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COURTING DISASTER

part 2 of 2
As much as their cases have become a rallying cry for women seeking payment for the controversial bone marrow transplant treatment, Barbara Tepe and Cynthia Snow could just as easily be held up as examples of why insurance companies ought not to pay. After all, both women received autologous bone marrow transplants--and are, or soon will be, dead.

"It may very well be that the promising preliminary response rates will translate into increased overall survival rates," says Dr. John Cova, who directs technology assessment for the Health Insurance Association of America in Washington, D.C. "But it may very well be that they don't."

If CU's Roy Jones has a philosophical doppelganger in the battle over insurance payments for bone marrow transplants, it is Cova, who is as passionate about the right of insurance companies to not pay for bone marrow transplants as Jones is about forcing them to do it.

"I know Dr. Jones," Cova says with not-at-all-disguised contempt. "I know him well. I know his tactics. And I will debate Dr. Jones anytime, anyplace, anywhere about the effectiveness of high-dose chemotherapy versus traditional treatments."

Cova does not dispute Jones's numbers. But he does take violent exception when Jones promotes bone marrow transplants as a proven treatment for cancer. A more accurate statement, Cova says, is that the procedure is "promising"--no more, no less. "If insurance companies now are paying for this," he says, "it's only because they have been forced into it by the courts."

This summer's congressional hearings, and the federal government's subsequent decision to cover the procedure for its employees, added fuel to Cova's fire. Public pressure and moist-eyed sentimentality have no place in medical science, he says.

"What Pat Schroeder did, and what any politician does when they mandate transplants, is to subvert the scientific process," he rages. "As a scientist, it's shaken me to the bone. These people have left the arena of biomedical research and entered the arena of biomedical politics."

As evidence of how public pressure has compromised science, Cova points to the process the medical community uses to prove to itself that a new treatment is working. These tests are called clinical trials.

Last year the National Cancer Institute began four such trials. To guarantee that the effectiveness of bone marrow transplants on breast cancer is measured accurately, the trials are "coin-flip," or randomized. That means half the women who enroll receive the transplant, and half receive traditional chemotherapy. That way researchers can determine whether high-dose chemotherapy/bone marrow transplants genuinely work better.

The NCI's trials are scheduled to be completed in two to three years. Recently, however, one of the tests had to be canceled. Physicians couldn't convince enough women to take the chance that they might be in the group that received traditional chemotherapy rather than the bone marrow transplant and high-dose chemo.

To people like John Cova, the cancellation is as worrisome to science as O.J. Simpson's trial is to justice. Simpson's lawyers claim the former football star's guilt or innocence cannot be determined by an impartial jury because so many people already have formed an opinion based on gossip. In the same way, Cova says the women eligible for the National Cancer Institute's clinical tests had heard too much misleading information from the Roy Joneses claiming that the treatment absolutely works better than standard chemo.

In fact, Cova points out that many women don't know that a bone marrow transplant can be significantly more dangerous than traditional chemotherapy. He says his numbers show that up to 15 percent of bone marrow transplant patients will die from the procedure, compared with less than 1 percent for traditional chemotherapy. (While Jones concedes that more women die from high-dose chemo/bone marrow transplants than with traditional cancer treatments, he says that the percentage doesn't even approach double digits.)

When public pressure outpaces science, insurance costs more for everyone who pays a premium, Cova says. "It's easier for Pat Schroeder to make insurers the fall guy than to explain to the public what's really going on. The end result of this is on you and me. We're financing clinical research with a form of hidden and regressive taxation--higher premiums for everyone."

(This, responds Jones, is "bullshit." Not only does the insurance industry have an obligation to pay for any treatment that is ethical and that seems promising, he says, but they do it all the time anyway. He points out that cardiologists regularly use anti-clotting drugs considered experimental. But insurers cover it because it costs far less than bone marrow transplants and usually is buried in hospital bills. By comparison, bone marrow transplants must be preapproved by insurance companies, making it simple to reject them.)

Although not all physicians are willing to admit it, some of the uncertainty over how well bone marrow transplants really work has been brought on by the cancer research community itself. High-dose chemotherapy/bone marrow transplants began appearing on the scientific radar screen more than a decade ago. Yet it has been only recently that NCI's definitive trials attempting to nail down the procedure's effectiveness have begun.

