Local Coverage Determination (LCD): Varicose Veins of the Lower Extremities (L31796)

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1 Local Coverage Determination (LCD): Varicose Veins of the Lower Extremities (L31796) Contractor Information Contractor Name Palmetto GBA LCD Information Document Information LCD ID L31796 LCD Title Varicose Veins of the Lower Extremities AMA CPT / ADA CDT / AHA NUBC Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks Original Effective Date For services performed on or after 03/19/2011 Revision Effective Date For services performed on or after 09/11/2014 Revision Ending Date Retirement Date Notice Period Start Date Notice Period End Date

2 of the American Dental Association. UB-04 Manual. OFFICIAL UB-04 DATA SPECIFICATIONS MANUAL, 2014, is copyrighted by American Hospital Association ( AHA ), Chicago, Illinois. No portion of OFFICIAL UB-04 MANUAL may be reproduced, sorted in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior express, written consent of AHA. Health Forum reserves the right to change the copyright notice from time to time upon written notice to Company. CMS National Coverage Policy Title XVIII of the Social Security Act, 1862(a)(1)(A), (a)(7), excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member; routine physical checkups, screening. Title XVIII of the Social Security Act, 1833(e); prohibits Medicare payment for any claim which lacks the necessary information to process the claim. 42 CFR (k)(1); reasonable and necessary for diagnoses and treatment of illness or injury or to improve the functioning of a malformed body member. CMS Manual System, Pub , Medicare Program Integrity Manual, Chapter 3, ; Diagnosis Code Requirements. Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity The treatment of varicose veins of the lower extremities is considered medically necessary when the following criteria are met prior to the decision for treatment: 1. A minimum 3-month trial of conservative therapy with graduated elasticized compression stockings has failed or was not feasible. 2. The patient is symptomatic and the varicosities result in any one or more of the following in spite of conservative therapy: Persistent symptoms interfering with activities of daily living such as aching, cramping, burning, pain, itching and/or swelling during activity or after prolonged standing.

3 Significant, recurrent superficial phlebitis. Hemorrhage from a ruptured varix. Non-healing skin ulceration of the lower extremity. 3. Duplex studies of the venous system are performed by an accredited vascular technician that fully defines the anatomy, size, and tortuosity of the greater and lesser saphenous vein, superficial venous segments and perforators. Studies must demonstrate the following criteria: Absence of deep venous thrombosis, and Greater saphenous vein valvular incompetence/reflux that correlates with the patient s symptoms. 4. In addition, the following conditions apply to specific individual procedures: Injection/Compression Sclerotherapy 1. No saphenofemoral insufficiency, incompetence, or occlusion of the deep venous system, and 2. Vessel diameter should be at least 3 millimeters in size. Surgical Ligation or Stripping: 1. May be covered as part of a combination procedure with sclerotherapy. 2. Number of veins and their locations should be documented. Endoluminal Radiofrequency Ablation (ERFA) or Laser Ablation 1. Patient s anatomy amenable to laser or radiofrequency catheter. 2. Non-aneurismal saphenous vein(s). 3. Absence of vein tortuosity that would impair catheter advancement. Ambulatory or Stab Phlebectomy 1. Use of 2mm stab incisions to remove vein via crochet type hook. 2. May be covered only when the patient displays symptoms and functional problems attributable only to the secondary, smaller vessels. 3. Not covered on the same date of service as another vein procedure, such as ERFA.

4 Subfascial Endoscopic Perforator Surgery (SEPS) 1. Must have symptoms of perforator incompetence. 2. Must have a venous stasis ulcer in which a history of conservative measures failed. LIMITATIONS Noncompressive sclerotherapy implies injection of the sclerosant into veins when the patient is upright and the veins are full. Technically, this is thrombotic therapy, not sclerotherapy. This method has not been shown effective in producing long-term obliteration of the incompetent veins and is not covered. The treatment of spider veins or superficial telangiectasis by any technique is considered cosmetic, and therefore not covered, unless there is associated significant and persistent bleeding. Laser treatment of superficial varicosities or spider veins is considered cosmetic and is not covered. Ultrasound-monitored or duplex-guided techniques for sclerotherapy will not be covered when used in conjunction with injection sclerotherapy techniques. Pre-operative venous studies will be covered when initially performed to determine the extent of venous valvular incompetence. Additional reimbursement is not available for these or other radiologically guided or monitoring techniques when performed solely to guide the needle or introduce the sclerosant into the varicose vein. Symptomatic improvement is the primary goal and indicator of a satisfactory outcome. Documentation of recanalization or failure of vein closure without recurrent signs and symptoms does not necessarily indicate a need for additional treatments. Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

5 Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes Not Applicable CPT/HCPCS Codes Group 1 Paragraph: CPT CODES Group 1 Codes: Injection therapy of vein Injection therapy of veins Endovenous rf 1st vein Endovenous rf vein add-on Endovenous laser 1st vein Endovenous laser vein addon Endoscopy ligate perf veins Revise leg vein Ligate/strip short leg vein Ligate/strip long leg vein Ligate leg veins open Stab phleb veins xtr Phleb veins - extrem Revision of leg vein Ligate/divide/excise vein ICD-9 Codes that Support Medical Necessity Group 1 Paragraph: Use of these codes does not guarantee reimbursement. The patient s medical record must document that the coverage criteria in this policy have been met. Group 1 Codes: VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER

