Varicose Vein Treatment, at Least Three Months Have Elapsed Since a Previous Ablation Procedure Or Phlebectomy

Medical Policy: Varicose Vein - Surgical Treatments (Commercial)

POLICY NUMBER EFFECTIVE DATE APPROVED BY

M20180005 11/01/2019 Medical Policy Committee IMPORTANT NOTE ABOUT THIS MEDICAL POLICY:

Property of ConnectiCare, Inc. All rights reserved. The treating physician or primary care provider must submit to ConnectiCare, Inc. the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, ConnectiCare will not be able to properly review the request for prior authorization. This clinical policy is not intended to pre-empt the judgment of the reviewing medical director or dictate to health care providers how to practice medicine. Health care providers are expected to exercise their medical judgment in rendering appropriate care. The clinical review criteria expressed below reflects how ConnectiCare determines whether certain services or supplies are medically necessary. ConnectiCare established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). ConnectiCare, Inc. expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Identification of selected brand names of devices, tests and procedures in a medical coverage policy is for reference only and is not an endorsement of any one device, test or procedure over another. Each benefit plan defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by ConnectiCare, as some plans exclude coverage for services or supplies that ConnectiCare considers medically necessary. If there is a discrepancy between this guideline and a member's benefits plan, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of the State of CT and/or the Federal Government. Coverage may also differ for our Medicare members based on any applicable Centers for Medicare & Medicaid Services (CMS) coverage statements including National Coverage Determinations (NCD), Local Coverage Determinations (LCD) and/or Local Medical Review Policies(LMRP). All coding and web site links are accurate at time of publication.

Overview

Varicose veins evolve from a series of events. The veins of the lower extremity contain one-way valves, which maintain blood flow towards the heart against gravity. As a result of several factors such as age, obesity, long periods of standing or sitting, a previous history of deep venous thrombosis, hormonal changes and pregnancies can cause the valves to weaken and not close properly, allowing some blood to flow backwards. The improperly functioning valves is known as venous insufficiency and the forward and backward flow of blood through the incompetent valve is termed reflux. Eventually, this backflow of blood increases the pressure within the venous system (venous hypertension) allowing the veins to become distended and elongated, which leads to the development of varicosities or varicose veins. Individuals with varicose veins can have symptoms such has leg heaviness, sensation of throbbing, leg tiredness, fatigue restless legs, swelling, pain, aching and itching. Longstanding varicosities can progress to bleeding from the varicosities, skin changes, compromised skin integrity leading to cellulitis and skin ulcerations.

Medical Policy: Varicose Vein - Surgical Treatments (Commercial)

There are several treatment therapies that can be utilized, which include conservative therapies (i.e. compression stockings, pain medication, leg elevation and exercise), and surgical treatments directed toward correcting the reflux.1

Varicose Vein Surgical Treatments Include: (If a covered benefit)

Ligation/Stripping, VNUS Closure (Radiofrequency ablation), ELAS (Endovenous Laser Ablation of the Saphenous System) or EVLT (Endovenous Laser Treatment), Ambulatory Phlebectomy; Transilluminated Powered Phlebectomy (TriVex), Sclerotherapy, Subfascial Endoscopic Perforator Vein Surgery (SEPS). Endovascular embolization using endovenous foam sclerotherapy with polidocanol endovenous microfoam (PEM) (e.g., Varithena®), Endovascular embolization using cyanoacrylate-based adhesive (e.g., VenaSeal™ Closure System). Unlisted procedure, vascular surgery.

Coding Criteria: To access the codes, please download the policy and click on the links below.

Applicable CPT and Diagnosis Codes

Criteria All procedures require labeled photographs of the area to be treated, which must be clear, in color, dated and recent (within 1 month of the requested procedures).

