This document addresses various modalities (listed below) for the treatment of valvular incompetence (reflux) of the great saphenous vein (GSV), anterior accessory great saphenous vein (AAGSV), or small saphenous vein (SSV) (also known as greater saphenous vein or lesser saphenous vein, respectively) and associated varicose tributaries as well as telangiectatic dermal veins.

The following modalities are included in this document:

• Coil embolization;
• Cyanoacrylate adhesion (VenaSeal^® Closure System);
• Echosclerotherapy (also known as ultrasound-guided sclerotherapy or ultrasound guided foam sclerotherapy [UGFS] [for example, Varithena], or microfoam sclerotherapy);
• Endoluminal cryoablation;
• Endoluminal laser ablation (also known as EVLT^® or ELAS);
• Endoluminal radiofrequency ablation (also known as VNUS Closure^® System or Venefit^™ Procedure);
• Endovenous thermal ablation (EVTA) which includes radiofrequency and laser ablation (EVLA);
• Mechanochemical ablation (for example: ClariVein^®);
• Sclerotherapy (including catheter-assisted balloon sclerotherapy [for example, KAVS procedure]).

Cosmetic: In this document, procedures are considered cosmetic when intended to change a physical appearance that would be considered within normal human anatomic variation. Cosmetic services are often described as those that are primarily intended to preserve or improve appearance.

Medically Necessary:

Endoluminal radiofrequency ablation and endoluminal laser ablation:

The following techniques are considered medically necessary when the criteria below (I, II, and III) have been met:

1. Ablative Techniques:
   1. Endoluminal radiofrequency; or
   2. Endoluminal laser; 
      and
2. Anatomy:
   1. Anterior accessory great saphenous vein (AAGSV); or
   2. Great saphenous vein (GSV); or
   3. Small saphenous veins (SSV)
      and
3. Criteria:
   1. Truncal vein incompetence (that is, reflux with retrograde flow of 0.5 second duration or greater in the GSV, AAGSV, or SSV) based on vein anatomy is confirmed by Doppler or duplex ultrasound evaluation and report; and
   2. Previous endoluminal radiofrequency ablation or endoluminal laser ablation for refluxing varicosities of the same named vein, on the same extremity, has not been performed within the previous 6 weeks nor more than 3 times in the previous 12 months; and
   3. One or more of the following criteria (1, 2, or 3) are met:
      1. Symptoms of venous insufficiency or recurrent thrombophlebitis (including but not limited to: aching, burning, itching, cramping, or swelling during activity or after prolonged sitting) which:
         1. are causing discomfort to the degree that employment or activities of daily living are compromised; and
         2. persist despite appropriate conservative therapy, for no less than 6 weeks, such as leg elevation, weight loss and exercise; and
         3. persist despite a trial of properly fitted gradient compression stockings for at least 6 weeks;
            or
      2. There is ulceration secondary to stasis dermatitis; or
      3. There is hemorrhage from a superficial varicosity.

Sclerotherapy and Echosclerotherapy (including ultrasound guided foam sclerotherapy [UGFS]),

The following techniques are considered medically necessary when the criteria below (I, II and III) have been met:

1. Ablative Techniques:
   1. Sclerotherapy; or
   2. Echosclerotherapy;
      and
2. Anatomy:
   1. Perforator veins; or
   2. Varicose tributary or extension (for example, anterolateral thigh vein, anterior accessory saphenous vein, or intersaphenous vein[s]);
      and
3. Criteria:
   1. Vein being treated is greater than 3.0 mm in diameter with reflux confirmed by Doppler or duplex ultrasound evaluation and report; and
   2. When performed during the same operative session as an endoluminal radiofrequency ablation procedure or endoluminal laser ablation procedure which meets the criteria above; or
   3. When performed for the treatment of residual or recurrent symptoms which meet the following criteria:
      1. Surgical ligation and stripping, endoluminal radiofrequency ablation, or endoluminal laser ablation of the AAGSV, GSV or SSV was previously performed; and
      2. Prior sclerotherapy or echosclerotherapy treatments for refluxing varicosities of the same extremity have not been performed within the previous 6 weeks; and
      3. One or more of the following criteria (a, b, or c) are met:
         1. Symptoms of venous insufficiency or recurrent thrombophlebitis (including but not limited to: aching, burning, itching, cramping, or swelling during activity or after prolonged sitting) which:
            1. Are causing discomfort to the degree that employment or activities of daily living are compromised; and
            2. Persist despite appropriate conservative therapy for 6 weeks (such as leg elevation, weight loss and exercise), excluding similar management prior to the required treatment of the great or small saphenous vein; and
            3. Persist despite a trial of properly fitted gradient compression stockings for at least 6 weeks, excluding similar management prior to the required treatment of the great or small saphenous vein; or
         2. There is ulceration secondary to stasis dermatitis; or
         3. There is hemorrhage from a superficial varicosity.

Not Medically Necessary:

Endoluminal radiofrequency ablation and endoluminal laser ablation, are each considered not medically necessary when the above criteria are not met, and for all other uses in the lower extremities including, but not limited to:

1. As an alternative to perforator vein ligation;
2. As treatment of saphenous vein tributaries or extensions not considered medically necessary above, (for example, anterolateral thigh and intersaphenous veins);
3. As an alternative to adjunctive sclerotherapy or echosclerotherapy of symptomatic varicose tributaries.

Sclerotherapy or echosclerotherapy (including UGFS) is considered not medically necessary when the above criteria are not met, and for all other uses including, but not limited to:

1. As the sole* treatment of symptomatic varicose tributary or extension or perforator veins in the presence of valvular incompetence of the great or small saphenous veins (by Doppler or duplex ultrasound scanning);
2. As the sole treatment of symptomatic varicose tributary or perforator veins in the absence of saphenous vein reflux or major saphenous vein tributary reflux;
3. For the treatment of secondary varicose veins resulting from deep-vein thrombosis or arteriovenous fistulae when used to treat valvular incompetence (that is, reflux) of the great or small saphenous veins with or without associated ligation of the saphenofemoral junction;
4. When performed as part of other protocols for sclerotherapy, including, but not limited to the COMPASS protocol, for the treatment of valvular incompetence (that is, reflux) of the great or small saphenous veins.
5. When used in conjunction with a balloon catheter (for example, KAVS procedure).

Endoluminal cryoablation is considered not medically necessary.

Mechanochemical ablation of any vein is considered not medically necessary.

Coil embolization is considered not medically necessary as treatment of lower extremity veins.

Note: COMPASS is an acronym for Comprehensive Objective Mapping, Precise Image-guided Injection, Antireflux Positioning and Sequential Sclerotherapy.

* Sole refers to sclerotherapy without concomitant or prior ligation (with or without vein stripping), or endoluminal radiofrequency ablation, or endoluminal laser ablation for valvular incompetence of the great or small saphenous veins.

Investigational and Not Medically Necessary:

Cyanoacrylate adhesion (for example, VenaSeal Closure System) is considered investigational and not medically necessary as treatment of venous reflux.

Cosmetic and Not Medically Necessary:

Treatment using sclerotherapy or various laser treatments (including tunable dye or pulsed dye laser, for example, PhotoDerm^®, VeinLase^™, Vasculite^™) of the telangiectatic dermal veins (for example, reticular, capillary, venule), which may be described as "spider veins" or "broken blood vessels" is considered cosmetic and not medically necessary.