PITTSBURGH, March 26, 1998 — A new federal regulation that calls for reform of the national transplant network and organ allocation system means patients’ needs will finally be at the forefront, says the University of Pittsburgh Medical Center (UPMC), which houses the world’s largest transplant program. The UPMC commends U.S. Secretary of Health and Human Services Donna Shalala for her action, because this regulation, plus a new government-sponsored initiative to increase organ donation, should go far in improving the prospects for patients awaiting organ transplants.
The final regulation governing the Organ Procurement and Transplantation Network (OPTN) to be published in tomorrow’s Federal Register call for changes that will address the system’s inequities and better serve patients’ needs, UPMC officials say. It also means a change in the government’s role, because for the first time it will be providing oversight of the transplant system, which has operated for years without ever being subject to federal regulations.
However, this regulation means nothing for patients if the United Network for Organ Sharing (UNOS), which holds the government contract, does not comply or if the Department of Health and Human Services (HHS) does not in a timely fashion exercise its authority to assure fair and equitable policies go into effect.
The UPMC, along with the major patient groups and other leading transplant centers, has publicly supported government oversight on behalf of patients. Central to UPMC’s arguments is its contention that the current way donated livers are allocated to patients on the national waiting list is inherently unfair, especially to those who are the sickest, resulting in more and more patients dying each year while waiting for the life-saving procedure.
"Although over the years the United Network for Organ Sharing and a majority of its member transplant programs have disagreed with our stance, patients have voiced their concern that the system is not fair. The government has finally recognized that something must be done. By standing up for the patient’s interest, the Secretary has done the right thing," said John J. Fung, M.D., Ph.D., chief of transplantation at the UPMC and associate professor at the University of Pittsburgh’s Thomas E. Starzl Transplantation Institute .
The regulation had been expected a year ago, 90 days after HHS held hearings on the OPTN policy development process, the fairness of the liver allocation system and organ donation. HHS held the hearings as an extension of a public comment period from a Notice of Proposed Rule Making in 1994. At the Dec. 10-12, 1996 hearings, 110 people testified, including Dr. Fung and numerous patients and their family members. On Feb. 26, 1998, Secretary Shalala sent a letter to 89 members of Congress which finally revealed her intentions to issue regulations that would restore equity in the system for patients and meet the goals of the 1984 National Organ Transplant Act (NOTA), which called for the development of a fair and equitable national system for organ distribution, with appropriate government oversight.
Since 1986, UNOS has held the HHS contract to operate the OPTN, which was created by NOTA. But because the Secretary for Health and Human Services had never before exercised authority over the OPTN by formally approving policy with published final regulations, UNOS had been allowed to develop policy that has favored its member transplant centers instead of patients. A 1993 General Accounting Office report concluded this practice was contrary to law.
The new regulation requires UNOS to be more accountable to the government and to patients. It provides a broad framework for the OPTN’s operation and activities but does not dictate medical practice. The regulation becomes effective in 90 days. Specifically, the rule stipulates the following :
-The OPTN will devise equitable national allocation policy based on common medical criteria and not accidents of geography. The policy must meet certain guiding principles and performance standards, including the requirement that waiting times across the country be equalized for patients in similar medical conditions and organs are offered first to those patients whose needs are more medically urgent before being offered to less-sick patients.
-The OPTN will establish standardized listing criteria and standardized criteria for determining medical status.
-If within 60 days after the effective date (or 150 days from publication) the OPTN does not establish a liver allocation policy that meets these performance standards, HHS has the authority to set such policy. The OPTN has up to a year to set allocation policies affecting other organs.
-Useful and timely data about transplant centers and outcomes must be more readily accessible to patients, and the structure of the OPTN contractor’s board must incorporate more representation by patients and donor families. Membership of the OPTN will be open to all who have an interest in transplantation.
It is not clear if UNOS will meet the HHS deadline or if UNOS does, what plan for liver allocation it will develop, but studies by both the UPMC and UNOS have shown that expanding the boundaries in which organs can travel to the sickest patients would reduce deaths on the waiting list and equalize patient waiting times.
"We are hopeful UNOS will work toward establishing a fair and equitable policy. But, for the patients’ sake, HHS absolutely must keep its word to step in if UNOS does not adhere to the terms of the regulations. Patients cannot afford for this debate to continue any longer than it already has," continued Dr. Fung.
The contentious debate within the transplant community about liver allocation dates back to 1991 when UNOS chose to do away with a policy that allowed national sharing of livers for the sickest patients. Since that time, UNOS has used artificial geographic boundaries so that patients closest to the donated liver are given priority regardless of their medical urgency and whether there may be sicker patients elsewhere in the country. And, this despite the fact that livers can remain viable for up to 18 to 20 hours. Currently, a donated liver is offered first to all compatible patients in descending order of their medical urgency status within the local area where the organ originates. If the organ is not allocated locally, it is offered in the same manner within a UNOS-defined larger region (there are 11 total) and then nationally if not placed in the local area or region.
The Secretary pointed out in her letter to Congress that in 1996, 60 percent of the livers donated were used locally, more than half of these in patients who were not sick enough to require hospitalization. Meanwhile, 400 of the 953 who died that year waiting for liver transplants did so in the hospital.
Dr. Fung testified last year that the 1991 change in policy has resulted in a practice by many liver transplant centers of transplanting an increasing proportion of less-sick while sicker patients on the waiting list are allowed to die. This has also created great disparities in the amount of time patients wait for transplants, with some patients in some areas waiting five times longer than patients elsewhere.
"By guaranteeing a center’s first right of refusal of donated organs, the current system has fostered the idea that organs belong to transplant programs instead of being considered a national resource for the benefit of patients," said Dr. Fung.
A recent analysis of UNOS data shows that one in four patients travel outside their state of residence to undergo liver transplantation, supporting the notion that broader sharing of donated livers will benefit patients. Patients may travel for reasons of personal or physician choice, insurance directives, to increase their odds of getting an organ or because they lack a local center. Fourteen states do not have liver transplant centers.