BlueCross BlueShield of Tennessee Medical Policy Manual

Varicose Vein Treatments for the Lower Extremities

DESCRIPTION

Varicose veins, enlarged, dilated, and tortuous vessels are a common clinical manifestation of chronic venous insufficiency. These veins can be found anywhere on the body but occur most often in the lower extremities.

The superficial venous system of the lower extremities includes the great and small saphenous veins and their tributaries. The deep system includes the popliteal and femoral veins. Perforator veins interconnect these parallel systems.  One way valves are located throughout the superficial system, that aids the cephalad flow of venous blood. Typically varicose veins are related to incompetence of these valves which leads to increased hydrostatic pressure in the unsupported superficial venous system that can ultimately result in an accumulation of blood and expansion /bulging of the veins.  Valves in the perforator veins can also become incompetent thus allowing a backflow of blood to the superficial system resulting in high venous pressure and the development of varicose veins.

Telangiectasias (i.e. spider veins, spider bursts, web veins, thread veins, dilated venules) are permanently dilated blood vessels that create fine, thread-like veins. Usually, they are limited to the dermis and are small (1 mm in diameter). The treatment of telangiectasias is most commonly performed for cosmetic improvement.

The CEAP classification is a method commonly used to document the severity of chronic venous disease and is based on clinical presentation (C), etiology (E), anatomy (A), and pathophysiology (P).

CEAP Classification:

Class

Definition

C - Clinical Classification, supplemented by “A” for  

asymptomatic and “S” for symptomatic presentation

Class 0: No visible or palpable signs of venous disease
Class 1: Telangiectasia, reticular veins, malleolar flare
Class 2: Varicose veins
Class 3: Varicose veins with edema alone (no skin changes)
Class 4: Varicose veins with skin changes ascribed to venous stasis (e.g., pigmentation, venous eczema, lipodermatosclerosis)
Class 5: Varicose veins with skin changes including healed ulceration
Class 6: Varicose veins with skin changes including active ulceration

E - Etiology

Congenital, Primary, Secondary, No venous disease

A - Anatomy

Superficial, Perforator, Deep, No venous location

P - Pathophysiology

Reflux or obstruction (alone or combined); Basic or Advanced

The treatment of varicose veins depends on the severity of the problem. Asymptomatic varicose veins and those with moderate symptoms are treated with conservative measures such as exercise, elevation of leg(s), supportive stockings, the avoidance of tight clothing, and prolonged standing. Varicose veins with severe symptoms may be treated with more invasive techniques including surgery.

Surgical techniques, generally used to treat large varicose veins, include ligation (tying off a vein), stripping (removing a long segment of vein with a special instrument), ambulatory phlebectomy (removal of a vein through tiny incisions), endoluminal radiofrequency ablation (e.g., VNUS® Closure™ System) and endoluminal laser ablation [e.g., EVLT (endovenous laser therapy) procedure kit]. Radiofrequency energy or laser therapy is similarly designed to damage the intimal wall of the vessel, resulting in fibrosis and ultimately obliteration of a long segment of the vein.

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 no longer able to serve as conduit for venous blood flow.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Transillumination, as a technique to enhance phlebectomy and ultrasound guidance may be utilized by the provider. However, both are considered incidental to the procedures and use in the performance of surgical procedures for the treatment of varicose veins is inclusive in the code description for the surgical intervention.

No controlled studies were found in the published literature that validate the application or the long-term outcomes of sclerotherapy of the greater saphenous vein, with or without associated ligation of the saphenofemoral junction or provide comparisons to conventional techniques. In addition, no controlled studies were found in the published literature that validates the long-term application of endoluminal radiofrequency ablation or endoluminal laser ablation for the treatment of other conditions/diseases.

Currently, in the United States, endovenous thermal ablation and surgical ligation and stripping are performed most often for saphenous veins. Ambulatory phlebectomy is an alternative for tributary veins or localized varicosities, especially at larger vein diameters. Surface laser therapy can be used for cosmetic improvements in telangiectasias and reticular veins, but liquid sclerotherapy is considered first-line cosmetic therapy for these veins on the lower extremity.

