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Frequently Asked Questions

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What special identifiers, codes, and modifiers are required when billing for clinical study protocol items/services?

Medicare, Medi-Cal, and many private payers require the following codes be properly applied on claims for items/services related to all Qualified Clinical Trials, approved Device Studies, and approved clinical studies or Registries under a CED:
        1. NCT# (required for all as of January 1, 2014)

  • Z00.6 (ICD-10) diagnosis code
  • Condition Code 30
  • Q0/Q1 Modifiers
  • Revenue Code 624 for study devices, with the FB modifier and nominal $1.01 charge if the device is provided free by the sponsor

(See <ahref="http: www.cms.gov="" manuals="" downloads="" clm104c32.pdf"="">http://www.cms.gov/manuals/downloads/clm104c32.pdf)


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