[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,S 1941 - 119
Introduced in Senate
Cure Hepatitis C Act of 2025
22
Sections
4
Dollar amounts
5
Deadlines and effective dates
Jun 4, 2025
Text version date
Largest fiscal amounts
5500000000 USD 1
4283000000 USD 1
25000000 USD 1
20000000 USD 1
Top affected agencies
Secretary of Health and Human Services to carry out 2
Administrator of the Centers for Medicare 1
Administrator of the Health Resources and 1
Secretary of Health and Human 1
Top statutory references
8 U.S.C. 1101 8
42 U.S.C. 256b 3
42 U.S.C. 300ff-11 3
6 U.S.C. 279 2
8 U.S.C. 1157 2
8 U.S.C. 1522 2
21
U.S.C. 355 1
21 U.S.C. 856 1
Deadline phrases
Not later than 3
effective date 1
not later than 1
Official PDF
Open official PDFStructured text
Sec. 1.
SECTION 1. SHORT TITLE.
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Cure Hepatitis C Act of 2025''.Sec. 2.
SEC. 2. DEFINITIONS.
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 underSec. 505
section 505 of the Federal Food, Drug, and Cosmetic Act (21
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.
SEC. 3. HEPATITIS C ELIMINATION PROGRAM.
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 thisSec. as
section as the ``Program''), under which the Secretary shall coordinate
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.
SEC. 4. PROVISION OF HEPATITIS C TREATMENTS TO CERTAIN POPULATIONS.
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 anyparticipating 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 minimumessential 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 HIV/AIDS Program'') and the
program under section 1928 of the
Social Security Act (42 U.S.C. 1396s;
commonly referred to as the ``Vaccines
for Children program'').
(iv) Indian health service.--The Director
of the Indian Health Service shall issue a
policy regarding determining which individuals
described in subparagraph (A)(iv) are eligible
to receive hepatitis C treatment in accordance
with paragraph (1)(A)(ii).
(3) Program participation.--
(A) In general.--Each State Medicaid or CHIP agency
or State or local correctional system that seeks to
participate in the program shall--
(i) for the applicable covered population
described in subclauses (I) through (III) of
paragraph (2)(A)(i), opt into the program by
notifying the Secretary by the end of such
reasonable period as the Secretary may
establish;
(ii) submit to the Secretary a letter of
intent for participation for the 5-year term of
the agreement entered into under paragraph (4);
(iii) agree to not impose prior
authorization requirements for screening and
treatment for hepatitis C virus with respect to
hepatitis C treatments obtained pursuant to the
program;
(iv) in the case of a State or local
correctional system, agree to provide to
individuals described in paragraph
(2)(A)(i)(III), upon release from confinement--
(I) the remainder of the course of
hepatitis C treatment; and
(II) a referral to ongoing care;
and
(v) agree to such other conditions relating
to participation in the program as the
Secretary may establish.
(B) Required participation.--The Bureau of Prisons
and the Indian Health Service shall participate in the
program.
(C) Correctional facilities operated on behalf of
participating state or local correctional systems.--AState or local correctional system that seeks to
participate in the program shall agree to provide
hepatitis C treatment to an individual in the covered
population who is or was confined in a correctional
facility operated by or on behalf of the State or local
correctional system.
(4) Procurement of hepatitis c drugs.--
(A) In general.--The Secretary shall enter into an
agreement with 1 or more drug manufacturers for the
purchase of hepatitis C treatments under a subscription
model described in subparagraph (B).
(B) Subscription model described.--Under a
subscription model described in this subparagraph, the
Secretary shall enter into an agreement under which 1
or more drug manufacturers agree to provide as many
units of hepatitis C treatment as the Secretary
requires for the term of the agreement for an amount
specified in the agreement, to be paid annually for the
term of the agreement.
(C) Term.--The term of an agreement under
subparagraph (A) shall be 5 years.
(D) Solicitation of bids.--
(i) In general.--Subject to clause (ii), in
seeking to enter into an agreement under
subparagraph (A), the Secretary shall--
(I) use competitive procedures to
solicit bids from drug manufacturers to
provide 100 percent of the hepatitis C
treatments for the covered population,
as specified by the Secretary under
clause (iii); and
(II) select 1 or more drug
manufacturers whose bid or bids
represent the best value to the Federal
Government, as determined by the
Secretary.
