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Clinical and Translational Science Institute

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CMS – ClinicalTrials.gov NCT Number Required

As of January 1, 2014, it is mandatory to report the ClinicalTrials.gov NCT number on Medicare claims for items/services provided in clinical research studies that are qualified for coverage as specified in the following CMS clinical research policies:

  • National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1)
  • Pre-approved Investigational Device Studies (IDEs) 
  • Pre-approved Coverage with Evidence Development (CEDs)
  • Use of an 8-Digit Registry Number on Clinical Trial Claims
  • Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims
  • Further Information on Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims 
  • Q & As for Mandatory Reporting of NCT Identifier Numbers on Medicare Claims
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Office of Clinical Research (OCR)

Clinical and Translational Science Institute

Physical Address
1300 Center Drive
PO Box 100158
Phone
(352) 273-5946
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