Diabetes Month and 340B

Announcer (00:05): 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 to David Glendinning with 340B Health. Before we turn to today's news update and interviews, we are thrilled to announce that our podcast is a winner of an Excellence in Communication Award from the Public Relations Society of America's National Capital Chapter in Washington, DC. This award recognizes and rewards outstanding achievement in key communications and public relations. David Glendinning (00:43): We are proud to be honored in the podcast category based on our first partial season of 340B Insight episodes in 2020. Our deepest thanks go to all the dedicated and engaging guests who made this achievement possible. Our guests today are from Salem Health, a two hospital system and Willamette, Oregon. Riley Protz is the pharmacy inventory and 340B program manager at Salem, and AJ Sowles is the systems manager of ambulatory care clinical pharmacy services. David Glendinning (01:15): AJ manages the health system's medication management clinic. Salem uses some of its 340B savings to fund this pharmacist-led clinic that helps manage drug therapies for patients living with diabetes. With November being American Diabetes Month, we saw this as the perfect time to hear about this innovative approach to chronic disease management. But before we go to that interview, let's take a minute to cover some of the latest news about 340B. David Glendinning (01:41): There has been a flurry of federal court opinions on the ongoing dispute over 340B community-based pharmacies. Judges in several jurisdictions, overseeing cases filed by drug companies have started weighing in on whether the government can require 340B discounts to safety net providers on drugs dispensed at community pharmacies. In two of the cases, the judges agreed the government has the authority to impose this requirement, though they questioned the scope of that mandate and the way it was implemented. David Glendinning (02:20): In another case, a judge said federal law does not prohibit company restrictions on community pharmacies. But that opinion did not go so far as the block government enforcement actions against the companies. The conflicting decisions continue the uncertainty over how this dispute will be resolved and the time it will take to do so. 340B Health members can check out the show notes for our deeper analysis of the court decisions so far. David Glendinning (02:47): And since you heard from us last, we have more clarity about the future of Medicare payment cuts to many 340B hospitals that have been in effect since 2018. As expected, the Centers for Medicare and Medicaid Services has finalized payment rates for 2022 that will continue the cuts for at least another year. That decision puts the agency at odds with safety net hospitals and many members of Congress who had called on CMS to abandon the reductions. David Glendinning (03:16): Later this month, US Supreme Court we'll take up the question of whether the government had the authority to impose those cuts in the first place. So there will be more to come on this issue. And now for our feature interview with Riley Protz and AJ Sowles with Salem Health in Oregon. As we started American Diabetes Month, Myles Goldman sat down with Riley and AJ to discuss Salem's medication management clinic, its importance to patients living with diabetes, and its connection to 340B. Here's that conversation. Myles Goldman (03:55): Thank you, David. I'm joined by Riley Protz and AJ Sowles from Salem Health. Riley, welcome to 340B Insight. Riley Protz (04:05): Thank you, Myles. It's a pleasure to be here. Myles Goldman (04:07): And AJ, I welcome you as well. AJ Sowles (04:09): Yeah, good morning. Thanks for having us. Myles Goldman (04:11): I'm really looking forward to this conversation on caring for patients living with diabetes and how it connects to 340B and the work Salem is doing. This is such an important topic. 30 million Americans are living with diabetes. And before we dive too deep into all of that, let's just start learning a little bit more about Salem. Riley, tell me about Salem Health and the community you're serving. Riley Protz (04:37): Salem health is a two hospital health systems. We have a dish hospital and we also have a critical access hospital, and we're located in the Willamette Valley in Oregon, which is just about an hour South of Portland. I like to think that we're a highly primary care focused organization. We have eight clinics in the surrounding area, and we have a pretty large geographic footprint since it's not as densely populated as Portland may be. Riley Protz (05:02): And so also for that reason, Salem Hospital ends up having one of the busiest Eds on the West Coast as well. Myles Goldman (05:08): AJ, what are the challenges you're seeing patients with diabetes having with managing the disease? AJ Sowles (05:16): Yeah. I think some of it is community oriented and then some of it is just how we've seen the disease change over the years, especially the last several decades or so. But from a patient population here in the Salem area, we actually have a higher prevalence of diabetes compared to other areas of the state and nation. Salem actually has... Or I should say Oregon in general has a lower prevalence of diabetes compared to the rest of the nation, around 8.9% versus the national average of 10.5%. AJ Sowles (05:48): We actually see an increase in that in our community at around 12.3%. Some of that is driven by the patient populations that we have in the area. We have a very large