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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 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: 
     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 
     d. 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. 
 
The following are considered not medically reasonable and necessary: 
 
1. A genetic test where either analytical validity, clinical validity, or clinical utility has not been established. 
2. Genetic testing in patients who do not demonstrate the disease-appropriate phenotype of the gene-disease 
association. 
3. Genetic testing of asymptomatic patients. 4. Genetic testing solely for purposes of proband identification. 
5. Genetic testing with family history as the only indication. 
6. Gene tests for cardiovascular disease are considered germline testing, and therefore only permitted once per 
beneficiarys lifecycle. 
 
The ordering provider of a genetic test for a patient with a cardiovascular disease-appropriate phenotype: 
 
     a. Must be the treating clinician who is responsible for the cardiovascular disease management of the 
patients condition; and, 
     b. Understands how the test result will impact the patients condition; and, 
     c. Has presented this information to the patient eliciting patient understanding. 
Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in 
this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and 
all existing CMS national coverage determinations, and all Medicare payment rules. You can find these rules in 
the 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.