Alzheimer's Disease & Related Disorders

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, approved by the FDA for treatment of Alzheimer's disease (AD) based upon evidence of efficacy from a change in a surrogate endpoint (amyloid reduction) considered as reasonably likely to predict clinical benefit may be covered in a randomized controlled trial conducted under an investigation new drug (IND) application.
  2. Monoclonal antibodies directed against amyloid, approved by the FDA for treatment of Alzheimer's disease (AD) based upon evidence of efficacy from a direct measure of clinical benefit may be considered as reasonably likely to predict clinical benefit may be covered in a randomized controlled trial conducted under an investigation new drug (IND) application.
  3. Medicare will cover drugs with FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world - the Registry
    • Leqembi (J0174) and Kisunla (J0175)
      • Temporary codes for future drugs: J3490, J3590, or C9399
    • ICD-10: Z00.6
    • Additional codes: G30.0, G30.1, G30.8, G30.9, G31.84
    • Modifier: Q0 or Q1
    • Condition (Institutional only) code: 30
    • Eight-digit National Clinical Trial (NCT) number 99999999
    • Type of Bill (Institutional): 012X, 013X, or 085X
  4. For CMS-approved studies, the protocol, including the analysis plan, must include:
    1. A study population whose diversity is representative of the national population with mild cognitive impairment (MCI) due to AD or mild AD dementia
    2. A neurocognitive evaluation and instruments used to assess cognition function for the clinical diagnosis of MCI due to AD or mild AD dementia for study enrollment and outcomes assessment
    3. A description of:
      1. Multidisciplinary dementia team and optimal medical management
      2. Study sites with clinical expertise and infrastructure
  5. CMS approved studies of anti-amyloid mAbs approved by FDA for the treatment of AD based upon evidence of efficacy from a direct measure of clinical benefit must address the following questions:
    1. Does the anti-amyloid meaningfully improve health outcomes?
    2. Do benefits and harms such as brain hemorrhage and edema, associated with use of the anti-amyloid mAb, depend on characteristics of patients, treating clinicians, and settings?
    3. How do the benefits and harms change over time?
  6. Review NCD 200.3 for more information on standards of scientific integrity identified by the Agency for Healthcare Research and Quality (AHRQ)

Resources

Last Updated Sep 16 , 2024