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.
New CDC Report; More than a Decade After a Cure, HepC Persists
Last year, the Centers for Disease Control and Prevention (CDC) published a Vital Signs report detailing how “too few people” are being “treated for Hepatitis C” (subtitled: “Reducing Barriers Can Increase Treatment and Save Lives”). Today, the CDC’s landing page reflects a finding from April 2020 that reads “dramatic increases in Hepatitis C” (subtitled: “CDC now recommends hepatitis C testing for all adults”). And in late June, the CDC published a new Morbidity and Mortality Weekly Report (MMWR) on a worryingly low rate of HCV clearance in the United States.
Our previous blog reviewed last year’s report under the lens of health disparities highlighted by researchers’ review of 48,000 patient charts that met the inclusion criteria for the analysis. Then, much like in this new report, identified that lack of curative treatment access was not uniform and was largely informed by the type of insurance patients qualified for. Those payer types (Medicaid, Medicare, and Commercial plans) also represent patients from different backgrounds – meaning different socio-economic statuses, different genders and racial backgrounds – with different outcomes. Overall, Medicaid recipients were only ever prescribed curative treatment about 23% of the time, whereas Commercial payer patients were able to see that rate increase to 35%. The CDC also recognized these payers, and the politicians who set the public policy of Medicaid, represent incredibly tangible barriers via administrative processes, like prior authorization, and policy barriers, like requiring sobriety, a high level of liver damage, or other restrictions to gaining access to curative treatments.
For this year’s report, researchers partnered with Quest Diagnostics to review the viral clearance (or cure) of approximately 1 million patients with an initial infection (Quest provided data for 1.7 million patients with evidence of a history of HCV during the direct acting agents era, or from January 1, 2013 – December 31, 2022). Based on an estimated 2.4 million people in the United States with HCV, this sample represents about 43% of those believed to have experienced an HCV infection in this time frame. This is noted as a limitation in the data, in part, because it only represents data from one commercial laboratory. Though, reasonable observers can make certain conclusions from this data.
Now, we should also note, only about 88% of the 1.7 million patients identified as having evidence of HCV infection ever had received testing and, of those, 69% were identified as having an initial infection. This means the majority of patients identified were newly diagnosed and not facing a chronic HCV infection. Of those, about 7% of patients showed evidence of viral persistence.
Authors note “These findings reveal substantial missed opportunities to diagnose, treat, and prevent Hepatitis C in the United States.”
Coverage was highest among those enrolled in commercial insurance (50%) and lowest in Medicare and Medicaid (8% and 9%, respectively). Particularly startling in the differences between payer types was the prevalence of viral testing; those with an unspecified payor type were screened at about 79% and those with commercial insurance or Medicare had a testing prevalence of about 91%.
Patients with “other”, “unspecified”, or Medicaid as their insurance or payer had showed a lower viral clearance rate (23%, 33% and 31% respectively) than their counterparts enrolled in Medicare or commercial plans (40% and 45%, respectively). Overall, the cure rate was about 34%.
The age range with the highest rate of HCV diagnoses was 40-59 years, representing about 43% of the patient records reviewed. 60% were identified in their charts as male. However, the highest rate of viral clearance was among those aged over 60 and the lowest was for those aged between 20-29 years.
Other limitations to the data include a lack of uniformity in the follow-up period between testing, which might lead to some difference in rates. Similarly, patients might use or be referred to a different lab for follow-ups. Though, the data also does not follow patients and would not capture any representation of subsequent reinfection and cannot make any assumptions as to clearance or viral persistence among those who did not have RNA testing (and referral for treatment) – meaning the data likely underestimates the patients in each of these categories.
Advocates can look toward these data and findings to inform necessary policy changes, particularly by payer type and in seeking appropriate provider activation on screening and treatment. The sheer reality is HCV is both preventable and curable and policymakers and payers need to work more efficiently in order to prevent the approximate 14,000 HCV related deaths this country faces annually.
National Monitoring Report Highlights Disruptions and Opportunities
In September, Community Access National network (CANN) and Health HIV, Health HCV, and the National Coalition for LGBT Health partnered for the 7th Annual National Monitoring report on HIV/HCV Co-Infection as a “pre-Sync” session, warming up public health advocates and professionals for SYNChronicity 2022, which will be held virtually December 6-8. Presented by Marissa Tonelli, Director of Health Systems Capacity Building for Health HIV, and yours truly. Attendees represented a variety of stakeholders including funders, patients, advocates, providers, and public health professionals. The National Monitoring Report was generously supported by ADAP Advocacy Association, Gilead Sciences, Janssen Pharmaceutical Companies of Johnson & Johnsons, Merck & Co, and ViiV Healthcare.
The annual report presented information highlighting coverage of hepatitis C (HCV) curative direct acting agents (DAAs) in public health programs, including AIDS Drug Assistance Programs (ADAP), Medicaid, and Veterans Affairs as public payers. Additional information was presented on areas of intersectional focus, including harm reduction policy and programs across different states and at the national level.
Particular note was made on disparities of HCV diagnoses along racial identity, age, and geography, emphasizing where public health programs and advocates have room to improve in outreach, education, screening, linkage to care, and coverage. Highlighting data from the Centers for Disease Control and Prevention (CDC) on HCV diagnoses in 2020 and data presented earlier this year from the CDC on HCV screening and linkage to care based on payer type, both presenters discussed a failure of providers to screen for HCV. The failure of providers, particularly hospitals, to effectively enact opt-out screening has impact of furthering health outcome disparities and not taking opportunities to stop chains of transmission. While some of these missed opportunities may be attributed to disruptions to care due to the crisis phase of the COVID-19 pandemic, many of these failures are related to a lack of incentive to screen. Both presenters insinuated an expectation of HCV diagnoses to increase in the coming years as a result of these disruptions and failures.
Barriers to care from providers include failure to adopt the 2019 recommendations for universal screening, utilization management practices from payers which may limit the ability for providers to ensure patients are receiving DAAs (including extraordinary prior authorization requirements), lack of infrastructure to implement HCV programming, and a lack of consensus in the care guidelines. Patient barriers to care include lack of knowledge, social barriers (like homelessness), cost of insurance and restrictions from payers, and substance use-associated comorbid conditions. The commonality of payer roles as barriers to care is worthy of particular attention as advocates engage public health program administrators and seek to leverage public programs for better practices. Advocating for integrating HCV screening as a standard of care and ensuring states adopt HCV screening and linkage to care as part of state level “Essential Health Benefit” benchmarks is one approach which would tie provider reimbursements with screening and linkage to care activities.
While no debate occurred, discussion was had around the issue of “co-located” and telehealth models as a means of extending care and support for affected communities. The model of providing comprehensive care in a single site proves an opportunity for patients to access providers and support services is effective for certain communities. But if this model consolidates access sites, it may also prove to be a barrier for patients not closely located to these “one stop shops”.
Despite these tools and a generally supportive statutory environment, the nature of health care access is not necessarily getting easier for service providers or patients but more complicated. Advocates should be mindful of unintended consequences and how to leverage broader health care reform as they approach solution finding.
An archive of the event is available here.