Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims

Effective January 1, 2014, it will be mandatory to report a clinical trial number on claims for items and services provided in clinical trials that are qualified for coverage as specified in the “Medicare National Coverage Determination (NCD) Manual,” Section 310.1.  This 8-Digit Clinical Trial Number is listed prominently on each specific study’s page and is always preceded by the letters ‘NCT’.  CMS uses this number to identify all items and services provided to beneficiaries during their participation in a clinical trial, clinical study, or registry. For professional claims, the 8-digit clinical trial number preceded by the 2 alpha characters of CT must be placed in Field 19 of the paper claim Form CMS-1500 or the electronic equivalent 837P.