Chronic venous disorders of the lower extremity incorporate a spectrum of
morphologic and functional abnormalities of the venous system. Symptoms and
findings include pain, leg heaviness, aching, swelling, skin dryness,
tightness, itching, irritation, and muscle cramps. Clinical signs of venous
disease include dilated veins (e.g. telangiectasia, varicose veins), leg
edema, skin changes (lipodermatosclerosis; a fibrosing dermatitis of the
subcutaneous tissue), and skin ulceration. The presence of symptoms and
clinical signs of venous disease correlates with the presence of venous reflux
(in the superficial or deep veins) and/or venous obstruction identified on
duplex ultrasound.1

The Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification serves as
a basis to categorize the clinical presentation of the patient, the underlying
etiology, what anatomic veins are affected, and the underlying pathology in
those veins. CEAP is a classification system. The following is the clinical
portion of the CEAP:2,10

**CEAP classification for chronic venous disorders:**

**Clinical Classification**  
---  
C0 | No visible or palpable signs of venous disease  
C1 | Telangiectasias, reticular veins  
C2 | Varicose veins  
C2r | Recurrent varicose veins  
C3 | Edema  
C4 | Changes in skin and subcutaneous tissue secondary to chronic venous
disease  
C4a | Pigmentation or eczema  
C4b | Lipodermatosclerosis or atrophie blanche  
C4c | Corona phlebectatica  
C5 | Healed  
C6 | Active venous ulcer  
C6r | Recurrent active venous ulcer  
S | With symptoms attributable to venous disease  
A | Absence of symptoms attributable to venous disease  
  
Venous duplex ultrasound examination confirms the diagnosis demonstrating the
presence of venous reflux (>500 milliseconds for superficial or perforator
veins; >1000 milliseconds for deep veins).3

A variety of treatment modalities are available to treat varicose
veins/chronic venous insufficiency. Treatment modalities include conservative
management and invasive procedures.

**_Conservative Management (Non-Invasive Procedures)_**

Components of conservative therapy should be discussed and individualized to
meet the needs of each patient and must be documented in the medical record.
The discussion should include, but is not limited to:

  * Weight reduction
  * Exercise plan and prescribed physical activity (walking, treadmill, cycling) 
  * Periodic leg elevation
  * Compressive therapy with use of surgical grade compression stockings (minimum 20-30 mmHg)

For patients who meet any 1 of the following criteria, conservative therapy
may be waived.

  * C4-C6 disease (skin changes assigned to venous disease, healed venous leg ulceration, and active venous leg ulceration)
  * Hemorrhage
  * Recurrent superficial thrombophlebitis

**_Invasive Procedures_**

**_A) Sclerotherapy:_**

Sclerotherapy is a minimally invasive percutaneous technique using chemical
irritants, that is, liquid and foam sclerotherapy techniques, to close
unwanted veins. Sclerotherapy for treatment of varicose veins or reflux is
followed by compression therapy of the affected lower limb using either
elastic or conventional bandaging.

  * ****_Liquid Sclerosant:_****

Liquid sclerotherapy can be used to treat telangiectasias, reticular veins,
small varicose veins (3-6 mm), residual or recurrent veins following
endovenous ablation or surgery, and perforator veins.4 Some examples of
sclerotherapy agents are polidocanol, hypertonic saline, sodium tetradecyl
sulfate, and glycerin.

  * ******_Foam Sclerosant: Ultrasound-Guided Foam Sclerotherapy (UGFS):_******

Foam sclerotherapy is a procedure that is performed under ultrasound guidance
and is a nonthermal therapy. The different types of foam are physician-
compounded foam (PCF) and non-compounded foam (NCF). Foam preparations are
used for treatment of symptomatic varicose veins 3 mm. The heavier foam is
needed to displace the increased volume of blood in these larger veins, which
increases the contact time of the sclerosant with the vein wall, enhancing the
sclerosant effect. Ultrasound-guided foam sclerotherapy (UGFS) is used for the
treatment of reflux of the superficial axial veins (great saphenous vein
(GSV), small saphenous vein (SSV), accessory saphenous vein (ASV)), reflux of
perforator veins, and venous malformations.5  It is recognized that foam
sclerotherapy is not Food and Drug Administration (FDA)-approved. However,
UGFS has been in use in the United States for more than 20 years and is a
standard of care for many venous disorders with an excellent safety profile.28

**_B) Thermal Ablation_** **:  **

  * ****_Radiofrequency Ablation (RFA), Endovenous Radiofrequency Ablation (ERFA):_****

RFA is a minimally invasive percutaneous technique using radiofrequency energy
and ultrasound guidance to puncture the vein and position a catheter to ablate
incompetent veins. The device is used primarily to treat insufficiency of the
axial veins (i.e., great, small, anterior accessory GSVs), but perforator
veins can also be treated with a specialized radiofrequency stylet. The
indications for RFA are the same as for other venous ablation techniques.6
Patients with persistent symptoms and signs of superficial venous disease and
documented axial venous reflux (i.e., retrograde flow >500 ms for superficial
or perforator veins) are candidates for treatment. The procedure may be
performed in an outpatient setting.

