ArticleActive
Billing and Coding: Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents
A53049
Novitas Solutions, Inc. (J12)
Effective: November 2, 2023
Updated: December 6, 2025
Policy Summary
Medicare covers drugs and biologicals only if they meet the statutory definition and compendia approval, are not usually self‑administered, are provided incident to a physician’s services, are medically reasonable and necessary per accepted standards, are not excluded immunizations, and have not been deemed less than effective by the FDA. Local Coverage Determinations may further define medically necessary uses, and providers must use the appropriate modifier when billing for non‑covered services.