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Living organ donors may get new protections

Federal guidelines would require doctors to spell out risks

BOONE
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.
Alan Marler / AP
updated 6:43 p.m. ET March 30, 2005

WASHINGTON - 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.

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“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.

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.


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