Local Coverage Determination (LCD)

Treatment of Chronic Venous Insufficiency of the Lower Extremities

L34924

Expand All | Collapse All
Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34924
Original ICD-9 LCD ID
Not Applicable
LCD Title
Treatment of Chronic Venous Insufficiency of the Lower Extremities
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL34924
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 12/27/2020
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
11/12/2020
Notice Period End Date
12/26/2020

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for treatment of chronic venous insufficiency of the lower extremities. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for treatment of chronic venous insufficiency of the lower extremities and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

IOM Citations:

  • CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
    • Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests
  • CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual
    • Chapter 1, Part 4, Section 220.5 Ultrasound Diagnostic Procedures,
  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD


Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
  • Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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.

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 (Rationale for Determination)

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.

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Please refer to the related Billing and Coding Article: Treatment of Chronic Venous Insufficiency of the Lower Extremities (A55229) for documentation requirements, utilization parameters and all coding information.

Sources of Information

N/A

Bibliography

 

  1. Spiridon M, Corduneanu D. Chronic Venous Insufficiency: a frequently underdiagnosed and undertreated pathology. J Clin Med. 2017;12(1):59-61.
  2. Perrin M, Eklof B, Maleti O. Baekgaard N, Davies A, Guex JJ. The vein glossary. Eur Venous Forum. 2017:1-207.
  3. Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011;53:2-48.
  4. Aber A, Poku E, Phillips P, et al. Systematic review of patient-reported outcome measures in patients with varicose veins. J Vasc Surg Venous Lymp Dis. 2017;6(1):1424-1432.
  5. Gibson K, Ferris B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study). Vascular. 2017;25(2):1-8.
  6. Biemans AA, Kockaert M, Akkersdijk GP, et al. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013;58(3):727-734.
  7. Meissner MH. Lower extremity venous anatomy. Sem Int Radiol. 2005;22(3):1-10.
  8. Eklof B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, et al. Revision of the CEAP classification for chronic venous disorders: Consensus statement. Am Venous Forum. 2004;40:1248-1252.
  9. Passman MA, McLafferty RB, Lentz MF, et al. Validation of Venous Clinical Severity Score (VCSS) with other venous severity assessment tools from the American Venous Forum, National Venous Screening Program. J Vasc Surg. 2011;54(19):2-9.
  10. American College of Phlebology. Practice guidelines. Superficial venous disease. Treatment of superficial venous disease of the lower leg. October 2014. Updated February 2016.
  11. Kundu S, Grassi CJ, Khilnani NM, et al. Multi-disciplinary quality improvement guidelines for the treatment of lower extremity superficial venous insufficiency with ambulatory phlebectomy from the Society of Interventional Radiology, Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology and Canadian Interventional Radiology Association. J Vasc Interv Radiol. 2010:21(1);1-13.
  12. Bishawi M, Bernstein R, Boter M, et al. Mechanochemical ablation in patients with chronic venous disease: A prospective multicenter report. Phlebology. 2014;29(6):397-400.
  13. Hamann SAS, Giang J, De Maeseneer MGR, Nijsten TEC, Van Den Bos RR. Editor’s choice- five year result of greater saphenous vein treatment: a meta-analysis. Eur J Endovasc Surg. 2017;54(6):760-770.
