Medical Affairs Policy

Service: Varicose Vein Treatments PUM 250-0032 Medical Affairs Policy Medical Policy Committee Approval 12/01/17 Effective Date 04/01/18 Prior Authorization Needed Yes Disclaimer: This policy is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may not provide coverage for all services listed in this policy. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical policy in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information. Medical policies are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG Health to assist in administering health benefits. This medical policy and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, email medical.policies@wpsic.com. Description: Varicose veins of the lower extremities are a common condition that affect 10-20 percent of the population in the United States. Rates increase with age. Varicose veins do not cause symptoms for most individuals, and the concern is primarily cosmetic. Varicose vein treatment is one of the most commonly performed cosmetic procedures in the United States. Although varicose veins are common, they do not usually require medical treatment until they become symptomatic. The spectrum of lower extremity chronic venous disease ranges from small superficial veins (e.g. spider veins ) to chronic venous insufficiency with complications. Complications such as skin ulceration, lipodermatosclerosis, and thrombophlebitis are infrequent. Varicose veins are abnormally enlarged tortuous and dilated veins that are usually the result of incompetent valves in the veins that allow backward flow (reflux) of the blood in the vein and weakening of the walls of the veins. Conservative therapy for varicose veins typically consists of leg elevation, oral medications for symptom relief, avoidance of prolonged periods of immobility, and/or compression therapy. When conservative therapy fails, treatment may include a variety of procedures depending upon the severity of the condition. The goal of treatment is to eliminate the sources of reflux and redirect blood flow through competent veins. Terms used for the various forms of varicose vein treatments include vein removal by stripping, phlebectomy, stab phlebectomy, division, or excision; surgically cutting and tying (vein ligation); laser or radiofrequency energy (thermal ablation, endovenous radiofrequency occlusion (VNUS, ablation), laser ablation (ELAS), endovenous laser ablation (ELVA); endovenous laser therapy (EVLT); subfascial endoscopic perforator Page 1 of 9

surgery (SEPS); transilluminated phlebectomy (TriVex), ablation through application of chemical agents (sclerotherapy), mechanochemical ablation (ClariVein), photothermal sclerosis, and percutaneous closure procedures. Indications of Coverage: I. Varicose vein treatments are considered medically necessary when ALL the following criteria are met: A. An ultrasound evaluation of the affected extremity documents vein size and reflux as specified below. Note: Although a vein described as incompetent denotes reflux, the measured reflux duration must be reported 1. Vein Size. If the treatment involves: a. The great (large) saphenous vein (GSV) or the saphenofemoral junction (SFJ), the vein must be 5 mm or greater in diameter, as measured by duplex ultrasonography. b. The small (lesser) saphenous vein (SSV), the vein must measure 4 mm or greater just below the saphenopopliteal junction. c. The named principal branches including (posterior accessory vein, anterior accessory vein and the cephalad extension of the small saphenous vein [vein of Giacomini]), the vein must measure 5 mm or greater. d. Perforator/tributary veins, the veins must measure 3.5mm or greater. Perforator veins connect the superficial veins to the deep veins. Perforator veins which may be pertinent to varicose vein treatments include those in the thigh (Hunter s veins), knee (Boyd s veins), and calf (Cockett s veins). 2. Reflux measured when the patient is standing or in reverse Trendelenburg position. Reflux has been defined as retrograde or reversed flow equal to or greater than: a. 500 ms (0.5 seconds) duration in the superficial (GSV, SSV, SFJ) Reflux of the deep veins-common femoral vein (CFV), Femoral Vein (also called the Superficial Femoral Vein or SFV), Popliteal Vein, Anterior Tibial, Posterior Tibial, and Peroneal) does not denote reflux in the superficial veins b. 350 ms of outward flow in the perforating/tributary veins. Page 2 of 9

B. There is documentation of severe and persistent pain, aching, or cramping to such a degree that it inhibits or interferes with mobility and activities of daily living (ADLs) or occupation. The limiting effect of the pain on the activity or occupation must be described in terms of frequency, intensity, reduced or discontinued activity. C. Within the past six months, a three-month trial of analgesic medications and fitted compression stockings (greater than 20 mmhg compression), and weight loss (where indicated) has been documented as ineffective. A trial of conservative therapy may be waived if one of the following is documented: a. Recurrent episodes of superficial phlebitis. b. Non-healing skin ulceration that is a direct result of the varicose vein (CEAP Class 6). c. Bleeding (internal or external) from a varicosity. If the criteria above are met, one Treatment Day of Service for each leg is approved. A Treatment Day of Service can consist of treatment (e.g. ablations, stab phlebectomies) of as many veins as have been approved, done during that one date of service. Multiple dates of service in the office setting will be considered medically necessary only when there is documentation of the medical need for repeated visits and a (required) Medical Director review. II. Sclerotherapy of varicose veins (especially perforators/tributaries) is considered medically necessary for either of these circumstances: A. After treatment of larger veins (of the saphenofemoral junction, saphenopopliteal junction, great saphenous vein, or lesser saphenous vein) that meet criteria have been treated, because many symptomatic varicosities of perforator and tributary veins will improve with resolution of reflux in the larger veins. Sclerotherapy of vessels is considered medically necessary after prior surgery/treatment when all the following are met: 1. A minimum of one month has elapsed since the previous treatment, and 2. There is documentation that the individual is symptomatic and 3. Post-operative ultrasound measurements for size and reflux meet criteria in section A.1. and A.2 above. NOTE: Another trial of conservative therapy is not required. Page 3 of 9

