August 2015 - Office of Pharmacy Affairs Update

August 2015

In an effort to ensure maximum success and compliance for all stakeholders involved in the 340B Program, HRSA works collaboratively with Apexus and the American Pharmacists Association to provide an extensive array of educational materials, program implementation tools and other resources.

340B Proficiencies

What knowledge and competencies should 340B covered entities and other stakeholders have to be proficient in the 340B Program? What resources are available for a stakeholder to use to address those competencies? A set of 340B proficiencies has been compiled and include a variety of “knowledge” (need to know) or “application” (need to do) items covering topics in categories such as eligibility, contract pharmacy, diversion, duplicate discount, inventory and general background information on the 340B Program. The following are some examples of 340B proficiencies used to drive the development and provision of the various, available resources:

• Regularly review verified 340B Program policy information and sources to remain up to date and know changes to requirements and compliance.
• Identify eligibility requirements for each covered entity type.
• Outline the registration process for each covered entity type.
• Define the major 340B compliance cornerstones (eligibility, prohibition against diversion, duplicate discounts prohibition, maintenance of records and standard operating procedures, or policies and procedures).
• Engage executive staff in the 340B Program.
• Establish and maintain a comprehensive contract pharmacy oversight process, including outlining the format and content of monitoring reports.
• Self-audit records and processes to prevent duplicate discounts.
• Describe the most common options for delivering 340B drugs to patients.

340B Resources

There are many resources available to covered entities and other stakeholders to support their efforts to ensure appropriate program implementation, program integrity and compliance with all 340B Program requirements. These resources include:

• FAQs (Frequently Asked Questions) or the most often asked inquiries, with answers
• 340B Prime Vendor Program Resources including tutorials, tools and webinars
• 340B Peer-to-Peer webinar series with practical examples and experiences from high- performing covered entities that have been recognized as 340B Leading Practice Sites
• HRSA Office of Pharmacy Affairs website

340B OnDemand

Apexus, the 340B Prime Vendor Program and one of the verified sources of information about the 340B Program, has recently released a new online educational resource, “340B University OnDemand”,  to support 340B Program compliance and integrity. The content is consistent with HRSA’s interpretation of 340B policy, and provides a high level of detail along with the integration of tools and resources on a free, online platform. The 340B University OnDemand e-learning modules are easily accessible and convenient, and are authored by subject matter experts. Here is a list of the currently available OnDemand modules, with additional modules coming soon:

1. Introduction to the 340B Drug Pricing Program
2. 340B Stakeholder Perspectives
3. Eligibility Overview
4. HRSA 340B Database Navigation
5. Registration for the 340B Drug Pricing Program

Covered entities and other 340b stakeholders are encouraged to take full advantage of these educational resources in order to be most proficient on the 340B Program and to ensure compliance with program requirements.

If you have any questions, or need further information, the team at ApexusAnswers-a service of the 340B contracted Prime Vendor Program-stands ready to assist by email (ApexusAnswers@340bpvp.com) or by phone (888-340-2787).