Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 31-year-old man with L5-S1 degenerative disc disease. The patient is status post L5-S1 revision discectomy. It has been recommended the patient undergo artificial disc replacement utilizing Prodisc II. The Health Plan has denied authorization for the requested procedure on the basis that the efficacy of artificial disc replacement has not been established. Lumbar disc replacement is in its infancy at this time. Several studies are currently being undertaken to investigate the risks, benefits, and outcomes of replacement. However, at this time there are no long-term studies to warrant use of the procedure. In fact, the surgery itself has only been performed sporadically by very few surgeons. Thus, at this time there is no evidence that artificial disc replacement is likely to be of greater benefit than standard treatment. Therefore, 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 2The patient is a 31-year-old man with degenerative disc disease. He has undergone surgical intervention without long-term relief. The patient has requested authorization and coverage for artificial disc replacement utilizing Prodisc II. The Health Plan has denied authorization for the requested procedure on the basis that the efficacy of the requested procedure has not been established. The Prodisc II is an experimental device. At this time, artificial disc replacement is an unproven procedure. There is no substantial proof of its effectiveness for the treatment of chronic back pain. The benefits and efficacy of artificial disc replacement have not been shown. Thus, the requested procedure is not likely to provide greater relief than standard treatment modalities. Therefore, 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 3The patient is a 31-year-old man who is seeking authorization for artificial disc replacement utilizing Prodisc II. The patient has a history of L5-S1 degenerative disc disease and has undergone revision discectomy. The patient continues to have symptoms postoperatively. The Health Plan has denied authorization for artificial disc replacement indicating that the efficacy of the requested procedure has not been established. The Prodisc II artificial disc is an experimental device at the current time. There are not sufficient long-term studies to establish the effectiveness of this device. Though there is some European literature, it is not adequate. Furthermore, there is no literature from the United States with more than one-year follow-up. The FDA study remains ongoing at this time. Thus, it is not known how the requested procedure will affect long-term outcomes.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. Therefore, the Health Plans denial should be upheld.