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

Noridian requires simplified documentation (notice of participation, FDA IDE designator, clinicaltrials.gov number, facility PTAN, and investigator names/NPIs) for IDE trials with FDA approval dated on/after 2015-01-01 that have been vetted/approved by CMS to allow claims processing. For IDE trials with FDA approval before 2015-01-01 Noridian requires full documentation including trial name, IDE and clinical trial numbers, study protocol, current institutional IRB approval, and IRB-approved informed consent with comprehensive financial disclosures; failure to provide required disclosures or submission of fraudulent information will result in denial and referral to enforcement.

"For IDE trials with an FDA approval letter dated on or after 2015-01-01 that have been approved/vetted by CMS, Noridian will accept simplified documentation and process provider claims upon receipt..."