MEDICAL COVERAGE POLICY. SERVICE: Varicose Veins of the Lower Extremities. PRIOR AUTHORIZATION: Required.

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1 Page 1 of 5 MEDICAL COVERAGE POLICY Important note Even though this policy may indicate that a particular service or supply may be considered covered, this conclusion is not based upon the terms of your particular benefit plan. Each benefit plan contains its own specific provisions for coverage and exclusions. Not all benefits that are determined to be medically necessary will be covered benefits under the terms of your benefit plan. You need to consult the Evidence of Coverage to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and your plan of benefits, the provisions of your benefits plan will govern. However, applicable state mandates will take precedence with respect to fully insured plans and selffunded non-erisa (e.g., government, school boards, church) plans. Unless otherwise specifically excluded, Federal mandates will apply to all plans. With respect to Senior Care members, this policy will apply unless Medicare policies extend coverage beyond this Medical Policy & Criteria Statement. Senior Care policies will only apply to benefits paid for under Medicare rules, and not to any other health benefit plan benefits. CMS's Coverage Issues Manual can be found on the CMS website. PRIOR AUTHORIZATION: Required. POLICY: Ablative therapy for lower extremity varicosities may be considered medically necessary for symptomatic patients or those with signs of more severe disease, after the trial and failure of conservative therapy and prior authorization by SWHP. Photographs of the affected limb(s) may be required at SWHP s discretion. Therapy may include: 1. Ligation and Stripping (usually reserved for cases where less invasive methods are not indicated) - may be considered medically necessary when ALL of the following criteria are met; a. Persistent symptoms which interfere with activities of daily living, and which have not responded to at least 3-6 months of conservative therapy including prescription grade gradient compression stockings, periodic leg elevation, exercise, and weight reduction. b. Evidence of more severe disease may be used in lieu of or in addition to the symptomatic and compression criteria above; e.g. intractable or recurrent ulceration, recurrent superficial phlebitis, stasis dermatitis, lipodermatosclerosis, or hemorrhage from a ruptured varicose vein (single major episode or more than one minor episode, may also consider exposed location and adjacent veins). c. Duplex study of the lower extremity venous system demonstrates greater and/or lesser saphenous vein valve incompetence/reflux (which correlates with the patient s symptoms) and the absence of deep vein thrombosis. 2. Phlebectomy may be considered medically necessary when ALL of the following criteria are met; b. Symptoms and functional problems are attributable to secondary, smaller vessels. 3. Endoluminal Radiofrequency Ablation and Endovenous Laser Ablation (primarily used for greater, lesser, and accessory saphenous veins, although smaller probes are available for intersaphenous and perforators) - may be considered medically necessary when ALL of the following criteria are met; b. Anatomy amenable to surgical catheter placement and advancement, and c. Non-aneurysmal saphenous vein. 4. Sclerotherapy (used for small to medium sized veins of 3-6 mm diameter, may be used in conjunction with alternative treatment of larger veins) - may be considered medically necessary when ALL of the following criteria are met;

2 b. Adjunctive compression is utilized. 5. Subfascial Endoscopic Perforator Vein Surgery (SEPS) (a largely abandoned procedure which may be considered in exceptional circumstance) - may be considered medically necessary when ALL of the following criteria are met; b. Refractory symptoms or ulceration, or recurrent ulceration associated with perforator reflux. c. Medicare considers SEPS medically necessary when all of the criteria in number one above are met and there is demonstration of primary valvular incompetence of superficial and perforating veins. EXCLUSIONS: 1. Ablative therapy for the treatment of lower extremity varicosities in the absence of symptoms or evidence of more severe disease. Such treatment would be considered cosmetic and not a covered benefit. 2. The treatment of spider veins, telangiectasias, reticular veins, and other superficial vascular anomalies as this would be considered cosmetic and not a covered benefit (including photothermal sclerosis or Vasculight and transdermal laser therapy). 3. Ultrasound guidance to deliver sclerotherapy. 4. Open perforator ligation for the treatment of severe chronic venous insufficiency, as the incisions are usually placed in a region of venous stasis. Endovenous ablation or SEPS are preferred. 5. Any treatment not meeting the criteria above. 6. Additional fees for a particular treatment technology are not reimbursable. 7. SEPS for the treatment of post-thrombotic syndrome as effectiveness has not been established. 8. More than 20 sclerotherapy injections per leg, per session. 9. More than 3 sclerotherapy injections per vessel. 10. More than 3 sclerotherapy sessions per leg. OVERVIEW: Varicose veins of the lower extremity are superficial veins that become dilated, elongated, and tortuous; and which may or may not cause symptoms or problems. They are caused by elevated pressure in the leg s venous system as a result of incompetent venous valves (reflux), obstruction, and/or inadequate muscle pumping function. The severity of disease usually correlates with the degree of reflux demonstrated by duplex ultrasound examination of the lower extremity venous system. Varicose veins are often asymptomatic and of no concern to patients except for appearance. However, they may cause pain, itching, swelling, skin changes, ulceration, infection, and superficial thrombophlebitis. The treatment of varicose veins may be considered medically necessary in the presence of symptoms or signs of more significant disease, but would not be covered for cosmetic (appearance) indications. The initial management of patients with symptomatic varicosities includes elevation of the lower extremity, gradient compression stockings, exercise, and weight reduction. If symptoms are not Page 2 of 5

