petition to which the
Secretary has responded
substantively already,
including if the subsequent
submission follows such
response from the Secretary
closely in time.</DELETED>
<DELETED> ``(ff) Whether the
petition requests changing the
applicable standards that other
applicants are required to
meet, including requesting
testing, data, or labeling
standards that are more onerous
or rigorous than the standards
the Secretary has determined to
be applicable to the listed
drug, reference product, or
petitioner's version of the
same drug.</DELETED>
<DELETED> ``(gg) The
petitioner's record of
submitting petitions to the
Food and Drug Administration
that have been determined by
the Secretary to have been
submitted with the primary
purpose of delay.</DELETED>
<DELETED> ``(hh) Other
relevant and appropriate
factors, which the Secretary
shall describe in
guidance.</DELETED>
<DELETED> ``(II) Guidance.--The
Secretary may issue or update guidance,
as appropriate, to describe factors the
Secretary considers in accordance with
subclause (I).'';</DELETED>
<DELETED> (C) by adding at the end the
following:</DELETED>
<DELETED> ``(iii) Referral to the federal
trade commission.--The Secretary shall
establish procedures for referring to the
Federal Trade Commission any petition or
supplement to a petition that the Secretary
determines was submitted with the primary
purpose of delaying approval of an application.
Such procedures shall include notification to
the petitioner by the Secretary.'';</DELETED>
<DELETED> (D) by striking subparagraph
(F);</DELETED>
<DELETED> (E) by redesignating subparagraphs (G)
through (I) as subparagraphs (F) through (H),
respectively; and</DELETED>
<DELETED> (F) in subparagraph (H), as so
redesignated, by striking ``submission of this
petition'' and inserting ``submission of this
document'';</DELETED>
<DELETED> (2) in paragraph (2)--</DELETED>
<DELETED> (A) by redesignating subparagraphs (A)
through (C) as subparagraphs (C) through (E),
respectively;</DELETED>
<DELETED> (B) by inserting before subparagraph (C),
as so redesignated, the following:</DELETED>
<DELETED> ``(A) In general.--A person shall submit a
petition to the Secretary under paragraph (1) before
filing a civil action in which the person seeks to set
aside, delay, rescind, withdraw, or prevent submission,
review, or approval of an application submitted under
subsection (b)(2) or (j) of this section or section
351(k) of the Public Health Service Act. Such petition
and any supplement to such a petition shall describe
all information and arguments that form the basis of
the relief requested in any civil action described in
the previous sentence.</DELETED>
<DELETED> ``(B) Timely submission of citizen
petition.--A petition and any supplement to a petition
shall be submitted within 60 days after the person
knew, or reasonably should have known, the information
that forms the basis of the request made in the
petition or supplement.'';</DELETED>
<DELETED> (C) in subparagraph (C), as so
redesignated--</DELETED>
<DELETED> (i) in the heading, by striking
``within 150 days'';</DELETED>
<DELETED> (ii) in clause (i), by striking
``during the 150-day period referred to in
paragraph (1)(F),''; and</DELETED>
<DELETED> (iii) by amending clause (ii) to
read as follows:</DELETED>
<DELETED> ``(ii) on or after the date that
is 151 days after the date of submission of the
petition, the Secretary approves or has
approved the application that is the subject of
the petition without having made such a final
decision.'';</DELETED>
<DELETED> (D) by amending subparagraph (D), as so
redesignated, to read as follows:</DELETED>
<DELETED> ``(D) Dismissal of certain civil
actions.--</DELETED>
<DELETED> ``(i) Petition.--If a person files
a civil action against the Secretary in which a
person seeks to set aside, delay, rescind,
withdraw, or prevent submission, review, or
approval of an application submitted under
subsection (b)(2) or (j) of this section or
section 351(k) of the Public Health Service Act
without complying with the requirements of
subparagraph (A), the court shall dismiss
without prejudice the action for failure to
exhaust administrative remedies.</DELETED>
<DELETED> ``(ii) Timeliness.--If a person
files a civil action against the Secretary in
which a person seeks to set aside, delay,
rescind, withdraw, or prevent submission,
review, or approval of an application submitted
under subsection (b)(2) or (j) of this section
or section 351(k) of the Public Health Service
Act without complying with the requirements of
subparagraph (B), the court shall dismiss with
prejudice the action for failure to timely file
a petition.</DELETED>
<DELETED> ``(iii) Final response.--If a
civil action is filed against the Secretary
with respect to any issue raised in a petition
timely filed under paragraph (1) in which the
petitioner requests that the Secretary take any
form of action that could, if taken, set aside,
delay, rescind, withdraw, or prevent
submission, review, or approval of an
application submitted under subsection (b)(2)
or (j) of this section or section 351(k) of the
Public Health Service Act before the Secretary
has taken final agency action on the petition
within the meaning of subparagraph (C), the
court shall dismiss without prejudice the
action for failure to exhaust administrative
remedies.''; and</DELETED>
<DELETED> (E) in clause (iii) of subparagraph (E),
as so redesignated, by striking ``as defined under
subparagraph (2)(A)'' and inserting ``within the
meaning of subparagraph (C)''; and</DELETED>
<DELETED> (3) in paragraph (4)--</DELETED>
<DELETED> (A) by striking ``Exceptions'' and all
that follows through ``This subsection does'' and
inserting ``Exceptions.--This subsection
does'';</DELETED>
<DELETED> (B) by striking subparagraph (B);
and</DELETED>
<DELETED> (C) by redesignating clauses (i) and (ii)
as subparagraphs (A) and (B), respectively, and
adjusting the margins accordingly.</DELETED>
<DELETED>SEC. 302. EXPEDITING COMPETITIVE BIOSIMILAR
COMPETITION.</DELETED>
<DELETED> (a) In General.--Section 351(k) of the Public Health
Service Act (42 U.S.C. 262(k)) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(10) Expediting competitive biosimilar
competition.--</DELETED>
<DELETED> ``(A) In general.--The Secretary may, at
the request of the sponsor of an application under this
