In the United States, Medicare allows payment of routine costs of care furnished to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies. In order to determine whether billing of routine costs (and in some cases the cost of the device itself) is permitted, a request for preauthorization must be submitted to Medicare in advance of the study.
Effective January 1, 2015, Medicare is changing the way it reviews and approves IDE preauthorization requests. Rather than requiring each research site to obtain preauthorization independently from each local Medicare Administrative Contractor (MAC), Medicare will now review only one preauthorization request per study at their central location. More information about this change is available on the Centers for Medicare and Medicaid Services (CMS) website.