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.
Assistant Research Director
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
Research Director for Biomedical Regulatory Policy
Senior Policy Analyst
Director of Margolis Center
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty