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Medical Policy: 02.01.12
Original Effective Date: August 1998
Reviewed: October 2011
Revised: April 2009
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:
Viscosupplementation is a procedure that involves the injection of hyaluronates into a joint to supplement the viscous properties of synovial fluid, thereby improving mobility, decreasing pain, and restoring the natural protective functions of hyaluronan in the joint. Depending on the preparation, hyaluronan is typically administered in a series of weekly intra-articular injections over a course of three to five weeks. Several preparations are available including, but not limited to, Synvisc® and Synvisc One®, Hyalgan®, Supartz™, OrthoVisc®, and Euflexxa™.
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Prior Approval:
Not applicable
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Policy:
A course of 3–5 weekly injections of intra-articular hyaluronan injections may be considered medically necessary for treatment of painful osteoarthritis of the knee in patients who have insufficient pain relief from conservative nonpharmacologic therapy and simple analgesics.
One additional course of intra-articular hyaluronan injections may be considered medically necessary under the following conditions:
Synvisc-One™ (hylan G-F 20), administered as a single intra-articular injection during a 6 month period of time, may be considered medically necessary for treatment of painful osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
The use of Synvisc-One™ in a period of time of less than 6 months is considered not medically necessary.
The use of all intra-articular hyaluronan injections into joints other than the knee is considered investigational.
Viscosupplementation continues to be investigated for off-label uses in other joints. Current information about these off-label uses is limited. clinical trials that are currently planned or ongoing should provide useful information about changes in net health outcome using intraarticular injections of hyaluronates for osteoarthritis of the shoulder and other joints.
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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 ICD-9 diagnostic 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:
- 1998 TEC Assessment; Tab 17
- Scali J.J. Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee; a long-term study. European Journal of Rheumatology and Inflammation. 1995; 15:57-62.
- Peyron JG Intraarticular hyaluronan injections in the treatment of osteoarthritis: state-of-the-art review. The Journal of Rheumatology. 1993. Volume 20, supplement 39, 10-15.
- Al-Assaj S, Meadows J, Phillips GO, Williams PA The application of shear and extensional viscosity measurements to assess the potential of hylan in viscosupplementation. Biorheology. 1996; 33(4-5):319-332.
- Lussier A, Cividino A.A, McFarlane CA, Olszynski WP, Potashner WJ, de Médicis, R. Visco supplementation with hylan for the treatment of osteoarthritis: findings from clinical practice in Canada. Jour of Rheum. 1996; 23:1579-85.
- Balazs EA, Denlinger JL Visco supplementation: a new concept in the treatment of arthritis. Jour of Rheum. 1993; (suppl. 39) 20:3-9.
- Yustin D, Kryshtalskyj B, Galea A. Use of Hylan G-F 20 for viscosupplementation of the temporomandibular joint for the management of osteoarthritis: a case report. Journal of Orofacial Pain. 1995; 9:375-379.
- Kotz R, Kolarz G. Intra-articular hyaluronic acid: Duration of effect and results of repeated treatment cycles. Am Jour of Ortho. 1999; 28 (suppl 1S):5-7.
- Carrabba M, Paresce E, Angeline M, et al. The safety and efficacy of different dose schedules of hyaluronic acid in the treatment of painful osteoarthritis of the knee with joint effusions. European Journal of Rheumatology and Inflammation. 1995; 15:25-31.
- Simon L. Viscosupplementation therapy with intraarticular hyaluronic acid. Rheumatic Diseases Clinics of North America. 1999; 25:345-357.
- Brandt K.D, Block JA, Michalski JP, Moreland LW, Caldwell JR, Lavin, PT Efficacy and safety of intraarticular sodium hyaluronate in knee osteoarthritis. ORTHOVISC Study Group. Clin Orthop 2001 Apr; (385):130-43.
- Karlsson J, Sjogren LS, Lohmander LS. Comparison of two hyaluronan drugs and placebo in patients with knee osteoarthritis. A controlled, randomized, double-blind, parallel-design multicentre study. Rheumatology (Oxford) 2002 Nov; 41(11):1240-8.
