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May 18, 2015 - Revised 04.23.19

CGS Process for IDE Extensions/Changes

Medicare may make payment for cost of routine care furnished in a approved clinical trial when CMS (or its designated entity) and CGS determines prior to the submission of the first related claim that the Medicare coverage IDE study criteria found in Federal Register § 405.212External PDF are met.

Routine care items and services refers to items and services that are otherwise generally available to Medicare beneficiaries (that is, a benefit category exists, it is not statutorily excluded, and there is no national decision to non-cover) that are furnished during a clinical study and that would be otherwise furnished even if the beneficiary were not enrolled in a clinical study.

Extensions, Protocol Changes, Roster Changes, Reportable Adverse Events:

To help streamline our processes for IDE submissions that are changes ONLY effective immediately CGS will now only require the following:

  1. IRB Approval Letter
  2. Letter that includes the following:
    1. PTAN of the facility
    2. Name(s) of the principal investigator with NPI
    3. Names of the sub-investigators with NPI numbers
  3. Any changes to the facility or investigators
    1. Please be sure to include ADD or DELETE with these changes
  4. Any Protocol Changes
    1. Please be sure to include a brief summary of the changes AND version number/letter
  5. Current (since last submission) list of IRB reportable Adverse Events

IDE Submission Tips

When submitting documentation for approval of an IDE the following TIPS are to help with the approval process.

  • Check that ALL information you submit is correct
  • Include the short name for the study only.
  • Include reportable Adverse Events
    • Send in a brief summary of these events, not each of the forms submitted to the IRB.
  • Include clinical protocol changes from last request
    • Send in a brief summary of the protocol changes

When submitting for any type of approval there is no need to include documentation from the initial study or previous approval. CGS keeps all IDE document submissions. The above tips will help CGS move your approval requests through the process in a more timely fashion.

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


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