Applying For or Updating a CLIA Waiver During The Pandemic

While much of the COVID-19 testing has been done by government and private dedicated laboratories, many providers in the acute and long-term care space are moving towards providing their own CLIA¹-waived tests.  The Department of Health & Human Services is also working to help ramp up testing by long-term care providers by providing rapid point-of-care diagnostic test instruments and tests to nursing homes, but only homes that hold a CLIA certificate.  Because the Food and Drug Administration (FDA) has granted emergency use authorizations for certain point-of-care COVID-19 tests, which in turn grant the tests CLIA-waived status during the national emergency declaration, providers now have the option of going through a relatively straightforward and in many cases expedited process to obtain or modify a CLIA certificate of waiver. In this article, we cover the process of obtaining a waiver, what the process has looked like during the pandemic, and how existing certificates of waiver can be modified to include COVID-19 testing.

Obtaining a CLIA Waiver

Tests run pursuant to a CLIA certificate of waiver must meet the following criteria: (1) be cleared by FDA for home use; (2) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or (3) pose no reasonable risk of harm to the patient if the test is performed incorrectly.  42 C.F.R. § 493.15.  A provider desiring to run such tests must submit a CMS Form-116 in order to obtain a CLIA waiver.  Note that Form-116 is used to request not only a CLIA certificate of waiver, but also a Certificate for Provider Performed Microscopy Procedures, Certificate of Compliance, and Certificate of Accreditation; only certain sections must be completed for a certificate of waiver, including:

• Contact information
• Lab director information (including credentials)
• Tests that will be performed

Unlike other forms from the Centers for Medicare & Medicaid Services (CMS), such as the CMS Form-855A for Medicare enrollment, Form-116 must be submitted to the designated state agency, as the state reviews, oversees, and interacts with the laboratory applicant.  In order to identify the state agency processing CLIA applications, providers may access a state-by-state list here.

Applicants must also be aware that there may be separate state requirements.  For example, California requires a state laboratory license in addition to a certificate of waiver in order to perform many waived tests.  Additionally, certificate of waiver holders also need to be aware of and abide by the conditions of the certificate (e.g., record and inspection requirements) and other state laboratory requirements (e.g., waste disposal and cleanliness requirements), as applicable.

Processing of Form-116 During the Pandemic

CMS has expressed its understanding that certificates of waiver need to be granted quickly to qualified providers during the pandemic.  In our experience assisting clients with submission of Form-116 and working with the state agencies to complete processing, CMS and the applicable state agencies have generally increased the speed with which they handle applications.  Applications have generally been processed in two to four weeks during the pandemic.

Updating an Existing CLIA Waiver to Include COVID-19 Testing

Many providers that obtained a certificate of waiver prior to the pandemic are interested in adding COVID-19 testing to their authorized list of tests.  Because the certificate of waiver authorizes a provider to perform waived testing in general, an updated Form-116 may not be required in all cases (however, note that certain changes are required by regulation to be reported, such as changes of location, ownership, name, and laboratory director).  Because Form-116 requests identification of waived tests that applicant plans to perform, it is best practice to contact the appropriate state agency to confirm whether any form updates will be necessary to add COVID-19 testing.

For more information, please contact Hedy S. Rubinger or Alexander B. Foster.

[1] “CLIA” stands for the “Clinical Laboratory Improvement Amendments,” the mechanism through which agencies regulate certain laboratory testing performed on humans.