Cures 2.0: Modernizing Access for Breakthrough Devices

Policy Brief

Cures 2.0: Modernizing Access for Breakthrough Devices

Published date

October 5, 2021


The 21st Century Cures Act (“Cures 2.0 Act”) draft, released June 22, 2021, strives to modernize the Centers for Medicare and Medicaid Services’ (CMS) coverage processes to provide faster and more effective access to new technologies for Medicare beneficiaries. As part of these efforts, provisions in Cures 2.0 seek to facilitate earlier access to breakthrough devices by establishing a transitional coverage and reimbursement pathway. The Duke-Margolis Center for Health Policy (“Duke-Margolis”) has explored issues impacting similar proposals on coverage and evidence needs for breakthrough devices. This issue brief, one of several Cures 2.0 Act-focused issue briefs developed by Duke-Margolis, offers recommendations to ensure the proposed transitional coverage pathway succeeds in providing Medicare patients faster and more effective access to innovative medical devices. Comments are informed by the Center’s independent analyses of the draft legislation and recent convenings with a broad set of stakeholders.

Duke-Margolis Affiliated Authors


Beena Bhuiyan Khan

Assistant Research Director

Hannah Graunke Headshot

Hannah Graunke, MPP

Policy Analyst


Rebecca (Becky) Ray

Senior Policy Analyst

morgan romine

Morgan Romine, MPA

Chief of Staff
Senior Team Member


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

Mark McClellan

Mark McClellan, MD, PhD

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