Bipartisan Hepatitis C Elimination Plan Presents Critical Lame Duck Opportunity

The presidential election results have created an urgent six-week window for advancing the National Hepatitis C (HCV) Elimination plan. With significant changes to federal healthcare policy likely under the incoming administration, Senators Bill Cassidy (R-LA) and Chris Van Hollen (D-MD) see the lame duck session as a critical opportunity to secure this public health initiative. The legislation's prospects benefit from Senator Cassidy's likely chairmanship of the Senate Health, Education, Labor and Pensions (HELP) Committee in the next Congress, providing potential continuity for implementation oversight despite the broader administrative transition.

The Congressional Budget Office's analysis provides compelling economic justification for swift action. Current estimates indicate between 2.5 and 3.0 million people in the United States are living with HCV, yet only one in three people diagnosed receive treatment within 12 months. This treatment gap resulted in over 14,000 deaths from HCV-related complications in 2020 alone - deaths that could have been prevented with existing curative treatments that demonstrate 95% effectiveness.

The scope of this crisis demands federal intervention. State-level efforts, while demonstrating potential, have proven insufficient for achieving elimination goals. The Cassidy-Van Hollen legislation addresses fundamental barriers beyond medication costs, including provider education, treatment infrastructure, and implementation support. These comprehensive elements, combined with projected long-term savings, position this bill as a rare opportunity for bipartisan achievement in public health policy during a period of political transition.

Economic Analysis Reveals Complex Implementation Challenges

The Congressional Budget Office's June 2024 analysis examines two treatment expansion scenarios among Medicaid enrollees, revealing both significant savings potential and implementation complexities. Under a conservative 10% peak increase in treatment rates, averted healthcare spending would reach $0.7 billion over ten years against $0.5 billion in testing and treatment costs. A more aggressive 100% peak increase could generate $7 billion in averted costs against $4 billion in treatment expenses.

These projections, however, exclude critical implementation costs that could significantly impact program effectiveness. The CBO notes successful expansion requires substantial investment in outreach activities, provider education, and infrastructure development. As treatment rates increase, identifying and engaging people who need treatment becomes progressively more complex and costly - a challenge demonstrated by state-level experiments with subscription models.

Louisiana's program illustrates both the potential and limitations of cost-focused approaches. While reducing projected costs from $760 million to $35 million annually and treating over 1,600 people since 2019, treatment rates have steadily declined. Washington state's experience proves more concerning - treatment rates fell below pre-subscription levels, dropping from 6,649 prescriptions in 2017 to 2,409 in 2021.

The CBO's analysis particularly focuses on Medicaid enrollees, noting this population includes many people at elevated risk for HCV, including people who inject drugs and people who have been involved with the criminal justice system. This targeted approach allows for more precise cost projections while addressing a key demographic in HCV elimination efforts. Notably, the standard 10-year budget window may undervalue long-term benefits, as many health complications from untreated HCV develop over decades.

State experiences reveal important lessons for federal policy design. Washington's planned initiatives - including emergency room screening programs, mobile testing units, and expanded clinic access - remained largely unrealized due to budget constraints. Louisiana's model, despite demonstrating viable cost-control mechanisms, approaches expiration without renewal funding. These outcomes emphasize the need for sustained federal support rather than relying on state-level innovation.

Carceral Settings Reveal Critical Implementation Lessons

Treatment access in prisons provides critical insight into healthcare system readiness for HCV elimination. Despite controlled environments ideal for treatment delivery, systematic failures in carceral settings expose fundamental weaknesses in current approaches. Between 2014-2019, 1,013 people died from HCV-related complications while incarcerated, with the prison death rate reaching 10.0 per 100,000 people by 2019 - more than double the 4.3 per 100,000 rate in the general population.

State-level data reveals how policy choices, rather than medical constraints, drive treatment disparities. Florida reported 7,000 untreated cases in 2021 despite court-ordered treatment expansion. Texas provided treatment to only half of its known HCV-positive population of 11,301-15,563 people. Oklahoma's statistics prove particularly alarming - its prison death rate of 71.9 per 100,000 exceeds its general population rate by more than five times, despite the corrections department requesting nearly $100 million for increased treatment.

Recent investigations have catalyzed improvements in several states' treatment protocols. The FDA's 2024 approval of point-of-care testing technology enables rapid diagnosis and treatment initiation in carceral settings. However, implementation remains inconsistent across state systems, with many maintaining restrictive eligibility criteria that delay treatment until people develop severe liver damage. Texas, for example, still lacks universal screening protocols at intake facilities, leaving countless cases unidentified and untreated.

Legal challenges have prompted some progress. Florida, under court order, treated over 3,000 people between 2018 and 2021. Texas agreed to treat at least 1,200 people annually following a 2020 settlement. However, these court-mandated improvements highlight both the potential for rapid treatment expansion and the need for comprehensive federal policy to ensure consistent care delivery.

These systemic failures in controlled environments underscore broader implementation challenges. If consistent HCV treatment proves difficult in settings with stable populations and established healthcare infrastructure, addressing treatment gaps in the general population requires even more robust support systems and sustained funding commitments.

Implementation Barriers Demand Federal Solutions

Provider engagement represents a critical barrier beyond cost reduction. Despite HCV treatment's relative simplicity compared to managing diabetes, primary care providers often hesitate to initiate treatment. A recent study found that while 94% of specialists prescribe HCV treatment, only 23% of primary care providers do so. Insurance authorization processes exacerbate this reluctance - a single prior authorization request consumes 35 minutes of staff time responding to questions often designed to find denial justifications rather than facilitate treatment.

Geographic barriers particularly impact rural communities. In Louisiana, people in certain parishes travel 50-70 miles to reach HCV treatment providers. This distance barrier disproportionately affects people receiving Medicaid who often lack reliable transportation. Rural provider shortages compound these access issues - many rural clinics lack staff trained in HCV care, while others face chronic understaffing that limits capacity for managing complex prior authorization requirements.

