Planning to Test for COVID? You’ll Need a CLIA Waiver or Certification
By Sean Price

The fast-spreading omicron variant has pumped up demand for COVID-19 testing, and that means physician offices need to make sure they have obtained the correct waiver or certification from the U.S. government to administer those tests. 

Medical testing is largely regulated by the 1988 Clinical Laboratory Improvement Amendments (CLIA) to the federal Public Health Services Act. To perform complicated tests that require sophisticated lab equipment, medical institutions must obtain various certificates from the Centers for Medicare & Medicaid Services (CMS) – a potentially time-consuming process. 

But simple tests, such as many of those for COVID-19, require a “certificate of waiver” that is easier to obtain. The waived tests – which include pregnancy tests and blood sugar tests – are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result” under CLIA, according to CMS

Several U.S. agencies oversee CLIA regulations: CMS, the Centers for Disease Control and Prevention, and the Food and Drug Administration. 

The application process also involves multiple agencies. Physicians obtain the CLIA application from CMS, but then must send it to the Texas Health and Human Services Commission (HHSC). In Texas, CLIA applications and information are handled via Texas HHSC regional offices

Physicians must pay a $180 biennial fee, but it is not required at the time of application, according to HHSC. 

There is no uniform time frame for receiving a waiver after the application is submitted, an HHSC spokesperson says. However, during the COVID-19 public health emergency, CMS has allowed applicants to begin testing as soon as their completed application is submitted to HHSC, the spokesperson says. 

A CDC booklet contains more information on COVID-19 testing, including preparation and proper testing protocols.

Last Updated On

April 05, 2022

Originally Published On

February 04, 2022

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