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University of Pittsburgh Schools of the Health Sciences

​University of Pittsburgh Refutes Arguments Made By UNOS in Reaction to Federal Transplant Regulations

PITTSBURGH, April 7, 1998 — The United Network for Organ Sharing (UNOS), which holds the federal contract to operate the Organ Procurement and Transplantation Network (OPTN) under authority of the U.S. Department of Health and Human Services, opposes the issuance of a final regulation published April 2 in the Federal Register and which becomes effective Oct. 1, 1998. For more than 10 years, UNOS has operated with no government oversight, and policies developed by the organization have tended to favor transplant center needs rather than patient needs. A 1993 General Accounting Office report concluded that such practice was in violation of the National Organ Transplant Act (NOTA) of 1984. NOTA called for a fair and equitable national system of organ transplantation and organ donation.

In order to better serve patients, the Secretary of Health and Human Services intends the new regulation to meet the goals of the law and make the system more fair and equitable for patients.

The following is a rebuttal of the points that UNOS asserts in its arguments against HHS oversight and the content of the regulation:

UNOS: Doctors and patients should decide how the liver transplant system should work, not the federal government.

RESPONSE: The government will not be taking over the day-to-day function of UNOS. Government involvement simply means there will be much needed oversight by the Secretary of Health and Human Services with regard to fair public policy, as stipulated in the National Organ Transplant Act. Medical prioritization will remain the function of UNOS and its members who have the expertise. The regulation does not dictate medical practice but provides a broad framework for the OPTN’s activities. The rule provides the OPTN the freedom and flexibility to determine the most effective policies.

The regulation does not change the role of the OPTN but it does clarify the role of the Secretary and HHS, which serves to address the concerns and interests of patients. Since human organs that are donated are a public resource and a public trust, HHS must assure that they are allocated fairly, according to certain principles and objectives. For 10 years, the system has permitted self-regulation and allowed a private entity to make life and death policy decisions. The major patient advocacy groups -- Transplant Recipients International Organization, American Liver Foundation, National Transplant Action Committee and Minority Organ Tissue Transplant Education Program -- support the Secretary’s actions on behalf of patients.

UNOS: The new "federalized" transplant system will actually save fewer lives than the cooperative system it replaces and fewer transplants will take place.

RESPONSE: In a system of broader sharing, the number or people who obtain transplants may be somewhat lower, but it allows more people to live-- those still on the waiting list and those transplanted-- by significantly increasing the life-years gained and decreasing the total deaths by about 300 each year. Contrary to what UNOS states, their own computer modeling and that done by CONSAD Research Corporation both show that a system of broader sharing of livers to the sicker patients saves more lives in the long and short run. Under the current system, a large number of liver transplants are performed in patients who would have a greater life expectancy without a transplant, according to a published UNOS study. Meanwhile, the system allows sicker patients to die on the waiting list. This system may benefit transplant centers, but it does not benefit patients.

UNOS: There will be an increase in second and third transplants and a decrease in survival rates if organs are allocated to sicker patients. More patients will have to wait until they are critically ill before they can be transplanted.

RESPONSE: Citing data that is reflective of the current system, UNOS argues that a system of broader sharing that gives priority to sicker patients would increase the incidence of second and third liver transplants in these patients. Under the current system, which promotes first-refusal of locally donated organs by the local centers, organs considered inferior and then turned down by the local center are often the only organs offered to sicker patients in other regions. But with a system of broader sharing, these patients would be offered better quality organs, the retransplant rate would decrease and survival among this group of patients would improve.

The new rule stipulates that UNOS establish standard medical criteria for the different waiting list status categories. In its deliberation of new policies, which includes setting these criteria plus giving priority to sicker patients over geographical considerations, UNOS has leeway to address its concerns about survival and retransplant rates in the sickest patient category. In the regulation, the Secretary suggests the OPTN devise a policy that will provide transplants to patients who are sick enough to benefit but who are not so sick that they may risk losing their transplanted graft and require retransplantation.

UNOS: The new "federalized" system will shut down liver transplant centers in many communities and make it much harder for many sick people -- especially those who are poor -- to get transplants.

RESPONSE: The general public perceives there to be a national waiting list, but in fact there are 63 separate lists each with its own set of odds. A national system of broader sharing will give priority to the sickest patients no matter where they are -- at a small center, medium center or large center. And poor patients will not be disadvantaged, but rather be treated more fairly. Nearly half of the U.S. population does not live near a transplant center and 25 percent travel outside their state of residence for liver transplantation. Whether rich or poor, there are a number of patients who would have to travel no matter what. And most third-party payers, including Medicare and Medicaid, cover travel expenses. Because half of the liver transplant centers aren’t even Medicare approved, travel expenses must be provided to those Medicare patients whose local center is not Medicare-approved. Prospects for poor patients should improve with the new regulation because it includes a provision that requires the transplant community to make transplantation accessible to all patients, including those who have little or no means to pay.

