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Quarles Partners Assess Risks to COVID-19 Testing Labs of Increased FCA Scrutiny in Article for Bloomberg Law


Mark Bina, Kirti Reddy and Jaya White, partners in the Quarles & Brady Health & Life Sciences Practice Group, wrote an article for Bloomberg Law about the implications for COVID-19 testing labs of new federal reports indicating there should be greater scrutiny around add-on tests ordered in connection with COVID testing.

The reports from the Department of Health and Human Services Office of Inspector General make it clear that clinical laboratories will come under closer review – and potential prosecution under the False Claims Act (FCA) – for allegations of unnecessary services, fraudulent billings and kickbacks.

In an excerpt from the article, Bina, Reddy and White touched on steps labs can take to minimize their risk:

To minimize risks associated with this closer scrutiny, labs must be diligent in monitoring patterns to ensure physicians are not routinely ordering the same set of add-on tests for each patient, without assessing individual necessity for the test.

Additionally, labs should request appropriate documentation to support the add-on tests as part of a robust compliance program. Labs should reassess their compliance programs and operations anew given this new enforcement environment.

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