Louisiana's experience highlights how workforce challenges undermine treatment expansion even when medication costs are controlled. The state's STI, HIV, and Hepatitis Program struggles with chronic understaffing due to uncompetitive wages and complex contracting arrangements. These staffing limitations directly impact program effectiveness - outreach activities decrease, patient engagement suffers, and treatment initiation rates decline despite medication availability.

The proposed federal legislation addresses these systemic barriers through targeted investments in:

• Provider education and ongoing support programs

• Infrastructure development for treatment expansion

• Resources for patient engagement and retention

• Support for innovative delivery models including mobile clinics

• Integration with existing healthcare systems and substance use treatment programs

• Workforce development and training initiatives

Early state experiences demonstrate that successful implementation requires simultaneous investment across these domains. Washington's inability to realize planned initiatives - including emergency room screening programs and mobile testing units - despite cost controls highlights the need for comprehensive federal support beyond medication access.

Political Window Demands Swift Advocacy Action

The lame duck session presents a rare confluence of political factors favoring HCV elimination policy. Senator Cassidy's likely ascension to HELP Committee chair in the next Congress, combined with his partnership with Senator Van Hollen, bridges current and future implementation efforts. The CBO's projection that a national elimination program could prevent 24,000 deaths and save $18.1 billion in healthcare costs provides compelling economic justification for swift action.

Recent developments strengthen the case for immediate passage. The FDA's approval of point-of-care testing technology enables rapid diagnosis and treatment initiation, particularly in high-impact settings. Louisiana's subscription model expiration creates urgency for federal intervention to sustain successful state initiatives. These factors, combined with potential changes to federal healthcare policy under the incoming administration, make the current legislative window critical for securing comprehensive HCV elimination policy.

The evidence from state experiences demonstrates both the promise and limitations of isolated initiatives. Federal legislation can build on these lessons, providing comprehensive support for implementation while ensuring sustained political commitment through bipartisan leadership. With only weeks remaining in the current congressional session, advocates must emphasize the unique opportunity this moment presents for achieving significant public health progress.

Conclusion

The opportunity for action is narrow, but the potential impact is immense. The bipartisan momentum behind the National Hepatitis C Elimination plan is a chance to advance public health policy at a time when it is desperately needed. The barriers are clear: implementation challenges, provider hesitancy, and geographic and economic obstacles. Yet the solutions are within reach, and the economic and human benefits are undeniable. Federal intervention can address the systemic gaps that state efforts alone cannot fill, providing comprehensive support to save lives and reduce costs.

However, uncertainty looms over the future of public health funding and support under a second Trump Administration, which looks to bring significant changes to federal healthcare priorities. This adds urgency to the current push for bipartisan action.

As advocates, the time to push is now. The lame duck session represents a rapidly closing window to secure funding, address legislative gaps, and ensure continuity into the next Congress. Swift passage of this legislation would not only demonstrate the power of bipartisan collaboration but also offer a meaningful legacy—one that saves thousands of lives and sets a precedent for effective, equitable public health initiatives in the United States. We cannot afford to let this window close without taking action.

The Promise of a Cure: Why Are We Still Failing People with HCV?

Hepatitis C virus (HCV) infection affects millions of Americans, contributing to thousands of preventable deaths each year. While a cure for HCV, in the form of direct-acting antiviral (DAA) medications, has been available for over a decade, achieving widespread treatment access has been a persistent challenge. This challenge is particularly acute among younger adults, who experience the highest rates of new HCV transmissions, often associated with injection drug use.

Historically, the high cost of DAAs led many state Medicaid programs to implement restrictive coverage policies, limiting treatment access based on factors like liver disease severity, sobriety, and prescriber specialty. In 2022, CANN highlighted in a blog post, these policies not only created barriers to care but also undermined public health efforts to interrupt HCV transmission. Advocacy and legal action have played a crucial role in dismantling these restrictions, as evidenced by the Center for Health Law and Policy Innovation's (CHLPI) successful litigation efforts in 13 states, which served as a model for similar efforts nationwide.

While this progress is encouraging, the fight to eliminate HCV as a public health threat is far from over. We must address the remaining barriers to care, particularly those that continue to disproportionately impact people who use drugs and those that persist within managed care organizations.

The Promise and Progress of HCV Treatment

Direct-acting antivirals represent a monumental advancement in HCV treatment. These medications offer cure rates of 95% or higher, achieving sustained virologic response in the vast majority of people treated. The benefits of DAA treatment extend far beyond individual health outcomes. Expanding access to these curative therapies holds immense promise for improving public health by reducing HCV-related mortality, interrupting transmission chains, and generating long-term cost savings.

The Centers for Disease Control and Prevention (CDC) has estimated that approximately 14,200 HCV-related deaths occurred in the United States in 2019 alone, a stark reminder of the urgent need for effective treatment. Treating HCV not only saves lives but also prevents ongoing transmission of the virus. When a person achieves sustained virologic response, they are no longer able to transmit HCV to others. Furthermore, a study published in JAMA Network Open found that HCV treatment is associated with reduced healthcare costs in the long term, as cure prevents the need for expensive interventions related to managing complications like cirrhosis and liver cancer.

The dismantling of restrictive Medicaid policies has been instrumental in increasing treatment access. A JAMA Health Forum study analyzing data from 39 state Medicaid programs found that easing or eliminating restrictions on DAAs led to a significant increase in treatment uptake. Specifically, these policy changes were associated with an increase of 966 DAA treatment courses per 100,000 Medicaid beneficiaries per quarter compared to states that maintained restrictions. This finding underscores the tangible impact of removing barriers to care.

Further progress is evident in the growing trend of states removing prior authorization requirements for DAAs. The 2024 National Snapshot Report from CHLPI and National Viral Hepatitis Roundtable (NVHR) reveals that, for the first time, more states have eliminated prior authorization for most patients than those that still require it. This shift toward streamlining access represents a critical step in ensuring timely treatment initiation.

Persistent Barriers to HCV Treatment Access

Despite the progress made in expanding HCV treatment access, significant barriers remain, particularly for people who use drugs. The 2024 National Snapshot Report from CHLPI and NVHR reveals that nine states still impose substance use restrictions, requiring sobriety or counseling as a prerequisite for DAA treatment. These restrictions are not only medically unnecessary but also demonstrably harmful, as the JAMA Network Open study found a significant association between sobriety requirements and reduced HCV treatment rates. The HealthHIV State of Harm Reduction survey further underscores this point, with respondents reporting that stigma and community resistance pose substantial obstacles to accessing drug user health services, including HCV care.

