Policy
The National Initiative to Eliminate HCV
&
The Debate Over Early Treatment
National Hepatitis C Elimination Initiative
The National Initiative to Eliminate Hepatitis C aims to significantly expand screening, testing, treatment, prevention, and monitoring of hepatitis C infections in the United States, with a specific focus on populations at the greatest risk for infection
Key Information on the National Hepatitis C Elimination Initiative:
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Scope and Funding: $12.3 billion was proposed over 10 years in the 2024 budget to eliminate HCV in the U.S., focusing on expanding screening, treatment access, and cost reduction for direct-acting antivirals (DAAs), which cure over 95% of cases in 8-12 weeks.
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Impact: The Congressional Budget Office estimates this could save 90,000 lives and $60 billion in healthcare costs by 2050 by preventing advanced liver diseases, like cirrhosis and liver cancer.
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Support for Providers: The initiative reduces barriers (e.g., prior authorization eased in 28 states, fibrosis restrictions lifted in all 50 states) and offers resources like training and surveillance, making it easier to screen and treat patients in your practice.
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Urgency and Relevance: With over 2 million Americans living with HCV (per CDC estimates) and only 1 in 3 diagnosed cases cured, your participation is pivotal in closing this gap, especially with DAAs’ simplicity and efficacy.
Organizations Promoting Hepatitis C Elimination:
Key players driving this initiative:
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Coalition for Global Hepatitis Elimination (CGHE): Partners with the White House and experts to advocate for the national plan, emphasizing cost-effectiveness.
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Centers for Disease Control and Prevention (CDC): Tracks HCV prevalence (over 2 million cases) and supports surveillance and screening efforts critical for clinicians and clinics.
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American Association for the Study of Liver Diseases (AASLD): Offers clinical guidelines and simplified treatment protocols.
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Hepatitis C Medicaid Affinity Group (via HHS): Works with states to boost access to HCV treatment, offering models that could fund non-billable work. ​​
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Non-billable services in the context of HCV care can include activities like care coordination, patient navigation, outreach, or education—services critical to linking patients to treatment but often not reimbursable under standard Medicaid billing codes. The Affinity Group supports states in exploring solutions to such gaps, though specific payment mechanisms for non-billable services depend on individual state Medicaid programs and their policies.
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The Affinity Group has helped states implement strategies to enhance screening, linkage to care, and treatment access. Some states have leveraged technical assistance from the Affinity Group to integrate HCV care into settings like substance use disorder treatment sites or correctional facilities, where non-billable support services are often vital but funding remains a challenge.
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The Affinity Group provides a collaborative platform for states to share best practices and potentially advocate for policy changes.
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U.S. Department of Health and Human Services (HHS): Oversees the Viral Hepatitis National Strategic Plan (2021-2025) and the proposed elimination program, providing policy and funding frameworks. Strategic Plan: A Roadmap to Elimination 2021–2025 is a comprehensive framework designed to guide the nation toward eliminating viral hepatitis, including Hepatitis C (HCV), as a public health threat by 2030, with significant progress targeted by 2025. Released in January 2021. Below are the key points HHS has promoted within this plan, focusing on its strategic vision, objectives, and actionable priorities:
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Vision and Overarching Goal
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Elimination by 2030: The plan’s ultimate aim is to eliminate viral hepatitis as a public health threat in the U.S., defined by reducing new infections and related deaths to minimal levels (e.g., a 90% reduction in new HCV infections and a 65% reduction in HCV-related mortality from baseline).
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Interim 2025 Targets: By 2025, HHS seeks measurable progress, such as reducing new HCV infections by 20% and HCV-related deaths by 25%, setting the stage for longer-term success.
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​2. Five Strategic Pillars
The plan is structured around five core pillars to drive coordinated action:
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Prevent New Infections: Emphasizes harm reduction (e.g., syringe service programs, opioid use disorder treatment), vaccination for Hepatitis A and B, and education to curb transmission, particularly among high-risk groups like people who inject drugs (PWID).
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Improve Diagnosis: Promotes universal screening—e.g., one-time HCV testing for all adults over 18 (per CDC 2020 guidelines)—and targeted outreach to underserved populations to close the diagnosis gap (only about 1 in 3 HCV cases are currently diagnosed).
