LCD/NCD Portal

L28999

 

TREATMENT OF VARICOSE VEINS OF THE LOWER EXTREMITY

 

 

03/27/2012

 

 

Indications and Limitations of Coverage and/or Medical Necessity

• 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."

o 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:

o Physician is properly enrolled in Medicare.

o 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.

o Consequently, the technologist and the physician must maintain proof of training and experience.

 All non-invasive vascular diagnostic studies must be:

• Performed by a qualified physician.

• Performed under the general supervision of a qualified physician or technologist who has demonstrated minimum entry level competency by being credentialed in vascular technology.

• Performed in a laboratory accredited in vascular technology.

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

o Registered Vascular Technologist (RVT) credential.

o Registered Vascular Specialist (RVS) credential.

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

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

o The Cardiovascular Credentialing International (CCI) which provides RVS credential.

• Appropriate, nationally recognized laboratory accreditation bodies include:

o Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL).

o 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.

o 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:

o 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.

o 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.

• 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:

o 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.

o 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.

o 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.

o Foam sclerotherapy, or chemical ablation, is supported as an effective treatment for saphenofemoral and saphenopopliteal valvular incompetence.

o 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.

o 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.

o 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 is 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.

o EVLT is FDA approved for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.

o 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.

• Ulceration.

o 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.

o 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.

o 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.

o Medicare will not consider the treatment of asymptomatic veins with endovenous radiofrequency or laser ablation reasonable and medically necessary.

o If it is determined on review that the varicose veins were asymptomatic, the claim will be denied as a non-covered (cosmetic) procedure.

o 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.

 

12x Hospital Inpatient (Medicare Part B only)

13x Hospital Outpatient

83x Ambulatory Surgery Center

85x 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.

 

0360 Operating Room Services - General Classification

0361 Operating Room Services - Minor Surgery

0362 Operating Room Services - Organ Transplant - Other than Kidney

0367 Operating Room Services - Kidney Transplant

0369 Operating Room Services - Other OR Services

0490 Ambulatory Surgical Care - General Classification

0499 Ambulatory Surgical Care - Other Ambulatory Surgical

0510 Clinic - General Classification

0511 Clinic - Chronic Pain Center

0512 Clinic - Dental Clinic

0513 Clinic - Psychiatric Clinic

0514 Clinic - OB-GYN Clinic

0515 Clinic - Pediatric Clinic

0516 Clinic - Urgent Care Clinic

0517 Clinic - Family Practice Clinic

0519 Clinic - Other Clinic

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

36476 ENDOVENOUS ABLATION THERAPY OF INCOMPETENT VEIN, EXTREMITY, INCLUSIVE OF ALL IMAGING 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

36479 ENDOVENOUS ABLATION THERAPY OF INCOMPETENT VEIN, EXTREMITY, INCLUSIVE OF ALL IMAGING 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

37735 LIGATION AND DIVISION AND COMPLETE STRIPPING OF LONG OR SHORT SAPHENOUS VEINS WITH 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

93965 NONINVASIVE PHYSIOLOGIC STUDIES OF EXTREMITY VEINS, COMPLETE BILATERAL STUDY (EG, 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

454.0 VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER

454.1 VARICOSE VEINS OF LOWER EXTREMITIES WITH INFLAMMATION

454.2 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

Diagnoses that Support Medical Necessity

See ICD-9 Codes that support medical necessity

 

 

ICD-9 Codes that DO NOT Support Medical Necessity

 

448.0 HEREDITARY HEMORRHAGIC TELANGIECTASIA

448.1 NEVUS NON-NEOPLASTIC

448.9 OTHER AND UNSPECIFIED CAPILLARY DISEASES

459.10 POSTPHLEBETIC SYNDROME WITHOUT COMPLICATIONS

459.11 POSTPHLEBETIC SYNDROME WITH ULCER

459.12 POSTPHLEBETIC SYNDROME WITH INFLAMMATION

459.13 POSTPHLEBETIC SYNDROME WITH ULCER AND INFLAMMATION

459.19 POSTPHLEBETIC SYNDROME WITH OTHER COMPLICATION

Diagnoses that DO NOT Support Medical Necessity

See ICD-9 codes that DO NOT support medical necessity

 

 

Documentation Requirements

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

o History and Physical with findings that support the diagnosis billed and the associated symptoms of the varicose veins.

o Failure of an adequate trial of conservative therapy as described in the indications and limitations section of the LCD.

o Exclusion of other causes of leg pain, ulceration and edema.

o Performance of appropriate tests used to confirm the presence and location of incompetent perforated veins and pre-treatment photos of the varicose veins.

o All other requirements of medical necessity outlined in the indications and limitations section of this LCD.

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:

o More than three (3) injections per vessel treated.

o More than five (5) sclerotherapy sessions for each leg.

o More than 20 injections per leg.

 

 

Treatment Logic

• 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.

o 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 performed for signs and symptoms of diseased vessels and can be used as an adjunct to surgical or ablative therapy (radiofrequency or laser).

o Sclerotherapy for cosmetic purposes is not considered medically reasonable and necessary.

o 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.

o 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.

 

 

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).

 

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).

 

FCSO LCD 29298, Treatment of varicose veins of the lower extremity, 03/27/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

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.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

 

CMS LCD TREATMENT OF VARICOSE VEINS OF THE LOWER EXTREMITY