Short title

This Act may be cited as the

Cure Hepatitis C Act of 2025

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.

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.

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.

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).

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.

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.

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).

Rulemaking authority

The Secretary may issue regulations to carry out this Act.

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.