Providers | Treatment of Varicose Veins of the Lower

PROVIDER POLICIES & PROCEDURES

TREATMENT OF VARICOSE VEINS OF THE LOWER EXTREMITY

The primary purpose of this document is to assist providers enrolled in the Connecticut Medical Assistance Program (CMAP) with the information needed to support a medical necessity determination for treatment of varicose veins of the lower extremities. By clarifying the information needed for prior authorization of services, HUSKY Health hopes to facilitate timely review of requests so that individuals obtain the medically necessary care they need as quickly as possible.

Varicose veins are abnormally enlarged and tortuous vessels caused by incompetent valves in the venous system that allow blood leakage or reflux. They are an indication of an underlying syndrome of venous insufficiency. Venous insufficiency syndromes allow venous blood to escape from its normal flow path and flow into an already congested leg. The condition becomes clinically significant when symptoms such as cramping, throbbing, burning and swelling become pronounced. Severe varicosities may be associated with dermatitis, ulceration, and thrombophlebitis.

Conservative measures often yield satisfactory results in relieving symptoms that produce functional impairment. When these don’t, however, a variety of invasive treatments are available. A significant number of individuals additionally seek treatment for cosmetic reasons. Invasive treatments include stab phlebectomy and sclerotherapy.

Ambulatory phlebectomy involves the removal of varicose veins through small “stab” 1-2 mm incisions in the skin overlying the vein. The varicose vein is hooked and brought to the surface at each incision site to release it from the surrounding tissues and to sever any connections to other veins.

Injection/compression sclerotherapy is a minimally invasive percutaneous technique using chemical irritants to close unwanted veins. Sclerotherapy works by destroying the endothelium of the target vessel in order to produce an inflammatory reaction which eventually leads to fibrosis and occlusion of the vessel lumen. This process is facilitated by the use of compression to keep the vein walls together.

Microfoam sclerotherapy (e.g., Varithena® [polidocanol injectable foam]) is a proprietary microfoam sclerosant that is dispersed from a canister. Varithena is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities.

The VenaSeal™ closure system works to close a diseased vein by injecting a medical adhesive, cyanoacrylate, through a catheter into specific areas along the vein. Compression is applied during the procedure.

V1 1 Please note that authorization is based on medical necessity at the time the authorization is issued and is not a guarantee of payment. Payment is based on the individual having active coverage, benefits and policies in effect at the time of service.

To determine if a service or procedure requires prior authorization, CMAP Providers may refer to the Benefit and Authorization Grids summaries on www.ct.gov/husky by clicking on “For Providers” followed by “Benefit Grids”. For a definitive list of benefits and service limitations, CMAP Providers may access the CMAP provider fee schedules and regulations at www.ctdssmap.com.

Radiofrequency Ablation (RFA), Endovenous laser therapy (EVLT), or Subfascial Endoscopic Perforator Surgery (SEPS) Because prior authorization is not currently required for radiofrequency ablation (RFA), endovenous laser therapy (EVLT), or subfascial endoscopic perforator surgery (SEPS), they will not be addressed in this policy.

Ligation, Division and Excision Because ligation, division and excision procedures as treatment for varicose veins either do not require prior authorization or are reviewed InterQual® criteria, they will not be addressed in this policy.

CLINICAL GUIDELINE Coverage guidelines are made in accordance with the Department of Social Services (DSS) definition of Medical Necessity. The following criteria are guidelines only. Coverage determinations are based on an assessment of the individual and his or her unique clinical needs. If the guidelines conflict with the definition of Medical Necessity, the definition of Medical Necessity shall prevail. The guidelines are as follows:

Chemical Ablation and Cyanoacrylate Adhesive (CPT Codes 36465, 36466, 36482, 36483)

