Six months after the government ordered a change in the way scarce organs are allocated for transplants, a national transplant network is still arguing with federal health officials over what to do.
The new rules were scheduled to take effect Thursday, but they have become embroiled in lawsuits and fights in Congress. On Wednesday, a federal judge in Louisiana temporarily blocked the rules from taking effect until an Oct. 14 hearing on a lawsuit by the state of Louisiana.In March, Health and Human Services Secretary Donna Shalala declared that people were dying simply because of where they live. She ordered the United Network for Organ Sharing to come up with a fairer policy.
But the network thinks the current system, which it created, is better. It fought back with aggressive lobbying to a receptive Congress, which already has delayed the new rules once. Talks this summer between the two sides went nowhere.
Despite all this, HHS officials say they expect the network to do as it's told and come up with a new policy. So far, the network is balking.
"The longer I look at this regulation, the longer I think it does allow the flexibility for the transplant community to go forward," said Dr. Claude Earl Fox, who heads the HHS agency charged with transplant policy.
As the fight drags on, the transplant system will continue to function. But all sides fear the battle could jeopardize support for organ donation if people see negative news about transplants. And HHS officials believe the new system is needed now to start saving more lives.
Some 17,000 transplants are performed every year, but about 4,000 people die each year waiting. The list of patients who need new hearts, lungs, livers, kidneys and pancreases now tops 50,000.
The battle, the culmination of years of tension between the network and HHS, is ultimately about whether the government has the power to veto network decisions. Is the network just another government contractor, as HHS contends? Or does it have special powers to make its own decisions?
The new rules give the network 60 days to adopt a new liver allocation policy, the source of most controversy, and a year to develop new policies for other organs.
But the network wants upfront negotiations with HHS promising not to impose its will.
In the meantime, it's working with allies in Congress. House supporters of the current system want a spending bill now being negotiated with the Senate to push the rules back for another year.
Presently, organs are offered first locally, then regionally, then nationally. Local patients get first chance, even if someone sicker waits in the next state, or even the next town.
HHS says the new system must use medical urgency, not geography, to determine who gets organs.
The network says that would threaten smaller transplant programs, who rely on locally donated organs and could see many siphoned off to larger centers with sicker patients. If local programs closed, some patients would have to travel to get a transplant.
Furthermore, the network worries that giving priority to sicker patients will mean more deaths, since patients who are relatively healthy are more likely to live after surgery.
HHS insists the new rules will be flexible, noting they say that any policy should follow sound medical judgment and avoid wasting organs.
But transplant officials aren't convinced.
"I'd like to see a window open and Secretary Shalala wave her handkerchief and say `Let's talk,' " said Dr. William Pfaff, a retired transplant surgeon who heads the network's board. "The clock is ticking, and all I've seen so far is a stone wall."