Header: Novitas MAC finalizes a massive LCD on oncology testing, proposed in Summer 2023 and delayed since Summer 2024.
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In June 2023, Novitas issued a massive and unexpected level of revisions to its LCD for oncology testing. There were protests to CMS that this final LCD different so much from its publicly-commented draft, that it was improper.
In July 2023, Novitas withdrew that "final" LCD and reissued it verbatim as a new, "draft" LCD for public comment. Of particular note, about a dozen branded tests were listed as non-covered. Of particular impact in my view, the LCD as a whole was hugely difficult to read, repetitive, and poorly written.
The final version was "due" per CMS rules in July 2024, but Novitas issued that CMS had granted a finalization delay.
On January 9, 2025, Novitas releases a final LCD (L39365), which will be effective in 45 days.
DRAFT
FINAL
BRUCE ZIP FILE
https://drive.google.com/file/d/1020FmaYQy_sOMAhcPLvWtNFq6Qe0TFc7/view?usp=sharing
ZIP includes draft, final, and redline.
At Genomeweb here. They summarize that the LCD rescinds coverage for, "Castle Biosciences' DecisionDx-SCC test; Pacific Edge Diagnostics' Cxbladder Detect, Enhanced Cxbladder Detect, Cxbladder Monitor, and Cxbladder Triage assays; Interpace Biosciences' PancraGen; Clinical Genomics' Colvera; and the University of Pittsburgh Medical Center's ThyroSeq Cancer Risk Classifier and PancreaSeq Genomic Classifier."
Novitas' explanation of "changes" (quote)
The provision of coverage for molecular testing endorsed by selected knowledgebases (e.g., NCCN, OncoKb, and ClinGen) has been removed. The knowledgebases will continue to serve as evidence resources, where applicable. As a result, the final LCD addresses 10 molecular tests, and the title has been changed to reflect the change in policy scope.
- Following review of additional evidence, limited coverage has been granted to the UroVysion fluorescence in situ hybridaztion (FISH) test.
- The following tests have been removed from the [non coverage] policy; DecisionDx Melanoma, Enhanced Cxbladder Triage and Cxbladder Resolve.
- Considering the lab’s location, DecisionDx-Melanoma claims are not processed within this jurisdiction; therefore, its coverage determination is outside of the scope of this LCD, and all text referencing DecisionDx-Melanoma has been removed.
- Enhanced Cxbladder Triage and Cxbladder Resolve are removed since they are not yet commercially available.
- Additional information has been added to the summary and analysis of evidence sections in response to comments and supporting literature received.
- Treating physician is the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who then uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary. Nonphysician practitioners that are enrolled in the program, who are operating within the scope of their authority under State law and within the scope of their Medicare statutory benefit, are also considered for this purpose, as treating and managing a beneficiary’s specific medical problem. (see CFR, Title 42, Volume 2, Chapter IV, Part 410.32(a))
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Comparing the draft and final versions of LCD 39365 reveals that both remain quite verbose and detailed, though the final version appears to have undergone some reorganization and minor editing to improve clarity. Here are the key observations:
Improvements in the Final LCD:
Streamlining: Some sections in the final version are more concise compared to the draft, focusing more directly on actionable points. However, the overall document still includes extensive background, definitions, and technical details that might overwhelm readers unfamiliar with the subject matter.
Specific Focus: The final version seems to narrow its focus on certain tests and their evidence. For example, UroVysion is discussed with clearer clinical indications, which helps make that section more targeted.
Additional Evidence: The final document includes more comprehensive summaries of evidence for specific tests, like the Cxbladder family, which were either absent or less detailed in the draft. This aligns with its intent to base coverage decisions on actionable and well-documented evidence.
Persistent Issues:
Verbose Nature: Both versions are dense, making it challenging for readers to extract key points quickly. Even in the final version, lengthy sections of background and technical definitions may obscure the coverage determinations.
