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Medicare coding change for clinical trial billing

October 17, 2013

Effective January 1, 2014, all Medicare claims associated with clinical trial participation must be submitted with the corresponding clinical trial number. The ClinicalTrials.gov website maintains a list of each registered clinical trial and the corresponding clinical trial number, which is an 8-digit number preceded by the letters “NCT”. The National Institutes of Health assigns a “National Clinical Trial Number” (also referred to as the Clinical Trials Identifier) each time a new study is registered through the ClinicalTrials.gov website. All clinical trial-related claims with dates of service on or after January 1, 2014 will be returned to the provider unpaid, if the claims are submitted without a corresponding clinical trial number. More information on this change can be found in the Medicare Claims Processing Manual, Transmittal 2758.

Previously, reporting of the clinical trial number with trial-related Medicare claims was voluntary. The Centers for Medicare & Medicaid Services (CMS) have stated that this change only affects the reporting requirements for Medicare claims and is not intended to alter what is covered by Medicare in clinical trials. The change, however, is part of CMS’ broader effort to better track Medicare payments in clinical trials and may signal increased scrutiny of Medicare payments for clinical trials in the future.

Providers that bill Medicare for clinical trial related claims must evaluate and modify their current billing processes to comply with this new requirement. At a minimum, providers should establish procedures to identify all claims that may be associated with clinical trials, confirm the clinical trial registration and verify the 8-digit clinical trial number on ClinicalTrials.gov prior to submitting any clinical trial-related claims. Providers also will need to ensure that their billing staff is appropriately trained to identify and code claims associated with clinical trial patients.

For assistance with the clinical trial billing change discussed above or any other issue relating to clinical trials, please contact one of our Health Care attorneys. 

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