If your practice conducts, or is considering conducting, simple in-house laboratory tests for such common medical conditions as pregnancy, diabetes, or drug dependency, then more than likely you have heard of CLIA.
But if you don’t know what a CLIA-waived test is, or if your knowledge of the program only extends to knowing that you should append HCPCS modifier QW (CLIA waived test) to a CPT® lab code, then you’re only getting part of the story.
If you want to know the rest, all you need to do is read the answers to the following four questions.
The Clinical Laboratory Improvement Amendments (CLIA) project is a Centers for Medicare and Medicaid Services (CMS)-administered program that issues waivers for any laboratory that performs “testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings.” In other words, if your practice performs basic laboratory tests, you need “a CLIA certificate regardless of how many tests you perform and even if you do not charge the patient or bill Medicare or other insurances.”
With a CLIA Certificate of Waiver, your practice can administer in-house any test that “the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined to be so simple that there is little risk of error,” according to CMS. This includes numerous basic laboratory tests, including lipid profiles, drug tests, pregnancy tests, and urine tests for many common conditions.
Simply complete a CMS-116 application form and return it to the State Agency for the state in which your laboratory is located. Once the application is accepted, and after you have paid the appropriate fee, CMS will grant your laboratory the waiver.
Note: You’ll find more information about the application process on the CMS website.
Reporting a CLIA-waived test is a simple, four-step process.
The list of waived tests that currently appears on the Categorization of Tests page on the CLIA site includes all quarterly additions up to Transmittal 4169, which was published on November 15, 2018 and became effective on January 1, 2019. (CMS lists tests that don’t require the QW modifier at the beginning of the list.)
Since then, CMS has made two more additions to the list, which appear in Transmittal 4195 (published January 11, 2019 and effective April 1, 2019) and Transmittal 4277 (published April 12, 2019 and effective July 1, 2019).
While CMS has not added any new CPT® tests so far this year, there have been significant additions to the list for tests produced by individual manufacturers. So, for example, Transmittals 4195 and 4277 include the following tests that meet the criteria for CPT® 80305 (Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; capable of being read by direct optical observation only (eg, utilizing immunoassay [eg, dipsticks, cups, cards, or cartridges]), includes sample validation when performed, per date of service):
Tip: You can stay ahead of the game each quarter and find the transmittal containing the most recent CLIA-waived tests by going to the CMS Transmittals page and typing “New Waived Tests” into the search box for the year in question.
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