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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 (00:03)
Welcome to 340B Insight from 340B Health.
David Glendinning (00:12)
Hello from Washington DC 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 Bibi Wishart the director of pharmacy at Atrium Health based in North Carolina. Bibi was a panelist on one of several round tables that occurred during the 340B Coalition Winter Conference where she spoke on the topic of good faith 340B inquiries from drug companies.
We know many of our listeners have been on the business end of one or more of these types of inquiries, and we wanted to get a sense of what is involved for a 340B hospital when a drug maker comes calling. But first, let's do a quick recap of some of the latest news about 340B.
340B Health has submitted comments to the Health Resources and Services Administration strongly opposing the agency's consideration of a 340B rebate model and urging it to maintain the long-standing upfront discount structure that Safety Net hospitals have relied on for more than 30 years. In our comments, we emphasize that replacing upfront discounts would force hospitals to effectively provide interest-free loans to drug makers,
which would increase hospital costs and divert resources away from patient care. We also highlight how a rebate model would disrupt decades of established hospital operations built around the industry's reliance on the current system. And we note that rebates are not necessary to address program integrity or prevent duplicate discounts under the Inflation Reduction Act. And while the 340B health position is that HRSA should not move forward with a rebate model,
We also outline key safeguards the agency should adopt if it continues to pursue this approach. Please visit the show notes to read more about these rebate comments.
And now for our feature interview with Bibi Wishart with Atrium Health. As the director of pharmacy, Bibi has seen her share of drug company inquiries related to 340B purchasing, and she recently shared some of that experience with coalition conference attendees. We caught up with her just after that roundtable to find out some of what she spoke about to the attendees. Here's that conversation. I am here with Bibi Wishart, who is director of pharmacy at Atrium Health.
Bibi, thank you for joining us during the 340B Coalition Winter Conference and welcome to 340B Insight. Before we get started, please tell us a little bit about Atrium Health and the patients you serve there.
Bibi Wishart (02:56)
Thanks for having me.
Atrium Health is a hospital system that's based in Charlotte, North Carolina. We're focusing on shaping health outcomes through research, education, and compassionate patient care. as an organization, we're a leader in virtual care, mobile medicine, and we're taking care of patients near or in their home. So it's going to allow us to reach out not only to our needy urban areas, but also to the patients that are in the rural areas of the foothills of North Carolina, Georgia, and Alabama.
David Glendinning (03:27)
Wonderful. And we are catching you just a little bit after you attended the Rural Health Morning Roundtable. So thank you for doubling up and coming in here to chat with us about your topic. And that topic is drug company good faith inquiries. And I will just start right off the bat by saying that we know that these inquiries can sometimes cause a little bit of controversy. ⁓ you know, fortunately or maybe unfortunately for our listeners, not really going to be
getting into the controversy side of it and we're not providing any legal advice to our listeners, but we did want to hear from a health system about their experiences with these inquiries. So at a high level, how would you describe a drug company good faith inquiry?
Bibi Wishart (04:12)
Really, I like to think about it as them just using the tools that they have on a day-to-day basis. They're looking at their data and they might see just something that looks a little bit different. they're looking at trends, they're looking at changes, and really it's just an outreach. Hey, I see something that may be different than what I've been seeing in the past. Let me seek a little bit of clarification from you. So they'll reach out with the intent just to see ⁓ if they can get a quick answer or perhaps they need something more.
thorough of an evaluation to see if there's been changes in purchasing patterns or dispenses, things along those lines.
David Glendinning (04:46)
So this is something that typically happens before an official audit by a company or some kind of enforcement action by HRSA.
Bibi Wishart (04:55)
Yeah, that's correct. So preliminary, really searching for information, try to clarify something in the event that there might be something that needs to be looked at closer.
David Glendinning (05:04)
So why do you think we're hearing so much more lately about good faith inquiries coming from jerk companies? So why are the manufacturers sending more of these inquiries out now?
Bibi Wishart (05:14)
We're seeing some increased scrutiny. And I think these good faith inquiries have always been around. It's just that now the drug manufacturers have more data and from different data sources. So as they're receiving data, they're trying to just make sure it matches up with their other data sets ⁓ and that the integrity of the program is maintained.
