Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient is a 35-year-old male who sustained an injury to his ankle in 2001. He now has an osteochondral defect. His provider has recommended autologous chondrocyte implant (ACI). The Health Plan considers this procedure experimental and has denied authorization for the requested procedure. ACI has approval from the Food and Drug Administration and has been available for years. It has proven especially effective in the treatment of knee lesions. Although the data on ankle lesions are not as complete as knee lesions, there is sufficient evidence establishing ACI as an appropriate procedure for the treatment of ankle lesions. It is likely that ACI will correct the patients defect, alleviate the patients pain and prevent further deterioration and arthritis. Given the fact the patient could be facing total ankle replacement, ACI is the most appropriate treatment option at this time. Based upon the information set forth above, I have determined 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. Physician 2: The patient is a 35-year-old male with a history of a traumatic ankle injury in 2001. Since the injury he has undergone two ankle procedures. Despite treatment the patient continues to have difficulty with his ankle and has an osteochondral lesion. His provider believes without autologous chondrocyte implant (ACI) the patient will require multiple further surgeries and possibly total ankle replacement. The Health Plan will not authorize ACI because it considers ACI an experimental procedure. The Health Plans denial is correct. ACI for the treatment of ankle lesions remains an experimental procedure. There is no significant data to support this procedure for ankle osteochondral defects. In addition, there is no evidence ACI will prevent osteoarthritis of the ankle. Furthermore, there are other procedures available for this patient. 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. Physician 3: The case involves a 35-year-old active male who injured his left ankle in August 2001. He subsequently developed an osteochondral lesion of the talus, which is painful. Initial surgery with drilling of the lesion was not successful. On 12/1/04, the patient underwent a second procedure with excision of the lesion from the medial talar dome and extensive debridement. He also underwent arthroscopy of the left knee at which time carticel biopsy was harvested from the intercondylar notch and was sent to the genzyme laboratory to be cultured. Authorization has been requested to transplant the autologous cultured chondrocytes to the talar defect. The Health Plan has denied coverage for the requested procedure on the basis it is considered investigational for treatment of the patients condition. The submitted documentation includes three outcome studies on the clinical efficacy of carticel to treat ankle defects, which were presented at the 2002 Winter Meeting of the American Orthopaedic Foot and Ankle Society. The results of these studies were favorable. Furthermore, the procedure does not carry significant risk. In light of the fact that the alternative is total ankle replacement, the requested procedure is medically reasonable and appropriate. Therefore, I have determined 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.