Article - Investigational Device Exemptions (IDE) - IDE Documentation Requirements for Studies with an FDA Approval dated January 01, 2015, or later (A54919)

CMS National Coverage PolicyN/AArticle TextEffective 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 FDA3. Clinical trial number as listed onclinical trials.govA 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 providers claims related to such trial. For further information on this process please visit the CMS website:CMS websiteIDE Documentation Requirements for Studies with an FDA Approval dated prior to January 01, 2015For 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 disclosuresshallbe 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 fromthe 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.IDE SubmissionsAll IDE submissions regardless of FDA letter date should be sent to one of the following:Email: iderequests@noridian.comHard Copy:ATTN: IDE CoordinatorPO Box 6782Fargo, ND 58103-6722For those IDE studies with an FDA approval letter datedbeforeJanuary 01, 2015, provider notification will be sent out upon approval/disapproval. If an application is approved, the system will be set to accept a providers 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.ResourcesProviders 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 68IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 14, Section 20Federal Register Vol. 78, No. 237CMS Change Request (CR) 8401