Wisconsin Sues Government over Organ Transplant Rule Change

July 7, 2008 - 8:02 PM

(CNSNews.com) - It's a sad fact of life that thousands of Americans die each year while waiting for organ transplants, but critics say that doesn't justify the federal government's move to inject itself squarely into the organ procurement process.

The federal government has just changed the rules governing the distribution of organs for transplant operations, and that has prompted a lawsuit from the state of Wisconsin.

"These rules benefit states that have poor organ procurement programs," said Wisconsin Governor Tommy Thompson. "Instead of taking organs from Wisconsin and other successful states, the federal government should work with struggling states to improve their programs," the governor said.

In Wisconsin, there are 30-35 organ donors per 1 million people, compared with a national average of 20 per million, but new moves by the federal government will take many of those available organs out of Wisconsin for distribution in states where there's been little effort to organize donor programs.

The Wisconsin lawsuit, filed in federal court Monday, accuses Health and Human Services Secretary Donna Shalala of exceeding her authority in changing the organ allocation process. Doctors say it is a big mistake for federal bureaucrats to be making life-and-death decisions in medical cases.

Until now, organ allocation has been decided by organ transplant groups and doctors. But the Department of Health and Human Services insists the sickest people should get the available organs, without regard to where that person lives or where the organ is coming from. In other words, the allocation will now be based on medical criteria, rather than geography.

But doctors say that some very sick patients have progressed to the point where it's too late for an organ transplant to do them any good. Giving these sickest patients scarce organs simply ends up wasting the organ without saving a life, critics say.

Such decisions - who will benefit most from an available organ - should be left to doctors and non-governmental organ procurement programs, critics say.

The United Network for Organ Sharing, which has the government contract for overseeing the organ donation system, says the government's new policy could force smaller transplant centers to close and could waste scarce organs on hopeless patients at the expense of healthier people who are more likely to survive.

Roughly half a million Americans are in need of a new heart, lung, liver, kidney, pancreas or intestine, according to the Coalition of Major Transplant Centers. Of these, 70,000 are on waiting lists, and thousands die each year waiting for a new organ.

Writing in Tuesday's Washington Times, HHS Secretary Donna Shalala says, "We're not saving as many lives as we could" under the old system of organ procurement.

Shalala says the biggest problem with the current system is the "local-first" allocation policy, which uses geography as well as medical need in deciding who gets an available organ. She says she wants a system "that will be more cooperative and more effective." In other words, more of the organs donated in states such as Wisconsin would go to recipients outside of Wisconsin.

Shalala writes that her department's new organ transplant rule is needed, first of all, to establish the legal framework for reviewing the nation's transplant policies."

"The Organ Procurement and Transplantation Network (OPTN) is national system created by Congress, and transplants are largely paid for by taxpayers, so its policies need to be publicly accountable," she says.

In addition to public accountability, Shalala says the new rule also will set performance goals for the system "as well as review and approval of policies based on those goals." In other words, the government will set the standards for organ transplantation (who get the organs, for instance) and enforce the policies needed to meet those standards.

Specifically, Shalala says the HHS rule will force the OPTN to develop "uniform medical criteria for identifying each patient's medical status. And on that foundation, we must build better cooperation and broader organ sharing, because cooperation and broader sharing are the key to saving more lives."