L28999-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Treatment of varicose veins of the lower extremity (L28999)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28999

LCD Title Treatment of varicose veins of the lower extremity

Contractor's Determination Number A36470

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 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 of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/16/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 03/27/2012

Revision Ending Date

CMS National Coverage Policy

CMS Manual System, Pub 100-08, Program Integrity Manual, Chapter 13, Section 5.1

Indications and Limitations of Coverage and/or Medical Necessity

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. Spider veins (telangiectasias) are dilated capillary veins that are most often treated for cosmetic purposes and are not covered by Medicare.

Sclerotherapy (liquid or foam) is preformed for signs and symptoms of diseased vessels and can be used as an adjunct to surgical or ablative therapy (radiofrequency or laser). Sclerotherapy for cosmetic purposes is not considered medically reasonable and necessary. The size of the vessels being treated with sclerotherapy (liquid or foam) must be such that a long lasting effect can be expected and that an acceptable risk/benefit outcome is favorable to the patient. With this, literature supports that the goal of treatment is to eliminate the primary and secondary sources of reflux, to reduce the reoccurrence of varicosities.

Ligation and stripping of varicose veins is a treatment option that aims to eliminate reflux at the saphenofemoral or saphenopopliteal junction.

The CMS Manual System, Pub. 100-8, Program Integrity Manual, Chapter 13, Section 5.1 (http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf) outlines that "reasonable and necessary" services

are "ordered and/or furnished by qualified personnel." Services will be considered medically reasonable and

necessary only if performed by appropriately trained providers.

A qualified physician for this service/procedure is defined as follows: A) Physician is properly enrolled in Medicare.

B) Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States.

The accuracy of non-invasive diagnostic studies depends on the knowledge, skill and experience of the technologist and the physician performing the interpretation of the study. Consequently, the technologist and the physician must maintain proof of training and experience. All non-invasive vascular diagnostic studies must be:

(1) performed by a qualified physician, or (2) performed under the general supervision of a qualified physician or technologist who has demonstrated minimum entry level competency by being credentialed in vascular technology, and/or (3) performed in a laboratory accredited in vascular technology.

Examples of certification in vascular technology for non-physician personnel include:

• Registered Vascular Technologist (RVT) credential

• Registered Vascular Specialist (RVS) credential

These credentials must be provided by nationally recognized credentialing organizations such as:

• The American Registry of Diagnostic Medical Sonographers (ARDMS) which provides RDMS and RVT credentials

• The Cardiovascular Credentialing International (CCI) which provides RVS credential Appropriate, nationally recognized laboratory accreditation bodies include:

• Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL)

• American College of Radiology (ACR)

General Supervision means the procedure is furnished under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the procedure. Under general supervision, the training of the non-physician personnel who actually performs the diagnostic procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of the physician.

*Note that technicians and therapist do not qualify to surgically treat varicose veins.

Medicare will consider sclerotherapy (standard or foam) and/or ligation with or without stripping medically necessary when the following indications are met:

A 3-month trial period of conservative therapy that includes but is not limited to any of the following:

• Weight reduction

• Daily exercise plan

• Leg elevation

• Use of graduated compression stockings

If, despite conservative therapy, the patient is symptomatic and presents with any of the following:

• Signs and symptoms of significantly diseased vessels of the lower extremities such as stasis ulcer of the lower leg, significant pain and significant edema that interferes with activities of daily living.

• Bleeding

Limitations

• Pregnant women

• Patients on anti-coagulant therapy*

• The inability to tolerate compressive bandages or stockings

• Severe distal arterial occlusive disease

• Obliteration of deep venous system

• Allergy to the sclerosant

• Hypercoaguable state

* Note for patients receiving anticoagulant therapy: if the decision is made to proceed with the service, the medical record should clearly support that the benefit outweighs the risk and the justification to proceed with the service should be given.