Chemical ablation (microfoam sclerotherapy, e.g., Varithena) may be considered medically necessary for treatment of symptomatic varicose veins (great saphenous veins) and cyanoacrylate adhesive (e.g.,Venaseal) may be considered medically necessary for treatment of symptomatic varicose veins (great or small saphenous veins) when the following criteria are met: A. There is moderate to severe (greater than 0.5 second saphenous reflux documented, within the past 6 months, on venous studies and CEAP [Clinical-Etiology-Anatomy-Pathophysiology] class C2 or greater; AND B. There is documentation of ONE or more of the following indications: • Venous stasis ulcers • Recurrent superficial thrombophlebitis • Hemorrhage or recurrent bleeding episodes from a superficial varicosity • Persistent pain, swelling, itching, burning at the affected area and: o These symptoms significantly interfere with activities of daily living; and o There is documentation of conservative management (including compression therapy) for at least 3 months that has not improved these symptoms. If compression therapy is contraindicated, documentation describing the contraindication is required. Note: Failure of conservative therapy is defined as pain, swelling, itching, burning, or other symptoms associated with vein reflux, despite conservative therapy, severe enough to require daily pain medicines and causing inability to manage daily activities at home or at work.

Chemical ablation (microfoam sclerotherapy, e.g., Varithena) or cyanoacrylate adhesive (e.g., Venaseal) may be considered medically necessary for treatment of symptomatic accessory saphenous

V1 2 Please note that authorization is based on medical necessity at the time the authorization is issued and is not a guarantee of payment. Payment is based on the individual having active coverage, benefits and policies in effect at the time of service.

veins/venous insufficiency when the following criteria are met: A. Incompetence of the accessory saphenous vein is isolated; AND B. Documented accessory saphenous reflux greater than 0.5 seconds; AND C. There is documentation of ONE or more of the following indications: • Venous stasis ulcers • Recurrent superficial thrombophlebitis • Hemorrhage or recurrent bleeding episodes from a superficial varicosity • Persistent pain, swelling, itching, burning at the affected area and: o These symptoms significantly interfere with activities of daily living; and o There is documentation of conservative management (including compression therapy) for at least 3 months that has not improved these symptoms. If compression therapy is contraindicated, documentation describing the contraindication is required. Note: Failure of conservative therapy is defined as pain, swelling, itching, burning, or other symptoms associated with vein reflux severe enough to require daily pain medicines and causing an inability to complete activities of daily living.

Concurrent treatment of the accessory saphenous veins along with the great or small saphenous veins may be considered medically necessary when criteria are met for each vein and there is documentation of anatomy showing that the accessory saphenous vein discharged directly into the common femoral vein.

Ambulatory Phlebectomy (Stab Avulsion, Hook Phlebectomy, or Transilluminated Powered Phlebectomy [TIPP]) and Sclerotherapy CPT Codes: 37765, 37766, 37799, 36470, 36471

Ambulatory phlebectomy or initial sclerotherapy (limited to a maximum of 3 sclerotherapy treatment sessions per leg) as a component of the treatment of symptomatic* varicose tributaries when performed either at the same time or following prior treatment (surgical, radiofrequency, or laser) of the saphenous veins is considered medically necessary.

*Symptoms include persistent pain, swelling, itching, and burning

For sclerotherapy treatment requests after ablation of the saphenous veins, when performed for the treatment of residual symptoms, there must be failure of 3 months of conservative therapy (weight reduction, daily exercise, periodic leg elevation, compression therapy) after the most recent varicose vein procedure. Note: Failure of conservative therapy is defined as pain, swelling, itching, burning, or other symptoms associated with vein reflux, severe enough to require daily pain medicines and causing an inability to complete activities of daily living.

Investigational and Not Medically Necessary • Sclerotherapy of isolated tributary veins without prior or concurrent treatment of saphenous veins is considered investigational.

V1 3 Please note that authorization is based on medical necessity at the time the authorization is issued and is not a guarantee of payment. Payment is based on the individual having active coverage, benefits and policies in effect at the time of service.

