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

Physician 1: The patient is a 37-year-old female with degenerative disc disease at L4-5. The patient has failed conservative therapy. Her provider is recommending a single level disc replacement utilizing the Charite artificial disc. The Health Plan considers this procedure experimental.The Health Plan is correct that the proposed procedure is considered experimental. There is no evidence to support disc replacement as the best available treatment for this patient. Artificial discs are currently being investigated for single level disc replacement in the treatment of degenerative disc disease in the lumbar spine. Current data for single level disc replacement demonstrates a 63% short-term success rate; however, long-term outcomes are unknown and complications may be severe. Because there is no evidence supporting the safety and efficacy of artificial disc replacement, 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. Therefore, the Health Plans denial should be upheld.Physician 2: The patient is a 37-year-old female with degenerative disc disease at L4-5. Artificial disc replacement has been recommended. The patients provider indicates the patient has attempted available conservative therapies without sustained relief. The Health Plan has denied authorization for the requested procedure indicating the efficacy of artificial disc replacement has not been established.The proposed procedure is experimental without established long-term safety and efficacy. Available data does not demonstrate an advantage to disc replacement over fusion. The long-term safety profile is unknown. There is no clinical indication demonstrating the proposed procedure is the best treatment option for this patient. There are other treatments available. For these reasons, 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. Therefore, the Health Plans denial should be upheld.Physician 3: The patient is a 37-year-old female with degenerative disc disease. She is seeking authorization for artificial disc replacement utilizing the Charite III disc. The Health Plan has denied this request because it considers artificial disc replacement experimental.The current clinical evidence regarding the Charite III disc has allowed for Food and Drug Administration (FDA) approval that it is not inferior compared to fusion. Similarly, current studies appear to indicate it is not worse than fusion. Additional claims of efficacy are based upon a small number of short-term, non-randomized studies. A 300 patient FDA regulated investigational device exemption trial with long-term follow-up is underway. Without the results of this trial, the Charite III disc replacement remains experimental. Furthermore, it is not established as superior to fusion. 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.