119-s1941

[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 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.--A 
 State 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 the 
 subscription 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. 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 awards 
 made 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 the 
 purpose 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. 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. 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. 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 supersede 

section 416 of the Controlled Substances Act (21 U.S.C. 856).

SEC. 9. RULEMAKING AUTHORITY.

 The Secretary may issue regulations to carry out this Act.

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 in 
 

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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