CMS Treatment of Chronic Venous Insufficiency of the Lower Extremities Form

Summary Of Evidence

A systemic review by Aber et al⁴ 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 Ferris⁵ 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 al⁶ 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 al¹¹ 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.

Bishawi et al¹² conducted a prospective observational multicenter study on the efficacy of MOCA in patients with lower extremity CVD. At baseline, 126 total patients were included, 81% females. The study included symptomatic patients of CEAP Class 2 or higher requiring treatment of the great saphenous vein (GSV) where the diameter of GSV was measured at 2 cm below the sapheno-femoral junction (SFJ), mid-thigh, and distal thigh. Only veins with >4mm and <12mm in diameter were included. The mean diameter of the great saphenous vein in the upper thigh was 7.3 mm and the mean treatment length was 38 cm. Adjunctive treatment was performed in 11% of patients during the procedure. Closure rates were 100% at one week, 98% at three months and 94% at six months. The post-procedure complications included hematoma, ecchymosis and thrombophlebitis. There were no cases of venous thromboembolism. The authors concluded that MOCA of the saphenous veins has the advantage of endovenous ablation without tumescent anesthesia. This study is limited by lack of randomization and control and short-term follow-up.

In a meta-analysis, Hamann et al¹³ compared the long-term efficacy of different treatment modalities for varicose veins high ligation with stripping (HL+S), endovenous thermal ablation (EVTA), mainly consisting of endovenous laser ablation (EVLA) or radiofrequency ablation and ultrasound guided foam sclerotherapy (UGFS). Included in this study were three randomized controlled trials (RCTs) and 10 follow-up studies of RCTs with follow-up ≥ 5 years. A total of 611 legs were treated with EVLA, 549 with HL+S, 121 with UGFS, and 114 with HL+EVLA. Legs treated with UGFS had significantly lower pooled anatomical success rates than HL+S, EVLA, and EVLA with high ligation: 34% (95% CI 26-44) versus 83% (95% CI 72-90), 88% (95% CI 82-92), and 88% (95% CI 17-100) respectively; p ≤ .001. The pooled recurrent reflux rate at the SFJ was significantly lower for HL+S than UGFS (12%, 95% CI 7-20, vs. 29%, 95% CI 21-38; p ≤ .001) and EVLA (12%, 95% CI 7-20, vs. 22%, 95% CI 14-32; p = .038). VCSS scores were pooled for EVLA and HL+S, which showed similar improvements. Based on the results of the meta-analysis, EVLA and HL+S show higher success rates than UGFS 5 years after GSV treatment. Recurrent reflux rates at the SFJ were significantly lower in HL+S than UGFS and EVLA. VCSS scores were similar between EVLA and HL+S.

Boersma et al¹⁴ completed a systematic review and meta-analysis of treatment methods for small saphenous vein insufficiency. The review included 49 studies (5 randomized controlled trials, 44 cohort studies) reporting on different treatment modalities: surgery (n=9), endovenous laser ablation (EVLA) (n=28), radiofrequency ablation (RFA) (n=9), ultrasound-guided foam sclerotherapy (UGFS) (n=6) and MOCA (n=1). The primary outcome of anatomical success was defined as closure of the treated vein on follow-up duplex ultrasound imaging. Secondary outcomes were technical success and major complications. The pooled anatomical success rate was 58.0% for surgery in 798 veins, 98.5% for EVLA in 2950 veins, 97.1% for RFA in 386 veins and 63.6% for UGFS in 494 veins. One study reported results of MOCA with an anatomical success rate of 94%. Neurologic complications were most frequently reported after surgery and thermal ablation. Deep venous thrombosis was a rare complication. The authors concluded that EVLA and RFA are preferred to surgery and foam sclerotherapy in the treatment of small saphenous vein insufficiency. Although data on nonthermal techniques is still sparse, the potential benefits such as the reduced risk of nerve injury, may be of considerable clinical importance.

