NTAC Urges Clinton Administration To Enforce Transplant Regulations

Transplant Patients Urge the Clinton Administration to Enforce Transplant Network Regulations

Contact: Craig Irwin of the National Transplant Action Committee 503-690-8265

PORTLAND, OR -- National Transplant Action Committee (NTAC) is urging the Clinton Administration to move forward with enforcement of new federal regulations governing the nation's organ transplant system. The regulations went into effect March 16, 2000 after years of debate and congressional delay. However, the private contractor in charge of the transplant system, the United Network for Organ Sharing (UNOS) has made no changes in the operation of the network or in the controversial organ allocation system despite the passing of two key deadlines.

NTAC's statement comes as new data published today in the journal "Science" concludes that patients are needlessly dying as a result of the failed organ allocation policies developed by UNOS. In a letter from Robert D. Gibbons of the Departments of Biostatistics and Psychiatry at the University of Illinois at Chicago, Dr. Gibbons found that nearly 300 patients on the liver transplant waiting list are dying each year solely because of the UNOS liver allocation policies. Gibbons concludes, "If broader sharing of organs were implemented during this time period as many as 298 of the most medically urgent patients who did not receive an organ could have received a liver transplant, alleviating substantially the shortage of organs for those most needy patients."

Gibbons was a member of the National Academy of Sciences' Institute of Medicine's Committee on Organ Procurement and Transplantation Policy that was formed at the request of Congress. The Committee issued its report in July 1999. Today's letter was cosigned by two of Gibbons' colleagues on the IOM Committee.

"I don't know how the Administration can turn its back and let UNOS continue to get away with this," stated NTAC President Craig Irwin. "I have a great deal of respect for everyone in the Administration who has worked to complete the transplant regulations. It has not been an easy task. But, the rules are meaningless unless they are enforced and until that happens patients will continue to needlessly die."

Last month, Irwin led a delegation of representatives from patient groups, minorities, and the Campaign for Transplant Patient Fairness at a meeting with officials from the Department of Health and Human Services (HHS). The group encouraged HHS to move forward to enforce the regulation and to begin development of the transplant policy advisory committee called for in the regulation.

"We felt the formation of the advisory committee was a logical step for HHS to take," stated Irwin. "I sensed that there was concern on the part of HHS to move forward. There is a small but boisterous anti-regulation faction in the transplant community and I think HHS is concerned how they will respond to any changes."

The formation of an advisory committee was recommended by the IOM in its report. Although HHS has not disclosed its plans yet it is envisioned that the committee would advise the Department on transplant policy and mediate differences between HHS and the network contractor.

In addition to the advisory committee, the federal regulations required UNOS to submit a new liver allocation proposal no later than March 16, 2000. UNOS failed to meet that deadline and instead submitted a plan to review the liver allocation system and submit proposed changes within six months. However, in subsequent meetings UNOS has failed to make any further progress in the development of those changes.

The regulations mandated changes to the UNOS policy board and membership criteria. They also required UNOS to submit a list of key policies to be enforced through Medicare conditions of participation. Once again UNOS failed to meet a June 30, 2000 deadline to submit its changes to the federal government.

In federal court documents, Dr. Earl Fox, Administrator of the Health Resources and Services Administration, cast doubts that the Administration was planning to enforce the transplant regulations anytime soon. In response to a suit filed by the state of Wisconsin to stop the regulation Fox stated that "the Amended Final Rule has not yet caused any changes in allocation policies," adding that "no allocation policies will be changed in the near future. The earliest we anticipate there could be a new liver allocation policy is several months from now, assuming the submission by the OPTN of an approvable policy and the concurrence by the Secretary after review by the public and the Advisory Committee," Dr. Fox said.

Currently, there are approximately 70,000 patients waiting for transplants in the United States. About 12 people die each day because a donated organ is not found in time.

NTAC is a patient advocacy organization with about 1500 members across the United States. In addition, other patient groups continue to support the HHS regulations and changes to the nation's organ transplant system.

Copyright © 2000 U.S. Newswire.

This article posted August 9, 2000.