Advocacy in Action

Speaker 1 (00:04): Welcome to 340B Insight from 340B Health. David Glendinning (00:11): Hello from Washington DC and welcome back to 340B Insight, the podcast about the 340B drug pricing program. I'm David Glendinning with 340B Health. David Glendinning (00:22): This episode is sponsored by Verity Solutions, an innovator and 340B program optimization. Verity Solutions drives continually improved 340B solutions and vigilantly addresses regulatory changes so that their customers can dedicate fewer resources to program administration and more resources to community wellness. David Glendinning (00:45): Our guest today is Julie Clements from the University of California's Federal Government Relations team. We spoke with Julie about how she and her team advocate on behalf of all the medical centers in the UC system, including on 340B related matters. Her experience provides some excellent guidance on how hospitals such as yours can engage directly with your elected officials. Julie also shares why it is important for professionals outside of government relations to participate in advocacy. David Glendinning (01:17): But before we go to that interview, let's take a minute to answer one of your questions about 340B. One of our listeners asks, "What is the significance of the new decision from the federal appeals court in DC about Medicare pay cuts to 340B hospitals? Didn't the court already ruled against hospitals in this case?" For the answer, we go to Amanda Nagrotsky, 340B Health's legal counsel. Amanda explains that, "Yes, the US Court of Appeals for the District of Columbia circuit had ruled at the end of July, that the administration had the authority to impose Medicare part B cuts on 340B hospitals that have been in effect since 2018. The hospital organizations and individual hospitals who are plaintiffs in the lawsuit subsequently asked the full appeals court to reconsider that two to one decision by a three judge panel. But earlier this month, the court denied that motion without further explanation." David Glendinning (02:15): Amanda explains that appeals courts typically set a high bar for reconsidering decisions by three judge panels. If the plaintiffs in the case decide they want to continue litigating this case, their sole remaining course of action would be to appeal the lawsuit to the US Supreme Court, which then would make the determination about whether to take up the case. In the meantime, the administration still is reviewing public comments on a proposal to extend or even deepen the Medicare 340B cuts for 2021. You can find out more about this issue in the show notes. David Glendinning (02:48): Now for today's feature interview with Julie Clements, director of health and clinical affairs, federal government relations at the University of California. Julie has been in current role for more than four years and has spent more than a decade advocating on regulatory and legislative policy for healthcare providers. Our own Kathryn DiBitetto recently sat down with Julie to discuss the need for 340B advocacy with members of Congress and other policymakers. Let's hear that conversation. Kathryn DiBitetto (03:19): Thanks David. Hello everyone. I'm Kathryn DiBitetto, vice president of government relations for 340B Health. I'm so pleased to be joined today by Julie Clements, who is the director of federal government relations at the University of California. Julie is a passionate and extremely knowledgeable healthcare advocate and of course, an expert on all things related to 340B advocacy. We are so honored to have her as our guest on the 340B Insight podcast today. Thank you so much for joining us today, Julie. Julie Clements (03:53): Thank you so much, Kathryn. It's a pleasure to be with you. Kathryn DiBitetto (03:56): Today's focus on advocacy comes at a challenging time for the 340B program and our hospitals. We're in the midst of navigating attacks from pharmaceutical companies who have stopped offering 340B pricing for community pharmacies. Additionally, there have been renewed calls from some lawmakers on Capitol Hill to reform the program. On the flip side, we continue to see so much support for 340B in the House and the Senate. The Independent Congressional Management Foundation has surveyed congressional staff and over the years, they consistently find that direct constituent interactions have more influence on lawmakers' decisions than any other advocacy strategy. We're going to talk all about that today on our advocacy focused episode. But before we do, it would be great for our audience to learn more about you, Julie and of course the University of California Health. First, can you tell us about the University of California and the patients it serves? We'd also love to hear more about what your day to day is like as a government relations professional. Julie Clements (05:05): Sure, Kathryn. University of California is the country's largest public academic medical center system. We have six academic health centers, five of which have UC hospitals. We have a very large cancer consortium comprised of five NCI designated cancer centers. We have myriad physician groups and clinics throughout the state. It's a phenomenal system. It trains half of the medical residents in the state of California each year. And all of its academic health centers are top ranked among the best in the country. My work as the health director, so my official title is director of health and clinical affairs in the office of federal relations for the system. I represent the system as far as all the health policy, legislative and regulatory. There's there's much breadth and there's much depth. And I think it's a really rewarding position because I get to interact on any given day on myriad policy topics with number of different constituencies. We are the safety net for the state of California, in addition to providing very high acuity care at all of our medical centers. Julie Clements (06:16): I interact a lot with chief pharmacy officers and 340B administrators, reimbursement directors. And it's everything you can imagine as far as representing, I guess I would say our tripartite mission, which is public mission of being the public academic health center to provide services to anybody who walks through our doors, but additionally training the next generation of clinicians and furthering advances and cures in biomedical research. Kathryn DiBitetto (06:44): It's clear that you're doing very powerful work and impacting lives on a daily basis. And you touched a little bit on the different departments that you work with as a GR professional. It's a good segue to our next question that I'm sure some of our listeners who are not in the government relations profession, they might be wondering why it's important for hospital professionals who are not in government relations to advocate on issues such as 340B. Julie Clements (07:13): I come to this role with a background in both law and public policy and that background while helpful, it