Clinical Trials – Commercial and Individual Exchange Medical Policyopen_in_new

UnitedHealthcare covers routine, medically necessary patient costs for qualifying members in Approved Clinical Trials (PPACA‑mandated for cancer/life‑threatening conditions and, per plan, select non‑life‑threatening cardiovascular and surgical musculoskeletal trials) but excludes investigational/experimental items (except narrow exceptions such as certain FDA Category B devices and limited promising interventions), sponsor‑provided items, procedures done solely for research/data collection, travel/lodging/meals, and out‑of‑network routine costs when no non‑network benefits apply. Coverage requires IRB‑approved trial protocol and proof the trial meets Approved Clinical Trial criteria (e.g., NIH/CDC/AHRQ/CMS/DOD/VA/cooperative group funding or FDA IND/IDE status), documentation of member eligibility per the protocol, referral or supporting medical/scientific information, and medical records demonstrating the services billed are routine and medically necessary.