LCD L38720: Treatment of Chronic Venous Insufficiency of the Lower Extremities

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Chronic Venous Insufficiency (CVI) is a cause of abnormalities of the venous system producing edema, skin changes, or venous ulcers that is associated with varicose veins. 1,2 Varicose veins of the lower extremities are a manifestation of chronic venous disease (CVD) and are a common disorder in the United States. They are dilated subcutaneous veins that are greater than or equal to 3 millimeters in diameter and have reflux >500 milliseconds in an upright position. They may be caused by primary venous disease with local or multifocal structural weakness of the vein wall leading to valvular insufficiency or valvular reflux. Secondary causes include a previous deep vein thrombosis, a deep venous obstruction, superficial thrombophlebitis, an arteriovenous fistula or a congenital venous malformation. Varicosities are frequently the cause of discomfort, pain, disability and deterioration of health-related quality of life (QOL). 3

Clinical outcome studies evaluate the results of procedures on patient-focused outcomes, including symptom improvement, recurrence of varicosity, healing or recurrence of skin ulcers, improvement in the chronic, progressive symptoms of CVD/CVI, improved QOL and improved activities of daily living. 3 Patient outcome assessments or quality of life instruments can be measured before and after treatment. Below are some examples (not all inclusive) of the validated assessment tools:

• AVVQ: Aberdeen Varicose Vein Questionnaire 4

• HASTI: (heaviness, achiness, swelling, throbbing, itching) score 5

• Veines-QOL: Venous Insufficiency Epidemiological and Economic Study-Quality-of-Life/Symptoms 5

• CIVIQ-20: Chronic Venous Insufficiency Quality-of-Life Questionnaire 6

Terminology of veins discussed within this LCD

Superficial, deep and perforating veins make up the lower extremity venous system. Superficial veins, which are located between the deep fascia and the skin, include the telangiectasia veins, the reticular veins and the main axial (truncal) superficial veins; the great and small saphenous veins and their tributaries. 2,7 Deep veins, which lie beneath the muscular fascia, include the following: inferior vena cava, common iliac, internal iliac, external iliac, pelvic, gonadal, broad ligament, common femoral, deep femoral, femoral, popliteal, crural (anterior tibial, posterior tibial, or peroneal), and muscular (gastrocnemius, soleus and other). 3,7,8 Perforating veins, which penetrate the muscular fascia and connect the superficial and deep veins, include numerous veins from those of the foot, the medial and lateral calf, and the thigh. 7

Telangiectasia veins (also known as “spider veins”) are small, dilated, flat, thin-walled, blue or red veins 2 Reticular veins are a network of veins parallel to the skin surface and lying between the saphenous fascia and dermis, which drain the lower extremity skin and subcutaneous tissue and have a diameter 1-3 mm (also known as blue veins or feeder veins). 2

The axial superficial veins communicate with the deep venous system at different locations. The point where the great saphenous vein (GSV) joins the common femoral vein, the saphenofemoral junction (SFJ), is located proximally at the groin. The point where the small saphenous vein (SSV) joins the popliteal vein, the saphenopopliteal junction (SPJ), is typically located behind the knee. Clinically significant reflux can also be found in accessory great saphenous veins (i.e., Anterior Accessory Great Saphenous Vein [AAGSV] or Posterior Accessory Great Saphenous Vein [PAGSV]) which parallel the GSV in the saphenous compartment, the SSV, or perforating veins. The perforator veins drain from the superficial veins toward the deep (intramuscular) veins. Pathologic perforator veins are defined by outward flow duration >500 ms, vein diameter >3.5 mm and located underneath skin damage or ulceration. 7 Variations in the anatomy of the deep and superficial venous systems are common.

Classification for chronic venous disorders (CVD and CVI)

The CEAP classification

The CEAP classification for chronic venous disorders was developed by an international committee that classifies venous disease according to the clinical manifestations (C), etiologic factors (E), anatomic distribution of disease (A), and underlying pathophysiologic findings (P), or CEAP. 8 Advanced CEAP: Same as basic CEAP, with addition that any of 18 named venous segments can be used as locators for venous pathology.