subsection for a biosimilar biological product that is
designated as a competitive biosimilar therapy pursuant
to subsection (b), expedite the development and review
of such application under this subsection.</DELETED>
<DELETED> ``(B) Designation process.--</DELETED>
<DELETED> ``(i) Request.--The sponsor of an
application under this subsection may request
the Secretary to designate the drug as a
competitive biosimilar therapy. A request for
such designation may be made concurrently with,
or at any time prior to, the submission of a
biosimilar biological product license
application under this subsection.</DELETED>
<DELETED> ``(ii) Criteria.--A biological
product is eligible for designation as a
competitive biosimilar therapy under this
paragraph if the Secretary determines that
there is inadequate biosimilar
competition.</DELETED>
<DELETED> ``(iii) Designation.--Not later
than 60 calendar days after the receipt of a
request under clause (i), the Secretary may--
</DELETED>
<DELETED> ``(I) determine whether
the biosimilar biological product that
is the subject of the request meets the
criteria described in clause (ii);
and</DELETED>
<DELETED> ``(II) if the Secretary
finds that such product meets such
criteria, designate the biosimilar
biological product as a competitive
biosimilar therapy.</DELETED>
<DELETED> ``(C) Actions.--In expediting the
development and review of an application under
subparagraph (A), the Secretary may, as requested by
the applicant, take actions including the
following:</DELETED>
<DELETED> ``(i) Hold meetings with the
sponsor and the review team throughout the
development of the biosimilar biological
product prior to submission of the application
under this subsection.</DELETED>
<DELETED> ``(ii) Provide timely advice to,
and interactive communication with, the sponsor
regarding the development of the drug to ensure
that the development program to gather the data
necessary for approval is as efficient as
practicable.</DELETED>
<DELETED> ``(iii) Involve senior managers
and experienced review staff, as appropriate,
in a collaborative, coordinated review of such
application, including with respect to
biological product-device combination products
and other complex products.</DELETED>
<DELETED> ``(iv) Assign a cross-disciplinary
project lead--</DELETED>
<DELETED> ``(I) to facilitate an
efficient review of the development
program and application, including
manufacturing inspections;
and</DELETED>
<DELETED> ``(II) to serve as a
scientific liaison between the review
team and the applicant.</DELETED>
<DELETED> ``(D) Inspections.--With respect to an
application described in subparagraph (A), in the case
of an inspection report that finds approval of such
biological product is dependent upon remediation of a
facility, if the applicant attests that necessary
changes have been made to the facility, the Secretary
shall expedite reinspection of such facility, including
establishing a set timeline to reinspect the facility
or make a determination about the response of the
applicant and whether to approve the
application.</DELETED>
<DELETED> ``(E) Reporting requirement.--Not later
than 1 year after the date of licensure under this
subsection with respect to a biosimilar biological
product for which the development and review is
expedited under this paragraph, the holder of the
license of such biosimilar biological product shall
report to the Secretary on whether the biosimilar
biological product has been marketed in interstate
commerce since the date of such licensure.</DELETED>
<DELETED> ``(F) Inadequate biosimilar competition.--
In this paragraph, the term `inadequate biosimilar
competition' means, with respect to a biological
product, there are fewer than 3 licensed biological
products on the list published under paragraph (9)(A)
(not including biological products on the discontinued
section of such list) that are biosimilar biological
products with the same reference product.''.</DELETED>
<DELETED>SEC. 303. INSULIN COMPETITION REPORT.</DELETED>
<DELETED> Not later than 1 year after the date of the enactment of
this Act, the Secretary of Health and Human Services, in collaboration
with the Administrator for the Centers for Medicare & Medicaid Services
and the Commissioner of Food and Drugs, shall--</DELETED>
<DELETED> (1) complete a study to determine the extent of,
and causes of, delays in getting insulin products to market,
and the market dynamics and extent biosimilar biological
product development and competition could increase, or is
increasing, the number of biological products approved and
available to patients, including by examining barriers to--
</DELETED>
<DELETED> (A) placement of biosimilar biological
products on health insurance formularies;</DELETED>
<DELETED> (B) market entry of insulin product in the
United States, as compared to other highly developed
nations; and</DELETED>
<DELETED> (C) patient and provider education around
biosimilar biological products; and</DELETED>
<DELETED> (2) submit a report to Congress that describes the
results of the study conducted pursuant to paragraph (1) and
recommended policy solutions.</DELETED>
<DELETED>TITLE IV--PROGRAMS FOR PROVIDING AFFORDABLE INSULIN TO
UNINSURED INDIVIDUALS</DELETED>
<DELETED>SEC. 401. PILOT PROGRAM FOR PROVIDING AFFORDABLE INSULIN TO
UNINSURED INDIVIDUALS.</DELETED>
<DELETED> Part P of title III of the Public Health Service Act (42
U.S.C. 280g et seq.) is amended by adding at the end the
following:</DELETED>
<DELETED>``SEC. 399V-8. PILOT PROGRAM FOR PROVIDING AFFORDABLE INSULIN
TO UNINSURED INDIVIDUALS.</DELETED>
<DELETED> ``(a) In General.--The Secretary shall conduct a 5-year
pilot program under which the Secretary awards grants to 10 States for
purposes of providing affordable insulin to uninsured
individuals.</DELETED>
<DELETED> ``(b) Awards.--The Secretary shall award grants under this
section to 10 States that--</DELETED>
<DELETED> ``(1) submit an application to the Secretary, at
such time, in such manner, and containing such information as
the Secretary may require; and</DELETED>
<DELETED> ``(2) have high rates of uninsured individuals and
individuals diagnosed with diabetes, which may include high
rates of newly diagnosed diabetes.</DELETED>
<DELETED> ``(c) Use of Funds.--A State shall use the grant funds
received under this section for any of the following
purposes:</DELETED>
