BlueCross BlueShield of Tennessee Medical Policy Manual

Varicose Vein Treatments for the Lower Extremities

DESCRIPTION

Varicose veins are enlarged, dilated, and tortuous vessels. These veins can be found anywhere on the body but most commonly in the lower extremities.

The superficial venous system of the lower extremities includes the greater and lesser 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. Valve incompetence leads to increased hydrostatic pressure transmitted to the unsupported superficial vein system, ultimately resulting in varicosities. Rather than flowing forward, blood flows backward across damaged valves, resulting in accumulation of blood and expansion of the vein.

Telangiectasias (i.e. spider veins, spider bursts, web veins, thread veins, dilated venules) are permanently dilated blood vessels that create fine, red lesions. Usually, they are limited to the dermis. 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:

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 “custom fitted” surgical weight stockings and 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 known as the Muller method (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 appropriate varicose veins. This involves injection of a sclerosing solution directly into the vein. This results 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

• Surgical interventions (e.g., ligation, stripping, ambulatory phlebectomy) for the treatment of varicose veins are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

• Endoluminal radiofrequency ablation and/ or endoluminal laser ablation for the treatment of varicose veins is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

• Sclerotherapy for the treatment of varicose veins is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

• Repeat sclerotherapy is considered not medically necessary.

• Surgical interventions and sclerotherapy for asymptomatic varicose veins and/or the treatment of telangiectasias or spider veins are considered cosmetic.

• Sclerotherapy of the greater saphenous vein, with or without associated ligation of the saphenofemoral junction is considered investigational.

MEDICAL APPROPRIATENESS

• Varicose vein treatments for the lower extremities is considered medically appropriate if ALL of the following criteria are met:

• ANY ONE of the following:

• Surgical intervention, endoluminal radiofrequency, and laser ablation, for the treatment of varicose veins if ALL of the following criteria are met:

• Photographic documentation (color photos), with the patient in the standing position, submitted demonstrating the varicose veins

• Identification of adequate venous capacity in deep veins as evidenced by ALL of the following:

• A duplex doppler and/or spectral flow ultrasound study has been performed in the upright position

• There is documented high volume reflux with significant venous insufficiency in either the saphenous veins or the perforating veins as manifested by ANY ONE of the following:

• outward flow lasting more than 500 milliseconds

• venous filling index greater than 7 ml/sec

• Individual with ANY ONE of the following conditions:

• Leg ulcerations, chronic cellulitis, continuous stasis dermatitis with associated dependent edema related to documented venous insufficiency (CEAP classification 4,5,6)

• History of a bleeding or recurrent bleeding of a varix

• Pain resulting in impaired mobility or inability to perform activities of daily living

• Recurrent episodes of phlebitis or thrombophlebitis

• Documentation of failed conservative management tried for at least 3 months including ANY ONE of the following:

• Custom fitted surgical weight hose that can achieve compression pressures of 20-40mm Hg

• Periodic elevation of the lower extremities

• Sclerotherapy for the treatment of varicose veins if ALL the following criteria are met:

• Photographic documentation (color photos) of the pathologic veins in question with the patient in the standing position

• The veins are visible

• Individual is symptomatic (e.g. pain, burning, skin changes, etc.)

• The varicose veins are at least 5 millimeters in size

• Documentation that surgical intervention or endoluminal/ laser ablation has failed to correct significant varicosities

• Documented absence of disease/occlusion of the deep venous system

• ABSENCE of ALL of the following:

• Pregnancy

• Allergy to the sclerosant

• Symptomatic arterial disease

• Recent deep venous thrombosis

• Critical limb ischemia

• Severe systemic disease

• Local or general infection

• Inability to ambulate

• Advanced collagen vascular disease

• Acute superficial venous thrombophlebitis

• Acute febrile illness

• Anticoagulant therapy

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION

Complications of venous stasis include but are not limited to the following:

• Induration

• Dermatitis

• Superficial ulceration

• Large varicosities subject to trauma

• Recurring phlebitis

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.

SOURCES

American Academy of Cosmetic Surgery. (2003). Guidelines for sclerotherapy. Retrieved November 3, 2009 from http://www.cosmeticsurgery.org/Surgeons/2003_Sclerotherapy_Guidelines.pdf.

