Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/ Case Summary:  The enrollee is requesting authorization and coverage for Synvisc-One injection to the left knee.  The enrollee has moderate osteoarthritis of the left knee. An x-ray of the left knee showed left knee osteoarthritis with 2mm medial asymmetric joint space narrowing and mild to moderate degenerative changes to the medial compartment. On focused physical exam of the left knee, the enrollee had tenderness to palpation at the joint line but had full range of motion (0 degrees extension to 130 degrees flexion) and no joint instability. The record indicates the enrollee has been treated with ibuprofen and physical therapy for more than six months; and was now in the process of getting a knee brace. He received a left knee cortisone injection on this visit for refractory knee pain. At about four months follow-up, the enrollees knee pain had improved greatly. He consented to a repeat cortisone injection into the left knee, and was instructed to follow-up in four months. However, the records indicate the next follow-up was not until six months later, at which time the enrollee indicated he received a cortisone injection approximately six months prior with less than two weeks of benefit. At the next visit, the enrollee denied any recent injuries but reported left knee pain was refractory to anti-inflammatory medication, Mobic, and knee exercises. It was determined the enrollee is an excellent candidate for Synvisc injection to his left knee. The scientific literature support for the requested treatment, hyaluronic acid (HA) injection, including Synvisc-One, for knee osteoarthritis (OA) is controversial, and not supported by clinical practice guidelines (CPG). A CPG is based on a rigorous systematic review of published literature with annual review and updates to provide recommended standards of care for specific clinical conditions or procedures. One CPG for knee OA, specifically recommends against the use of HA for patients with knee OA based on the systematic review of evidence used to develop this guideline. The appropriate use criteria (AUC) explicitly excludes the use of HA among other therapies. The clinical evidence of the effectiveness of HA on knee OA for patients with mild and moderate knee OA with a failed or incomplete response to previous nonsurgical treatment is still lacking. Expert review of the medical literature on HA found few  randomized controlled trials to assess the effectiveness of HA injections by disease severity, let alone in the context of failed non-HA treatments. In placebo controlled studies, hyaluronic acid was no better than injecting saline in patients with mild osteoarthritis. Synvisc injections are not recommended for patients with symptomatic osteoarthritis of the knee and have not shown substantial improvement over a placebo treatment. The enrollee has moderate osteoarthritis of the left knee with positive patellar grind test. Current medical literature does not support its use secondary to a lack of efficacy within the published medical literature. Final Result: The reviewer determined that the requested services were not medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in orthopedic surgery 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 similar medical condition.