Arizona's Cancer Clinical Trials Law: Flawed Process, Flawed Product

Article excerpt

For many cancer patients, participation in a clinical trial is more attractive than receiving standard therapies, which may be limited in effectiveness. Lately, however, this choice has been complicated by the fact that many insurers explicitly refuse to reimburse for expenses incurred as part of a clinical trial.

In the pre-managed care era, experimental procedures were routinely covered by a combination of sources: the administrative and experimental agent costs of clinical trials were borne by the pharmaceutical industry or the government (through the National Institutes of Health or the Veterans Administration), and other costs were unwittingly absorbed by patients' third-party insurers.[1] As managed care review brought this expenditure to light, insurers began to deny reimbursement for "investigational" or "experimental" regimens, on the grounds that covering unproven services was outside the intended use of the pooled funds for which managed care insurers were responsible. Clinical researchers at first responded to this refusal by persuading insurers to cover investigational treatments on a case-by-case basis, or by camouflaging a patient's research participation so as to slip the claims through the increasingly vigilant payment systems.[2]

In spite of increases in government funding for clinical research, an ongoing conflict evolved among doctors, patients, and insurers over the question of whether insurers should reimburse for investigational procedures. Some patients have gone to court when faced with the prospect of paying for an investigational intervention themselves, or when they were unable to pay for an experimental therapy that they saw as a last chance treatment. But attempts to resolve this controversy in the courts have resulted in such varied and at times illogical outcomes that no consistent legal direction has emerged.[3] In response, researchers and patients have taken the problem to Congress and to state legislatures.

Thus Arizona's Cancer Clinical Trials legislation. In April 2000, the governor of Arizona signed into law a bill requiring insurers to provide coverage for some costs associated with their enrollees' participation in cancer clinical trials. The bill was modeled on legislation already enacted in Georgia, Maryland, and Rhode Island, among other states, and was developed in the same year as similar legislation in Illinois and Louisiana.[4] In Arizona, the legislation had been sharply contested since its inception, and it remained controversial at the time it was signed into law. Predictably, oncologists at academic medical centers, cancer patients, and their advocates were the most vocal supporters of the bill, while third party payers, including Medicaid medical administrators, were opposed to it.

Problems with the Law

The Cancer Clinical Trials bill was supposed to respond to the fact that cancer clinical trials are underenrolled.[5] Most people from both sides of the debate agreed that only 3 percent of cancer patients currently enroll in clinical trials, while up to 20 percent may be eligible. The hypothesis behind the legislation was that patients do not participate in clinical trials because they would have to pay for it themselves, since most managed care insurers explicitly refuse to reimburse their enrollees for any experimental interventions.

The trouble with this hypothesis is that it is flatly contradicted by the best evidence available. According to a study by the United States General Accounting Office, insurers tend to make case-by-case exceptions to their general policy not to cover experimental interventions.[6] The finding was corroborated by lobbyists for managed care organizations during public hearings on the Arizona bill, as well as by research oncologists in a study at the University of Arizona's Medical Center.[7] The GAO study concluded that "many factors, in addition to insurance coverage practices, can influence patient participation in clinical trials. …