Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: A female enrollee has requested authorization and coverage for Hymovis injections. The Health Plan has denied this request indicating that the requested treatment is not medically necessary for treatment of the enrollees osteoarthritis. At issue in this case is whether the requested treatment, Hymovis injections, is medically necessary for treatment of the enrollees medical condition.Hyaluronic acids (HA) are naturally occurring connective tissue materials that help cushion and lubricate joints. Intra-articular injection of avian-derived or synthetic HA, also called viscosupplementation, can decrease osteoarthritis (OA) symptoms in some but not all patients; with sustained improvements in pain and functional outcomes, and few adverse events. However, data indicates that HA compared to placebo for knee OA had similar overall results; but HA showed somewhat superior improvement in knee pain and function, with no differences noted between three or six consecutive injections.The American Academy of Orthopaedic Surgeons guideline for treatment of osteoarthritis of the knee does not recommend HA for patients with symptomatic OA, based on strong evidence. Fourteen HA studies were analyzed, and it was noted that a few individual trials found statistically significant treatment effects, but when combined in a meta-analysis, the evidence did not meet their minimum clinically important improvement (MCII) thresholds. It was conceded that there might be some subgroup of responders who could be helped by HA, but that subgroup has not yet been identified. The American College of Rheumatology and Osteoarthritis Research Society make no official recommendation regarding HA. The U.K. National Institute for Health and Care Excellence (NICE) does not recommend HA. Per national guidelines, criteria for viscosupplementation are as follows:(1) Patients experience significantly symptomatic osteoarthritis but have not responded adequately to recommended conservative non-pharmacologic (e.g., exercise) and pharmacologic treatments, or are intolerant of these therapies (e.g., gastrointestinal problems related to anti-inflammatory medications), after at least 3 months;(2) Documented symptomatic severe osteoarthritis of the knee, which may include the following: Bony enlargement; Bony tenderness; Crepitus (noisy, grating sound) on active motion; Less than 30 minutes of morning stiffness; No palpable warmth; Over 50 years of age.(3) Pain interferes with functional activities (e.g., ambulation, prolonged standing) and not attributed to other forms of joint disease;(4) Failure to adequately respond to aspiration and injection of intra-articular corticosteroids;(5) Generally performed without fluoroscopic or ultrasound guidance;(6) Are not currently candidates for total knee replacement or who have failed previous knee surgery for their arthritis, unless younger patients wanting to delay total knee replacement.(7) Repeat series of injections: If documented significant improvement in symptoms for 6 months or more, and symptoms recur, may be reasonable to do another series. No maximum established by high-quality scientific evidence; see the section `Repeat series of injections` below.(8) Hyaluronic acid injections are NOT recommended for any other indications such as chondromalacia patellae, facet joint arthropathy, osteochondritis dissecans, patellofemoral arthritis, patellofemoral syndrome (patellar knee pain), plantar nerve entrapment syndrome, or for use in joints other than the knee (e.g., ankle, carpo-metacarpal joint, elbow, hip, metatarsophalangeal joint, shoulder, or temporomandibular joint) since the effectiveness of hyaluronic acid injections for these indications has not been established.In this case the submitted clinical documentation does not support the use of viscosupplementation injections to treat the patients medical condition. Requested treatment is not endorsed by the American Academy of Orthopaedic Surgeons or the American College of Rheumatology due to lack of convincing evidence supporting its efficacy. In addition, the clinical documentation does not support that the patients condition, patellofemoral arthritis, meets treatment criteria supported by national guidelines. Therefore, the requested treatment is not medically necessary.Final Result: The reviewer determined that the requested treatment is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.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.