"The problem is that this has been a treatment that polemicizes people," says Michael Friedman, associate director of the National Cancer Institute's Cancer Therapy Evaluation Program in Maryland. As a result, he says, those who believe the transplant procedure to be effective see no reason to compare it with existing therapies, while "insurance companies see it as very expensive and for many years refused to test it."

Concedes Friedman, "It took a long time to get everyone together on this."
Further complicating the picture is the inevitable appearance of big money in bone marrow transplants. Public opinion is not the only thing that has outpaced definitive proof of the procedure's success. So have profits. Insurance industry claims that bone marrow transplants are unproven have not prevented the treatment from becoming a thriving business.

Exhibit No. 1, says Cova, is CU's Jones. "Of course he says it works," says Cova. "He has a vested financial interest."

Jones readily admits that his bone marrow transplant program is a "cash cow" for the university. "We make a lot of money," he says. "And it causes some problems for us."

But Jones adds that his personal income does not depend on how bustling or successful the university's bone marrow transplant center is. He adds that the center's profits are used to finance other worthwhile CU medical programs.

Universities aren't the only ones cashing in on high-dose chemotherapy/bone marrow transplants.

Five years ago a group of physicians started a company in Memphis, Tennessee, called Resource Technologies Inc. Today the company, which is for-profit and traded on the American Stock Exchange, owns and/or operates three dozen clinics around the country that specialize in the procedure. In 1992 Resource Technologies opened a clinic in Colorado Springs. According to its latest quarterly financial report, the company reported revenue of nearly $10 million.

As chief financial officer of Resource Technologies, it is Daryl Johnson's business to keep track of which insurance companies will pay for high-dose chemotherapy and which won't. He says that the shifting sands of public pressure and scientific posturing have caused a lot of unevenness in the industry's coverage policies.

Despite the federal government's recent decision to include the treatment on its employees' coverage, he says, insurers across the country remain radically divided on whether they will pay for the high-dose chemotherapy/bone marrow transplants for breast and ovarian cancers. According to Johnson, for instance, Blue Cross/Blue Shield of North Carolina explicitly mentions the procedure as covered under its plan. Blue Cross/Blue Shield of Missouri, meanwhile, explicitly excludes it.

In Colorado, physicians say that many more insurance companies pay for the treatment than did two or three years ago. Even so, Robert Rifkin, medical director of the bone marrow transplant program at Presbyterian-St. Luke's Medical Center, estimates that about one-quarter of his patients still have to fight for payment. Jones adds that while as many as half of his patients were forced to go to an attorney five years ago to challenge insurers' policies, today that number has dropped to about 10 percent.

Still, Jones says that decline provides him only marginal comfort. He suspects that women covered by some tightfisted HMOs are being advised to not even pursue the treatment because their policies explicitly exclude payment for the transplants. For example, he points out that while Blue Cross/Blue Shield of Colorado's various health plans pay for the treatment, the company's HMO subsidiary, HMO Colorado, does not.

(True, says Carl Miller, Blue Cross/Blue Shield's vice president of government and media relations. But, he explains, HMO Colorado doesn't cover any transplants, although a separate transplant rider may be purchased. He explains that people interested in catastrophic care generally choose not to participate in the HMO. "It all has to do with the cost people are willing to pay for their health-care plan. So we try to give our consumers a wide range of choices.")

And, although many insurers have begun paying for the procedure, Jones says that a number of self-insured corporations continue to hold out. Most notable for its resistance, he says, is the Hewlett-Packard Company, which employs 7,500 people in Colorado.

(H-P's medical-plan director in San Francisco, Amy Velenchenko, confirms that the company does not cover high-dose chemo/bone marrow transplants for breast or ovarian cancers. "Medical consultants internally and externally have told us it does not work," she says. Still, she adds that the policy is under review and that changes might be made soon.)

So far, there has been only one large-scale attempt to unravel how insurance companies determine which women are eligible for paid bone marrow transplants for breast cancer. Last year a North Carolina physician examined the files of more than 500 women who between 1989 and 1992 had applied to their insurance companies for preapproval to get reimbursement for the procedure.

