COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

New CMS Guidelines Permit SARS-CoV-2 Antigen Tests for Asymptomatic Patients

CMS maze of rules and regulations
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Temporary enforcement discretion at work for now for asymptomatic SARS-CoV-2 antigen testing

The US Centers for Medicare and Medicaid Services (CMS) recently provided clarification for clinical laboratories about using SARS-CoV-2 antigen testing to test asymptomatic individuals. The key element in the late August 2020 policy guidance is that “CMS requires facilities with a CLIA Certificate of Waiver to follow the manufacturer’s instructions (Instructions For Use) when performing laboratory testing.”

Typically, emergency use authorizations (EUA) for SARS-CoV-2 antigen tests are only authorized by the US Food and Drug Administration (FDA) for testing specimens from individuals who are suspected of COVID-19 by their healthcare provider. Also referred to in the CMS clarification is FDA guidance for healthcare providers ordering authorized tests outside their authorization (e.g., antigen tests for asymptomatic individuals).

Of note in the CMS guidance, however, is the temporary exercise of enforcement discretion for antigen testing, stated as: “CMS will temporarily exercise enforcement discretion for the duration of the COVID-19 public health emergency under CLIA for the use of SARS-CoV-2 POC antigen tests on asymptomatic individuals. Specifically, CMS will not cite facilities with a CLIA Certificate of Waiver when SARS-CoV-2 POC antigen tests are performed on asymptomatic individuals, as described in the FDA FAQ.”

Related resources:

COVID-19 TESTING DATA

Helping Your Lab Stay Afloat During Challenging Times

Dear Colleague,

Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

We’ve added analysts, writers and skilled editors to the COVID-19 STAT team to uncover, analyze, and immediately report to you what’s happening with the SARS-CoV-2 pandemic, packaged with the insights you need to deliver quality testing for patient care and keep your lab’s financial ship afloat. As part of our mission, we are also bringing you real-time data from our partners around testing that you will not find anywhere else.

Please let me know how we can better improve this service to fit your needs. If you would like to offer a grant to keep our mission going with this site, please contact me at rmichel@darkreport.com.

Sincerely,

Robert L. Michel
President, Founder
The Dark Intelligence Group