[Congressional Record Volume 172, Number 106 (Wednesday, June 24, 2026)]
[Senate]
[Pages S3285-S3289]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 6075. Mrs. SHAHEEN (for herself, Ms. Collins, Mr. Warnock, and Mr.
Kennedy) submitted an amendment intended to be proposed by her to the
bill S. 4784, to authorize appropriations for fiscal year 2027 for
military activities of the Department of Defense, for military
construction, and for defense activities of the Department of Energy,
to prescribe military personnel strengths for such fiscal year, and for
other purposes; which was ordered to lie on the table; as follows:
At the end of title X, add the following:
Subtitle H--Insulin Act
SEC. 1099. SHORT TITLE; SENSE OF CONGRESS.
(a) Short Title.--This subtitle may be cited as the
``Improving Needed Safeguards for Users of Lifesaving Insulin
Now Act of 2026'' or the ``INSULIN Act of 2026''.
(b) 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 subtitle.
CHAPTER 1--COMMERCIAL MARKET PATIENT PROTECTIONS
SEC. 1099A. 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
[[Page S3286]]
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. 1099A-1. 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 ``and 726'' and inserting ``726, and 727''.
(b) IRC.--The Internal Revenue Code of 1986 is amended--
(1) in section 9831(a)(2), by striking ``section 9826'' and
inserting ``sections 9826 and 9827''; and
(2) in section 4980D(d)(1), by striking ``section 9811''
and inserting ``section 9811 or 9827''.
SEC. 1099A-2. 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 chapter 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 chapter.
CHAPTER 2--PHARMACY BENEFIT MANAGER TRANSPARENCY AND REBATE REFORM
SEC. 1099B. 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 1099A, 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 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.
``(b) Form and Manner of Remittance.--Such rebates, fees,
alternative discounts, and other remuneration shall be--
``(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;
``(2) fully disclosed and enumerated to the group health
plan sponsor; and
``(3) available for audit by the plan sponsor, or a third-
party designated by a plan sponsor no less than once per plan
year.''.
(b) 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.), as amended by section 1099A, is further
amended by adding at the end the following:
``SEC. 728. 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 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.
``(b) Form and Manner of Remittance.--Such rebates, fees,
alternative discounts, and other remuneration shall be--
``(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;
``(2) fully disclosed and enumerated to the group health
plan sponsor; and
``(3) available for audit by the plan sponsor, or a third-
party designated by a plan sponsor no less than once per plan
year.''.
(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 1099A, is further
amended by inserting after the item relating to section 727
the following:
``Sec. 728. Full rebate on insulin pass-through to plan.''.
(c) Internal Revenue Code.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986, as amended by section 1099A,
is further amended by adding at the end the following new
section:
``SEC. 9828. FULL REBATE ON INSULIN PASS-THROUGH TO PLAN.
``(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.
``(b) Form and Manner of Remittance.--Such rebates, fees,
alternative discounts, and other remuneration shall be--
``(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;
``(2) fully disclosed and enumerated to the group health
plan sponsor; and
``(3) available for audit by the plan sponsor, or a third-
party designated by a plan sponsor no less than once per plan
year.''.
(2) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of such Code, as amended by
section 1099A, is further amended by adding at the end the
following new item:
``Sec. 9828. Full rebate on insulin pass-through to plan.''.
[[Page S3287]]
CHAPTER 3--BIOSIMILAR BIOLOGICAL PRODUCT AND GENERIC DRUG COMPETITION
AND AFFORDABILITY
SEC. 1099C. 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 or
reasonably should have known the relevant information relied
upon to form the basis of such petition.
``(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.
``(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.
``(dd) Whether the petition was submitted without relevant
data or information in support of the scientific positions
forming the basis of such petition.
``(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.
``(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.
``(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.
``(hh) 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 adding at the end the following:
``(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.'';
(D) by striking subparagraph (F);
(E) by redesignating subparagraphs (G) through (I) as
subparagraphs (F) through (H), respectively; and
(F) in subparagraph (H), 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 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.'';
(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'' 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. 1099C-1. EXPEDITING COMPETITIVE 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 competitive biosimilar competition.--
``(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.
``(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 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.
``(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.
``(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 therapy.
``(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:
``(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.
``(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.
``(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.
``(iv) Assign a cross-disciplinary project lead--
``(I) to facilitate an efficient review of the development
program and application, including manufacturing inspections;
and
``(II) to serve as a scientific liaison between the review
team and the applicant.
``(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
[[Page S3288]]
about the response of the applicant and whether to approve
the application.
``(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.
``(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.''.
SEC. 1099C-2. INSULIN COMPETITION REPORT.
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--
(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--
(A) placement of biosimilar biological products on health
insurance formularies;
(B) market entry of insulin product in the United States,
as compared to other highly developed nations; and
(C) patient and provider education around biosimilar
biological products; and
(2) submit a report to Congress that describes the results
of the study conducted pursuant to paragraph (1) and
recommended policy solutions.
CHAPTER 4--PROGRAMS FOR PROVIDING AFFORDABLE INSULIN TO UNINSURED
INDIVIDUALS
SEC. 1099D. 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 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.
``(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.
``(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 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);
``(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
``(C) is not entitled to a premium assistance tax credit
under section 36B of the Internal Revenue Code of 1986.
``(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. 1099D-1. GAO STUDY ON UNINSURED INDIVIDUALS WHO USE
INSULIN.
(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--
(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.
(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 1099D.
SEC. 1099D-2. 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 (f); 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
[[Page S3289]]
(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--
(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
(B) is not entitled to a premium assistance tax credit
under section 36B of the Internal Revenue Code of 1986.
(i) Funding.--To carry out this section, there are
authorized to be appropriated $2,000,000 for each of fiscal
years 2027 through 2032.
______