CMS – Z00.6 and Q0/Q1 Modifiers

Applies to:  All Human Subjects Clinical Research that includes protocol-required services that will be billed to participants/insurance

Effective date:  01/01/08

The Centers for Medicare & Medicaid Services (CMS) requires that the following diagnosis code be used on Medicare research claims to identify Medicare patients who are participating in a Qualifying Trial:

  • Diagnosis code Z00.6: Encounter for examination for normal comparison and control in clinical research program

In addition, the claims must include one of the following modifiers  to differentiate between routine and investigational clinical services:

  • Q0 – Investigational clinical service provided in a clinical research study that is in an approved clinical research study.
  • Q1 – Routine clinical service provided in a clinical research study that is in an approved clinical research study.

For more detail, see CMS MLN Matters Article MM5805 and Medicare Claims Processing Manual.