State Clinical Trials Law
VA. Code Ann. §§ 2.2-2818 (16), 38.2-3418.8
Who must cover the costs? Private insurers, specified managed care plans, and public employee health plans; however, health plans (including specific limited benefit policies, policies designed for those eligible for Medicare, and other similar state or governmental plans) delivered, issued, or renewed in the state before July 1, 1999, are not required to comply
What must be covered? Patient costs arising from cancer clinical trials. Phase II, III, and IV trials are covered, while Phase I clinical trials may be covered on a case-by-case basis.
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.
Qualifying Trials: The trial must be approved by either (1) the NCI, (2) an NCI cooperative group or center, (3) the U.S. F.D.A. in the form of an investigational new drug application, (4) the U.S. Dept. of Veterans Affairs, or (5) a state IRB with a multiple project assurance contract approved by the Office of Protection from Research Risks of the NCI.
(Current as of 8/2022)