340B Audit


 Are you ready for a HRSA Bizzell Group 340B audit?

It’s important to make sure your healthcare facility is on the right track and understands the 340B audit process. As you consider your future goals, an independent 340B audit can help you plan ahead with confidence. What is a 340B audit? We’ll analyze your pharmacy’s 340B policies and procedures and compliance with all 340B Drug Pricing Program requirements ((42 USC 256b(a)(5)(C)) so that you can optimize your program quickly and compliantly. Please fill out the form below to determine your 340B Audit Readiness.

340B Audit Ready Questionnaire
1. Is your covered entity prepared for HRSA’s Bizzell Group return to onsite 340B Audits [vs. virtual audits], which engage added scrutiny around 340B program registration, inventory management, program controls and staff knowledge? *
2. Has your team implemented a comprehensive compliance process that employs targeted patient-level testing, regular reviews of split-billing software filters, and drug utilization data feed integrity? *
3. Has your covered entity engaged an independent third party 340B audit in the past year and received an attestation that an external 340B audit was performed? *
4. Are you confident related staff (finance, pharmacy, informatics, internal audit) can articulate their knowledge and role in overseeing the 340B program, along with providing evidence of an enterprise-wide approach with supporting documentation such as 340B Steering Committee minutes? *
5. Are your 340B Policies & Procedures up to date? As a 340b hospital, do your policies and procedures address updated guidance around provider-based offsite locations not yet listed on the most recent Medicare Cost Report, material breach threshold monitoring, and drug-specific treatment of Non-Covered Outpatient Drugs (“NCOD’s”)? *

What is a 340b audit? Why is it important? Maintaining 340B program integrity requires constant communication, regular self-auditing, and strong controls. Utilize our 340B experts and audit services to bridge any gaps and safeguard your covered entity against a poor HRSA audit. HRSA remains committed to the integrity of the 340B program, including prevention of diversion of covered outpatient drugs to non-qualified patients and prevention of drugs subject to duplicate discounts under both the 340B program and Medicaid rebate program. Failure to comply with 340B statutes may make the 340B covered entity liable to manufacturers for refunds of discounts or cause the covered entity to be removed from the 340B Program. Make sure your healthcare facility is prepared today!