Update: Drug claims edits to focus on FDA‑approved indications

Beginning April 1, 2025, claims processed and submitted with pharmaceutical drug procedure codes must be supported by an approved FDA indication or an approved off‑label indication as listed in the CMS-defined list of pharmaceutical compendia. The approved off‑label usage listed in the compendia is determined using evidence‑based criteria from clinical trials and studies.

Drug procedure codes that have a prior authorization requirement or medical policy are excluded from this enhancement.

If you believe a claim reimbursement decision should be reviewed, please follow the normal claims dispute process outlined in the provider manual and include the portion of the medical record relevant to the drug provided.

If you have questions about this notification, contact your contract manager or provider relationship management representative.