Latino, Latina, Latinx community. About one in four people who reside in Salem fall under that demographic. We now have over 150 different medications that we use to treat diabetes, whether it's a complex insulin regimen, various oral medications, newer injectable medications. Everything is just becoming more difficult, more complex. AJ Sowles (06:20): And we're seeing that translate into how patients manage their condition. We're also seeing COVID-19 specific complications as well. Overall, we're noticing people delaying healthcare needs, especially for something like diabetes or high blood pressure or cholesterol, diseases where you don't really feel sick. You don't really feel the necessity to seek treatment if you're not acutely ill. We're seeing those types of delayed care really impact the overall health of the patients that we see on a day to day basis. Myles Goldman (06:53): Riley, I'll turn to you now to talk a little bit more about the 340B program at Salem. When did Salem Health establish its 340B program and how has it been using its 340BB savings, especially for diabetes care? Riley Protz (07:08): Thanks, Myles. Yeah, we established our program back in 2012, so it's been almost 10 years now. It's really only been the last couple years that we've actually had organizational goals around the 340B program. For example, my position as 340B program manager was not a position prior to me coming on board here, and we didn't have a dedicated team actually looking at 340B. It's actually our pharmacy informatics team was trying to wear multiple hats. Riley Protz (07:34): Similarly, the focus on diabetes care didn't really occur until the last couple years as well. This clinic that I'm sure we'll get into in depth in a minute was our way of combining diabetes care with 340B savings. Myles Goldman (07:49): Let's definitely now start talking about the clinic. What prompted Salem to create the clinical pharmacist program and how is the clinic funded. AJ Sowles (08:00): Yeah, so I'll start with that. We actually implemented our clinical pharmacy services prior to our current model of care. Back in 2015, when our medical group was undergoing kind of a paradigm shift in how we wanted to provide care to our patients, moving more away from that fee for service model that healthcare was based off of for so long, moving more into what we all now know as like a value-based care delivery model. AJ Sowles (08:26): Things like A1C reduction in people who have diabetes, blood pressure control, statin utilization, lots of these value-based care metrics involved medication use. It made sense intuitively to us at that point that involving a clinical pharmacist in that care model made a lot of sense. At that time, what we had actually done is we'd embedded pharmacists within our primary care clinics. AJ Sowles (08:51): Started as a test of change with just one pharmacist, myself being embedded in one of our primary care clinics kind of working with the physicians and our nurse practitioners and PAs at that time to work on things like blood pressure control, diabetes control. One of the challenges that we ran into though was how do you pay for this, right? Pharmacists don't have provider status nationally. And so because of that, we don't have the ability to bill for the services that we provide. AJ Sowles (09:22): Pharmacy has always traditionally been thought of as a product market, right, where you're selling a drug or medication. It's never been a cognitive service, which is where we're seeing the model shift to, especially in these last several decades. So really what that turned into is us providing a service within our primary care clinics, but not having a way of getting reimbursed for it, which is challenging to justify if you want to grow the service to incorporate more care into the community. AJ Sowles (09:53): It became pretty clear a couple years ago are that we needed to kind of reinvent our model, so to speak. And one of the ways that we did that was by creating our new medication management clinic, which is 100% pharmacist run clinic, still doing the same activities that we did while we were working under the family medicine umbrella, but now centralizing the service and utilizing 340B to help fund the program. Myles Goldman (10:18): Great to hear how 340B has really helped get this clinic up and running. When was this program launched? Riley Protz (10:27): Yeah, we launched the program in the spring of 2020, which looking back was probably not the perfect timing for this. But I will say that by the end of this summer 2020, we were fully staffed, moved into the location that the team is at now and already seeing patients. I think that we were very fortunate since many projects with our own organization and other organizations were definitely stalled during that time. Riley Protz (10:51): Of course, there were challenges, but I will commend our hospital leadership with making this work an organizational goal, as I discussed. This was definitely a goal of ours for the last two years was to focus on diabetes and focus on the 340B program. Myles Goldman (11:03): Were there any challenges and how did you overcome them if there were? Riley Protz (11:08): We might get into this a little bit later, but the manufacturer dispute, the blocking of contract pharmacy claims, that has impacted diabetes care the most. That happened in the summer of 2020. That was another challenge regarding we were worried about the funding of the program. That definitely was a challenge as well that we've had to navigate. Myles Goldman (11:24): Yeah, definitely