Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 68-year-old woman with chronic venous insufficiency and recent ulceration of the left calf. Duplex scan reveals reflux in the left greater saphenous vein and incompetent perforator in the left calf. She has failed conservative therapy secondary to arthritis and an inability to place compression stockings. The patient has chronic venous insufficiency and venous stasis ulceration in the left calf and duplex confirmed reflux in the saphenous vein and an incompetent perforator vein. Standard indicated treatment for this patient would include radiofrequency ablation (VNUS closure) of the left greater saphenous vein, stab phlebectomies of accessory varicose veins, ligation of incompetent perforator vein and continued local wound care of the venous ulcer. There is no indication for endovenous laser therapy (EVLT) as short-term and long-term benefits are unknown. Therefore, 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. Physician 2: This is a 68-year-old female who was exposed to radiation as a child and has a history of chronic venous insufficiency as well as multiple surgeries for skin cancer of the leg. She last had surgery in 2003, which resulted in failure of primary intent closure and pseudomonas infection and has been attending a wound care center for treatment of the leg. The wound appears under control. Her biopsies are negative. She has a history of varicose veins with the use of support stockings although the notes in the chart suggest that she has not been completely compliant with this therapy. It appears that she was ambulatory prior to her surgery and that since her surgery she has had pain and problems with ambulation. Physician exams suggest that she has greater saphenous vein incompetence, hemosiderin deposition and an ulcer, all suggesting at least stage IV to stage V chronic venous incompetence as well as perforator incompetence. The patients provider proposed endovenous laser therapy for her varicose veins in an attempt to ameliorate her problem. Her arterial exam shows that she has no obvious pulse deficit although no objective evidence such as an ABI has been performed. The issue in this case is whether the requested endovenous laser ablation therapy may in fact be more beneficial for treatment of the patients medical condition than available standard therapy. The Health Plan does allow for endoluminal radiofrequency ablation of the veins for symptomatic varicose veins defined as recurrent thrombophlebitis, severe persistent pain and swelling with a limitation of activities and intractable ulceration secondary to venous stasis disease. The patient has a multi-factorial ulcer with venous stasis contributing to its poor healing but the other factors are radiation therapy, scar tissue secondary to multiple biopsies and pseudomonas infection. She has had pain and swelling prior to this biopsy with a trial of support stockings, which are separate from the present pain that she has, which is related to the nature of her wound infection.The patient has varicose veins. She has had a trial of conservative therapy but her present condition is complicated by surgery on a radiated area, surgery in a previously biopsied area and a pseudomonas infection. She has documentation of saphenofemoral junction incompetence and also evidence of perforator incompetence, physical evidence of at least stage IV to stage V chronic venous insufficiency. The Health Plan has performed an adequate and substantial review for endovenous laser therapy and this review with the supporting literature documentation confirms the fact that endovenous laser therapy is not proven in randomized controlled trials.There is limited data on endovenous laser therapy and no randomized clinical trials to compare it to standard therapy or to radiofrequency ablation. The laser fiber is less expensive than the radiofrequency catheter, the pull back treatment time is shorter, and the saphenous obliteration and lack of reflux results appear to be similar in non-randomized trials. Post treatment pain and ecchymosis is considered to be greater but there are no significant long-term follow-up studies, which prove that endovenous laser therapy is more effective than anything else that is presently on the market. The recurrence rate is approximately 7 to 10% at two years in the case control literature published with many of the recurrences occurring before nine months. Therefore, 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. Physician 3: This is a 68-year-old female who was exposed to radiation as a child and has a long history of venous insufficiency and multiple surgeries for skin cancer. Her last surgery was in 2003 and she has had ulceration and is currently under treatment at a wound care center. She is requesting coverage for endovenous laser therapy. The Health Plan has denied this request indicating the requested therapy is considered investigational. The patient has severe GSV reflux with active ulceration due to GSV reflux. She does require elimination of the GSV reflux. However, EVLT does not have proven long-term benefits. Studies of greater than 2 years follow-up are few, but suggest a higher rate of recanalization. However, RFA would provide a long-term benefit (proven 96% effective at 5 years) without invasive surgery, which would be contraindicated with severe ulcer. Therefore, 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.