MolDX: Corus CAD Assay - R4 - Effective June 03, 2021

This Local Coverage Determination (LCD) has been revised under contractor numbers: 02101 (AK), 02201 (ID), 02301 (OR), 02401 (WA), 03101 (AZ), 03201 (MT), 03301 (ND), 03401 (SD), 03501 (UT), and 03601 (WY).

Medicare Coverage Database (MCD) Number: L37675
LCD Title: MolDX: Corus® CAD Assay
Effective Date: June 03, 2021
Summary of Changes:

  • Under CMS National Coverage Policy added regulation CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests and §80.1.1 Certification Changes.
  • Under Summary of Evidence subheading Intended Use Population deleted the verbiage “This following assertion is still present on the sponsor’s website, accessed in November, 2017 (Corus® CAD, 2017): Corus® CAD demonstrated high sensitivity (89%) and highly negative predictive value (96%) at a score threshold <15 in the COMPASS study population in men and women.”
  • Under Bibliography changes were made to citations to reflect AMA citation guidelines. Reference #10 was deleted as it was a duplicate to reference #8.
  • Citations were updated as appropriate throughout the LCD. Formatting, punctuation, and typographical errors were corrected throughout the LCD. Acronyms were defined and inserted where appropriate throughout the LCD. Corus® was inserted throughout the LCD where applicable.

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Local Coverage Determination from the “Active LCD” Webpage.

Visit the Active LCDs webpage to view the locally hosted Active LCD or access it via the CMS MCD.

            Last Updated Fri, 04 Jun 2021 12:37:26 +0000