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Hepatitis C virus (HCV) infection is a communicable disease that affected approximately 3.5 million persons in the United States as of 2017. Despite the introduction of new, highly effective treatments in2011,HCVinfection rates in theUnited States tripled from 850 in 2010 to 2436 in 2015. This increase was largely a result of the opioid epidemic, with injection drug use the most common method of new HCV transmissions. In addition, the lack of enforcement of laws that entitle persons to life-saving, medically necessary care such as HCV treatment is a missed opportunity to reverse this trend. New treatments for HCV infection with direct-acting antiviral (DAA) therapies are curative for patients and eliminate their ability to spread the virus. However, US health systems have not responded to the potential of new treatments by promoting access to them. Instead, because of high initial list prices, state Medicaid programs and correctional health facilities have created rationing. They have limited access to HCV treatment by instituting restrictions that are based on disease severity, as measured by damage to the liver (ie, treating only persons with advanced-stage HCV infection) and prescriber specialty. In addition, despite the syndemic between the opioid crisis and increasing use of injection drugs, periods of sobriety from drugs and/or alcohol are required before treatment. These restrictions contradict leading medical guidance recommending treatment of virtually all persons with chronic HCV infection and hinder our ability to reduce HCV incidence, let alone end the HCV epidemic. Despite the tension created between scarce resources and public health concerns, the initial budgetary fears cited as justifications for restrictions were less severe than anticipated and have diminished over time, in part because increased competition has led to decreased prices. Regardless of the rationale used to explain limitations on access to treatment, such restrictions violate federal laws. As a result, litigation to remove barriers to HCV treatment in both correctional facilities and state Medicaid programs has met with success. Litigation seeking to enforce the Eighth Amendment to the US Constitution (prohibiting cruel and unusual punishment) has successfully removed disease severity restrictions imposed by correctional facilities in several states. Similarly, lawsuits aimed to enforce federal Medicaid law (known colloquially as the “Medicaid Act”) have been successful. As of January 2019, most states had removed their disease severity restrictions for HCV treatment; only 13 states (Alabama, Arkansas, Indiana, Iowa, Louisiana, Maryland, Michigan, Montana, Nebraska, Oregon, South Dakota, Texas, and West Virginia) still maintained restrictions in their Medicaid programs. Nineteen states still imposed sobriety restrictions ranging from 1 to 6 months in their Medicaid programs (Table 1). This commentary reviews the role of the courts in removing HCV treatment restrictions by summarizing and analyzing successful litigation using the Medicaid Act and the Eighth Amendment. To our knowledge, this is the first commentary to synthesize these legal theories. In addition, we propose a novel legal strategy under the Americans with Disabilities Act (ADA) to challenge sobriety restrictions; this approach has largely been untested but may provide another avenue to further expand access to HCV treatment for persons with a history of substance use.

public health reports

Enforcement of Legal Remedies to Secure Hepatitis C Virus Treatment With Direct-Acting Antiviral Therapies in Correctional Facilities and Medicaid Programs