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Preliminary Findings: National Summary Report November 14, 2016
The advent in 2013 of direct acting antiviral agents (DAAs) to combat Hepatitis C (HCV) is a
major development in treating the deadliest infectious disease in the United States.
Unfortunately, despite the important individual and public health potential of these
medications, many public and private payers limit access to DAAs due to cost concerns.
These limitations, generally expressed in prior authorization requirements, form a
significant barrier to care for millions of Americans enrolled in Medicaid, despite clear
guidance from the Centers for Medicare and Medicaid Services that such restrictions often
violate federal law. Additionally, they are in direct opposition to the “Recommendations for
Testing, Managing, and Treating Hepatitis C” as published by the American Association for
the Study of Liver Diseases (AASLD) and the Infectious Disease Society of America (IDSA).
In 2015, the Center for Health Law and Policy Innovation of Harvard Law School (CHLPI),
along with academic researchers at Brown University and the Miriam Hospital, University
of New South Wales, and the Treatment Action Group, published in the Annals of Internal
Medicine a survey of fee-for-service (FFS) restrictions in access to DAAs in state Medicaid
programs from December 2014.
Since December 2014, access to DAAs in state Medicaid programs has been incrementally expanded, generally in response to advocacy and impact litigation. In our 2016 “Hepatitis C: The State of Medicaid Access” survey, CHLPI and the
National Viral Hepatitis Roundtable (NVHR) are updating and expanding upon the initial
survey to document the current state of access to DAAs for Medicaid enrollees across
America. The 2016 survey of Medicaid restrictions on HCV treatment access provides an in-
depth evaluation of DAAs access in each state’s Medicaid program while highlighting
successes in access expansion as well as ongoing challenges. It evaluates HCV treatment
access through the end of October 2016. The data presented in this National Summary is
preliminary and may be subject to revision in the coming months.
The 2016 survey focuses on three of the most significant restrictions to treatment: 1)
fibrosis criteria (liver damage or disease progression requirements); 2) sobriety
requirements (periods of abstinence from substance use requirements prior to and/or
during treatment); and 3) prescriber limitations (medical provider requirements as to
eligibility for reimbursement for treatment prescribed).