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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 & Medicaid Services, Internet Only Manual, Publication 100-08, Medicare Program Integrity 
Manual, Chapter 3, Section 3.3.2.1. 
 
The rules say that Local Medicare coverage of such biomarkers must be predicated upon four fundamental 
principles: 
1. First, the biomarkers must have proven clinical validity/utility (CVU).  
2. Second, to support the medical necessity of the service, there must be acceptance/uptake of specific 
testing into patient management. It is essential that physicians be familiar enough with all specific 
biomarkers, which they order, such that all test results may become clinically actionable. 
3. Providers managing oncological conditions must demonstrate that the use of biomarkers will be used to 
assist in the management/treatment of the beneficiary. 
4. Peer-reviewed full manuscript evidence is required to support combination panels for multiple 
biomarkers, particularly regarding their alleged composite clinical validity/utility. For example; such 
potential billing for multiple, diverse biomarkers (e.g., diagnostic/monitoring/prognostic/predictive) can 
only achieve medical necessity when it is clearly evident how each requested biomarker can be 
individually contributory. 
 
You can find this rule in the Local Coverage Determination for Biomarkers for Oncology, L35396. 
 The rules say that the commercial availability does not ensure that a molecular diagnostic test is indicated for 
clinical application. Molecular diagnostic testing is a rapidly evolving science in which the significance of 
detecting specific mutations has yet to be clarified in many circumstances. Analytical and clinical validity as 
well as clinical utility are the responsibility of the provider, and all testing must meet standards of care. The 
medical record must include documentation of how the ordering/referring practitioner used the test results in 
the management of the beneficiarys specific medical problem. You can find this rule in the Local Coverage 
Determination for Biomarkers Overview, L35062, and in the Local Coverage Article for the Billing and coding 
of Molecular Pathology and Genetic Testing, A58917. 
 
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.