Endovenous Radiofrequency and Laser Ablation

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1 Endovenous Radiofrequency and Laser Ablation [For the list of services and procedures that need preauthorization, please refer to go to Comunicados a Proveedores, and click Cartas Circulares.] Medical Policy: MP-SU Original Effective Date: September 29, 2011 Revised: November 23, 2015 Next Revision: December, 2015 This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), and MCS Advantage, Inc. (Classicare) and, provider s contract; unless specific contract limitations, exclusions or exceptions apply. Please refer to the member s benefit certification language for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the aforementioned exceptions. For MCS Advantage (Classicare) lines of business (LOB) refer to CMS-First Coast Service Options, Local Coverage Determination (LCD) for Treatment of varicose veins of the lower extremity (L29403). DESCRIPTION Varicose veins are caused by venous insufficiency as a result of valve reflux (incompetence). The venous insufficiency results in dilated, tortuous, superficial vessels that protrude from the skin of the lower extremities (CMS, L29403, 2012). Vein related problems may or may not be symptomatic, and include a wide range of clinical signs that vary from minimal superficial venous dilation to chronic skin changes with ulceration. Chronic venous disease refers to a wide spectrum of morphologic (i.e., venous dilation) and /or functional abnormalities (e.g., venous reflux) of long duration (Alguire, Scovell, et al, 2014). Radiofrequency ablation (RFA) is a minimally invasive percutaneous technique using thermal energy to ablate incompetent veins. This procedure is used primarily to treat insufficiency of the axial veins (i.e., great, small, or accessory saphenous veins) but intersaphenous veins or perforator veins can also be treated with specialized probes (ref-2). Radiofrequency ablation devices generate a high frequency alternating current (in the radio range of frequencies, 300 KHz to 1 MHz) that is transmitted through an electrode. The resultant energy heats the tissue surrounding the probe to a pre-specified temperature (Alguire, Scovell, et al, 2014). Radiofrequency ablation can be performed in the office setting (appropriate equipped operative suite) or ambulatory surgery center under sterile conditions. Although some surgeons will perform bilateral saphenous ablation in a single session (Alguire, Scovell, et al, 2014). 1

2 The procedure is typically performed with local anesthesia with or without oral or intravenous sedation, but general anesthesia maybe appropriate depending on the nature of the procedure (i.e., extensive concurrent phlebotomy) or patient and/or surgeon preference (Alguire, Scovell, et al, 2014). COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate member certificate and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, benefits, and coverage. INDICATIONS Medical Card System Inc., (MCS) will consider Endovenous Radiofrequency and Laser Ablation for the treatment of symptomatic varicosities of the lesser or greater saphenous vein medically necessary when the following criteria are met: 1. A three (3) to six (6) months trial of conservative therapy including support hose, leg elevation or weight reduction when appropriate; and 2. Patient should present signs and symptoms of large bulging veins with patient complaints of leg heaviness, exercise intolerance, leg pain or tenderness; or 3. Venous stasis changes which may be exhibited by chronic skin and soft tissue changes that begin with mild swelling and then progress to include discoloration, inflammatory dermatitis, recurrent or chronic cellulitis, cutaneous infarction and ulceration. In addition to the above conditions, the following must be met: 1. The physician must submit a recent copy venous doppler report, 2. Absence of aneurysm in the target segment, 3. Maximum vein diameter of 20 mm for ERFA or laser ablation 4. Absence of thrombosis or vein tortuosity,which would impair catheter advancement 5. Absence of significant peripheral artery disease 6. A documented reflux (i.e., retrograde flow > 0.5 second duration) as a source of their symptoms. 2

