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Mandatory Reporting of the 8-Digit National Clinical Trial Identifier Number. Rosemarie Hakim PhD P at Brocato-Simons CMS Coverage & Analysis Group. National Clinical Trial (NCT) Identifier Number.

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Mandatory Reporting of the 8-Digit National Clinical Trial Identifier Number

Rosemarie Hakim PhD

Pat Brocato-Simons

CMS Coverage & Analysis Group

national clinical trial nct identifier number
National Clinical Trial (NCT) Identifier Number
  • The NCT identifier number is assigned by the National Library of Medicine (NLM) at http://clinicaltrials.gov/ website when a new study appears in the NLM Clinical Trials data base.
  • This number is listed prominently on each specific study’s page and is always preceded by the letters ‘NCT’.
  • CMS uses the NCT number to identify all items and services provided to beneficiaries during their participation in a clinical trial, clinical study, or registry.
nct identifier number
NCT Identifier Number
  • The NCT identifier number allows CMS to:
    • Track Medicare payments,
    • Ensure that the information gained from the research is used to inform coverage decisions, and,
    • Make certain that the research focuses on issues of importance to the Medicare population.
nct coding instructions
NCT Coding Instructions
  • Institutional claims
    • Paper: 8-digit NCT identifier number in the value amount value code ‘D4’ of FORM CMS UB-04 (Form Locators 39-41)
    • Electronic: 8–digit NCT identifier number on equivalent 837I in Loop 2300 REF02 (REF01=P4)

when a clinical trial claim includes:

      • Condition code 30;
      • ICD-9 code V70.7/ICD-10 code Z00.6 in either the primary or secondary positions; and
      • Modifier Q0 and/or Q1, as appropriate (outpatient claims only).
nct coding instructions1
NCT Coding Instructions:
  • Professional claims
    • Paper: 8-digit NCT identifier number preceded by alpha characters ‘CT’ in Field 19 of Form CMS-1500 (e.g., CT12345678)
    • Electronic: 8-digit NCT identifier number on equivalent 837P in Loop 2300 REF02(REF01=P4) no ‘CT’ (e.g., 12345678)

When a clinical trial claim includes:

    • ICD-9 code V70.7/ICD-10 code Z00.6 (in either the primary or secondary positions), and,
    • Modifier Q0 and/or Q1, as appropriate (outpatient claims only).
optional directions for reporting nct identifier number
Optional Directions for Reporting NCT Identifier Number
  • For those CMS stakeholders who do not have the capacity at this time to report the NCT identifier number, a generic, 8-digit number 99999999 may be reported instead.
  • Instructions provided in CR8401 would continue to apply for entering the optional, generic number effective 1/1/14 – 1/1/15.
  • The designated fields may not be left blank or the claim will be returned.
  • This in no way precludes those already reporting and/or able to report the actual 8-digit NCT identifier number from doing so.
reference links
Reference Links
  • http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2805CP.pdf
  • http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM8401.pdf
  • http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1344.pdf