• Techniques other than ambulatory phlebectomy or sclerotherapy (liquid or foam) for the treatment of symptomatic varicose tributaries, when performed either at the same time or following prior treatment of saphenous veins, is considered investigational. • Sclerotherapy techniques, other than microfoam sclerotherapy (e.g. Varithena), of great, or accessory saphenous veins is considered investigational. • Sclerotherapy of perforator veins is considered investigational • Ambulatory phlebectomy of perforator, great or small saphenous, or accessory veins is considered investigational

Treatment of Telangiectasia CPT Code 36468 Treatment, by any method, of telangiectasia (spider veins) or superficial reticular veins (1- 2 mm) is considered cosmetic and therefore not medically necessary.

Note: Prior authorization requests received for services not addressed above will be reviewed on a case by case basis. Determinations will be made based on the available peer-reviewed literature and evidenced based guidelines and the DSS definition of Medical Necessity.

NOTE: EPSDT Special Provision Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) is a federal Medicaid requirement that requires the Connecticut Medical Assistance Program (CMAP) to cover services, products, or procedures for Medicaid enrollees under 21 years of age where the service or good is medically necessary health care to correct or ameliorate a defect, physical or mental illness, or a condition identified through a screening examination. The applicable definition of medical necessity is set forth in Conn. Gen. Stat. Section 17b-259b (2011) [ref. CMAP Provider Bulletin PB 2011-36].

PROCEDURE Prior authorization of the above treatments is required. Requests will be reviewed in accordance with procedures in place for reviewing requests for surgical procedures. Coverage determinations will be based upon a review of requested and/or submitted case-specific information.

The following information is needed to review requests for these treatments: • Fully completed Outpatient Prior Authorization Request Form or fully completed authorization request via on-line web portal • Specific vein(s)/leg(s) to be treated and whether the proposed treatment • Results of duplex ultrasonography • CEAP class • Documentation from the requesting physician which includes: o History and physical examination with description of varicose vein(s) o Operative notes from primary procedure (i.e., ligation and stripping, endovenous ablation etc.), if applicable o Modalities used to manage the condition conservatively or documentation supporting the individual’s inability to fully participate in conservative management o Current symptoms o Functional impairment V1 4 Please note that authorization is based on medical necessity at the time the authorization is issued and is not a guarantee of payment. Payment is based on the individual having active coverage, benefits and policies in effect at the time of service.

o Type of sclerosant, if applicable

Note: Photographs may be requested.

EFFECTIVE DATE This Policy is effective for prior authorization requests for varicose vein treatments for individuals covered under the HUSKY Health Program beginning November 1, 2019.

LIMITATIONS N/A

CODES: Ambulatory Phlebectomy Code Description 37765 Stab phlebectomy of varicose veins, 1 extremity; 10-20 stab incisions 37766 Stab phlebectomy of varicose veins, 1 extremity; more than 20 incisions 37799* Unlisted procedure, vascular surgery

*May be used for TIPP

Sclerotherapy Code Description 36465 Injection of non-compounded foam sclerosant with ultrasound compression maneuvers to guide dispersion of the injectate, inclusive of all imaging guidance and monitoring; single incompetent extremity truncal vein (eg, great saphenous vein, accessory saphenous vein 36466 Injection of non-compounded foam sclerosant with ultrasound compression maneuvers to guide dispersion of the injectate, inclusive of all imaging guidance and monitoring; multiple incompetent truncal veins (eg, great saphenous vein, accessory saphenous vein), same leg 36468 Single or multiple injections of sclerosing solutions, spider veins (telangiectasia); limb or trunk 36470 Injection of sclerosant; single incompetent vein (other than telangiectasia) 36471 Injection of sclerosant; multiple incompetent veins (other than telangiectasia), same leg