3 LIMITATIONS Medical Card System Inc., (MCS) WILL NOT considers the treatment of asymptomatic veins with endovenous radiofrequency or laser ablation as medically necessary: 1. If it determined on review that the varicose veins were asymptomatic, the claim will be denied as a non-covered (cosmetic) procedure. 2. Any method of treatment for telangiectases (spider veins) is not covered. 3. Intraoperative ultrasound guidance is not separately reimbursable. Only preoperative Doppler ultrasound study or duplex scan will be covered. 4. It is not expected that phlebectomy on the same vein will be performed on the same day as endovenous radiofrequency and laser ablation. CONTRAINDICATIONS: 1. Pregnancy or Nursing*. 2. Acute superficial or deep venous thrombosis and/or thromboembolism. 3. Moderate to severe peripheral artery disease. 4. Advance generalized systemic disease. 5. Joint disease that interferes with mobility and/or inability to adequately ambulate after the procedure. 6. Diabetes. 7. Very large veins. 8. Liver dysfunction or local anesthetic allergy limiting local anesthetic agent use. 9. Severe uncorrectable coagulopathy, intrinsic or iatrogenic. 10. Severe hypercoagulopathy syndromes. 3

4 11. Inability to wear compression stocking secondary to inadequate arterial circulation, hypersensitivity to the compressive materials, or musculoskeletal or neurologic limitations to donning the stocking itself. 12. Sciatic vein reflux. 13. Nerve stimulator. Note 1 *= Secondary to concerns related to anesthetic drug use and related to vein or heated blood effluent which may pass through the placenta to the fetus. CODING INFORMATION CPT Codes (List may not be all inclusive) CPT Codes DESCRIPTION Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring percutaneous, radiofrequency: first vein treated Second and subsequent veins treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure) Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser, first vein treated Second and subsequent veins treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure) (use in conjunction with 36478) Current Procedural Terminology (CPT ) 2014 American Medical Association: Chicago, IL. HCPCS CODES (List may not be all inclusive) HCPCS CODES N/A 2014 HCPCS LEVEL II Professional Edition (American Medical Association). ICD-10 Codes (List may not be all inclusive) ICD-10-Codes I78.0 Hereditary hemorrhagic telangiectasia I78.8 Other diseases of capillaries I78.9 Disease of capillaries, unspecified DESCRIPTION N/A DESCRIPTION I80.00 Phlebitis and thrombophlebitis of superficial vessels of unspecified lower extremity I80.01 Phlebitis and thrombophlebitis of superficial vessels of right lower extremity I80.02 Phlebitis and thrombophlebitis of superficial vessels of left lower extremity 4

5 I80.03 Phlebitis and thrombophlebitis of superficial vessels of lower extremities, bilateral I80.10 Phlebitis and thrombophlebitis of unspecified femoral vein I80.11 Phlebitis and thrombophlebitis of right femoral vein I80.12 Phlebitis and thrombophlebitis of left femoral vein I80.13 Phlebitis and thrombophlebitis of femoral vein, bilateral I Phlebitis and thrombophlebitis of unspecified deep vessels of right lower extremity I Phlebitis and thrombophlebitis of unspecified deep vessels of left lower extremity I Phlebitis and thrombophlebitis of unspecified deep vessels of lower extremities, bilateral I Phlebitis and thrombophlebitis of unspecified deep vessels of unspecified lower extremity I Phlebitis and thrombophlebitis of right popliteal vein I Phlebitis and thrombophlebitis of left popliteal vein I Phlebitis and thrombophlebitis of popliteal vein, bilateral I Phlebitis and thrombophlebitis of unspecified popliteal vein I Phlebitis and thrombophlebitis of right tibial vein I Phlebitis and thrombophlebitis of left tibial vein I Phlebitis and thrombophlebitis of tibial vein, bilateral I Phlebitis and thrombophlebitis of unspecified tibial vein I Phlebitis and thrombophlebitis of other deep vessels of right lower extremity I Phlebitis and thrombophlebitis of other deep vessels of left lower extremity I Phlebitis and thrombophlebitis of other deep vessels of lower extremity, bilateral I Phlebitis and thrombophlebitis of other deep vessels of unspecified lower extremity I80.3 Phlebitis and thrombophlebitis of lower extremities, unspecified I Varicose veins of unspecified lower extremity with ulcer of thigh I Varicose veins of unspecified lower extremity with ulcer of calf I Varicose veins of unspecified lower extremity with ulcer of ankle I Varicose veins of unspecified lower extremity with ulcer of heel and midfoot I Varicose veins of unspecified lower extremity with ulcer other part of foot I Varicose veins of unspecified lower extremity with ulcer other part of lower leg I Varicose veins of unspecified lower extremity with ulcer of unspecified site I Varicose veins of right lower extremity with ulcer of thigh I Varicose veins of right lower extremity with ulcer of calf I Varicose veins of right lower extremity with ulcer of ankle I Varicose veins of right lower extremity with ulcer of heel and midfoot I Varicose veins of right lower extremity with ulcer other part of foot 5

