Appeal type: Experimental/Investigational
Decision: Overturned

Physician #1:  The patient is a 63-year old male requesting right total ankle arthroplasty for treatment of painful arthritis. He has a 20-year history of right ankle pain with multiple sprains and previous ligament reconstruction. X-rays confirm loss of joint space at the ankle joint. Ankle motion is described as crepitant, restricted and painful and the patient limps. He also has left ankle arthritis to a lesser degree. Authorization for ankle arthroplasty utilizing the STAR or HINTEGRA prosthesis has been denied and is being appealed.Review of the available scientific literature reveals that ankle replacement surgery is being performed though not on a widespread basis. There are various prosthetic devices available and some are pending Food and Drug Administration approval. An article in the June 2004 Journal of Bone and Joint Surgery concluded, Agility total ankle replacement is a viable and durable option for the treatment of ankle arthritis in selected patients. The available data are such that total ankle arthroplasty utilizing the Agility device is likely to be superior to standard surgical intervention (ankle fusion). There is not adequate data at this time to recommend the STAR or HINTEGRA devices, which have not been approved by the FDA.Accordingly, I have determined that although a total ankle arthroplasty utilizing the STAR or HINTEGRA prosthesis is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy, a total ankle arthroplasty utilizing the Agility device is likely to be more beneficial than any available standard therapy. Therefore, the Health Plans denial should be partially overturned.Physician #2:  The patient is a 63-year old male with severe ankle arthritis. After extensive research and discussion with his treating surgeon, he has requested authorization for a total ankle arthroplasty utilizing the STAR or HINTEGRA prosthesis. The Health Plan has denied his request on the basis that total ankle arthroplasty remains investigational at this time.Prior to end stage, ankle arthritis is treated with conservative measures including medications, bracing, etc. At end stage, the most common procedure has been ankle fusion; however, certain patients benefit from ankle arthroplasty. Though not as successful as hip and knee arthroplasty, total ankle arthroplasty is an accepted alternative and is appropriate in selected patients such as this patient. While the patient is an appropriate candidate for total ankle arthroplasty, the STAR and HINTEGRA prostheses have not yet been approved by the Food and Drug Administration. However, FDA approval of the Agility ankle prosthesis has been obtained and there is sufficient data to warrant the use of the Agility ankle prosthesis in this clinical setting. Therefore, I have determined that although a total ankle arthroplasty utilizing the STAR or HINTEGRA prosthesis is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy, a total ankle arthroplasty utilizing the Agility ankle prosthesis is likely to be more beneficial than any available standard therapy. The Health Plans denial should be partially overturned.Physician #3:  The patient is a 63-year-old male with right ankle arthritis. He is status post surgical ligament reconstruction. The patient has been evaluated by a provider who has recommended ankle arthroplasty over fusion. The patient wishes to utilize the STAR or HINTEGRA prosthesis. The Health Plan indicates there is insufficient scientific evidence supporting the safety and efficacy of the requested procedure. Therefore, the Health Plan has determined the requested procedure is considered experimental. The standard of care for the surgical treatment of severe osteoarthritis of the ankle joint is fusion therapy. This is clearly and thoroughly supported in the literature. Additionally, the results of ankle fusion are very good for pain relief and restoration of function. Total ankle arthroplasty is not currently the standard of care for severe osteoarthritis as there is not sufficient peer-reviewed data establishing the long-term efficacy of ankle arthroplasty. 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. As such, the Health Plans denial should be upheld.