The Alzheimer’s Association recognizes that the Centers for Medicare & Medicaid Services (CMS) has announced their conceptual approach to fulfill their commitment to immediate coverage of Food and Drug Administration (FDA) traditionally approved Alzheimer’s treatments. We continue to believe that registry as a condition of coverage is an unnecessary barrier.
Registries are important tools to gather much needed real-world evidence to transform and improve patient care. But, registries should not be a requirement for coverage of a FDA-approved treatment.
We look forward to learning more details from CMS and we are hopeful for the future of health care access for our constituents. However, we remain concerned that the requirement of clinicians to register and enter data will create unnecessary hurdles.
In its announcement CMS said it will have a nationwide CMS-facilitated portal and other future registries may also qualify. Additional information about the data submission, registry requirements and details about how patients and physicians can enroll is still needed.