OBJECTIVES: To understand key stakeholder recommendations for the Centers for Medicare & Medicaid Services (CMS) regarding the application of its CED policy, the outcome of national coverage determinations (NCD) in which Medicare makes coverage contingent on additional evidence collection through a registry or prospective trials, and identify primary concerns with the policy across various stakeholders. METHODS: The authors analyzed stakeholder comments submitted to CMS during a public comment period on draft updates to the agency’s 2006 CED policy.  The comment period was from November 29, 2012 to January 28, 2013.  Comments were retrieved from CMS’ Medicare Coverage Database and assessed to understand stakeholder positions on issues related to the CED process. RESULTS: Of the 27 stakeholders who submitted comments to CMS, over half were from the life sciences industry.  The majority of stakeholders called for CMS to provide more clarity on how the agency plans to address operational issues with CED implementation.  Stakeholders who may be impacted by the issuance of a CED, such as manufacturers, are seeking greater transparency from CMS on policies and processes for applying CED as well as greater clarity on the parameters for executing CED studies.  Specifically, 17 stakeholders called on CMS to prohibit CED at the local level and restrict its application to the NCD process while 12 stakeholders recommended CMS to provide clear timelines for the duration of CED studies.  In addition, 11 stakeholders requested clarity from CMS on how it intends to collaborate with the Food and Drug Administration (FDA) on post-market evidence requirements, urging that CED should not duplicate or replace FDA's authority. CONCLUSIONS: Going forward, CMS will likely continue to invoke CED with increasing frequency and potentially on a broader range of products.  Therefore, clearer guidance from CMS is critical to ensuring continued stakeholder engagement through Medicare’s coverage determination process.