Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 25-year-old male with disc disease including a 3 mm central disc herniation at L5-S1. He has failed extensive conservative management. His physician has recommended artificial disc replacement surgery. The Health Plan had denied authorization for the procedure on the basis that the efficacy of artificial disc replacement has not been established.Artificial disc replacement has only recently been FDA approved. The procedure is of unproven efficacy. Long-term results are unknown and the procedures risks, long-term viability, and complications are unclear. Though a small study has been completed and short-term results are favorable, further studies and results are needed. As such, the procedure cannot be recommended at this time. 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 has approximately a three-year history of low back pain with tingling in the lower extremities. An MRI of the lumbar spine revealed a 3 mm central disc protrusion at the L5-S1 level and a 2 mm posterior disc bulge at the L4-5 level. Conservative management of the patients condition has not been effective. A request has been made for disc replacement at L5-S1 utilizing the Charite III disc. The Health Plan has denied this request indicating artificial disc replacement is 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 25-year-old male with degenerative disc disease. An MRI revealed disc protrusion at L5-S1. His provider is recommending artificial disc replacement at this level. The Health Plan considers this procedure experimental and therefore has denied authorization and coverage.The Health Plan is correct that the proposed procedure is considered experimental. The artificial disc is 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. Because there is inadequate 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.