There are two FDA approved solutions to perform sclerotherapy. (Sotradecol®, Polydocanol®) on veins less than 3mm in diameter. These solutions are much safer and have a better side effect profile that the old hypertonic saline solution. Foam application of these agents is considered off-label.

SOURCES

American Academy of Cosmetic Surgery. (2003). Guidelines for sclerotherapy. Retrieved May 2, 2012 from http://www.cosmeticsurgery.org/media/2003_sclerotherapy_guidelines.pdf.

American College of Phlebology. (2012) Practice guidelines, varicose vein surgery. Retrieved March 26, 2014 from http://phlebology.org/resources/Varicose-Vein-Rx-Guidelines.pdf.

American College of Radiology. (2009). ACR appropriateness criteria-treatment of lower extremity venous insufficiency. Retrieved May 2, 2012 from http://www.guideline.gov/

American Society of Dermatologic Surgeons. (2014). Sclerotherapy for spider veins. Retrieved March 20, 2014 from https://www.asds.net/PrintTemplate.aspx.

BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2014). Treatment of varicose veins/venous insufficiency. (7.01.124). Retrieved March 20, 2014 from BlueWeb. (62 articles and/or guidelines reviewed)

BlueCross BlueShield of Tennessee network physicians. June - July 2012.

Bush, R., Bush, P., Flanagan, J., Gueldner, T., Koziarski, J., McMullen, K., et al. 92014). Factors associated with recurrence of varicose veins after thermal ablation: results of the recurrent veins after thermal ablation study. The Scientific World Journal, 2014 (505843).

ECRI Institute. Health Technology Information Service. Windows on Medical Technology. (2006, August). Endovenous radio-frequency ablation (VNUS Closure® System) for the treatment of varicose veins. Retrieved August 9, 2007 from ECRI Institute. (59 articles and/or guidelines reviewed)

ECRI Institute. Health Technology Information Service. Windows on Medical Technology. (2004, December). Endovenous laser ablation of the greater saphenous vein. Retrieved August 9, 2007 from ECRI Institute. (58 articles and/or guidelines reviewed)

Galeandro, A., Quistelli, G., Scicchitano, P., Gesualdo, M., Zito, A., Caputo, P., et al. (2012). Doppler ultrasound venous mapping of the lower limbs. Vascular Health and Risk Management, 2012 (8), 59 - 64. (Level 3 Evidence - Independent)

Glovicki, P., Comerota, A., Dalsing, M., Eklof, B., Gillespie, D., Glovicki, M., et al (2011). The care of patients with varicose veins and associated chronic venous diseases: Clinical practice guidelines of the Society of Vascular Surgery and the American Venous Forum. Journal of Vascular Surgery, 53 (5), 2s-48s. (Level 1 Evidence - Independent) 

International Accreditation Commission. (2012). IAC standards and guidelines for vascular testing accreditation. Retrieved March 20, 2014 from http://intersocietal.org/vascular/standards/IACVascularTestingStandards2013.pdf.

Kundu,S., Grassi, C., Khilnani, N., Fanelli, F., Kalva, S., Ahmed, A., et al. (2010). 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. Journal of Vascular Interventional Radiology, 21 (1), 1-13.

Meissner, M. (2012). What is the medical rationale for the treatment of varicose veins? Phlebology, 27 (10), 27-33.

Michaels, J. A., Campbell, W. B., Brazier, J. E., Macintyre, J. B., Palfreyman, S., Ratcliffe, J., et al. (2006). Randomized clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial). Health Technology Assessment, 10 (13), 1-196. (Level 1 Evidence - Independent)

Murad, M.., Coto-Yglesias, F., Zumaeta-Garcia, M., Elamin, M., Duggirala, M., Erwin, P., et al. (2011) A systematic review and meta-analysis of the treatments of varicose veins. Journal of Vascular Surgery, 53 (16S) 49S-65S. (Level 1 Evidence - Independent)

National Institute for Health and Clinical Excellence. (2003, September). Endovenous laser treatment of the long saphenous vein. Retrieved May 2, 2012 from http://www.nice.org.uk/nicemedia/pdf/IPG052guidance.pdf.

