ClinicalTrials.Gov – New Federal Regulation for Billing

There is a new federal regulation for billing Medicare recipients participating in clinical trials.  As of January 1, 2014, the clinicaltrials.gov number (NCT#) assigned to the study must be listed on Medicare claims for services provided to clinical trial participants.  If the number is not listed on the claim, payment will be denied.

In order to support this initiative and ensure that the NCT# is available when needed, OCR has been contacting researchers to obtain the number for all trials, including multi-center, industry-supported studies.  The goal is to place NCT#s in ERMS for all trials which are registered on ClinicalTrials.gov for existing studies, as well as to ensure that the NCT is captured and placed in ERMS for all new studies in the future.  University IT is working with Emory Healthcare IS to ensure that the NCT placed in ERMS will be available to Emory Healthcare billers.

If your assistance is needed, we will contact you directly.

From the Office of Clinical Research