1. Aetna considers the following procedures medically necessary for treatment of varicose veins when the following criteria are met: varicose vein excision, ligation, radiofrequency endovenous occlusion (VNUS procedure), and endovenous laser ablation of the saphenous vein (ELAS) (also known as endovenous laser treatment (EVLT)).

   1. Incompetence (i.e., reflux) at the saphenofemoral junction
      or saphenopopliteal junction or greater saphenous vein or lesser saphenous vein is documented by Doppler or duplex ultrasound scanning; and 

   2. Saphenous varicosities result in any of the following:

      1. Intractable ulceration secondary to venous stasis; or
      2. More than one episode of minor hemorrhage from a ruptured superficial varicosity; or a single significant hemorrhage from a ruptured superficial varicosity, especially if transfusion of blood is required; or

      3. Saphenous varicosities result in either of the following, and symptoms persist despite a three-month trial of conservative management* (e.g., analgesics, prescription gradient support compression stockings):

         1. Recurrent superficial thrombophlebitis; or

         2. Severe and persistent pain and swelling interfering with activities of daily living and requiring chronic analgesic medication.

         *Note: A trial of conservative management is not required for persons with persistent or recurrent varicosities who have undergone prior endovenous procedures or stripping in the same leg because conservative management is unlikely to be successful in this situation.)

   These procedures are considered cosmetic for all other indications.

   Note: Doppler or duplex ultrasound studies are considered necessary prior to varicose vein treatment to assess the anatomy and to determine whether there is significant reflux at the saphenofemoral junction requiring surgical repair. Ultrasound guidance is also considered medically necessary during the VNUS or ELAS procedures.
   
   Note: The term endovenous catheter ablation (EVCA) is a nonspecific term that refers to the several catheter based minimally invasive alternatives to surgical stripping such as radiofrequency endovenous occlusion (VNUS procedure) and endovenous laser ablation of the saphenous vein (ELAS).  In assessing the medical necessity of EVCA, reference should be made to the specific technique that is being employed.

2. Aetna considers ambulatory phlebectomy or transilluminated powered phlebectomy (TriVex System) medically necessary as adjunctive treatment of varicose veins for members who meet the medical necessity criteria for varicose vein treatment above where any reflux at the saphenofemoral junction has been eliminated by one of the procedures in section I. Ambulatory phlebectomy and the TriVex system is considered cosmetic for all other indications. Note: Transilluminated powered phlebectomy has not been proven to be superior to other methods of varicose vein removal. Therefore, the TriVex procedure should be billed as any other varicose vein removal procedure.

3. Liquid or foam sclerotherapy is considered medically necessary adjunctive treatment of symptomatic small to medium sized veins (< 6 mm diameter) for persons who meet medical necessity criteria for varicose vein treatment in section I above and who are being treated or have been treated by one or more of the procedures noted in section I above. 

   Sclerotherapy is considered experimental and investigational for treatment of the saphenofemoral junction or the saphenous veins because sclerotherapy has not been proven to be effective for treatment of these large veins. Sclerotherapy alone has not been shown to be effective for persons with reflux at the saphenofemoral or saphenopopliteal junctions; under established guidelines, individuals with reflux should also be treated with ligation or division of the junction to reduce the risk of varicose vein recurrence. Sclerotherapy is considered experimental and investigational for all other indications.

   Note: Since ultrasound-monitored or duplex-guided techniques for sclerotherapy have not been shown to definitively increase the effectiveness or safety of this procedure, these tests are only considered medically necessary when initially performed to determine the extent and configuration of varicose veins. Ultrasound or radiologically guided or monitoring techniques are of no proven value when performed solely to guide the needle or introduce the sclerosant into the varicose veins.

