Medical Policy: 02.01.54 

Original Effective Date: August 2014 

Reviewed: May 2018 

Revised: May 2018 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Echosclerotherapy

Sclerotherapy is a non-surgical procedure used to eradicate varicose veins and/or improve the appearance of the leg. This involves injection of a sclerosant/foam directly into the vein resulting in changes to the lining of the vein wall. The vein is then considered sclerosed or thrombosed and no longer able to serve as a conduit for venous blood flow.

 

In Echosclerotherapy, the use of duplex ultrasound is being utilized during sclerotherapy to guide injections. Ultrasound imaging is used to guide a needle into the abnormal vein and deliver medication to destroy the lining of the blood vessel and seal it shut. Ultrasound guided sclerotherapy (echosclerotherapy) is primarily used to treat large veins beneath the surface of the skin.

 

During echosclerotherapy, duplex ultrasound is said to enhance the precision of the therapy. Echosclerotherapy is also called aimed sclerotherapy, duplex sclerotherapy, or sonographic sclerotherapy.

 

The COMPASS procedure represents a distinct sclerotherapy protocol for the treatment of valvular incompetence (i.e. reflux) of the greater or lesser saphenous veins. COMPASS is an acronym for Comprehensive Objective Mapping, Precise Image-guided Injection (i.e., echosclerotherapy), Antireflux Positioning and Sequential Sclerotherapy.

 

Mechanochemical Ablation (MOCA)

This technique is also referred to as Endomechanical ablation, mechanico-chemical endovenous ablation (MCEA) and mechanically enhanced endovenous chemical ablation (MEECA). Mechanochemical endovenous ablation utilizes both sclerotherapy and mechanical damage to the lumen. Following ultrasound imaging, a disposable catheter with a motor drive is inserted into the distal end of the target vein and advanced to the saphenofemoral junction. As the catheter is pulled back, a wire rotates within the lumen of the vein, abrading the lumen. At the same time, a liquid sclerosant (sodium tetradecyl sulphate) is infused near the rotating wire. It is proposed that mechanical ablation allows for better efficacy of the sclerosant, without the need for the tumescent anesthesia used in radiofrequency ablation or endovenous laser ablation. The ClariVein® Infusion Catheter is utilized to perform MOCA and received 510(k) approval by the U.S. Food and Drug Administration (FDA) in February 2008. The system includes an infusion catheter, motor drive, stopcock and syringe and is intended for the infusion of physician-specified agents in the peripheral vasculature.

 

Embolization of the Ovarian or Internal Iliac Veins /Sclerotherapy for Pelvic Congestion Syndrome

Pelvic venous congestion syndrome is most commonly recognized as the persistence of noncyclical chronic pelvic pain for longer than 6 months in the absence of known pelvic pathology. Under fluoroscopic guidance, an interventional radiologist guides a catheter to the affected vein, and inserts inert embolic agents to completely seal the vein. As a result, blood flow is rerouted, thereby reducing pressure within the targeted veins. Several types of embolic agents may be used, and include, but are not limited to, metal coils, sclerosing agents, and gelatin sponges. These agents may either be temporary or permanent. Since the Ovarian Veins and Internal Iliac Veins are in close proximity, embolization of the Internal Iliac Veins may also be necessary. Considering the difficulty of making the diagnosis clinically and radiologically, outcomes are also difficult to assess (often anecdotal), and there remains a lack of evidence to robustly assess clinical efficacy of treatment.

 

Endovenous Cryoablation

Cryoablation uses extreme cold to cause injury to the vessel. The objective of endovenous techniques is to cause injury to the vessel, causing retraction and subsequent fibrotic occlusion of the vein. A modified Erbe Erbokryo® cryosurgical unit (Erbe USA) received FDA clearance for marketing in 2005. A variety of clinical indications are listed, including cryostripping of varicose veins of the lower limbs.

 

Transilluminated Powered Phlebectomy (TIPP, TriVex)

TIPP is an alternative to stab avulsion or hook phlebectomy. This procedure uses 2 instruments: an illuminator, which also provides irrigation, and a resector, which has an oscillating tip and can perform suction. Following removal of the saphenous vein, the illuminator is introduced via a small incision in the skin and tumescence solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity.

 

The resector is then inserted under the skin from the opposite direction, and the oscillating tip is placed directly beneath the illuminated veins to fragment and loosen the veins from the supporting tissue. Irrigation from the illuminator is used to clear the vein fragments and blood through aspiration and additional drainage holes. The illuminator and resector tips may then be repositioned, thereby reducing the number of incisions needed when compared with stab avulsion or hook phlebectomy. It has been proposed that TIPP might result in decreased operative time, decreased complications such as bruising, and faster recovery compared with the established procedures.

