340B Insight

Health information technology (IT) is intertwined with 340B operations and compliance. So how can hospitals and health systems manage IT while keeping 340B in mind? To find out, we hear from Robert Owens, director of pharmacy enterprise shared services at Atrium Health. Bob is a pharmacy health IT expert, and he shares how the technology intersects with 340B. He also shares insights to ensure strong 340B operations and compliance when undergoing an electronic health records (EHR) system conversion. Before the interview, we provide an update on two more drug companies restricting 340B discounts.  

IT's Intersection With 340B Operations
Bob discusses the different types of IT systems providing data that are important for closely monitoring your 340B program, including electronic health records, automated dispensing cabinets, and IV workflow software. He emphasizes the importance of the 340B team members becoming experts on 340B data. 

EHR Conversions
Bob explains how EHR system conversions affect 340B operations and compliance. He walks through the steps his team took before and during one of its conversions and points out the potential pitfalls to avoid.  

Strategies for Managing NDCs 
An EHR conversion means 340B professionals need to be aware of potential NDC challenges that go along with it. Bob shares some questions 340B professionals should ask about charging and administration practices when planning for a change in EHR systems. 


Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at podcast@340bhealth.org.

Resources 
  1. List of Drugmaker 340B Restrictions Grows in Wake of Court Decision 
  2. 340B Insight Episode 67: Maureen Testoni’s Outlook for 340B in 2023
  3. 340B Coalition 2023 Winter Conference 

Creators & Guests

Host
Myles Goldman
Writer
Cassidy Butler
Editor
Ismael Balderas Wong
Producer
Laura Krebs

What is 340B Insight?

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.

Speaker 1 (00:04):
Welcome to 340B Insight from 340B Health.

David Glendinning (00:12)):
Hello from Washington, D.C., and welcome back to 340B Insight, the podcast about the 340B Drug Pricing Program. I'm David Glendinning with 340B Health. Our guest today is Robert Owens, Director of Pharmacy Enterprise Shared Services at Atrium Health, which is headquartered in North Carolina. Bob is a pharmacy health information technology expert and we wanted to hear from him about how IT intersects with 340B, especially in the areas of operations and compliance. But before we go to that discussion, let's take a minute to cover some of the latest news about 340B.

(00:57):
Starting March 1st, at least 21 drug companies will be restricting access to 340B pricing on drugs dispensed at contract pharmacies. Earlier this month, the drug makers Bayer and EMD Serono announced their new restrictions. The Bayer policy will apply to all but a dozen of its 340B drugs, and it includes some of its top multiples sclerosis and cancer treatments. EMD Serono's policy will target two of its high cost specialty drugs designed to treat MS and infertility. Bayer will continue allowing unlimited contract pharmacy use for hospitals that submit claims data for those pharmacies, but EMD Serono will not offer such an exception. These two developments are the first restrictions that drug companies have announced since a federal appeals court in Philadelphia ruled largely in favor of three drug makers that have had similar contract pharmacy restrictions in place for more than two years. 340B Health President and CEO Maureen Testoni provides analysis of that court decision in our most recent episode, so be sure to download it and listen. 340B Health members can learn more about the court development and these two new announcements by visiting the show notes.

(02:20):
And now for our feature interview with Bob Owens at Atrium Health. We know that health information technology affects 340B operations and compliance, so we wanted to hear more about how one health system managed its IT while keeping 340B in mind, including through an electronic health record system conversion. Myles Goldman spoke with Bob to learn more. Here's that conversation.

Myles Goldman (02:45):
Thank you, David. I'm joined by Bob Owens. Bob, welcome to 340B Insight.

Robert Owens (02:50):
Thank you.

Myles Goldman (02:51):
This is the first time we've discussed IT's intersection with 340B, and I'm glad to have you with us to help us understand some important details about what IT systems mean for 340B operations and compliance. But before we get too far into that conversation and examine the issue further, can you provide us with a brief background about Atrium Health and the community and patients it serves?