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Enhance Treatment Access: Pushes for access to curative treatments like direct-acting antivirals (DAAs) for HCV, removing barriers such as cost, insurance restrictions, and provider shortages. The goal is to treat at least 80% of diagnosed individuals.
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Strengthen Surveillance and Response: Calls for improved data collection, real-time monitoring, and outbreak response capabilities to track progress and adapt strategies.
3. Key Objectives and Indicators
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Specific Metrics: The plan includes 11 core indicators to measure success, such as reducing HCV incidence from 1.0 to 0.2 per 100,000 people and increasing treatment initiation rates. For HCV, it prioritizes curing 250,000 people annually by 2025.
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Integration with Other Diseases: Recognizes the intersection of viral hepatitis with HIV, STIs, and substance use disorders, advocating for integrated care models (e.g., co-locating testing and treatment services).
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Workforce Development: Encourages training for healthcare providers to simplify HCV treatment protocols and expand the pool of clinicians delivering care beyond specialists.
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4. Priority Populations
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HHS identifies groups disproportionately affected by HCV for targeted intervention:
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People Who Inject Drugs (PWID): The leading cause of new infections, needing harm reduction and treatment access.
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Incarcerated Individuals: High prevalence due to limited healthcare access in correctional settings.
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Baby Boomers (born 1945–1965): A significant portion of chronic cases linked to historical exposures like transfusions.
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Racial/Ethnic Minorities: Higher mortality rates due to systemic barriers in care.
5. Collaboration and Funding
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Whole-of-Society Approach: HHS emphasizes partnerships across federal agencies (e.g., CDC, HRSA, SAMHSA), states, tribes, private sector, and community organizations to implement the plan.
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Resource Mobilization: While the 2021–2025 plan itself isn’t a funding mechanism, it underpins initiatives like the proposed $12.3 billion National Hepatitis C Elimination Program in the 2024 budget, which would amplify these efforts with dedicated resources.
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6. Motivation for Providers
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Simplified Care: The plan supports streamlined HCV treatment (e.g., AASLD/IDSA guidelines for non-specialists),
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Support Systems: HHS promotes tools like telehealth, training, and potential reimbursement models (e.g., for non-billable services under future programs), easing the practical burden.
Why It Matters:
HHS frames this as a winnable battle: with 2.4 million Americans living with HCV (per 2013–2016 estimates), and DAAs offering a cure, the gap is in execution—not capacity.
Arguments for & against Treating Hepatitis C Early In the Course of the Disease
Is the benefit worth the spend?
Why strategically pursue HCV treatment?
These are legitimate questions that deserve an earnest answer.
The proposed answer to the financial stewardship part of the debate is that it will save money in the long run.
Arguments For...
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Expensive Drugs That Cure Hepatitis C Are Worth The Cost, Even At Early Stages Of Liver Fibrosis
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Hepatitis C in Oklahoma prisons is an expensive time bomb
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Arguments Against...
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6th Circuit: OK to ration hepatitis C treatment to prisoners
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Costly Hepatitis C Drugs Threaten To Bust Prison Budgets
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Expanding access to hepatitis C drugs will cost taxpayers and might not improve health
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VA, DoD spend more than $450M on costly hepatitis drug
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Why The Focus On HCV In Prisons and Jails?
An argument can be made with a shopping metaphor. When looking for the best deal, everyone goes to the place where you can get the most bang for your buck. Because of the prevalence of HCV in the correctional setting, it is an ideal opportunity to attack the hepatitis C virus..
Prevalence of HCV in Inmates and Detainees
The prevalence of HCV in the United States is estimated to be around 1% (1). However, the prevalence of HCV in correctional institutions is much higher. A recent estimate of HCV infection in US prisons is 17.4% (2), with chronic infection estimated to be between 12 and 35% (3). Correctional populations account for about one-third of all HCV cases in the US(4). The high prevalence of HCV in correctional settings is because many people most affected by incarceration, such as the poor, IV drug users, and the mentally ill, are more likely to have HCV.
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[1] National Center for Health Statistics, Centers for Disease Control. National Health and Nutrition Examination Survey. Available at: http://www.cdc.gov/nchs/about/major/nhanes/currentnhanes.htm. Retrieved 4.2.2014.
[2] Varan et al.Hepatitis C Seroprevalence Among Prison Inmates Since 2001: Still High but Declining. Public Health Reports, 2014; 129: 187-195.
