Alan Marler  /  AP
Rhonda Boone sits on a swing outside her home in Burnsville, N.C., on March 28. Boone's husband died in 1999 after donating a piece of liver to his half brother.
updated 3/30/2005 5:43:54 PM ET 2005-03-30T22:43:54

Hospitals would be required to tell prospective living organ donors of the risks of donating a kidney or a slice of liver under proposed government rules that seek to protect those donors and ensure quality care at transplant centers.

While many living donors suffer no problems, others fight pain after surgery and other complications, and a few die. Hospitals vary widely in what they tell potential donors and how they screen them.

The new rules would require hospitals to spell out the risks. Those that fail to comply could lose Medicare payments, a powerful tool aimed at ensuring 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.”

The proposed regulation touches on a wide set of transplantation issues. Several aspects mirror guidelines already used by 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 other transplants. Beyond that, if Medicare drops a program, private insurance companies sometimes follow suit.

Proposal gets mixed reaction
The proposal, which would subject transplant centers to more scrutiny, is getting a mixed reaction. Some say the government has no business trying to judge medical practice; others contend 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 organ donor 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 and the number of transplanted organs that last a year with the numbers expected given various medical factors such as how sick the patient was before the transplant. If statistical tests show the difference was not just due to chance, the hospital could lose Medicare reimbursements.

Using the proposed criteria, 10 percent of 541 existing adult heart, kidney, liver and lung transplant programs would fail the test, as would 2 percent of 309 pediatric transplant centers, the government said. It did not name the centers.

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Programs that fail to meet the standard would be subject to a more extensive review and would be given the opportunity to improve before Medicare cut them off, said Marcia Newton, a senior policy analyst at 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.

Still, some doctors object to the government stepping in to regulate a field that has been self-policed. The last time HHS tried to regulate transplantation — specifically, how organs were distributed — it led to a yearslong battle.

Dr. Richard Freeman, a liver surgeon at Tufts University, noted the proposed standards were developed by the private transplant network, which does its own, more collegial review of transplant programs. He fears the government will automatically conclude there are problems when a detailed inquiry might find none.

“Maybe the quality is just fine,” he said.

Boone, whose husband died after donating part of his liver, rejects that argument, saying, “Any transplant center of excellence that’s doing a good job will not be afraid of accountability.”

Risks without medical rewards
Many say federal oversight is particularly essential to protect 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 by their physicians to seek 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 the number 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, as well as 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, that wouldn’t guarantee that potential donors would know the risks, because little national data exist on long-term medical effects on living donors. An HHS advisory committee has recommended a long-term registry of donor health and welfare, but it has not been implemented.

That committee also recommended that an independent advocate be established at each transplant center to look out for donors’ interests without regard to the would-be recipient’s health or the surgeons’ interests.

It’s essential, argued 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.”

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