DEFINITIONS 1. HUSKY A: Connecticut children and their parents or a relative caregiver; and pregnant women may qualify for HUSKY A (also known as Medicaid). Income limits apply. 2. HUSKY B: Uninsured children under the age of 19 in higher income households may be eligible for HUSKY B (also known as the Children’s Health Insurance Program) depending on their family income level. Family cost-sharing may apply. 3. HUSKY C: Connecticut residents who are age 65 or older or residents who are ages 18-64 and who are blind, or have another disability, may qualify for Medicaid coverage under HUSKY C (this includes Medicaid for Employees with Disabilities (MED-Connect), if working). Income and asset limits apply. 4. HUSKY D: Connecticut residents who are ages 19-64 without dependent children and who: (1) do V1 5 Please note that authorization is based on medical necessity at the time the authorization is issued and is not a guarantee of payment. Payment is based on the individual having active coverage, benefits and policies in effect at the time of service.

not qualify for HUSKY A; (2) do not receive Medicare; and (3) are not pregnant, may qualify for HUSKY D (also known as Medicaid for the Lowest-Income populations). 5. HUSKY Health Program: The HUSKY A, HUSKY B, HUSKY C, HUSKY D and HUSKY Limited Benefit programs, collectively. 6. HUSKY Limited Benefit Program or HUSKY, LBP: Connecticut’s implementation of limited health insurance coverage under Medicaid for individuals with tuberculosis or for family planning purposes and such coverage is substantially less than the full Medicaid coverage. 7. Medically Necessary or Medical Necessity: (as defined in Connecticut General Statutes § 17b-259b) Those health services required to prevent, identify, diagnose, treat, rehabilitate or ameliorate an individual's medical condition, including mental illness, or its effects, in order to attain or maintain the individual's achievable health and independent functioning provided such services are: (1) Consistent with generally-accepted standards of medical practice that are defined as standards that are based on (A) credible scientific evidence published in peer- reviewed medical literature that is generally recognized by the relevant medical community, (B)recommendations of a physician-specialty society, (C) the views of physicians practicing in relevant clinical areas, and (D) any other relevant factors; (2) clinically appropriate in terms of type, frequency, timing, site, extent and duration and considered effective for the individual's illness, injury or disease; (3) not primarily for the convenience of the individual, the individual's health care provider or other health care providers; (4) not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the individual's illness, injury or disease; and (5) based on an assessment of the individual and his or her medical condition. 8. Prior Authorization: A process for approving covered services prior to the delivery of the service or initiation of the plan of care based on a determination by CHNCT as to whether the requested service is medically necessary.

ADDITIONAL RESOURCES AND REFERENCES:

• Howard DP, Howard A, Kothari A, et al. The role of superficial venous surgery in the management of venous ulcers: a systematic review. Eur J Vasc Endovasc Surg. Oct 2008;36(4):458-465. PMID 18675558

• O'Donnell TF, Jr. 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. J Vasc Surg. Oct 2008;48(4):1044-1052. PMID 18992425

• Jones L, Braithwaite BD, Selwyn D, et al. Neovascularisation is the principal cause of varicose vein recurrence: results of a randomised trial of stripping the long saphenous vein. Eur J Vasc Endovasc Surg. Nov 1996;12(4):442-445. PMID 8980434

• Rutgers PH, Kitslaar PJ. Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the incompetent greater saphenous vein. Am J Surg. Oct 1994;168(4):311-315. PMID 7943585

V1 6 Please note that authorization is based on medical necessity at the time the authorization is issued and is not a guarantee of payment. Payment is based on the individual having active coverage, benefits and policies in effect at the time of service.

• Brittenden J, Cotton SC, Elders A, et al. A randomized trial comparing treatments for varicose veins. N Engl J Med. Sep 25 2014;371(13):1218-1227. PMID 25251616

• Rass K, Frings N, Glowacki P, et al. Comparable effectiveness of endovenous laser ablation and high ligation with stripping of the great saphenous vein: two-year results of a randomized clinical trial (RELACS study). Arch Dermatol. Jan 2012;148(1):49-58. PMID 21931012

• Christenson JT, Gueddi S, Gemayel G, et al. Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up. J Vasc Surg. Nov 2010;52(5):1234-1241. PMID 20801608

• Biemans AA, Kockaert M, Akkersdijk GP, et al. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. Sep 2013;58(3):727-734 e721. PMID 23769603

