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

Physician #1:  The patient is a 39-year-old male who underwent left knee arthroscopy in May 2005 for evaluation of his left knee pain.  At the time of his arthroscopy, he was found to have an area of grade IV chondromalacia over his medial femoral condyle. Following his diagnostic arthroscopy, he underwent a multi-compartment synovectomy and then OBI implantation using two implants which measured 11mm and 7mm each. The Health Plan denied the patients request for reimbursement for the OBI implantation procedure contending that the procedure was experimental/investigational for treatment of the patients chondromalacia lesions.This patient was diagnosed with grade IV chondromalacia, which is an abnormal softness of cartilage. The two devices implanted during the patients procedure were Bone Graft Substitutes (BGS) made by PolyGraft, or more commonly referred to as resorbable bone void fillers.  The manufacturers Indications for Use specify that the device is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The graft material is typically packed gently into the bony void or skeletal gap and the device provides a bone void filler that resorbs and is replaced with bone during the healing process.  The description of the device does not indicate that it is a cartilage substitute. Its intended use is to fill bone void defects and it is not considered a form of osteochondral allografting.  Therefore, I have determined that the procedure 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 39-year-old male with a history of left knee pain. He had a diagnostic arthroscopy in May 2005 and grade IV chondromalacia of the medial femoral condyle was identified. The Operative Report indicates an OBI implantation procedure was performed to repair the defect in the cartilage. The patients request for reimbursement for the OBI implantation was denied by the Health Plan based upon the investigational nature of the procedure.There is no class I data to support the use of the procedure at issue in cases involving chondromalacia of the femoral condyle, such as this one. While there is some class III data to support the use of autograft, the procedure at issue remains an experimental procedure at this time. Accordingly, I have determined that the procedure 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 #3:  The patient is a 39-year old male who underwent arthroscopic examination of his left knee in May 2005 due to a history of persistent knee pain. During the arthroscopic procedure, his provider performed arthroscopy, left knee multi-compartmental synovectomy and then implanted two OBI grafts of 11mm and 7mm into the medial femoral condyle to treat the osteoarthritis.  The Health Plan denied reimbursement for the procedure because they consider it an experimental and investigational procedure.Based upon a review of the Operative Report, chondromalacia was identified on the medial femoral condyle and two OBI grafts were inserted.  The OBI graft is intended to fill bony voids or gaps caused by trauma or surgery.  The patient in this case had an osteoarthritic condition and OBI grafting was not indicated.  In osteoarthritis the bony substrate is essentially normal and there is deterioration of the cartilage.  This patient had grade IV cartilage deterioration and the procedure at issue was not likely to be more beneficial for treatment of his medical condition than any available standard therapy. The Health Plans denial should be upheld.