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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 for this episode is Danny Ackert with the Minnesota Hospital Association. Minnesota was one of three states to enact a 340B reporting law last year. As it is one of the first such laws of its kind, we wanted to speak with Danny to give our listeners some insight into how that statute is affecting covered entities in his state since it became law. But first, let's do a quick recap of some of the latest news about 340B.
(00:51):
A group of three Republican and three Democratic members of the US Senate recently issued a discussion draft of a bill aimed at making changes to the 340B statute. Last year, this group of six lawmakers had issued a request for information from stakeholders on possible changes to the law, and the discussion draft based on that feedback is a step toward the potential introduction of official legislation. The provisions in the draft have varying levels of detail, and the senators are requesting more feedback from 340B stakeholders by April 1st on a range of issues around contract pharmacy, patient definition, and child site eligibility. Listeners can visit the show notes to read the discussion draft, 340B Health's press release, welcoming the opportunity to review and weigh in on it, and a member-only resource with more details about the document.
(02:00):
Now for our feature interview with the Minnesota Hospital Association's Danny Ackert. Minnesota is part of a trio of states that have enacted new reporting requirements for 340B-covered entities. Danny was a presenter at the 340B Coalition Winter Conference in San Diego to give the perspective on the new mandates from 340B hospitals in the North Star State. I caught up with Danny in the conference exhibit hall before his presentation to learn more. Here's that conversation.
(02:31):
I am here with Danny Ackert, who is director of state government relations at the Minnesota Hospital Association. So, Danny, thank you very much for being here, and welcome to 340B Insight.
Danny Ackert (02:42):
You're welcome, David. I wouldn't want to be anywhere else.
David Glendinning (02:45):
Tell us a little bit if you could, to start with, about the Minnesota Hospital Association and the work you do for them.
Danny Ackert (02:53):
The Minnesota Hospital Association has 141 hospital members across the state, ranging from small critical access hospitals and what we, I think, is nationally known as frontier counties, all the way to the large flagship hospitals in the Twin Cities metro area and other metro areas around the state. So we have, all the way from the smallest critical access hospital to the largest hospitals that you see across the nation. Further, our members employ around 127,000 people in Minnesota. What most people think hospitals do is obviously emergency rooms and surgeries and taking care of your loved ones yourself, and it's when you need that level of care. They're also the largest group of employers in the state.
(03:40):
So in my role with the team on government relations at the state and federal level, we're problem solvers with regulatory issues, legislative issues, policy issues, rulemaking, etc. As I describe it to people who ask is, anywhere the sun touches on healthcare, is where hospitals are involved. So our journey through a lot of issues involves everything under the sun, including 340B of note for this conversation we're having today, but reimbursement, patient access right now, emergency room boarding of mental health patients, an incredible amount of pressures that our members are under.
David Glendinning (04:19):
Yes, as you say, the sun is touching on 340B issues among all of those that you mentioned. Today specifically, we are speaking about legislation on 340B reporting. So let's get down to the brass tacks. What do we mean when we talk about 340B reporting bills?
Danny Ackert (04:39):
Minnesota is one of the first three states in the nation to pass legislation requiring certain levels of reporting on 340B. As states have sought to make changes to Medicaid pharmacy benefits, in particular, 340B is intersected with that in a way where this federal program and state agencies collide, which then brings in questions, so the stateside, what is this federal program? What does it do? Who's involved? How much savings are generated through this? Where do those savings go, and why are these hospitals, FQHCs, other covered entities talking about it? Because it doesn't show up anywhere in our state budget. It's not a state program, and their interest in other changes has led, at least in Minnesota in particular, a lot of interest in 340B, asking for more information about this and going so far as now putting into law that we have to report starting this April.
David Glendinning (05:39):
I will mention, the other two states, in addition to Minnesota, are Maine and Washington State. So those three states, clearly a relatively new area of 340B law and are affecting those three states so far. So now that it is law, what does the Minnesota reporting law require?
Danny Ackert (06:03):
There's a short list of about 10 aggregated categories of information. The first four are just identification, which is interesting because on one of them it's the National Provider ID, or NPI, and an optional 340B ID. They did not include the 340B ID as a required element, but then aggregated by payer, the acquisition cost, the reimbursement, and also including everything around cost reimbursement with contract pharmacies. For hospitals in particular, there's also an item of reporting that is surrounded by the national drug code identification. So they're asking hospitals by payer to report the top 50 NDCs that they use for or through 340B. This language, that is now state law, was passed on the last day of the legislative session and had not been seen by any covered entity and any member of the public.
(07:07):
So we've been on a fast track since last June to start our reporting by April 1st. As a result, we've had very interesting conversations internally and with the state departments that are overseeing this new reporting, but they've also added an optional field to report, by payer, third-party administrator costs associated with administering the program. There's questions of why it was included, how it was included, and what that again means for our members, not just our members, but all covered entities in the state of Minnesota, on what these costs are going to be associated with and how the program does have costs. That is an important piece of 340B. You can't just do this program without committing staff, having TPAs involved.
David Glendinning (07:52):
So it sounds to me like April 1st is going to be a big red date on the calendar for all the covered entities in Minnesota, a lot of data that is going to be required by that date. One of the immediate questions that comes to mind for me is, "What would the state do with this information that it collects?"
Danny Ackert (08:11):
There's going to be a report that aggregates the aggregated reporting requirements that's due in November of this year, November of 2024. So individual submissions starting in April will not be made public. That's our understanding that they won't be identifying it by an individual covered entity in terms of this hospital or this FQHC. This is their report, but the aggregated report that's due in November will be made public to first the legislature and then, by extension, the people of Minnesota.
