Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 54-year-old female who when seen in July 2005, had a four-month history of severe bilateral knee pain, right greater than left, and problems with knee locking without reported falls or trauma. She also complained of back pain, which began two to three months after the onset of the knee pain. There was medial joint line tenderness of the right knee and she had worn an unloader brace, which was breaking down and required a replacement. The patient had taken a number of medications including Valium, Baclofen, Norco, Kadian and Fentanyl and had Kenalog and Lidocaine injections into both knees.  In August 2005 surgery with arthroscopy or knee replacement was discussed in the event that conservative management failed. According to her orthopedist, the right knee MRI was consistent with contusion or sprain and the lumbar spine x-rays showed degenerative changes at L3-4. The patient also tried pool therapy and used crutches as needed. In December 2005 her orthopedist noted that the patient had obtained the Bionicare system but unfortunately the intensity and duration were too strong for her and she had reduced the intensity on her own. In January 2005 he noted that the Bionicare system was producing moderate (knee) pain control, approximately 30%. The device appeared not to work for the patients back pain.  Her provider felt that the Bionicare device was indicated as the patient had used every possible modality of (knee) pain control, including weight loss. The patient still complained of constant severe pain at that time.  The patient has requested coverage for treatment with the Bionicare device. The Health Plan considers the device experimental/investigational and has denied her request.The Bionicare Bio-1000 system remains investigational at this time. It is not widely used and has not been generally accepted by practicing orthopedists as a suitable treatment option for arthritic joints or painful back conditions. There is insufficient evidence in the peer-reviewed literature demonstrating that the Bionicare system is efficacious for patients such as this patient. Therefore, I have determined that the requested device is not likely to be more beneficial for treatment of the patients medical condition than available standard therapy.  The Health Plans denial should be upheld.Physician 2: The patient is a 54-year-old female with a several-month history of bilateral knee pain and back pain.  Conservative management failed to relieve her symptoms, and she began to use the Bionicare electrical stimulation device in late 2005.   It appeared that the patient could not tolerate the full intensity of the device, and adjustments were made for her knee pain, and it was discontinued for her back pain.  The patients provider stated the device was used faithfully and produced an approximate 30% reduction in her pain.  Subjectively, the patient reported a pain level of 7.5 on a 1 to 10 scale for her knees and 8.5/10 for her back.  Previously she had rated her worst pain as 9/10. The patient has requested authorization and coverage for the Bionicare device. The Health Plan has denied the request based upon a determination that the device is experimental/investigational in this clinical setting.There is no Class I data to establish the efficacy of electrical stimulation for the treatment of osteoarthritis or degenerative spinal changes. The device is not within the mainstream of care for orthopedic practice. Available data does not demonstrate an advantage to the Bionicare system over standard pain management modalities. Therefore, I have determined that the requested device 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 54-year-old woman with osteoarthritis of the knee. She had tried multiple medications and other conservative treatment modalities, but continues to experience severe bilateral knee pain. She began using the Bionicare electrical stimulator a few months ago, and achieved a reported 30% improvement in her pain symptoms.  She has requested authorization and coverage from the Health Plan for the Bionicare system.  The Health Plan deemed the device experimental/investigational and denied the patients request.The device in question is experimental and investigational with regard to its unproven efficacy in the treatment of osteoarthritis. There are no long-term, prospective studies to warrant its use in this clinical context.  Although the risks are minimal, the benefits have not yet been substantiated.  For these reasons, I have determined that the requested device 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.