(ii) Awarding multiple agreements.--In
selecting drug manufacturers with which to
enter into an agreement under clause (i), the
Secretary may enter into an agreement with--
(I) a single drug manufacturer to
provide 100 percent of the hepatitis C
treatments for the covered population,
for the total amount specified in the
bid submitted by the drug manufacturer;
or
(II)(aa) the drug manufacturer with
the best bid, as determined by the
Secretary, to provide 70 percent of the
hepatitis C treatments for the covered
population, for an amount that is 70
percent of the total amount specified
in the bid submitted by the drug
manufacturer; and
(bb) the drug manufacturer with the
second-best bid, as determined by the
Secretary, to provide 30 percent of the
hepatitis C treatments for the covered
population, for an amount that is 30
percent of the total amount specified
in the bid submitted by the drug
manufacturer described in item (aa).
(iii) Required information.--Prior to
beginning the contracting process under this
paragraph, and in any case not later than 180
days after the date of enactment of this Act,
the Secretary shall specify the covered
population, and a reasonable estimate of the
size of that population, to support the
development of bids by interested drug
manufacturers under this subparagraph.
(5) Distribution of hepatitis c drugs to program
participants.--
(A) In general.--In providing for distribution of
hepatitis C treatments procured pursuant to 1 or more
agreements under paragraph (4), the Secretary may--
(i) provide in such an agreement that the
drug manufacturer shall--(I) distribute, or provide for the
distribution of, such hepatitis C
treatments to registered pharmacies and
registered sites of dispensing, State
and local correctional systems, the
Indian Health Service, and the Bureau
of Prisons;
(II) provide data about
distribution in the form and manner
prescribed by the Secretary; and
(III) meet such other conditions
relating to such distribution as are
prescribed by the Secretary; or
(ii) enter into a separate agreement for
the distribution of such hepatitis C treatments
to registered pharmacies and registered sites
of dispensing, State and local correctional
systems, the Indian Health Service, and the
Bureau of Prisons.
(B) Registered pharmacies and registered sites of
dispensing.--A retail pharmacy or site of dispensing
that seeks to receive hepatitis C treatments under
subparagraph (A) shall become a registered pharmacy or
registered site of dispensing by entering into an
agreement with the Secretary under which such retail
pharmacy or site of dispensing shall agree--
(i) to dispense hepatitis C treatments to
individuals described in clauses (i)(I),
(i)(II), and (iii) of paragraph (2)(A); and
(ii) to such conditions as the Secretary
may establish for the program.
(C) Advance stock.--In providing for the
distribution of hepatitis C treatments under an
agreement entered into under paragraph (4), the
Secretary shall provide for the provision of advance
stock of such hepatitis C treatments to registered
pharmacies, registered sites of dispensing,
participating State and local correctional systems,
facilities of the Bureau of Prisons, and facilities of
the Indian Health Service with high volumes of patients
in need of hepatitis C treatments, as determined by the
Secretary.
(D) Dispensing fees.--The Secretary shall pay,
based on customary and usual fees for the region,
reasonable dispensing fees to registered pharmacies
that dispense hepatitis C treatments to individuals
within the covered population.
(E) Requirement to use existing inventory.--
Registered sites of dispensing, participating State and
local correctional systems, facilities of the Bureau of
Prisons, and facilities of the Indian Health Service
shall use unexpired, on-hand inventory of previously
purchased hepatitis C treatments, if any, before
dispensing hepatitis C treatments received under
subparagraph (A) to individuals within the covered
population.
(c) Exclusion From Medicaid Best Price and Average Manufacturer
Price Calculation.--Section 1927 of the Social Security Act (42 U.S.C.
1396r-8) is amended--
(1) in subsection (c)(1)(C)(i)--
(A) in subclause (V), by striking ``; and'' and
inserting a semicolon;
(B) in subclause (VI), by striking the period at
the end and inserting ``; and''; and
(C) by adding at the end the following new
subclause:
``(VII) any prices charged under
the subscription program for hepatitis
C treatments established under section
4(b) of the Cure Hepatitis C Act of
2025.''; and
(2) in subsection (k)(1)(B)(i)--
(A) in subclause (IV), by inserting a semicolon at
the end;
(B) in subclause (VII), by striking ``; and'' and
inserting a semicolon;
(C) in subclause (VIII), by striking the period at
the end and inserting ``; and''; and
(D) by adding at the end the following new
subclause:
``(IX) any prices charged under thesubscription program for hepatitis C
treatments established under section
4(b) of the Cure Hepatitis C Act of
2025.''.
