Local Coverage Article

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

A54917

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Article ID
A54917
Article Title
Investigational Device Exemptions (IDE) - IDE Documentation Requirements for Studies with an FDA Approval dated January 01, 2015 or later
Article Type
Article
Original Effective Date
10/01/2015
Revision Effective Date
10/01/2015
Revision Ending Date
N/A
Retirement Date
N/A
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Article Guidance

Article Text

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

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

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

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
IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 14, Section 20
Federal Register Vol. 78, No. 237
CMS Change Request (CR) 8401


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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
10/01/2015 R3

Hyperlink removed from "Other URL" section as it is no longer a valid link.

10/01/2015 R2

Removed hyperlink to CR8401 as it is no longer a valid link

10/01/2015 R1 R1 Typographical Error with clinical trials link & correct PO Box number

Associated Documents

Related Local Coverage Documents
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Related National Coverage Documents
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Statutory Requirements URLs
Rules and Regulations URLs
CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
06/08/2022 10/01/2015 - N/A Currently in Effect You are here
04/29/2022 10/01/2015 - N/A Superseded View
03/10/2016 10/01/2015 - N/A Superseded View
02/18/2016 10/01/2015 - N/A Superseded View

Keywords

  • Investigational Device Exception
  • IDE
  • Clinical trial