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 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 genetic testing for thrombophilia testing for the Factor V Leiden (FVL) variant in the F5 
gene, the G20210G>A (G20210A) variant in the F2 gene, and the MTHFR gene which encodes the 5,10-
methylenetetrahydrofolate reductase enzyme for all risk factors, signs, symptoms, diseases, or conditions, 
including cardiovascular risk assessment, are non-covered except for pregnant patients. 
 
Testing for FVL and F2 G20210A mutations is indicated for pregnant patients who have a history of personal 
VTE associated with a non-recurrent (transient) risk factor who are not otherwise receiving anticoagulant 
prophylaxis. The results of genetic testing can inform risk stratification for venous thromboembolism (VTE) 
recurrence and subsequent need for antenatal prophylaxis. However, Medicare will not add coverage of 
thrombophilia testing for pregnant women because they likely represent a very small group of potential 
Medicare (disabled) patients. Claims submitted on this limited Medicare population will deny per the policy, 
but should be appealed for coverage with submission of medical records supporting the necessity for testing, 
and specify how testing changed anticoagulant prophylaxis management for the patient. 
 
There is insufficient evidence in the published peer-reviewed scientific literature to support coverage for 
genetic testing for inherited thrombophilias outside the pregnant women. Genetic testing for FVL and F2 
G20210A is considered investigational for all other indications. However, Medicare may consider coverage for 
FVL and/or F2 genetic testing in unusual circumstances where testing will change clinical management of the 
patient. Denied claims can be appealed with supporting evidence of specific medical necessity. Only providers 
with evidence of formal training with board eligibility or certification in hematology/oncology, 
hematopathology or coagulation disorders at an accredited program satisfy reasonable and necessary criteria for 
these tests. There is broad consensus in the medical literature that MTHFR genotyping has no clinical utility in 
any clinical scenario. This testing is considered investigational and is NOT a Medicare benefit. 
 
You can find this information in the Local Coverage Determination (LCD): MolDX: Genetic Testing for 
Hypercoagulability / Thrombophilia (Factor V Leiden, Factor II Prothrombin, and MTHFR) (L36155). 
 
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.