Varicose Veins of the Lower Extremity, Treatment of

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) 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.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Abstract:

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 (telangiectases) are dilated capillary veins that are most often treated for cosmetic purposes. Treatment of telangiectases CPT code 36468) is not covered by Medicare.

Ligation and stripping of varicose veins is a treatment option that aims to eliminate reflux at the saphenofemoral junction. The treatment of choice for moderate to large symptomatic varicose veins, ligation and stripping of the saphenous vein, has the lowest failure rate.

Sclerotherapy, injecting sclerosing solutions directly into the abnormal veins, is an alternative occasionally selected for the treatment of varicose veins without significant saphenofemoral or saphenopopliteal incompetence. However, it is not considered to be as reliable and effective as surgical ligation and stripping.

Sclerotherapy for cosmetic purposes is considered not medically necessary. Sclerotherapy is considered medically necessary for the treatment of small to medium sized vessels (less than or equal to 4 mm in diameter.) Sclerotherapy is not considered medically necessary for vessels larger than 4 mm in diameter.

Foam sclerotherapy of the saphenous vein at its junction with the deep venous system has been proposed as an alternative to ligation or saphenectomy, but its efficacy lacks significant scientific evidence to support its widespread use. The current consensus is that most recommendations for conventional sclerotherapy also apply to foam sclerotherapy.

Sclerotherapy of the saphenous vein at its junction with the deep system is not a covered procedure.

Non-compressive sclerotherapy involves injection of a sclerosant into a vein without the application of a compressive dressing. Because it is not effective in producing long-term obliteration of the incompetent veins, noncompressive sclerotherapy is not covered by Medicare.

Compressive sclerotherapy is the injection of the sclerosant into an empty vein (elevated limb) followed by application of a compressive bandage or dressing. This is the most commonly performed sclerotherapy procedure for varicose veins of the lower extremity. Compressive sclerotherapy is indicated for local small to medium symptomatic varices, isolated incompetent perforators, or recurrence of symptomatic varices after adequate surgical removal of varices. It is not considered an appropriate option for large, extensive or truncal varicosities.

High ligation and compression sclerotherapy refers to ligation of a truncal junction (saphenofemoral or saphenopopliteal) followed by compressive sclerotherapy of one or more veins.

Endovenous radiofrequency ablation (EFRA) and laser ablation are minimally invasive alternatives to vein ligation and stripping. Endovenous radiofrequency ablation is FDA-approved for treatment of the greater saphenous vein, perforators and tributary veins. Endovenous laser ablation is FDA-approved for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.

Indications:

Medicare will consider interventional treatment of varicose veins (sclerotherapy, ligation with or without stripping, and endovenous radiofrequency or laser ablation) medically necessary if the patient remains symptomatic after a six-week trial of conservative therapy. The components of the conservative therapy include, but are not limited to:

• weight reduction,
• a daily exercise plan,
• periodic leg elevation, and
• the use of graduated compression stockings.

The conservative therapy must be documented in the medical record.

The patient is considered symptomatic if any of the following signs and symptoms of significantly diseased vessels of the lower extremities are documented in the medical record:

• stasis ulcer of the lower leg, as above,
• significant pain and significant edema that interferes with activities of daily living,
• bleeding associated with the diseased vessels of the lower extremities,
• recurrent episodes of superficial phlebitis,
• stasis dermatitis, or
• refractory dependent edema.

Additional indications and limitations are discussed according to type of treatment.

In addition to the requirement for failure of a six-week trial of conservative treatment and the symptoms described above, coverage of endovenous ablation therapy is limited to patients with:

• a maximum vein diameter of 20 mm for laser ablation;
• absence of thrombosis or vein tortuosity, which would impair catheter advancement; and
• absence of significant peripheral artery disease.

Radiofrequency/laser ablation is covered only for treatment of the lesser or greater saphenous veins to improve symptoms attributable to saphenofemoral or saphenopopliteal reflux. Coverage is only for FDA devices specifically approved for these procedures.

Non-cosmetic sclerotherapy will also be covered if performed in conjunction with surgical ligation or stripping procedures in appropriately selected patients.

Limitations:

Duplex ultrasound is often used in conjunction with other non-invasive physiologic testing to define the anatomy and physiology of the varicose vein network prior to injection or surgical intervention. There is adequate evidence that the pre-procedural ultrasound is helpful, and Medicare will cover a pre procedure Duplex scan CPT code 93970 or 93971) used in conjunction with other non-invasive physiologic testing CPT code to determine the extent and configuration of the varicosities. CGS expects that these studies will be performed by the provider planning to provide the therapy. CGS will allow this study once per provider or provider group. Clinical experience supports the use of ultrasound during the sclerotherapy procedure, and evidence shows that the outcomes may be improved and complication rates may be minimized when ultrasound guidance is used.

Medicare will cover intraoperative ultrasonic guidance in situations when it is medically necessary.

Medicare includes payment for the ultrasound in the payment for the ERFA and laser ablation procedures.

Cosmetic surgery is statutorily excluded from coverage by Medicare. The following interventional treatments are considered to be cosmetic and will be denied as such:

• Interventional treatment of asymptomatic varicosities.
• Treatment of telangiectases (36468).
• Sclerotherapy for cosmetic purposes.

