Medicare Program; Criteria and Procedures for Extending Coverage to Certain Devices and Related Services

This final rule establishes in regulations that certain devices with an investigational device exemption (IDE) approved by the Food and Drug Administration (FDA) and certain services related to those devices may be covered under Medicare. Specifically, it sets forth the process by which the FDA will assist HCFA in identifying non- experimental investigational devices that are potentially covered under Medicare. This rule responds to the mandate that Federal agencies streamline their regulatory processes to make them less burdensome and more customer-focused. It is intended to provide Medicare beneficiaries with greater access to advances in medical technology and encourage clinical researchers to conduct high quality studies of newer technologies.