Mandated Benefits Review - Senate Bill 1198 - Overview

Senate Bill 1198 - the proposed Cancer Clinical Trials Act - would require insurers to provide coverage for routine patient care costs when an insured participates in an approved cancer clinical trial. Senate Bill 1198 would also create the Pennsylvania Cancer Clinical Trial Review Board within the Department of Health.

Routine patient care costs would be covered if the patient has been referred for such treatment by two oncologists and if the trial has been approved by one of the following organizations: the National Institutes of Health, The United States Food and Drug Administration, the United States Department of Defense, or the United States Department of Veterans Affairs. In addition, the cancer clinical trial must be reviewed and approved by the applicable institutional review board and the available data must indicate that the treatment provided in the clinical trial will be at least as effective as standard treatment.

The Pennsylvania Cancer Clinical Trials Review Board would be established in the Department of Health. The Board would consist of nine members: an oncologist representing a comprehensive or clinical cancer center, an oncologist who does not represent a comprehensive or clinical cancer center, a medical ethicist, a medical economist, a physician representing an insurer, a physician representing a non-profit health plan, a physician representing a health maintenance organization, a consumer of oncology services, and a representative of the Pennsylvania Cancer Control, Prevention and Research Advisory Board. The Board would meet at least four times a year and would adjudicate hearings involving third-party reimbursement for patient care costs in cancer clinical trials.

As a state law, the measure would be preempted by the federal Employee Retirement Income Security Act of 1974 (ERISA) (PL 93-406), which precludes state laws from applying to the benefit plans of self-insured companies. According to the Pennsylvania Department of Insurance, the percentage of private payers that are preempted by ERISA is approximately 50% of all privately insureds. Although Senate Bill 1198 would not currently apply to ERISA exempt companies, it is the stated intent of the bill that, "this act be given the broadest possible application and that its scope include application permitted by future legislative amendments and judicial interpretations of ERISA."

Senate Bill 1198 has a sunset date of June 30, 2005.