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:
NCT# (required for all as of January 1, 2014)
Z00.6 (ICD-10) diagnosis code
Condition Code 30
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)