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New Federal Mandate Regarding Research Billing Requirements Effective January 1, 2014

September 24, 2013

Effective January 1, 2014, the Centers for Medicare & Medicaid Services (CMS) will require inclusion of an 8-digit clinical trial number on claims associated with clinical trial participation. Clinical trial related claims submitted to Medicare for dates of services on or after January 1, 2014, will be returned to the provider if the 8-digit clinical trial number is not present.

The 8-digit clinical trial number, also called the National Clinical Trial (NCT) Number or Clinical Trials identifier, can be found on the ClinicalTrials.gov website. Applicable clinical trials must be registered with ClinicalTrials.gov by the responsible party within 21 days of enrollment of the first participant. Commercially sponsored clinical trials will be registered by the commercial sponsor of the trial. Investigator Initiated trials and Federally Funded trials must be registered by the Principal Investigator or designee. The 8-digit NCT number is then assigned 2-5 business days after the clinical trial information has been submitted.

This 8-digit NCT number will be added to the list of other required data:

  • Q0 & Q1 Modifiers as applicable (Outpatient claims only)
  • ICD-9 Diagnosis Code V70.7 (Examination of a participant in a clinical trial)
  • Revenue Code 0624 for FDA Investigational Devices, as applicable
  • Condition Code 30 (Institutional claims only)
  • Medical record documentation of clinical trial title, sponsor name and sponsor protocol number

Research Coordinators will be required to furnish the NCT Number to our health care affiliates in order to bill Medicare for routine care (standard of care) items and services related to clinical trial participation. To obtain the NCT Number, contact the commercial sponsor of your clinical trial or visit, clinicaltrials.gov to determine if your clinical trial has been registered. If your investigator- initiated trial has not been registered, it will need to be registered promptly. If you do not have a ClinicalTrials.gov account, please contact Kristy Armour, amourk@iu.edu, for user access.

Information from our health care affiliates regarding how they will collect the NCT number to comply with this clinical research billing requirement will be forthcoming.