Coverage With Evidence Development for Medicare Beneficiaries

JAMA Intern Medicine: May 6, 2013

Physicians and patients must routinely make important decisions using limited and imperfect evidence. This includes decisions about new drugs and devices, which require a regulatory determination by the US Food and Drug Administration (FDA) that they are safe and effective for their intended use. For drugs, FDA approval is typically based on rigorous randomized clinical trials; for devices, requirements for approval depend on the potential risks and similarity with existing versions of devices on the market. Unsurprisingly, such evidence is often not ideal for “real-world” decision-making. Premarket evidence has limited ability to resolve uncertainty regarding long-term outcomes, effectiveness in different practice settings, and benefits and risks in populations poorly represented in trials.  Read more