LCD L39121: Treatment of Varicose Veins of the Lower Extremities

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

C 0

No visible or palpable signs of venous disease

C 1

Telangiectasias, reticular veins

C 2

Varicose veins

C 2r

Recurrent varicose veins

C 3

Edema

C 4

Changes in skin and subcutaneous tissue secondary to chronic venous disease

C 4a

Pigmentation or eczema

C 4b

Lipodermatosclerosis or atrophie blanche

C 4c

Corona phlebectatica

C 5

Healed

C 6

Active venous ulcer

C 6r

Recurrent active venous ulcer

With symptoms attributable to venous disease

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).

• 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) ( 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.

• 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:

• Ulceration secondary to venous stasis;

• Significant pain or significant edema associated with saphenous reflux that interferes with activities of daily living (ADLs);

• Bleeding associated with ruptured superficial varicosity;

• Recurrent episodes of superficial phlebitis;

• Stasis dermatitis;

• Refractory dependent edema

• 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 necessary 9 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:

• 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;

• 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;

• Severe distal arterial occlusive disease;

• Acute deep vein thrombosis (DVT) or superficial vein thrombosis;

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 Th e 1-year result defined as anatomic success according to duplex ultrasound, is equally high for EVLA and CS and lower for UGFS.