CRITERIA: VARICOSE VEIN SURGICAL TREATMENTS (IF A COVERED BENEFIT) PART I: I. Must meet all of the following: 1. Doppler or duplex ultrasound scanning has been performed documenting the presence/absence of reflux, duration of reflux and vein size. 2. One or more of the following is present: a. Intractable leg ulcerations secondary to venous stasis; b. > 1 one episode of minor hemorrhage from a superficial varicosity; c. A single, significant hemorrhage from a superficial varicosity, especially if a blood transfusion is required; d. Recurrent thrombophlebitis; e. Severe and persistent symptoms interfering with activities of daily living (including pain, cramping, throbbing, burning, itching, or swelling during activity or after prolonged sitting). f. Physician office progress notes document at least three (3) months of consistent but unsuccessful management with both properly fitted surgical pressure gradient (20-30 mm stockings or greater, nonprescription support stockings are not sufficient) and other conservative treatments including medications (analgesics and/or NSAIDs), frequent elevation of the affected leg(s), avoidance of hot baths, avoidance of prolonged standing, exercise, and weight control programs (if necessary).

1 Varicose vein surgery or sclerotherapy during pregnancy is not usually appropriate because dilatation of veins in the legs is physiologic and will revert to normal after delivery, at which time a more accurate appraisal can be made.

Medical Policy: Varicose Vein - Surgical Treatments (Commercial)

CRITERIA: VARICOSE VEIN SURGICAL TREATMENTS (IF A COVERED BENEFIT) PART II: II. Must meet all of Part I and one of the following:

1. For an ablation procedure such as ligation and division, stripping, endoluminal radiofrequency ablation (ERFA or VNUS), endovenous laser ablation of the saphenous system (ELAS), or endovenous laser treatment (EVLT), Endovascular embolization using endovenous foam sclerotherapy with polidocanol endovenous microfoam (PEM) (e.g., Varithena®), Endovascular embolization using cyanoacrylate-based adhesive (e.g. VenaSeal™ Closure System):

a. The Doppler/duplex scan demonstrates significant venous incompetence (greater than 0.5 seconds) at one or more of the following: 1) The saphenofemoral junction; 2) The saphenopopliteal junction; 3) The Great or Small saphenous veins; 4) Other major axial accessory veins (e.g., anterolateral branch vein, accessory saphenous vein). b. A single date of service is being requested per leg (i.e., all of the symptomatic axial veins in a single leg are being treated 1 on one date of service).

1Only one primary ablation CPT code and one secondary ablation CPT code are being used to treat all of the axial veins in one leg.

CRITERIA: AMBULATORY PHLEBECTOMY or Transilluminated Powered Phlebectomy (TriVex®) (IF A COVERED BENEFIT) A. Must meet all of Part B and one of the following: 1. The Doppler/duplex scan demonstrates no reflux at the saphenofemoral junction, the saphenopopliteal junction, the Great of Small saphenous veins or other major axial accessory veins, or 2. Reflux is present, but the procedure is being performed at the same time as an ablation procedure. B. The veins to be treated are 3 mm or greater in size.

CRIT ERIA: SUBFASCIAL ENDOSCOPIC PERFORATOR VEIN SURGERY (SEPS) (IF A COVERED BENEFIT)

Must meet all of the following: 1. The individual has advanced chronic venous insufficiency secondary to primary valvular incompetence of perforating veins. 2. The individual has chronic venous ulcers caused by perforating veins. 3. The procedure is not being performed together with an ablation procedure.

Medical Policy: Varicose Vein - Surgical Treatments (Commercial)

CRITERIA SCLEROTHERAPY INJECTIONS (IF A COVERED BENEFIT) Must meet A and B of the following: A. High quality color photographs submitted for review meet all of the following: 1. The photographs have been taken in the provider office; 2. The photographs are within 1 month of the requested procedure; 3. The photographs contain a centimeter ruler directly adjacent to the varicosities so that the size of the vessels can be determined; 4. Each photograph is labeled with the corresponding body location (e.g., right thigh, left ankle, etc.)

B. All of the following are met: 1. The Doppler/duplex scan demonstrates no reflux at the saphenofemoral junction, the saphenopopliteal junction, the Great or Small saphenous veins or other major axial accessory veins. 2. In individuals with previous Varicose Vein Treatment, at least three months have elapsed since a previous ablation procedure or phlebectomy. 3. In individuals with previous Varicose Vein Treatment, updated physician office progress notes and photographs clearly demonstrate severe and persistent symptoms. 4. The veins to be treated are between 3 and 6 mm in size. 5. No more than three sclerotherapy sessions are being requested per leg.

