One-Year Delay in Clinical Trial Number Requirement — But Not for Everyone

On January 6, 2014, the Centers for Medicare & Medicaid Services (CMS) announced a one-year delay in the requirement that an eight-digit identification number be included on all Medicare claims for services and items relating to a clinical trial. The requirement, scheduled to be effective January 1, 2014, has been delayed until January 1, 2015. But the reprieve doesn't apply to everyone.

For years the National Library of Medicine (NLM) has assigned an eight-digit identification number to every new study that appears in the NLM Clinical Trials data base. Since January 2008, providers and suppliers have voluntarily reported that number on all claims associated with a study. CMS had decreed that reporting the number would be mandatory as of January 1, 2014.

On January 6, 2014, CMS relented, acknowledging that finding the number would be an "undue hardship" for some claimants—namely, those without the "capacity at this time" to do so. So, CMS pushed the effective date of the requirement forward by one year for those claimants. Throughout 2014, they have the option of entering the number 99999999 rather than the accurate number.

As for claimants that do have the capacity to report the accurate number, they must do so. In practical terms, this means that a claimant that has been entering the accurate number for a particular study must continue to do so, rather than using the 99999999 number.