David Glendinning (05:34)
And in your experiences, what are the things that set off one of these good faith inquiries? I guess a trigger for lack of a better term that could lead to an inquiry.
Bibi Wishart (05:43)
Yeah, absolutely. And these are the things that I was talking about before, where they're looking at some anomalies in their data. So they might be seeing things like different purchasing patterns or different volumes. And this can happen for a lot of reasons. Perhaps you get a new provider in the area that's looking at a specific drug. So you might see a sudden spike in 340B purchasing for that new provider. Additionally, there's always questions about contract pharmacy activity, where perhaps the Medicaid is handled differently. There might be a little bit less visible.
And then other things you might see are some drugs that are used in both inpatient and outpatient settings. Sometimes it's not clear to manufacturers exactly how something is being administered in the hospital. And so there can be just a little bit of confusion there. And so you might see spikes in a 340B where they didn't expect to see it there. But indeed, it is a fair and documented administration. And certainly, really, it's just a...
kind of a lack of understanding across the board of how a hospital functions. They're very, very complicated and the drug delivery process and documentation is very, very complicated. a lot of times it's providing education about how hospitals are moving product through giving them to their patients. And these may show up on data sets that appear different that cause the manufacturer to reach out to ask some more questions.
David Glendinning (07:00)
Okay, so certainly a lot of understandable and expected situations that could ⁓ prompt one of these inquiries to happen. So if we can expect hospitals might be receiving more of these these days because of all the reasons you mentioned, when a hospital receives one of those inquiries, what should they do? What's the right way to respond, at least in those first few days after they get that?
Bibi Wishart (07:23)
Normally you're going to get an email, you might even get a phone call nowadays from a manufacturer. Usually it's going to go to the AO or the PC. And when it does come, you know, I generally like to answer immediately within one to two business days. I won't have the answers they're looking for, certainly, because I'll need time to review the data. But I do want to let them know and confirm that I have received the inquiry and that we are going to be looking at it. And then I will be following up within a few days with any questions, clarifications, things along those lines.
I think what this does is it really sets the tone for the inquiry. I think it just shows the spirit of cooperation. You know, we're supposed to, as covered entities in good faith, work with the manufacturers, and I think this process is very, very important. And so by setting up that tone, letting them know that you're willing to work collaboratively, if there's an issue, let's identify it, let's deal with it, let's close it out and move on, maintaining the integrity that our data processes are intended to do.
David Glendinning (08:18)
Okay and you mentioned the gatekeeper for these inquiries are the AO and the PC so that's authorized official and primary contact right? That's correct. Alright I did my homework. Thank you. Thank you. Okay so ⁓ that's the right way to respond in those initial days. What are some of the mistakes that hospitals can make and that they should avoid when responding to a good faith inquiry?
Bibi Wishart (08:39)
I think initially sometimes folks respond a little bit defensively instead of collaboratively. thinking, you know, they begin to panic that the inquiry is automatically implying that they've done something wrong and that's just not always the case. And so I think it's really important to make sure that you're communicating with the manufacturer, giving them deadlines for when you will respond back. Once you receive the information, it may take a couple of days for you.
to even understand what they ask is from the manufacturer. It might just be a simple question. It might be claims that need to be reviewed, things along those lines. And so once you understand what the data is, then you can begin putting together your response. And this may take a couple of days. It could take a couple of weeks or more. So just constantly communicating with the manufacturer what you need to do to get the data to respond to their request.
David Glendinning (09:32)
Okay, so speaking of that data, what kinds of data is that? What kinds of information typically does a hospital need to pull together, compile, to be able to respond effectively to one of these inquiries?
Bibi Wishart (09:44)
I think it's the things that you would typically think, right? Your administrations, your accumulations, your purchasing history, maybe wholesale data, things along those lines. Depending on the type of inquiry, if it's a duplicate discount inquiry, then you're going to want to be looking at your carve in and carve out methodology. Where does that make sense? Is that contributing to some of their questions? Any sort of accumulation issues, billing issues, things along those lines that could contribute to changes or anomalies in the data that they're seeing.
