Finalized rule coming on broader sharing of organs

Should geography determine your patient’s chances of getting a kidney or pancreas transplant?

Absolutely not, says the Department of Health and Human Services (HHS), which is poised for final implementation of its regulations on organs for transplant. Even though the government’s rule on organ allocation is a hot issue, say the experts, broad-based allocation is already in place and the new rule will not substantially change the system.

The core of the issue is that dozens of organ procurement organizations operate around the country, some with a population base as high as 12 million and others with a population base of as little as 1 million. The regulation is expected to make population-based organ allocation more equitable by creating sharing programs, essentially broadening some regions and shrinking others.

"Patients who need an organ transplant should not have to gamble that an organ will become available in their local area, nor should they have to travel to transplant centers far from home simply to improve their chances of getting an organ," HHS Secretary Donna Shalala said in a written statement. "Instead, patients everywhere in the country should have an equal chance to receive an organ, based on their medical conditions and the judgement of their physicians."

The Rule, as it is now commonly known, was issued in March of 1998, but Congress imposed an 18-month moratorium on its implementation to allow time for comment. The moratorium expires Oct. 21, and the originally proposed regulation is expected to go into effect shortly thereafter with only minor revisions, according to HHS sources.

"Medical need and equity to access need to be balanced," says kidney-pancreas transplant surgeon Christopher Shackleton, MD, associate director of the multi-organ transplant center at Cedars-Sinai Medical Center in Los Angeles.

In fact, most of the Rule is already in place, says Shackleton, who has studied in detail three organ allocation banks. UNOS (United Network for Organ Sharing) in Richmond, VA, manages the national transplant waiting list and has a sophisticated nationwide computerized matching system. "The current allocation system is not found to be all that wanting," he says.

The issue is emotional, Shackleton adds. "From the lay viewpoint, the sickest patients should have greater access sooner," he says. "But we’re looking at the utilization of a constrained resource, and we know from looking at the results, sicker patients have poorer outcomes."

Sanford Mallin, MD, an endocrinologist in private practice in Milwaukee, says residents of Wisconsin get a raw deal because of their proximity to Chicago and that metropolitan area’s demand for organs and its comparatively less successful recruiting program.

"Wisconsin has the highest donor rate in the country," says Mallin, "And Chicago has less success in recruiting and a larger potential need for donors. It’s like a vacuum sucking it up from us."

Mallin says a compromise was reached after Chicago hospitals got three donated livers from Wisconsin, but agreed not to take any more until the three livers were repaid from Chicago-area donors. The battle heated up after Illinois reneged on the bargain and both Wisconsin and Minnesota threatened to cut Illinois out of their region completely. Before that could happen, all parties agreed to a federally supervised sharing program, Mallin says.

He agrees with Shackleton that the organs should go to patients who have the best chance to survive. "It’s a population-based controversy only in the sense each state wants to get its fair share, and I think the new rule will help make that happen," Mallin adds.

[Contact Sanford Mallin at (414) 276-1906.]