Gel-one Injection denials: what the review data shows

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient requested Gel One injections. Findings: The physician reviewer found that requested injections are medically necessary. The submitted orthopedic report documented complaints of bilateral knee pain. Functional limitations were noted in sitting, standing, and walking for prolonged periods of time, and pain interfered with activities of daily living. Bilateral knee X-rays demonstrated severe bilateral osteoarthritis. The diagnosis included severe bilateral medial compartment degenerative and post-traumatic osteoarthritis. The provider recommended the Gel One injections for the patient’s bilateral knees for primary osteoarthritis. In a meta-analysis of 137 studies with 33,243 participants, hyaluronic acid was found to be better than injected placebo or injected corticosteroids.

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for bilateral knee injections with Gel-One. Findings: The physician reviewer found that 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.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Gel-One® injections to the right knee, every six months. Findings: The physician reviewer found that viscosupplementation with hyaluronic acid for knee osteoarthrosis has been performed in the United States since 1997 and is now an established part of treatment algorithms for the management of osteoarthritic knee pain and is a second-line treatment after simple pain medications such as nonsteroidal anti-inflammatory medications. Multiple studies have documented both safety and efficacy, but individual results vary. There is currently a lack of scientific evidence that one brand name is more effective than another.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Gel-one Injectionwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.