3 improved after 3-6 months of conservative therapy, then ablative therapy may be indicated. Ablative therapy includes ligation and stripping (surgical removal), phlebectomy (surgical removal), endovenous thermal ablation (laser or radiofrequency treatment thorough a catheter), and sclerotherapy (chemical treatment). Sclerotherapy is used primarily in the treatment of telangiectasias, reticular veins, and small varicose veins, which are most often considered cosmetic in nature. CODES: CPT Codes: CPT Not Covered: HCPCS Not Covered Injection of sclerosing solution; single vein ; multiple veins, same leg Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated : second and subsequent veins treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure) Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; first vein treated ; second and subsequent veins treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure) Vascular endoscopy, surgical, with ligation of perforator veins, subfascial (SEPS) Ligation and division of long saphenous vein at saphenofemoral junction, or distal interruptions Ligation, division, and stripping, short saphenous vein Ligation, division, and stripping, long (greater) saphenous veins from saphenofemoral junction to knee or below Ligation and division and complete stripping of long or short saphenous veins with radical excision of ulcer and skin graft and/or interruption of communicating veins of lower leg, with excision of deep fascia Stab phlebectomy of varicose veins, one extremity; stab incisions ; more than 20 incisions Ligation and division of short saphenous vein at saphenopopliteal junction (separate procedure) Ligation, division, and or excision of varicose vein cluster(s), one leg Single or multiple injections of sclerosing solutions, spider veins (telangiectasia); limb or trunk Ligation of perforator veins, subfascial, radical (Linton type), with or without skin graft, open Ultrasonic guidance for needle placement S2202 Echosclerotherapy Page 3 of 5

4 ICD9 codes: Varicose veins of the lower extremities ICD9 Not covered: Asymptomatic varicose veins Hayes Rating: B - For the use of endoluminal radiofrequency ablation for the treatment of symptomatic varicose veins associated with greater saphenous vein reflux. B For the use of endovenous laser therapy for the treatment of symptomatic varicose veins due to incompetence of the greater saphenous vein in adults. C For sclerotherapy for the treatment of varicose veins of the leg in patients who have contraindications to surgery or who wish to avoid a surgical procedure. C For the use of endovenous laser therapy as a treatment for symptomatic varicose veins due to small saphenous vein incompetence in adult patients. CMS: There is no National Coverage Determination on the subject; however there is a Local Coverage Determination (LCD) dated March 1, 2008 (updated September 10, 2010) titled Treatment of in Lower (4S-144AB-R4). The LCD coverage criteria have been incorporated into the policy above. POLICY HISTORY: Status Date Action New 12/1/2010 New policy Reviewed 11/1/2011 Reviewed. Reviewed 10/25/2012 Reviewed. REFERENCES: The following scientific references were utilized in the formulation of this medical policy. SWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available and they are not included in the list, please forward the reference(s) to SWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order. 1. Trailblazer Health Enterprises. Treatment of in Lower 4S -144AB R4. March 1, 2008 (Updated September 10, 2010). 2. Up to Date OnLine Accessed November 5, Overview and management of lower extremity chronic venous disease. Laser and light therapy of lower extremity telangiectasias, reticular veins, and small varicose veins. Liquid and foam sclerotherapy techniques for the treatment of lower extremity veins. Medical management of lower extremity chronic venous disease. Open surgical techniques for lower extremity vein ablation. Radiofrequency ablation for the treatment of lower extremity chronic venous disease. 3. Hayes Medical Technology Directory Report. Endoluminal Radiofrequency Ablation for Varicose Veins of the Leg. May 15, 2006 (Updated June 8, 2010). Winifred S. Hayes, Inc. 4. Hayes Medical Technology Directory Report. Endovenous Laser Therapy for Due to Great Saphenous Vein Reflux. February 6, 2009 (Updated March 9, 2010). Winifred S. Hayes, Inc. Page 4 of 5

