Organ transplantation can go one of two ways: down the road of patient interests or the route of the current system's self-interest.
On April 2 HHS published final regulations governing the operation of the Organ Procurement and Transplantation Network. They require the development of a system that gives equal priority to transplant candidates who are equally sick, regardless of where they live, and uniform criteria for deciding which recipients are listed.
These regulations will increase equity and access for patients by basing allocation on need instead of geographic location. But they are perceived as meddlesome by the United Network for Organ Sharing, the private contractor for the OPTN. UNOS argues that the current system functions well and change is unnecessary.
However, the regulations are needed because of the system's failure to increase donation rates, weed out poorly performing transplant programs, incorporate public viewpoints into UNOS policy and mediate a fair solution to enormous geographic discrepancies in waiting times and the deaths of patients on waiting lists.
The ideas in the HHS regs didn't originate with the department. During the past 20 years, many groups-including the American Medical Association, the General Accounting Office, HHS' inspector general's office, the Senate Labor and Resources Committee and the U.S. Task Force on Organ Transplantation-have opposed using geography as a basis for organ donation or have recognized the OPTN's potential for conflict of interest.
That conflict is shown by the fact that most UNOS members don't meet the minimum annual requirements for Medicare, yet the network has stated its commitment to their survival.
UNOS is lobbying legislators to intervene on its and its members' behalf. To support their case, the organization and some of its members have resorted to half-truths and superficial statements. For instance, UNOS has stated that the "very sickest patients-those who are in intensive-care units-(have) relatively equal waiting times." However, the chance of dying in an intensive-care unit varies fivefold among the 11 UNOS regions, according to the network's own documents.
UNOS says the HHS regs would make it more difficult for most patients to get transplants, decrease the number who get them, force the closure of many smaller transplant centers and possibly decrease donations. There are no data to support any of UNOS' claims. The regs don't affect patients' freedom to select a transplant center, force patients to travel farther than they wish or call for the closing of any transplant centers. It seems unlikely that donations would decrease, since surveys show the public supports basing allocation on need.
UNOS argues that transplanting the sickest patients is not the optimal use of donor organs. But patients in the elective-transplant category have an overall one-year survival rate of more than 90% without liver transplantation. A UNOS analysis of the relative risk of death for liver transplant candidates who are "homebound," or Status 3, and on the waiting list vs. the risk for patients who underwent elective liver transplants concluded that "there is no net survival benefit of liver transplantation for Status 3 patients within the first two years following transplantation."
On the other hand, studies show that liver transplantation is most efficient for hospitalized or ICU-bound patients. The maximum net benefit is greatest for the sickest patients. They have higher than a 60% survival rate one year after transplantation compared with most elective patients, whose survival rates show no difference for more than two years after the procedure.
HHS has stated that its regulations are intended not to force transplantations for patients who would die anyway but to leave the decision to physicians. As long as the transplant community recognizes that one group of patients has a greater medical urgency than another, the regulations require the sicker group to be given priority.
Unfortunately, some programs currently perform more than 90% of their liver transplants as elective procedures, while others are forced to perform more than 90% of their transplants on sicker patients.
Under the new regs, if programs are willing to accept higher-urgency patients, the programs' viability is assured.
UNOS claims that donation rates would fall if organs were sent outside the local area. There is no evidence that donor families ever question where the organs are going as a condition of the donation. In a 1994 UNOS-commissioned survey and a recent Gallup survey, the vast majority of respondents assigned top priority to patients who had the least amount of time to live, regardless of those patients' locations.
At least two states, Wisconsin and Louisiana, have passed legislation giving priority to state residents for organs donated within those states. But these laws don't truly represent the interests of their states' residents. A resident of Wisconsin or Louisiana who lists an out-of-state program will not be given preference for organs donated from those states, but out-of-state patients who list centers in Wisconsin or Louisiana will be given preference. These laws benefit the transplant centers.
In the United States, one-quarter of liver transplant candidates travel outside their home states to receive transplants. Fourteen states have no in-state liver transplant program, and almost half of all Americans don't live in a metropolitan statistical area that has a liver transplant program.
With broader geographic sharing of organs, patients will have a fair chance at receiving a donated organ even if they must travel for a transplant because of insurance requirements or the lack of a local program, or if they choose to travel because of specific treatment needs or low mortality rates. This point is important considering that poorly performing transplant programs outnumber the excellent-performing centers two to one, according to UNOS documents.
A 1994 UNOS survey found that 66% of the public would be more strongly influenced to sign a donor card under a policy of national distribution than local distribution. But regardless of how many organs are available, the issue of fairness to all patients must be foremost in allocation policies.
Fung is chief of the division of transplantation surgery at the Thomas E. Starzl Transplantation Institute at the University of Pittsburgh and has been involved in organ transplantation since 1984. He serves as a representative to the UNOS Board of Directors.
Editor's note: UNOS didn't respond to an offer to submit its viewpoint on the issue.