Liver Transplantation for Malignancies other than Hepatocellular Carcinoma

CMS NCA document | source_status=Closed | review_type=New | public_comment_open=False | document_id=CAG-00101N

In summary, after studying the technology assessment report prepared by AHRQ, reviewing much of the literature independently and discussing the issue with noted leaders in the transplant community in the U.S., we find that: (1) available evidence does not indicate that liver transplantation for malignancies other than HCC produces outcomes that are comparable to those achieved with other liver transplants; (2) there are no cohort studies comparing liver transplantation to other treatment options for any non-HCC malignancy; and (3) most of the available literature is individual case studies or very small case series and is not adequate to make a positive coverage determination. Nonetheless, we evaluated the information provided in the studies and found that: (1) the information suggests that liver transplantation for non-HCC malignancy produces outcomes statistics in terms of mortality that are substantially lower than transplantation for other diagnoses; (2) the transplants do not appear to be curative in the majority of the cases since in over half of recipients the disease recurs; (3) there has been a significant decline in the number of transplants performed for non-HCC malignant disease in the U.S. National coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act. (Section 1869(f)(1)(B).) In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within part A or part B, and must not be otherwise excluded from coverage. (In this case, liver transplantation falls within the inpatient hospital and physician services benefit categories.) Moreover, in general, the expenses incurred for items or services must be “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. (section 1862(a)(1)(A).) As described in this decision memorandum, we have fully examined the medical and scientific evidence submitted with the request for a national coverage decision. CMS determines that the evidence is not adequate to conclude that liver transplantation in patients with non-HCC malignancies is clinically effective. Therefore, the item or service is considered experimental, and, thus, is not reasonable and necessary, for the treatment or diagnosis of the illness or injury or to improve the functioning of a malformed body member in the population(s) specified in the request for national coverage. Therefore, we intend to continue national noncoverage of liver transplantation for malignancies other than HCC.