Clinical Trials 11.01.10
Clinical trial participation coverage requires that the member is eligible under the trial's protocol, that a copy of the protocol including institutional review board approval is provided to the Health Plan, and that the trial is an approved Phase I, II, III, or IV trial conducted for the prevention, detection, or treatment of cancer or another life-threatening disease or condition and approved or funded by a listed body such as the NIH, CDC, AHRQ, or CMS. Routine costs of approved trials are eligible for coverage, while the investigated item or service, services used only to collect trial data, non-health care services such as transportation, lodging and meals, and items provided free by the sponsor are not. The current effective date is September 17, 2026, and the annual review kept the policy intent unchanged.