<DELETED> ``(1) To assist in the purchase or dispensing of
insulin, through Federally qualified health centers and retail
community pharmacies, for uninsured individuals.</DELETED>
<DELETED> ``(2) To enroll individuals in programs under
which drug manufacturers provide financial or medication
assistance to low-income individuals, in order to assist such
individuals in obtaining insulin.</DELETED>
<DELETED> ``(3) To allow Federally qualified health centers
to establish new, or maintain or expand existing, on-site
pharmacies owned and operated by the health center that provide
low-cost insulin to patients, and to allow retail community
pharmacies to provide low-cost insulin to patients.</DELETED>
<DELETED> ``(4) To engage in other activities to assist
uninsured individuals in obtaining insulin, as the Secretary
determines appropriate.</DELETED>
<DELETED> ``(d) Formula.--The Secretary shall establish a formula
for purposes of determining the grant amount under this section for
each State. Such formula shall--</DELETED>
<DELETED> ``(1) provide for a minimum amount that will be
provided to each State; and</DELETED>
<DELETED> ``(2) take into account the rates of individuals
with type 1 or type 2, insulin-dependent diabetes and of
uninsured individuals in each State for purposes of determining
any additional amounts provided to a State.</DELETED>
<DELETED> ``(e) Accountability and Oversight.--A State receiving a
grant under this section shall, not later than 1 year after receiving
the grant, submit a report to the Secretary that includes--</DELETED>
<DELETED> ``(1) a description of the purposes for which the
grant funds received by the State were expended in the
preceding fiscal year, and the activities of the State under
the grant during such year; and</DELETED>
<DELETED> ``(2) the number of individuals served through the
grant.</DELETED>
<DELETED> ``(f) Definitions.--In this section:</DELETED>
<DELETED> ``(1) Affordable.--The term `affordable', with
respect to insulin, means that the out-of-pocket cost to the
individual for the insulin is not more than $35 per 1-month
supply.</DELETED>
<DELETED> ``(2) Federally-qualified health center.--The term
`Federally-qualified health center' has the meaning given such
term in section 1905(l)(2) of the Social Security
Act.</DELETED>
<DELETED> ``(3) Insulin.--The term `insulin' means insulin
that is licensed under subsection (a) or (k) of section 351 and
continues to be marketed under such section.</DELETED>
<DELETED> ``(4) Retail community pharmacy.--The term `retail
community pharmacy' has the meaning given such term in section
1927(k)(10) of the Social Security Act.</DELETED>
<DELETED> ``(5) Uninsured individual.--The term `uninsured
individual' means an individual who--</DELETED>
<DELETED> ``(A) is a citizen of the United States or
a qualified alien (as defined in section 431(b) of the
Personal Responsibility and Work Opportunity
Reconciliation Act of 1996);</DELETED>
<DELETED> ``(B) does not qualify for coverage under
a Federal health care program (as defined in section
1128B(f) of the Social Security Act), the health
program established under chapter 89 of title 5, United
States Code, or a group health plan or group health
insurance coverage (as defined in section 2791);
and</DELETED>
<DELETED> ``(C) is not entitled to a premium
assistance tax credit under section 36B of the Internal
Revenue Code of 1986.</DELETED>
<DELETED> ``(g) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $100,000,000 for fiscal
year 2027, to remain available until expended.''.</DELETED>
<DELETED>SEC. 402. GAO STUDY ON UNINSURED INDIVIDUALS WHO USE
INSULIN.</DELETED>
<DELETED> (a) In General.--The Comptroller General of the United
States shall conduct a study, in consultation with patient, clinical,
and provider groups and other experts, and not later than 2 years after
the date of enactment of this Act, issue a report, on the
characteristics of uninsured individuals who use insulin. Such study
and report shall, to the extent data is available, include
consideration of--</DELETED>
<DELETED> (1) any States or regions in which there is a
higher prevalence of such individuals;</DELETED>
<DELETED> (2) any identifiable potential reasons for
uninsured status;</DELETED>
<DELETED> (3) demographic characteristics of such
individuals, such as race and ethnicity; and</DELETED>
<DELETED> (4) income level of such individuals.</DELETED>
<DELETED> (b) Definitions.--In this section, the terms ``insulin''
and ``uninsured individual'' have the meanings given such terms in
section 399V-8 of the Public Health Service Act, as added by section
401.</DELETED>
<DELETED>SEC. 403. INSULIN RESOURCE CENTER AND HOTLINE FOR UNINSURED
INDIVIDUALS.</DELETED>
<DELETED> (a) In General.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary'') shall award
a grant to an eligible entity for purposes of--</DELETED>
<DELETED> (1) establishing and maintaining a resource center
of assistance programs offered by manufactures or other
entities that are available to uninsured individuals seeking
affordable insulin; and</DELETED>
<DELETED> (2) conducting the public education activities
described in subsection (c)(7).</DELETED>
<DELETED> (b) Eligible Entities.--To be eligible to receive the
grant under subsection (a), an entity shall--</DELETED>
<DELETED> (1) be a trade, industry, or professional
association, community- and consumer-focused nonprofit entity,
or other entity, as determined by the Secretary that--
</DELETED>
<DELETED> (A) is capable of carrying out the duties
described in subsection (c);</DELETED>
<DELETED> (B) meets the standards described in
subsection (e); and</DELETED>
<DELETED> (C) provides information consistent with
the standards developed under subsection (f);
and</DELETED>
<DELETED> (2) submit an application to the Secretary, at
such time, in such manner, and containing such information as
the Secretary may require, including information demonstrating
that the entity--</DELETED>
<DELETED> (A) has existing relationships, or could
readily establish relationships, with consumers
(including uninsured individuals), health care
providers, manufacturers of insulin, social service
providers, pharmacies, and other experts that the
Secretary determines appropriate, to meet the goals of
this section; and</DELETED>
<DELETED> (B) has, or will establish, partnerships
