The board of the United Network for Organ Sharing, the federal contractor that sets national organ allocation policy, voted last week to revise controversial criteria approved last year for distribution of donated livers for transplant.
Under the change, patients with chronic liver disease that suddenly becomes critical would constitute a new second rung on the transplant ladder, designated as "Status 2A."
That would place them just behind a newly tightened group, called "Status 1," made up of acutely ill patients whose previously healthy livers fail suddenly from illness or injury and those patients whose transplants have failed. These patients make up less than 4% of those waiting for liver transplants.
The revision appears to remedy criticism of UNOS' previous arrangement. Critics contended that system unfairly penalized chronically ill patients whose condition became immediately life-threatening as compared with otherwise healthy patients with acutely severe liver disease, critics said.
"If you have two equivalent patients with the same severity of illness, then one shouldn't distinguish between being acute or chronic," said John J. Fung, M.D., a transplant surgeon at University of Pittsburgh Medical Center who had vocally opposed the previous UNOS rules.
"What the (UNOS) liver committee has done is come up with a situation where chronic patients are given some sort of escape hatch," he said. "It's not perfect, but I'd rather have that than no rescue ability for the chronics."
UNOS reworked its allocation arrangement last November, moving otherwise healthy patients with acute liver failure to the front of the transplant line. Critics, including Fung, said that would doom many patients with chronic liver disease. In reaction to the furor, UNOS amended its policy with a grandfather clause for chronic patients already on the waiting list and later suspended implementation of the revised system.
But the UNOS leadership maintained that even without the refinements, the system had been fair to chronic patients.
"Claims that all patients with chronic illness were closed out of organ access were completely erroneous-approximately 50% of patients in the (previous) . . . Status 1 have chronic liver disease," said James Burdick, M.D., a transplant surgeon at Johns Hopkins Hospital, Baltimore, and president of UNOS.
UNOS' latest changes will be open for public comment for 45 days. After reviewing any comments, the board will take final action on the proposals in November, UNOS said.
Meanwhile, HHS Secretary Donna Shalala is studying recommendations from an expert commission that gathered comments at a contentious public hearing on liver allocation policy held outside Washington last December. The panel's recommendations were not publicly released. Later this summer, Shalala is expected to decide whether to uphold, overturn, or modify UNOS' actions on liver allocation policy.