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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 local Medicare coverage of biomarkers must be predicated upon three fundamental 
principles: 
 
1. First, there must be an underlying performance of acceptable, high-quality analytical validity for all such 
laboratory testing. As a result, the laboratory shall have available upon request: 
 
-Analytical and clinical validation reports for Clinical Laboratory Improvement Amendments (CLIA), 
including the test description, intended use, and indications for testing. 
-If applicable, all formal, written minutes and correspondences (including any Q & A and supporting 
documentation) with the New York State Department of Health (NYSDOH) or the United States (U.S.) Food 
and Drug Administration (FDA). 
-Most recent inspection results (including recommendations) or scheduled inspection(s) from CLIA, College of 
American Pathologists (CAP), or NYSDOH, as applicable. 
 
2. Second, there must be an appreciation of evidence-in-transition where new biomarkers should be brought on-
line in harmonization with their proven clinical validity/utility (CVU). Although analytical validity is an 
equally important metric, it remains more outside of a payer's purview to conduct such detailed evaluations. 
Therefore, in the absence of a standard CVU referee process (e.g., although FDA labeling of biomarkers can be 
a helpful adjunct, it may not always be relevant), the key imperative is for medical necessity to be reflected by 
the clear articulation of a particular biomarker niche. 
 
3. Third, there must be a recognized decision impact of such biomarkers by the clinical community. In other 
words, there must be acceptance/uptake of specific testing into patient management. It should be taken into 
account that to reach the medical necessity threshold, such acceptance should be based on the strongest 
evidence available, ideally from along the spectrum of high-quality masked, randomized controlled clinical 
trials, and much less preferably from lower levels of evidence, which are predicated upon expert opinion only 
without primary study data. 
 
You can find this rule in the Local Coverage Determination (LCD) - Biomarkers Overview (L35062) - 
Effective October 1, 2015. 
 
The rules say that effective for services performed on or after March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory 
test is reasonable and necessary and covered nationally, when performed in a Clinical Laboratory Improvement 
Amendments (CLIA)-certified laboratory, when ordered by a treating physician, and when all of the following 
requirements are met: 
1. Patient has: 
 
-either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and, 
-either not been previously tested using the same NGS test for the same primary diagnosis of cancer, or repeat 
testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; 
and, 
-decided to seek further cancer treatment (e.g., therapeutic chemotherapy). 
2. The diagnostic laboratory test using NGS must have: 
- Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and, 
- an FDA-approved or -cleared indication for use in that patients cancer; and, 
- results provided to the treating physician for management of the patient using a report template to specify 
treatment options. 
 
You can find this rule in National Coverage Determination (NCD) for Next Generation Sequencing (NGS) 
(90.2) - Effective March 16, 2018. 
 
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.