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

Physician 1: This patient is a 35-year-old male who has degenerative disc disease at L4-5 and L5-S1 with resultant disabling back pain. A discectomy performed in 1997 has not provided enduring pain relief. His physician indicated that the patient has tried conservative measures and is unable to relieve his pain. Therefore, the physician has recommended an artificial disc replacement based on the patients young age. The Health Plan has denied authorization for the requested procedure on the basis it is considered investigational.To date, there is no long-term data supporting the benefits of artificial disc replacement over more conventional surgical interventions.  Additionally, there is a paucity of data on the outcome of multiple disc replacements in general and more specifically when the disc replacements are at non-contiguous levels. These procedures are still considered experimental/investigational and are not the standard of care. 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 35-year-old man with chronic right radicular symptoms and low back pain.  He has had two prior surgeries, in 1997 and 2001 for these complaints, but his symptoms have persisted.  His surgeon has suggested an artificial disc replacement. Previous conservative treatment has included physical therapy and epidural steroid injection for continued right lower extremity symptoms following surgery.  Imaging studies showed post-operative changes at L4-L5 and L5-S1. There was a left lateral disc herniation at L4-L5 affecting the L5 nerve root and sparing the L4 nerve root. A later CT scan showed a mild anterolisthesis and hypertrophic changes causing foraminal stenosis bilaterally at L5-S1. The patient is currently using a cane to ambulate and is maintained on multiple medications.  The Health Plan has denied authorization for artificial disc replacement because the procedure is considered investigational.The proposed procedure, intervertebral disc replacement, is an investigational one.  There is no evidence that supports disc replacement as more effective than discectomy and fusion. Much of the literature explains the goal of providing a procedure that results in greater function and less long-term sequelae.  However, further studies comparing the procedure to existing standard treatments are needed.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 still exist include simulation of the biomechanics of the intervertebral segment; finding materials that are compatible to humans and work; and making sure that it 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. Some authors have concluded that the artificial disc is comparable to fusion, but none have proven that it is truly better.  When McAfee looked at indications for lumbar disc replacement, radiculopathy was exclusionary. This patient has evidence of advancing radiculopathy, which appears to be a relative contraindication. There is no evidence that he will have less disability long-term despite the preservation in motion.  Anderson opined that the gross overall motion lost after fusion is difficult to quantify and rarely a patient complaint if pain relief is satisfactory. Several abstracts were submitted by the patient. Overall, the follow-up time is limited and the cohort groups are too small. To date, there is no evidence that artificial disc replacement is more efficient than fusion. Although some single-level disc replacement studies appear promising, there is only two years of follow-up data. From a broader perspective, it is not clear what the pain generator is in many cases of  discogenic back pain. The disease is likely multi-factorial and hence different results are apparent for the same treatment in multiple individuals. Fusion is considered the standard of care and has a longer study history, but questions still remain.   Artificial disc replacement will have to have longevity to prove advantage over fusion.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.Physician 3: The patient is a 35-year-old man who has degenerative disc disease at L4-5 and L5-S1. His physician has recommended multi-level artificial disc replacement surgery. The Health Plan has denied authorization for the requested procedure citing a lack of proven efficacy.The proposed procedure is experimental without established long-term safety and efficacy particularly when a multi-level procedure is involved. Available data does not demonstrate an advantage to disc replacement over fusion. The long-term safety profile is unknown. There is no clinical indication demonstrating the proposed procedure is the best treatment option for this patient. There are other treatments available. 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. Therefore, the Health Plans denial should be upheld.