Treatment of telangiectasias (spider veins) is considered cosmetic and is not covered by Medicare

Ultrasound guidance or duplex scanning will be considered medically necessary when used to initially determine the extent and mapping of the varicose veins and identify the location of incompetence. The use of ultrasound or duplex scanning during the procedure may be covered when the situation arises that it is medically necessary to visualize the sclerosing agent to ensure it is in the appropriate location. The medical necessity for the use of ultrasound/duplex scanning during the sclerotherapy procedure must be clearly documented in the medical record.

Medical literature supports the use of liquid sclerotherapy with compression for the treatment of branch varicosities and small tributaries but does not see this as effective for the treatment of saphenofemoral or saphenopopliteal valvular incompetence. Foam sclerotherapy, or chemical ablation, is supported as an effective treatment for saphenofemoral and saphenopopliteal valvular incompetence. Sclerotherapy (with the exception of foam/chemical ablation) will not be considered medically necessary if the patient’s saphenofemoral or saphenopopliteal incompetence is left untreated. Medical literature supports that these patients should be treated with ligation and/or division of the junction to reduce the risk of varicose vein recurrence.

The scope of this LCD does not include solutions used to perform liquid or chemical ablation sclerotherapy. It is the responsibility of the provider to comply with all applicable State and Federal laws related to the human use of agents.

Endovenous ablation therapy

Endovenous radiofrequency ablation (ERFA)and endovenous laser treatment (EVLT) also known as laser ablation are minimally invasive alternatives to vein ligation and stripping. ERFA (VENUS® Closure System) is FDA approved for endovascular coagulation of blood vessels with superficial vein reflux. EVLT is FDA approved for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.

Medicare will consider endovenous radiofrequency and laser ablation for the treatment of symptomatic varicosities of the lesser or greater saphenous vein medically reasonable and necessary for the following conditions:

• A three to six month trial of conservative therapy including support hose, leg elevation or weight reduction where appropriate; and

• Large bulging veins with patient complaints of leg heaviness, exercise intolerance, leg pain or tenderness; or

• 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, the following must be supported:

• Absence of aneurysm in the target segment

• Maximum vein diameter of 20mm for ERFA or laser ablation

• Absence of thrombosis or vein tortuosity, which would impair catheter advancement

• Absence of significant peripheral artery disease

One post-operative ultrasound will be allowed for follow up care when ERFA or EVLT is performed. The medical record must clearly indicate that the reason for the follow up ultrasound is related to the ERFA or EVLT procedure performed.

Limitations

Intraoperative ultrasound guidance is not separately reimbursable. One preoperative Doppler ultrasound study or duplex scan will be covered.

It is not expected that a phlebectomy of the same vein will be performed on the same day as endovenous radiofrequency and laser ablation.

If sclerotherapy is done in conjunction with endovenous ablation, the medical record should support that each service is separately identifiable and distinct from the other. The medical necessity criteria set forth in the indications and limitations section of this LCD must be met and the approach must be to the patients benefit. Medicare will not consider the treatment of asymptomatic veins with endovenous radiofrequency or laser ablation reasonable and medically necessary. If it is determined on review that the varicose veins were asymptomatic, the claim will be denied as a non-covered (cosmetic) procedure. Any method of treatment for telangiectases (spider veins) is not covered.

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.

012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient

083x Ambulatory Surgery Center 085x Critical Access Hospital

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.

036X Operating Room Services - General Classification 049X Ambulatory Surgical Care - General Classification 051X Clinic - General Classification

0761 Specialty Services - Treatment Room

0920 Other Diagnostic Services - General Classification 0921 Other Diagnostic Services - Peripheral Vascular Lab 0929 Other Diagnostic Services - Other Diagnostic Service

CPT/HCPCS Codes

36470 INJECTION OF SCLEROSING SOLUTION; SINGLE VEIN

36471 INJECTION OF SCLEROSING SOLUTION; MULTIPLE VEINS, SAME LEG

36475 ENDOVENOUS ABLATION THERAPY OF INCOMPETENT VEIN, EXTREMITY, INCLUSIVE OF ALL IMAGING GUIDANCE AND MONITORING, PERCUTANEOUS, RADIOFREQUENCY; FIRST VEIN TREATED

