Hyalgan Injections denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for a series of Hyalgan injections and arthrocentesis to the left knee. Evidence from systematic reviews and randomized controlled trials indicate that although viscosupplementation may relieve knee pain in some patients with osteoarthritis, data has not established which patients will benefit. Several studies have tried mixing hyaluronic acid with corticosteroids, platelet-rich plasma, and other agents, to increase its effectiveness. Guidelines from the American Academy of Orthopedic Surgeons (AAOS) indicate that the data on the safety and efficacy of viscosupplementation remain inconclusive. As such, the AAOS does not currently recommend viscosupplementation as routine treatment for osteoarthritis of the knees.

Nature of Statutory Criteria/Case Summary: An enrollee has requested viscosupplementation with Hyalgan injections. Findings – The physician reviewer found the submitted documentation supports that the requested medication is medically necessary. Current medical literature continues to support the use of viscosupplementation for osteoarthritis of the knees. There is good evidence that intra-articular hyaluronic acid injections reduce pain and increase function in knee osteoarthritis, and the benefits are long-lasting as compared with intra-articular corticosteroids. Evidence from studies of repeat courses of intra-articular hyaluronic acid demonstrates an improvement in pain or function lasting up to 40 months, a reduction in use of concomitant analgesia by up to 50%, and suggests that there may be a delay in the need for total knee replacement of around two years.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient with a diagnosis of chronic low back, bilateral hip, and bilateral shoulder pain. The patient rated pain a 7 out of 10 without medications. She was taking Vicodin and ibuprofen without relief. She reported that she was having a lot of bilateral shoulder pain, alternating between the right and left, with an associated cracking sound. She reported pain and difficulty performing activities of daily living. She reported that her hip pain was constant and making it difficult for her to walk, stand, sit or move. She had physical therapy but felt like it made the pain worse. Her symptoms had improved after a corticosteroid injection into the hips. Bilateral shoulder and hip examinations were not documented.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Hyalgan injections for treatment of her osteoarthritis. Findings: The physician reviewer found that the American Academy of Orthopedic Surgeons (AAOS) has changed their policy with regard to viscosupplementation and state that “we cannot recommend using hyaluronic acid for patients with symptomatic osteoarthritis of the knee”. The medical literature concluded that treatment of knee osteoarthritis with injections of intra-articular hyaluronic acid does not meet CTAF criteria for safety, efficacy and improvement in health outcomes for progression to knee replacement or progression of disease. In addition, the medical literature reported that in patients with knee osteoarthritis, viscosupplementation is associated with a small and clinically irrelevant benefit and an increased risk for serious adverse events.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Hyalgan Injections, then check the rights and deadlines that apply to your plan.