Duke-Margolis Comment Letter to CMS on Buffer Stock Proposed Rule

Comment Letter

Duke-Margolis Comment Letter to CMS on Buffer Stock Proposed Rule

Published date

September 11, 2023

The Robert J. Margolis, MD, Center for Health Policy at Duke University (“Duke-Margolis”) appreciates this opportunity to provide comments and recommendations regarding provision “XXII. Request for Public Comments on Potential Payment Under the IPPS and OPPS for Establishing and Maintaining Access to Essential Medicines” of this proposed rule.

Duke-Margolis has conducted years of research and stakeholder engagement aimed at promoting drug supply chain resilience and preventing drug shortages, most recently including the launch of the new Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium. The recommendations herein do not necessarily represent the views of any Consortium Members and are not intended to limit the ability of Consortium members to provide their own comments on behalf of their independent organizations, but are informed by Duke-Margolis’ work with Consortium Members. Please note that in addition to the recommendations put forth in this comment, Duke-Margolis also recently published a white paper, Advancing Federal Coordination to Address Drug Shortages, with a broader set of recommendations for administrative and legislative action on drug shortages. The white paper proposes the establishment of a Prevent Drug Shortages Initiative to coordinate ongoing efforts across the federal government, including within CMS, to more effectively address pressing drug shortage issues.

Read the entire letter here.

Duke-Margolis Authors

Stephen Colvill headshot

Stephen Colvill, MBA

Assistant Research Director


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

A headshot of Gerrit, where he stands on a bridge overlooking a forest and wears a light blue collared shirt with a dark blue jacket and light blue pocket square.

Gerrit Hamre, MA

Research Director for Biomedical Regulatory Policy

Thomas Roades Photo

Thomas Roades, MPP

Senior Policy Analyst

Mark McClellan

Mark McClellan, MD, PhD

Director of the Duke-Margolis Institute for Health Policy
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty