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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that hyaluronic acid, also known as hyaluronan or hyaluronate, is a naturally occurring substance 
found in the synovial fluid surrounding joints. Osteoarthritic joints are found to have lower concentrations of 
hyaluronic acid. Intra-articular injection of hyaluronic acid, also known as viscosupplementation, has been 
proposed as a means of restoring the normal viscoelasticity of the synovial fluid in individuals with 
osteoarthritis. 
 
Viscosupplementation is most commonly used to treat symptoms of osteoarthritis of the knee. Osteoarthritis 
(OA) results from articular cartilage failure due to the complex interplay of genetic, metabolic, biochemical and 
biomechanical factors with a secondary component of inflammation. In most patients the initiating mechanism 
is damage to the articular cartilage either as a single large injury or a series of repeated smaller injuries. The 
primary symptom of osteoarthritis of the knee is pain, however, because cartilage is aneural, significant 
radiographic findings are often noted in asymptomatic individuals imaged for other reasons. 
 
Typical candidates for viscosupplementation are those with knee osteoarthritis who have failed to improve with 
other non-surgical treatments. Several synthetic preparations of hyaluronic acid-based polymers have been 
approved by the U.S. Food and Drug Administration (FDA) as a device indicated for the treatment of pain in 
OA of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy 
and simple analgesics (e.g., acetaminophen) or non-steroidal anti-inflammatory drugs (NSAIDS). 
 
The most recent research, however, has not found viscosupplementation to be effective at significantly 
reducing pain or improving function. Although some patients report pain relief with the procedure, others are 
not helped by the injections. 
 
Viscosupplementation therapy for the knee via intra-articular injections of hyaluronic preparations will be 
considered medically reasonable and necessary when ALL of the following conditions are met: 
 
    The patient is symptomatic. Such symptoms may include pain which interferes with the activities of daily 
living such as ambulation and prolonged standing, or pain interrupting sleep, crepitus, and/or knee stiffness. 
    The clinical diagnosis is supported by radiologic evidence of osteoarthritis of the knee such as joint space 
narrowing, subchondral sclerosis, osteophytes and sub-chondral cysts. 
    If appropriate, other diagnoses have been excluded by appropriate evaluation and management services, 
laboratory and imaging studies (i.e., the pain and functional disability is not considered likely to be due to a 
diagnosis other than osteoarthritis of the knee).     The patient has failed at least three months of conservative therapy. Conservative therapy is defined as: 
        Nonpharmacologic therapy (such as but not limited to home exercise program, education, weight loss, 
physical therapy if indicated); and 
        If not contraindicated, simple analgesics and (e.g., acetaminophen) or NSAIDS per hyaluronan product 
prescribing information. 
    The patient has failed to respond to aspiration of the knee when effusion is present and intra-articular 
corticosteroid injection therapy when inflammation is a significant component of the patients symptoms and 
intra-articular corticosteroids are not contraindicated. 
 
A repeat series* of hyaluronan knee injection(s) for patients who have responded to a prior series is considered 
to be reasonable and necessary under the following circumstances: 
 
    Symptoms have recurred 
    And, 
    At least six months have elapsed since the prior series of injections 
    And, 
    There was significant improvement in pain and functional capacity achieved with the prior series of 
injections using a standardized assessment tool 
    Or, 
    There is significant reduction in the doses of NSAID medications taken or reduction in the number of intra-
articular steroid injections to the knees during the six-month period following the injection(s). 
 
*Note: A series is defined as a set of injections for each joint and each treatment (initial or repeat). 
 
The following are considered not reasonable and necessary and therefore will be denied: 
 
    Drugs and biologicals and other products approved for marketing by the FDA are considered safe and 
effective when used for indications specified on the labeling. The labeling lists the safe and effective, i.e., 
medically reasonable and necessary dosage and frequency. Therefore, doses and frequencies that exceed the 
accepted standard of recommended dosage and/or frequency, as described in the package insert, are considered 
not reasonable and necessary and therefore, not subject to coverage. 
    Intra-articular injections of other therapeutic agents, such as corticosteroids, should not be performed in the 
same knee during the course of viscosupplementation therapy unless there is documented medical necessity 
(e.g., for documented reactions requiring the use of the additional therapeutic agent). 
    Viscosupplementation of joints other than the knee(s) are considered not reasonable and necessary and are 
not subject to coverage. 
    Imaging procedures (e.g., arthrography, CT scan, MRI) for the purpose of visualization of the knee to 
provide guidance for needle placement are considered not medically reasonable and necessary and will not be 
covered. The only imaging procedures that may be considered reasonable and necessary for the purpose of 
needle guidance for viscosupplementation are fluoroscopy or ultrasound. If needle guidance is utilized, the 
documentation must support that the presentation of the patients affected knee on the day of the procedure 
makes needle insertion problematic. Routine use of fluoroscopy or ultrasound guidance may result in a pre-
payment medical review of records. No other imaging modality for the purpose of needle guidance and 
placement will be covered. The imaging modality used for the purpose of needle guidance must be reported 
appropriately and in conjunction with the appropriate intra-articular injection procedure code for the knee. For 
coding information on the use of imaging procedures with viscosupplementation of the knee, please refer to the 
companion Article A55036, Billing and Coding: Hyaluronan Acid Therapies for Osteoarthritis of the Knee. 
    If the hyaluronan preparation is denied, then any associated procedure code(s) (e.g., intra-articular injection, 
fluoroscopy, ultrasound) would be considered not medically reasonable and necessary. 
   
You can find these rules in the Local Coverage Determination (LCD) Hyaluronan Acid Therapies for 
Osteoarthritis of the Knee L35427. If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.