Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 39-year-old male with degenerative disc disease at L5-S1. The patients provider indicates the patient has failed conservative treatment. His provider has recommended the patient undergo disc replacement at L5-S1. The Health Plan has denied coverage for artificial disc replacement indicating the requested procedure is considered investigational.The patient is a male with degenerative disc disease with chronic low back pain. He has not had improvement with conservative measures. Unfortunately, artificial disc replacement is of unproven efficacy for the treatment of chronic low back pain. The long-term results of this procedure are not yet known. Further studies are needed to determine outcomes beyond two years. 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 39-year-old man with a diagnosis of degenerative disc disease. He has requested coverage for artificial disc replacement surgery. The Health Plan has denied coverage for the requested procedure on the basis it is considered investigational.There is little data supporting the long-term efficacy of artificial disc replacement. There is presently at least a 35% failure rate associated with this procedure. Additionally, revision remains a potentially life threatening proposition. At present, the efficacy of disc replacement remains unproven. 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 3: The patient is a 39-year-old male with degenerative disc disease. He 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, the indications for disc replacement are retained disc space height and no evidence of facet arthropathy. The submitted clinical evidence indicates the patient has moderate facet arthropathy at L4-5 and L5-S1. As such, the patient does not meet the criteria for consideration of artificial disc replacement. Thus, even if the efficacy of the requested procedure was established, the patient is not an appropriate 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.