Seeking to end the bickering over distribution of scarce organs for transplant, the federal government last week issued a revised regulation that would overhaul the current system starting in November.
But the HHS rule immediately whipped smoldering embers of resentment in the transplant community into flame, raising questions about when, or if, the regulation would ever take effect.
Opponents of the regulation quickly mobilized 33 senators from both sides of the aisle to support a moratorium that would postpone the rule until legislation governing the nation's organ allocation system was reauthorized.
Behind the fuss are transplant rules that would generally favor the sickest patients and minimize the influences of geography in making matches, especially for livers. Under development for longer than a year, the regulation also would create an HHS advisory board on transplant policy and explicitly give the department final say on organ allocation rules.
"The rule is a good one," said Charles Miller, M.D., a transplant surgeon and director of the Recanti/Miller transplantation unit at Mount Sinai Hospital and School of Medicine, New York. "I think Secretary (Shalala) reached a very good compromise."
The latest organ policy brouhaha came a week after HHS released a report documenting wide variations in waiting times at centers in different parts of the country (Oct. 18, p. 19).
At the University of Kansas Medical Center in Kansas City, for instance, 89% of candidates for liver transplants received one within a year. By contrast, patients waiting for livers in Baltimore faced much tougher odds. Only 21% of patients on the waiting list at the University of Maryland Medical System and 23% at Johns Hopkins Hospital got livers within a year.
But some surgeons at other centers opposed provisions they say would change the federal government's role from overseer to primary policymaker.
"The bottom line is that the secretary continues to insist on having the final word on decisions relating to the allocation of organs to transplant patients," said a statement by Ronald Busuttil, M.D., president of the American Society of Transplant Surgeons.
The latest regulation represents a power grab by HHS, according to these opponents. They fear it would reduce physicians' roles in setting transplant policy, which they consider to be a medical decision.
Though the revised rules backed off from a previously proposed national sharing scheme, many small and medium-size centers also believe that broad geographic matching of donors and patients could shift organs, especially livers, to more-established centers at the expense of newcomers.
"About 85% of the transplant community feels the system is working relatively effectively and that it could be improved through modest changes," said Stu Van Scoyoc, a spokesman for the Patient Access to Transplantation Coalition, a Washington-based consortium of 32 transplant centers. "The concern is that HHS is becoming overly aggressive in managing the organ distribution system."
In particular, he said, the group thinks that any changes in the sharing system should be "voluntary and not imposed from the secretary on down."
Supporters of the rule changes argued that HHS had made revisions that reflected the concerns of transplant professionals, patients and a report by the Institute of Medicine, a branch of the National Academy of Sciences, which Congress requested.
The new rules, for instance, back away from a national transplant list previously discussed in favor of standardized criteria for patient listing at centers. Also the regulation states that sharing should not be so broad as to waste organs through prolonged shipping or allocation to patients with little chance of success.
"Fundamentally, the key principles of the original regulation haven't been changed," said Lisa Rossi, spokeswoman for the transplant program at the University of Pittsburgh Medical Center Health System, the granddaddy of transplant medicine and a supporter of an overhaul.
The intent of the new regulation, Rossi said, was to be fairer in allocation and to make clear that HHS has the right and the duty to oversee transplant policy.
"It's time for everybody to concede and get to work," she said.
The way HHS introduced the rule, however, appeared to have reopened opponents' old wounds.
Last fall, Congress ordered a one-year moratorium against changes in organ allocation amid a rancorous battle involving the United Network for Organ Sharing, a private contractor that administers the current system, HHS and various factions in the transplant community.
The revised regulation, unveiled last week, would become effective in late November. It was published in the Federal Register Oct. 20, the day before the congressional standstill was set to expire.