Federal Rules Offer First Protection to Living Organ Donors

ST. LOUIS _ The federal government for the first time has set standards to protect living organ donors through independent donor advocates and the mandatory disclosure of surgery risks.

The rules were set by the Centers for Medicare and Medicaid Services, the government agency that tells hospitals what they must do to be reimbursed by Medicare.

“This is the first time that Medicare regulations have been written to address the rights of living donors,” said Jeannie Miller, who directed the analysts who wrote the rules. Two years in the making, the rules will be published Friday in the Federal Register and take effect 90 days after that.

A 2005 series of stories in the St. Louis Post-Dispatch underscored the need to regulate the fast-growing ranks of living donors by showing some of the complications they faced after they gave up a kidney or part of their liver.

The living donor rules were one part of standards for the organ transplant system. To meet the new standards, hospitals must perform at least 10 surgeries a year for most of the common organs like kidneys or livers. Recipients also must survive at the expected rate.

To protect living donors, transplant centers must:

_Provide a donor advocate who is independent of the transplant team.

_Explain the statistical chance of success for both the donor and the recipient.

_Warn donors that future health problems may not be covered by insurance and that gaining insurance could become more difficult.

_Tell donors that they may opt out at any time.

“There’s no question some sort of standards needed to be established,” said Dr. Jeffrey Crippin, a Washington University liver specialist and president of the American Society of Transplantation. “I saw it as a first step.”

Miller said that, based on a six-month-old review of about 260 transplant centers nationwide, 20 would fall short of the new standards.

Advocates for living donors said that one element in the rules is still missing: a national registry that would track living donors for years after transplantation. That data could uncover long-term health risks still unknown.

The number of living donors has risen dramatically, tripling since 1990 as the U.S. Department of Health and Human Services, which oversees the Medicare programs, has pushed publicly for more organ donations. Nearly 96,000 people are waiting for an organ, according to the United Network for Organ Sharing, which organizes transplants. More than 6,000 people died last year waiting for an available organ.

In 2006, there were 6,726 living organ donors _ most of them kidney donors _ and 8,023 deceased ones.

Some living donors have faced health problems and psychological hardships. Organ recipients got a new lease on life, but some of the donors said they felt as if they didn’t matter once their donation was completed.

Transplant centers track living donors only through one year after the surgery _ and 36 percent of the time, they lose contact within the year. The United Network for Organ Sharing says a new rule, currently under consideration and up for a June vote, may bump the follow-up period to two years.

Still, most organ transplants are highly successful, and risks to living donors are slim. In the 50-year history of kidney transplants, living donors die as a result of transplantation in 3 of 10,000 surgeries, according to a 2005 report issued when the rules were first proposed.

Liver transplants are more risky, with living donors dying in 1 of 100 surgeries. And because it is a relatively new procedure, available for less than 20 years, there is less information on long-term complications for donors, Crippin said.

The main hindrance to long-term tracking of living donors is cost. Donors are difficult to track down, because most feel fine and have little incentive to submit to annual checkups, Crippin said.

That’s why Crippin says an independent donor advocate is important _ to make sure a potential donor is fully aware of what is known and what is not. He said many transplant centers require not only an independent internist, but also a psychologist or psychiatrist. Sometimes, he said, there can be donor coercion, even within a family.

“The donor has to have an out,” Crippin said.

Rhonda Boone said an advocate would have made a difference for her family. Her husband, Danny Boone, was 41 when he died in 1999 after donating part of his liver to his half brother, who died five years later. The rest of Boone’s liver shifted, blocking bile ducts and causing septic shock.

Rhonda Boone said her husband had pre-existing conditions that should have excluded him from being a donor.

“I was left to be the teacher of the lessons learned in his case,” said Boone, a retired schoolteacher in Burnsville, N.C.

She went on to advocate for standards. North Carolina, along with New York, became one of two states to provide living donors with some protection.

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(c) 2007, St. Louis Post-Dispatch.

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