The concern that liver centers would shut down is a common misconception about the ramifications of a national system of broader sharing. While UNOS has not yet devised the allocation policies that meet HHS’s goals, there is no reason to believe UNOS could not devise policies that allowed organs to go to the sickest local patient before being offered within a larger region or nationally. Transplant centers should be supportive of a system that serves their patients who are in the greatest need. Besides, when a patient must seek care outside their state of residence, organs will be provided to them through a fair and equitable system. Computer modeling indicates that annual volume changes under a national system would be minimal. For example, a center that performs 30 transplants a year might perform 26 or 27 transplants. A center that performs four a year, might do three. These differences hardly would be cause for a center to close. A center concerned about its decline in volume would do what was necessary to attract patients and remain economically viable.

UNOS: Organs will go to large centers where there are more sick patients, which will cause small centers to close.

All programs will receive organs on an equitable basis, in proportion to the number of patients registered there. If a transplant center can attract patients on the basis of their medical proficiency, cost and other factors patients value, there is no reason that centers of any size cannot compete in an environment of broader sharing. If it so chooses, UNOS can address this concern in its development of allocation polices so that smaller centers are not severely impacted.

UNOS: The current "cooperative" system gives the same fair treatment to very sick people nationwide and does NOT favor one part of the country over another. The waiting period for those in desperate need of liver transplants does NOT vary significantly from region to region, and the new "federalized" system would NOT change that.

RESPONSE: The reason UNOS contends waiting times across the country are equal for sicker patients is because current policy dictates that patients can only be listed in the most urgent status for seven days. So the fact that their average wait is four to six days makes sense because these patients are either transplanted or they die before an organ is available. The chance that the most medically urgent patients will die waiting is 30 times greater than for other patients. Under the current system, the odds that an intensive care unit-bound patient will die on the waiting list can range from 17 percent in one region to 50 percent in another.

With broader sharing, only about 4 percent of the most critically ill patients will die while waiting.

In regions where healthier patients are being transplanted because of the preferential use of local organs, these patients seldom reach the more urgent status categories. Consequently, their waiting times are artificially much lower than in other areas. Average waiting times can range from 23 days in one region to 126 days in another. Under a system of broader sharing, the average waiting time would vary between 105 and 124 days. While it appears that such a system would increase time on the waiting list, this would only be for patients who were not so sick that they could not afford the wait.

UNOS: Our ultimate goal is to save every sick person by persuading more people to donate their livers, but the new "federalized" system would do the opposite, reducing the supply of available livers and helping fewer sick people.

The new rule, in combination with a government-sponsored organ donation initiative, aims to substantially increase donations (by 20 percent in two years) and allocate donated organs equitably. Organ donation is not a panacea. While increased donations would increase the number of people whose lives would be saved and reduce waiting times, it would not necessarily reduce disparities in waiting times. Only an equitable organ allocation policy can.

UNOS: Broader sharing will hurt donations, especially in local communities.

RESPONSE: In the regulation, HHS concludes there is no credible evidence that local donations would be hurt by broader sharing. In fact, OPTN-sponsored studies have shown that the public and donor families themselves want organs to go to those who need them the most no matter where they may be in the United States. One study had 75 percent of its respondents disagree with the statement "donor organs should go to someone in the area where the donor lived." It is unlikely that a family will consent to donate a liver and heart for local use but not consent to the lungs because they might be transplanted into a patient in another state. Donated organs are a national resource; they do not belong to a procurement agency, a transplant center or a state. Any patient, no matter where they live or choose to receive their transplant, should have equal opportunity to benefit by organ donation. As long as there are precious few organs, they ought to be allocated equitably. A public that perceives the system to be fair and equitable will be more apt to embrace the idea of organ donation.

UNOS: These are very complex issues. HHS does not provide the OPTN with sufficient time to develop allocation policy.

RESPONSE: The rule provides UNOS with 150 days to come up with an equitable liver allocation policy and a year to develop policies affecting other organs. For more than two years, UNOS and the transplant community have been engaged in exhaustive deliberations on various liver allocation policies. Two computer modeling firms have provided invaluable data on the impact of different policies. There is no reason that the OPTN cannot rely on its collective expertise to come up with a policy that addresses the HHS performance goals and any other concerns that the OPTN members may have. However, instead of getting to the task of developing new policies for the good of the patients, UNOS is instead launching an aggressive lobbying and public relations campaign to undermine the Secretary’s rule and uphold a system that favors transplant center needs.


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