Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1The patient is a 38-year-old woman with bilateral symptomatic venous disease due to greater saphenous vein incompetency. The patient has requested authorization for radiofrequency ablation, which has been denied by the Health Plan on the basis that it is considered investigational in nature.There is now sufficient peer-reviewed, randomized, controlled clinical trials with medium and long-term follow-up to support the use of radiofrequency ablation closure in the treatment of greater saphenous vein incompetence of symptomatic varicose veins. It is as effective as standard surgical therapy and is associated with significantly less rehabilitation and long-term morbidity. 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.Physician 2The patient is a 38-year-old female with bilateral symptomatic varicose veins who has attempted conservative therapy without success. The patient indicates her condition has increased in severity over the last two years and it appears that her function as a traveler for her company with frequent air trips makes her condition worse. An ultrasound demonstrated extensive insufficiency of the greater saphenous veins (GSVs) in the right leg from the patients groin to her ankle and some minor insufficiency in the right lesser saphenous vein. On the left, the ultrasound demonstrated similar findings; however, the GSV in the mid-thigh to knee level appeared to be normal and the lesser saphenous vein was incompetent related to branches from the GSV only. No deep venous disease was noted. A request has been made for authorization and coverage for radiofrequency ablation. The request has been denied by the Health Plan.Recently, there has been a growing interest in venous closure 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. However, radiofrequency ablation is technically more challenging to perform successfully. 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 unrandomized trial and at least two reasonably sized cohort studies, which support the basis of the previously mentioned randomized trials. These results are now widely available and have been considered by the medical community. As such, the standard of care for symptomatic venous disease is changing and at the present time the data would suggest that the procedures are equivalent in the short-term and that they can both be applied to symptomatic varicose veins.The patient has saphenofemoral junction incompetence and GSV disease and requires therapy. Radiofrequency ablation has been shown to be more beneficial in the initial post-procedure period, but has equivalent efficacy for treatment of GSV disease in the short-term. Furthermore, radiofrequency ablation has not been shown to be more beneficial than standard therapy in long-term follow up.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. Therefore, the Health Plans denial should be upheld.Physician 3The patient is a 38-year-old female with symptomatic bilateral varicose veins despite stocking use. The patient has bilateral greater saphenous vein (GSV) incompetence documented by duplex. The patients provider has recommended radiofrequency ablation as an alternative to high ligation/stripping. The Health Plan has denied authorization and coverage for the requested procedure on the basis that it is considered investigational.The patient has well-documented symptomatic varicose veins and GSV incompetence thereby requiring treatment.  Since the year 2000, minimally invasive radiofrequency ablation has been widely used with well-documented safety and efficacy and with less morbidity and recovery time. The mid-term data suggest good results after six months and the 2-year data is also positive. The shorter recovery time associated with radiofrequency ablation makes it a more beneficial and medically reasonable alternative to standard treatment such as high ligation/stripping. Based upon the information set forth above, 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. Therefore, the Health Plans denial should be overturned.