Medical Affairs Policy

Service: Varicose Vein Treatments PUM 250-0032 Medical Affairs Policy Implemented 04/04/14, 04/01/15, 4/1/16 Reviewed 12/12/14 Revised 12/12/14, 12/11/15 Developed Arise/WPS Policy 12/12/14, 12/11/15 Committee Approval Note: For review/revision history prior to 2014 see previous Medical Policy or Coverage Policy Bulletin 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 Wisconsin Physicians Service and Arise Health Plan (WPS/AHP) may not utilize WPS/AHP 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. WPS/AHP 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 Health 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 to medical.policies@wpsic.com. Description: Varicose veins are abnormally enlarged tortuous and dilated veins that are usually the result of weakening of the walls of the veins or incompetent valves in the veins that allow backward flow of the blood in the vein. Although varicose veins are not uncommon, they do not usually require medical treatment until they become symptomatic. Various forms of varicose vein treatments are available including: vein ligation (stripping, division, or excision, or stab phlebectomy), endovenous radiofrequency occlusion (VNUS, ablation), laser ablation (ELAS), subfascial endoscopic perforator surgery (SEPS), transilluminated Page 1 of 8

phlebectomy (TriVex), sclerotherapy, mechanochemical ablation (ClariVein), and photothermal sclerosis. Indications of Coverage: I. Varicose vein treatments are considered medically necessary when ALL of the following criteria are met: A. An ultrasound evaluation of the affected extremity documents vein size and reflux as specified below: 1. Vein Size. If the treatment involves: a. The great (large) saphenous vein (GSV) or the sapheno-femoral 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 principle 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) and deep calf veins. b. 350 ms of outward flow in the perforating/tributary veins. 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. Page 2 of 8

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: 1. Recurrent episodes of superficial phlebitis. 2. Non-healing skin ulceration that is a direct result of the varicose vein (CEAP Class 6). 3. 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. II. Sclerotherapy of varicose veins (especially perforators/tributaries) is considered medically necessary for either of these circumstances: A. After treatment of larger deep 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 of 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 above. B. When larger veins do not meet size or reflux measurement criteria above, but there is documentation of bleeding or ruptured varicose veins necessitating emergent treatment or there is skin ulceration present with large surrounding superficial varices requiring treatment, sclerotherapy of vessels/veins without prior surgery/treatment of larger veins is considered medically necessary. 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. Page 3 of 8

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 Additional treatments may be approved if criteria for the initial approval have been met, a minimum of one month has elapsed since the previous treatment, there is documentation that the individual is symptomatic, and post-operative ultra-sound measurements meet criteria. Another trial of conservative therapy is not required. Limitations of Coverage: A. Review contract and endorsements for exclusions and prior authorization or benefit requirements. 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. Page 4 of 8

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. H. Sclerotherapy of varicose veins (especially perforators) is considered not medically necessary when the ultrasound evaluation of the affected extremity documents reflux of the saphenofemoral junction, saphenopopliteal junction, great saphenous vein, or lesser saphenous vein and these veins were not treated. If the criteria above are met, one date of service for each leg may be approved I. 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 Documentation Required: Office notes Ultrasound report Rationale: Varicose veins of the lower extremities are a common condition that affect up to 25 percent of women and 15 percent of men in the Unites States. Although varicose veins do not cause symptoms for most individuals, it is one of the most commonly performed cosmetic procedures in the United States. While common, there is no current consensus regarding the best approach for treatment, although ligation and stripping remains the Page 5 of 8

standard. Recent studies have shown a high recurrence rate for varicose veins treated with sclerotherapy alone as high as 50 percent at ten years. Conservative therapy for varicose veins typically consists of leg elevation, oral medications for symptom relief, avoidance of prolonged periods of immobility, and compression therapy. When conservative therapy fails, treatment may include a variety of percutaneous closure procedures, sclerotherapy, laser or radiofrequency ablation, and surgical stripping or ligation 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. Many of the percutaneous procedures have not been adequately evaluated or compared against the standard surgical procedure and studies typically lack adequate long-term follow up. For example, the COMPASS sclerotherapy technique completed only a three year follow up, which is not comparable to the twenty year follow up reported following surgical intervention. Long term data on efficacy and recurrence for varicose veins treated with sclerotherapy is lacking. References: 1. Belcaro G, Cesarone MR, Di Renzo A, Brandolini R, Coen L, Acerbi G, et al. Foamsclerotherapy, 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. Page 6 of 8

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: 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. 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. 15. UpToDate Overview and management of lower extremity chronic venous disease. Literature review current through Aug 2015. This topic last updated: Mar 19, 2015. 16. UpToDate Medical management of lower extremity chronic venous disease. Literature review current through Sep 2015. This topic last updated: Aug 18, 2014 17. MCG Ambulatory Care 19 th Edition. ACG-A-0174 (AC). Saphenous Vein Ablation, Radiofrequency 18. MCG Ambulatory Care 19 th Edition. ACG-A-0425 (AC). Saphenous Vein Ablation, Laser Page 7 of 8

19. MCG Ambulatory Care 19 th Edition. ACG-A-0171 (AC). Sclerotherapy Plus Ligation, Saphenofemoral Junction 20. MCG Ambulatory Care 19 th Edition. ACG-A-0172 (AC). Saphenous Vein Stripping 21. MCG Ambulatory Care 19 th Edition. ACG-A-0170(AC).Sclerotherapy, Leg Veins 22. Hayes Technology Brief Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter) for Treatment of Varicose Veins Pub Date March 15, 2015 Hayes D2 23. UpTo Date Endovenous Laser Ablation for the Treatment of Lower Extremity Chronic Venous Disease. Lit review current through Aug 2015. Topic last updated March 20, 2015. 24. UpToDate Radiofrequency Ablation for the Treatment of Lower Extremity Chronic Venous Disease. Lit review current through Aug 2015. Topic last updated Aug 2, 2013. 25. Hayes HTB Varithena (Polidocanol Injectable Foam) 1% (Provensis Ltd.) Pub date March 31, 2015. Hayes D2. Approved by Medical Director Page 8 of 8