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.
N.C.G.S §58-3-255 – The statute applies to health insurance plans and state employees’ comprehensive major medical plan. The law requires these entities to cover medically necessary costs of health care services associated with covered clinical trials. The statute emphasizes that non-FDA approved drugs (i.e., investigational drugs) will not be covered by the mandate.
Covered clinical trials include Phases I, II, III and IV studies designed to evaluate new treatments and drugs for life-threatening illnesses. The tx and drugs being evaluated must be preferable to non-investigational alternatives. Furthermore, clinical and pre-clinical data must exist to show the efficacy of the experimental treatment. The trials must involve by centered or cooperative groups funded by one of the following: (1) NIH, (2)U.S. F.D.A., (3) CDC, (4) the Agency for Health Care Research and Quality, (5) U.S. Dept. of Defense, or (6) U.S. Dept. of Veterans Affairs. Moreover, the insurer itself may cover clinical trials sponsored by the entities. For coverage, the insured participants must meet protocol requirements and provide informed consent. (Updated 7/2011)