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/IDE
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:
- MLN Matters Article Number MM8921: "Medicare Coverage of Items and Services in Category A and B Investigational Device Exemption (IDE) Studies"
- CMS Medicare Benefit Policy Manual (Pub. 100-02), chapter 14;
- More information on Category A and B IDE study review requests, along with the list of CMS-approved studies: http://www.cms.gov/Medicare/Coverage/IDE
Questions concerning this process may be submitted to J15IDE@cgsadmin