Effective Date:

a) This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1.    Synvisc, Synvisc One, Hyalgan, Supartz, Euflexxa, Gel-One, Monovisc, and Orthovisc do not meet QualChoice medical necessity criteria for fully insured and level funded products.   (See BI024)

2.    Synvisc, Synvisc One, Hyalgan, Supartz, Euflexxa, Gel-One, Monovisc, and Orthovisc are covered without preauthorization in the treatment of knee arthritis only for the self-funded plans who cover this treatment.

3.    Durolane (J7318), Gelsyn-3 (J7328), Trivisc (J7329), J7331, J7332, and J7333 are non-formulary and not covered.

This medical policy statement does not apply to QualChoice fully insured or Level Funded Products as viscosupplementation is not covered for these lines of business. For those plans who cover this treatment, QualChoice will cover Hyalgan, Supartz, Orthovisc, Gel-One, Monovisc, Euflexxa, Synvisc-One, Synvisc or Gelsyn-3, for intra-articular injections for patients with osteoarthritis of the knee without preauthorization.  While the evidence supporting clinical benefit is equivocal at best, the following criteria are generally recommended for identifying potentially suitable candidates:

• The patient has symptomatic osteoarthritis of the knee documented with weight-bearing radiographs showing narrowing of the joint space, without evidence of bone-on-bone contact in the knee joint; and
• The patient must not have end-stage joint disease and;
• The member reports pain which interferes with functional activities (e.g., ambulation, prolonged standing); and 
• Conservative therapy (such as non-steroidal anti-inflammatory drugs,  acetaminophen and topical capsaicin cream) has been attempted in each joint to be treated with viscosupplements and has not resulted in functional improvement after at least three months or the member is unable to tolerate conservative therapy because of adverse side effects; and
• The pain cannot be attributed to other forms of joint disease; and 
• There are no contraindications to the injections (e.g., active joint infection, bleeding disorder).

Additional series of injections for members who have responded to previous series may be considered under the following circumstances:

• The medical record documents significant improvement in pain and functional capacity as the result of the previous injections; and
• Recent weight bearing x-ray confirms that there is no bone-on-bone contact and
• At least six months has elapsed since the prior series of injections.

Codes Used In This BI:

J7318   HYALURONAN/DERIVATIVE DUROLANE FOR IA INJ 1 MG

J7321   Hyaluronan or derivative, Hyalgan, Supartz or Visco-3, for intra-articular inj, per dose

J7323   Hyaluronan or derivative, Euflexxa, for intra-articular inj, per dose

J7324   Hyaluronan or derivative, Orthovisc, for intra-articular inj, per dose

J7325   Hyaluronan or derivative, Synvisc or Synvisc-One, for intra-articular inj, per dose

J7326   Hyaluronan or derivative, Gel-One, for intra-articular inj, per dose

J7327   Hyaluronan or derivative, Monovisc, for intra-articular inj, per dose

J7328   Hyaluronan/derivative (Gelsyn-3) for intra-articular inj, per dose

J7329   HYALURONAN/DERIVATIVE TRIVISC FOR IA INJ 1 MG

J7331   Hyaluronan or derivative, synojoynt

J7332   Hyaluronan or derivative, triluron

J7333   Hyaluronan or derivative, Visco-3

1.    http://www.arkmedicare.com/provider/medpolb/as01011.asp

2.    Lo, Grace H et al. Intra-articular Hyaluronic Acid in Treatment of Knee Osteoarthritis. JAMA. 2003;290:3115-3121

3.    Felson, David T.  Hyaluronate Sodium Injections for Osteoarthritis.  Arch Intern Med. 2002;162:245-247

4.    Leopold, Seth S et al.  Increased Frequency of Acute Local Reaction to Intra-Articular Hylan GF-20 in Patients Receiving More Than One Course of Treatment.  The Journal of Bone and Joint Surgery. 2002;84A:1619-1623

5.    Leopold, Seth S et al.  Corticosteroid Compared with Hyaluronic Acid Injections for the Treatment of Osteoarthritis of the Knee.  The Journal of Bone and Joint Surgery.  2003;85A:1197-1203

6.    Hinman, Rana S et al.  Efficacy of Knee Tape in the Management of Osteoarthritis of the Knee: Blinded Randomized Controlled Trial.  BMJ. 2003;327:135-140

7.    Hochberg M, Altman R, et al. American College of Rheumatology 2012 Recommendations for the Use of Nonpharmacological and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care & Research 2012; 64:465-474.

8.    American Academy of Orthopedic Surgeons Evidence-Based Guideline 2nd Edition: Treatment of Osteoarthritis of the Knee. May 18, 2013.

This policy applies to all health plans and products administered by QualChoice, both those fully insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products fully insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.