Cure Hepatitis C Act of 2025
- Bill Number
- S. 1941
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-06-04: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Last Updated
- 2026-05-27T20:42:16Z
AI-Generated Summary
Purpose
The Cure Hepatitis C Act of 2025 aims to eliminate hepatitis C virus (HCV) infections in the United States by directing the Secretary of Health and Human Services (HHS) to coordinate federal efforts. This includes developing strategies for prevention, detection, and treatment, while ensuring access to curative drugs for high-risk groups through new programs and funding.
Key Provisions
- Hepatitis C Elimination Program (Section 3): Establishes a national program within 90 days of enactment. Requires HHS to issue a strategy and implementation plan within 180 days, identifying priority populations (e.g., those with higher infection rates), federal gaps/duplications, goals for prevention/detection/treatment, and performance metrics. Includes an advisory committee with diverse experts (e.g., patients, clinicians, public health officials), an interagency working group (involving CDC, CMS, Indian Health Service, etc.), a public dashboard for progress tracking, stakeholder consultations, and annual reports to Congress through 2032.
- Subscription Program for Hepatitis C Treatments (Section 4): Creates a 5-year program to purchase direct-acting antiviral (DAA) drugs—medications approved by the FDA to cure HCV—from manufacturers via a subscription model (fixed annual payment for unlimited supply based on bids). Covers specific "covered populations" without cost-sharing (copays or deductibles):
- Medicaid/CHIP enrollees in participating states.
- Individuals in state/local correctional facilities (or recently released if treatment started in custody).
- Federal prisoners (Bureau of Prisons) or those recently released.
- Uninsured individuals (verified by designated providers).
- Users of Indian health programs.
Participating states/correctional systems must opt in, waive prior authorizations for screening/treatment, and ensure continuity of care post-release. Distribution occurs through registered pharmacies/sites, with dispensing fees paid. Prohibits overlap with other federal drug discounts (e.g., 340B program) and requires audits. Excludes subscription prices from Medicaid's "best price" calculations to avoid affecting rebates. Authorizes $5.5 billion for FY 2025–2031.
- Public Health Activities (Section 5): Provides grants/contracts to states, localities, opioid treatment programs, community health centers, correctional systems, tribal areas, and Ryan White HIV/AIDS clinics for HCV screening, diagnosis, treatment, and support services (e.g., outreach, coordination with social services, outbreak response). Includes:
- Formula-based allocation considering infection rates and covered populations.
- Technical assistance, coordination with hepatitis B efforts and opioid treatment.
- Point-of-care testing (rapid diagnostics) distribution and development (up to $20 million).
- National provider training network.
- Public awareness campaign tailored to priority groups.
Authorizes $4.283 billion for FY 2025–2031 (5% max for administration; $25 million to Bureau of Prisons).
- Medicare Changes (Section 7): Eliminates deductibles and cost-sharing for DAA drugs under Medicare Part D for plan years 2027–2031 (delayable to 2028 if needed). Applies to low-income subsidy enrollees.
- Other Provisions (Sections 8–10): Funds follow certain appropriations rules; does not override laws on controlled substances sites. HHS has rulemaking authority. Funds limited to U.S. citizens and specific lawfully present immigrants (e.g., refugees, asylees, trafficking victims; excludes undocumented individuals except via rulemaking).
Significant Changes to Existing Law
- Medicaid (Social Security Act, Section 1927): Adds exclusions for subscription program prices from "best price" and average manufacturer price calculations, preventing these from reducing manufacturer rebates to states (previously, all discounts counted).
- Medicare Part D (Social Security Act, Sections 1860D-2 and 1860D-14): Introduces zero cost-sharing for HCV DAAs starting 2027, a new carve-out not previously applied to specific drugs (expands on general Part D rules).
- New Mandates: Creates first-of-its-kind federal HCV elimination program, subscription purchasing model (similar to but distinct from existing VA or state models), and dedicated funding streams, building on but expanding beyond current HHS viral hepatitis strategies.
Potential Impacts
- Government Agencies: HHS gains coordination role, with new dashboards/reports increasing transparency and accountability. Agencies like CDC, CMS, and Indian Health Service must integrate efforts, potentially straining resources but supported by $9.783 billion total funding (FY 2025–2031). States/localities may see reduced treatment costs via free drugs but must opt in and report data.
- Citizens: Improves access to free, curative HCV treatment for ~3–4 million estimated infected individuals, especially underserved groups (e.g., 30–40% of cases in correctional settings; higher rates among uninsured/rural/Native American populations). Could reduce liver disease/cancer rates, healthcare costs (HCV treatment saves ~$50,000–$100,000 per cure vs. complications), and transmission (e.g., via shared needles). Public awareness and screening may boost early detection.
- International Relations: Minimal direct impact; focuses domestically but could indirectly support global HCV goals (e.g., WHO elimination targets) through U.S. leadership in drug procurement models.
Main Stakeholders Affected
- Federal Government: HHS (lead), CDC, CMS, HRSA, Indian Health Service, FDA, Bureau of Prisons—must implement programs, procure drugs, and report progress.
- State/Local Entities: Medicaid/CHIP agencies, public health departments, correctional systems—opt-in participants handling screening/treatment; potential cost savings but administrative burdens.
- Healthcare Providers and Facilities: Pharmacies, community health centers, opioid clinics, Ryan White HIV sites—gain funding/training for expanded services; must register and comply with distribution rules.
- Drug Manufacturers: Compete for 5-year subscription contracts (single or split bids); fixed payments may stabilize revenue but limit pricing flexibility.
- Patients and Communities: High-risk groups (e.g., Medicaid enrollees, prisoners, uninsured, Native Americans, people with substance use disorders)—primary beneficiaries of free treatments and services. Community-based organizations support outreach.
- Insurers/Payers: Medicare/Medicaid programs benefit from lower long-term costs; private plans unaffected directly.
Notable Legal, Constitutional, or Political Implications
- Legal: Establishes enforceable mandates (e.g., timelines for strategy/dashboard) with HHS rulemaking flexibility; subscription model may face challenges over bidding fairness or 340B conflicts but includes audit/enforcement mechanisms. Immigration restrictions (Section 10) align with existing federal benefits laws, limiting to qualified individuals to avoid broader eligibility disputes.
- Constitutional: No major issues; falls under Congress's spending power (Article I) for public health/welfare. Federalism considerations via state opt-ins preserve local control.
- Political: Bipartisan sponsorship (Sens. Cassidy, Van Hollen) addresses opioid/HCV crisis without partisan divides; emphasizes equity for marginalized groups (e.g., prisoners, tribes). Could set precedent for subscription models in other diseases (e.g., HIV), influencing future drug pricing debates, but funding reliance on appropriations may delay full impact if not renewed.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (1)
Recent Actions
- 2025-06-04: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2025-06-04: Introduced in Senate
Bill Versions
- Cure Hepatitis C Act of 2025 — issued 2025-06-04 — PDF (41 pages)