   Note: The number of medically necessary sclerotherapy injection sessions varies with the number of anatomical areas that have to be injected, as well as the response to each injection. Usually one to three injections are necessary to obliterate any vessel, and 10 to 40 vessels, or up to 20 injections in each leg, may be treated in any one session. Initially, up to 3 sclerotherapy sessions for both legs are considered medically necessary for members who meet selection criteria. Requests for additional sclerotherapy sessions are subject to medical necessity review.

4. Aetna considers photothermal sclerosis (also referred to as an intense pulsed light source, e.g., the PhotoDerm VascuLight), which is used to treat small veins such as small varicose veins and spider veins, cosmetic because such small veins are cosmetic problems and do not cause pain, bleeding, ulceration, or other medical problems.
   

5. Aetna considers transdermal laser treatment experimental and investigational for the treatment of large varicose veins because it has not been proven in direct comparative studies to be as effective as sclerotherapy and/or ligation and vein stripping in the treatment of the larger varicose veins associated with significant symptoms (pain, ulceration, inflammation).  Note: Although transdermal Nd:YAG laser has been shown to be effective for the treatment of telangiectasias and reticular veins, treatment of these small veins is considered cosmetic.

6. Aetna considers subfascial endoscopic perforator vein surgery (SEPS) medically necessary for the treatment of members with advanced chronic venous insufficiency secondary to primary valvular incompetence of superficial and perforating veins, with or without deep venous incompetence, when conservative management has failed.

   Aetna considers SEPS experimental and investigational for the treatment of members with post-thrombotic syndrome, varicose veins, and other indications because its effectiveness for these indications has not been established.

Varicose veins are a common condition. In adult western populations visible varicose veins are present in 20-25% of women and 10-15% of men.  In most persons, varicose veins do not cause symptoms other than poor cosmesis.  Varicose vein surgery is one of the most commonly performed cosmetic procedures in the United States.

Most varicose veins do not require medical treatment (Tapley, et al., 2003).  In some cases, however, the circulation may be hindered enough to cause swelling of the foot and ankle, discomfort, a tingling sensation, or a feeling of heaviness.  For most people with varicose veins, wearing specially fitted elastic stockings is all that is needed. The stockings should be carefully fitted to the individual, providing the most pressure in the lowest part of the leg.  The stockings should be put on when first arising in the morning, preferably before getting out of bed. Exercise such as walking or cycling also helps promote better circulation from the lower part of the body. Resting with the legs elevated will help promote circulation; in contrast, sitting with the legs crossed can aggravate the condition.

In patients with varicose veins, leg pain may be associated with superficial thrombophlebitis or venous leg ulcers.  In evaluating the role of varicose vein surgery in treatment of these conditions, the effectiveness of varicose vein surgery must be compared to conservative management.

If the patient is suffering from superficial thrombophlebitis, conservative management is indicated.  According to available guidelines, uncomplicated superficial thrombophlebitis is usually treated symptomatically with heat, simple analgesia, non-steroidal anti-inflammatory drugs (NSAIDs), and compression stockings (SCHIN, 2002).  Treatment should continue until symptoms have completely subsided (usually 2-6 weeks to subside but the thrombosed vein may be palpable and tender for months). More severe thrombophlebitis, as indicated by the degree of pain and redness and the extent of abnormality, should be treated by bed rest with elevation of the extremity and application of hot, wet compresses.

Leg ulcers arising from venous problems are called venous (varicose or stasis) ulcers. The main conservative treatment has been to apply a firm compression garment (bandage or stocking) to the lower leg in order to help the blood return back up the leg. Cullum, et al. (2002) recently conducted a meta-analysis of the literature on the effectiveness of compression bandaging and stockings in the treatment of varicose leg ulcers. The authors concluded that compression increases ulcer-healing rates compared with no compression. The authors also found that multi-layered systems are more effective than single-layered systems. High compression is more effective than low compression but there are no clear differences in the effectiveness of different types of high compression. In a meta-analysis, Nelson, et al. (2002) found circumstantial evidence of the benefit of compression in reducing recurrence of varicose ulcers. The authors also noted that recurrence rates may be lower in high compression hosiery than in medium compression hosiery and therefore patients should be offered the strongest compression with which they can comply.

