Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Varicose Veins
Treatment: Endovenous Ablation Therapy
The insurer denied: Endovenous Ablation Therapy
The denial is overturned

The patient is an elderly female. The patient underwent Venaseal closure to treat axial vein reflux. The procedure was denied coverage by the health plan on the basis that the cyanoacrylate embolization is unproven. The denial is being appealed.

The Endovenous Ablation Therapy was medically necessary.
The patient underwent Venaseal closure to treat axial vein reflux. The procedure was denied coverage by the health plan on the basis that the cyanoacrylate embolization is unproven.

The sole reason for denial of coverage was that the effectiveness of cyanoacrylate embolization (CAE) is unproven. Therefore, the data on the efficacy of the procedure will be addressed.

Treatment of saphenous incompetence is currently performed by different interventionist alternatives, which include surgical, endothermal, and nonthermal ablation therapies. In the last 15 years, two endothermal therapies, namely, endovenous laser ablation (EVLA) and radiofrequency ablation (RFA), were developed as new standard procedures. The guidelines of the European Society for Vascular Surgery, the American Venous Forum, and the United Kingdom's National Institute for Health and Care Excellence recommend endovenous thermal treatment as the first-choice therapy for this condition. However, endothermal therapies have side-effects linked to thermal energy that damages the venous wall and causes pain, skin burns, skin pigmentation, nerve damage, and even the formation of arteriovenous fistula. Tumescent anesthesia is mandatory to prevent thermal damage to surrounding tissues and to avoid causing pain to the patient.

To avoid some of these unwelcome effects, non-thermal, non-tumescent endovenous ablation techniques have recently emerged, including mechanochemical endovenous ablation, ultrasound-guided foam sclerotherapy, and cyanoacrylate ablation (CAE).

CAE (cyanoacrylate ablation) has been analyzed in multiple recent studies, including three comparative studies and two randomized controlled trials [2-4]. All these studies demonstrate that CAE (cyanoacrylate ablation) is safe and effective in achieving saphenous vein closure. The randomized studies demonstrate that CAE's (cyanoacrylate ablation's) efficacy is equivalent to thermal ablation and that adverse outcomes may be lower with CAE (cyanoacrylate ablation).

A recent systematic review [1] concluded that "Compared with EVLA [endovenous laser ablation] and RFA [radiofrequency ablation], CA [cyanoacrylate ablation] treatments yield comparable effectiveness outcomes and lead to less frequent and fewer mild adverse events, without difference in major adverse events. Furthermore, CA [cyanoacrylate ablation] devices have advantages in terms of quality of care indicators, such as pain during intervention, treatment and recovery times, lower use of anesthesia, and zero use of compression bandages after treatment."

Based on the above discussion, it is concluded that CAE (cyanoacrylate ablation) has been proven to be at least as safe and effective as traditional ablation techniques such as RFA (radiofrequency ablation) and EVLA (endovenous laser ablation) CAE (cyanoacrylate ablation) should not be considered unproven.

The procedure was medically necessary, because the patient met well accepted criteria for axial vein closure. Specifically, the patient had symptoms significant enough to adversely affect normal function, she had failed a trial of compression therapy, she had duplex-proven reflux affecting the treated vein, and the technique used (cyanoacrylate ablation) has been proven to be at least as safe and effective as traditional ablation methods (as per discussion above).