Note: The number of medically necessary sclerotherapy injection sessions varies with the number of anatomical areas that have to be injected, as well as the response to each injection. Usually 1 to 3 injections are necessary to obliterate any vessel, and 10 to 40 vessels, or up to 20 injections in each leg, may be treated in any 1 session. Three (3) sessions per leg are usually sufficient. Requests for additional sessions would require medical documentation and review.

Limitations and Exclusions

The following procedures are excluded from coverage: 1. Endovenous mechanochemical ablation (MOCA) (e.g. ClariVein® Infusion Catheter) is considered investigational for our Commercial members (CPT Codes 36473 & 36474) 2. Varicose Vein Treatment is a benefit exclusion for our Individual Exchange, Solo, CT Small Group (including SHOP) and CMI Small Group members; except when there is a history of ulcers or bleeding from a varicose vein 3. The following procedures are not considered medically necessary because they are regarded as cosmetic: a. Injection of reticular veins, telangiectasia or visible subcuticular veins < 4 mm in size (e.g., spider veins, angiomata and hemangiomata). (CPT codes: 36468 and 36469) b. Transdermal laser therapy and photodermal sclerosis. 4. All other procedure codes not list in the table titled Coding Criteria 5. Any procedure that does not meet the specific procedure criteria in the section above titled Criteria

Medical Policy: Varicose Vein - Surgical Treatments (Commercial)

Definitions:

PROCEDURE: DEFINITION: Ligation and Division Indicated when reflux is demonstrated at the saphenofemoral and/or saphenopopliteal junction. The procedure is usually performed when varicosities are very large (>6 mm), extensive in distribution or occur in large clusters. Incisions are made over the varicose vein; the vein is tied off and excised.

Stripping Stripping of the greater and/or lesser saphenous veins performed in conjunction with ligation and division occurs when the saphenous veins show varicose changes (usually >1 cm in diameter). Incisions are made at each end of the vein, a thin wire-like instrument is inserted into the vein and the vein is stripped from the inside.

VNUS Closure or Employs an electrode- containing catheter capable of delivering controlled Endoluminal heat to the venous wall causing the vessel to collapse and seal. In patients Radiofrequency with reflux, the catheter is usually placed 1-2 cm below the saphenofemoral Ablation (ERFA) junction. VNUS® Closure System one of the most common RFA techniques.

ELAS (Endovenous Employs a catheter containing a small laser fiber. Laser light is delivered Laser Ablation of the inside the vein causing the vessel to collapse and seal. Saphenous System) or EVLT (Endovenous Laser Treatment) Endovenous Non-thermal non-tumescent ablation technique (e.g. ClariVein® Infusion mechanochemical Catheter) which incorporates the use of a flexible, steerable infusion ablation (MOCA) catheter with a 360° rotatable dispersion wire. The wire tip causes minimal mechanical damage to the endothelium, inducing vasospasm, and the rotating tip evenly distributes a sclerosing agent to the targeted treatment area. After treatment, sealing of the vein is confirmed ultrasonically. Sclerosis of the vein activates the clotting system, resulting in formation of a thrombus and occlusion of the vessel. Not covered. See Limitations and Exclusions.

Microfoam Polidocanol injectable foam (e.g Varithena™) is a sclerosing agent indicated Endovenous Ablation for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee

Endovascular Cya noacrylate adhesion (VenaSeal™ Closure system) is a medical grade embolization using adhesive, which is applied along the target vein via a catheter, usually cyanoacrylate-based inserted just below the knee. Approximately 1.2 ml of adhesive is applied adhesive every inch or so along the vein, this effectively seals it off to reroute circulate to veins that are not tortuous. The procedure takes less than half an hour on average and is considered a minimally invasive office procedure.