  14. Boersma D, Kornmann VNN, Van Eekeren RRJP, et al. Treatment modalities for small saphenous vein insufficiency: systematic review and meta-analysis. J Endosc Ther. 2016;23(1):199-211.
  15. Osman NMM, Hameed AAA, El Sherief MAF. The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins. Egypt J Radiol Nuc Med. 2015;46:981-986.
  16. Baber JT, Mao J, Sedrakyan A, Connolly PH, Meltzer AJ. Impact of provider characteristics on use of endovenous ablation procedures in Medicare beneficiaries. J Vasc Surg. 2019;7:203-209.
  17. Beale RJ, Gough MJ. Treatment options for primary varicose veins-a review. Eur J Vasc Endovasc Surg. 2005;30:83-95.
  18. Bellam Premnath K, Joy B, Raghavendra VA, et al. Cyanoacrylate adhesive embolization and sclerotherapy for primary varicose veins. Phlebology. 2018;33(8):547-557.
  19. Berridge D, Lees T, Earnshaw JJ. The venous intervention (VEIN) project. Phlebology. 2009;24(1)1-2.
  20. Bissacco D, Stegher S, Calliari FM, Viani MP. Saphenous vein ablation with a new cyanoacrylate glue device: a systematic review on 1000 cases. Minimally Invasive Ther Allied Technol. 2019;28(1):6-14.
  21. Bootun R, Lane TRA, Dharmarajah B, et al. Intra-procedural pain score in a randomised controlled trial comparing mechanochemical ablation to radiofrequency ablation: The Multicentre VenefitTM versus ClariVein_ for varicose veins trial. Phlebology. 2016;3(1)61-65.
  22. Brittenden J, Cooper D, Dimitrova M, et al. Five-year outcomes of a randomized trial of treatments for varicose veins. N Engl J Med. 2019;381(10):912-922.
  23. Brittenden J, Cotton SC, Elders A, et al. A randomized trial comparing treatments for varicose veins. N Engl J Med. 2014;371(13):1218-1227.
  24. Çalik ES, Arslan Ü, Erkut B. Ablation therapy with cyanoacrylate glue and laser for refluxing great saphenous veins - a prospective randomised study. Vasa. 2019;48(5):405-412.
  25. CEAP & Venous Severity Scoring. American Venous Forum. 2018:1-5.
  26. Darvall KA, Bate GR, Bradbury AW. Patient-reported outcomes 5-8 years after ultrasound-guided foam sclerotherapy for varicose veins. Br J Surg. 2014;101(9):1098-1104.
  27. Deak ST. Retrograde administration of ultrasound-guided endovenous microfoam chemical ablation for the treatment of superficial venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2018;6(4):477-484.
  28. Deijen CL, Schreve MA, Bosma J, et al. Clarivein mechanochemical ablation of the great and small saphenous vein: Early treatment outcomes of two hospitals. Phlebology. 2015;0(0):1-6.
  29. Elias S, Raines JK. Mechochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012;27:67-72.
  30. Epstein DM, Gohel MS, Heatley F, et al. Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration. Brit J Soc. 2018;1-8.
  31. Eroglu E, Yasim A. A randomised clinical trial comparing N-Butyl cyanoacrylate, radiofrequency ablation and endovenous laser ablation for the treatment of superficial venous incompetence: two year follow up results. Eur J Vasc Endovasc Surg. 2018;56(4):553-560.
  32. Gibson K, Kabnick L; Varithena® 013 Investigator Group. A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena® (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence. Phlebology. 2017;32(3):185-193.
  33. Gibson K, Minjarez R, Gunderson K, Ferris B. Need for adjunctive procedures following cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of postprocedure compression: Three-month data from a postmarket evaluation of the VenaSeal System (the WAVES Study). Phlebology. 2019;34(4):231-237.
  34. Gibson K, Morrison N, Kolluri R, et al. Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J. Vasc Surgery, Venous & Lymphatic Disorders. 2018;6(5):606-613.
  35. Gloviczki P, and Gloviczki ML. Guidelines for the Management of Varicose Veins. SAGE. 2012;(1):2-9.
