Clinical Trials Offer Reimbursement Possibilities

Infectious disease practitioners who conduct clinical trials should make sure they seek reimbursement for usual and customary care from their carriers, advises Ronald Keeney, MD, head of the Pediatric Research Initiative at the contract research organization Parexel International, in Research Triangle Park, N.C.

According to Keeney, who previously conducted clinical trials at Wake Medical Center in Raleigh, N.C, most clinical trial expenses will be covered by the pharmaceutical company or sponsorif they relate to the trial itself. However, most sponsors will not cover expenses related to usual and customary care; thats where your insurance carrier comes in. In my experience, carriers always reimbursed for usual and customary care expenses in infectious diseasessuch as hospitalization for pneumonia, Keeney says. We just didnt have problems at alleither on the inpatient or outpatient side.

Unlike the infectious disease area, however, insurance companies didnt pay for almost any experimental clinical trials involving cancer therapies. That may be changing: In late 1999, several insurance companies announced that they would pay for experimental treatments for cancer, although coverage will be limited to policy-holders participating in clinical trials approved by federal agencies.

The insurers, including Oxford Health Plans, Cigna Health Care, Aetna/U.S. Healthcare and Prudential HealthCare, plan to pay for the clinical trial expenses of cancer patients in New Jersey. These insurers say they are going to cover all phases of the clinical trial processfrom early tests of safety and efficacy to later, large-scale tests comparing the experimental treatment with a more standard therapy.

Historically, carriers didnt reimburse for clinical trial expenses for cancer or other diseases because the trials were, of course, experimental. Insurance companies shouldnt have to pay for unproven therapies, the carriers argued. However, several insurance companies now see a benefit to reimbursing clinical trials expenses: enrollment of more subjects in the trials themselves. Thats important because greater enrollments mean a greater likelihood that effective pharmaceutical solutions can be brought to market more quickly.

To make sure that they would be reimbursing only for clinical trials that truly advanced the oncology field, the insurers who plan to cover clinical trials in New Jersey indicated that only studies sanctioned by these federal health agencies would receive endorsement: Food and Drug Administration, National Institutes of Health, and the U.S. Departments of Defense and of Veterans Affairs. According to Aetnas senior medical director, Joseph Carver, MD, limiting coverage to federally sanctioned trials prevents carriers from reimbursing physicians who conduct pseudo-studies just to take advantage of an economic opportunity.

Infectious diseases and cancer are similar disease states in one aspect of clinical trialsthe small percentage of patients who participate in studies. In cancer, its about 3 percent to 5 percent of all [...]

- Published on 2000-03-01