Surgery (ligation and stripping), endovenous radiofrequency, laser ablation of greater or lesser saphenous veins or sclerotherapy (e.g. Varithena) may be considered medically necessary for symptomatic varicose veins/venous insufficiency when the following criteria have been met:
NOTE: If compression and pain-reliever therapy are successful, those therapies should be continued for as long as they are working. Failure of conservative therapy is defined as pain, swelling, itching, burning, or other symptoms associated with vein reflux, despite conservative therapy, severe enough to require daily pain medicines and causing inability to manage daily activities at home or at work.
Surgery, endovenous radiofrequency, laser ablation or sclerotherapy that does not meet the criteria described above is considered not medically necessary.
Treatment of the greater or lesser saphenous veins using any other techniques than noted above is considered investigational, including, but not limited to:
Accessory Saphenous Veins
Surgery (ligation and stripping), endovenous radiofrequency, laser ablation or sclerotherapy of the accessory saphenous veins may be considered medically necessary for symptomatic varicose veins/venous insufficiency when the following criteria have been met:
NOTE: If compression and pain-reliever therapy are successful, those therapies should be continued for as long as they are working. Failure of conservative therapy is defined as pain, swelling, itching, burning, or other symptoms associated with vein reflux, despite conservative therapy, severe enough to require daily pain medicines and causing inability to manage daily activities at home or at work.
Surgery, endovenous radiofrequency, laser ablation, or sclerotherapy of the accessory saphenous veins that does not meet the criteria described above is considered not medically necessary.
Treatment of the accessory saphenous veins using any other techniques than noted above is considered investigational, including, but not limited to:
Symptomatic Varicose Tributaries
The following treatments are considered medically necessary as a component of the treatment of symptomatic varicose tributaries when performed at the same time as treatment (surgical, radiofrequency or laser) of the saphenous veins (none of these techniques has been shown to be superior to another):
When stab avulsion, hook phlebectomy, sclerotherapy, or transilluminated powered phlebectomy is not done concurrently with a surgical, radiofrequency or laser treatment and is requested following a prior surgical, radiofrequency or laser treatment, it may be considered medically necessary when there is documentation of one or more of the following indications:
Treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment of saphenous veins using any other techniques than noted above is considered investigational, including, but not limited to:
Surgical ligation (including subfascial endoscopic perforator surgery) or endovenous radiofrequency or laser ablation of incompetent perforator veins may be considered medically necessary as a treatment of leg ulcers associated with chronic venous insufficiency when ALL of the following conditions have been met:
Ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery is not medically necessary.
Treatment of incompetent perforator veins using any other techniques than noted above is considered investigational, including, but not limited to:
Treatment, by any method, of small telangiectasia such as spider veins (1mm or less), superficial reticular veins (1-2 mm), angiomata, and hemangiomata is considered cosmetic.
Review of this technology requires the provider to specifically indicate:
Sclerotherapy: There is no specific CPT for microfoam sclerotherapy such as Varithena.
Providers might elect to use CPT codes describing sclerotherapy (36468-36471) or the unlisted vascular surgery procedure code 37799.
Stab avulsion or stab/hook/micro-phlebectomy may be billed using CPT codes 37765 or 37766
Transilluminated powered phlebectomy (TIPP) : There is no specific CPT code for transilluminated powered phlebectomy. Providers might elect to use CPT codes describing stab phlebectomy (37765 or 37766) or unlisted vascular surgery procedure (37799).
Greater/long saphenous veins – Superficial vein running the entire length of the leg and is generally 3 mm in its normal state. A typical GSV contains an average of 7 valves throughout its entire length, and it is the most common superficial vein to develop venous reflux.
Lesser/short saphenous veins – Superficial vein of the calf and is generally 2.5 mm in its normal state. The small saphenous vein originates at the back of the ankle near the outer malleous bone, and usually runs up the back of the lower leg to the popliteal vein behind the knee.
Accessory saphenous veins – Travel in parallel with the greater and lesser saphenous veins and are generally 2 - 2.5 mm in their normal state.
Tributary veins – Veins that empty into a larger vein
Perforator veins – Connect superficial veins to deep veins. They contain one-way valves to direct the blood from the superficial system to the deep system and are generally less than 3mm in their normal state.
Telangiectasia/Spider veins –Very small (≤1 mm in diameter) thread veins found commonly just under the surface of the skin, usually not distorting skin or surrounding tissues.
Moderate to severe reflux – In current practice, most vascular laboratories consider the presence of venous flow reversal for greater than 0.5 second with proximal compression, Valsalva maneuver, or distal compression and release to represent pathologic reflux.
Stab avulsion - This technique is also known as stab/hook phlebectomy. Stab avulsion results in removal of the varicose veins through incisions that are 2-3 mm in length. The veins are hooked with a tiny hook-like instrument and pulled out. The wounds are closed with tapes, not sutures, and the leg is wrapped in elastic compression support. Once healed, the incision sites are almost invisible.