[3] http://www.cdc.gov/hepatitis/Settings/Corrections.htm
[4] Varan et al.Hepatitis C Seroprevalence Among Prison Inmates Since 2001: Still High but Declining. Public Health Reports, 2014; 129: 187-195.
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Rock and water are opposing forces, with one eroding and the other resisting erosion.
This is an example of the dynamic relationship between two opposing forces. Neither force can claim 100% righteousness. Sometimes they have to find a way to coexist. ​
Executive Summary
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Viral hepatitis is a serious, preventable public health threat that puts people who are infected at increased risk for liver disease, cancer, and death. The Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination (2021–2025) (Hepatitis Plan or Plan) provides a framework to eliminate viral hepatitis as a public health threat in the United States. Elimination is defined by the World Health Organization (WHO) as a 90% reduction in new chronic infections and a 65% reduction in mortality, compared to a 2015 baseline. The Hepatitis Plan focuses on hepatitis A, hepatitis B, and hepatitis C—the three most common hepatitis viruses and that have the most impact on the health of the nation. The Hepatitis Plan, which builds on three previous plans, is necessary as the nation faces unprecedented hepatitis A outbreaks, progress on preventing hepatitis B has stalled, and hepatitis C rates nearly tripled from 2011 to 2018. In 2016, it was estimated that 3.3 million Americans were living with chronic viral hepatitis: 862,000 with hepatitis B and 2.4 million with hepatitis C. Yet hepatitis A and hepatitis B are preventable by vaccines, and hepatitis C is curable in one short course of treatment. Reversing the rates of viral hepatitis, preventing new infections, and improving care and treatment require a strategic and coordinated approach by federal partners in collaboration with state and local health departments, tribal communities, community-based organizations, and other nonfederal partners and stakeholders.
The Hepatitis Plan provides goal-oriented objectives and strategies that can be implemented by a broad mix of stakeholders at all levels and across many sectors, both public and private. It serves as a mechanism to identify and leverage areas of synergy and resources and to avoid duplication of efforts across agencies. The Hepatitis Plan was developed under the direction of the Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services (HHS), in collaboration with subject matter experts from across the federal government and with input from a wide range of stakeholders including the public.
Click on the link to the PDF to see what The Plan establishes as the vision for the nation.
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The 340B Drug Pricing Program originated in the United States as a response to unintended consequences of an earlier legislative effort. In 1990, Congress established the Medicaid Drug Rebate Program, which required pharmaceutical manufacturers to provide rebates to state Medicaid programs for drugs purchased for Medicaid beneficiaries, in exchange for having their drugs covered by Medicaid. This program aimed to control rising drug costs for the Medicaid population. However, it inadvertently disrupted existing voluntary discount arrangements that drug manufacturers had with safety-net providers—such as public hospitals and clinics serving low-income and uninsured patients. When manufacturers adjusted their pricing to comply with the Medicaid "best price" requirement, these safety-net providers faced significant cost increases, with some outpatient drug prices rising by as much as 32% on average, far exceeding typical annual increases.
To address this issue, Congress created the 340B program in November 1992 through the Veterans Health Care Act, signed into law by President George H. W. Bush. Named after Section 340B of the Public Health Service Act, the program was designed to restore and formalize discounted drug pricing for eligible healthcare providers, known as "covered entities." These entities include certain hospitals (like disproportionate share hospitals treating a high percentage of low-income patients), federally qualified health centers, and specialized clinics such as Ryan White HIV/AIDS programs. The intent was to enable these providers to "stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services," as articulated in congressional reports at the time.
Under the 340B program, pharmaceutical manufacturers participating in Medicaid are required to sell outpatient drugs to covered entities at significantly reduced prices, typically determined by a statutory formula based on the average manufacturer price minus a rebate amount. The program was initially modest in scope, starting with about 90 safety-net hospitals, but it built on the framework of the Medicaid Drug Rebate Program by extending similar cost-relief principles to a broader group of providers serving vulnerable populations. Its inclusion in the Veterans Health Care Act reflects its initial tie to veterans' healthcare, though its reach quickly expanded to other safety-net providers. Since its inception, the program has grown significantly, driven by rising drug costs, expansions in eligibility (notably through the Affordable Care Act in 2010), and increased use of contract pharmacies, though its core purpose remains rooted in supporting care for underserved communities.