ENDOVENOUS ABLATION THERAPY OF INCOMPETENT VEIN, EXTREMITY, INCLUSIVE OF ALL IMAGING 36476 GUIDANCE AND MONITORING, PERCUTANEOUS, RADIOFREQUENCY; SECOND AND SUBSEQUENT VEINS

TREATED IN A SINGLE EXTREMITY, EACH THROUGH SEPARATE ACCESS SITES (LIST SEPARATELY IN

ADDITION TO CODE FOR PRIMARY PROCEDURE)

36478 ENDOVENOUS ABLATION THERAPY OF INCOMPETENT VEIN, EXTREMITY, INCLUSIVE OF ALL IMAGING GUIDANCE AND MONITORING, PERCUTANEOUS, LASER; FIRST VEIN TREATED

ENDOVENOUS ABLATION THERAPY OF INCOMPETENT VEIN, EXTREMITY, INCLUSIVE OF ALL IMAGING 36479 GUIDANCE AND MONITORING, PERCUTANEOUS, LASER; SECOND AND SUBSEQUENT VEINS TREATED IN

A SINGLE EXTREMITY, EACH THROUGH SEPARATE ACCESS SITES (LIST SEPARATELY IN ADDITION TO

CODE FOR PRIMARY PROCEDURE)

37700 LIGATION AND DIVISION OF LONG SAPHENOUS VEIN AT SAPHENOFEMORAL JUNCTION, OR DISTAL INTERRUPTIONS

37718 LIGATION, DIVISION, AND STRIPPING, SHORT SAPHENOUS VEIN

37722 LIGATION, DIVISION, AND STRIPPING, LONG (GREATER) SAPHENOUS VEINS FROM SAPHENOFEMORAL JUNCTION TO KNEE OR BELOW

LIGATION AND DIVISION AND COMPLETE STRIPPING OF LONG OR SHORT SAPHENOUS VEINS WITH 37735 RADICAL EXCISION OF ULCER AND SKIN GRAFT AND/OR INTERRUPTION OF COMMUNICATING VEINS OF

LOWER LEG, WITH EXCISION OF DEEP FASCIA

37760 LIGATION OF PERFORATOR VEINS, SUBFASCIAL, RADICAL (LINTON TYPE), INCLUDING SKIN GRAFT, WHEN PERFORMED, OPEN,1 LEG

37761 LIGATION OF PERFORATOR VEIN(S), SUBFASCIAL, OPEN, INCLUDING ULTRASOUND GUIDANCE, WHEN PERFORMED, 1 LEG

37765 STAB PHLEBECTOMY OF VARICOSE VEINS, 1 EXTREMITY; 10-20 STAB INCISIONS

37766 STAB PHLEBECTOMY OF VARICOSE VEINS, 1 EXTREMITY; MORE THAN 20 INCISIONS

37780 LIGATION AND DIVISION OF SHORT SAPHENOUS VEIN AT SAPHENOPOPLITEAL JUNCTION (SEPARATE PROCEDURE)

37799 UNLISTED PROCEDURE, VASCULAR SURGERY

NONINVASIVE PHYSIOLOGIC STUDIES OF EXTREMITY VEINS, COMPLETE BILATERAL STUDY (EG, 93965 DOPPLER WAVEFORM ANALYSIS WITH RESPONSES TO COMPRESSION AND OTHER MANEUVERS,

PHLEBORHEOGRAPHY, IMPEDANCE PLETHYSMOGRAPHY)

93970 DUPLEX SCAN OF EXTREMITY VEINS INCLUDING RESPONSES TO COMPRESSION AND OTHER MANEUVERS; COMPLETE BILATERAL STUDY

93971 DUPLEX SCAN OF EXTREMITY VEINS INCLUDING RESPONSES TO COMPRESSION AND OTHER MANEUVERS; UNILATERAL OR LIMITED STUDY

ICD-9 Codes that Support Medical Necessity

451.11 PHLEBITIS AND THROMBOPHLEBITIS OF FEMORAL VEIN (DEEP) (SUPERFICIAL)

451.19 PHLEBITIS AND THROMBOPHLEBITIS OF OTHER

451.2 PHLEBITIS AND THROMBOPHLEBITIS OF LOWER EXTREMITIES UNSPECIFIED

454.1 VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER

454.2 VARICOSE VEINS OF LOWER EXTREMITIES WITH INFLAMMATION

454.3 VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER AND INFLAMMATION

454.8 VARICOSE VEINS OF LOWER EXTREMITIES WITH OTHER COMPLICATIONS

459.81 VENOUS (PERIPHERAL) INSUFFICIENCY UNSPECIFIED

782.3 EDEMA

Printed on 9/29/2012. Page 5 of 9

Diagnoses that Support Medical Necessity

See ICD-9 codes that support medical necessity

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity

Diagnoses that DO NOT Support Medical Necessity

448.1 Hereditary hemorrhagic telangiectasia

448.2 Nevus, non-neoplastic

448.9 Other and unspecified capillary diseases 459.10-459.19 Postphlebitic syndrome

General Information

Documentations Requirements

The following must be documented in the patient's medical record and made available to Medicare upon request:

History and Physical with findings that support the diagnosis billed and the associated symptoms of the varicose veins. Failure of an adequate trial of conservative therapy as described in the indications and limitations section

of the LCD. Exclusion of other causes of leg pain, ulceration and edema. Performance of appropriate tests used to confirm the presence and location of incompetent perforated veins and pre-treatment photos of the varicose veins. All other requirements of medical necessity outlined in the indications and limitations section of this LCD.

Appendices

Utilization Guidelines The procedures addressed in this LCD may be performed by and reimbursed to Podiatrists to the extent that they are within the scope of practice in the State or territory where the podiatrist is providing the service.

Medicare recognizes that multiple injections are needed to perform sclerotherapy and that responses differ due to the anatomical site being treated. Medicare would not expect to see the following when performing sclerotherapy:

• More than three (3) injections per vessel treated,

• More than five (5) sclerotherapy sessions for each leg, and

• More than 20 injections per leg

Sources of Information and Basis for Decision

The American Academy of Cosmetic Surgery (2003). 2003 Guidelines for Sclerotherapy. Retrieved from www.cosmeticsurgery.org on 3/21/2006.

American Academy of Dermatology. Guidelines of care for sclerotherapy treatment of varicose and telangiectatic leg veins. Retrieved from http://www.aadassociation.org/Guidelines/sclero.html on 5/3/2005.

American College of Phlebology (2005). Venous Digest. 12 (5). Printed on 9/29/2012. Page 6 of 9

American College of Phlebology (2006). Venous Digest. 13 (2).

Barrett, J.M., et al (2004). Microfoam Ultrasound-Guided Sclerotherapy of Varicose Veins in 100 Legs. American Society for Dermatological Surgery, Inc. 30: 6-12. Blackwell Publishing, Inc.

De Zeeuw, R., Toonder, I.M., et al. (2005). Ultrasound-guided foam sclerotherapy in the treatment of varicose veins: tips and tricks. Phelbology 20 (4).

Feied, C (2005). Varicose veins and Spider veins. Retrieved from http://www.emedicine.com/derm/topic475.htm on 3/26/2006. WebMD.com

Merchant, R.F., Pichot, O., and Myers, K. (2005). Four-year follow-up on Endovascular Radiofrequency Obliteration of Great Saphenous Reflux. American Society for Dermatologic Surgery, Inc. 31:129-134. Published by BC Decker Inc.

Merchant, R.F., and Pichot, O. (2005). Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for superficial venous insufficiency. Journal of Vascular Surgery 42 (3).

