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Chronic venous insufficiency secondary to venous reflux in the lower extremities can lead to thrombophlebitis, leg ulcerations and hemorrhage. The clinical, etiologic, anatomic, and pathologic (CEAP) characteristics of venous insufficiency range from class 0 (no visible sign of disease) to class 6 (skin changes with active venous stasis ulcer).

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. Most venous reflux is secondary to incompetent valves at the saphenofemoral or saphenopopliteal junctions but 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 great or small saphenous veins are eliminated, and blood flow is diverted through the accessory veins.

Treatment of symptomatic varicose veins typically involves two components. The first step is elimination of the refluxing saphenous vein using either ligation and stripping, or endovenous radiofrequency or laser ablation. A second component of treatment is elimination of the superficial varices, which are the visible component of the condition. Treatment of these varices may include sclerotherapy. The application of each of these treatment options is influenced by the severity of symptoms, type of vein treated, source of venous reflux and the use of prior or concurrent treatment.

Vein ligation/stripping is not addressed in this policy. The following treatments are addressed:

• Cyanoacrylate closure
• Endovenous radiofrequency and laser ablation
• Endovenous cryosurgery
• Endovenous mechanochemical embolization
• Noninvasive techniques including but not limited to intense pulsed light and transdermal laser (eg, Photoderm VL, Vasculight IPL, Nd:YAG laser)
• Phlebectomy
• Sclerotherapy, including echosclerotherapy and microfoam sclerotherapy

Definitions

Cyanoacrylate Closure of varicose veins uses a specially formulated adhesive and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips and syringes. The U.S. Food and Drug Administration (FDA) approved the VenaSeal™ closure system via a premarket approval (PMA) process. The VenaSeal™ System is intended for permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound.

Echosclerotherapy utilizes ultrasound to guide the injections and enhance the precision of the therapy. Echosclerotherapy is also called aimed sclerotherapy, or sonographic sclerotherapy.

Endovenous ablation refers to minimally invasive alternatives to vein ligation and stripping for treatment of varicose superficial and perforator veins. Endovenous ablation is designed to damage the vessel wall, resulting in fibrosis and, ultimately, obliteration of a long segment of the vein. Radiofrequency ablation is performed by means of a specially designed catheter inserted through a small incision in the distal medial thigh to within 1 to 2 cm of the saphenofemoral junction. The catheter is slowly withdrawn, closing the vein. Laser ablation involves introduction of a laser fiber into the great 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 following devices have received FDA marketing clearance for the endovenous treatment of superficial vein reflux:

• Venefit™ with ClosureFast™ catheter formerly known as the VNUS Closure™ System (radiofrequency device)
• Endovenous laser therapy devices include the Medilas D FlexiPulse surgical laser, VenaCure EVLT® system, ELVeS® PL Laser System, Vari-Lase® Endovenous Laser Procedure Kit, Cooltouch CTEV®, and Pro-V™
• Modified Erbe Erbokryo® (cryosurgical device)

Endovenous mechanochemical ablation is a minimally invasive treatment for varicose veins, combining sclerotherapy and mechanical damage to the lumen. The procedure involves the use of a special percutaneous infusion catheter which contains a rotating wire, providing endovenous mechanical destruction. Simultaneously, an FDA-approved sclerosing agent is administered in order to enhance occlusion of the vein. The ClariVein® Infusion Catheter received marketing clearance through the FDA's 510(k) process in 2008. 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.

Phlebectomy, also referred to as ambulatory phlebectomy, microphlebectomy, hook phlebectomy stab avulsion or transilluminated powered phlebectomy (TIPP) is a surgical technique to remove varicosed veins. Phlebectomy is generally performed in an outpatient setting using local anesthesia and may be performed along with other treatments for varicose veins such as laser or radiofrequency ablation. Phlebectomy is a procedure and is exempt from FDA approval requirements. One device for performing TIPP, The Trivex® system, 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."

Sclerotherapy is a form of treatment for varicose veins that involves injecting an irritant (sclerosing agent) into the target vessel to destroy the endothelium, resulting in occlusion of the vessel. Technical improvements in sclerotherapy have included the routine use of duplex or Doppler ultrasound to target refluxing vessels, luminal compression of the vein with anesthetics, and use of a foam sclerosant in place of liquid sclerosant. The long-term advantage of sclerotherapy compared to surgical treatment has not been documented in the peer-reviewed medical literature. The FDA has approved several sclerosing agents for use in treating varicose veins of the lower extremities. These include sodium tetradecyl sulfate (e.g., Sotradecol®), polidocanol (e.g., Asclera®) and morrhuate sodium (e.g., Scleromate™). Varithena™ formerly known as Varisolve® was approved by the FDA in 2013 under a new drug application. It is a 1% polidocanol injectable foam indicated for treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee.

Venous system: The venous system of the lower extremities includes the following:

• Superficial veins including the great and small saphenous and accessory, or duplicate veins that travel in parallel with the great and small saphenous veins
• Deep vein system consisting of the popliteal and femoral veins
• Perforator veins cross through the fascia and connect the deep and superficial venous systems
• Tributary veins empty into a larger vein.

