Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Varicose Veins.
Treatment: Vein Treatment (sclerotherapy), Pre-service.
The insurer denied the Vein Treatment (sclerotherapy), Pre-service.
The denial is upheld. 

The patient is a female. The patient underwent bilateral great saphenous vein (GSV) ablation. She presents now with recurrent symptoms of bilateral leg pain, heaviness, and cramping. Exam shows mild edema with no significant large varicose veins. Reflux testing shows closed bilateral GSVs (great saphenous veins) and competent short saphenous veins (SSVs). However, the patient has bilateral accessory vein reflux, for which reason the provider has proposed bilateral Varithena therapy. Varithena is the principal method of non-thermal ablation.

These procedures have been denied as being experimental/investigational. An additional reason for denial is that the provider has not given a reason to not perform the more widely accepted treatment of thermal ablation (e.g., radiofrequency or laser ablation).

No, the health plan should not cover the sclerotherapy.
The patient underwent bilateral great saphenous vein (GSV) ablation in previous year. She presents now with recurrent symptoms of bilateral leg pain, heaviness, and cramping. Exam shows mild edema with no significant large varicose veins. Reflux testing shows closed bilateral GSVs (great saphenous veins) and competent short saphenous veins (SSVs). However, the patient has bilateral accessory vein reflux, for which reason the provider has proposed bilateral Varithena therapy. Varithena is the principal method of non-thermal ablation.

These procedures have been denied as being experimental/investigational. An additional reason for denial is that the provider has not given a reason to not perform the more widely accepted treatment of thermal ablation (e.g., radiofrequency or laser ablation).

To evaluate the appropriateness of Varithena ablation, the available published clinical data [1-3] regarding thermal and non-thermal endovenous ablation of the axial and accessory saphenous veins were evaluated. Varithena outcomes are not as good as thermal ablation. For this reason, current consensus is that Varithena should be used only when thermal ablation is not feasible (e.g., tortuous axial vein).

Varithena is medically appropriate when:
	 1) The patient has venous insufficiency symptoms severe enough to affect normal function.
	 2) The patient has failed a trial of prescription compression stockings.
	 3) The patient has duplex-proven reflux affecting the vein in question, and this reflux is a likely contributor to the patient's symptoms.
	 4) The target vein is clinically appropriate, and the modality of ablation is suitable for the vein in question.

Requirement 1 has been met. The patient has symptoms compatible with venous insufficiency, including pain, heaviness, and cramping. The symptoms are severe enough to affect her normal function.

Requirement 2 has been met. The office note states that the patient has worn prescription stockings regularly with no benefit.

Requirement 3 has not been met. The record states that the patient has bilateral incompetent "medial calf" accessory veins. An accessory vein in the medial calf is considered a "minor" accessory vein. Reflux in minor accessory veins is of questionable clinical significance. The provider has not explained why he believes that reflux in these veins is contributing to the patient's symptoms.

Requirement 4 has not been met. Treatment of minor accessory veins by endovenous ablation is controversial, regardless of the modality of ablation. Excellent (Grade A) data support ablation of the GSV (great saphenous vein) and small saphenous vein [1-2]. Good quality (Grade B) data are available to support anterior accessory vein treatment [1-3]. However, the data to support ablation of other axial is absent or of low quality (Grade C) [1]. Moreover, foam sclerosant ablation (of which Varithena is the prime example) has the poorest intermediate- and long-term outcomes among the available ablation modalities [1].

Therefore, the patient does not meet published, well-accepted criteria for medial calf accessory vein Varithena ablation.

No, the requested therapy is not likely to be more beneficial.