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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.
Monica Forero [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 Monica Forero with 340B Health filling in today for our host, David Glendinning. Our guest today is Michelle Schmitt, the Vice President of Pharmacy Financial Operations at SSM Health, based in St. Louis, Missouri. Michelle spoke at this year's 340B Coalition Summer Conference about how 340B helped her health system innovate care for patients experiencing behavioral health needs and substance use disorder. Following a community health assessment in 2018, SSM Health launched its first outpatient Long Acting injectable clinic. David sat down with Michelle during the conference to learn more about this essential service that SSM Health can offer because of 340B.
Monica Forero [00:01:07]:
But before we get to that interview, let's do a quick recap of some of the latest news about 340B. Last week, lawmakers introduced bills in the US House of Representatives and the US Senate to stop drugmakers from imposing 340B contract pharmacy restrictions or conditions on covered entities. Congresswoman Doris Matsui and Senator Peter Welch introduced the 340B pharmaceutical access to Invest in Essential Needed Treatments and Support act, or 340B Patients Act. The bill would require drug makers to provide 340B discounted drugs to covered entities that use contract pharmacies to dispense these drugs to their patients. It would also ban companies from placing conditions on such access, including contract pharmacy claim submission mandates. Drug makers that do not comply with the requirements would face civil monetary penalties. 340B Health members met with members of Congress and their staff last week and called on lawmakers to support the 340B Patients Act. Urge congressional leaders to bring up the bill for consideration.
Monica Forero [00:02:23]:
Be sure to check the show notes for more information on this legislation. And now for our feature interview with Michelle Schmitt with SSM Health. Behavioral health services are commonly subsidized with health Systems relying on 340B to help make up the difference. David spoke with Michelle about how her health System has used 340B to assess, treat and support patients experiencing substance use disorder within inner St. Louis. Here's that conversation.
David Glendinning [00:03:01]:
I am here with Michelle Schmitt, who is Vice President of Pharmacy Financial Operations at SSM Health. Michelle, you're here at the 340B Coalition Summer Conference. You've already given your panel presentation on a Long Acting Injectable Clinic initiative that you have at SSM Health and that's what we're here to talk about today. So welcome to 340B Insight.
Michelle Schmitt [00:03:23]:
Thank you for having me.
David Glendinning [00:03:24]:
Before we speak about the clinics, could you please tell us a little bit about SSM Health and the patients you serve there.
Michelle Schmitt [00:03:31]:
SSM Health is a Catholic, not for profit health system. We're located in four states in the Midwest, so Illinois, Wisconsin, Missouri and Oklahoma. 23 hospitals in total across the system. A large clinic presence or ambulatory presence as well. From a 340B perspective, we have 12 registered hospital covered entities. In addition to that, three of our hospitals are registered as actually as child sites of those parent entities. And then we have two hemophilia treatment centers as well. So kind of a pretty broad spectrum of 340B eligibility across SSM Health.
David Glendinning [00:04:09]:
Wonderful. And part of the 340B savings that you generate at those sites goes into funding this long acting injectable clinic. So we could back up and talk a little bit more about how did SSM Health bring about these clinics in the first place?
Michelle Schmitt [00:04:24]:
We have these clinics in our St. Louis region, which is very inner city. One of our hospitals, DePaul Hospital in the St. Louis area, has had a really large inpatient behavioral health presence for a very long time. Their 2018 community health needs assessment that our community health team completed showed behavioral health insurance substance use as a health priority, a primary health priority. At that time, they were trying to get a little bit more into the outpatient behavioral health space to start to address that and be more proactive rather than reactive and try to prevent those hospitalizations. So in 2018, they opened the first LAI clinic at DePaul that was largely successful in the first couple of years in showing growth in patients treated, but also in reducing hospitalizations and when there were hospitalization, reducing the number of behavioral health days, so reducing the length of stay that they had. And so with that demonstrated success, they were able to expand that clinic in 2020 and service more patients at the same time.