Osman, Hameed and El Sherief¹⁵ evaluated the role of ultrasound guided foam sclerotherapy in the treatment of truncal varicose veins of the lower extremity. Nine males (30%) and 21 females (70%) with various degrees of varicose veins were included in this study. Each case had foam injection under duplex guidance. All patients suffered from cosmetic disfigurement, whereas 24 patients (80%) complained of leg pain. In the first phase (after 2 weeks) 28 patients (93.3%) showed complete clinical improvement of the pre-interventional symptoms, while only 2 patients (6.7%) showed no improvement. Four patients (13.3%) suffered from complications in the form of thrombophlebitis. The 2nd phase follow up demonstrated the final patients' outcomes. 86.7% of the subjected sample (26 patients) showed further improvement. Based on the result of this study, it was determined that foam sclerotherapy is an effective, simple and safe technique for the treatment of truncal varicose veins with minimal complications.

Professional Societies

Society for Vascular Surgery (SVS) / American Venous Forum (AVF)

Gloviczki et al 2011, released the SVS and AVF³ joint clinical practice guidelines regarding the care of patients with varicose veins. The guidelines recommend that in patients with chronic venous disease, a complete history and detailed physical examination are complemented by duplex scanning of the deep and superficial veins. The guidelines state that endovenous thermal ablation is recommended over high ligation and inversion stripping of the saphenous vein to the level of the knee. For treatment of the incompetent saphenous vein, the SVS and AVF recommend endovenous thermal ablation over chemical ablation with foam. The policy also states that patients who undergo high ligation alone of the great saphenous vein (GSV) have recurrent reflux in the residual GSV. This causes new symptoms and increases the risk of reoperation or further treatment. For compression therapy, the SVS and AVF recommend using moderate pressure (20 to 30 mm Hg) for patients with symptomatic varicose veins and as a primary therapeutic modality for healing venous ulcers.

The guidelines state that the four components that should be included in a complete duplex scanning examination for CVD are (1) visibility, (2) compressibility, (3) venous flow, including measurement of the duration of reflux, and (4) augmentation. The cutoff value for abnormally reversed venous flow (reflux) in the saphenous, tibial, and deep femoral veins has been 500 ms. International consensus documents previously recommended 0.5 seconds as a cutoff value for all veins to use for lower limb venous incompetence. For the perforating veins, cutoff values of both 350 ms and 500 ms have been suggested. The Committee recommends 500 ms as the cutoff value for saphenous, tibial, deep femoral, and perforating vein incompetence, and 1 second for femoral and popliteal vein incompetence. The SVS/AVF Guideline Committee definition of “pathologic” perforating veins includes those with outward flow of 500 ms, with a diameter of 3.5 mm, located beneath a healed or open venous ulcer (CEAP class C5-C6).³

American Venous Forum (AVF)

Eklof et al⁸ 2004, revised the CEAP (Clinical-Etiology-Anatomy-Pathophysiology) Classification due to the lack of precision in diagnosis. The revised classification now includes the following: refinement of several definitions used in describing CVD; refinement of the C classes of CEAP; addition of the descriptor n (no venous abnormality identified); elaboration of the date of classification and level of investigation; and as a simpler alternative to the full (advanced) CEAP classification, introduction of a basic CEAP version.

American College of Phlebology

The American College of Phlebology Guidelines Committee¹⁰ updated their evidence-based recommendations for treatment of superficial venous disease of the lower leg. They recommend that named veins (great saphenous vein [GSV], small saphenous vein [SSV], anterior accessory of the great saphenous vein [AAGSV], posterior accessory of the great saphenous vein [PAGSV], intersaphenous vein [Vein of Giacomini]) must have a reflux time greater than 500 milliseconds regardless of the reported vein diameter. Treatment indications include pain or other discomfort (i.e. heaviness, fatigue, soreness, or burning), edema, recurrent superficial phlebitis, stasis dermatitis or ulceration. The committee defines medically necessary as a CEAP classification of C2 or higher. Endovenous thermal ablation (laser and radiofrequency) and chemical/cyanoacrylate adhesive is the preferred treatment for saphenous and accessory saphenous (GSV, SSV, AAGSV, PAGSV) vein incompetence. MOCA may also be used to treat truncal venous reflux. The committee recommends that open surgery is appropriate in veins not amenable to endovenous procedures but otherwise is not recommended because of increased pain, convalescent time, and morbidity.

