CLIA  waived tests are categorized by the FDA as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”

What are CLIA waived tests?

CLIA waived tests are generally simple tests that are non-technical. There are over 1,400 test systems that have been waived. Most tests meet the following requirements:

• Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible.

• Use unprocessed specimens (whole blood or oral fluid)

• Pose no reasonable risk of harm to the patient if the test is performed incorrectly.

• Are cleared by the FDA

If your lab is conducting only waived testing, you must have a valid Certificate of Waiver (COW) from CLIA and your lab will not be routinely inspected. However, COW labs may be randomly inspected as part of a compliance investigation to ensure that they are only performing waived testing.

CLIA Certificate of Waiver (COW) Requirements

To qualify for a certificate of waiver, your lab must only perform tests that have received the CLIA waived status. If you meet this requirement, simply fill out the application form CMS-116 at the CMS website or from your state health. The COW is valid for two years. 

Information required is straightforward and includes:

• Organization Location

• Type of Laboratory

• Hours of Laboratory Testing

• Multiple Sites

• Number of Waived Tests performed annually (estimate)

• Individuals Involved in Laboratory Testing

Step 1: Submit an application to apply for a CLIA Certificate of Waiver

The first step in receiving any Medicare reimbursement is to obtain a CLIA Certificate of Waiver. The physician’s office or laboratory will need to pay a fee to the Centers for Medicare and Medicaid Services (CMS) every two years and agree to follow the device manufacturer’s instructions for performing clinical tests.

Step 2: Submit the Appropriate CPT Codes

The following Current Procedural Terminology (CPT) codes are suggested for submitting tests performed with PTS Diagnostics products for Medicare and Medicaid reimbursement. These are suggested codes.

83036 QW — For professional use in the management of diabetes mellitus where regular determinations of blood glucose levels are required.  Glycated hemoglobin assesses glycemic control over a period of approximately 120 days.

36416 — Collection of capillary blood (Fingerstick) specimen 

A Value-Based Resource