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!

18 Replies

Amanda Casavant

Mon Sep 26, 2022 at 2:19PM

THANK YOU
And Oh Dear!

Adonica Wilson

Mon Sep 26, 2022 at 2:53PM

No, but thank you!! I had to go look at my IFU again lol. Thank goodness it doesn't specify symptoms.

Shana Gaug

Mon Sep 26, 2022 at 6:06PM

Thanks for sharing this Kathleen! So the Sofia and Abbott IDnow both recommend serially testing for asymptomatic patients, are the labs responsible/considered noncompliant if the patient does not return within the expected window for the retest?

Autilia Sisti

Tue Sep 27, 2022 at 7:47AM

This is most certainly going to require some conversation.

Katie Blauwet

Tue Sep 27, 2022 at 10:46AM

I cannot find this CMS memo online. Where did you get this? Game changer for some instruments.

Kathleen David

Tue Sep 27, 2022 at 10:59AM

https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/cms-rescinds-december-7-2020-enforcement-discretion-use-sars-cov-2-tests-asymptomatic-individuals

Kathleen David

Tue Sep 27, 2022 at 11:04AM

QSO-22-25-CLIA (1).pdf

Here's the document from CMS

Ashlee Holland

Tue Sep 27, 2022 at 11:48AM

This looks like it includes all molecular and antigen testing for Covid on asymptomatic patients, waived or non-waived. Am I reading that correctly? If so this could pose an issue for our entire lab, not just POC

Autilia Sisti

Tue Sep 27, 2022 at 12:22PM

If they are in existence because of an Emergensy Use Authorization- you are correct. All labs will be affected, unless the test has been put in place as laboratory developed.

Kathleen David

Tue Sep 27, 2022 at 12:53PM

Basically, it's saying that we need to follow the manufacturer's instructions for use, including patient type, for our waived devices at POCT. For the lab, if the test is being used outside of IFU, then it would be high complexity, so could only be run in a high complexity lab that has done a complete validation, including validating asymptomatic patients. For our sites, we're good with the labs as we did a validation and they are mostly high complexity labs (doing transfusion medicine). For POCT, we do have devices at sites doing pre-procedure, pre-op testing, so we'll need to stop that. As Rosann Rosannadanna says "It's always something".

Amanda Casavant

Thu Sep 29, 2022 at 3:00PM

Kathy
Thank you so much for relaying this information to the group! The directive states we have 30 days from issuance to come into compliance.
Our incident command convened today to discuss the ramifications:

Patients sent to LTR/DTR require a negative COVID test - per State Regulations??
Current RI Regulation for HCW with an exposure having serial testing
Preprocedural testing for Overnight Surgical Procedures
Testing on patient admitted through the Emergency Department.

Updated algorithms would be very helpful as we have a limited window to make these changes.

Stephen Wong

Tue Oct 04, 2022 at 1:15PM

Hi everyone,

Has anyone found a EAU POC waived antigen test that can be performed on asymptomatic patients without also requiring serial testing?

Like many of you, the CMS memo is throwing a wrench in our current processes.

Thanks,

EDIT: well i think i found the answer to my own question. Answer is no according to fda list of ag tests.
In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 | FDA

Max Mauch

Wed Oct 05, 2022 at 8:18AM

Stephen,

Looks like there are two on this list:
At-Home OTC COVID-19 Diagnostic Tests | FDA

Danyel Olson

Fri Oct 07, 2022 at 1:17PM

Today's latest!! What is happening??

Kathleen David

Fri Oct 07, 2022 at 1:22PM

Someone sent this to me as well. We think it's related to rescinding the earlier document that allowed testing asymptomatic patients, meaning outside of the IFU. I'm not going to do anything on this until any further information.

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CMS communication for waived Covid testing devices