Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 28-year-old female who has a long history of scoliosis and low back pain. She is status post a long scoliosis fusion. Her provider has recommended she undergo artificial disc replacement surgery. The Health Plan has denied coverage for artificial disc replacement indicating the requested procedure is considered investigational.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. There is no data regarding artificial disc use below scoliosis fusion in the lumbar spine. Because there is no evidence supporting the safety and efficacy of 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.Physician 2:The patient is a 28-year-old young woman who has had a long history of back pain. She has undergone a T10-L4 fusion and still continues to experience back and leg pain. Her physician has recommended artificial disc replacement at the levels below the prior fusion. The Health Plan has denied authorization for the requested procedure.The proposed procedure is experimental without established long-term safety and efficacy. In fact, its use in this setting is far outside of the limited indications for artificial disc replacement approved by the Food and Drug Administration. The long-term safety profile is unknown. The proposed procedure is a potentially dangerous use of this technology. There is no clinical indication demonstrating the proposed procedure is the best treatment option for this patient. 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: This patient is a 28-year-old female status post fusion from T10 to L4 with continuing low back and leg pain. Her physician has recommended artificial disc replacement surgery. The Health Plan indicates 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.