Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that the provider, supplier, or beneficiary, as appropriate, must furnish to the intermediary or 
carrier sufficient information to determine whether payment is due and the amount of payment. You can find 
this rule at 42 CFR 424.5. 
 
The rules say for Medicare to consider coverage and payment for any item or service, the information 
submitted by the supplier or provider must corroborate the documentation in the beneficiary's medical 
documentation and confirm that Medicare coverage criteria have been met. You can see this in the Centers for 
Medicare and Medicaid Services, Internet Only Manual, Publication 100-08, Medicare Program Integrity 
Manual, Chapter 3, Section 3.3.2.1. 
 
The rules say that 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 Barretts esophagus (NDBE); and 
 They also have at least three additional risk factors for Barretts 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. 
 
Although there are several promising molecular biomarker tests designed to further identify at-risk patients, 
this contractor finds that there are currently no existing tests that have demonstrated AV, CV, and clinical 
utility (CU) to fulfill the necessary criteria. You can find this rule in the Local Coverage Determination for 
Molecular Diagnostics (MolDX): Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, 
Dysplasia, and Neoplasia, L39264. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.