American Academy of Dermatology. (2009). Spider vein, varicose vein therapy. Retrieved November 3, 2009 from http://www.aad.org/public/publications/pamphlets/cosmetic_spider.html.

American Society for Dermatologic Surgery. (2008). Spider and varicose vein treatment information. Retrieved November 3, 2009 from http://www.asds.net/_ConsumerPage.aspx?id=916&terms=spider+(telangiectatic)+and+varicose+veins# .

Bachoo, P. (2009). Interventions for uncomplicated varicose veins. Phlebology, 24 Supplement 1, 3 - 12.

BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2009). Sclerotherapy as a treatment of varicose veins. (7.01.55). Retrieved October 9, 2009 from BlueWeb. (24 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2008). Endoluminal radiofrequency or laser ablation for treatment of varicose veins/venous insufficiency (7.01.76). Retrieved October 9, 2009 from BlueWeb. (19 articles and/or guidelines reviewed)

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)

Gibson, K., Ferris, B., & Pepper, D. (2007). Foam sclerotherapy for the treatment of superficial venous insufficiency. Surgical Clinics of North America, 87 (5), 1285 -1295 xi - xiii.

Gohel, M., & Davies, A. (2009). Radiofrequency ablation for uncomplicated varicose veins. Phlebology, 24 Supplement 1, 42 - 49. (Level 5 Evidence - Independent)

Lorenz, D., Gabel, W., Redtenbacher, M., Weissenhofer, W., Minzlaff, M., & Stengel, D. (2007). Randomized clinical trial comparing bipolar coagulating and standard great saphenous stripping for symptomatic varicose veins. The British Journal of Surgery, 94 (4), 434-440. (Level 1 Evidence - Independent)

Michaels, J. A., Brazier, J. E., Campbell, W. B., Macintyre, J. B., Palfreyman, S. J., & Ratcliffe, J. (2006). Randomized clinical trial comparing surgery with conservative treatment for uncomplicated varicose veins. The British Journal of Surgery, 93 (2), 175-181. (Level 1 Evidence - Independent)

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

National Institute for Health and Clinical Excellence. (2003, September). Radiofrequency ablation of varicose veins. Retrieved November 3, 2009 from http://www.nice.org.uk/nicemedia/pdf/ip/ipg008guidance.pdf.

National Institute for Health and Clinical Excellence. (2003, September). Endovenous laser treatment of the long saphenous vein. Retrieved November 10, 2009 from http://www.nice.org.uk/nicemedia/pdf/IPG052guidance.pdf.

Nijsten, T., van den Bos, R., Goldman, M., Kockaert, M., Proebstle, T., Rabe, E., et al. (2009). Minimally invasive techniques in the treatment of saphenous varicose veins. Journal of the American Academy of Dermatologists, 60 (1), 110 - 119. (Level 5 Evidence - Independent)

Sadick, N. S. (2005). Advances in the treatment of varicose veins: Ambulatory phlebectomy, foam sclerotherapy, endovascular laser, and radiofrequency closure. Dermatologic Clinics, 23, 443-455.(Level 5 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.

Society of Interventional Radiology. (2009). Varicose Veins and Venous Insufficiency. Retrieved November 3, 2009 from http://www.sirweb.org/patients/varicose-veins/.

Tan, K., Nalachandran, S., & Chia, K. (2009). Endovenous laser treatment for varicose veins in Singapore: a single centre experience of 169 patients over two years. Singapore Medical Journal, 50 (6), 591 - 594. (Level 4 Evidence - Independent)

Teruya, T. H. & Ballard, J. L. (2004). New approaches for the treatment of varicose veins. Surgical Clinics of North America, 84 (5), 1397-1417. (Level 5 Evidence - Independent)

Tisi PV, 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. (2010, April). Treatment of varicose veins of the Lower Extremities. Retrieved August 26, 2010 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.

Winifred S. Hayes, Inc. Medical Technology Directory. (2004, December). Sclerotherapy for symptomatic varicose veins. Retrieved August 13, 2007 from www.Hayesinc.com/subscribers.  (46 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2006, May). Endoluminal radiofrequency ablation for varicose veins of the legs. Retrieved October 9, 2009 from www.Hayesinc.com/subscribers.  (29 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2009, February). 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). 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)

ORIGINAL EFFECTIVE DATE:  10/1998  

MOST RECENT REVIEW DATE:  12/3/2010

ID_BT

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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