Latest Review Date: May 2024

Category: Surgery                                                                  

POLICY:

Great or Small Saphenous Veins

Surgery (stripping and ligation), endovenous radiofrequency, laser ablation, microfoam sclerotherapy (Varithena™), or cyanoacrylate adhesive of symptomatic varicose veins/venous insufficiency with ultrasound documented saphenous reflux and CEAP* (Clinical-Etiology-Anatomy-Pathophysiology) class C2 – C6 may be considered medically necessary when all of the following conditions/criteria are met for procedure codes:  36465, 36466 , 36475, 36476, 36478, 36479, 36482, 36483, 37700, 37718, 37722, 37735, 37780, 37785:

• Persistent pain, itching or burning, associated with one or more of the following:
  • Bleeding
  • Bulging, ropy varicose veins
  • Clotting in vessels
  • Edema
  • Stasis dermatitis
  • Ulceration

AND

• the symptoms significantly interfere with activities of daily living, AND
• conservative management (elevation of lower extremity above heart level 2-3 times per day, compression therapy or exercise) for at least 3 months has not improved the symptoms, AND
• there is duplex ultrasound documentation of a patent deep venous system.

 

Treatment of the great or small saphenous veins by surgery, endovenous radiofrequency, laser ablation, or microfoam sclerotherapy (Varithena™), or cyanoacrylate adhesive that do not meet the criteria described above is considered cosmetic and not medically necessary.

 

*The standard classification of venous disease is the CEAP classification system.  The following is the Clinical portion of the CEAP.

Clinical Classification
C0	No visible or palpable signs of venous disease
C1	Telangiectasies or reticular veins
C2	Varicose veins
C3	Edema
C4a	Pigmentation and eczema
C4b	Lipodermatosclerosis and atrophie blanche
C5	Healed venous ulcer
C6	Active venous ulcer

 

Accessory Saphenous Veins

Surgery (stripping and ligation), endovenous radiofrequency, laser ablation, microfoam sclerotherapy (Varithena™), or cyanoacrylate adhesive of symptomatic varicose veins/venous insufficiency with ultrasound documented accessory saphenous reflux may be considered medically necessary when all of the following conditions/criteria are met:

1. Incompetence of the accessory saphenous vein is isolated;

AND

• Persistent pain, itching or burning, associated with one or more of the following:
  • Bleeding
  • Bulging, ropy varicose veins
  • Clotting in vessels
  • Edema
  • Stasis dermatitis
  • Ulceration

AND

• the symptoms significantly interfere with activities of daily living, AND
• conservative management (elevation of lower extremity above heart level 2-3 times per day, compression therapy or exercise) for at least 3 months has not improved the symptoms, AND
• there is duplex ultrasound documentation of a patent deep venous system

OR

2. The great or small saphenous veins have been previously eliminated (at least 3 months); AND

• Persistent pain, itching or burning, associated with one or more of the following:
  • Bleeding
  • Bulging, ropy varicose veins
  • Clotting in vessels
  • Edema
  • Stasis dermatitis
  • Ulceration

AND

• the symptoms significantly interfere with activities of daily living, AND
• there is duplex ultrasound documentation of a patent deep venous system.

Concurrent treatment of the accessory saphenous veins along with the great or small saphenous veins may be considered medically necessary when the criteria above is met for each vein and there is documentation of anatomy showing that the accessory saphenous vein drains directly into the common femoral vein.

Treatment of accessory saphenous veins by surgery, endovenous radiofrequency, laser ablation, microfoam sclerotherapy (Varithena™), or cyanoacrylate adhesive that do not meet the criteria described above is considered cosmetic and not medically necessary.

Symptomatic Varicose Tributaries

Hook phlebectomy (CPT 37765, 37766), Sclerotherapy (CPT 36470, 36471), Microfoam sclerotherapy (Varithena) (CPT 36470, 36471), Stab avulsion (CPT 37765, 37766), or Transilluminated powered phlebectomy (CPT 37765, 37766, or 37799) may be considered medically necessary for the treatment of symptomatic varicose tributaries that are greater than 3.0mm in diameter with demonstrated reflux when the following criteria are met:

• Performed at the same time as a GSV or SSV procedure (i.e. stripping/ligation, endovenous radiofrequency, laser ablation, microfoam sclerotherapy [Varithena™], or cyanoacrylate adhesive) which meets the criteria specific to GSV/SSV above;

OR

• Performed for the treatment of residual or recurrent symptoms which meet the following criteria:
  • Surgical ligation and stripping, endovenous radiofrequency, laser ablation, or microfoam sclerotherapy (Varithena™) of the great or small saphenous veins was previously performed; AND
  • Persistent pain, itching or burning, associated with one or more of the following:
• Bleeding
• Bulging, ropy varicose veins
• Clotting in vessels
• Edema
• Stasis dermatitis
• Ulceration

AND

• the symptoms significantly interfere with activities of daily living, AND
• conservative management (elevation of lower extremity above heart level 2-3 times per day, compression therapy or exercise) for at least 6 weeks has not improved the symptoms.

Treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment of saphenous veins using any other techniques other than noted above is considered investigational.

Perforator Veins

Subfascial endoscopic perforator surgery (SEPS) (CPT 37500), endovenous radiofrequency ablation (36475), or laser ablation (CPT 36478) may be considered medically necessary as a treatment for leg ulcers associated with chronic venous insufficiency when the following conditions have been met:

• There is demonstrated perforator reflux; AND
• The superficial saphenous veins have been previously eliminated; AND
• Ulcers have not resolved following combined superficial vein treatment and compression therapy for at least 3 months; AND
• The venous insufficiency is not secondary to deep venous thromboembolism.

Ligation of perforators, subfascial, radical (Linton type) (CPT 37760), with or without skin graft may be considered medically necessary when the presence of diseased skin is documented and requires extensive subcutaneous dissection.

Ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery is considered not medically necessary.

Telangiectasias

Treatment of telangiectasia such as spider veins, angiomata, and hemangiomata by any technique is considered cosmetic and not medically necessary.