Robert Owens (03:17):
I could do that, Myles. Thank you. Atrium Health is a vertically integrated nonprofit health system, which is now becoming part of Advocate Health. The headquarters are in Charlotte, North Carolina. Atrium Health's community benefit was greater than $1 billion in 2019 and growing. There is 12 340B covered entities in Atrium Health. Those covered entities and their child sites are spread across a lot of rural areas and communities and we also have some community impact in urban areas. And we provide the type of comprehensive care in rural markets that you can usually only get in a large city and a lot of that is made possible by the 340B [inaudible 00:03:59].

Myles Goldman (04:00):
Not all pharmacy professionals become involved with information technology. Can you share with us more about your career path and what led you to become interested in IT?

Robert Owens (04:11):
It seems like a meandering path throughout my career, but from an early age, I was more drawn to technology and programming, but when I decided to go to pharmacy school, I thought I would leave all of that behind. I really got interested in clinical pharmacy. I thought that's where I was going to go, and that was until I got to my first clinical staff pharmacist position. I kept getting selected for technical projects or more complex data analysis that others didn't really have the patience for or the time to complete. Everyone kind viewed me as one of the techiest of the pharmacists, so I got a lot of these projects and over time I proved I had a knack for data and analytics and automated processes with [inaudible 00:04:51]. And this is also when I got exposed to 340B the first time. I was the only person in the department at the time deemed techie or nerdy enough to collect and collate our 340B accumulations.

(05:04):
And just to give you a timeframe here, this was prior to the GPO prohibition enforcement. This was also before most third party administrators actually came onto the scene. Later on in that role I also ended up leading electronic health record transition, or EHR transition, building a clinical dosing database application. My next role was a 340B centric role at a health system, and in that role I really got to put my skills into practice and honed my craft. But I discovered that auditing and monitoring hundreds of thousands of transactions and encounters and dispenses and even purchases throughout an entire health system required a lot of automation and technical approach to do it well.

(05:46):
I really got into big data at this point in time and I started learning new approaches that I hadn't even tried in the past. My winding path to where I am today was basically because I love solving problems and I ended up following those problems into different roles and I kept pulling technology out of my toolbox as my go-to tool.

Myles Goldman (06:08):
It's really interesting to hear how you've integrated technology into your career and into making you a better pharmacist and supporting the patient care mission. I want to take a broad view to start with of this intersection of information technology and 340B. What are some of the information technology systems that intersect with 340B operations?

Robert Owens (06:34):
You get information from your electronic health records, from dispensing systems. You get it from billing systems. Pharmacy dispensing systems even contribute to that data pool. For most people, their third party administrator or TPA will correlate a lot of this stuff for them, but if you want to get real granular in your monitoring of the 340B program, you have to find a way to incorporate all those disparate data sources and be able to make sure that you're following the rules and regulations and maintaining audible records.

Myles Goldman (07:06):
Besides electronic health records, are there other examples of those disparate data sources that need to be integrated together?

Robert Owens (07:15):
Yes. The automated dispensing cabinets and IB workflow software also could contribute to the data that a 340B covered entity needs to consider. The retail dispensing systems from either contract pharmacies, whether they're internal or external, are another big data source for 340B operations. It really depends on where you find the most accurate information for your 340B program. The TPAs do so many things for Kubernetes that we often take for granted, and those things help keep us compliant, but the 340B program oversight must have some element of understanding your own data and the data that touches your programmer.

Myles Goldman (07:54):
How does your team become well versed in these different systems?

Robert Owens (07:59):
That's a good question. It first started as a way for us to increase our ability to audit more transactions. What we discovered over time is small inconsistencies in the data and we wanted to figure out why they were there, why did they not look exactly what we expected? We didn't really understand the workflow entirely in the EHR or to the IB workflow software systems and how it contributed to our data, so we took a deep dive into that. We found some individual transactions that we thought were characteristic of a new data anomaly, and we would go to our IT department and find some experts to help walk us through the functionality of the system. It really helped us connect the dots from a physician placing an order or a prescription coming into a pharmacy and then the ultimate replenishment purchase on the back end.