I.   Endovenous Radiofrequency and Laser Ablation

Great Saphenous Vein (GSV) and/or Small Saphenous Vein (SSV) 

• Endovenous radiofrequency or laser ablation of the GSV or SSV may be considered MEDICALLY NECESSARY AND APPROPRIATE as a treatment of symptomatic varicose veins/venous insufficiency when ALL of the following criteria have been met:
  • Duplex ultrasound demonstrates that the diameter of target vessel is 3.5 mm to no more than 15 mm; AND
  • Duplex ultrasound performed while the patient is standing document reflux of 0.5 seconds or greater; AND
  • Duplex ultrasound of the deep and superficial venous system demonstrates the absence of deep venous thromboembolism; AND
  • Documentation of one of more of the following indications:
    • Ulceration secondary to venous stasis that fails to respond to at least 3 months of compression therapy or recurrence of previously healed venous ulcer despite ongoing use of compression therapy; OR
    • Recurrent superficial thrombophlebitis that fails to respond to at least 3 months of compression therapy; OR
    • Recurrent bleeding episodes from a ruptured superficial varicosity; OR
    • Symptoms characterized by severe, persistent pain, swelling, or heaviness and throbbing that interfere with activities of daily living (e.g., impaired mobility) after compression therapy for at least 3 months has not improved symptoms.

Accessory Saphenous Veins

• Endovenous radiofrequency or laser ablation of accessory saphenous veins may be considered MEDICALLY NECESSARY AND APPROPRIATE as a treatment of symptomatic varicose veins/venous insufficiency when ALL of the following criteria are met:
  • All the criteria in the policy statement directly above (for GSV and/or SSV) have been met; AND
  • Duplex ultrasound of the deep and superficial venous system demonstrates that the incompetence of the accessory saphenous vein is isolated, or the great or small saphenous veins have been previously eliminated.

Perforator Veins

• Endovenous radiofrequency or laser ablation of perforator veins may be considered MEDICALLY NECESSARY AND APPROPRIATE as a treatment of leg ulcers associated with chronic venous insufficiency when ALL of the following criteria are met:
  • Duplex ultrasound demonstrates that the diameter of target vessel is 3.5 mm to no more than 15 mm; AND
  • Duplex ultrasound of the deep and superficial venous system performed while the patient is standing documents perforator vein reflux of 0.5 seconds or greater; AND
  • Duplex ultrasound of the deep and superficial venous system demonstrates that the incompetence of the perforator vein is isolated, or the great and small saphenous veins have been previously eliminated; AND
  • Duplex ultrasound of the deep and superficial venous system demonstrates the absence of deep venous thromboembolism; AND
  • Ulceration secondary to venous stasis that fails to respond to at least 3 months of compression therapy.

Treatment that does not meet does not meet the criteria described above is considered NOT MEDICALLY NECESSARY.

II.    Cyanoacrylate Closure

Great Saphenous Vein (GSV) and/or Small Saphenous Vein (SSV)

• Cyanoacrylate adhesive for closure of the GSV and/or SSV may be considered MEDICALLY NECESSARY AND APPROPRIATE as a treatment of symptomatic varicose veins/venous insufficiency when ALL of the following criteria are met:
  • Duplex ultrasound demonstrates that the diameter of target vessel is 3.5 mm to no more than 12 mm; AND
  • Duplex ultrasound performed while the patient is standing documents reflux of 0.5 seconds or greater; AND
  • Duplex ultrasound of the deep and superficial venous system demonstrates the absence of deep venous thromboembolism; AND
  • Documentation of one of more of the following indications:
    • Ulceration secondary to venous stasis that fails to respond to at least 3 months of compression therapy or recurrence of previously healed venous ulcer despite ongoing use of compression therapy; OR
    • Recurrent superficial thrombophlebitis that fails to respond to at least 3 months of compression therapy; OR
    • Recurrent bleeding episodes from a ruptured superficial varicosity; OR
    • Symptoms characterized by severe, persistent pain, swelling, or heaviness and throbbing that interfere with activities of daily living (e.g., impaired mobility) after compression therapy for at least 3 months has not improved symptoms.

Accessory Saphenous Veins

• Cyanoacrylate adhesive closure of accessory saphenous veins may be considered MEDICALLY NECESSARY AND APPROPRIATE as a treatment of symptomatic varicose veins/venous insufficiency when ALL of the following criteria are  met:
  • All the criteria in the policy statement directly above (for GSV and/or SSV) have been met; AND
  • Duplex ultrasound of the deep and superficial venous system demonstrates that the incompetence of the accessory saphenous vein is isolated, or the great or small saphenous veins have been previously eliminated.

Treatment that does not meet does not meet the criteria described above is considered NOT MEDICALLY NECESSARY.

