According to a new study, 46% of Medicaid patients with the chronic hepatitis C virus (HCV) who were prescribed new and highly effective antiviral drugs were denied insurance coverage because the treatments were not considered medically necessary or for reasons that included the patients testing positive for alcohol or drugs use.
The study findings were presented at the recent annual meeting of the American Association for the Study of Liver Diseases (AASLD) by Vincent Lo Re III, MD, MSCE, an assistant professor of Medicine and Epidemiology at the Perelman School of Medicine, University of Pennsylvania, and the Center for Clinical Biostatistics and Epidemiology. The study was titled “Incidence and Determinants of Denial of DAA Treatment for Chronic HCV Infection by Insurance Type During the First 6 Months of the Modem HCV Treatment Era.” Its results came through a prospective analysis of prescriptions submitted to a specialty pharmacy serving patients in Delaware, New Jersey, Pennsylvania, and Maryland.
This is the first study on delay and denial rates in a group of Medicare, Medicaid, and privately insured patients for direct-acting antiviral agents (DAA), drugs with successful cure rates in patients with the HCV infection. These drugs are very expensive, with a 12-week treatment course costing up to $90,000 per patient. “It’s the high costs of these agents to treat —and in most cases, cure — these infections and barriers to coverage that have resulted in denials and delays for the therapies,” Dr. Lo Re said in a news release. “It has created a serious health disparity. 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.”
This issue was the topic of two studies published in the Annals of Internal Medicine in 2015, finding that restrictions for the drugs vary across state Medicaid programs, with one study noting many of the restrictions violate federal law. In the U.S., Medicaid generally covers low-income individuals and families, and Medicare typically insures older and disabled people, although there is overlap between the two. Medicaid is administered by states under federal guidelines, while Medicare is a federal program.
To determine the incidence and nature of the denials among HCV patients, the researchers analyzed drug DAA prescriptions from 2,342 patients submitted to Burman’s Specialty Pharmacy branches in the four US states between Nov. 1, 2014, and April 20, 2015.
Of those patients, 504 were covered by Medicaid, 810 by Medicare, and 1,036 by commercial insurance. In total, 16% — or 375 patients — received an absolute denial, the researchers found. But among Medicaid (low income) patients, that number soared — 46% were denied DAA therapy, compared to 5% of those on Medicare and 10% of those privately insured. The most common reasons for denial by Medicaid were insufficient information to assess medical need (48%), lack of medical necessity (31%), and a positive alcohol/drug screen (4%).
Moreover, the median time to DAA prescription fill was longer (10 days) for those on Medicaid than for with Medicare or private insurance.
“The implications of these denials remain unknown, but there may be adverse downstream outcomes for both patients and providers,” Dr. Lo Re said. “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. 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 less people have to be treated.”