- Tamir E, Robinson, D, Koren R, Agar G, Halperin N. Intra-articular hyaluronan injections for the treatment of osteoarthritis of the knee: a randomized, double blind, placebo controlled study. Clin Exp Rheumatol 2001 May-Jun; 19(3):265-70.
- Maheu E, Ayral X, Dougados M. A hyaluronan preparation (500-730 kDa) in the treatment of osteoarthritis: a review of clinical trials with Hyalgan®. Int J Clin Pract 2002 Dec; 56(10):804-13.
- Arrich J, Piribauer F, Mad P et al. Intra-articular hyaluronic acid for the treatment of osteoarthritis of the knee: systematic review and meta-analysis. CMAJ 2005;172(8).
- Qvistgaard E, Christensen R, Torp-Pederson S et al. Intra-articular treatment of hip osteoarthritis: a randomized trial of hyaluronic acid, corticosteroid, and isotonic saline. Osteoarthritis Cartilage. 2006;14(2):163-170.
- Caglar-Yagci H, Unsal S, Yagci I et al. Safety and efficacy of ultrasound-guided intra-articular hylan G-F 20 injection in osteoarthritis of the hip: a pilot study. Rheumatol Int. 2005;25(5):341-344.
- Shibata Y, Midorikawa K, Emoto G et al. Clinical evaluation of sodium hyaluronate for the treatment of patients with rotator cuff tear. J Shoulder Elbow Surg. 2001;10(3):209-216.
- Fuchs S, Monikes R, Wohlmeiner A et al. Intra-articular hyaluronic acid compared with corticoid injections for the treatment of rhizarthrosis. Osteoarthritis Cartilage. 2006;14(1):82-88.
- Alpaslan GH, Alpaslan C. Efficacy of temporomandibular joint arthrocentesis with and without injection of sodium hyaluronate in treatment of internal derangements. J Oral Maxillofac Surg. 2001;59(6):613-18.
- Stahl S, Karsh-Zafrir I, Ratzon N et al. Comparison of intra-articular injection of depot corticosteroid and hyaluronic acid for treatment of degenerative trapeziometacarpal joints. J Clin Rheumatol. 2005;11(6):299-302.
- Samson DJ, Grant MD, Ratko TA, Bonnell CJ, Ziegler KM, Aronson N. Treatment of Primary and Secondary Osteoarthritis of the Knee. Evidence Report/Technology Assessment No. 157 (Prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). AHRQ Publication No. 07-E012. Rockville, MD: Agency for Healthcare Research and Quality. September 2007.
- Bannuru RR, Natov NS, Obadan IE et al. Therapeutic trajectory of hyaluronic acid versus corticosteroids in the treatment of knee osteoarthritis: s systematic review and meta-analysis. Arthritis Rheum. 2009 Dec 15; 61(12):1704-11.
- Jorgensen A, Stengaard-Pedersen K, Somonsen O et al. Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomized, placebo-controlled, double-blind study of 337 patients followed for 1 year. Ann Rheum Dis. 2010 Jun; 69(6):1097-102. Epub 2010 May 6.
- Migliore A, Massafra U, Bizzi E et al. Comparative, double-blind, controlled study of intra-articular hyaluronic acid (Hyalubrix) injections versus local anesthetic in osteoarthritis of the hip. Arthritis Res Ther. 2009; 11(6):R183. Epub 2009 Dec 9.
- Saito S, Furuya T, Kotake S. Therapeutic effects of hyaluronate injections in patients with chronic painful shoulder: a meta-analysis of randomized controlled trials. Arthritis Care Res (Hoboken). 2010 Jul; 62(7):1009-18.
- National Institutes of Health. Clinicaltrials.gov. Available online at: http://www.clinicaltrials.gov. Last accessed October 2011.
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Policy History:
Date Reason Action
August 2010 Annual review Policy renewed
October 2011 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 © 2010 American Medical Association. All Rights Reserved.
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