OR B. When sclerotherapy is the only treatment being requested: 1. Larger veins do not meet size or reflux measurement treatment criteria above, AND there is documentation of bleeding or ruptured varicose veins necessitating emergent treatment. OR 2. There is skin ulceration present with large surrounding superficial varices requiring treatment. If the sclerotherapy criteria above are met, one Treatment Day of Service for each leg is approved. A Treatment Day of Service can consist of sclerotherapy treatments of as many veins as have been approved, done during that one date of service. More than one sclerotherapy date of service for each approved leg from 12 months from the start of sclerotherapy therapy is considered not medically necessary. CEAP CLINICAL CLASSIFICATION descriptions: 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) Class C - Clinical Classification, supplemented by A for asymptomatic and S for symptomatic presentation E - Etiology A - Anatomy P - Pathophysiology Definition Class 0: No visible or palpable signs of venous disease Class 1: Telangiectasia, reticular veins, malleolar flare Class 2: Varicose veins Class 3: Edema without skin changes Class 4: Skin changes ascribed to venous disease (e.g., pigmentation, venous eczema, lipodermatosclerosis) Class 5: Skin changes as defined above with healed ulceration Class 6: Skin changes as defined above with active ulceration Congenital, Primary, Secondary, No venous disease Superficial, Perforator, Deep, No venous location Reflux or obstruction (alone or combined); Basic or Advanced Limitations of Coverage: A. Review contract and endorsements for exclusions and prior authorization or benefit requirements. Page 4 of 9

B. If used for a condition/diagnosis other than is listed in the Indications of Coverage, deny as experimental or investigative. C. If used for a condition/diagnosis that is listed in the Indications of Coverage, but the criteria are not met, deny as not medically necessary. D. The use of ultrasound guidance during a treatment is an integral component of the procedure, and is not reimbursed separately. E. Treatment of any vein less than 3.5 millimeters in size (e.g. telangiectasias, spider veins, reticular veins) with any method, is considered cosmetic and not medically necessary. F. Treatment with Varithena (polidocanol injectable foam 1%) for treatment of varicose veins is considered experimental, investigational, unproven G. Treatment of varicose veins is considered not medically necessary in any of the following situations: 1. Without documentation of failed conservative therapy. 2. For the treatment of asymptomatic tributary veins, also known as high veins or supramelic veins. 3. Multiple dates of service in the office setting will be considered not medically necessary unless there is documentation of the medical need for repeated visits AND required Medical Director review. 4. Multiple dates of service in an outpatient surgical-center are considered not medically necessary H. The following treatments are considered experimental or investigative as there is insufficient peer-reviewed literature documenting the effectiveness of these treatments, comparing methodologies and long-term outcomes: 1. Photothermal sclerosis. 2. Transilluminated phlebectomy (TriVex). 3. Transdermal laser therapy. 4. ClariVein Occlusion Catheter (Endovenous Mechanochemical Ablation [MOCA]), Nonthermal Vein Ablation System Page 5 of 9

Documentation Required: Office notes Ultrasound report Documentation of location for planned procedure (office, outpatient surgical center, inpatient etc.) References: 1. Belcaro G, Cesarone MR, Di Renzo A, Brandolini R, Coen L, Acerbi G, et al. Foam sclerotherapy, surgery, sclerotherapy, and combined treatment for varicose veins: a 10- year, prospective, randomized, controlled trial (VEDICO trial). Angiology. 2003 May 1; 54(3):307-15. 2. Darwood RJ, Gough MJ. Endovenous laser treatment for uncomplicated varicose veins. Phlebology. 2009; 24 Suppl 1:50-61. 3. Eklof B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, Meissner MH, Moneta GL, Myers K, Padberg FT, Perrin M, Ruckley CV, Smith PC, Wakefield TW; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004 Dec; 40(6):1248-52. 4. Labropoulos N, Definition of venous reflux in lower-extremity veins. Journal of Vascular Surgery Oct 2003 38(4): 793-798 accessed 12/9/2011, 11/4/14. 5. Min RJ, Khilnani N, Zimmet SE. Endovenous laser treatment of saphenous vein reflux: long-term results. J Vasc Interv Radiol. 2003 Aug; 14(8):991-6. 6. Rigby KA, Palfreyman SJ, Beverley C, Michaels JA. Surgery versus sclerotherapy for the treatment of varicose veins. The Cochrane Database of Systematic Reviews. 2006 Issue 3. 7. Shamiyeh A, Schrenk P, Huber E, Danis J, Wayand WU. Transilluminated powered phlebectomy: advantages and disadvantages of a new technique. Dermatol Surg. 2003 Jun; 29(6):616-9. 8. Society for Interventional Radiology. Position statement. Endovenous ablation. 2003 Dec. Available at: Page 6 of 9

