Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/ Case Summary:  The enrollee is requesting authorization and coverage for the injection, Orthovisc, for the right knee for a diagnosis of primary osteoarthritis. An MRI revealed chondromalacia patella. She has grinding in both knees. She underwent right knee surgery for a meniscus tear and cyst. She has previously completed an Orthovisc series and reported good results.  She contacted her orthopedic surgeons office reporting a return of right knee pain.  Imaging studies of the right knee show mild patellofemoral osteoarthritis.  She denies injuries or major changes since her last visit.  She wishes to postpone knee replacement surgery for as long as possible. The orthopedic surgeon has ordered an Orthovisc series. The record indicates the patient has a history of mild osteoarthritis of the knees; most pronounced in the patellofemoral compartment.  She had received prior injections and reported moderate relief.  To date, support in the scientific literature for hyaluronic acid (HA) injections, including Orthovisc for knee osteoarthritis (OA) is controversial, and not supported by clinical practice guidelines (CPG). Clinical practice guidelines for knee OA, specifically recommend against the use of HA for patients with knee OA based on the systematic review of evidence used to develop this guideline. Further, to provide clinical guidance on areas that lack evidence for non-arthroplasty treatment of knee OA, appropriate use criteria (AUC) explicitly exclude 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 non-surgical treatment is still lacking. The workgroups expert review of the medical literature on HA found no randomized controlled trials to assess the effectiveness of HA injections by disease severity, let alone in the context of failed non-HA treatments. Though the workgroups review of available studies suggests that patients with mild to moderate knee OA may benefit from HA intervention, they indicate there is limited evidence from two trials that focused on patients with grade I or II OA and found no difference between intra-articular HA and intra-articular saline as a placebo. Very recent reviews of the role of hyaluronic acid for knee osteoarthritis have continued to recommend against it use. A review of intraarticular therapy indicates although HA and glucocorticoids can provide clinically meaningful benefits to an appreciable number of patients, emerging evidence indicates that the apparent effectiveness of these treatments is largely a result of other factors, including the placebo effect. Similarly, an extensive review also found no benefit for HA, when trials at risk for bias were excluded. Based on this review of the medical literature and records, HA (Orthovisc) injection is not medically necessary. Although the patient indicates a successful course with Orthovisc in the past, current medical evidence does not support the efficacy of this treatment.Final Result: The reviewer determined that the requested service is not medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in orthopedic surgery and orthopedic sports medicine 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.