Botulinum Toxin Injections

Medicare covers botulinum toxin injections when administered per FDA labeling or when off-label use is supported by robust published evidence, with specific diagnosis-based criteria for achalasia, anal fissure, blepharospasm (including orofacial dystonia), cervical dystonia, and chronic migraine prophylaxis. Coverage requires objective documentation (validated scales, HRM for achalasia, documented conservative treatment trials for fissure, prior medication trials for migraine), adherence to serotype-specific dosing limits, and injections no more frequently than every 12 weeks; cosmetic uses and multiple same-day procedures are excluded.

"Botulinum toxin dosing must follow FDA-approved labeling; off-label serotype or dosing requires robust published clinical evidence from the qualified health care professional."

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