Investigational Device Exemption Requests ‒ Renewals and Modifications

Effective for Category A and B IDE studies approved by the FDA on or after 1/1/2015, interested parties (i.e. study sponsors) seeking Medicare coverage must submit a request for review and approval to CMS. Revised Chapter 14 of the Medicare Benefit Policy Manual contains detailed instructions on seeking CMS approval of Category A and B IDE studies for purposes of Medicare coverage. Additional information regarding submission of Category A and B IDE study review requests, along with the list of CMS-approved studies is available at CMS Coverage Related to Investigational Device Exemption (IDE) Studies.

To avoid any delays in claims processing, for IDE studies approved by CMS, please provide the following information to National Government Services:

IDE Number
Copy of CMS approval letter
Name and UPIN of Facility where services will be provided
Principal Investigator Information

Please submit all information to National Government Services by one of the following methods:

Email: NGSIDERequests@anthem.com

Fax: 315-442-4257