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.
MO St. Ann. §376.429 – The statute applies to all health benefit plans issued, delivered, continued, or renewed on or after August 28, 2006 to Missouri residents. These insurers must provide coverage of routine patient care costs for clinical trials. The final provision of the statute specifically excludes various plans, including many limited benefit policies.
Only Phase III and IV clinical trials are covered, the purposes of which must be the prevention, early detection, or treatment of cancer. The trial must be approved or funded by one of the following: (1) NIH, (2) NIH cooperative group or center, (3) a qualified research entity that meets NIH Center support grant eligibility requirements, (4) U.S. F.D.A., (5) U.S. Dept. of Defense, (6) U.S. Dept. of Veterans Affairs, or (7) a Missouri IRB that has been approved by the U.S. Dept. of Health and Human Services. The facility or personnel providing the experimental treatment must be experienced. There must be equal to or superior non-investigational treatment alternatives. Data related to the clinical trial must provide a reasonable expectation that the treatment will be superior to the non-investigational alternatives. (Current 6/7/11)