Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1:  The patient is a 62-year-old male with post-phlebitic syndrome and a history of deep vein thromboses (DVT). He has associated lymphedema and varicose veins secondary to his DVT.  The patient has bilateral deep venous incompetence with residual thrombus in his right leg. His provider has requested authorization for endovenous laser ablation and six sessions of ultrasound guided sclerotherapy for both legs.  The Health Plan denied the request citing the experimental/investigational nature of the therapy.The patient has symptomatic post-thrombotic syndrome. Interventions on the right greater saphenous vein and multiple varicosities could potentially worsen his condition. Intervention on his left leg may assist his condition. The patient is at high risk for recurrent DVT on the right, irrespective of the modality used. Conservative management and weight reduction may offer the safest alternatives. Venous therapy to the right leg is associated with a significant risk of worsening venous hypertension. Venous therapy to the left leg may partially assist the patient.  It appears the Plan covers both greater saphenous vein stripping and radiofrequency ablation. The literature to date would support radiofrequency ablation; there is limited data on endovenous laser therapy.In summary, endovenous laser therapy for this patient is experimental and investigational and is not likely to be more beneficial for treatment of his medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2:  The patient is a 62-year-old male with extensive bilateral venous disease of the lower extremities including phlebitis and deep vein thromboses along with reflux of the saphenofemoral and popliteal vessels. His provider reports the patient has used compression hose for over three months and his ability to perform activities of daily living is decreased.  The patient has requested authorization for endovenous laser ablation and sclerotherapy for treatment of his varicosities.  The Health Plan denied the request based on a determination that the therapy is experimental/investigational for the treatment of the patients condition.There have been significant advances in the technology of endovenous laser treatment (EVLT) and several recent clinical trials. The procedures general acceptance is evidenced by the FDAs approval and Medicare authorization of the procedure. While there are no direct comparison studies involving endovenous laser treatment and standard ligation and stripping procedures, the efficacy of EVLT has been clinically established. This procedure is less invasive and has a lower risk of side effects and will likely replace ligation in the next several years.  Based upon the information set forth above, I have determined that the requested therapy is 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 62-year-old male with a history of multiple deep venous thromboses of the lower extremities. He now has pain and swelling of both legs. He has tried conservative treatments including compression stockings. A venous duplex exam revealed bilateral greater saphenous vein reflux. His provider has submitted a request for authorization of bilateral greater saphenous endovenous laser ablation and sclerotherapy treatments. The health plan has classified this approach as experimental/investigational and denied authorization and coverage.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 as 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 2006 update of the Milliman Care Guidelines states that the role of EVLT `remains uncertain.` Similarly, current academic references in vascular surgery have concluded that the efficacy of EVLT is not yet proven. RFA is the standard for endovenous treatment of saphenous reflux at this time.  Based on a review of the literature, I have determined that the requested therapy is 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.