Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1: The patient is a 23-year-old female who has experienced repeated early pregnancy losses and then underwent evaluation and treatment for recurrent loss. Evaluation included a borderline positive ANA, no evidence of thyroid antibodies, no immune reaction to her partners antigens and heterozygosity of MTHFR. There is no evidence the patient was tested for Factor V Leiden mutation, prothrombin gene mutation, lupus anticoagulant, or anticardiolipin antibodies (ACA).The patient was treated with IVIG, Humira, Lovenox, and low dose aspirin for her most recent pregnancy, which was carried to term.Review of the submitted clinical information reveals no documentation of significant autoimmune disease or thrombophilia. The low positive ANA (which was intermittently negative) does not cause pregnancy loss or require treatment. The MTHFR mutation in the homozygous state can cause thrombosis, but this is treated with folate (prenatal vitamins). The heterozygous state did not require treatment. The multiple tests for ANA, natural killer cells, and HLA typing were not of clinical value in this setting. Furthermore, there was no medical indication for use of IVIG and Humira. The patients workup for thrombophilia was incomplete. While Lovenox is useful in patients with thrombophilia, there is no evidence the patient carried a diagnosis of thrombophilia. Thus, there is insufficient evidence Lovenox was medically necessary for treatment of the patients recurrent pregnancy loss.Based upon the information set forth above, I have determined that specialized testing for recurrent pregnancy loss, IVIG, and Humira were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In addition, I have determined that Lovenox was not medically necessary for treatment of the patients medical condition. Accordingly, the Health Plans denial should be upheld.Physician 2: The patient is a 23-year-old female who had experienced multiple early miscarriages and no successful pregnancies. She was referred to a provider who ordered specialized testing and diagnosed various immunologic disorders, which the provider termed category 2, 3 and 5. In the records provided it is noted the patient was found to have a borderline positive fluorescent antinuclear antibody. It is not clear if she tested positive for anticardiolipin antibody (ACA). The patients provider recommended the patient be treated with Lovenox, Humira, progesterone suppositories, dexamethasone, Folgard, aspirin and intravenous immunoglobulin (IVIG). The patient had an apparently successful pregnancy and delivered a live infant at term.The use of IVIG to treat immunologic abnormalities felt to cause recurrent miscarriages is not considered the standard of care. An article in the Cochrane Review (Scott, 2003) clearly showed there was no significant increase in live births in patients treated with IVIG versus the control group, with an odds ratio of 0.98. The Cochrane Review analysis is also in agreement with a fairly recent meta analysis from six trials, which indicated IVIG had no clinically meaningful effect on life birth rate (Days, 1998). Furthermore, there is no evidence supporting the use of the specialized testing that was utilized in this case. Moreover, the use of Humira is not standard of care for patients such as this patient and was not likely to be more effective than standard treatment in cases of recurrent miscarriage.With regard to the use of Lovenox, no evidence has been provided indicating the patient tested positive for ACA or the lupus antibody. If such were the case, treatment with Lovenox would have been medically reasonable and appropriate and within standard of care. However, in the absence of documented evidence of positivity for ACA or lupus antibody, there was no medical justification for use of Lovenox.Based upon the information set forth above, I have determined that specialized testing, IVIG, and Humira were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In addition, I have determined that Lovenox was not medically necessary for treatment of the patients medical condition. Accordingly, the Health Plans denial should be upheld.Physician 3: The patient is a 23-year-old female who sought evaluation and treatment for recurrent pregnancy loss after recurrent first trimester losses. She was evaluated by a provider who diagnosed immune-based pregnancy loss, and prescribed IVIG, Humira, Lovenox, aspirin, and Folgard, as well as specialized recurrent testing. While the patient had an intermittently positive (low) ANA, there is no evidence of anticardiolipin antibodies. The patient was heterozygous for MTHFR, without a history of thrombosis. The patient has requested reimbursement for the specialized testing, IVIG, Humira, and Lovenox, which has been denied by the Health Plan.Specialized testing and treatment for immune-based recurrent pregnancy loss has not been proven to be beneficial in studies performed to date. In addition, the use of IVIG and Humira has not been shown to be more effective than untreated controls. Furthermore, there was no medical indication for use of Lovenox therapy in this case based upon the evidence provided. Therefore, I have determined that specialized testing, IVIG, and Humira were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In addition, I have determined Lovenox was not medically necessary for treatment of the patients medical condition. As such, the Health Plans denial should be upheld.