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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that Medicare may cover a drug or biological if it is safe and effective and otherwise reasonable 
and necessary. You can find this rule in the Centers for Medicare and Medicaid Services, Internet Only 
Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1. 
 
The rules say that purified natural hyaluronates have been approved by the Food and Drug Administration 
(FDA) for the treatment of symptomatic osteoarthritis of the knee in patients who have failed to respond to 
simple analgesics or conservative nonpharmacologic therapy. Osteoarthritis leads to changes in hyaluronan, a 
natural substance that helps provide the fluid within the joint with elasticity and viscosity. The therapeutic goal 
of administration of intraarticular hyaluronate is to provide and maintain intraarticular lubrication, which 
increases the viscoelastic properties of synovial fluid; this form of therapy is therefore termed 
viscosupplementation. Osteoarthritis (OA) is a common condition affecting the knee/s. Comprehensive 
management of OA should always include a combination of treatment options directed toward the common 
goal of alleviating pain and improving function. These include symptomatic pharmacological treatment with 
analgesics, non-steroidal anti-inflammatory drugs (NSAID) and intraarticular corticosteroid injections. Muscle 
strengthening exercises, weight loss, and assistive devices such as canes have been helpful in managing 
osteoarthritis. 
 
Various polymers of hyaluronic acid have been approved and marketed as implanted prosthetic devices. 
 
The FDA has approved Viscosupplementation as a device. Medicare is allowing this nonpharmacologic 
therapy. The contractor expects the use of those drugs and biologicals not listed here to be medically necessary 
and used according to their FDA indications. 
This treatment will only be covered for the treatment of pain in osteoarthritis of the knee. All other uses will be 
denied as investigational. 
All procedures are furnished by and administered by a physician and/or appropriately trained providers in the 
appropriate setting. 
Documentation in the patient's medical record must support the patient failed to respond adequately over a 
three-month period to a past history of treatment with analgesics and conservative nonpharmacological therapy 
(exercise or physical therapy, weight loss if appropriate, use of assistive devices). A radiological exam to support the clinical diagnosis of osteoarthritis of the knee will be available in the 
patients medical record. 
If subsequent courses of treatment are given, the medical records must support the effectiveness of the prior 
treatment and must clearly establish reduction of patient symptomatology and medication usage. This 
documentation must be submitted upon request. Claims submitted without requested supporting evidence in the 
medical record will be denied as being not medically necessary. 
 
The following guidelines identify three categories in which medications would not be reasonable and necessary 
according to accepted standards of medical practice: 
 
Medications given for a purpose other than the treatment of a particular condition, illness, or injury are not 
covered. 
Medications administered for treatment of a disease and which exceed the frequency or duration of injections 
indicated by accepted standards of medical practice are not covered. 
If a medication is determined not to be medically reasonable and necessary for diagnosis or treatment of an 
illness or injury according to these guidelines, the entire charge (i.e., for both the drug and its administration) is 
not considered medically necessary. You can find these rules in the LCD Reference Article Billing and Coding 
Article Billing and Coding: Intraarticular Knee Injections of Hyaluronan A56157. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.