CMS Varicose Veins of the Lower Extremity, Treatment of Form

Summary Of Evidence

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.  

Among the several prospective, non-controlled, cohort studies, the one by Witte has the longest follow-up (Witte 2016). The midterm (median 3 year follow-up) results on a group of 85 consecutive MOCA patients showed an anatomic success rate of 92.8%/89.5%/86.5% at 1/2/3 years, respectively, with a mean GSV diameter of only 5.2mm. Three year clinical success (accounting for return of varicosities between 12 and 36 months was 83%. The authors note: “Between 12 and 36 months, however, a significant deterioration was observed in venous clinical severity score (VCSS), which was accompanied by worsening of disease-specific and general quality of life, and also associated with recurrent varicosities between 12 and 36 months.”  

In the largest multicenter prospective cohort study, 507 limbs in 449 patients were treated for incompetence of GSV or small saphenous vein (SSV) with MOCA (Deijen 2015). Rates of venous closure at 6 weeks and 3 months for GSV were 94.5% and 89%; and for SSV at 6 weeks 85% and 80.5% at 3 months.  

Another prospective, multicenter, observational study of 126 patients treated with MOCA reported 2 year follow-up on 65 patients with a 92% GSV closure rate (Kim 2016). Overall clinical success rate at 2 years was 89%. Average GSV diameter was only 7.6mm. There was significant improvement in Classification for Chronic Venous Disorders (CEAP) and clinical severity scores compared with baseline.  

A single center cohort study of 63 patients (73 limbs) treated with MOCA for GSV insufficiency reported an occlusion rate of 95% at 2 years and an associated significant improvement in VCSS (Ozen 2014). Another cohort study assessed MOCA in 50 patients with insufficiency of the SSV (Boersma 2013). The anatomic success rate was 94% at 1 year, also associated with a significant improvement in VCSS. 

In a recent systematic review (Witte 2017), the short-term pooled anatomical success rate was 92% (n=1314 veins). After 6 and 12 months these numbers were 92% (n-284) and 91% (n=228). The long-term anatomical success rates at 2 and 3 years were 91% (n=136) and 87% (n=48). Another recent systematic review (Kugler 2017) reported early, 1, and 2 year anatomical success ranges of 87-99%, 88-97% and 96-97%, respectively.  

American Venous Forum (AVF) 2017 Guidelines give MOCA a “strong” recommendation for above-knee (AK) GSV treatment for diameters <12mm.

Polidocanol endovenous microfoam (PEM) ablation

There are three randomized controlled trials comparing foam ablation with EVLA and surgery. Brittenden (2014) randomized 798 patients with primary varicose veins. The foam group had worse disease-specific survival after 6 months (p=0.006), and less successful ablation (p<0.001). Biemans (2013) compared the one year outcomes in 240 patients randomized similarly to foam, EVLA, or surgical ablation. While the anatomic success rate was only about 72% with foam compared with about 88% for EVLA and surgical ablation (p<0.001), quality of life and complications were comparable. Rasmussen (2011) randomized 500 patients to EVLA, RF, foam, or surgical ablation had similar results. However, all three RCTs did not involve standardized polidocanol microfoam (PEM).

Three RCTs compare PEM with placebo. The VANISH-1 study (King 2015) randomized 279 patients between five groups, PEM at 3 different concentrations (0.5%, 1%, 2%) and controls (PEM 0.125% and placebo). At week 8, VVSymQ (patient reported venous symptom improvement) was significantly superior to placebo. Occlusion rates were 58.8%, 80.4%, and 82.5% in the 0.5%, 1%, and 2% groups, respectively. The VANISH-2 study (Todd 2015) randomized 232 patients between four groups, PEM at 2 different concentrations (0.5%, 1%) and controls (PEM 0.125% and placebo). The primary endpoint at 8 weeks of improved VVSymQ was similar to the VANISH-1 study, and was maintained at one year (n=221). Occlusion rates were 89% and 73% at 8 weeks and one year, respectively. Gibson (2016) randomized 77 patients and found PEM provided significantly greater symptom relief and improvement in leg appearance compared with placebo. Anatomic success was 90% at 4 weeks. 

Four meta-analyses (van den Bos 2009, Nesbitt 2014, Carroll 2014, Demody 2015) all conclude that there is little to choose between surgery and newer minimally invasive techniques (foam, laser, RF ablation) in terms of either efficacy or safety.

Recent systematic review articles (Davies 2016, Kugler 2017) suggest improved anatomic success after EVLA as measured by duplex ultrasound; however, overall clinical outcomes and safety are similar between laser and foam ablation.

American Venous Forum (AVF) 2017 Guidelines give PEM a “strong” recommendation for above-knee (AK) GSV treatment for diameters <12mm.

