Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 46-year-old female with degenerative disc disease. Her condition has become more painful over the past several years, and MRI indicates marked desiccation along with extensive spurring and endplate changes at L5-S1. The patient is seeking authorization for single level artificial disc replacement. The Health Plan has denied the requested authorization because it considers artificial disc replacement an experimental/ investigational procedure.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 severe degenerative disc/facet changes. 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. 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 2:  The patient is a 46-year-old female with low back pain progressively worsening over the past eight years. MRI confirmed degenerative disc disease at L5-S1. Conservative treatment has not resolved her symptoms. The patient has explored available treatment alternatives and is requesting authorization for artificial disc replacement due to her age and single level involvement. Her request was denied by the Health Plan citing the experimental/investigation nature of the procedure.The Charite artificial disc was granted premarket application (PMA) approval by the FDA in October 2004. Experience with its use is limited and therefore the risks, long-term viability, and complications of the procedure have not been clearly established. As such, available data indicates 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 46-year-old female with single-level degenerative lumbar disc disease. Her orthopedist indicates that conservative therapy has not been effective for the treatment of her lower back pain. The patient was determined to be a viable candidate for artificial disc replacement at L5-S1 and she sought authorization for the procedure from her Health Plan. The Health Plan considers this an experimental procedure and denied the requested authorization.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. 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. Accordingly, the Health Plans denial should be upheld.