Clinical Trials

Coverage, as required by Missouri law, for routine patient care costs incurred as the result of a Phase I, II, III, or IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition. The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration or is a drug trial that is exempt from having such an investigational new drug application. Life-threatening condition means any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted. Routine patient care costs include all items and services consistent with the coverage provided in Plan benefits and would otherwise be covered for a member that is not enrolled in a clinical trial. Routine patient care costs do no not include the investigational item, device or service itself; items and services that are provided solely to satisfy data collection and analysis needs and are not used in the direct clinical management of the member; or a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis. The member must be eligible to participate in the clinical trial according to the trial protocol with respect to treatment of cancer or other life-threatening disease or condition. The clinical trial must be approved or funded by one of the following:

• the National Institutes of Health;
• the Centers for Disease Control and Prevention;
• the Agency for Health Care Research and Quality;
• the Centers for Medicare & Medicaid Services;
• a cooperative group or venter of any of the previously named agencies or the Department of Defense or the Department of Veteran Affairs;
• a qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants; or
• a study or investigation that is conducted by the Department of Veteran Affairs, the Department of Defense, or the Department of Energy and has been reviewed and approved to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health and assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.