(d) Funding.--To carry out this section, there is authorized to be
appropriated, and there is appropriated, to the Secretary, out of any
amounts in the Treasury not otherwise appropriated, $5,500,000,000 for
fiscal year 2025, to remain available through fiscal year 2031.Sec. 5.
SEC. 5. PUBLIC HEALTH ACTIVITIES TO SUPPORT HEPATITIS C ELIMINATION.
SEC. 5. PUBLIC HEALTH ACTIVITIES TO SUPPORT HEPATITIS C ELIMINATION.
(a) State Awards.--
(1) Definition of covered individual.--In this subsection,
the term ``covered individual'' means an individual within the
covered population (as defined in section 4(a)) who is at
increased risk of hepatitis C virus infection.
(2) Awards.--
(A) In general.--The Secretary shall make grants
to, or enter into contracts or cooperative agreements
with, States and, as appropriate, political
subdivisions of States, for purposes of facilitating
access to hepatitis C virus screening, diagnosis,
treatment, and related wraparound services for covered
individuals.
(B) Designated lead entities.--A State or political
subdivision of a State receiving an award under
subparagraph (A) may designate a lead entity, such as
an institution of higher education, that demonstrates
the capacity to fulfill the requirements of the award,
to manage the award.
(3) Use of funds.--A State or political subdivision of a
State that receives an award under paragraph (2)(A) shall use
funds received pursuant to such award--
(A) to improve outreach to covered individuals,
which may include activities to increase awareness of
the risks of hepatitis C virus and the availability of
curative treatments;
(B) to increase rates of screening for, diagnosis
of, and treatment of hepatitis C virus among covered
individuals;
(C) to support the coordination and provision of
appropriate health care and social services to covered
individuals to improve health outcomes relating to
hepatitis C virus infection; and
(D) improve, as appropriate, other public health
capacities and capabilities relating to hepatitis C
virus prevention, detection, diagnosis, treatment, and
outbreak preparedness and response.
(4) Applications.--
(A) In general.--A State or political subdivision
of a State seeking to receive an award under paragraph
(2)(A) shall submit to the Secretary an application at
such time, in such manner, and containing such
information as the Secretary may require.
(B) Awards to other entities.--In the case of a
State that does not submit an application for an award
under subparagraph (A), the Secretary may make an award
to an entity within such State, such as an institution
of higher education, that demonstrates the capacity to
fulfill the requirements of the award.
(5) Partnerships.--A State or political subdivision of a
State or an entity described in paragraph (4)(B) that receives
an award under this subsection shall carry out the activities
described in paragraph (3) through partnerships with entities
located in such State or political subdivision of a State,
including through subawards to public and private entities such
as--
(A) local public health departments;
(B) community-based organizations; and
(C) health care providers and health care
facilities.
(6) Allocation formula.--
(A) In general.--The Secretary shall establish a
formula to allocate funds under this subsection among
States and political subdivisions of States.
(B) Considerations.--In establishing the formula
under subparagraph (A), the Secretary shall consider--
(i) the relative incidence of hepatitis C
virus, and morbidity and mortality associated
with hepatitis C virus within each State; and
(ii) the anticipated covered population (as
defined in section 4(a)), within each State.
(b) Other Awards.--
(1) In general.--The Secretary shall make grants, or enter
into contracts or cooperative agreements, in accordance with
paragraphs (4) through (8).
(2) Use of funds.--Funds received pursuant to an award
under paragraph (1) may be used by the recipient to carry out
the activities described in subparagraphs (A) through (D) of
subsection (a)(3), as applicable, in addition to applicable
activities described in paragraphs (4) through (8).
(3) Coordination.--The Secretary shall ensure that awardsmade under paragraph (1) are coordinated with the activities of
the Hepatitis C Elimination Program established under section
3(a).
(4) Opioid treatment programs and certified community
behavioral health clinics.--The Secretary shall make awards
described in paragraph (1) to opioid treatment programs and
certified community behavioral health clinics, as determined
eligible by the Secretary, to support hepatitis C virus testing
and treatment at such programs and clinics.
(5) Tribal areas.--The Secretary shall make awards
described in paragraph (1) to Indian health programs and health
facilities located in Tribal areas for hepatitis C virus
testing, linkage to care, and treatment.
