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.

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.

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.