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SEATTLE -- The headlines are harrowing, the plights chilling.
A Bellevue, Wash., man, dying of a brain tumor the size of a plum, wants a stem-cell transplant. A Seattle woman whose cancer spread from her breasts to her lungs asks for a new type of bone-marrow transplant. A Covington, Wash., man, suffering from an aggressive form of multiple sclerosis, wants a stem-cell transplant.

In each of these cases during the past decade, the insurer said no.

The reason? No payment for "investigational or experimental procedures," an escape clause usually buried in the insurance contract near the exclusion for "health services required as a result of war." These cases don't come up very often, maybe 10 times a year for even the largest health plan.

But the denials, which grab headlines and hearts, are often portrayed as a battle between a greedy insurer and a dying consumer.

It's often not that simple. Many so-called experimental treatments fail. Some are much riskier for patients than other available treatments. Many cost hundreds of thousands of dollars.

Promising but unproven last-chance therapies pose the most difficult moral- and clinical-policy challenge facing our health-care system, said Norman Daniels, a Tufts University professor who studies ethics and health policy.

They raise the questions of what insurance should cover in a time when escalating medical costs are sending premiums soaring, and who exactly should make health-care decisions.

The two cancer patients didn't get their transplants. They died.

The third patient, James Ellison of Covington, is the most recent to take his battle public. His insurer, Premera Blue Cross, refused to pay for a stem-cell transplant for his multiple sclerosis. But an anonymous donor last week offered to pay $75,000 for the treatment, and the Fred Hutchinson Cancer Research Center will cover the remaining $25,000.

State Insurance Commissioner Deborah Senn blasted Premera's denial as the most dramatic injustice she had witnessed in her career. But it was hardly a black-and-white case.

Fewer than 50 of these procedures have been performed worldwide. Although Fred Hutchinson doctors call this transplant Ellison's only hope, the National Multiple Sclerosis Society says more study is needed.

At least one person died after a stem-cell transplant, said Stephen Reingold, a neurophysiologist and vice president for research programs at the society.

"This is a potentially risky procedure," he said. "You wipe out their immune system. You make them vulnerable to anything coming down the pike."

Defining an "experimental procedure" isn't simple. The experiment of yesterday, after all, is the standard of today -- for example, bone-marrow transplants for leukemia.

Even insurers who use impeccable science and hold hearings risk lawsuits, bad publicity and legislative mandates requiring coverage, Daniels said.

Aetna U.S. Healthcare was hit with a $120 million jury verdict last month after delaying treatment to a patient for a rare form of stomach cancer. In New York, a law firm has set up an Internet page to help people file lawsuits against insurers "when denial is a death sentence."

The Washington Legislature is now considering a patients' Bill of Rights that would create independent review committees for patients to appeal insurance-company decisions. A similar bill is being debated in Congress.

"What's so important about independent review is that it removes the economic factor from the decision maker," Senn said. An insurance company "is obviously economically invested in the decision. If an experimental treatment costs 10 bucks, you're not going to hear about it."

Insurers are starting to act on their own. Earlier this month, the American Association of Health Plans told its members to adopt binding review programs allowing patients to quickly challenge coverage decisions.

That trade group also is about to sign an agreement with the National Institutes of Health urging its members to pay for the patient-care costs involved in clinical trials of experimental procedures and treatments.

"Where do we draw the line?" asks Art Sprenkle, the  senior medical director for Qualmed Health Plans in  Washington state. "It would make it much more comfortable for a lot of people if there was a neutral  party, making decisions."

Company officials say they don't consider economics in  these decisions as much as whether a treatment is safe  and effective. In most companies, a committee determines what technology is experimental.

Insurers say they insist on random tests of new  treatments in many centers. They want to know whether  the new treatment is as effective as the standard  treatment, whether it's safe and whether the test  results can be achieved outside of the lab.

There are horror stories of experiments that jumped  the gun. Several years ago, new drugs did wonders for  people who had extra heartbeats. Those drugs also were  given to people who had extra heart beats after  suffering heart attacks.

"It made sense to get rid of those extra beats,"  said Michael Stuart, who sits on the Medical

Technology Assessment Committee at Group Health. But  as it turned out, he said, "One in 20 patients given  those drugs were killed by them. You think you're  doing good. But you're harming them. In fact, killing  them."

For all the publicity, formal appeals of insurers'  decisions don't come up that often.

Less than 10 percent of the 70 appeals received by  Regence BlueShield, Washington's largest health plan,  involved experimental-treatment issues, said Chris  Bruzzo, Regence spokesman. Only 10 people last year  appealed Group Health Co-operative's denials for  experimental treatment. Group Health decided to pay  for five of those cases.

The independent-review panel in Texas, one of the only  states to have such a panel, heard only a dozen cases  last year.

But many such cases involve life-or-death decisions.

Seattle breast-cancer patient Rhonda Bast fought back  after her insurer denied coverage for a bone-marrow  transplant that doctors said could save her life.

Months later, after a lawyer got involved and letters  flew back and forth, Prudential Insurance Company of  America agreed that it had made a mistake. Bast went  to her doctor, trying to get the transplant. But the  cancer had spread from her breast to her lungs to her  brain. It was too late.

In 1993, she died at the age of 40. Her brother,  lawyer Mick Fleming, has been fighting for changes  ever since Bast made it a dying wish.

"She was just so angry," Fleming said. "They had a  chance to save her life. They basically killed her."

Most insurers now pay for stem-cell transplants for  women with advanced breast cancer. A spate of lawsuits, including an $89 million verdict in a 1993  California case brought by a breast-cancer patient,  pushed many insurers to cover the procedure even  though it didn't meet their standards for coverage.

In fact, said Daniels, the Tufts University ethicist,  it's still not clear that stem-cell transplants give  patients a better shot at survival than conventional  therapy. But lawsuits -- and laws enacted by many  states -- mandated coverage before clinical trials had  answered the question.

Perhaps insurers should take into account society's  need to "rescue" dying patients even if the science  isn't there, said Art Caplan, director of the Center  for Bioethics at the University of Pennsylvania.

One large health-maintenance organization in Minnesota  decided to cover some promising but still-unproven  treatments, even though they would ordinarily fall  into the "investigational" exclusion, Daniels said.

Once insurers start paying for a procedure, however,  "it becomes very difficult to enroll people in  clinical trials," because patients in a control group  would have to be denied the treatment, he adds.

But even people who don't want to pay more for insurance premiums, and who believe there should be  limits on health care, gain a different view when they  get sick.

When they're dying, they often want any treatment  possible, even if there's only a tiny chance of  success, even if the procedure doesn't fall neatly  into insurance coverage.

"If somebody says something works 80 percent of the  time, that sounds pretty therapeutic," Caplan said.  "But if it only works 2 percent of the time, that  sounds pretty good, too, if it's your only shot."
 
 

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