[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1941 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 1941
To require the Secretary of Health and Human Services to carry out
activities to eliminate hepatitis C virus in the United States.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 4, 2025
Mr. Cassidy (for himself and Mr. Van Hollen) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To require the Secretary of Health and Human Services to carry out
activities to eliminate hepatitis C virus in the United States.
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 ``Cure Hepatitis C Act of 2025''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Correctional facility.--The term ``correctional
facility'' has the meaning given that term in section 901 of
title I of the Omnibus Crime Control and Safe Streets Act of
1968 (34 U.S.C. 10251).
(2) Hepatitis c treatment.--The term ``hepatitis C
treatment'' means a direct acting antiviral drug approved under
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) for the treatment of hepatitis C virus infection.
(3) Indian health program.--The term ``Indian health
program'' has the meaning given the term in section 4 of the
Indian Health Care Improvement Act (25 U.S.C. 1603).
(4) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(5) State.--The term ``State'' means--
(A) each of the several States of the United
States;
(B) the District of Columbia;
(C) the Commonwealth of Puerto Rico;
(D) Guam;
(E) American Samoa;
(F) the Commonwealth of the Northern Mariana
Islands;
(G) the Federated States of Micronesia;
(H) the Republic of the Marshall Islands;
(I) the Republic of Palau; and
(J) the United States Virgin Islands.
(6) State or local correctional system.--The term ``State
or local correctional system'' means a department, agency, or
other instrumentality of a State or unit of local government
(as such term is defined in section 901 of title I of the
Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C.
10251)) that operates or contracts for the operation of 1 or
more correctional facilities.
SEC. 3. HEPATITIS C ELIMINATION PROGRAM.
(a) Establishment.--Not later than 90 days after the date of
enactment of this Act, the Secretary shall establish a program, to be
known as the ``Hepatitis C Elimination Program'' (referred to in this
section as the ``Program''), under which the Secretary shall coordinate
activities under this Act for the purposes of eliminating hepatitis C
virus.
(b) Strategy and Implementation Plan.--Not later than 180 days
after the date of enactment of this Act, the Secretary shall issue a
national strategy and implementation plan to carry out activities under
this Act, including--
(1) a description of priority populations that experience
higher rates of hepatitis C virus infection and related adverse
health outcomes;
(2) an inventory of all relevant Federal strategies, plans,
policies, and programs relating to hepatitis C virus, including
an assessment of any gaps within, or areas of duplication
between, such strategies, plans, policies, and programs;
(3) specific goals, objectives, and strategies to improve
the prevention, detection, and treatment of hepatitis C virus
in order to achieve the goals of the Program; and
(4) performance metrics to assess progress toward achieving
each goal, strategy, and objective identified under paragraph
(3).
(c) Advisory Committee.--
(1) In general.--The Secretary shall establish an advisory
committee to advise the Secretary with respect to the Program.
(2) Membership.--The advisory committee established under
paragraph (1) shall be composed of--
(A) individuals with lived experience with
hepatitis C virus;
(B) clinicians;
(C) State and local public health officials;
(D) pharmacists;
(E) representatives of drug and diagnostic test
manufacturers;
(F) representatives of health plans and health
insurance issuers; and
(G) others individuals engaged in the Program.
(d) Interagency Working Group.--
(1) In general.--The Secretary shall establish an
interagency working group to support the development,
implementation, evaluation, and improvement of the Program.
(2) Membership.--The interagency working group shall
include the following individuals or their designees:
(A) The Director of the Centers for Disease Control
and Prevention.
(B) The Administrator of the Health Resources and
Services Administration.
(C) The Administrator of the Centers for Medicare &
Medicaid Services.
(D) The Assistant Secretary for Mental Health and
Substance Use.
(E) The Director of the Indian Health Service.
(F) The Commissioner of Food and Drugs.
(G) The Assistant Secretary for Health.
(H) The Director of the Bureau of Prisons.
(I) The heads of such other relevant Federal
departments and agencies, as the Secretary designates.
(e) Hepatitis C Dashboard.--The Secretary shall establish and
maintain a publicly available dashboard for purposes of monitoring
progress toward achieving the goals of the Program, including
performance metrics established pursuant to subsection (b)(4).
(f) Stakeholder Engagement.--In carrying out this Act, the
Secretary shall consult with all relevant stakeholders, which may
include through public meetings, publication of notices in the Federal
Register, and other strategies.
(g) Reports.--Not later than 90 days after the date of issuance of
the strategy and implementation plan under subsection (b), and annually
thereafter until September 30, 2032, the Secretary shall submit to the
Committees on Finance, Health, Education, Labor, and Pensions and
Appropriations of the Senate and the Committees on Energy and Commerce,
Ways and Means, and Appropriations of the House of Representatives a
report that describes the progress of activities carried out under this
Act and the amendments made by this Act.
SEC. 4. PROVISION OF HEPATITIS C TREATMENTS TO CERTAIN POPULATIONS.
(a) Definitions.--In this section:
(1) Covered population.--The term ``covered population''
means the population of individuals determined under subsection
(b)(2).
(2) Minimum essential coverage.--The term ``minimum
essential coverage'' means health insurance coverage under a
public or private plan that constitutes minimum essential
coverage under section 5000A(f)(1) of the Internal Revenue Code
of 1986.
(3) Participating state or local correctional system.--The
term ``participating State or local correctional system'' means
a State or local correctional system that opts to participate
in the program under subsection (b)(3)(A).
(4) Program.--The term ``program'' means the subscription
program for hepatitis C treatments established under subsection
(b)(1).
