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

Physician 1: The patient is a 44-year-old woman with degenerative disc disease. She has undergone surgical intervention without long-term relief. The patient has requested authorization and coverage for artificial disc replacement at L5-S1 utilizing the Charite artificial disc. The Health Plan has denied authorization for the requested procedure on the basis that its efficacy has not been established. The Charite artificial disc is an experimental device. At this time, artificial disc replacement is an unproven procedure. There is no substantial proof of its effectiveness for the treatment of chronic back pain. The benefits and efficacy of artificial disc replacement have not been shown. Thus, the requested procedure is not likely to provide greater relief than standard treatment modalities. 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 2: The patient is a 44-year-old female with degenerative disc disease. She is seeking authorization for single level 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 has not been 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.Physician 3: The patient is a 44-year-old female with L5-S1 degenerative disc disease. The patient is status post microdiscectomy. It has been recommended the patient undergo artificial disc replacement utilizing the Charite artificial disc. The Health Plan has denied authorization for the requested procedure on the basis that the efficacy of artificial disc replacement has not been established. 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. Moreover, this patient has had a previous discectomy, which is a relative contraindication to the proposed procedure. 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.