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

Physician 1: This patient is a 47-year-old male with a history of disc herniation at L5-S1 who is status post microdiscectomy at that level.  He has attempted conservative measures without complete relief of his back pain. In June 2005 he had a positive discogram at L5-S1. He has now requested authorization for artificial disc replacement at L5-S1. The Health Plan has denied authorization citing the experimental nature of the procedure.The proposed artificial lumbar disc replacement is an experimental procedure without established safety and efficacy. There is no Class I long-term data demonstrating an advantage to disc replacement over fusion. The long-term safety profile is unknown and complications may be severe. 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.Physician 2: The patient is a 47-year-old man who has degenerative disc disease at L5-S1.  He underwent microdiscectomy in 2004 but still has severe lower back pain.  His provider has recommended artificial disc replacement surgery and authorization was requested. The Health Plan considers the procedure experimental/investigational, and authorization was denied.Despite its investigational use in Europe, the benefit of artificial disc replacement remains unproven. It has been associated with multiple severe and often catastrophic clinical events and numerous clinical failures. It remains unproven as a technique and the technology is without proven clinical value. Additionally, there is no viable revision strategy should this device fail. This is a particular concern in patients with a previously failed spinal surgery such as this one. 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 3: The patient is a 47-year-old male with discogenic, low back pain at L5-S1 confirmed by discography. He has tried and failed conservative treatments and is now requesting authorization for artificial disc replacement to resolve his back symptoms.  The Health Plan deems the procedure experimental/investigational and authorization and coverage were denied.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. Based upon the information set forth above, 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.