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CMS Sends Cease and Desist Letters to 171 Clinical Laboratories Without Correct CLIA Certification

CMS maze of rules and regulations
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COVID-19 antigen testing may be leading to testing without the correct CLIA certification

The US Centers for Medicare and Medicaid Services (CMS) announced Oct. 9, 2020, that it sent cease and desist letters to 171 clinical laboratories. The primary reason for these letters is because the facilities “did not have proper Clinical Laboratory Improvement Amendments (CLIA) certifications in place.”

These cease and desist letters come at a time when point-of-care (POC) COVID-19 antigen testing is becoming more prevalent. While not explicitly stated by CMS, the implication was that entities have begun performing POC antigen testing without realizing that these tests can only be performed by a CLIA-certified laboratory. Some of the entities that do not traditionally perform patient testing may not realize that they are even considered a clinical laboratory.

“Testing capacity has rightly been at the top of President Trump’s priority list since the early stages of this pandemic,” said CMS Administrator Seema Verma. “But we also understood that for testing to fulfill its potential, tests must be reliable. Today’s announcement will help ensure that Americans can rest secure that they will receive test results that are both fast, accurate, and trustworthy.”

Of the 171 letters that were sent, CMS reports that 34% of these letters were issued to facilities that were conducting laboratory testing without a CLIA certificate, and 66% went to laboratories performing COVID-19 testing outside the scope of their existing CLIA certification.

CMS states, “The letters ordered these laboratories to stop immediately to safeguard the integrity of COVID-19 testing, and protect patients from potential endangerment if provided inaccurate or unreliable test results.” Further, these clinical laboratories are required to provide CMS an attestation certifying they have ceased testing.

CMS has not published a list of the clinical laboratories that received the cease and desist letters.

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