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A variety of treatment modalities are available to treat varicose veins/venous insufficiency, including surgical approaches, thermal ablation, and sclerotherapy. The application of each of these treatment options is influenced by the severity of the symptoms, type of vein, source of venous reflux, and the use of other (prior or concurrent) treatments.
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 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 which become incompetent when the great or small saphenous veins are eliminated and blood flow is diverted through the accessory veins.
Saphenous Veins and Tributaries
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.
Endovenous Mechanochemical Ablation
Transilluminated Powered Phlebectomy
Treatment of Perforator Veins
Outcomes of interest for venous interventions include healing and recurrence, recannulation of the vein, and neovascularization. Recannulation (recanalization) is the restoration of the lumen of a vein after it has been occluded; this occurs more frequently following treatment with endovenous techniques. Neovascularization is the proliferation of new blood vessels in tissue, and occurs more frequently following vein stripping. Direct comparisons of durability for endovenous and surgical procedures are complicated by these different mechanisms of recurrence. Relevant safety outcomes include the incidence of paresthesia, thermal skin injury, thrombus formation, thrombophlebitis, wound infection, and transient neurologic effects.
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.
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:
Great or Small Saphenous Veins
Treatment of the great or small saphenous veins by surgery (ligation and stripping), endovenous radiofrequency or laser ablation, or microfoam sclerotherapy 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, or microfoam sclerotherapy that do not meet the criteria described above is considered cosmetic and not medically necessary.
Accessory Saphenous Veins
Treatment of accessory saphenous veins by surgery (ligation and stripping), endovenous radiofrequency or laser ablation, or microfoam sclerotherapy may be considered medically necessary for symptomatic varicose veins/venous insufficiency when the following criteria have been met:
Treatment of accessory saphenous veins by surgery or endovenous radiofrequency or laser ablation, microfoam sclerotherapy, that do not meet the criteria described above is considered cosmetic and not medically necessary.
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):
Treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment of saphenous veins using any other techniques than noted above is considered investigational.
Surgical ligation (including SEPS) 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:
Ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery is not medically necessary.
Treatment of telangiectasia such as spider veins, angiomata, and hemangiomata is considered cosmetic and not medically necessary.
Techniques for conditions not specifically listed above are investigational, including, but not limited to:
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.
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 Classification Active venous ulcer
Active venous ulcer
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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 added.
Blue Cross Blue Shield Association policy # 7.01.124
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.