340B Audit Readiness


Are you 340B audit ready?

Please fill out the form below to determine your 340B Audit Readiness.
340B Audit Ready Questionnaire
1. Are you adhering to the GPO Purchase Prohibition/Orphan Drug Exclusion? *
2. Have you engaged the necessary reconciliation testing to ensure patient-administered drugs are auditable and documented properly? *
3. Has you covered entity engaged an independent 3rd party 340B audit in the past year? *
4. Does your organization have a plan to address the recent drug manufacturer letters aimed at reducing contract pharmacy participation? *
5. Does your organization have a "jump plan" for HRSA audits? *
6. Are you confident related staff (finance, pharmacy, internal audit) can articulate their knowledge and frequent monitoring of your 340B program? *
7. Do you have a comprehensive 340B compliance/education program that focuses on interdepartmental coordination, issue resolution, and ongoing monitoring? *
8. Have you evaluated the impact of upcoming regulatory changes, such as the Medicaid AMP Rule, 340B Omnibus Rules, and Bipartisan Budget Act 603? *
9. Do you engage with hospital legal counsel/policy affairs personnel in handling policy interpretation? *
10. Are your Policies & Procedures comprehensive and do they define Material Breach thresholds and procedures to handle OPA and Manufacturer disclosure? *
11. Are you confident that your program coordination, including your compliance and internal audit team, utilize a "best practice" approach to ensure 340B compliance in an evolving 340B regulatory environment? *
12. Is your OPA database registration current and correct? *
13. Are all "child sites" listed appropriately, meeting provider-based requirements and GPO Prohibition requirements? *
14. Are you adhering to your state's Medicaid reimbursement guidelines as well as out-of-state Medicaid requirements for both billing and duplicate discount compliance? *
15. Do you engage a compliance process for identifying and updating eligible patient filter criteria for your 340B contract pharmacies? *
16. Can you ensure physician prescriptions are generated in a provider-based setting, rather than the physician's private practice? *