Retreatment restrictions present another hurdle for people seeking HCV care. According to the 2024 National Snapshot Report, 15 states impose stricter criteria for retreatment than for initial therapy, often denying access based on factors like adherence challenges or previous treatment failure. These policies fail to recognize the complex social and structural factors that can contribute to reinfection or treatment interruptions, particularly among people who use drugs.

Furthermore, disparities in treatment rates among Medicaid recipients persist. The CDC's Vital Signs report found that Medicaid recipients who are Black were 7% less likely to initiate timely DAA treatment compared to White recipients. These disparities reflect the systemic inequities that permeate the healthcare system and demand targeted interventions to ensure equitable access to care.

Discrepancies between state Medicaid policies and managed care organization (MCO) practices present an additional layer of complexity. While many states have eased restrictions on DAAs, the JAMA Health Forum study revealed that these policy changes did not translate into increased treatment uptake in states where DAAs were predominantly reimbursed by MCOs. This finding aligns with the 2022 National Summary Report from CHLPI and NVHR, which found that MCOs often impose more restrictive criteria for HCV treatment access than their fee-for-service counterparts.

These persistent barriers raise serious ethical concerns. Denying treatment based on substance use or adherence challenges perpetuates harmful stereotypes and undermines the principles of patient autonomy and healthcare equity. As Jen Laws argues, "We don't get to tell patients how to prioritize their care based on a payer or provider's biases." The HealthHIV harm reduction survey echoes this sentiment, with respondents emphasizing the importance of meeting people "where they're at" and respecting their right to make informed decisions about their health.

Other administrative barriers, such as requirements to fill prescriptions at specialty pharmacies, further complicate access. The 2022 National Summary Report highlights the challenges posed by specialty pharmacies, which often impose additional restrictions and logistical hurdles that can delay or prevent treatment initiation, particularly for people experiencing homelessness or housing instability.

Harm Reduction and HCV Elimination: A Holistic Approach

Achieving HCV elimination requires a holistic approach that goes beyond simply removing treatment restrictions. We must recognize that HCV treatment access is inextricably linked to broader harm reduction efforts. As Jen Laws aptly stated, "If we are to meaningfully invest in harm reduction policies at the intersection of drug use and HCV, we have to get a handle on what's working and what's not." This means embracing a comprehensive strategy that addresses the social, economic, and structural factors that contribute to HCV risk and disparities.

A 50-state survey of harm reduction laws conducted by the Network for Public Health Law revealed significant variations in the legal landscape surrounding syringe access and naloxone distribution. These variations underscore the need for a coordinated national effort to expand access to these life-saving interventions. The HealthHIV State of Harm Reduction survey further highlights the importance of harm reduction in HCV prevention and care, with respondents emphasizing the need for services that prioritize their safety and well-being.

A truly comprehensive approach to HCV elimination must encompass the following key elements:

• Removal of All Remaining Medicaid Restrictions: Eliminating all restrictions based on substance use, retreatment history, and other arbitrary factors is essential for ensuring equitable access to DAAs.

• Ensuring Parity Between State Medicaid Policies and MCO Practices: States must strengthen oversight and enforcement mechanisms to ensure that MCOs adhere to state Medicaid policies and do not impose additional barriers to HCV treatment.

• Expanding Access to Harm Reduction Services: Increasing the availability of syringe exchange programs, naloxone distribution, and other harm reduction services is critical for preventing new HCV transmissions and connecting people who use drugs to care. However, even in states that do have syringe exchange programs, access can vary widely, with many programs facing funding limitations, geographic restrictions, and community resistance. For example, a 2017 report indicated that 26 states had either no syringe exchange programs or limited these services to one or two major cities. Research suggests that existing programs meet only a fraction of the estimated need, highlighting the need for continued advocacy and policy reform.

• Addressing Social Determinants of Health: HCV elimination efforts must address the underlying social and economic factors that contribute to HCV risk and disparities, such as poverty, homelessness, and lack of access to healthcare. The HealthHIV harm reduction survey found that inadequate housing and transportation were significant barriers to clients engaging in care. Investing in housing, transportation, and other social support services is necessary for creating a more equitable and effective HCV response.

The Biden Administration's proposed HCV elimination plan offers a transformative framework for addressing many of these challenges. The plan's key elements include a subscription-based payment model for medications, investment in rapid point-of-care testing, and increased federal support for community-based healthcare infrastructure and provider training. However, as CANN CEO Jen Laws emphasizes, successful implementation requires more than just affordable drugs. The plan must prioritize reinvestment of cost savings into public health systems, support community-based testing and integrated treatment models, and address logistical barriers to care. Federal legislation mandating opt-out HCV screening in hospitals, universal screening in prisons, and cost-sharing limits on commercial insurance plans would further strengthen the plan's foundation.

Conclusion

While significant progress has been made in expanding HCV treatment access, the fight to eliminate HCV as a public health threat demands a sustained and multifaceted effort. The Biden Administration's proposed plan offers a promising roadmap, but its success hinges on congressional budget approval and addressing the systemic barriers that continue to impede progress.

To effectively combat HCV, we must move beyond a narrow focus on medication access and embrace a holistic approach that prioritizes harm reduction, addresses social determinants of health, and ensures equitable access to care for all. CANN’s latest HIV/HCV Co-Infection Watch report provides a valuable resource for understanding the current landscape of HCV treatment access and harm reduction programs across the United States, empowering advocates and communities to push for meaningful change. Together, we can translate the promise of a cure into a reality for all Americans affected by HCV.

Addressing the High Burden of HCV in HIV-Positive MSM

The threat of Hepatitis C (HCV) co-infection casts a long shadow over the lives of men who have sex with men (MSM) living with HIV, demanding a swift and decisive response. Globally, 7% of this group also faces chronic HCV infection—a disproportionately high burden compared to the estimated 1% prevalence in the general population. A recent meta-analysis published in Health Sciences Reports, which synthesized data from 56 studies across various countries, also revealed a 9% global prevalence of hepatitis B virus (HBV) among MSM living with HIV, further highlighting their vulnerability to viral hepatitis co-infection.