6 I Varicose veins of right lower extremity with ulcer other part of lower leg I Varicose veins of right lower extremity with ulcer of unspecified site I Varicose veins of left lower extremity with ulcer of thigh I Varicose veins of left lower extremity with ulcer of calf I Varicose veins of left lower extremity with ulcer of ankle I Varicose veins of left lower extremity with ulcer of heel and midfoot I Varicose veins of left lower extremity with ulcer other part of foot I Varicose veins of left lower extremity with ulcer other part of lower leg I Varicose veins of left lower extremity with ulcer of unspecified site I83.10 Varicose veins of unspecified lower extremity with I83.11 Varicose veins of right lower extremity with I83.12 Varicose veins of left lower extremity with I Varicose veins of unspecified lower extremity with both ulcer of thigh and I Varicose veins of unspecified lower extremity with both ulcer of calf and I Varicose veins of unspecified lower extremity with both ulcer of ankle and I Varicose veins of unspecified lower extremity with both ulcer of heel and midfoot and I Varicose veins of unspecified lower extremity with both ulcer other part of foot and I Varicose veins of unspecified lower extremity with both ulcer of other part of lower extremity and I Varicose veins of unspecified lower extremity with both ulcer of unspecified site and I Varicose veins of right lower extremity with both ulcer of thigh and I Varicose veins of right lower extremity with both ulcer of calf and I Varicose veins of right lower extremity with both ulcer of ankle and I Varicose veins of right lower extremity with both ulcer of heel and midfoot and I Varicose veins of right lower extremity with both ulcer other part of foot and I Varicose veins of right lower extremity with both ulcer of other part of lower extremity and I Varicose veins of right lower extremity with both ulcer of unspecified site and I Varicose veins of left lower extremity with both ulcer of thigh and 6

7 I Varicose veins of left lower extremity with both ulcer of calf and I Varicose veins of left lower extremity with both ulcer of ankle and I Varicose veins of left lower extremity with both ulcer of heel and midfoot and I Varicose veins of left lower extremity with both ulcer other part of foot and I Varicose veins of left lower extremity with both ulcer of other part of lower extremity and I Varicose veins of left lower extremity with both ulcer of unspecified site and I Varicose veins of right lower extremities with pain I Varicose veins of left lower extremities with pain I Varicose veins of bilateral lower extremities with pain I Varicose veins of unspecified lower extremities with pain I Varicose veins of right lower extremities with other complications I Varicose veins of left lower extremities with other complications I Varicose veins of bilateral lower extremities with other complications I Varicose veins of unspecified lower extremities with other complications I Postthrombotic syndrome with ulcer of right lower extremity I Postthrombotic syndrome with ulcer of left lower extremity I Postthrombotic syndrome with ulcer of bilateral lower extremity I Postthrombotic syndrome with ulcer of unspecified lower extremity I Postthrombotic syndrome with of right lower extremity I Postthrombotic syndrome with of left lower extremity I Postthrombotic syndrome with of bilateral lower extremity I Postthrombotic syndrome with of unspecified lower extremity I Postthrombotic syndrome with ulcer and of right lower extremity I Postthrombotic syndrome with ulcer and of left lower extremity I Postthrombotic syndrome with ulcer and of bilateral lower extremity I Postthrombotic syndrome with ulcer and of unspecified lower extremity I Postthrombotic syndrome with other complications of right lower extremity I Postthrombotic syndrome with other complications of left lower extremity I Postthrombotic syndrome with other complications of bilateral lower extremity I Postthrombotic syndrome with other complications of unspecified lower extremity I87.2 Venous insufficiency (chronic) (peripheral) 7

