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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for bilateral Euflexxa injections for treatment of the enrollees chronic bilateral knee pain. Findings:  The physician reviewer found that Evidence based medical peer reviewed literature supports the use of repeat viscosupplementation injections for the treatment of pain in patients with osteoarthritis of the knee. Bannuru and colleagues concluded that hyaluronic acid was the best 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.  Pagnano and Westrich conducted a systematic review on the efficacy and safety of repeat courses of hyaluronan therapy in patients with osteoarthritis of the knee and concluded that repeat courses of the hyaluronans were safe and effective in the treatment of pain associated with osteoarthritis of the knee. Turajane and colleagues concluded that repeated cycles of intra-articular sodium hyaluronate treatment, to delay total knee replacement in patients with knee osteoarthritis who failed conservative treatment, was found efficacious during a 54 month follow up period. Additionally, current medical evidence states that hyaluronic acid injections in the knee are recommended as a possible options for patients with osteoarthritis who have not responded adequately to conservative treatments for at least three months, including failure to adequately respond to aspiration and injection of intra-articular steroids. The medical literature supports hyaluronic acid injections to potentially delay total knee replacement for patients with pain that interferes with functional activities. The literature also states that if there is documented significant improvement in symptoms for six months or more, and symptoms recur, it may be reasonable to do another series. This patient presents with chronic bilateral knee pain. Clinical examination findings are consistent with x-ray evidence of severe osteoarthritis with 100 percent medial joint space narrowing on the right and 100 percent lateral joint space narrowing on the left with tricompartmental changes, osteophyte formation, and subchondral sclerosis. Reasonable conservative treatment, including medications, activity modification, weight loss, and corticosteroid injections have failed to provide adequate symptom relief. Bilateral total knee replacement has been recommended but he is required to reduce his weight prior to surgery. The patients current body mass index is 45. It was noted that two prior viscosupplementation injections had provided pain relief allowing him to exercise for weight loss. Evidence based medical peer reviewed literature supports the use of viscosupplementation injections for the treatment of pain in patients with osteoarthritis of the knee. Repeat viscosupplementation injections have been found to be safe and effective and allow for delay of knee replacement surgery. Given the previous response and to assist in delaying total knee replacement while he continues to lose weight, repeat Euflexxa injections are indicated. Therefore, bilateral Euflexxa injections are medically necessary for treatment of the patients medical condition.  Final Result: The reviewer determined that the requested services 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.