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HRSA audits are inevitable, but they don't have to be intimidating.
If you operate a covered entity, you know one thing is certain: At some point, HRSA will review your 340B Program integrity. Everything else—including when your notice will arrive—is up to chance.
However, unexpected shouldn't mean unprepared.
Whether you're a veteran or you’re a first-timer, it's normal to have questions about what to expect during the much-anticipated HRSA audit. Where you have questions, our 340B Program experts have answers.
This paper is your HRSA audit guide. Prepared by our Apexus-certified 340B Program compliance experts, the guide will help you:
- Learn what to expect during each stage of the HRSA audit—from data request list (DRL) preparation to the on-site audit review and beyond.
- Navigate tricky compliance questions and scenarios with ease.
- Understand how to prepare a compliance strategy reinforcing continuous readiness.
- Feel calmer and more prepared when your notice arrives.
HRSA’s auditors will be here soon. Download the guide to find out what you need to know to prepare.
Fill out the form below to
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Guide: What to Expect During a HRSA Audit
A step-by-step timeline of what to expect before, during, and after the audit
How Does Your Hospital Pharmacy Benefit?
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IN-DEPTH ASSESSMENTS We review clinical and financial performance, regulatory requirements, compliance status, standards of practice, accreditation standards, policies and procedures, and more
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GUIDANCE BY PHARMACY PRACTICE SPECIALISTS We advise your pharmacy while addressing performance barriers and introducing a culture of continuous improvement
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CORRECTIVE ACTION PLANS We benchmark performance and identify opportunities
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SPECIAL COMPLIANCE PROGRAM We deliver keen focus on 340B programs, USP 797/800, controlled substance risk, accreditation readiness, and more
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LEVERAGE OUR YEARS OF EXPERIENCE CPS has delivered over 250 customized sterile compounding consultative assessments for diverse compounding operations
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RECEIVE A COMPLETE SITE ASSESSMENT using our proprietary audit tool
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RECEIVE A DETAILED EVALUATION OF STAFF AND SYSTEMS including personnel training and evaluation, an operational review, and more
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FOLLOWING ASSESSMENT, CPS will deliver a written compliance report and a corrective action plan detailing findings and recommendations to bring your compounding pharmacy into regulatory compliance.
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CPS WORKS WITH YOUR THIRD-PARTY ADMINISTRATORS to capture the claims which now meet the standards for inclusion in your 340B program
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YOUR ORGANIZATIONAL REVENUE INCREMENTALLY IMPROVES FROM THIS PROCESS
Case Study: How Drew Memorial Slashed Total Drug Spend to <$20 PPD