|Subject:||Treatment of Varicose Veins (Lower Extremities)|
|Policy #:||SURG.00037||Current Effective Date:||10/08/2013|
|Status:||Revised||Last Review Date:||08/08/2013|
This document addresses various modalities (listed below) for the treatment of valvular incompetence (i.e., reflux) of the greater or lesser saphenous veins and associated varicose tributaries as well as telangiectatic dermal veins.
Cosmetic: In this document, procedures are considered cosmetic when intended to change a physical appearance that would be considered within normal human anatomic variation. Cosmetic services are often described as those that are primarily intended to preserve or improve appearance.
Not Medically Necessary:
Endoluminal radiofrequency ablation, endoluminal laser ablation, sclerotherapy and echosclerotherapy are each considered not medically necessary when the above criteria are not met.
Investigational and Not Medically Necessary:
Note: COMPASS is an acronym for Comprehensive Objective Mapping, Precise Image-guided Injection, Antireflux Positioning and Sequential Sclerotherapy.
* Sole refers to sclerotherapy without concomitant or prior ligation [with or without vein stripping], or endoluminal radiofrequency ablation, or endoluminal laser ablation for valvular incompetence of the greater or lesser saphenous veins
Cosmetic and Not Medically Necessary:
Treatment using sclerotherapy or various laser treatments (including tunable dye or pulsed dye laser, e.g., PhotoDerm®, VeinLase™, Vasculite™) of the telangiectatic dermal veins (e.g. reticular, capillary, venule), which may be described as "spider veins" or "broken blood vessels" is considered cosmetic and not medically necessary.
In 2011, Gloviczki and colleagues released clinical practice guidelines for the Society for Vascular Surgery and the American Venous Forum. The authors summarized available venous research related to the care of individuals with varicose veins and associated chronic venous diseases, and graded it by quality of data and relevance. Recommendations were based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system as strong (GRADE 1) if the benefits clearly outweighed the risks, burden, and costs and (GRADE 2) if the benefits closely balanced with risks and burden. The level of available evidence to support the evaluation or treatment was stated to be of high (A), medium (B), or low or very low (C) quality. Key recommendations included:
These guidelines do not address treating symptomatic tributaries or perforators when GSV/LSV is not diseased. Also, of note, treatment of perforators is only supported if associated with an ulcer.
Endovenous Thermal Ablation (EVTA):
Gloviczki and colleagues (2011) addressed endovenous thermal ablation (laser and radiofrequency) as a safe and effective procedure for the treatment of saphenous incompetence. These ablative procedures are associated with less pain and morbidity than open surgery. Sclerotherapy is recommended for treatment for telangiectasia, reticular veins and varicose veins. Endovenous thermal ablation is recommended over sclerotherapy for treatment of an incompetent saphenous vein.
Khilnani and colleagues (2010) address the use of EVTA for perforator and surface varicose veins in guidelines from a multi-society consensus:
The use of EVTA to close incompetent perforating veins has been described. At this point, the indications and contraindications for use as well as the success rates and safety of this approach have only recently begun to be evaluated. The use of EVTA to directly close surface varicose veins is not encouraged. These veins are usually too tortuous for current generation devices to pass through. Also, these veins are very superficial; EVTA of such veins carries a high risk of thermal skin injury.
In a joint statement, the American Venous Forum (AVM) and the Society of Interventional Radiology (SIR) addressed the research of endovenous ablation (EVA) as an alternative to GSV stripping for reflux disease:
This document provides recommended reporting standards for physicians performing clinical research studies evaluating EVA in the treatment of lower extremity venous reflux and is thereby expected to facilitate comparison between the results of different studies and to improve the overall quality of clinical research on venous disease (Kundu, 2007).
Endoluminal radiofrequency (RF) ablation (thermal heating):
The VNUS ClosureSystem (VNUS Medical Technologies, Inc., San Jose, CA) received U.S Food and Drug Administration (FDA) 510k clearance in 1999. VNUS has been evaluated as an alternative to vein ligation and stripping or stripping alone, for the treatment of saphenofemoral or saphenopopliteal junction incompetence and saphenous vein reflux. Endoluminal RF ablation of the saphenous vein is based on the principle of treating reflux disease by control of the point of reflux and isolation of the refluxing saphenous vein from circulation. The current evidence suggests that this procedure has success rates similar to those reported for surgical ligation and stripping with less postoperative pain and faster postoperative recovery. The use of this procedure outside the criteria specified in the position statement criteria has not been adequately evaluated to allow conclusions regarding efficacy (Lurie, 2005; Rautio, 2002). The VNUS Closure System is currently known as the Venefit™ Procedure.
