Imagine trying to build a house with no experience or resources. It’s a massive undertaking that requires proper permits and licensing, architects, general contractors, a labor force, and many different vendors and suppliers working together to make the new home a reality. Launching and maintaining a compliant 340B program is similar to building a house. It, too, requires significant resources. And without careful planning, it, too, could become a costly disaster. Successful programs often have leaders and staff who are knowledgeable about the 340B Program and understand its impact on the entire covered entity organization, beyond the walls of the pharmacy department. For example, a hospital executive might be unaware that not all outpatient centers associated with the hospital are automatically 340B eligible. This illustrates the importance of 340B knowledge in hospital leadership decisions, but 340B education is equally important within all levels of an organization. Without proper education, staff members might not understand how the 340B Program affects their role and their facility. A successful, compliant program requires effective education that adapts to meet the needs of many different learners across several disciplines, environments, and knowledge bases.
Questions you should be asking about your organization’s level of 340B education:
Let’s tackle each of these topics and discuss how Apexus can support 340B education at your organization.
What resources should I use when I have 340B-related questions?
As the 340B Prime Vendor, Apexus communicates HRSA-aligned 340B education. Our staff is in constant communication with HRSA to ensure that our messaging and education are consistent with HRSA expectations. Since Apexus was awarded its first Prime Vendor Program (PVP) agreement in 2004, the range of education services has evolved from providing 340B stakeholders with answers to basic questions about program compliance to now offering high-impact online and in-person educational offerings, dynamically tailored to all 340B stakeholders.
The best place to start when you have a 340B compliance-related question is HRSA FAQs. The FAQs provide information on a variety of topics affecting 340B Program operations. If you search the FAQs website and still have questions, you should contact Apexus Answers for more information. Apexus Answers is a free HRSA-aligned 340B information resource to promote program integrity. Apexus Answers is available by calling 888.340.BPVP (888.340.2787), emailing ApexusAnswers@340Bpvp.com, or by web chat. Additional resources can be found on the HRSA website.
In addition to providing 340B support through Apexus Answers and FAQs, PVP has developed comprehensive tools to support 340B Program compliance. The most commonly used tools help entities develop their 340B policies and procedures and self-audit practices. Additional tools, however, provide even further benefits, such as how to calculate 340B savings or show how your 340B savings benefit the community and underserved patient populations. Important HRSA communication forms are also available on the tools website, such as the 340B Price Unavailable Notification Template or Self Disclosure to HRSA and Manufacturer Template. These and other valuable tools are available on the 340B Tools page.
Historically, it was common for one staff member in a covered entity’s pharmacy department to be tasked with overseeing the 340B Program. Often this person focused on pharmacy business operations, and 340B oversight was only a portion of his or her day-to-day responsibilities. Today, however, many larger health systems have expanded program oversight to multiple full-time employees, including a dedicated 340B manager or coordinator. For smaller entities with fewer resources, a best practice is to have at least one dedicated staff member responsible for 340B operations and compliance, knowing that he or she may also have other responsibilities within the organization (e.g., pharmacy director, compliance officer).
Because of the multiple 340B stakeholders involved in an organization’s 340B program, entities often create multidisciplinary 340B oversight committees to provide program direction and compliance oversight. These committees generally include members from the organization’s legal, compliance, finance, information technology, pharmacy, and other departments. This team must be well informed about the 340B Program and have access to tailored information related to their roles in order to provide strong direction for an organization. Proper education is important to make both leadership and frontline staff effective in supporting the entity’s 340B program.
What’s the best way to provide ongoing education for our 340B staff?
At the heart of Apexus’ educational efforts are both the web-based 340B University OnDemand and 340B University Live events. For most entity staff members, 340B University OnDemand is the best way to receive 340B foundational education, as online modules can be completed at the users’ pace and tailored to their roles. For example, a pharmacy buyer would benefit from different education than, say, a director of compliance. A 340B Program director and his or her compliance staff would likely complete the entire OnDemand education, but the director may assign only purchasing-related modules to a pharmacy buyer. Entities often require 340B OnDemand modules to be completed annually or once every two years by staff if their role is affected by the 340B Program.
340B University Live is an interactive day-long event in which those newer to the 340B Program can learn about compliance best practices. Prior to each session, attendee demographics are evaluated and content adjusted to match the needs of the learners. Peer faculty members from covered entities provide perspective and real-life examples showing how to maintain compliance in the present environment. Most 340B University Live events are held prior to major industry conferences, and additional events are organized in areas where no nearby industry conferences are scheduled for that year. This allows covered entities and other stakeholders to send more members of their frontline staff to the event.
How can our organization elevate education expectations for our 340B compliance staff?
A best practice to improve the 340B knowledge base of compliance staff is to require 340B education for their positions. This could include annual completion of 340B University OnDemand or Live sessions. In addition, when hiring new 340B-related positions, including 340B education (OnDemand Statement of Completion) as a job requirement or preferred experience will elevate the level of candidates for the position.
Whether you’re looking for something as simple as an answer to a 340B question or for more complex education for staff training, Apexus provides relevant, HRSA-aligned educational resources to fit your needs and support your 340B Program compliance.
Apexus Answers can help with questions about 340B University or OnDemand. Staff members are available by phone, email, or online chat.
Find out more about 340B University, which provides basic information about 340B through in-person live events.