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

Physician 1: The patient is a 67-year-old woman with knee arthritis. She is in need of a knee replacement. A request has been made for use of the BioniCare BIO-1000 System. The Health Plan indicates the requested equipment has not been shown to be effective for treatment of the patients condition.The patient has an arthritic knee that has failed conservative treatment. There are no long-term prospective studies establishing the requested equipment as effective treatment for an arthritic knee. The efficacy of this treatment remains unproven. Conservative therapies are likely to be more beneficial for this patient than the requested equipment. Therefore, I have determined that the requested equipment 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 2: The patient is a 67-year-old woman with bilateral pain and what appears to be fairly advanced arthritis. She consulted her orthopedic surgeon in September 2004 and was diagnosed with obesity and bilateral medial arthritis. The patient subsequently did not respond to non-steroidal anti-inflammatories, Cortisone injections, Synvisc injections or physical therapy. In May 2005, a BioniCare BIO-1000 System was prescribed to treat her knee arthritis. The Health Plan indicates there is insufficient evidence demonstrating the BioniCare BIO-1000 System is effective for treatment of the patients condition. The BioniCare BIO-1000 System hypothesizes that a negative monophonic pulse to electrically stimulate growth of cartilage can restore the balance between cartilage breakdown and cartilage repair and halt, or at least dramatically slow, the progression of knee osteoarthritis. The submitted information includes a comparison between BioniCare stimulation, osteogenesis stimulation, and TENS. In this publication, it is stated that cartilage regeneration is possible and the target tissue with Bionicare is cartilage. Osteoarthritis is not purely a disease of the knee. It is a degenerative inflammatory condition involving a significant degree of synovitis of the knee, osteophyte formation, destruction of articular cartilage and destruction of both menisci. Ligamentous support is affected in many of these knees. Thus, to target purely cartilage with the BioniCare System would not resolve the problem.Furthermore, recent studies involving non-pharmacologic treatment guidelines for osteoarthritis of the hip and knee do not include the requested equipment as an alternative to surgery. As such, there are insufficient peer-reviewed prospective or retrospective studies supporting the use of BioniCare BIO-1000 System in the orthopedic literature.Based on the evidence set forth above, I have determined that the requested equipment 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 67-year-old female with progressive right knee pain secondary to radiographically confirmed osteoarthritis. Her medical comorbidities include obesity, hypertension, hyperlipidemia, and hypothyroidism. Her pain and disability have persisted despite trials with numerous analgesics and anti-inflammatory agents, physical therapy, intraarticular steroid injections and viscosupplementation. Her condition has been deemed severe enough to warrant knee arthroscopy. The patient and her physician have requested authorization for use of a BioniCare BIO-1000 System. The requested equipment utilizes pulse electrical stimulation to hypothetically stimulate cartilage growth and thereby relieve pain. The requested equipment is offered as an adjunct to the treatment of knee arthritis with the hope of deferring or avoiding knee arthroplasty.The Health Plan has denied coverage for the BioniCare BIO-1000 System on the basis it is considered investigational for treatment of the patients medical condition.There is no peer-reviewed literature containing a prospective, double blind, placebo-controlled study documenting the efficacy of the BioniCare BIO-1000 System in the treatment of knee osteoarthritis. In the referenced study by Hungerford et al., the control group did not receive placebo or sham treatment. The placebo effect of any device cannot be overlooked or discounted. The Hungerford study in no way documents superiority of the pulse electrical stimulation over traditional arthritic therapies. The BioniCare BIO-1000 System therefore remains investigational and lacks sufficient peer-reviewed medical literature to demonstrate any advantage over traditional forms of arthritic treatment.Based upon the information set forth above, I have determined that the requested equipment 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.