  * ****_Endovenous Laser Ablation (EVLA), Endovenous Laser Ablation Therapy (EVLT):_****

EVLA is a percutaneous technique that uses laser energy to ablate incompetent
superficial veins. The axial veins are the primary target for this therapy and
include the GSV, SSV, and anterior accessory great saphenous veins (AAGSVs). A
relative contraindication to thermal ablation (EVLA and RFA) is severe
tortuosity of a vein segment in which passage of the device may not be
possible. Minimally invasive therapies, including RFA and EVLA, provide
similar or improved clinical outcomes compared with GSV ligation and
stripping.7,24

**_C) Chemical Adhesive (_** ** _Cyanoacrylate Embolization):_**

This nonthermal ablation technique uses a glue delivered into the saphenous
vein using a catheter for access that induces a foreign body reaction leading
to inflammation and fibrotic occlusion of the vessel. It is used for the
treatment of incompetent saphenous veins (GSV, SSV, AAGSV).8,14,15,22

**_D) Mechanochemical Ablation_** **_(MOCA):_**

This nonthermal technique uses both mechanical damage to the vein endothelium
with a rotating wire and simultaneous chemical injury with installation of a
liquid sclerosant to lead to scarring and fibrosis. The most common site of
treatment is the GSV. It is used for the treatment of incompetent saphenous
veins (GSV, SSV, AAGSV).11,19

**_E_** _ **)** **Surgical: Ligation, Stripping, Phlebectomy:**_

Saphenous vein ligation and division is the detachment of the saphenous vein
(GSV, SSV, AGSV) through an incision at the groin at its confluence with the
saphenofemoral junction and common femoral vein. It is the traditional
treatment and is called high ligation and saphenous vein stripping. The
primary goal is removal of the refluxing veins at the saphenofemoral junction.
Phlebectomy, also known as stab phlebectomy, ambulatory phlebectomy, or
microphlebectomy, involves the removal of secondary smaller veins as the
removal of the varicose veins are through a small 1-2 mm incision in the skin
overlying the vein.24

**_Covered Indications_**

Medicare will consider invasive procedures (only with the techniques outlined
in this local coverage determination (LCD) and under the conditions described)
as reasonable and necessary when documentation in the medical record includes
a history, physical examination, CEAP clinical classification, and a venous
duplex scan documenting reflux (>500 msec).

  1. Liquid sclerotherapy will be considered reasonable and necessary to treat telangiectasias, reticular veins, small varicose veins (3-6 mm), residual or recurrent veins following endovenous ablation or surgery, and perforator veins. Treatment of telangiectasias and reticular veins (C1) (<3 mm) is considered reasonable and necessary with documentation of spontaneous and/or traumatic venous hemorrhage, **OR** for dilated intradermal veins in the elderly judged to be a substantial risk for hemorrhage with minimal trauma, **OR** near an active or healed ulcer if judged to contribute to local venous hypertension.
  2. Saphenous veins (GSV, SSV, AAGSV) management, with UGFS, endovenous thermal ablation (radiofrequency or laser), chemical adhesive (cyanoacrylate embolization), MOCA, and surgery (surgical ligation and stripping) is considered reasonable and necessary with documentation in the medical record of CEAP class C2-C6 disease, reflux (>500 msec), and **ANY** of the following signs or symptoms:
    1. Ulceration secondary to venous stasis;
    2. Significant pain or significant edema associated with saphenous reflux that interferes with activities of daily living (ADLs);
    3. Bleeding associated with ruptured superficial varicosity;
    4. Recurrent episodes of superficial phlebitis;
    5. Stasis dermatitis;
    6. Refractory dependent edema
  3. Incompetent perforator veins (IPVs) are the most common cause of recurrent varicose veins after treatment. Minimally invasive treatments have replaced traditional surgical treatments for IPVs. UGFS and endovenous thermal ablation with either radiofrequency or laser energy sources will be considered reasonable and necessary9 with the following conditions:
    * Demonstrated perforator reflux >500 msec; **AND**
    * No saphenous reflux (greater, small, or accessory) and/or symptomatic varicose tributaries; **AND**
    * An active venous ulcer;  **AND**
    * The IPV is at least 3.5 mm in diameter; **AND**
    * The perforator is in the vicinity of the ulcer.

