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.
Conn. Gen. Stat. Ann. §§ 38a-483c, 38a-504a – 38a-504g, 38a-513b, 38a-542a – 38a-542g – The statutes apply to individual and group health insurance plans. These insurers must pay for routine patient care costs associated with cancer clinical trials. The statutes define “cancer clinical trial,” and specifically mention that prevention trials are covered only in Phase III and only if they involve “therapeutic intervention.”
The clinical trial protocol must be reviewed & approved by (1) NIH, (2) NCI cooperative group, (3) U.S. F.D.A. in the form of an investigational new drug application, (4) U.S. Dept. of Defense, or (5) U.S. Dept. of Veterans Affairs. Second, the insurer may require documentation of the likelihood of therapeutic benefit, informed consent, protocol information and test results, and/or a summary of the costs involved. (Current 6/2011)