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 Medicare may cover a drug or biological if it is safe and effective and otherwise reasonable 
and necessary. You can find this rule in the Centers for Medicare and Medicaid Services, Internet Only 
Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1. 
 
Covered Indications 
 
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 osteoarthritis (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: 
a. Non-pharmacologic therapy (e.g., physical therapy, exercise, weight management, self-management 
programs, knee brace, cane) 
b. Pharmacologic therapy (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) (oral, topical), 
topical capsaicin) 
4. Failure of or contraindication to intra-articular glucocorticoid injections. 
 
For patients who have responded to a prior series, a REPEAT* series of viscosupplement therapy is considered 
reasonable and necessary when ALL of the following are met: 
a. Patient continues to meet initial criteria 
b. Symptoms have recurred 
c. Patient has experienced improvement in pain and functional capacity following the previous series of 
injections 
d. At least 6 months have elapsed since the prior series of injections 
* A series is defined as a set of injections for each joint and each treatment as per the FDA prescribing 
information Limitations 
 
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 Food and Drug Administration 
(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 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. The Plan 
contract also says that the use of the drug must be approved by the FDA or supported by certain medical 
references as a treatment for your condition. Your doctor may prescribe a certain drug to treat your condition, 
even though it wasnt approved to treat the condition. This is called off-label use. The Plan usually doesnt 
cover drugs prescribed for off-label use. 
 
You can find this information on page 101 of the Plan's 2023 Evidence of Coverage.