Treatment of Varicose Veins/Venous Insufficiency

POLICY NUMBER

A.7.01.124

DESCRIPTION

A variety of treatment modalities are available to treat varicose veins/venous insufficiency, including surgery, thermal ablation, sclerotherapy, mechanochemical ablation (MOCA), cyanoacrylate adhesive (CAC), and cryotherapy. The application of each modality is influenced by the severity of the symptoms, type of vein, 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 the 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 of venous disease 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 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 has traditionally included 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 great and/or small 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. They include forms of sclerotherapy, cyanoacrylate adhesive, and thermal ablation using cryotherapy, high-frequency radio waves (200–300 kHz), or laser energy.

Thermal Ablation

Radiofrequency ablation is performed using 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 is performed similarly. A laser fiber is introduced into the great saphenous vein under ultrasound guidance. The laser is then activated and slowly removed along the course of the saphenous vein. Cryoablation uses extreme cold. The objective of endovenous techniques is to injure 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.

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 occluding the vessel. Treatment success 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 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 produced by forcibly mixing a gas (eg, 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. A commercially available microfoam sclerosant with a proprietary gas mix is available that is proposed to provide a smaller and more consistent bubble size than what is produced with physician-compounded sclerosant foam.

Endovenous Mechanochemical Ablation

Endovenous mechanochemical ablationuses 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 3500 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 the need for the tumescent anesthesia used with endovenous thermal ablation techniques (radiofrequency ablation, endovenous laser ablation).

Cyanoacrylate Adhesive

A cyanoacrylate adhesive is a clear, free-flowing liquid that polymerizes in the vessel via an anionic mechanism (ie, 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 surgical incisions or other skin wounds.

Transilluminated Powered Phlebectomy

Transilluminated powered phlebectomy is an alternative to stab avulsion and hook phlebectomy. This procedure uses two instruments: an illuminator, which also provides irrigation, and a resector, which has an oscillating tip and suction pump. 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 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 transilluminated powered phlebectomy might decreasesurgical time, decrease complications such as bruising, and lead to a faster recovery than established procedures.

In 2015, the VenaSeal™ Closure System (Sapheon, 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.

In 2013, Varithena® (formerly Varisolve), a sclerosant microfoam made with a proprietary gas mix, was approved by the FDA under a new drug application (205-098) 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 were cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for endovenous treatment of superficial vein reflux:

• In 1999, the VNUS Closure® System, a radiofrequency device, was cleared by the FDA through the 510(k) process for "endovascular coagulation of blood vessels in patients with superficial vein reflux." In 2005, the VNUS RFS® and RFSFlex® devices were cleared by the FDA for “use in vessel and tissue coagulation including treatment of incompetent (i.e., refluxing) perforator and tributary veins." In 2008, the modified VNUS® ClosureFast® Intravascular Catheter was cleared by the FDA through the 510(k) process.

• In 2002, the Diomed 810 nm surgical laser and EVLT® (endovenous laser therapy) procedure kit were cleared by the FDA through the 510(k) process "... for use in the endovascular coagulation of the great saphenous vein of the thigh in patients with superficial vein reflux."

• In 2005, a modified Erbe Erbokryo cryosurgical unit (Erbe USA) was approved by the FDA for marketing through the 510(k) process. A variety of clinical indications are listed, including cryostripping of varicose veins of the lower limbs.

• In 2003, the Trivex system (InaVein), a device for transilluminated powered phlebectomy, was cleared by the FDA through the 510(k) process for “ambulatory phlebectomy procedures for the resection and ablation of varicose veins.”

• In 2008, the ClariVein® Infusion Catheter (Merit Medical) was cleared by the FDA through the 510(k) process (K071468) for mechanochemical ablation. The FDA determined that this device was substantially equivalent to 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.

