Clinical Trials – (A003)

Cigna covers routine patient care costs (services ordinarily covered if not in a trial—e.g., radiology, labs, IV therapy, anesthesia, hospital/physician/office visits) for qualified individuals in phase I–IV clinical trials, but excludes the investigational drug/device/item itself, services provided solely for data collection, sponsor‑provided items, travel/transportation (unless the plan permits), and out‑of‑network routine costs when non‑network benefits do not exist. Coverage requires trial eligibility per protocol plus either a referring participating provider’s determination of appropriateness or the patient’s medical/scientific justification, documentation that the trial meets specified criteria (federally funded, FDA IND-reviewed, or IND‑exempt), proof that billed services are ordinarily covered, and, for in‑network‑only plans, acceptance by a participating provider if required.

"Routine Patient Care Costs/Services related to a clinical trial for a Qualified Individual consistent with the Families First Affordable Care Act (ACA) requirements."