Appeal type: unknown
Decision: unknown

 
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. 
 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. 
Repeat treatments are considered medically necessary for patients being treated for osteoarthritis of the knee, 
who meet both of the following criteria: 
 Significant improvement in knee pain and known improvement in functional capacity resulted from the 
previous series of injections which has been documented in the record; and 
 At least six (6) months have elapsed since the last injection in the series. 
The Medicare program covers drugs that are furnished incident to a physicians service provided, that the 
drugs are not usually self-administered by the patients. Please refer to the WPS GHA Guides and Resources: 
Incident to Services. 
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. 
Billing of Viscosupplements 
When reporting C, J or Q HCPCS codes for hyaluronan acid therapy, it should be noted that some codes are 
per dose and some are per mg as specified in the code descriptor. When reporting a per mg drug code, 
report the appropriate number of units that reflect the dosage given. Units of service are to be billed in 
multiples of the dosage specified in the full HCPCS descriptor. This descriptor does not always match the dose 
given. The units billed must correspond with the smallest dose (vial) available for purchase from the 
manufacturer(s) that could provide the appropriate dose for the patient. Dosing frequency of injections per 
series and/or dosing frequency per series as listed/supported with the FDA approved dosing/package insert 
must be documented in the medical record. Providers are responsible for determining the code that most 
accurately describes the intraarticular agent furnished. 
You can find this rule at the Medicare Local Coverage Article (LCA) A56157: Billing and Coding: 
Intraarticular Knee Injections of Hyaluronan. 
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.