While highly effective direct-acting antiviral (DAA) therapies offer a cure for HCV, access to these life-saving medications remains uneven, perpetuating health disparities and undermining global elimination efforts. This disparity is driven by a complex interplay of factors, including shared transmission routes for HIV and HCV, persistent stigma surrounding both viruses, and structural barriers such as poverty, homelessness, and lack of access to healthcare.

To dismantle these barriers and chart a path towards HCV elimination and health equity, we need a comprehensive strategy. This includes expanding ADAP coverage of DAA therapies, streamlining convoluted authorization processes, and implementing tailored interventions that address the unique needs and vulnerabilities of MSM living with HIV.

The Case for DAAs

The advent of direct-acting antiviral (DAA) therapies has revolutionized HCV treatment, offering a cure for a disease that was once considered a chronic, debilitating condition. DAAs are now the standard of care for HCV, providing a safe and effective cure for most people within a relatively short treatment duration, typically 8 to 12 weeks.

The benefits of DAA treatment extend beyond curing HCV. Studies have demonstrated a profound impact on long-term health outcomes, including a lower risk of both liver and non-liver complications. A large, real-world analysis published in JAMA Internal Medicine found that DAA therapy was associated with a remarkable 57% reduction in all-cause mortality among patients with chronic HCV. This underscores the life-saving potential of these medications and the importance of ensuring timely access for all who need them.

The Economics of DAAs

Despite the high initial cost of DAAs, concerns about affordability are countered by the substantial long-term cost savings they generate. A 2022 study in the Journal of Managed Care & Specialty Pharmacy demonstrated that treating HCV with DAAs in the Veterans Affairs (VA) system resulted in $7 billion in savings over a lifetime compared to pre-DAA treatments. These savings are achieved through reduced healthcare utilization, as fewer patients experience the costly complications of advanced liver disease. The study further highlighted that DAAs become less expensive than both pre-DAA treatments and no treatment within just five years, demonstrating a rapid return on investment.

The budgetary impact of expanded HCV treatment extends beyond individual payers like the VA. The Congressional Budget Office (CBO) has reported that increased HCV treatment leads to net budget savings for the federal government due to averted healthcare spending. Even a modest 10% increase in Medicaid treatment rates could save $700 million over 10 years, according to the CBO's estimates. This underscores the fiscal responsibility of investing in HCV elimination efforts, as treating the disease upfront prevents more costly interventions down the line.

Furthermore, the CBO highlights the importance of considering the long-term budgetary impact of HCV treatment, particularly the savings that accrue beyond the typical 10-year budget window. As HCV is a slow-progressing disease, the full economic benefits of treatment may not be realized within a decade. By taking a longer-term perspective, policymakers can better appreciate the true value of investing in HCV elimination and the potential for significant cost savings over time.

The Consequences of Limited Coverage

Despite the transformative potential of DAAs and the compelling evidence for their cost-effectiveness, access to these life-saving therapies remains uneven for people living with HIV (PLWH). A significant barrier is the limited coverage of HCV therapies by some state AIDS Drug Assistance Programs (ADAPs). CANN's HIV/HCV Co-Infection Watch for April 2024 reveals that only 47 out of 56 ADAPs in the United States offer some form of coverage for HCV treatment, meaning that a substantial number of PLWH, particularly those who rely on ADAPs as a safety net, face significant financial barriers to accessing the care they need.

This echoes the challenges faced within Medicaid programs, where restrictive policies driven by cost concerns have historically limited HCV treatment access. A 2024 study published in JAMA Health Forum analyzed data from 39 state Medicaid programs and found that easing restrictions related to liver disease severity, sobriety, or prescriber specialty led to a substantial increase in DAA utilization. Specifically, these policy changes were associated with an increase of 966 DAA treatment courses per 100,000 Medicaid beneficiaries each quarter. This evidence strongly suggests that similar policy shifts within ADAPs could significantly expand access to curative therapies for PLWH.

The consequences of limited ADAP coverage are far-reaching. Without access to DAAs, PLWH face a higher risk of progressing to advanced liver disease, experiencing debilitating complications, and ultimately succumbing to HCV-related mortality. This not only jeopardizes patient health outcomes but also undermines public health efforts to control and eliminate HCV. Furthermore, the financial burden imposed by limited coverage exacerbates existing health disparities. People of color, low-income persons, and those living in rural areas are more likely to rely on ADAPs and also experience higher rates of HCV infection. Denying them access to curative treatment perpetuates a cycle of inequity, further entrenching health disparities and undermining the goal of achieving health justice for all.

Policy Barriers and Provider Discouragement

The path to HCV treatment for MSM living with HIV is fraught with obstacles, a tangled web of restrictive policies and a healthcare system that often fails to prioritize their needs. Compounding the challenges of limited ADAP coverage are state-level restrictions that create a patchwork of barriers, disproportionately impacting vulnerable populations. Stringent eligibility criteria, complex authorization processes, sobriety requirements, and limited provider networks—often justified by cost concerns—prioritize short-term budget considerations over the long-term health and well-being of PLWH.

These policy barriers intersect with personal and systemic biases to create a system that perpetuates inequities in HCV care. A 2019 study published in the International Journal of STD & AIDS revealed that Medicare enrollees and patients with drug abuse diagnoses were significantly less likely to initiate DAA treatment, highlighting the impact of cost-sharing requirements and stigma. Stigma surrounding substance use can discourage patients from seeking treatment or disclosing their drug use history, while providers may harbor biases about the effectiveness of DAAs in this population.

This complex landscape also contributes to provider discouragement, further limiting access to HCV care. The administrative complexity of ADAPs, with their varying formularies, eligibility criteria, and authorization processes, creates a confusing and burdensome system for providers. Many providers also lack familiarity with newer DAA regimens and the latest treatment guidelines, particularly those who primarily focus on HIV care. Persistent stigma surrounding HCV and substance use can also lead to provider fatigue and bias, compounding these challenges.

