Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (AD)
NCD375
CMS nationally covers FDA-approved monoclonal antibodies directed against amyloid for treatment of Alzheimer’s disease only when furnished under Coverage with Evidence Development (CED) for patients with MCI due to AD or mild AD dementia with confirmed amyloid-beta pathology, and only within appropriate FDA-approved randomized trials (IND), CMS-approved prospective comparative studies (registries allowed), or NIH-supported trials. CMS-approved studies must meet detailed protocol standards (representative population, neurocognitive assessments, multidisciplinary care, site safety infrastructure), adhere to AHRQ scientific integrity standards, register on ClinicalTrials.gov (and RoPR for registries), obtain informed consent, and publicly report outcomes within 12 months; treatments provided outside these approved or supported studies are nationally non-covered.
"Medicare covers FDA-approved monoclonal antibodies directed against amyloid for treatment of Alzheimer’s disease when furnished under Coverage with Evidence Development (CED) for patients with a cl..."