The Venous Clinical Severity Score (VCSS)

The VCSS system includes 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, size of ulcer, and compressive therapy use), scored from 0 to 3 (total possible score, 30) that may be used to assess changes in response to therapy. 9

Duplex Scanning

International consensus documents previously recommended 0.5 seconds as a cutoff value for all veins to use for lower limb venous incompetence. 10 Cutoff values of both 350 milliseconds and 500 milliseconds have been suggested for the perforating veins. 500 milliseconds is recommended as the cutoff value for saphenous, tibial, deep femoral, and perforating vein incompetence, and 1 second for femoral and popliteal vein incompetence. 3

Conservative management for chronic venous insufficiency (Noninvasive procedures)

Conservative therapy for uncomplicated cases may be sufficient for symptom relief and early signs of venous insufficiency. Conservative therapy refers to the nonsurgical management of varicose veins which includes leg elevation, weight management for the overweight and obese, and the use of graduated compression stockings or wraps. Leg elevation helps venous return and decreases venous hypertension; in contrast, standing for long periods or sitting with legs dependent for long periods, can aggravate the symptoms and signs of venous insufficiency.

The rationale for compression therapy is to decrease venous hypertension and to assist the calf muscle pump. Compression therapy is an important adjunct for patients with advanced signs of venous insufficiency especially those with edema, skin changes, and venous stasis ulcers (C3-C6). Patients with symptomatic venous insufficiency and/or swollen limbs often find that properly fitted graduated compression stockings relieve many of their symptoms.

Invasive Procedures for the management of chronic venous insufficiency:

• Sclerotherapy:

Sclerotherapy is a treatment of the veins using liquid sclerosant agents or sclerosing foam. 2 Sclerosing agents are a chemical agent that causes endothelial damage leading to sclerosis of the venous segment once it is injected into the vein lumen. Sclerosing foam is made from a sclerosant agent and a gas. 2

• Foam Sclerosant: Ultrasound-Guided Foam Sclerotherapy (UGFS):

Foam sclerotherapy is a procedure that is performed under ultrasound guidance. There are different types of foam: physician-compounded foam (PCF) and non-compounded foam (NCF). The target, non-target, perforating, and adjacent deep veins are evaluated by ultrasound. UGFS is used for treatment of primary and recurrent varicose veins, including the distal GSV and SSV, perforating veins, and venous malformations. 3

• Liquid Sclerosant:

Liquid sclerotherapy is often used to treat cosmetic telangiectasias and reticular veins. Liquid sclerotherapy is also of value in addressing bleeding telangiectasia and for select cases of large vein treatment where unique patient features suggest liquid may be a safer option.

Some examples (not all inclusive) of agents for sclerotherapy include sodium tetradecyl sulfate (STS), polidocanol, sodium morrhuate, and glycerin, which is typically used with epinephrine.

• Thermal Ablation: Radiofrequency Ablation (RFA), Endovenous Radiofrequency Ablation (ERFA), Endovenous Laser Ablation (EVLA), Endovenous Laser Ablation Therapy (EVLT)

Radiofrequency ablation is a minimally invasive endovenous thermal ablation procedure that involves using ultrasound guidance to puncture the vein, position a catheter and perform tumescent anesthesia. Radiofrequency current is delivered resulting in heat destruction while an inflammatory response enhances wall destruction. The purpose of RFA is to damage the collagen of the vein wall resulting in fibrosis and occlusion of a vein segment to eliminate reflux. This procedure may be performed in the outpatient setting.

EVLT is a minimally invasive alternative to high ligation and saphenous vein stripping (HL/S). It is only a treatment option for sufficiently straight superficial vein segments that will allow passage of the device. The purpose of EVLA is to damage the endothelium of the vein resulting in fibrosis and occlusion of a vein segment to eliminate reflux. The thermal ablation techniques are appropriate for the primary treatment of the GSV and/or SSV, and incompetent accessory saphenous veins.

• Chemical Adhesive:

Chemical adhesive (also known as glue embolization, glue adhesive ablation or cyanoacrylate adhesive) is a procedure where an embolic agent is injected into the vein. The embolic agent polymerizes upon contact with blood and causes the adhesive to form a solid, permanent implant, thus closing the vein. T here is no tumescent local anesthesia required, minimizing risks and no postoperative compression therapy required.

The technique of cyanoacrylate closure (CAC), which is one of the most common liquid embolic agents, 2 uses a proprietary adhesive for the treatment of refluxing saphenous veins. 5

• Mechanochemical Ablation:

Mechanochemical ablation (also referred to as MOCA, MECA) is a technique used to ablate superficial veins with an oscillating wire that rotates and disrupts the endothelial lining of target veins while a sclerosant is injected to penetrate the deep layers of the vein causing vein sclerosis. This technique is appropriate for the treatment of truncal veins. 2

• Surgical: Ligation, Stripping, Phlebectomy:

