Investigational Device Exemptions (IDE) - IDE Documentation Requirements for
Studies with an FDA Approval dated January 01, 2015 or later

Effective January 01, 2015, CMS Coverage Analysis Group began reviewing all
IDE trials for approval. Once CMS approves the trial they list the trial on
their web site as approved. This process is streamlining the approval process
for all parties involved.  
  
Noridian has reviewed our requirements for such studies. For IDE trials with
an FDA approval letter on or after January 01, 2015 that have been approved by
CMS Noridian will only require:  
  
1\. Notice of participation in the trial,  
2\. IDE designator assigned by the FDA  
3\. Clinical trial number as listed on [clinical
trials.gov](https://clinicaltrials.gov)  
  
A letter including the three above stated requirements along with the PTAN of
the facility, the names of the principal investigator, study doctors and their
NPIs is to be submitted at time of request to Noridian.  
  
Such notice is necessary to input into the Noridian claims payment systems to
assure proper processing of our provider's claims related to such trial. For
further information on this process please visit the CMS website: [CMS
website](http://www.cms.gov/Medicare/Coverage/IDE/index.html)  
  
 **IDE Documentation Requirements for Studies with an FDA Approval dated prior
to January 01, 2015**  
  
For any IDE trial with an FDA approval letter date before January 01, 2015,
Noridian will continue to require the following documentation:  
  
1\. Name of the trial, the assigned FDA IDE number and the Clinical Trial
number;  
2\. The study protocol;  
3\. The most recent institutional IRB approval letter;  
4\. The most recent IRB approved informed consent which includes a financial
disclosure for the facility and investigators;  
5\. For the purposes of an IDE approval the following financial disclosures
**shall** be included in the informed consent and be clearly marked as such
therein:  
  

    * Funding source(s) for the project;



    * Funding for the facility;



    * Funding for the investigators and if that funding is direct to the provider or if the facility is provided funds to offset his/her salary



    * Any relationship that the provider has with the sponsor. These include but are not limited to being a speaker for the sponsor, receiving other gratuities from   
the sponsor and/or being a paid consultant for the sponsor.



    * Other financial interests in the sponsor(s) such as stocks or other investments;



    * Any other potential conflict of interest as it regards the respective study;



    * Any such interest as disclosed to the Institutional Review Board.

  
  
  
The informed consent does not necessarily need to include the extent of such
potential conflict (e.g. how many stocks the institution/ primary investigator
(PI)/ secondary or other investigators (SI) has from the sponsor or the actual
monies paid directly to the institution/PI/SI) only that one exits. Noridian
does reserve the right to request a budgetary review of IDE trials/studies but
the latter does not need to be submitted with the application.  
  
Failure to provide such information either in the affirmative with a listing
of such items or in the negative (no known conflicts) will result in a denial
of the request. The provision of fraudulent information will be referred to
Medicare enforcement agencies.  
  
 **Form**  
[FDA Approved IDE pre-Approval Data Submission
Request](https://med.noridianmedicare.com/documents/10546/2911943/FDA+Approved+IDE+Pre-
Approval+Data+Submission+Request)  
  
 **IDE Submissions**  
All IDE submissions regardless of FDA letter date should be sent to one of the
following:  
  
Email: iderequests@noridian.com  
Hard Copy:  
ATTN: IDE Coordinator  
PO Box 6782  
900 42nd St. S  
Fargo, ND 58103-6722  
  
For those IDE studies with an FDA approval letter dated **before** January 01,
2015, provider notification will be sent out upon approval/disapproval. If an
application is approved, the system will be set to accept a provider's claims.  
  
For those studies with an FDA approval letter dated on or after January 01,
2015, a notice of receipt of the information and confirmation that the study
has been vetted by CMS will be sent to the provider.  
  
 **Resources**  
Providers should adhere to the CMS billing requirements to ensure the proper
processing of IDE claims.  
  
[CMS Internet Only Manual (IOM), Publication 100-4, Medicare Claims Processing
Manual, Chapter 32, Section 68](https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Downloads/clm104c32.pdf)  
[IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 14, Section
20](https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Downloads/bp102c14.pdf)  
 **Federal Register Vol. 78, No. 237**  
CMS Change Request (CR) 8401