Endovenous/Endoluminal laser ablation:
Venacure EVLT (Angiodynamics, Inc., Latham, NY) received FDA 510k clearance in 2002. EVLT of the greater saphenous vein has been studied in two large-scale case series studies and several smaller case series studies. These studies demonstrate lower relapse rates when compared to ligation and stripping, as well as comparable symptom relief and complication rates similar to endoluminal radiofrequency ablation. With respect to long-term outcomes and head-to-head comparison to other therapies, including ligation and stripping or RF ablation, the data is not adequate to make sufficient comparisons. The use of this procedure outside the criteria specified in the position statement criteria has not been adequately evaluated to allow conclusions regarding efficacy (Darwood, 2008; Min, 2003; Rasmussen, 2007).
In a meta analysis, van den Bos and colleagues (2009) reported that the literature supported minimally invasive interventions in the treatment of lower extremity varicosities despite the lack of large controlled studies. However, comparing the outcomes of RF and laser ablation of the GSV and LSV in the literature showed that laser ablation was more effective than RF ablation. They also stated that larger controlled studies are necessary to validate the clinical efficacy of RF and laser procedures.
RF or laser ablation for veins other than the saphenous veins (e.g. anterolateral thigh, anterior accessory saphenous and Giacomini veins) has been proposed. Peden and colleagues (2007) and Elias and colleagues (2007) addressed the feasibility of endoluminal radiofrequency and endovenous laser ablation for refluxing perforator veins. They concluded that clinical studies are needed to validate these treatment techniques. Van den Bos and colleagues (2009) reported on RF ablation of 14 incompetent perforator veins in 12 individuals. At three months, nine (64%) of the 14 perforators treated were obliterated on ultrasound examination and the other five showed remaining reflux. The authors found that while RF ablation of perforator veins may be a promising procedure, further standardization of the procedure is required as well as comparative clinical trials between RF ablation and standard therapies. In a small study, Bush and colleagues (2007) reported laser and sclerotherapy ablation of the Giacomini vein in fourteen individuals. The ablations were successful and without complications. No recanalization occurred during a 2-4 year follow-up.
Endovenous laser ablation has been considered for treatment of refluxing saphenous tributaries. This was addressed in one small study of 18 participants (Bush, 2007) and a case report of two individuals (Theivacumar, 2007).
Theivacumar and colleagues (2009) proposed treating sapheno-femoral reflux and preserving the GSV by laser ablation of the anterior accessory great saphenous vein (AAGSV) in those with isolated sapheno-femoral junction (SFJ)/AAGSV reflux. They studied 66 individuals with SFJ reflux treated with EVLT, which included GSV ablation with 33 matched individuals with (SFJ)/AAGSV reflux treated with EVLT of the AAGSV. This feasibility study showed successful laser ablation of the AAGSV when the vein was relatively straight, at least 10 cm. long, greater than or equal to 3 mm. in diameter and free of varicosities within the treatment length. Both groups had similar outcomes e.g. sclerotherapy for residual varicosities. Doppler ultrasound (DUS) was performed at 6, 12 and 52 weeks to assess SFJ and tributary competence and ablation of the axial vein. Absence of flow in a noncompressible vein or a non-visible axial (GSV or AAGSV) vein on ultrasound represented successful ablation. The AAGSV was not visible in those treated for SFJ/AAGSV reflux. The authors pointed out that isolated SFJ/AAGSV reflux occurs in only 10% of those with reflux. In conventional surgery, many surgeons strip a competent GSV because of the possibility of neovascularization after SFJ ligation may promote GSV reflux and recurrence. The authors further stated that selective ablation of incompetent axial veins preserves a healthy GSV for other coronary or vascular procedures, if needed. They concluded that this procedure requires randomized controlled studies and long-term outcome follow-up.
Nesbitt and colleagues (2011) published a Cochrane review of randomized controlled trials (RCT) to determine any advantages or disadvantages of endovenous ablation (radiofrequency and laser) with foam sclerotherapy compared to conventional surgical, saphenofemoral junction ligation and stripping of great saphenous vein varices. Primary outcomes included:
The authors reviewed thirteen reports from five studies that met inclusion criteria with a combined total of 450 subjects. Their findings indicated that early recurrence and recanalisation of GSV varices appears to be similar whether treated by conventional surgery or endovenous ablation and the risk of recanalisation in the ablation group appears to increase with time post-ablation. Further, they found that neovascularisation can occur with both ablation and surgical procedures, however the risk was reduced following endovenous ablation compared with conventional surgery, but the trend was not statistically significant. There appear to be no differences in satisfaction and quality of life measures between endovenous and conventional treatments, however the return to normal activities and work may be sooner following RFA compared with conventional surgery. These findings were based upon the 3-year follow up of the studies reviewed.
