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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 state 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
1
; 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;  
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. 
 
The following is considered not medically reasonable and necessary: 
 Genetic testing where either analytical validity, clinical validity, or clinical utility has not been 
established. 
 Germline testing may be performed once in a lifetime per beneficiary.  o 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 the Local Coverage Determination (LCD) for Pharmacogenomics Testing, L39073. 
 
The rules state 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. 
You can find this rule in the Local Coverage Determination (LCD) for 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.