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Response to Comments: Off-Label Use of Intravenous Immune Globulin (IVIG)
A60252
National Government Services, Inc. (J06)
Effective: September 7, 2025
Updated: December 31, 2025
Policy Summary
This document is a response to public comments regarding off-label use of intravenous immune globulin (IVIG) and serves as notification of the LCD administrative timeline. The official notice period begins July 24, 2025, and the final LCD determination becomes effective September 7, 2025; the document does not specify clinical coverage criteria, indications, limitations, or claim documentation requirements.
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Key requirements from the full policy
"This document is a response to comments and notice of the LCD development process for off-label IVIG; the official LCD notice period begins 2025-07-24 and the final determination is effective 2025-..."
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