The Cure Hepatitis C Act of 2025 would create a national Hepatitis C Elimination Program under the Secretary of Health and Human Services. It sets up a national strategy and implementation plan, an advisory committee, and an interagency working group to coordinate activities across federal agencies.
TheAct also establishes a subscription-based procurement model for hepatitis C treatments, distributes drugs through registered pharmacies, correctional systems, and federal facilities, and prohibits use of 340B discounts for program drugs. It expands coverage to include Medicaid/CHIP enrollees and certain incarcerated or recently released individuals, and it makes broad funding and Medicare cost-sharing changes to support treatment access.
The legislation requires ongoing reporting, dashboards, and stakeholder engagement to drive progress through 2032 and beyond.
At a Glance
What It Does
A federally run program to eliminate hepatitis C that includes a national strategy, governance bodies, a drug subscription purchase model, and a monitoring dashboard.
Who It Affects
Medicaid/CHIP enrollees, prisoners and recently released individuals, Indian Health Service patients, registered pharmacies and dispensing sites, state and local health departments, and drug manufacturers participating in the subscription program.
Why It Matters
It formalizes a centralized approach to treatment access and measurement, aims to close gaps in prevention, detection, and care, and ties drug pricing and distribution to a coordinated national effort that spans custody settings and public health systems.
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What This Bill Actually Does
The bill creates the Hepatitis C Elimination Program within the Department of Health and Human Services. It requires a national strategy and implementation plan within 180 days, plus an advisory committee and an interagency working group to guide cross-agency effort.
A dashboard will publicly track progress against measurable goals. The core mechanism is a patient-centered subscription model for hepatitis C drugs, negotiated with one or more drug manufacturers for a fixed term (five years) and distributed to registered pharmacies, correctional facilities, the Indian Health Service, and other participating providers.
Individuals who receive drugs through the program would do so without cost-sharing. The program also restricts the use of 340B discounts for these medications and creates oversight to enforce that prohibition.
The covered population includes those diagnosed with hepatitis C who are enrolled in Medicaid or CHIP, those in correctional systems (or released from confinement) who began treatment, people without minimum essential coverage, and patients served by Indian health programs. The Act authorizes substantial federal funding ($5.5 billion for 2025 under Sec. 4 and $4.283 billion under Sec. 6 through 2031) to support program activities, prioritizes supply to high-need settings, and broadens Medicare Part D benefits to eliminate cost-sharing for direct-acting antivirals for hepatitis C through plan years 2027–2031 (or 2028 if feasibility is delayed).
State and local awards, tribal and community health center programs, and corrections programs are all supported to expand screening, diagnosis, and treatment, with attention to coordination and avoidance of duplicative efforts. The Act also preserves rulemaking authority and sets boundaries on fund use.
Overall, the proposal seeks to accelerate treatment, reduce transmission, and address disparities by aligning pricing, access, and care across federal and nonfederal actors.
The Five Things You Need to Know
The Secretary must issue a national Hepatitis C Elimination Program strategy and implementation plan within 180 days.
The bill creates a subscription model for hepatitis C treatments and requires no cost-sharing for recipients.
It prohibits use of the 340B drug discount program for program hepatitis C medications and mandates audits and data sharing to enforce this.
Covered populations include Medicaid/CHIP enrollees, certain incarcerated individuals, and those without minimum essential coverage, with steps to verify enrollment.
Funding support totals billions of dollars (5.5B for 2025 and 4.283B for 2025 onward) and includes Medicare cost-sharing eliminations for direct-acting antivirals in later years.
Section-by-Section Breakdown
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Definitions and Scope
Defines key terms used throughout the Act, including correctional facilities, hepatitis C treatment, Indian health programs, the Secretary, and the evolving roster of States and territories covered by the program. These definitions establish who and what is eligible for participation and help map the program’s reach across federal, state, and local entities.
Hepatitis C Elimination Program
Establishes the program within HHS, requiring a national strategy and implementation plan within set timeframes. Also creates an advisory committee with diverse stakeholders and an interagency working group to coordinate across agencies, plus a public dashboard and ongoing reporting to Congress on progress toward goals.
Provision of Treatments: Subscription Model
Creates a subscription-based procurement system for hepatitis C medicines. The Secretary will contract with drug manufacturers to supply treatments for the covered population for a five-year term, distribute through registered pharmacies and dispensing sites, and ensure no-cost access for beneficiaries. It also bans 340B pricing for these program drugs and sets oversight and data-sharing measures to enforce compliance.
Public Health Activities and Awards
Authorizes state and local awards to support screening, diagnosis, treatment, and wraparound services, with designated lead entities and partnerships. The section outlines multiple funding streams for tribal health programs, community health centers, correctional facilities, opioid treatment programs, and Ryan White clinics to broaden access and integration with existing public health infrastructure.
Funding
Authorizes substantial appropriations to support Sections 3 and 5 through 2031, plus a dedicated transfer to the Bureau of Prisons. The funds cover program administration caps and ensure targeted use for expanding access and implementing the subscription model, with explicit constraints on use for non-qualified individuals.
Medicare Cost-Sharing for Hepatitis C Drugs
Amends Medicare Part D to phase out cost-sharing for direct-acting antivirals for hepatitis C for plan years 2027–2031 (or 2028 if implementation is not feasible), and includes conforming changes to related cost-sharing rules for low-income beneficiaries.
Other Matters; Rulemaking and Use of Funds
Contains miscellaneous provisions, noting that the Secretary can issue regulations to implement the Act, and that funds are subject to existing statutory controls and eligibility requirements for appropriations.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Medicaid and CHIP enrollees diagnosed with hepatitis C who qualify for the program, gaining access to treatment with no out-of-pocket costs.
- Individuals released from correctional facilities who began treatment and can continue care after release, improving continuity of care.
- Indian Health Service patients and tribal health programs that will be included in distribution and coverage.
- Registered pharmacies and registered sites of dispensing that participate in procurement and distribution under the program.
- Drug manufacturers that enter into the subscription agreements, securing a predictable demand and market for hepatitis C medications.
Who Bears the Cost
- State Medicaid and CHIP programs bear the administrative and coordination costs of enrollment verification and program participation.
- State and local correctional systems must implement the program’s distribution and clinical care requirements for incarcerated individuals.
- Health care providers and pharmacies will have to engage in reporting, compliance, and patient verification activities.
- The federal government bears the upfront cost of the subscription contracts and administration of the program, funded by appropriations.
- Non-covered entities or entities outside the program might face operational changes due to prohibition of 340B pricing for program drugs.
Key Issues
The Core Tension
Balancing universal, rapid access to hepatitis C treatment with the practical realities of drug pricing, supplier capacity, and multi-agency governance—especially when extending treatment into prisons and other hard-to-reach populations.
The Act creates a bold, centralized approach to hepatitis C treatment access that relies on a subscription drug model and cross-agency coordination. While this can drive scale and price discipline, it also introduces implementation complexity across Medicaid/CHIP programs, correctional systems, tribal health services, and private providers.
Ensuring data alignment, preventing duplication with existing federal programs, and managing the transition for patients in custody or in transition will require robust governance and continuous oversight. The prohibition on 340B pricing for program drugs will need careful monitoring to avoid unintended consequences for safety-net providers and drug supply security.
The funding allocations, while substantial, will need to be matched with real-world capacity across states and facilities to avoid bottlenecks in treatment access and follow-up care.
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