Other

Contraindications for varicose vein treatment:

• Within 6 months of pregnancy
• Presence of primary or congenital lymphedema
• Arterial insufficiency
• A non-patent deep vein system

Techniques for conditions not specifically listed above are considered investigational, including, but not limited to:

• Sclerotherapy techniques, other than microfoam sclerotherapy (Varithena™) as the sole treatment of great or small saphenous, accessory saphenous.
• Sclerotherapy as the sole treatment of perforator veins
• Sclerotherapy of isolated tributary veins without prior or concurrent treatment of saphenous veins
• Sclerotherapy techniques, other than microfoam sclerotherapy (Varithena™) of the greater or lesser saphenous vein with or without associated ligation of the saphenofemoral junction
• Sclerotherapy as the sole treatment of varicose tributaries with documented reflux of the saphenofemoral junction or reflux isolated to the perforator veins of the upper thigh
• Stab avulsion, hook phlebectomy, or TIPP of great or small saphenous, accessory saphenous or perforator veins
• COMPASS technique for management of greater saphenous varicosities with saphenofemoral incompetence
• Endoluminal radiofrequency or laser ablation of tributary veins
• Endoluminal cryoablation of any vein
• Endomechanical or mechanochemical ablative approach of any vein(e.g., ClariVein™ Catheter)

A variety of treatment modalities are available to treat varicose veins/venous insufficiency, including surgical approaches, thermal ablation, cyanoacrylate adhesive (CRC) and sclerotherapy. The application of each of these treatment options is influenced by the severity of the symptoms, the type of vein, the source of venous reflux, and the use of other (prior or concurrent) treatments.

Venous Reflux/Venous Insufficiency

The venous system of the lower extremities consists of the superficial veins (this includes the great and small saphenous, and accessory or duplicate veins that travel in parallel with the great and small 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 considers the clinical, etiologic, anatomic, and pathologic characteristics of venous insufficiency, ranging from Class 0 (no visible sign of disease) to Class 6 (active ulceration).

Treatment

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.

Treatment of Saphenous Veins and Tributaries

Saphenous veins include the great and small saphenous and accessory saphenous veins that travel in parallel with the great or small saphenous veins. Tributaries are veins that empty into a larger vein. Treatment of venous reflux typically includes the following:

1. Identification by preoperative Doppler ultrasonography of the valvular incompetence
2. Control of the most proximal point of reflux, traditionally by suture ligation of the incompetent saphenofemoral or saphenopopliteal junction
3. Removal of the superficial vein from circulation, for example by stripping of the greater and/or lesser saphenous veins
4. Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab avulsion (phlebectomy) or injection sclerotherapy.

Minimally invasive alternatives to ligation and stripping have been investigated. These include sclerotherapy, transilluminated powered phlebotomy, and thermal ablation using cryotherapy, high frequency radio waves (200–300 kHz), or laser energy.

Sclerotherapy

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). Physician compounded foam is produced at the time of treatment. Varithena™ (previously known as Varisolve, BTG PLC, London) is different in that it is a proprietary microfoam sclerosant that is dispersed from a canister with a controlled density and more consistent bubble size.

Endovenous Mechanochemical Ablation

Endovenous mechanochemical ablation (MCOA) 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 at 3,500 rpm within the lumen of the vein, abrading the lumen. 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, and results in less pain and risk of nerve injury without need for the tumescent anesthesia used with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous laser treatment [EVLT]).

Thermal Ablation

Radiofrequency 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 small saphenous vein.

Cyanoacrylate Adhesive

Cyanoacrylate adhesive is a clear, free-flowing liquid that polymerizes in the vessel via an anionic mechanism (i.e., polymerizes into a solid material on contact with body fluids or tissue). The adhesive is gradually injected along the length of the vein in conjunction with ultrasound and manual compression. The acute coaptation halts blood flow through the vein until the implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the treated vein. Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of indications, including gastrointestinal bleeding, embolization of brain arteriovenous malformations, and to seal surgical incisions or other skin wounds.

Transilluminated Powered Phlebectomy

Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook phlebectomy. This procedure uses two 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. Endovenous ablation of incompetent perforator veins with sclerotherapy and radiofrequency has also been reported.

KEY POINTS:

The most recent literature update was performed through April 5, 2024.

Summary

Saphenous Veins

For individuals who have varicose veins/venous insufficiency and saphenous vein reflux who receive thermal endovenous ablation (radiofrequency or laser), the evidence includes randomized controlled trials (RCTs) and systematic reviews of controlled trials. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. There are a number of large RCTs and systematic reviews of RCTs assessing endovenous thermal ablation of the saphenous veins. Comparison with the standard of ligation and stripping at 2- to 5-year follow-up has supported use of both radiofrequency ablation (RFA) and endovenous laser ablation. Evidence has suggested that ligation and stripping leads to more neovascularization, while thermal ablation leads to more recanalization, resulting in similar clinical outcomes for endovenous thermal ablation and surgery. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have varicose veins/venous insufficiency and saphenous vein reflux who receive microfoam sclerotherapy, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. For physician-compounded sclerotherapy, there is high variability in success rates of this procedure and some reports of serious adverse events; therefore physician compounded sclerotherapy is considered investigational. By comparison, rates of occlusion with the microfoam sclerotherapy (polidocanol 1%) approved by the Food and Drug Administration are similar to those reported for endovenous laser ablation or stripping. Results of a noninferiority trial of physician-compounded sclerotherapy have indicated that, once occluded, recurrence rates at 2 years are similar to those of ligation and stripping. Together, this evidence indicates that the more consistent occlusion with the microfoam sclerotherapy preparation will lead to recurrence rates similar to ligation and stripping in the longer term. The evidence is sufficient to determine that the technology for microfoam sclerotherapy (i.e. Varithena) results in an improvement in the net health outcomes.

