Clinical Trials

This policy covers routine costs and medically necessary services associated with qualifying clinical trials—including standard-of-care items provided in trial arms, services to diagnose or treat trial-related complications, and ancillary services needed to provide or monitor investigational interventions—for enrollees participating in trials with therapeutic intent (therapeutic trials enrolling patients with the diagnosed disease; diagnostic trials may enroll healthy controls). Coverage is limited to trials that meet qualifying criteria (written scientifically sound protocol, IRB approval, and federal or specified agency/NIH-equivalent approval or IND/IND-exempt status) and to routine costs as defined by CMS/PPACA; investigational items themselves, services solely for data collection, sponsor‑provided free items, trials outside covered benefit categories or testing only toxicity/pathophysiology, and applicable Medicare, prior‑authorization, and out‑of‑network limitations are excluded.