The traditional treatment of varicose veins in the lower legs includes a surgical procedure called high ligation and saphenous vein stripping (HL/S). Its primary goal is removal of refluxing veins and improvement of symptoms. HL/S is typically a three-step process. The first step is controlling reflux by proximal ligation of an incompetent vein. The second step is stripping a vein segment (usually the GSV or SSV) or removing of an incompetent long axial vein segment (usually the saphenous vein) from circulation through incisions in the groin and lower in the leg. The third step is removing tributaries via stab phlebectomies or sclerotherapy, either at the time of ligation or subsequent to the ligation. Phlebectomy, also referred to as stab avulsion, ambulatory stab phlebectomy, or microphlebectomy, is a surgical treatment involving the removal of varicose veins through small “stab” 1-2 mm incisions in the skin overlying the vein. The vein is hooked and brought to the surface at each incision site to release it from the surrounding tissues and to sever any connections to other veins. 2

Plan of Care for Invasive Procedures:

The plan of care, for a 90 day episode of care, is based on the treating physician’s assessment. The minimum evaluation that must be documented includes the history, physical examination, CEAP clinical classification, VCSS, and a venous duplex scan documenting the venous flow.

Supplemental plethysmography, contrast venography, venous pressure measurements, intravascular ultrasound (IVUS), computed tomography (CT) venography, or magnetic resonance (MR) venography may be relevant to the plan of care in patients with severe or unusual presentations of venous disease in which there is possible concurrent involvement of pelvic veins or arterial-venous malformations or fistulae. Indications for these more extensive procedures should be documented in the plan of care.

Covered Indications

• Invasive procedures will be considered medically reasonable and necessary if the patient meets the criteria as outlined in this LCD, and the intervention is addressed and supported in the plan of care, for a 90 day episode of care, that includes a specific treatment plan determined by the assessment and evaluation of the lower extremity venous incompetence.

• Invasive procedures for the treatment of varicose veins are considered medically reasonable and necessary when ALL of the following criteria have been met:

• An evaluation of the patient has been performed including a history and physical examination, the CEAP clinical classification and the revised Venous Clinical Severity Score (VCSS), AND

• A duplex scan of the deep and superficial venous systems supports the examination findings, 3 AND

• A duplex scan confirms the presence of reversed venous flow (reflux) with provocative maneuvers in the saphenous, or perforator veins is 500 milliseconds or greater 3 and absence of deep venous obstruction, AND

• The documentation supports signs and/or symptoms that interfere with activities of daily living and/or quality of life, AND

• The CEAP clinical classification is C1 to C6 with the following criteria:

• Treatment of C1 disease (telangiectasia and their feeding reticular veins) is considered medically reasonable and necessary for patients with spontaneous and/or traumatic venous hemorrhage.

• For patients with C2 or C3 disease and VCSS

• VCSS ≥6

• C4-C6 disease (skin changes assigned to venous disease, healed venous leg ulceration, and active venous leg ulceration)

• Hemorrhage

• Recurrent superficial thrombophlebitis

• Incompetent perforator vein (IPV) management by foam sclerotherapy or thermal ablation, will be considered medically reasonable and necessary when:

• An active venous ulcer is in close proximity to the IPV, OR

• The proximal significant reflux has been treated and an IPV persists under or adjacent to a healed venous ulcer, OR

• The proximal and regional venous reflux has been treated and there is persisting focal pain and tenderness or stasis dermatitis overlying an IPV, OR

• The incompetent perforator demonstrates reflux >500 ms and diameter > 3.5 mm.

• Ultrasound guided foam sclerotherapy (UGFS), physician-compounded foam (PCF) and non-compounded foam (NCF) will be considered medically reasonable and necessary for ablation of incompetent saphenous veins and tributary veins for the treatment of patients with symptomatic CEAP clinical classification C2 to C6 disease. UGFS is also considered medically reasonable and necessary for ablation of venous malformations.

• Liquid sclerotherapy will be considered medically reasonable and necessary for ablation of incompetent saphenous veins and tributary veins for the treatment of patients with symptomatic CEAP clinical classification C2 to C6 disease. Liquid sclerotherapy is also considered medically reasonable and necessary for the treatment of patients with symptomatic CEAP clinical classification C1 (telangiectasia and their feeding reticular veins) with spontaneous and/or traumatic venous hemorrhage.

• Thermal ablation (radiofrequency or laser) will be considered medically reasonable and necessary for ablation of incompetent saphenous veins for the treatment of patients with symptomatic CEAP clinical classification C2 to C6 disease.

• Chemical adhesives will be considered medically reasonable and necessary for ablation of incompetent saphenous veins for the treatment of patients with symptomatic CEAP clinical classification C2 to C6 disease.

• Mechanochemical ablation (MOCA) will be considered medically reasonable and necessary for ablation of incompetent saphenous veins for the treatment of patients with symptomatic CEAP clinical classification C2 to C6 disease.

• It is the responsibility of the provider to comply with all applicable State and Federal laws related to the human use of agents.

