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Viscosupplementation for Osteoarthritis

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 02.01.12 
Original Effective Date: August 1998 
Reviewed: September 2014 
Revised: September 2013 


Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description: 

The intent of the viscosupplementation for osteoarthritis medical policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines and clinical studies.  There are seven (7) intra-articular hyaluronic acid derivatives included in this policy that have been approved by the Food and Drug Administration for the treatment of osteoarthritis of the knee in patients who have failed to respond to conservative non-pharmacologic therapy and simple analgesics:

  • Supartz® and Hyalgan® (sodium hyaluronate)
  • Euflexxa® (1% sodium hyaluronate)
  • Orthovisc® (high molecular weight hyaluronan)
  • Synvisc® and Synvisc-One® (hylan G-F 20)
  • Gel-One®(cross-linked hyaluronate)

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Prior Approval: 

 

Not applicable


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Policy: 

I.  A course of 3-5 weekly intra-articular hyaluronan injections be considered medically necessary for the treatment of painful osteoarthritis of the knee in patients when all of the following criteria are met:

  • The patient is 18 years of age or older
  • The patient has experienced insufficient pain relief from conservative non-pharmacologic therapies and simple analgesics.

II.  Synvisc-One® and Gel-One®, which are administered as a single intra-articular injection during a 6 month period of time, are considered medically necessary for the treatment of painful osteoarthritis of the knee in patients when all of the following criteria are met:

  • The patient is 18 years of age or older
  • The patient has experienced insufficient pain relief from conservative non-pharmacologic therapies and simple analgesics.

III.  One additional course of intra-articular hyaluronan injections may be considered medically necessary for treatment of painful osteoarthritis of the knee in patients when all of the following criteria are met:

  • Significant pain relief was achieved with the prior course of injections
  • At least 6 months has passed since the prior course of injections

 

IV.  Intra-articular hyaluronan injections are considered not medically necessary for patients who do not meet the criteria set forth above.

 

V.   The use of intra-articular hyaluronan injections into joints other than the knee is considered investigational.

 

 

CLINICAL RATIONALE

 

Osteoarthritis (OA) is the result of an imbalance between the breakdown and repair of the tissues in the synovial joint organ and occurs as a result of multiple risk factors including trauma, overuse and genetic predisposition. Pathological presentation in the knee is characterized by deterioration and loss of articular cartilage along with increased osteophyte formation, causing joint pain and stiffness.

 

Viscosupplementation involves the injection of hyaluronic acid derivates into the knee to supplement the viscous properties of the synovial fluid, thereby improving mobility, decreasing pain and restoring protective function on the joint.

 

In the 2012 American College of Rheumatology (ACR) recommendations for the use of pharmacologic therapies in knee OA, treatment modalities conditionally recommended for initial management include acetaminophen, oral and topical NSAIDs, tramadol and intra-articular corticosteroid injections. Intra-articular hyaluronate (IAHA) injections are among the agents conditionally recommended in those who fail conservative management. The 2007 Osteoarthritis Research Society International (OARSI) guidelines made similar recommendations but went on to state IAHA therapies were effective for symptomatic relief of knee OA; however their effect was delayed and prolonged when compared to intra-articular corticosteroids. The American Academy of Orthopaedic Surgeons (AAOS) released its 2013 revised guidelines on the treatment of knee OA which does not recommend use of IAHA agents. Although a few individual studies found statistically significant treatment effects, the evidence did not meet minimum thresholds for clinical improvement when combined together in a meta-analysis.

 

A treatment cycle for most hyaluronic acid derivatives involves weekly injections with the exception of Synvisc One® and Gel One® which requires only one injection. Improvements in symptoms can last one to six months. Recently, evidence regarding repeat courses of IAHA for knee OA was evaluated by the California Technology Assessment Forum. Their findings stated that repeated IAHA injections have shown symptomatic relief of knee OA. They did note that repeated injections have not been shown to slow progression of knee OA or progression to knee replacement.

 

The evidence for use of IAHA injections for joints other than the knee is less robust. While some studies show benefit, others do not. Systematic reviews have not concluded that there is a clinically significant benefit. Given the limited and inconsistent data available, these uses are considered investigational.





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Procedure Codes and Billing Guidelines: 

  • To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
  • 20610 for professional services for Intraarticular injection
  • J7321 Hyaluronan or derivative, Hyalgan or Supartz, for intra-articular injection, per dose
  • J7323 Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose
  • J7324 Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose
  • J7325 Hyaluronan or derivative, Synvisc or Synvisc-One, for intra-articular injection, 1 mg
  • J7326 Hyaluronan or derivative, Gel-One, for intra-articular injection, per dose

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Selected References: 

  • Supartz. (2012, June). [package insert]. Durham, NC: Seikagaku Corporation.
  • Hyalgan (2011, June). [package insert]. Parsippany, NJ: Fidia Pharma USA Inc.
  • Euflexxa (2011, September). [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.
  • Orthovisc (2005, June). [package insert]. Woburn, MA: Anika Therapeutics Inc.
  • Synvisc (2010, March). [package insert]. Ridgefield, NJ: Genzyme Corporation.
  • Synvisc One (2010, March). [package insert]. Ridgefield, NJ: Genzyme Corporation.
  • Gel-One (2011, May). [package insert]. Warsaw, IN: Seikagaku Corporation.
  • Zhang W, Moskowitz R, Nuki G et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008; 16(2):137-162.
  • Hochberg M, Altman R, April KT et al. American College of Rheumatology 2012 recommendations for the use of non-pharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis care & research 2012; 64(4):465-474.
  • California Technology Assessment Forumleave site&trade. Hyaluronic acid for treatment of osteoarthritis of the knee: repeated injections and progression to knee replacement. February 2012. Accessed on August 28, 2013.
  • American Academy of Orthopaedic Surgeons (2013). Treatment of osteoarthritis of the knee: evidence- based guideline 2nd. American Academy of Orthopaedic Surgeons.
  • Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Intra-Articular Hyaluronan Injections for Treatment of Osteoarthritis of the Knee. TEC Assessments 1998; Volume 13, Tab 17.

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Policy History: 

 

Date                                        Reason                               Action

August 2010                           Annual review                     Policy renewed

October 2011                         Annual review                     Policy renewed

October 2012                         Annual review                     Policy renewed

September 2013                     Annual review                     Policy renewed

September 2014                     Annual review                     Policy renewed


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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.

 
Contact Information
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
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