Billing and Coding: The Routine Costs of Investigational Chemotherapy Drugs Studied In a Qualifying Clinical Trial

Medicare covers routine costs of qualifying clinical trials and reasonable and necessary items/services to diagnose or treat complications from trial participation. Investigational chemotherapy drugs provided by research sponsors generally may not be billed to Medicare and, if billed for an investigational indication in an outpatient clinical trial, must be reported as noncovered with condition code 30, modifier Q0, and diagnosis code Z00.6 per CMS guidance.

"Medicare covers routine costs of qualifying clinical trials as described in CMS guidance."

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