LCD L33575: Varicose Veins of the Lower Extremity, Treatment of

Indications:

Varicose veins are caused by venous insufficiency as a result of valve reflux (incompetence). The venous insufficiency results in dilated, tortuous, superficial vessels that protrude from the skin of the lower extremities. Spider veins (telangiectases) are dilated capillary veins that are most often treated for cosmetic purposes.

The accepted treatments for eliminating saphenous (great saphenous vein (GSV), anterior accessory GSV (AAGSV), small saphenous vein (SSV)) reflux (saphenofemoral or saphenopopliteal) are radiofrequency ablation (RFA), laser ablation (EVLA), polidocanol microfoam (PEM), cyanoacrylate embolization (CAE) ablation, and mechanochemical ablation (MOCA). Coverage is only for devices with FDA approval or clearance consistent with saphenous ablation and used according to its approved instructions for use (IFU).

RFA and EVLA are classified as thermal tumescent (TT) techniques; PEM, CAE and MOCA are non-thermal non-tumescent (NTNT) techniques. Each endovenous ablation approach has advantages and disadvantages; which one is best depends on the unique clinical/anatomical scenario. While saphenous vein ligation and stripping remains an important option in selected cases, it has been largely supplanted by endovenous ablation therapy as primary treatment of saphenous (axial/truncal) vein incompetence. The treatments to eliminate the saphenous vein reflux will be considered medically necessary if the patient remains symptomatic after a six-week trial of conservative therapy and has reflux in a saphenous vein.

The treatments for symptomatic varicose tributaries are either compressive sclerotherapy or microphlebectomy. The treatments of the tributary veins will be considered medically necessary if saphenous reflux is not present or already successfully eliminated, the veins are > than 4 mm in diameter and if the patient remains symptomatic after a six-week trial of conservative therapy.

The components of the conservative therapy include, but are not limited to:

• weight reduction,

• a daily exercise plan,

• periodic leg elevation, and

• the use of graduated compression stockings.

The conservative therapy must be documented in the medical record. Inability to tolerate compressive bandages or stockings and the reason for such intolerance must be documented in the medical record.

The patient is considered symptomatic if any of the following signs and symptoms of significantly diseased vessels of the lower extremities are documented in the medical record:

• stasis ulcer of the lower leg,

• significant pain and significant edema that interferes with activities of daily living,

• bleeding associated with the diseased vessels of the lower extremities,

• recurrent episodes of superficial phlebitis,

• stasis dermatitis, or

• refractory dependent edema.

Coverage of endovenous ablation therapy is limited to patients with:

• a maximum vein diameter of 12 mm for CAE, PEM and MOCA; and

• absence of thrombosis or vein tortuosity, which would impair catheter advancement (except for PEM).

Medicare includes payment for the ultrasound guidance in the payment for endovenous ablation procedures.

Limitations:

Coil embolization is non-covered for any varicose vein procedure.

The following interventional treatments are not considered medically reasonable or necessary and are denied as such:

• Surgery, endovenous ablation, or sclerotherapy are typically not performed for varicose veins that develop or worsen during pregnancy because most will spontaneously resolve or improve after delivery.

• Reinjection following recanalization or failure of vein closure without recurrent signs or symptoms.

• Sclerotherapy of the saphenous vein at its junction with the deep system.

• Noncompressive sclerotherapy.

• Compressive sclerotherapy for large, extensive or truncal varicosities.

• Sclerotherapy, ligation and/or stripping of varicose veins, or endovenous ablation therapy are generally not covered for patients with severe distal arterial occlusive disease; obliteration of deep venous system; an allergy to the sclerosant; or a hypercoaguable state.

• Any interventional treatment that uses equipment or sclerosants not approved for such purposes by the FDA.

Mechanochemical endovenous ablation

The impetus for alternatives to RFA and EVLA is the desire to eliminate the need for thermal energy which necessitates tumescent anesthesia and can cause pain and complications.

In a randomized control trial (RCT) involving MOCA, the “Venefit™ versus ClariVein for varicose veins trial”, 170 patients with symptomatic saphenous vein insufficiency were randomized to either MOCA or RFA (Bootun 2016, Lane 2016). MOCA was associated with significantly lower procedure related pain, and “occlusion rates, clinical severity scores, disease specific and generic quality of life scores were similar between groups at one and six months.”

Two non-randomized controlled studies have also been published. Van Eekeren prospectively compared MOCA with RFA in 68 consecutive patients (van Eekeren 2013). The treated great saphenous vein (GSV) was significantly wider at the saphenofemoral junction (SFJ) in the RFA group than in the MOCA group (P=.03). The primary endpoint, postoperative pain, was significantly less for MOCA initially and similar at 6 weeks. A major limitation to the study was that occlusion rates were not reported. The second prospective, non-randomized controlled study compared MOCA (n=57) with RFA (n=50) and EVLA (n=40) (Vun 2014). The MOCA group demonstrated significantly lower procedural pain scores and shorter treatment times, but occlusion rates beyond six weeks were not measured.