1. DO YOU HAVE THE DOCUMENTATION TO CONFIRM YOUR ENTITY CURRENTLY MEETS 340B ELIGIBILITY?While this may seem like a simple question, many entities can fall out of eligibility range if they do not meet the specific requirements listed in the 340B statute. Additionally, having the necessary documentation in event of an audit can assist in avoiding an OPA finding.

2. IS YOUR HOSPITALS INFORMATION UP-TO-DATE ON THE HRSA 340B DATABASE?Entities are responsible for keeping their information up-to-date on the HRSA 340B database. In the past few years, HRSA has added new complexity to properly registering all of your eligible sites (e.g., o�-site locations with a single address). You are required to recertify your entity information annually.

3. DO YOU HAVE POLICIES AND PROCEDURES IN PLACE THAT REFLECT ACTUAL PRACTICES OF YOUR ORGANIZATION? It is critically important that your policies and procedures are customized to reflect your organization’s actual operating procedures. Covered entities should establish a schedule for regular reviews of policies and procedures as well as a process for how those changes are made and who approves them.

4. COULD YOUR PROGRAM PASS A HRSA AUDIT? Covered entities are required to ensure program integrity and maintain accurate records documenting compliance. It is critical to understand that a robust internal auditing program is the foundation to a successful, compliant program.

5. DO YOU HAVE A CHECK POINT IN PLACE TO ENSURE YOU DO NOT PURCHASE A DRUG WITH A DUPLICATE DISCOUNT? Covered entities are responsible for managing their Medicaid list for program exclusion. It is important to make sure that all updates to the list are documented in case of a HRSA audit.

6. ARE YOU ABLE TO CONSISTENTLY AND ACCURATELY APPLY YOUR UNIQUE PATIENT QUALIFICATION LOGIC TO YOUR TO CONTRACT PHARMACY CLAIMS? It is crucial to have the documentation in your qualification logic that validates that the prescription was written in an eligible location. 340B administrators, such as PSG, are a key partner in ensuring your unique patient qualification logic is consistently and accurately applied to contract pharmacy claims.

7. ARE YOU ABLE TO VALIDATE THAT PRESCRIPTIONS ORDERED IN THE HOSPITAL WERE WRITTEN BY AN ELIGIBLE PROVIDER?Many mixed-use pharmacy programs are not setup to validate provider’s relationship. Outside specialists (e.g., oral surgeon) could cause compliance challenges and lead to an OPA finding.

If you can’t answer YES to most of these questions, you are not alone. The 340B program is complex, but PSG helps hospitals like you navigate those complexities.

Want to learn more about how PSG can help your hospital maintain compliance while optimizing your program? Visit: psgconsults.com/340Bcompliance

340B COMPLIANCE CHECKLIST