Osteoarthritis is the most common form of arthritis. Pathologically, it is characterized by deterioration and loss of articular cartilage, subchondral sclerosis, and osteophyte formation. Since there are currently no curative therapies for this condition, the overall goals of existing therapies are to reduce pain, prevent disability, and postpone the need for total knee replacement surgery.

Conservative methods of therapy for osteoarthritis may include the use of simple analgesics (e.g., acetaminophen), nonsteroidal anti-inflammatory drugs (NSAIDs), and intra-articular corticosteroid injections. For patients who fail to respond to these conservative therapies, there is yet another form of treatment for the osteoarthritic knee called intra-articular injections of hyaluronan (e.g., Synvisc-code J7320 or Hyalgan-code J7315).

Intra-articular injections of hyaluronan act as lubricants to restore elasticity and viscosity to the osteoarthritic knee. The procedure involves an arthrocentesis to aspirate the bad or damaged synovial fluid from the knee and then, to replace it by injecting the hyaluronan preparation (e.g., Synvisc or Hyalgan). Specific to these preparations, treatment using Synvisc requires one injection per week for three weeks. In contrast, one injection per week for five weeks is required if Hyalgan is utilized. Repeated treatment cycles (i.e., any further injections over and above the number specified above) have not been FDA-approved and, therefore, are considered not medically necessary and are nonbillable.

When therapeutic injections are a benefit, intra-articular hyaluronan injections are eligible when all of the following criteria have been met:

1. The patient has symptomatic osteoarthritis of the knee (715.16, 715.26, 715.36, 715.96);

2. The patient has failed to respond to conservative therapy (such as those examples referenced above), or is unable to tolerate therapy (e.g., NSAIDs) because of adverse side affects;

3. There are no contraindications to the hyaluronan injections;

4. The hyaluronan product is FDA-approved for intra-articular injections of the knee.

   NOTE: Both Synvisc and Hyalgan are FDA-approved.
   

Also, if the patient does not have coverage for therapeutic injections, Synvisc (J7320)/Hyalgan (J7315) and the arthrocentesis (20610) should be denied as a noncovered service.

NOTE: Intra-articular hyaluronan injection (e.g., Synvisc, Hyalgan) for osteoarthritis of the knee are classified as therapeutic injection procedures under medical-surgical benefits and are not subject to the pharmacy benefit.

See Medical Policy Bulletin S-31 when arthrocentesis is performed as a stand-alone procedure. Policy S-31 guidelines are not to be used for intra-articular hyaluronan injections.

PRN References

10/1998, Intra-articular hyaluronan injection coverage varies with patient benefits
02/1998, Intra-articular hyaluronan injections for osteoarthritis, not covered
02/1999, New reporting guidelines for intra-articular hyaluronan injections
06/1999, Correction: New reporting guidelines for intra-articular hyaluronan injections