Coverage and/or Medical Necessity for the Use of Hyaluronan or Derivitive

by  Find-A-Code™
Jan 9th, 2018

• Knee pain associated with radiographic evidence of osteophytes in the knee joint, sclerosis in bone adjacent to the knee, or joint space narrowing.
• Morning stiffness of less than 30 minutes in duration or crepitus on motion of the knee. 
• The pain cannot be attributed to other forms of joint disease.
• There are no contraindications to the injections.
• The prosthetic device is approved by the Food and Drug Administration (FDA) for intra-articular injection.
• Pain that interferes with functional activities (e.g., ambulation, prolonged standing, ability to sleep).
• Lack of functional improvement following a trial of at least three months of conservative therapy, or the patient is unable to tolerate Non-Steroidal Anti-inflammatory Drug (NSAID) therapy because of adverse side effects.
• Bilateral injections may be allowed if both knees meet the criteria.

The frequency of injections is:

An initial series of three to five weekly injections per knee. Note: Synvisc-One® and Gel-One® are administered through a single intra-articular injection.

A repeat series of injections for patients who have responded to the first series may be given individual consideration by Medicare for coverage under the following circumstances:

• The medical record objectively documents significant improvement in pain and functional capacity using a standardized assessment tool; OR

• The medical record documents significant reduction in the doses of non-steroidal anti-inflammatory medications taken or reduction in the number of intra-articular steroid injections to the knees during the six-month period following the injection; and

• At least six months have elapsed since the prior series of injections.

• A series is defined as a set of injections for each joint and each treatment. The EJ modifier must be used with the HCPCS code for the drug administered to indicate subsequent injections of a series. The modifier is not to be used with the first injection of each series.

• The appropriate records documenting the improvement must be maintained in the medical record and made available to Medicare upon request.

• If the series of injections using sodium hyaluronate did not prove to be beneficial to the patient, it would not be reasonable to repeat the therapy again using any of these products. Thus, a repeat series of injections would not be covered.

• Topical application is not covered.

Drug Wastage

Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient's condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored, and used the drug, and made good faith efforts to minimize the unused portion of the drug in how it is supplied, the program will cover the amount of drug discarded along with the amount administered.

Note: The JW modifier is not used on claims for drugs or biologicals provided under the Competitive Acquisition Program (CAP).