21st Century Cures Act 2.0

21st Century Cures Act 2.0


Duke-Margolis Cures Act 2.0 Icon

The 21st Century Cures Act 2.0 seeks to build on the bipartisan successes of the 21st Century Cures Act (2016) to support more effective medical product development and regulation. The Cures 2.0 Act draft, released June 22, 2021, includes provisions on real-world evidence, streamlining Medicare coverage processes, future pandemic preparedness, development of new antimicrobial therapies, clinical trial representativeness, digital health technologies, cell and gene therapies, accelerated approval, and the proposed Advanced Research Projects Agency for Health (ARPA-H). Many of these provisions are intended to modernize processes at the US Food and Drug Administration and the Centers for Medicare and Medicaid Services.

The issue briefs from Duke-Margolis linked below detail recommendations for legislators developing the 21st Century Cures Act 2.0 to expand the impact of the bill by advancing a national health data infrastructure and streamlining Medicare coverage for breakthrough devices. Implementing these recommendations will help improve Federal health agency communication, accelerate medical research and development, and expand patient access to innovative drugs and devices.

Building a Modern Health Data Infrastructure:
Cures 2.0 Act Provisions on Real‐world Evidence and Federal Agency Communication
Published October 5, 2021
Modernizing Access for Breakthrough Devices:
Cures 2.0 Act Provisions on Medicare Coverage
Published October 5, 2021