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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.
Speaker 1 (00:04):
Welcome to 340B Insight, from 340B Health.
David Glendinning (00:13):
Hello from Washington DC and welcome back to 340B Insight, the podcast about the 340B drug pricing program. I'm your host, David Glendinning with 340B Health. Our guest today is Anja Wilkinson, 340B program manager at St. Francis Health in Oklahoma. Anja spoke on a panel about 340B crosswalks at the most recent 340B Coalition Summer Conference. We wanted to learn more from her about that important operations and compliance topic, including some of the best practices for 340B hospitals looking to set up and maintain such crosswalks. But first, let's do a quick recap of some of the latest news about 340B.
(01:05):
Late last month, the Centers for Medicare and Medicaid Services released the names of the first 10 Medicare Part D drugs that will be subject to price caps starting in 2026 under the Inflation Reduction Act. Once the caps take effect, Medicare reimbursement for these drugs will be closer to the 340B ceiling prices, thereby reducing 340B savings. 340B Health is analyzing the projected financial impact of these reduced savings and will be providing resources for member hospitals to make their own projections. All 10 of these drugs currently are subject to contract pharmacy restrictions, which already have reduced overall 340B savings for these drugs. For more about the IRA and the effects it will have on 340B, be sure to check out our most recent episode. We spoke with a pharmacy director at a member hospital that projected its potential loss of 340B savings using an earlier set of drug data that included most of the drugs that made the initial top 10 list.
(02:11):
340B Health recently sent a comment letter to Capitol Hill about a draft drug shortage bill that would have negative effects on 340B if it were to become law. House Energy and Commerce Committee Chair, Cathy McMorris Rodgers, a Republican from Washington State, is the lead author of a discussion draft of the Stop Drug Shortages Act. Included in the draft bill is a provision that would eliminate 340B discounts on many generic sterile injectable drugs. The 340B Health comment letter cites data showing that 340B makes up only 7% of total US purchases for such generic sterile injectables.
(02:52):
Given this low volume, the letter urges the committee to remove 340B specific sections of the bill, stating that it is not credible to claim that 340B plays a major role in drug shortages. Read the full letter and statement by visiting the show notes.
(03:18):
Now, for our feature interview with Anja Wilkinson, data crosswalks are an essential element of running an effective, efficient, and compliant 340B program at a hospital or a health system. This is especially true for systems that have frequent changes in their departments and sites of care. I caught up with Anja just after her presentation on 340B crosswalks at the most recent 340B coalition conference. Here's that conversation.
David Glendinning (03:46):
I'm here at the 340B Coalition Summer Conference with Anja Wilkinson. Anja is the 340B program manager at St. Francis Health System based in Tulsa, Oklahoma. Anja, today we're going to be speaking about 340B crosswalks, which I know that you just came from a presentation on. Thank you very much for being here and welcome to 340B Insight.
Anja Wilkinson (04:10):
Thank you, I'm excited to be a part of this.
David Glendinning (04:13):
Tell us a little bit please about St. Francis Health System and the patients you serve there.
Anja Wilkinson (04:20):
I have two dish covered entities. The one in Tulsa is about a 1200 bed hospital, 14 child sites in 91 contract pharmacies, and then we have one in Muskogee, about 300 beds, seven child sites, and just five contract pharmacies. Our mission is to provide care, healing in Christ's name across green country in the northeast corner of Oklahoma.
David Glendinning (04:48):
As I mentioned before, we are going to be talking today about 340B crosswalks. For those who are not familiar with the term, me among them, what is a 340B crosswalk?
Anja Wilkinson (05:01):
The way I like to explain it to individuals is, think about a pedestrian crosswalk. You're actually going from point A to point B and there's this safe little road, you're taking data from different departments and all of that and trying to provide that 340B crosswalk.
David Glendinning (05:21):
Well, I'm a big fan of the explanatory metaphors, especially when it comes to complex healthcare terms and issues. In a 340B crosswalk, what kind of information are you mapping from place to place, from database to database?