For individuals who have varicose veins/venous insufficiency and saphenous vein reflux who receive mechanochemical ablation, the evidence includes 4 RCTs with 6 months to 2 year results that compared MOCA to thermal ablation, a prospective cohort with follow-up to 5 years. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. Mechanochemical ablation is a combination of liquid sclerotherapy with mechanical abrasion. A potential advantage of this procedure compared with thermal ablation are that mechanochemical ablation does not require tumescent anesthesia and may result in less pain during the procedure. Results to date have been mixed regarding a reduction in intraprocedural pain compared to thermal ablation procedures. Occlusion rates at 6 months to 2 years from RCTs indicate lower anatomic success rates compared to thermal ablation, but a difference in clinical outcomes at these early time points has not been observed. Experience with other endoluminal ablation procedures suggests that lower anatomic success in the short term is associated with recanalization and clinical recurrence between 2 to 5 years. The possibility of later clinical recurrence is supported by a prospective cohort study with 5-year follow-up following treatment with MOCA. However, there have been improvements in the technique since the cohort study was begun, and clinical progression is frequently observed with venous disease. Because of these limitations, longer follow-up of the more recently conducted RCTs is needed to establish the efficacy and durability of this procedure compared with the criterion standard of thermal ablation. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have varicose veins/venous insufficiency and saphenous vein reflux who receive CAC, the evidence includes 3 RCTs and a prospective cohort. The relevant outcomes are symptoms, change in disease status, morbid events, QOL, and TRM. Evidence includes a multicenter noninferiority trial with follow-up through 36 months, 2 RCTs with follow-up through 24 months, and a prospective cohort with 30 month follow-up. The short-term efficacy of VenaSeal CAC has been shown to be noninferior to RFA at up to 36 months. At 24 and 36 months the study had greater than 20% loss to follow-up, but loss to follow-up was similar in the two groups at the long-term follow-up and is not expected to influence the comparative results. Another RCT (N=248) comparing VenaSeal CAC with RFA found similar proportions of vein closures at 24 months with both treatments, with potentially shorter procedure duration with CAC vs RFA. A third RCT (n=525) with an active CAC ingredient (N-butyl cyanoacrylate) that is currently available outside of the U.S. found no significant differences in vein closure between CAC and thermal ablation controls at 24 month follow-up. The CAC procedure and return to work were shorter and pain scores were lower compared to thermal ablation, although the subjective pain scores may have been influenced by differing expectations in this study. A prospective cohort reported high closure rates at 30 months. Overall, results indicate that outcomes from CAC are at least as good as thermal ablation techniques, the current standard of care. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have varicose veins/venous insufficiency and saphenous vein reflux who receive cryoablation, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. Results from a recent RCT of cryoablation have indicated that this therapy is inferior to conventional stripping. Studies showing a benefit on health outcomes are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

Varicose Tributary Veins

For individuals who have varicose tributary veins who receive ablation of tributary veins (stab avulsion sclerotherapy or phlebectomy), the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. The literature has shown that sclerotherapy is effective for treating tributary veins following occlusion of the saphenofemoral or saphenopopliteal junction and saphenous veins. No studies have been identified comparing RFA 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 evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Perforator Veins

For individuals who have perforator vein reflux who receive ablation of perforator veins (e.g., subfascial endoscopic perforator surgery), the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. The literature has indicated that the routine ligation or ablation of incompetent perforator veins is not 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). Comparative studies are needed to determine the most effective method of ligating or ablating incompetent perforator veins. Subfascial endoscopic perforator surgery has been shown to be as effective as the Linton procedure with a reduction in adverse events. Endovenous ablation with specialized laser or radiofrequency probes has been shown to effectively ablate incompetent perforator veins with a potential decrease in morbidity compared with surgical interventions. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Practice Guidelines and Position Statements

American Venous Forum et al

In 2020, in response to published reports of potentially inappropriate application of venous procedures, the American Venous Forum, Society for Vascular Surgery, American Vein and Lymphatic Society, and the Society of Interventional Radiology published appropriate use criteria for the treatment of chronic lower extremity venous disease. Appropriate use criteria were developed using the RAND/UCLA method incorporating best available evidence and expert opinion.

Appropriate use criteria were determined for various scenarios (e.g., symptomatic, asymptomatic, CEAP [Clinical, Etiology, Anatomy and Pathophysiology] class, axial reflux, saphenofemoral junction reflux) for the following:

• Saphenous vein ablation
  • Great saphenous vein
  • Small saphenous vein
  • Accessory great saphenous vein
• Nontruncal varicose veins
• Diseased tributaries associated with saphenous ablation
• Perforator Veins
• Iliac Vein or inferior vena cava stenting as a first line treatment
• Duplex ultrasound
• Timing and Reimbursement.

Treatment of saphenous veins for asymptomatic CEAP class 1 and 2, or symptomatic class 1, was considered to be rarely appropriate or never appropriate, and treatment of symptomatic CEAP class 2, 3, and 4-6 without reflux was rated as never appropriate. Based on the 2011 Guidelines from the Society for Vascular Surgery and American Venous Forum (see below), treatment of perforator veins for asymptomatic or symptomatic CEAP class 1 and 2 was considered to be rarely appropriate or never appropriate. Perforator vein treatment was rated as appropriate for CEAP classes 4-6, and may be appropriate for CEAP class 3. Except for a recommendation to use endovenous procedures for perforator vein ablation, techniques used to treat veins in these scenarios were not evaluated.

Society for Vascular Surgery, American Vein and Lymphatic Society, and the American Venous Forum

The Society for Vascular Surgery and the American Venous Forum published joint clinical practice guidelines in 2011. 

Table 1. Guidelines on Management of Varicose Veins and Associated Chronic Venous Diseases

Recommendation	Gradea	SOR	QOE
Compression therapy for venous ulcerations and varicose veins
Compression therapy is recommended as the primary treatment to aid healing of venous ulceration	1B	Strong	Moderate
To decrease the recurrence of venous ulcers, ablation of the incompetent superficial veins in addition to compression therapy is recommended	1A	Strong	High
Use of compression therapy for patients with symptomatic varicose veins is recommended	2C	Weak	Low
Compression therapy as the primary treatment if the patient is a candidate for saphenous vein ablation is not recommended	1B	Strong	Moderate
Treatment of the incompetent great saphenous vein
Endovenous thermal ablation (radiofrequency or laser) is recommended over chemical ablation with foam or high ligation and stripping due to reduced convalescence and less pain and morbidity. Cryostripping is a technique that is new in the United States, and it has not been fully evaluated.	1B	Strong	Moderate
Varicose tributaries
Phlebectomy or sclerotherapy are recommended to treat varicose tributaries	1B	Strong	Moderate
Transilluminated powered phlebectomy using lower oscillation speeds and extended tumescence is an alternative to traditional phlebectomy	2C	Weak	Low
Perforating vein incompetence
Selective treatment of perforating vein incompetence in patients with simple varicose veins is not recommended	1B	Strong	Moderate
Treatment of pathologic perforating veins (outward flow of ≥500 ms duration, with a diameter of ≥3.5 mm) located underneath healed or active ulcers (CEAP class C5-C6) is recommended	2B	Weak	Moderate

QOE: quality of evidence; SOR: strength of recommendation.

a Grading: strong = 1 or weak = 2, based on a level of evidence that is either high quality = A, moderate quality = B, or low quality = C.

