Botulinum Toxin Injections

Botulinum toxin injections are covered when used according to FDA-approved labeling or supported by robust published evidence for off-label serotype/dose, with specific diagnosis-based criteria for achalasia, chronic anal fissure, blepharospasm (including orofacial dystonia), cervical dystonia, and chronic migraine. Coverage requires objective diagnostic documentation and standardized baseline and follow-up assessments, adherence to specified dosing ranges per diagnosis/serotype, and adherence to safety exclusions (contraindications, neuromuscular disorders, infection, severe clotting disorders); injections generally must not be given more often than every 12 weeks. Cosmetic use, image guidance, conscious sedation/MAC, and certain concurrent procedures or non-indicated pain conditions are excluded from coverage.

"Botulinum toxin administration consistent with FDA-approved labeling is covered; off-label dosing or serotype use requires the qualified clinician to provide robust published clinical evidence supp..."