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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 Dave Lacknauth, Executive Director of Pharmacy Services at Broward Health, based in Fort Lauderdale, Florida. Dave was one of the presenters at this year's 340B Coalition Winter Conference, and he spoke about the need for hospitals to maintain their audit readiness. We sat down with him to learn a bit more about what hospitals should know about that crucial compliance topic. But before we get to that interview, let's do a quick recap of some of the Latest news about 340B. The list of states that ban drug company restrictions on access to 340B drugs through contract pharmacies continues to grow.
David Glendinning [00:01:11]:
Utah, South Dakota, and North Dakota recently became the 9th, 10th, and 11th states to put such contract pharmacy protections on the books, and legislation that would do the same is still pending in more than 20 other states. The pharmaceutical industry has gone to federal courts to challenge all the laws that were enacted in previous years, and 340B Health expects litigation over the newer state laws as well. Recently, Idaho became the fourth state to enact legislation requiring annual 340B reports from covered entities in the state. That law will require covered entities to submit significant data to the state that include acquisition costs for 340B drugs, payments received for those drugs, payments made to contract pharmacies, and information on the use of 340B savings, including on charity care. 340B Health remains concerned that such state reporting laws provide inaccurate information about 340B savings amounts, impose burdensome requirements on hospitals, and raise the prospects of decreased Medicaid payments for 340B drugs. And now for our feature interview with Dave Lacknauth with Broward Health. Part of Dave's responsibilities include ensuring his health system is compliant with all 340B rules and ready to demonstrate that compliance through the HRSA audit process. We wanted to learn more about how Broward maintains that state of audit readiness and what other hospitals could learn from their example.
David Glendinning [00:02:48]:
Here's that conversation.
David Glendinning [00:02:50]:
I am here with Dave Lacknauth, who is Executive Director of Pharmacy Services at Broward Health. Dave, thank you for being here and welcome to 340B Insight.
Dave Lacknauth [00:03:00]:
Thanks for the invite. Pleasure to be here.
David Glendinning [00:03:02]:
We'll be speaking today about audit preparedness, so we've had guests on the podcast before talking about individual elements of that, such as internal audits or what to expect from a HRSA audit. But we're going to take a more general approach to this, maybe more of a overarching philosophical approach to that from an audit preparedness standpoint. But before we get into that, if you could please tell us a little bit about Broward Health and the patients you serve there.
Dave Lacknauth [00:03:30]:
Yeah. So Broward Health, we're a safety net healthcare system. We are composed of five hospitals that take care of the catastrophic care and we have 14 community clinics. Our main focus is two to ensure we take care of the under or uninsured patients in Broward County. And our mission and vision is to make sure those folks have world class healthcare.
David Glendinning [00:03:52]:
Can you give us an example of how your health system has extended needed care to the uninsured, the underinsured, populations that you serve?
Dave Lacknauth [00:04:02]:
Yeah, absolutely. And you think of South Florida as a very populated area, but believe it or not, in South Florida we have what are called healthcare deserts. There are counties and sit in areas where there isn't a lot of community care. And our health system just recently opened mother baby clinics in areas that don't have that support for moms in the area. And if you think about from a population health standpoint, maternity deaths in this country are in the double digits. Right? And we have one of the most sophisticated health systems in the world. So Broward Health invested in the community by putting the mother baby clinic in the area to take care of these moms and babies for decreasing mortality. Well, in this patient population, the underserved, the uninsured, guess what? Moms have a hard time getting to appointments.
Dave Lacknauth [00:04:53]:
Moms have other kids they have to take care of. Well, not only did Broward open the clinic, but they actually have a babysitting service in the clinic. So mom can bring babies and babies can be three taken care of in the babysitting service. And then mom can spend concentrated time with the physician on prenatal care, the care that she needs to. She can actually listen to what she needs to do to be safe through her pregnancy and carry that baby through. And again, those are the types of things that will make an impact on decreasing morbidity and mortality because we're looking at what the needs are of the actual patient. And I give that example because that is truly an area that needs help and needs support. And then what are the barriers, and not just the barriers of what we typically see, but what is the barrier of mom? And by asking that question and supporting that, I think that shows an example of investment in community and access to care.
David Glendinning [00:05:44]:
Wonderful. Thank you for sharing that example. What's your team's general approach when we're speaking about 340B compliance and HRSA audits and all of that? What's that philosophy that you take to those issues?