Michelle Schmitt [00:05:24]:
In about 2021, a couple of our other covered entities or hospitals also completed their community health needs assessment and showed a continued need to address behavioral health and substance use through throughout the St. Louis area. So in, I believe August of 2021, we opened a second LAI clinic at St. Joseph Hospital in Wentzville, which is a local community in that St. Louis area. And then going into 2024, we completed yet another one and opened a third LAI location associated with St. Louis University Hospital, which is right in that inner city area. Really high needs.
Michelle Schmitt [00:06:01]:
And so we have the three that are open at this point point and really extending our reach to try to capture and address some of those behavioral health needs.
David Glendinning [00:06:08]:
So the behavioral health and the substance use disorder, we've certainly heard other member hospitals and health systems talk about those needs. I confess I was not familiar with LAI clinics before I looked into your presentation. So what types of treatments do these clinics provide patients with those needs?
Michelle Schmitt [00:06:26]:
We are providing both antipsychotic injections and then antagonist injections to, to address those that have substance abuse disorder. Typically the right patient for this is somebody who is not adequately controlled on their daily oral therapies that are available or that just doesn't work for their lifestyle for whatever reason. And so they need a little bit more long term treatment. And so we were able to offer those injectables at that point and get them a little bit farther between treatments, but also better controlled for those who don't know. So the anti guys psychotic injections treat those with like schizophrenia, bipolar use disorder, severe depression, things like that. The antagonists are for substance use, so people with alcohol dependence, opioid use disorder, those types of things. The antagonists essentially block the effects of those substances. And so it makes it so that they do not get that gratification or that high from those substances and they're able to kind of stop utilizing those substances.
David Glendinning [00:07:24]:
Excellent. And how does 340B come into this? How does the 340B funding element of these clinics come into play?
Michelle Schmitt [00:07:32]:
Yeah, it's so important. So in general, behavioral health is a subsidized health service, which means it's offered generally at a loss to the institution and would not otherwise be available if it went away. It's not financially viable or a margin generator for any health system. And so 340b and really optimizing that is extremely important. Important. And so we work together. All of our LAI clinics are reimbursable on our MCR of those, excuse me, Medicare cost reports of those covered entities. Which means that every patient that comes in is established as a patient of the covered entity.
Michelle Schmitt [00:08:05]:
Meaning that they are meeting our, amongst other things, our patient definition to be 340B eligible. We did have some learning opportunities. So each of our locations has a community pharmacy that's owned by the covered entity on site. Initially, when we set these up, they actually were registered as contract pharmacies and not owned pharmacies. And so in the 340B world, that has a few implications. So Medicaid is carved out. Behavioral health tends to be a pretty high population of Medicaid. Underinsured, uninsured.
Michelle Schmitt [00:08:35]:
And so that carve out meant maybe some of those most vulnerable patients weren't actually giving getting any 340B drug. And so we had that learning opportunity that the Medicaid was not necessarily included at the same time, you know, 20, 20, 2021, we had those manufacturer restrictions coming up. And so our covered our owned pharmacies as registered contract pharmacies were not actually getting the 340B pricing on anything. And so we saw our drug costs increase substantially. We saw our revenue stay about the same, so wasn't financially viable. So we made the decision at that point to move purchasing to like a clinic, the clinic department. So not through the pharmacies at all. All of our hospitals do carbon, both Missouri and Illinois Medicaid, because we're right on the border.
Michelle Schmitt [00:09:22]:
And so essentially every patient was eligible, both Medicaid and non Medicaid. And we were able to really treat that as a clean site with some auditing behind the scenes to make sure we didn't have a random patient slip in that was not eligible. So, so we were able to do that and everything was great until we found out that not everybody pays for the injectables on the medical benefit. And so we finally had these great low costs that we were able to provide to the patients. And then we saw our revenue go down. We were really getting high rates of denials from some of those payers. So we've made it into more of a blended model at this point.
David Glendinning [00:09:58]:
It's so interesting how often the story of the contract pharmacy restrictions from those manufacturers comes up even in topics that are not ostensibly about that. It's still obviously very much a, very much a factor. We're always, of course, very interested in, you know, who is going to benefit from this at the end of the day, which is the patient. And so what might a typical patient experience with one of these LAI clinics look like?
