The Medicare program regularly faces difficult decisions about whether to pay for novel medical devices approved by the Food and Drug Administration (FDA) because substantial uncertainty may remain about devices’ real-world benefits and risks, particularly among older and sicker patients. As one way to address this challenge, Medicare created the “Coverage with Evidence Development” (CED) pathway, which provides access to promising technologies while requiring structured data collection to address evidence gaps. The policy was used to provide national coverage with evidence generation requirements for Transcatheter Aortic Valve Replacement (TAVR) for symptomatic aortic stenosis, which offers a minimally invasive alternative to open-heart surgery.
