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!