Moving Towards Equitable HCV Care and Elimination

The evidence is clear: MSM living with HIV face significant and unjust barriers to accessing life-saving HCV treatment. We must act decisively to dismantle these barriers and create a healthcare system that prioritizes equity, accessibility, and the well-being of all PLWH.

Achieving this vision requires a bold policy agenda that addresses the systemic issues driving disparities in HCV care. We must demand action from policymakers and hold them accountable for creating a more just and equitable healthcare system.

Policy Changes are Needed:

1. Mandate DAA Coverage for All ADAPs: Every state ADAP must be required to cover all FDA-approved DAA regimens for HCV treatment, ensuring that no PLWH is denied access to a cure based solely on their geographic location.

2. Streamline Prior Authorization Processes: The administrative burden of navigating complex and inconsistent prior authorization processes within ADAPs discourages both providers and patients. We must demand a streamlined, standardized system, ideally with a single prior authorization form that can be used across all payers, including ADAPs and Medicaid, as recommended by NASTAD. Better yet, remove the need for prior authorizations all together.

3. Increase Funding Allocations for ADAPs: ADAPs are a lifeline for PLWH, yet these programs are chronically underfunded. We must advocate for increased federal and state funding allocations, ensuring they have the resources to provide comprehensive HCV care, including DAA treatment, without imposing undue restrictions.

4. Expand Financial Assistance Programs for Medicare Enrollees: Medicare's cost-sharing requirements create a significant financial barrier to DAA access for many PLWH. ADAPs must expand financial assistance programs to cover out-of-pocket costs for DAA treatment for Medicare enrollees with HIV/HCV co-infection.

These policy recommendations are concrete steps that can be taken to create a more just and equitable healthcare system for PLWH. By advocating for these changes, we can dismantle the barriers to HCV treatment, improve health outcomes, and move closer to eliminating HCV.

Tailored Interventions: Addressing the Unique Needs of MSM Living with HIV

While expanding ADAP coverage and addressing cost concerns are crucial, policy changes alone are insufficient to achieve equitable HCV care. We must also invest in tailored public health interventions that address the unique needs of MSM living with HIV.

This includes:

• Targeted Testing and Linkage to Care: MSM living with HIV should be routinely screened for HCV, with a focus on re-engaging those who have fallen out of care or disengaged from traditional healthcare settings. Implementing targeted testing programs in community-based organizations, substance use treatment facilities, and MSM-centric settings, coupled with robust linkage to care services, is essential.

• Peer Support Programs: Peer support programs, led by MSM living with HIV who have successfully navigated HCV treatment, can be powerful tools for addressing stigma, providing emotional support, and promoting adherence to DAA regimens.

• Provider Training and Education: Provider training programs are necessary for addressing implicit bias, promoting harm reduction, and fostering patient-centered communication. These programs should equip providers with the knowledge, skills, and attitudes necessary to provide equitable and compassionate care to all PLWH, regardless of substance use history or other social challenges.

By investing in these tailored interventions, we can create a more responsive and equitable healthcare system that meets the unique needs of MSM living with HIV. Combining policy reform with targeted programmatic efforts will empower PLWH to access life-saving HCV treatment, improve health outcomes, and advance our shared goal of eliminating HCV.

A Shared Responsibility for Health Equity

The disproportionate burden of HCV among MSM living with HIV is a reminder of the persistent health disparities that plague our healthcare system. We have the tools to eliminate HCV, yet systemic barriers and inequities continue to impede access to life-saving treatment for many vulnerable populations.

Addressing HCV co-infection among MSM living with HIV is critical for improving patient health outcomes and essential for achieving broader public health goals, including the Ending the HIV Epidemic (EHE) initiative. Eliminating HCV among PLWH will reduce liver-related morbidity and mortality, improve overall health, and contribute to reducing HIV transmission.

Achieving HCV elimination and health equity for all PLWH is a shared responsibility. Policymakers must enact bold reforms that expand access to DAAs, simplify authorization processes, increase funding for ADAPs, and address systemic inequities. Healthcare providers must embrace patient-centered care, commit to ongoing education, and actively dismantle stigma and bias. Communities must mobilize to advocate for change, support peer-led initiatives, and create a culture of support and empowerment for PLWH.

The time for action is now. By working together, we can create a healthcare system that upholds the dignity and well-being of all PLWH, ensures equitable access to life-saving HCV treatment, and paves the way for a future free from the burden of this devastating disease.

Equitable and Data-Driven Viral Hepatitis Quality Measures

Viral hepatitis remains a significant public health threat in the United States, affecting approximately 3.3 million people with chronic hepatitis B and C infections. In 2021, there were 12,715 reported cases of chronic hepatitis B (HBV) and 117,105 reported cases of chronic hepatitis C (HCV). Despite the availability of effective treatments, these infections disproportionately impact marginalized communities, including people who inject drugs, those experiencing homelessness, and Black and Indigenous populations. This reality underscores the urgent need for a comprehensive and equitable approach to viral hepatitis care.

Recognizing this challenge, the U.S. Department of Health and Human Services’ (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) has issued a call for public comment on proposed viral hepatitis quality measures for Medicaid. This initiative, aimed at supporting the nation's goal of eliminating viral hepatitis by 2030, focuses on a crucial measure: hepatitis C screening and treatment initiation.

OIDP's call for public comment presents a critical opportunity to advance health equity, strengthen data-driven decision-making, and foster collaboration to accelerate progress towards eliminating viral hepatitis as a public health threat. Engaging in this process is essential for ensuring that the final measures effectively address disparities, improve care, and ultimately save lives.

The Landscape of Disparities and the Need for Action

The urgency for action is amplified by the significant disparities that exist in HCV care. Research consistently demonstrates that Black, Indigenous, and people of color, as well as those with lower socioeconomic status, face significant barriers to timely diagnosis and treatment. A study of Medicare beneficiaries found that while disparities in Direct-Acting Antiviral (DAA) use between Black and White patients narrowed by 2016, socioeconomic disparities persisted, with those receiving a Part D low-income subsidy less likely to access these life-saving medications. As the researchers noted, "DAA use among Medicare patients remained far below the level needed to eradicate HCV. The black-white gap in HCV treatment was closed by 2016, but disparities by patient socioeconomic status remained."

