Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars

This policy outlines billing, coding, and documentation expectations for on-label and off-label use of rituximab and its biosimilars. Coverage requires a valid ICD-10-CM diagnosis code, adherence to standard dosing per medical literature, and comprehensive documentation of prior treatments and responses; re-treatment is allowed only after documented positive response. Claims must include signed, dated records and the referring/ordering physician name and NPI where applicable, and procedure codes remain subject to NCCI and OPPS edits.

"Rituximab (and biosimilars) may be billed for on-label and off-label uses when medical necessity is supported in the medical record and an appropriate ICD-10-CM diagnosis code is reported on the cl..."

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