In response to the COVID-19 pandemic, HRSA’s Office of Pharmacy Affairs has made a number of adjustments to its guidelines for the 340B drug pricing program for stakeholders. While HRSA has no plans to suspend 340B audits during the pandemic, it has switched from conducting onsite visits to remote-only for the time being.
Remote site visits will be conducted between the auditor and the primary person (or people) leading the audit response for the covered entity. Audits will be conducted via the Adobe Connect screen-sharing capability, with all data uploaded to a secure National Institutes of Health portal.
Covered entities will receive a welcome email containing a Data Request List, which must be completed before the remote audit. In addition, CEs will receive an agenda and Remote Site Visit List, which details document requests specific to the audit, one business day in advance.
The move from in-person site visits to virtual audits brings both advantages and disadvantages for the covered entity, as outlined below.
The remote audit involves a single virtual meeting with the auditor, conducted all in one day, and generally takes up to eight hours. If necessary, the covered entity will be given three business days to upload further documentation after the audit.
• The auditor may supply covered entities with testing samples the day before the audit, giving the CE the ability to start gathering data for the remote session ahead of time.
• The audit will be conducted in real-time, so the auditor will outline what they are looking for as they proceed.
• With onsite visits, a covered entity could expect to see an auditor for two days, whereas remote audits are considered “one and done.” Everything HRSA needs in terms of documentation and data is generally in hand by the time the audit is over. Those with scarce time and few resources to devote to the 340B program may appreciate the convenience of spending less time overall on audit efforts.
• Staff of the covered entity may find virtual audits less stressful — with no auditor onsite observing operations, CE staff may feel more free to focus exclusively on collecting data.
• There is less time for covered entities to collect data and documentation, so remote site visits may actually be a heavier lift, with a lot of work to be done in a short time period.
• Those who are less familiar with the 340B program, their data or their 340B management software may find it more difficult.
How Sentry can help
At Sentry, our priority is to provide you with comprehensive, expert service during HRSA audits.
Our Apexus-certified audit team understands the workload, demands and stresses covered entities have been facing as a result of COVID-19, and that’s why we’re here to help you every step of the way. In addition to real-time audit support, Sentry helps covered entities by:
• Helping you to understand 340B rules and regulations and stay up to date
• Reviewing your configuration settings to help you confirm they comply with HRSA guidelines
• Helping you understand the nuances of our 340B management and compliance software and how it can work for you to optimize 340B program savings
• Conducting self-assessments to help you review data before submitting it to HRSA, assess policies and procedures, evaluate your internal controls, and identify areas that may need attention
Whether virtual or in-person, Sentry’s audit services are another example of how Sentry customers can expect MORE.
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