About this policy
Jurisdiction: JM Part B. States: North Carolina, South Carolina, Virginia, West Virginia. Type: Active LCD
Coverage indications
Current molecular diagnostic tests that identify individuals with upper gastrointestinal metaplasia, dysplasia, and neoplasia are non-covered by this contractor. We expect these types of tests to meet the following criteria: The beneficiary is being actively managed for chronic gastroesophageal reflex disease (GERD) and/or non-dysplastic Barrett’s esophagus (NDBE); and They also have at least three additional risk factors for Barrett’s esophagus (BE) as described in nationally recognized guidelines. The beneficiary has not been previously diagnosed with dysplasia or esophageal carcinoma; and The beneficiary is tested no more than recommended by established national or society guidelines; and The test identifies patients with dysplastic disease that may benefit from endoscopic treatment or surveillance, or patients with non-dysplastic disease who may benefit from surveillance; and The test results will be used in determining treatment or management of the beneficiary. The beneficiary is within the population for which the test was developed and validated. The laboratory providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use. The test demonstrates analytical validity (AV) including an analytical and clinical validation for any given measured analytes, and has demonstrated equivalence or superiority for sensitivity or specificity of detecting dysplasia to other already accepted methods for the same intended use measuring the same or comparable analytes. Clinical validity (CV) of any analyte measured must be demonstrated in the published peer-reviewed literature, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) their clinical management decision within a clearly defined population. The test successfully completes a Technical Assessment that will ensure that criteria set in this policy are met to establish the test as Reasonable and Necessary.
Codes in this policy
Code numbers and each code’s status as the policy records it. CPT code descriptions are left out of this page, as are the passages that cite CPT codes; the official document has them.