Payment for Investigational Device Exemption (IDE) Studies

10.7.2 – Payment for Investigational Device Exemption (IDE) Studies (Rev. 121, Issued: 04-22-16, Effective: 04-22-16, Implementation: 04-22-16) MAOs are responsible for payment of claims related to enrollees’ participation in both Category A and B IDE studies that are covered by the MAC with jurisdiction over the MA plan’s service area. The MAO is responsible for payment of routine care items and services in CMS-approved Category A and Category B IDE studies. The MAO is also responsible for CMS-approved Category B devices. CMS will not approve Category A devices because they are statutorily excluded from coverage. CMS finalized changes to the IDE regulations (42 CFR § 405 Subpart B), effective January 1, 2015. A listing of all CMS-approved Category A IDE studies and Category B IDE studies will be posted on the CMS Coverage webpage site located at: http://www.cms.hhs.gov/center/coverage.asp and published in the Federal Register.