Appeal type: Experimental/Investigational
Decision: Overturned

Physician #1:  The patient is a 44-year-old female who was symptomatic with varicose veins and great saphenous vein reflux bilaterally.  She had concerns regarding general anesthetic and learned from her surgeon that endovenous laser ablation (EVLT) could be performed with local anesthesia.  She elected to proceed with EVLT and has submitted a request for reimbursement.  The Health Plan considers this an investigational therapy and has denied coverage and reimbursement.Endovenous ablation is well studied and there are numerous publications including the recent article by Merchant et al. and a randomized, prospective trial conducted by Hinchliffe et al., which compared stripping to endovenous ablation for recurrent saphenous disease. The two techniques, laser and radiofrequency ablation (RFA), are more or less interchangeable and are primarily a matter of physician preference.  This patient was clearly a candidate for EVLT based on the documented symptoms and the presence of saphenous reflux on two duplex ultrasounds.  Endovenous ablation is an accepted alternative to vein ligation and stripping is not considered experimental by the vascular community.  In fact, most venous surgeons now perform endovenous ablation instead of stripping.  For the reasons outlined above, I conclude the procedure at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician #2:  The patient is a 44-year-old female with symptomatic varicose veins bilaterally, and duplex evidence of great saphenous vein (GSV) reflux bilaterally. She underwent EVLT for ablation of her left GSV, and now seeks reimbursement. The Health Plan denied her request citing the investigational nature of the therapy.The Health Plan suggests that EVLT is an experimental procedure for treatment of the patients condition and that it has not been proven to be of more benefit than standard therapy.  I do not agree with this view. EVLT has been an FDA approved modality since 2000.  EVLT, along with venous closure, are the current standards for minimally invasive treatment of symptomatic varices. Both modalities use an ablation technique with ultrasound guidance, and both have much less morbidity and faster return to work than the old standard, vein stripping. Frankly, stripping as treatment for GSV reflux with varices is used less and less, being widely replaced by venus closure and EVLT ablation.  Based upon the information set forth above, I have determined that the therapy at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician #3:  The patient is a 44-year-old woman with bilateral leg pain associated with varicose veins. There is no documentation of conservative therapy, including the use of compression stockings. A venous duplex exam showed bilateral saphenous vein reflux. The patient underwent endovenous laser ablation (EVLT) in January 2006. She now requests reimbursement and coverage for the therapy. The Health Plan considers EVLT experimental/investigational and has denied her request.Although endovenous laser therapy (EVLT) is FDA approved for symptomatic saphenous reflux, a recent study has shown it to be inferior to both endovenous radiofrequency ablation (RFA) and traditional surgical ligation and stripping. The study found that treatment failure was twice more common with EVLT than with RFA. There are no randomized studies with long-term follow-up comparing EVLT to traditional surgical ligation and stripping, as opposed to RFA, which has been shown to have efficacy similar to surgical therapy in a randomized study. The 2005 edition of a standard vascular surgery text concludes that the efficacy of EVLT is yet to be proven.  Therefore, I have determined that the therapy at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.