Rasmussen and colleagues (2011) reported a randomized controlled trial (RCT) of 500 subjects comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous veins (GSV). The primary outcome was failure rate at one year. Significantly more GSVs were open and refluxing at 1 year in the ultrasound guided foam sclerotherapy (UGFS) group than in the other groups (P less than 0.001). There was no statistically significant difference in patent GSVs in the three other groups (P = 0.543).
Klem and colleagues reported a randomized trial in 2009 that found endoluminal cryoablation (n = 249) to be inferior to conventional stripping (n = 245) for treating individuals with symptomatic varicose veins. The percentage of individuals with great saphenous vein remaining was 44% in the endoluminal 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 SF-36 subscores, and neural damage was the same (12%) in both groups.
Elias and colleagues (2012) described an industry-sponsored safety and efficacy study of the ClariVein® system. Thirty greater saphenous veins in 29 subjects were treated with this device. Greater saphenous veins with diameters greater than 12 mm were excluded. A total of 77% of veins were CEAP Class 2 with 7% in Class 3 (varicose veins and edema) and 16% in class 4a (varicose veins with skin changes). At six-months follow-up one vein had recanalized, for a primary closure rate of 96.7%. No pain during the procedure or adverse events were reported. Controlled studies with longer follow-up are needed.
There is sufficient evidence in the peer-reviewed medical literature to support the use of sclerotherapy when used adjunctively for the treatment of symptomatic varicose tributaries when done either at the same time as surgical ligation and stripping, endoluminal radiofrequency ablation, or endoluminal laser ablation of the saphenous vein or for the treatment of residual or recurrent symptomatic varicose tributaries following the above procedures (Tisi, 2006).
Sclerotherapy as the sole treatment of symptomatic varicose tributaries of the greater saphenous vein is not indicated in the presence of saphenofemoral or saphenopopliteal junctional reflux. The published studies indicate that such treatment, without definitive treatment of valvular incompetence (i.e., reflux) of the saphenous veins with stripping and ligation or other surgical treatments (e.g., endoluminal radiofrequency ablation, or endoluminal laser ablation), provides little long-term benefit and leads to high recurrence rates. Individuals who undergo definitive treatment as well as adjunctive sclerotherapy of the varicose tributaries have shown better long-term results, lower rates of recurrence, and better quality of life scores.
The overwhelming majority of varicosities of the saphenous tributaries are related to co-existing valvular incompetence (i.e. reflux) of the greater or lesser saphenous veins. However, a small subset of individuals may be symptomatic in the absence of underlying reflux. Sclerotherapy as a sole therapy has been proposed for these individuals. However, a literature search identified only one controlled study of this group. In this randomized study of 25 individuals, those receiving sclerosant reported a higher obliteration rate compared to those receiving normal saline at a 12-week follow-up. The study does not address the key issue of long-term symptom resolution (Kahle, 2004).
Sclerotherapy directed at the underlying refluxing saphenous veins (as opposed to the visible varicosities of the tributary veins) requires ultrasound guidance. This procedure may be referred to as echosclerotherapy or ultrasound-guided sclerotherapy. Controlled studies have shown that sclerotherapy/echosclerotherapy of the underlying refluxing greater or lesser saphenous veins is associated with a higher rate of recurrence compared to the gold standard of ligation and stripping. Additionally, sclerotherapy of the saphenous vein raises issues regarding both the appropriate volume and concentration of the sclerosant and the ability to provide adequate post-procedure compression (Belcaro, 2003).
The COMPASS procedure represents a distinct sclerotherapy protocol for the treatment of valvular incompetence (i.e. reflux) of the greater or lesser saphenous veins. COMPASS is an acronym for Comprehensive Objective Mapping, Precise Image-guided Injection (i.e., echosclerotherapy), Antireflux Positioning and Sequential Sclerotherapy. The literature in support of this technique, in particular the study published by Belcaro and colleagues (2003), suffers from flaws in design, including a failure to address specific information in regard to participant selection criteria, no description of the randomization process, and a failure to randomize against standard surgical treatment consisting of vein stripping and ligation. In addition, one of the surgical reference arms was not a part of the randomization process but was actually a retrospective historical control group, limiting its ability to be adequately compared to the rest of the prospective data collected. Additionally, the re-treatment as a result of ongoing ultrasound monitoring is regarded as a continuation of the initial therapy in the COMPASS protocol, thus eliminating the consideration that such occurrences represent recurrences or treatment failures. This aspect of the COMPASS protocol may be responsible for the low "recurrence rate" being reported in the published studies. With the COMPASS protocol, individuals are viewed as being in the latter "phases" of therapy for prolonged periods of time. Some reports indicate that individuals have received therapy in excess of one year. This is in contrast to alternative treatment methods, including standard surgical techniques, laser ablation or radiofrequency ablation procedures that report completion of treatment within a week to 10 days.