• van der Velden SK, Biemans AA, De Maeseneer MG, et al. Five-year results of a randomized clinical trial of conventional surgery,endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. Br J Surg. Sep 2015;102(10):1184-1194. PMID 26132315

• Theivacumar NS, Darwood RJ, Gough MJ. Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein (AAGSV): abolition of sapheno-femoral reflux with preservation of the great saphenous vein. Eur J Vasc Endovasc Surg. Apr 2009;37(4):477-481. PMID 19201621

• Hamann SAS, Giang J, De Maeseneer MGR, et al. Editor's Choice - Five Year results of great saphenous vein treatment: a metaanalysis. Eur J Vasc Endovasc Surg. Dec 2017;54(6):760-770. PMID 29033337

• Shadid N, Ceulen R, Nelemans P, et al. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. Aug 2012;99(8):1062-1070. PMID 22627969

• U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Summary Review: 205098 Varithena. 2013; https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205098Orig1s000SumR.pdf Accessed August 2019.

• Todd KL, 3rd, Wright D, for the Vanish-Investigator Group. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence. Phlebology. Oct 2014;29(9):608-618. PMID 23864535

• Eroglu, EE, Yasim, AA. A Randomised Clinical Trial Comparing N-Butyl Cyanoacrylate, Radiofrequency Ablation and Endovenous Laser Ablation for the Treatment of Superficial Venous

V1 7 Please note that authorization is based on medical necessity at the time the authorization is issued and is not a guarantee of payment. Payment is based on the individual having active coverage, benefits and policies in effect at the time of service.

Incompetence: Two Year Follow up Results. Eur J Vasc Endovasc Surg,2018 Jul 26;56(4). PMID 30042039

• Vasquez M, Gasparis AP, Varithena 017 Investigator G. A multicenter, randomized, placebo- controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. Phlebology. May 2017;32(4):272-281. PMID 26957489

• Bootun R, Lane T, Dharmarajah B, et al. Intra-procedural pain score in a randomised controlled trial comparing mechanochemical ablation to radiofrequency ablation: The Multicentre Venefit versus ClariVein(R) for varicose veins trial. Phlebology. Feb 2016;31(1):61-65. PMID 25193822

• Lane T, Bootun R, Dharmarajah B, et al. A multi-centre randomised controlled trial comparing radiofrequency and mechanical occlusion chemically assisted ablation of varicose veins - Final results of the Venefit versus Clarivein for varicose veins trial. Phlebology. Mar 2017;32(2):89-98. PMID 27221810

• Vähäaho, SS, Mahmoud, OO, Halmesmäki, KK, Albäck, AA, Noronen, KK, Vikatmaa, PP, Aho, PP, Venermo, MM. Randomized clinical trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins. Br J Surg, 2019 Mar 26;106(5). PMID 30908611

• Witte ME, Zeebregts CJ, de Borst GJ, et al. Mechanochemical endovenous ablation of saphenous veins using the ClariVein: A systematic review. Phlebology. Dec 2017;32(10):649- 657. PMID 28403687

• Lam YL, Toonder IM, Wittens CH. Clarivein(R) mechano-chemical ablation an interim analysis of a randomized controlled trial dose-finding study. Phlebology. Apr 2016;31(3):170-176. PMID 26249150

• Sun JJ, Chowdhury MM, Sadat U, et al. Mechanochemical ablation for treatment of truncal venous insufficiency: a review of the current literature. J Vasc Interv Radiol. Oct 2017;28(10):1422-1431. PMID 28811080

• Witte ME, Holewijn S, van Eekeren RR, et al. Midterm outcome of mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency. J Endovasc Ther. Feb 2017;24(1):149-155. PMID 27742900

• U.S. Food and Drug Administration. VenaSeal Closure System. PMA P140018. 2015; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140018 Accessed August 2019.

• Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. Apr 2015;61(4):985- 994. PMID 25650040

V1 8 Please note that authorization is based on medical necessity at the time the authorization is issued and is not a guarantee of payment. Payment is based on the individual having active coverage, benefits and policies in effect at the time of service.

