Industry News

CMS Implementing Mandatory Reporting of Clinical Trial Numbers on Claims.

Jennifer Kirchner | August 2013

The Centers for Medicare & Medicaid Services (CMS) recently issued a transmittal requiring providers and suppliers to report clinical trial numbers on Medicare claims.  Effective January 1, 2014, providers and suppliers must report items and services furnished in clinical trials that are qualified for coverage as specified in the Medical National Coverage Determination (NCD) Manual (Publication 100-03), Section 310.  CMS is mandating that providers and suppliers report the 8-digit clinical trial number assigned by the National Library of Medicine (NLM) website when a new study appears in the NLM Clinical Trials database.  The number is preceded by the letters “NCT” and is listed prominently on a specific study’s page. 

CMS uses the clinical trial numbers to identify all items and services provided to beneficiaries in a clinical trial, clinical study, or registry that may result from a study covered under the coverage with evidence development, Medicare Clinical Trial Policy, or a CMS-approved investigational device exemption study.

 The CMS transmittal (2758) is available at:

Centers for Medicare & Medicaid Services.  “Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims.”  Transmittal 2758.  9 Aug. 2013. 

About the Author

Jennifer Kirchner is a licensed attorney in Illinois and Wisconsin. Ms. Kirchner has expertise in assessing provider compliance with the Anti-Kickback Statute, Stark Law, the False Claims Act, HIPAA Privacy and Security Rules and clinical research laws and regulations.