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

Physician 1:  The patient is a 47-year-old female with a history of back pain. MRI results revealed a grade II annular fissure at L4-5 and a small posterior disc bulge with apparent contact with the right S1 nerve root and mild bilateral neural foraminal stenosis at L5-S1. A discogram demonstrated concordant pain at L5-S1. The patient tried conservative measures including chiropractic therapy, physical therapy, and epidural steroid injections without sustained relief of her symptoms. The patient underwent artificial disc replacement at L5-S1 in February 2006.  She is now seeking reimbursement for the procedure.The procedure at issue 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 was no clinical indication demonstrating the procedure at issue was the best treatment option for this patient. For these reasons, I have determined the procedure at issue was 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 47-year-old female with symptomatic disc disease at L5-S1 diagnosed by discogram. She underwent a single level artificial disc replacement procedure in February 2006. The patient has requested reimbursement for the procedure. The Health Plan has denied her request on the basis that artificial disc replacement remains experimental.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 procedure at issue was 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 47-year-old female with degenerative disc disease. She had a positive discogram at L5-S1. Her provider recommended artificial disc replacement. The procedure was performed in February 2006 and the patient reports good results. The Health Plan has denied reimbursement for the procedure citing a lack of established efficacy.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 insufficient evidence supporting the safety and efficacy of artificial disc replacement, I have determined the procedure at issue was 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.