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Update Regarding NCT# Mandate

December 20, 2013

Effective January 1, 2014, the Centers for Medicare & Medicaid Services (CMS) will require inclusion of an 8-digit clinical trial number on claims for routine care items and services associated with 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.

This 8-digit National Clinical Trial (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. Information regarding the process of providing the NCT# to our health care affiliates may be obtained by contacting:


Jack Bishop, Program Director of Specialty Billing

Sana Smith, Team Lead Specialty Billing

Camille Gilliam


Steve Pidcock, Manager Patient Financial Services

Additional information regarding the new mandate can be found at: