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.