The Society for Vascular Surgery, the American Vein and Lymphatic Society (AVLS), and the American Venous Forum published a joint clinical practice guideline in 2022 on management of lower extremity varicose veins. The guideline will be published in sections; the first part (published in 2022) focuses on duplex scanning and treatment of superficial truncal reflex. Superficial truncal veins are defined as the great saphenous vein, small saphenous vein, anterior accessory great saphenous vein, and posterior accessory great saphenous vein. A summary of the guideline recommendations is provided below in Table 2. The second part of the guideline was published in 2023 and focuses on the management of varicose vein patients with compression, treatment with drugs and nutritional supplements, evaluation and treatment of varicose tributaries, superficial venous aneurysms, and management of complications of varicose veins and their treatment. Relevant guideline recommendations regarding the management of varicose veins and varicose tributaries are summarized in Table 3.

 

Table 2. Summary of Recommended Treatment of Superficial Truncal Reflex

Recommendation	Grade	SOR	QOE
Symptomatic varicose veins and axial reflux
Reflux in the great or small saphenous vein - superficial venous intervention preferred over long-term compression stockings	1B	Strong	Moderate
Reflux in the anterior accessory or posterior accessory great saphenous vein - superficial venous intervention preferred over long-term compression stockings	2C	Weak	Low
Reflux in the superficial truncal vein - compression therapy suggested for primary treatment	2C	Weak	Low
Reflux in the great saphenous vein - endovenous ablation preferred over high ligation and stripping	1B	Strong	Moderate
Reflux in the small saphenous vein - endovenous ablation preferred over high ligation and stripping	1C	Strong	Low
Reflux in the anterior accessory or posterior accessory great saphenous vein - endovenous ablation(with phlebectomy if needed) over ligation and stripping	2C	Weak	Low
Patients who place a high priority on long-term outcomes (quality of life and recurrence) – laser ablation, radiofrequency ablation, or ligation and stripping over ultrasound-guided foam sclerotherapy	2C or 2B	Weak	Moderate or Low
Symptomatic axial reflux
Reflux in the great saphenous vein - thermal and non-thermal ablation recommended	1B	Strong	Moderate
Reflux in the small saphenous vein - thermal and non-thermal ablation recommended	1C	Strong	Low
Reflux in the anterior accessory or posterior accessory great saphenous vein - either thermal or non-thermal ablation suggested	2C	Weak	Low
Varicose veins (CEAP class C2)
Reflux in the great or small saphenous vein - recommend against concomitant initial ablation and treatment of incompetent perforating veins	1C	Strong	Low
Reflux in the anterior accessory or posterior accessory great saphenous vein - recommend against concomitant initial ablation and treatment of incompetent perforating veins	2C	Weak	Low
Persistent or recurrent symptoms after previous complete ablation - treatment of perforating vein incompetence suggested	2C	Weak	Low
Symptomatic reflux and associated varicosities
Reflux in the great or small saphenous vein - ablation and concomitant phlebectomy or ultrasound-guided foam sclerotherapy recommended	1C	Strong	Low
Reflux in the anterior accessory or posterior accessory great saphenous vein - ablation and concomitant phlebectomy or ultrasound-guided foam sclerotherapy suggested	2C	Weak	Low

CEAP: Clinical Etiology Anatomy Pathophysiology; QOE: quality of evidence; SOR: strength of recommendation.  Grading: strong = 1 or weak = 2, based on a level of evidence that is either high quality = A, moderate quality = B, or low quality = C. Ligation and stripping can be performed if endovenous ablation is not feasible.

 

Table 3. Summary of Recommendations for Varicose Veins and Varicose Tributaries.

