Many hepatitis C patients on Medicaid denied drug coverage

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Nearly half of all Medicaid claims for direct-acting antiviral drugs to treat chronic hepatitis C virus infections have been denied in four states recently because they were not considered “a medical necessity,” according to a new study.

Nearly half of all Medicaid claims for direct-acting antiviral (DAA) drugs to treat chronic hepatitis C virus (HCV) infections have been denied in four states recently because they were not considered “a medical necessity,” according to a new study.

“The high cost of DAAs and the highly anticipated demand for them has led insurers to restrict access to the drugs,” lead author Vincent Lo Re III, MD, MSCE, assistant professor of medicine and epidemiology in the division of infectious diseases at the Perelman School of Medicine at the University of Pennsylvania and the Center for Clinical Biostatistics and Epidemiology, said in an interview with Medical Economics. “Many affected states and insurers in general are worried that the drugs will overwhelm their health care budgets.”

However, many insurers have misinterpreted guidelines to restrict access to subgroups. “The idea was to give providers some sense of who to treat first,” he said.

On November 5, 2015, the Centers for Medicare & Medicaid Services submitted a letter to all state Medicaid programs and DAA manufacturers that suggests the restrictions on the drugs is not in the spirit of the Social Security Act that created the Medicaid program.

Lo Re presented an analysis of prescriptions from 2,342 HCV patients between November 1, 2014 and April 20, 2015 submitted to Burman’s Specialty Pharmacy branches in Pennsylvania, New Jersey, Delaware, and Maryland at the American Association for the Study of Liver Diseases 2015 Liver Meeting in San Francisco, November 14-16, 2015.

Some 517 patients were covered by Medicaid, 800 patients by Medicare, and 1,025 patients by commercial insurers. A total of 377 patients (16%) received an absolute denial. In the Medicaid group, 46% received a denial, while 5% who had Medicare received a denial, as did 10% of those who had private insurance.

The most common reasons for denial by Medicaid were “insufficient information to assess medical need” (48%) and “lack of medical necessity” (31%).

“We expected Medicaid denials to be higher, but not to that extent,” Lo Re said. “Patients on Medicaid are more likely to be suffering from these infections, yet they are much more likely to be denied coverage for the drugs.”

The researchers also found that those who did receive therapy through Medicaid had to wait 10 days longer to have prescriptions filled compared to privately insured and Medicare patients.

“Patients who need treatment, but are unable to gain access, may see their liver disease progress, putting them at a high risk for cirrhosis and liver cancer, and may develop extra-hepatic complications, such as bone, kidney, and cardiovascular diseases,” Lo Re said. “What’s more, it’s crucial to treat chronic hepatitis C patients so that rates of transmission are significantly reduced and the spread of the disease is limited-and fewer people have to be treated.”

What providers need to know, he said, is that “all hepatitis C patients are eligible for therapy. Counsel them about the benefits of treatment and risk factor modification to care for their liver.”