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 degenerative joint disease (usually termed OA) of the knee is a condition characterized by 
the progressive destruction of the articular cartilage that lines the knee joints, the subchondral bone surfaces, 
and synovium, accompanied by pain, immobility, and reduction in function and the ability to complete 
activities of daily living (ADL). Knee OA is a chronic debilitating condition - predominantly occurring among 
the elderly - that affects a large share of the population worldwide. It is the predominant form of arthritis and 
the leading cause of disability in the U.S. 
Hyaluronic acid (HA) is a component of synovial fluid, which lubricates the joint and absorbs shock. HA is a 
glycosaminoglycan molecule within the knee joint where it provides viscoelastic properties to synovial fluid. 
HA is a glycosaminoglycan that occurs naturally within the synovial fluid of the knee, providing lubrication of 
the joint and protecting the cartilage from mechanical degradation. HA has been shown to provide anti-
inflammatory and chondroprotective effects, increase proteoglycan and HA synthesis, and reduce nerve 
impulses and nerve sensitivity associated with OA pain. HA production is generally reduced and may be of 
poorer quality with OA, which may exacerbate inflammation. Intra-articular HA aims to replace depleted or 
poor-quality HA in the joint. HA is available commercially prepared and ready for injection. HA products 
differ by molecular weight and cross-linkage. HA injections reduce cartilage breakdown that results from a loss 
of cartilage oligomeric matrix protein and also reduces inflammatory cytokines such as interleukin 1. Patients 
with OA of the knee who are not responsive to conservative treatments, may be candidates for intra-articular 
HA for treatment of knee OA. There are several viscosupplementation products (such as Euflexxa

, Durolane

, 
Gel-One

, GenVisc

 850, Gelsyn-3

, Hyalgan

, Hymovis

, Monovisc

, Orthovisc

, Supartz FX

, Synvisc

, 
Synvisc-One

, SynoJoyntTM, Visco-3TM, TriVisc

, and Triluron

) that have been approved by the U.S. Food 
and Drug Administration (FDA) for the treatment of pain associated with OA of the knee who have failed to 
respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).  
Various Hyaluronan preparations (viscosupplementation) for intra-articular injections of the knee are 
considered reasonable and necessary when ALL of the following criteria documented in the medical record are 
met: 
1. Symptomatic OA of the knee. Pain that interferes with functional activities (such as, ambulation and 
prolonged standing). 
2. The diagnosis is supported by radiographic evidence of OA of the knee, for example, joint space narrowing, 
subchondral sclerosis, osteophytes, and subchondral cysts. 3. Trial and failure or contraindication of at least 3 months of conservative therapy: 
 Non-pharmacologic therapy (e.g., physical therapy, exercise, weight management, self-management 
programs, knee brace, cane) 
 Pharmacologic therapy (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) (oral, 
topical), topical capsaicin) 
4. Failure of or contraindication to intra-articular glucocorticoid injections.  
Services that are not reasonable and necessary and cannot be covered by Medicare are the following: 
1. The dose and frequency of administration should be consistent with the FDA approved labeling. Doses and 
frequencies that exceed the FDA recommended dosage/frequency as per the prescribing information, are 
considered not reasonable and necessary and not covered by Medicare. 
2. Initiation of a repeat series of treatment when at least 6 months have not elapsed since the prior series of 
injections is considered not reasonable and necessary and not covered. 
3. It is considered not reasonable and necessary as the initial treatment of OA of the knee. 
4. It is contraindicated with infections or skin disease in the area of the injection site or joint and considered not 
reasonable and necessary and not covered by Medicare.  
5. It is contraindicated to administer these products if you are allergic to hyaluronate products. 
6. A diagnosis other than OA is considered not reasonable and necessary and not covered by Medicare. 
7. When there was no improvement in knee pain and functional improvement from a previous series of 
injections, a repeat series of injections will be considered not reasonable and necessary and will not be covered. 
8. Imaging procedures for the purpose of needle guidance that may be considered reasonable and necessary are 
ultrasound or fluoroscopy. The documentation must support why imaging is needed for needle guidance and 
insertion. Other imaging modalities (e.g., computed tomography (CT) scan, magnetic resonance imaging 
(MRI), arthrography) for the purpose of needle guidance and insertion will be considered not reasonable and 
necessary and not covered by Medicare. 
You can find these rules in the Local Coverage Determination (LCD) Hyaluronic Acid Injections for Knee 
Osteoarthritis L39260. 
 
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.