PhotoDerm, VeinLase, and Vasculite are laser devices primarily used in treating telangiectatic and reticular veins and other skin related applications. There is no compelling evidence that these conditions have any significantly negative health impact and as such fail to meet the criteria for medical necessity. However, there is adequate evidence that these treatment methods do significantly decrease the appearance of these superficial veins. Therefore, these techniques are considered cosmetic in nature.
Compression therapy is the basic and most frequently used treatment of varicose veins of the lower extremities. Compression is recommended to decrease ambulatory venous hypertension to those with CVD in addition to lifestyle modifications that include weight loss, exercise, and elevation of the legs during the day whenever possible (Gloviczki, 2011). However, controversy does exist surrounding the need for a period of conservative treatment prior to any intervention for simple varicose veins. Michaels and colleagues (2006) reported on a randomized trial performed at two large UK hospitals which compared surgery with conservative treatment for uncomplicated varicose veins. A total of 246 subjects were recruited from 536 consecutive referrals to vascular outpatient clinics with uncomplicated varicose veins suitable for surgical treatment. Conservative treatment consisted of lifestyle advice relating to exercise, management of weight and diet, leg elevation, and the use of compression hosiery. In the surgical arm of the study, subjects received the same lifestyle advice but also underwent surgical treatment. The primary outcome of the study was clinical effectiveness at one year, as measured by a quality of life questionnaire. There were significant losses to follow-up reported due to individuals failing to attend or withdrawing from the trial (21 of 122 following conservative treatment and 43 of 124 after surgery). The authors reported quality of life benefit from surgery at two years' post treatment and benefits were also reported in symptomatic and anatomical measures. Limitations of this study included not only the high loss to follow-up, but also the fact that many subjects declined randomization, or withdrew from the conservative treatment group in order to undergo surgical treatment to cosmetically improve their varicose veins. This was the first randomized trial comparing surgery with conservative treatment for varicose veins and additional study appears to be warranted.
Duplicate greater saphenous vein (GSV)
True duplicate GSV systems have been reported, however this is an uncommon occurrence. The duplicate GSV system will lie in the same plane, parallel to the skin, and run along the aponeurotic deep fascia. These two GSVs will also have the same diameter draining a common cutaneous territory. An anterior accessory vein (AASV) is often mistaken for a duplication of the GSV, but the AASV is usually smaller and does not drain the same cutaneous territory as the GSV. A true duplicate GSV is not an accessory vein and should be treated as any other GSV.
Veins carry deoxygenated and nutrient depleted blood back to the heart and lungs. The veins located in the legs must work against gravity to move the blood upward toward the heart and lungs. The vascular system in the legs consists of the superficial and deep veins. The superficial veins lie on top of the muscles of the leg and include the GSV and the lesser saphenous vein (LSV) and their associated tributaries. The deep veins lie deep within the muscle compartments and generally parallel their associated arteries. The deep veins include the tibial, popliteal and femoral veins. The superficial and deep veins run vertically within the leg and are connected by perforator veins in a ladder like pattern. One-way valves are present in all the leg veins. These valves act against gravity to prevent the blood from flowing backwards (refluxing) to the legs instead of flowing towards the heart and lungs (Cavezzi, 2007). Reflux of blood back into the vein causes dilation of the vessel, restriction of adequate blood flow to portions of the leg, and in some cases, discomfort or pain. Varicose veins are found most often on the back of the calf or on the inside of the leg between the groin and ankle. The most common valvular failures occur at the saphenofemoral junction (groin) between the GSV and the common femoral vein or at the saphenopopliteal junction (knee) between the LSV and the popliteal vein. Venous anatomy can vary significantly between individuals by the absence or presence of accessory and tributary veins. The following are some examples and locations (GSV or LSV) of these veins:
An imaging technique called ultrasound or duplex scanning can be used to identify whether venous reflux is in the superficial, deep or perforating veins. It also can help determine whether reflux is confined to veins above or below the knee. This information is important in diagnosing the cause of this condition and in the planning of treatment.