A variety of treatment modalities are available to treat varicose veins/venous insufficiency, including surgical approaches, thermal ablation, and sclerotherapy. The application of each of these treatment options is influenced by the severity of the symptoms, type of vein, source of venous reflux, and the use of other (prior or concurrent) treatments.
The venous system of the lower extremities consists of the superficial veins (this includes the greater and lesser saphenous and accessory, or duplicate, veins that travel in parallel with the greater and lesser saphenous veins), the deep system (popliteal and femoral veins), and perforator veins that cross through the fascia and connect the deep and superficial systems. One-way valves are present within all veins to direct the return of blood up the lower limb. Since venous pressure in the deep system is generally greater than that of the superficial system, valve incompetence at any level may lead to backflow (venous reflux) with pooling of blood in superficial veins. Varicose veins with visible varicosities may be the only sign of venous reflux, although itching, heaviness, tension, and pain may also occur. Chronic venous insufficiency secondary to venous reflux can lead to thrombophlebitis, leg ulcerations, and hemorrhage.
The CEAP classification allows for a precise description of the type of venous disease being discussed and provides an orderly framework for decision making. It considers the clinical, etiologic, anatomic, and pathologic (CEAP) characteristics of venous insufficiency, ranging from class 0 (no visible sign of disease) to class 6 (active ulceration).
Treatment of venous reflux/venous insufficiency is aimed at reducing abnormal pressure transmission from the deep to the superficial veins. Conservative medical treatment consists of elevation of the extremities, graded compression, and wound care when indicated. Conventional surgical treatment consists of identifying and correcting the site of reflux by ligation of the incompetent junction followed by stripping of the vein to redirect venous flow through veins with intact valves. While most venous reflux is secondary to incompetent valves at the saphenofemoral or saphenopopliteal junctions, reflux may also occur at incompetent valves in the perforator veins or in the deep venous system. The competence of any single valve is not static and may be pressure-dependent. For example, accessory saphenous veins may have independent saphenofemoral or saphenopopliteal junctions that become incompetent when the greater or lesser saphenous veins are eliminated and blood flow is diverted through the accessory veins.
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that travel in parallel with the greater or lesser saphenous veins. Tributaries are veins that empty into a larger vein. Treatment of venous reflux typically includes the following:
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an irritant solution (either a detergent, osmotic solution, or chemical irritant), ultimately resulting in the occlusion of the vessel. The success of the treatment depends on accurate injection of the vessel, an adequate injectate volume and concentration of sclerosant, and compression. Historically, larger veins and very tortuous veins were not considered to be good candidates for sclerotherapy due to technical limitations. Technical improvements in sclerotherapy have included the routine use of Duplex ultrasound to target refluxing vessels, luminal compression of the vein with anesthetics, and a foam/sclerosant injectate in place of liquid sclerosant. Foam sclerosants are commonly produced by forcibly mixing a gas (e.g., air or carbon dioxide) with a liquid sclerosant (e.g., polidocanol or sodium tetradecyl sulfate). The foam is produced at the time of treatment.. Varithena (previously known as Varisolve, BTG PLC, London) is dispersed from a canister with a controlled density and more consistent bubble size.
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted through a small incision in the distal medial thigh to within 1–2 cm of the saphenofemoral junction. The catheter is slowly withdrawn, closing the vein. Laser ablation is performed similarly; a laser fiber is introduced into the greater saphenous vein under ultrasound guidance; the laser is activated and slowly removed along the course of the saphenous vein. Cryoablation uses extreme cold to cause injury to the vessel. The objective of endovenous techniques is to cause injury to the vessel, causing retraction and subsequent fibrotic occlusion of the vein. Technical developments since thermal ablation procedures were initially introduced include the use of perivenous tumescent anesthesia, which allows successful treatment of veins larger than 12 mm in diameter and helps to protect adjacent tissue from thermal damage during treatment of the lesser saphenous vein.
Transilluminated Powered Phlebectomy
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook phlebectomy. This procedure uses 2 instruments: an illuminator which also provides irrigation, and a resector, which has an oscillating tip and can perform suction. Following removal of the saphenous vein, the illuminator is introduced via a small incision in the skin and tumescence solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity. The resector is then inserted under the skin from the opposite direction, and the oscillating tip is placed directly beneath the illuminated veins to fragment and loosen the veins from the supporting tissue. Irrigation from the illuminator is used to clear the vein fragments and blood through aspiration and additional drainage holes. The illuminator and resector tips may then be repositioned, thereby reducing the number of incisions needed when compared with stab avulsion or hook phlebectomy. It has been proposed that TIPP might result in decreased operative time, decreased complications such as bruising, and faster recovery compared to the established procedures.
