The much-debated new rules governing donor organ allocation (distribution) in the USA have been held up again, just one day before they were to take effect in October. Angered by what they saw as not enough time for comment and review, opponents attached delaying language to legislation. 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 option most preferred by doctors for many patients suffering from end-stage organ failure. 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 organ shortage grows wider each year. The number of potential transplant recipients on the UNOS waiting list 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. If the waiting list continues to grow 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.
The main reason for the shrinking donor pool is 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 to donate organs; cultural and psychological factors that stop people from donating; the prevalence of HIV/AIDS; and fewer deaths by trauma that leaves organs available.
Transplant professionals have gradually 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 this has worsened transplant recipient survival.
In June of 1998, to increase donation, the HHS issued rules called "Hospital Conditions of Participation for Medicare and Medicaid." These rules required that hospitals have written procedures for spotting and referring potential organ donors to a certified organ procurement organization (OPO). This also required that hospitals notify OPOs of all imminent deaths. Failure to comply with these rules could result in loss of Medicare and Medicaid reimbursement - death to most hospitals - so this was an order that has to be obeyed.
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 defined how organs in the US could be legally distributed. It set up a national system, established grants for OPOs, and prohibited sale of human organs. NOTA also established a Task Force on Organ Procurement to study medical, legal, ethical, economic, and social issues regarding 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 provide a safe and effective national system for donation, procurement, distribution and transplant of human organs. In 1986, in a unique public-private partnership called 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 operates a 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 are all different in structure and performance. For example, some take care of a small geographic area containing only one transplant center, while others serve up to 6 states with 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 is from 10 to 40.
Two major factors are considered when distributing 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 geography. 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. 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 policies without much federal input. Although NOTA expired several years ago, transplant programs have mostly complied voluntarily with these policies. Now, because of controversy over geographic differences in waiting times - mainly for liver transplants - HHS stepped in. HHS redefined the legal framework for the transplant network. In April of 1998, HHS Secretary Donna Shalala issued final regulations governing OPTN operation. The proposed Final Rule stated:
This Final Rule intensified a long-standing debate over how to fairly allocate organs. Liver allocation has been at the center of this controversy. The original liver distribution rules set up in 1987 were based mostly on urgency of need. Over the years, that perception of donor organs has changed from one in which they were considered a national resource to one of local resource.
In 1991, the most urgent category 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.
In fact, there has long been conflict among UNOS liver transplant centers. A few centers do 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 but a dominant number of members - out vote 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 tier system - local, regional, national - in favor of a large national waiting list. Large programs have also 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. These centers argue that changing the system to one that makes "their" donor organs available to the sickest patients in their regions (rather than locality), will siphon off their organs to the larger centers, eliminating 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 to my knowledge
The Final Rule eliminated current geographic regions and created a new system with more smaller regions. 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. If organs are given to the sickest first, smaller programs with fewer very sick patients might get fewer organs. If this happened, there would be less access to transplant for some people, especially in rural areas. Opponents also say that offering organs to the sickest patients first results in wasted organs, because the sickest patients are the least likely to survive. Jon's note: the statistics on this apply to liver transplant, not heart transplant
Equally controversial is the issue of who should set medical policy for transplant. The Final Rule gave Shalala authority to set transplant policy. This is one thing the 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 about this. In testimony before Congress, members have reminded Shalala that when Congress authorized NOTA in 1984, it intended for the transplant network to make policy based only on 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 the Final Rule from taking effect 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 way to compare centers' effectiveness.
The IOM 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 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 to less sick patients.
In August of 1999, the HHS Inspector General's office issued its own report on patient access to livers for transplant. It said that liver transplant centers are concentrated around major urban areas, leaving large parts of the US population far from a center. The report also found that the majority of liver transplants are done at only a few 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' proposed changes - emphasizing medical urgency over geographic area - has supporters and opponents. Division over this proposed change continues within the professional transplant community, although that community agrees that HHS should not be setting medical standards and policy, period. The system 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.
Updated April 26, 2002
All information on this site is opinion only. All concepts, explanations, trials, and studies have been re-written in plain English and may contain errors. I am not a doctor. Use the reference information at the end of each article to search MedLine for more complete and accurate information. All original copyrights apply. No information on this page should be used by any person to affect their medical, legal, educational, social, or psychological treatment in any way. I am not a doctor. This web site and all its pages, graphics, and content copyright © 1997, 1998, 1999, 2000, 2001, 2002, 2003, 2004 Jon C.