with, and solicit feedback from, other entities in
other industries, professional associations, and
community- and consumer-focused nonprofit
organizations, to meet the goals of this
section.</DELETED>
<DELETED> (c) Duties.--An entity that receives a grant under this
section shall--</DELETED>
<DELETED> (1) distribute fair and impartial information
concerning eligibility for manufacturer, foundational, and
other assistance programs available to patients seeking
affordable insulin;</DELETED>
<DELETED> (2) facilitate enrollment in manufacturer
assistance programs or other assistance programs for uninsured
individuals;</DELETED>
<DELETED> (3) make available to the public, through a
standardized website, a clearinghouse of support available to
patients, including--</DELETED>
<DELETED> (A) a link to Federally qualified health
centers and other providers, by ZIP Code;</DELETED>
<DELETED> (B) a link to retail community pharmacies,
by ZIP Code; and</DELETED>
<DELETED> (C) information about how to enroll in
health insurance;</DELETED>
<DELETED> (4) provide information in a manner that is
culturally and linguistically appropriate;</DELETED>
<DELETED> (5) establish a hotline through which individuals
may reach experts with questions about access to insulin, and
that--</DELETED>
<DELETED> (A) is a 24/7 real-time hotline;</DELETED>
<DELETED> (B) provides voice and text support;
and</DELETED>
<DELETED> (C) is staffed by navigators or licensed
health care professionals;</DELETED>
<DELETED> (6) provide guidance to hospitals on how to share
the website and hotline with patients; and</DELETED>
<DELETED> (7) conduct public education activities, in
collaboration with the Department of Health and Human Services,
to raise awareness of the availability of all manufacturer,
foundational, and other assistance programs available to
patients seeking affordable insulin, with a focus on uninsured
individuals; including by--</DELETED>
<DELETED> (A) partnering with community health
centers, hospitals, retail community pharmacies, and
community-based organizations with a focus on access to
affordable medicine; and</DELETED>
<DELETED> (B) working with State and local health
departments to target the programs carried out using
the grant to underserved communities.</DELETED>
<DELETED> (d) Duties of the Secretary.--The Secretary shall--
</DELETED>
<DELETED> (1) ensure adequate maintenance of the resource
center established by the entity receiving a grant under
subsection (a);</DELETED>
<DELETED> (2) publicize such resource center on the website
of the Department of Health and Human Services and across
Federal agencies, as the Secretary determines appropriate;
and</DELETED>
<DELETED> (3) ensure that such resource center meets the
standards under subsection (e), and withdraw the grant and make
an award to a different eligible entity in the case that an
eligible entity fails to meet such standards.</DELETED>
<DELETED> (e) Standards.--The Secretary shall establish standards
for the resource center under this section, including provisions to
ensure that the entity receiving a grant under this section is
qualified to engage in the activities described in this section and to
avoid conflicts of interest. Under such standards, such entity--
</DELETED>
<DELETED> (1) shall not--</DELETED>
<DELETED> (A) be a manufacturer of insulin products;
or</DELETED>
<DELETED> (B) receive any consideration directly or
indirectly from any manufacturer of insulin products in
connection with the enrollment of any individuals in an
assistance program; and</DELETED>
<DELETED> (2) shall provide information that is fair,
accurate, and impartial.</DELETED>
<DELETED> (f) Data Collection and Evaluations.--The Secretary may
collect data and conduct evaluations with respect to the services
provided by the resource center described in this section for purposes
of assessing the extent to which the provision of the services--
</DELETED>
<DELETED> (1) reduces out of pocket insulin costs for
uninsured individuals;</DELETED>
<DELETED> (2) increases awareness of assistance programs or
foundational support available for uninsured individuals;
and</DELETED>
<DELETED> (3) improves utilization of the resources
described in paragraph (2) by uninsured individuals.</DELETED>
<DELETED> (g) Reports to Congress.--The Secretary shall submit to
the Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee on Energy
and Commerce and the Committee on Appropriations of the House of
Representatives, and make publicly available, annual reports on the
activities carried out under this section, including any changes in the
availability or scope of assistance programs offered by insulin
manufacturers and information about the number of individuals who use
the resource center, including the website or hotline.</DELETED>
<DELETED> (h) Definitions.--In this section--</DELETED>
<DELETED> (1) the term ``assistance program'' means a
program to assist patients in obtaining a drug at a reduced
cost, and includes third-party payments, financial assistance,
discounts, product vouchers, and other reductions in out-of-
pocket expenses;</DELETED>
<DELETED> (2) the term ``Federally-qualified health center''
has the meaning given such term in section 1905(l)(2) of the
Social Security Act (42 U.S.C. 1396d(l)(2));</DELETED>
<DELETED> (3) 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> (4) the term ``retail community pharmacy'' has the
meaning given such term in section 1927(k)(10) of the Social
Security Act (42 U.S.C. 1396r-8(k)(10)); and</DELETED>
<DELETED> (5) the term ``uninsured individual'' means an
individual who--</DELETED>
<DELETED> (A) does not qualify for coverage under a
Federal health care program (as defined in section
1128B(f) of the Social Security Act (42 U.S.C. 1320a-
7b(f))), the health program established under chapter
89 of title 5, United States Code, or a group health
plan or group health insurance coverage (as defined in
section 2791 of the Public Health Service Act (42
U.S.C. 300gg-91)); and</DELETED>
<DELETED> (B) is not entitled to a premium
assistance tax credit under section 36B of the Internal
Revenue Code of 1986.</DELETED>
<DELETED> (i) Funding.--To carry out this section, there are
authorized to be appropriated $2,000,000 for each of fiscal years 2027
through 2032.</DELETED>
SECTION 1. 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''.