**_Non-Invasive Venous Studies_**

Pre-operative venous studies are considered reasonable and necessary prior to
varicose vein treatment when initially performed by an accredited vascular
technician. The study will fully define the anatomy, size, and tortuosity of
the great and lesser saphenous vein, superficial venous segments, and
perforators and will determine the extent of venous valvular incompetence.
Medicare will cover a pre-procedure duplex scan used in conjunction with other
non-invasive physiologic testing to determine the extent and configuration of
the varicosities. It is expected that these studies will be performed by the
physician planning to provide the therapy or by a registered vascular
technologist (RVT). Medicare will cover intraoperative ultrasonic guidance in
situations when it is medically necessary. Also, Medicare includes payment for
the ultrasound in the payment for ERFA and laser ablation procedures. This A/B
MAC will allow for post-procedure studies within a 6-month period.

**_Credentialing and Accreditation Standards_**

A vascular diagnostic study may be performed by a physician, a certified
technologist, or in a certified vascular testing lab. The accuracy of non-
invasive vascular diagnostic studies depends on the knowledge, skill, and
experience of the technologist and interpreter. Services will be considered
reasonable and necessary only if performed by appropriately trained providers.

All non-invasive vascular diagnostic studies must be performed meeting at
least 1 of the following:

  * Performed by a licensed qualified physician, **OR**
  * Performed by a technician who is certified in vascular technology, **OR**
  * Performed in facilities with laboratories accredited in vascular technology.

**_Limitations_**

Services that are not reasonable and necessary cannot be covered by Medicare
in the following:

  1. CEAP clinical classification C0 (no visible or palpable signs of venous disease) is considered cosmetic, and therefore, not reasonable and necessary and cannot be covered by Medicare;
  2. CEAP clinical classification C1 (telangiectasias or reticular veins) is considered cosmetic and not reasonable and necessary with the exception of documentation of spontaneous and or traumatic venous hemorrhage;
  3. Severe distal arterial occlusive disease;
  4. Acute deep vein thrombosis (DVT) or superficial vein thrombosis;
  5. Allergy to the sclerosant;
  6. Pregnancy;
  7. Advanced generalized systemic disease that limits quality-of-life (QOL) improvements would require a statement of the objective of treatment in such cases;
  8. Failure of a vein closure without recurrent signs or symptoms;
  9. Any interventional treatment that uses equipment not approved for such purposes by the FDA

Kuyumcu, et al. (2016) evaluated minimally invasive treatments for perforator
vein insufficiency.9 Incompetent superficial veins are the most common cause
of lower extremity superficial venous reflux and varicose veins; however,
incompetent or insufficient perforator veins are the most common cause of
recurrent varicose veins after treatment, often unrecognized. Perforator vein
insufficiency can result in pain, skin changes, and skin ulcers and often
merit intervention. They concluded that minimally invasive treatments have
replaced traditional surgical treatments for incompetent perforator veins.
Current minimally invasive treatment options include ultrasound guided
sclerotherapy (USGS) and endovascular thermal ablation (EVTA) with either
laser or radiofrequency energy sources.

Kim, et al. (2017) conducted a 2-year analysis of the efficacy of
mechanochemical ablation in patients with C2 or more advanced chronic venous
disease.11 This was an observational study during which data were
prospectively collected from 6 vein centers using an electronic database.
Patients with reflux in the GSV involving the sapheno-femoral junction and no
previous venous interventions were included. They concluded that the sustained
closure rates of >90% at 2 years with mechanochemical ablation is associated
with significant clinical improvement, which is maintained at 24 months,
making it a very good option for the treatment of GSV incompetence. Results
showed early high occlusion rate with MOCA is associated with significant
clinical improvement that is maintained at 24 months.

Lane, et al. (2017) presented a multi-center randomized controlled trial
assessing the difference in pain during truncal ablation using MOCA and RFA
with 6 months follow-up.12 Patients undergoing local anesthetic endovenous
ablation for primary varicose veins were randomized to either MOCA or RFA. The
authors concluded that pain secondary to truncal ablation is less painful with
MOCA than RFA with similar short-term technical, QOL, and safety outcomes. A
limitation of this study is the lack of long-term follow-up.

