Why Every Clinical Pharmacy Should Obtain a CLIA Waiver

What Is a CLIA Waiver?

A CLIA (Clinical Laboratory Improvement Amendments) Waiver allows pharmacies to legally perform simple, low-risk diagnostic tests (CLIA-waived tests) onsite and report results. These tests provide immediate clinical insight and are reimbursed via medical claims.

Why should I get a CLIA Waiver?

A CLIA waiver allows pharmacies to generate billable clinical encounters through tests like A1c, INR, flu, COVID, and strep—maximizing the value of each patient interaction.
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Over time, a consistent practice of CLIA-waived testing increases patient touchpoints, visit frequency and revenue per encounter. Testing services pair naturally with immunizations, DSME counseling, MTM, CCM, and RPM

How a Pharmacist Obtains a CLIA Waiver

To expand into clinical services and medical billing, a pharmacist must first obtain a Collaborative Practice Agreement. Here’s some guidance to do so:

• Step 1: Identify waived tests for your community
• • Research CLIA-waived tests diagnostic tests that you are planning to perform at your pharmacy to help you decide on which manufacturer’s testing supplies to partner with. 
  • If you are unsure of how to begin the research process, speak with us by emailing support@airx.health or call about how to choose which testing types make sense for your population. 
• Step 2: Complete the CLIA Application (CMS-116)
• • Apply using Form CMS-116: https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms116.pdf
  • Guidance for applying: https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/howobtaincertificateofwaiver.pdf
  • Have Ready:
  • • Practice location & Tax information
    • Laboratory director designation (often the pharmacist-in-charge)
    • A list of CLIA waiver Tests you’ll be offering
  • The application is submitted to the state CLIA agency, not directly to Medicare. To find your state CLIA Agency, refer to the CMS CLIA Laboratory Improvement State Agency Contact List:
    https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf
• Step 3: Receive & Utilize CLIA Certificate

• Once approved, the pharmacy receives a CLIA Certificate of Waiver, allowing immediate testing once:

  • FDA-approved, CLIA-waived, testing supplies are in the pharmacy
  • Train your staff on how to use to equipment, refer to your equipment provider for guidance
  • See the CDC’s website for approved resources: https://www.cdc.gov/laboratory-systems/php/educational-materials/
• Step 4: Integrate POCTesting Into Billing Workflows

• This step is critical to turning testing into revenue, not just clinical activity.

  • Get your new CLIA waiver configured with your medical billing company.
  • Load your testing inventory into your medical billing software platform.
  • Get training on and practice billing procedures with your medical billing software company.

Bottom Line

A CLIA waiver is one of the simplest, highest-ROI credentials a pharmacy can obtain. It enables medical billing, expands clinical services, and serves as a foundation for long-term growth in 2026 and beyond.

If you’re ready to implement testing the right way, a CLIA waiver is where it starts.