Wednesday, September 2, 2026

MolDX MACs Delay Finalization of Prelude DCISion-RT LCD

MolDx released a draft non coverage LCD for the DCISion-RT test last year, and it's not finalized yet.

It may be a while: they've announced an official delay.

https://www.cgsmedicare.com/parta/pubs/news/2026/07/news-206951.html

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July 13, 2026

Notice Regarding MolDX: Biomarker Testing for Risk Stratification in DCIS (DL40246)

Medicare Administrative Contractors (MACs) carefully considered all feedback received from interested parties regarding proposed Local Coverage Determination (LCD) DL40246: MolDX: Biomarker Testing for Risk Stratification in DCIS.

Given the impact of this determination, MACs will delay finalization of the proposed LCD issued on 7.17.2025. Additional information will be forthcoming in the following months.

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Here's what GOOGlE automatically offered as a summary of the state of play when I googled the topic;

The Backlash & Editorial Responses
  • Corporate Resistance: PreludeDx’s CEO publicly criticized the draft policy, pointing out that DCISionRT has over a decade of use, more than 10 published studies, and backing from breast cancer specialists. [1]
  • Patient and Provider Advocacy: Patient advocacy groups (such as Learn Look Locate) and oncologists launched public campaigns, petitions, and formal commentary pushes. They argue that withdrawing coverage takes away a vital tool for personalized medicine, potentially forcing thousands of women into undergoing expensive, unnecessary, and invasive radiation therapies. [1, 2, 3, 4]
  • Clinical Arguments: Supporters emphasize data from trials like the PREDICT registry, which showed that DCISionRT results changed radiation treatment recommendations for roughly 42% of patients, leading to a net reduction in over-treatment. [1, 2]
Google also cited my blog:

  • The "Rhetorical Proof" Critique: In its editorial guidance and teaching rationales, MolDX criticized reliance on "decision-support narratives". They stated that using a test merely to provide peace of mind or reassure a patient about skipping radiation ("rhetorical proof") is insufficient for Medicare coverage without statistically robust, multi-factor validation.