340B Audits are reviews conducted by HRSA with serious consequences, including manufacturer paybacks, sanctions, and disbarment from the 340B program. We use our signature 340B program audit to test your pharmacy’s HRSA audit preparedness. We separate our process into two major phases for 340B Mock Audits.
- Maxor will begin with an initial conference call with your entity to discuss 340B operational assessment, strategy, timeline, and data request. We will also develop and refine the scope of the 340B program audit.
- Maxor will then obtain all requested data elements, internally review them, and request data supplementation or clarifications if needed.
- We will proceed to cross-reference the data with the HRSA requirements and guidelines to ensure 340B criteria is met and that all child sites are properly registered
- We will review systems information and perform a data analysis of prescription and purchase data – The Rx data analysis conducted by Maxor will consist of a 100% validation of all 340B eligible prescriptions for the time period rather than simply a sampling.
- We will then identify all prescription outliers and compile a test sample of these prescriptions to be reviewed individually and validated on-site.
- Maxor will conduct an entrance conference to outline an agenda and interview key personnel involved in 340B purchasing and dispensing activities
- We will observe purchasing and dispensing processes and review prescription outliers, including a minimum of 30 records for each contract pharmacy corporate entity. (In the event that there are insufficient outliers, a random sample of prescriptions will be selected for review.)
- We will review covered entity records to ensure all prescribers are employed or contracted
- At the conclusion of the site visit, hold an exit conference to discuss any preliminary findings
- At the conclusion of our review, Maxor will provide the client with an initial draft report of our findings. The report will be confidential and, upon receipt, the client will have the opportunity to review and respond to our initial findings prior to Maxor finalizing the report.
- Maxor’s assessment will consist of a comprehensive review of your 340B program. It will require multiple conference calls, as well as an on-site visit from the Maxor consulting team. Any areas of non-compliance and recommendations for corrective action will be detailed in Maxor’s official written report.
13 Years of 340B Experience
Maxor ensures that you know what to do for HRSA audit preparedness. Our 340B program audit is a multiphase process that comprehensively reviews all processes, technologies, and child sites to show you exactly where your organization stands with compliance. Visit The Maxor 340B Program Solution or call 1-800-658-6146 now to learn more about how 13 years of continued excellence in 340B compliance can prepare you for HRSA audits.