Advanced 340B Operations Certificate Program: A Covered Entity Perspective

Why Specialized 340B Training at an Advanced Level is Important

A discussion with Felicity Homsted, PharmD, BCPS

The 340B Program is highly complex and constantly evolving, so it's important for people working with the program, particularly those who are involved in 340B compliance, to have a high level of specialized training to ensure they understand all of the components of the program and maintain compliance with each element. Because there's so much information in the industry around the 340B Program - that isn't necessarily validated - it's important to have a resource that has gone through the process of making sure they've tied, and validated, all of the information back to the original statutes. Because of the complexity of the program, it's important for covered entities to have this knowledge in house as well as to be assured that when they extend beyond their internal resources the vendors and consultants they're using have a solid knowledge base as well.

With the Apexus Advanced 340B Operations Certificate, there are continuous updates offered through the program, which helps maintain the knowledge base of those who participate.

Advanced 340B Operations Certificate assists with hiring decisions.

Prior to the 340B Operations Certificate, covered entities did not have a way of validating the knowledge base of the consultants and vendors they engaged. With this program, they now have a way to actually see that they have demonstrated a solid foundation in the concepts of the 340B program, but beyond that, they can validate that the consultant or vendor has experience and understanding of the complexity of each of the different entity types.

If you are disproportionate share hospital (DSH), you look very different from a federally qualified health center (FQHC). Previously, we were unable to determine that the consultant had experience in each area. Particularly, if you're a smaller type of covered entity, you may get an experienced 340B vendor, but they've only worked with one entity type, and not yours. Then, maybe they're not able to account for the different nuances that go with your entity type. The Apexus Advanced 340B Operations Certificate Program gives them broad exposure as well as deep knowledge to each type of covered entities, as well as the considerations they're going to need to make when working with you. This helps ensure that they're looking specifically at what the requirements are for your system.

This is a seal of approval that allows covered entities to know they’ve demonstrated proficiency at a very high level and that they're someone who can be relied upon to help develop a program in a way that is compliant with high integrity and also aligns with program intent.

340B Program Value

One of the most challenging things with the 340B program is feeling as though you don't know as much as you need to, or feeling uncertain about how to operationalize something within your organization. Nobody starts their day wanting to be mediocre, and as a member of a covered entity, you know how important the 340B program is to your patients and health system. Employees have a strong desire to be able to perform their jobs well, and part of this is having a knowledge base that allows them to do so.

By participating in the Advanced 340B Operations Certificate program, employees are able to elevate their knowledge base so they can be confident while they're working with the 340B program. They're going to be able to assure that their program is compliant, that they're making the right choices at the right point in time, that they're keeping their knowledge base up to date, and that they have the solid foundation to base all of those decisions on. There's nothing better, at the end of the day, than knowing you've done a great job. This program helps ensure that you have the skills and the tools to be able to do so.

Rise above the competition as an Apexus Certified Expert.

The 340B space is becoming more and more competitive. Vendors and consultants are now looking for ways to distinguish themselves from the rest of the competition. It's incredibly important for 340B vendors and consultants to have a high level of knowledge and program understanding, and be able to demonstrate they have gone through the 340B certificate program, and demonstrated proficiency at a comprehensive level. It really is the seal of approval that says you have the advanced 340B knowledge and expertise that covered entities can rely on.

Who should complete Advanced 340B Operations Certificate Program training?

Anyone who's involved in 340B compliance should be expected to have this level of training. 340B professionals, including program directors, 340B program coordinators, directors of pharmacy, and operations managers should all enroll in the Advanced 340B Operations Certificate Program. Having the certificate training ensures they consider all of the decision points they will encounter, and makes sure that compliance is held to the highest standard. We always think about those involved with internal compliance, but we should also think about the value it brings if you're a 340B vendor or consultant, or someone working with a wholesaler.

If you're involved in designing a split billing software and you don't truly understand how the 340B program works, it's very difficult to program a viable solution. Anyone who's involved in the systems of 340B is going to benefit from the 340B Certificate Program.

Using program information within your organization.

The 24 learning modules that are offered in the 340B certificate program curriculum are structured in a way that helps the learner become deeply engaged in the content. It starts at the policy level, actually referring to each of the policies. Then, after you've gotten a solid foundation in policy, it focuses on 340B operations. How do you take that policy and put it into practice within your organization?