These disparities are deeply intertwined with social determinants of health. Factors such as poverty, limited access to healthcare, inadequate transportation, and low health literacy create significant obstacles to receiving quality HCV-related care. As one study aptly pointed out, "A variety of elements contribute to lower quality of care in rural areas, including shortages of medical equipment and services, poor health literacy, lack of transportation, and travel time and long distances."

Quality measures offer a vital tool for dismantling these barriers and fostering health equity. By tracking screening rates, treatment initiation, and outcomes across different populations, quality measures can illuminate where disparities exist and guide targeted interventions. They provide a data-driven framework for holding healthcare systems accountable for providing equitable care and for measuring progress towards eliminating viral hepatitis.

Analyzing the Proposed Measures

At the heart of OIDP’s proposal lies the HCV screening and treatment initiation measure. This measure, designed to track the percentage of Medicaid beneficiaries who receive both timely screening and treatment for HCV, is structured with a clear numerator and denominator. The numerator encompasses those Medicaid members who are screened for HCV and, if diagnosed, initiate treatment within a specified timeframe. The denominator includes all adult Medicaid enrollees within a defined age range, excluding those with evidence of Medicare or third-party insurance coverage.

This measure, viewed through an equity lens, holds immense potential for dismantling the barriers that prevent marginalized communities from accessing life-saving HCV care. By promoting universal screening, the measure encourages a proactive approach to diagnosis, reaching people who might otherwise remain unaware of their infection until they experience serious complications. Furthermore, the focus on timely treatment initiation is crucial for addressing disparities in treatment access. By tracking this metric, healthcare systems can be held accountable for ensuring that all patients diagnosed with HCV receive prompt and effective treatment, regardless of their background or socioeconomic status.

The transcript from HHS’s Viral Hepatitis Quality Measures Technical Consultation Meeting provides compelling insights into how similar measures have been leveraged at the state level to advance health equity. Dr. Su Wang, a clinician and advocate deeply involved in hepatitis care, shared her perspective, stating, "We really believe, those of us who have been doing this clinical work and also advocacy work, that quality metrics can really help us achieve hepatitis elimination by 2030." This sentiment is echoed by the experiences of states like Michigan, which has implemented a suite of HCV quality measures, including those focused on screening during pregnancy and medication adherence. These measures have not only helped Michigan track progress towards elimination but have also provided valuable data for identifying and addressing disparities in care.

Data Considerations

The success of this measure hinges on the feasibility of data collection and the robustness of the data sources used. While claims data, readily available through Medicaid programs, offer a practical starting point for tracking screening and treatment initiation, this source has limitations. Claims data primarily capture billing codes, which may not fully reflect the nuances of clinical encounters or capture social determinants of health that influence care access.

Electronic Health Record (EHR) data, on the other hand, hold a wealth of clinical information that can provide a more comprehensive picture of patient care. As noted during the technical consultation meeting, "There's a lot more information, digitally available through EHRs, health information exchanges, etc. that are readily available and allows us to get closer to real-time measurement and response." Leveraging EHR data could enhance the measure's accuracy and timeliness, enabling more rapid identification of disparities and interventions. However, widespread use of EHR data for quality measurement faces challenges, including variations in EHR systems, interoperability issues, and privacy concerns.

Additionally, capturing the influence of social determinants of health requires going beyond traditional clinical data sources. Integrating data from community organizations, social service agencies, and patient surveys could provide valuable insights into the social and economic factors that shape health outcomes. This multifaceted data approach, while complex, is essential for developing a truly equitable and effective hepatitis C quality measure.

Collaborative Action

The successful implementation of the HCV quality measure demands a collaborative approach that transcends traditional silos and brings together a diverse array of stakeholders. Public health agencies, Medicaid programs, healthcare providers, community organizations, and, most importantly, patients themselves must be actively engaged in the process.

The transcript from the technical consultation meeting showcases inspiring examples of collaborative action from states at the forefront of viral hepatitis elimination efforts. In Pennsylvania, the Department of Human Services (DHS) and the Department of Health (DOH) forged a strong partnership to drive their elimination plan, recognizing the critical role of Medicaid in reaching those most impacted by HCV. As Lauren Orkis, HBV supervisor at the Pennsylvania DOH, emphasized, "Our Medicaid partners are absolutely critical in our elimination planning efforts, statewide. So we made the partnerships strong between DHS and DOH in Pennsylvania from the get-go as we got our elimination plan underway."

Similarly, Washington State's Bree Collaborative, a legislatively mandated group focused on quality improvement for Medicaid, exemplifies the power of multi-stakeholder engagement. This collaborative, which includes representatives from various sectors, has been instrumental in developing and recommending quality measures for a range of health issues, including HCV. By bringing diverse perspectives to the table, these collaborative models foster innovation, ensure buy-in from key stakeholders, and pave the way for effective implementation.

Conclusion

OIDP's call for public comment on proposed viral hepatitis quality measures presents a defining moment in the fight against this silent epidemic. By engaging in this process, we have the power to shape measures that not only track progress but also drive meaningful change, reduce disparities, and improve the lives of millions. Let us seize this opportunity to advocate for equity, data-driven decision-making, and collaborative action.

Submit your comments, raise your voice, and join the movement to eliminate viral hepatitis. Together, we can ensure that quality measures become powerful tools for achieving health equity and creating a future where viral hepatitis is no longer a threat to our communities. The path to elimination is within reach, and quality measures, shaped by our collective voice, can light the way.

HCV Cases Down, But Not Out

The Centers for Disease Control and Prevention (CDC) recently released data analysis from 2022 indicating a 6% decrease in new viral Hepatitis C (HCV) infections, a revelation that leaves infectious disease specialists cautiously optimistic. Yet, despite the existence of a cure, thousands of Americans still die needlessly from this disease each year. Systemic barriers – restrictive insurance policies, inefficient testing, and neglect of marginalized communities – prevent many from accessing the lifesaving treatment they need. These failures fuel a public health crisis, with over 14,000 Americans dying from HCV complications in 2020 alone. The most vulnerable suffer the worst consequences, including young people, people impacted by substance use and the justice system, and those experiencing homelessness. While experts remain cautious, this decline after a decade of steady increases could signal a turning point. "We've had a decade of bad news…I am cautiously encouraged," said Daniel Raymond, director of policy at the National Viral Hepatitis Roundtable. "This could be a sign the tide has turned."

