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University of Pittsburgh Applauds Medicare Decision to Cover Liver Transplants for Patients with Hepatocellular Carcinoma

PITTSBURGH, August 30, 2001 — Surgeons from the Thomas E. Starzl Transplantation Institute at the University of Pittsburgh Medical Center (UPMC) are calling the federal government's decision to expand Medicare coverage for liver transplants to include patients with hepatocellular carcinoma (HCC) a "victory for patients." The new policy becomes effective Sept. 1.

The decision is significant because more than 10 percent of all patients with cirrhosis will develop HCC. This is particularly true with hepatitis B and C patients, who make up the single largest group of liver transplant patients (40%), and with rates of hepatitis on the rise in the United States, more patients are expected to require transplants. According to data from an international registry, about 27 percent of HCC transplant patients had a history of hepatitis B, and about 33 percent had hepatitis C.

Prior to the new policy decision, patients whose transplants were to be paid for by Medicare might have had to be removed from the transplant waiting list had their evaluation provided evidence that HCC had developed. Some physicians were placed in an awkward position of being the advocate for their patients, but being mandated to order diagnostic tests, which, if indicated cancer, would eliminate their patients from Medicare coverage.

"We had evidence from scientific studies that could predict those HCC patients who had excellent chances of being cured of their cancer with transplantation. So, during the evaluation process, it was not in some of our patients' best interests to prove the presence of HCC. If we had strictly adhered to the rules we would have condemned many of our patients to death," stated John J. Fung, M.D., Ph.D., the Thomas E. Starzl professor of transplantation surgery at the University of Pittsburgh School of Medicine and chief of transplant surgery at UPMC.

"We argued with Medicare that the criteria that was used was outdated and they finally came to appreciate the mounting scientific data in support of our claims. Their decision is a victory for patients."

As far back as 1993, UPMC surgeons had urged the U.S. Health Care Financing Administration (HCFA) to reconsider its liver transplant policy that excluded patients with certain diagnoses, including liver cancers. Earlier this year, HCFA, which is now called the Centers for Medicare and Medicaid Services (CMS), began an internal review under the agency's new national coverage process that bases coverage decisions on the best available scientific evidence.

CMS officials worked closely with UPMC because of its extensive experience with transplants in HCC patients, and with surgeons from the University of Southern California, the Oregon Health Sciences University and the Baylor Institute for Transplant Sciences, which maintains an international registry of outcomes data for liver transplants involving liver tumors.

Based on its review of the scientific literature, CMS concluded that HCC does not negatively impact post-transplant survival rates and that indeed transplantation is the treatment of choice for selected patients.

Specifically, CMS will allow Medicare to pay for transplants in patients with HCC if their cancer is unresectable, no tumors are greater than 5 cm in size and there is no evidence that the cancer has spread to vessels within the liver or to surrounding lymph nodes or other organs. In addition, Medicare will only pay for the transplant if it is performed at a CMS-approved facility.

HCC accounts for 80 to 90 percent of primary liver cancers. The disease is usually limited to patients with some pre-existing liver disease, including hepatitis B or C and hemochromatosis.

Patients with other types of liver cancer will continue to be ineligible for transplantation. A separate CMS review is underway.

The University of Pittsburgh's transplant programs are internationally renowned for their far-reaching influence on the entire field of transplantation. In 20 years, more than 11,300 transplants have been performed at University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh and the VA Pittsburgh Healthcare System, by far the most of any center in the world.

In addition to its many scientific contributions impacting clinical practice, UPMC has led major efforts that have improved patient access to organ transplantation. Last year, a UPMC appeal to HCFA resulted in the agency's approval for Medicare coverage of intestinal transplants, a decision that affects thousands of patients with intestinal failure as well as the entire transplant community. More recently, UPMC has asked CMS to review its national policies concerning living donors so that coverage can be extended to include adult living-donor liver transplants.

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