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

Physician 1:  The patient is a 37-year-old male who had a history of disc herniations and multiple disc ruptures. He underwent various laminectomies from L3 through S1 but had persistent pain. The surgery note indicates a positive discogram with concordant pain at L4-5 and L5-S1. The patient underwent multi-level artificial disc replacement at L4-5 and L5-S1 in November 2004. By report, the patient was pain free three months after the procedure. His request for reimbursement for the artificial disc replacement was denied by the Health Plan citing the experimental/investigational nature of the procedure.Despite the fact that artificial discs have been implanted for almost 15 years, there are currently insufficient data to adequately assess the performance of this technology. There is no evidence indicating disc replacement is reliable, reproducible, and will sustain continued motion with few degenerative problems in adjacent segments over an extended period of time. Total disc replacement has been associated with a high rate of re-operation and the potential problems that may occur in the long term have not been fully documented. Additionally, multiple level disc replacement poses added risks. Total disc replacement remains an experimental procedure and should only be utilized within the context of strict clinical trials. Based upon the information set forth above, I have determined that 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 2:  The patient is a 37-year-old male with a history of multiple lower lumbar disc herniations and surgeries dating back to 1993. His symptoms have been ongoing and he has been on multiple medications. The patient researched treatment options and determined artificial disc replacement surgery was his best treatment alternative.  The procedure was performed in November 2004 with disc replacement at L4-5 and L5-S1.  The patient now requests reimbursement for the procedure.  The Health Plan considers artificial disc replacement experimental/investigational and has denied his request.In October 2004 the FDA granted premarket application approval for the Charite Artificial disc for the treatment of degenerative disc disease. Current data for single level disc replacement demonstrates a 63% short-term success rate. Although additional studies regarding the long-term efficacy of two level artificial disc replacement is needed, there is adequate evidence at this time supporting artificial disc replacement in patients such as this patient who have exhausted standard treatment modalities. Accordingly, I have determined the procedure at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.Physician 3:  The patient is a 37-year-old male who has had extensive disc problems and has undergone several laminectomies.  He had continued low back pain and proceeded with treatment via multi-level artificial disc replacement. The Health Plan indicates the efficacy of this procedure has not been established and has therefore denied the patients request for reimbursement.Artificial disc replacement is a novel surgical option for the management of discogenic lower back pain.  To date, there is no long-term data supporting the benefits of this procedure over more conventional surgical interventions such as fusion and it is not the standard of care for management of discogenic pain.  Long-term safety and efficacy studies are lacking in the peer-reviewed literature along with head-to-head comparison between disc replacement and interbody fusion surgery.  This is particularly true for multi-level disc replacements. 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.