CMS communication for waived Covid testing devices

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Have y'all seen this? It looks like our waived EUA devices won't be able to test asymptomatic patients unless it's allowed in the IFU. Not sure how this will affect our operations at this point, but I wish they had saved this for a later time!
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Does anyone have the Reference number for the original CMS document that allowed for use on asymptomatic patients?

I found this about the a possible reason behind why the order was rescinded.

The Centers for Medicare and Medicaid Services (CMS) has rescinded QSO-22-25-CLIA, which barred the use of SARS-CoV-2 tests outside of the FDA test’s instructions for use. AHCA/NCAL highlighted the memo in a recent blog post

This comes after AHCA/NCAL strongly advocated that this memo should be rescinded as it limited the use of the BinaxNOW COVID-19 Ag Card being sent by the U.S. Department of Health and Human Services (HHS) to symptomatic individuals.

This means the BinaxNOW COVID-19 Ag Card being sent to long term care providers from the HHS program can continue to be used on both asymptomatic and symptomatic individuals.

Specifically, CMS indicates that for the duration of the public health emergency, it will not cite facilities with a CLIA Certificate of Waiver when authorized SARS-CoV-2 molecular or antigen POC tests are performed on asymptomatic individuals outside of the test’s authorization. In addition, CMS will not cite nonwaived facilities when modified authorized, cleared or approved SARS-CoV-2 molecular or antigen POC tests are performed in such manner without establishing performance specifications.

I have a colleague who used to work for CMS, and she feels someone sent out the letter of September 26th when it hadn't been fully vetted. So, on Oct 7th they rescinded that letter. Basically, it looks like, for the remainder of the public health emergency, we will be able to use the devices as we've been using them, including using waived devices on asymptomatic patients. I know in our facilities, we're evaluating all covid testing, but we'll see what this respiratory season looks like. I will say, we definitely didn't need this right now!

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Kathleen David
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