Communications between CMS and FDA regarding Aduhelm

To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

-All communications between CMS and FDA regarding Aduhelm (Aducanumab) and/or monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease between the dates of January 1, 2017 and September 1, 2023.

I am a fellow at Columbia University's Toni Stabile Center for Investigative Journalism. This is an educational request.

I submitting this FOIA request to understand the rationale and reasoning of the Centers for Medicare and Medicaid Services (“CMS”) in issuing its April 7, 2022 National Coverage Determination regarding Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease, CAG-00460N (“NCD”).

The requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.

Sincerely,

Juan Vassallo