Consultation Summary

A consultation meeting with the American Vein and Lymphatic Society was held April 7, 2020. Also, a consultation meeting with a vascular surgeon from The Vascular Society of New Jersey and a vascular surgeon who is a fellow with the Society for Vascular Surgery was held on April 24, 2020. The subject matter experts (SMEs) conducted a review of the literature submitted to them by First Coast and Novitas in a bibliography. They also provided information regarding additional literature. They responded to questions discussing the treatment of chronic venous insufficiency of the lower extremities. The SMEs agree that an assessment with the CEAP classification, VCSS and duplex scan are necessary to determine the severity of the chronic venous insufficiency and to determine the appropriate treatment modality for the patient. Sclerotherapy (foam and liquid), endovenous laser therapy, radiofrequency ablation, chemical/cyanoacrylate adhesive, mechanochemical ablation and surgical treatments were discussed and also which veins to treat with which treatment were mentioned. Representatives of both societies agreed that the treatments for varicose veins are safe and effective and have positive patient health outcomes.

Analysis of Evidence

The evidence reviewed for the treatment of chronic venous insufficiency of the lower extremities includes systemic reviews, a meta-analysis, a prospective observational multicenter study and practice guidelines from the following: Society for Vascular Surgery (SVS), American Venous Forum (AVF), American College of Phlebology, Society of Interventional Radiology, Cardiovascular Interventional Radiological Society of Europe, and Canadian Interventional Radiology Association. The literature evaluated compared the different methods of treating patients with chronic venous insufficiency as well as it discussed the CEAP classifications that are recommended for the various treatment methods. The literature supports that a complete history and detailed physical examination complemented by duplex scanning of the deep and superficial veins is crucial for proper selection of patients who will benefit from treatment. Following review of the evidence and discussion with subject matter experts, it has been determined that treatment of chronic venous insufficiency utilizing liquid sclerotherapy, foam sclerotherapy, thermal ablation, cyanoacrylate/chemical adhesives, mechanochemical ablation and/or surgical ablation techniques is safe and effective, results in acceptable closure rates, improves quality of life and demonstrates good outcome measures with no serious complications. Therefore, treatment of chronic venous insufficiency will be considered medically reasonable and necessary when performed as outlined within this LCD.

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 Questionnaire⁴
• HASTI: (heaviness, achiness, swelling, throbbing, itching) score⁵
• Veines-QOL: Venous Insufficiency Epidemiological and Economic Study-Quality-of-Life/Symptoms⁵
• CIVIQ-20: Chronic Venous Insufficiency Quality-of-Life Questionnaire⁶

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 <1 mm in diameter that are seen near the surface of the skin.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. There 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

1. 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.
2. 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 greater³ 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 <6, the plan of care shall include documentation of a period of conservative therapy (2 to 4 weeks) including graduated compression 20-30 mmHg or greater, ambulation, elevation, and avoiding prolonged sitting and standing.
   • For patients who meet any one of the following criteria, the mandatory conservative therapy prior to the invasive procedure may be waived.
     • VCSS ≥6
     • C4-C6 disease (skin changes assigned to venous disease, healed venous leg ulceration, and active venous leg ulceration)
     • Hemorrhage
     • Recurrent superficial thrombophlebitis
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. It is the responsibility of the provider to comply with all applicable State and Federal laws related to the human use of agents.
10. 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.
11. 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:

1. 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.
2. 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.