This report focuses on coverage for devices and issues related to procedural delays, the lack of transparency in Medicare’s National Coverage Determination (NCD) process, the use of Coverage with Evidence Development, harmonizing with the Food and Drug Administration (FDA), and ensuring patient safety. CMS has conducted its NCD review process for medical devices for many years but in recent years the process has slowed and become less predictable. The operational flaws that exist within the NCD process ultimately could prevent Medicare beneficiaries from accessing innovative technologies, especially at a time when CMS considers assuming new responsibilities for evaluating new technologies.