The Health Care Financing Administration (HCFA) is expanding Medicare coverage of liver transplants to include certain patients with primary hepatocellular carcinoma (HCC). This will be Medicare's first movement towards transplant coverage for a liver malignancy.

"This is another important example of how Medicare is reaching out to include more and more beneficiaries with potentially life-saving treatment," said Jeffrey Kang, M.D., director of HCFA's Office of Clinical Standards and Quality.

"Although we do not expect a large number of Medicare transplants for hepatocellular carcinoma, the procedure is extremely important because there are few alternative curative therapies for these patients," said Kang, chief clinical officer of HCFA, the federal agency that operates Medicare.

Kang said a technology assessment would be sought for other types of malignancies in an effort to further expand Medicare coverage. A technology assessment is a study conducted either internally by HCFA specialists or by an outside consulting firm.

Hepatocellular carcinoma is the predominant primary malignancy of the liver. It accounts for more than 80 percent of liver tumors. The tumors are predominantly found in male patients with cirrhotic livers from other disease, such as hepatitis.

Medicare has covered liver transplants for adults since 1990, beginning with limited coverage of only 7 diagnoses. Coverage was expanded significantly in 1996 and 1999 to include all types of end-stage liver disease except for malignancies.

Under a May 18, 2001 Decision Memorandum, Medicare announced that it intends to make a National Coverage Decision expanding coverage for patients with primary HCC if the patient is not a liver resection candidate, the patient's tumor(s) is less than or equal to 5 cm in diameter, there is no macrovascular involvement, and there is no identifiable extrahepatic spread of tumor to surrounding lymph nodes, lungs, abdominal organs, or bone.

The review of existing policy that led to the decision memorandum issued today was initiated internally at HCFA under the agency's new national coverage process, which bases coverage decisions on the best available scientific evidence. Scientific literature studied emphasized the appropriateness of performing transplants on carefully selected patients and used statistical techniques to identify significant risk factors, such as tumor size.