CMS Comment Letter on Proposed Coverage Decision, February 2022


CMS Comment Letter on Proposed Coverage Decision, February 2022

CMS's January announcement proposes to cover the class of anti-amyloid mAb treatments for AD under a coverage with evidence development (CED) framework in randomized controlled trials. Our recommendations describe opportunities for CMS to refine their proposed coverage decision in light of the evolving body of evidence for mAb treatments and to address the priorities of patient access, equity, and further needed evidence development.

Duke-Margolis Authors

Mark McClellan

Mark McClellan, MD, PhD

Director of Margolis Center
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty


Marianne Hamilton Lopez, PhD, MPA

Senior Research Director, Biomedical Innovation
Faculty Director of the Duke-Margolis Postdoctoral Associates & Affiliated Fellows Program
Adjunct Associate Professor
Senior Team Member
Margolis Core Faculty


Beena Bhuiyan Khan, MSc

Research Director for Payment and Coverage Policy

nitzan arad

Nitzan Arad, LLM

Assistant Research Director

Hannah Graunke Headshot

Hannah Graunke, MPP

Senior Policy Analyst