Medical Policy: Varicose Vein - Surgical Treatments (Commercial)

PROCEDURE: DEFINITION: Ambulatory These techniques are most often used for branch varicosities of the greater Phlebectomy; saphenous vein, pudendal veins in the groin and varicosities of the Transilluminated popliteal fold or lateral thigh. TriVex involves endoscopic resection and Powered ablation using an illuminator and a powered resector. The veins are Phlebectomy identified with a marker, a light source is introduced into the leg via a (TriVex®) small incision allowing the surgeon to quickly and accurately target the vein, the powered resector is introduced to cut and dislodge the vein and the pieces of the vein are removed by suction. Ambulatory Involves making multiple small incisions, grasping the vein with a small phlebectomy (also hook or hemostat, clamping, dividing and extracting the vein. known as stab phlebectomy, stab avulsion)

Injection A process by which an irritating solution is injected into the vein resulting Sclerotherapy or in fibrosis and vessel occlusion. The technique is usually used for small- to Sclerotherapy medium-sized varicose veins (<6 mm diameter) in the superficial tributaries of the greater and/or lesser saphenous veins. Spider veins and telangiectasias are usually <3 mm diameter, do not cause symptoms and their treatment is cosmetic. Subfascial a minimally invasive endoscopic procedure for treating chronic venous Endoscopic insufficiency in which incompetent perforating veins located in the calf are Perforator Vein believed to be a contributing factor. The procedure is an alternative to Surgery (SEPS) open surgical treatment of chronic venous insufficiency (open subfascial perforator vein surgery also called the Linton procedure). Because the procedure is endoscopic, there is no need for a large incision in the leg.

Photothermal A technique used to treat small varicosities and spider veins sclerosis (also (telangiectasias). Such small veins are usually cosmetic and not covered referred to as intense pulsed-light source or PhotoDerm VascuLight)

TERM: DEFINITION: Accessory/Tributary Axial accessory or tributary saphenous veins indicate any venous segment Vein ascending parallel to the Great Saphenous Vein and located more superficially above the saphenous fascia, both in the leg and in the thigh. These can include the anterior Accessory Vein, the postero-medial vein, circumflex veins [anterior or posterior], intersaphenous veins, Giacomini vein or posterior [Leonardo] or anterior arch veins.

Cosmetic Procedures Procedures or services that change or improve appearance without significantly improving physiological function

Medical Policy: Varicose Vein - Surgical Treatments (Commercial)

TERM: DEFINITION: Great Saphenous The GSV originates from the dorsal arch of the foot and progresses Vein (GSV) medially and proximally along the distal extremity to join the common femoral vein.

Junctional Reflux: Reflux that exceeds a duration of 0.5 seconds at either: 1. The saphenofemoral junction (SFJ) – Confluence of the Great Saphenous Vein and the femoral vein; or 2. The saphenopopliteal junction (SPJ) – Confluence of the Small Saphenous Vein and the popliteal vein. Reticular Veins Reticular Veins are dilated dermal veins <4mm in diameter that communicate with either or both Telangiectasia and saphenous tributaries. Small Saphenous The SSV originates from the lateral side of the foot and drains blood into Vein (SSV) the popliteal vein, joining it usually just proximal to the knee crease Spider Veins Spider Veins/Telangiectasia are the permanent dilation of preexisting small (Telangiectasia) blood vessels, generally ≤3 mm in size. Superficial Inflammation of a vein due to a blood clot in a vein just below the skin’s Thrombophlebitis surface. Varicose Veins Abnormally enlarged veins that are frequently visible under the surface of the skin; often appear blue, bulging and twisted. (≥3mm in size) Venous Ulcer Also referred to as stasis, insufficiency or varicose ulcers, are the result of malfunctioning venous valves causing pressure in the veins to increase. These typically occur along the medial or lateral distal (lower) leg.

