Treatment of Varicose Veins of the Lower Extremities

Language quoted from 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 a 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, §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.

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

CMS Manual System, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.1 indicates services will be considered medically reasonable and necessary only if ordered and furnished by appropriately trained personnel.

This training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty or must reflect extensive continued medical education activities. If these skills have been acquired by way of continued medical education, the courses must be comprehensive, offered or sponsored or endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States, and designated by the American Medical Association (AMA) as Category 1 Credit.

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. Treatment of telangiectasias is not covered by Medicare.

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).

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. Foam sclerotherapy is FDA indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. It is usually given with ultrasound guidance. Non-Compressive sclerotherapy is not covered by Medicare.

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 one ultrasound or duplex scan prior to the procedure to determine the extent and configuration of the varicosities.

Evidence and clinical experience supports the use of ultrasound guidance during the procedure (ERFA and laser ablation only) and shows 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 intraoperative ultrasound service in the valuation and ultrasound may not be billed separately with these procedures.

In contrast to ERFA and laser procedures, intra-operative ultrasound guidance techniques have not been shown to increase the effectiveness or safety of sclerotherapy for varicose veins, therefore, intra-operative ultrasound guidance will not be separately covered for sclerotherapy.

A. Indications for surgical treatment: For example venous ligation, vein stripping and/or sclerotherapy:

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

2. The patient is symptomatic and has one, or more, of the following:
     a. Pain or burning in the extremity severe enough to impair mobility
     b. Recurrent episodes of superficial phlebitis 
     c. Non-healing skin ulceration 
     d. Bleeding from a varicosity 
     e. Stasis dermatitis 
     f. Refractory dependent edema

B. 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:

1. Absence of aneurysm in the target segment.
2. Maximum vein diameter of 12 mm for ERFA or 20 mm for laser ablation
3. Absence of thrombosis or vein tortuosity, which would impair catheter advancement. –4. The absence of significant peripheral arterial diseases.

C. Limitations for ERFA and laser ablation:
1. 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.
2. Intra-operative ultrasound guidance is not separately payable with ERFA, laser ablation, and sclerotherapy.
3. 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.
4. The treatment of spider veins or superficial telangiectasis by any technique is considered cosmetic, and therefore not covered.
5. Coverage is only for devices specifically FDA-approved for these procedures.
6. One pre-operative Doppler ultrasound study or duplex scan will be covered.

Noridian notes that 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.

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

Noridian will not consider the treatment of asymptomatic veins with endoluminal ablation or sclerotherapy 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.

Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review.

N/A

N/A

1. Each claim must be submitted with an ICD-10-CM 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 Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to the CCI 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.

Refer to Bibliography

1. Other carrier policies including those from Empire, HGSA and CIGNA.

2. Manufacturer's Literature. VNUS Medical Technologies, Inc.

3. Chandler JG, Pichot O, Sessa C, et al. Treatment of primary venous insufficiency by endovenous saphenous vein obliteration. Vasc Surg 2000; 34:201-14.

4. Goldman M. Closure of the greater saphenous vein with endoluminal radiofrequency thermal heating of the vein wall in combination with ambulatory phlebectomy: preliminary 6 month follow-up. Dermatol Surg 2000; 26:452-56.

5. Kabnick LS, Merchant RF. Twelve and twenty-four months follow-up after endovascular obliteration of saphenous vein reflux - A report from the multi-center registry. J Phlebology 2001; 1:17-24.

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

7. Fassiadis N, Kianifard B, Holdstock JM, Whiteley MS. A novel approach to the treatment of recurrent varicose veins. Int Angiol, 2002 Sep; 21(3): 275-6. Abstract. PubMed.

8. Forrestal, MD, Min, RJ, et. al. Endovenous Laser Treatment (EVLT) for Varicose Veins-A review. Today's Therapeutic Trends, 299-310. Communications Media for Education, Inc., Princeton, New Jersey.

9. Winifred S. Hayes Technology Assessment - Endoluminal Radiofrequency Ablation for Varicose Veins of the Leg. Winifred S. Hayes, Inc. June 2002.

10. 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.

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

12. Rautio T, Ohinmaa A, Perala J, Ohtonen P, Heikkinen T, Wiik H, Karjalainen P, Haukipuro K, Juvonen T. Endovenous versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs. J Vasc Surg 2002 May; 35(5): 958-965.

13. Sybrandy JE, Wittens, CH. Initial experiences in endovenous treatment of saphenous vein reflux. J Vasc Surg. 2002 Dec; 36(6): 1207-12. 10. Weiss, R. MD. Varicose Veins Treated with Radiofrequency Ablation Therapy. Emedicine. Accessed April 3, 2003.

14. Noridian Contractor Advisory Committee Members.

15. Todd K., Wright, DI, VANISH-2 Investigator Group. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidoncanol endovenous microfoam 035% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence. Phlebology. Sage

16. Department of Varicose Vein Clinic, Charm Vein Center, Seoul, Republic of Korea; Initial Outcomes of Cyanoacrylate Closure, VenaSeal System, for the Treatment of the Incompetent Great and Small Saphenous Veins; Vascular Endovascular Surgery; 2017 Nov; 51(8):545-549.

17. Lake Washington Vascular Surgeons, Bellevue, WA, USA; Cyanoacrylate closure of incompetent great, small and accessory saphenous veins withought the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (The WAVES study); Vascular; 2017 Apr;25(2):149-156.

18. Bellam Premnath, KP., Joy, B.,Raghavendra, VA., Toms, A., Sleeba, T.; Cyanoacrylate adhesive embolization and sclerotherapy for primary varicose veins. Phlebology; 2017 Jan 1.

19. Prasad, Bp K., Joy,B., Toms, A., Sleeba, T.; Treatment of incompetent perforators in recurrent venous insufficiency with adhesive embolization and sclerotherapy. Phlebology; 2017 Jan 1.

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