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What does CLIA-Waived mean?

The CLIA (Clinical Laboratory Improvement Amendments) exemption framework includes two important concepts regarding the admissibility of tests carried out. First, the test should be a simple procedure in which the probability of error is negligible and the risk of incorrect results should be negligible, that is, no more than 0.5% error rate. Second, the test should not pose a risk to the person if performed incorrectly. A simple test, which is performed and gives an accurate result with a negligible percentage of errors (in case it is not performed correctly), is a feature of a renounced test defined by CLIA.

The CLIA repealed tests are defined as simple procedures approved by the FDA for private use and labeled as such that an error is unlikely. 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 tests 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. Some programs are required to obtain a CLIA-waiver certificate, and accreditation is required if a healthcare provider uses only waived equipment for its laboratory tests.

Why is CLIA-waived important?

CLIA-waived tests are important to both patients and healthcare providers because they represent an easy way to examine a patient in a safe manner without incurring the extra expenses and waiting times of laboratory testing.

One advantage of using CLIA tests, for example, is that they exempt you from having to comply with a long list of lab requisites, such as quality control and training. Another advantage is that they meet the same reimbursement requirements as those that can be carried out in a lab.
CLIA testing standards apply nationally and are provided through the CMS (Center for Medicare and Medicaid Services). Any laboratory seeking to receive the reimbursement potential from providing CLIA-waived tests must have a CLIA-waived certificate and use CLIA-approved drug screens.

In addition to inspecting accredited laboratories, CMS checks abandoned laboratories to ensure that the candidates receive adequate training, meet the minimum annual competence standards and follow due procedures.
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.

Assuming that the CLIA waiver test is part of the practice, you can do two things to get reimbursed. First, the laboratory requesting reimbursement for the provision of a CLIA test must either use a CLIA waiver certificate or a drug screening approved by the CLIA. Secondly, if you perform a CLIA waiver test with an error rate of less than 0.5%, you will not only perform the test, but you will also be reimbursed for the waiver test.

Where can you buy CLIA-waived tests?

You can look for CLIA-waived tests in your local pharmacy, although depending on where you live, you may or may not find the test you need. A sure-fire way to find the CLIA-waived test you need is to look for them in reputable and certified online stores.

If you’re looking for CLIA-waived drug tests, Halux Diagnostic provides safe, easy, quick and reliable drug screens that will make testing much more efficient. You can find our supply of CLIA-waived tests here or contact us to ask for any specific product you need.

Phone: (407) 680-2209