Dave Lacknauth [00:05:56]:
Continuous readiness is our philosophy. We ensure that we follow rules, regulations regarding 340B, and we go through the process to, as I would say, measure three times, cut once. So we want to make sure that we are meeting the intent of the program and that we are compliant with program requirements.
David Glendinning [00:06:16]:
Measure three times, cut once. I like that approach. And what would be the downsides if you were not to do that? You know, why is it important to have that level of a, you know, I would say clean, conservative program?
Dave Lacknauth [00:06:30]:
It's, it's a, it's a federal governed program. And, and it's really important to us to make sure we maintain integrity of the program. And for us, the program really gives us the avenues to ensure our patients can receive care. As a healthcare system, our job is access. Our job is to make sure patients in our community have access to medications. When you look at that outcome, really a big part of that is the ability to be enrolled in a 340B program where we can spread scarce resources to the community members that need them. So when I look at the outcome of taking care of the patients in our community, the 340B program plays a big impact in our ability to do so and our ability to improve healthcare outcomes in that community we serve.
David Glendinning [00:07:18]:
Okay, so all about the patients at the end of the day and how that patient mission fits into 340B. And of course, the compliance issue, that is, that is overarching all of that. So hopefully you've sold everybody now on the need to, to be compliant and to adopt that approach. Let's get into some more Broward specifics. How does Broward maintain that state of constant readiness, as you mentioned on 340B?
Dave Lacknauth [00:07:45]:
So there's requirements with all of our transactions, interactions, and qualifications of a 340B prescription so we understand what those rules are. What we do is we audit our systems to ensure they meet the intent of the rule. We do internal audits. We actually audit the audit that we did, that's my measure, three times. And then we internally, in addition to that, we layer on an external consultant to come in with outside eyes on the audit. So we look at what we're doing internally, we look externally, and then we identify areas of opportunity. There's always areas of opportunity. And then we Laser focus on those areas of opportunity to see what are we going to do to systematically improve those areas, to add a high level of reliability with the program and program expectations.
Dave Lacknauth [00:08:35]:
I think it's that full cycle of see it, say it, do it, measure it. Right? We do that, we see it, say it, we do it, we measure it, and then it comes right back around again to make sure that our program is doing what we think it should be doing.
David Glendinning [00:08:49]:
So that sounds to me like a significant amount of moving parts that you would need to coordinate. What steps do you take to ensure all the team members who are working on this compliance are doing the tasks that they need to?
Dave Lacknauth [00:09:04]:
So our team has a very structured process with orientation of any team member to the program. We teach them, we allow them to do it, but then we check to ensure they're doing it at a high level of reliability as well. So we teach them how to audit, then we audit their audit. When they reach a certain percentage of reliability in the process, then we let them go to then work on a independently doing the activity. So our process of orientation is very detail oriented. Our process of quality assurance in the back end, we inspect what we expect. Right? Inspect what we expect. And then once we feel that we have a high level of reliability, then we can start to let that person do it independently.
Dave Lacknauth [00:09:49]:
That process is, I think, a reflection of our staff who are very detail oriented. We have very good people on our 340B team, and those members are very particular in the specificity of each of those elements.
David Glendinning [00:10:03]:
And you mentioned both the internal and the external audits. You know, we've spoken with folks in the past from 340B hospitals about both of those individual elements. But I'm curious, for the Broward example, what are some of the areas within the 340B program where you are conducting the internal audits?
Dave Lacknauth [00:10:21]:
So in the 340B world, they call it universes, and in the universes, it's mixed use. So we absolutely look at a mixed use universe. We look in the retail pharmacy universe, we look at contract pharmacy universe, those are the big major players. And then we look at vulnerabilities in system to make sure that we're focused in on that. If we know an area might be specifically a vulnerable area because a new system was put in, or where we're installing a new program, we. We spend even more time there because we want to ensure we understand what's happening around or the ripple effect that may occur with a new system or new program within that universe. But we Follow the guidelines of what HRSA puts out there as far as universes that they audit. And then we focus in on each of those universes.
Dave Lacknauth [00:11:07]:
For the elements that HRSA would expect us to meet, great.
David Glendinning [00:11:11]:
And for the areas where you do bring in that outside help, what about the audits you are doing with those external.
