This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

The following FDA approved hyaluronan preparations are the preferred Injections:

Synvisc®, Synvisc-One® (hylan G-F 20) and  Euflexxa® (sodium hyaluronate)
Intra-articular hyaluronan injections may be considered medically necessary when ALL of the following are met:

• The patient has documentation of diagnosis and symptomatic 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 (ex., MD, DO, PA and CRNP). Injections cannot be performed by nursing or other medical personnel. Generally, intra-articular injections are administered in an office-setting. 

*Conservative therapy includes all of the following:

• Activity modification, participation in a home exercise program implemented by a physical therapist, protective weight bearing; and
• Analgesics (e.g., acetaminophen, NSAIDS) up to four times daily, topical anti-inflammatory preparations including capsaicin cream applied to affected knee joint, and
• Intra-articular corticosteroid injections; or
• The individual is unable to tolerate conservative therapy because of adverse side effects or other medical condition.

If the arthrocentesis and the injection are performed for reasons other than those stated in the above criteria, or for other body joints they will be considered not medically necessary.

Non-Preferred Injections (Hyalgan or Supartz, Orthovisc, Gel One, Monovisc)
Non-preferred Intra-articular hyaluronan injections may be considered medically necessary when ANY ONE of the following are met:

• The member must have had an adequate therapeutic trial and experienced a documented drug therapy failure with all applicable preferred intra-articular hyaluronan products; or
• The member is being treated with a non-preferred intra-articular hyaluronan product for an indication for which a non-preferred product is FDA-approved.

Note:

• An “adequate therapeutic trial” consists of using a preferred product at recommended doses for a period of time adequate to assess therapeutic benefit (unless the patient 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 or Supartz, Orthovisc, Gel One, Monovisc) are considered not medically necessary if the above criteria is not met.

Repeat Treatment Cycles
Repeat treatment cycles, (i.e., any further injections over and above the specified frequency requirements) for patients who have responded to the previous courses of treatment may be given individual consideration for coverage under these circumstances:

• At least six months must have elapsed since the previous injection (e.g., Synvisc-One) or completion of  the prior series of injections (e.g., Supartz, Hyalgan, Synvisc, Euflexxa, Monovisc or Orthovisc); 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 are considered not medically  necessary if the above criteria is not met.

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

The following hyaluronan products are FDA-approved for intra-articular injections of the knee: 

• Supartz®   (sodium hyaluronate)
• Hyalgan®  (sodium hyaluronate)
• Synvisc®   (hylan G-F 20)
• Synvisc-One™(hylan G-F 20)
• Euflexxa®  (1% sodium hyaluronate)
• Orthovisc® (high-molecular-weight hyaluronan)
• Gel-One®  (hyaluronic acid)
• Monovisc® 

Dosage recommendations per the FDA label.

The administration of Intra-Articular Hyaluronan Injections for Osteoarthritis of the Knee is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

• Link to Provider Resource Center for the Medical Policy Update

11/2015, Hyaluronan Injections Criteria Revised

• Link to Diagnosis Codes

• Link to References