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.

HRSA confirmed the 340B audit policy change last week. “HRSA is planning to conduct both on-site and remote audits for FY22 audits which begin in October 2021,” a spokesperson said. “If a covered entity has specific questions regarding an audit once it has been engaged, please contact the Bizzell Group (the 340B audit contractor) at who will coordinate with HRSA based on the specifics of the request. HRSA will continue to monitor the COVID-19 response and provide updates accordingly.”

Audit Notices Raise Concerns

A consultant who assists covered entities being audited for 340B compliance said that with COVID-19 cases rising and Americans navigating new rules for work, school, and travel, “HRSA audit requests should be clear about the option to either be onsite or remote and permit the entity to weigh in.”

“Many of our clients are still off-site or restricting vendors,” the consultant said. “But the audit notice and kickoff call script do not seem to invite this conversation.”