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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 medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 
411.15(o). 
The rules say that genetic testing for hereditary cardiovascular disease will be considered medically reasonable 
and necessary if: 
1. The patient has rigorous disease-appropriate phenotyping to establish clinical diagnosis or suspected 
diagnosis for which the test results would directly impact the management of the patients condition, 
prior to ordering the test 
AND 
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 all 
bulleted metrics:  
o Disease severity of sudden death, possible death or major morbidity, modest morbidity 
o Substantial or moderate evidence of a >40% likelihood of disease 
o Substantial or moderate evidence of a highly effective or moderately effective intervention o The nature of intervention is either low risk/medically acceptable/low intensity intervention or 
moderately acceptable/risk/intensive interventions, 
AND 
3. Clinical validity and qualitative descriptors from Moderate, Strong & Definitive with contradictory 
evidence NOT being reported as disputed or refuted. 
You can find this in Local Coverage Determination (LCD) Genetic Testing for Cardiovascular Disease 
L39084. 
The rules say that Pharmacogenetics testing will be considered medically reasonable and necessary if: 
1. The patient has a condition where clinical evaluation has determined the need for a medication that has 
a known gene-drug interaction(s) for which the test results would directly impact the drug management 
of the patients condition; AND 
2. The test meets evidence standards for genetic testing as evaluated by a scientific, transparent, peer-
reviewed process and determined to demonstrate actionability in clinical decision making by CPIC 
guideline level A or B; or is listed in the FDA table of known gene-drug interactions where data support 
therapeutic recommendations or a potential impact on safety or response or the FDA label; 
https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-
labeling ; https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations  
Some panel/combinatorial tests may include content that has demonstrated actionability and some that has not. 
In these circumstances, the components of the tests that have demonstrated actionability as noted in #2 will be 
considered medically reasonable and necessary. Refer to the related billing and coding article for coding 
information. You can find this rule in Local Coverage Determination (LCD) Pharmacogenomics Testing 
L39073. 
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.