Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for bilateral Synvisc One injections. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees osteoarthritis of both knees.There is sufficient support in the medical literature for the requested medication in this clinical setting. Evidence based medical peer-reviewed literature supports the use of viscosupplementation injections for the treatment of pain in patients with osteoarthritis of the knee. A study concluded that hyaluronic acid is an effective pharmacologic intervention for knee osteoarthritis in their meta-analysis of 137 studies with 33,243 participants. Hyaluronic acid was found to be better than injected placebo or injected corticosteroids. Turajane and colleagues concluded that repeated cycles of intra-articular sodium hyaluronate treatment to delay time to total knee replacement in patients with knee osteoarthritis who failed conservative treatment was found efficacious during a 54-month follow-up period. Nationally recognized evidence based medical guidelines state that hyaluronic acid injections in the knee are recommended as a possible option for patients with osteoarthritis who have not responded adequately to recommended conservative treatments for at least three months, including failure to adequately respond to aspiration and injection of intra-articular steroids. Guidelines support hyaluronic acid injections to potentially delay total knee replacement for patients with pain that interferes with functional activities. Guidelines state that if there is documented significant improvement in symptoms for six months or more, and symptoms recur, it may be reasonable to perform another series. There is no maximum amount of injections established by high quality scientific evidence. The American Medical Society for Sports Medicine (AMSSM) recommends hyaluronan acid for appropriate knee osteoarthritis patients, based on a very large network meta-analysis. Viscosupplementation has been found to be safe and effective and allow for delay of total knee replacement, and is more effective than corticosteroid injections. In this case, the patient has been diagnosed with osteoarthritis of both knees. She reports a history of chronic bilateral knee pain and functional impairment in mobility that has failed to respond adequately to other conservative treatment, including prescription medications, corticosteroid injections, bracing, exercise, and cane use. She reports medical issues that preclude on-going corticosteroid injections or the use of non-steroidal anti-inflammatory drugs (NSAIDs). She also reports that she is not a good candidate for total knee replacement. Prior Synvisc One injections have been performed to both knees approximately every six months since 4/16/15, with significant reduction in pain, decreased need for medications, and improved functional mobility. Therefore, the requested reimbursement and prospective authorization and coverage for bilateral Synvisc One injections provided on 12/12/17 forward for both knees were and are medically necessary for treatment of the patients medical condition. Findings:The reviewer has determined that the services at issue were and are 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.