(08:48):
What we ended up realizing was we needed to be the experts on the 340B data, and that's exactly what we set out to do and that's what we did. The 340B team at Atrium is now the source of truth for 340B locations from the EHR, 340B provider information, and they're also experts at how pharmacy billing can affect accumulations, TPAs.

Myles Goldman (09:11):
Let's dive deeper into electronic medical record system conversions, so EMR conversions, and how this affects 340B operations and compliance. Tell me about Atrium's EMR conversion process. What was the health system aiming to accomplish from the conversion? Were there specific goals related to 340B for the conversion?

Robert Owens (09:35):
Atrium was converting from one EHR to another EHR so they could have a consistent EHR and billing system across the entire enterprise. There were no specific 340B related goals. It was more of an expectation that nothing would change. We had already undertaken a massive project to overhaul our 340B reports in our previous system. I'm sure that caused some PTSD from the folks in our IT department. The 340B program had gained a notoriety or maybe even infamy and nobody really wanted to mess with those data feeds anymore. In all seriousness, the 340B benefit had become so important to how we care for patients that nobody from the C-suite on down wanted an interruption, and we had gained a reputation for finding serious issues and solving them and where we needed support for the 340B program or for our reports, they usually came to the table to help us.

Myles Goldman (10:32):
When did you and your team start to consider 340B implications in this conversion process and what are some of the implications to be thinking about?

Robert Owens (10:43):
We started considering these immediately. Even prior to the announcement, I'd gotten wind of a potential change, because we had converted our billing system, and I just thought we would continue to do that and convert into our clinical system as well. I used the networking and health system round table sessions at summer coalitions to gather some intel and tips and tricks prior to what I thought was going to be an inevitable conversion. Once our announcement was made, I started emailing all the contacts I had made, I had the coalition, and I started talking with folks in our IT department to make sure that the 340B concerns were on their radar. I've been a part of about four EHR conversions in the past. The 340B reports and their extracts out of the EHRs always needed to be worked on because the different EHRs would handle transactions and billing in a slightly different manner.

(11:36):
Workflows are different, the end user did things differently, and sometimes the data model was so different that parts of the extracts had to be rewritten completely. Other problems that we had seen in the past were query performance and scaling that and automating it. When the query pulls from so many different places within the system and you're doing it on such a large footprint, it can get to be where it won't even finish or complete. Sometimes we have to work with our IT members to make sure that, that gets to be as efficient as possible, because we have to automate these and operationalize it and count on it happening and transferring the data.

Myles Goldman (12:16):
Well, I'm glad to hear the 340B Coalition Conferences, attending those was helpful in your preparing process.

Robert Owens (12:23):
It was. I hijacked some round table discussions to gather as much intel as I could.

Myles Goldman (12:31):
Well, it's good. That's certainly what these conferences are for. Information sharing is a huge piece of that. And so now you've been preparing for the integration. Now we're at the point of integration. What was the process of integrating 340B data feeds into the EMR system and did challenges arise?

Robert Owens (12:53):
Challenges seem to always arise when you do a conversion, no matter how plug and play it seems. The difference in workflows were the main source of our challenges. It's a massive undertaking just to start a discovery and alignment process between operational and clinical units to match the features of the new system. Most corporate IT departments will want to just go ahead and make it work as closely to the processes that are already in place. That way the implementation timelines are not drawn out for too long. 340B is no different. We had no experience with the new system. We took the canned reports that our EHR vendor gave us and just added a few fields for validating and troubleshooting purposes.

(13:39):
But when we looked at quantity and exact NDC administered, we thought that would be the exact NDC administered at the bedside. We thought that the quantity would come from the order that's in our EHR system. We had to learn a few caveats about the workflow because we were not getting exactly what we thought we were and we had to correct a lot of that after the fact, after the go live.