And I really think that one of the most important things to understand is this data is just not coming directly from pharmacy. You might need other teams in the system. And what I mean by that is IT, compliance, legal, even your other 340B teams to coordinate the information to make sure that you're answering the questions that the manufacturers are looking for.
David Glendinning (10:34)
Yeah, and I like the mention you made earlier of the spirit of collaboration and cooperation, especially when there might be some legitimate questions coming from drug makers or areas in which they might be confused that you could help them with. So how do you help drug companies? How do you help connect the dots for them once you have all of this data together?
Bibi Wishart (10:54)
think it's really important to tell the story of what's happening in your health system. So, you know, they're only seeing little pieces of it. They're seeing purchases, perhaps, or they're seeing chargebacks, things along those lines. And so you really have to explain the processes that are happening in the very, very complicated healthcare system that we're working in. If you can tell the story of the drug delivery process, and then they could pair that up with the actual data that they're seeing on their end.
and that'll help fill in the dots for them to describe the drug delivery process that's going on in our hospitals every single day.
David Glendinning (11:27)
I like that. It's telling a story to the drug companies, not just giving them spreadsheets and lines of numbers. hopefully everybody's listened to your advice. They keep calm and carry on and they put together the right data. They get the right people on the team and that they tell that story, as you mentioned, to the drug companies. What if a hospital doesn't exactly follow that advice? So what are the risks if a hospital mishandles one of these good faith inquiries?
Bibi Wishart (11:55)
the big risk is they can escalate it to a more formal process. And so the point of these inquiries is to just to work in good faith, to identify issues early, to look at opportunities to create more integrity in your program. And so let's take the opportunities early before they turn into something larger. And if you're not working in good faith with these companies, I think certainly there's a potential for escalation. Certainly the result can be escalation into a more formal process.
and that can include an ADR situation.
David Glendinning (12:27)
Okay, so hopefully hospitals are not just waiting around for one of these inquiries to come in through the door. Hopefully they have a process in place to be able to anticipate one of them. So what are the best practices here? What processes can hospitals have in place before one of these inquiries ever arrives?
Bibi Wishart (12:44)
I think it's the general maintenance that we're doing on a day-to-day basis. Our internal audits, we're catching discrepancies early and we're actually resolving the errors. This happens on a day-to-day basis. It's so extremely complicated. There's data feeds coming from all different places, your TPAs, your vendors, your EMR. So while your daily audits are doing the catching of the discrepancies and things along those lines, some things just might get missed.
As you're maintaining, making sure that you're looking at the things that the drug companies are going to be looking for, especially with duplicate discounts. You know, are your billing modifiers correct? Are they being added? Any sort of data integrity alignment across the systems is really, really important. And certainly making sure that your P's and P's are very clearly defined on what happens. Not only if you get an inquiry, but if you find something in your regular daily processes, that you have that outline so you can deal with that beforehand.
Good faith inquiries, you don't have to wait for the drug company to reach out to you. And I just want to make sure that I stress that if you do find something and you have to solve an error, you can always reach out to the drug company proactively. And that again sets the tone and shows that you're working collaboratively to fix any issues that may exist in the very, very complicated processes that we deal with every day.
David Glendinning (14:02)
Well, BB, thank you for those best practices. Some marching orders perhaps for hospitals that have not thought through this process quite as thoroughly as you have. So I certainly learned a lot about good faith inquiries and hope some of our listeners did as well. So thank you again for sharing your expertise with the conference and with us.
Bibi Wishart (14:21)
Thanks for having me.
David Glendinning (14:24)
Our thanks again to Bibi Wishart for the primer on good faith inquiries and for sharing some of her advice for other covered entities that might receive one or more of these inquiries in the future. Registration is open for the 340B Coalition Summer Conference, occurring July 13th to 15th here in the nation's capital. So if you've not already booked your spot, please do so now so you can learn much more about operations and compliance topics like these. You can register at 340bsummerconference.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 (15:04)
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@340bhealth.org.