  36. Gloviczki P, Dalsing MC, Henke P, Lal BK, O’Donnell TF, Shortell CK, et al. Report of the Society for Vascular Surgery and the American Venous Forum on the July 20, 2016 meeting of the Medicare Evidence Development and Coverage Advisory Committee panel on lower extremity chronic venous disease. J Vas Surg. 2017;5(3);1-21.
  37. Gohel MS, Barwell JR, Taylor M, et al. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial. Brit Med J. 2007:1-6.
  38. Gohel MS, Heatley F, Liu X, et al. A randomized trial of early endovenous ablation in venous ulceration. N Engl J Med. 2018:1-10.
  39. Holewijn S, van Eekeren RRJP, Vahl A, et al. Two-year results of a multicenter randomized controlled trial comparing mechanochemical endovenous ablation to radiofrequency ablation in the treatment of primary great saphenous vein incompetence (MARADONA trial). J Vasc Surg Venous Lymphat Disord. 2019;7(3):364-374.
  40. Jones WS, Vemulapalli S, Parikh KS, et al. Treatment strategies for patients with lower extremity chronic venous disease (LECVD). Technology Assessment Program. Research review disposition of comments report. AHRQ. 2017:1-83.
  41. Jones WS, Vemulapalli S, Parikh KS, et al. Treatment strategies for patients with lower extremity chronic venous disease (LECVD). Technology Assessment Report. AHRQ. 2017:1-198.
  42. Kayassi A, Pope M, Vucemilo I, Werneck C. Endovenous radiofrequency ablation for the treatment of varicose veins. Can J Surg. 2015;58(2):1-2.
  43. Khor SN, Lei J, Kam JW, Kum S, Tan YK, Tang TY. ClariVeinTM – One year results of mechano-chemical ablation for varicose veins in a multi-ethnic Asian population from Singapore. Phlebology. 2018;33(10)687-694.
  44. Kim PS, Bishawi M, Draughn D, et al. Mechanochemical ablation for symptomatic great saphenous vein reflux: A two-year follow-up. Phlebology. 2016;0(0):1-6.
  45. Kim SY, Safir SR, Png CYM, et al. Mechanochemical ablation as an alternative to venous ulcer healing compared with thermal ablation. J Vasc Surg Venous and Lym Dis. 2019;7:699-705.
  46. King JT, O'Byrne M, Vasquez M, Wright D; VANISH-1 Investigator Group. Treatment of truncal incompetence and varicose veins with a single administration of a new polidocanol endovenous microfoam preparation improves symptoms and appearance. Eur J Vasc Endovasc Surg. 2015;50(6):784-793.
  47. Lane T, Bootun R, Dharmarajah B. A multi-centre randomised controlled trial comparing radiofrequency and mechanical occlusion chemically assisted ablation of varicose veins – Final results of the Venefit versus Clarivein for varicose veins trial. Phlebology. 2016;0(0):1-10.
  48. Lawaetz M, Serup J, Lawaetz B, et al. Comparison of endovenous ablation techniques, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Extended 5-year follow-up of a RCT. Int Angiol. 2017;36(3):281-288.
  49. Leopardi D, Hoggan BL, Fitridge RA, Woodruff PWH, Maddern GJ. Systematic review of treatments for varicose veins. Ann Vasc Surg. 2009;23(2):264-276.
  50. Lin F, Zhang S, Sun Y, Ren S, Liu P. The management of varicose veins. Int Surg. 2015:100;185-189.
  51. Lurie F, Lal BK, Antignani PL, et al. Compression therapy after invasive treatment of superficial veins of the lower extremities: clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology. J Vasc Surg: Venous and Lym Dis. 2019;7:17-28.
  52. Malgor RD, Labropoulos N. “Pattern and types of non-saphenous vein reflux.” Phlebology. 2013;28(1):51-54.
  53. Mann M, Wang P, Schul M, et al. Significant physician practice variability in the utilization of endovenous thermal ablation in the 2017 Medicare population. J Vasc Surg: Veno Lym Dis. 2019;7:808-816.
  54. McDonagh B, Huntley DE, Rosenfeld R, et al. Efficacy of the Comprehensive Objective Mapping, Precise Image Guided Injections, Anti-reflux Positioning and Sequential Sclerotherapy (COMPASS) technique in the management of greater saphenous varicosities with saphenofemoral incompetence. Phlebology. 2002;17(1):19-28.
