Virginia Code Title 38.2. Insurance § 38.2-3453. Clinical trials

1. “Approved clinical trial” means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition, and the study or investigation is (i) a federally funded or approved trial, (ii) conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration, or (iii) a drug trial that is exempt from having an investigational new drug application.

2. “Life threatening condition” means any disease or condition from which the likelihood of death is probable unless the course of disease or condition is interrupted.

3. “Qualified individual” means a covered person who is eligible to participate in an approved clinical trial according to the trial protocol, with respect to treatment of cancer or other life-threatening disease or condition, and the referring health care professional has concluded that the individual's participation in such trial is appropriate to treat the disease or condition, or the individual's participation is based on medical and scientific information.

4. “Routine patient costs” means all items and services consistent with the coverage provided under the health benefit plan that is typically covered for a qualified individual who is not enrolled in a clinical trial.  Routine patient costs do not include the investigational item, device, or service itself;  items or services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient;  or a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.