we'll want to hear more about that. Tell me about the collaboration between Riley, yourself, focusing on the 340B program and AJ, you focusing more on the clinical side. Riley Protz (11:36): Really it's a perfect duo. We're tag teaming this interview here. It's really what we do in the meetings as well. AJ has that clinical expertise with some 340B knowledge, and then I'm also a pharmacist, so I have some pharmacy knowledge, but I'm the 340B expert. Going into meetings, it's very effective having us both there to talk about both sides of the equation. This clinic is the majority of our contract pharmacy. Riley Protz (11:58): We're able to actually look at these claims that have qualified or not qualified and then take them actually back to AJ or his providers and identify issues earlier than they may have. I think one good example is where if a patient runs out of refills and the pharmacy will most likely call, they're used to calling the primary care physician to get refills. But in our situation, we actually want the pharmacy to reach out to the clinical pharmacist. AJ Sowles (12:25): Yeah, absolutely. I think one of the things that it's really done is it almost put a magnifying glass on all the prescriptions, right? It allows us to better to track adherence. It allows us to better track fill rates. A lot of times that can be kind of the first clue from a clinical standpoint that the patient may not be doing so well with this treatment, right? Maybe there's an adverse event from one of their treatments that they don't like, and so they haven't been filling their prescription as often. AJ Sowles (12:50): Riley's team is probably going to be the first one that'll catch that and say, "Hey, by the way, this patient hasn't been filling their name X diabetes drug. You might want to look into that and see what's going on." That can be that first little flag that tells us that we need to think differently from a clinical standpoint. Myles Goldman (13:07): A shift a little bit to really talking about just how this clinic works on a day to day basis. How does someone become a patient of the clinic? AJ Sowles (13:17): Yeah, absolutely. We work under a referral based model of care. A primary care provider seeing a patient would refer their patient into our clinic, just like they would for any other specialists that they would be referring their patients to. AJ Sowles (13:32): In Oregon, like many of the other states, pharmacists are able to operate under what's known as a collaborative drug therapy management agreement, which is essentially a pre-specified agreement between a physician and a pharmacist that allows a pharmacist to essentially have the scope of practice that allows us to medically manage a patient who's been referred to us. AJ Sowles (13:54): We're lucky and fortunate in Oregon that our collaborative practice agreements tend to grant pharmacists a very wide ability to provide these care services. They tend to be disease state focused, so things like diabetes, high blood pressure, high cholesterol, COPD. Those are all conditions that a physician would be able to refer a patient to a pharmacist for management. Myles Goldman (14:20): How are you collaborating with the patient's primary care physician? AJ Sowles (14:25): We have a shortage of primary care providers, physicians. Their schedules are full. One of the ways that we were able to help kind of collaborate with them was by opening up their schedules more by having patients come in and see us. If you have a really complex patient with diabetes who may be on multiple insulins, they may need multiple insulin adjustments in a very short period of time, that can really dramatically increase the number of touch points and the number of visits a patient needs. AJ Sowles (14:52): Our primary care providers just didn't always have that access available. By us being able to kind of offset a large majority of those visits, it improved our physicians' access to be able to extend their reach into the community more effectively so they could start seeing other patients. Myles Goldman (15:10): You've only been doing this for a pretty short time, obviously a little more than a year. But are you seeing any initial data on patient health outcomes? AJ Sowles (15:20): Yeah, absolutely. To date we've seen about 1,500 patients who have been referred into our service, which we're pretty proud of for only being in existence for a little bit over a year at this point. Of those 1,500 patients that have been referred to us, about 500 or so have had an A1C that's more than 9%. So really not meeting those quality care metrics that we're striving for in a primary care setting. AJ Sowles (15:44): I'm happy to report that after about three to six months of us managing those higher risk patients, around 70% of them have actually decreased below that quality threshold of a 9% A1C and about half of them have actually further decreased their A1C to a more clinically relevant target of an A1C of seven to 8%, which we're really proud of those results. AJ Sowles (16:07): We've also seen an increase in statin utilization and adherence for patients who have been referred. Our medical group had a baseline of about 82% adherence rate for those types of medications, and we were able to increase that to about 91% following our targeted interventions from the pharmacy team. Myles Goldman (16:25): Oh, really great to hear the successes, especially again given how short in general the time span has been that the clinics been open. We've discussed a lot about what's happening at the clinic. As we get to the