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems. Incompetent perforating veins were originally addressed with an open surgical procedure, called the Linton procedure, which involved a long medial calf incision to expose all posterior, medial, and paramedial perforators. While this procedure was associated with healing of ulcers, it was largely abandoned due to a high incidence of wound complications. The Linton procedure was subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin flap to provide access to incompetent perforator veins in the lower part of the leg. The modified Linton procedure may be occasionally utilized for the closure of incompetent perforator veins that cannot be reached by less invasive procedures. Subfascial endoscopic perforator surgery (SEPS) is a less-invasive surgical procedure for treatment of incompetent perforators and has been reported since the mid-1980s. Guided by Duplex ultrasound scanning, small incisions are made in the skin, and the perforating veins are clipped or divided by endoscopic scissors. The operation can be performed as an outpatient procedure. Endovenous ablation of incompetent perforator veins with sclerotherapy and RF has also been reported.
Deep vein valve replacement is being investigated.
Outcomes of interest for venous interventions include healing and recurrence, recannulation of the vein, and neovascularization. Recannulation (recanalization) is the restoration of the lumen of a vein after it has been occluded; this occurs more frequently following treatment with endovenous techniques. Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently following vein stripping. Direct comparisons of durability for endovenous and surgical procedures are complicated by these different mechanisms of recurrence. Relevant safety outcomes include the incidence of paresthesia, thermal skin injury, thrombus formation, thrombophlebitis, wound infection, and transient neurologic effects.
The following devices have received specific U.S. Food and Drug Administration (FDA) marketing clearance for the endovenous treatment of superficial vein reflux:
Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.
A 2009 Cochrane review on compression for venous ulcers included a total of 39 randomized, controlled trials (RCTs), with 47 different comparisons. (1) Objective measures of healing were the time to complete healing, the proportion of ulcers healed within the trial period (typically 12 weeks), the change in ulcer size, and the rate of change in ulcer size. Evidence from 7 trials indicated that venous ulcers healed more rapidly with compression than without. Findings from 6 trials suggested that multi-component systems (bandages or stockings) were more effective than single-component compression. In addition, multi-component systems containing an elastic bandage appeared more effective than those composed mainly of inelastic constituents. Although this meta-analysis did not include time to healing, studies included in the review reported that the mean time to ulcer healing was approximately 2 months, while the median time to healing in other reports was 3 to 5 months.
A Cochrane review on compression stockings for the initial treatment of varicose veins in patients without venous ulceration was published in 2011. (2) Included in the review were 7 studies involving 356 participants with varicose veins without healed or active venous ulceration (CEAP [Clinical, Etiology, Anatomy, Pathophysiology] classification C2 to C4). Six of the studies compared different types or pressures of stockings. Subjectively, participants’ symptoms improved, but results were not compared with a control arm. Due primarily to inadequate reporting, the methodologic quality of the included trials was unclear. Meta-analyses were not performed due to inadequate reporting and suspected heterogeneity. The authors concluded that there is insufficient high-quality evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in patients without venous ulceration, or whether any type of stocking is superior to any other type.
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers with superficial vein surgery and conservative compression treatments but a reduction in ulcer recurrence rate with surgery. (3, 4) In general, recurrence rates after ligation and stripping are estimated at around 20%. Jones and colleagues reported on the results of a study that randomized 100 patients with varicose veins to undergo either ligation alone or ligation in conjunction with stripping. (5) At 1 year, reflux was detected in 9% of patients, rising to 26% at 2 years. Rutgers and Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation and stripping or ligation combined with sclerotherapy. (6) At 2 years, Doppler ultrasound demonstrated reflux in approximately 10% of patients after ligation and stripping, increasing to 15% at 3 years.
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus ligation/stripping for saphenous vein varices.8 Included in the review were 13 randomized studies with a combined total of 3081 patients. The overall quality of the evidence was moderate. There was no significant difference between sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR], 1.74; p=0.06) or for symptomatic recurrence (OR=1.28). For endovenous laser ablation (EVLA) versus surgery, there were no significant differences between the treatment groups for clinician noted or symptomatic recurrence, or for recanalization. Neovascularization and technical failure were reduced in the laser group (OR=0.05, p<0.001; and OR=0.29, p<0.001, respectively). For endovenous radiofrequency ablation (RFA) versus surgery, there were no significant differences between the groups in clinician noted recurrence, recanalization, neovascularization, or technical failure. The authors concluded that sclerotherapy, EVLA, and RFA are at least as effective as surgery in the treatment of great saphenous varicose veins.
In 2014, Brittenden et al. reported a multicenter randomized trial that compared foam sclerotherapy, EVLA, and surgical treatment in 798 patients.9 The study was funded by U.K.’s Health Technology Assessment Programme of the National Institute for Health Research. Veins greater than 15 mm were excluded from the study. At the 6-week follow-up visit, patients who were assigned to treatment with foam or laser had the option of treatment with foam for any residual varicosities; this was performed in 38% of patients in the foam group and 31% of patients in the EVLA group. Six months after treatment, mean disease-specific quality of life was slightly worse after sclerotherapy than after surgery (p=0.006), and there were more residual varicose veins, although the differences were small. Disease-specific quality of life was similar for the laser and surgery groups. The frequency of procedural complications was similar for the foam sclerotherapy (6%) and surgery (7%) groups, but was lower in the laser group (1%). The rate of complications at 6 months (primarily lumpiness and skin staining), was highest for the sclerotherapy group.
