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

Physician 1The patient is a 48-year-old female who presents with progressively painful right calf varicosities. She has a family history of veins on her grandmothers side. She has mild lymphedema, which could be a result of cellulitis. She also had knee surgery, which may have contributed to this swelling. She has no past history of problems with her veins with no bleeds, phlebitis or thrombosis. The physicians clinical exam suggested she had bulging varicosities in the right anterolateral and medial thigh as well as the proximal right calf; all from the greater saphenous vein access. Duplex imaging suggested there was saphenofemoral junction incompetence. The patient was offered therapy, which could be surgical ligation and stripping, endovenous laser ablation or ultrasound directed sclerotherapy. The patient has not had any compressive stocking therapy to ameliorate her symptoms. The patients physician has recommended ultrasound-guided sclerotherapy for the greater saphenous vein. The Health Plan indicates there is insufficient evidence to support the long-term safety and efficacy of the requested procedure. Data would suggest that the success rate with ultrasound-guided sclerotherapy is 80% in the best series. Review of the most recent literature would suggest that in the presence of hemodynamically significant reflux originating at the level of the incompetent saphenofemoral junction sclerotherapy treatment of the greater saphenous vein and its varicosities is short-lived and is not recommended. Long-term studies have failed to prove that sclerotherapy is more beneficial than high ligation, high ligation with sclerotherapy or stripping. There has been no direct comparison with radiofrequency ablation or endolaser therapy.Physician 2A 10-year report comparing endovascular saphenous sclerotherapy with surgical ligation of the saphenofemoral junction and surgical ligation of the saphenofemoral junction plus sclerotherapy reveals superior results for surgery and inferior results for sclerotherapy. Sclerotherapy produces at least an 18.8% failure rate in controlling saphenofemoral junction incompetence and a 43.8% failure rate in obliteration of distal saphenofemoral reflux. As such, there is no evidence that sclerotherapy is likely to be of greater benefit for treatment of this patients varicosities than standard treatment modalities.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 48-year-old female with right leg painful varices with duplex documented reflux. The patient reports experiencing pain and mild edema at night. The duration and response to compression stocking use is not documented in the submitted records. The patient was evaluated by a provider who offered stripping, endovenous laser therapy (EVLT) or ultrasound-guided sclerotherapy for her condition. The patient wishes to have ultrasound-guided sclerotherapy for treatment of her greater saphenous vein (GSV) insufficiency as well as other varices. The Health Plan has denied authorization and coverage for the requested procedure on the basis it is considered investigational.The use of ultrasound-guided sclerotherapy is an excellent intervention for recurrent varices; however, there is very little support in the medical literature for ultrasound-guided sclerotherapy for greater saphenous vein ablation. As Dr. Kanters own letter suggests, the success rate of sclerotherapy in GSV ablation is 86%, which is significantly lower than the 95-98% success rate cited for radiofrequency ablation and EVLT. Thus, ultrasound-guided sclerotherapy for the treatment of primary GSV ablation is not considered standard of care and is not likely to be more beneficial than conventional therapies. Therefore, 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.The patient is a 48-year-old female with painful right leg varicose veins associated with right greater saphenous vein (GSV) valvular incompetence. The patient has requested authorization and coverage for ultrasound-guided sclerotherapy. The Health Plan has denied the request on the basis that ultrasound-guided sclerotherapy is considered investigational.Analysis and Findings:Review of the current scientific literature does not document any comparative, published reports showing the benefit of ultrasound-guided sclerotherapy over traditional surgical treatment. There are standard, beneficial therapies available for treatment of this patients condition. Ultrasound-guided sclerotherapy is likely to be unsuccessful and is not medically indicated. Therefore, I have determined 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.