Appeal type: unknown
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 state that Pharmacogenetics testing will be considered medically reasonable and necessary if: 
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 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 B1; 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. 
The ordering provider of a PGx test for a patient with a medical condition: 
 Must be the treating clinician who is responsible for the pharmacologic 
management of the patients condition. The ordering provider of a PGx test is restricted to providers who have 
the licensure, qualifications, and necessary experience/training to both diagnose the condition being treated and 
to prescribe medications (the provider must be able to do both) for the condition either independently or in an 
arrangement as required by all the applicable state laws; and 
 is considering or has prescribed a pharmacologic treatment with actionable gene-drug interactions; and 
 understands the actionability of the ordered test. 
You can find this information in Local Coverage Determination (LCD): Pharmacogenomics Testing (L39073) 
 
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 information 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.