Endovenous Radiofrequency Ablation
In 2008, Luebke and colleagues reported a meta-analysis of 8 studies that included a total of 224 patients who underwent RFA and 204 patients who underwent stripping. (8) There was no significant difference between RFA and surgery in immediate or complete greater saphenous vein occlusion, incomplete greater saphenous vein closure, freedom from reflux, recurrent varicose veins, recanalization, or neovascularization between the 2 treatments. There were significant reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours, 1 week, and 3 weeks with RFA. Quality-of-life results, including return to normal activity and return to work, favored RF over surgery. The authors noted that rates of recanalization, retreatment, occlusion, and reflux may alter with longer follow-up and that further RCTs with longer follow-up are needed.
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical registry in 2005. (9) Thirty-four centers (1,006 patients, 1,222 limbs) participated in the registry, with 12 centers contributing 5-year data (406 limbs). The registry included data on the treatment of 52 lesser saphenous veins and 16 accessory saphenous veins. Follow-up at 1 week showed a 97% anatomical success rate and a decrease in pain in 50% (from 85% to 30%) of patients. An additional 162 failures were identified over the 5 years of follow-up; 129 veins were found to have recanalization, and 33 limbs had reflux in the groin. Logistic regression analysis (risk factors of gender, age, body mass index [BMI], vein diameter, and catheter pullback speed) showed that BMI was associated with long-term failure. The rate of pull-back speed of the catheter during treatment was associated with failure to occlude or recanalization.
Endovenous Laser Ablation
The largest trial on EVLA is the 2012 RELACS study, which was a practical design that randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping performed by a different surgeon at a second location.12 At 2-year follow-up, there was no significant difference between the groups for clinically recurrent varicose veins, medical condition on the Homburg Varicose Vein Severity Score, or disease-related quality of life. Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous laser treatment (EVLT) (17.8% vs 1.3%). This study will follow patients for 5 years. Another trial compared EVLA with ligation and stripping in 200 limbs (100 in each group).13 At 1-year follow-up, 98% of the limbs were reported to be free of symptoms. At 2-year follow-up, the EVLA group had 2 veins completely reopened and 5 partially reopened, which was significantly greater than in the ligation and stripping group. In the 2013 MAGNA trial, 223 consecutive patients (240 legs) with great saphenous vein reflux were randomized to EVLA, ligation and stripping, or foam sclerotherapy.14 At 1-year follow-up, the anatomic success rates were similar between EVLA and stripping (88.5% and 88.2%,respectively), which were superior to foam sclerotherapy (72.2%). Ten percent of the stripping group showed neovascularization. Health-related quality of life improved in all groups. The CEAP classification improved in all groups with no significant difference between the groups. Transient adverse events were reported in 11 patients after stripping, 7 after EVLA, and 5 after sclerotherapy.
Literature on isolated treatment of the anterior accessory saphenous vein is limited. In a 2009 study, outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory saphenous vein were compared with 33 matched controls undergoing EVLA of the greater saphenous vein.15 In 21 of the patients (64%) in the accessory saphenous vein group, there had been no previous treatment of the greater saphenous vein. At 12-month follow-up, there was no evidence of reflux in these patients, and the treated accessory saphenous vein was not visible with ultrasound. The Aberdeen Varicose Vein Symptom Severity Score had improved in both groups, with no significant difference between the 2 groups. Patient satisfaction scores were also similar.
Klem and colleagues reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose veins. (14) The percentage of patients with greater saphenous vein remaining was 44% in the endovenous cryoablation group and 15% in the conventional stripping group. The Aberdeen Varicose Vein Questionnaire also showed better results for conventional stripping (score of 11.7) in comparison with cryoablation (score of 8.0). There were no differences between the groups in Short-Form-36 (SF-36) subscores, and neural damage was the same (12%) in both groups.
Disselhoff and colleagues reported 2 and 5 year outcomes from a randomized trial that compared cryostripping with EVLA. (15, 16) Included were 120 patients with symptomatic uncomplicated varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux. At 10 days after treatment, EVLA had better results than cryostripping with respect to pain score over the first 10 days (2.9 vs. 4.4), resumption of normal activity (75% vs. 45%) and induration (15% vs. 52%). At 2 year follow-up, freedom from recurrent incompetence was observed in 77% of patients after EVLA and 66% of patients after cryostripping (not significantly different). At 5 years, 36.7% of patients were lost to follow-up; freedom from incompetence and neovascularization was found in 62% of patients treated with EVLA and 51% of patients treated with cryostripping (not significantly different). Neovascularization was more common after cryostripping, but incompetent tributaries were more common after EVLA. There was no significant difference between groups in the Venous Clinical Severity Score or Aberdeen Varicose Vein Severity Score at either 2 or 5 years.