(6) Community health centers.--The Secretary shall make
awards described in paragraph (1) to health centers eligible
for awards under section 330 of the Public Health Service Act
(42 U.S.C. 245b)--
(A) to expand access to hepatitis C virus testing,
case management, and treatment; and
(B) to build capacity--
(i) to track anticipated referrals for
hepatitis C treatment for patients within the
target population of the health center; and
(ii) to provide hepatitis C treatment to
individuals within the covered population (as
defined in section 4(a)).
(7) Correctional facilities.--
(A) In general.--The Secretary shall make awards
described in paragraph (1) to entities described in
subparagraph (B) to provide diagnostic testing and
treatment to individuals in State and local
correctional systems and to facilitate continued care
for individuals who began receiving hepatitis C
treatment while in custody and who require continued
hepatitis C treatment after being released from
custody.
(B) Recipients.--The Secretary may make awards
under this paragraph to State, local, or territorial
health departments, State or local correctional
systems, and community-based organizations.
(8) Ryan white clinics.--
(A) In general.--The Secretary shall establish a
pilot program under which the Secretary shall make
awards described in paragraph (1) to not more than 25
eligible entities for the purposes of providing care at
facilities that receive funding under title XXVI of the
Public Health Service Act (42 U.S.C. 300ff-11 et seq.)
to individuals infected with hepatitis C virus, without
regard to whether such infection is a co-occurring
condition (as defined in section 2689 of such Act (42
U.S.C. 300ff-88)).
(B) Eligible entities.--To be eligible to receive
an award under the pilot program established under
subparagraph (A), an entity shall be a recipient of an
award under part A, B, or C of title XXVI of the Public
Health Service Act (42 U.S.C. 300ff-11 et seq.).
(C) Requirements.--An eligible entity that receives
an award under this paragraph shall use the award funds
to provide core medical services and support services
relevant to individuals with hepatitis C virus.
(c) Technical Assistance.--The Secretary, in consultation with the
heads of other relevant Federal agencies, shall provide technical
assistance to States and other eligible entities seeking awards under
this section.
(d) Coordination.--The Secretary shall issue guidance to States
regarding ensuring that--
(1) patients in need of the care of a specialist for
hepatitis C management are appropriately referred for specialty
services;
(2) existing hepatitis B virus screening, vaccination
services, programs, and activities are coordinated with
activities carried out under this section to support linkage to
care for patients with hepatitis B virus; and
(3) activities carried out under this section are
coordinated with other existing Federal efforts relating to
hepatitis C prevention, such as treatment for opioid use
disorder, carried out by the Department of Health and Human
Services, the Department of Veterans Affairs, and the
Department of Defense.
(e) Hepatitis C Point-of-Care Testing.--
(1) Point-of-care testing.--The Secretary may--
(A) enter into agreements with vendors for thepurpose of purchasing and distributing in vitro
diagnostic point-of-care tests to facilitate hepatitis
C virus diagnosis and treatment;
(B) provide for the distribution of hepatitis C in
vitro diagnostic point-of-care tests to entities
receiving an award under subsections (a) and (b); and
(C) set conditions, including reporting and
effective use requirements, for entities receiving
hepatitis C in vitro diagnostic point-of-care tests
under this subsection.
(2) Diagnostic test development.--Of the amounts made
available to carry out this section, the Secretary may use not
more than $20,000,000 to support development of diagnostic
point-of-care tests to facilitate hepatitis C diagnosis and
treatment, including point-of-care hepatitis B tests to
facilitate timely hepatitis C treatment.
(f) Provider Training Network.--The Secretary, in consultation with
the interagency working group established under section 3(d), shall
award 1 or more contracts to eligible public or private entities to
establish a national network to provide training and technical
assistance on implementing hepatitis C prevention, diagnostic testing,
care, coordination, and treatment in support of the Hepatitis C
Elimination Program established under section 3(a).
(g) Public Awareness and Education.--
(1) In general.--The Secretary shall carry out a national
public awareness and education campaign relating to hepatitis C
virus treatment and the activities carried out under this Act.
(2) Materials.--In carrying out paragraph (1), the
Secretary shall--
(A) tailor information to priority populations for
hepatitis C virus; and
(B) consult with the advisory committee established
under section 3(c).Sec. 6.
SEC. 6. FUNDING.
SEC. 6. FUNDING.
