The federal government is proposing the first legal protections for living organ donors, suggesting that transplant hospitals be required to detail medical and other risks of donating a kidney or a slice of liver.
While many living donors suffer no problems at all, others fight pain after surgery and other complications, and a handful die. Hospitals vary widely in what they tell potential donors and how they screen them.
The new rules, which touch on a wide set of transplantation issues, would require that hospitals spell out the risks. Those that don't comply could lose Medicare payments, a powerful tool aimed at assuring that centers are providing quality care and looking out for living donors, whose numbers have soared amid an acute shortage of organs from the dead.
"That's really going to get people's attention," said Rhonda Boone of Burnsville, N.C., whose husband died in 1999 after donating a piece of liver to his half brother. "When you dip into their pocketbooks, they start paying attention."
And in an effort to assure quality care, the government every three years would review survival rates at each center to be sure transplant recipients were doing at least as well as would be expected.
Several aspects of the proposed rules mirror guidelines are already in place in the United Network for Organ Sharing, a private group that runs the nation's transplant system under a government contract. But federal regulations carry more weight. Medicare now pays for more than half of kidney transplants done each year and a smaller portion of others. Beyond that, if Medicare drops a program, private insurance companies sometimes follow suit.
The proposal, which would subject transplant centers to more scrutiny than ever, is being met with mixed reaction. Some say the government has no business trying to judge medical practice; others argue the oversight is overdue.
The Department of Health and Human Services is seeking comments on the regulations, published last month. Officials expect it will be two years before they are put in place.
For hospitals, the biggest change would require programs to be certified by the government every three years.
In doing so, HHS officials would compare the number of transplant recipients who survive one year, as well as the number of transplanted organs that last a year, with numbers that would be expected given various medical factors. If a hospital's success rate is below expected, officials would apply three statistical tests to be sure that the difference is not just due to chance.
If the hospital fails those tests too, it could lose Medicare reimbursements.
Using the criteria proposed, 10 percent of 541 existing adult heart, kidney, liver and lung transplant programs would fail the test, as would 2 percent of 309 pediatric centers, the government said. It did not identify them.
Programs that fail to meet the standard would be subject to a more extensive review and be given the opportunity to improve before Medicare cut them off, said Marcia Newton, who helped write the rules for the Center for Medicare and Medicaid Services.
"The goal is to assist the transplant center in determining where the problem is and what needs to be done," she said.
The rules also require that hospitals tell both potential donors and patients awaiting transplants what the success rates have been - nationally and at the center where the surgery will be performed. While potentially embarrassing to less successful centers, this could arm patients with helpful data in choosing a hospital.
Some object to the government stepping in to regulate a field that has been self-policed until now. The last time HHS tried to regulate transplantation - in that case, how organs were distributed - it led to a years long battle. Ultimately, Congress gave HHS the power to set allocation policy, but the department has yet to use it.
There is similar resistance to this proposal.
Dr. Richard Freeman, a liver surgeon at Tufts University, noted that the standards being proposed were developed by the private transplant network, which does its own, more collegial review of transplant programs. He fears that the government will automatically conclude that there are problems when a detailed inquiry might find none.
"Maybe the quality is just fine," he said.
Boone rejects that argument. "Any transplant center of excellence that's doing a good job will not be afraid of accountability," she said.
Many say the federal oversight is particularly essential in protecting living organ donors, who agree to undergo a procedure that has risks without medical rewards.
Kidney and sometimes liver transplant patients are now routinely urged to look for living donors after being told it will take years before they reach the top of the waiting list, which now numbers more than 87,000 for all organs. Relatives and friends could feel pressured to say yes.
Last year, there were nearly 7,000 living organ donors - more than double a decade ago. Most gave a kidney; about 300 gave a liver lobe, and 28 donated a piece of lung.
The proposed Medicare rules would include requirements that transplant centers "fully inform" potential donors about their right to opt out at any point and about the "medical or psychosocial risks to the donor."
Additionally, centers would have to tell would-be donors that future health problems related to the donation may not be covered by their insurance and that their ability to obtain health, disability or life insurance may be affected.
Even so, this wouldn't guarantee that all potential donors would know all the risks, because little national data exist on long-term medical effects on living donors. Advocates have pressed for a long-term registry of donor health and welfare.
An HHS advisory committee recommended an independent advocate be established to look out for the donor's interests without regard to the health of the would-be recipient or the interests of the surgeons. Medicare officials asked for feedback on this idea.
"There needs to be one or two people completely divorced from the emotion," said Dr. Elizabeth Pomfret, who directs the live donor liver program at the Lahey Clinic in Burlington, Mass.
It's essential the government require an advocate and then enforce the rule, said Vickie Hurewitz, whose husband, Mike, died in New York City after giving a piece of liver to his brother.
"An advocate must follow the donor from the time he walks in the door until discharge," she said. "Somebody has to protect the donor from himself."
By Laura Meckler By Laura Meckler