State Clinical Trials Law
The ACA requires that most, non-grandfathered, group health plans provide coverage for the routine costs when participating in clinical trials. Some states have more consumer protections. Click here for more information about clinical trials.
215 ILCS §5/364.01 – No individual or group policy may be cancelled or not renewed due to an enrollee’s participation in a qualified clinical trial. In order to be considered “qualified,” the clinical trial must be testing a treatment that has not been determined relative to established therapies. Furthermore, only Phase II, III, and IV clinical trials may qualify. Next, the trial must either be approved by the U.S. F.D.A. or by one of the following: (1) National Institutes of Health (2) CDC, (3) Agency for Healthcare Research and Quality, (4) U.S. Dept. of Defense, (5) U.S. Dept. of Veterans Affairs, or (6), or a cooperative group or center of any entity set forth herein. Lastly, the participant’s primary care physician must be involved in the coordination of care.
NOTE: There is currently no Illinois law that requires health plans to cover patient care costs in clinical trials. (current as of 7/2011).