As we continue to see an acceleration in healthcare to increase accessibility to faster diagnostic services, 2025 has brought a wave of new CLIA-waived tests that have the potential to reshape how labs operate. Since these tests are approved for use in non-complex settings, labs of all types have significant opportunities ahead.
New CLIA-Waived Tests
In MLN Matters article MM14025, CMS published the latest CLIA-waived tests approved this year. These tests use nucleic acid amplification technology (NAAT) and RT-PCR, offering high sensitivity and specificity in a waived format:
| Effective Date | CPT Code | Test | Use Case Example |
|---|---|---|---|
| Jan 16, 2025 | 87563QW | Mycoplasma genitalium (NAAT) | OB/GYN, Urgent Care, Outpatient |
| Jan 16, 2025 | 87491QW | Chlamydia trachomatis (NAAT) | OB/GYN, Urgent Care, Outpatient |
| Jan 16, 2025 | 87591QW | Neisseria gonorrhoeae (NAAT) | OB/GYN, Urgent Care, Outpatient |
| June 27, 2025 | G0567QW | Hepatitis C Virus (HCV) Screening | Pre-op, High Risk Populations |
| July 1, 2025 | 0563UQW | Respiratory Pathogen Panel (11 viral + 4 bacterial) | Ideal for flu/COVID season |
| July 1, 2025 | 0564UQW | Respiratory Pathogen Panel (10 viral + 4 bacterial) | Ideal for flu/COVID season |
What Types of Labs Benefit from These Tests?
- Hospital-Owned Labs: Faster turnaround times, reduced burden on the high-complexity lab, and improved patient flow.
- Independent, Hospital-Based Pathology Groups: Optimizing the use of inpatient, outpatient, and outreach diagnostic services through enhanced service offerings.
- Physician-Owned Labs (POLs): Faster treatment decisions and improved patient satisfaction through in-office STI screening and/or respiratory pathogen panels.
- Independent Clinical or Anatomic Pathology Labs: Expand/Diversify services offered in outreach programs and long-term care support.
Implications for Lab Staffing
New or changing service lines bring both opportunities and challenges for staffing:
- Hospital Labs: Additional staff may need to be trained in protocols related to point-of-care testing. Internal stakeholders will need to adjust related workflows that have historically supported more complex lab services.
- Pathology Groups: Internal coordination with clinical teams will be required. Pathology groups may need to consider modifying staff roles involved with test integration and oversight.
- POLs: Must ensure that appropriate staff are trained in CLIA-waived procedures and quality control.
- Independent Labs: May need to consider adding to their staff to accommodate expanded service lines.
The newly announced 2025 CLIA-waived test approvals are indicative of the industry moving towards more accessible, rapid diagnostic services. Whether you’re the owner of a private practice, part of a pathology group, or a hospital lab director, these tests offer new paths forward in enhancing your services, streamline operations, and stay competitive in an ever-changing healthcare environment.
Reach out to our team at MSN for more information about how we can support your lab today!
Dyana Williams
MSN Pathology Revenue Cycle Manager
Dyana Williams is a seasoned healthcare operations leader with over two decades of experience in revenue cycle management, client strategy, and organizational change within the laboratory and physician services space. She has served in senior roles at national RCM firms and as a laboratory consultant, guiding diverse teams through vendor transitions, regulatory compliance, and challenging reimbursement environments while maintaining a strong focus on growth and integrity. Her core strengths include strategic consulting, navigating payer relationships, and shaping operational initiatives that deliver meaningful results. Dyana is recognized for her combination of wit, humility, and a results-oriented mindset that creates lasting value for teams and organizations alike.
