Botulinum Toxin Injections

Medicare covers botulinum toxin injections when used according to FDA labeling or supported off‑label by robust evidence, with diagnosis-specific objective documentation, validated severity scales, and required trials of conservative or pharmacologic therapies where specified. General limits include avoidance of cosmetic use, contraindications (e.g., neuromuscular disorders, hypersensitivity, bleeding or infection at injection site), not administering more often than every 12 weeks (with limited exceptions such as achalasia allowing a 30-day repeat up to 100 U), and adherence to specified dosing and documentation requirements for each covered diagnosis.

"Botulinum toxin use must follow FDA-approved labeling; off-label serotype or dosing requires robust published clinical evidence or updated FDA prescribing information for new approvals."

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