III.  Sclerotherapy

• Sclerotherapy may be considered MEDICALLY NECESSARY AND APPROPRIATE for initial or follow-up treatment of varicose tributaries, accessory or perforator veins when ALL of the following criteria are met:
  • Duplex ultrasound demonstrates that the diameter of the target vessel is between 3 mm and 6 mm; AND
  • Duplex ultrasound performed while the patient is standing demonstrates reflux of accessory or tributary veins of >0.5 seconds or >0.35 of perforator veins. AND
  • Duplex ultrasound of the deep and superficial venous system demonstrates that the incompetence of the tributary, accessory or perforator vein is isolated or the great or small saphenous veins have been previously eliminated. AND
  • Duplex ultrasound of the deep and superficial venous system demonstrates the absence of deep venous thromboembolism; AND
  • Documentation of one of more of the following indications: 
    • Ulceration secondary to venous stasis that fails to respond to at least 3 months of compression therapy or recurrence of previously healed venous ulcer despite ongoing use of compression therapy; OR
    • Recurrent superficial thrombophlebitis that fails to respond to at least 3 months of compression therapy; OR
    • Recurrent bleeding episodes from a ruptured superficial varicosity; OR
    • Symptoms characterized by severe, persistent pain, swelling, or heaviness and throbbing that interfere with activities of daily living (e.g., impaired mobility) after compression therapy for at least 3 months has not improved symptoms.

Treatment that does not meet does not meet the criteria described above is considered NOT MEDICALLY NECESSARY.

IV.   Phlebectomy

• Phlebectomy may be considered MEDICALLY NECESSARY AND APPROPRIATE as adjunctive treatment of varicose accessory and tributary veins when performed with surgical, radiofrequency or laser ablation of the great or small saphenous veins and ALL of the following criteria are met:
  • Duplex ultrasound demonstrates that the diameter of the target vessel is 2.5 mm or greater; AND
  • Duplex ultrasound performed while the patient is standing demonstrates reflux of 0.5 seconds or greater; AND
  • Duplex ultrasound of the deep and superficial venous system demonstrates the absence of deep venous thromboembolism AND
  • Documentation of one or more of the following indications:
    • Ulceration secondary to venous stasis that fails to respond to at least 3 months of compression therapy or recurrence of previously healed venous stasis ulcer despite ongoing use of compression therapy; OR
    • Recurrent superficial thrombophlebitis that fails to respond to at least 3 months of compression therapy; OR
    • Recurrent bleeding episodes from a ruptured superficial varicosity; OR
    • Symptoms characterized by severe, persistent pain, swelling or heaviness and throbbing that interfere with activities of daily living (e.g., impaired mobility) after compression therapy for at least 3 months has not improved symptoms.
• Phlebectomy may be considered MEDICALLY NECESSARY AND APPROPRIATE as adjunctive treatment of varicose accessory and tributary veins in the absence of saphenous vein reflux or when performed during or after the patient has undergone saphenous vein ablation, ligation or stripping and ALL of the following criteria are met:
  • Duplex ultrasound demonstrates that the diameter of the target vessel is 2.5 mm or greater; AND
  • Duplex ultrasound performed while the patient is standing demonstrates reflux of 0.5 seconds or greater; AND 
  • Duplex ultrasound of the deep and superficial venous system demonstrates that the incompetence is isolated, or the great or small saphenous veins have been previously eliminated; AND
  • Duplex ultrasound of the deep and superficial venous system demonstrates that the absence of deep venous thromboembolism; AND
  • Documentation of one or more of the following indications:
    • Ulceration secondary to venous stasis that fails to respond to at least 3 months of compression therapy or recurrence of previously healed venous stasis ulcer despite ongoing use of compression therapy; OR
    • Recurrent superficial thrombophlebitis that fails to respond to at least 3 months of compression therapy; OR
    • Recurrent bleeding episodes from a ruptured superficial varicosity; OR
    • Symptoms characterized by severe, persistent pain, swelling or heaviness and throbbing that interfere with activities of daily living (e.g., impaired mobility) after compression therapy for at least 3 months has not improved symptoms.

Treatment that does not meet does not meet the criteria described above is considered NOT MEDICALLY NECESSARY.

V.   Experimental/Investigative Uses

The following are considered EXPERIMENTAL/INVESTIGATIVE for the treatment of varicose veins of the lower extremities due to the lack of clinical evidence demonstrating an impact on improved health outcomes:

• Endovenous cryosurgery (including but not limited to cryoablation, cryofreezing and transilluminated cryosurgery)
• Endovenous mechanochemical ablation (e.g. ClariVein™ Catheter)
• Noninvasive techniques including but not limited to intense pulsed light and transdermal laser (eg, Photoderm VL, Vasculight IPL, Nd: YAG laser)

VI.  Cosmetic Uses

Treatment of varicose veins of the lower extremities with any procedure is considered COSMETIC for the following as it is performed primarily to enhance or otherwise alter physical appearance without correcting or improving a physiological function:

• Treatment of telangiectasias (e.g., spider veins, angiomata and hemangiomata)

Documentation Submission

The following documentation may be requested:

• Clinical history including duration and outcomes of conservative therapies;
• Duplex ultrasound report demonstrating duration of reflux for the vein(s) being treated; and
• High-resolution color photos documenting skin changes, dermatitis, and/or ulceration.