Modifiers Added for Clinical Trials

CMS is discontinuing the QA (FDA Investigational Device Exemption), QR (Item or Service Provided in a Medicare Specified Study), and QV (Item or Service Provided as Routine Care in a Medicare Qualifying Clinical Trial) HCPCS modifiers as of December 31, 2007, and creating two new modifiers that will be used solely to differentiate between routine and investigational clinical services. These new modifiers will be included in the 2008 Annual HCPCS Update and are effective for dates of service on and after January 1, 2008:

• Q0 – Investigational clinical service provided in a clinical research study that is in an approved clinical research study. Q0 replaces QA and QR.
• Q1 – Routine clinical service provided in a clinical research study that is in an approved clinical research study. Q1 replaces QV.