Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 50-year-old woman who has degenerative disc disease at L4-5 and L5-S1. Her physician has recommended single level artificial disc replacement surgery at L4-5. 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. There is no evidence that disc replacement reliably, reproducibly, and over long periods of time fulfills the three primary aims of clinical efficacy, continued motion, and few adjacent segment degenerative problems. Total disc replacement has been associated with a high rate of re-operations and the potential problems that may occur with longer follow-up have not been fully documented. Available data does not demonstrate an advantage to disc replacement over fusion. 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 2:  The patient is a 50-year-old female with degenerative disc disease. She has a positive discogram at L4-5 and L5-S1. Her provider is recommending artificial disc replacement at the L4-5 level only. 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. Furthermore, this case involves two levels of degeneration and spondylolisthesis. Performing a single level disc replacement for this pathology is not recommended based on the existing short-term follow-up literature. Because there is insufficient 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.Physician 3:  The patient is a 50-year-old female with discogenic low back 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.