(Reproduced by permission from Medicare Focus, June, 1999, pg. 43)

Coverage of Testing for Hepatitis C in Patients Exposed to Infected Blood

Parts A and B

Hepatitis C virus (HCV) is the most common cause of post-transfusion hepatitis. Overall, HCV is responsible for 15 to 20 percent of all cases of acute hepatitis and is the most common cause of chronic liver disease. Prior to 1992, blood was not routinely tested for HCV prior to transfusion. Presently, the Food and Drug Administration (FDA) guidelines require testing of all blood for HCV.

HCV has become a major public health concern, and public health agencies have engaged in an active search to identify patients exposed to HCV-infected blood. In cooperation with the FDA and HCFA, the Department of Health and Human Services will issue new regulations requiring hospitals to search their records to identify the recipients of HCV-infected blood and to notify exposed patients of such a risk. See Program Memorandum AB-99-4 (Change Request 786) for more information about this look-back program.

In accordance with Section 1862(a)(1)(A) of the Social Security Act, Medicare coverage of items and services is limited (except as specifically covered by other statutory provisions) to those that are reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member. This provision generally prohibits Medicare coverage of screening services. Most Medicare contractors have interpreted screening services as those services furnished in the absence of signs, symptoms, or past history of disease.

Questions have been raised regarding Medicare coverage of HCV testing for patients identified as exposed to potentially infected blood when the patient does not exhibit signs and symptoms of hepatitis. Patients who become infected via transfusion may often not exhibit overt signs of disease. Because these patients have been injected with a known pathogen, we believe the medical risks make these tests reasonable and necessary.

The purpose of this Program Memorandum is to clarify that Medicare covers HCV testing for patients believed to have been exposed to HCV-infected blood, including those identified through the FDA look-back process. Patients who have been exposed are: (1) those receiving blood from a donor who tested negative at the time of donation but subsequently test repeatedly reactive for the antibody to HCV on a later donation; or (2) those receiving blood from a donor who tested positive on the FDA-licensed, more specific test or other follow-up testing recommended or required by FDA, and for whom the timing of seroconversion cannot be precisely estimated.