Immune Globulin

Immune globulin (IVIG) is covered for FDA-approved indications and for specific off-label uses where evidence supports benefit, including several immunodeficiency states, select transplant-related indications, and a range of refractory autoimmune and neuromuscular disorders. Subcutaneous immune globulin off‑label use and intravenous IG uses not listed in this LCD are not covered; many covered off‑label indications require documentation of lab abnormalities (e.g., hypogammaglobulinemia or subprotective antibody titers), prior treatment failure or intolerance, biopsy proof where specified, and appropriate provider qualifications. Services may be audited and must comply with CMS medical necessity rules and any applicable NCDs.

"Administration of immune globulin for FDA-labeled indications for immune globulin products."

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