Immune Globulin
L34007
Medicare covers immune globulin products for FDA‑labeled indications and a defined set of evidence‑supported off‑label intravenous IG indications (e.g., specific immune deficiencies, certain post‑transplant and autoimmune/neuroimmunologic conditions). Coverage requires condition‑specific documentation (e.g., Ig levels, subprotective antibody titers, biopsy proof, failed prior therapies, infection exclusion) and adherence to CMS rules; subcutaneous IG off‑label use and IVIG off‑label uses not listed are not covered. Providers must document appropriate licensure/training, match product selection to patient characteristics, and be prepared for post‑payment review and audits.
"Immune globulin products are covered when administered for FDA-approved (FDA-labeled) indications for immune globulin."
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