Repetitiveness: Definitions and concepts, such as clinical utility, clinical validity, and test categories, are repeated in multiple sections, which adds to the bulk without necessarily aiding comprehension.
Complexity: The use of highly technical language and exhaustive references to external guidelines and databases like NCCN, ClinGen, and OncoKB may make the document less accessible to general stakeholders, including clinicians without specialized genomic expertise.
[References to ClinGen etc were ONLY in draft, not in Final- BQ]
Is It Still Confusing?
Yes, the final LCD retains a level of complexity and verbosity that can confuse readers. While the reorganization and added specificity are steps in the right direction, the document still lacks a user-friendly structure or clear summaries to aid quick understanding, particularly for clinicians needing actionable guidance.
##References to ClinGen, NCCN, and OncoKB that were present in the draft LCD appear to have been entirely removed in the final LCD.
Draft LCD:
The draft contained detailed references to ClinGen, NCCN, and OncoKB as evidence-based sources for evaluating genetic tests' clinical actionability and utility. These sections outlined criteria for determining whether specific tests meet the medical necessity requirements based on these organizations' guidelines.
Final LCD:
The final LCD does not mention ClinGen, NCCN, or OncoKB at all. Instead, it focuses on specific tests like UroVysion and Cxbladder, with evidence drawn directly from the literature or clinical studies without citing these external knowledge bases.
This change suggests a deliberate shift in approach, possibly to simplify the document or avoid reliance on external organizations' frameworks, which might have been seen as too complex or non-essential for the final coverage policy.
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Response to Comments
The Response to Comments document for LCD 39365 shows that Novitas Solutions adopted a mixed approach in addressing public feedback. Below is an analysis of their responses:
Strengths in Novitas' Approach:
Acknowledgement of Comments: Novitas consistently acknowledged all submitted comments, showing that they reviewed them and incorporated changes where appropriate.
- Example: Removing references to knowledge bases (e.g., ClinGen, NCCN, OncoKB) in the final LCD was a direct response to significant stakeholder concerns about outsourcing decision-making to unaccountable external sources.
Specific Revisions Based on Feedback:
- Histologic/Cytologic Requirement: Flow cytometry was added as an acceptable method for establishing a "substantiated suspicion of cancer" in response to stakeholder concerns about diagnostic flexibility.
- Limitations Adjusted: For example, they removed overly restrictive provisions like the "one-time germline testing" rule and clarified the allowance for repeat molecular testing when clinically appropriate.
Clarity of Justifications: They provided detailed explanations and cited CMS guidelines or NCD precedence to support their decisions, lending credibility to their responses.
Weaknesses and Potential Gaps:
Perception of Dismissiveness: While Novitas made several significant changes, there are instances where responses seem to brush off stakeholder concerns by reiterating their initial rationale rather than substantively engaging with the issues raised.
- Example: Concerns about the restrictive nature of evidence requirements (e.g., analytical validity, clinical utility) were acknowledged but largely dismissed, with no substantial revision to these requirements.
Insufficient Action on Complex Issues:
- The request for clearer integration of NCD 90.2 (NGS for solid tumors) with the LCD was not fully addressed, leading to lingering ambiguity about how NGS for hematologic malignancies will be handled.
- Comments requesting a maintained, up-to-date database of covered tests were not implemented, even though such a resource could simplify navigation for stakeholders.
Changes Without New Supporting Evidence:
- The removal of coverage for specific tests (e.g., Cxbladder, Colvera) relied heavily on Novitas’ claim of insufficient evidence without offering updated evidence reviews or detailed counter-arguments to address comments.
Overall Assessment:
Novitas made meaningful changes in response to key stakeholder comments, demonstrating a willingness to revise their policies and enhance flexibility where justified. However, their approach was sometimes dismissive or overly reliant on existing guidelines without addressing the practical complexities raised by stakeholders. The final LCD is less controversial than the draft but retains some of the verbosity and complexity that led to the initial concerns.
