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Response to Comments: Genetic Testing in Oncology: Specific Tests
A59967
First Coast Service Options, Inc. (J09)
Effective: January 9, 2025
Updated: December 31, 2025
Policy Summary
Coverage for genetic testing in oncology under this policy is granted only when the test and its clinical application are supported by published, peer-reviewed evidence demonstrating general acceptance (e.g., original research, systematic reviews, evidence-based guidelines) and evaluated according to CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13. Anecdotal or unpublished information has limited influence and may not support coverage; MACs may redact or consolidate submitted comments and will rely on the documented, peer-reviewed evidence when making determinations.
Coverage Criteria Preview
Key requirements from the full policy
"Genetic testing in oncology is covered when the test and its clinical use are supported by available evidence demonstrating general acceptance by the medical community, such as published original r..."
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