From there, you're going to learn all about auditing. We know that it's important to set up a compliant program, but equally important is the ability to verify and validate. The program explains the audit pieces that are involved for each of the different segments, whether that's a contract pharmacy, in-house pharmacy, or what’s happening in clinics. There are a number of elements highlighted, and the program works well by building on foundational elements. It then adds to this foundational knowledge to explain implementation. Then, it provides the tools and skills to be able to follow up and make sure that you've done so correctly, and that your program is compliant as possible.

You're able to have a strong level of confidence when you've completed this program to go back and look at what you're doing, and say: Is this best practice? Are there ways we can improve? Once you've made those changes, you have the skills to be able to make sure that what you've put in place is correct and going to carry forward in a compliant manner.

Importance of teaching exact 340B policy language.

The 340B program has evolved considerably over the years. So the information today and program understanding is very different from its inception. In that time, 340B policy has been changing, as well as the guidance that goes with it. It's important to understand where the policy is today, and recognize the history of where it's come from. This offers a deeper understanding of the program and the program's intent. If you don't begin with a policy-level understanding of the program, you're not able to understand how each of the different elements of your program are tied back to compliance. And we know with the 340B Program, compliance is the most important part.

The 340B program is intended to stretch resources, to help create access for patients to not just medications, but also to different types of services. Understanding the policy allows us to build a strong foundation to ensure the program is being used appropriately, that we're creating access for patients, and that is done compliantly in case of an audit.

The 340B Education Standard

Compliance is of the utmost importance with the 340B program and education standards help ensure that those participating in the program have the level of knowledge needed, and the expertise to be able to design programs that are going to remain compliant with the expectations of HRSA and the Office of Pharmacy Affairs. The level of complexity encountered on a day-to-day basis goes well beyond the baseline knowledge people tend to have about the 340B program, particularly in the C-suite. Those on the ground actually operating the program need to have a deep understanding of the different pieces of compliance and the regulation that's involved. The 340B Operations Certificate provides that level of understanding, explaining difficult concepts within the program as well as where there's opportunity for interpretation. When there's an opportunity for interpretation, there's also an opportunity for risk. The program helps learners look at various decision points and what will be right for each organization.

Having a standard is so essential, because those in charge of such a complex program must be able to verify that they have the skills necessary to do so in a compliant ways. This program is an excellent way to validate 340B expertise.

Invest in your 340B knowledge.

The 340B operations certificate really is bar none the best investment you can make into your 340B knowledge. Both for leadership as well as with the 340B program, this program is exceptional regarding cost to value.

It will build on the foundations that you may have gotten through 340B University OnDemand or 340B University. It will elevate you to a level of knowledge in the program that is beyond what you will encounter in your day-to-day work and beyond what you'll encounter across the country as well. This program is not a program that was developed overnight, but was built intentionally, by subject matter experts from across the country. It brings into account a number of different pieces that are operational from experts' day-to-day practices. It's impossible to have that type of depth from a singular encounter within your own organization. If you are a pharmacist looking for advancement into an operations manager position, or another leadership position involving 340B, you're going to have a distinguished knowledge base beyond your peers.

Get a clear understanding of the 340B program.

The way that the Office of Pharmacy Affairs and HRSA has written the guidance, regulations, and statutes, are intended to be open enough that covered entities can set up the program in such a way that will work with their facility type, but also restrictive enough to give guidance to how the program should operate.

One of the values of the Advanced 340B Operations Certificate is that it discusses many different scenarios that you're going to encounter on a day to day basis, and also review the different solutions, which could be used and the risk points involved with each of them. It allows you to think about your organization and how it relates to those that are covered in the scenarios and case studies. Learners can then apply best practices as well as be aware of risk points as they make decisions within their organization.

Why does your organization need Apexus Certified Experts?

It is critically important for organizations to invest in staff members who are experts in the 340B program. The Apexus Advanced 340B Operations Certificate optimizes the program, both in compliance and integrity, so if an organization has an audit, they’ll be able to demonstrate alignment with program intent.

Having someone knowledgeable in the 340B program means that you can expand your access to the program. Whether that's through in-house pharmacies or improving medications utilization within your practices or even through contract pharmacy relationships – there are a number of benefits in having a validated expert within the organization.