Appeal type: Experimental/Investigational
Decision: Upheld

Physician #1:  The patient is a 57-year-old female with degenerative arthritis of the right knee.  She underwent lateral meniscectomy in 2001 and a 2004 MRI revealed tibial edema.  She has had persistent knee pain and after the failure of several conventional therapies, her provider prescribed the BioniCare device.  The patient is requesting 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 osteoarthritis of the knee 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 #2:  The patient is a 57-year-old female with right knee lateral compartment arthritis. She had arthroscopic surgery in 2001 for a meniscectomy. The BioniCare System was prescribed in November 2005 to avoid knee replacement. The records from her orthopedist indicate he would like for her to use the device for 750 hours.  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 arthritis.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 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.Physician #3:  The patient is a 57-year-old woman with a history of right knee surgery and unrelenting knee pain. The BioniCare System was prescribed in November 2005 and she has used it for more than 300 hours.  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 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.