On March 26, 1998, Donna E. Shalala, Secretary, U.S. Department of Health and Human Services (HHS), announced a new regulation revising organ allocation policies. This new rule hopes to reduce the geographic disparities of organ allocation created by the current system. According to HSS, the current system causes patients in some areas to wait five times longer than in other areas (HRSA, on-line source). The rule was scheduled to go into effect on October 1, 1998, but has been delayed because the rule is being legally challenged by several states.
As a result of the new rule, the Organ Procurement and Transplantation Network (OPTN) must develop uniform criteria to determine a patient's medical status and eligibility to be placed on the United Network for Organ Sharing (UNOS) waiting list. The ultimate criteria will be the patient's perceived medical need, removing geographical concerns from the formula so that no matter where the patient lives or at which transplant center they are awaiting treatment, the sickest patient is the one who will get first chance at the organ.
According to Secretary Shalala,
"[p]atients who need an organ transplant should not have to gamble that an organ will become available in their local area, nor should they have to travel to transplant centers far from home simply to improve their chances of getting an organ. Instead, patients everywhere in the country should have an equal chance to receive an organ, based on their medical condition and the judgment of their physicians" (HHS, U.S. Department of Health & Human Services, 1998, April 27, on-line source).Although the new rule sounds equitable on the surface, there has been a heated debate on just how fair and practical it will be. The rule has the support of five large organ transplant centers, but is almost uniformly opposed by smaller transplant centers, such as the Shands Hospital Transplant Center at the University of Florida. These smaller centers contend that "their patients shouldn't be penalized just because they do a good job of encouraging organ donation and therefore have relatively short waiting lists" (Juda, pp. A6).
Many opponents to the new rule do not view it as a positive change, but rather as a profit-motivated change. It will mean that the larger centers, which by their very nature have sicker patients, will be receiving more organs for transplant. This will reduce the income to the smaller centers and may even force some of them to close.
Dale Edlin, M.D., chapter president of the New Jersey Chapter of the American College of Cardiology, strongly opposes Secretary Shalalas proposal, calling it "a process that eliminates the subjective input of a responsible medical community." Although he acknowledges that the intent of the HHS proposal is laudable in its attempt to save even more lives, Dr. Edlin holds that
"Disbanding regionalization will force successful programs to close. The result could be dire for a wide group of people. This includes the critically ill patients or those without personal funds or insurance coverage to travel farther away from their homes to receive new hearts. Families and friends will be unable to accompany the few who can travel. An entire population of uninsured or underinsured patients will be denied treatment because someone equally ill on the priority list may have the resources to connect sooner with the center designated for treatment."Dr. Edlin supports a program, like the one in New Jersey, which focuses solely on medical needs and not financial issues. However, such an allocation program is not feasible under the current structure because each transplant center takes the patients financial criteria into consideration before that individual can even be placed on the UNOS waiting list.
Another aspect of this opposing view examines how the new rule unfairly punishes geographic areas which have worked to develop their local organ donation programs. By removing geographic considerations from the formula, areas which have no proactive programs to promote organ donation have the same access to organs as those areas which spend significant man-hours and dollars on promoting organ donation, such as Florida. The provisions of the new rule wind up penalizing these actions by sending the "extra" organs donated to areas where local powers simply don't work as hard to sign people up as organ donors.
The organ allocation debate is further aggravated by the fact that, of the 63 organ banks, the best organ banks collect four times as many organs as those on the bottom of the list, and these disparities are most obvious along geographic lines. The Associated Press conducted an analysis based on 1996 and 1997 transplant data. They concluded, "if every organ bank performed like the top 10, there would be 14,600 more transplants each year" (Associated Press, September 8, 1998, pp. A1). This data supports the idea that the reason for higher levels of organ donation in certain areas is a direct result of proactive campaigns by local institutions to increase organ donation.