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

Physician 1: The patient is a 48-year-old female who has a history of isthmic spondylolistheses. She underwent a spinal fusion from L4 to S1. She had tried multiple treatment modalities without lasting benefit. In September 2005, the patient underwent artificial disc replacement surgery. Her request for reimbursement for the procedure has been denied by the Health Plan on the basis that artificial disc replacement is considered experimental. The Health Plan is correct that the proposed procedure is considered experimental. There is no evidence to support disc replacement surgery for this patient. The procedure is still under investigation and is not considered standard of care. The long-term success rate and safety profile remain unknown. Furthermore, there is no literature to support the use of artificial disc replacement in patients who have had previous fusions. Because there is no evidence supporting the long-term 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.Physician 2: The patient is a 48-year-old female who has undergone laminectomy and insertion of artificial disc. She has had multiple surgeries in the past and was developing severe radiculopathy in addition to increasingly hard to control back pain. The patient underwent artificial disc replacement surgery in September 2005. The Health Plan has denied coverage for the procedure on the basis it is considered investigational.Intervertebral artificial disc replacement remains investigational at this time. There is no evidence supporting artificial disc replacement as more effective than discectomy and fusion. To date the artificial disc has not yet been adequately tested in humans, with comparison to existing standard treatments. The artificial intervertebral disc has been proposed as a method for treating symptomatic degenerative discs. Scientists have been investigating the possibility of developing such a device for over 30 years. The challenges that exist include simulation of the biomechanics of the intervertebral segment, and making sure that the device will last long-term. It is hypothesized that such a disc would have advantages over discectomy and fusion because of increased or preserved range of motion, and avoiding increasing degeneration at adjacent levels. Though several authors concluded that the artificial disc was comparable to fusion, none have proven that it is truly better. An article by McAfee looked at indications for lumbar disc replacement; radiculopathy was exclusionary. This patient had evidence of advancing radiculopathy, which appears to be a relative contraindication. There is no evidence that patients such as this patient will have less disability long-term despite the preservation in motion. 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 3: The patient is a 48-year-old female with a history of degenerative disc disease. She is status post a previous fusion. The patient underwent artificial disc replacement surgery in September 2005 and is seeking reimbursement for the procedure.  The Health Plan has denied her request.The proposed procedure is experimental without established long-term efficacy. The best published results reveal outcomes equivalent to fusion. However, the majority of studies show a failure rate of 35%. Furthermore, the long-term safety profile is unknown. For these reasons, 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.