• Gibson K, Ferris B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of postprocedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study). Vascular. Apr 2017;25(2):149-156. PMID 27206470

• Eroglu E, Yasim A, Ari M, et al. Mid-term results in the treatment of varicose veins with N-butyl cyanoacrylate. Phlebology. Dec 2017;32(10):665-669. PMID 28669248

• Klem TM, Schnater JM, Schutte PR, et al. A randomized trial of cryo stripping versus conventional stripping of the great saphenous vein. J Vasc Surg. Feb 2009;49(2):403-409. PMID 19028042

• Morrison, NN, Kolluri, RR, Vasquez, MM, Madsen, MM, Jones, AA, Gibson, KK. Comparison of cyanoacrylate closure and radiofrequency ablation for the treatment of incompetent great saphenous veins: 36-Month outcomes of the VeClose randomized controlled trial. Phlebology, 2018 Nov 8;268355518810259:268355518810259. PMID 30403154

• Zierau UT. Sealing veins with the VenaSeal Sapheon Closure System: results for 795 treated truncal veins after 1000 days. Vasomed. 2015;27:124-127.

• Disselhoff BC, der Kinderen DJ, Kelder JC, et al. Randomized clinical trial comparing endovenous laser with cryostripping for great saphenous varicose veins. Br J Surg. Oct 2008;95(10):1232- 1238. PMID 18763255

• Gibson, KK, Khilnani, NN, Schul, MM, Meissner, MM. American College of Phlebology Guidelines - Treatment of refluxing accessory saphenous veins. Phlebology, 2016 Oct 16;32(7). PMID 27738242

• Disselhoff BC, der Kinderen DJ, Kelder JC, et al. Five-year results of a randomized clinical trial comparing endovenous laser ablation with cryostripping for great saphenous varicose veins. Br J Surg. Aug 2011;98(8):1107-1111. PMID 21633948

• Tisi PV, Beverley C, Rees A. Injection sclerotherapy for varicose veins. Cochrane Database Syst Rev. Oct 18 2006(4):CD001732. PMID 17054141

• Leopardi D, Hoggan BL, Fitridge RA, et al. Systematic review of treatments for varicose veins. Ann Vasc Surg. Mar 2009;23(2):264-276. PMID 19059756

• El-Sheikha J, Nandhra S, Carradice D, et al. Clinical outcomes and quality of life 5 years after a randomized trial of concomitant or sequential phlebectomy following endovenous laser ablation for varicose veins. Br J Surg. Aug 2014;101(9):1093-1097. PMID 24916467

• Yamaki T, Hamahata A, Soejima K, et al. Prospective randomised comparative study of visual foam sclerotherapy alone or in combination with ultrasound-guided foam sclerotherapy for treatment of superficial venous insufficiency: preliminary report. Eur J Vasc Endovasc Surg. Mar 2012;43(3):343-347. PMID 22230599

V1 9 Please note that authorization is based on medical necessity at the time the authorization is issued and is not a guarantee of payment. Payment is based on the individual having active coverage, benefits and policies in effect at the time of service.

• Michaels JA, Campbell WB, Brazier JE, et al. Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial). Health Technol Assess. Apr 2006;10(13):1- 196, iii-iv. PMID 16707070

• Barwell JR, Davies CE, Deacon J, et al. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. Jun 5 2004;363(9424):1854- 1859. PMID 15183623

• Gohel MS, Barwell JR, Taylor M, et al. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial. BMJ. Jul 14 2007;335(7610):83. PMID 17545185

• Nelzen O, Fransson I. Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic perforator surgery in patients with a venous ulcer. Br J Surg. Apr 2011;98(4):495-500. PMID 21656715

• Blomgren L, Johansson G, Dahlberg-Akerman A, et al. Changes in superficial and perforating vein reflux after varicose vein surgery. J Vasc Surg. Aug 2005;42(2):315-320. PMID 16102633

