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340B Insight provides members and supporters of 340B Health with timely updates and discussions about the 340B drug pricing program. The podcast helps listeners stay current with and learn more about 340B to help them serve their patients and communities and remain compliant. We publish new episodes twice a month, with news reports and in-depth interviews with leading health care practitioners, policy and legal experts, public policymakers, and our expert staff.
Narration [00:00:04]:
Welcome to 340B Insight from 340B Health.
David Glendinning [00:00:12]:
Hello from Washington, D.C. and welcome back to 340B Insight, the premier podcast about the 340B drug pricing program. I'm your host David Glendinning with 340B Health. Our guest for this episode is Pooja Shah, the System pharmacy manager of 340B programs at University of North Carolina Carolina Health. Pooja and her team have developed a comprehensive education program for UNC Health professionals who work on 340B issues, and she shared the details of those educational approaches with attendees of the most recent 340B Coalition Summer Conference. We met up with her there to learn more about how the UNC Health team learns about 340B. But before we get to that interview, let's do a quick recap of some of the latest news about 340B. 340B Health and two of our member hospitals recently urged a federal appeals court in Washington, D.C.
David Glendinning [00:01:17]:
to uphold two lower court decisions that blocked drug companies from imposing unauthorized 340B rebate schemes. In our brief with the court, we argue that the plain language of the federal 340B statute does not allow the government to approve backend rebates in place of upfront discounts. The appeals court is considering rebate lawsuits that four drug makers brought against the Health Resources and Services Administration. Our opening brief provides the arguments of 340B Health, Genesis Healthcare System and UMass Memorial Medical center as intervener defendants in those cases. The three judge panel overseeing the litigation is planning to schedule oral arguments in the cases for later this fall and could issue a decision soon after that. 340B Health members can check out the show notes to read our brief and see more information about the cases. And now for our feature interview with Pooja Shah with UNC Health. As our listeners can attest, 340B can be a very complex subject.
David Glendinning [00:02:31]:
Those who are new to the 340B world, and even those who have been in it for years, need educational resources to ensure they can navigate it effectively. That's why Pooja and her team came up with tailored approaches to get the UNC Health team up to speed and ready for anything unexpected or expected that could come their way. We spoke more about these approaches during the 340B Coalition Summer Conference. Here's that conversation.
David Glendinning [00:03:00]:
I am sitting here with Pooja Shah, who is System pharmacy manager of 340B programs at university of North Carolina Health. Pooja is joining us during the Ice Cream Social here at the 340B summer conference. So seems a little cruel to make you sit here and watch people enjoying their gelato. But you are here to discuss a very important topic, which is how you provide education for your 340B team. So thank you so much for being here. Welcome to 340B Insight.
Pooja Shah [00:03:32]:
Yeah, thank you for inviting me.
David Glendinning [00:03:34]:
First, please tell us a little bit about UNC Health and the patients you serve there.
Pooja Shah [00:03:40]:
UNC Health includes UNC hospitals and its provider network, as well as the clinical programs of the School of medicine. We have 16 hospitals across 20 campuses within the state of North Carolina. From a 340B standpoint, we have 15 covered entities within the health system. Most of them are disproportionate, share hospitals or DISH entities. We all work to support our mission, which is to improve the health and well being of North Carolinians as well as other patients who we may serve. And we accomplish this by providing leadership and excellence in the interrelated areas of patient care, education and research. The 340B program, of course, plays a critical role for our covered entities. For example, we use these savings to support charity care as well as the expansion of clinical services within the state.
David Glendinning [00:04:30]:
Wonderful. And you are the second Tar Heel to come on the program. We had your colleague Melissa Bruce just over a year ago discussing duplicate discounts. So why is it so important to have an education process in place for 340B teams like yours?
Pooja Shah [00:04:50]:
So we can all probably agree that 340B is a pretty complex program, and program integrity is at the forefront of our intention. And we also know that this is a priority from hrsa. It's common for auditors, when they have program visits or audits at the program to ask questions around education and training for relevant teammates. And overall, we want to make sure that we ensure those who are involved in the program understand the importance of the program, as well as how they play a critical role in its compliance, its integrity, and ultimately, patients being served.
David Glendinning [00:05:31]:
Well, that's interesting. I didn't know that HRSA auditors tended to ask about education. I suppose I should back up a little bit and get a sense of your team as you speak about educational efforts. Who's involved with the education infrastructure at UNC health?