8 I87.9 Disorder of vein, unspecified Z41.1 Encounter for cosmetic surgery I78.0 Hereditary hemorrhagic telangiectasia I78.8 Other diseases of capillaries I78.9 Disease of capillaries, unspecified I80.00 Phlebitis and thrombophlebitis of superficial vessels of unspecified lower extremity I80.01 Phlebitis and thrombophlebitis of superficial vessels of right lower extremity I80.02 Phlebitis and thrombophlebitis of superficial vessels of left lower extremity I80.03 Phlebitis and thrombophlebitis of superficial vessels of lower extremities, bilateral I80.10 Phlebitis and thrombophlebitis of unspecified femoral vein I80.11 Phlebitis and thrombophlebitis of right femoral vein I80.12 Phlebitis and thrombophlebitis of left femoral vein I80.13 Phlebitis and thrombophlebitis of femoral vein, bilateral I Phlebitis and thrombophlebitis of unspecified deep vessels of right lower extremity I Phlebitis and thrombophlebitis of unspecified deep vessels of left lower extremity I Phlebitis and thrombophlebitis of unspecified deep vessels of lower extremities, bilateral I Phlebitis and thrombophlebitis of unspecified deep vessels of unspecified lower extremity I Phlebitis and thrombophlebitis of right popliteal vein I Phlebitis and thrombophlebitis of left popliteal vein I Phlebitis and thrombophlebitis of popliteal vein, bilateral I Phlebitis and thrombophlebitis of unspecified popliteal vein I Phlebitis and thrombophlebitis of right tibial vein I Phlebitis and thrombophlebitis of left tibial vein I Phlebitis and thrombophlebitis of tibial vein, bilateral I Phlebitis and thrombophlebitis of unspecified tibial vein I Phlebitis and thrombophlebitis of other deep vessels of right lower extremity I Phlebitis and thrombophlebitis of other deep vessels of left lower extremity I Phlebitis and thrombophlebitis of other deep vessels of lower extremity, bilateral I Phlebitis and thrombophlebitis of other deep vessels of unspecified lower extremity I80.3 Phlebitis and thrombophlebitis of lower extremities, unspecified 8

9 I Varicose veins of unspecified lower extremity with ulcer of thigh I Varicose veins of unspecified lower extremity with ulcer of calf I Varicose veins of unspecified lower extremity with ulcer of ankle I Varicose veins of unspecified lower extremity with ulcer of heel and midfoot I Varicose veins of unspecified lower extremity with ulcer other part of foot I Varicose veins of unspecified lower extremity with ulcer other part of lower leg I Varicose veins of unspecified lower extremity with ulcer of unspecified site I Varicose veins of right lower extremity with ulcer of thigh I Varicose veins of right lower extremity with ulcer of calf I Varicose veins of right lower extremity with ulcer of ankle I Varicose veins of right lower extremity with ulcer of heel and midfoot I Varicose veins of right lower extremity with ulcer other part of foot I Varicose veins of right lower extremity with ulcer other part of lower leg I Varicose veins of right lower extremity with ulcer of unspecified site I Varicose veins of left lower extremity with ulcer of thigh I Varicose veins of left lower extremity with ulcer of calf I Varicose veins of left lower extremity with ulcer of ankle I Varicose veins of left lower extremity with ulcer of heel and midfoot I Varicose veins of left lower extremity with ulcer other part of foot I Varicose veins of left lower extremity with ulcer other part of lower leg I Varicose veins of left lower extremity with ulcer of unspecified site I83.10 Varicose veins of unspecified lower extremity with I83.11 Varicose veins of right lower extremity with I83.12 Varicose veins of left lower extremity with I Varicose veins of unspecified lower extremity with both ulcer of thigh and I Varicose veins of unspecified lower extremity with both ulcer of calf and I Varicose veins of unspecified lower extremity with both ulcer of ankle and I Varicose veins of unspecified lower extremity with both ulcer of heel and midfoot and I Varicose veins of unspecified lower extremity with both ulcer other part of foot and I Varicose veins of unspecified lower extremity with both ulcer of other part of lower extremity and I Varicose veins of unspecified lower extremity with both ulcer of unspecified site and 9

