Feds give transplant ultimatum: Allocate organs to sickest first
Opponents say new policy is death toll for small centers
The wait is finally over and the dust is settling, but the controversy about proposed changes to the organ allocation system rages on. Just last month, Medical Ethics Advisor reported on the proposed changes and their consequences for both large and small transplant centers across the nation. Now that the long-expected changes are imminent, patients on local waiting lists for livers could wait longer if they are considered "less sick" than other patients.
What's more, ethical dilemmas may result: Hospitals may be faced with informing local patients they may have to get sicker before the possibility of a transplant becomes reality.
The proposed rules established by the U.S. Department of Health and Human Services (HHS) represent the first set of guidelines the government has established for the private contractor that operates the nation's transplant network: the Organ Procurement and Transplant Network (OPTN). The transplant network was created as a result of the National Organ Transplant Act of 1984. Currently, the OPTN is operated by United Network for Organ Sharing (UNOS) in Richmond, VA.
The HHS proposal of its final rules appeared in the April 2 Federal Register. Comments regarding the rule must be received by June 1, 1998. (See sources, p. 52, for details on submitting comments.) HHS is requiring UNOS to develop a plan for allocating livers that gives priority to the sickest patients, regardless of geography. "Make no bones about it, this is about living or dying," says HHS Secretary Donna Shalala, emphasizing that her agency is not making medical judgments.
"The point [of the regulations] is to make sure you are treated fairly and equitably no matter where you are in the country," she says.
Deadline is loomingThe proposed regulations go into effect July 1, 1998, and have left UNOS officials - who strongly oppose changes to the current system - crying foul. "The regulations proposed by the Depart ment of Health and Human Services effectively put the federal government in charge of deciding who gets an organ transplant," says UNOS president Larry Hunsicker, MD. "The regulations mean that in the long run, fewer people will get liver transplants, and fewer lives will be saved."
While the regulations affect all organs, liver allocation is the most controversial because livers are viable long enough to transport across the country. And while patients waiting for kidney transplants can live on dialysis, patients waiting for livers can die. Patients already on waiting lists will not be affected by the changes to the allocation system. (For more on the regulations, see story, p. 52.)
A second requirement that is less controversial requires UNOS to establish standard criteria for putting patients on waiting lists and create medical status classifications.
The current allocation system works like this: First, procured organs are offered to hospitals in the local area, then regionally, then nationally. Patients are ranked by medical necessity within the local or regional area. Usually, organs are offered to relatively healthy local patients before being sent to sicker patients across the country.
As a result, local transplant centers depend on a supply of local organs. And because smaller centers outnumber large ones, the smaller centers have controlled UNOS policies. (For a distribution of transplant programs, see chart, p. 51.)
Perhaps most controversial is the idea of giving organs to the sickest patients first. UNOS argues that healthier patients have better survival rates following transplant surgery. "A survey of transplant programs conducted in 1996 revealed that 95% of the centers supported the current allocation system established by UNOS," says Joel Newman, spokesman for the organization.
Under the new system, patients wouldn't have a realistic chance for an organ until they became very sick, Hunsicker says. "The regulations will require doctors to put a greater emphasis on providing liver transplants to the very sickest patients, a sentiment with which we sympathize. But there is a dire shortage of organs, and many of the very sickest patients would not be able to survive without a second or even a third transplant. This change means that fewer livers will be available and over time thousands fewer lives will be saved."
An emotional issueThe regulations are welcomed by large transplant centers and patient and family advocacy groups. The University of Pittsburgh Medical Center, which is the world's largest center in the number of transplant surgeries performed, has lobbied for the change and welcomes the new regulations. "Patients' needs will finally be in the forefront," says Lisa Rossi, spokeswoman for the medical center's transplant program.
Changes in allocation also are being welcomed by patients and advocacy groups. Bruce Weir, for instance, president of Transplant Recipients International Organization, a patient and family support group in Washington, DC, says the changes will improve organ allocation. "I think it's a good fine-tuning of the system," he says.
Despite the debate over whether the changes will be beneficial, the matter still has a possible hurdle to overcome. UNOS, for example, is lobbying members of Congress to overturn the proposed regulations. "That's where hospital ethics committees can help if they feel this is detrimental. They can warn their communities that the new system could shut down their program," Hunsicker says.
In fact, Sen. Bill Frist (R-TN), a transplant surgeon himself and the only physician in the U.S. Senate, conducted a public hearing on the regulations in early April. UNOS president Hunsicker presented testimony to the Human Resources Subcommittee of the House Government Reform and Oversight Committee.
"Our computer models indicate that in the long run, more patients will die under the HHS regulation. There is no scientific or medical evidence to support the assertion, as argued by HHS, that technology now permits all livers safely to be shipped to any part of the country without detriment to the organ or the patient," Hunsicker says.
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