Michelle Schmitt [00:10:24]:
To start under, like the normal or the typical treatments, we're taking a daily oral therapy. Right, Right. Even not with any sort of antipsychotic or antagonist, I find that to be difficult. I can't imagine for those that are experiencing high volumes of symptoms or, you know, just don't have as stable of a lifestyle as I do, how, how difficult that is. And so those who come to our LAI clinics are receiving injections. They're usually anywhere from every month to every three to six months, depending on the patient, how they tolerate the dose, all types of things. Right. And so they're coming to see us at that cadence, whatever is defined for them, they're not just coming for a shot and a see you later.
Michelle Schmitt [00:11:04]:
Right. So when they're there, they have access to a full team. So we have pharmacists, psychiatrists, nurses, therapists, we have social or caseworkers available, pharmacy access specialists that really help us to understand is there programs for free drug grants, those types of things. Is a prior authorization needed? All of those types of things are addressed. And so it really is a comprehensive discussion visit. Outside of those actual injectable appointments. They also have access to things like group therapy sessions, private therapy sessions, things like that that they can come in for. So really the clinic is treating the whole person and not just, you know, giving them an injection, sending them on their way.
Michelle Schmitt [00:11:41]:
And that's really helped with adherence to the medication, some stability, making sure that we're addressing more than just the acute need for an injection at that time, but being able to, to address all of the patient instead of just this one part of the patient.
David Glendinning [00:11:55]:
Wonderful. You know, you've spoken when you were talking about the blended payment model, you know, trying to maximize that 340B benefit, prior authorization. Obviously, the issue of affordability for some of these patients is clearly coming up. So how do the clinics handle issues that do arise when there's an affordability concern on behalf of the patient?
Michelle Schmitt [00:12:14]:
These patients actually taught us a lot. We realized early that there was a huge need to make sure that cost was not a barrier to treatment for these patients. That's common throughout all kind of drugs. And when you're talking about an injectable that can be upwards of $1,000, not really affordable, if someone can't afford their $20 daily medication, they're not going to be able to afford their $1,000 injection. And so it really taught us very quickly that we needed to develop a program that made sure that we took away the financial burden from our patients so that we didn't lose the retention of those patients. And so we developed what we call the 340B access to care program. It was born out of these LEI clinics. It is now adopted at all of our community pharmacies that are 340B eligible throughout the system.
Michelle Schmitt [00:12:59]:
So it really has been a strong process and workflow for us. And essentially what that means is at the point of either picking up or getting their injection, if a patient expresses that they cannot afford, whether it's their full medication or just the cost share component, they can fill out the application for this Access to Care program, it's based on their affordability within SSM's larger thing, larger policy. So anyone that's from 0 to 400% of the federal poverty level under a couple different circumstances is eligible to receive some sort of financial assistance. So essentially we have two programs. We have the cost share assistance and that is for insured patients that have just said, I cannot afford my cost share for this medication. We extend that to those that are up to 250% of the federal poverty level. That is evaluated by our pharmacy access team to determine eligibility and determine what level of coverage it could be. Any up to their entire cost share amount for those injections could be covered.
Michelle Schmitt [00:13:59]:
We have a second program that is available to either those that are not insured or somebody that insurance has denied cost or coverage for these injectable medications. There are within that are two groups. So anyone up to 250% of the federal poverty level, theirs is like covering cost. Right? And that's the build cost of the medication. For those that are higher than 250% anywhere up to 400% out of the poverty level, we extend the those 340B discounts. The maximum they would pay is the 340B cost plus a small admin fee. So. And that could be covered as well, again, just based on the patient's need and where they're at at that time.
David Glendinning [00:14:36]:
So clearly a lot of assistance that you're providing to patients in need throughout the system. How are the patients responding to these services that you offer through the LAA clinics and that financial support? Do you have success stories to tell?
Michelle Schmitt [00:14:51]:
Yeah, we love to share the success stories of. We've had some really, I think, compelling stories of patients that have come in and said they were experiencing, you know, unemployment, they were unhoused or didn't have access to transportation, things like that, because their symptoms were uncontrolled. They just didn't have that stability. And there's a couple really great success stories. One person came in in 2023 and was had been recently diagnosed with bipolar, but had started to receive injections. And he was graduating from college this year and had been able to find that stability and I think was inspired by his own journey. And so I believe that he was graduating and hoping to enter like the public health world. So it's amazing to see things kind of come full circle to be able to treat patients, get them to that stable lifestyle, and then in this case be able to see them give back to the community in some way and hopefully go on to help help others in the same way.
