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.
A CLIA certificate is not required in the following situations:
A CLIA certificate is required in the following situations:
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.
Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.