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

Physician 1: The patient is a 38-year-old female with degenerative disc disease at L5-S1 attributed to lifting a heavy object. The patients provider believes the L5-S1 disc is responsible for her pain based upon a discogram performed in August 2005.  The patient has been identified as a candidate for artificial disc replacement, but the Health Plan considers this procedure experimental and has denied authorization and coverage.The Health Plan is correct that the requested procedure 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.  Because there is insufficient evidence supporting the safety and efficacy of artificial disc replacement, 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.Physician 2: The patient is a 38-year-old female with degenerative disc disease due to injury. She is seeking authorization for single disc replacement at L5-S1. The Health Plan has denied this request because it considers the artificial disc replacement procedure experimental.The proposed procedure is experimental without established long-term safety and efficacy. Available data does not demonstrate an advantage to disc replacement over fusion. The long-term safety profile of the procedure is unknown. There is no clinical indication that the proposed procedure is the best treatment option for this patient. Furthermore, there are other treatments available. For these reasons, 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.Physician 3: The patient is a 38-year-old woman with now chronic low back pain that began in April 2005 after lifting a heavy item. She had unremitting pain and bilateral leg radiation that ultimately led to her hospitalization. She was treated with IV steroid (Decadron), oral pain medications including opiates, and epidural steroid injection. Despite this care, she has had continued low back pain with radiation down the right leg, stopping at the knee.Imaging studies including MRI, discogram and post-discogram CT scan, all confirmed L5-S1 disc bulge or herniation, with impression onto the right thecal sac.  She has obtained at least two surgical opinions. The inpatient consultation suggested conservative care and ultimately discectomy if conservative measures were not successful. The most recent consultation suggests artificial disc replacement. The Health Plan denied the patients request for artificial disc replacement.  According to the Health Plan, this procedure is considered investigational and is therefore not a covered benefit.The proposed procedure is an investigational one. Review of the relevant scientific literature does not demonstrate that disc replacement is more effective than discectomy and fusion. 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. In his 2005 review, Schwarzenbach noted that long-term follow-up data and controlled prospective randomized studies are not available for most of the cited implants but are essential to prove the safety, efficacy, and appropriateness of these methods. Several authors have concluded that the artificial disc is comparable to fusion, but none have proven that it is superior. 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 she 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. Artificial disc replacement will have to have longevity to prove advantage over fusion.This patient has not truly explored conservative care because physical medicine has not been used according to the records submitted.  Trials of physical therapy, and possibly, work conditioning at some point, may be helpful for her and provide long-term benefit without surgical intervention.  If such modalities have not been explored, they should be tried before considering any surgical alternative.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.