5 5. Hayes Medical Technology Directory Report. Sclerotherapy for Symptomatic. December 7, 2004 (Updated January 16, 2009). Winifred S. Hayes, Inc. 6. Hayes Medical Technology Directory Report. Endovenous Laser Therapy for Due to Small Saphenous Vein Reflux. May 17, 2009 (Updated March 11, 2010). Winifred S. Hayes, Inc. 7. Hayes Search & Summary. Endovenous Laser Therapy for Incompetent Perforator Veins. December 18, Winifred S. Hayes, Inc. 8. Hayes Medical Technology Directory Report. Transilluminated Powered Phlebectomy for Symptomatic. May 22, 2002 (Updated April 5, 2007). Winifred S. Hayes, Inc. 9. InterQual Guidelines 2009, Endovenous Ablation-, Ligation and Stripping-Varicose Veins, Branch-Excision-, Sclerotherapy Department of Health & Human Services Food and Drug Administration. Smith & Nephew TriVexTM System 510(k) Approval: K032387, October 29, Accessed February 13, Available at: 11. Weingarten MS. State-of-the-Art Treatment of Chronic Venous Disease. Clinical Practice, March 2001; 32: Nguyen TH. Evaluation of Venous Insufficiency. Seminars in Cutaneous Medicine and Surgery, 2005; 24: 1, Nijsten T, van den Bos RR, Goldman MP, et al. Minimally Invasive Techniques in the Treatment of Saphenous. Journal of the American Academy of Dermatology, January 2009; 60(1):1, Jones RH, Carek PJ. Management of. American Family Physician, 2008; 78(11) 15. Eklof B, Rutherford RB, Bergan JJ et al. Revision of the CEAP Classification for Chronic Venous Disorders: Consensus Statement. Journal of Vascular Surgery, December 2004; 40(6):1, O Donnell Jr. TF. The Present Status of Surgery of the Superficial Venous System in the Management of Venous Ulcer and the Evidence for the Role of Perforator Interruption. Journal of Vascular Surgery, 2008; 48(4): Barswell JR, Davies CE, Deacon J et al. Comparison of Surgery and Compression with Compression Alone in Chronic Venous Ulceration (ESCHAR Study): A Randomised Controlled Trial. Lancet, 2004; 363(9424): Bianchi C, Ballard JL, Abou-Zamzam and Teruya TH. Subfascial Endoscopic Perforator Vein Surgery Combined with Saphenous Vein Ablation: Results and Critical Analysis. Journal of Vascular Surgey, 2003; 38(1): Luebke T, Brunkwall J. Meta-Analysis of Subfascial Endoscopic Perforator Vein Surgery (SEPS) for Chronic Venous Insufficiency. Phebology, 2009; 24(1): Kalra M, Gloviczki P, Noel AA et al. Subfascial Endoscopic Perforator Vein Surgery in Patients with Post-Thrombotic Venous Insufficiency Is It Justified? Vascular - Endovascular Surgery, 2002; 36(1). 21. TenBrook Jr JA, Iafrati MD, O Donnell Jr TF et al. Systematic Review of Outcomes after Surgical Management of Venous Disease Incorporating Subfascial Endoscopic Perforator Surgery. Journal of Vascular Surgery, 2004; 39(3): Clinical Practice Guidelines from the Society of Vascular Surgery and the American Venous Forum, Journal of Vascular Surgery, 2011, Vol. 53, Supplement. Page 5 of 5

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