Question:

What is an unlabeled use of a drug?

Answer:

According to the Medicare Benefits Policy Manuel:

“An unlabeled use of a drug is a use that is not included as an indication on the drug’s label as approved by the Food and Drug Administration (FDA). FDA approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the A/B Medicare Administrative Contractor (MAC) (B) determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice.”

Facebook
Twitter
LinkedIn
Email
Print

CPT® copyright 2021 American Medical Association (AMA). All rights reserved.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

CPT is a registered trademark of the American Medical Association.