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In this series of articles, we will highlight cases in which Apexus Answers, a resource provided by the 340B Prime Vendor Program, was a valuable resource for 340B stakeholders who contacted the call center. Read Part II of this series here, and Part III here.
The 340B Program is complex, so it’s understandable that you will have questions when putting policy into practice at your organization. Although Section 340B of the Public Health Service Act is the core of 340B Program policy, additional regulations, guidelines, and policy releases have been published over the years to clarify important information about program compliance and requirements. As a 340B stakeholder, it can sometimes be difficult to understand how these requirements should be implemented operationally. Apexus Answers is a free resource to answer any of your 340B questions!
Before we get to the cases, those newer to 340B may still be wondering what services are provided by Apexus Answers.
Apexus Answers is the only HRSA-aligned national 340B call center available to all 340B stakeholders that is operated as part of an agreement with HRSA in the 340B Prime Vendor Program. As a service of the HRSA-contracted 340B Prime Vendor, Apexus Answers provides information consistent with HRSA policy and guidance. Apexus Answers is in constant communication with HRSA to ensure consistent messaging to stakeholders, but information about entities that submit questions is kept confidential (unless requested by the entity) so users can feel safe contacting Apexus Answers with compliance questions or concerns.
Answers to your 340B questions are just a phone call, email, or online chat away. Apexus Answers is available by phone and online chat Monday through Friday from 8 am to 5 pm (Central); emails, however, can be sent at any time, 24 hours a day, 7 days a week. Apexus Answers receives more than 2,500 inquires per month from 340B stakeholders, including covered entities, manufacturers, distributors, consultants, and other stakeholders.
A disproportionate share hospital (DSH) contacted Apexus Answers via web chat questioning a letter it received about upcoming NDC changes to a manufacturer’s product line. The hospital was unsure how these changes would affect its 340B mixed-use inventory operations and accumulations from the prior products.
Resolution: The Apexus Answers specialist discussed NDC replenishment expectations, specifically how products purchased with a new NDC will require new accumulations, unless a manufacturer and covered entity work together on a mutually agreed upon practice and keep written auditable records accordingly.
Outcome: The hospital will be able to handle the new product in a manner consistent with 340B compliance expectations for NDC replenishment.
A community health center (CHC) called Apexus Answers during recertification because its associated sites required a new authorizing official (AO) to be listed in 340B OPAIS (Office of Pharmacy Affairs Information System) to perform recertification. The recertification deadline was quickly approaching that evening.
Resolution: The Apexus Answers specialist contacted HRSA directly and worked with HRSA to ensure the entity was able to update its AO information and perform recertification for the associated sites.
Outcome: The CHC was able to update its AO and recertify all associated sites so they retained 340B eligibility. Without this quick communication between Apexus Answers and HRSA, the entity could have missed the recertification window and lost its 340B eligibility at these locations, a potentially devastating result for its sites and the communities they serve.
Knowing there’s a HRSA-aligned resource where you can submit questions 24/7 is invaluable. Contact us today! For additional clarification on 340B policy, search the HRSA frequently asked questions (FAQs) available on the HRSA website and find additional 340B FAQs on the PVP website.
Watch 340B OnDemand Module 1, “Introduction to the 340B Drug Pricing Program,” and get the basics in less than 15 minutes.