Comments to CMS on Proposed Guidance for Coverage with Evidence Development

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Editor’s note: The attached comment letter was submitted to the Centers for Medicare and Medicaid Services (CMS) on Aug. 21, 2023.

Coverage with Evidence Development (CED) is an important policy that CMS has implemented in various forms since its inception in 2006. It has the potential to be a valuable tool to promote and support meaningful innovation, generate evidence and ensure appropriate resource utilization. Eleven Schaeffer Center fellows commented on CMS’s proposed guidance, providing input on how the program could be improved. As described in greater detail in the letter, the researchers raised the following points with CMS:

  • Adding as an explicit, primary goal of CED: the need to promote meaningful innovation
  • Limiting use of CED to those scenarios where real-world evidence is needed and will be informative rather than using it to, in effect, re-evaluate an earlier regulatory approval
  • Tailoring constraints on coverage to the purpose of generating evidence; real-world evidence depends on real-world utilization
  • Building clear and predictable decision-making tools to guide stakeholders (including CMS) on how and when to use CED, including specific guidance about when CED will be triggered (i.e. when there are significant research questions)
  • Right-sizing CED to narrowly address the questions or concerns identified, and removing it as soon as those questions are answered or after a pre-specified period
  • Involving patients and the patient community as primary stakeholders in the decision-making throughout the process

Read the full comment letter here.

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