Implementing Point-of-Care Testing (CLIA Waived): Billing Checklists for Clinics

Point-of-Care Testing (POCT) has become a cornerstone of modern healthcare delivery, especially in primary care, urgent care, and specialty clinics. With the ability to provide rapid, actionable results for conditions such as strep throat, influenza, COVID-19, and chronic disease monitoring, POCT enhances patient outcomes, reduces hospitalizations, and improves clinical efficiency.

However, the financial benefits of POCT are only realized if clinics implement it correctly and ensure compliant billing. Many providers overlook the administrative, regulatory, and coding requirements that accompany POCT. Errors in Clinical Laboratory Improvement Amendments (CLIA) waiver compliance, CPT/HCPCS coding, or documentation can quickly turn a revenue opportunity into denied claims or compliance risks.

This blog provides a comprehensive guide and billing checklist for clinics implementing CLIA-waived point-of-care testing to ensure accurate reimbursements while maintaining regulatory compliance.

Understanding CLIA Waived Testing

What is a CLIA Waiver?

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing in the U.S. A CLIA waiver allows clinics to perform simple, low-risk tests at the point of care without the need for complex laboratory certifications. Common CLIA-waived tests include:

• Rapid strep A
• Influenza A/B
• Hemoglobin A1c
• COVID-19 antigen
• Urinalysis dipstick
• Lipid panel (in some kits)

Clinics must apply for and maintain a CLIA Certificate of Waiver through the Centers for Medicare & Medicaid Services (CMS).

Why CLIA Waived Tests Matter for Clinics

• Patient convenience: Onsite testing provides immediate results, reducing delays in diagnosis.
• Revenue stream: POCT reimburses for both the test itself and related evaluation and management (E/M) services.
• Operational efficiency: Avoids unnecessary external lab referrals.

Billing Challenges with POCT

Despite their simplicity, POCT billing is often mishandled. Common pitfalls include:

• Using the wrong CPT/HCPCS code for a test.
• Failing to append the QW modifier, which is required for most CLIA-waived tests.
• Performing tests without an active CLIA waiver on file.
• Incorrect linkage of ICD-10 diagnosis codes to justify medical necessity.
• Double billing for bundled services.

Billing Checklist for CLIA Waived Point-of-Care Tests

To minimize errors, clinics should adopt a structured billing checklist when implementing POCT.

1. Verify CLIA Waiver Certification
   – Ensure your facility has an active CLIA Certificate of Waiver.
   – Keep the certificate current with CMS.
   – Display the certificate in a visible location in the clinic.
   – Enroll all National Provider Identifier (NPI) numbers under the CLIA waiver.
2. Correct CPT/HCPCS Coding
   Each POCT has a specific CPT code. Examples include:
   – 87880 – Strep A (QW required)
   – 87804 – Influenza A/B (QW required)
   – 83036 – Hemoglobin A1c (QW required for waived device)
   – 87426 – COVID-19 antigen test (QW required for waived device)
   Pro Tip: Always review the most recent CMS CLIA-waived test list to confirm whether the QW modifier applies.
3. Apply the QW Modifier Correctly
   – Append modifier QW to all CPT codes for CLIA-waived tests unless CMS specifically excludes the requirement.
   – Example: 87880QW instead of 87880 alone.
   – Claims without QW are often denied.
4. Document Medical Necessity
   – Always link the correct ICD-10-CM diagnosis code that supports the test.
   – For example:
   – J02.9 (Acute pharyngitis, unspecified) for a strep test.
   – R05.9 (Cough, unspecified) for flu or COVID testing.
   – Ensure the physician or mid-level provider documents why the test was ordered.
5. Avoid Double Billing
   – Do not bill separately for specimen collection unless specifically permitted.
   – Many POCTs include specimen collection in their reimbursement.
6. Track Inventory and Usage
   – Keep logs of test kit lot numbers, expiration dates, and usage for compliance.
   – Some payers request documentation for audit purposes.
7. Payer-Specific Rules
   – Medicare and commercial payers may have different coverage rules.
   – Verify if prior authorization or medical policy requirements apply.

Workflow Integration for Clinics

Beyond billing accuracy, successful POCT integration requires operational planning:

• Staff Training: Train nurses, medical assistants, and billing staff on test procedures, documentation, and coding.
• EHR Integration: Configure the electronic health record (EHR) to include test-specific order sets, CPT codes, and documentation prompts.
• Patient Education: Communicate test results during the same visit to enhance patient satisfaction and adherence.
• Quality Control: Follow manufacturer protocols and maintain quality control logs for compliance with CLIA requirements.

Financial and Clinical Benefits

When implemented correctly, POCT brings both clinical and financial advantages to a practice:

• Faster decision-making: Providers can initiate treatment during the same visit.
• Improved revenue: Each test generates reimbursement in addition to the office visit.
• Reduced denials: Proper coding and documentation minimize payer pushback.
• Patient loyalty: Patients prefer clinics that offer “one-stop” diagnostic care.

Common Mistakes to Avoid

• Skipping CLIA registration: Performing tests without certification can lead to fines.
• Incorrect use of modifiers: Missing QW is one of the top denial reasons.
• Using outdated CPT codes: CMS updates waived test codes annually.
• Ignoring payer edits: Some insurers may bundle POCT services with E/M codes.
• Poor documentation: Lack of rationale for ordering a test leads to denials.

Final takeaway

Implementing CLIA-waived point-of-care testing is one of the most effective ways for clinics to improve patient care, streamline operations, and increase revenue. However, without the right billing strategies and compliance safeguards, clinics risk denials, lost income, or even regulatory penalties.

A structured billing checklist—covering CLIA waiver verification, proper CPT/HCPCS coding, QW modifier use, medical necessity documentation, and payer-specific compliance—is essential for success.

By combining regulatory compliance with accurate billing, clinics can turn POCT into a sustainable revenue stream while enhancing the patient experience. In today’s value-driven healthcare environment, mastering the integration of point-of-care testing is no longer optional—it’s a strategic necessity.

For help and queries Implementing Point-of-Care Testing (CLIA Waived): Billing Checklists for Clinics, please CONTACT RIGHT MEDICAL BILLING, today!