All concepts, explanations, trials, and studies have been re-written in plain English and may contain errors. I am not a doctor ----------------------------------------------------------- Organ Allocation at the Crossroads by Susan Smith, RN, PhD Enactment of much-debated and rules governing donor organ allocation in the USA have been held up yet again, just one day before they were to take effect in October. Angered by what they saw as an not enough time for comment and review, opponents outmaneuvered supporters by attaching delaying language to legislation sure to be approved by President Clinton. The move blocked the rules from taking effect for at least 90 days. The vote was the latest in an ongoing series of maneuvers sparked by debate over the fairness of the current organ distribution system. The new rules were proposed by Shalala's HHS (US Department of Health and Human Services). Over the past 10 years, organ transplant has become the preferred option for many patients suffering from end-stage failure of vital organs. The number of transplant centers and the number of patients waiting for organs have increased sharply in the United States. Yet despite medical advances, demand for donor organs outstrips the supply, and the gap grows wider each year. The number of potential transplant recipients on the UNOS waiting list for donor organs has increased 100% since 1987. More than 66,000 people are now on the list, with a new patient added every 16 minutes. Every day, 8 people on the list die. The average waiting time for kidney transplants has increased to more than 1000 days, with some groups such as black Americans, waiting even longer. If the waiting list continues to increase at this rate (20% per year) and the number of kidney transplants remains below 10,000 per year, the average wait for a kidney will be 10 years by the year 2010. Many factors contribute to the shrinking donor pool, most notably family refusals. On average, families refuse organ donation more than half the time. Other roadblocks include the failure of health professionals to routinely offer families the option of donation; cultural and psychological factors that negatively influence the decision to donate; the prevalence of HIV/AIDS; and fewer traumatic deaths. Seeking solutions, transplant professionals have gingerly expanded acceptable organ donor standards. Marginal and high-risk patients who were not even considered a few years ago are now routinely accepted as donors. Unfortunately, recent evidence suggests that these broadened donor criteria have adversely affected transplant recipient survival rates. In June of 1998, in an effort to spot potential donors and increase donation, the HHS issued rules entitled "Hospital Conditions of Participation for Medicare and Medicaid." These rules required that hospitals have written protocols for spotting and referring potential organ donors to a certified organ procurement organization (OPO), and that hospitals notify OPOs of all imminent deaths. Failure to comply with these rules could result in loss of Medicare and Medicaid reimbursement. This was not the first time the federal government has entered the debate over organ donation. In 1984, Congress passed the National Organ Transplant Act (NOTA), which provided the legal framework for distributing organs in the US by establishing a national system, establishing grants for OPOs, and prohibiting sale of human organs. NOTA also established a Task Force on Organ Procurement to do a study of medical, legal, ethical, economic, and social issues relevant to human organ transplant. Among the task force's recommendations was to avoid using geography as the basis for organ distribution. NOTA created the organ procurement and transplant network (OPTN) to ensure a fair, safe and effective national system for donation, procurement, distribution and transplant. In 1986, in a unique public-private partnership, UNOS was given the federal contract to establish and operate the OPTN, which it has managed since 1986. The OPTN operates The Organ Center, which maintains a centralized computer network linking all OPOs and transplant centers. A 1986 law ordered that all transplant centers and OPOs be members of the OPTN. Today, there are 62 UNOS-member OPOs serving defined geographic regions within the US. However, OPOs vary in both structure and performance. For example, some OPOs service a small geographic area with only one transplant center, while others serve as many as 6 states representing more than 15 centers. The test of OPO performance has been the number of organs procured per million population. Although the national average is 21 donors per million people per year, the range for all OPOs is from 10 to 40. Two major factors are taken into consideration when deciding how to distribute organs for transplant: geography and medical urgency. A complex formula takes these factors into account, along with organ-specific information such as blood type, tissue type, organ size, time on the waiting list, and distance between donor and recipient. That formula produces a list of donor-recipient matches. The present system heavily favors geographic distribution. All patients accepted on a center's waiting list are registered with the UNOS Organ Center. The US is divided into 62 local organ procurement areas ranging in population from 1 to 12 million. These areas are part of 11 larger UNOS regions. When an organ becomes available, it is first offered locally within one of the 62 procurement areas because of the harmful effect of prolonged lack of blood flow to the organ on patient survival. If a matching patient is not found, or the organ is not accepted within the local area, it is offered regionally. In rare cases, when organs are not placed locally or regionally, they are offered nationwide. UNOS has developed OPTN policies without much federal input. Although NOTA expired several years ago, transplant programs and OPOs mostly have complied voluntarily with these policies, but due to recent concerns over geographic differences in waiting times - mainly for liver transplants - HHS stepped in. Saying that these regional differences have resulted in a fundamental imbalance in the system, HHS redefined the legal framework for the OPTN. In April of 1998, HHS Secretary Donna Shalala issued final regulations governing OPTN operation. The proposed Final Rule redefined the legal framework for organ allocation. It stated: 1) The place of residence and place of listing must not be used as a major factor when determining who receives an organ. 