SEC. 2. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN INSULIN
PRODUCTS.
(a) In General.--Subpart II of part A of title XXVII of the Public
Health Service Act (42 U.S.C. 300gg-11 et seq.) is amended by adding at
the end the following:
``SEC. 2729A. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN
INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after January 1,
2028, 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) Insulin.--The term `insulin' means insulin that is
licensed under subsection (a) or (k) of section 351, including
insulin deemed to be licensed under section 351 pursuant to
section 7002(e)(4) of the Biologics Price Competition and
Innovation Act of 2009, and continues to be marketed pursuant
to such licensure.
``(2) Selected insulin products.--The term `selected
insulin products' means, for any plan year beginning on or
after January 1, 2028, at least one of each dosage form and
delivery device (such as vial, pen, inhaler dosage forms, or
such other delivery devices approved by the Secretary) 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.
``(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 if
permitted under applicable law.
``(d) Rules of Construction.--Subsection (a) shall not be construed
to--
``(1) 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 that is
not a selected insulin product, to the extent that such
coverage is not otherwise required and such cost-sharing is
otherwise permitted under Federal and applicable State law; or
``(2) permit a group health plan or health insurance issuer
to pay any amount in excess of the amount specified under
section (a)(2) to an entity providing pharmaceutical benefit
management services, a provider, or a pharmaceutical
manufacturer with respect to the provision of selected insulin
products.
``(e) Application of Patient Protections.--The provisions of this
title shall apply to selected insulin product benefits described in
subsection (a) as though such benefits were required to be provided
under section 2707(a).
``(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 services to the plan or
coverage, any prior authorization or 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 plan years beginning on or after January 1, 2028,
the exemption of coverage of selected insulin products
(as defined in section 2729A of the Public Health
Service Act) from the application of any deductible
pursuant to section 2729(a)(1) of such Act shall not be
treated as increasing the actuarial value of a plan
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, 2028, a health plan described in paragraph (1) shall
provide coverage of selected insulin products, in
accordance with section 2729A 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
2729A(b) of the Public Health Service Act; and
``(ii) the requirements of section 2729A 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) Conforming Amendments.--
(1) ERISA.--Section 715(a)(1) of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1185d(a)(1)) is amended
by inserting ``and the INSULIN Act of 2026'' after ``Affordable
Care Act''.
(2) IRC.--Section 9815(a)(1) of the Internal Revenue Code
of 1986 is amended by inserting ``and the INSULIN Act of 2026''
after ``Affordable Care Act''.
SEC. 3. 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, section 2 for plan years that begin
on or after January 1, 2028, 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, section 2.
SEC. 4. GAO STUDY ON UNINSURED INDIVIDUALS WHO USE INSULIN.
The Comptroller General of the United States shall conduct a study,
in consultation with patient, clinical, and provider groups and other
experts, and not later than 2 years after the date of enactment of this
Act, issue a report, on the characteristics of uninsured individuals
who use insulin. Such study and report shall, to the extent data is
available, include consideration of--
(1) any States or regions in which there is a higher
prevalence of such individuals;
(2) any identifiable potential reasons for uninsured
status;
(3) demographic characteristics of such individuals, such
as race and ethnicity; and
(4) income level of such individuals.
SEC. 5. ENSURING TIMELY ACCESS TO GENERICS.
Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(q)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)(i), by inserting ``,
10.31,'' after ``10.30'';
(B) in subparagraph (E)--
(i) by striking ``application and'' and
inserting ``application or'';
(ii) by striking ``If the Secretary'' and
inserting the following:
``(i) In general.--If the Secretary''; and
(iii) by striking the second sentence and
inserting the following:
``(ii) Primary purpose of delaying.--
``(I) In general.--In determining
whether a petition was submitted with
the primary purpose of delaying an
application, the Secretary may consider
the following factors:
``(aa) Whether the petition
was submitted in accordance
with paragraph (2)(B), based on
when the petitioner knew the
relevant information relied
upon to form the basis of such
petition.
