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 at the junctions between the bifurcation point of the deep and superficial system. Typically varicose veins are related to incompetence of these valves. Since the venous pressure in the deep system is generally greater than the superficial system, valve incompetence leads to increased hydrostatic pressure transmitted to the unsupported superficial vein system. This ultimately results 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 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 and the avoidance of tight clothing and prolonged standing. Varicose veins with severe symptoms are treated with custom fitted surgical weight stockings and surgery.
An invasive treatment of varicose veins is known as sclerotherapy. It involves the injection of an inflammatory solution directly into the vein. This irritates and damages the lining and tissue of the vein wall. The vein is sclerosed or thrombosed and is no longer able to serve as a conduit for venous blood flow. Over time some of these veins may channelize again becoming visible as a varicose vein.
Surgical techniques, generally used to treat large varicose veins, include ligation (tying off a vein), stripping (pulling out 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).
POLICY
Sclerotherapy and/or 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.)
Sclerotherapy of symptomatic varicose tributaries, as an adjunct to prior or concomitant surgical treatment of venous reflux disease, is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Endoluminal radiofrequency ablation for the treatment of varicose veins is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Endoluminal laser ablation for the treatment of varicose veins is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Repeat sclerotherapy, for varicose veins greater than 7mm without evidence of previous sclerotherapy effectiveness is considered not medically necessary.
Sclerotherapy for asymptomatic varicose veins is considered not medically necessary.
Sclerotherapy and/or surgical interventions for the treatment of telangiectasias or varicose veins equal to or less than 2mm in diameter are considered cosmetic.
Sclerotherapy of the greater saphenous vein, with or without associated ligation of the saphenofemoral junction is considered investigational.
Endoluminal radiofrequency ablation or endoluminal laser ablation for the treatment of other conditions/disease is considered investigational.
See also: Graduated Elastic Compression Stocking Therapy
MEDICAL APPROPRIATENESS
Sclerotherapy and surgical intervention, including endoluminal radiofrequency or laser ablation, in the treatment of varicose veins greater than 2mm are considered medically appropriate if all of the following criteria are met:
Photographic (color photos preferred) documentation of the varicose veins is submitted; and
Documentation of the location, size and number of veins involved; and
Documentation of conservative management tried for at least 3 months (e.g., avoidance of prolonged immobility, mild exercise, periodic elevation of legs, weight loss and compression hose that can achieve compression pressures of 20-40mm Hg); and
Documentation of one of the following conditions:
Peripheral edema
Hemorrhage
Thrombophlebitis
Severe venous insufficiency with recurrent venous ulceration
Dermatitis or ecchymoses
Severe itching and burning
Pain that impairs mobility or activities of daily living
Functional impairment unrelieved by conservative management
For individuals with venous symptoms and/or vessels greater than 4 mm in diameter, or large numbers of spider telangiectases indicating venous hypertension, a doppler ultrasound scan demonstrating incompetent veins; and
Identification of adequate venous capacity in deep veins by duplex doppler ultrasonography, or plethysmography; and
The individual has none of the following contraindications to sclerotherapy:
Pregnancy
Allergy to the sclerosant
Severe arterial disease
Recent deep venous thrombosis
Critical limb ischemia
Severe systemic disease
Local or general infection
Inability to ambulate
Advanced collagen vascular disease
Osteoarthritis
Acute deep venous thrombophlebitis
Acute febrile illness
Anticoagulant therapy
ADDITIONAL INFORMATION
Complications of venous stasis include but are not limited to the following:
Induration, dermatitis, superficial ulceration; or
Large varicosities subject to trauma; or
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 August 10, 2007 from http://www.cosmeticsurgery.org/Surgeons/2003_Sclerotherapy_Guidelines.pdf.
American College of Phlebology. (2006). Treatment of varicose and spider veins. Retrieved August 10, 2007 from http://www.phlebology.org/index.cfm?sector=patients&page=brochure&b=ip.
American Society for Dermatologic Surgery. (2005). Spider (telangiectatic) and varicose veins. Retrieved August 10, 2007 from http://www.asds-net.org/Patients/FactSheets/patients-Fact_Sheet-veins.html.
