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

Physician 1: The patient is a 51-year-old female who had degenerative discs from L2-L3 to L5-S1 along with persistent back and buttock pain. She tried physical therapy and medications without successful long-term pain relief. She requested authorization from the Health Plan for artificial disc replacement at L2-L3, L3-L4 and L4-L5, which was denied, and she proceeded with the surgery under a compassionate use exemption in October 2005. The patient is now requesting reimbursement but the Health Plan has denied the request citing the experimental nature of artificial disc replacement surgery.Disc arthroplasty in the initial stages of critical evaluation. It has not been shown to be superior to fusion surgery in well-selected patients with single level disease and without facet sclerosis. Proponents claims of reduced adjacent level disease have not been proven in the current studies. In this patient who has multi-level disease, it is highly unlikely that multiple disc replacement arthroplasty would be superior to lumbar fusion.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 51-year-old woman with degenerative discs at L2-L3, L3-L4, L4-L5 and L5-S1. She received a compassionate use exemption for a three-level artificial disc replacement by the Food and Drug Administration and manufacturer of the device. She underwent the artificial disc procedure in October 2005. Prior to surgery, she suffered from back spasms and back pain unrelieved by conservative treatment. The Heath Plan considers this procedure experimental/investigational and has denied coverage for the surgery.Artificial disc replacement is experimental and 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. Furthermore, there is no data supporting a three-level disc replacement. There is no clinical indication that multi-level disc replacement is the best or only treatment option for this patient. For these reasons, 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. Therefore, the Health Plans denial should be upheld.Physician 3: The patient is a 51-year-old female with extensive degenerative disc disease of the lumbar spine. She had intractable pain and artificial disc replacement at L2-L3, L3-L4 and L4-L5 was performed in October 2005 after the patient received a compassionate use exemption allowing the procedure to be performed at more than two levels.  The Health Plan has denied coverage for the procedure on the basis that the efficacy of artificial disc replacement has not been established. The Health Plan is correct that the procedure at issue is considered experimental. There is no evidence to support disc replacement as the best available treatment for this patient. Artificial discs are 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, there is no data regarding multi-level disc replacement at this time.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.