``(bb) When the petition
was submitted in relation to
when the petitioner reasonably
should have known the relevant
information relied upon to form
the basis of such petition.
``(cc) Whether the
petitioner has submitted
multiple or serial petitions or
supplements to petitions
raising issues that reasonably
could have been known to the
petitioner at the time of
submission of the earlier
petition or petitions.
``(dd) Whether the petition
was submitted close in time to
a known, first date upon which
an application under subsection
(b)(2) or (j) of this section
or section 351(k) of the Public
Health Service Act could be
approved.
``(ee) Whether the petition
was submitted without relevant
data or information in support
of the scientific positions
forming the basis of such
petition.
``(ff) Whether the petition
raises the same or
substantially similar issues as
a prior petition to which the
Secretary has responded
substantively already,
including if the subsequent
submission follows such
response from the Secretary
closely in time.
``(gg) Whether the petition
requests changing the
applicable standards that other
applicants are required to
meet, including requesting
testing, data, or labeling
standards that are more onerous
or rigorous than the standards
the Secretary has determined to
be applicable to the listed
drug, reference product, or
petitioner's version of the
same drug.
``(hh) The petitioner's
record of submitting petitions
to the Food and Drug
Administration that have been
determined by the Secretary to
have been submitted with the
primary purpose of delay.
``(ii) Other relevant and
appropriate factors, which the
Secretary shall describe in
guidance.
``(II) Guidance.--The Secretary may
issue or update guidance, as
appropriate, to describe factors the
Secretary considers in accordance with
subclause (I).'';
(C) by striking subparagraph (F);
(D) by redesignating subparagraphs (G) through (I)
as subparagraphs (F) through (H), respectively; and
(E) in subparagraph (G), as so redesignated, by
striking ``submission of this petition'' and inserting
``submission of this document'';
(2) in paragraph (2)--
(A) by redesignating subparagraphs (A) through (C)
as subparagraphs (C) through (E), respectively;
(B) by inserting before subparagraph (C), as so
redesignated, the following:
``(A) In general.--A person shall submit a petition
to the Secretary under paragraph (1) before filing a
civil action in which the person seeks to set aside,
delay, rescind, withdraw, or prevent submission,
review, or approval of an application submitted under
subsection (b)(2) or (j) of this section or section
351(k) of the Public Health Service Act. Such petition
and any supplement to such a petition shall describe
all information and arguments that form the basis of
the relief requested in any civil action described in
the previous sentence.
``(B) Timely submission of citizen petition.--A
petition and any supplement to a petition shall be
submitted within 180 days after the person knew the
information that forms the basis of the request made in
the petition or supplement.'';
(C) in subparagraph (C), as so redesignated--
(i) in the heading, by striking ``within
150 days'';
(ii) in clause (i), by striking ``during
the 150-day period referred to in paragraph
(1)(F),''; and
(iii) by amending clause (ii) to read as
follows:
``(ii) on or after the date that is 151
days after the date of submission of the
petition, the Secretary approves or has
approved the application that is the subject of
the petition without having made such a final
decision.'';
(D) by amending subparagraph (D), as so
redesignated, to read as follows:
``(D) Dismissal of certain civil actions.--
``(i) Petition.--If a person files a civil
action against the Secretary in which a person
seeks to set aside, delay, rescind, withdraw,
or prevent submission, review, or approval of
an application submitted under subsection
(b)(2) or (j) of this section or section 351(k)
of the Public Health Service Act without
complying with the requirements of subparagraph
(A), the court shall dismiss without prejudice
the action for failure to exhaust
administrative remedies.
``(ii) Timeliness.--If a person files a
civil action against the Secretary in which a
person seeks to set aside, delay, rescind,
withdraw, or prevent submission, review, or
approval of an application submitted under
subsection (b)(2) or (j) of this section or
section 351(k) of the Public Health Service Act
without complying with the requirements of
subparagraph (B), the court shall dismiss with
prejudice the action for failure to timely file
a petition.
``(iii) Final response.--If a civil action
is filed against the Secretary with respect to
any issue raised in a petition timely filed
under paragraph (1) in which the petitioner
requests that the Secretary take any form of
action that could, if taken, set aside, delay,
rescind, withdraw, or prevent submission,
review, or approval of an application submitted
under subsection (b)(2) or (j) of this section
or section 351(k) of the Public Health Service
Act before the Secretary has taken final agency
action on the petition within the meaning of
subparagraph (C), the court shall dismiss
without prejudice the action for failure to
exhaust administrative remedies.''; and
(E) in clause (iii) of subparagraph (E), as so
redesignated, by striking ``as defined under
subparagraph (2)(A)'' and inserting ``within the
meaning of subparagraph (C)''; and
(3) in paragraph (4)--
(A) by striking ``Exceptions'' in the paragraph
heading and all that follows through ``This subsection
does'' and inserting ``Exceptions.--This subsection
does'';
(B) by striking subparagraph (B); and
(C) by redesignating clauses (i) and (ii) as
subparagraphs (A) and (B), respectively, and adjusting
the margins accordingly.
SEC. 6. EXPEDITING BIOSIMILAR COMPETITION.
(a) In General.--Section 351(k) of the Public Health Service Act
(42 U.S.C. 262(k)) is amended by adding at the end the following:
``(10) Expediting biosimilar competition.--
``(A) In general.--The Secretary may, at the
request of the sponsor of an application under this
subsection for licensure of a biosimilar biological
product that is designated as a competitive biosimilar
biological product pursuant to subparagraph (B),
expedite the development and review of such application
under this subsection.
