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Intestine Transplants to Be Covered By Medicare: Decision Result of University of Pittsburgh Appeal

PITTSBURGH, October 5, 2000 — Intestinal transplants will now be covered by Medicare, according to a decision made public today by the U.S. Health Care Financing Administration (HCFA). The University of Pittsburgh Medical Center's (UPMC) Thomas E. Starzl Transplantation Institute , which had requested the policy change in February 1999, called the measure a victory for patients with intestinal failure. UPMC successfully argued the case, citing improved survival rates matching those for organs currently approved for reimbursement as well as data proving intestinal transplantation's cost-effectiveness.

Under the decision, posted today on the HCFA web site (http://www.hcfa.gov/quality/8b3-g.htm), Medicare will cover all types of intestinal transplants for patients with irreversible intestinal failure who have specific life-threatening complications from long-term intravenous nutrition, called total parenteral nutrition (TPN). Medicare's criteria for approved centers include an annual volume of at least 10 intestinal transplants and a one-year actuarial survival of at least 65 percent. In addition to the University of Pittsburgh, Medicare is aware of two other centers that meet this criteria.

The decision is important because most state Medicaid and other third-party payers usually follow Medicare reimbursement guidelines.

"While these procedures have been approved by some third-party payers at our facility and at other transplant centers in the United States, and they have been recognized by European and Canadian governments as standard procedures and eligible for reimbursement, without Medicare's approval, it has been a real battle with insurance companies for most patients," said Kareem Abu-Elmagd, M.D., Ph.D., FACS, associate professor of surgery and director of intestinal transplantation at the University of Pittsburgh's Thomas E. Starzl Transplantation Institute.

"Without the financial burden and associated hassles, patients can now concentrate on getting well with transplantation," continued Dr. Abu-Elmagd, who took the lead on behalf of UPMC and the other major intestine transplant centers in the United States.

Intestinal transplantation allows patients with intestinal failure to be free of the need of intravenous nutrition and its associated risks of complications, including the potential for liver failure. The majority of the intestine recipients in Pittsburgh (95 percent) are now able to eat a normal diet. And according to quality of life studies conducted at the University of Pittsburgh, patients experience other significant improvements in their physical and psychological well-being as well.

In their appeal to HCFA, University of Pittsburgh surgeons reported a 72 percent one-year patient survival rate and a five-year survival of 52 percent. Since May 1990, the center has performed 160 transplants in 150 patients with irreversible intestinal failure. Such results are comparable to lung transplantation, which HCFA recognizes as a reimbursable procedure under its Medicare program, UPMC surgeons said.

"Therefore, we thought it justifiable to consider intestinal transplantation as a nonexperimental procedure that is eligible for reimbursement," said Dr. Abu-Elmagd.

At the University of Pittsburgh, improved management of rejection, refined donor and recipient selection criteria and modification of the surgical procedure, including donor bone marrow augmentation, have contributed to the current one-year results. In addition, the recent use of low-dose irradiation to the donor organ before transplantation has significantly reduced the risk of rejection with 100 percent patient survival, according to preliminary results obtained in the first seven patients to receive transplants with irradiated intestines.

The small intestine can be transplanted in one of three ways: alone, in combination with the liver, or in combination with the liver, pancreas and stomach. The majority (81 percent) of the patients at the UPMC required intestinal transplants because of short-gut syndrome, the loss of more than 70 percent of the intestine due to trauma, surgery or disease. For adults, short gut syndrome can be caused by trauma or Crohn's disease; for children, it may be due to a volvulus -- a twisting of the intestines, or congenital conditions.

Patients with intestinal failure must be sustained nutritionally with TPN, or intravenous feedings. Liver failure often results after long-term use, hence the need for a life-saving combined liver and intestine transplantation in some patients. In addition to the potential for liver failure, other life-threatening complications of failed TPN therapy include clotting of the major central veins, frequent line infections and sepsis, and frequent episodes of severe dehydration. Medicare will cover transplants in patients who have any of these complications of failed TPN.

According to 1992 Medicare figures cited in UPMC's appeal, TPN's annual price tag is more than $150,000 per patient, a conservative figure that does not include associated costs for medical equipment, nursing home-health care, and frequent hospitalizations. Today's costs are believed to be much higher.

"Based on these data, intestinal transplantation becomes cost-effective by the second year after transplantation," UPMC surgeons told HCFA, noting also the costs to perform the three types of transplants at their center have markedly reduced.

The UPMC has performed about 30 percent of all the transplants performed worldwide and reported to the International Intestinal Transplant Registry.

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