Frequently Asked Questions

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