ArticleActive
Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars
A59101
National Government Services, Inc. (J06)
Effective: October 1, 2025
Updated: December 31, 2025
Policy Summary
This billing/coding article supplements the LCD for off-label use of rituximab and biosimilars by requiring that off-label or non‑compendia uses be supported by documentation of prior treatments, dosing/frequency/duration, and clinical response. Re-treatment is only allowed with documented positive prior response and all care must follow standard dosing per medical literature; claims must include a valid ICD-10-CM diagnosis code, required provider identifiers, signed documentation, and comply with NCCI/OPPS billing edits.
Coverage Criteria Preview
Key requirements from the full policy
"Off-label use of rituximab or rituximab biosimilars is allowable when the patient has documented lack of efficacy of prior treatments, including dosing, frequency, duration, and documentation of re..."
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