Pooja Shah [00:05:50]:
From a 340B team standpoint, we operate at the system or enterprise level. Currently, we have 21 members on our team. That includes most myself. And within that 21 number, we have compliance and data analyst, as well as myself serving as the manager and a director of pharmacy. Many years ago, we were a small team of about four to five individuals and we've grown to 21. That's a lot of education and training needed as many people tend to be new to the 3, 4D space when they first join our team. So that from a just from a solely team standpoint, there's been a need to ensure that we're educating and training individuals. And beyond our team, we have so many different stakeholders that we interact with at the system level as well as the covered entity level.
Pooja Shah [00:06:42]:
And so with that in mind, we oftentimes involve purchasing agents, directors of pharmacy who are oftentimes serving as primary contacts, as well as other executive leaders within the system to really be a part of the conversation and ensure that they understand the program.
David Glendinning [00:07:01]:
Can you describe your basic educational philosophy here? So what's your general approach to educating your teammates and these other stakeholders that you mention on 340B?
Pooja Shah [00:07:13]:
We definitely try to target those who are new to the program, new to 340B. Generally, we take a didactic approach in our initial training and then we also look for venues or have identified venues for interactive discussions or what we call a venue for just in time education and decision making. So I would say overall we have a two pronged approach at UNC Health. We have a didactic approach and an interactive approach.
David Glendinning [00:07:48]:
Okay, Didactic and interactive. So let's drill down a bit more on each of those. Let's start with the didactic strategy.
Pooja Shah [00:07:56]:
What does that look like from a didactic strategy? We've decided to develop three self paced online learning modules and these vary in their level of information. The first one we've developed or adapted was one that we call the basics of 340B. This is intended to be a very much high level overview. It focuses on the intention of the program as well as key stakeholders and really how generally we would define a 340B eligible patient per HRSA's guidance. This is probably about a 10 minute module. It's short and sweet and is one that we intend to assign to all pharmacy staff within the system at the system level as well as at covered entity levels upon hiring to complete within 90 days. And we're relatively new in rolling out this didactic approach. So as we gain feedback and experience, our goal is to have this be assigned to all UNC Health teammates, not just pharmacy, but starting off small and then we'll scale beyond the basics of 340B.
Pooja Shah [00:09:07]:
Learning module. We also have a learning module geared towards stakeholders and this is more so a learning module that weaves together the compliance cornerstones with the Operational pieces. And so it's really targeted towards your primary contacts. For us, those are often directors of pharmacy at covered entities, as well as purchasing agents that are oftentimes purchasing inventory for those covered entities and have to work through the complexities of split billing orders and all that fun stuff as well. And that's one that we intend to assign upon hire to complete within 90 days as well as annually. And then the last learning module that we've developed is one for the system 340B team. As one would expect, this is definitely more comprehensive, it's probably about an hour long and focuses on the cornerstones of 340b compliance as well as the operational pieces and kind of builds on those elements. And it's one that we assign upon hire as well as annually, so that we can have documented records of demonstrating competency even within our own team.
David Glendinning [00:10:19]:
It certainly sounds like you put a great deal of thought into, into rolling out those resources that'll be great ones for the team. So what will those benefits be of having the learning modules in place?
Pooja Shah [00:10:32]:
As most of us also recognize, teams don't stay static. There's always opportunity for individuals to continue to grow and move on to new positions and for new people to join our team. And so this provides a venue for standardized education for new employees that join the health system and our team and really eases the burden of having to schedule one off meetings for continuous education. They can work through these learning modules and then as they gain more experience and have random questions, we can engage with them through various forums as well. And it really just allows for a more meaningful conversation and more productivity around compliance integrity.
David Glendinning [00:11:20]:
Okay, that covers the didactic strategy. And now moving on to the interactive strategy, that other element you spoke about. What form does that strategy take?
Pooja Shah [00:11:30]:
At UNC Health, the interactive strategy takes a couple different forms. I would say. We have broken into two pathways. So as a system team, we have 12 covered entities that we oversee. And so we have taken the approach of having an entity level or local level oversight committee pathway, and then a system level oversight committee pathway. And from an entity standpoint, we have dedicated 340B oversight committee meetings. The shape and form of those meetings, the titles can vary, but the essence is the same where we discuss compliance as well as financial metrics. From a compliance standpoint, that includes things like compliance pass rates for different 340B universes, or your annual external independent audit results and the corrective action plans associated with those and how we're progressing on those items, as well as any special projects, and then generally that committee will report to a form of a governance committee.