(a) In General.--To carry out sections 3 and 5, there is authorized
to be appropriated, and there is appropriated, to the Secretary, out of
any amounts in the Treasury not otherwise appropriated, $4,283,000,000
for fiscal year 2025, to remain available through fiscal year 2031.
(b) Administrative Expenses.--Of the amount made available under
paragraph (1), the Secretary may not use more than 5 percent for
administrative expenses of the Hepatitis C Elimination Program
established under section 3(a).
(c) Bureau of Prisons.--Of the amount appropriated under subsection
(a), the Secretary shall transfer $25,000,000 to the Director of the
Federal Bureau of Prisons for purposes of expenses of the Bureau of
Prisons to carry out sections 3 and 5.Sec. 7.
SEC. 7. INCREASING ACCESS TO TREATMENTS FOR HEPATITIS C IN THE MEDICARE
SEC. 7. INCREASING ACCESS TO TREATMENTS FOR HEPATITIS C IN THE MEDICARE
PROGRAM.
(a) In General.--Section 1860D-2 of the Social Security Act (42
U.S.C. 1395w-102(b)) is amended--
(1) in subsection (b)--
(A) in paragraph (1)(A), by striking ``and (9)''
and inserting ``, (9), and (10)'';
(B) in paragraph (2)(A), by striking ``and (9)''
and inserting ``, (9), and (10)''; and
(C) by adding at the end the following new
paragraph:
``(10) Elimination of cost-sharing for direct acting
antivirals for the treatment of hepatitis c.--
``(A) In general.--For plan years 2027 through
2031, subject to subparagraph (B), with respect to a
covered part D drug that is a direct acting antiviral
for the treatment of hepatitis C--
``(i) the deductible under paragraph (1)
shall not apply; and
``(ii) there shall be no coinsurance or
other cost-sharing under this part with respect
to such drug.
``(B) Authority to delay implementation.--If the
Secretary determines that it is not feasible to
implement subparagraph (A) for plan year 2027,
subparagraph (A) shall be applied by substituting
`2028' for `2027'.''; and
(2) in subsection (c), by adding at the end the following
new paragraph:
``(7) Treatment of cost-sharing for direct acting
antivirals for the treatment of hepatitis c.--The coverage is
provided in accordance with subsection (b)(10).''.
(b) Conforming Amendments to Cost-Sharing for Low-Income
Individuals.--Section 1860D-14(a) of the Social Security Act (42 U.S.C.
1395w-114(a)) is amended--
(1) in paragraph (1)(D), in each of clauses (ii) and (iii),
by striking ``paragraph (6)'' and inserting ``paragraphs (6)
and (7)''; and
(2) by adding at the end the following new paragraph:
``(7) No application of cost-sharing or deductible for
direct acting antivirals for the treatment of hepatitis c.--
``(A) In general.--For plan years 2027 through
2031, subject to subparagraph (B), with respect to a
covered part D drug that is a direct acting antiviral
for the treatment of hepatitis C--
``(i) the deductible under section 1860D-
2(b)(1) shall not apply; and
``(ii) there shall be no cost-sharing under
this section with respect to such drug.
``(B) Authority to delay implementation.--If the
Secretary determines that it is not feasible to
implement subparagraph (A) for plan year 2027,
subparagraph (A) shall be applied by substituting
`2028' for `2027'.''.Sec. 8.
SEC. 8. OTHER MATTERS.
SEC. 8. OTHER MATTERS.
(a) Application of Provisions.--Amounts appropriated pursuant to
this Act and the amendments made by this Act shall be subject to the
requirements contained in Public Law 118-47 for funds provided under
division D of such Public Law.
(b) Rule of Construction.--Nothing in this Act shall supersedeSec. 416
section 416 of the Controlled Substances Act (21 U.S.C. 856).
section 416 of the Controlled Substances Act (21 U.S.C. 856).
Sec. 9.
SEC. 9. RULEMAKING AUTHORITY.
SEC. 9. RULEMAKING AUTHORITY.
The Secretary may issue regulations to carry out this Act.Sec. 10.
SEC. 10. USE OF FUNDS.
SEC. 10. USE OF FUNDS.
Notwithstanding section 4(b)(2), the amounts appropriated pursuant
to this Act and the amendments made by this Act may only be used to
carry out the provisions of this Act with respect to an individual who
is--
(1) a citizen of the United States; or
(2)(A) an alien lawfully admitted for permanent residence
(as defined in section 101(a) of the Immigration and
Nationality Act (8 U.S.C. 1101(a)));
(B) an alien paroled into the United States under section
212(d)(5) of the Immigration and Nationality Act (8 U.S.C.
