When the Centers for Medicare and Medicaid Services (CMS) considers billing issues tied to Investigational Device Exemption (IDE) studies, it's usually not the facts about such details as the National Clinical Trial number or an institutional review board’s decisions that come into question. More often, CMS is challenging the principal purpose of the study along with its methodology and applicability to Medicare beneficiaries and health outcomes. This session focuses on troubleshooting the "justifications" for the 10 approval criteria that matter most to CMS and learning more about what kinds of IDEs become winners

CEU: 1.00 ACRP

Speaker:

Wendy Schroeder, Principal Strategy Consultant, Clinical. NAMSA