Dave Lacknauth [00:11:18]:
So the external consultants come in and they perform a mock audit just like HRSA would. So they will come in, look at each of these universes just like HRSA would. The external audit actually puts more emphasis on areas of vulnerability too, because we don't. We want to know if there's an area of vulnerability. We want to spend a lot of time there. So we actually ask our external consultants and they actually make the suggestion too that, hey, let's spend time in these areas that we understand are most vulnerable because we want to make sure we weed everything out. And if we want complete transparency on these fixes to make sure that what we thought we fixed is actually fixed.
David Glendinning [00:11:58]:
So hopefully other hospitals listening to this are maintaining that same level of constant readiness. And HRSA never comes knocking. But I don't think hope isn't a good enough strategy for that. So we when HRSA does come calling, when they conduct an audit, what should hospitals do in advance and during that audit?
Dave Lacknauth [00:12:19]:
340B is a lot bigger than just the pharmacy team. And I think what you have to identify in your entire health care system is all of those external elements that make up the comprehensive team. And what do I mean by that? The folks who file your Medicare cost report, they need to be in the room. Credentialing of physicians. That's a medical credentialing group. They need to be in the room and available. The compliance folks at corporate are involved, legal is involved. We have all of these folks on standby and ad hoc.
Dave Lacknauth [00:12:53]:
But should the HRSA auditor have any specific questions? I go right to the source of who has the information at the time of the audit? One, I have the expert in the room who can give the best answer. Two, it answers HRSA auditors needs on the spot, on time. To me that shows neat, clean, organized and transparent. And it lets us move forward with the next part or element of an audit.
David Glendinning [00:13:21]:
And I understand this is not just a theoretical exercise for you. I understand Broward Health navigated such an audit recently. And so how did that turn out?
Dave Lacknauth [00:13:30]:
So we had an audit recently in one of our hospitals. We had zero recommendations for improvement and zero findings in that audit. And I think that has a lot to do with the entire team that was the again, as we described earlier, bringing in all of our experts into the room as the inspector was going through asking questions, we were very transparent in navigating through the medical record to show them exactly where the information was to answer his questions on the spot, what he needed to hear. So the audit went well, good outcome. And I think that's a result of all of this collaboration of bringing these experts in and being fully transparent with our process and our systems.
David Glendinning [00:14:12]:
Well, congratulations on seeing, I guess, the fruits of all of that labor that went into the preparedness. You've already spoken, Dave, several given several practical considerations I think, for hospitals to to take into account here. Any closing thoughts? What advice would you have for other hospitals looking to have the same audit readiness success that Broward Health has had?
Dave Lacknauth [00:14:35]:
The number one thing I think for all healthcare systems is transparency from the top of the organization all the way down to the auditors who are doing the transactional audits. So if there's any vulnerabilities or opportunities for improvement in your program, you might need to invest in new software, you might need to invest in more people, you might need to invest in resources to be compliant. I think it's really important that the top of the organization understands the value of the program and what's needed to support the program. I think if you can put all of that in alignment, the top of the organization, we have an executive oversight team with all the key C suite members, the listening to program needs, program results and program outcomes. And it really all the information filters up from the actual audits that we're doing all the way up to the top of what is the things that they need to see to help support the program. I think if you have a 340B program, you have to be committed to alignment and that alignment has to be with fluid communication throughout your organization.
David Glendinning [00:15:40]:
All right, so hopefully the hospitals are thinking about that alignment, they're thinking about those resource conversations they need to have with leadership and they're ready to get to that state of constant readiness.
Dave Lacknauth [00:15:51]:
Absolutely.
David Glendinning [00:15:52]:
Dave, thank you so much for your time. I've learned a lot and really enjoy speaking with you about this.
Dave Lacknauth [00:15:58]:
Thank you. Thank you for having me again. Appreciate it.
David Glendinning [00:16:01]:
Our thanks again to Dave Lacknauth for walking us through this important 340B compliance topic. How does your hospital or health system ensure that you are ready for the HRSA auditors to come knocking on your doors? Please contact us at podcast@340bhealth.org to let us know and perhaps we could feature your example on a future episode, and our next future episode will be in a few weeks, so we look forward to having you join us again then. In the meantime, as always, thanks for listening and be well.
Narration [00:16:35]:
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.