U.S. rule: Organs for transplants go to sickest in nation

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U.S. rule: Organs for transplants go to sickest in nation

Friday, March 27, 1998

By Judy Packer-Tursman, Post-Gazette Washington Bureau

WASHINGTON -- Vowing to save more lives, the nation's top health official yesterday announced the first-ever federal regulation for organ transplants, which would direct scarce organs to the sickest patients first regardless of where they live.

Health and Human Services Secretary Donna Shalala said the rule is needed because "people are dying unnecessarily -- not because they don't have health insurance, not because they don't have access to care, but simply because of where they happen to live in this country."

If it withstands legal and legislative scrutiny, the rule will force the United Network for Organ Sharing, a private enterprise that runs the nation's transplant system under federal contract, to devise a new system for distributing livers by Labor Day. It gives UNOS a year to address distributing other organs.

Shalala stressed that the rule includes a mechanism to protect those on the transplant waiting list now, so they are "in no way disadvantaged" during the transition.

This creates the first federal regulatory framework for UNOS, of Richmond, Va., which has run the Organ Procurement and Transplantation Network for a dozen years.

Reacting angrily to Shalala's announcement, UNOS officials yesterday accused the federal government of "turning a deaf ear" to their viewpoint, and suggested that her department will face a fierce fight over allocation policies.

Under the current policy, which UNOS established, organs are offered first to patients in the donor's local community. If no local match is found, organs are offered regionally, then nationally. This has helped sustain small transplant centers nationwide, while reducing the number of organs available to some of the nation's largest programs, including the University of Pittsburgh Medical Center.

Because UPMC is world-renowned as a liver transplant center, it tends to have sicker patients and long waiting lists. Thus, the new rule could make more organs available to UPMC in the future.

Shalala, at a news conference in her department headquarters yesterday, disputed UNOS' claim that her action will create a "nationally run system." Instead, she said, it would fix a system "so decentralized that both the (medical) criteria and the movement of organs have not followed need.

"Under the system that we have today, a matching organ may not reach the patient with the greatest medical need. Instead, the availability of organs, especially livers, can be constrained within an arbitrary geographical area," she said. "Technology now makes it possible for us to share the organs more widely, so they can reach the patients who need them most."

The new regulation would:

Require the network to make public "timely and accurate" information about patient outcomes and transplant centers' performance;

Limit the network's board to no more than half transplant surgeons and require more seats for transplant candidates, recipients, family members and donors;

Direct the network's board to set policies that "reduce inequities resulting from socioeconomic status." This includes setting procedures for hospitals "to make reasonable efforts to make available from their own resources, or obtain from other sources," aid for patients who can't afford transplants and follow-up care.

The department put the regulation on public display yesterday. Formal publication in the Federal Register is expected next week. It takes effect 90 days later, including a 60-day public comment period. UNOS has 60 days from the effective date to give the department a revised plan for liver distribution.

Shalala said the rule was developed "so that an accident of location doesn't affect whether you live or die." She said it offers three broad goals to guide UNOS: standardizing criteria for placing patients on the waiting list, standardizing determination of their medical status, and giving priority to those with greatest medical urgency.

She insisted that the rule won't create a federally managed system, but instead leaves specifics to the medical community, including a definition of "greatest medical need."

"We are in no way substituting our judgment for the judgment of medical professionals," she said. "We're asking them to make the system fairer."

But minutes later in a nearby Washington hotel, UNOS officials blasted the federal action. Executive Director Walter Graham said: "UNOS started a process five years ago, working very closely with the department on the contract to evaluate the allocation policies. ... They participated with us, they sat on the panel that conducted the public hearings. We submitted this information to them as part of our contract. They accepted it. ...

"And here we are today with this. We're in sort of a Catch-22 of not knowing quite" what the government wants, he said.

Sen. Bill Frist, R-Tenn., himself a transplant surgeon, opposes "usurpation" of UNOS' role in the driver's seat. Frist, who heads the panel that reauthorizes federal transplant law, yesterday announced that he'll hold hearings on the rule.

Shalala denied that the rule results from political influence: At the request of UPMC, Pittsburgher David Matter, a college friend of President Clinton, successfully sought hearings in 1996 to consider a more equitable system.

Shalala also dismissed UNOS' contentions that a "sickest-first" policy would force small centers to close or slow donation because people want organs to stay in their communities.

UPMC, dismissing claims that its stance is motivated by greed, took on UNOS and small programs at that 1996 hearing, blasting network policies that directed organ distributions locally first and put acutely ill liver candidates above chronically ill ones on the waiting list.

UPMC spokeswoman Lisa Rossi yesterday said Shalala's department "should be admired for what they're doing because they're taking a lot of heat. They're standing by their principles."

After a cursory review of the rule, she added: "Things look to be a definite improvement, but we have a concern that UNOS meets the terms of the regulation. What happens after 150 days if they don't come up with a plan? ... The fact that these regs are out is fantastic, but we have to look at the track record of both (the department) and UNOS ... and hope this policy is implemented as soon as possible."

Indeed, the rule is coming out 14 years after federal law set up a national transplant system, 12 years after UNOS began running it and nine years after the department began its rule-making. It's also 15 months after Shalala promised to decide the matter.

The secretary, asked about the delay, said her department decided to "go through a very careful process" because her staff knew it would be controversial.

"It seems to me that when you're talking about an issue of life and death, the thoughtfulness with which you conduct yourself is very important," she said.