Live Organ Donors Get Protection

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Politics & Economics: Live Organ Donors Get Protection --- Transplant Centers Face New Standard For Performance

By Laura Meckler
23 March 2007
The Wall Street Journal

WASHINGTON -- The federal government set the first national standards protecting living organ donors with new rules that require transplant centers to detail the risks of surgery and provide independent advocates to protect donors' interests.

Hospitals that fall short of the new standards could lose Medicare reimbursement for the expensive procedures.

The regulation, more than two years in the making, also sets out new standards for evaluating the quality of transplant programs. Those whose transplant recipients fare worse than what would be statistically expected risk losing Medicare funding, said the Centers for Medicare and Medicaid Services, or CMS. All transplant centers must be recertified every three years under the rules, giving the government an opportunity to review transplant success rates.

"This is a major milestone in our efforts to make sure that people needing transplants get the best possible care," said Leslie Norwalk, acting administrator for CMS, the government agency that runs Medicare. The new rules take effect in 90 days.

About 20 programs within the more than 300 transplant centers now in operation, many of which have more than one program, would have failed under the new standards, given their most recent data, according to a CMS analyst.

The number of living donors has doubled over the last decade to nearly 7,000 a year. The vast majority give kidneys. About 400 people a year give a lobe of liver, a riskier surgery.

Donors typically give to a close family member or friend, but an increasing number are offering kidneys anonymously or to people they know casually. Bioethicists and others worry that some potential donors don't understand the risks and that hospitals may be approving donors who are not medically or emotionally suitable for the surgery.

Many transplant centers, particularly those offering liver programs, have voluntarily created independent donor-advocate teams to look out for the interests of donors. But they aren't mandated and some advocates are more forthcoming than others about patient risks.

Under the new regulation, transplant centers must assure that prospective living donors are given available statistics on how recipients and donors fare nationally and at their hospital. There is extensive data available on recipient success rates, though much less for donor outcomes.

Potential donors must also be told about medical and psychological risks, the surgical procedure including post-operative treatment, and availability of alternate treatments for the recipient. The rules also require they be informed about the possibility that future health problems related to the donation may not be covered by the donor's health insurance, and the chance that the donor may have trouble obtaining health, disability or life insurance in the future. Donors must be told that they can opt out of donation at any time.

The mandatory donor advocate, or team of advocates, must be independent of the transplant team, to minimize potential conflicts of interest.

Two states enacted regulations governing living transplantation -- New York and North Carolina -- following the deaths of two living liver donors.

The new rules for judging the quality of transplant centers replace what had been less-formal coverage guidelines. Under the old rules, centers had to perform a minimum number of transplants per year, generally 12, and patients had to reach certain survival rates. CMS had a spotty record of enforcing these rules, though media attention to some poorly performing centers prompted a crackdown last year. As a result, two programs voluntarily stopped doing transplants and five others submitted corrective action plans, said a CMS spokesman.

The new rules require centers do a minimum of 10 transplants per year in most cases. Each program's success will be judged by comparing how many patients would have been expected to survive, given various factors, to how many actually survived. After some statistical adjustments, those centers that fail to meet the standards could lose Medicare funding.