Media Contact: Sandra Van
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LOS ANGELES (Feb. 01, 2000) -- Responding to a two-year campaign waged by the American Liver Foundation, the federal agency that oversees Medicare reimbursement last month reversed a policy that denied coverage of liver transplantation for patients with hepatitis B.

In a letter to John M. Vierling, M.D., chair of the Foundation's Board of Directors, the Health Care Financing Administration (HCFA) announced its decision and acknowledged the Foundation's influential input. Dr. Vierling headed the American Liver Foundation (ALF) campaign with Alan P. Brownstein, M.P.H., Foundation president and chief executive officer, and Lewis W. Teperman, M.D., member of the Foundation board and director of transplantation at New York University Medical Center.

The effort officially got underway in mid-1998 when the Foundation held an international Hepatitis B Transplant Symposium in Tucson, Ariz. Based on the data presented, participants unanimously adopted a motion that was forwarded to HCFA, stating that the agency's rationale for denying reimbursement was no longer valid. HCFA has denied reimbursement for transplantation in hepatitis B patients because of historically low survival rates due to rapidly recurrent hepatitis B infection in the transplanted liver.

"The agency's policies were based on outdated information. With newer regimens to prevent recurrent infection using hepatitis B immune globulin and lamivudine the success rates for hepatitis B transplant patients are comparable to those for other liver transplant indications," said Dr. Vierling. In addition to his position at the Foundation, Dr. Vierling serves as Director of Hepatology and Medical Director of Liver Transplantation at Cedars-Sinai Medical Center's Center for Liver Diseases and Transplantation.

Experts in hepatology and liver transplantation from around the world attended the June 1998 symposium. Based on the evidence in medical literature and emerging data presented at the symposium, the assembly adopted the recommendation that HCFA, an agency within the U.S. Department of Health and Human Services, reverse its policy. American Liver Foundation leaders met with HCFA officials in December of that year, submitted additional scientific evidence and data requested by the agency, and made a formal request for the policy change on April 22, 1999.

Despite the evidence presented, HCFA offered a noncommittal response on June 15, saying additional "very specific scientific evidence" would be required if the agency were to consider making a national coverage decision. To bolster its case, the ALF then commissioned a survey of the eight largest liver transplant centers in the country to assess coverage for hepatitis B liver transplants by private insurers. This survey found that 99 private insurance companies and even the Department of Defense's program covered liver transplants for patients with hepatitis B.

Private insurers often follow the lead of Medicare in setting coverage policies, but in this case, the overwhelming acceptance of transplantation for hepatitis B -- pointed out by the ALF's study -- led to HCFA's policy reversal. In its Dec. 13, 1999 letter, HCFA announced that liver transplants for hepatitis B would be covered, effective three days earlier.

"This victory, which will reverse the despair of many patients and families with end-stage liver disease due to hepatitis B, is the result of a tremendous team effort," said Dr. Vierling. Liver specialists at key national and international transplant centers, the United Network for Organ Sharing, and the Foundation's Public Policy Committee compiled and organized volumes of data that supported the change.

The entire proceedings of the Foundation's 1998 symposium were published as a supplement to the journal "Seminars in Liver Disease," and mailed to subscribers on Jan. 28.

Hepatitis B is a viral disease that can be acquired through small amounts of infected blood. Heterosexual and male homosexual intercourse are considered high risk factors, but the virus can also be spread through the sharing of contaminated tattooing or body piercing equipment, sharing of contaminated personal care utensils such as toothbrushes and razors, and sharing of paraphernalia for injecting or inhaling drugs.

Also, a baby born to a mother infected with hepatitis B has a nearly 90 to 100 percent chance of being infected at birth. Babies infected with hepatitis B have a 90 to 95 percent chance of developing chronic infection. In contrast, only about five percent of adults who become infected develop chronic disease. The immune systems of the other 95 percent of adults are able to mount an effective defense to overcome and eliminate the illness.

Although many people become infected with hepatitis B without ever knowing it, a specific blood test can diagnose the disease, allowing early intervention. A safe and effective vaccine is also available to prevent disease.

"Hepatitis B is a preventable disease and all children and adolescents should be vaccinated," said Dr. Vierling. "An individual who is successfully vaccinated has eliminated any possibility of contracting hepatitis B in the future. Patients who have the disease should be under a physician's care to determine whether it is appropriate for them to be treated with antiviral medications."

A persistent assault on the liver can lead to cirrhosis, which can result in liver failure or cancer of the liver. For patients who do not respond to therapy and in cases of advanced, decompensated cirrhosis, liver transplantation may provide the only hope of survival.

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For media information and to arrange an interview with Dr. Vierling, please call 1-800-396-1002. Thanks for not publishing this number in stories.

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