	Gradea	SOR	QOE
Endovenous Ablation vs High Ligation and Stripping
For patients with symptomatic varicose veins and axial reflux in the GSV, who are candidates for intervention, we recommend treatment with endovenous ablation over HL&S of the GSV.	1	Strong	Moderate
For patients with symptomatic varicose veins and axial reflux in the SSV, who are candidates for intervention, we recommend treatment with endovenous ablation over ligation and stripping of the SSV.	1	Strong	Low to very low
For patients with symptomatic varicose veins and axial reflux in the AAGSV or PAGSV, who are candidates for intervention, we suggest treatment with endovenous ablation, with additional phlebectomy, if needed, over ligation and stripping of the accessory vein.	2	Weak	Low to very low
For patients with symptomatic varicose veins and axial reflux in the GSV or SSV, we recommend treatment with HL&S of the saphenous vein if technology or expertise in endovenous ablation is not available or if the venous anatomy precludes endovenous treatment.	1	Strong	Moderate
For patients with symptomatic varicose veins and axial reflux in the AAGSV or PAGSV, we suggest treatment with ligation and stripping of the accessory saphenous vein, with additional phlebectomy if needed, if technology or expertise in endovenous ablations is not available or if the venous anatomy precludes endovenous treatment.	2	Weak	Low to very low
For patients with symptomatic varicose veins and axial reflux in the GSV who place a high priority on the long-term outcomes of treatment (QOL and recurrence), we suggest treatment with EVLA, RFA, or HL&S over physician-compounded UGFS, because of long-term improvement of QOL and reduced recurrence.	2	Weak	Moderate
For patients with symptomatic varicose veins and axial reflux in the SSV, we suggest treatment with EVLA, RFA, or ligation and stripping from the knee to the upper or midcalf over physician-compounded UGFS because of long-term improvement of QOL and reduced recurrence.	2	Weak	Low to very low
For patients with symptomatic varicose veins and axial reflux in the AAGSV or PAGSV who place a high priority on the long-term outcomes of treatment (QOL and recurrence), we suggest treatment of the refluxing superficial trunk with endovenous laser ablation, RFA, or HL&S, with additional phlebectomy if needed, over physician-compounded UGFS because of long-term improvement of QOL and reduced recurrence.	2	Weak	Low to very low
Thermal vs nonthermal ablation of superficial truncal veins
For patients with symptomatic axial reflux of the GSV, we recommend either thermal or nonthermal ablation from the groin to below the knee, depending on the available expertise of the treating physician and the preference of the patient.	1	Strong	Moderate
For patients with symptomatic axial reflux of the SSV, we recommend either thermal or nonthermal ablation from the knee to the upper or midcalf, depending on the available expertise of the treating physician and the preference of the patient.	1	Strong	Low to very low
For patients with symptomatic axial reflux of the AAGSV or PAGSV, we suggest either thermal or nonthermal ablation, with additional phlebectomy if needed, depending on the available expertise of the treating physician and the preference of the patient.	2	Weak	Low to very low
Telangiectasias and reticular veins
For patients with symptomatic telangiectasias and reticular veins, we recommend sclerotherapy with liquid or foam.	1	Strong	Moderate
For patients with symptomatic telangiectasias or reticular veins, we suggest transcutaneous laser treatment if the patient has sclerosant allergy, needle phobia, sclerotherapy failure, or small veins (<1mm) with telangiectatic matting.	2	Weak	Moderate
Varicose tributaries
For treatment of symptomatic varicose tributaries, we recommend mini-phlebectomy or ultrasound-guided sclerotherapy using PCF or PEM.	1	Strong	Moderate
For treatment of symptomatic varicose tributaries, we suggest transilluminated powered phlebectomy as an alternative treatment for patients with clusters of varicosities by a physician who is trained in the procedure.	2	Weak	Low to very low
Treatment of varicose tributaries concomitant or staged with superficial truncal ablation
For patients with symptomatic reflux in the GSV or SSV and associated varicosities, we recommend ablation of the refluxing venous trunk and concomitant phlebectomy or ultrasound-guided foam sclerotherapy of the varicosities with PCF or PEM.	1	Strong	Low to very low
For patients with symptomatic reflux in the AAGSV or PAGSV, we suggest simultaneous ablation of the refluxing venous trunk and phlebectomy or UGFS of the varicosities with PCF or PEM.	2	Weak	Low to very low
For patients with symptomatic reflux in the GSV or SSV, we suggest ablation of the refluxing venous trunk and staged phlebectomy or UGFS of the varicosities only if anatomical or medical reasons are present. We suggest shared decision-making with the patient regarding the timing of the procedure.	2	Weak	Low to very low
For patients with symptomatic reflux in the AAGSV or PAGSV, we suggest ablation of the refluxing venous trunk and staged phlebectomy or UGFS of the varicosities only if anatomical or medical reasons are present. We suggest shared decision-making with the patient regarding the timing of the procedure.	2	Weak	Low to very low
Ablation of incompetent perforating veins
For patients with varicose veins (CEAP class C2) who have significant, symptomatic axial reflux of the GSV or SSV, we recommend against treatment of incompetent perforating veins concomitant with initial ablation of the saphenous veins.	1	Strong	Low to very low
For patients with varicose veins (CEAP class C2) who have significant, symptomatic axial reflux of the AAGSV or PAGSV, we suggest against treatment of incompetent perforating veins concomitant with initial ablation of the superficial truncal veins.	2	Weak	Low to very low

AAGSV: anterior accessory great saphenous vein; CEAP: Clinical, Etiologic, Anatomic, Pathophysiologic classification system; EVLA: endovenous laser ablation; GSV: great saphenous vein; HL&S: high ligation and stripping; PCF: physician-compounded foam; PEM: polidocanol endovenous microfoam; PAGSV: posterior accessory great saphenous vein; QOE: quality of evidence; QOL: quality of life; RFA: radiofrequency ablation; SOR: strength of recommendation; SSV: small saphenous vein; UGFS: ultrasound-guided foam sclerotherapy. a Grading: strong = 1 or weak = 2, based on a level of evidence that is either high quality = A, moderate quality = B, or low quality = C.

American Vein and Lymphatic Society

In 2015, the American Vein and Lymphatic Society (AVLS, previously named the American College of Phlebology) published guidelines on the treatment of superficial vein disease.

AVLS gave a Grade 1 recommendation based on high quality evidence that compression is an effective method for the management of symptoms, but when patients have a correctable source of reflux definitive treatment should be offered unless contraindicated. AVLS recommends against a requirement for compression therapy when a definitive treatment is available. AVLS gave a strong recommendation based on moderate quality evidence that endovenous thermal ablation is the preferred treatment for saphenous and accessory saphenous vein incompetence, and gave a weak recommendation based on moderate quality evidence that mechanochemical ablation may also be used to treat venous reflux.

In 2017, AVLS published guidelines on the treatment of refluxing accessory saphenous veins. The College gave a Grade 1 recommendation based on level C evidence that patients with symptomatic incompetence of the accessory saphenous veins be treated with endovenous thermal ablation or sclerotherapy to reduce symptomatology. The guidelines noted that although accessory saphenous veins may drain into the great saphenous vein before it drains into the common femoral vein, they can also empty directly into the common femoral vein.

National Institute for Health and Clinical Excellence (NICE)

NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in 2013. 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 ischemic attacks and stroke.”

In 2015, NICE published a technology assessment on the clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation, and surgery for varicose veins.

NICE revised its guidance on endovenous mechanochemical ablation in 2016, concluding that “Current evidence on the safety and efficacy of endovenous mechanochemical ablation for varicose veins appears adequate to support the use of this procedure....." 

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force has not addressed the treatment of varicose veins/venous insufficiency.

