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May 18, 2015 - Updated 07.02.19

CGS Process for INITIAL IDE Submissions

Beginning in January 2015, there are some changes to the Investigational Device Exemption (IDE) submission process.

What Is Changing

Effective for Category A and B IDE studies approved by the FDA on or after January 1, 2015, interested parties (i.e., study sponsors) that wish to seek Medicare coverage must submit a request for review and approval to CMS.

  • The CMS Medicare Benefit Policy Manual (Pub. 100-02), chapter 14, 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 on the CMS website at http://www.cms.gov/Medicare/Coverage/IDEExternal Website

CGS will have the responsibility of providing approval for system updates at the local level; in order to do this we require the documents listed below via J15IDE@cgsadmin.com.

  • Local IRB Approval
  • CMS Approval letter provided to your sponsor

Along with the above 2 requirements please include a letter with the following information:

  • PTAN of the facility,
  • Name(s) of the principal investigator with NPI
  • Names of the sub-investigators with NPI numbers

J15 Medicare Providers will continue to submit requests to CGS for Category A and B IDE studies approved by the FDA prior January 1, 2015 please continue to submit to CGS for approval via J15IDE@cgsadmin.com. Required documentation:

  • Letter from the Principle Investigator to include:
    • PTAN of the facility
    • Name(s) and PTAN of principle and sub investigators
  • Unredacted FDA Approval letter
  • Local IRB Approval
  • Protocol

Please note: for claims outside the J15 jurisdiction; check with that MAC contractor regarding their local coverage approval requirements.

Reference:

Questions concerning this process may be submitted to J15IDE@cgsadmin

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