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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 state that purified natural hyaluronates have been approved by the 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. 
&#61623; 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. 
&#61623; This treatment will only be covered for the treatment of pain in osteoarthritis of the knee. All other uses 
will be denied as investigational. 
&#61623; All procedures are furnished by and administered by a physician and/or appropriately trained providers 
in the appropriate setting. 
&#61623; 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). 
&#61623; A radiological exam to support the clinical diagnosis of osteoarthritis of the knee will be available in the 
patient?s 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. 
You can find these rules in the Local Coverage Article for Billing and Coding: Intraarticular Knee Injections of 
Hyaluronan, A56157. This Local Coverage Article is effective for services provided on or after July 30, 2020. 
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.