MolDX: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia

This contractor considers molecular diagnostic tests for upper gastrointestinal (esophageal) metaplasia, dysplasia, and neoplasia non-covered unless a set of stringent criteria are met, including active management for GERD and/or non-dysplastic Barrett's esophagus, ≥3 guideline-defined Barrett's risk factors, no prior dysplasia or esophageal carcinoma, adherence to guideline frequency, and demonstrable analytical and clinical validity. Tests must be validated in the intended population, supported by peer-reviewed evidence, clearly reported by the laboratory, and pass a Technical Assessment to be established as reasonable and necessary.

"Beneficiary is being actively managed for chronic gastroesophageal reflux disease (GERD) and/or non-dysplastic Barrett's esophagus (NDBE)."

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