Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Family history of Factor V Leiden
Treatment: Factor V Leiden Genetic Testing (81241-F5)
The insurer denied the Factor V Leiden Genetic Testing (81241-F5)
The denial is upheld.

The patient is a male. The provider ordered Factor V Leiden Genetic Testing (81241-F5). There is no information on why the test was ordered.

No, the health plan should not cover the proposed treatment.


Yes, the medical records and accompanying information are sufficient to answer the following questions.
Venous thromboembolus (VTE) is a common source of morbidity and mortality in the United States. Most often, the thrombotic event begins as deep vein thrombosis (DVT) in the legs. Subsequently, a portion of the clot may break off and migrate to the pulmonary arteries, obstructing the blood flow. Venous thromboembolus has been estimated to occur at an annual rate of 4866 per 100,000 and pulmonary embolism in 3369 per 100,000 in the general population. Individuals who have experienced one episode of Venous thromboembolus are at increased risk for suffering a recurrent thrombotic event. In the absence of continued anticoagulant medication, Venous thromboembolus will recur in approximately 20% of patients within five years and 30% within ten years. Unprovoked Venous thromboembolus may be viewed as a chronic disease because of its high frequency of recurrence. The American College of Chest Physicians currently recommends that patients with unprovoked deep vein thrombosis (DVT) be treated with a Vitamin K antagonist for at least three months. After three months of anticoagulant therapy, all patients with unprovoked deep vein thrombosis (DVT) should be evaluated for the risk-to-benefit ratio of long-term therapy. Long-term treatment is recommended for patients with a first unprovoked episode of proximal deep vein thrombosis, when risk factors for bleeding are absent and good anticoagulant monitoring is achievable. The duration of therapy to avoid recurrence depends on a balance between persistent risk factors and risk of bleeding. 

The PT (Prothrombin) mutation is the second most common heritable risk factor for Venous thromboembolus. In the United States, approximately 2.2%, 2.2%, and 0.6% of non-Hispanic white, Hispanic white, and African American populations, respectively, are heterozygous for the prothrombin mutation. Individuals homozygous for this mutation are rare (12, 12, and <1 per 100,000 individuals, respectively). The prothrombin mutation is present in 6% of individuals with an initial episode of venous thrombosis and seems to increase risk for Venous thromboembolus by two- to four-fold. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found adequate evidence to recommend against routine testing for Factor V Leiden (FVL) and/or prothrombin 20210G>A (PT) in the following circumstances: (1) adults with idiopathic venous thromboembolism (VTE). In such cases, longer term secondary prophylaxis to avoid recurrence offers similar benefits to patients with and without one or more of these mutations. (2) Asymptomatic adult family members of patients with Venous thromboembolus and an Factor V Leiden or prothrombin mutation, for the purpose of considering primary prophylactic anticoagulation. There is no evidence of routine testing of asymptomatic children with a family history of Factor V Leiden mutation improves the care of these patients. 

Therefore, at the present time, such testing is not medically appropriate.

No, the requested health service is not more beneficial than any standard treatment for the insured's condition or disease.
The provided clinical information does not justify the necessity of the testing ordered. Therefore the testing was not medically appropriate and would not benefit the patient.