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Response to Comments: Amniotic and Placental-Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound
A59894
Novitas Solutions, Inc. (J12)
Effective: October 17, 2024
Updated: December 31, 2025
Policy Summary
This response-to-comments policy states that coverage decisions for amniotic and placental-derived product injections/applications for non-wound musculoskeletal indications will be grounded in the best available published clinical evidence (peer-reviewed studies, systematic reviews, meta-analyses, consensus statements, and guidelines) per CMS Program Integrity Manual Chapter 13. Anecdotal or unpublished non-peer-reviewed information is given limited weight, and MACs may consolidate or redact portions of public comments submitted during the comment period.
Coverage Criteria Preview
Key requirements from the full policy
"Anecdotal or unpublished non-peer-reviewed information has limited influence and is not sufficient by itself to support coverage determinations."
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