Routine Costs in Clinical Trials

Medicare covers routine costs of qualifying clinical trials (effective July 9, 2007) and reasonable and necessary items to diagnose or treat complications from trial participation, provided the trial evaluates an item/service within a Medicare benefit category and is not statutorily excluded. Trials qualify when they meet AHRQ/multi-agency panel criteria and are certified by the principal investigator and enrolled in the Medicare clinical trials registry; certain federally funded or FDA-reviewed trials are automatically qualified. Investigational items themselves, data-collection-only procedures, and sponsor‑provided free items are excluded from routine-cost coverage, and statutory non-covered items remain non-covered though complication care may be paid.

"For items and services furnished on or after July 9, 2007, Medicare covers the routine costs of qualifying clinical trials and reasonable and necessary items and services to diagnose or treat compl..."