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®, and J7324 for Orthovisc®.

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 and Orthovisc 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. They are not covered. 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 noncovered services. However, the arthrocentesis will pay on initial processing.

NOTE:

Intra-articular hyaluronan injections, (e.g., Supartz, Hyalgan, Synvisc, Synvisc-One, Euflexxa and Orthovisc), 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 S-31 guidelines to intra-articular hyaluronan injections.

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

• 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.

• 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.

NOTE:

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

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 and Orthovisc.

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 or Orthovisc) 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.

PRN References

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

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

Anandacoomarasamy A, Bagga H, Ding C, Burkhardt D, Sambrook PN, March LM. Predictors of clinical response to intraarticular Hyalan injections – a prospective study using synovial fluid measures, clinical outcomes, and magnetic resonance imaging. J Rheumatol. 2008;35(4):685-90.

Atlay T, Asian A, Baydar ML, Ceylan B, Baykal B, Kirdemir V. The efficacy of low- and high-molecular weight hyaluronic acid applications after arthroscopic debridement in patients with osteoarthritis of the knee. Acta Orthop Traumatol Turc. 2008;42(4):228-33.

Brzusek D, Petron D. Treating knee osteoarthritis with intra-articular hyaluronans. Curr Med Res Opin. 2008;24(12):3307-22.

Conrozier T, Chevalier X. Long-term experience with hylan GF-20 in the treatment of knee osteoarthritis. Expert Opin Pharmacother. 2008;9(10):1797-804.

Huskin JP, Vandekerckhove B, Delince P, Verdonk R, Dubuc JE, Willems S, Hardy P, Blanco FJ, Charrois O, Handelberg F. Multicentre, prospective, open study to evaluate the safety and efficacy of hylan G-F 20 in knee osteoarthritis subjects presenting with pain following arthroscopic meniscectomy. Knee Surg Sports Traumatol Arthrosc. 2008;16(8):747-52.

Raman R, Dutta, A, Day N, Sharma HK, Shaw CJ, Johnson GV. Efficacy of hylan G-F 20 and sodium hyaluronate in the treatment of osteoarthritis of the knee – a prospective randomized clinical trial. Knee. 2008;15(4):318-24.

Zietz PM, Selesnick H. The use of hylan G-F 20 after knee arthroscopy in an active patient population with knee osteoarthritis. Arthroscopy. 2008;24(4):416-22.

Briem K, Axe MJ, Snyder-Mackler L. Medial knee joint loading increases in those who respond to hyaluronan injection for medial knee osteoarthritis. J Orthop Res. 2009 [Epub ahead of print].

Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, Bailleul F, Pavelka K. Single, intra-articular treatment with 6 ml of hyalan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: A randomized, multi-centre, double-blind, placebo-controlled trial. Ann Rheum Dis. 2009 [Epub ahead of print].