Botulinum Toxin Injections

Medicare covers botulinum toxin injections when used per FDA-approved labeling or for off-label dosing/serotype supported by robust published evidence, with detailed objective diagnostic documentation and objective severity scales required at baseline and follow-up. General restrictions include a minimum interval of 12 weeks between administrations (with limited, specified exceptions such as a 30-day subsequent dose allowance for achalasia), exclusion of cosmetic uses, serotype-specific unit non-interchangeability, and contraindications such as hypersensitivity, neuromuscular disorders, severe clotting disorders, or injection-site infection.

"Botulinum toxin is covered when used per FDA-approved labeling; off-label serotype or dosing uses are covered only if the qualified clinician provides robust published clinical evidence supporting ..."

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