David Glendinning (08:46):
We are always interested in how legislation and laws are actually landing on the 340B community when they involve 340B issues. So at the end of the day, what does all this mean from your perspective for Minnesota-covered entities?
Danny Ackert (09:03):
This is an entirely new system of reporting that the 340B program has not been trained to. Essentially, it's a new reporting requirement that creates this very strange intersection of answering questions for the first time with data and across systems and across pharmacy and other benefits. We're figuring it out, and our members are working very hard to figure it out, but there's new systems, there's new costs, there's new questions, there's new uncertainties, there's things that our members are dealing with, we're helping them solve. I want to be clear, they're doing this because 340B is that important. They're not going to just shrug this off. Hospitals in Minnesota, 60% and growing, unfortunately, have a negative operating margin. So I look at that as saying, this is the perfect example, the perfect context for which Congress, I think, planned on 340B to be the critical vital resource that it has been since 1992. When stuff goes bad, 340B is exactly where it's supposed to be, as a great resource to extend federal resources as far as possible to keep delivering comprehensive services.
(10:16):
So that's my 340B fanboy moment right there. But it really does support so much for patients, and we obviously talked about that. Where we're having to do a lot of education is that all covered entities are already required to provide a lot of information to federal government, to state Medicaid agencies because you can't have dual discounts, and to contract pharmacies and to drug manufacturers. So it isn't like 340B is this, "Choose your own adventure." It is under lock and key, and as I've said to state legislators before, a lot of people take a jeweler's eye to this program and make sure that there's excellent compliance year in, year out because the stakes are so high and it's an important program. So this new requirement, it's an added thing on top of already pretty strict and sizable amount of requirements.
David Glendinning (11:12):
It does sound like that added amount of reporting is a significant amount of work being done by these covered entities, and certainly more to come before April. Is there anything those covered entities can do to try to minimize the lift, to minimize the burdens?
Danny Ackert (11:29):
I think we're married to it in Minnesota. This is happening April 1st. But reporting requirements aside, the 340B community in Minnesota has recognized that we're the incumbent party to bring the information to the decision-makers in Minnesota and say, "Here's this federal program that's been around since 1992. It's been extremely important, even if you didn't know about it. It's okay you didn't know about it because it's a federal program. We are here to tell you about why it matters. Again, reporting or not, this is something we're going to stand firmly in support of and make sure that these important benefits continue to flow to support the entire kaleidoscope of services and operations that have benefited the critical access hospital, the large hospital, the FQHC, and most importantly, their patients in the communities that they serve."
David Glendinning (12:25):
Danny, you spoke a little bit before about what potentially will happen to all the information collected. Are there concerns about how the state health commissioner or the lawmakers who received this report, how they would use that?
Danny Ackert (12:42):
It's important to note that in the journey started in 2021 when state legislators proposed legislation that would follow what New York and California did, which is setting up a prescription drug purchasing program and a pharmacy benefit transfer from managed care to fee for service, and that basically eliminates the ability to generate 340B savings on fee for service Medicaid. Where this information might end up or where we think it might end up is really codifying a dollar amount of what that barrier is to doing more centralized control of benefits. I think it's important to note, at least from the Minnesota perspective, that our health and human services community is very supportive of each other, and our message will remain that if you want to improve something, don't take 340B and shelve it. We need to keep 340B front and center and realize that, again, this very important federal program is something that should be dealt with with incredible concern for any negative impacts that may happen.
(13:48):
We're also heading into our next legislative session. 340B remains a topic of discussion, not only with state agency staff letting legislators know how this implementation of the reporting requirements is going, we're also aware that there's conversations about how the reporting requirements as written do not include some specificity on certain elements, like, for instance, taking the optional TPA cost requirement, making it mandatory, along those lines. So whether or not anything does change, our members are fully committed to this April 1st start date. We're just prepared for the continued need for advocacy and conversation on this program at the state level and at the federal level with our congressional delegation.
David Glendinning (14:34):
You are a government relations expert, and so advocacy is a big part of what you do. What would you say hospitals and other covered entities in this case can do to advocate on such reporting measures in their states, whether they're in Minnesota or another state considering this?
Danny Ackert (14:52):
Start talking about 340B right now. Again, I can stress over and over again that the intersection of a federal program and a state program has some complicating factors to it, where you're showing up with brand new information that legislators haven't seen before. While legislators are extremely busy with other things they're working on, it's really hard to get the needed attention on a federal program within a state landscape when it's talking about pharmacy benefits and discounts, acquisition costs and savings, contract pharmacies, and all this other stuff. There's really no way to talk about 340B without getting in these details. That can seem very complicated. So I'd say give yourself as much of a runway with key stakeholders that you have relationships with to make sure you're not trying to get them to bite off more than they can chew really fast. You don't want to be surprising anyone with 340B.
David Glendinning (15:49):
Danny, we appreciate this report from the frontier of 340B reporting as it were, and I know this perspective will be useful to others that are seeing reporting discussed in their states. So thank you for taking the time to walk through all of this with us.
Danny Ackert (16:05):
You're very welcome, David.
David Glendinning (16:08):
Our thanks again to Danny Ackert for his dispatch from the forefront of 340B reporting in Minnesota. We appreciate him and all the advocates throughout the country who are speaking with their elected officials about 340B and its importance to health systems and hospitals. We thank all of you who visited our podcast booth at the 340B Coalition Winter Conference in San Diego, including those who came by to get the scoop at our ice cream social. This is the first of several interviews we recorded at the conference and that we will be releasing in the coming weeks. We are excited to bring you these operations and compliance-focused episodes directly from the nation's largest gathering of the 340B community, and we will be back in a few weeks with that next episode. As always, thanks for listening, and be well.
Speaker 1 (17:03):
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.