  55. Michaels JA, Campbell WB, Brazier JE, et al. Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV) trial. Health Tech Assess. 2006;10(13)1-198.
  56. Mohamed AH, Leung C, Wallace, et al. Mechanochemical ablation for the treatment of superficial venous incompetence: A cohort study of a single centre’s early experience. Phlebology. 2019;34(7):466-473.
  57. Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015;61(4):985-994.
  58. Mulla SA, Pai S. Varicose veins: a clinical study. Int Surg J. 2017;4(2):529-533.
  59. Murad MH, Coto-Yglesias F, Zumaeta-Garcia M, et al. A systematic review and meta-analysis of the treatments of varicose veins. J Vasc Surg. 2011;53(16):1-17.
  60. O’Flynn N, Vaughan M, Kelley K. Diagnosis and management of varicose veins in the legs. NICE Guideline. British J Gen Prac. 2014;64:314–315.
  61. Ozen Y, Cekmecelioglu D, Sarikaya S, et al. Mechanochemical Endovenous Ablation of Great Saphenous Vein Insufficiency: two year results. Venous Diseases. 2014;23(3):176-179.
  62. Position Statement Healthcare Policy Committee Mechanochemical Venous Ablation. American Vein and Lymphatic Society. 2019:1-6.
  63. Radhakrishnan N, Jayakrishnan R, Deepu G. Microfoam Sclerotherapy for Varicose veins: a retrospective analysis of a modified technique. 2015;77(3):1-6.
  64. Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011;98(8):1079-1087.
  65. Shadid N, Ceulen R, Nelemans P, et al. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012;99(8):1062-1070.
  66. Shadrina AS, Sharapov SZ, Shashkova TI, Tsepilov YA. Varicose veins of lower extremities: Insights from the first large-scale genetic study. PLOS Genetics. 2019; 15(4):1-23.
  67. Stanisic MG, Wegrzynowski A, Pawlaczyk-Gabriel K. One year results of fifty consecutive patients treated with mechanochemical ablation of great and small saphenous vein. Phlebological Rev. 2015;23(4):102-105.
  68. Tang TY, Kam JW, Gaunt ME. ClariVein_ – Early results from a large single-centre series of mechanochemical endovenous ablation for varicose veins. Phlebology. 2017;32(1):6-12.
  69. Thierrens NDE, Holewijn S, Vissers WHPM, Werson DAB, de Vries JPPM, Reijnen MMPJ. Five year outcomes of mechanochemical ablation of primary great saphenous vein incompetence. Phlebology. 2019;0(0)1-7.
  70. Todd KL, Wright DI. “The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence.” SAGE Journals. 2013;29(9):608-618.
  71. Vahaaho S, Mahmoud O, Halemesmaki K, et al. Randomized control trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins. Br J Surg. 2019;106:548-554.
  72. van Eekeren RRJP, Boersma D, Elias S, et al. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein Device: a safety study. J Endovasc Ther. 2011;18:328-334.
  73. van Eekeren RRJP, Boersma D, Holewijm S, et al. Mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency. J Vasc Surg: Venous Lym Dis. 2014;4(2):282-288.
  74. van Eekeren RRJP, Boersma D, Konijn V, et al. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013;57:445-50.
  75. Vasquez M, Gasparis AP; Varithena® 017 Investigator Group. A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. Phlebology. 2017;32(4): 272-281.
  76. Vashist MG, Malik V, Singhal N. Role of Subfascial Endoscopic Perfortor Surgery (SEPS) in management of perforator incompetence in varicose veins: a retrospective study. Indian J Surg. 2012;76(2):117-123.
  77. Vun SV, Rashid ST, Blest NC, Spark JL. Lower pain and faster treatment with mechanico-chemical endovenous ablation using ClariVein. Phlebology. 2014;0(0):1-5.
  78. Wallace TT, El-Sheikha J, Nandhra S, et al. Long-term outcomes of endovenous laser ablation and conventional surgery for great saphenous varicose veins. Brit J Surg. 2018;105:1759-1767.
  79. Witte ME, Holewihn S, van Ekeren RR, de Vries JP, Zeebregts CJ, Reijnen MMPJ. Midterm outcomes of mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency. J Endovasc Ther. 2016;0(0):1-7.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
12/27/2020 R15