In an article published earlier this year in the New England Journal of Medicine, the author concluded that there was no clear reason why one woman's case might be accepted for payment while another's was rejected. "The predetermination process," he wrote, "was arbitrary and capricious."

In letters to the editor following publication of the article, many physicians and insurance administrators howled at that conclusion. One reason: The study's author was William Peters, who heads Duke University's Bone Marrow Transplant Program, one of the largest and busiest in the country.

"At the commonly quoted price of $150,000 per treatment," one insurance executive pointed out, "treatment of the 533 women in the analysis represents an annual income of $20 million to [Duke] alone."

At age 51, Judith Phillips of Fort Collins considers her life to be a fragile structure held together by the glue of a bone marrow transplant. First diagnosed with breast cancer in 1989, she suffered a recurrence in April 1993. After a visit to CU's bone marrow transplant center, she submitted a formal request for preapprovement of a transplant in June. She didn't expect a problem.

"I never even thought about checking my insurance plan," she says. "Our family had been with Blue Cross since the early Seventies." Although the company didn't immediately say no, she recalls that "nothing really happened until I got an attorney."

Soon after Phillips filed a lawsuit, the company agreed to cover the cost. "When they told me that," she recalls, "it was a great relief to me."

That relief has since dissolved. One month ago Blue Cross requested that the U.S. Supreme Court review the decision based on the insurance company's contention that the case should have been decided in federal court and not Denver's district court. Phillips says a loss could set her back more than $200,000.

"Why are they doing this?" she says. "I don't understand. I thought that as soon as I heard that they were covering the treatment, that was the end of it. But it's not."

Nor is it likely that Stephanie Cracraft has heard the last from her insurance company, Golden Rule Insurance Co., based in Illinois. Cracraft, of Denver, was first diagnosed with ovarian cancer in July 1991. After a series of conventional chemotherapy treatments, the cancer seemed to go into remission.

One year ago, however, a CAT scan showed the cancer had reappeared; a tumor had developed in Cracraft's lung. Her physicians recommended a bone marrow transplant to control the cancer. When she applied to Golden Rule last October for coverage, the company said it would pay. Two months later, according to a complaint filed in U.S. District Court in Denver, it reversed itself, claiming that the treatment was experimental and medically unnecessary.

Cracraft hired an attorney and filed suit. Last February Golden Rule agreed to pick up the tab. According to a settlement agreement, however, the company has reserved the right to come back and re-collect up to $25,000, depending on the outcome of other, similar bone marrow transplant lawsuits.

Perhaps the people most familiar with insurance companies' resolve to fight court-ordered payments for bone marrow transplants are Morris Hecox and Lester Tepe. Linking the two men is Barbara Tepe--Hecox's sister and Lester's wife.

It was soon after seven separate physicians in California recommended that Barbara seek high-dose chemo and a bone marrow transplant that the family got a glimpse of their future legal entanglements. After seeking treatment in her home state, Barbara Tepe received a letter in December 1992 from Blue Cross/Blue Shield: "High dose chemotherapy...was a nonbenefit of Ms. Tepe's health plan. Therefore, we regret that we are unable to give prior approval."

Once Barbara was accepted by CU's bone marrow transplant program, the family, convinced that they'd have to pay the estimated $150,000 cost themselves, set about raising the money. "My first response was, `There's no way I can do that,'" Lester recalls. But after borrowing heavily from family members and against his own retirement plan, as well as holding several fundraisers, by early 1993 the Tepes had access to nearly the entire amount.

At about the same time, a friend of Barbara Tepe's referred her to an attorney in New Jersey named Arlene Grosch. Grosch had had some prior success convincing Blue Cross's federal government insurance plan to cover the costs of a bone marrow transplant for breast cancer patients. In February 1993, after Blue Cross and the federal Office of Personnel Management refused to authorize payment for the treatment at CU, the Tepes filed a suit against Blue Cross/Blue Shield of Colorado.

In the suit, Grosch followed the tactic that has won her three separate cases against other Blue Cross plans. She contended that the company had covered the treatment prior to 1991--but then changed its policy in a deliberately misleading way.

Explains Hecox, who, as a lawyer, assisted Grosch in his sister's lawsuit, "The policy obviously was misleading. Because if Blue Cross was clear on not covering this treatment when 10 percent of women eventually are going to have some involvement with breast cancer, I don't think they'd sell very many policies."

