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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 the following is considered not medically reasonable and necessary: 
1. Genetic testing where either analytical validity, clinical validity, or clinical utility has not been 
established. 
2. Germline testing may be performed once in a lifetime per beneficiary.  
a. Any laboratory test that investigates the same germline genetic content, for the same genetic 
information, that has already been tested in the same Medicare beneficiary is not medically 
reasonable and necessary as it is duplicative. The germline sequence of an individual does not 
change over time, and therefore repeat testing of the same germline content for the same genetic 
information does not provide new clinical information. 
You can find this rule in You can find this rule in Local Coverage Determination (LCD) Pharmacogenomics 
Testing L39073. 
 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 
 
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:  
A. Disease severity of sudden death, possible death or major morbidity, modest morbidity 
B. Substantial or moderate evidence of a >40% likelihood of disease 
C. Substantial or moderate evidence of a highly effective or moderately effective intervention 
3. The nature of intervention is either low risk/medically acceptable/low intensity intervention or 
moderately acceptable/risk/intensive interventions Clinical validity and qualitative descriptors from 
Moderate, Strong & Definitive with contradictory evidence NOT being reported as disputed or refuted. 
 
You can find this rule in You can find these rules in Local Coverage Determination (LCD) Genetic Testing for 
Cardiovascular Disease L39084. 
 
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.