In the 2013 MAGNA trial (previously described), 223 consecutive patients (240 legs) with great saphenous vein reflux were randomized to EVLA, ligation and stripping, or physician compounded foam sclerotherapy (1 cc aethoxysclerol 3%: 3 cc air).14 At 1-year follow-up, the anatomic success rate of foam sclerotherapy (72.2%) was inferior to both EVLA and stripping (88.5% and 88.2%, respectively). Twentyone patients in the sclerotherapy group had partial occlusion with reflux, though the clinical complaint was completely relieved. A 2012 study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430 patients.16 Analysis was per protocol. Forty patients (17%) had repeat sclerotherapy. At 2 years, the probability of clinical recurrence was similar in the 2 groups (11.3% sclerotherapy vs 9.0% ligation and stripping), although reflux was significantly more frequent in the sclerotherapy group (35% vs. 21%). Thrombophlebitis occurred in 7.4% of patients after sclerotherapy. There were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and pulmonary emboli) that occurred within 1 week of treatment.
In 2013, Varithena™ microfoam was approved under a new drug application for the treatment of varicose veins. Efficacy data were from 2 randomized, blinded, multicenter studies.17 One evaluated Varithena™ at 0.5%, 1.0%, and 2.0% polidocanol and the second evaluated Varithena™ at 0.5% and 1.0% polidocanol compared with endovenous placebo or a subtherapeutic dose of polidocanol foam. The primary end point was improvement in symptoms at week 8, as measured by the Varicose Vein Symptoms Questionnaire. The improvement in symptoms was greater in the pooled Varithena™ treatment group (p<0.001) and in each of the individual dose-concentration groups compared with vehicle alone. Secondary and tertiary end points (appearance, duplex ultrasound response, quality of life) were also significantly better for the Varithena™ groups compared with controls.
The second study, called VANISH-2, was published in 2014.18 At the 8-week assessment, there was elimination of reflux and/or occlusion of the previously incompetent vein in 85.6% of the combined 0.5% and 1.0% groups, 59.6% of patients in the 0.125% group, and 1.8% of the placebo group. Analysis of data from both studies showed a dose response from 0.5% to 2.0% for improvement in appearance and from 0.5% to 1.0% for Duplex responders. The 1.0% dose of Varithena™ was selected for the FDA approval. Safety analysis found deep vein thrombosis detected by ultrasound in 2.8% of Varithena™-treated patients with 1% of patients having proximal symptomatic thrombi; these were treated with anticoagulants. There was no signal of an increase in neurological adverse events, and there were no adverse cardiac or cardiopulmonary effects following treatment with Varithena™ injectable foam. Rates of occlusion with Varithena™ are similar to those reported for EVLA or stripping. A randomized trial comparing EVLA and stripping with this new preparation of foam sclerotherapy is needed to evaluate its comparative effectiveness. Evaluation out to 5 years is continuing.
Klem et al. reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose veins. (24) The percentage of patients with greater saphenous vein remaining was 44% in the endovenous cryoablation group and 15% in the conventional stripping group. The Aberdeen Varicose Vein Questionnaire also showed better results for conventional stripping (score, 11.7) in comparison with cryoablation (score, 8.0). There were no differences between the groups in SF-36 subscores, and neural damage was the same (12%) in both groups.
Disselhoff et al. reported 2 and 5 year outcomes from a randomized trial that compared cryostripping with EVLA. (25, 26) Included were 120 patients with symptomatic uncomplicated varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux. At 10 days after treatment, EVLA had better results than cryostripping with respect to pain score over the first 10 days (2.9 vs 4.4), resumption of normal activity (75% vs 45%) and induration (15% vs 52%). At 2-year follow-up, freedom from recurrent incompetence was observed in 77% of patients after EVLA and 66% of patients after cryostripping (not significantly different). At 5 years, 36.7% of patients were lost to follow-up; freedom from incompetence and neovascularization was found in 62% of patients treated with EVLA and 51% of patients treated with cryostripping (not significantly different). Neovascularization was more common after cryostripping, but incompetent tributaries were more common after EVLA. There was no significant difference between groups in the Venous Clinical Severity Score or Aberdeen Varicose Vein Severity Score at either 2 or 5 years.
Both steam injection and microwave ablation for endovenous treatment of varicose veins were reported outside of the United States.27-29 These procedures have not been approved or cleared for marketing by FDA.
There are a number of large randomized trials on endovenous ablation of the saphenous veins. Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA. Evidence suggests that ligation and stripping may lead to neovascularization, while thermal ablation may lead to recanalization. Controlled studies with longer follow-up are needed to determine the long-term efficacy of these treatments with greater certainty. Two RCTs suggest that cryotherapy is not as effective as available alternatives. For physician-compounded sclerotherapy, there is high variability in success rates of the procedure and reports of serious adverse events. Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar to those reported for EVLA or stripping.
