2024
Medicare Coverage Determination Still Under Review
Pacific Edge notes that Novitas, the Medicare Administrative Contractor (MAC) with responsibility for Pacific Edge’s US lab, remains in discussion with the Centers for Medicare & Medicaid Services (CMS) regarding the Local Coverage Determination (LCD) ‘Genetic Testing for Oncology’ (DL 39365).
Pacific Edge expected the finalization of the LCD overnight, i.e. within 365 days of initial posting. The company reached out to Novitas for comment overnight and was notified that: “[Novitas] is currently in discussion with the Centers for Medicare & Medicaid Services (CMS) regarding this proposed LCD. A timeframe for finalization is not available at this time. Please continue to watch our website for any future updates.”
The continued deliberation on the LCD means that Pacific Edge’s tests Cxbladder Triage, Detect and Monitor continue to receive reimbursement from Medicare and Medicare Advantage payers in line with historical reimbursement rates and subject to medical necessity guidelines.
Pacific Edge continues to expect Novitas to finalize the LCD, but the timeframe is unknown. Pacific Edge will update shareholders as it gains certainty on the status of the LCD and the timeline for its resolution. Pacific Edge will not be making further comment on the matter until then.