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Response to Comments: Botulinum Toxins
A60163
Novitas Solutions, Inc. (J12)
Effective: September 25, 2025
Updated: December 31, 2025
Policy Summary
This response-to-comments document for LCD DL38809 (Botulinum Toxins) explains that Novitas reviewed stakeholder input but bases final coverage decisions on the best available published clinical evidence per CMS Program Integrity Manual Chapter 13. Peer‑reviewed research, systematic reviews/meta‑analyses, consensus statements, and clinical guidelines are prioritized, while anecdotal or unpublished information is given limited weight; procedural notes include that comments may be consolidated or redacted.
Coverage Criteria Preview
Key requirements from the full policy
"Anecdotal or unpublished information not subject to peer review has limited influence on policy determinations and will not be weighted equally with peer‑reviewed published evidence."
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