Hyaluronic Acid Injections for Knee Osteoarthritis

Jurisdiction: JJ Part B. States: Alabama, Georgia, Tennessee. Type: Active LCD

In the United States (U.S.), osteoarthritis (OA) is the most common type of arthritis and joint disorder, with the knee being the most frequently involved symptomatic joint. 7 Degenerative joint disease (usually termed OA) of the knee is a condition characterized by the progressive destruction of the articular cartilage that lines the knee joints, the subchondral bone surfaces, and synovium, accompanied by pain, immobility, and reduction in function and the ability to complete activities of daily living (ADL). 1 Knee OA is a chronic debilitating condition - predominantly occurring among the elderly - that affects a large share of the population worldwide. It is the predominant form of arthritis and the leading cause of disability in the U.S. 5 Hyaluronic acid (HA) is a component of synovial fluid, which lubricates the joint and absorbs shock. HA is a glycosaminoglycan molecule within the knee joint where it provides viscoelastic properties to synovial fluid. 3 HA is a glycosaminoglycan that occurs naturally within the synovial fluid of the knee, providing lubrication of the joint and protecting the cartilage from mechanical degradation. HA has been shown to provide anti-inflammatory and chondroprotective effects, increase proteoglycan and HA synthesis, and reduce nerve impulses and nerve sensitivity associated with OA pain. 16 HA production is generally reduced and may be of poorer quality with OA, which may exacerbate inflammation. Intra-articular HA aims to replace depleted or poor-quality HA in the joint. HA is available commercially prepared and ready for injection. HA products differ by molecular weight and cross-linkage. HA injections reduce cartilage breakdown that results from a loss of cartilage oligomeric matrix protein and also reduces inflammatory cytokines such as interleukin-1. 7 HA is also known as Hyaluronan or Hyaluronate. Intra-articular injection of HA is also known as viscosupplementation. Viscosupplementation is the injection of an intra-articular compound made of high molecular weight fluid containing hylan products (derivative of hyaluronan) that essentially functions as a viscoelastic glycosaminoglycan. 8 Patients with OA of the knee who are not responsive to conservative treatments, may be candidates for intra-articular HA for treatment of knee OA. There are several viscosupplementation products (such as Euflexxa ® , Durolane ® , Gel-One ® , GenVisc ® 850, Gelsyn-3 ® , Hyalgan ® , Hymovis ® , Monovisc ® , Orthovisc ® , Supartz FX ® , Synvisc ® , Synvisc-One ® , SynoJoynt™, Visco-3™, TriVisc ® , and Triluron ® ) that have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of pain associated with OA of the knee who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). Covered Indications Various Hyaluronan preparations (viscosupplementation) for intra-articular injections of the knee are considered reasonable and necessary when ALL of the following criteria documented in the medical record are met: 1. Symptomatic OA of the knee. Pain that interferes with functional activities (such as, ambulation and prolonged standing). 2. The diagnosis is supported by radiographic evidence of OA of the knee, for example, joint space narrowing, subchondral sclerosis, osteophytes, and subchondral cysts. 3. Trial and failure or contraindication of at least 3 months of conservative therapy: Non-pharmacologic therapy (e.g., physical therapy, exercise, weight management, self-management programs, knee brace, cane) Pharmacologic therapy (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) (oral, topical), topical capsaicin) 4. Failure of or contraindication to intra-articular glucocorticoid injections. For patients who have responded to a prior series, a REPEAT* series of viscosupplement therapy is considered reasonable and necessary when ALL of the following are met: Patient continues to meet initial criteria Symptoms have recurred Patient has experienced improvement in pain and functional capacity following the previous series of injections At least 6 months have elapsed since the prior series of injections * A series is defined as a set of injections for each joint and each treatment as per the FDA prescribing information Limitations Services that are not reasonable and necessary and cannot be covered by Medicare are the following: 1. The dose and frequency of administration should be consistent with the FDA approved labeling. Doses and frequencies that exceed the FDA recommended dosage/frequency as per the prescribing information, are considered not reasonable and necessary and not covered by Medicare. 2. Initiation of a repeat series of treatment when at least 6 months have not elapsed since the prior series of injections is considered not reasonable and necessary and not covered. 3. It is considered not reasonable and necessary as the initial treatment of OA of the knee. 4. It is contraindicated with infections or skin disease in the area of the injection site or joint and considered not reasonable and necessary and not covered by Medicare. 5. It is contraindicated to administer these products if you are allergic to hyaluronate products. 6. A diagnosis other than OA is considered not reasonable and necessary and not covered by Medicare. 7. When there was no improvement in knee pain and functional improvement from a previous series of injections, a repeat series of injections will be considered not reasonable and necessary and will not be covered. 8. Imaging procedures for the purpose of needle guidance that may be considered reasonable and necessary are ultrasound or fluoroscopy. The documentation must support why imaging is needed for needle guidance and insertion. Other imaging modalities (e.g., computed tomography (CT) scan, magnetic resonance imaging (MRI), arthrography) for the purpose of needle guidance and insertion will be considered not reasonable and necessary and not covered by Medicare.