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.
Del. Code Ann. Tit. 18, §§3351, 3567: The statutes apply to all health insurance policies delivered or issued in the state, including those issued by a health service corporation as well as group or blanket insurance policies. The sections do not specify which clinical trial phases are covered.
The clinical trial must be approved or funded by (1) NIH, (2) NIH cooperative group or center, (3) U.S. Dept. of Veterans Affairs, (4) U.S. Dept. of Defense, (5) IRB, or (6) a qualified research entity that meets certain NIH Center Support criteria. Second, the trial must not be designed to test solely for toxicity or disease pathophysiology. Rather, the trial must have a therapeutic intent and enroll patients with diagnosed disease. Third, the purpose of the trial must be to test whether intervention could improve the participant’s health. The trial must be supported by scientific information or must intend to clarify/establish health outcomes of interventions already used. (Current as of 7/2011)