Demand for COVID-19 tests, including over-the-counter at-home tests, has soared with the surge of the Omicron variant of the COVID-19 virus. However, health care providers, employers, and individuals have lacked clarity on if and how federal requirements might apply to such tests, including the Clinical Laboratory Improvement Amendments (CLIA), which govern most laboratory testing and the operations of clinical laboratories.
On November 22, 2021, the Centers for Medicare & Medicaid Services (CMS) published a guidance document titled Over The Counter (OTC) Home Testing and CLIA Applicability Frequently Asked Questions (the Guidance Document). The Guidance Documents describes when a CLIA certificate is necessary for at-home COVID-19 tests. Below we summarize the highlights of that guidance.
CLIA Certificate Not Required
A CLIA certificate is not required in the following situations:
- An at-home test is self-administered by a patient in accordance with the Food and Drug Administration's (FDA) authorization and labeling.
- A parent or guardian for a child or adult unable to test themselves performs an at-home COVID-19 test for the patient.
- Someone other than the patient (such as an employee of a home health agency or hospice) assists a patient in self-administering an at-home test, but the individual does not perform the test for the patient or interpret the test results.
- A patient shows a test result to someone else, like an employer, but the patient performed and interpreted his or her own test.
CLIA Certificate Required
A CLIA certificate is required in the following situations:
- Someone other than the patient (e.g., a facility staff person, or employee health personnel) performs the test for the patient and/or interprets and reports the test results.
Importantly, CMS provides that this guidance applies to facilities such as schools, shelters and jails.
The location where the test is performed may also impact which parameters apply to at-home testing. CLIA-certified facilities may use at-home tests if the FDA has authorized the tests for that setting. CLIA-certified laboratories that perform or analyze any test are required to report the COVID-19 test results, regardless of the type of CLIA certificate the laboratory holds. Consequently, a CLIA-certified facility that performs a COVID-19 self-test for a patient or interprets the results of such a test must report the test results in accordance with Federal and state requirements.
In addition to the Federal CLIA requirements, many states separately license, register, or certify diagnostic laboratories. Testing providers and their customers, including employers, should review state level guidance on at-home COVID-19 testing to confirm if state licensure or certification is required. For instance, California follows CMS guidance and requires a CLIA certificate and state license/registration if someone other than the individual being tested performs the test. Similarly, a Washington state Department of Health regulator confirmed that Washington does not require a CLIA certificate unless someone other than the individual being tested performs the test, or interprets and reports the test result.
The CMS Guidance Document provides much needed clarity that will likely inform how employers, health care providers, and individuals use at-home COVID-19 tests. Given the rapid evolution of COVID-19 laboratory testing, many health care providers entered the COVID-19 testing space prior to the development of at-home tests, but have since expanded their services to include supervision of patients undergoing at-home COVID-19 testing, including remote supervision via telehealth. With the Guidance Document, providers can better understand what type of testing services may be provided without a CLIA certificate, and when a CLIA certificate is required. Likewise, employers requiring employees to test for COVID-19 may desire to facilitate testing with at-home tests. However, employers must be aware of (and conform their practices) when a CLIA certificate is required.
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