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

Physician 1The patient is a 47-year-old woman with a long history of varicose veins. The patients provider has recommended endovenous radiofrequency ablation of the patients left leg varices. The Health Plan has denied authorization and coverage for radiofrequency ablation (RFA) on the basis that it is considered investigational.The patient has symptomatic varicose veins. Based upon the patients physical exam it appears the patient has greater saphenous vein (GSV) incompetence with normal deep venous system. This clinical situation is best treated by elimination of the GSV and varicose veins. There is a great deal of peer-reviewed literature including randomized, controlled trials that support the long and short-term efficacy of RFA as opposed to stripping for patients such as this patient. RFA 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 has symptomatic left leg varices and has used compression stockings with no relief. The results of the patients duplex exam did not specifically describe the greater saphenous vein (GSV) incompetence, but only reported a localized dilation of a portion of the GSV (described as aneurysmal dilation of the GSV by the radiologist). The duplex exam also noted that the patients vein valves were competent, as suggested by flow pattern. The patients provider has recommended that the patient undergo radiofrequency ablation (RFA) using VNUS system, as well as phlebectomies. The Health Plan has denied authorization and coverage for RFA on the basis that it is considered experimental.RFA was approved by the Food and Drug Administration in 1999 and is a well-established procedure for treatment of GSV reflux with adequate data in the medical literature. In the case of this patient, she has large varices in the left leg, which are symptomatic despite compression stocking use. The submitted records do not include documentation of GSV incompetence. Neither RFA nor high ligation/stripping are medically indicated based upon the clinical information provided. The submitted duplex study does not address the presence or absence of GSV reflux. A repeat duplex is indicated to determine if GSV incompetence is present. The submitted information does document localized varices, which can be appropriate treated with phlebectomies. However, without documented evidence of GSV, RFA is not medically indicated.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 at this time. The Health Plans denial should be upheld at this time. The patient should undergo a repeat duplex exam to determine if GSV incompetence is present. If the duplex exam demonstrates GSV incompetence, the patients request for RFA should be reconsidered.    The Health Plans denial should be upheld.Physician 3The patient is a 47-year-old woman who has had a history of varicose veins for 16 years. The patient has had increasing pain during the period prior to her surgical consultation. It is confined to her left leg. She reports that she has tried support stockings in the past. The patient presented to her vascular surgeon for treatment of increasingly painful varicose veins. She has a family history positive for varicose veins. There is no documentation in the submitted materials as to whether the patient had deep vein thrombosis (DVT) in the past. Physical exam revealed a varicose vein measuring 20mm in the mid-thigh and 12mm in the distal thigh. The submitted documentation does not demonstrate whether there are accessories present. The submitted ultrasounds reveal no evidence of a DVT in the left leg. A color flow duplex suggests that the left GSV demonstrates no evidence of intraluminal defects. There is an area of dilation approximately 18cm from the origin, which measures 1.4 x 1.6 x 0.9cm at a depth of 0.29cm. No additional aneurysmal formation or significant tortuosity is observed and both size and distance in depth are given of the vein in preparation for possible radiofrequency ablation (RFA). There is no evidence of valvular incompetence in the deep system. The Health Plan has denied authorization and coverage for RFA on the basis that it is considered experimental.RFA is now in common usage with venous and surgical practices in the United States and Western Europe with significant patient acceptance. The uptake among physicians has been increasing dramatically. The data suggests that RFA is likely to be, for the appropriate patient who has both saphenofemoral junction incompetence and a vein of adequate size and depth, more beneficial in the short-term for treatment of the condition than standard therapy. This short-term benefit extends up to two years. RFA appears to be equivalent to greater saphenous vein ligation and stripping at two years. There is no further long-term data available. RFA remains on the cusp of investigational therapy since long-term efficacy remains poorly defined.This patient may have superficial venous insufficiency of her left leg based upon her physical exam. However, the submitted imaging studies do not demonstrate whether the patient has saphenofemoral junction incompetence or whether the problem has resulted from a perforator further down in the thigh. There is limited data on the role of RFA for Hunter, Dotter or Linton perforator incompetence and the patients ultrasound does not demonstrate whether perforator incompetence is at issue in this case. A repeat duplex exam is indicated in this case in order to determine if the patient has saphenofemoral junction incompetence that would respond to treatment with RFA.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 at this time. Therefore, the Health Plans denial should be upheld at this time. The patient should undergo a repeat duplex exam. If the duplex exam demonstrates saphenofemoral junction incompetence, the patients request for RFA should be reconsidered.