Are You Covered?


In the old days, medical decisions were made by doctors.

Now they're also being developed in the media and courtrooms. And there's a fourth party to the discussion: the health insurer.

Recently, all four factions have been arguing about a treatment for breast cancer. Several Maryland women have sued their insurer, which has refused to pay for the treatment because the insurer, Blue Cross and Blue Shield of Maryland, regards it as experimental. Several doctors, however, disagree that the technique is experimental.

And which side you take in the dispute seems to depend on how you define the word "experimental" and who is doing the defining.

There is, in fact, no central authority that determines whether a procedure is experimental or established, no procedure comparable to the process by which the Food and Drug Administration extends marketing approval to new drugs and medical devices.

The treatment involved in the most recent dispute aims to eliminate malignant cells that have begun to wander about and produce new tumors, by bombarding the body with chemotherapy in doses known to be toxic to the cancer. But those doses are also toxic to bone marrow, which manufactures blood cells; without marrow, you die.

So the women must have some of their own ("autologous") bone marrow removed, treated and preserved before they have chemotherapy; afterward it's reinfused, as in the more familiar bone marrow transplant from a donor, a procedure that is not regarded as experimental.

The two-phase autologous bone marrow procedure carries a price tag of about $122,000 per patient for the first year's care. And whatever the insurerpays out this year is going to be reflected in higher insurance premiums next year. "Society is saying to the medical care system in general: 'Reduce costs,' " says Dr. Stephen Schimpff, vice president of the University of Maryland Medical System.

"But as individuals," he says, "we want the best possible care for our family members and our friends."

Besides, expense isn't really the issue, according to Dr. Dan McCrone, director of the organization that develops policy regarding reimbursement for Blue Cross and Blue Shield of Maryland.

"We do not pay for experimental treatment," he says.

If "experimental" means something that has not been proven safe, effective and superior to other forms of treatment for this particular form of cancer through wide-scale comparative testing and long-term follow-up, then the term may apply.

On the other hand, it's been done often enough and successfully enough to persuade some physicians that it could totally eliminate cancer cells throughout the body and restore the patient to good health.

When cancer has spread beyond the breast and underarm lymph nodes, other treatments are of limited benefit, said oncologist Enser W. Cole III in federal court last week, as he testified on behalf of a woman suing Blue Cross and Blue Shield for payment for the new treatment. "The best evidence . . . of effective treatment is to use extremely high doses of chemotherapy followed by bone marrow transplant from the patient's own bone marrow," he said.

That recommendation for this patient was developed after consultation with three oncologists at Hopkins, where he is on the medical faculty, two Maryland surgeons and other physicians at the University of Pittsburgh and Duke, he said.

But everyone does not always agree so emphatically.

"There are those who will tell you it is absolutely well-proven, and others who say, 'I'm not sure, get me more data,' " says Dr. Schimpff, who is also president of the Maryland division of the American Cancer Society.

"Within the oncology community, probably no one would say it has no value," he continues. "But is it really better than current-day, standard therapy? Yes, I think the data show that intensive chemotherapy and autologous bone marrow transplant give a person an edge. But other people would argue that less intensive therapy would be just as effective."

"There are suggestions that it will cure patients with metastatic breast cancer; I don't think the optimism is completely unfounded," says Dr. Michael Friedman, associate director of the National Cancer Institute's cancer therapy evaluation program.

"On the other hand, some patients suffer greatly from the treatment, they are in the hospital for a couple of weeks, and some of them die. But patients with metastatic breast cancer also suffer, and some of them also die. It's a very complex question; there are no answers."

If the care for a single patient is expensive, the cost for the hundreds of patients required for a major study is monumental. Nevertheless, it will be done. The Chicago-based Blue Cross and Blue Shield Association has announced that Blue plans in 15 states will put about $10 million into a program designed by the National Cancer Institute to show whether high dose chemotherapy and autologous bone marrow transplant are indeed the most effective treatment. Blue Cross and Blue Shield of Maryland is not among the participants.

"The Association has devised a way to do some clinical research; it has not come out in support of the technique," says Dr. McCrone.

Even if the Association had come out in support, the local Blues would not have to comply; each state plan sets its own policy, based on its own technology review process.

Other health insurers, HMOs, Medicare and Medicaid are also unlikely to pay for procedures considered "experimental." And like the Blues, each has its own way of determining what is in that category.

Even if the Health Care Financing Administration, which administers Medicare, orders Blue Cross and Blue Shield of Maryland to pay for a procedure for Medicare subscribers, the Blues do not have to extend the coverage to non-Medicare subscribers.

Physicians determine the best care based on their own experience and that of their colleagues, on reports presented in the medical literature and at medical meetings, and on the evaluations of their specialty organizations and the American Medical Association. An AMA panel has, in fact, decided that autologous bone marrow transplant is an "appropriate" technology; the panel did not, however, consider it in conjunction with high-dose chemotherapy for breast cancer.

It is possible that the results of the big Blue Cross and Blue Shield test will persuade all the different people, agencies and organizations that the procedure is no longer experimental. But those results are years away, and women with metastatic breast cancer haven't got years to wait for treatment.

Want to know more?

In disputes between subscribers and insurers, government agencies can sometimes help:

Health Education and Advocacy Unit of Consumer Protection Division of AG's Office: Call Hot line for health complaints at 528-1840.

*Maryland Insurance Division, complaint and inquiry line: 333-6300.

*Or read: "Who Should Pay for Clinical Research?" in Journal of Clinical Oncology, November 1990.

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