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Lab Compliance Will Change When the Public Health Emergency Ends

by | May 13, 2022 | Articles, News, Open Content

The relaxed regulatory environment labs have provided during the COVID-19 pandemic is set to come to and end soon.

The COVID-19 pandemic has had a direct and significant impact on just about every aspect of lab operations, including compliance. While the COVID-19 pandemic has created unprecedented testing demands and shortages, labs have at least been given the latitude to meet those challenges in a relaxed regulatory environment. But that will come to an end when the public health emergency (PHE) expires.

Explanation: On January 21, 2020, as part of its early response to the COVID-19 outbreak, the U.S. Department of Health and Human Services (HHS) exercised its power to declare a PHE under Section 319 of the Public Health Service Act on January 21, 2020. In so doing, it laid the legal groundwork for many of the notable policies that have marked the COVID-19 era, including free tests and vaccines, relaxed Medicare coverage of telehealth services, and what are called Section 1135 (of the Social Security Act) blanket waivers temporarily providing relief from anti-kickback, Stark, HIPAA, and other regulations to clear the deck for arrangements dedicated to diagnosing and treating coronavirus. The PHE is also what made it possible for the FDA to grant emergency use authorization to the literally hundreds of COVID-19 tests that have reached the US market since the pandemic began.

A PHE lasts 90 days unless it’s renewed. The most recent renewal came on April 15, which means that the PHE could end as early as July 15. HHS Secretary Xavier Becerra has said that the administration will provide 60 days’ notice before allowing the PHE to expire. The government can still keep its temporary policies in place after the PHE ends, as it has with the extension of expanded telehealth coverage rules until at least November. But blanket waivers won’t likely survive; in fact, they may even be revoked before the PHE ends.

Learn more in the upcoming June 2022 issue of National Lab Reporter.