Cure Hepatitis C Act of 2025
- Sponsor
- Sen. Cassidy, Bill [R-LA]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Jun 4, 2025
Bottom line
The Cure Hepatitis C Act of 2025 aims to eliminate hepatitis C in the U.S. by providing free treatment to key populations, funding public health infrastructure, and removing Medicare cost-sharing, utilizing a novel drug procurement 'subscription model'.
What it actually does
This bill establishes a comprehensive national program to eliminate hepatitis C virus (HCV) in the United States. It mandates the Secretary of Health and Human Services (HHS) to create a subscription program for direct-acting antiviral (DAA) HCV treatments, making them available without cost-sharing to specific vulnerable populations, including those on Medicaid/CHIP, uninsured individuals, and those in correctional facilities or served by Indian health programs. It also provides significant funding for public health activities, such as state awards for screening and treatment, and eliminates Medicare Part D cost-sharing for HCV DAAs from 2027-2031.
Proponents argue
Proponents argue that this bill represents a historic opportunity to eliminate hepatitis C in the United States, a curable disease that disproportionately affects vulnerable populations. They highlight the innovative subscription model as a way to overcome high drug costs and expand access to life-saving treatments, ultimately reducing long-term healthcare expenditures associated with chronic HCV infection and improving public health outcomes.
Opponents contend
Critics may raise concerns about the substantial federal spending authorized by the bill, questioning the long-term fiscal implications of such a large-scale program. Some might also scrutinize the drug procurement model, arguing that it could still lead to inflated drug prices or limit competition, while others may express reservations about the scope of federal involvement in state-level public health activities or the specific eligibility criteria for treatment.
The bill is moderately complex, requiring careful reading to understand the various program components and funding mechanisms. The estimated reading time is sufficient for an informed reader to grasp its core provisions.
Section 3(a)-(g)
Establishment of Hepatitis C Elimination Program
This section requires the Secretary of Health and Human Services (HHS) to establish a 'Hepatitis C Elimination Program' within 90 days of enactment. It mandates the development of a national strategy and implementation plan, including identifying priority populations, assessing existing federal programs, setting specific goals for prevention, detection, and treatment, and establishing performance metrics. The program will be advised by an advisory committee and an interagency working group, and progress will be monitored via a public dashboard.
Supporters argue
Supporters argue that a centralized, coordinated national strategy is essential for effective disease elimination, ensuring resources are directed efficiently and efforts are harmonized across federal agencies and stakeholders. The advisory committee and interagency group ensure broad expertise and collaboration.
Critics contend
No specific opposition is typically raised against establishing a coordinated public health program, though some might express concerns about potential bureaucratic inefficiencies or the scope of federal oversight.
Tradeoffs
The tension lies in balancing comprehensive coordination with flexibility for local implementation. The program aims to standardize efforts while allowing for tailored approaches to diverse populations.
Section 4(b)(1)-(3)
Hepatitis C Treatment Subscription Program for Covered Populations
This section establishes a subscription program where HHS will enter agreements with drug manufacturers to purchase hepatitis C treatments. These treatments will then be distributed to specific 'covered populations' without cost-sharing. Covered populations include individuals enrolled in participating State Medicaid/CHIP programs, those in participating State/local correctional facilities or the Bureau of Prisons, uninsured individuals, and those receiving care through Indian health programs. State/local correctional systems and Medicaid/CHIP agencies must opt-in and agree to certain conditions, such as not imposing prior authorization for HCV treatment.
Section 4(b)(4)
Procurement of Hepatitis C Drugs via Subscription Model
This provision details the core of the subscription model: HHS will enter 5-year agreements with one or more drug manufacturers. Under this model, manufacturers agree to provide as many units of hepatitis C treatment as the Secretary requires for a fixed annual amount. The Secretary will use competitive procedures to solicit bids, potentially awarding 100% to a single manufacturer or splitting the award (70%/30%) between the top two bidders based on best value.
Section 5(a)-(b)
Public Health Activities to Support Hepatitis C Elimination
This section authorizes HHS to make grants, contracts, or cooperative agreements to States, political subdivisions, and various entities (e.g., opioid treatment programs, Indian health programs, community health centers, correctional facilities, Ryan White clinics) to support hepatitis C virus screening, diagnosis, treatment, and related wraparound services. Funds can be used for outreach, increasing screening/diagnosis/treatment rates, coordinating care, and improving public health capacities. Awards to States will be based on a formula considering HCV incidence and anticipated covered populations.
Section 7
Elimination of Cost-Sharing for Hepatitis C Treatments in Medicare Part D
This section amends the Social Security Act to eliminate the deductible and any coinsurance or other cost-sharing for direct-acting antiviral (DAA) drugs used to treat hepatitis C under Medicare Part D. This change applies for plan years 2027 through 2031. The Secretary is granted authority to delay implementation until 2028 if it is not feasible to implement by 2027.
Prohibits health care providers, pharmacies, and sites of dispensing from utilizing any other Federal drug discount program, including the 340B drug discount program, with respect to hepatitis C treatments obtained through this new subscription program.
Section 4(b)(1)(B)
Why it matters:This is standard legislative practice to prevent 'double-dipping' or stacking federal benefits, ensuring that entities do not receive multiple federal discounts for the same drug. It clarifies the operational boundaries of the new program relative to existing ones.
Case for: Supporters argue this prevents abuse of federal programs and ensures that the significant investment in the subscription model is the primary mechanism for providing these drugs to the covered populations, maintaining the integrity and financial model of the new program.
Case against: Some covered entities currently relying on 340B discounts might find this restrictive, as it limits their flexibility in drug procurement and potentially reduces their ability to generate revenue from 340B savings that could be reinvested into patient care.
Estimated impact: This provision will significantly impact 340B covered entities that treat hepatitis C patients, requiring them to choose between obtaining drugs through the new subscription program or the 340B program for these specific treatments for the covered populations.
Limits the use of funds appropriated by this Act to individuals who are U.S. citizens or specific categories of lawfully residing aliens (e.g., permanent residents, refugees, asylees, certain parolees, victims of trafficking, unaccompanied alien children, and citizens/nationals of specific countries like Afghanistan and Ukraine under special acts). It also allows the Secretary of HHS to determine additional eligible categories through rulemaking.
Section 10
Why it matters:This is a common legislative practice to define eligibility for federal benefits based on immigration status, often reflecting political compromises or existing federal policy on alien eligibility for public assistance. Its placement at the end is typical for general applicability clauses.
Case for: Proponents argue that limiting federal benefits to citizens and specific categories of lawfully present aliens aligns with existing immigration policy and ensures that taxpayer funds are directed towards those with a more established legal connection to the United States. The rulemaking authority provides flexibility for future adjustments.
Case against: Critics might argue that excluding certain immigrant populations, particularly those who are undocumented or in other legal statuses, creates a public health loophole, as hepatitis C can spread regardless of immigration status. They contend that a public health elimination program should be universal to be most effective.
Estimated impact: This provision will exclude a potentially significant number of individuals residing in the United States who are infected with hepatitis C but do not meet the specified immigration status criteria, thereby limiting the reach and potential effectiveness of the elimination program.