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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 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:
&#61623; Nonpharmacologic therapy (such as but not limited to home exercise program, education, weight loss, physical therapy if indicated); and
&#61623; 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.
You can find this rule at Local Coverage Determination (LCD): Hyaluronan Acid Therapies for Osteoarthritis of the Knee (L35427) (eff. 10/1/19). 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).
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 contract says that the Plan has step therapy requirements for certain Medicare Part B covered drugs/biologicals. Enrollees may be required to try a preferred drug before the Plan will approve the requested medication. You can find this information on page 73 of the 2021 Evidence of Coverage (EOC).