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: 
 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  
 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 
 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.) 
 The patient has failed at least three months of conservative therapy. Conservative therapy is defined as:  
o Nonpharmacologic therapy (such as but not limited to home exercise program, education, 
weight loss, physical therapy if indicated); and 
o If not contraindicated, simple analgesics and NSAIDS. 
 The patient has failed to respond to aspiration of the knee and intra-articular corticosteroid injection 
therapy when inflammation is a significant component of the patients symptoms and intra-articular 
corticosteroids are not contraindicated. 
Limitations 
1. Drugs and biologicals 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. 
3. If the first course of treatment produces relief, subsequent courses of treatment may be reasonable if 
symptoms return. Subsequent courses of treatment will be allowed six (6) months after the last injection 
of a previous course of treatment. 4. Viscosupplementation of joints other than the knee(s) will be considered not reasonable and necessary 
and will not be subject to coverage.  
5. Imaging procedures performed routinely for the purpose of visualization of the knee to provide 
guidance for needle placement will not be covered. Fluoroscopy may be medically necessary and 
allowed if documentation supports that the presentation of the patients affected knee on the day of the 
procedure makes needle insertion problematic. No other imaging modality for the purpose of needle 
guidance and placement will be covered. 
6. Arthrography to provide needle guidance for knee injections will not be covered. 
7. Coverage of viscosupplementation therapy of the knee assumes that knee arthroplasty is not being 
considered as a current treatment option. 
8. The course of treatment should consist of the use of one agent. One agent should be used 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. 
9. It is not expected that routine imaging for the purpose of needle guidance would be required. Therefore, 
routine use of fluoroscopy may result in a pre- payment medical review of records. Documentation 
should provide justification when imaging is performed for the purpose of needle guidance. The use of 
hand held ultrasound devices are not separately reimbursed. 
10. Viscosupplementation will not be covered:  
o When the diagnosis is anything other than osteoarthritis 
o For intra-articular injection in joints other than the knee 
o As the initial treatment of osteoarthritis of the knee 
o When failure of/or contraindication to conservative therapy and/or corticosteroid injections are 
not documented in the medical record 
o When the dose and treatment regimen exceeds those approved under the FDA label 
o When a repeat series of injections is initiated prior to six months after completion of the 
previous course of treatment 
o When a repeat series of injections is administered when there was no symptomatic/functional 
improvement evidenced from the previous series of injections 
o For topical application of hyaluronate preparations 
You can find this in the Local Coverage Determination (LCD): Viscosupplementation Therapy For Knee 
(L33767). 
 
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.