Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is 31-year-old female with degenerative disc disease. She has requested authorization and coverage for two-level artificial disc replacement surgery. The Health Plan has denied this request indicating the efficacy of the proposed procedure has not been established.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.Physician 2: The patient is a 31-year-old female with degenerative disc disease at L4-5 and L5-S1. The patient has failed conservative therapy. Her provider is recommending a multi-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. Furthermore, in this case there is MRI evidence of some impingement of the L-5 nerve root, which is a contraindication to artificial disc replacement surgery. 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 3: The patient is a 31-year-old young woman who has had a long history of back pain. An MRI revealed central disc protrusions at L4-5 and L5-S1. Her physician has recommended multi-level artificial disc replacement surgery. The Health Plan has denied authorization for the requested procedure.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.