We often hear about slow timeliness for LCDs, and outsiders can't always believe the numbers. ("We can turn in your LCD request by August 1, 2026; contemporary data shows the LCD may be finaled as late as in August, 2032.") A bill for quicker LCDs, H.R.8500, has been proposed.
Case Study
MolDx received a dossier and coverage request for DCIS breast cancer molecular testing in June, 2020 (here).
MolDx held a streamed, expert advisors meeting on July 15, 2024 (scroll for Stratification in DCIS on this page.) For two hours, 7 experts addressed 12 structured questions. A 120-page transcript was posted. (More here, incl. transcript summary.)
The next summer, July 17, 2025, MolDx posted a draft non coverage LCD, DL40142. After reviewing 57 publications, the LCD concludes:
"This contractor believes the utility of risk stratification, based on all evidence reviewed, is in the identification of patients who may not derive meaningful benefit from RT aside from individualized risk considerations given current practices and dependence on RT use. At this time, there is no convincing evidence that any test (and their analytes measured) can identify a patient who would not reasonably benefit from RT beyond clinicopathologic factors already demonstrated to risk stratify patients.
A fiinal LCD would be expected sometime in summer 2026.
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I asked Chat GPT for a concise comparison of the transcript and draft LCD.
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The CAC meeting was exploratory, dialogic, and clinically nuanced; the Draft LCD is the same discussion converted into a formal MolDX coverage standard.
In the CAC, MolDX framed the task as understanding whether DCIS biomarker risk-stratification tests had enough analytical validity, clinical validity, and especially clinical utility to meet Medicare’s “reasonable and necessary” threshold. The experts generally agreed that DCIS is frequently overtreated, that many patients receive radiation therapy for small absolute benefit, and that a test able to identify patients who could safely avoid radiation would have real clinical value. But the meeting also exposed disagreement over what counts as low risk, whether IBTR or invasive recurrence should drive decisions, how much absolute radiation benefit is clinically meaningful, and whether current biomarker tests add enough beyond ordinary clinicopathologic tools.
The Draft LCD adopts much of that CAC logic but resolves the ambiguity -- against present coverage.
It acknowledges the clinical need and even states confidence that biomarkers may eventually improve DCIS risk stratification. However, it concludes that current tests such as DCISionRT and Oncotype DX DCIS have only limited evidentiary support and have not yet shown, with sufficient validation, that they identify a Medicare-relevant group for whom radiation therapy provides no meaningful benefit. The LCD’s key move is to define “sufficiently low risk” operationally: a group in which the absolute reduction in ipsilateral breast tumor recurrence from radiation is 5% or less. It then requires future tests to complete MolDX technical assessment, be used only in their validated population, and show incremental value over existing clinicopathologic nomograms or risk systems. In short, the CAC supplied the clinical dilemma and evidentiary questions; the Draft LCD turns them into a noncoverage policy with a clear but demanding path to future coverage.
Key source anchors: MolDX’s CAC purpose was to assess evidence, decision-making, and whether tests improve patient outcomes rather than merely change management. The LCD summarizes the CAC as finding clinical need but debate over evidence, endpoints, clinicopathologic comparators, and the 5% absolute-risk-reduction threshold. The LCD’s rationale then concludes that current biomarker evidence is insufficient and must show incremental value over existing tools.