The venous severity score is used for the assessment of clinical outcomes after therapy for varicose veins and more advanced chronic venous disease. Nine clinical characteristics of chronic venous disease are graded from 0 to 3 (absent, mild, moderate, severe) with specific criteria to avoid overlap or arbitrary scoring.
Some form of venous disorder affects approximately 80 million Americans and varicose veins are present in about 30% of women and 10 to 20% of men. Often, varicose veins present as a cosmetic concern but they may cause symptoms such as cramping, throbbing, burning, swelling, feeling of heaviness or fatigue, and may interfere with activities of daily living. There is frequent confusion between varicose veins and "spider veins," which are small blue or red veins at the surface of the skin. Spider veins, also known as telangiectatic dermal veins, spider nevi, or broken blood vessels, while potentially unattractive, are not associated with any physical symptoms and are a benign condition.
Treatment for symptomatic varicose veins includes conservative measures such as frequent elevation of affected leg(s), walking, weight reduction and avoidance of prolonged sitting, analgesics and the use of compression stockings. The key to treatment of varicose veins is prevention of reflux in the short and long saphenous veins that connect to the major veins in the hip and pelvic area (femoral veins), a condition referred to as saphenofemoral reflux. When this non-invasive approach fails to relieve symptoms, several invasive options exist, as described below.
Surgical ligation and stripping
The traditional therapy for venous reflux in the saphenous vein is surgical ligation and stripping. This begins with an incision in the groin region to expose the saphenous vein. The surgeon then ligates (ties off) the saphenous vein and small veins in the area. A second incision is made either just below the knee or at the ankle for the same purpose. Once both ends of the vein are free, a wire-like instrument is threaded through the vein from the groin to the second incision and secured to the vein. The vein is then pulled out (or "stripped") and removed from the leg.
Also known as ambulatory phlebectomy or stab avulsion, microphlebectomy is a technique to remove varicose veins. In this procedure, several tiny incisions are made in the skin through which the varicose vein is removed. This technique is best suited for tortuous varicosities where passage of a probe or catheter cannot be accomplished.
Hook phlebectomy, also known as avulsion phlebectomy or small incision avulsion, is a surgical procedure performed alone or together with vein stripping. During avulsion phlebectomy, the surgeon makes a series of tiny incisions in the leg to remove varicose veins with a hook. Historically, hook phlebectomy has been performed as a blind procedure involving multiple incisions.
Subfascial endoscopic perforating vein surgery (SEPS)
SEPS is a minimally invasive surgical technique used to treat chronic venous ulcers caused by incompetent perforating veins due to chronic venous insufficiency. Prior to SEPS, the perforator veins were treated via an open surgical technique however, the open surgical approach had significant complication rates, including poor healing of incisions in ulcerated skin. Once the affected perforators are identified by imaging, the target veins are accessed percutaneously by instruments used to separate the connective tissue (fascia) from the incompetent perforator and ligation is accomplished by clip or cautery.
Trans-Illuminated Powered Phlebectomy (TIPP):
This technique uses the TRIVEX™ System. Through a small incision, a fiber optic illuminator is positioned by the varicose vein. A resector with a rotating blade is then guided through the skin next to the vein. Suction draws the vein into the tip of the vein resector. The vein fragments are removed by suction.
Endoluminal radiofrequency ablation (VNUS Closure or Venefit™ Procedure) System:
Also known as radiofrequency endovenous occlusion, endoluminal radiofrequency ablation is typically performed by using a thin catheter inserted into the saphenous vein through a small opening in the skin. Radiofrequency energy is then delivered through the end of the catheter to heat the saphenous vein wall, causing it to collapse, scar and seal shut. The U.S. Food and Drug Administration (FDA) approved modifications to this device to include use in vessel and tissue coagulation, including treatment of incompetent (i.e., refluxing) perforator and tributary veins (FDA, 2006). However, there is a lack of clinical evidence that demonstrates clinical efficacy for vessels other than the saphenous vein.
Endovenous Laser Treatment (EVLT):
Endovenous laser ablation of the saphenous vein utilizes a small laser fiber that is inserted through a small incision in the skin into the vein. Pulses of laser light are emitted inside the vein, heating the vein wall causing it to collapse, scar and seal shut. A bandage or compression hose is placed on the treated leg following the treatment.
