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 say that the provider, supplier, or beneficiary, as appropriate, must furnish to the intermediary or 
carrier sufficient information to determine whether payment is due and the amount of payment. You can find 
this rule at 42 CFR 424.5. 
 
The rules say for Medicare to consider coverage and payment for any item or service, the information 
submitted by the supplier or provider must corroborate the documentation in the beneficiary's medical 
documentation and confirm that Medicare coverage criteria have been met. You can see this in the Centers for 
Medicare and Medicaid Services, Internet Only Manual, Publication 100-08, Medicare Program Integrity 
Manual Chapter 3, 3.3.2.1. 
 
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
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 
 
You can find this rule in the Local Coverage Determination for 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 
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: 
 Disease severity of sudden death, possible death or major morbidity, modest morbidity 
 Substantial or moderate evidence of a >40% likelihood of disease 
 Substantial or moderate evidence of a highly effective or moderately effective intervention 
 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 rule in the Local Coverage Determination 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.