Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Recurrent pregnancy loss. 
Treatment: Tests for inherited thrombophilia disorders, described by codes 81241, 81240, 85306, 85303 and 85300. 

The insurer denied coverage for the tests for inherited thrombophilia disorders, described by codes 81241, 81240, 85306, 85303 and 85300. 

The denial is upheld. 

This is a female patient with a reported diagnosis of recurrent miscarriage who underwent expanded genetic carrier testing. The test results revealed that the patient is a carrier of Factor XI deficiency. Factor 2 and antithrombin III deficiency testing was ordered by her physician. 

Venous thrombosis or thromboembolism is the most common manifestations of thrombophilia, although a minority of patients, particularly those with other vascular risk factors, also develop arterial thrombosis. Less usual presentations include visceral or cerebral vein thrombosis, second- or third-trimester pregnancy loss, and severe preeclampsia. Laboratory assays are widely available to identify most thrombophilia conditions. Knowledge of these disorders can affect patient management, including the duration of anticoagulant treatment, the use of prophylactic antithrombotic agents, and counseling patients regarding the relative risks of pregnancy and use of oral contraceptives or hormone replacement. 

Based in part on published recommendations and reviews of other experts, and the experience of authors as reviewed elsewhere the patients who meet one of the following criteria should be tested for all thrombophilia conditions including: (1) unprovoked venous thromboembolism (VTE); (2) recurrent thrombotic events; (3) provoked VTE in patients younger than age 50 years; (4) VTE provoked by pregnancy, oral contraceptives, or hormone replacement therapy; (5) a family history of VTE; (6) cerebral or visceral vein thrombosis; (7) three or more consecutive unexplained fetal losses during the first trimester of gestation, one or more fetal losses during the second or third trimester, or one or more stillbirths. 

Based on the documentations submitted for this case, there is no evidence of obstetrical, medical or family histories of the patient. Therefore the patient does not have a confirmed history of recurrent miscarriage, unprovoked VTE, recurrent thrombotic events, provoked VTE, VTE provoked by pregnancy, oral contraceptives, or hormone replacement therapy, a family history of VTE, cerebral or visceral vein thrombosis, three or more consecutive unexplained fetal losses during the first trimester of gestation, one or more fetal losses during the second or third trimester, or one or more stillbirths. Therefore the patient does not meet the criteria for Factor 2 and antithrombin III testing, based on the standard of care. The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. 

The tests for inherited thrombophilia disorders, described by codes 81241, 81240, 85306, 85303 and 85300do not have final approval from the appropriate regulatory bodies for this diagnosis. The patient is not a good candidate for tests for inherited thrombophilia disorders, described by codes 81241, 81240, 85306, 85303 and 85300. The tests for inherited thrombophilia disorders, described by codes 81241, 81240, 85306, 85303 and 85300 are not the best available test for this patient at this time. Therefore, the thrombophilia panel ordered on this patient is not likely to be more beneficial than any of the standard treatments/procedures for this patient. 

The carrier's denial of tests for inherited thrombophilia disorders, described by codes 81241, 81240, 85306, 85303 and 85300 should be upheld.