U.S. announces national rules for organ transplants Shalala cites need for 'level playing field'

March 27, 1998|By LOS ANGELES TIMES

WASHINGTON -- The Clinton administration announced a new policy on organ transplantation yesterday, aiming to ensure that organs go to the sickest patients first, regardless of where they live.

The current system, a patchwork of regional plans, more often than not favors patients by geography rather than medical necessity, said officials from the Department of Health and Human Services.

"This is about living or dying," Health and Human Services Secretary Donna E. Shalala told reporters at a briefing. "This is about where you happen to live affecting whether you live or die. People are dying unnecessarily -- not because they don't have health insurance, not because they don't have access to care, but because of where they happen to live. We need a level playing field for all patients."

It is estimated that 10 people every day die in the United States while waiting for a donated kidney, liver, heart, lung or other organ. About 54,500 are waiting for organs, and the list grows by about 500 every month, according to the Health and Human Services Department.

There also is a significant disparity in waiting times for organs, with patients in some areas having to wait five times or more longer than in other areas, the department said.

The new rules would require the Organ Procurement and Transplantation Network -- the private sector system created by the National Organ Transplant Act of 1984 -- to develop standardized medical criteria that would rank patients nationally, with the neediest being the first on the list.

Currently, patients are ranked locally, where donated organs are first made available; if an organ cannot be used locally, either because there is no needy patient or the biological match is incompatible, the organs are offered regionally, and then nationally.

Shalala emphasized that the federal government does not want to dictate medical standards; the government's primary interest is in creating a fairer distribution system, she said.

The rules also would establish uniform standards for deciding when to place a patient on a waiting list for an organ. Currently, each transplant center establishes its own criteria, which can be more stringent at one center than another.

The rules will become effective in three months, but the actual system probably will not be in place and functioning until the new medical criteria have been reviewed and approved by the department.

The policy requires that criteria for liver recipients be developed first -- 60 days after the rules become effective -- and the standards for other organs are due within one year.

The new system, which has been debated for several years, has sparked some controversy. The United Network for Organ Sharing, which runs the distribution system under a federal contract, has opposed the changes, saying the new system could drive some local, smaller transplant centers out of business.

Network officials also have argued that with the change, patients will not have a realistic chance for an organ until they become extremely sick, thus reducing their chances for survival.

But Transplant Recipients International Organization Inc., which represents organ and tissue donors, recipients and candidates, hailed the new policy "as a tremendous step toward an equitable distribution of this life-saving resource."

Sen. Bill Frist, a Tennessee Republican and a heart and lung transplant surgeon who chairs the Senate Labor and Human Resources subcommittee on public health and safety, said he planned to hold hearings on the regulations.

Pub Date: 3/27/98

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