Anja Wilkinson (05:38):
There's a few different ways or a few different crosswalks. You have your CDM to NDC crosswalk, or some covered entities has an NDC to NDC crosswalk, and that's tied directly to drug utilization, whether it be scanned on administration or charged on dispense. You have that, and then you also have your trial balance to your MCR or your Medicare Cost Report. This is normally always done once a year after our Medicare Cost Report is filed, but there's a lot of data points in that trial balance and that Medicare Cost Report, and again, it's mapping departments from the trial balance to the cost report to make sure that, one, if we need to register it, we know we need to register it, or two, if a department closed and we weren't told, then we need to unregister it.
(06:33):
And then of course you have your EMR that directly ties to your drug utilization and your department IDs. This is another crosswalk that I use to make sure that we are educated, informed on new departments or departments closing. I always keep a tie to my facilities' management because they're the ones that are going to be able to tell me, hey, we're moving this here, or hey, we're moving this over there, because you go outside the four walls of the hospital, you have an issue. Coming into the four walls is not as detrimental as something moving outside the four walls.
David Glendinning (07:14):
Okay. I know in all of the alphabet soup that we use, you had mentioned NDC, which I believe is national drug code. CDM, which I believe is charge description master-
Anja Wilkinson (07:25):
Absolutely.
David Glendinning (07:25):
And EMR, which is electronic medical record, right?
Anja Wilkinson (07:28):
Yes.
David Glendinning (07:29):
All right, great. We are all on the same page. That sounds to me like a lot of ones and zeros that are involved here, that need to be wrangled. What types of systems do hospitals use to handle all that data?
Anja Wilkinson (07:46):
Of course your first one is going to be your electronic medical record. Very important that you have someone internally that understands how that works. I am definitely not the expert on how our EMR works, and so having someone that can help me define what I need out of that EMR is a great resource. Again, I talked about the facilities management and their reporting, and then financial software. I have access to the software, but I do not know how to pull a Medicare Cost Report. That is not my expertise. I can read it and I just need to know who's doing it. Is it being done internally, or do I need to reach out to an external source to make sure that I get that cost report?
David Glendinning (08:39):
What is at stake here? Why is it so important for 340B hospitals to set up these crosswalks and to use these crosswalks correctly?
Anja Wilkinson (08:50):
Overall, is compliance. That is the name of everything, is compliance. But if we want to break it down, let's talk about the NDC crosswalk, or to the CDM, whichever one is used, you're not going to... The CE will not accumulate on their 340B, and if they're a dish hospital, on their inpatient GPO accumulator within their TPA, if that crosswalk is not linked together in their third party administrator, and so right there, that's number one, that's how they're going to actually be able to replenish and make sure that they are getting the most of their 340B discounts. Your Medicare Cost Report to trial balance, again, it's departments. Is this a new department? Did this department move? Is this department still on a reimbursable line of the Medicare Cost Report or did they move it off and put it on a non-reimbursable? To your question, overall compliance and optimization of the program, that's our focus. How do we stay compliant and how do we optimize the 340B drug discount savings.
David Glendinning (10:06):
Mapping this data correctly is also important on the compliance side for 340B auditing purposes, correct?
Anja Wilkinson (10:13):
Absolutely. That's one of the areas that HRSA will look at during a audit. They will ask for six months of utilization, purchasing, all of that information. They'll ask for your trial balance, MCR crosswalk. This is really focused on not just internally to the CE, but knowing that when you receive that HRSA letter, you're not having to start from scratch, you already have all of your information, you know you're compliant, you're looking at these things, whether it be a daily, monthly, quarterly, yearly basis, so you're not going to be thrown anything that you're not aware of, and that's important for a compliant program.
David Glendinning (11:00):
Okay, so hopefully hospitals are now sold on the idea of setting up these 340B crosswalks. Based on your experience at St. Francis, how should a hospital approach the process of setting up these crosswalks?
