Understanding the 340B Prime Vendor Program and Supporting Stakeholders During COVID-19

Since an agreement was finalized with Health Resources and Services Administration (HRSA) in 2004, Apexus has worked as the 340B Prime Vendor (PV) under the 340B Prime Vendor Program (PVP). This year, changes were made to adapt to the coronavirus disease 2019 (COVID-19) pandemic in order to continue to allow 340B stakeholders to have access to the PV’s distribution, education, and general assistance resources during the pandemic, according to a session at the 2020 American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition.

Under the PVP, the PV has several functions that it carries out to support stakeholders in operating and navigate the field so that they can effectively achieve lower 340B drug pricing for those who need it most.

One function carried out by the PV is negotiating contracts with manufacturers and wholesalers that support compliance and improve access to program savings for participating covered entities. Examples of these types of contracts can include sub-340B contracts that are below the statutory ceiling price, or sub-wholesale acquisition cost (WAC) contracts, which are primarily aimed to help entities who are subjected to the group purchasing organization (GPO) prohibition. Additionally, the PV also allows for the negotiation of contracts on nondrug items commonly used in outpatient settings, such as vaccines or blood-glucose testing supplies.

According to Gavin Magaha, the 340B education and compliance support manager for Apexus, the second function provided by the PV within the agreement with HRSA is education and training on the 340B program, which can be a confusing and complicated arena without additional support. For this reason, the PV works to meet each learner’s levels, responsibilities, and needs.

“Our most popular offering, likely because it is our most accessible one, is the 340B university on-demand series. They are entirely online modules designed to be a self-paced, basic or introductory level training that many of the stakeholders out there are using for onboarding for their new staff or even incorporating into their annual assessment of competencies,” Magaha explained.

The third function that the PV provides in the 340B PVP is the HRSA-aligned national call center, known as Apexus Answers. In this role, the PV answers technical assistance questions from covered entities regarding the program both over the phone and over email. Apexus Answers also provides HRSA’s frequently asked questions (FAQs), tools, and other resources to anyone with questions about the program.

The PV has also expanded its educational offerings on its virtual platform this year because of the impact of the COVID-19 pandemic. These include 2 new virtual education offerings, which include 340B university virtual workshops and manufacturer bootcamps.

“The virtual workshops are designed to help support virtual learning and intermediate-level instruction. Each event highlights a specific topic and is designed to help participants engage with one another in much the same way they would in a live event by breaking out into small group discussions and applying lessons learned to targeted case study activities, as well as sharing individual experiences,” Magaha said.

This year, topics offered on these new virtual education offerings have included Medicaid and avoiding duplicate discounts, covered entities’ self-audits and manufacturing good faith inquiries, and best practices for purchasing.

Additionally, the 340B PVP website was rebuilt this year and moved to a more flexible platform that makes navigation and access easier for 340B stakeholders. Magaha also noted that over the next few months, more content will be added on the website to aid stakeholders in their compliance and purchasing efforts this year.

At the beginning of the COVID-19 pandemic, HRSA recognized the pressures that were being placed on 340B stakeholders, according to Magaha. HRSA acknowledged that the changing landscape and impact of the pandemic on health care systems required a quick and effective response from HRSA to support stakeholders in light of the changes taking place.

“HRSA developed and put out FAQs specific to many of the topics being discussed in relation to treating COVID-19 patients. Included in these, HRSA clarified their expectations for telemedicine and mobile care, permitting the use of 340B for these encounters, as long as the care could still align with the entities’ definition of ‘patient,’” Magaha said.

HRSA also developed a process that allowed for the emergent registration of new care sites as well as contract pharmacy arrangements that help to ensure patient access to critical medications throughout the pandemic.

“As shortages impacted the marketplace, HRSA recognized the potential for burdensome reporting that could impede medication purchasing activities, so they allowed certain relaxations in regard to record-keeping when a hospital was forced to purchase something on GPO due to those marketplace shortages,” Magaha said.

Additionally, this year, HRSA moved all audits from being conducted with stakeholders on-site and in-person to their being conducted over a virtual platform, Magaha noted. Such a migration was a common shift that took place throughout those organizations that were able to make the change due to the COVID-19 pandemic.

REFERENCE

Magaha G. Review of 340B Trending Topics. Presented at: 2020 ASHP Midyear Clinical Meeting and Exhibition; Virtual; December 6-10, 2020. Accessed December 10, 2020.