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FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends

by Glenn S. Demby | Feb 13, 2023 | Essential, FDA-nir, National Lab Reporter

Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.

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High Billing by Labs Continues to Be Trigger for Audits

by Danielle H. Tangorre | Feb 13, 2023 | Enforcement-nir, Essential, National Lab Reporter

As we move further into 2023, COVID-19, add-on, and genetic tests will likely remain targets for federal regulators.

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Why Mobile Phlebotomy Companies and Labs Should Be on Alert

by Glenn S. Demby | Feb 9, 2023 | Enforcement-nir, Essential, National Lab Reporter

Recent fraud case involving phlebotomy company shows why labs need to pay special attention to Medicare specimen collection and travel allowance rules.

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Normal Kickback and Billing Rules Return When PHE Ends on May 11

by Glenn S. Demby | Feb 9, 2023 | Compliance-nir, Essential, National Lab Reporter

A look at the US end-of-emergency game plan and how it will impact lab compliance.

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End of Public Health Emergency Won’t End COVID-19 EUAs

End of Public Health Emergency Won’t End COVID-19 EUAs

by Glenn S. Demby | Feb 8, 2023 | News, Open Content

FDA will still be able to issue EUAs for COVID-19 tests after May 11.

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