Lawyers for Blue Cross responded by arguing that the company's policy had never covered bone marrow transplants for breast cancer--that prior to 1991 the procedure had been "experimental"--and that subsequent policy manuals were clear that the treatment was excluded. They concluded by pointing out that Tepe could have the treatment if she wanted. Blue Cross just wouldn't pick up the six-figure tab.

"This unfortunate case is not about whether [Barbara Tepe] should or will receive the medical treatment [she] wants," the company's lawyers wrote. "This case is about who should pay."

On March 1, 1993, Denver District Court Judge Connie Peterson decided in favor of the Tepes. Within days Barbara Tepe was admitted to CU's medical center.

She spent four weeks there. After leaving she spent another month at Hecox's house recovering. Lester ate up more than a year's worth of leave to accompany her. Hecox hired a private nurse to come to his house and care for his sister; another relative flew in from Washington, D.C., to help.

On April 13 Blue Cross appealed the decision. At the same time, Barbara Tepe's condition was worsening. Tepe's California physicians tried to attack the advancing disease with radiation. By the end of the summer, however, she'd had enough. In August she moved into a hospice; by October Barbara Tepe was dead. "Basically," explains Lester, "her cancer recurred faster than her health did."

Ten months later, on June 30, 1994, the state Court of Appeals, in a unanimous decision, shot down the insurance company again. The justices not only found that Tepe's Blue Cross policy had been, at best, ambiguous; they also pointed out that in most instances in which the question had been raised, other judges had no trouble deciding whether bone marrow transplants are medically sound.

"The majority of courts...have concluded that the treatment is not experimental," the Colorado justices wrote.

This past September, after Schroeder's congressional hearing, the federal Office of Personnel Management changed its mind. Effective immediately, the agency, which is responsible for writing the federal-employee health plan, mandated that its various insurance plans for government workers reimburse high-dose chemotherapy/autologous bone marrow transplants for women with breast and ovarian cancers.

According to Lucretia Myers, OPM's assistant director for insurance programs in Washington, some of the insurance companies the agency contracted with paid for the procedure prior to this fall. She adds that many of them had resisted providing coverage for transplants for breast cancer patients because they didn't want to be swamped by women needing the expensive treatment. After reviewing mounting acceptance of the procedure in the medical community and among private insurance plans, Myers says OPM finally decided to mandate coverage for government employees.

Despite the recent change in OPM's policy, though, Blue Cross is persisting. Five weeks ago the company submitted a request to the Colorado Supreme Court to review the Tepe case one more time. Blue Cross's lawyers are asking the state's highest court to move the case to a federal court where, Hecox and Grosch say, federal laws would tend to favor the insurer.

Blue Cross spokesman Carl Miller explains that the appeals against the Tepe family are not the insurance company's doing. He says that Blue Cross is required by law to defend the health policies it administers.

Moreover, Miller says that it has not been Blue Cross's decision to pursue the cases against Tepe and other women. Oddly, it is the federal Office of Personnel Management that is pushing the legal appeals. In fact, Miller says, Blue Cross's attorneys are getting reimbursed by OPM to take the Tepe bone marrow case the legal distance.

OPM's Myers declines to comment on individual lawsuits. But she says that in cases in which a woman has challenged the government's health policy, it makes sense for the personnel management office to pay for the legal appeals. "The money we are defending is the government's," she says.

Myers also acknowledges that the cost to the agency of continuing the legal battles against Phillips, Tepe and other women may be higher than the price of the actual operation. But, she explains, "sometimes it is important for reasons other than money" to push a legal argument, although she declines to elaborate.

Lester Tepe doesn't care who's responsible. To date, he says, he has written $40,000 in checks to cover the continuing legal battle over who will pay for his late wife's treatment. As for Barbara Tepe's brother, he says he is not unmindful of the issue of containing the high cost of health care.

"But," Hecox adds, "the likelihood here is that the bone marrow transplant might have bought Barbara five more years. I mean, this happened to a relatively young woman with children and grandchildren.

"If somebody knew all the facts, I'm sure they'd decide that this was not the place to cut costs."

end of part 2