Millions of Americans rely on medical devices every day, including pacemakers for heart conditions, breathing machines for sleep apnea and continuous glucose monitors for diabetes management. Throughout the Covid-19 pandemic, diagnostics played a key role, and shortages of tests dramatically hindered America’s response. While the pandemic showed the value of public-private partnerships through Operation Warp Speed, it also revealed how antiquated systems for regulating and paying for new devices and diagnostics can hurt patients and public health. At the same time, few people understand the interplay between FDA regulation and the CMS coverage and reimbursement process for medical devices.
Join Schaeffer Center Co-Director Erin Trish in conversation with Schaeffer Center Nonresident Senior Fellow and Former Director of the Domestic Policy Council Joe Grogan and AEI Senior Fellow and Former FDA Commissioner Scott Gottlieb, whose New York Times’ bestselling book Uncontrolled Spread explains why the American healthcare system was overwhelmed in the face of a global pandemic, due to key regulatory failures and structural reimbursement problems. They’ll discuss the challenges and opportunities facing the FDA and CMS in an age of breakthrough medical devices, and suggest policy solutions.