 

Cyanoacrylate Adhesive

Cyanoacrylate adhesive is a clear, free-flowing liquid that polymerizes in the vessel via an anionic mechanism (ie, polymerizes into a solid material on contact with body fluids or tissue). The adhesive is gradually injected along the length of the vein in conjunction with ultrasound and manual compression. The acute coaptation halts blood flow through the vein until the implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the treated vein. Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of indications, including gastrointestinal bleeding, embolization of brain arteriovenous malformations, and to seal surgical incisions or other skin wounds.

 

VeinGogh Ohmic Thermolysis System

The VeinGogh Ohmic Thermolysis System generates a tiny, regulated, high frequency current delivered to the vessel via a hair-thin probe. A "microburst" of energy selectively heats the vein, coagulating the blood and collapsing the vessel wall, which is reabsorbed into the body. This can be used in smaller veins that would be too small for sclerotherapy.

 

The National Institute for Health and Clinical Evidence issued guidance on endovenous mechanochemical ablation in 2013, concluding that current evidence on the safety and efficacy of endovenous mechanochemical ablation for varicose veins is inadequate in quantity and quality and the procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

 

The Society for Vascular Surgery and the American Venous Forum published clinical practice guidelines in 2011 (Gloviczki, 2011). The recommendations are rated as strong=1 or weak=2, based on a level of evidence that is either high quality=A, moderate quality=B, or low quality=C, and include the following:

  • Treatment of the incompetent great saphenous vein: Endovenous thermal ablation (radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B, strong recommendation, moderate quality evidence)

 

Prior Approval:

Not applicable

 

Policy:

Treatment of asymptomatic varicose veins is considered not medically necessary.

 

Treatment using sclerotherapy (including but not limited to Asclera), various laser treatments or microwave energy (including tunable dye or pulsed dye laser, for example, PhotoDerm®, VeinLase™, Vasculite™, Veinwave) of the telangiectatic dermal veins (for example, reticular, capillary, venule or any vein less than 3mm in diameter), which may be described as "spider veins" or "broken blood vessels" is considered not medically necessary.

 

Treatment with the VeinGogh Thermolysis System is considered not medically necessary. The effectiveness has only been shown in veins less than 3mm in diameter and the treatment of veins this size are considered not a medical necessity.

 

Cyanoacrylate adhesive (including VenaSeal®) of any vein is considered investigational. Longer term follow-up is needed to permit conclusions on the durability of this procedure.

 

Echosclerotherapy is considered investigational.

 

There is no evidence that ultrasound makes a significant difference in optimizing outcome or decreasing complications from sclerotherapy for varicose veins, when compared to non-ultrasound-guided techniques. There is very little published medical literature on the use of echosclerotherapy, and no large long-term outcomes have been reported.

 

Mechanochemical Ablation (i.e. The ClariVein®) is considered investigational for all veins.

 

Endovenous Cryoablation is considered investigational for all veins.

 

There is minimal evidence on the safety and long term results for mechanochemical ablation and endovenous cryoablation at this time. There is also a lack of improvement on health outcomes in comparison to standard procedures at this time.

 

Intense pulsed-light source (also known as PhotoDerm, VeinLase or Vasculite or in general, photothermal sclerosis) treatment of a varicose vein is considered investigational for all veins.

 

Transilluminated powered phlebectomy (TIPP, TriVex™) treatment of a varicose vein is considered investigational when used as the sole treatment for varicose vein (without prior or concurrent treatment of saphenous veins).

 

Coil embolization is considered investigational as a treatment of lower extremity veins.

 

High intensity focused ultrasound with the ECHOPULSE device for the treatment of varicose veins is considered investigational (see policy 02.01.53 High Intensity Focused Ultrasound).

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • S2202 Echosclerotherapy
  • 36473 Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; first vein treated
  • 36474 Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)
  • 36482 Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and onitoring, percutaneous; first vein treated
  • 36483 Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)
  • 37241 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles)
  • 37799 Unlisted procedure, vascular surgery
  • 96999 Unlisted special dermatological service or procedure [when specified as tunable dye or pulsed dye laser treatment]

 

Selected References:

