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WHAT IS CLIA-WAIVED AND WHY IS IT IMPORTANT?

The clinical laboratory Improvement amendments were established in 1988 as a set of guidelines to specify which drug test are to be CLIA- waived based on the complexity of the test performed.  Tests that meet the requirements are able to be waived from regulatory oversight. Waived tests are defined as simple procedures that are cleared by the FDA for home use and labeled as easy to use and accurate enough that it’s unlikely any mistakes will occur.  Another regulatory requirement is that the test must pose no risk to the patient if the test were to be performed incorrectly.    Quality standards for laboratories are established by CLIA to ensure reliability, accuracy, and timeliness of the patients test results.  CLIA requirements apply to the clinical usage of drug testing. This includes any entity that performs tests on materials derived from the human body in order to provide assessment of the person’s health, information for diagnosis, and treatment or prevention of any impairment or disease.  Any company performing test for these set of purposes are considered by CLIA to be a laboratory and must abide by CLIA regulations by registering with the CLIA program if they want to receive the benefits.

CLIA testing standards apply nationally and are provided through CMS (Center for Medicare and Medicaid Services).  Any laboratory seeking to receive the reimbursement potential from providing CLIA- Waived test must have a CLIA- waived certificate and use CLIA approved drug screens.  CLIA- Waived test reimbursements are provided in accordance with the insurance providers guidelines.  For information regarding current CPT codes please reference the American Medical Association’s Coding Resources.

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