(5) Registered pharmacy; registered site of dispensing.--
The terms ``registered pharmacy'' and ``registered site of
dispensing'' mean a pharmacy or site of dispensing,
respectively, that enters into an agreement with the Secretary
under subsection (b)(5)(B).
(b) Subscription Program for Purchase of Hepatitis C Treatments for
Covered Populations.--
(1) Establishment.--
(A) In general.--The Secretary shall establish a
subscription program for hepatitis C treatments under
which--
(i) the Secretary--
(I) shall enter into agreements
with 1 or more drug manufacturers for
the purchase of hepatitis C treatments
under a subscription model described in
paragraph (4); and
(II) shall provide for the
distribution of hepatitis C treatments
purchased under such agreements among
registered pharmacies and registered
sites of dispensing, participating
State and local correctional systems,
the Bureau of Prisons, and facilities
of the Indian Health Service, in
accordance with paragraph (5); and
(ii) each individual within the covered
population, in receiving hepatitis C treatments
that were purchased under such an agreement, is
entitled to receive the treatments without
cost-sharing.
(B) Program prohibition.--
(i) In general.--Health care providers,
pharmacies, and sites of dispensing shall not
utilize any other Federal drug discount
program, including the drug discount program
under section 340B of the Public Health Service
Act (42 U.S.C. 256b), with respect to hepatitis
C treatments obtained through the program.
(ii) Enforcement.--To ensure compliance
with clause (i), the Secretary shall--
(I) ensure that relevant data,
including data on health care
providers, pharmacies, manufacturers,
and sites of dispensing participating
in the program, is available for
administration of the drug discount
program under such section 340B;
(II) provide necessary resources,
from the amounts made available to the
Secretary under this section, to carry
out program audit, oversight, and
administrative activities;
(III) supplement existing audit
guidance issued pursuant to section
340B(a)(5)(C) of the Public Health
Service Act (42 U.S.C. 256b(a)(5)(C))
to give notice to relevant health care
providers, pharmacies, and sites of
dispensing related to the prohibition
and its enforcement; and
(IV) audit, at the Secretary's
expense, the records of any
participating health care provider or
registered pharmacy or registered site
of dispensing to ensure compliance with
the requirements under this subsection.
(C) Effect.--Nothing in this paragraph shall
prohibit a covered entity (as defined in section
340B(a)(4) of the Public Health Service Act (42 U.S.C.
256b(a)(4))) that receives hepatitis C treatments under
the program from purchasing hepatitis C treatments
pursuant to an agreement under section 340B(a)(1) of
such Act (42 U.S.C. 256b(a)(1)), provided that such
covered entity complies with section (B)(i).
(2) Covered population.--
(A) In general.--Subject to subparagraph (B), the
covered population of individuals entitled to receive
hepatitis C treatment under the program in accordance
with paragraph (1)(A)(ii) is composed of individuals
who have been diagnosed with hepatitis C infection and
who--
(i) subject to paragraph (3)(A)--
(I) are enrolled in medical
assistance under a State Medicaid
program that is participating in the
program;
(II) are enrolled in child health
assistance or pregnancy-related
assistance under a State CHIP program
that is participating in the program;
or
(III)(aa) are confined in a
correctional facility operated by or on
behalf of a participating State or
local correctional system; or
(bb) were confined in a
correctional facility operated by or on
behalf of a participating State or
local correctional system, and who, at
the time of release from confinement,
had started but not completed a course
of hepatitis C treatment;
(ii)(I) are confined in a facility operated
by or on behalf of the Bureau of Prisons; or
(II) were confined in a facility operated
by or on behalf of the Bureau of Prisons, and
who, at the time of release from confinement,
had started but not completed a course of
hepatitis C treatment;
(iii) are without minimum essential
coverage; or
(iv) receive health care services through
an Indian health program.
(B) Requirements.--
(i) Medicaid and chip.--In the case of an
individual described in subclause (I) or (II)
of subparagraph (A)(i), the State Medicaid or
CHIP program, as applicable, shall coordinate
with registered pharmacies and registered sites
of dispensing to verify such individual's
enrollment in the State Medicaid program or
State CHIP program, as applicable, before the
dispensing of a hepatitis C treatment to the
individual in accordance with paragraph
(1)(A)(ii).
(ii) Bureau of prisons.--The Director of
the Bureau of Prisons shall issue a policy
regarding determining which individuals in the
custody of the Bureau of Prisons are eligible
to receive hepatitis C treatment in accordance
with paragraph (1)(A)(ii).
(iii) Individuals without minimum essential
coverage.--
(I) In general.--In the case of an
individual described in subparagraph
(A)(iii), a health care provider
designated under subclause (II) shall--
(aa) assess whether such
individual qualifies as an
individual without minimum
essential coverage; and
(bb) if such individual
qualifies as an individual
without minimum essential
coverage, authorize such
individual to receive hepatitis
C treatment in accordance with
paragraph (1)(A)(ii).
(II) Designation of health care
providers.--The Secretary, in
consultation with State public health
departments, shall designate health
care providers for purposes of
subclause (I).
(III) List.--For purposes of
verifying whether an individual is
authorized under subclause (I)(bb), the
Secretary shall maintain, and make
available to registered pharmacies and
registered sites of dispensing that are
dispensing hepatitis C treatment under
the program, a list of health care
providers designated under subclause
(II).
(IV) Guidance.--The Secretary shall
issue guidance for health care
providers designated under subclause
(II) to make determinations under
subclause (I)(aa) based on relevant
best practices from the program under
title XXVI of the Public Health Service
Act (42 U.S.C. 300ff-11 et seq.;
commonly referred to as the ``Ryan
White