Appeal type: Medical necessity
Decision: Overturned

Primary diagnosis- Cardiac/Circulatory Problems
Primary treatment- Surgical service
The insurer denied: Varithena Injection. 
The denial is overturned in whole.

The patient is a male who presented with bilateral lower extremity symptomatic varicose veins. His main symptoms include: pain, aching, heaviness and hyperpigmentation. His symptoms interfere with his activities of daily living. He has undergone prior ablation of his great and small saphenous veins. He has attempted and failed conservative therapy with graded compression stockings. His duplex ultrasound demonstrated persistent reflux in his bilateral distal great saphenous veins. He underwent Varithena chemical ablation of his bilateral distal great saphenous veins. At issue is the medical necessity of Varithena injection. The health plan's determination is overturned in whole. The proposed Varithena injection chemical ablation is medically necessary based on the peer reviewed literature. This particular patient is a good candidate for Varithena chemical ablation of the right distal great saphenous vein. His proximal axial reflux has been treated and postoperative duplex demonstrates successful closure of the proximal segment of the great saphenous vein. The patient presents with residual symptoms and duplex evidence of distal great saphenous reflux. Varithena chemical ablation is supported by the peer reviewed literature to be an effective treatment for this patient's medical condition (after a trial of conservative therapy with graded compression stockings has failed). Varithena is supported by randomized Level 1, multi center evidence which has demonstrated safety and efficacy for this patient's indications.
Polidocanol microfoam injection is a newer compound recently approved by the Food and Drug Administration for treatment of saphenous vein incompetence and symptomatic varicose veins. This commercially available drug replaces conventional bedside foam sclerotherapy which is performed by mixing the sclerosant solution with air to create an injectable foam. The peer reviewed literature supports the use of Varithena Polidocanol Microfoam for treatment of this patient's condition. Todd and colleagues performed a randomized multicenter study (VANISH-2 trial) evaluating the use of Varithena endovenous microfoam and demonstrated excellent results. Patients were randomized equally to receive polidocanol endovenous microfoam 0.5%, polidocanol endovenous microfoam 1.0% or placebo. The primary efficacy endpoint was patient-reported improvement in symptoms, as measured by the change from baseline to Week 8 in the 7-day average electronic daily diary Varicose Vein Symptom Questionnaire (VVSymQ) score. The co-secondary endpoints were the improvement in appearance of visible varicosities from baseline to Week 8, as measured by patients and by an independent physician review panel. In 232 treated patients, polidocanol endovenous microfoam 0.5% and polidocanol endovenous microfoam 1.0% were superior to placebo, with a larger improvement in symptoms  Varicose Vein Symptom Questionnaire [VVSymQ] (-6.01 and-5.06, respectively, versus -2.00; P)
Regan and colleagues tested the safety and efficacy of endovenous polidocanol microfoam in patients with varicose veins. The authors wrote that foam generated by manual agitation of liquid sclerosant with air or gas is routinely utilized to treat refluxing veins. Although generally well- tolerated, serious neurological events have been reported. The composition and properties of the foam, including bubble size and gaseous components, may contribute to the potential for microcirculatory obstruction and cerebral ischemia. We tested an ultra-low nitrogen polidocanol endovenous microfoam with controlled bubble size and density and hypothesized that patients at risk due to the presence of middle cerebral artery (MCA) bubble emboli during microfoam injection would not demonstrate evidence of clinical or subclinical cerebral infarction. Patients with great saphenous vein incompetence were treated with ultra-low nitrogen (less than or equal to [<=] 0.8%) polidocanol endovenous microfoam injected under ultrasound guidance. Patients with right-to-left shunt were included to evaluate the safety of cerebral arterial bubbles. All patients with MCA emboli detected by transcranial Doppler during endovenous microfoam ablation received intensive surveillance for microinfarction, including brain magnetic resonance imaging and measurement of cardiac troponin-I. MCA bubble emboli were detected in 60 of 82 treated patients; 22 patients had no detectable emboli. Among patients with MCA bubbles detected, 49 (82%) had less than or equal to 15 bubbles. No patients developed magnetic resonance imaging abnormalities, neurological signs, or elevated cardiac troponin. Patients treated with foamed liquid sclerosants are commonly exposed to cerebrovascular gas bubbles. In this series of 60 high-risk patients with MCA bubble emboli during or after treatment with ultra-low nitrogen polidocanol endovenous microfoam, there was no evidence of cerebral or cardiac microinfarction. The results of this study cannot be generalized to foams compounded using bedside methodologies, since the composition of these foams is substantially different.