Reimbursement
Coverage with Evidence Development(CED)
In one line
Medicare paradigm conditioning coverage on participation in approved clinical studies or registries.
Definition
Under CED, CMS provides coverage for promising items or services on the condition that beneficiaries are enrolled in an approved study or data collection effort that addresses outstanding questions.
CED is applied through an NCD, with study requirements described in CMS's CED guidance, and participating facilities must enroll patients in an approved registry or trial. Transcatheter valve replacement, linked to the TVT Registry, is a well known device example. CED decisions can be reconsidered and the study requirement removed once enough evidence exists.
Why it matters
CED is common for novel devices with developing evidence (e.g., TAVR, leadless pacemakers historically). Registry participation requirements influence hospital adoption and total cost of evidence generation.
Common pitfalls
- •Manufacturers might underestimate the resources required for data collection and study participation under CED.
- •Failing to design studies that adequately address the evidence gaps identified by CMS can lead to delays or non-coverage.
- •Misinterpreting CMS requirements for data submission and study protocols can result in compliance issues.
- •Assuming that CED implies permanent coverage without the need for submitting conclusive evidence is a common misconception.
- •Ignoring the impact of CED on market access strategies and product launch timelines can lead to commercial challenges.
Sources
- CMS CED · CMS