Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has a history of multiple chronic medical conditions, including arthropathy, for which he underwent a total left knee replacement in the past. This was complicated by an infection, and he ultimately underwent a left transfemoral amputation on 11/1/11. The patient underwent rehabilitation, including prosthetic ambulation training. He received a `preparatory` endoskeletal prosthesis in or around 2011 with an Ossur Symbionic (microprocessor-aided) knee, but he reportedly gained weight and could no longer use this prosthesis.  Case management notes indicate that he received a replacement prosthesis in 2013 due to a weight gain of approximately 80 lbs. On 9/17/18, his provider noted that he is a current smoker of 11-20 cigarettes per day. On 9/17/18, a prosthetic evaluation noted that he had asthma, obesity, shortness of breath and back pain.  He had broken his femur in 2015 and had three falls within the past six months. He was 5'11` and 281 lbs.  He had a definitive endoskeletal prosthesis with a mechanical hydraulic knee that was 4 years and 9 months old, but it was not being used as he did not like suction fit, and he did not feel safe without the stumble recovery feature offered by his prior prosthesis with microprocessor knee.  He was noted to be wearing his preparatory prosthesis with Ossur Symbionic (microprocessor-aided) knee daily, and this prosthesis was seven years old.  A definitive endoskeletal replacement prosthesis with elevated vacuum suspension, Ossur Rheo knee, multiaxial ankle and K3-appropriate foot was recommended. On 10/16/18, his provider noted that the patient needed a replacement prosthesis, as his current prosthesis was almost four years old and he had lost 20 lbs since it had been fabricated. Further socket modifications would not be sufficient for proper fitment.  He was using crutches to ambulate.  He was doing light housework and driving.  He was assessed to be a K3 level ambulator. The patient has requested authorization and coverage for Rheo Knee microprocessor-controlled prosthetic knee. The Health Plan has denied this request and reported that the requested device is not medically necessary for the treatment of this patient. At issue in this case is whether a Rheo Knee microprocessor-controlled prosthetic knee is medically necessary for treatment of this patient. A microprocessor-controlled prosthetic knee is not of proven clinical benefit over a conventional prosthetic knee without microprocessor control.  The contention that this type of device affords significant functional benefits is largely anecdotal or industry-generated.  A clinical trial showed higher performance with a passive prosthetic knee versus the microprocessor-controlled C-Leg. In a study, it was noted that a simpler knee joint could perform better than a microprocessor-aided prosthetic knee on soft or uneven surfaces because users have a more expedient and direct impact on the knees behavior over a microprocessor-aided knee.The records in this case indicate that there have been large fluctuations in weight over time and that his primary issue has been fitment, which is best addressed with strategies for residual limb volume, edema control and weight stabilization.  This is not addressed with a prosthetic knee programmed with an intent to prevent falls. Despite his reported current use of a prosthesis with a microprocessor knee, he has been using crutches, and according to the 9/17/18 prosthetic evaluation, had three falls within the past six months. A replacement socket and or prosthesis that provides better fitment would mitigate his fall risk. A replacement microprocessor knee would not be expected to marginally affect his function and outcomes.  Therefore, the requested Rheo Knee microprocessor-controlled prosthetic knee is not medically necessary for treatment of this patients medical condition.Final Result: The reviewer determined that the requested services are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in physical medicine and rehabilitation and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.