October 2014 HRSA has provided information to stakeholders on many aspects of 340B Program integrity efforts. This month, we’d like to focus on the expansion of our oversight of HRSA Grantees in the Bureau of Primary Health Care and the HIV/AIDS Bureau through the addition of a 340B Drug Pricing Program Assessment Supplement to program site visits. Starting in Fiscal Year 2015, grantees that participate in the 340B program and are scheduled for a HRSA site visit will be asked to demonstrate compliance with the 340B program. While the primary focus of the site visit remains on the HRSA grant, several basic questions will serve as an important reminder for grantees of the importance of 340B compliance, as well as a potential trigger for further investigation by the Office of Pharmacy Affairs (OPA). As a result of these site visits, the OPA will also be able to highlight best practices to assist covered entities with compliance. Our goal is to maximize the reach of our program integrity efforts, while ensuring transparency for all stakeholders to understand 340B compliance requirements and site visit expectations. Site Visit PreparationIn general, covered entities should be able to efficiently and effectively prevent compliance issues and identify any material breach; propose a plan for periodic assessment and continuous monitoring; and outline a clear method to monitor contract pharmacies to maintain compliance with program requirements. Successful covered entities have also routinely identified annual policy review date, entity contact person, and clarified an internal 340B communication/education strategy. Due to the diversity of covered entities and the need for flexibility in program implementation, HRSA recommends that each covered entity establish and document criterion that demonstrates compliance for the following requirements as outlined below.
Technical AssistanceThere are many tools and resources available to 340B stakeholders to ensure compliance with 340B Program requirements. The 340B Prime Vendor Program, managed by Apexus, provides assistance with creating appropriate policies and procedures to address the criteria listed above. |
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