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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 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 Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1. 
  
Medicare rules also allow the plan to use step therapy. This is the process of beginning drug therapy for a 
medical condition with "preferred" (or more cost-effective) on-formulary drug alternative(s) and progressing to 
other drug therapies only as necessary. A plan must grant an exception to its step therapy rules if it determines 
that the requested drug is medically necessary, consistent with the prescriber's statement. The statement must 
show that the step therapy drugs: have been ineffective in treating the enrollee; or are likely to be ineffective or 
adversely affect the drug's effectiveness or patient compliance; or are likely to cause an adverse reaction or 
other harm to the enrollee.  
 
Medicare Advantage plans should ensure that new step therapy requirements do not disrupt ongoing Part B 
drug therapies for enrollees. Step therapy may only be applied to new prescriptions or administrations of Part B 
drugs for enrollees that are not actively receiving the affected medication. You can find this information at 42 
CFR Section 423.578(b)(5)(ii). 
 
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 patient?s 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). 
 
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 patient?s 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 information in Medicare's 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.