How to Obtain a CLIA Certificate of Waiver

START POINT-OF-CARE TESTING

Test For COVID-19 At Your Pharmacy, Workplace or Facility

As more opportunities arise for pharmacies to provide point-of-care testing, it’s increasingly important to be prepared to provide these tests. A CLIA Certificate of Waiver allows your pharmacy to perform point-of-care tests that have a waived degree of complexity as assigned by the U.S. Food and Drug Administration according to 42 CFR 493.15(c). This now includes testing for SARS-CoV-2, the virus that causes COVID-19.

This page will guide you through completing a CLIA application and provide state-specific submission instructions.

1.

The Application Process

Open the CLIA Application for Certification CMS-116 Form

2.

Fill out Sections 1-6, 9, and 10

3.

Print out the completed CMS-116 Form and sign it in ink

4.

Scan the signed CMS-116 Form into your computer to save a copy

5.

Complete additional forms and fees as required by your state and send to your State Agency contact

6.

Once your application has been processed, CMS will send your test site’s CLIA Number

7.

State-Specific Instructions
For your convenience, we have gathered each state’s requirements and forms that will need to be submitted with the CMS-116 Form. Click on How to Obtain a CLIA Certificate of Waiver

Billing Codes for COVID-19 Rapid Antigen Tests

 

HCPCS 

  • U0002: 2019-nCoV coronavirus, SARS-CoV-2 /2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC

Specimen Collection Code 

  • G2023: Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source

CPT Antigen Code 

  •  CPT code 87426 for infectious agent antigen detection by immunoassay technique of SARS-CoV and/or SARS-CoV-2 is effective and must be used for dates of service as of June 25, 2020, and after.

Flowflex™ SARS-CoV-2

Antigen Rapid Test

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