Intra-articular hyaluronan injections should be reported under code 20610 (arthrocentesis, major joint) to represent the aspiration/injection procedure.  The specific preparation used should be reported using code J7321 for Supartz® and Hyalgan®, J7325 for Synvisc® or Synvisc-One™, J7323 for Euflexxa®, J7324 for Orthovisc®, and J7326 for Gel-One®.

Coverage for intra-articular hyaluronan injections is determined according to individual or group customer benefits.  When a benefit, intra-articular hyaluronan injections are eligible when all of the following criteria have been met:

1. The patient has symptomatic osteoarthritis of the knee;
2. The medical record contains documentation that the patient has failed to respond to conservative therapy methods (analgesics, NSAIDs or intra-articular corticosteroid injections), or is unable to tolerate conservative therapy methods, because of adverse side effects;
3. There are no contraindications to the hyaluronan injections;
4. The hyaluronan product is FDA-approved for intra-articular injections of the knee. Supartz, Hyalgan, Synvisc, Synvisc-One, Euflexxa, Orthovisc, and Gel-One are FDA-approved for this indication.

If the arthrocentesis and the injection are performed for reasons other than those stated in criteria 1, 2, 3 and 4, deny both the arthrocentesis and the preparation as not medically necessary.

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

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

When therapeutic injections are not a benefit of a member's contract, deny the preparation administered and the arthrocentesis as non-covered services. However, the arthrocentesis will pay on initial processing.

NOTE:

Intra-articular hyaluronan injections, (e.g., Supartz, Hyalgan, Synvisc, Synvisc-One, Euflexxa, Orthovisc, and Gel-One), for osteoarthritis of the knee are classified as therapeutic injection procedures under medical-surgical benefits. They are not subject to the pharmacy benefit.

When arthrocentesis is performed as a stand-alone procedure, see Medical Policy Bulletin S-31 for guidelines.

Do not apply Medical Policy Bulletin S-31 guidelines to intra-articular hyaluronan injections.

Following are the frequency requirements for Supartz, Hyalgan, Synvisc, Synvisc-One, Euflexxa, Orthovisc, and Gel-One:

• Supartz - one injection per week for five weeks.
• Hyalgan - one injection per week for three or five weeks.
• Synvisc - one injection per week for three weeks.
• Synvisc-One - a single intra-articular injection
• Euflexxa - one injection per week for three weeks.
• Orthovisc - one injection per week for three to four weeks.
• Gel-One - a single intra-articular injection.

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 (Synvisc-One) or completion of  the prior series of injections (Supartz, Hyalgan, Synvisc, Euflexxa, or Orthovisc).
• The medical record must objectively document significant improvement in pain and functional capacity of the knee joint.

Refer to Pharmacy Policy Bulletin J-501 for information on intra-articular hyaluronan injections.

Place of Service: Outpatient

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 pseudoseptic reactions.

Description

Osteoarthritis is the most common form of arthritis. Pathologically, in the knee, osteoarthritis is characterized by deterioration and loss of articular cartilage, subchondral sclerosis and osteophyte formation. Since there are no curative therapies for osteoarthritis at this time, the overall goals of existing therapies are to reduce pain, prevent disability, and postpone the need for total knee replacement surgery.

Conservative methods of therapy for osteoarthritis may include the use of simple analgesics, (e.g., acetaminophen), nonsteroidal anti-inflammatory drugs (NSAIDs) and intra-articular corticosteroid injections. For patients who fail to respond to these conservative therapies, there is yet another form of treatment for the osteoarthritic knee called intra-articular injections of hyaluronan. Brand name examples of hyaluronan are Supartz, Hyalgan, Synvisc, Synvisc-One, Euflexxa, Orthovisc, and Gel-One.

Intra-articular injections of hyaluronan act as lubricants to restore elasticity and viscosity to the arthritic knee. The procedure involves an arthrocentesis to aspirate the bad or damaged synovial fluid from the knee. Then, to replace the fluid, the hyaluronan preparation (Supartz, Hyalgan, Synvisc, Synvisc-One, Euflexxa, Orthovisc, or Gel-One) is injected.

NOTE:

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.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits or a contract. Benefits are determined by the Federal Employee Program.

10/1998, Intra-articular hyaluronan injection coverage varies with patient benefits
02/1998, Intra-articular hyaluronan injections for osteoarthritis, not covered
02/1999, New reporting guidelines for intra-articular hyaluronan injections
06/1999, Correction: New reporting guidelines for intra-articular hyaluronan injections
08/2001, Repeat treatment cycles of intra-articular hyaluronan injections (e.g., Synvisc, Hyalgan)
04/2006, Coverage guidelines for intra-articular hyaluronan injections for osteoarthritis of the knee apply to Synvisc, Hyalgan, Supartz, and Orthovisc
10/2011, Criteria for intra-articular hyaluronan injections for osteoarthritis of the knee revised
08/2012, Place of service designation included on additional medical policies 

Facility Bulletin

Medical Policy on Hyaluronan Injections for Osteoarthritis of the Knee to apply to Facility Business, effective July 23, 2012

Euflexxa™ (1% sodium hyaluronate) [package insert]. Parsippany, NH: Ferring Pharmaceuticals Inc.

Hyalgan® (Sodium Hyaluronate) [package insert]. Bridgewater, NJ: sandi-aventis U.S. LLC;09/2007.

Orthovisc® High Molecular Weight Hyaluronan [package insert]. Raynham, MA: DePuy Mitek, Inc.

Supartz® (sodium hyaluronate) [package insert]. Memphis, TN: Smith & Nephew, Inc.; 01/2007.

Synvisc® Hylan G-F 20 [package insert]. Ridgefield, NJ: Genzyme Biosurgery: 12/2006.

Sinvisc-One™ Hylan G-F 20 [package insert]. Ridgefield, NJ: Genzyme Biosurgery: 02/2009

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