Sclerotherapy of varicose tributaries may be used adjunctively with stripping and ligation, radiofrequency ablation or endovenous laser ablation of the greater saphenous vein and this procedure is typically performed in a physician's office. During this procedure, a chemical known as a sclerosing agent, typically a 0.5%-3% solution of sodium tetradecyl sulfate (STS), is injected into the vein to collapse its walls so it can no longer transport blood. Following the procedure, pressure is applied to the vein through padding and compression stockings worn for 7 to 10 days. This continuous pressure allows a scar to form between the two walls of the vein preventing the further development of varicosities. Response to each injection can vary and it may require more than one injection to obliterate any vessel.
Echosclerotherapy is a term used to describe ultrasound-guided sclerotherapy where the veins are injected under direct ultrasound visualization.
A variation of ultrasound-guided sclerotherapy, Comprehensive Objective Mapping, Precise Image-guided Injection, Antireflux Positioning and Sequential Sclerotherapy; also known as the COMPASS protocol, has also been proposed as a treatment for varicose veins. This therapy proposes the use of ultrasound-guided sclerotherapy followed by multiple diagnostic ultrasound imaging procedures and sclerotherapy treatments for the treatment of subsequent varicose veins. This therapy may involve several weeks or months of treatment.
Endovenous mechanochemical ablation utilizes both sclerotherapy and mechanical damage to the lumen. Following ultrasound imaging, a disposable catheter with a motor drive is inserted into the distal end of the target vein and advanced to the saphenofemoral junction. As the catheter is pulled back, a wire rotates within the lumen of the vein. At the same time, a liquid sclerosant (sodium tetradecyl sulfate) is infused near the rotating wire. It is proposed that mechanical ablation allows for better efficacy of the sclerosant, without the need for the tumescent anesthesia used in RF ablation or EVLT.
Note: The term "varicose veins" does not apply to telangiectatic (spider) veins or reticular veins. Similar to varicose veins, these veins are created when the valves that control the blood flow in the veins weaken. This causes the formerly small veins located just below the skin to become engorged with blood. As a result, these veins widen becoming visible beneath the skin but have not been known to be associated with pain, bleeding, ulceration or other medical problems and therefore their treatment is purely cosmetic.
Activities of daily living (ADL): a term used in healthcare that refers to everyday routines involving personal care, such as bathing, dressing, toileting and meal preparation. An inability to perform these tasks indicates a functional mobility deficit.
Anti-embolism hose (also called elastic stockings or compression stockings): A type of stocking worn to prevent the formation of blood clots in the legs (thromboses); assisting in the return flow of the blood to the heart, and prevention of pooling in the veins; there are three support grades of prescription hose; mild to severe support (15-20, 20-30, 30-40 mmHg) which are generally used to assist with a medical condition and light support (8-15 mmHg) that may be used as a preventive measure.
Arteriovenous fistulae: A condition where a vein and artery are directly connected without the usual intervening small vessels.
Catheter ablation: A technique involving the application of either radiofrequency or laser energy through an endovenous catheter for the purpose of ablating varicose vein tissue of the GSV or LSV; this does not include the "closure" or ablation of a vein using the injection of a sclerosing agent through a hollow catheter.
CEAP (clinical, etiology, anatomy, pathological) classification: A descriptive classification for chronic venous disorders. Used for the classification of varicose veins.
1. Clinical classification
C0 No visible or palpable signs of venous disease
C1 Telangiectases or reticular veins
C2 Varicose veins
C4a Pigmentation and/or eczema
C4b Lipodermatosclerosis and/or atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
CS Symptoms, including ache, pain, tightness, skin irritation, heaviness, muscle cramps, as well as other complaints attributable to venous dysfunction
2. Etiologic classification
Es Secondary (postthrombotic)
En No venous etiology identified
3. Anatomic classification
As Superficial veins
Ap Perforator veins
Ad Deep veins
An No venous location identified
4. Pathophysiologic classification
Pr,o Reflux and obstruction
Pn No venous pathophysiology identifiable
Adapted from Eklöf, 2004.
PhotoDerm: A pulsed laser light treatment to aesthetically treat a specific area of leg telangiectasis.
Perforator veins: Connect the superficial veins to the deep veins.
Reticular vein: Dilated bluish subdermal vein, generally 1 mm to less than 3 mm in diameter and usually tortuous.
Synonyms include blue veins, subdermal varices and telangiectasia.
Saphenofemoral reflux: A backflow of blood in the veins causing varicose vein symptoms and bulging.
Saphenous vein: A vein that serves as the principal blood vessel returning blood from the surface of the leg back to the trunk.
Sclerotherapy: A treatment for varicose veins in which a chemical is injected into the vein causing the vein to shrink and close.