6 454.1 VARICOSE VEINS OF LOWER EXTREMITIES WITH INFLAMMATION VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER AND INFLAMMATION VARICOSE VEINS OF LOWER EXTREMITIES WITH OTHER COMPLICATIONS CHRONIC VENOUS HYPERTENSION WITH ULCER CHRONIC VENOUS HYPERTENSION WITH ULCER AND INFLAMMATION ICD-9 Codes that DO NOT Support Medical Necessity Paragraph: All other ICD-9 codes not listed under "ICD-9 Codes that Support Medical Necessity" will be denied as not medically necessary. General Information Associated Information Documentation Requirements Documentation supporting the medical necessity should be legible, maintained in the patient's medical record for each date of service billed, and must be made available to the A/B MAC upon request. For all varicose vein treatment modalities discussed in this policy, the patient s operative report, medical treatment history, and progress notes documenting patient compliance with prescribed conservative treatment must clearly indicate that all initial and procedural coverage criteria are met as outlined under the Indications section of this policy. Medical record documentation must specifically state the vessel(s) and perforator(s) treated for each procedure, as well as the vessel diameter. If additional procedures are performed on the same vessel(s) at a future date, documentation must show a recurrence of signs and symptoms, which are specifically caused by that vessel. Otherwise, the procedure will be considered cosmetic. Utilization Guidelines Services performed for excessive frequency are not medically necessary. Frequency is considered excessive when services are performed more frequently than generally accepted by peers and the reason for additional services is not justified by documentation.

7 Sources of Information and Basis for Decision 1. Bergan JJ, Kumins NH, Owens EL, et al. Surgical and Endovascular Treatment of Lower Extremity Venous Insufficiency. J Vasc Interv Radiol. 2002;13(6): Ballard JL, Rulli F, Carcia-Rinaldi R, et al. Subfascial Endoscopic Perforator Vein Surgery Combined with Saphenous Vein Ablation: Results and Critical Analysis. J Vasc Surg. 2003;38(5): 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): Goldman MP, Weiss RA, Bergan JJ. Diagnosis and Treatment of Varicose Veins: A Review. J Am Acad Dermatol. 1994;31(3 Pt 1): Goldman MP. Treatment Of Varicose And Telangiectatic Leg Veins: Double-Blind Prospective Comparative Trial Between Aethoxyskerol And Sotradecol. Dermatol Surg. 2002;28(1): Merchant RF, DePalma RG, Kabnick LS. Endovascular Obliteration of Saphenous Reflux: A Multicenter Study. J Vasc Surg. 2002;35(6): Min RJ, Khilnani N, Zimmet SE. Endovenous Laser Treatment of Saphenous Vein Reflux: Long Term Results. J Vasc Interv Radiol. 2003;14: TenBrook JA, Jr, Iafrati MD, O'donnell TF, Jr, et al. Systematic Review of Outcomes After Surgical Management of Venous Disease Incorporating Subfascial Endoscopic Perforator Surgery. J Vasc Surg. 2004;39(3): Weiss RA, Weiss MA. Controlled Radiofrequency Endovenous Occlusion Using a Unique Radiofrequency Catheter Under Duplex Guidance to Eliminate Saphenous Varicose Vein Reflux: A 2-Year Follow-Up. Dermatol Surg. 2002;28(1):38-42 Revision History Information Please note: Most Revision History entries effective on or before 01/24/2013 display with a Revision History Number of "R1" at the bottom of this table. However, there may be LCDs where these entries will display as a separate and distinct row. Revision History Date Revision History Number Revision History Explanation Reason(s) for Change

8 09/11/2014 R3 11/14/2013 R2 10/18/2012 R1 Under Sources of Information and Basis for Decision removed the verbiage "The development and coverage guidelines in this policy were based on a review of pertinent medical literature, policies from other Medicare contractors, and discussions with appropriate specialists," as this section is for bibliographies used to develop the LCD. Corrected the authors names in #s 2 removed Bianchi C and Abou- Zamom AM and replaced with Rulli F, and Garcia-Rinaldi R,#5 removed authors names Peterson JD, Weiss RA and et al. Under CMS National Coverage Policy added the following reference citations: 42 CFR (k)(1); Reasonable and necessary for diagnoses and treatment of illness or injury. CMS On-Line Manual, Publication , Chapter 3, Section , Diagnosis Code Requirements. Under Sources of Information and Basis for Decision added additional authors to the various articles and put bibliographies in AMA format. Annual review and validation completed. Revision #4, 10/18/2012 Under CMS National Coverage Policy added Social Security Act Title XVIII publications; 1862 (a)10, 1862 (a)(1)a, 1862 (a)(7) and 1833 (e). Under ICD-9 CM Codes That Support Medical Necessity ICD-9 codes , were added. Under Documentation Requirements the verbiage "All documentation must be available upon request by Medicare" was replaced with "Documentation supporting the medical necessity should be legible, maintained in the patient's medical record for each date of service billed, and must be made available to the A/B MAC upon request." This revision becomes effective on 10/18/2012. Provider Education/Guidance Public Education/Guidance Provider Education/Guidance Other (Reviewed bibliography, adding authors names and putting in AMA citation format style.)

9 3 06/18/2011 Revision Effective Date: Services performed on or after 06/18/2011 Per scheduled J11 implementation, LCD added to South Carolina #11202 and West Virginia # /28/2011 Revision Effective Date: Services performed on or after 05/28/2011 Per scheduled J11 implementation, LCD added to North Carolina MAC# /19/2011 Effective Date: 3/19/2011 In accordance with the Medicare Modernization Act of 2003, LCD# L1389 from Carrier# has been selected for the J11 implementation. Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Version(s) Updated on 09/04/2014 with effective dates 09/11/ Updated on 11/08/2013 with effective dates 11/14/ /10/2014

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