National Institute for Health and Clinical Excellence. (2003, September). Radiofrequency ablation of varicose veins. Retrieved May 2, 2012 from http://www.nice.org.uk/nicemedia/pdf/ip/ipg008guidance.pdf.

National Institute for Health and Clinical Excellence. (2004, January). Transilluminated powered phlebectomy for varicose veins. Retrieved May 2, 2012 from http://www.nice.org.uk/nicemedia/live/11117/31130/31130.pdf.

National Institute for Health and Clinical Excellence. (2009, August). Ultrasound guided foam sclerotherapy for varicose veins. Retrieved May 2, 2012 from http://www.nice.org.uk/nicemedia/live/11149/45254/45254.pdf.

Nesbitt, C., Coyne, p., Badri, H., Bhattacharya, V & Stansby, G. (2011) Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional surgery for the great saphenous vein varices (2011). Cochrane Database of Systematic Reviews 2011, Issue 10. Art. No. CD005624. DOI: 10.1002/14651858.pub2 (Level 1 Evidence - Independent)

Society of Interventional Radiology. (2003). Position Statement: Endovenous Ablation. Retrieved November 3, 2009 from http://www.scvir.org/clinical/cpg/SIR_venous_ablation_statement_final_Dec03.pdf.

Stucker, M., Kobus, S., Altmeyer, P., & Reich-Schupke, S. (2010). Review of published information on foam sclerotherapy. Dermatologic Surgery, 36 (S2), 983-992. (Level 1 Evidence – Industry sponsored)

Tisi, P.V., Beverley C., Rees A. Injection sclerotherapy for varicose veins. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.:CD001732. DOI: 10.1002/14651858.CD001732.pub2. (Level 1 Evidence - Independent)

U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. LCD for Wisconsin Physicians Service Insurance Corporation. (2012, March). Treatment of varicose veins of the Lower Extremities. Retrieved April 6, 2012 from http://www.cms.gov/mcd/viewlcd.asp?lcd_id=30143&lcd_version=9&show=all.

U. S. Food and Drug Administration. (1999. October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K990723. Retrieved August 11, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf/K990723.pdf.

U. S. Food and Drug Administration. (2003. June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K030700. Retrieved August 11, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/K030700.pdf.

U. S. Food and Drug Administration. Center for Drug Evaluation and Research. (2005). Asclera®(polidocanol). Retrieved May 2, 2012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf.

Vasquez, M., Rabe, E., McLafferty, R., Shortell, C., Marston, W., Gillespie, D., et al. (2010). Revision of the venous clinical severity score: Venous outcomes consensus statement: Special communication of the American Venous Forum Ad Hoc Outcomes Working Group. Journal of Vascular Surgery, 52 (5), 1387-1396.

Winifred S. Hayes, Inc. Medical Technology Directory. (2009, February, last updated March 16, 2012). Endovenous laser therapy for varicose veins due to great saphenous vein reflux. Retrieved October 9, 2009 from www.Hayesinc.com/subscribers. (47 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2009, March, last updated March 19, 2012). Endovenous laser therapy for varicose veins due to small saphenous vein reflux. Retrieved October 9, 2009 from www.Hayesinc.com/subscribers. (53 articles and/or guidelines reviewed)

Wisconsin Physician Service. (February, 2014). LCD Treatment of varicose veins of the lower exremities (L 30143). Retrieved March 20, 2014 from http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx?CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Tennessee&KeyWord=Varicose+veins&KeyWordLookUp=Title&KeyWordSearchType=And&from2=search.asp&bc=gAAAAAAAAAAAAA%3d%3d&=&.

ORIGINAL EFFECTIVE DATE: 10/1998

MOST RECENT REVIEW DATE:  5/22/2014

ID_BT

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