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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 effective April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) covers Food 
and Drug Administration (FDA) approved monoclonal antibodies directed against amyloid for the treatment of 
AD when furnished in accordance with Section B under coverage with evidence development (CED) for 
  
  patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia, 
both with confirmed presence of amyloid beta pathology consistent with AD. 
 
Coverage Criteria: 
 
1) Monoclonal antibodies directed against amyloid that are approved by the FDA for the treatment of AD based 
upon evidence of efficacy from a change in a surrogate endpoint (e.g., amyloid reduction) considered as 
reasonably likely to predict clinical benefit may be covered in a randomized controlled trial conducted under an 
investigational new drug (IND) application. 
 
2) Monoclonal antibodies directed against amyloid that are approved by the FDA for the treatment of AD based 
upon evidence of efficacy from a direct measure of clinical benefit may be covered in CMS-approved 
prospective comparative studies. Study data for CMS-approved prospective comparative studies may be 
collected in a registry. 
 
3) For CMS-approved studies, the protocol, including the analysis plan, must include: 
 
    A study population whose diversity of patients are representative of the national population with MCI due to 
AD or mild AD dementia. 
    A neurocognitive evaluation and a description of the instruments used to assess cognition and function for 
the clinical diagnosis of MCI due to AD or mild AD dementia for study enrollment and outcomes assessment. 
    A description of: 
        The multidisciplinary dementia team and optimal medical management. 
        Study sites with clinical expertise and infrastructure to provide treatments consistent with the safety 
monitoring outlined in the FDA-approved label. 
 
4) CMS-approved studies of a monoclonal antibody directed against amyloid (antiamyloid mAb) approved by 
the FDA for the treatment of AD based upon evidence of efficacy from a direct measure of clinical benefit 
must address all of the questions below: 
 
a. Does the antiamyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and 
function) for patients in broad community practice? 
 
b. Do benefits, and harms such as brain hemorrhage and edema, associated with use of the antiamyloid mAb, 
depend on characteristics of patients, treating clinicians, and settings? 
 
c. How do the benefits and harms change over time? 
 
5) CMS-approved studies must adhere to the following standards of scientific integrity that have been 
identified by the Agency for Healthcare Research and Quality (AHRQ) 
 
You can find this rule in the Center for Medicare and Medicaid Services (CMS) Internet-Only Manual, 
Publication 100-03, Medicare National Coverage Determination (NCD) Manual, Section 200.3. 
 
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.