According to a systematic review of the evidence, pentoxifilline has also been shown to be effective for treatment of venous leg ulcers (Nelson, et al., 2002).  According to the systematic evidence review, compression has been shown to prevent venous leg ulcers.  The effectiveness of vein surgery for prevention or treatment of venous ulcers is "unknown" (Nelson, et al., 2002).

Beyond conservative therapy, the treatment of varicose veins in the lower legs includes injection/compression sclerotherapy and surgical stripping or ligation or a combination of these approaches depending upon the severity of the condition. Despite many years of experience, there is still a disappointingly high recurrence rate of varices because many patients are inadequately investigated before treatment. As it has been shown that physical examination alone is unreliable, pre-treatment Doppler or Duplex ultrasound examination must be performed for localization of the sites of incompetence to allow the individualization of the treatment strategy for each patient. Photographs or office diagrams may be helpful in assessing the size and extent of the varices.

Under established guidelines, the basic tenet of successful treatment is to eliminate the primary and secondary sources of the reflux. These sources are usually a nearby perforator, or most often a major junction that causes redirected venous return through veins with intact valves. Sclerotherapy has been found to be more effective in patients with dilated superficial or residual varicose veins, recurrent varicosities or incompetent perforating veins of small to moderate size (< 6 mm) scattered throughout the leg(s). Inadvertent intra-arterial injection has been an untoward sequela of this technique. When reflux at the saphenofemoral and/or saphenopopliteal junctions is present, accepted guidelines provide that sclerotherapy should not be performed until surgical ligation and division of the junction has been done.

Ligation and division of the saphenofemoral and/or saphenopopliteal junction is indicated when reflux is demonstrated by Doppler examination or Duplex scanning. The literature states that operative excision of varicose veins in the leg(s) should be reserved for those that are very large (> 6 mm), extensive in distribution, or occur in large clusters. Stripping of the greater and/or lesser saphenous vein, performed in conjunction with ligation and division of their respective junctions, is indicated when the saphenous veins themselves show varicose changes (usually > 1 cm in diameter). Varicose vein surgery and/or sclerotherapy during pregnancy is not appropriate because dilatation of veins in the legs is physiologic and will revert to normal after delivery, at which time a more accurate appraisal can be made. Visible subcuticular veins (i.e., spider angiomas, and telangiectasias) less than 2 mm in size do not cause symptoms and their treatment is purely cosmetic.

Ambulatory phlebectomy (AP) (also known as microphlebectomy) is a minimally invasive procedure performed under local anesthesia, and is an accepted outpatient therapy for the removal of varicose veins. This treatment allows excision of almost all of the large varicose veins except the proximal long saphenous vein, which is better-managed by stripping. Patients can ambulate immediately after AP. Complications associated with AP include blister formation, localized thrombophlebitis, skin necrosis, hemorrhage, and persistent edema. The use of broad compression pads following AP reduces hemorrhage and enhances resorption.

The TriVex System (transilluminated powered phlebectomy) is an alternative method of providing ambulatory phlebectomy. This entails endoscopic resection and ablation of the superficial veins using an illuminator and a "powered vein rejector", a small powered surgical device. In this procedure, veins are marked with a magic marker. In order to enhance visualization of the veins, a bright light is introduced into the leg through a tiny incision. The powered vein rejector, which has a powered oscillating end, is then introduced to cut and dislodge the veins. The pieces of vein are then gently retrieved by suction down a tube. Transilluminated powered phlebectomy is usually performed in the hospital on an outpatient basis and under general anesthesia or using local anesthesia with sedation.