Biemans, et al. (2013) compared endovenous laser ablation, foam sclerotherapy,
and conventional surgery (high ligation and short stripping) for GSVs in a
randomized controlled trial.13 The primary outcome was anatomic success
defined as obliteration or absence of the treated vein on ultrasound
examination after 1 year. The anatomic success rate was highest after EVLA
(88.5%), followed by conventional surgery (CS) (88.2%), and UGFS (72.2%) (P <
0.001). 84.3% of all treated patients showed an improvement of the "C" of the
CEAP classification. The 1-year result defined as anatomic success according
to duplex ultrasound, is equally high for EVLA and CS and lower for UGFS.

Gibson, et al. (2017) reported the results of a prospective study of
cyanoacrylate closure for the treatment of GSV, SSV, and/or ASVs with the
VenaSeal Closure System.8  Fifty subjects with symptomatic GSV, SSV, and/or
ASVs incompetence were each treated at a single session. Compression stockings
were not used post-procedure. Duplex ultrasound showed that all treated veins
(48 GSVs, 14 ASVs, and 8 SSVs) had complete closure at 7 days and 1 month.
Phlebitis in the treatment area or side branches occurred in 10 subjects (20%)
and completely resolved in all but 1 subject (2%) by 1 month. The authors
concluded that cyanoacrylate closure is safe and effective for the treatment
of 1 or more incompetent saphenous or accessory saphenous veins. Efficacy as
measured by complete vein closure was high. Closure rates were high even
without the use of compression stockings or side branch treatment. The
limitations of this study include its single arm design and relatively small
sample size at a single center.

Gibson, et al. (2018) reported on a prospective, randomized controlled,
multicenter trial conducted under an investigational device exemption from the
FDA at 10 trial centers in the United States.15  This trial demonstrates that
duplex ultrasound assessed closure rates after GSV treatment with
cyanoacrylate closure (CAC) were noninferior to RFA at 24 months. The 24-month
complete closure rate was 95.3% in the CAC group and 94.0% in the RFA group,
demonstrating continued noninferiority of CAC compared with RFA (P = 0.0034).
Both treatments produced statistically and clinically significant improvement
in venous clinical severity score (VCSS) and QOL measurements, and these
improvements were maintained at 24 months. These results suggest that CAC of
the GSV is safe and durable out to 2 years. The investigators will continue to
observe the patient cohorts, and longer-term data will be collected at 3 and 5
years.

Smith PC (2009) reviewed the published literature on the methods and outcome
of UGFS for the treatment of superficial venous incompetence.18  He concluded
that there is sufficient evidence that UGFS is a safe and effective treatment
for superficial truncal saphenous incompetence as well as for varices. This
treatment is suitable for the management of primary uncomplicated varices,
recurrent varicose veins, and patients with lipodermatosclerosis.

Kim, et al. (2019) conducted a single-center retrospective cohort study to
compare MOCA and thermal ablation (RFA and EVLT) for venous ulcer healing in
patients with clinical class 6 chronic venous insufficiency.19  74% of
patients treated with MOCA healed their ulcers compared with 35% of those
treated with thermal ablation (P = 0.01). A healed ulcer was defined as
elimination of ulcer depth and superficial skin coverage. The mean time to
heal was 4.4 months in the thermal ablation group compared with 2.3 months
with MOCA (P = 0.01). The authors concluded that MOCA is safe and effective
for treating venous ulcers and can be considered an alternative modality to
thermal ablation techniques. The limitation of this study was a retrospective
single-center review of a relatively small sample size rather than a
prospective randomized controlled trial.

The analysis of evidence reviewed for the treatment of varicose veins of the
lower extremities included a multicenter randomized controlled trial,
prospective study, observational study, retrospective cohort study, single-
center retrospective cohort study, published literature review, and practice
guidelines of the Society for Vascular Surgery and the American Venous Forum.
The literature supports the key recommendations of the guidelines that in
patients with chronic venous insufficiency, a complete history and detailed
physical examination are complemented by duplex ultrasound scanning of the
deep and superficial veins (GRADE 1A). Guidelines also recommend CEAP
classification be used for patients with chronic venous disorders (GRADE 1A)
and that the revised VCSS is used to assess treatment outcome (GRADE 1B).6 The
"C" part of CEAP classification is more useful and practical in rating the
severity of varicose veins. VCSS has been used to measure clinical improvement
after treatment of varicose veins.

The literature reviewed and evaluated compared the different methods of
treatment in patients with chronic venous insufficiency. Treatment of chronic
venous insufficiency with liquid sclerotherapy, UGFS, thermal ablation (RFA or
EVLA), chemical adhesive (cyanoacrylate embolization), MOCA, surgical
ligation, stripping, and phlebectomy techniques is considered safe and
effective with improved QOL and is considered medically reasonable and
necessary when the coverage indications are met in this LCD.