The Alzheimer’s Association understands that CMS’ evaluation of the impact of brain amyloid imaging on health outcomes is ongoing, however the needs of Alzheimer’s community are acute.

With 5 million Americans living with Alzheimer’s and more than 15 million people providing care, the need to accelerate improved care and an early and accurate diagnosis today, when scientifically supported, is critical.

Neither families directly impacted by the disease, nor our federal government, can afford to wait as much as seven years for a final decision about national coverage, as was the case with the National Oncology Patient Registry and the evaluation by CMS of FDG PET coverage. Seven years ago, this brain amyloid imaging technology did not even exist.

The timeframe at which CMS has conducted CED processes is wholly unsuited and unacceptable to both the pace of scientific and technological innovation in the Alzheimer’s field, and more importantly, the rapidly increasing needs posed by the escalating Alzheimer’s epidemic.

If the federal government follows this example and timeline, it will hinder coverage of a badly needed, already FDA approved diagnostic tool in limited populations in which sufficient evidence indicates this technology has meaningful impact.

Understanding that this is a draft decision from CMS, and it is not yet final, the Alzheimer’s Association will continue to engage the scientific and healthcare communities, as well as advocates, to educate CMS on behalf of our constituents about the benefits of coverage for brain amyloid imaging-in limited populations as defined by the scientifically-driven appropriate use criteria-as CMS develops a final decision.