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What are the documentation requirements for items and services related to participation in clinical trials?

Medicare Claims Processing Manual, Chapter 32,

§69.6: Requirements for Billing Routine Costs of Clinical Trials 

(Rev. 1723, Issued: 05-01-09, Effective: 10-01-09, Implementation: 10-05-09) (Notice first issued in Medicare Program Memorandum dated September 19, 2000.)

Routine Costs Submitted by Practitioners/Suppliers

Claims shall include:

  • Condition Code 30 (institutional claims);
  •  HCPCS modifier Q0 or Q1 as appropriate for outpatient setting (CMS Transmittal 310, January 18, 2008);
  • ICD -9 diagnosis code V70.7/ICD-10 diagnosis code Z00.6 (Examination of participant in clinical trial) reported as the secondary diagnosis  for therapeutic clinical trial service; primary diagnosis code for healthy volunteer;
  • 8-digit National Clinical Trials (NCT) number (CMS Transmittal 2758, August 9, 2013, Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims)

Diagnosis code required for all Medicare claims which contain “routine costs.” It is the provider’s attestation that the claim contains routine costs during a qualifying trial.


If the Q1 modifier is billed and diagnosis code is submitted by practitioners as a secondary rather than the primary diagnosis, do not consider the service as having been furnished to a diagnostic trial volunteer. Instead, process the service as a therapeutic clinical trial service.


*** Effective January 1, 2014: Claims submitted without the clinical trial number shall be returned as unprocessable.

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