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
• Q & As for Mandatory Reporting of NCT Identifier Numbers on Medicare Claims