On April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) released a national policy for coverage of aducanumab (brand name Aduhelm™) and any future monoclonal antibodies directed against amyloid approved by the FDA with an indication for use in treating Alzheimer’s disease. In its official statement, the Biotechnology Innovation Organization (BIO) shares why the CMS Decision is an enormous setback for Alzheimer’s patients and a dangerous infringement on FDA’s Scientific Autonomy.