Various polymers hyaluronic acid have been approved and marketed as implanted prosthetic devices. Clinical studies of sodium hyaluronate and hylan G-F 20 have demonstrated that injection of these agents into the joint space of osteoarthritic knees is sometimes marginally more effective than placebo procedures in reduction of pain and improvement in functional capacity in some patients. These marginal beneficial results are more pronounced with the larger molecular weight compound hylan G-F 20. There are no data indicating that these agents reverse or retard the osteoarthritic process in the injected joints. The long-term effects of repeated injections are unknown.

The injection and the injected hyaluronate polymer costs will be covered for patients who meet the following clinical criteria:

• Knee pain associated with radiographic evidence of osteophytes in the knee joint, sclerosis in bone adjacent to 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 is 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 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 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. Documentation requirements are given below.

NOTE:

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

Reasons for Noncoverage

Services provided for conditions not outlined on this policy will be denied as not medically necessary. A 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, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Utilization Guidelines

The frequency of injections is:

• An initial series of three to five weekly injections per knee. Note: Synvisc-ONE is 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 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.

Documentation Requirements

• Documentation supporting the medical necessity should be legible, maintained in the patient's medical record and made available upon request.
• An appropriate diagnosis code must be submitted on the claim. The patient's medical record should indicate the signs/symptoms supporting the diagnosis and functional impairment. The appropriate records documenting the improvement must be maintained in the medical record and made available upon request.
• An X-ray report of the knees must be available in the event of a review.
• Medical records should reflect failure of conservative treatment defined as physical therapy and use of simple non-narcotic analgesics including acetaminophen.

Drug Wastage Documentation Requirements
Any amount wasted must be clearly documented in the medical record, regardless of whether the JW modifier will be used in billing for the drug/biological, with:

• Date and time.
• Amount of medication wasted.
• The reason for the wastage.

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.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.

Covered Diagnosis Codes

For codes J7321, J7323, J7324, J7325, and J7326