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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 10227 Introduced in House (IH)]
<DOC>
119th CONGRESS
2d Session
H. R. 10227
To reduce the price of insulin and provide for patient protections with
respect to the cost of insulin.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 2, 2026
Ms. DeGette (for herself, Mrs. Miller-Meeks, Ms. Schrier, Mr.
Bresnahan, and Ms. Craig) introduced the following bill; which was
referred to the Committee on Energy and Commerce, and in addition to
the Committees on Ways and Means, and Education and Workforce, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To reduce the price of insulin and provide for patient protections with
respect to the cost of insulin.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
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) 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.
``(2) 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.
``(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 plans 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, this title 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, this title.
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. 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
(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.
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).''.
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