KEY WORDS:

Varicose vein, varicosity, telangiectasia, venous insufficiency, spider veins, sclerotherapy, ultrasound guided sclerotherapy, echosclerotherapy, greater saphenous vein, VNUS Closure System, radiofrequency ablation, Endovenous Laser Ablation, SEPS, Subfascial Endoscopic Perforator Surgery, GSV, COMPASS technique, Linton procedure, EVLT, Trivex*, Trivex* System, transilluminated power phlebectomy, TIPP, stab avulsion, phlebectomy, ambulatory phlebectomy, foam sclerotherapy, perforator, ClariVein, endomechanical, VenaCure, Varithena

APPROVED BY GOVERNING BODIES:

In 2015, the VenaSeal® Closure System (Sapheon, a part of Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for the permanent closure of clinically significant venous reflux through endovascular embolization with coaptation. The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent. FDA product code: PJQ.

In 2013, Varithena™ (formerly known as Varisolve®; BTG Plc, London), a sclerosant microfoam made with a proprietary gas mix, was approved by FDA under a new drug application for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee.

The following devices have received specific U.S. Food and Drug Administration (FDA) marketing clearance for the endovenous treatment of superficial vein reflux:

• In 1999, the VNUS® Closure™ system (a radiofrequency device) received FDA clearance through the 510(k) process for "endovascular coagulation of blood vessels in patients with superficial vein reflux." The VNUS RFS™ and RFSFlex™ devices received FDA clearance in 2005 for “use in vessel and tissue coagulation including: treatment of incompetent (i.e., refluxing) perforator and tributary veins.” The modified VNUS® ClosureFAST™ Intravascular Catheter received FDA clearance through the 510(k) process in 2008.

• In 2002, the Diomed 810 nm surgical laser and EVLT™ (endovenous laser therapy) procedure kit received FDA clearance through the 510(k) process, "… for use in the endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux."

• A modified Erbe Erbokryo® cryosurgical unit (Erbe USA) received FDA clearance for marketing in 2005. A variety of clinical indications are listed, including cryostripping of varicose veins of the lower limbs.

• The Trivex® system (InaVein, LLC) is a device for transilluminated powered phlebectomy that received FDA clearance through the 510(k) process in October 2003. According to the label, the intended use is for “ambulatory phlebectomy procedures for the resection and ablation of varicose veins.”

• The ClariVein® Infusion Catheter received marketing clearance through the 510(k) process in 2008 (K071468). It is used for mechanochemical ablation. Predicate devices were listed as the Trellis® Infusion System (K013635) and the Slip-Cath® Infusion Catheter (K882796). The system includes an infusion catheter, motor drive, stopcock and syringe and is intended for the infusion of physician-specified agents in the peripheral vasculature.

BENEFIT APPLICATIONS:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Policy provisions apply

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT codes:

0524T	Endovenous catheter directed chemical ablation with balloon isolation of incompetent extremity vein, open or percutaneous, including all vascular access, catheter manipulation, diagnostic imaging, imaging guidance and monitoring
36465	Injection of non-compounded foam sclerosant with ultrasound compression maneuvers to guide dispersion of the injectate, inclusive of all imaging guidance and monitoring; single incompetent extremity truncal vein (eg, great saphenous vein, accessory saphenous vein)
36466	Injection of non-compounded foam sclerosant with ultrasound compression maneuvers to guide dispersion of the injectate, inclusive of all imaging guidance and monitoring; multiple incompetent truncal veins (eg, great saphenous vein, accessory saphenous vein), same leg
36468	Injection(s) of sclerosant for spider veins (telangiectasia), limb or trunk
36470	Injection of sclerosant; single incompetent vein (other than telangiectasia)
36471	Injection of sclerosant; multiple incompetent veins (other than telangiectasia), same leg
36473	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; first vein treated.
36474	;subsequent vein(s) treated in a single extremity, each through separate access sites
36475	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated
36476	; 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	; subsequent veins treated in a single extremity, each through separate access sites
36482	Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; first vein treated
36483	Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)
37500	Vascular endoscopy, surgical, with ligation of perforator veins, subfascial (SEPS)
37700	Ligation and division of long saphenous vein at saphenofemoral junction, or distal interruptions
37718	Ligation, division, and stripping, short saphenous vein
37722	Ligation, division, and stripping, long (greater) saphenous veins from saphenofemoral junction to knee or below
37735	Ligation and division and complete stripping of long or 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
37760	Ligation of perforator veins, subfascial, radical (Linton Type), including skin graft, when performed, open, 1 leg
37761	Ligation of perforator veins(s), subfascial, open, including ultrasound guidance, when performed, 1 leg
37765	Stab phlebectomy of varicose veins, one extremity; 10-20 stab incisions
37766	Stab phlebectomy of varicose veins, one extremity; more than 20 incisions
37780	Ligation and division of short saphenous vein at saphenopopliteal junction (separate procedure)
37785	Ligation, division and/or excision varicose veins cluster(s), one leg
37799	Unlisted procedure, vascular surgery
75894	Transcatheter therapy, embolization, any method, radiological supervision and interpretation
76942	Ultrasonic guidance for needle placement (e.g., biopsy, aspiration, injection, localization device), imaging supervision and interpretation
93970	Duplex scan of extremity veins including responses to compression and other maneuvers; complete bilateral study
93971	Duplex scan of extremity veins including responses to compression and other maneuvers; unilateral or limited study

HCPCS:

S2202

Echosclerotherapy

ICD-10-CM

I83.001-I83.899	Varicose veins of lower extremities, code range
I87.2	Venous, insufficiency (chronic, peripheral)

 