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the gold standard for the treatment of saphenofemoral incompetence based on improved long-term recurrence rates, with sclerotherapy used primarily as an adjunct to treat varicose tributaries. A 2006 Cochrane Review, based primarily on RCTs from the 1980s, concluded that, “The evidence supports the current place of sclerotherapy in modern clinical practice, which is usually limited to treatment of recurrent varicose veins following surgery and thread veins.” (27) Sclerotherapy and phlebectomy are considered appropriate in the absence of reflux of the saphenous system, e.g., post- or adjunctive treatment to other procedures such as surgery. In 2014, El-Sheikha et al reported a small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for varicose veins.32 Quality of life and clinical severity scores were similar between the groups by 1 year, with 16 of 24 patients (67%) in the sequential phlebectomy group receiving a secondary intervention.
A small proportion of patients may present with tributary varicosities in the absence of saphenous reflux. For example, of 1,009 patients recruited for an RCT, 64 patients were found to have minor varicose veins without reflux, 34 of whom agreed to be randomized to sclerotherapy or conservative treatment. (28) At baseline, 92% had symptoms of heaviness, 69% had cosmetic concerns, 53% reported itching, and 30% reported relief of symptoms through the use of compression hosiery. At 1 year follow-up, there was an improvement in clinicians’ assessment of the anatomical extent of varicose veins, with 85% of patients in the sclerotherapy group improved compared to 29% of patients in the conservative-therapy group. Symptoms of aching were better or eliminated in 69% of the sclerotherapy group and 28% of the group treated with conservative therapy. Cosmetic concerns were improved in 85% of the sclerotherapy patients and 14% of controls.
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of the saphenous vein, as opposed to the varicose tributaries. In 2012, Yamaki et al. reported a prospective randomized controlled trial that compared visual foam sclerotherapy vs. ultrasound-guided foam sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose tributary veins. (29) A total of 51 limbs in 48 patients were treated with ultrasound-guided foam sclerotherapy plus visual foam sclerotherapy of the varicose tributaries, and 52 limbs in 49 patients were treated with foam sclerotherapy alone. At 6-month follow-up, complete occlusion was found in 23 limbs (45.1%) treated with ultrasound-guided and visual-guided foam sclerotherapy and in 22 limbs (42.3%) treated with visual sclerotherapy alone. Reflux was absent in 30 limbs (58.8%) treated with ultrasound and visual guidance and in 37 (71.2%) treated with visual guidance alone (not significantly different). The authors note that for the treatment of tributary veins in clinical practice, most patients receive direct injection of foam without ultrasound guidance.
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery. (30) Results showed a significant advantage of TIPP over the conventional treatment for number of incisions, mean cosmetic score, and duration of the procedure. However, TIPP also increased the incidence of hematoma and resulted in worse mean pain scores. Included in the meta-analysis was a randomized clinical trial by Chetter et al. that compared TIPP (n=29) with a multiple stab incision procedure (n=33). (31) A single surgeon performed all but 2 of the procedures, and there was no difference in operating time. Patients treated with TIPP had an average of 5 incisions, compared with 20 for the multiple stab procedure. However, blinded evaluation revealed that bruising or discoloration was higher for the TIPP group at both 1 and 6 weeks after surgery. At 6 weeks after surgery, patients in the TIPP group showed no improvement in pain (-2 points on the Burford pain scale), while patients in the multiple stab incision group had a significant improvement in pain score compared with presurgical baseline (-20 points). At 6 weeks after surgery, quality-of-life measures had improved in the multiple-stab incision group but not in the TIPP group. Thus, although TIPP had the advantage of fewer surgical incisions, in this single-center study, it was associated with a more prolonged recovery due to more extensive bruising, prolonged pain, and reduced early postoperative quality of life. The current literature does not show an advantage of TIPP over conventional treatment.
Evidence indicates that both sclerotherapy and TIPP are as effective as stab phlebectomy in eliminating varicose tributaries. However, there is limited evidence that TIPP is associated with more pain, bruising, discoloration, and a longer recovery.
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of incompetent perforator vein surgery. (4) These conclusions were based on 4 RCTs published since 2000 that compared superficial vein surgery with conservative therapy in advanced chronic venous insufficiency (CEAP category C5/6). The 4 trials included 2 level I (large subject population) and 2 level II (small subject population) studies. Two of the trials combined surgical treatment of the incompetent perforator veins with concurrent or prior treatment of the superficial saphenous veins; the other 2 treated the greater saphenous vein alone. The 2 randomized studies in which the greater saphenous vein alone was treated (including the ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative therapy. (32, 33) A 2011 community hospital-based multicenter, double-blind, randomized trial found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and incompetent perforators. (34)
Treatment of the great saphenous vein alone has been reported to improve perforator function. For example, one study showed that reversal of perforator vein incompetence (41% of 68 previously incompetent perforators) was more common than new perforator vein incompetence (22% of 183 previously competent perforators) following superficial vein surgery. (35) O’Donnell discusses additional (lower quality) evidence to suggest deep venous valvular involvement rather than incompetent perforators in venous insufficiency. (4) Thus, although incompetence of perforator veins is frequently cited as an important etiologic factor in the pathogenesis of venous ulcer, current evidence does not support the routine ligation or ablation of perforator veins.
