New protection eyed for living organ donors

WASHINGTON -- 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 a liver.

While many living donors suffer no problems, 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 part of his 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 of 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 the level expected, officials would apply three statistical tests to be sure the difference is not 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 failed 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 date could help patients choose 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 battle that lasted years. Ultimately, Congress gave HHS the power to set allocation policy, but the department has yet to use it. There is similar resistance to the current 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.

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 part of a lung.