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.
W. Va. Code §§33-25F-2, 5-16-7d, 5-16B-6a – 6b, 9-2-12 – 12a – These sections apply to insurers and non-profit group and individual health service plans. These entities must provide coverage for patient costs resulting from participation in clinical trials testing for life threatening conditions and cancer studies.
For both types of trials, coverage is limited to Phases II, II and IV. The study must be approved by either: (1) NIH, (2) NIH cooperative group or center, (3) U.S. F.D.A. in the form of an investigational new drug application or device exemption, (5) U.S. Dept. of Veterans Affairs, or (6) a state IRB with a multiple project assurance contract approved by the Office of Protection from Research Risks of the NIH. The faculty and personnel providing the treatment must be capable of doing so because of their experience. A clearly superior, non-investigational treatment alternative must not exist, and the patient’s physician must recommend participation as being appropriate treatment. Reimbursement for treatment by an out of network or noncontracting provider shall be reimbursed at a rate which is no greater than that provided by an in network or contracting provider. Coverage shall not be required if the out of network or noncontracting provider will not accept this level of reimbursement. (Updated 1/2011)
House Bill 2675