References 1. Arumugasamy M, McGreal G, O’Connor A, et al. The technique of transilluminated powered phlebectomy a novel, minimally invasive system for varicose vein surgery. Eur J Vasc Endovasc Surg. 2002;23 (2):180-182. 2. Belcaro G, Micolaides AN, Ricci A, et al. Endovascular sclerotherapy, surgery and surgery plus sclerotherapy in superficial venous incompetence: A randomized 10-year follow-up trial — final results. Angiology. 2000;51 (7):529-534. 3. Ciostek P, Myrcha P, Noszczyk W. Ten years experience with subfascial endoscopic perforator vein surgery. Ann Vasc Surg. 2002;16 (4):480-487. 4. Goldman MP, Amiry S. Closure of the greater saphenous vein with endoluminal radiofrequency thermal heating of the vein wall in combination with ambulatory phlebectomy: 50 patients with more than 6 month follow-up. Dermatol Surg. 2002;28 (1):29-31. 5. Kabnick LS, et al. Twelve and twenty-four-month follow-up after endovascular obliteration of saphenous vein reflux—a report from the multi-center registry. J Phlebol. 2001;1:17-24. 6. Kalra M, Gloviczki P. Surgical treatment of venous ulcers: Role of subfascial endoscopic perforator vein ligation. Surg Clin North Am. 2003;83(3):671-705. 7. Kurz X, Kahn SR, Abenhaim L, et al. Chronic venous disorders of the leg: Epidemiology, outcomes, diagnosis and management: summary of an evidence-based report of the VEINES task force. Int Angiol. 1999;18(2): 83-102. 8. Lurie F, Creton D, Eklof B, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS study). J Vasc Surg. 2003;38(2):207-214 Proprietary information of ConnectiCare. © 2019 ConnectiCare, Inc. & Affiliates Page 7 of 9

Medical Policy: Varicose Vein - Surgical Treatments (Commercial)

9. Min RJ, Khilnani N, Zimmet SE. Endovenous laser treatment of saphenous vein reflux: Long- term results. J Vasc Interv Radiol. 2003;14(8):991-996. 10. Radiofrequency ablation of varicose veins. National Institute for Clinical Excellence (NICE). London, UK: NICE. Sept 2003. Accessed at http://www.nice.org.uk/guidance/IPG8 11. Transilluminated powered phlebectomy for varicose veins. National Institute for Clinical Excellence (NICE). London, UK: NICE. Jan 2004. Accessed at http://www.nice.org.uk/guidance/ipg37 12. Subfascial endoscopic perforator vein surgery. National Institute for Clinical Excellence (NICE). London, UK: NICE. May 2004. Accessed at http://www.nice.org.uk/guidance/IPG59 13. Ultrasound-guided foam sclerotherapy for varicose veins. National Institute for Clinical Excellence (NICE). London, UK: NICE. Feb 2013. Accessed at http://www.nice.org.uk/guidance/IPG440 14. Rautio T, Ohinmaa A, Perala J, et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: A randomized controlled trial with comparison of the costs. J Vasc Surg. 2002;35(5):958-965. 15. National Government Services. Local Coverage Determination (LCD): Varicose Veins of the Lower Extremity. January 2018. https://www.cms.gov/medicare-coverage- database/details/lcd- details.aspx?LCDId=33575&%3bver=33&%3bCntrctrSelected=300*1&%3bCntrc tr=300&%3bname=National%2bGovernment%2bServices%2c%2bInc.%2b(National%2b Government%2bServices%2c%2bInc.%2b(13202%2c%2bA%2band%2bB%2band%2bHHH% 2bMAC%2c%2bJ%2b%2bK))&%3bLCntrctr=300*1&%3bDocType=Active&%3bb c=AgACAAQBAAAA

Revision history

DATE REVISION 08/2019 • Updated policy to include CPT Codes 36465, 36466, 36482 and 36483 • Reformatted and reorganized policy, transferred content to new template • Limitations/Exclusions Section: Included additional plan exclusions • Added to criteria section: “Labeled photographs of the area to be treated, which must be clear, in color, dated and recent (within 1 month of the requested procedure).” • Changed under sclerotherapy injections section: “The photographs are no more than three (3) months old” to “The photographs are within 1 month of the requested procedure.”

7/12/2006 • Original policy