• Tenbrook JA, Jr., Iafrati MD, O'Donnell T F, Jr., et al. Systematic review of outcomes after surgical management of venous disease incorporating subfascial endoscopic perforator surgery. J Vasc Surg. Mar 2004;39(3):583-589. PMID 14981453

• Van Gent WB, Catarinella FS, Lam YL, et al. Conservative versus surgical treatment of venous leg ulcers: 10- year follow up of a randomized, multicenter trial. Phlebology. Mar 2015;30(1 Suppl):35-41. PMID 25729066

• Luebke T, Brunkwall J. Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency. Phlebology. Feb 2009;24(1):8-16. PMID 19155335

• Hirsch SA, Dillavou E. Options in the management of varicose veins, 2008. J Cardiovasc Surg (Torino). Feb 2008;49(1):19-26.PMID 18212684

• Hissink RJ, Bruins RM, Erkens R, et al. Innovative treatments in chronic venous insufficiency: endovenous laser ablation of perforating veins: a prospective short-term analysis of 58 cases. Eur J Vasc Endovasc Surg. Sep 2010;40(3):403-406. PMID 20547462

• Myers KA, Jolley D. Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins. Eur J Vasc Endovasc Surg. Nov 2008;36(5):602-605. PMID 18718772

• Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. May 2011;53(5 Suppl):2S-48S. PMID 21536172

V1 10 Please note that authorization is based on medical necessity at the time the authorization is issued and is not a guarantee of payment. Payment is based on the individual having active coverage, benefits and policies in effect at the time of service.

• Kundu S, Lurie F, Millward SF, et al. Recommended reporting standards for endovenous ablation for the treatment of venous insufficiency: joint statement of the American Venous Forum and the Society of Interventional Radiology. J Vasc Interv Radiol. Sep 2007;18(9):1073-1080. PMID 17804767

• National Institute for Health and Care Excellence (NICE). Ultrasound-guided foam sclerotherapy for varicose veins [IPG440] 2013; https://www.nice.org.uk/guidance/ipg440 Accessed August 2019.

• National Institute for Health and Care Excellence (NICE). Endovenous mechanochemical ablation for varicose veins [IPG557].2016; https://www.nice.org.uk/guidance/ipg557 Accessed August 2019.

• National Institute for Health and Care Excellence (NICE). Varicose veins: diagnosis and management [CG168]. 2013; https://www.nice.org.uk/guidance/cg168 Accessed August 2019.

• Brittenden J, Cotton SC, Elders A, et al. Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial. Health Technol Assess. Apr 2015;19(27):1-342. PMID 25858333

• Guo, LL, Huang, RR, Zhao, DD, Xu, GG, Liu, HH, Yang, JJ, Guo, TT. Long-term efficacy of different procedures for treatment of varicose veins: A network meta-analysis. Medicine (Baltimore), 2019 Feb 15;98(7). PMID 30762775

• Sarac, AA. Two-year follow-up of a n-butyl-2-cyanoacrylate glue ablation for the treatment of saphenous vein insufficiency with a novel application catheter with guiding light. Vascular, 2019 Feb 12;1708538118823838:1708538118823838. PMID 30739600

• Moreno-Moraga, JJ, Pascu, MM, Alcolea, JJ, Smarandache, AA, Royo, JJ, David, FF, Trelles, MM. Effects of 1064-nm Nd:YAG longpulse laser on polidocanol microfoam injected for varicose vein treatment: a controlled observational study of 404 legs, after 5-year-long treatment. Lasers Med Sci, 2019 Feb 2. PMID 30707327 • History

PUBLICATION HISTORY Status Date Action Taken Original September 2019 Approved at the August 28, 2019 Medical Reviewer meeting. Publication Approved by the CHNCT Clinical Quality Subcommittee on September 16, 2019. Approved by DSS on September 19, 2019.

V1 11 Please note that authorization is based on medical necessity at the time the authorization is issued and is not a guarantee of payment. Payment is based on the individual having active coverage, benefits and policies in effect at the time of service.