POLICY

Great or Small Saphenous Veins

Treatment of the great or small saphenous veins by surgery (ligation and stripping), endovenous thermal ablation (radiofrequency or laser), microfoam sclerotherapy or cyanoacrylate adhesive may be considered medically necessary for symptomatic varicose veins/venous insufficiency when the following criteria have been met:

Treatment of great or small saphenous veins by surgery, endovenous radiofrequency or laser ablation, microfoam sclerotherapy or cyanoacrylate adhesive that does not meet the criteria described above is considered cosmetic and investigational.

Accessory Saphenous Veins

Treatment of accessory saphenous veins by surgery (ligation and stripping), endovenous radiofrequency or laser ablation, microfoam sclerotherapy or cyanoacrylate adhesive may be considered medically necessary for symptomatic varicose veins/venous insufficiency when the following criteria have been met:

• Incompetence of the accessory saphenous vein is isolated; AND

• • Ulceration secondary to venous stasis; OR

  • Recurrent superficial thrombophlebitis; OR

  • Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity; OR

  • Persistent pain, swelling, itching, burning, or other symptoms are associated with saphenous reflux, AND the symptoms significantly interfere with activities of daily living, AND conservative management including compression therapy for at least 3 months has not improved the symptoms.

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

Treatment of accessory saphenous veins by surgery, endovenous radiofrequency or laser ablation, or microfoam sclerotherapy or cyanoacrylate adhesive that does not meet the criteria described above is considered cosmetic andinvestigational.

Symptomatic Varicose Tributaries

The following treatments are considered medically necessary as a component of the treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment (surgical, radiofrequency, or laser) of the saphenous veins (none of these techniques has been shown to be superior to another):

• Stab avulsion

• Hook phlebectomy

• Sclerotherapy

• Transilluminated powered phlebectomy.

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

Perforator Veins

Surgical ligation (including subfascial endoscopic perforator surgery) or endovenous radiofrequency or laser ablation of incompetent perforator veins may be considered medically necessary as a treatment of leg ulcers associated with chronic venous insufficiency when the following conditions have been met:

• There is demonstrated perforator reflux; AND

• The superficial saphenous veins (great, small, or accessory saphenous and symptomatic varicose tributaries) 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 or ablation of incompetent perforator veins performed concurrently with superficial venous surgery is investigational.

Telangiectasia

Treatment of telangiectasia such as spider veins, angiomata, and hemangiomata is considered cosmetic and investigational.

Other Veins

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

• Sclerotherapy techniques, other than microfoam sclerotherapy, of great, small, or accessory saphenous veins;

• Sclerotherapy of perforator veins;

• Sclerotherapy of isolated tributary veins without prior or concurrent treatment of saphenous veins;

• Stab avulsion, hook phlebectomy, or transilluminated powered phlebectomy of perforator, great or small saphenous, or accessory saphenous veins;

• Endovenous radiofrequency or laser ablation of tributary veins;

• Mechanochemical ablation of any vein;

• Endovenous cryoablation of any vein.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

The standard classification of venous disease is the CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) classification system. The following is the Clinical portion of the CEAP.

Clinical Portion of the CEAP Classification System

Adapted from: https://www.jvsvenous.org/article/S2213-333X(20)30063-9/pdf CEAP: Clinical, Etiologic, Anatomic, Pathophysiologic classification system; CVD: Chronic venous disease. Each clinical class subcharacterized by a subscript indicates the presence (symptomatic, s) or absence (asymptomatic, a) of symptoms attributable to venous disease.

It should be noted that the bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of the saphenous vein, as opposed to the varicose tributaries. When ultrasound guidance is used to guide sclerotherapy of the varicose tributaries, it would be considered either investigational or incidental to the injection procedure.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/22/2010: Approved by Medical Policy Advisory Committee.

04/20/2011: Policy reviewed; no changes.

04/26/2012: Policy reviewed; no changes.

08/09/2013: For consistency, the term “endoluminal” was with “endovenous” throughout the policy. Intent of policy statements unchanged. Mechanochemical ablation was added as an investigational technique.

02/20/2014: Added echosclerotherapy to the investigational policy statement. Added HCPCS code S2202 to the Investigational Codes table. (Note: Procedure was previously addressed in a separate medical policy for Echosclerotherapy.)