2) Uniform standards should be used in deciding which patients are placed on the waiting list. 3) A system must be designed so that patients who are equally sick are given equal priority, regardless of where they live. This Final Rule intensified a long-standing debate over what constitutes fair organ allocation. Liver allocation has been at the center of this controversy. The original liver allocation rules set up in 1987 were based mostly on the opinion that distribution should be based on urgency of need. Over the years, the perception of donor organs has changed from one in which they are considered a national resource to one of local resource. In 1991, the most urgent category standard was removed from liver allocation policy, and sharing of organs outside the UNOS regions was discouraged. The impact was felt almost overnight. Liver transplants had been done mainly in the most medically urgent cases. Since then, the trend has shifted to elective transplant. Some argue that this is exactly why there is an increasing imbalance in the average wait time for donor livers across the US. In fact, there has long been conflict among UNOS member liver transplant centers, the majority of which perform at less than the OPTN performance standards. Furthermore, a few centers perform 90% of liver transplants for Status 1 and 2 patients (the sickest), while most transplant mainly Status 3 and 4 patients (the least sick). When policy issues are put to a vote, the majority of centers - with small programs and a dominant number of members - outvote the smaller number of large centers. Under the present system, large transplant programs have the longest waiting lists and thus a greater number of Status 1 patients. These centers have long pushed for eliminating the present 3-tiered (local, regional, national) system in favor of a large national waiting list. Furthermore, large programs have pressed for establishing a small number of mega-centers where all liver transplants would take place, arguing that low-volume centers cannot do liver transplants with acceptable complication and survival rates. Many of the smaller programs have fewer Status 1 patients on their lists. Advocates for these centers argue that by changing the allocation system to one that makes "their" donor organs available to the sickest patients in their regions, the larger centers will siphon off their supply of organs and eliminate smaller programs. (Jon's note: the mega-center route would mean a lot of expensive and difficult travel for those of us not living close to one of the centers. Who can afford it? This is rarely addressed by transplant professionals at any level.) The Final Rule eliminated current geographic regions and created a new system with more smaller regions, each with a population of about 9 million. It also ordered donor livers to be offered REGIONALLY to the SICKEST patients before being offered locally. This last point is at the center of the current debate. There are several arguments against automatically assigning organs to the most severely ill. First, some argue that if organs are given to the sickest first, smaller programs with fewer very sick patients would get fewer organs. If this happened, there would be less access to transplant for some peoplem, especially in rural areas. Finally, opponents to the policy change say, offering organs to the sickest patients first results in wasted organs, because the sickest patients are the least likely to survive. There is some evidence to the contrary. Liver transplant has been found to be most efficient for the sickest patients, while Status 3 and 4 patients have an overall survival of 90% without transplant. (Jon's note: this does NOT apply to heart transplant statistics.) Equally controversial is the issue of who should have authority to set medical policy for transplant. The Final Rule gave Shalala authority to set transplant policy. This is one aspect of the rule the professional transplant community IS united on - they bitterly oppose it. They say medical policy decision making should remain within the medical community. Both the American Society of Transplantation and the American Society of Transplant Surgeons have been vocal in this debate. In testimony before Congress, members have reminded Shalala that when Congress authorized NOTA in 1984, it intended for the OPTN to make transplant policy based only on sound medical and ethical principles and scientific data. UNOS opposed the new regulations, saying the current system worked just fine and there was no need for government oversight. UNOS specifically objected to the allocation of organs (mainly livers) based on medical urgency. In response, Dr. Shalala told UNOS to draft a plan that would comply with the Final Rule. When UNOS and HHS did not reach agreement, Congress held public hearings and soon after that, delayed implementing the Final Rule until October 21, 1999. In the meantime, HHS asked the Institute of Medicine (IOM) to study the issue. Because much of the policy debate centered on liver transplant, that was the focus of the IOM study. In June of 1999, it issued a report. The IOM said that average waiting time was a poor measure of equality in access to transplant. They recommended it be deleted from UNOS standards for arranging patients on the waiting list. The IOM also found the present system reasonably fair for the most severely ill patients, but said it could be improved with more regional sharing of livers for patients in most urgent need. Despite strong opposition by some in the transplant community, UNOS responded to the IOM by approving changes to the liver allocation policy. The new policy required that livers be offered to Status 1 patients within the region first, before they are offered locally. In August of 1999, HHS Inspector General's office issued its own report on patient access to organs in liver transplant. It said that liver transplant centers are concentrated around major metropolitan areas, leaving large portions of the US population at considerable distance from a center. The report also found that the majority of liver transplants are done at only a few centers. The Inspector General's report was consistent with the IOM report in saying that there was no evidence that broader organ sharing would force closing small transplant centers. It concluded that national policies on transplant are not likely to affect overall distribution one way or the other. Despite ongoing efforts to increase organ donation, there still are not enough organs to meet current demand, let alone future demand. So the debate over allocation will probably continue. HHS's proposed changes to the system - emphasizing medical urgency over geographic area - has supporters and opponents. Division over this proposed change continues within the professional transplant community, although that community seems to agree that HHS should not be setting medical standards and policy period. The present system, inadequate as it may be, depends on public trust. So the transplant community, UNOS, and HHS must seek common ground on how to preserve the best of the present system while correcting its problems. How they will do this remains to be seen.