Stasis dermatitis: A condition caused by too little circulation in the legs; it begins with swelling of the ankles and progresses to tan-colored skin, patchy reddening, tiny, round, purplish-red spots, and hardening of the skin.
Subfascial: Below the fascia; fascia is a strong connective tissue that performs a number of functions, including surrounding and providing structural support within the body.
Telangiectasia: Dilated superficial blood vessels, especially of the upper reticular dermal plexus.
Thrombophlebitis: Inflammation of a vein, along with the formation of a clot; this occurs most commonly as the result of injury to the vessel wall, abnormal increased clotting capacity of the blood (hypercoagulability), infection, or a chemical irritation.
Tributary vein: A superficial vein branch that flows into larger veins.
Varicose vein or varicosity: Veins that are abnormally swollen or enlarged due to weakening in the vein's wall. Measured in an upright position they are 3 mm in diameter or greater.
Venous insufficiency: An abnormal circulatory condition marked by decreased return of venous blood from the legs to the trunk of the body.
Venous Severity Score: A score used for the assessment of clinical outcomes after therapy for varicose veins and more advanced chronic venous disease.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services may be Medically Necessary when criteria are met:
|36470||Injection of sclerosing solution; single vein|
|36471||Injection of sclerosing solution; multiple veins, same leg|
|36475||Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated|
|36476||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|
|36478||Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; first vein treated|
|36479||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|
|39.92||Injection of sclerosing agent into vein|
|448.0||Hereditary hemorrhagic telangiectasia|
|451.0-451.2||Phlebitis and thrombophlebitis of vessels of lower extremities|
|453.6||Venous embolism and thrombosis of superficial vessels of lower extremity|
|454.0-454.8||Varicose veins of lower extremities [with complications]|
|459.11-459.19||Postphlebitic syndrome [with complications]|
|459.81||Venous (peripheral) insufficiency, unspecified|
|459.89||Other specified disorders of circulatory system (phlebosclerosis)|
|707.10-707.19||Ulcer of lower limbs, except decubitus|
|729.5||Pain in limb|
|729.81||Swelling of limb|
|747.64||Other anomalies of peripheral vascular system, lower limb vessel anomaly|
|V12.51||Personal history of venous thrombosis and embolism|
|V12.52||Personal history of thrombophlebitis|
|ICD-10 Procedure||ICD-10-PCS draft codes; effective 10/01/2014:|
|065P3ZZ-065Q4ZZ||Destruction of greater saphenous vein [right or left, by percutaneous or percutaneous endoscopic approach; includes codes 065P3ZZ, 065P4ZZ, 065Q3ZZ, 065Q4ZZ]|
|065R3ZZ-065S4ZZ||Destruction of lesser saphenous vein [right or left, by percutaneous or percutaneous endoscopic approach; includes codes 065R3ZZ, 065R4ZZ, 065S3ZZ, 065S4ZZ]|
|06LP0ZZ-06LQ4ZZ||Occlusion of greater saphenous vein [right or left, by approach; includes codes 06LP0ZZ, 06LP3ZZ, 06LP4ZZ, 06LQ0ZZ, 06LQ3ZZ, 06LQ4ZZ]|
|06LR0ZZ-06LS4ZZ||Occlusion of lesser saphenous vein [right or left, by approach; includes codes 06LR0ZZ, 06LR3ZZ, 06RP4ZZ, 06LS0ZZ, 06LS3ZZ, 06LS4ZZ]|
|3E030TZ||Introduction of destructive agent into peripheral vein, open approach|
|3E033TZ||Introduction of destructive agent into peripheral vein, percutaneous approach|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective 10/01/2014:|
|I78.0||Hereditary hemorrhagic telangiectasia|
|I80.00-I80.9||Phlebitis and thrombophlebitis|
|I82.501-I82.599||Chronic embolism and thrombosis of deep veins of lower extremity|
|I82.5Y1-I82.5Y9||Chronic embolism and thrombosis of unspecified deep veins of proximal lower extremity|
|I82.5Z1-I82.5Z9||Chronic embolism and thrombosis of unspecified deep veins of distal lower extremity|
|I82.811-I82.819||Embolism and thrombosis of superficial veins of lower extremities|
|I83.001-I83.899||Varicose veins of lower extremities [with complications]|
|I87.011-I87.099||Postthrombotic syndrome [with complications]|
|I87.2||Venous insufficiency (chronic) (peripheral)|
|I87.8||Other specified disorders of veins (phlebosclerosis)|
|I96||Gangrene, not elsewhere classified|
|L97.101-L97.929||Non-pressure chronic ulcer of lower limb, not elsewhere classified|
|M79.604-M79.606||Pain in leg|
|M79.661-M79.669||Pain in lower leg|
|Q27.32||Arteriovenous malformation of vessel of lower limb|
|Q27.8||Other specified congenital malformations of peripheral vascular system|
|R22.40-R22.43||Localized swelling, mass and lump, lower limb|
|Z86.71||Personal history of venous thrombosis and embolism|
|Z86.72||Personal history of thrombophlebitis|
When services are Not Medically Necessary:
For the procedure and diagnosis codes listed above, when criteria are not met, and for the following diagnosis
|454.9||Asymptomatic varicose veins|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective 10/01/2014:|
|I83.90-I83.93||Asymptomatic varicose veins of lower extremities|
When services are Cosmetic and Not Medically Necessary:
For the procedure codes listed above, for the following diagnosis, or when the code describes a procedure indicated in the Position Statement section as cosmetic and not medically necessary.
