Medical Device Regulation and Reimbursement: What the Pandemic Revealed

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.

Event Date
Wednesday, October 27, 2021
11:00 AM - 11:45 AM Pacific

Erin Trish, PhD (Moderator), is co-director of the USC Schaeffer Center and an assistant professor of pharmaceutical and health economics at the USC School of Pharmacy. In addition, she is a nonresident fellow in Economic Studies at the Brookings Institution and a scholar with the USC-Brookings Schaeffer Initiative for Health Policy.

Her research focuses on the intersection of public policy and healthcare markets, with recent projects focused on surprise medical bills, prescription drug spending, healthcare market concentration, and healthcare reform. Her research has been funded by grants from the Robert Wood Johnson Foundation and the Laura and John Arnold Foundation and published in leading health policy, health economics, and medical journals. She has testified in the California State Assembly and presented her research at numerous federal agencies, including the Congressional Budget Office, Federal Trade Commission, Office of the Assistant Secretary for Planning and Evaluation, and the Center for Consumer Information and Insurance Oversight. In 2018 she received the Seema Sonnad Emerging Leader in Managed Care Research Award.

Trish completed a postdoctoral fellowship at the USC Schaeffer Center and the Fielding School of Public Health at the University of California, Los Angeles. She received her PhD in Health Policy and Economics from the Johns Hopkins Bloomberg School of Public Health and her BS in Biomedical Engineering from Johns Hopkins University.

Joseph Grogan, JD, served as Assistant to President Donald J. Trump and Director of the Domestic Policy Council. He was the President’s lead advisor on a variety of domestic policy issues relating to healthcare, regulatory and deregulatory initiatives, economic expansion, commercial space exploration, environment, agriculture, civil rights, and education. He is a health policy thought leader who has played a key role in the health sector’s most consequential debates of the last decade.

Grogan was also a member of the White House’s COVID-19 Task Force, where he worked with Executive Branch officials to respond to the COVID-19 public health emergency.

During his time as Director of the Domestic Policy Council, Grogan led a White House team that directed the focus and attention of all major policy initiatives, including the development of regulations, Executive Orders, Presidential Decision Memorandums, and major Presidential announcements. In his role, Grogan coordinated with the President’s Cabinet, National Economic Council, White House Communications, Office of Management and Budget, and White House Legislative Affairs to drive the President’s domestic policy agenda. Notably, Grogan negotiated provisions of the 2020 Omnibus Spending Bill with Congressional leadership and members which eliminated a number of significant healthcare taxes. He developed a reputation as having an open door across the political spectrum for innovators and private industry seeking to solve complex problems in a highly regulated environment.

Scott Gottlieb, MD, is a senior fellow at the American Enterprise Institute (AEI). He returned to AEI in 2019 after serving as the 23rd commissioner of the Food and Drug Administration (FDA). At AEI, he continues his work on improving public health through entrepreneurship and medical innovation and on expanding regulatory approaches to maintain patient and physician autonomy. Dr. Gottlieb is also a special partner with the venture capital firm New Enterprise Associates and serves on the boards of Pfizer, Illumina, Aetion, and Tempus.

At the FDA, Dr. Gottlieb focused on a wide variety of issues, including drug pricing, medical product innovation, food safety, vaccination, and tobacco and vaping. He advanced new policies to address opioid addiction, working to rationalize prescribing as a way to reduce the rate of new addiction. He helped make the regulatory process for the development and review of novel drug and medical devices more efficient, including the approval of the first gene-therapy-based cancer treatment. He also presided over a record number of novel drug and medical device approvals in 2017 — and then broke that record in 2018.

Dr. Gottlieb helped promote competition through the approval of a record number of generic drugs, including the creation of new pathways for developing generic copies of complex drugs. He also helped advance the FDA’s Oncology Center for Excellence, which fosters a collaborative scientific environment to improve the development and regulation of oncology products. In addition, he helped implement the 21st Century Cures Act to accelerate medical product development.

Dr. Gottlieb previously served in other capacities at the FDA, including as deputy commissioner for medical and scientific affairs, senior adviser for medical technology, and director of medical policy development. Earlier, he served as senior policy adviser to the administrator at the Centers for Medicare & Medicaid Services. Until he joined the FDA as commissioner, he was also a clinical assistant professor at New York University School of Medicine. Earlier, he was a practicing physician and hospitalist concurrently with his AEI work.

In addition to his frequent testimonies before Congress, Dr. Gottlieb is often published and interviewed by the media. A contributor to CNBC, his interviews range from Face The Nation, CBS News to Fox News, and his commentary and articles have appeared in Health Affairs, The Wall Street Journal, The Washington Post, and The New York Times, among other outlets.

Dr. Gottlieb has a medical degree from Mount Sinai School of Medicine and did his residency in internal medicine at the Mount Sinai Medical Center. He has a BA in economics from Wesleyan University.