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

Physician 1: The patient is 62-year-old woman with arthritis of the ankle. She wishes to proceed with ankle replacement utilizing the Agility Total Ankle Arthroplasty device. The Health Plan has denied coverage for the proposed procedure indicating there is in sufficient evidence of its efficacy in the peer-reviewed literature.The recommended prosthesis has been approved by the Food and Drug Administration and there is growing support in the medical literature for total ankle arthroplasty in the scientific literature. Several articles have been published regarding the efficacy of the procedure in appropriately selected patients. Based upon the records provided, the patient is a good candidate for total ankle arthroplasty. The only other option in this case is arthrodesis, which is not likely to be as effective. Accordingly, 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 2: The patient is 62-year-old female with a long history of right ankle pain. She has been diagnosed with osteoarthritis.  The patients provider has recommended total ankle replacement as a treatment option. The Health Plan has determined total ankle arthroplasty with the Agility Total Ankle device is an investigational procedure and therefore has denied coverage for the procedure.   The requested procedure remains experimental at this time. There is no significant long-term follow-up data available regarding total ankle arthroplasty. Additional data is needed before the procedure can be recommended. The standard of care in this clinical setting is ankle fusion, which has very good long-term data and has yielded good results for patients such as this patient.  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.Physician 3: The patient is a 62-year-old woman who has a long history of arthritis in her right ankle. Her history dates back to 1970 when she fractured her distal tibia. In June, 2005, the patient consulted an orthopedist who obtained a history, examined her right ankle and recommended right total ankle replacement with the Agility Total Ankle Arthroplasty device.The submitted clinical information does not delineate the patients therapy prior to the recommendation of ankle replacement. There is no mention of the patient being treated with analgesics, anti-inflammatories, steroid injections, bracing or casting. The history states that she has pain at night and while at rest, but also indicates, She is extremely active with running.The patients request for authorization and coverage for total ankle replacement with the Agility Total Ankle Arthroplasty device has been denied by the Health Plan on the basis the procedure is experimental/investigational.The Agility total ankle was approved by the FDA in May 2002. Early results of total ankle replacement procedures were not very promising. Kofoed in 1999 published a series of 100 consecutive ankle replacements. The author split his experience into patients over and under 50 years of age. The first group of 30 ankles had a revision rate of over 10% at 5-9 years. The second group (the older age group) also had a revision rate over 10% at 2-8 years follow-up. Rockett in 2001 reports until total ankle implant stands the test of time, ankle arthrodesis would be the gold standard in operative treatment of ankle arthrosis.Stamatis and Myerson in 2003 reported that further laboratory investigation and clinical trials were needed to improve ankle replacement as a major alternative to arthrodesis.Knecht and colleagues in 2004 published intermediate term results with the Agility Total Ankle Arthroplasty device for disabling ankle arthritis. The report includes 132 arthroplasties in 126 patients. Mean follow-up was 9 years. The results indicate one-quarter of the patients had died and 11% of the patients had a revision of the implant or ankle arthrodesis. Furthermore, 7 or 8 patients included in the studies are still alive and a significant number of them had a reduction of pain. The authors concluded the functional outcome of this procedure is uncertain.Considering the above review of the literature, a total ankle procedure with the Agility ankle is not likely to be more effective in this patient than a traditional procedure such as ankle arthrodesis.For the reasons 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.