Off-Label Use of Intravenous Immune Globulin (IVIG)

This LCD expands Medicare coverage for a set of off-label IVIG uses when specific clinical criteria are met, including autoimmune retinopathy (sight‑threatening, steroid/immunosuppressant‑refractory), chronic GVHD with documented hypogammaglobulinemia and infection history ≥100 days post‑transplant, HSCT recipients age ≥20 during the first 100 days post‑transplant, IMNM/dermatomyositis, parvovirus B19–related pure red cell aplasia, scleromyxedema, stiff‑person syndrome (anti‑GAD positive, treatment‑refractory), Susac syndrome (refractory/relapsing), SCLS with monoclonal gammopathy, and selected severe refractory SLE cases. Key limitations include no indication for HSCT patients <20 years or autologous transplants, insufficient evidence for prophylactic IVIG without hypogammaglobulinemia, and trial-based/appeals‑driven coverage for SCLS and other off‑label claims; required documentation includes diagnosis confirmation, relevant labs (e.g., IgG, parvovirus B19 viremia, anti‑GAD), prior therapy failure, transplant timing/type, and supporting literature for off‑label requests.