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Response to Comments: Genetic Testing in Oncology: Specific Tests
A59856
Novitas Solutions, Inc. (J12)
Effective: January 9, 2025
Updated: December 31, 2025
Policy Summary
This response-to-comments document states that coverage decisions for genetic testing in oncology are based on evidence of general acceptance in the medical community, prioritizing peer-reviewed research, systematic reviews/meta-analyses, and evidence-based guidelines per CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13. Anecdotal or unpublished information has limited influence on policy determinations, and MACs may consolidate or redact public comments when appropriate.
Coverage Criteria Preview
Key requirements from the full policy
"Coverage determinations prioritize evidence of general acceptance in the medical community, specifically published original research in peer-reviewed journals, systematic reviews, meta-analyses, ev..."
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