10 I Varicose veins of right lower extremity with both ulcer of thigh and I Varicose veins of right lower extremity with both ulcer of calf and I Varicose veins of right lower extremity with both ulcer of ankle and I Varicose veins of right lower extremity with both ulcer of heel and midfoot and I Varicose veins of right lower extremity with both ulcer other part of foot and I Varicose veins of right lower extremity with both ulcer of other part of lower extremity and I Varicose veins of right lower extremity with both ulcer of unspecified site and I Varicose veins of left lower extremity with both ulcer of thigh and I Varicose veins of left lower extremity with both ulcer of calf and I Varicose veins of left lower extremity with both ulcer of ankle and I Varicose veins of left lower extremity with both ulcer of heel and midfoot and I Varicose veins of left lower extremity with both ulcer other part of foot and I Varicose veins of left lower extremity with both ulcer of other part of lower extremity and I Varicose veins of left lower extremity with both ulcer of unspecified site and I Varicose veins of right lower extremities with pain I Varicose veins of left lower extremities with pain I Varicose veins of bilateral lower extremities with pain I Varicose veins of unspecified lower extremities with pain I Varicose veins of right lower extremities with other complications I Varicose veins of left lower extremities with other complications I Varicose veins of bilateral lower extremities with other complications I Varicose veins of unspecified lower extremities with other complications I Postthrombotic syndrome with ulcer of right lower extremity I Postthrombotic syndrome with ulcer of left lower extremity I Postthrombotic syndrome with ulcer of bilateral lower extremity I Postthrombotic syndrome with ulcer of unspecified lower extremity I Postthrombotic syndrome with of right lower extremity I Postthrombotic syndrome with of left lower extremity I Postthrombotic syndrome with of bilateral lower extremity 10

11 I Postthrombotic syndrome with of unspecified lower extremity I Postthrombotic syndrome with ulcer and of right lower extremity I Postthrombotic syndrome with ulcer and of left lower extremity I Postthrombotic syndrome with ulcer and of bilateral lower extremity I Postthrombotic syndrome with ulcer and of unspecified lower extremity I Postthrombotic syndrome with other complications of right lower extremity I Postthrombotic syndrome with other complications of left lower extremity I Postthrombotic syndrome with other complications of bilateral lower extremity I Postthrombotic syndrome with other complications of unspecified lower extremity I87.2 Venous insufficiency (chronic) (peripheral) I87.9 Disorder of vein, unspecified Z41.1 Encounter for cosmetic surgery REFERENCES 1. Centers for Medicare & Medicaid Services. (First Coast Service Options, Inc.). Local Coverage Determination (LCD) for Treatment of varicose veins of the lower extremity (L29403). Determination effective Date: 03/02/2009. Revision Effective Date: for Services performed on or after 03/27/2012. Accessed September 11, Available at URL address: 198&name=First+Coast+Service+Options%2c+Inc.+(09202%2c+MAC+- +Part+B)&s=46&bc=AggAAAIACAAAAA%3d%3d& 2. ECRI institute. Title: Endovenous Treatment of the Small Saphenous and Perforator Veins. Published: 04/27/2011. Searched September 11, Available at URL address: Document was retired in the Ecri website. Document available at MCS electronic folder. 3. ECRI Institute. Title: Endovenous Radiofrequency Ablation (VNUS Closure System) for the Treatment of Varicose Veins. Published: 08/08/2008. Searched on September 11, Available at URL address: Document was retired in the Ecri website. Document available at MCS electronic folder. 4. ECRI Institute. Title: Endovenous Laser Ablation of the Greater Saphenous Vein. Published: 12/30/2004. Accessed September 11, Available at URL address: 5. ECRI Institute. Endovenous Radio-Frequency ablation (VNUS Closure System) for the Treatment of varicose Veins. Published: 08/24/ (Health Technology Assessment Information)- 11

