Synvisc One denials in California external review

What the reviewers wrote

Where the denial was overturned

The enrollee is requesting authorization and coverage for an injection, Synvisc One, for the left knee. The enrollee has moderate left knee osteoarthritis. A magnetic resonance imaging (MRI) scan was ordered due to acute pain. The enrollee was status-post arthroscopic surgery and the documentation noted there was concern for another tear. The MRI results showed osteoarthritis with no new tears. His range of motion is restricted and painful. There is no effusion. There is medial femoral condyle tenderness. His patellar grind test is positive. There is no instability. The enrollee has received cortisone injections multiple times with good benefit in the beginning. However, they are no longer effective. The enrollee reported receiving less than one week of benefit from the last cortisone injection. He has received Synvisc One injections twice; one year ago and six months ago.

Findings: The physician reviewer found that the patient has requested authorization and coverage for a hyaluronan injection (Synvisc One) into 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. 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. Viscosupplementation is reserved for patients with a history of lasting benefit from prior injections and in cases where the remaining options are limited.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: A patient 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 patient’s primary bilateral osteoarthritis of the knees. The submitted documentation does not support the medical necessity of the requested medication. Evidence-based medical guidelines state that hyaluronic acid injections in the knee are recommended as a possible option for patients with severe osteoarthritis who have not responded adequately to recommended conservative treatments for at least three months, including failure to adequately respond to corticosteroid injections.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Synvisc-One injections (48 mg/6 ml syringe for treatment of the enrollee’s medical condition. Findings: The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested services. The evidence-based medical guidelines state that hyaluronic acid injections in the knee are recommended as a possible option for severe osteoarthritis for patients who have not responded adequately to recommended conservative treatments, to potentially delay total knee replacement. There is insufficient evidence for other conditions, including patellofemoral arthritis, chondromalacia patella, patellofemoral syndrome, or osteochondritis dissecans. This patient presents with right knee pain with reported difficulty weight-bearing and walking.

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 Synvisc One, then check the rights and deadlines that apply to your plan.