Discovering the Cause and the Cure for America’s Health Care Crisis

Experimental Exclusion—The Hard Way Late in 1988, EHIC received a request for authorization for high dose chemotherapy and autologous bone marrow transplant (ABMT) for treatment of breast cancer. Chemotherapy drugs are poisons that kill cells. They are designed to kill fast growing, rapidly multiplying, cancer cells, while having less effect on stable cells (nerves), and slower reproducing cells (bone marrow, gut lining and hair). The oncologist practices the medical art of poisoning the patient, just enough to kill the cancer cells, while only making the other cells temporarily very sick. If the bone marrow is killed, the patient dies of anemia (no red cells) or infection (no white cells). If the intestines are damaged, the patient dies of dehydration (like having cholera) or infection when bacteria cannot be kept out of the blood. If the patient is kept alive long enough for the weakened cells to recover, the bald patient survives. If the patient survives and all the cancer cells are killed, the patient is cured. Well, at least the five-year survival rate is very high. One of the critical limits to the amount of poison the patient will live through is the amount of drugs the bone marrow will tolerate. Some cancers require higher levels of poisons than the rest of the cells in the body can survive. If the patient’s own bone marrow is sucked out and stored for later reinfusion (an “autologous” infusion), much higher levels of poison can be achieved. Then the gut lining survival becomes the critical limiting factor for how much chemical poison may be administered. High dose chemotherapy is given with the hope the cancer cells are all killed. Of course, all the bone marrow cells and most of the cells lining the gut are also killed. Following chemotherapy, the patient’s stored “autologous” bone marrow cells are transfused back into the patient. This scenario was being tested experimentally in the late 1980s. This human experiment was classified as a Phase I protocol designed to determine the toxicity levels of the chemicals being used. Human experiments are never considered standard care or attempts at cure. If the patient survives the chemo long enough for the transfused marrow cells to take hold, the patient survives. How long the patient would survive was under study. The insured in this particular case was a young woman diagnosed with advanced breast cancer by her physician. The physician, knowing standard chemotherapy and radiation therapy for this disease was usually not effective, requested referral authorization for his patient to the University of Nebraska Medical Center. The physician referred the patient for human experimentation because he believed no other therapy would be effective. Following the request and receipt of the medical records by facsimile, the literature search was completed by the next day. Review of the medical information revealed that standard therapy was available and review of contracted specialists in western Wisconsin where the patient lived established that standard care was accessible. The literature also supported the conclusion that the requested therapy at the University of Nebraska Medical Center was an experimental study. A practicing medical oncologist and professor on the clinical staff of the University of Wisconsin Medical School was called for an opinion regarding the status of the proposed therapy. The outside consultant confirmed the treatment was not available in Wisconsin and was only being performed at three American university medical centers under experimental conditions. One of these sites was the University of Nebraska Medical Center. Our consultant was told he would receive the documents we assembled for his written report. We would provide the attending PCP a timely verbal denial based on the benefit exclusion. This was done within 48 hours of the request. I believed we connected all the dots between the patient’s condition, the practicing physician’s authorization request, the status of available therapies and the benefit language in the contract. Given the state of the art in managed care at the time, our decision-making process and turnaround time were excellent. All the medical facts regarding the case had been identified and evaluated. An outside expert had been consulted and confirmed our determination that the proposed therapy was experimental. The contract language excluding experimental treatment was clear and explicit. The decision was reasoned, fair and timely. What could go wrong? The insured was the daughter of the owner of one of our larger companies in western Wisconsin. His lawyer contacted our legal department several days after our decision to deny coverage for the experimental therapy was communicated. It was clear our benefit determination would be going to court. This would be an administrative hearing before a judge to determine if the decision of the EHIC medical department should be reversed. The Employee Retirement Income Security Act (ERISA) became law in 1974 (Pub.L. 93-406, 88 Stat. 829) and protected employee benefits from punitive damage judgments. Protection of health insurance companies by this act may have been an unintended consequence, but there it was. Health care insurance is an employee benefit and immune from punitive damage awards. What was being placed on the table, or rather the judge’s bench, was the validity of the decision to deny and if reversed, the cost, within other terms and limitations, of the care in question. Norm and I met with the Legal Department staff lawyers frequently for the following several weeks. The legal department staff felt the decision process was appropriate. All elements of fact and procedures used to make the decision had to be examined prior to the court appearance to assure the file would be complete. We had a very short time to prepare. The judge fast-tracked the case so if our decision were reversed, therapy would not be unreasonably delayed. This was a reasonable stipulation. The facts of the case were not in dispute, nor the explicit language excluding experimental medical care. We determined that the case would come down to the literature and our outside expert determining the care was “experimental” vs. the primary care physician determination that the care was “necessary.” The central issue became the meaning of the word “experimental.” The additional information uncovered through meticulous research about this general topic was very esoteric. The contract defined “experimental” as treatment that was not considered the “generally accepted practice in the community.” This definition triggered several questions: Is it sufficient to define “experimental” in terms of negatives? Is it possible a treatment that is not the community standard will not be experimental? Could a treatment that is not widely available be accepted as standard care? Expert opinion is just an opinion and not necessarily fact. The literature and our consulting expert supported our benefit determination but would it be enough? A site visit to the University of Nebraska Medical Center was productive, but no additional medical information about the insured was available. The transplant team had not evaluated the patient.