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is then slowly withdrawn while controlled radiofrequency or laser energy is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.