LCD posted for notice on 11/12/2020. LCD becomes effective for dates of service on and after 12/27/2020.

06/25/2020 DL34924 Draft LCD posted for comment.

  • Creation of Uniform LCDs With Other MAC Jurisdiction
11/14/2019 R14

LCD revised and published on 11/14/2019. All codes and related coding information have been removed and placed in the related billing and coding article, A55229, consistent with Change Request (CR) 10901. NCD and manual language has been removed and replaced with the applicable references. The sources have been moved to the bibliography section and numbered. There has been no coverage change with this LCD revision

  • Other (changes in response to CMS change request)
04/18/2019 R13

LCD revised and published on 04/18/2019 in response to CMS Change Request (CR) 10901 to add CMS IOM Publication 100-08, Chapter 13 to the IOM Reference section and to remove the reference and language from the body of the LCD. CMS IOM reference for Publication 100-09 pertains to coding therefore it has been removed from the LCD. There has been no change in content to the LCD.

  • Other (Changes in response to CMS change request)
05/17/2018 R12

LCD updated on 05/17/2018 for administrative purposes. No changes have been made to the LCD content.

At this time the 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination, therefore, not all the fields included in the LCD are applicable as noted in this policy.

  • Other (Administrative Update-No LCD content change)
01/01/2018 R11

LCD revised and published on 01/25/2018 effective for dates of service on and after 01/01/2018 to reflect the annual CPT/HCPCS code updates. For the following CPT/HCPCS codes either the short description and/or the long description was changed: 36468, 36470, 36471, 37760, and 37761. Depending on which description is used in this LCD there may not be any change in how the codes display in the document.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; therefore, not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To CPT/HCPCS Code Changes
10/01/2017 R10

LCD revised and published on 10/05/2017 effective for dates of service on and after 10/01/2017 to reflect the ICD-10 Annual Code Updates.  The following ICD-10 code(s) have undergone a descriptor change: I83.891, I83.892, I83.899.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; therefore, not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To ICD-10-CM Code Changes
01/01/2017 R9 LCD revised and published on 01/12/2017 effective for dates of service on and after 01/01/2017 to reflect the annual CPT/HCPCS code updates. The following CPT/HCPCS code 93965 has been deleted and therefore removed from group 1 of the LCD. For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD there may not be any change in how the codes display in the document: 36476 and 36479.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R8 Due to system limitations the ICD-10 code groups have been reorganized. Group 1 CPT/HCPCS codes do not have any associated diagnosis. Group 1 ICD-10 codes now correspond to Group 2 CPT/HCPCS codes and Group 2 ICD-10 codes now correspond to Group 3 CPT/HCPCS codes. For each group of ICD-10 codes, the relevant CPT/HCPCS codes are listed in the Group paragraph.


  • Other (Clarification
    Annual Review )
10/01/2015 R7 LCD revised and published on 10/16/2015 for dates of service on and after 10/01/2015 to add several ICD-10 codes for higher specificity to Group 2 and 3 as covered diagnoses and more specific codes to the group of codes that do not support medical necessity. Also corrected typographical errors.
  • Typographical Error
  • Other (Inquiry)
10/01/2015 R6 LCD revised and published on 09/11/2015 to include sources submitted for review. No changes made to the content of the LCD.
  • Reconsideration Request
10/01/2015 R5 LCD revised and published on 05/14/2015 to provide clarification regarding the treatment of varicose veins below 10mm and to provide clarification regarding the use of duplex and ultrasound during certain procedures.
  • Reconsideration Request
10/01/2015 R4 LCD revised and published on 03/12/2015. The following statement has been revised in response to a reconsideration request to remove the reference to ERFA; “ERFA and EVLT have not been established as medically safe or effective and are not FDA approved for perforator or short vein ligation. Therefore, ERFA and EVLT are not covered for perforator vein ligation or ablation.” Additional reconsideration request regarding the size requirement for saphenous vein treatment, occlusion of non-acute deep vein thrombosis, and a weight reduction requirement was taken under consideration. No change to the policy was made in response to this request other than to add the Article that was submitted to the sources.
  • Reconsideration Request
10/01/2015 R3 LCD revised on 12/09/2014 to correct formatting, spelling error. No substantial changes made to the content of the LCD.
  • Typographical Error
10/01/2015 R2 LCD revised to correct wording in the Indications section to include "minimum of " in bullet #1.

To correct LCD title name to "Treatment of Varicose Veins and Venous Stasis Disease of the Lower Extremities"
  • Typographical Error
10/01/2015 R1 LCD revised on 10/09/2014 and posted on 12/04/2014 to create uniform LCD with other MAc Jurisdiction.
  • Creation of Uniform LCDs With Other MAC Jurisdiction
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
11/06/2020 12/27/2020 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • N/A

Read the LCD Disclaimer