04/01/2014: Policy statement updated to include medically necessary criteria for the treatment of accessory saphenous veins.

01/19/2015: Policy description updated regarding saphenous veins and tributaries, endovenous mechanochemical ablation, and devices. Added microfoam sclerotherapy to the medically necessary policy statements for the treatment of the greater or lesser and accessory saphenous veins. Added "techniques, other than microfoam sclerotherapy" to the investigational policy statement and removed echosclerotherapy.

09/01/2015: Code Reference section updated for ICD-10. Added ICD-9 procedure code 38.89.

02/10/2016: Terminology changed throughout policy from "greater" and "lesser" to "great" and "small." Policy description updated regarding cyanoacrylate adhesive and devices. Added CEAP class C2 or greater as a medically necessary indication for great or small saphenous veins. Removed the requirement of failure to respond to compressive therapy from the medically necessary policy statements on ulceration secondary to venous stasis and recurrent superficial thrombophlebitis. Cyanoacrylate adhesive of any vein added as investigational. Policy guidelines updated to add the clinical classification table and medically necessary and investigative definitions. Code Reference section updated to remove deleted CPT code 36469.

05/31/2016: Policy number A.7.01.124 added.

12/30/2016: Code Reference section updated to add new 2017 CPT codes 36473 and 36474. Revised code descriptions for CPT codes 36476 and 36479.

06/22/2017: Policy description updated. Policy statements unchanged.

09/29/2017: Code Reference section updated to add new ICD-10 diagnosis codes L97.105, L97.106, L97.108, L97.115, L97.116, L97.118, L97.125, L97.126, L97.128, L97.205, L97.206, L97.208, L97.215, L97.216, L97.218, L97.225, L97.226, and L97.228. Revised description for ICD-10 diagnosis codes I83.811 - I83.819 and I83.891 - I83.899. Effective 10/01/2017.

12/21/2017: Code Reference section updated to add new 2018 CPT codes 36465, 36466, 36482, and 36483. Revised descriptions for CPT codes 36470, 36471, and 36468.

06/19/2018: Policy description updated. Policy statements unchanged.

03/08/2019: Policy description updated. Policy statements unchanged. Policy Guidelines updated regarding ultrasound guidance. Code Reference section updated to remove deleted ICD-10 procedure codes 06DR0ZZ, 06DR3ZZ, 06DR4ZZ, 06DS0ZZ, 06DS3ZZ, 06DS4ZZ, 06LR0CZ, 06LR0DZ, 06LR0ZZ, 06LR3CZ, 06LR3DZ, 06LR3ZZ, 06LR4CZ, 06LR4DZ, 06LR4ZZ, 06LS0CZ, 06LS0DZ, 06LS0ZZ, 06LS3CZ, 06LS3DZ, 06LS3ZZ, 06LS4CZ, 06LS4DZ, and 06LS4ZZ.

02/12/2020: Policy description updated regarding sclerotherapy. Cyanoacrylate adhesive changed from investigational to medically necessary. Added medically necessary statement regarding concurrent treatment of the accessory saphenous veins. Table in Policy Guidelines updated. Code Reference section updated to move CPT codes 36482 and 36483 from investigational to covered. Added ICD-10 diagnosis codes I83.001 - I83.009, I83.011 - I83.019, and I83.021 - I83.029.

07/08/2020: Policy description updated regarding treatment of saphenous veins and tributaries. Policy statements unchanged. Policy Guidelines updated regarding the CEAP classification system.

08/24/2021: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

06/20/2022: Policy reviewed. Second policy statement regarding treatment of great or small saphenous veins updated to change "not medically necessary" to "investigational." Policy intent unchanged.

07/14/2023: Policy reviewed. Policy section and Policy Guidelines updated to change "not medically necessary" to "investigational."

06/13/2024: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to revise definition on the classification system.

08/13/2025: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to add table heading and source link.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.124

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

Investigational Codes

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