A Roadmap for Improving Medicare’s Application of Coverage With Evidence Development

Highlights

• Coverage with evidence development (CED) has the potential to expedite access to promising items or services while providing the Centers for Medicare and Medicaid Services (CMS) with a lever to generate additional evidence designed to address outstanding questions about the impact of these items and services on Medicare beneficiaries.
• Medicare’s CED policy has not fully achieved its goals because CMS has not clearly defined when it will apply CED requirements or its process and timeline for ending CED requirements. Additionally, there have been times when data collection activities implemented in response to CED have placed unnecessary burdens on providers, as well as times when CED has failed to improve access to technologies.
• We provide a roadmap for addressing these issues, which describes steps CMS can take in partnership with other interested parties. These steps include, for example, adopting predictable criteria for when CED should be considered, such as when evidence suggests a technology is beneficial but there are significant outstanding questions about its value or risks. Once CMS addresses these issues, it could consider expanding the use of CED to technologies not subject to National Coverage Determinations.

Abstract

The Centers for Medicare and Medicaid Services’ coverage with evidence development (CED) policy allows the agency to provide coverage for an item or service through a National Coverage Determination (NCD), conditional upon an agreement to collect evidence designed to address specific questions or uncertainties. The goals of this policy are to expedite beneficiary access to new items and services and to generate additional evidence on the impact of these items or services for Medicare beneficiaries. However, these goals have not been fully realized because of several issues with the way the policy has been implemented, including (1) a lack of clear criteria for when CED will be applied, (2) examples of CED data collection activities placing unnecessary burdens on clinicians and the potential for undue inducement on beneficiaries, and (3) a lack of clarity around the process and timeline for reconsidering and ending CED requirements. Additionally, there are cases in which the application of CED has failed to improve access to services for certain Medicare beneficiaries because no data collection activity was implemented in response to the CED requirement or because the NCD only allows the technology to be provided and studied in certain centers of excellence. We describe a roadmap for addressing these issues, which includes, for example, developing a framework to guide the application of coverage constraints in NCDs with CED requirements. Once these issues are addressed, the Centers for Medicare and Medicaid Services could consider expanding the use of CED to technologies that are not subject to NCDs.

The full study can be viewed at Value in Health.

Lakdawalla, D., Tunis, S., Neumann, P., Whicher, D., Zeitler, E., & Liden, B. (2024). A Roadmap for Improving Medicare’s Application of Coverage with Evidence Development. Value in Health.