end of 2021 and start to think about 2022, what are the future plans for Salem Health's pharmacy management clinic? Riley, I'll start with you. Riley Protz (16:51): Yeah. We've talked about a lot of things that we've done in the last year or two, but we definitely still have some more goals of seeing this clinic grow. I'm going to come back to that contract pharmacy dispute that I alluded to earlier. That's really affected our projected savings immensely since diabetes medications are our focus. To be honest, I think without the incredible clinical results that AJ just shared, I mean, you don't see those with medication therapy, those reductions in A1C. Riley Protz (17:17): I have not personally seen any of those patients in the clinic, but I'm still very proud of those results. Without those results, I expect there probably would be more questions around the financial viability of this clinic because of those manufacture blocking issues. But with that said, we definitely still would see more 340B savings that we can then use to pass on to these patients or grow the clinic. We have almost completed the construction of a hospital owned retail pharmacy that's located in the same building as the clinic. Riley Protz (17:48): This will be beneficial for a few reasons. First, we'll be meeting the patient where they are. So just imagining the clinical pharmacist prescribing the medication. The patient then just walks down the hall and is able to pick up the medication from their community pharmacist. So that's going to reduce some barriers there. And then also just the coordination of care. You've got your clinical pharmacist working next to your retail pharmacist, and they're still part of the same care team as their primary care physician. Riley Protz (18:15): Secondly, the other benefit is a lot of those blocked diabetes scripts that we've been talking about then become 340B eligible again when they're filled at a hospital owned pharmacy. We'll be able to grab back some of those savings, and we'll also be implementing a patient assistance program at this new pharmacy to help the patients with the financial need to pay for their therapy. Directly passing on those 340B savings to our patients. Myles Goldman (18:40): AJ, you must at the clinic hear a lot about patients struggling to afford their medications. AJ Sowles (18:45): Yeah, absolutely. That was something I was going to touch on. We've seen a really big shift in just the overall cost of drugs in general, but especially in the diabetes realm. In the last 10, 15 years or so, we've seen a lot of advancements in medications used to manage diabetes. We've had newer types of insulin that have come to the market, longer-acting insulins, GLP-1 agonists, SGLT2 inhibitors. They have a high price tag as a result. AJ Sowles (19:12): Many of these treatments, which I think are very much life saving treatments, are in the hundreds of dollars for patients at times. And for a large majority, that just is not something that's obtainable. By us being able to leverage the 340B discounts that we're able to have access to with this program, it allows us to directly impact and pass on those savings to these patients who otherwise wouldn't be able to be on these treatments. And that's going to be a real big game changer for us. AJ Sowles (19:44): I have lots of patients who decline treatment. I have patients that ration insulin simply because they're unable to afford the very high copays that they have. Myles Goldman (19:57): I'm really looking forward to hearing as the months, go on more about how you continue to grow the clinic and continue to help more and more patients manage diabetes and other chronic diseases as well. AJ and Riley, thank you both so much for taking the time to speak today and really give us a sense of how 340B connects to clinical care for diabetes. Riley Protz (20:21): Yeah, thank you so much for having us. We're really happy to discuss this. We're really excited about what we're doing here. I just wanted to point out that if anybody has any questions or comments or interest in implementing a model such as this, please feel free to reach out to at least myself. I can't say if AJ wants to reach out to him. But I think if they want to reach out to myself, just LinkedIn is the best way to connect and happy to connect with anybody. AJ Sowles (20:43): Yeah, happy to connect with anybody who has any interest in learning more about what we do here. David Glendinning (20:47): Our thanks again to Riley Protz and AJ Sowles for giving us the rundown on their 340B funded medication management clinics. You can learn more about this Salem Health initiative by reading 340B Health's most recent case study report on how 10 hospitals and health systems use their 340B safe savings in ways that are tailored to specific community health needs. Please visit the show notes to download that report, which features other examples of how hospitals embed pharmacists more fully into patient care teams. David Glendinning (21:19): We hope it inspires those of you who work on similar 340B funded care innovations to share your stories with us. As always, if you have stories or ideas for our award-winning podcast, please email us. We can be reached at podcast@340bhealth.org. We will be back with our next episode after Thanksgiving. We wish you a happy and healthy holiday with your loved ones. As always, thanks for listening and be well. Announcer (21:54): 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 @340BHealth and submit a question or idea to the show by emailing us at podcast@340bhealth.org.