by Amanda Conschafter, blog editor
A new study published in the Annals of Internal Medicine raises a provocative question about hepatitis C care: Does state rationing of new cures violate federal Medicaid law? The study, released June 30, examines which states limit Medicaid patients’ access to the hepatitis C cure sofosbuvir.
Though the treatment offers a 90 percent cure rate, many states limit access – presumably due to cost. According to the study:
- 42 state Medicaid systems limit payment in some way
- 2/3 of states restrict who may prescribe the hepatitis C cure, with 1/3 of states requiring that a specialist write the prescription
- Approximately 3/4 of states allow access only when liver damage has resulted in fibrosis or cirrhosis
- Most states limit access based on alcohol and drug use
- About 1/4 of states restrict access based on HIV status.
Rationing techniques vary by state, researchers found, and they do not reflect the guidance of the Infectious Diseases Society of America and the American Association for the Study of Liver Disease. What’s more, they don’t align with the uses approved by the Food and Drug Administration. And that may mean they violate federal law.
Federal regulation says that if manufacturers offer a rebate on the cost of drugs to the Department of Health and Human Services, Medicaid systems must provide coverage consistent with FDA labeling. Sofosbuvir does provide HHS with a rebate.
Whatever the legality of Medicaid rationing, the techniques create a significant barrier to patients with hepatitis C. As Harvard Law School’s Robert Greenwald, also an author of the study, explained, “The real story here is that we have this tremendous opportunity. We have a cure for the number one communicable disease killer in the United States…and yet we have failed to develop a national plan and state plan to make sure we are really promoting access to this cure.”
Roughly 3.2 million Americans have hepatitis C, with 17,000 new cases developing every year.