Response to Comments: Genetic Testing in Oncology: Specific Tests

The following are the comment summaries and contractor responses for Novitas Solutions' Proposed Local Coverage Determination (LCD) DL39365 Genetic Testing for Oncology: Specific Tests which was posted for comment on June 9, 2022 through September 6, 2022, and July 27, 2023 through September 09, 2023, and presented at the June 24, 2022 and August 11, 2023, Open Meetings. Novitas Solutions appreciates the comments received from stakeholders during the open comment period. All comments were reviewed in their entirety. Submitted comments that cite published, peer-reviewed literature provide a suitable source of data that may inform draft policy revision(s). However, while anecdotal or unpublished information not subject to peer-review offer important perspectives, its influence on policy determinations is limited, reflecting the established evidence hierarchy which prioritizes more rigorously vetted sources. Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13: In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines. Accordingly, the final policy and our response to comments are grounded in the best currently available published clinical evidence. This approach ensures that our decisions are informed by the best available research, ultimately supporting optimal health outcomes in Medicare beneficiaries. NOTE: Novitas Solutions review all submitted comments; however, MACs may choose to consolidate similar thematic comments, redact, or withhold certain submissions (or portions thereof) such as those containing unrelated proprietary subject matter, or inappropriate language. This may result in discrepancies between the number of comments in the article and the actual number of comments received. Please note, the LCD has been renamed to ‘Genetic Testing in Oncology: Specific Tests’ to reflect the updated coverage determination.