The CLIA Waiver Boom: Capitalizing on Point-of-Care Testing Trends

The CLIA Waiver Boom: Capitalizing on Point-of-Care Testing Trends
The CLIA Waiver Boom: Capitalizing on Point-of-Care Testing Trends A major shift is underway in the world of diagnostics. In communities across the country, pharmacies, clinics, and physician offices are transforming into decentralized testing hubs. This is not just a post-pandemic ripple. It is a long-term trend driven by the widespread adoption of CLIA-waived testing. For healthcare sales professionals in diagnostics, lab equipment, and point-of-care (POC) solutions, this trend represents a significant opportunity. The key is knowing where to look, who to target, and how to offer value in a fast-changing landscape. This article explains the rise in CLIA-waived labs, what it means for diagnostic sales, and how tools like NPIScope can help you connect with the right buyers. What Is a CLIA Waiver? Under the Clinical Laboratory Improvement Amendments (CLIA), all U.S. facilities performing tests on human specimens for health assessments or diagnosis must be certified. However, certain tests are categorized as low-complexity and may be performed under a CLIA waiver. This waiver allows sites to conduct simple tests that pose minimal risk of error.

These sites can include:
- Independent and group physician offices
- Pharmacies and retail clinics
- Urgent care centers
- Mobile clinics and school-based facilities

CLIA-waived tests typically include flu, COVID-19, RSV, strep, pregnancy, glucose, and cholesterol tests. For sales teams offering rapid test kits, analyzers, consumables, or consulting services, these facilities are now active buyers with ongoing needs. The Boom in CLIA-Waived Sites

Between 2019 and 2023, the number of U.S. pharmacies holding CLIA waivers grew from approximately 20,000 to over 48,000. This represents a 140 percent increase, fueled by pandemic-era policy expansions and the demand for quick in-person testing.
This surge is not just temporary. The convenience and reimbursement potential of on-site testing are driving permanent adoption in:
- Pharmacies
- Urgent care clinics
- Family medicine practices
- College health centers
- Mobile testing units

This trend has created a surge in demand for rapid testing devices, kits, digital analyzers, billing support tools, and waiver management services. Why This Matters for Healthcare Sales

Many CLIA-waived facilities are still operating without strong vendor relationships. That presents a wide-open opportunity for diagnostic suppliers and sales reps to build first-mover trust.
Targeted sales outreach can address needs such as:

- Faster result turnaround
- Improved test accuracy
- Easier data capture and billing integration
- Simplified waiver renewals and compliance

However, to reach these buyers effectively, you need access to current, structured CLIA and NPI data. This is where NPIScope provides an advantage. How to Find and Qualify CLIA-Waived Labs

NPIScope offers a fast and precise way to identify testing sites and the providers behind them. You can:

- Search all CLIA-waived labs by ZIP code, city, or state
- Filter by certification type, lab class, or waiver status
- View issue and expiration dates of waivers
- Link labs to provider NPI records to verify leadership and affiliations
- Export contact lists directly into your CRM or outreach platform

For example, a company selling an RSV and flu combo rapid test could:

1. Search for all CLIA-waived labs in Michigan
2. Filter for facilities with recent certification renewals
3. Link each lab to its supervising NPI provider
4. Prioritize outreach to high-volume prescribers with relevant CPT billing history

This eliminates guesswork and ensures outreach is relevant and timely.

Understanding the Buyer Personas

To improve engagement, tailor your pitch to the typical roles involved in waived testing decisions.

RoleFacility TypeWhat They Prioritize
Pharmacist in chargeChain or independent pharmaciesEase of use, CLIA compliance, test storage
Office ManagerFamily or urgent care clinicsSimplicity, patient experience, billing codes
Medical DirectorMulti-site labs or health groupsVolume efficiency, automation, cost per test
Clinic AdministratorRetail clinics or mobile unitsWaiver renewals, space constraints, device footprint
Knowing the priorities of each persona helps position your product or service as a direct solution to their operational pain points. Bonus Strategy: Combine CLIA and CPT Insights

NPIScope does more than show where a lab exists. It helps you understand what that site is likely doing.

By combining CLIA data with CPT billing trends, you can:

- Verify whether the lab is actively billing for diagnostic testing
- Understand which tests are performed (e.g., 87804 for flu, 87426 for COVID)
- Prioritize high-volume testing sites for larger sales opportunities

This approach increases lead quality and shortens sales cycles by focusing on confirmed testing behavior, not assumptions.

Final Thoughts: Act While the Market is Underserved

The CLIA waiver boom is redefining how and where testing happens in the U.S. It opens up entirely new verticals for diagnostic sales teams, especially those agile enough to adapt quickly.
Sales professionals who act now can:

- Gain early trust with clinics and pharmacies not yet locked into supplier contracts
- Offer bundled solutions that include device training, waiver support, and ongoing replenishment
- Align their outreach with actual testing behavior using CLIA and CPT data

Visit npiscope.com to find high-potential CLIA-waived sites, link them to provider data, and build your most precise diagnostic sales campaign yet.