State Clinical Trials Law
Va. Code §§ 33-25F-2, 5-16-7d, 5-16B-6a – 6b, 9-2-12 – 12a
Who must cover the costs? Insurers, non-profit groups, and individual health service plans.
What must be covered? Patient costs resulting from participation in clinical trials testing for life-threatening conditions and cancer studies that are Phase II, Phase III, or Phase IV
Requirements for Coverage: 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 that 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.
Qualifying Trials: 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.
(Current as of 8/2022)