[Congressional Record Volume 171, Number 112 (Saturday, June 28, 2025)]
[Senate]
[Pages S4008-S4011]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2561. Mrs. SHAHEEN submitted an amendment intended to be proposed
to amendment SA 2360 proposed by Mr. Thune (for Mr. Graham) to the bill
H.R. 1, to provide for reconciliation pursuant to title II of H. Con.
Res. 14; which was ordered to lie on the table; as follows:
Strike section 70523 and insert the following:
SEC. __. 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-11. REQUIREMENTS WITH RESPECT TO COST-SHARING
FOR CERTAIN INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after
January 1, 2026, 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, 2027, $35; or
``(B) for any plan year beginning on or after January 1,
2027, 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, 2026, 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 coverage 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, 2027, the exemption of
coverage of selected insulin products (as defined in section
2799A-11(b) of the Public Health Service Act) from the
application of any deductible pursuant to section 2799A-
11(a)(1) of such Act, section 726(a)(1) of the Employee
Retirement Income Security Act of 1974, or section 9826(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), a
health plan described in paragraph (1) shall provide coverage
of selected insulin products, in accordance with section
2799A-11 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-11(b) of the Public Health
Service Act; and
``(ii) the requirements of section 2799A-11 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
[[Page S4009]]
seq.) is amended by adding at the end the following:
``SEC. 726. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR
CERTAIN INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after
January 1, 2026, 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, 2027, $35; or
``(B) for any plan year beginning on or after January 1,
2027, 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, 2026, 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 coverage from imposing cost-sharing
other than the levels specified in subsection (a) on, insulin
products that are not selected insulin products, to the
extent that such coverage is not otherwise required and such
cost-sharing is otherwise permitted under Federal and
applicable State law.
``(e) Application of Cost-Sharing Towards Deductibles and
Out-of-Pocket Maximums.--Any cost-sharing payments made
pursuant to subsection (a)(2) shall be counted toward any
deductible or out-of-pocket maximum that applies under the
plan or coverage.
``(f) Other Requirements.--A group health plan or health
insurance issuer offering group health insurance coverage
shall not impose, directly or through an entity providing
pharmacy benefit management services, any prior authorization
or other medical management requirement, or other similar
conditions, on selected insulin products, except as
clinically justified for safety reasons, to ensure reasonable
quantity limits and as specified by the Secretary.''.
(2) Clerical amendment.--The table of contents in section 1
of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1001 et seq.) is amended by inserting after the item
relating to section 725 the following:
``Sec. 726. 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 new section:
``SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR
CERTAIN INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after
January 1, 2026, 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, 2027, $35; or
``(B) for any plan year beginning on or after January 1,
2027, 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, 2026, 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, as amended by this
Act, is further amended by adding at the end the following
new item:
``Sec. 9827. Requirements with respect to cost-sharing for certain
insulin products.''.
SEC. __. APPLICATION TO RETIREE AND CERTAIN SMALL GROUP
PLANS.
(a) ERISA.--Section 732(a) of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1191a(a)) is amended
by striking ``section 711'' and inserting ``sections 711 and
726''.
(b) IRC.--The Internal Revenue Code of 1986 is amended--
(1) in section 9831(a), by adding at the end the following
flush text:
``Paragraph (2) shall not apply to the requirements under
sections 9811 and 9826.''; and
(2) in section 4980D(d)(1), by striking ``section 9811''
and inserting ``sections 9811 and 9826''.
SEC. ___. ADMINISTRATION.
(a) Implementation.--Notwithstanding any other provision of
law, the Secretary of Health and Human Services, the
Secretary of Labor, and the Secretary of the Treasury may
implement the provisions of, including the amendments made
by, this title for plan years that begin on or after January
1, 2026, and end not later than January 1, 2029, by
subregulatory guidance, program instruction, or otherwise.
(b) Non-Application of the Paperwork Reduction Act.--
Chapter 35 of title 44, United States Code (commonly referred
to as the ``Paperwork Reduction Act of 1995''), shall not
apply to the provisions of, including the amendments made by,
this title.
SEC. ___. FULL REBATE ON INSULIN PASS-THROUGH TO PLAN.
Part A of title XXVII of the Public Health Service Act (42
U.S.C. 300gg et seq.) is further amended by adding at the end
the following:
``SEC. 2729A. 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.''.
SEC. __. 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'';
[[Page S4010]]
(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. __. 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 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
[[Page S4011]]
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. ___. 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.
______