The manufacturer of the TriVex System states that the unique illumination feature allows the surgeon to quickly and accurately target and remove the vein and then visually confirm its complete extraction. The manufacturer claims that this new process makes varicose vein removal more effective, complete and less traumatic for patients, by reducing the number of incisions required to perform the procedure and the duration of surgery. The manufacturer also claims that this method not only reduces the pain associated with varicose vein removal but also reduces the potential for post-operative infection. There is inadequate evidence, however, in the published peer-reviewed medical literature substantiating these claims. The potential advantages of the TriVex System over standard ambulatory phlebectomy have not been proven. Therefore, the TriVex procedure should be billed as any other varicose vein removal procedure.

The term endovenous catheter ablation (EVCA) has been used to refer to the several new catheter based minimally invasive alternatives to surgical stripping, including laser ablation and radiofrequency ablation.

Endovenous laser ablation of saphenous vein (ELAS) is a treatment alternative to surgical ligation and stripping of the greater saphenous vein. A small laser fiber is inserted percutaneously into the damaged vein. Pulses of laser light are emitted inside the vein, and the vein collapses, and seals shut. This procedure may be performed in the office under local anesthesia. A bandage or compression hose is placed on the treated leg following the treatment.  The procedure is performed on an outpatient basis.  Short and mid-term follow up of up to 37 months has shown that vein occlusion persists and patient symptoms are markedly reduced following ELAS treatment.

Endoluminal radiofrequency thermal heating (VNUS Closure Procedure) has been used with or without ligation and division for treatment of incompetence of the saphenofemoral junction and varicosities of the greater saphenous vein. A radiofrequency catheter is inserted into the lumen of the greater saphenous vein, starting at its junction with the femoral vein. Under some protocols, the placement of the catheter is guided by duplex ultrasonography. The radiofrequency catheter heats the inner lumen of the vein to 85°C, with subsequent scarring and closure of the treated vein. The procedure is performed in an office setting without general anesthesia; treatment time averages 20 minutes. Adverse sequelae include purpura, erythema and pain, which generally resolve days or weeks after treatment, and indurated fibrous cords that may remain for several months. Prospective case series extending to 24 months have shown success rates similar to those reported for vein ligation and stripping. Weiss and Weiss (2002) reported complete disappearance of the treated saphenous vein in 90% of 21 patients followed for 24 months. Endothermal radiofrequency thermal heating may be performed with or without high ligation of the greater saphenous vein. Chandler, et al. (2000) found no statistically significant difference in 1-year success rates from endovenous radiofrequency catheter ablation in 120 limbs treated without saphenofemoral ligation and 60 limbs treated with saphenofemoral ligation. The authors concluded that "these early results suggest that extended SFJ ligation may add little to effective GSV [greater saphenous vein] obliteration, but our findings are not sufficiently robust to warrant abandonment of SFJ ligation as currently practiced in the management of primary varicose veins associated with GSV reflux."

Doppler ultrasound is often used in conjunction with other non-invasive physiologic testing to characterize the anatomy and physiology of the varicose vein network prior to injection or surgical intervention. However, duplex scans are also sometimes utilized during the sclerotherapy procedure itself. Their purported usefulness in this regard includes the localization of deep or inaccessible injection sites, such as when there are extensive networks of large deep varicosities, areas of significant reflux between superficial and deep systems, or risks to arterial structures. Ultrasound has also been used to monitor the effectiveness of compressive sclerotherapy in obliterating the lumen of the target vein and reducing reflux/retrograde flow. However, these indications have not been scientifically validated. There is little evidence, in the form of randomized prospective clinical trials, to support that ultrasound makes a significant difference in optimizing outcome or decreasing complications, from sclerotherapy for varicose veins, when compared to non-ultrasound-guided techniques.  A structured evidence review conducted by the Alberta Heritage Foundation for Medical Research (AHFMR) (2003) concluded that “the reviewed evidence does not adequately address the questions; which sclerosant is superior and which technique with or without ultrasound guidance is most efficacious.”