Anja Wilkinson (11:15):
Depending on which one, you have different players that will come into the game, so to speak. In your NDC crosswalk, you're going to include the buyers, the wholesaler, all of those different aspects of it. You're going to have to look at how your drug utilization file is pulled out of your EMR, so you know what's going to your third party administrator. That open line of communication with the buyers is highly effective. And then your Medicare Cost Report and your trial balance, every CE may call their department different. It may be financial reporting, financial services, revenue integrity. Reach out to a manager or a director and just ask, internally, do we have someone that does our Medicare Cost Report? Find out who that is. Every year they have to be filed by the same day, and reach out to them and say, can you send me the cost report and the trial balance?
(12:16):
And then of course have that direct line to facilities management. Normally, we're a large health system, so there's always construction, there's always renovation, and so I actually reach out to the project managers that are actually controlling specific aspects of where they're going or where we're moving. 340B is not just pharmacy. I mean, it is everyone in the organization. It's from the top down, so to speak. A lot of that is educating your nurses, explaining to them when they scan something upon administration, how that comes over in that crosswalk, in that drug utilization file and why that's important for overall savings of the 340B program.
David Glendinning (13:06):
It's clear from our conversation that there are a lot of numerous complexities involved here. What should hospitals do if they need help with the setup process from somewhere outside?
Anja Wilkinson (13:19):
The first place that I would recommend is Apexus, the Prime Vendor Program. Over the years... I've been in 340B for over a decade, and just to see the information and resources change on their website is just phenomenal for a new person in 340B, so that would be my first go-to. Reach out to Apexus, review their sites, look at all their documentations from, they have example policies and procedures. They have borrow loan policy that you can download, and then of course 340B Health has been, at least in my time in 340B, has been a great resource. What I say on the floor, and they're advocating for CEs day in and day out. They're in Washington DC and they're providing that feedback to their members. But then also look at your TPA and see what kind of services they offer.
(14:17):
Some TPAs offer audit services internally, and then some of them actually do it externally, so you definitely want that person or that group that you feel comfortable with for that subject matter expert. Those are really where my top three, but also, and I just cannot stress how important it is to network among 340B. I always say, let's not try to reinvent the wheel, let's talk and see how one CE is doing something and let's walk it through, save you time, save you resources, and ask them, how did this come up in an audit? What did you do? How did you respond? Networking is so important. Open up those resources and conversations, don't be afraid to start that conversation.
David Glendinning (15:09):
Well, we can hear that there are a lot of conversations going on here in the exhibit hall about networking, as we speak. Certainly these conferences give us a lot of opportunity to share best practices with each other. Any other parting crosswalk advice you have for health systems and hospitals?
Anja Wilkinson (15:27):
I definitely would recommend before going live with a new CE, look at your crosswalks, especially from the drug utilization side, purchasing. Make sure that you're going to be able to recognize as much 340B savings as possible at go live. Again, use your resources, look at Apexus, 340B Health, your network to see, and ask what have you seen and what were some of your downfalls with your implementation? Or what were some of your successes with your implementation? But I think honestly, it just goes to conversation. Let me learn from your experience and I'll let you learn from mine, and therefore you can move forward compliant and being able to recognize that 340B savings.
David Glendinning (16:18):
Well, Anja, I very much appreciate our conversation and for you being right here after your presentation to do it all over again on 340B crosswalks. Thank you for sharing all of this great information with our listeners, and we appreciate you being here.
Anja Wilkinson (16:33):
All right, thank you.
David Glendinning (16:35):
Our thanks again to Anja Wilkinson for walking us through the concept of 340B crosswalks and for underscoring how important it is for hospitals to set them up correctly. We also appreciate her willingness to share these best practices with other hospitals that are looking to ensure they receive all the 340B savings they're eligible for while remaining compliant with all 340B rules. Do you have knowledge on a 340B operations and compliance topic that you can share with the covered entity community? If so, please apply to be a speaker at the next 340B Coalition Winter conference, which will take place January 29th to 31st, 2024 in San Diego. You can find a link to the speaker application website by visiting the show notes. We will be back in a few weeks, as always, thanks for listening, and be well.
Speaker 1 (17:34):
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.