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​University of Pittsburgh Medical Center Statement Concerning Pending HHS Transplant Regulations

PITTSBURGH, March 2, 1998 — The National Organ Transplant Act (NOTA) of 1984 called for a national system that would make organs available on an equitable basis. Yet, as U.S. Secretary for Health and Human Services Donna Shalala points out in a Feb. 26 letter to members of Congress, the goals established by this law are not being met. Patients’ needs are not served by the current system operated by the Organ Procurement and Transplantation Network (OPTN), which gives preference to the distribution of donated organs on a local basis rather than treating them as a national resource as envisioned by NOTA.

The Secretary should be congratulated for recognizing what she must do to restore equity in the system on behalf of patients throughout the United States. In federal regulations the Department of Health and Human Services (HHS) has promised to publish, the Secretary, on behalf of patients, will establish the guiding principles and performance standards that national policy must meet. The role of the OPTN, which the Secretary fully supports, will continue to be one to set medical criteria and recommend national policy, according to the HHS objectives. Those centers that oppose federal regulations fail to realize that the issuance of regulations does not place their patients, their centers or the United Network for Organ Sharing (UNOS) in jeopardy. Patients throughout the country will benefit.

"...[T]he Department has an important and constructive role to play, particularly on behalf of patients. Human organs that are given for donation are a public resource and a public trust. It is the responsibility of HHS to ensure that this resource is made available equitably, subject to sound medical practice," the Secretary wrote.

The University of Pittsburgh Medical Center (UPMC) has long recognized the glaring inequities of the system and has argued that federal regulations are needed to ensure the best interests of patients throughout the United States are served. The UPMC has not been alone in voicing its concerns. The nation’s leading patient advocacy groups, such as the American Liver Foundation, Transplant Recipients International Organization and National Transplant Action Committee, as well as other major transplant centers, have also urged the Secretary to exercise her authority and issue final regulations.

Even the American Medical Association has elucidated the principles the Secretary has outlined in her letter to members of Congress. In 1977, the AMA’s Council on Ethical and Judicial Affairs identified the principles of a fair, national organ transplant system and reaffirmed and published these in 1996 in the 150th Edition of the Code of Medical Ethics.

Under the current system, not all patients have the same opportunities to receive a liver transplant. Because policy preferentially favors the local use of donated organs, great disparities in waiting times exist and many patients die on waiting lists while less-sick patients receive transplants. While those who support the current system claim it encourages donation by families who aim to help those in their local communities, no public survey has ever provided such evidence. In fact, an OPTN survey concluded donor families and the general public want donated organs to go to those in the most need, regardless of their location.

In expressing her concerns about current practice, the Secretary points to these and other facts. In 1996, more than 60 percent of the livers were transplanted in patients in the local areas where they were donated, and more than half of these organs were used in patients not sick enough to require hospitalization. Meanwhile, 400 of the 953 patients who died on the waiting list did so in a hospital. "Thus even though technology has increased our capability to share organs over a wider geographic area and thereby give more preference to patients with the greatest medical need, the OPTN allocation system has so far failed to take full advantage of that opportunity," she wrote.

Many patients are fortunate to live nearby one of the 124 liver transplant programs in the United States. But there are scores of patients for whom a local center offers no advantage.

Often, even if a patient lives near a transplant center, that center may not have the expertise to treat that patient’s particular condition, making it necessary for the patient to seek care elsewhere. Some patients who have financial means may opt to list at another center or multiple centers with shorter waiting lists in order to increase their odds of receiving a transplant. But not all patients have the luxury of choice. Insurance companies often dictate where a patient may go. Veterans are limited to one of only a few centers in the United States. Patients who live in the 14 states that do not have a liver transplant program have no choice but to travel out of state. For any of a number of reasons, one in four patients travels out of their state of residence to undergo liver transplantation, according to a recent analysis of OPTN data.

Federal regulations that strive to minimize these inequities will benefit all patients, whether they are listed at a small center or a large center. For the first time, there will be equitable access to organs, and it will no longer matter what choices patients make or are forced to make in terms of where they are listed.

It is unfortunate that some choose to reduce the arguments in favor or against regulating the transplant system to economic terms. Simply stated, patients stand to benefit under a fair and equitable system, whether they are at centers in South Carolina, Tennessee, New York or Texas.


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