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

Physician 1: The patient is a 63-year-old female with degenerative disc disease. She is status post posterior spinal fusion at L4-S1. Her provider has recommended a disc replacement at L3-4. 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 evidence supporting the safety and efficacy of artificial disc replacement above a previous two-level 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 63-year-old female with degenerative disc disease. Artificial disc replacement has been recommended above the level of previous fused lumbar segments. The Health Plan has denied authorization for the requested procedure.The proposed procedure is experimental without established long-term safety and efficacy. The long-term safety profile is unknown. It has received an FDA indication for use as a single level device at L4-5 or L5-S1. Attempting to use this device above a previous fused segment has no validated benefit and carries significant risk. There is no clinical indication demonstrating the proposed procedure is the best treatment option for this patient. Accordingly, 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 63-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 the 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, the submitted radiological reports suggest the patient has loss of disc space, facet arthropathy, and has had previous surgery. Given these factors, the patient is not a candidate for artificial disc replacement. 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.