A new study suggests that most states violate Medicaid law by putting barriers that prevent hepatitis c patients from getting an effective treatment by denying them coverage for the drug sofosbuvir, also known as Sovaldi.
For their new study published in the Annals of Internal Medicine, Lynn Taylor, from The Miriam Hospital, and colleagues looked at Medicaid policies for treatment of hepatitis c virus using sofosbuvir and found that many should change policy to boost treatment access.
The researchers identified 42 state Medicaid programs that placed restrictions on payment for the drug, which costs about $1,000 per day. Only about three quarters likewise allowed the drug to be used when the hepatitis C already led to fibrosis, or the scarring of the liver, or a later stage of the damage known as cirrhosis.
Such restrictions are in violation of guidelines that support treatment for all individuals with hepatitis C except those who have less than 12 months of life expectancy due to non-liver related health conditions.
"Federal Medicaid law requires coverage, yet reimbursement criteria for Medicaid programs effectively deny access," Taylor said. "In our analysis, we found that most states with known sofosbuvir Medicaid reimbursement requirements impose undue restrictions on eligible recipients."
The researchers also found that restrictions that are based on drug or alcohol use were also prevalent with 88 percent of states having drug and/or alcohol use eligibility. Sixty four percent also required negative urine drug screening and half required an abstinence period of up to 12 months.
Taylor said that this is a matter of concern because most hepatitis c cases in the country occur in individuals who have injected drugs. She said that instead of excluding individuals who use drugs or alcohol from hepatitis C treatment, they should be prioritized.
Taylor and colleagues found that most of the Medicaid coverage restrictions for the treatment are in violation of recommendations from professional organizations and illegal as states are required to cover drugs consistent with the labels of the FDA.
"Restrictions do not seem to conform with recommendations from professional organizations, such as the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases," the researchers wrote. "Current restrictions seem to violate federal Medicaid law, which requires states to cover drugs consistent with their U.S. Food and Drug Administration labels."
Hepatitis c affects about 3 million Americans albeit many are not aware that they have the condition.