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004, Tenbrook and colleagues published a review of the literature of SEPS, which included 19 case series and one randomized trial. (36) In total, the reviewed studies included 1,031 patients with 1,140 treated limbs. The authors concluded that SEPS was associated with excellent results in terms of ulcer healing and prevention of recurrence. However, the authors also noted that randomized trials are required to define the relative contributions of compression therapy, superficial venous surgery, and SEPS in the management of severe venous disease. A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that “Its [SEPS] use should not be employed routinely and could only be justified in patients with persistent ulceration thought to be of venous origin, and in whom any superficial reflux has already been ablated and post-thrombotic changes excluded.” (37) The authors also state that “introduction of less invasive techniques for perforator vein ablation, such as ultrasound-guided sclerotherapy or radiofrequency ablation, may diminish the role of SEPS in the future."
A 2008 review of procedures for management of varicose veins recommends duplex-guided foam sclerotherapy, microincision phlebectomy, or thermal ablation using a new short RF catheter for the treatment of symptomatic residual perforator vein incompetence. (38) Ablation of incompetent perforator veins with laser or RFA had been shown to be technically feasible, although no studies had been identified that showed an improvement in clinical outcomes (e.g., ulcer healing or recurrence). (18-20, 26) The 2011 literature update identified one study of EVLA for perforating veins in 33 patients with a CEAP classification of 4 (skin changes), 5 (healed ulcer), or 6 (active ulcer). (39) All incompetent saphenous trunks were treated simultaneously (63% of limbs). At 3-month follow-up, occlusion was achieved in 78% of the perforating veins. Five patients (15%) had active ulcers at baseline; 4 of the 5 ulcers had healed by 6 weeks after EVLA. Evidence regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited, and there is a risk of deep venous occlusion. (25)
Although randomized, controlled trials with longer follow-up are needed to evaluate long-term durability, and repeat treatments may be required, evidence indicates that endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-term clinical outcomes (e.g., pain and return to work) in comparison with surgery. Ultrasound-guided foam sclerotherapy leads to success rates that approach that of surgery. There are no trials comparing the recently FDA-approved microfoam sclerotherapy with other treatments of varicose veins, although studies comparing microfoam sclerotherpay to placebo showed statistically significant success in the elimination of reflux and/or occlusion of previously incompetent veinsResults from a recent randomized, controlled trial of cryoablation indicate that this therapy is inferior to conventional stripping.
The literature indicates that sclerotherapy of tributaries following occlusion of the saphenofemoral or saphenopopliteal junction and saphenous veins may be considered medically necessary. Evidence is insufficient to evaluate the health benefit of sclerotherapy as a sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous veins. No studies have been identified that compare radiofrequency or laser ablation of tributary veins with standard procedures (microphlebectomy and/or sclerotherapy). Transilluminated powered phlebectomy is effective at removing varicosities; outcomes are comparable to available alternatives such as stab avulsion and hook phlebectomy.
The literature indicates that the routine ligation/ablation of incompetent perforator veins is not medically necessary for the treatment of varicose veins/venous insufficiency at the time of superficial vein procedures. However, when combined superficial vein procedures and compression therapy have failed to improve symptoms (i.e., ulcers), treatment of perforator vein reflux may be as beneficial as any alternative (e.g., deep vein valve replacement). Therefore, treatment of incompetent perforator veins may be considered medically necessary in this specific situation.
Comparative studies are needed to determine the most effective method of ligating/ablating incompetent perforator veins. SEPS has been shown to be as effective as the Linton procedure with a reduction in adverse events. Although only one case series has been identified showing an improvement in health outcomes, endovenous ablation with specialized laser or radiofrequency probes has been shown to effectively ablate incompetent perforator veins with a potential decrease in morbidity in comparison with surgical interventions. For sclerotherapy, concerns have been raised about the risk of deep vein occlusion, and evidence is currently insufficient to evaluate the safety or efficacy of this treatment for incompetent perforator veins.
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum published clinical practice guidelines in 2011. (40) The recommendations are rated as strong=1 or weak=2, based on a level of evidence that is either high quality=A, moderate quality=B, or low quality=C, and include the following:
In 2009, the American College of Radiology published appropriateness criteria for the treatment of lower-extremity venous insufficiency. (41) The following is a summary of treatment options:
In 2003, the Society of Interventional Radiography (SIR) published a position statement (42) that considered endovenous ablation therapy, using either laser or radiofrequency devices under imaging guidance and monitoring, an effective treatment of extremity venous reflux and varicose veins under the following conditions:
In a joint statement published in 2007, the American Venous Forum and SIR recommended reporting standards for endovenous ablation for the treatment of venous insufficiency. (43) The document recommended that reporting in clinical studies should include the symptoms of venous disease, history of disease and prior treatment, the presence of major comorbidities, and any exclusion criteria. It was noted that potential candidates for endovenous ablation may include patients with reflux in an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch of the greater or smaller saphenous veins such as the anterior thigh circumflex vein, posterior thigh circumflex vein, or anterior accessory greater saphenous vein. The presence of reflux in these veins is important to document using duplex ultrasound imaging, and the ultrasound criteria used to define reflux should be indicated. It was also stated that in current practice, most vascular laboratories consider the presence of venous flow reversal for greater than 0.5 to 1.0 second with proximal compression, Valsalva maneuver, or distal compression and release to represent pathologic reflux.
