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

This policy provides billing, coding, and documentation requirements for off-label intravenous immune globulin (IVIG) use, emphasizing that medical necessity must be clearly documented (H&P, tests, prior therapies, weight in kg, and objective measures). Specific indications include documented IgG subclass deficiency, functional antibody deficiency with recurrent infections, neuromuscular disorders with objective improvement, and certain transplant CMV serostatus scenarios; monitoring (e.g., IgG troughs and antibody titers) is required at least every 3 months and dosing should follow FDA labeling unless literature supports deviations.

"IVIG may be used for recurrent severe infections when there is documented severe deficiency or absence of IgG subclass deficiency demonstrated by blood level results prior to initial treatment."

Sign up to see full coverage criteria, indications, and limitations.