Medicare ends reimbursement for Pacific Edge's Cxbladder tests

Cancer diagnostics company Pacific Edge has announced that Novitas, the Medicare Administrative Contractor for its US laboratory, has made a final non-coverage determination, ending reimbursement for Cxbladder Triage, Detect, and Monitor by Medicare.

The new Local Coverage Determination (LCD), titled 'Genetic Testing in Oncology: Specific Tests', reverses Novitas' previous determination in July 2020 that provided for Medicare coverage of Cxbladder.

If not challenged, the finalized LCD will come into effect in 45 days, with reimbursement for Pacific Edge's Cxbladder tests ceasing on February 23, 2025.

Pacific Edge expressed disappointment with Novitas' determination, citing a misunderstanding of the standard of care in evaluating hematuria patients and a failure to consider new peer-reviewed evidence supporting the use of Cxbladder.

The company said it is now activating contingency plans to reduce its expense base and will explore legal challenges and other strategic alternatives.