Health Affairs April 9, 2020
Biomedical innovators have mobilized across the world to address COVID-19, from the initiation of clinical trials for potential vaccines to ongoing studies of repurposed medications for potential therapeutic and prophylactic benefit. Most policy commentary for therapeutic development has focused on issues such the availability of master clinical trial protocols and manufacturing capacity following development. Missing from the conversation has been the Centers for Medicare and Medicaid Services (CMS), which plays an important yet often underappreciated role in regulating access to and payment for novel medical products (drugs and devices).
Legislators drew attention to the important role of CMS guidance in the development and financing of COVID-19 therapies during their negotiations on the third iteration of the COVID-19 stimulus bill. An...
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