Parsons, M (2004). Sclerotherapy basics. Dermatology Clinics 22(4). W.B. Saunders Company. Retrieved from http://home.mdconsult.com/das/article on 2/21/2006.

Pletnicks, J. (2000). Sclerotherapy. The Doctor’s Medical Library. Retrieved from http://www.medical- library.net/specialties/_sclerotherapy.html on 5/3/2005.

Sadick, N. (2005). Advances in the treatment of varicose veins: ambulatory phlebectomy, foam sclerotherapy, endovascular laser and radiofrequency closure. Dermatologic Clinics, 23 (3). W.B. Saunders Company. Retrieved from http://home.mdconsult.com/das/article/body on 2/21/06.

Teruya, T. and Ballard, J (2004). New approaches for the treatment of varicose veins. Surgical Clinics of North America, 85 (5). W.B. Saunders Company. Retrieved from http://home.mdconsult.com/das/article on 2/21/06.

Advisory Committee Meeting Notes

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/01/2010

Revision History Number 3

Revision History Explanation Revision Number:3 Start Date of Comment Period:N/A

Start Date of Notice Period:05/01/2012 Revised Effective Date:03/27/2012

LCR A2012-033

April 2012 Connection

Explanation of Revision: Under the “Indications and Limitations of Coverage and/or Medical Necessity” section with the subheading “Endovenous ablation therapy,” verbiage was added to include endovenous laser treatment (EVLT). The effective date of this LCD is based on date of service.

Revision Number:2

Start Date of Comment Period:N/A Start Date of Notice Period:07/01/2011 Revised Effective Date:06/14/2011

LCR A2011-056

Printed on 9/29/2012. Page 7 of 9

June 2011 Connection

Explanation of Revision: Based on an outside request to clarify our current training statement outlined in this

LCD, language under the “Limitations” section of the LCD has been deleted and replaced with a revised statement regarding the qualification and training. Revisions will be effective based on process date.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2010 Revised Effective Date: 01/01/2010

LCR A2010-001

December 2009 Bulletin

Explanation of Revision: Annual 2010 HCPCS Update. Added CPT code 37761. Revised descriptor for CPT code 37760. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009

LCR A2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28999) replaces LCD L23082 as the policy in notice. This document (L28999) is effective on 02/16/2009.

8/10/2009 - The description for Revenue code 0761 was changed

11/15/2009 - The description for CPT/HCPCS code 37760 was changed in group 1 11/15/2009 - The description for CPT/HCPCS code 37765 was changed in group 1 11/15/2009 - The description for CPT/HCPCS code 37766 was changed in group 1

8/1/2010 - The description for Bill Type Code 12 was changed 8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 83 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0360 was changed 8/1/2010 - The description for Revenue code 0361 was changed 8/1/2010 - The description for Revenue code 0362 was changed 8/1/2010 - The description for Revenue code 0367 was changed 8/1/2010 - The description for Revenue code 0369 was changed 8/1/2010 - The description for Revenue code 0490 was changed 8/1/2010 - The description for Revenue code 0499 was changed 8/1/2010 - The description for Revenue code 0510 was changed 8/1/2010 - The description for Revenue code 0511 was changed 8/1/2010 - The description for Revenue code 0512 was changed 8/1/2010 - The description for Revenue code 0513 was changed 8/1/2010 - The description for Revenue code 0514 was changed 8/1/2010 - The description for Revenue code 0515 was changed 8/1/2010 - The description for Revenue code 0516 was changed 8/1/2010 - The description for Revenue code 0517 was changed 8/1/2010 - The description for Revenue code 0519 was changed 8/1/2010 - The description for Revenue code 0761 was changed 8/1/2010 - The description for Revenue code 0920 was changed 8/1/2010 - The description for Revenue code 0921 was changed 8/1/2010 - The description for Revenue code 0929 was changed

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

36475 descriptor was changed in Group 1

36476 descriptor was changed in Group 1 36478 descriptor was changed in Group 1 37765 descriptor was changed in Group 1

Reason for Change Other