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®.

Preferred Injections
Synvisc, Synvisc-One (hylan G-F 20)
Euflexxa (sodium hyaluronate)

Intra-articular hyaluronan injections may be considered medically necessary when ALL of the following are met:

1. The patient has symptomatic osteoarthritis of the knee; and
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; and
3. There are no contraindications to the hyaluronan injections; and
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.

Arthrocentesis and the injection are performed for reasons other than those stated in the above criteria is considered not medically necessary.

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

Non-Preferred Injections
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 and all preferred products are not FDA-approved

Dosage recommendations per the FDA label.

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.

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.

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 (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.

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.

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

Services that do not meet the criteria of this policy will not be considered medically necessary. A Pennsylvania participating, preferred or 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. Out of Network/Non-participating providers and providers located outside of Pennsylvania may be able to bill members if the service is denied.

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.

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 
06/2013, Preferred and non-preferred injections for intra-articular hyaluronan injections

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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