LCD L34536

Coverage Guidance

Title XVIII of the Social Security Act §1862(a)(1)(a). This section excludes coverage and payment for items and services that are not considered reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the function of a malformed body member.

Title XVIII of the Social Security Act §1862(a)(10). Cosmetic surgery is excluded from coverage.

Title XVIII of the Social Security Act §1862(a)(7). This section excludes routine physical examinations and services.

Title XVIII of the Social Security Act §1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Change Request 10901, Local Coverage Determinations (LCDs)

CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 - Reasonable and Necessary Provisions in an LCD.

Indications and Limitations of Coverage

Historically, varicose veins have been treated by conservative measures such as exercise, periodic leg elevation, weight loss, compressive therapy, and avoidance of prolonged immobility. When conservative measures are unsuccessful, and symptoms persist, the next step has been sclerotherapy or surgical ligation with or without stripping. Sclerotherapy involves the injection of a sclerosing solution into the varicose vein(s).

More recently, endoluminal radiofrequency ablation (ERFA) and endoluminal laser ablation have been developed as alternatives to sclerotherapy and surgical intervention. These procedures are designed to damage the intimal wall of the vein resulting in fibrosis and subsequent ablation of the lumen of a segment of the vessel. Both procedures utilize specially designed catheters inserted through a small incision in the distal thigh and advanced, often under ultrasound guidance, nearly to the saphenofemoral junction. The catheter is then slowly withdrawn while controlled radiofrequency or laser energy is applied. This is followed by external compression of the treated segment.

Doppler ultrasound or duplex studies are often used to map the anatomy of the venous system prior to the procedure. There is adequate evidence that pre-procedural ultrasound is helpful, and Medicare will cover 1 ultrasound or duplex scan prior to the procedure to determine the extent and configuration of the varicosities when it is medically necessary.

Evidence and clinical experience support the use of ultrasound guidance during the procedure and show that the outcomes may be improved and complication rates may be minimized when ultrasound guidance is used. The CPT codes for radiofrequency and laser include the intra-operative ultrasound service in the evaluation, and ultrasound may not be billed separately with these procedures.

A duplex ultrasound examination is considered medically necessary and 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.

• Indications for surgical treatment and sclerotherapy:

• A 3-month trial of conservative therapy such as exercise, periodic leg elevation, weight loss, graduated compressive therapy, and avoidance of prolonged immobility where appropriate, has failed, AND

• The patient is symptomatic and has 1, or more, of the following:

• Pain, aching, cramping, burning, itching and/or swelling during activity or after prolonged standing severe enough to impair mobility

• Recurrent episodes of superficial phlebitis

• Non-healing skin ulceration

• Bleeding from a varicosity

• Stasis dermatitis

• Refractory dependent edema

• The treatment of spider veins/telangiectasis will be considered medically necessary only if there is associated hemorrhage.

• Indications for ERFA or laser ablation:

In addition to the above (see A), the patient's anatomy and clinical condition are amenable to the proposed treatment including ALL of the following:

• Absence of aneurysm in the target segment.

• Maximum vein diameter of 20 mm for ERFA or 30 mm for laser ablation.

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

• The absence of significant peripheral arterial diseases.

• Limitations for ERFA and laser ablation:

• ERFA and laser ablation are covered only for the treatment of symptomatic varicosities of the lesser or greater saphenous veins and their tributaries which have failed 3 months of conservative therapy.

• Intra-operative ultrasound guidance is not separately payable with ERFA, laser ablation.

• The treatment of asymptomatic varicose veins, or symptomatic varicose veins without a 3-month trial of conservative measures, by any technique, will be considered cosmetic and therefore not covered.

• The treatment of spider veins or superficial telangiectasis by any technique is also considered cosmetic, and therefore not covered unless there is associated bleeding.

• Coverage is only for devices specifically FDA-approved for these procedures.

• One pre-operative Doppler ultrasound study or duplex scan will be covered.

• Post –procedure Doppler ultrasound studies will be allowed if medically necessary.

The stab phlebectomy of the same vein performed on the same day as endovenous radiofrequency or laser ablation may be covered if the criteria for reasonable and necessary as described in this LCD are met.

If sclerotherapy is used with endovenous ablation, it may be covered if the criteria for reasonable and necessary as described in this LCD are met.

The treatment of asymptomatic veins with endoluminal ablation or sclerotherapy is not considered medically reasonable and necessary. If it is determined on review that the varicose veins were asymptomatic, the claim will be denied as a noncovered (cosmetic) procedure.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Documentation Requirements

1. Each claim must be submitted with a diagnosis code(s) that reflects the condition of the patient and indicates the reason(s) for which the service was performed.

2. The patient's medical record must contain a history and physical examination supporting the diagnosis of symptomatic varicose veins, and the failure of an adequate (at least 3 months) trial of conservative management.

3. The medical record must document the performance of appropriate tests, if medically necessary, to confirm the pathology of the vascular anatomy.

4. This documentation must be made available to Medicare upon request.

5. The HCPCS/CPT code(s) may be subject to National Correct Coding Initiative (NCCI) edits. This policy does not take precedence over NCCI edits. Please refer to the NCCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.

6. When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862(a)(1) of the Social Security Act.

7. When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the request.

Bibliography

Chandler JG, Pichot O, Sessa C, et al. Defining the role of extended saphenofemoral junction ligation: a prospective comparative study. Vasc Surg. 2000;32:941-953.

Lurie F, Creton D, Eklof B, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population. J Vasc Surg. 2003;38:207-14.

Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of saphenous reflux: a multicenter study. J Vasc Surg. 2002;35(6):1190-6.

Min RJ, Khilnani N, Zimmet SE. Endovenous laser treatment of saphenous vein reflux. Long term results. J Vasc Interv Radiol. 2003;14:991-96.

Raju S, Neglen P. Chronic venous insufficiency and varicose veins. N Engl Med. 2009;360:2319-27.

Rautio T, Ohinmaa A, Perala J, et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs. J Vasc Surg. 2002;35(5):958-965.

Sybrandy JE, Wittens CH. Initial experiences in endovenous treatment of saphenous vein reflux. J Vasc Surg. 2002;36(6):1207-1210.

Raju S, Neglén P. Clinical practice. Chronic venous insufficiency and varicose veins. N Engl J Med. 2009;360(22):2319-2327. doi:10.1056/NEJMcp0802444