|448.1||Nevus non-neoplastic (spider veins)|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective 10/01/2014:|
|I78.1||Nevus non-neoplastic (spider veins)|
When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
When services are also Investigational and Not Medically Necessary:
|37799||Unlisted procedure, vascular surgery [when specified as COMPASS protocol, endoluminal cryoablation or mechanochemical ablation of varicose veins]|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective 10/01/2014:|
When services are Cosmetic and Not Medically Necessary:
|36468||Single or multiple injections of sclerosing solutions, spider veins (telangiectasia); limb or trunk|
|96999||Unlisted special dermatological service or procedure [when specified as tunable dye or pulsed dye laser treatment]|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective10/01/2014:|
Peer Reviewed Publications:
Government Agency, Medical Society and Other Authoritative Publications:
|Web Sites for Additional Information|
Endosaphenous Radiofrequency or Laser Ablation for Primary Venous Insufficiency
Laser Ablation for Primary Venous Insufficiency
Primary Venous Insufficiency, Endosaphenous Radiofrequency or Laser Ablation for
Radiofrequency Ablation for Primary Venous Insufficiency
Subfascial endoscopic perforating vein surgery (SEPS)
Telangiectatic Dermal Veins
Trans-Illuminated Powered Phlebectomy (TIPP)
VNUS Closure™ Catheter Systems
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Revised||08/08/2013||Medical Policy & Technology Assessment Committee (MPTAC) review. Mechanochemical ablation of any vein is added as an investigational and not medically necessary statement. Rationale, Coding, Reference and Index sections updated.|
|Revised||02/14/2013||MPTAC review. Position statement reformatted. Description, Rationale, Reference, and Index sections updated.|
|Revised||05/10/2012||MPTAC review. Medically Necessary criteria reorganized. Rationale and References updated.|
|Revised||05/19/2011||MPTAC review. Addition of reticular vein to position statement. Description, Rationale and References updated.|
|Revised||05/13/2010||MPTAC review. Medically necessary and investigational and not medically necessary criteria revised to address saphenofemoral and saphenopopliteal junction incompetence and endoluminal cyoablation. Rationale, Background, Coding and References updated.|
|10/01/2009||Updated Coding section with 10/01/2009 ICD-9 changes; removed ICD-9 diagnosis code 453.8 (no longer applicable).|
|Revised||05/21/2009||MPTAC review. Vein anatomy clarified in position statement. Background updated to address standard therapies. References updated.|
|Revised||11/20/2008||MPTAC review. Criteria updated to address saphenous vein tributaries and extensions. Rationale, Background, Coding and References updated.|
|Revised||11/29/2007||MPTAC review. Criteria for perforator ligation clarified. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary" and the phrase "cosmetic/not medically necessary" was clarified to read "cosmetic and not medically necessary." References updated.|
|Revised||12/07/2006||MPTAC review. Minimal pressure criteria (30mmHg) for compression stockings deleted. Coding updated; removed HCPCS S2130, S2131 deleted 12/31/2004.|
|11/21/2005||Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).|
|Revised||04/28/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review Date||Document Number||Title|
|10/28/2004||SURG.00037||Treatment of Varicose Veins (lower extremities)|
|WellPoint Health Networks, Inc.||03/11/2004||3.01.23||Endosaphenous Radiofrequency or Laser Ablation for Treatment of Primary Venous Insufficiency|
|09/23/2004||Clinical Guideline||Sclerotherapy-Varicose Veins|
|12/02/2004||Clinical Guideline||Treatment of Refluxing Saphenous Vein in Patients with Varicose Veins|