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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 Covered Indications: 
 
Three evidence-based databases and/or knowledge bases have been identified as valid and reliable sources. 
Note that a specific genetic test may be listed in one database or knowledge base, but not others; therefore, 
providers may choose to utilize guidelines from any of the three databases/knowledge bases. However, for 
services to be considered medically reasonable and necessary, #1 below is required regardless of which 
guidelines are utilized. Genetic testing for oncology will be considered medically reasonable and necessary if: 
 
1. The provider has either established a diagnosis of cancer or found significant evidence to create suspicion for 
cancer in their patient. (See Social Security Act (SSA) 1862(a)(1)(A)) Both a clinical evaluation AND 
abnormal results from histologic, cytologic and/or flow cytometric examination are required to establish a 
diagnosis of cancer or suspicion of cancer. If then, as a next step in the clinical management of the patient, 
genetic testing would directly impact the management of the patients specific condition, the testing would be 
indicated. (see CFR, Title 42, Volume 2, Chapter IV, Part 410.32(a)) 
 
Note: In rare circumstances where patients have significant evidence to create suspicion for cancer AND are 
not candidates for a tissue biopsy due to high risk for complications AND genetic testing would directly impact 
the management of the patients specific condition, cell-free genetic testing could be indicated. 
 
Note: See below regarding NCD 90.2 Next Generation Sequencing (NGS). The NCD does not allow for 
suspicion of cancer as a covered indication for DNA-only NGS testing of non-hematologic malignancies. 
 
AND ONE OF THE FOLLOWING (2-4): 
 
2. The evidence for the gene-disease association is evaluated by the evidence-based, transparent, peer-reviewed 
process of the National Institutes of Health (NIH) sponsored Clinical Genome Resource (ClinGen) and is 
determined to demonstrate actionability in clinical decision making, meeting the criteria for all 5 categories 
below. At least one of the items listed under each of the categories (severity, likelihood of disease, nature of the 
intervention, effectiveness, and validity) must be satisfied: Disease severity equal to: 
Sudden death (Level 3), or 
Possible death or major morbidity (Level 2), or 
Modest morbidity (Level 1) 
Likelihood of disease equal to: 
Substantial evidence of a greater than 40 percent chance (Level 3A), or 
Moderate evidence of a greater than 40 percent chance (Level 3B) 
Nature of the intervention is equal to: 
Low risk/medically acceptable/low intensity (Level 3), or 
Moderately acceptable/risk/intensive (Level 2) 
Effectiveness equal to: 
Substantial evidence of a highly effective intervention (Level 3A), or 
Moderate evidence of a highly effective intervention (Level 3B), or 
Substantial evidence of a moderately effective intervention (Level 2A), or 
Moderate evidence of a moderately effective intervention (Level 2B) 
Validity of the gene-disease relationship equal to: 
Definitive, or 
Strong, or 
Moderate 
 
3. The evidence for the intervention is evaluated by the National Comprehensive Cancer Network (NCCN) and 
is determined to demonstrate actionability in clinical decision making, meeting the following metric: 
Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate 
(Category 1), or 
Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate 
(Category 2A). 
 
4. OR 
 
The evidence for the intervention is evaluated by the Memorial Sloan Kettering Cancer Center-sponsored 
Oncology Knowledge Base (OncoKB)26 and is determined to demonstrate actionability in clinical decision 
making, meeting one of the following metrics: 
 
For therapeutic use cases: 
The intervention is an FDA-recognized biomarker predictive of response to an FDA-approved drug in this 
indication (Level 1) 
 
OR 
 
The intervention is a standard care biomarker recommended by the NCCN or other professional guidelines 
predictive of response to an FDA-approved drug in this indication (Level 2) 
 
OR 
 
The intervention is a standard care biomarker predictive of resistance to an FDA-approved drug in this 
indication (Level R1) 
 
For diagnostic use cases: 
 
The intervention is an FDA and/or professional guideline-recognized biomarker required for diagnosis in this 
indication (Level Dx1) 
 OR 
 
The intervention is an FDA and/or professional guideline-recognized biomarker that supports diagnosis in this 
indication (Level Dx2). You can find this information in Medicare's Local Coverage Determination (LCD): 
Genetic Testing for Oncology (L39365). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.