Medicaid Enrollees With Hepatitis C Face Reimbursement Challenges

Heterogeneity in Medicaid coverage of the anti-viral agent sofosbuvir is rampant across the United States, with varying reimbursement criteria and lack of conformation to recommendations by professional infectious disease organizations. These are the conclusions of a study published online today in the Annals of Internal Medicine.

Reserachers at Brown University, Harvard University, and at the University of New South Wales in Sydney, examined Medicaid policies governing reimbursement for the anti-hepatitis C medication sofosbuvir across the 50 states and in Washington DC.These criteria included : stage of liver disease, HIV co-infection, prescriber type, and drug or alcohol use. The findings were quite surprising and underscored that the states may not be following recommendations by organizations like the Infectious Diseases Society of America and American Association for the Study of Liver Diseases (AASLD). AASLD issued a detailed guidance in 2014 to test, manage, and treat HCV.

of the 42 states with reimbursement criteria for Medicaid:

The Annals authors found that

• 74% limit access to persons with advanced fibrosis
• 25% of states require persons co-infected with HCV and HIV to receive antiretroviral therapy or suppressed HIV RNA
• 67% of states use restrictions on prescriber type
• 88% include drug/alcohol abuse to determine eligibility: 50% need abstinence for a pre-determined period and 64% need a drug screen

Mediciad fee-for-service programs

The data extracted by the authors included and not Medicaid managed care, which means only a subset of Medicaid reimbursement policies for hepatitis C were evaluated by this study. However, even based on the results of this "subset" study, the author conclude that the widespread restriction observed across states violate federal Medicaid law that needs states to cover drugs consistent with their FDA labels. Per the federal statute, write the authors, "virtually all drugs from pharmaceutical manufacturers that have rebate agreements with the Secretary of Health and Human Services (which includes the manufacturer of sofosbuvir) must be available under state Medicaid programs, with only limited methods of restricting coverage." The current restrictions violate this statute.

While cost of course is the major concern with sofosbuvir and with some of the subsequent anti-hepatitis C medications that were approved, the authors cite the example of the state of Massachusetts, where despite unrestricted access to sofosbuvir under Medicaid fee-for-service, only 14% of Medicaid enrollees in the state who carry the virus opted to be treated with sofosbuvir.