The Society for Interventional Radiologists (2003) has a position statement on VNUS that states that “[d]uplex ultrasound is necessary to map the anatomy of the venous system prior to the procedure, and imperative during the procedure for correct catheter placement and for proper tumescent anesthetic administration to minimize potential complications. Duplex ultrasound also is necessary for follow-up after endovenous ablation.”

Sadick (2000) has noted that the new less-invasive technologies for treatment of varicose veins must be evaluated with caution. "Long-term studies with other technologies must be compared with surgical ligation of the incompetent SFJ [saphenofemoral junction]. Six-month and 5-year follow-ups are two different end points. The latter is a more accurate time interval of therapeutic efficacy."

Subfascial endoscopic perforator vein surgery (SEPS) is a minimally invasive endoscopic procedure that eliminates the need for a large incision in the leg.  It has been explored as an alternative to the traditional open surgical treatment of chronic venous insufficiency.  The aim of the procedure is to interrupt incompetent medial calf perforating veins to reduce venous reflux and decrease ambulatory venous hypertension in critical areas above the ankle where venous ulcers most frequently develop.  Kalra and Gloviczki (2002) stated that available evidence confirmed the superiority of SEPS over open perforator ligation, but do not address its role in the surgical treatment of advanced chronic venous insufficiency (CVI) and venous ulceration.  Ablation of superficial reflux by high ligation and stripping of the greater saphenous vein with avulsion of branch varicosities is concomitantly performed in the majority of patients undergoing SEPS.  The clinical and hemodynamic improvements attributable to SEPS thus are difficult to ascertain.  As with open perforator ligation, clinical and hemodynamic results are better in patients with primary valvular incompetence (PVI) than in those with the post-thrombotic (PT) syndrome.  Until prospective, randomized, multicenter clinical studies are performed to address lingering questions regarding the effectiveness of SEPS, the procedure is recommended in patients with advanced CVI secondary to PVI of superficial and perforating veins, with or without deep venous incompetence. The performance of SEPS in patients with PT syndrome remains controversial.

Contraindications for SEPS include associated arterial occlusive disease, infected ulcer, a non-ambulatory patient, and a medically high-risk patient.  Diabetes, renal failure, liver failure, morbid obesity, ulcers in patients with rheumatoid arthritis, or scleroderma, and presence of deep vein obstruction at the level of the popliteal vein or higher on pre-operative imaging are relative contraindications.  Patients with extensive skin changes, circumferential large ulcers, recent deep vein thrombosis, severe lymphedema, or large legs may not be suitable candidates (Kalra and Gloviczki, 2002).

McDonagh, et al. (2002, 2003) has reported on the effectiveness of ultrasound-guided foam sclerotherapy (comprehensive objective mapping, precise image-guided injection, antireflux positioning and sequential sclerotherapy (COMPASS) technique) in the treatment persons with varicosities of the greater saphenous vein with saphenous vein reflux.  Published studies of the COMPASS technique involve relatively short-term follow up.  Study subjects were followed for three years, and for only two years after completion of a series of repeat sclerotherapy injections that were administered over one year.  In addition, these studies do not include a comparable group of subjects treated with surgery, which has been the primary method of treating incompetent long saphenous veins.  Thus, it is not possible to reach definitive conclusions about the durability of results of the COMPASS technique or its effectiveness compared with surgery for treatment of greater saphenous vein varicosities and saphenofemoral incompetence.   In addition, published studies of the COMPASS technique come from a single group of investigators.  In reviewing the study by McDonagh (2002), Allegra (2003) commented: “Surgical treatment has a long history with 5-20 year follow-ups being routine.  The 3 year follow-up in the present study is certainly not comparable …. This study does not answer questions raised against ultrasound guided sclerotherapy.  It would be important to have the relevant aspects of this study duplicated, reproduced, and verified.”