``(B) Designation process.--
``(i) Request.--The sponsor of an
application under this subsection may request
the Secretary to designate the drug as a
competitive biosimilar biological product. A
request for such designation may be made
concurrently with, or during the 60-day period
immediately prior to, the submission of a
biosimilar biological product license
application under this subsection.
``(ii) Criteria.--A biosimilar biological
product is eligible for designation as a
competitive biosimilar biological product under
this paragraph if the Secretary determines that
there is inadequate biosimilar competition.
``(iii) Designation.--Not later than 60
calendar days after the receipt of a request
under clause (i), the Secretary may--
``(I) determine whether the
biosimilar biological product that is
the subject of the request meets the
criteria described in clause (ii); and
``(II) if the Secretary finds that
such product meets such criteria,
designate the biosimilar biological
product as a competitive biosimilar
biological product.
``(C) Inadequate biosimilar competition.--In this
paragraph, the term `inadequate biosimilar competition'
means that, with respect to a biological product
licensed under subsection (a)--
``(i) on the list published under paragraph
(9)(A) (not including biological products on
the discontinued section of such list), there
are fewer than 3 biological products licensed
under this subsection pursuant to an
application that uses such biological product
licensed under subsection (a) as a reference
product; and
``(ii) not less than 3 years have passed
since the expiration of all exclusivity periods
applicable to such biological product licensed
under subsection (a), or applicable to a
biosimilar biological product licensed under
this subsection using such biological product
licensed under subsection (a) as a reference
product, including any exclusivity periods
under--
``(I) paragraph (6);
``(II) paragraph (7)(A);
``(III) section 527 of the Federal
Food, Drug, and Cosmetic Act; and
``(IV) subsection (m).''.
SEC. 7. PILOT PROGRAM FOR PROVIDING AFFORDABLE INSULIN TO UNINSURED
INDIVIDUALS.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following:
``SEC. 399V-8. PILOT PROGRAM FOR PROVIDING AFFORDABLE INSULIN TO
UNINSURED INDIVIDUALS.
``(a) In General.--The Secretary shall conduct a 5-year pilot
program under which the Secretary awards grants to 10 States for
purposes of providing affordable insulin to uninsured individuals.
``(b) Awards.--The Secretary shall award grants under this section
to 10 States that--
``(1) submit an application to the Secretary, at such time,
in such manner, and containing such information as the
Secretary may require; and
``(2) have high rates of uninsured individuals and
individuals diagnosed with diabetes, which may include high
rates of newly diagnosed diabetes.
``(c) Use of Funds.--A State shall use the grant funds received
under this section for any of the following purposes:
``(1) To assist in the purchase or dispensing of insulin,
through Federally-qualified health centers and retail community
pharmacies, for uninsured individuals.
``(2) To provide assistance to individuals in programs
under which drug manufacturers provide financial or medication
assistance to low-income individuals, in order to assist such
individuals in obtaining insulin.
``(3) To support Federally-qualified health centers in
establishing new, or maintaining or expanding existing, on-site
pharmacies owned and operated by the health center that provide
low-cost insulin to patients, and to support retail community
pharmacies in providing low-cost insulin to patients.
``(4) To engage in other activities to assist uninsured
individuals in obtaining insulin, as the Secretary determines
appropriate.
``(d) Formula.--The Secretary shall establish a formula for
purposes of determining the grant amount under this section for each
State. Such formula shall--
``(1) provide for a minimum amount that will be provided to
each State; and
``(2) take into account the rates of individuals with type
1 or type 2, insulin-dependent diabetes and the number of
uninsured individuals in each State for purposes of determining
any additional amounts provided to a State.
``(e) Accountability and Oversight.--A State receiving a grant
under this section shall, not later than 1 year after receiving the
grant, submit a report to the Secretary that includes--
``(1) a description of the purposes for which the grant
funds received by the State were expended in the preceding
fiscal year, and the activities of the State under the grant
during such year; and
``(2) the number of individuals served through the grant.
``(f) Definitions.--In this section:
``(1) Affordable.--The term `affordable', with respect to
insulin, means that the out-of-pocket cost to the individual
for the insulin is not more than $35 per 1-month supply.
``(2) Federally-qualified health center.--The term
`Federally-qualified health center' has the meaning given such
term in section 1905(l)(2) of the Social Security Act.
``(3) Insulin.--The term `insulin' means insulin that is
licensed under subsection (a) or (k) of section 351 and
continues to be marketed under such section.
``(4) Retail community pharmacy.--The term `retail
community pharmacy' has the meaning given such term in section
1927(k)(10) of the Social Security Act.
``(5) Uninsured individual.--The term `uninsured
individual' means an individual who--
``(A) is a citizen of the United States or a
qualified alien (as defined in section 431(b) of the
Personal Responsibility and Work Opportunity
Reconciliation Act of 1996); and
``(B) is not enrolled in coverage under a Federal
health care program (as defined in section 1128B(f) of
the Social Security Act), the health program
established under chapter 89 of title 5, United States
Code, or a group health plan or group health insurance
coverage (as defined in section 2791).
``(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $100,000,000 for fiscal year
2027, to remain available until expended.''.
SEC. 8. INSULIN RESOURCE CENTER AND HOTLINE FOR UNINSURED INDIVIDUALS.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall award a grant
to an eligible entity for purposes of--
(1) establishing and maintaining a resource center of
assistance programs offered by manufactures or other entities
that are available to uninsured individuals seeking affordable
insulin; and
(2) conducting the public education activities described in
subsection (c)(7).
