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

Physician 1: The patient is a 59-year-old female with multi-level degenerative disc disease. The patient has failed conservative therapy. Her provider has recommended artificial disc replacement at L2-3 and L4-5 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. Furthermore, there is no data regarding multi-level disc replacement at this time.Because there is insufficient 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 59-year-old female who has had chronic back pain since she was involved in a motor vehicle accident in 2004. A discogram performed in June 2005 showed annular leaks at L2-3 and L3-4 and annular fissure at L5-S1. Her provider has recommended the patient undergo artificial disc replacement at L2-3 and L3-4. The Health Plan has denied authorization for the proposed surgery on the basis it is considered experimental. 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. Furthermore, there is no data supporting the proposed two-level disc replacement. 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 that 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 59-year-old female with degenerative disc disease. She is seeking authorization for a two level disc replacement utilizing the Charite disc. The Health Plan has denied this request because it considers the Charite disc 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. However, artificial disc replacement has not been proven to be more effective than fusion. Long-term, randomized studies are needed to determine if artificial disc replacement is superior to standard modalities. Moreover, artificial disc replacement at two levels has not been sufficiently studied and outcomes compared to fusion are unknown. 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.