Published long-term randomized controlled clinical studies have demonstrated that surgery plus sclerotherapy is more effective than surgery alone for treatment of varicosities associated with incompetence of the saphenofemoral junction.  Belcaro, et al. (2003) reported on the results from the Venous Disease International Control (VEDICO) trial, the first long-term randomized controlled clinical trial of foam sclerotherapy.  The VEDICO trial involved 749 patients with varicose veins and saphenous vein incompetence who were randomly treated by six different approaches: standard sclerotherapy, high-dose sclerotherapy, surgical ligation, stab avulsion, foam sclerotherapy, and combined surgery (ligation or stab avulsion) and high dose sclerotherapy.   At 10 years, the occurrence of new veins was 56% for standard sclerotherapy, 51% for foam sclerotherapy, 49% for high-dose sclerotherapy, 41% for stab avulsion, 38% for ligation, and 27% for combined surgery and sclerotherapy. 

Belcaro, et al. (2000) reported on the results of a randomized controlled clinical study comparing ultrasound-guided sclerotherapy with surgery alone or surgery combined with sclerotherapy in 96 patients with varicose veins and superficial venous incompetence.  Although all approaches were reported to be effective in controlling the progression of venous incompetence, surgery appeared to be the most effective method on a long-term basis, and that surgery combined with sclerotherapy may be more effective than surgery alone.  After 10 years follow up, no incompetence of the saphenofemoral junction was observed in both groups assigned to surgery, compared to 18.8 percent of limbs of subjects assigned to ultrasound-guided sclerotherapy.  Of limbs treated with ultrasound-guided sclerotherapy, 43.8% of the distal venous systems were incompetent, compared to 36% of limbs of subjects treated with surgery alone, and 16.1% of limbs of subjects treated with surgery plus sclerotherapy.  

The L'Agence Nationale d' Accreditation et d'Evaluation en Sante (l'ANAES) (Grange, et al., 1998) conducted a systematic review of the literature on the indications of surgery for varicose veins of the legs.  Given the lack of good scientific evidence on the various treatments for primary varicose veins, the working group made recommendations based on professional agreement.  They concluded that surgery is the treatment of choice for saphenous veins with reflux.  An evidence review of surgical treatments for deep venous incompetence by the Alberta Heritage Foundation for Medical Research (Scott & Corabain, 2003) stated that "[s]clerotherapy is particularly effective in superficial venous incompetence when there is a large vein located in close proximity to the ulcer. However, surgery is indicated when there is substantial proximal incompetence in a saphenous vein."

A comprehensive evidence review of sclerotherapy for varicose veins conducted by the Alberta Heritage Foundation for Medical Research (2003) concluded that "the reviewed evidence does not adequately address the questions; which sclerosant is superior and which technique with or without ultrasound guidance is most efficacious … In recent years, new methods such as ES [endovascular sclerotherapy] and foam sclerotherapy (using ultrasound guidance) have been developed and proposed to improve the safety and efficacy of sclerotherapy for various types of varicose veins.  Evidence about these new techniques for treating patients with incompetence of the long saphenous vein is limited."   The assessment concluded that although "[s]clerotherapy appears to be the treatment of choice for reticular varicosities, telangiectasia and other small, unsightly blood vessels … [t]he place of sclerotherapy as the first treatment for larger varicose veins (saphenous or non-saphenous) remains controversial."

Jia and colleagues (2007) evaluated the safety and effectiveness of foam sclerotherapy for varicose veins.  The authors concluded that serious adverse events associated with foam sclerotherapy are rare.  However, there is insufficient evidence to allow a meaningful comparison of the effectiveness of this treatment with that of other minimally invasive therapies or surgery.  Kendler and associates (2007) noted that "[r]ecently the use of foam sclerotherapy had a renaissance.  Several studies have documented the efficacy of foam sclerotherapy in selected patients.  The possibility of treating patients in an outpatient setting, with low costs and rapidly, makes foam sclerotherapy very attractive compared to invasive and minimally invasive methods.  However long-term follow-ups in properly controlled randomized trials are needed before foam sclerotherapy can be recommended as a routine procedure".