Cures 2.0: Modernizing Access for Breakthrough Devices

Background

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.