American Society for Plastic Surgeons. (2007). Spider veins (sclerotherapy). Retrieved August 10, 2007 from http://www.plasticsurgery.org/patients_consumers/procedures/Sclerotherapy.cfm.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2006). Sclerotherapy as a treatment of varicose veins. (7.01.55). Retrieved August 9, 2007 from BlueWeb. (12 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2007). Endoluminal radiofrequency or laser ablation for treatment of varicose veins/venous insufficiency (7.01.76). Retrieved August 9, 2007 from BlueWeb. (16 articles and/or guidelines reviewed)
Drake, L. A., Dinehart, S. M., Goltz, R. W., Graham, G. F., Hordinsky, M. K., Lewis, C. W., et al. (1996). Guidelines of care for sclerotherapy treatment of varicose and telangiectatic leg veins. Journal of the American Academy of Dermatology, 34 (3), 523-528.
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)
Goldman, M. P. (2004). Intravascular lasers in the treatment of varicose veins. Journal of Cosmetic Dermatology, 3 (3), 162-166. Abstract retrieved August 10, 2007 from Pubmed database.
Hayes. 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)
Hayes. Medical Technology Directory. (2006, May). Endoluminal radiofrequency ablation for varicose veins of the leg. Retrieved August 9, 2007 from www.Hayesinc.com/subscribers. (29 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2006, October). Endovenous laser therapy for varicose veins of the leg. Retrieved August 9, 2007 from www.Hayesinc.com/subscribers. (49 articles and/or guidelines reviewed)
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. Abstract retrieved August 10, 2007 from PubMed database.
Lurie, F., Creton, D., Eklof, B., Kabnick, L. S., Kistner, R. L., Pichot, O., et al. (2003). Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study). Journal of Vascular Surgery, 38 (2), 207-214. Abstract retrieved August 10, 2007 from PubMed database.
Mayo Clinic. (2007, January). Varicose veins. Retrieved August 10, 2007 from http://www.mayoclinic.com/invoke.cfm?id=DS00256.
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. Abstract retrieved August 10, 2007 from PubMed database.
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. Abstract retrieved August 10, 2007 from PubMed database.
Min, R. J., Khilnani, N., & Zimmet, S. E. (2003). Endovenous laser treatment of saphenous vein reflux: Long-term results. Journal of Vascular and Interventional Radiology, 14 (8), 991-996.
Proebstle, T. M., Lehr, H. A., Kargl, A., Espinola-Klein, C., Rother, W., Bethge, S., et al. (2002). Endovenous treatment of the greater saphenous vein with a 940-nm diode laser: Thrombotic occlusion after endoluminal thermal damage by laser-generated steam bubbles. Journal of Vascular Surgery, 35 (4), 729-736.
Proebstle, T. M., Moehler, T., Gul, D., & Herdemann, S. (2005). Endovenous treatment of the great saphenous vein using a 1,320 nm Nd:YAG laser causes fewer side effects than using a 940 nm diode laser. American Society for Dermatologic Surgery, 31, (12), 1678-1683. Abstract retrieved August 10, 2007 from PubMed database.
Ratcliffe, J., Brazier, J. E., Campbell, W. B., Palfreyman, S., MacIntyre, J. B., & Michaels, J. A. (2006). Cost-effectiveness analysis of surgery versus conservative treatment for uncomplicated varicose veins in a randomized clinical trial. The British Journal of Surgery, 93 (2), 182-186. Abstract retrieved August 10, 2007 from PubMed database.
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.
Society of Interventional Radiology. (2007). Vascular disease treatments. Retrieved August 17, 2007 from http://www.sirweb.org/patPub/vascularTreatments.shtml.
Teruya, T. H. & Ballard, J. L. (2004). New approaches for the treatment of varicose veins. Surgical Clinics of North America, 84 (5), 1397-1417.
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.
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. LMRPs/LCD for CIGNA Government Services. (2007, May). LCD for endoluminal radiofrequency or laser system ablation of varicose veins (L12797). Retrieved August 10, 2007 from http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=12797&lcd_version=11&show=all.
ORIGINAL EFFECTIVE DATE: 10/1998
MOST RECENT REVIEW DATE: 10/11/2007
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.
This document has been classified as public information.