Regulatory and reimbursement issues in treating patients with immune-mediated neuropathies

Neurologists are prescribing intravenous immunoglobulin (IVIg) with increasing frequency to treat many neurologic conditions that have a proven or presumed autoimmune or inflammatory pathogenesis. Although IVIg is not FDA approved for any neurologic condition, physicians can safely prescribe it for several disorders with reasonable certainty that the cost for the agent will be reimbursed by third-party carriers. This article discusses present FDA indications for using IVIg, off-label uses of IVIg, policies of third-party payers toward reimbursement, the Local Medical Review Policy of Medicare, coding, billing, and reimbursement for IVIg infusion, and approaches to use when reimbursement is delayed or denied.