(b) Eligible Entities.--To be eligible to receive the grant under
subsection (a), an entity shall--
(1) be a trade, industry, or professional association,
community- and consumer-focused nonprofit entity, or other
entity, as determined by the Secretary, that--
(A) is capable of carrying out the duties described
in subsection (c);
(B) meets the standards described in subsection
(e); and
(C) provides information consistent with the
standards developed under subsection (e); and
(2) submit an application to the Secretary, at such time,
in such manner, and containing such information as the
Secretary may require, including information demonstrating that
the entity--
(A) has existing relationships, or could readily
establish relationships, with consumers (including
uninsured individuals), health care providers,
manufacturers of insulin, social service providers,
pharmacies, and other experts that the Secretary
determines appropriate, to meet the goals of this
section; and
(B) has, or will establish, partnerships with, and
solicit feedback from, other entities in other
industries, professional associations, and community-
and consumer-focused nonprofit organizations, to meet
the goals of this section.
(c) Duties.--An entity that receives a grant under this section
shall--
(1) distribute fair and impartial information concerning
eligibility for manufacturer, foundational, and other
assistance programs available to patients seeking affordable
insulin;
(2) facilitate enrollment in manufacturer assistance
programs or other assistance programs for uninsured
individuals;
(3) make available to the public, through a standardized
website, a clearinghouse of support available to patients,
including--
(A) a link to Federally-qualified health centers
and other providers, by ZIP Code;
(B) a link to retail community pharmacies, by ZIP
Code; and
(C) information about how to enroll in health
insurance;
(4) provide information in a manner that is culturally and
linguistically appropriate;
(5) establish a hotline through which individuals may reach
experts with questions about access to insulin, and that--
(A) is a 24/7 real-time hotline;
(B) provides voice and text support; and
(C) is staffed by navigators or licensed health
care professionals;
(6) provide guidance to hospitals on how to share the
website and hotline with patients; and
(7) conduct public education activities, in collaboration
with the Department of Health and Human Services, to raise
awareness of the availability of all manufacturer,
foundational, and other assistance programs available to
patients seeking affordable insulin, with a focus on uninsured
individuals, including by--
(A) partnering with community health centers,
hospitals, retail community pharmacies, and community-
based organizations with a focus on access to
affordable medicine; and
(B) working with State and local health departments
to target the programs carried out using the grant to
underserved communities.
(d) Duties of the Secretary.--The Secretary shall--
(1) ensure adequate maintenance of the resource center
established by the entity receiving a grant under subsection
(a);
(2) publicize such resource center on the website of the
Department of Health and Human Services and across Federal
agencies, as the Secretary determines appropriate; and
(3) ensure that such resource center meets the standards
under subsection (e), and withdraw the grant and make an award
to a different eligible entity in the case that an eligible
entity fails to meet such standards.
(e) Standards.--The Secretary shall establish standards for the
resource center under this section, including provisions to ensure that
the entity receiving a grant under this section is qualified to engage
in the activities described in this section and to avoid conflicts of
interest. Under such standards, such entity--
(1) shall not--
(A) be a manufacturer of insulin products; or
(B) receive any consideration directly or
indirectly from any manufacturer of insulin products in
connection with the enrollment of any individuals in an
assistance program; and
(2) shall provide information that is fair, accurate, and
impartial.
(f) Data Collection and Evaluations.--The Secretary may collect
data and conduct evaluations with respect to the services provided by
the resource center described in this section for purposes of assessing
the extent to which the provision of the services--
(1) reduces out of pocket insulin costs for uninsured
individuals;
(2) increases awareness of assistance programs or
foundational support available for uninsured individuals; and
(3) improves utilization of the resources described in
paragraph (2) by uninsured individuals.
(g) Reports to Congress.--The Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions and the Committee
on Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives, and make publicly available, annual reports on the
activities carried out under this section, including any changes in the
availability or scope of assistance programs offered by insulin
manufacturers and information about the number of individuals who use
the resource center, including the website or hotline.
(h) Definitions.--In this section--
(1) the term ``assistance program'' means a program to
assist patients in obtaining a drug at a reduced cost, and
includes third-party payments, financial assistance, discounts,
product vouchers, and other reductions in out-of-pocket
expenses;
(2) the term ``Federally-qualified health center'' has the
meaning given such term in section 1905(l)(2) of the Social
Security Act (42 U.S.C. 1396d(l)(2));
(3) 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;
(4) the term ``retail community pharmacy'' has the meaning
given such term in section 1927(k)(10) of the Social Security
Act (42 U.S.C. 1396r-8(k)(10)); and
(5) the term ``uninsured individual'' means an individual
who is not enrolled in coverage under a Federal health care
program (as defined in section 1128B(f) of the Social Security
Act (42 U.S.C. 1320a-7b(f))), the health program established
under chapter 89 of title 5, United States Code, or a group
health plan or group health insurance coverage (as defined in
section 2791 of the Public Health Service Act (42 U.S.C. 300gg-
91)).
(i) Funding.--To carry out this section, there are authorized to be
appropriated $2,000,000 for each of fiscal years 2027 through 2032.
Calendar No. 552
119th CONGRESS
2d Session
S. 4189
_______________________________________________________________________
A BILL
To reduce the price of insulin and provide for patient protections with
respect to the cost of insulin.
_______________________________________________________________________
August 7, 2026
Reported with an amendment