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

Molecular tests for detecting upper GI metaplasia, dysplasia, and neoplasia are non-covered by this contractor unless a test meets stringent criteria including active management of GERD and/or NDBE, at least three additional BE risk factors, absence of prior dysplasia or esophageal carcinoma, adherence to guideline frequency, demonstrated analytical and clinical validity supported by peer-reviewed literature, laboratory specification of intended population, and successful completion of a contractor Technical Assessment. Tests must provide clinically actionable information that will influence endoscopic treatment or surveillance decisions and be used within the validated population to be considered reasonable and necessary.

"Coverage is allowable only when the beneficiary is being actively managed for chronic gastroesophageal reflux disease (GERD) and/or non-dysplastic Barrett's esophagus (NDBE)."