Systemic Barriers to HCV Care

Despite the existence of a cure, a shockingly low percentage of those with HCV achieve viral clearance. Systemic barriers rooted in insurance practices, fragmented testing, and neglect of marginalized communities prevent countless Americans from accessing the treatment they need.

Insurance Roadblocks

Insurance restrictions present a formidable obstacle to HCV treatment, often creating a maze of administrative hurdles. State Medicaid programs frequently require proof of months-long sobriety, specialist-only prescriptions for treatment, or evidence of existing liver damage before approving care. These arbitrary restrictions fly in the face of medical best practices and delay treatment, increasing the risk of liver failure, liver cancer, and even death.

Even those with commercial insurance face barriers to HCV care. Despite the high cost of HCV medications, many insurers impose prior authorization requirements. These delays, coupled with restrictive formularies and high copays, discourage patients and providers. The fact that only about 50% of commercially insured patients in a recent CDC study achieved viral clearance speaks volumes about how deep-seated this issue is, impacting people regardless of their insurance status.

The Burden of Diagnosis

A shocking number of people live with Hepatitis C without knowing it, with the CDC estimating over 40% of those infected are unaware of their status. This highlights a problem of insufficient screening and inefficient testing procedures. The current multi-step diagnostic process, requiring separate blood draws for the initial HCV antibody check and subsequent confirmation, creates logistical barriers. Many face issues like needing multiple appointments, additional travel costs, or potential delays in results.

Populations most impacted by HCV, including young people, those experiencing homelessness or substance use, and people who are incarcerated, often face additional challenges accessing even basic healthcare. Routine HCV screening within prisons, expanded outreach testing in underserved communities, and integration of HCV screening into substance use treatment programs are essential to reaching those at heightened risk.

Modern medicine offers rapid point-of-care tests for many conditions, including HIV. Similar technology exists for HCV, yet approval and widespread use lag behind. Streamlining the diagnostic process through rapid, single-visit testing would revolutionize care by connecting people to treatment far earlier, minimizing disease progression and preventing transmission.

How Barriers Foster Disparities

HCV treatment disparities highlight a system that consistently fails our most vulnerable populations. Cure rates are lowest among those without insurance and people on Medicaid, a stark reflection of restrictive insurance practices and a lack of support to navigate complex healthcare systems. The disease disproportionately impacts marginalized communities, including:

• Young People: Driven by the opioid crisis, new HCV cases have surged among millennials and Gen Z, with over 60% of new chronic infections found in these younger populations. This highlights the need for increased prevention and treatment efforts tailored to this age group.

• People Experiencing Homelessness: Lack of stable housing leads to missed appointments, medication storage issues, and prioritization of immediate survival over long-term health concerns.

• Incarcerated People: An estimated 13% of those moving through prisons and jails annually have HCV, yet treatment is rarely offered. Post-release, they face navigating insurance and accessing care with limited support.

• Those with Substance Use Disorders: Stigma and outdated treatment requirements often bar this population from receiving HCV care. Integrated treatment models, combining HCV care with substance use treatment and harm reduction services, are vital to reaching this underserved population.

Untreated HCV is a Public Health Threat

The systemic barriers discussed – restrictive insurance practices, the cumbersome diagnostic process, and inadequate outreach to marginalized communities – contribute to a critical public health issue: a significant portion of people living with HCV remain undiagnosed and untreated. This compromises their health and increases the risk of unknowingly transmitting the virus through unprotected sex or sharing drug paraphernalia. Ensuring equitable access to HCV testing, treatment, and care is essential to protecting public health. By dismantling these barriers and ensuring everyone has the opportunity to be diagnosed and cured, we can protect those most vulnerable and achieve a future free from HCV.

Cost of Inaction

The human and economic toll of failing to address HCV is staggering:

• Deaths: More than 14,800 Americans died from HCV-related complications in 2020.

• Liver Cancer: HCV is a leading cause of liver cancer, with rates of new cases rising 38% between 2003 and 2012.

• Economic Burden: The Biden Administration's proposed HCV elimination plan projects that over 10 years, it would prevent 24,000 deaths and save $18.1 billion in healthcare costs.

National Strategy & the Biden Plan

The persistent low cure rates, widening health disparities, and the staggering human and economic cost of untreated HCV reveal that relying on any single solution won't achieve elimination. A coordinated national strategy is essential to overcome existing systemic failures and ensure that no one falls through the cracks. The Biden Administration's proposed HCV elimination plan offers a transformative framework for addressing these challenges, but its success hinges on learning from the lessons of past initiatives.

Key Elements of the Biden Plan:

• The "Netflix Model": To address insurance barriers, this model proposes a subscription approach, where the government negotiates a fixed price with drug companies to provide treatment for vulnerable groups (uninsured, Medicaid, incarcerated, and others). This simplifies coverage and ensures those who need it most can access life-saving medication.

• Rapid Testing & Community Focus: Investment in rapid point-of-care testing would enable same-day diagnosis and treatment initiation, revolutionizing care. Federal funding to support expanded testing in non-traditional settings, like mobile clinics, prisons, and substance use treatment centers, would directly reach the populations most impacted by HCV.

• Federal Support & Coordination: Centralized guidance, resources, and funding for healthcare providers are crucial for expanding screening, streamlining care models, and educating both providers and communities.. This investment in public health infrastructure would create a ripple effect, increasing capacity for effective HCV treatment long-term.

Subscription models like those piloted in Louisiana and Washington have demonstrated the potential to reduce medication costs. However, as Jen Laws, CEO of CANN, highlights, even with affordable drugs, systemic shortcomings remain a significant barrier to care. The Biden Plan must recognize that:

• Price isn't the only issue: Drug costs are a major factor but investment in community-based healthcare infrastructure, provider training, outreach programs, and addressing logistical barriers to care and testing are just as crucial.

