Summary: Nearly all the 26 private health insurers, the large indemnity plans, and the several health maintenance organizations that GAO interviewed approve case-by-case exceptions to the general exclusion of coverage for patients' participation in experimental clinical trials for the sake of finding effective treatments. Insurers generally agree in approved cases to pay for standard, nonexperimental care costs associated with a trial, but payments vary from insurer to insurer. Uncertainty about approval and payment levels results in patients and physicians being discouraged from seeking prior approval for trial enrollment, although insurers may pay for medical care that they are unaware is being provided in a research context. Cancer research centers reported no serious difficulties in enrolling adequate numbers of patients for trials sponsored by the National Cancer Institute but described enrollment as challenging because of administrative burdens, payment issues, and paperwork requirements. Other difficulties are community physicians' being unaware of trials and patients' being ineligible or uncertain about the benefits and risks of experimental treatments. Available data do not document the concern expressed anecdotally by the National Institutes of Health that trial enrollment is declining.
