Appeal type: Experimental/Investigational
Decision: Upheld

Physician #1:  The patient is a 63-year-old woman with a history of right knee surgeries and unrelenting knee pain. She began using the Bionicare System in November 2004 and believes it has enabled her to enjoy a more active lifestyle.  The patient now requests reimbursement for the device. The Health Plan considers the Bionicare System experimental/investigational and has denied her request.The efficacy of an electric stimulator such as the Bionicare system for the treatment of chronic knee pain remains unproven at this time. No prospective studies have been conducted to validate its general usage. The risks, benefits and long-term results of such therapy remain unknown. There is no evidence that the use of the Bionicare system is likely to result in a clinical outcome superior to that achieved with more traditional treatment modalities. Therefore, I have determined that the device 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 #2:  The patient is a 63-year-old female with degenerative joint disease of the right knee.  She has had two surgeries for torn menisci and a tibial osteotomy.  Prior to the introduction of the Bionicare System, the patient wore an elastic knee support.  She has been using the Bionicare System for over a year and no longer requires the knee support.  The patient has requested reimbursement and continued authorization and coverage for the device.  The Health Plan denied the request based upon a determination that the device is experimental/investigational in this clinical setting.There is no class I data supporting the efficacy of the Bionicare System for the treatment of degenerative joint disease in the long term. The clinical role of the device has not been demonstrated in the literature. There are no long-term prospective studies supporting the use of the Bionicare System and the orthopedic community has not adopted it as the standard of care. There are other treatment modalities available to manage the patients pain. Therefore, I have determined that the device at issue offers no clinical advantage over traditional therapies for treatment of the patients medical condition. The Health Plans denial should be upheld.Physician #3:  The patient is a 63-year-old female with degenerative joint disease of the right knee. She had arthroscopic surgery in 1999 for a meniscus tear and again in 2001 for a lateral meniscus tear. In 2002 she had a tibial osteotomy of the right leg to straighten it by eight degrees along with meniscus and cartilage repairs. She states the Bionicare System was prescribed in November 2004 and she has found it beneficial. The records from her orthopedist describe her treatment and the course of her knee condition and indicate a progression of the joint arthrosis.  Her providers notes make no reference to the Bionicare device.  The patient submitted a request for reimbursement for the cost of the Bionicare System, which was denied by the Health Plan because the device is considered investigational for treatment of her degenerative joint disease.The Bionicare System is not generally used by specialists in orthopedic surgery for the treatment of degenerative joint disease. The orthopedic literature does not provide sufficient peer-reviewed, prospective or retrospective studies to support the use of this device in the treatment of progressive joint disease such as the patients.  The device is still considered investigational and 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.