• Reinvestment of savings is key: The substantial cost-savings generated from the "Netflix model" must be reinvested directly into strengthening public health systems, ensuring long-term success.

• Policy-driven solutions are essential: Federal legislation mandating opt-out HCV screening in hospitals, universal screening in prisons, and cost-sharing limits on commercial insurance plans would provide a powerful foundation to support and guide the Biden Plan.

Addressing Disparities

The Biden Plan's focus on equity directly confronts the health disparities highlighted earlier. By specifically targeting uninsured and Medicaid populations, it helps ensure that financial barriers don't translate into needless deaths. The emphasis on community-based testing and integrated treatment models is crucial for reaching marginalized populations like:

• Young People: Increased outreach and testing aligned with this age group is vital to curbing the surge of new infections fueled by the opioid epidemic.

• People Experiencing Homelessness: Integrating HCV screening and care into supportive services for this population is essential to address their often complex healthcare needs.

• Incarcerated People: By treating HCV within prisons, not only would patient health outcomes improve, but it could also help prevent transmission within facilities and in communities upon release.

• Those with Substance Use Disorders: The plan's support for harm reduction strategies and integrated treatment models recognizes the need to address HCV without discriminatory sobriety restrictions.

The Cost-Benefit Argument

The Biden Plan isn't just compassionate; it's a sound fiscal investment. Projections indicate it would save 24,000 lives and $18.1 billion in healthcare costs over ten year. By preventing long-term HCV complications like liver failure, cancer, and transplants, we can reduce the significant future economic burden of this preventable disease.

Despite a small, yet significant decrease in new HCV infections, there remains the staggering toll of untreated HCV. The promise of the Biden Plan demands immediate action, according to advocates, because it addresses preventable deaths, widening health disparities, and the economic strain of a solvable public health crisis. It will take a larger, systemic approach to remove many of the barriers impending the elimination of Hepatitis C in the United States.

Alcohol Use Does Not Harm DAA Efficacy, Yet Payer Barriers Persist

In healthcare, the interplay between perceptions and policies can sometimes adversely affect the very individuals they intend to benefit. One such area of contention is the perceived impact of alcohol use on the effectiveness of treatments for hepatitis C Virus (HCV). A recent study, published in JAMA Network Open and spotlighted by MedPage Today, led by Christopher T. Rentsch, PhD, and co-authored by Emily J. Cartwright, MD, explored this relationship. Their findings were clear: alcohol use and alcohol use disorder (AUD) did not diminish the odds of achieving a sustained virologic response with Direct-Acting Antiviral (DAA) therapy for chronic HCV infection.

Yet, despite such evidence, certain clinicians still hesitate or even refuse to administer HCV therapy to patients who consume alcohol. Furthermore, some payers mandate alcohol abstinence as a precondition for reimbursing DAA therapy for HCV. This stance becomes even more alarming in light of the Center for Disease Control & Prevention's (CDC) recent data, which shows a staggering 129% surge in reported cases of acute hepatitis C since 2014. It's imperative that we prioritize evidence over misconceptions, especially when lives are at stake.

The NIH's Perspective

A study supported by the National Institutes of Health (NIH) echoes these findings, revealing that individuals with alcohol use disorder (AUD) are less likely to receive antiviral treatments for hepatitis C. Despite current guidelines recommending such treatment irrespective of alcohol use, the study, led by scientists at Yale University, found that those with AUD, even if they were currently abstinent, were less likely to receive curative DAA treatment for hepatitis C within one or three years of diagnosis compared to those without AUD. This treatment gap, attributed to stigma around substance use and concerns about treatment adherence, underscores the need to address these disparities, especially among those with AUD.

The Case for Change

The implications of these studies are clear: policies need revision. Evidence-based policies in healthcare are paramount. Denying HCV patients access to DAA therapy based on their alcohol consumption habits is not only unwarranted but also counterproductive. As the study's authors have highlighted, such restrictions could pose unnecessary barriers for patients and hinder efforts to eliminate HCV.

Both state-specific policies and national guidelines, like those from The American Association for the Study of Liver Diseases (AASLD), need to evolve in light of these findings. Healthcare providers, policymakers, and advocacy groups have a pivotal role in driving this change, ensuring that all HCV patients, irrespective of their alcohol consumption habits, have access to the best possible care.

Charting a Path Forward

The revelations from these studies underscore more than just the need for policy adjustments; they challenge our collective commitment to championing evidence-based healthcare. In an era where misinformation can easily cloud judgment, it's crucial that treatments for HCV are not just theoretically available but are genuinely accessible to all, regardless of their alcohol consumption habits.

The findings from both the NIH and JAMA studies don't merely point out gaps; they expose deep-rooted systemic issues. Current policies have not adequately addressed the needs of HCV patients, and there's a pressing need for more inclusive guidelines.

To transform this call to action into tangible progress, we must:

• Reassess and Revise Existing Policies: Ensure that guidelines, especially those from influential bodies like AASLD, are updated in line with the latest scientific evidence, removing any unwarranted barriers related to alcohol consumption. As demonstrated by the efficacy of the Center for Health Law and Policy Innovation’s (CHLPI) work in assessing and breaking down barriers to curative DAAs in Medicaid programs, further work must be done to break these payer-based barriers to care in private and employer sponsored plans.

• Strengthen Advocacy and Awareness: Engage with healthcare providers, policymakers, and patients to spread awareness about the non-impact of alcohol on DAA therapy's efficacy, countering prevailing misconceptions.

• Promote Continuous Research and Dialogue: Encourage further studies and maintain an open dialogue with all stakeholders to continuously refine our understanding and approach to HCV treatment.

The conclusions drawn from these studies underscore the challenges and opportunities that lie ahead of us. As the research emphatically states, alcohol consumption should not be a barrier to HCV treatment. Such restrictions are discriminatory in nature and threaten efforts in the fight to eliminate HCV. With evidence-based policy decisions and unwavering dedication, we can eliminate the barriers and ensure access to curative HCV treatment.