New HCPCS modifiers for reporting patient care in clinical research studies

The Centers for Medicare & Medicaid (CMS) have created two new HCPCS modifiers to capture investigational and routine clinical services provided to patients in a clinical research study that is approved by Medicare. New HCPCS modifiers Q0, Investigational clinical service provided in a clinical research study that is in an approved clinical research study , and Q1, Routine clinical service provided in a clinical research study that is in an approved clinical research study , were created to replace now discontinued modifiers QA, FDA investigational device exemption , QR, Item or service provided in a Medicare specified study , and QV, Item or...

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Note:  The following article synopsis was NOT provided by the AHA. It was created by Find-A-Code/innoviHealth.

Article Overview

This article covers CMS guidance on HCPCS modifiers used in approved clinical research studies, including the shift from older modifier usage to newer reporting categories for investigational and routine clinical services. It is relevant to coders, billing staff, compliance teams, and clinical research administration professionals who need to understand how Medicare distinguishes services in research settings and why the modifier set changed.

Why This Topic Matters

Accurate reporting in clinical research studies depends on using the correct HCPCS modifier framework. This article helps readers understand the CMS update, the clinical research context, and the general categories of services affected.

What You Will Learn

  • How CMS distinguishes broad categories of services in approved clinical research studies
  • Why certain prior HCPCS modifiers were discontinued
  • Which general service categories are discussed for research-study reporting
  • How the article frames Medicare-approved clinical research study reporting

Who Should Read This

  • Medical coders
  • Billing professionals
  • Compliance staff
  • Clinical research coordinators
  • Revenue cycle professionals

Codes Discussed

Modifiers Discussed


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