Myles Goldman (14:03):
And I'm imagining maybe that's where testing comes in. Tell us more about the role of testing in the EMR conversion process.

Robert Owens (14:12):
The testing is huge. The testing prior to the conversion starts usually about six months out of an initial go live, and that's just a rule of thumb we've had for years. We actually had to wait until testing started to get enough data in our 340B extracts to even let our TPA validate them. And we validated those against that testing, that integrated testing scripts that were used by our IT department. And then once we went live with the EHR, we continued to monitor and test and anything that looked different than what we had seen in the sample files, the sample 340B extracts, we would look into. And what we saw was the live data as real users were using the system did not look exactly like the test data.

Myles Goldman (15:00):
I want to also talk more about NDCs. Are there NDC related issues that 340B professionals need to be on the lookout for during a conversion?

Robert Owens (15:11):
Yes, there is. We thought that we would be capturing the NDC at the bedside, and for the most part, we do. And what NDC you get passed as your reports should be representative of what you're giving to the patient. And there are other situations that 340B professionals need to keep in mind when it comes to charging and administration. If you don't have a bedside scan, how are you going to get the NDC that was given to the patient? There are other situations where bulk charging or even IB workflow processes could lead to variation in the NDC that gets sent to the 340B extracts. In some EHRs, if you don't have the NDC that was scanned because you don't have a scan, it's going to pull a representative NDC and it becomes really important that the 340B team knows how that representative NDC is selected. More importantly, what do you do with it once you send that in your extract to your TPA? You got to find strategies around dealing with that and how you can make sure your accumulations are reflective of what you're using in your practice.

Myles Goldman (16:19):
You've walked us through this whole process of how this worked and so now, as you look back on it, what are the 340B lessons learned from the whole conversion process?

Robert Owens (16:31):
Yeah, I've got several lessons learned. First one is, don't try to fit a round peg in a square hole. Don't assume that everything you were doing before is going to work exactly the same in your new EHR. Also, start your own discovery process early. Even if your system doesn't undertake a sufficient discovery process, you need to learn how those workflows are going to end up affecting the data that you send your TPA. It's very helpful to find others around the country, especially at conferences, that have gone through the same conversion that you're about to go undertake, so reach out. Do lots of transaction testing in the integrated testing phase. Make sure you see a variety of edge cases, a variety of things that are somewhat rare so that you can see if the data is going to be okay when it gets into your TPA.

(17:21):
This leads me to my last lesson learned. You've got to be intellectually curious. Most of the data issues that we've discovered that were really bad started out as a quirk or somewhat insidious and it stayed underneath the surface. You've got to be able to dive into that to figure out if you have a big problem and you need to understand it and catch it before it's a major issue.

Myles Goldman (17:43):
I appreciate you sharing these tips for 340B professionals. We know professionals working in 340B are going to continue to need to work with technology successfully to operate effective and compliant programs, so thank you, Bob, for joining us.

Robert Owens (17:59):
Thank you, boss. Thanks for having me.

Myles Goldman (18:01):
Our thanks again to Bob Owens for describing his journey at the intersection of 340B and health IT at Atrium Health, including all the lessons learned during the system's EHR conversion. We appreciate hearing from Bob that the 340B Coalition Conference Round Tables have been such a benefit to him and other health professionals who deal with the intersection of 340B and health IT. If you are interested in learning more about these and other operations and compliance issues, we encourage you to attend the upcoming 340B Coalition Winter Conference, which will be March 27th through March 29th in San Diego. The deadline to pre-register is March 17th, so please sign up today. And please let us know what you think of the show and any 340B topics you would like to hear us cover. You can email us at podcast@340Bhealth.org. We will be back in a few weeks with our next episode. In the meantime, as always, thanks for listening and be well.

Speaker 1 (19:04):
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 at 340B Health, and submit a question or idea to the show by emailing us at podcast@340Bhealth.org.
340B-Owens-ReleaseCutMastered
Page of