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

Physician 1: The patient is a 46-year-old male who has been diagnosed with degenerative disc disease. The patients physician indicates the patient has tried and failed several attempts at conservative treatment. A CT scan performed in March 2005 showed a disc bulge and facet hypertrophy at L4-5 as well as disc degeneration at L5-S1. The patients physician has recommended the patient undergo fusion and artificial disc replacement. The Health Plan has denied coverage for artificial disc replacement indicating the requested procedure is experimental in nature.The Health Plan is correct that the proposed procedure is considered experimental. There is no evidence to support disc replacement surgery for this patient. The proposed procedure is still under investigation and is not considered standard of care. The long-term success rate and safety profile remain unknown. Furthermore, based upon the clinical information provided, artificial disc replacement is contraindicated in this patient. 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.Physician 2: The patient is a 46-year-old male with degenerative disc disease. He is seeking authorization for artificial disc replacement utilizing the Charite 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 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 3: The patient is a 46-year-old male diagnosed with degenerative disc disease at L5-S1 by provocative discography. The patient has requested authorization and coverage for artificial disc replacement. The Health Plan has denied this request on the basis the proposed procedure is considered experimental.Although artificial disc replacement is a promising intervention with potential, at this time it has not been demonstrated to have superior efficacy to traditional standard surgical treatment, i.e., surgical fusion. Furthermore, the long-term safety profile is unknown. There are other treatments available for this patients condition. 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.