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

Physician 1: This patient is a 41-year-old male who has degenerative disc disease at L4-5 with resultant back pain and radiculopathy. A laminectomy and laminotomy performed in 1997 has not provided enduring pain relief. His physician indicated that the patient has tried conservative measures and is unable to relieve his pain. Therefore, the patient is requesting an artificial disc replacement.  This procedure has been denied by the Health Plan because it is considered experimental.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 given his history of previous lumbar disc surgery. 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 41-year-old male with degenerative disc disease at L4-5. The patient has failed conservative therapy. His provider is recommending artificial disc replacement surgery. The Health Plan considers this procedure 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. 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.Physician 3: The patient is a 41-year-old male with degenerative disc disease at L4-5. The patient has failed conservative therapy. His provider is recommending artificial disc replacement utilizing the artificial disc. The Health Plan considers this procedure experimental.The current clinical evidence regarding the artificial 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, artificial 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.