Coverage with Evidence Development

New medical technologies undergo a development and testing process often narrowly designed to achieve regulatory clearance into the marketplace but lack key evidence needed by payers to assess the extent to which innovation is medically necessary and beneficial for typical patients in routine clinical settings.  Coverage with Evidence Development (CED) is a policy tool designed to address this evidence gap.  Under CED, the Centers for Medicare and Medicaid or other payers agree to cover new medical technologies provided that patients who receive care using those technologies are enrolled in a clinical study to generate the additional benefit and safety information needed to make an informed coverage decision.

CED falls under the category of managed-entry scheme designed to address key health policy issues pertaining to increasing cost pressure, uncertain effectiveness, and the improvement in the level of patient benefit per dollar spent.  Another variant of these schemes, known as performance-based risk-sharing agreements, entail contractual arrangements between payers and manufacturers such that the price, level or nature of reimbursement for a particular technology is tied to future measures of clinical endpoints and real world effectiveness of technologies.

Key concepts concerning CED can be found in the following documents:

  • Coverage with Evidence Development – pdf CED Issue Brief (pdf) (171.92 kB)
  • Coverage with Evidence Development – pdf CED Key Issues (pdf) (847.96 kB)

The concept of CED was spearheaded by the founder of CMTP, Sean Tunis, in his tenure as Chief Medical Officer and Director of the Office of Clinical Standards and Quality for CMS and implemented under the direction of Steve Phurrough, COO & Senior Clinical Director at CMTP.  CMTP continues to be a thought leader in the field, exploring ways to create a more conducive environment for public and private health plans to support and participate in CED for potentially important new medical technologies.  Our work in this area has featured prominently in peer reviewed journals.