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

Olson-Garewal, J. Kristin, Hessler, Kristen, The Hastings Center Report

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 …

Questia, a part of Gale, Cengage Learning. www.questia.com
Publication information: Article title: Arizona's Cancer Clinical Trials Law: Flawed Process, Flawed Product. Contributors: Olson-Garewal, J. Kristin - Author, Hessler, Kristen - Author. Journal title: The Hastings Center Report. Volume: 31. Issue: 3 Publication date: May 2001. Page number: 22. © 1999 Hastings Center. COPYRIGHT 2001 Gale Group.

This material is protected by copyright and, with the exception of fair use, may not be further copied, distributed or transmitted in any form or by any means.