IOM releases report on organ allocation
IOM releases report on organ allocation
Although the nation’s existing donor organ allocation policy functions well, distribution of available organs should be made across wider geographic areas in order to improve access for patients in most urgent need of a transplant.
That’s the recommendation based on a report from the national Institute of Medicine (IOM) committee on organ procurement and transplantation policy.
"The current system of organ procurement and allocation works reasonably well, but significant improvements in both its fairness and effectiveness could be made," explains committee chair Edward Penhoet, dean of the school of public health at the University of California, Berkeley.
Over a period of two years, the committee studied data on 68,000 patients on waiting lists for livers from 1995 to 1999. The committee found that organ procurement organizations serving larger populations are associated with improved access for patients most in need of a transplant and with lower mortality rates following transplantation.
The report recommends that donor livers, for example, should be allocated over regions with no fewer than 9 million people. Currently, defined geographic regions for liver allocation range in populations of 1 million to 12 million people.
Geography not a factor
In evaluating the data, the committee concluded that one key assumption held by critics of the existing organ allocation policies — that geographic variability in waiting time is an indicator of system fairness — was misleading.
"Based on a thorough review of waiting times for liver transplants, however, the committee found that those with the highest medical need actually wait for a comparable period of time at sites around the country," the statement reads.
However, transplant rates vary significantly for patients who are not as ill, depending on the size and location of the organ procurement organization (OPO) that serves the transplant center where the patient is registered.
The committee also discovered that low-income patients, regardless of racial or ethnic backgrounds, are less likely than affluent white patients to be referred for evaluation because they often do not have access to health insurance and higher-quality health services. Once patients are referred for a transplant, however, there do not appear to be disparities in acceptance to a waiting list.
The committee was originally charged with evaluating the impact of a proposed Washington, DC-based U.S. Department of Health and Human Services (HHS) regulation that set new rules for organ procurement and allocation nationwide.
After receiving complaints from many transplant surgeons, OPOs, and transplant centers, HHS suspended implementation of the new regulations pending study of the new rules’ potential impact on donation rates, equitable access to transplantation, and cost.
The study found no evidence that the regulation would reduce access by minorities, force closure of smaller transplant centers, or drive down donation rates. However, the committee did find that increasing the geographic area for distribution could result in a more expensive overall system due to increased transportation costs and higher costs associated with transplants for sicker patients.
The United Network for Organ Sharing (UNOS), the private, nonprofit umbrella organization in Richmond, VA, that administers the nation’s organ transplant system, praised the committee’s report in a response released after the report was made public.
The committee essentially affirmed that the UNOS system was effective and equitable, proposed a geographic basis for organ allocation that is similar to the one currently in use, and found that UNOS policies do not discriminate based on race or economic factors, according to UNOS president William D. Payne in a statement released to UNOS members and posted on the organization’s Web site (http://www.unos.org).
"The Institute of Medicine report could not be clearer. Its second recommendation is to discontinue use of waiting time as an allocation criterion for statuses 2b and 3,’" explains Payne. "It later adds: Overall median waiting time, which has dominated the policy debate, is a poor measure of differences in access to transplantation.’ The report notes that the heavy emphasis placed on waiting times by the Department of Health and Human Services created the perception that the current system was unfair. The report repudiates this notion."
Because the report calls into question the "basic medical premises" of the pending federal regulations, the regulations should be withdrawn, says Payne.
"Although the Institute of Medicine’s report endorses increased federal oversight, its scientific findings knock out the very foundation of the pending regulations and we will respectfully ask the Department of Health and Human Services to withdraw them," his statement reads.
Members of the transplant community must simply wait to see how the IOM report’s recommendations will be incorporated into the HHS rule that is implemented, says Goran B. Klintmalm, MD, PhD, FACS. Klintmalm is chairman of the Baylor Institute of Transplant Sciences and Director of the Dallas Liver Transplant Program at Baylor University Medical Center in Dallas.
"I think the IOM report is a carefully crafted compromise, but the bottom line is that the IOM says the organs should be given to the patients in need and not the transplant centers, which is how it now works out," he says. "[U.S. Secretary of Health and Human Services Donna] Shalala has said that she will adjust her proposed recommendations to reflect the IOM report. But of course, both sides — UNOS, which is most of the transplant centers, and HHS — claim that the report supports their position."
The report does call for the formation of an independent advisory board to oversee the nation’s organ allocation system, which is an essential step in establishing a fully equitable system, says Klintmalm.
According to the IOM statement, the report calls for the formation of an independent multidisciplinary board to provide guidance on how the system should best serve the public. The recommendations also call for HHS to establish better performance measures for determining how efficiently the system is working.
However, experts on both sides of the debate feel that congressional action is needed clarify the organ transplant system. "With as much rancor as has been part of the debate, if she [Shalala] just issues rules instead of Congress passing laws, the rule will be challenged in various states," concludes Klintmalm.
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