What Does CLIA Waived Mean?

What Does CLIA Stand For?

CLIA stands for “Clinical Laboratory Improvement Amendments”. Any facility in the United States that performs lab based testing, assessments or diagnoses is regulated under these amendments. While being CLIA waived typically refers to the physical location of a testing site (physician office, clinics, home health agencies, etc.) it also refers to the quality and regulation of certain onsite testing supplies. When a specific testing product is CLIA waived, it has been cleared and regulated by the FDA for home and onsite use. Part of this approval process ensures that the product is of simple design, easy to perform, and has a low risk for producing inaccurate results.

What does this mean for my business?

If you own, operate, or work in a healthcare related facility and use rapid result, point of collection testing kits (POCT kits) you are probably very familiar with using CLIA waived products. In a nutshell, if a product used for patient diagnosis, assessment or lab related testing is CLIA waived, a certain dollar amount per test is reimbursable through the patient’s insurance plan. It is by no means required to use CLIA waived products in the office, but it is certainly beneficial. Reimbursement rates vary by state, as do the specific codes needed to apply for reimbursement. A general range of reimbursement for a typical urine based drug screen is around $6-14. This means the better the deal you seek out when purchasing these supplies, the higher the margin you will receive when administering these types of tests in the office.

What does this mean for at home use?

Unfortunately, there are no reimbursement rates for personal use when it comes to using CLIA waived products. However, seeking out a CLIA waived product is still very beneficial! When shopping around for the testing kit needed, whether it be an onsite drug test or an iFOB testing kit for at home use, you will come across products that are CLIA waived and some that are not. The products that have the CLIA seal of approval have gone through various regulation protocols with the FDA, assuring users that the product is not only simple and easy to use, but also of high quality, giving you the peace of mind that the results received onsite are reliable.


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