Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Venous Insufficiency (chronic) (Peripheral). 
Treatment: 36465 - Varithena - Right/Left (RT/LT) Injection Of Non-Compounded Foam Sclerosant With Ultrasound Compression Maneuvers To Guide Dispersion Of The Injectable, inclusive Of All Imaging Guidance And Monitoring; Single Incompetent Extremity Truncal Vein (e.g. great saphenous vein, accessory saphenous vein). 

The insurer denied the 36465 - Varithena - RT/LT Injection Of Non-Compounded Foam Sclerosant With Ultrasound Compression Maneuvers To Guide Dispersion Of The Injectable, inclusive Of All Imaging Guidance And Monitoring; Single Incompetent Extremity Truncal Vein (e.g. great saphenous vein, accessory saphenous vein). 

The denial is upheld. 

The patient is a female who has been evaluated for the treatment of lower extremities venous disease. This patient suffers from pain and swelling of her legs. There is reportedly bilateral GSV (great saphenous vein) reflux disease. 

Previously approved services include code 36475 endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated. 36475 has been performed bilaterally already. There is no post-procedure follow-up documented. 

No, the health plan should not cover the requested health service. 

Varithena is a drug/device combination product that generates an injectable foam. Varithena microfoam (polidocanol injectable foam) was FDA (United State Food and Drug Administration)-approved under a new drug application as a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the GSV (great saphenous vein) system above and below the knee (Varithena prescribing information, 2016). Todd and colleagues reported results of VANISH-2 (Polidocanol Endovenous Microfoam Versus Vehicle for the Treatment of Saphenofemoral Junction Incompetence), a randomized, blinded multicenter pivotal trial designed to evaluate the safety and efficacy of polidocanol endovenous microfoam (Varithena). Participants were randomized to receive polidocanol endovenous microfoam 0.5%, polidocanol endovenous microfoam 1.0% or placebo. In 232 treated participants, polidocanol endovenous microfoam 0.5% and polidocanol endovenous microfoam 1.0% were reported as superior to placebo, with a larger improvement in symptoms and greater improvements in assessments of appearance. Results of duplex ultrasound and other clinical measures supported the findings. Of the subjects treated with polidocanol endovenous microfoam, 60% had an adverse event compared with 39% of placebo. 

Controlled studies have shown that sclerotherapy/echosclerotherapy of the underlying refluxing great or small saphenous veins is associated with a higher rate of recurrence compared to ligation and stripping (Belcaro). Van den Bos and colleagues (2009) conducted a meta-analysis of 64 studies (12,320 limbs) evaluating treatment of lower extremity varicosities, including GSVs (great saphenous veins) and SSVs (short saphenous veins). Study authors reported that UGFS (ultrasound guided foam sclerotherapy) was comparable to conventional surgical stripping, but not as effective as EVLA (endovenous laser ablation). Comparable results were observed between UGFS (ultrasound guided foam sclerotherapy) and RFA (radiofrequency ablation). 

No, the requested health service is not more beneficial. 

In addition, the previously approved service, 36475 endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated are well accepted in the medical literature for the treatment of GSV (great saphenous vein) reflux disease.