Pooja Shah [00:12:34]:
Once again, that shape title, name may look different, covered entity to covered entity, but the essence is there of oversight of 340B. For example, at our academic medical center in Chapel Hill, we recently developed a governance committee quickly assembling stakeholders so that they could have a venue for senior level executive leadership to be well informed around some of the industry updates related to, for example, rebate models. So if a decision was needed then or in the future, we're preparing them for that conversation. And then the other pathway that I mentioned is the system level. So we have a dedicated system 340B oversight committee that meets about every six to eight weeks. This is a forum that is open to all covered entities, not only the ones that we oversee within the health system. Because we value being one great team. It's a core value for us.
Pooja Shah [00:13:36]:
So we want participation, we want discussion. Generally we have our primary contacts as well as authorizing officials from each covered entity attend, as well as enterprise stakeholders, for example, in hospital components, compliance, legal credentialing. The list can really go on and on. And at that forum, we oftentimes discuss things like industry updates, any court cases, litigation advocacy efforts, organizational updates, strategic initiatives that may be shared amongst multiple covered entities. If there's any programmatic changes on the horizon, how we're preparing for them, and then this committee will roll up to what we call our system Pharmacy Roundtable. They also meet monthly. Typically it's minutes that roll into that meeting forum. However, every couple of months we do have dedicated 340B discussions because it's a different set of stakeholders, but still invested in the program and ensuring that they're well informed and educated on 340B matters.
David Glendinning [00:14:43]:
I'm interested in what all of this looks like in practice. So can you give an example of how the interactive strategy at UNC Health kicked in when some sort of 340B related issue arose?
Pooja Shah [00:14:57]:
So a great example of this that comes to mind was when we learned, I think it was about two years ago, that the public health emergency for COVID 19 was going to end, and we received notice that HRSA was also going to end their child site registration flexibility ruling. And so with that, we needed to have a venue which we leveraged our 340B Oversight Committee venue for to discuss and ensure that we were providing assessments for each covered entity within our oversight so that they knew essentially how to react, what their marching orders were to ensure that we were compliant. With this update by hrsa That's a great example.
David Glendinning [00:15:40]:
Thanks. I'm sure there were many hospitals and health systems at the time that were figuring out how to proceed during that issue. What advice would you have for other 340B hospitals about their education efforts?
Pooja Shah [00:15:56]:
I would say it's certainly been a labor of love and one that has taken a lot of time and reflection to figure out what works for our organization as a whole and for each covered entity within our health system. I would certainly say it's important to explore existing resources related to education in the 340B space. There are definitely multiple resources out there, so leverage what you have have to not reinvent the wheel. I also encourage you to work with your stakeholders to have a discussion around what they envision could be beneficial for them to learn more about the program. I would also recommend understanding your existing governance structures and adapting them as you can to incorporate 340B needs. You may not need a separate dedicated 340B oversight meeting. You may be able to leverage an existing meeting or forum and add in 340v program updates and have the right stakeholders at the table. And then I would also recommend stay nimble, stay agile.
Pooja Shah [00:17:07]:
A lot is moving and shaking in the 340v space and so we've been thoughtful in really being able to assemble our key plan layers quickly, identifying them, pulling them together. If that means a 6:30am meeting or a 6:00am meeting, you do what you got to do at that point to ensure that everyone is well informed and prepared for any decisions that need to be made or make those decisions at that forum.
David Glendinning [00:17:36]:
Pooja, thank you for running through how you keep your team educated and informed and all on the same page and very much appreciate you bypassing the ice cream social to get here. We really do thank you for being here.
Pooja Shah [00:17:50]:
Well, thank you very much for inviting me and thankfully it looks like it's still open, so I'm probably going to grab some gelato.
David Glendinning [00:17:56]:
Awesome. Let's go do it.
David Glendinning [00:17:59]:
Our thanks again to Pooja Shah for educating us on how she helps educate her colleagues at UNC Health. Do you have expertise in 340B operations and compliance that you can share with your peers? The call for speakers is Open for the 340B Coalition Winter Conference taking place in San Diego February 9th to 11th, 2026. You can find out how to apply by visiting 340bwinterconference.org we will be back in a few weeks with our next episode. In the meantime, as always, thanks for listening and be well.
Narration [00:18:37]:
Thanks for listening to 340B Insight. Subscribe and rate us on Apple Podcasts, Google Play, Spotify, or wherever you listen to podcasts. For more information, visit our website at 340bpodcast.org. You can also follow us on Twitter @340BHealth and submit a question or idea to the show by emailing us at podcast@340B.org.