Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG)

This billing and coding article supplements the LCD for off-label IVIG use and requires that off-label IVIG be supported by the LCD, medical necessity documentation, and relevant literature when deviating from FDA labeling. Documentation requirements include history/physical, diagnostic test results, weight in kg, prior therapies, and objective monitoring (e.g., IgG subclass troughs every 3 months, quantitative neuromuscular assessments); dose/frequency should follow FDA labeling unless justified by literature and may be reviewed for medical necessity.

"Off-label IVIG use may be billed when supported by the applicable Local Coverage Determination (LCD) and by documentation of medical necessity; off-label is defined as not in Medicare-approved comp..."

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