Michelle Schmitt [00:15:47]:
I think is really heartwarming.
David Glendinning [00:15:48]:
It's such an inspiring story, for sure. You know, you had spoken about some of the, you know, learning lessons and how the model has changed and all of that. So in general, how have these clinics evolved over the time?
Michelle Schmitt [00:16:00]:
Expanded hugely. I believe depaul started that first year. They treated somewhere around 250 patients. I believe in 2024, we were closer to the 600 patients a year number. And knowing that some of those patients are coming in monthly, you can imagine the amount of injections. They're over capacity even at this point. Right. We have wait lists.
Michelle Schmitt [00:16:20]:
We've had. We have further trying to expand those clinics. And so even though we feel like we've done great things with these clinics in the communities and reducing hospitalization, There is such a need to still continue to address behavioral health in general substance use throughout the St. Louis region that we're really trying to figure out, like, how can we. We reach more patients, how can we be more effective, and how can we teach, even within SSM health, the rest of the system that maybe have similar types of patients in their markets but haven't had this lai presence, Is there an opportunity to expand and do that in one of our other states?
David Glendinning [00:16:54]:
So I'd like to bring this all back to the 340B element at the core of all of this. So when you describe this success story of these clinics, what part did does 340B generally play in that telling?
Michelle Schmitt [00:17:06]:
If we didn't have 340B? I think there's an assumption when you talk to outside of 340B stakeholders that nothing else would change. Those services would continue to be offered. You'd just have to pay more. Everything else would be fine. Right. But from a health system perspective, we used to have a president that would say, you know, no margin, no mission. And I love that phrase, I repeat it often in my role. But there comes a point where you can't continue to lose on services like that.
Michelle Schmitt [00:17:36]:
And so health systems really have to make the difficult decision of, like, can we continue these services. I mentioned earlier, behavioral health is often a subsidized service. So we're offering it as a loss already. And that's with 340B. What happens without 340B? Right. That's really the question. And maybe that's a pessimistic question, but it is also a little bit realistic given kind of the volatility and some of the things that we've seen and some of the restrictions in place, and it would be detrimental to the patients. We have a pretty significant amount of financial assistance that we provide.
Michelle Schmitt [00:18:07]:
So DePaul Hospital had more than $400,000 that was provided in financial assistance just in 2024. Our estimates, assuming the same patients that can't afford their medications now, just knowing that that goes from 340B price to the non 340B, whether that be GPO or WAC pricing, that's a 60 to 70% increase potentially in that one location. And again, that's not even factoring in those patients that can afford their medications now, but maybe can't when that price goes up. And so we feel like that would cause them to not be able to seek the care that they really need. And that's really helps them to get get back in some cases to the community, give back and things like that. And so you can't underscore the importance of 340B and being able to provide these types of services. It's the type of story that needs to be out there. Right? It's more.
Michelle Schmitt [00:18:59]:
340B is more than just giving discounted drugs to patients. It really is about what types of services can covered entities and health systems like us provide that really the community needs and the community benefits from. And that's the most important thing at the end of the day is those patients.
David Glendinning [00:19:15]:
Absolutely. Michelle, really appreciate you sharing this interesting and inspiring story not just with us, but with the folks here at the Summer conference. And clearly these LAI clinics are doing great things and going great places. So we'd love to have you back on the show sometime in the in the future and see where. See where you are at that point.
Michelle Schmitt [00:19:34]:
Yeah. Thank you so much.
Monica Forero [00:19:36]:
Our thanks again to Michelle Schmitt for sharing her expertise with our listeners and attendees of the 340B Coalition Summer Conference. This is the first of several conversations you will be hearing on the show from that event. Thank you to everyone who came by our Podcast Lounge and Ice Cream Social while you were in National Harbor. Whether that was to sit for an interview or just to get the scoop on 340B, we will be back in a few weeks with that next episode. As always, thanks for listening and be well.
Narration [00:20:11]:
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.