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

Physician 1The patient is a 44-year-old male being evaluated for severe bilateral chronic venous insufficiency manifested by leg pain. The patient states that his activities of daily living are impacted. He complains of pain in both the thigh and calf areas. The patient has bilateral venous stasis leg ulcers with hemosiderin deposition of both medial ankles. He underwent left leg stripping and ligation of his greater saphenous vein (GSV) in 1994 with painful recurrence since 1997. He then underwent injection sclerotherapy and repeat local venous stripping. An ultrasound showed reflux on his right leg saphenofemoral junction and a large bulb of about 15.3mm. Left saphenofemoral junction also has large bilateral venous varicosities with reflux in the medial thighs and calves. The patients provider has recommended endovenous occlusion of the patients right GSV and saphenofemoral junction followed by sclerotherapy. There is no note in the submitted records regarding treatment for the patients ulcers. The Health Plan has denied authorization for endovenous laser ablation on the basis that it is considered experimental. The patient meets the criteria for venous surgery. He has documented symptomatic varicose veins on ultrasound with leg ulceration. He has failed conservative therapy. The patients provider has recommended endovenous laser ablation and sclerotherapy. It does not appear ulcer treatment has been offered.The treatment for varicose veins due to GSV incompetence and varicosities is changing. The classical and standard treatment regimen for patients who have failed conservative therapy is high ligation and GSV stripping with stab avulsions, which provides probable maximum symptomatic relief of up to 10 years. Recently, there has been a growing interest in radiofrequency ablation of the GSV in combination with stab avulsions. There is significant and growing literature that strongly suggests that radiofrequency ablation of the GSV is equivalent to high ligation and GSV stripping. It produces the same clinical efficacy, has a shorter recovery time, and appears to have greater patient acceptance. There are two level 1 trials available in the literature at the present time, which prospectively examine a randomized sample of patients between endovascular radiofrequency ablation and conventional stripping for primary varicose veins. Both trials appear appropriately powered and both show that there are early advantages of up to two years with radiofrequency ablation compared to standard stripping. Furthermore, there is a large patient acceptance of radiofrequency ablation because of the shorter recovery time. There is also one large randomized trial and at least two reasonably sized cohort studies, which support the basis of the previously mentioned randomized trials. While support for radiofrequency ablation is growing, there is limited data on endovenous laser ablation and no randomized clinical trials to compare it to standard therapy or to radiofrequency ablation. 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; however, there are no significant long-term follow-up studies, which prove that endovenous laser ablation is more effective than other available treatment. The recurrence rate in the case-controlled literature is approximately seven to ten percent at two years out with many of the recurrences occurring before nine months. Thus, there is insufficient evidence the requested therapy is likely to be of greater benefit than any other standard treatment.Based upon the information set forth above, I have determined that the requested procedure 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 2The patient is a 44-year-old man with severe venous insufficiency and ulcer due to greater saphenous vein (GSV) incompetence. He has requested authorization for endovenous laser ablation. The Health Plan has denied the patients request on the basis that the requested procedure is considered investigational.Although the submitted documentation indicates the patient requires intervention, there is insufficient evidence the requested procedure is likely to result in a better clinical outcome than other available treatment. Review of the scientific evidence does not demonstrate endovenous laser ablation has been documented to have long-term success compared to surgical stripping or radiofrequency ablation. It appears the patient is an appropriate candidate for radiofrequency ablation, which can now be used in veins larger than 12mm with adequate use of compression. Thus, there are other treatment options available to this patient that demonstrate better efficacy than endovenous laser ablation.Based upon the information set forth above, I have determined that the requested procedure 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 3The patient is a 44-year-old male with severe symptomatic bilateral varicose veins, who underwent stripping with recurrence. The patient has documented reflux on duplex scan. The patients provider notes the patients greater saphenous vein (GSV) is 12mm. Endovenous laser ablation has been recommended by the patients provider. The Health Plan has denied authorization for endovenous laser ablation on the basis that it is considered investigational.The patient has very severe symptomatic varices, which require intervention. Although high ligation and stripping with phlebotomies is an option, it carries a high recurrence rate (as the patients history demonstrates). Furthermore, high ligation and stripping is a more invasive procedure than minimally invasive alternatives of radiofrequency ablation and endovenous laser ablation. These procedures have been approved by the Food and Drug Administration and are the new standard for treatment of patients such as this patient. Given that the vein site is greater than 12mm, endovenous laser ablation is the most appropriate minimally invasive option for this patient. Therefore, I have determined that the requested procedure 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.