12 Windows on Medical Technology. Accessed September 11, Available at URL address: 6. John F Eidt, MD. ; Joseph L Mills, Sr, MD. Section Editors. Deputy Editor. Kathryn A Collins, MD, PhD, FACS. Open Surgical Techniques for lower extremity vein Ablation. Literature review current through: August Last updated: November 14, Accessed September 11, Available at URL address: 7. Khilnani et al. Multi- society consensus quality improvement guidelines for the treatment of lower extremity superficial venous insufficiency with endovenous thermal ablation from the society of interventional radiology, Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology, and Canadian Interventional Radiology Association. J Vasc Interven Radiol 2010; 21: Accessed September 15, Available at URL Address: 8. Khilnani et al. Varicose Vein Treatment with Endovenous Laser Therapy. Medscape. Updated April 10, Accessed September 15, Available at URL Address: 9. Patrick C Alguire, MD, FACP. Sherry Scovell, MD, FACS. Section Editors John F Eidt, MD. Joseph L Mills, Sr, MD. Deputy Editot. Kathryn A Collins, MD, PhD, FACS. Overview and Management of Lower extremity chronic venous disease. Literature review current through: August Last updated: May 05, Accessed September 11, Available at URL address: nic+venous+disease.&selectedtitle=1%7e Patrick C Alguire, MD, FACS; Barbara M Mathes, MD, FACP, FAAD. Section Editors John F Eidt, MD; Joseph L Mills, Sr, MD; Deputy Editor Kathryn A Collins, MD, PhD, FACS. Medical management of lower extremity chronic venous disease. Literature review current through: August Last updated: August 18, Accessed September 11, Available at URL address: Sherry Scovel, MD, FACS. Sections Editors John F. Edits, MD; Joseph L Mills, Sr, MD; Deputy Editor Kathryn A Collins, MD, PhD, FACS. Radiofrequency Ablation for the treatment of lower extremity chronic venous disease. Literature review current through: August This topic 12

13 last updated: August 02, Accessed September 11, Available at URL address: POLICY HISTORY DATE ACTION COMMENT September 29, 2011 Origination of Policy November 7, 2012 Revised References updated. To the Coding Information: Deleted CPT Code and ICD-9 Code September 24, 2013 Reviewed References updated. References #6 to #9 were added to the Medical Policy January 29, 2014 Revised References #6 to #9 was reviewed with the information contained in this medical policy and UpToDate. To the indications section: Indication #6 was added. To the contraindications section: Contraindications #6, 7 were added. February 21,2014 Revised To the Coding section: A new ICD-10 Codes (Preview Draft) section was added to the policy. September 15, 2014 Revised References updated. To the contraindications section: The word Nursing was added to the contraindication #1. New contraindications 1, 5, 8, 9, 10, 11, 12, 13 and note1 were added to the policy. To the References section: New References (#7, 8) were added to the Policy. November 23, 2015 Revised To the coding section: Eliminate ICD-9 codes since they are no longer valid for diagnosis classification. Add new section of ICD-10 codes which are the valid diagnosis classification system since October 1, This document is for informational purposes only. It is not an authorization, certification, explanation of benefits, or contract. Receipt of benefits is subject to satisfaction of all terms and conditions of coverage. Eligibility and benefit coverage are determined in accordance with the terms of the member s plan in effect as of the date services are rendered., (MCS) medical policies are developed with the assistance of medical professionals and are based upon a review of published and unpublished information including, but not limited to, current medical literature, guidelines published by public health and health research agencies, and community medical practices in the treatment and diagnosis of disease. Because medical practice, information, and technology are constantly changing, Medical Card System, Inc., (MCS) reserves the right to review and update its medical policies at its discretion. ; (MCS) medical policies are intended to serve as a resource to the plan. They are not intended to limit the plan s ability to interpret plan language as deemed appropriate. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment they choose to provide. 13

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