Medicare cannot cover services which are not reasonable and necessary for the treatment of illness or injury or to improve the functioning of a malformed body member. The following interventional treatments are not considered medically reasonable or necessary and are denied as such:

• Interventional treatment of symptomatic varicosities without documentation of a failed six week trial of conservative therapy.
• Sclerotherapy for vessels larger than 4 mm in diameter.
• Reinjection following recanalization or failure of vein closure without recurrent signs or symptoms.
• Sclerotherapy of the saphenous vein at its junction with the deep system.
• Noncompressive sclerotherapy.
• Compressive sclerotherapy for large, extensive or truncal varicosities.
• Sclerotherapy, ligation and/or stripping of varicose veins, or endovenous ablation therapy are not covered for pregnant women, or patients with the inability to tolerate compressive bandages or stockings; severe distal arterial occlusive disease; obliteration of deep venous system; an allergy to the sclerosant; or a hypercoaguable state.
• Any interventional treatment that uses equipment or sclerosants not approved for such purposes by the FDA.
• Laser ablation of veins with a diameter greater than 20 mm.
• Endovenous ablation therapy in the presence of thrombosis or venous tortuosity which would impair catheter advancement.

CPT codes 37760 and 37761 should not be reported in conjunction with CPT codes 76937, 76942, 76998 or 93971.

Other Comments:

For claims submitted to the Part A MAC: this coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS Administrators to process their claims.

Bill type codes only apply to providers who bill these services to the Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.

For dates of service prior to April 1, 2010, FQHC services should be reported with bill type 73X. For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services.

Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.

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The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (Please see "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

The patient's medical record must document the following:


•history and physical findings supporting a diagnosis of symptomatic varicose veins;

•failure of an adequate trial of conservative treatment as described in the "Indications" section of this LCD;

•exclusion of other causes of edema, ulceration and pain in the limbs;

•performance of appropriate tests to confirm the presence and location of incompetent perforating veins;

•location and number of varicosities, level of incompetence of the vein and the veins involved; and

•necessity of utilizing ultrasound guidance, if used.
The medical record must also include pre-treatment photographs of the varicose veins for which claims for sclerotherapy are submitted to Medicare. These photographs must be made available to the carrier upon request for review.

Not applicable

Coverage for podiatrists is limited by scope of practice specific to the state in which the service is provided.

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 sclerotherapy sessions for each leg.

•Only one sclerotherapy service per treatment session should be reported for either leg, regardless of how many veins are treated per session.
Patients are not expected to require ablation of the saphenous vein by radiofrequency or laser more than once for either leg.

A duplex ultrasound examination will be allowed when performed within 1 week (preferably within 72 hours) of EFRA to check for any evidence of thrombus extension from the saphenofemoral junction into the deep system.

This bibliography presents those sources that were obtained during the development of this policy. CGS Administrators is not responsible for the continuing viability of Web site addresses listed below.

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

Feied C. Varicose veins and spider veins. http://www.emedicine.com/derm/topic475.htm. Accessed on March 26, 2006.

Merchant RF, Pichot O, Myers K. Four-year follow-up on endovascular radiofrequency obliteration of great saphenous reflux. Dermatology Surgery. 2005;31:129-134.

Parsons M. Sclerotherapy basics. Dermatology Clinics. 22(4). W.B. Saunders Company.

Pletnicks J. Sclerotherapy. The Doctor’s Medical Library. http://www.medical-library.net/specialties/_sclerotherapy.html. Accessed on May 3, 2005.

Sadick N. Advances in the treatment of varicose veins: ambulatory phlebectomy, foam sclerotherapy, endovascular laser and radiofrequency closure. Dermatologic Clinics. 23(3). W.B. Saunders Company.

Schultz C. Laser Treatment of Vascular Lesions. Dermatology Clinics. 23(4). W.B. Saunders Company.

Teruya T, Ballard J. New approaches for the treatment of varicose veins. Surgical Clinics of North America. 85(5). W.B. Saunders Company.

Thibault P. Sclerotherapy and ultrasound-guided sclerotherapy: The Vein Book. London U. Elsevier Academic Press; 2007:189-199.

The American Academy of Cosmetic Surgery (2003). 2003 Guidelines for sclerotherapy. http://www.cosmeticsurgery.org. Accessed on March 21, 2006.

Trelles M. The 800-nm diode laser in the treatment of leg veins: Assessment at 6 months. Journal of American Academy of Dermatology. 54(2).

Other Medicare contractor policies consulted in development of the draft:

First Coast Service Options Local Coverage Determination (LCD) [L23082]

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Sources added based on a reconsideration request:

Manfrini S, Vincenzo G, Danielsson G, et al. Endovenous management of saphenous vein reflux. Endovenous Reflux Management Study Group. J Vasc Surg. 2000;32:330-42.

Van Rij AM, Jiang P, Solomon O, Ross CA, Hill G. Recurrence after varicose vein surgery: A prospective long-term clinical study with duplex ultrasound scanning and air plethysmography. Department of Surgery, Dunadin School of Medicine, University of Otago, New Zealand. J Vasc Surg. 2003;38:935-43.

Van Rij AM, Andre M, Jones GT, Hill G and Jiang P. Neovascularization and recurrent varicose veins: more histologic and ultrasound evidence. Department of Surgery, Dunadin School of Medicine, University of Otago, New Zealand. J Vasc Surg. 2004;40:298-302.

Varicose Veins, Essentials of Diagnosis. McGraw-Hill's Access Medicine. Chapter 36, Veins & Lyphatics, The Veins, Disease of the Venous Sytem. http://www.acessmedicine.com. Accessed on April 8, 2009.

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