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71. Sun JJ, Chowdhury MM, Sadat U, et al. Mechanochemical ablation for treatment of truncal venous insufficiency: a review of the current literature. J Vasc Interv Radiol. Oct 2017;28(10):1422-1431.
72. Tang TY, Kam JW, Gaunt ME. ClariVein®- Early results from a large single-centre series of mechanochemical endovenous ablation for varicose veins. Phlebology. 2017 Feb; 32(1):6-12.
73. Tenbrook JA Jr, MD Iafrati, et al.  Systematic review of outcomes after surgical management of venous disease incorporating subfascial endoscopic perforator surgery. J Vasc Surg, March 2004; 39(3): 583-589.
74. Thierens N, Holewijn S, Vissers WH, et al. Five-year outcomes of mechano-chemical ablation of primary great saphenous vein incompetence. Phlebology. May 2020; 35(4): 255-261.
75. Todd KL III, Wright DI. Durability of treatment effect with polidocanol endovenous microfoam on varicose vein symptoms and appearance (VANISH-2). Journal of Vascular Surgery. July 2015; (3):258-264.
76. Todd KL III, Wright D, for the V-IG. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence. Phlebology 2013.
77. U.S. Food and Drug Administration. VenaSeal Closure System - P140018. 2015; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P140018.
78. U.S. Food and Drug Administration Center for Drug Evaluation and Research. 205098 Varithena Summary Review. 2013; www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205098Orig1s000SumR.pdf. 
79. Vahaaho S, Halmesmaki K, Alback A, et al. Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins. Br J Surg. May 2018;105(6):686-691.
80. Vahaaho SS, Mahmoud OO, Halmesmäki KK, et al. Randomized clinical trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins. Br J Surg, 2019 Mar 26;106(5).
81. van den Bos RR, Malskat WS, De Maeseneer MG, et al. Randomized clinical trial of endovenous laser ablation versus steam ablation (LAST trial) for great saphenous varicose veins. Br J Surg. Aug 2014; 101(9):1077-1083.
82. van der Velden SK, Biemans AA, De Maeseneer MG, et al. Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. Br J Surg. Sep 2015; 102(10):1184-1194.
83. van Eekeren RR, Boersma D, Konijn V et al. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg 2013; 57(2):445-50.
84. van Gent WB, Catarinella FS, Lam YL, et al. Conservative versus surgical treatment of venous leg ulcers: 10-year follow up of a randomized, multicenter trial. Phlebology. Mar 2015; 30(1 Suppl):35-41.
85. Vasquez M, Gasparis AP. A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. Phlebology. May 2017; 32(4):272-281.
86. Wallace T, El-Sheikha J, Nandhra S, et al. Long-term outcomes of endovenous laser ablation and conventional surgery for great saphenous varicose veins. Br J Surg. Dec 2018;105(13):1759-1767. 
87. Whing J, Nandhra S, Nesbitt C, et al. Interventions for great saphenous vein incompetence. Cochrane DatabaseSyst Rev. Aug 11 2021; 8: CD005624.
88. Witte ME, Holewijn S, van Eekeren RR, et al. Midterm outcome of mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency. J Endovasc Ther. Feb 2017; 24(1):149-155.
89. Witte ME, Zeebregts CJ, de Borst GJ, et al. Mechanochemical endovenous ablation of saphenous veins using the ClariVein: A systematic review. Phlebology. Dec 2017; 32(10):649-657.
90. Yamaki T, Hamahata A, Soejima K et al. Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency: Preliminary Report. Eur J Vasc Endovasc Surg 2012.
91. Zierau U. Sealing Veins with the VenaSeal Sapheon Closure System: Results for 795 Treated Truncal Veins after 1000 Days. Vasomed. 2015; 27:124-127.

POLICY HISTORY:

Medical Policy Administration Committee, May 2002

Medical Policy Administration Committee, June 2002

Medical Review Committee, July 2002

Available for Comment July 2-August 15, 2002

Medical Policy Group, July 2002

Medical Policy Group, June 2004 (1)

Medical Policy Administration Committee, July 2004

Available for comment July 12-August 25, 2004

Medical Policy Group, March 2005 (1)

Medical Policy Group, February 2007 (1)

Medical Policy Administration Committee, February 2007

Available for comment March 1-April 14, 2007

Medical Policy Group, February 2009 (1)

Medical Policy Group, January 2010 (1)

Medical Policy Administration Committee, January 2010

Available for comment January 26-February 22, 2010

Medical Policy Group, February 2010 (1): Update policy statements

Medical Policy Administration Committee, February 2010

Available for comment February 23-April 8, 2010

Medical Policy Group April 2010 (1): Update Policy statements, Description, Key Points, Governing Bodies

Medical Policy Administration Committee, April 2010

Available for comment April 15-May 28, 2010

Medical Policy Group, September 2010 (1): Complete policy update, some coverage statement clarifications e.g. echosclerotherapy

Medical Policy Administration Committee, October 21, 2010

Available for comment October 21 through December 6, 2010

Medical Policy Group, June 2011 (1): Entire policy reformatted; Coverage statement clarifications

Medical Policy Administration Committee, June 2011

Available for comment June 23 – August 8, 2011

Medical Policy Group, November 2012 (1): Update to Policy, Key Points, Key Words, Coding and References related to addition of ClariVein as investigational and related to MPP update

Medical Policy Administration Committee, November 2012

Available for comment November 14 through December 28, 2012

Medical Policy Group, January 2013 (1): Clarification of verbiage for echosclerotherapy with addition of ultrasound/duplex ultrasound CPT codes to policy statement and to coding section; no change in policy coverage

Medical Policy Panel, March 2013

Medical Policy Group, September 2013 (1): Addition of coverage statement to accessory saphenous vein criteria to include coverage for isolated incompetent accessory saphenous vein, made clarification statement under perforator section stating that RFA and EVLA are not covered for perforators, this is not a change in coverage, and for procedures not covered. “including, but not limited to” was added to the statement; Update to Description, Key Points and References

Medical Policy Administration Committee, September 2013

Available for comment September 18 through November 1, 2013

Medical Policy Group, November 2013 (1): changed the follow-up period after primary procedure for sclerotherapy treatments from 6 months to 12 months, retro effective 09/01/13; no other changes to policy statements

Medical Policy Group, December 2013 (3):  2014 Coding Update – added new code 37241 to current coding (effective 01/01/2014); moved code 37204 to previous coding (deleted effective 01/01/2014)

Medical Policy Panel, January 2014

Medical Policy Group, January 2014 (1): Update to Key Points and References; no change to policy statement

Medical Policy Group, March 2014 (5):  Added ICD-9 and ICD-10-CM diagnosis under Coding; no change to policy statement.

