Appeal type: Experimental/Investigational
Decision: Upheld

Physician #1:  The patient is a 50-year-old female with multi-level degenerative lumbar disc disease. She has had surgery for her cervical spine in the past.  The patients orthopedist indicates that conservative therapy has not been effective for the treatment of her lower back pain. He recommends artificial disc replacement at L4-5 and L5-S1 utilizing either the ProDisc or the Charite artificial disc. The Health Plan considers this procedure experimental and has denied the patients request for authorization and coverage.The Health Plan is correct that the proposed procedure is considered experimental. Although the artificial disc is currently being investigated for single level disc replacement in the treatment of degenerative disc disease of the lumbar spine, there is no evidence supporting the safety and efficacy of a two-level disc replacement. Current data for single level disc replacement demonstrates that the majority of the procedures may be  successful in the short term, however the long-term outcomes are 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 50-year-old woman with degenerative disc disease of the lumbar spine. She has undergone surgical intervention for her cervical spine and conservative treatment of the lumbar spine did not provide long-term relief. The patient has requested authorization and coverage for artificial disc replacement at L4-5 and L5-S1. The Health Plan has deemed the procedure experimental/investigational and denied coverage. At this time, multi-level artificial disc replacement is an unproven procedure. There is no substantial proof of its effectiveness for the treatment of chronic lower back pain. The long-term benefit and efficacy of artificial disc replacement has not yet been shown. Thus, the requested procedure is not likely to provide greater relief than standard treatment modalities. Consequently, 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.Physician #3:  The patient is a 50-year-old female with discogenic low back pain at L4-5 and L5-S1, confirmed by discography. Her provider indicates she has tried and failed conservative treatments and the patient is requesting authorization for multi-level artificial disc replacement to resolve her back symptoms. The procedure was determined to be experimental/investigational by the Health Plan 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.  This is particularly true for multi-level disc replacements.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.