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.
M.G.L.A. 175 §110L, 176A §8X – The statute applies to all health plans issued or renewed in the commonwealth on or after January 1, 2003. Health plans must cover all patient care services associated with all Phases of qualified clinical trials.
A “qualified clinical trial” is one that is intended to treat cancer. Second, it must be peer reviewed and approved by either: (1) NIH, (2) NIH-sponsored cooperative group or center, (3) a qualified nongovernmental research entity, (4) U.S. F.D.A., (5) U.S. Dept. of Defense, (6) U.S. Dept. of Veterans Affairs, or (7) a qualified IRB (applies to Phase II, III, and IV clinical trials only). Third, the facility or personnel providing the experimental treatment must be experienced. Fourth, the patient must meet specified criteria set forth in the protocol. Fifth, the patient must provide informed consent for participation. Sixth, data related to the clinical trial must provide a reasonable expectation that the treatment will provide a medical benefit to the participant. Seventh, the clinical trial must not duplicate existing studies. Eighth, the clinical trial must have a “therapeutic intent.”
This state has mandated an additional requirement on Phase I clinical trials – the facility must be an academic medical center or affiliated facility and the clinicians conducting the trial must have privileges at the academic medical center. (current 5/31/2011).