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CMS changes modifiers used in clinical research studies

Device Regulation Alert: Safety, Compliance and Reimbursement News, February 11, 2008

Three modifiers for use in identifying clinical services in research studies are being discontinued because they were vague and not used properly, CMS announced in a January 18 transmittal.

The three modifiers being discontinued are:

• QA - FDA investigational device exemption
• QR - Item or service provided in Medicare Specified Study
• QV - Items of routine care in Medicare qualifying clinical trial

CMS introduced two new modifiers that distinguish between routine and investigational clinical services provided in approved studies. CMS notes that investigational services are items and services that are investigated as part of the study and may include approved, unapproved, or covered items and services. Routine services are those that Medicare covers outside a research study.

The following new modifiers must be used for claims having dates of service on or after January 1, 2008:

• Q0 - Investigational service provided in approved clinical research study (replacing the QA and QR modifiers)
• Q1 - Routine clinical services in an approved clinical research study (replacing the QV modifier).

Any claims that use the old modifiers for services with dates of service on or after January 1, 2008, will be returned as unprocessable. A MLN Matters article notes that if Category A or B investigational devices are used the Investigational Device Exemption number should be included on the claim form.

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