• Surgery will be considered medically reasonable and necessary for treatment of incompetent saphenous veins for patients with symptomatic CEAP clinical classification C2 to C6 disease.

• Phlebectomy will be considered medically reasonable and necessary for symptomatic bulbous varicosities greater than 3mm diameter above and below the knees. If saphenous vein ablation is performed, phlebectomy may be staged or concomitant depending upon the vein pattern and/or provider preferences.

Limitations

The following are considered not medically reasonable and necessary:

• The treatment of CEAP clinical classification C0 (no visible or palpable signs of venous disease) is considered cosmetic, and therefore, not reasonable and necessary for the purposes of Medicare coverage.

• The treatment of CEAP clinical classification C1 (telangiectasias or reticular veins) will be considered cosmetic, and therefore, not reasonable and necessary for the purposes of Medicare coverage except in patients with spontaneous and/or traumatic venous hemorrhage.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

A systemic review by Aber et al 4 was conducted of patient reported outcome measures (PROMs) in patients with varicose veins. They noted that there is a scarcity of psychometric evidence for PROMs used in patients with varicose veins. The study suggests that one of the most ruinously evaluated PROMs in patients with varicose veins is the Aberdeen Varicose Vein Questionnaire (AVVQ). This review identified only one generic measure (SF-36) and three disease-specific instruments (AVVQ, VVSymQ, SQOPR-V) that have undergone psychometric assessment in patients with varicose veins. The evidence suggests that the SF-36 exhibits good internal consistency and acceptability among patients with varicose veins, with some evidence of construct validity and responsiveness. It is the only generic PROM with evidence to support its use in patients with varicose veins. The AVVQ had good test retest reliability, construct and criterion validity, and responsiveness. However, the evidence for the content validity was weak, and clinicians and researchers generated the items with limited input from patients; the weighting of the items was based on the judgement of two clinicians. However, it was the most evaluated PROM with five studies examining its psychometric validity. Most varicose vein guidelines recommend using patient quality of life tools (PROMs) to determine the impact or effectiveness of treatment and this study helped to determine which tools would be appropriate by identifying the AAVQ and the 36-Item Short Form Health Survey (SF-36).

Gibson and Ferris 5 discuss the results of a prospective study of cyanoacrylate closure for the treatment of great saphenous vein, small saphenous veins, and/or accessory saphenous veins up to 20mm in diameter. The study included 50 subjects that were treated at a single session that had symptomatic great saphenous vein, small saphenous veins, and/or accessory saphenous veins incompetence. After the procedure was completed these subjects did not use compression stockings and returned for follow up in 1 week and again at 1 month which included numerical pain rating score, revised VCSS, the AVVQ score and time to return to work and normal activities. Each follow up visit included a duplex ultrasound. The authors concluded that cyanoacrylate closure is a safe and effective treatment for the incompetent saphenous or accessory saphenous veins and closure rates were high despite the absence of compression stockings. The patient outcome measures were significant with short time frame of returning to work or normal activities and improvements in VCSS or QOL in comparison to alternative favorable treatment modalities.

Biemans et al 6 in 2013, compared endovenous laser ablation, foam sclerotherapy and conventional surgery for great saphenous varicose veins. The objective was to compare the anatomic success rate, frequency of major complications, and quality-of-life improvement of endovenous laser ablation (EVLA), ultrasound-guided foam sclerotherapy (UGFS), and conventional surgery (CS), after 1-year follow-up. Out of 240 consecutive patients, 80% were classified with C2 or C3 venous disease. The anatomic success rate was highest after EVLA (88.5%), followed by CS (88.2%) and UGFS (72.2%) after 1 year follow up. The authors concluded that EVLA is as effective as conventional surgery and superior to UGFS according to occlusion on ultrasound duplex. All of the patients had significant quality of life improvement.

Kundu et al 11 released joint guidelines (from the Society of Interventional Radiology, Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology and Canadian Interventional Radiology Association) regarding treatment of lower extremity superficial venous insufficiency with ambulatory phlebectomy. The purpose of these guidelines was to be used in quality improvement programs to assess ambulatory phlebectomy (AP). The most important elements of care are (i) pretreatment evaluation and patient selection (ii), performance of the procedure, and (iii) post procedure follow-up care. The outcome measures or indicators for these processes are indications, success rates, and complication rates. The authors concluded that AP is safe and effective as well as an aesthetic procedure for removal of varicose and reticular veins of the lower extremity that can be performed in either the outpatient or inpatient setting. Ambulatory phlebectomy is important for the interventional physician in the treatment of CVD. Thorough training and careful technique are essential for producing optimal results and preventing complications.