Intra-articular injections of hyaluronan (also known as sodium hyaluronate) act as lubricants to restore elasticity and viscosity to the arthritic knee. The procedure involves an arthrocentesis to aspirate the damaged synovial fluid or joint effusion if present from the knee as directed by product. Then the hyaluronan preparation is injected intra-articularly into the knee synovial capsule (if treatment is bilateral, a separate syringe is used for each knee).

The following preferred hyaluronan preparations Euflexxa® (1% sodium hyaluronate), Durolane® (hyaluronic acid), Supartz™ (sodium hyaluronate), and GelSyn-3™ (hyaluronic acid) may be considered medically necessary when ALL of the following are met:

• The patient has documentation of diagnosis of symptomatic painful osteoarthritis of the knee and there is no evidence of inflammatory arthritis (e.g., rheumatoid arthritis); and
• There is documentation of failure to respond adequately to at least three (3) months of conservative* therapy; and
• There are no contraindications to the hyaluronan injections; and
• There is documentation that the pain interferes with functional activities (e.g., ambulation, prolonged standing); and
• Cause of pain cannot be attributed to other forms of joint disease; and
• The injections are performed by a licensed medical professional (e.g., MD, DO, PA or CRNP). Injections cannot be performed by nursing or other medical personnel.

*Conservative therapy includes the following:

• Activity modification, participation in a home exercise program implemented by a physical therapist, protective weight bearing; and
• Non-narcotic analgesics (e.g., acetaminophen, NSAIDS) at Food and Drug Administration (FDA) or compendia based recommended therapeutic doses for osteoarthritis of the knee for a period of time adequate to assess therapeutic benefit, topical external analgesic preparations including capsaicin cream applied to affected knee joint, topical anti-inflammatory preparations applied to affected knee joint; and
• Intra-articular corticosteroid injections; or                                            
• The individual is unable to tolerate conservative therapy due to adverse side effects or other medical condition.

Arthrocentesis and the injection of hyaluronic acid derivatives for all other body joints is considered not medically necessary.

The use of hyaluronan preparations Euflexxa (1% sodium hyaluronate), Durolane (hyaluronic acid), Supartz (sodium hyaluronate), and GelSyn-3 (hyaluronic acid) for any other indication is considered not medically necessary.

The following Non-Preferred hyaluronan preparations  (Hyalgan® (sodium hyaluronate), Orthovisc® (high molecular weight hyaluronan), Gel One® (cross-linked hyaluronate), Monovisc® (lightly cross-linked high molecular weight hyaluronic acid), GenVisc 850® (sodium hyaluronate), Synvisc® (hylan G-F 20), Synvisc-One® (hylan G-F 20), Hymovis® (high molecular weight viscoelastic hyaluronan)) Synojoynt^TM (1% sodium hyaluronate) Triluron^TM (Sodium Hyaluronate), Visco-3 (sodium hyaluronate), and generic sodium hyaluronate 1% solution for injection may be considered medically necessary when BOTH of the following are met:

• The member has met ALL the clinical criteria requirements as stated above for the preferred injections; and
• The member must have had an adequate* therapeutic trial and experienced a documented drug therapy failure** with all applicable preferred intra-articular hyaluronan products.

*An adequate therapeutic trial is defined as six (6) months following a complete injection series of a preferred product at FDA or compendia based recommended therapeutic doses (unless the individual experiences an intolerable adverse effect due to drug therapy within that time period).  

**Drug therapy failure consists of not achieving the desired therapeutic goal, development of an intolerable adverse effect due to drug therapy, or development of a hypersensitivity reaction to the drug product. The length of therapy with the preferred product(s) and the reason(s) for drug therapy failure should be documented.

Non-Preferred Injections (Hyalgan (sodium hyaluronate), Orthovisc (high molecular weight hyaluronan, Gel One (cross-linked hyaluronate), Hymovis (high molecular weight viscoelastic hyaluronan), GenVisc 850 (sodium hyaluronate), Synvisc (hylan G-F 20), Synvisc-One (hylan G-F 20), Monovisc (lightly cross-linked high molecular weight hyaluronic acid) Synojoynt (1% sodium hyaluronate) Triluron (Sodium Hyaluronate) and generic 1% sodium hyaluronate solution for injection) for any other indication are considered not medically necessary.

Repeat Treatment Cycles

An additional course of the previously approved viscosupplementation therapy may be considered medically necessary for treatment of painful osteoarthritis of the knee when ALL of the following are met:

• At least six (6) months must have elapsed since the previous injection or completion of  the prior series of injections; and
• The patient and provider have elected to continue conservative/non-surgical management of the osteoarthritis (no surgery planned within six (6) months of viscosupplementation therapy); and
• The medical record must document a reduction in the dose of analgesics or anti-inflammatory medications in the three (3) month period following the injection series (NOTE: not required if the member requires these medications for a comorbid medical condition in addition to knee osteoarthritis); and
• The medical record must objectively document significant improvement in pain and functional capacity of the knee joint. (e.g., an improvement in an objective measurement of pain and/or functional status Visual Analog Scale [VAS], Western Ontario and McMaster Universities Osteoarthritis [WOMAC] Index, or other validated objective measure).

Repeat treatment cycles of Intra-Articular Hyaluronan injections for any other indication are considered not medically necessary.

Imaging guidance is considered not medically necessary when performed during intra-articular hyaluronan injections for osteoarthritis of the knee.

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.