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

Physician #1:  The patient is a 46-year-old male with degenerative disc disease. He has had a positive discogram at L4-5 and L5-S1. His provider is recommending a two-level artificial disc replacement at these levels. The Health Plan considers this procedure experimental.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 no evidence supporting the safety and efficacy of a two-level 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 46-year-old male with a long history of low back pain aggravated by bending, lifting, twisting, walking and sitting. He reports that the pain is better when he lies down. He has been taking Vicodin for pain relief. There is only occasional leg radiation. Posture and back motion are good and there is no neurological deficit. The patients condition is worsening. He has had x-rays, MRI, discography and a CT scan of the lumbar spine following the discography. His provider saw him in May 2005 and noted that the tests show concordant pain, which is severe at L4-L5 and L5-S1 with degenerative disc disease at both levels. His provider believes the patient is an appropriate candidate for a multi-level artificial disc replacement. The Health Plan has denied authorization and coverage for the requested procedure indicating that it has not been shown to be efficacious for treatment of degenerative disc disease.To date, the Food and Drug Administration has approved a premarket application for the Charite artificial disc for patients with degenerative disc disease at one level from L4-S1. The approval is conditional on a five-year prospective study because long-term results have yet to be determined. At this time, the procedure is of unproven efficacy. Long-term results are unknown and the procedures risks, long-term viability, and complications are unclear. Accordingly, 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 46-year-old man who has degenerative disc disease at L4-5 and L5-S1. His physician has recommended multi-level artificial disc replacement surgery. The Health Plan has denied authorization for the requested procedure citing a lack of proven efficacy.The proposed procedure is experimental without established long-term safety and efficacy, particularly when a multi-level procedure is involved. 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.