Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Durolane knee injections for their medical condition of knee pain.  Findings:  The physician reviewer found that The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patients primary osteoarthritis of the left knee. The submitted documentation supports the medical necessity of the requested medication. There is significant current medial evidence supporting the use of viscosupplementation for management of osteoarthritis of the knees. The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis treatment algorithm recommends intra-articular hyaluronic acid for the management of knee osteoarthritis as second-line treatment in patients who remain symptomatic despite use of non-steroidal anti-inflammatory drugs. This recommendation is based upon accumulating evidence that intra-articular hyaluronic acid provides a significant benefit in knee osteoarthritis. There is good evidence that intra-articular hyaluronic acid injections reduce pain and increase function in knee osteoarthritis with long-lasting benefits as compared with intra-articular corticosteroids. Evidence from real-life studies show that repeat courses of intra-articular hyaluronic acid demonstrates an improvement in pain or function lasting up to 40 months 12 months after the last injection cycle a reduction in use of concomitant analgesia by up to 50 percent, and suggests that there may be a delay in the need for total knee replacement of around two years. The clinical benefit of intra-articular hyaluronic acid on knee osteoarthritis may be two-fold: 1) Mechanical viscosupplementation of the joint allows lubrication and shock absorption; and 2) Joint homeostasis may be reestablished through induction of endogenous hyaluronic acid production, which continues long after the exogenous injection has left the joint (Maheu, E., et al). Campbell and colleagues conducted a systematic review of overlapping meta-analyses, which compared viscosupplementation with other non-operative treatment modalities for knee osteoarthritis. Their review showed that the current highest level of evidence suggests that intra-articular hyaluronic acid is a viable option for knee osteoarthritis. Its use results in improvements in knee pain and function that can persist for up to 26 weeks. Viscosupplementation has a good safety profile, and its use should be considered in patients with knee osteoarthritis. In this case, the patient has exhausted all other conservative treatment including  corticosteroid injections and arthroscopic debridement. As such, this patient is a candidate for viscosupplementation. In light of the foregoing, (CPT J3490) for left knee injections are reasonable, appropriate, and medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The 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 a similar medical condition.