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.
24-A MRSA §4310 – The statute applies to all private insurers, both individual and group policies, contracted for in the state. These insurers must cover routine patient costs furnished in connection with the clinical trial. For an enrollee to qualify for coverage for participation in a clinical trial, the person: (1) must have a life-threatening illness for which no standard treatment is effective, (2) must be eligible to participate pursuant to the protocol, (3) has meaningful potential to sustain significant clinical benefit, and (4) has obtained approval to participate from his/her referring physician based on the aforementioned criteria. The trial must be approved and funded by either: (1) NIH, (2) NIH cooperative group or center, or (3) U.S. D.H.H.S. (current as of 7/2011)