Medical Policy Group, June 2014 (1): Added Varithena information to policy; removed criteria dated December 2010 and before; no change to coverage statements

Medical Policy Group, November 2014(4): 2015 Annual Coding update.  Moved code 36469 to Previous Coding.

Medical Policy Panel, November 2014

Medical Policy Group, November 2014 (4): Updates to Description, Key Points, Approved Governing Bodies and References.  Policy statement change to include microfoam sclerotherapy (Varithena) may be considered medically necessary effective November 1, 2014.

Medical Policy Administration Committee, December 2014

Available for comment December 9, 2014 through January 22, 2015

Medical Policy Panel, November 2015

Medical Policy Group, January 2016 (4): Updates to Description, Key Points, Approved Governing Bodies, and References. Verbiage change edit throughout the policy for Greater/Lesser saphenous vein to Great/Small saphenous vein. Policy statement updates: added CEAP criteria to Great/Small saphenous and separated points of incompetence ASV and having GSV eliminated prior to ASV treatment in the accessory saphenous veins.  Also, added cyanoacrylate adhesive to other investigation treatment list.

Medical Policy Administration Committee, January 2016

Available for comment January 12, 2016 through February 25, 2016

Medical Policy Group, July 2016 (4): Updated the policy section to include criteria for the Symptomatic Varicose Tributary section.  Removed policy statements with effective dates December 7, 2010 through August 31, 2013

Medical Policy Administration Committee Meeting, July 2016

Available for comment June 11 through August 25, 2016

Medical Policy Group, December 2016: 2017 Annual Coding Update.  Added new codes 36473 and 36474 to Current Coding.  Also clarified policy statement by adding “mechanochemical” and “of any vein” to clarivein statement. Updated verbiage for revised cpt codes 36476 and 36479.

Medical Policy Panel, May 2017

Medical Policy Group, May 2017 (4): Updates to Description, Key Points and References. No change to Policy statements.

Medical Policy Group, December 2017: Annual Coding Update 2018.  Added new codes 36465, 36466, 36482, and 36483 effective 01/01/18 to Current Coding. Updated verbiage for revised codes 36468, 36470, and 36471.

Medical Policy Group, March 2018: added CPT codes 36465 and 36466 to policy statement for Varithena.  Codes effective 1/1/18.

Medical Policy Group, April 2018 (4): Removed CPT code 37241 from Current Coding.

Medical Policy Panel, May 2018

Medical Policy Group, May 2018 (4): Updates to Description, Policy, Key Points, and References. Removed policy statements effective for dates of service from September 1, 2013 through October 31, 2014.  Removed Previous Coding section including codes 36469 (deleted 1/1/15) and 27204 (deleted 1/1/14).

Medical Policy Group, December 2018:  2019 Annual Coding Update.  Added CPT code 0524T to the Current coding section.

Medical Policy Panel, January 2019

Medical Policy Group, February 2019: Updates to Description, Key Points, and References.. Removed policy statements effective for dates of service on or after November 1, 2014 and prior to February 26, 2016. No other changes to policy statements.

Medical Policy Panel, May 2019

Medical Policy Group, June 2019 (4):  Updates to Description, Policy, Key Points, and References.  Policy statements updated to allow cyanoacrylate adhesive in certain situations and allow concurrent treatment of accessory saphenous veins and GSV/SSV when criteria are met.

Medical Policy Administrative Committee: June 2019

Available for Comment June 18, 2019 through August 2, 2019.

Medical Policy Group, September 2019 (4): Removed policy statements for dates of service 2/20/16-8/25/16.  Updated policy statements to allow coverage for endovenous RFA and laser ablation for perforator veins with criteria.  Removed coverage statement regarding Linton procedure.

Medical Policy Administrative Committee: September 2019

Available for Comment September 5, 2019 through October 20, 2019.

Medical Policy Group, April 2020: Clarified statements regarding Linton procedure.

Medical Policy Panel, May 2020

Medical Policy Group, June 2020 (4): Updates to Key Points and References.  No change to policy statements.

Medical Policy Group, November 2020 (4): Clarification of policy statement for varicose tributaries by adding microfoam sclerotherapy (Varithena).  No change in intent of policy.

Medical Policy Panel, May 2021

Medical Policy Group, May 2021 (4): Updates to Key Points and References.  Policy statement updated to remove “not medically necessary,” no change to policy intent. The following References were removed: Barwell JR, Davies CE, et al.  Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): Randomised controlled trial; Teruya Theodore H and Ballard Jeffrey L. New approaches for the treatment of varicose veins; McDonagh B, Huntley DE, et al. Efficacy of the comprehensive objective mapping, precise image guided injection, anti-reflux positioning and sequential sclerotherapy (COMPASS) technique in the management of greater saphenous varicosities with saphenofemoral incompetence.

Medical Policy Group, April 2022 (4): Clarified policy statement section to update contradictions for stripping, ligation to contraindications for varicose vein treatment.

Medical Policy Panel, May 2022

Medical Policy Group, June 2022 (4): Updates to Description, Key Points and References.  Removed policy statements effective for dates of service August 26, 2016 through June 9, 2019. Added CPT codes to policy statement related to Tributary veins.  Removed Echosclerotherapy IV statement, however; it is not separately payable.

Medical Policy Group, July 2022 (4): Clarification of policy statement related to tributary treatment concurrent with GSV/SSV treatment.

Medical Policy Group, May 2023 (4): Updates to Policy, Key Points, and References. Removed policy statements that were effective for dates of service June 10, 2019 through September 4, 2019.  No change to policy statements.

Medical Policy Group, July 2023 (4): Clarification to policy contraindications.  Clarified presence of lymphedema is related to primary or congenital lymphedema and dvt or a non-patent vein system was clarified to a non-patent deep vein system.

Medical Policy Panel, May 2024

Medical Policy Group, May 2024 (4): Updates to Key Points and References. No change to  policy statements.  Removed notes from Current Coding related to Varithena (no code Prior to 01/01/18, used unlisted 37799 and no code prior to 1/1/17 for mechanochemical ablation, used unlisted 37799).

 

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and   

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent   

    therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.