Coverage with Evidence Development

When developing a new drug or technology, researchers focus on getting the evidence they need to achieve regulatory clearance and bring the product to market.  However, payers need a different set of evidence to determine if the innovation is medically necessary, and beneficial for patients in routine clinical settings.  Coverage with Evidence Development (CED) is a policy tool designed to address this evidence gap.  Under CED, insurers agree to cover promising new technologies and treatments if patients enroll in studies that will generate the additional safety and patient benefit information medical directors need to make an informed coverage decision.

CED helps address insurer’s concerns about cost, effectiveness, and the patient benefit per dollar spent.  In a variant approach called performance-based risk-sharing agreements, payers and manufacturers make contractual arrangements that tie the price, level or nature of reimbursement to future measures of clinical endpoints or to real world effectiveness measures.

Please review our  CED Issue Brief and our  CED Key Issues for more details.

The concept of CED was spearheaded by the CMTP founder Sean Tunis, in his tenure as Chief Medical Officer and Director of the Office of Clinical Standards and Quality for CMS.  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 has featured prominently in peer reviewed journals. For details on workshops, projects, reports and journal articles, visit the CED section of our Resource Center.