Summary Of Evidence

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Analysis of Evidence

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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 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.