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 say that viscosupplementation therapy for the knee via intra-articular injections of hyaluronic 
preparations will be considered medically reasonable and necessary when ALL of the following conditions are 
met: 
1. The patient is symptomatic. Such symptoms may include pain which interferes with the activities of 
daily living such as ambulation and prolonged standing, or pain interrupting sleep, crepitus, and/or knee 
stiffness. 
2. The clinical diagnosis is supported by radiologic evidence of osteoarthritis of the knee such as joint 
space narrowing, subchondral sclerosis, osteophytes and sub-chondral cysts. 
3. If appropriate, other diagnoses have been excluded by appropriate evaluation and management services, 
laboratory and imaging studies (i.e., the pain and functional disability is not considered likely to be due 
to a diagnosis other than osteoarthritis of the knee). 
4. The patient has failed at least three months of conservative therapy. Conservative therapy is defined as: 
 Nonpharmacologic therapy (such as but not limited to home exercise program, education, 
weight loss, physical therapy if indicated); and 
 If not contraindicated, simple analgesics and (e.g., acetaminophen) or NSAIDS per hyaluronan 
product prescribing information. 
5. The patient has failed to respond to aspiration of the knee when effusion is present and intra-articular 
corticosteroid injection therapy when inflammation is a significant component of the patients 
symptoms and intra-articular corticosteroids are not contraindicated. 
 
A repeat series* of hyaluronan knee injection(s) for patients who have responded to a prior series is 
considered to be reasonable and necessary under the following circumstances: 
 Symptoms have recurred 
And, 
 At least six months have elapsed since the prior series of injections 
And, 
 There was significant improvement in pain and functional capacity achieved with the prior series of 
injections using a standardized assessment tool 
Or,  There is significant reduction in the doses of NSAID medications taken or reduction in the number of 
intra-articular steroid injections to the knees during the six-month period following the injection(s). 
*Note: A series is defined as a set of injections for each joint and each treatment (initial or repeat). 
 
Limitations 
The following are considered not reasonable and necessary and therefore will be denied: 
1. Drugs and biologicals and other products approved for marketing by the FDA are considered safe and 
effective when used for indications specified on the labeling. The labeling lists the safe and effective, 
i.e., medically reasonable and necessary dosage and frequency. Therefore, doses and frequencies that 
exceed the accepted standard of recommended dosage and/or frequency, as described in the package 
insert, are considered not reasonable and necessary and therefore, not subject to coverage. 
2. Intra-articular injections of other therapeutic agents, such as corticosteroids, should not be performed in 
the same knee during the course of viscosupplementation therapy unless there is documented medical 
necessity (e.g., for documented reactions requiring the use of the additional therapeutic agent). 
3. Viscosupplementation of joints other than the knee(s) are considered not reasonable and necessary and 
are not subject to coverage. 
4. Imaging procedures (e.g., arthrography, CT scan, MRI) for the purpose of visualization of the knee to 
provide guidance for needle placement are considered not medically reasonable and necessary and will 
not be covered. The only imaging procedures that may be considered reasonable and necessary for the 
purpose of needle guidance for viscosupplementation are fluoroscopy or ultrasound. If needle guidance 
is utilized, the documentation must support that the presentation of the patients affected knee on the 
day of the procedure makes needle insertion problematic. Routine use of fluoroscopy or ultrasound 
guidance may result in a pre-payment medical review of records. No other imaging modality for the 
purpose of needle guidance and placement will be covered. The imaging modality used for the purpose 
of needle guidance must be reported appropriately and in conjunction with the appropriate intra-
articular injection procedure code for the knee. For coding information on the use of imaging 
procedures with viscosupplementation of the knee, please refer to the companion Article A55036, 
Billing and Coding: Hyaluronan Acid Therapies for Osteoarthritis of the Knee. 
5. If the hyaluronan preparation is denied, then any associated procedure code(s) (e.g., intra-articular 
injection, fluoroscopy, ultrasound) would be considered not medically reasonable and necessary. 
6. The course of treatment must consist of the use of one agent for the entire course of treatment. 
Therefore, initiating a course of treatment with one agent, then switching before completion to a 
different agent is considered not medically reasonable and necessary. Example: Treatment is initiated 
with Synvisc. After the application of two doses, the provider switches to Synvisc-One. The Synvisc-
One would not be considered medically reasonable and necessary. 
7. Coverage of viscosupplementation therapy of the knee assumes that knee arthroplasty is not being 
considered as a current treatment option. 
8. Viscosupplementation is considered not medically reasonable and necessary following total or partial 
knee arthroplasty. 
9. Viscosupplementation is considered not medically reasonable and necessary at the end of a knee 
surgical procedure or during the postoperative period following a knee surgical procedure (e.g., anterior 
cruciate ligament [ACL] reconstruction or arthroscopic meniscectomy). It would be expected that use of 
viscosupplementation would not be initiated until after the patient has made a full recovery from the 
knee surgery (individualized for each patient); and the patient is symptomatic with a diagnosis of 
osteoarthritis; and clinical presentation meets the covered indications as stated. 
10. Viscosupplementation is considered not medically reasonable and necessary and will not be covered for 
the any of the following:  When the diagnosis is anything other than osteoarthritis 
 As the initial treatment of osteoarthritis of the knee 
 When failure of/or contraindication to conservative therapy and/or corticosteroid injections are 
not documented in the medical record 
 When a repeat series of injections is initiated prior to six months after completion of the 
previous course of treatment 
 When a repeat series of injections is administered when there was no symptomatic/functional 
improvement evidenced from the previous series of injections 
 Topical application of hyaluronate preparations 
You can find this in the Local Coverage Determination (LCD): Hyaluronan Acid Therapies for Osteoarthritis 
of the Knee (L35427). 
 
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.