The COVID-19 pandemic has had an enduring effect across the entire spectrum of law and policy, in areas ranging from health equity and racial justice, to constitutional law, the law of prisons, federal benefit programs, election law, and much more. This collection provides a critical reflection on what changes the pandemic has already introduced and what its legacy may be. Chapters evaluate how healthcare and government institutions have succeeded and failed during this global “stress test,” and explore how the United States and the world will move forward to ensure we are better prepared for future pandemics. This timely volume identifies the right questions to ask as we take stock of pandemic realities and provides guidance for the many stakeholders of COVID-19’s legal legacy. This book is also available as Open Access on Cambridge Core.

The COVID-19 pandemic has had an enduring effect across the entire spectrum of law and policy, in areas ranging from health equity and racial justice, to constitutional law, the law of prisons, federal benefit programs, election law, and much more. This collection provides a critical reflection on what changes the pandemic has already introduced and what its legacy may be. Chapters evaluate how healthcare and government institutions have succeeded and failed during this global “stress test,” and explore how the United States and the world will move forward to ensure we are better prepared for future pandemics. This timely volume identifies the right questions to ask as we take stock of pandemic realities and provides guidance for the many stakeholders of COVID-19’s legal legacy. This book is also available as Open Access on Cambridge Core.

The FDA’s Guidance to the Breakthrough Devices Program states the agency “may accept a greater extent of uncertainty of the benefit-risk profile for these devices if appropriate under the circumstances.” The CMS recently began providing supplemental reimbursement through New Technology Add-On Payments for “Breakthrough Devices.” CMS has waived a nearly two-decade criterion that devices receiving such payments must provide a “substantial clinical improvement” to Medicare beneficiaries. These policies will accelerate the approval and adoption into clinical practice of novel medical devices which may later be determined to not meet the statutory standard of reasonable assurance of safety and effectiveness (FDA) and/or “reasonable and necessary” (CMS). A crucial, but underutilized, regulatory authority can improve patient safety: conditional approval with withdrawal of approval when (1) clinical data demonstrate the threshold of reasonable assurance of safety and effectiveness is not met or (2) postmarket studies are not completed in a timely manner to demonstrate safety and effectiveness. It is rarely used, but there is precedent for FDA revocation of pharmaceutical approvals. In addition, payor coverage should be conditional (and proportional) on data of safety and effectiveness and withdrawn for data showing net harms or if data are not generated in a timely manner.