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

Physician 1The patient is a 45-year-old female with a history of back pain dating to 1990. In addition, she reports she has tried and failed multiple modalities including physical therapy, chiropractic, acupuncture, pain management as well as three surgical procedures. MRI showed post-operative changes at L5-S1 with residual endplate osteophytes and a protruding disc with collapse. MRI also revealed protruding disc at L4-5. The patients physician recommended total disc arthroplasty, which the Health Plan has denied due to a lack of scientific evidence in peer-reviewed medical literature to support its efficacy.Total disc arthroplasty is still in experimental/investigational studies. Short-term data is sparse, with no long-term prospective study on establishing its effectiveness. In addition, the procedures risks are uncertain with long-term benefits. Furthermore, there are other treatments available for this patient.At this time total disc arthroplasty cannot be recommend, there is very little data to warrant its general use; it is clearly investigational. 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 45-year-old female with a history of back pain since 1990. She has tried physical therapy, chiropractic, acupuncture pain management and has undergone three surgical procedures, all have failed to bring her relief of her back pain. A MRI dated July 2004 showed postoperative changes at the L5-S1 with residual endplate osteophytes and a protruding disc with collapse, also a protruding disc at the L4-5. Her physician has recommended total disc arthroplasty. Total disc replacements must be considered to be experimental at this point in time. There is no United States study with greater than two years follow-up. Also, the studies in the US currently show results equal to fusion at this point. Complications are unknown, and more data is required. Further, the patient has a 2-level pathology. The total disc should only be done on 1-level. 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 45-year-old female with failed lumbar discectomy and adjacent segment disease who is now requesting total disc arthroplasty. She has attempted a number of conservative therapies without success.Total disc arthroplasty has recently received FDA approval in the US for single level disease. This patient has had two-level disease and has failed back surgery syndrome. In this context, use of total disc arthroplasty remains investigational and of unproven benefit. There is no evidence of established efficacy. 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.