Chat GPT Risk-Rating of Geneoscopy Request

  I would not take this too seriously but it's provided "FYI" only as an example of AI writing with science policy documents.  Not as a real "expert" judgment.

AI picked up on topics like CMS staff overload and the contrast with an accelerated NCD in 2014 and whether that could occur again.

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### Chat GPT 5

Based on the content of the letter and CMS precedent, the chances of favorable CMS action look fairly strong, with a few nuanced considerations that experts would flag for monitoring:

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Reasons CMS Is Likely to Act Favorably

1. Strong Regulatory Trigger

• ColoSense is FDA-approved via PMA and even had Breakthrough Device designation, which CMS generally views positively.

• CMS has a history of aligning coverage decisions with FDA approval for CRC screening tests — notably, Cologuard’s NCD was updated within 60 days of FDA approval in 2014.

2. Clear Clinical Validation Evidence

• The pivotal CRC-PREVENT trial is large (8,900+ participants) and published in JAMA, which meets CMS expectations for peer-reviewed evidence.

• Performance metrics (≈93–94% sensitivity for CRC, ≈45–56% for advanced adenomas, ≈88% specificity) are comparable to or slightly better than Cologuard, which CMS already covers.

3. Category-Wide Policy Trend

• CMS has been moving away from single-test NCDs toward category-based coverage (e.g., NCD 90.2 for NGS, 2021 blood-based CRC test NCD).

• This request aligns with CMS’s stated aim to reduce administrative burden by avoiding repeated reconsiderations for each new technology.

4. Public Health Framing

• Letter ties request to Cancer Moonshot priorities and COVID-related screening backlogs — aligning with [2024] White House and CMS equity initiatives.

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Potential Red Flags / Risks

1. CMS Resource Constraints

• NCD reconsiderations compete with many priorities. CMS may delay due to staffing bandwidth rather than scientific objections.

2. Frequency / Utilization Management

• CMS might scrutinize the three-year screening interval, especially given concerns about over-utilization and cost. They could request additional modeling or health-economic analysis.

3. Category-Wide Language

• CMS may hesitate to immediately grant category-wide coverage for all future sRNA tests, preferring to first set precedent with ColoSense specifically, then broaden coverage later.

4. Sensitivity for Advanced Adenomas

• ColoSense shows ~45–56% sensitivity for AAs — comparable to Cologuard but not perfect. CMS could ask whether this represents a “meaningful clinical improvement” over FIT. 

• That said, CMS did not require Cologuard to show superiority over FIT, so this is likely not disqualifying.

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Bottom Line

• Probability of favorable action: High (80% of higher) given FDA approval, strong evidence, and CMS precedent.

• Biggest risk: Timeline, not outcome — CMS could take 6–12 months to issue a Proposed Decision Memo rather than fast-tracking as they did for Cologuard in 2014.

• Likely compromise: CMS may first issue coverage for ColoSense specifically (test-specific coverage) before moving to category-wide sRNA coverage. [BQ: Not likely]

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