HRSA says it may resume some onsite audits of 340B covered entities as early as next month, sparking concerns among some providers already battling the fallout from the Delta variant of COVID-19.

Starting Next Month, HRSA Plans to Audit Some 340B Entities Onsite for First Time Since Pandemic

The U.S. Health Resources and Services Administration (HRSA) says it plans to resume some onsite 340B compliance audits of covered entities starting in October. This is sparking concern among 340B providers in light of crisis conditions in some states fueled by the extremely transmissible Delta variant of the coronavirus.

HRSA has been conducting audits remotely since March 2020, soon after the COVID-19 national emergency was declared and after states began issuing mandatory stay-at-home orders. The change comes as the U.S. is seeing an increase in COVID-19 cases after experiencing a brief decline, according to the U.S. Centers for Disease Control and Prevention. Idaho last week authorized overwhelmed hospitals to ration care. Kentucky National Guard members have been deployed to hospitals this month to free up staff to care for COVID-19 patients. Alabama declared a state of emergency in August due to near-record-high hospitalizations and a shortage of ICU beds due to COVID-19.

The U.S. Health Resources and Services Administration (HRSA) says it plans to resume some onsite 340B compliance audits of covered entities starting in October.

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