In 2003 and 2004, the U.K.’s National Institute for Health and Clinical Excellence (NICE) published guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of the long saphenous vein. (44, 45) NICE concluded that the evidence on the safety and efficacy appeared adequate to support the use of these procedures provided that the normal arrangements were in place for consent, audit, and clinical governance. The evidence on efficacy at this time was limited to case series with limited follow-up. Clinicians were encouraged to collect longer-term follow up data.
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in 2013.52
The guidance states that:
“1.1 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose veins is adequate. The evidence on safety is adequate, and provided that patients are warned of the small but significant risks of foam embolization (see section 1.2), this procedure may be used with normal arrangements for clinical governance, consent and audit.
1.2 During the consent process, clinicians should inform patients that there are reports of temporary chest tightness, dry cough, headaches and visual disturbance, and rare but significant complications including myocardial infarction, seizures, transient ischaemic attacks and stroke.”
NICE issued guidance on endovenous mechanochemical ablation in 2013, concluding that current evidence on the safety and efficacy of endovenous mechanochemical ablation for varicose veins is inadequate in quantity and quality.53 Therefore this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
In 2013, NICE published practice guideline on the diagnosis and management of varicose veins in the leg.54 NICE recommends a study of the clinical and cost effectiveness of
U.S. Preventive Services Task Force Recommendations
Medicare National Coverage
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.
Single or multiple injections of sclerosing solutions, spider veins (telangiectasia); limb or trunk
Single or multiple injections of sclerosing solutions, spider veins (telangiectasia); face
Injection of sclerosing solution; single vein
Injection of sclerosing solution; multiple veins, same leg
Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated
Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; second and subsequent veins treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)
Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; first vein treated
Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; second and subsequent veins treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)
Vascular endoscopy, surgical, with ligation of perforator veins, subfascial (SEPS)
Ligation and division of long saphenous vein at saphenofemoral junction, or distal interruptions
Ligation, division, and stripping, short saphenous vein
Ligation, division, and stripping, long (greater) saphenous veins from saphenofemoral junction to knee or below
Ligation and division and complete stripping of long and short saphenous veins with radical excision of ulcer and skin graft and/or interruption of communicating veins of lower leg, with excision of deep fascia
Ligation of perforator veins, subfascial, radical (Linton type) including skin graft, when performed, open, 1 leg
Ligation of perforator vein(s), subfascial, open, including ultrasound guidance, when performed, 1 leg
Stab phlebectomy of varicose veins, 1 extremity; 10-20 stab incisions
Stab phlebectomy of varicose veins, 1 extremity; more than 20 stab incisions
Ligation and division of short saphenous vein at saphenopopliteal junction (separate procedure)
Ligation, division, and/or excision of varicose vein cluster(s), one leg
Unlisted procedure, vascular surgery
Ultrasonic guidance for needle placement (e.g., biopsy, aspiration, injection, localization device), imaging supervision and interpretation
Duplex scan of extremity veins including responses to compression and other maneuvers; complete bilateral study
Duplex scan of extremity veins including responses to compression and other maneuvers; unilateral or limited study
Replace policy. Formatting changed to now organize procedures by type of vein. Policy statement extensively revised with additional medically necessary criteria for each procedure. Sclerotherapy now considered medically necessary only for accessory and tributary veins. Policy on hold for provider notification; the effective date is May 19, 2013.
Policy statement clarification. In criteria for sclerotherapy of accessory saphenous veins when not done concurrently with other listed treatments, the moderate to severe saphenous reflux criterion has been removed. To clarify the definition of “symptomatic” for treatment of tributaries not done concurrently with other listed treatments, specific criteria added for stab avulsion, hook phlebectomy, sclerotherapy or transilluminated powered phlebectomy treatment of tributaries. Tributary criterion for moderate to severe saphenous reflux, when not done concurrently with other listed treatments, has been removed.
Minor clarification. Hook phlebectomy clarified to indicate that it is also known as stab phlebectomy or micro-phlebectomy.
Replace policy. CPT codes for sclerotherapy (36468, 36469, 36470, 36471), TIPP (37765 or 37766, stab avulsion (37765, or 37799), etc. added to Policy Guidelines section.
Update Related Policies. Add 10.01.514.
Interim update. Criteria for vein size removed from policy statement. Minor edit to change definition of “moderate to severe reflux” to greater than 0.5 second. Coding update: ICD-9 and ICD-10 diagnosis and procedure codes removed – these are not utilized for adjudication.
Annual Review. Policy updated with literature review through September 23, 2014; reference 8-9, 18, 24 33 added and some references removed; policy statement revised to allow sclerotherapy as medically necessary when criteria are met. Information added regarding FDA approval of Varithena sclerotherapy. Documentation requirements added to Policy Guidelines.
Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).