1182(d)(5)) for a period of not less than 1 year;
(C) a refugee admitted to the United States under section
207 of the Immigration and Nationality Act (8 U.S.C. 1157);
(D) an alien granted asylum under section 208 of the
Immigration and Nationality Act (8 U.S.C. 1158);
(E) an alien entrant referred to in section 501(e) of the
Refugee Education Assistance Act of 1980 (8 U.S.C. 1522 note;
Public Law 96-422);
(F) an alien admitted to the United States as an immigrant
under section 584 of the Foreign Operations, Export Financing,
and Related Programs Appropriations Act, 1988 (8 U.S.C. 1101
note; Public Law 100-202);
(G) an alien admitted to the United States as a special
immigrant described in section 101(a)(27) of the Immigration
and Nationality Act (8 U.S.C. 1101(a)(27)) pursuant to--
(i) section 1059 of the National Defense
Authorization Act for Fiscal Year 2006 (8 U.S.C. 1101
note; Public Law 109-163);
(ii) section 1244 of the Refugee Crisis in Iraq Act
of 2007 (8 U.S.C. 1157 note; Public Law 110-181); or
(iii) section 602 of the Afghan Allies Protection
Act of 2009 (8 U.S.C. 1101 note; Public Law 111-8);
(H) a citizen or national of Afghanistan (or a person with
no nationality who last habitually resided in Afghanistan)
described in section 2502 of the Afghanistan Supplemental
Appropriations Act, 2022 (8 U.S.C. 1101 note; Public Law 117-
43);
(I) a citizen or national of Ukraine (or a person with no
nationality who last habitually resided in Ukraine) described
in section 401(a) of the Additional Ukraine Supplemental
Appropriations Act, 2022 (8 U.S.C. 1101 note; Public Law 117-
128);
(J) an alien who is a victim of a severe form of
trafficking in persons (as defined in section 107(b)(1)(C) of
the Trafficking Victims Protection Act of 2000 (22 U.S.C.
7105(b)(1)(C)));
(K) an alien who entered the United States as an
unaccompanied alien child (as defined in section 462(g) of the
Homeland Security Act of 2002 (6 U.S.C. 279(g))) who--
(i) is a special immigrant under section
101(a)(27)(J) of the Immigration and Nationality Act (8
U.S.C. 1101(a)(27)(J));
(ii) on the date on which a dependency order
described in that section was made--
(I) was in the custody of the Secretary of
Health and Human Services as an unaccompanied
alien child; or
(II) was receiving services under section
501(a) of the Refugee Education Assistance Act
of 1980 (8 U.S.C. 1522 note; Public Law 96-
422); or
(iii) an alien who entered the United States as an
unaccompanied alien child (as defined in section 462(g) of the
Homeland Security Act of 2002 (6 U.S.C. 279(g))) and has been
granted nonimmigrant status under section 101(a)(15)(U) of the
Immigration and Nationality Act (8 U.S.C. 1101(a)(15)(U));
(L) an individual who lawfully resides in the United States
in accordance with a Compact of Free Association described inSec. 402
section 402(b)(2)(G) of the Personal Responsibility and Work
section 402(b)(2)(G) of the Personal Responsibility and Work
Opportunity Reconciliation Act of 1996 (8 U.S.C.
1612(b)(2)(G));
(M) an alien described in section 431(c) of the Personal
Responsibility and Work Opportunity Reconciliation Act of 1996
(8 U.S.C. 1641(c));
(N) an alien granted conditional entry under subsection
(a)(7) of section 203 of the Immigration and Nationality Act (8
U.S.C. 1153) (as in effect on March 31, 1980);
(O) an alien granted withholding of deportation under
subsection (h) of section 243 of the Immigration and
Nationality Act (8 U.S.C. 1253) (as in effect on the day before
the effective date of section 307 of the Illegal Immigration
Reform and Immigrant Responsibility Act of 1996 (division C of
Public Law 104-208; 110 Stat. 3009-546));
(P) an alien granted withholding of removal under section
241(b)(3) of the Immigration and Nationality Act (8 U.S.C.
1231(b)(3)); or
(Q) determined by the Secretary of Health and Human
Services, through notice and comment rulemaking, to be eligible
for services under this Act or the amendments made by this Act.
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