www.sirweb.org/clinical/cpg/sir_venous_ablation_statement_final_dec03.pdf. Accessed: 10 Apr 10. 9. Tisi PV, Beverley CA. Injection sclerotherapy for varicose veins. The Cochrane Database of Systematic Reviews. 2006 Issue 3. 10. Oxford Health Plans > Medical and Administrative Policies > Procedures for Ablation of Varicose Veins ACCESED 12/9/2011 at https://www.oxhp.com/secure/policy/procedures_ablation_varicose_veins_611.html. 11. Hayes Medical Technology Directory. Endovenous Laser Therapy for Varicose Veins due to Great Saphenous Vein Reflux. Publication Date: February 6, 2009. Annual Review February 21, 2013. Report archived Mar 01, 2014. 12. Hayes Medical Technology Directory. Endovenous Laser Therapy for Varicose Veins due to Small Saphenous Vein Reflux. Publication Date: February 6, 2009. Annual Review February 21, 2013. Archived Apr 16, 2014 13. Hayes Search and Summary. ClariVein Occlusion Catheter, Nonthermal Vein Ablation System. November 7, 2013. 14. Health Technology Brief. Ultrasound-Guided Foam Sclerotherapy (UGFS) for Varicose Veins. Publication Date: November 4, 2011. Annual Review: December 9, 2013. Archived Dec 4, 2014 15. UpToDate Overview and management of lower extremity chronic venous disease. Literature review current through Oct. 2017. This topic last updated: July 27, 2016. 16. UpToDate Medical management of lower extremity chronic venous disease. Literature review current through Oct 2017 This topic last updated: Nov 7,2017 17. MCG 21 st Edition. ACG-A-0174 (AC). Saphenous Vein Ablation, Radiofrequency 18. MCG 21 st Edition. ACG-A-0425 (AC). Saphenous Vein Ablation, Laser 19. MCG 21 st Edition. ACG-A-0171 (AC). Sclerotherapy Plus Ligation, Saphenofemoral Junction 20. MCG 21 st Edition. ACG-A-0172 (AC). Saphenous Vein Stripping 21. MCG 21 st Edition. ACG-A-0170(AC). Sclerotherapy, Leg Veins 22. MCG 21 st Edition. ACG-A-0735(AC). Stab Phlebectomy Page 7 of 9

23. Hayes Technology Brief Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter) for Treatment of Varicose Veins Pub Date March 15, 2015, Annual review March 14, 2016 See reference # 24 24. Hayes HTB Endovenous Mechanochemical Ablation (MOCA) (ClariVein Infusion Catheter, Nonthermal Vein Ablation System; Vascular Insights LLC) for Treatment of Varicose Veins, Publication Date: June 30, 2017 25. Hayes MTD: Comparative Effectiveness of Endovenous Radiofrequency Ablation Versus Conventional Surgery for Symptomatic Varicose Veins: A Review of Reviews. Publication Date Oct 17, 2017 26. Hayes MTD: Comparative Effectiveness of Endovenous Laser Therapy Versus Conventional Surgery for Symptomatic Varicose Veins: A Review of Reviews. Publication Date Sep 07, 2017 27. UpToDate Endovenous Laser Ablation for the Treatment of Lower Extremity Chronic Venous Disease. Lit review current through Oct 2017. Topic last updated June 22, 2017 28. UpToDate Radiofrequency Ablation for the Treatment of Lower Extremity Chronic Venous Disease. Lit review current through Oct 2017. Topic last updated June 13, 2017. 29. UpToDate Clinical manifestations of lower extremity chronic venous disease. Literature review current through Oct 2017, Topic last updated June 13, 2017 30. Hayes HTB Varithena (Polidocanol Injectable Foam) 1% (Provensis Ltd.). First published March 31, 2015; updated May 12, 2016 to the following: 31. Hayes HTB Polidocanol Endovenous Microfoam (Varithena) for treatment of Varicose Veins Publication date May 12, 2016, Annual Review April 19, 2017 32. UpToDate. Liquid, foam, and glue sclerotherapy techniques for the treatment of lower extremity veins, Literature review current through Oct 2017, Topic last updated Jul 28, 2017 Page 8 of 9

WPS / Arise Review History: Implemented 04/04/14, 04/01/15, 04/01/16, 01/01/17, 04/01/18 Medical Policy 12/12/14, 12/11/15, 12/09/16, 12/01/17 Committee Approval Reviewed 12/12/14, 12/11/15, 12/09/16, 12/01/17 Revised 12/12/14, 12/11/15, 12/09/16, 12/01/17 Developed Note: For review/revision history prior to 2014 see previous Medical Policy or Coverage Policy Bulletin Page 9 of 9