  • Marsden G ,Perry M ,Kelley K ,Davies AH. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ 2013;347:f4279
  • National Institute for Health and Care Management (2013) Varicose Veins in the Legs: the Diagnosis and Management of Varicose Veins. London: NICE
  • Hamel-Desnos, C, Ouvry, P, Benigni, JP et al. Comparison of 1% and 3% polidocanol foam in ultrasound guided sclerotherapy of the great saphenous vein: a randomised, double-blind trial with 2 year-follow-up. "The 3/1 Study".  Eur J Vasc Endovasc Surg. 2007;34(6):723-729.
  • National Health Service. National Institute for Clinical Excellence. Ultrasound-guided foam sclerotherapy for varicose veins February 2013.
  • American College of Phlebology. (2012) Practice guidelines, varicose vein surgery Retrieved March 26, 2014.
  • Myers KA, Jolley D. Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins. Eur J Vasc Endovasc Surg. 2008; 36(5):602-605.
  • Klem TM, Schnater JM, Schütte PR, et al. A randomized trial of cryo stripping versus conventional stripping of the great saphenous vein. J Vasc Surg 2009; 49(2):403-409.
  • 13.National Health Service. National Institute for Clinical Excellence. Ultrasound-guided foam sclerotherapy for varicose veins February 2013.
  • Tassie E, Scotland G, Brittenden J, et al; CLASS study team. Cost-effectiveness of ultrasound-guided foam sclerotherapy, endovenous laser ablation or surgery as treatment for primary varicose veins from the randomized CLASS trial. Br J Surg. 2014;101(12):1532-1540.
  • 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 Technol Assess. Apr 2006;10(13):1-196, iii-iv. PMID 16707070
  • Brittenden J, Cotton SC, Elders A, et al. A randomized trial comparing treatments for varicose veins. N Engl J Med. Sep 25 2014;371(13):1218-1227.
  • van der Velden SK, Biemans AA, De Maeseneer MG, et al. Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. Br J Surg. Sep 2015;102(10):1184-1194. PMID 26132315
  • U.S. Food and Drug Administration. VenaSeal Closure System - P140018. 2015
  • 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. Apr 2015;61(4):985-994. PMID 25650040
  • Almeida JI, Javier JJ, Mackay EG, et al. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology. Jul 2015;30(6):397-404. PMID 24789750
  • Zierau U. Sealing Veins with the VenaSeal Sapheon Closure System: Results for 795 Treated Truncal Veins after 1000 Days. Vasomed. 2015;27:124-127. PMID
  • Brittenden J, Cotton SC, Elders A, et al. Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial. Health Technol Assess. Apr 2015;19(27):1-342. PMID 25858333
  • Yasim A, Eroglu E, Bozoglan O, et al. A new non-tumescent endovenous ablation method for varicose vein treatment: Early results of N-butyl cyanoacrylate (VariClose®). Phlebology. 2016 Mar 27
  • Witte ME, Holewijn S, van Eekeren RR, et al. Midterm outcome of mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency. First published: October 14, 2016.
  • Tang TY, Kam JW, Gaunt ME. ClariVein® - Early results from a large single-centre series of mechanochemical endovenous ablation for varicose veins. Phlebology. 2016 Feb 22
  • Kwon SH, Oh JH, Ko KR, et al. Transcatheter ovarian vein embolization using coils for the treatment of pelvic congestion syndrome. Cardiovasc Intervent Radiol. 2007;30:655-661.
  • Nasser F, Cavalcante RN, Affonso BB, et al. Safety, efficacy, and prognostic factors in endovascular treatment of pelvic congestion syndrome. Int J Gynaecol Obstet. 2014; 125(1):65-68.
  • Siqueira FM, Monsignore LM, Rosa-E-Silva JC, et al. Evaluation of embolization for periuterine varices involving chronic pelvic pain secondary to pelvic congestion syndrome. Clinics (Sao Paulo). 2016 Dec 1;71(12):703-708.
  • Guirola JA, Sánchez-Ballestin M, Sierre S, et al. A randomized trial of endovascular embolization treatment in pelvic congestion syndrome: fibered platinum coils versus vascular plugs with 1-year clinical outcomes. J Vasc Interv Radiol. 2017 Nov 22. [Epub ahead of print]
  • Daniels JP, Champaneria R, Shah L, et al. Effectiveness of embolization or sclerotherapy of pelvic veins for reducing chronic pelvic pain: a systematic review. J Vasc Interv Radiol. 2016 Oct;27(10):1478-1486.
  • ECRI Institute, Executive Summary. ClariVein Infusion Catheter for Peripheral Vascular Interventions. 6/20/2017
  • National Institute for Health and Care Excellence (NICE). Endovenous mechanochemical ablation for varicose veins [IPG557]. 2016 
  • Lane T, Bootun R, Dharmarajah B, et al.(2017) 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 Mar 2017;32(2):89-98. PMID 27221810
  • Eroglu E, Yasim A, Ari M, et al. Mid-term results in the treatment of varicose veins with N-butyl cyanoacrilate. Phlebology. 2017;32(10):665-669
  • 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):149-156
  • Lam YL, De Maeseneer M, Lawson J, et al. Expert review on the VenaSeal® system for endovenous cyano-acrylate adhesive ablation of incompetent saphenous trunks in patients with varicose veins. Expert Rev Med Devices. 2017;14(10):755-762.
  • Brittenden J, Cotton SC, Elders A, et al. Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial. Health Technol Assess. Apr 2015;19(27):1-342. PMID 25858333

 

Policy History:

  • May 2018 - Annual Review, Policy Revised
  • May 2017 - Annual Review, Policy Revised
  • June 2016 - Annual Review, Policy Revised
  • July 2015 - Annual Review, Policy Revised
  • September 2014 - Interim Review, Policy Revised
  • August 2014 - New Medical Policy, Policy Implemented

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.