Cyanoacrylate embolization (CAE) ablation 

Cyanoacrylate embolization (CAE) ablation received FDA PMA approval on 2/20/15 to treat superficial leg varicosities via endovascular embolization. CPT codes for CAE for the treatment of incompetent veins become effective 1/1/18. CAE is the only non-sclerosant NTNT for symptomatic venous reflux and is also unique in not requiring post-procedure compression. The polymerized adhesive chemically bonds to the apposed intimal walls of the vein, effectively embolizing the vein by immediate closure. A foreign body reaction incites an inflammatory response in the vessel, ultimately leading to fibrotic occlusion. 

The 3 year results of a single-center, prospective feasibility study were recently reported (Almeida 2017). Inclusion criteria included symptomatic GSV incompetence (CEAP stage C2-C4). No post-procedure compression was used. Among the 29 subjects (of 38 initially treated), the 36 month occlusion rate was 94.7%, and the mean VCSS improved from 6.2 to 2.2 (p<.0001).  

The European multicenter eSCOPE prospective study of 70 patients with symptomatic GSV incompetence (CEAP stage C2-C4) demonstrated a one year anatomic success rate (N=68) of 92.9% (Proebstele 2015). Statistically significant clinical outcomes paralleled anatomic success as measured by VCSS as well as patient-rated disease-specific Aberdeen Varicose Vein Questionnaire (AVVQ) and European Quality of Life 5 dimensions questionnaire (EQ-5D). Adverse events were generally mild and self-limited. 

The VenaSeal Sapheon Closure System (VeClose) non-inferiority pivotal trial randomized 222 patients with symptomatic GSV incompetence (CEAP stage C2-C4) to either CAE (108) or RFA (114) (Morrison 2017). This trial did use post-operative compression as a fair comparison to RFA. Twelve month follow-up in 192 (95 CAE and 97 RFA), demonstrated a nearly identical complete occlusion rate in both groups (97.2% CAE and 97% RFA), demonstrating non-inferiority of CAE compared with RFA (p<.0001). Symptom improvement, as measured by VCSS, AVVQ, and EQ-5D were similar in both groups, as were adverse events.

American Venous Forum (AVF) 2017 Guidelines give CAE a “strong” recommendation for above-knee (AK) GSV treatment for diameters <12mm. 

Analysis of Evidence

Mechanochemical endovenous ablation 

In summary, the study data, including an RCT, consistently demonstrates relative parity with thermal ablation techniques in terms of anatomic success, at least in small to medium axial veins, but with less pain and complications. The amount and consistency of the data, in addition to the two recent systematic reviews and the “strong” recommendation by the American Venous Forum (AVF), the US’s major venous society, have convinced NGS that Medicare coverage criteria is met for MOCA as an alternative to current ablation standard of care techniques.

Polidocanol endovenous microfoam (PEM) ablation 

In summary, although anatomical success appeared slightly higher with endothermal ablation than foam, clinical success as measured by physician-derived and patient-reported outcomes measures appear similar, at least for the standardized polidocanol microfoam (PEM) preparation in small to medium axial veins. Anatomic success (closure or presence of reflux) may lack sensitivity in that it’s a binary response (ignores whether any small residual reflux is physiologically important). Re-canalisation may not lead to return of symptoms or need for further intervention (Theivacumar 2008). According to AVF Guidelines, “the idea of the occlusion rate being the primary endpoint has faded in recent years,” replaced by quality of life. In fact, the FDA seems to favor assessing treatment benefit in terms of patient-reported outcome (PRO) over surrogate measures “that do not directly capture the treatment effect on how a patient survives, feels, or functions.”  

The combination of the RCTs, meta-analyses, systematic reviews, the “strong” recommendation by the American Venous Forum (AVF), and written endorsement by a coalition of other vascular societies (Society of Vascular Surgery (SVS), American college of Phlebology (ACP), Society for Cardiovascular Angiography and Interventions (SCAI), and Society of Interventional Radiology (SIR)), have convinced NGS that Medicare coverage criteria is met for PEM as an alternative to current ablation standard of care techniques. 

Cyanoacrylate embolization (CAE) ablation

In summary, the study data, especially the non-inferiority RCT with RFA, the current standard of care, demonstrates relative parity with thermal ablation techniques in terms of anatomic success and quality of life measures, at least in small to medium veins. In addition, the “strong” recommendation by the American Venous Forum (AVF), and written endorsement by a coalition of other vascular societies (Society of Vascular Surgery (SVS), American college of Phlebology (ACP), Society for Cardiovascular Angiography and Interventions (SCAI), and Society of Interventional Radiology (SIR)), have convinced NGS that Medicare coverage criteria is met for CAE as an alternative to current ablation standard of care techniques.

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.