can interpret regulations and laws. It can understand complex legal nuance physicians. It can try to help somebody formulate policy suggestions, but it's no substitute for clinical experience. Without having a pharmacy degree, without being a medical doctor, you just go down the list of all the constituencies that I depend upon to be able to do this job well. I really depend upon a pharmacist for example, or a person who works in the hospitals seeing patients take their medications on a daily basis, to be able to help me understand how invaluable this 340B drug discount program is as well as to get the understanding of the flexibility of the program. Every campus can utilize it in a different way and that certainly is the case that UC Health. Julie Clements (08:10): I depend upon having good relationships with our pharmacists and they've been invaluable too, often coming in and talking to policymakers about and lawmakers about how these programs actually work. I think it's one thing to read about it on paper, but it's another thing to actually interact with the patients on a daily basis and see how it's working. Kathryn DiBitetto (08:30): Thank you. I could not agree more with that sentiment. I can also speak to that, having lobbied and advocated with many pharmacists, they are truly the subject matter experts on 340B. It's such a technical program and we need their expertise to help us make sense of it to Capitol Hill. Let's talk a little bit more about the types of advocacy that the University of California Health participates in. What are some of the outcomes you're hoping to achieve or have achieved? And what are you looking to move forward through these efforts? Julie Clements (09:06): We really participate in a lot of different forms of advocacy, specifically with respect to the 340B program. This is a program that as you have earlier detailed, it's very complex. It's very nuanced to understand. And frankly, a few years back when Congress was trying to do a deep dive and look into this program, we became aware of how uninformed a lot of people were about how it works. And so in recent years, I think at least I've been in this position for over four years, there's been a stepped up effort to participate in advocacy days annually. 340B Health, as well as some of our other partners associations put on advocacy days. These have been great opportunities for us to bring together a team of chief pharmacy officers who've usually flown to Washington DC. Anywhere from two to five of them have met with members of our California congressional delegations health staffers and sometimes the members themselves. Julie Clements (10:03): We oftentimes, when we have members who are traveling back to their districts, we use that opportunity to have our chief pharmacy officers meet with them in their district offices. This is actually something that has worked pretty well. We've actually had a few chief pharmacy officers who've met so frequently with the health staffers and the members within their districts that they're on a one on one first name basis. And that is invaluable whenever there's a problem that's posed by legislation or by administration rules, because we can quickly get expertise from our chief pharmacy officer to that particular congressional member and his or her staff. Kathryn DiBitetto (10:41): For sure. And you've touched on it a little bit regarding how your team works with other teams within the system. And obviously pharmacy is a big component of 340B advocacy, but I'm curious to know if the UC government relations team collaborates with other colleagues outside of the department, for example, finance or C-suite? How does that work in the UC health system? Julie Clements (11:08): That's right, Kathryn. The constituencies with whom we communicate on 340B goes well beyond the pharmacist staff. It's a broad group. And in recent years, even communications officials. We've tried to run stories on the benefits of this program at our specific campuses and we do have in compliance with the 340B good stewardship principles, that came about just in September of 2019, we have made a concerted effort to publicize on every academic medical center website. You Google 340B and UC, you will get one of those web pages that comes up detailing how many dollars were saved last year as a consequence of this program and how are the proceeds, the benefit? How has the benefit of this drug discount been used to benefit patients? Kathryn DiBitetto (11:57): That's incredible. And your team has done such a great job of getting that story told and not only telling it, but sharing it with lawmakers. And that continues to be a very important piece of 340B advocacy regardless of the climate or the challenges that the program is facing. Kathryn DiBitetto (12:15): Let's pivot to the pandemic. Everyone's world or profession has been impacted by the pandemic in some way. The same goes for advocacy. For example, 340B Health recently conducted our first virtual Hill day. I will be honest. It was certainly new for all of us, but it did allow more hospitals to participate. I was so pleased. We had nearly 300 attendees just last month. But Julie, we'd love to get your thoughts on how you feel advocacy has changed due to the pandemic. Julie Clements (12:47): I think that advocacy has changed. We've been able to have a broader cohort of people involved in advocacy because it's virtual. Think about it, the University of California academic medical centers, it's a six hour flight to get out to Washington DC, it's a six hour flight to get back. It's a huge commitment. And so oftentimes we're limited even in good years when we don't have COVID is to how many of our pharmacists can take time out of their work schedule and come out to DC to champion this program. What we have found with virtual meetings is that it's much easier to get our C-suite people to participate. Not just chief pharmacy officers with some other policy topics, we've been able to have chief executive officers meet with legislators virtually as well as their staffers. Kathryn DiBitetto (13:35): At the top of the podcast, I mentioned one of the biggest issues that 340B advocates are facing is the drug manufacturers are refusing or threatening to refuse to provide 340B discounts when drugs are dispensed at community pharmacies. Let's talk a little bit about the best ways that 340B hospitals can advocate specifically on this issue. Julie Clements (13:57): Yes. I think that this is something that has definitely emboldened all of our 340B program participants, our health government relations directors on the various UC campuses and our chief pharmacy officers, they're all very interested in seeing how we can address this. It's disturbing and it feels actually somewhat unconscionable actually, some of the letters that we've gotten in recent weeks from some manufacturers. And the sense from our members and our pharmacy advocates is, hey, we've been complying with the program. The terms of the program allow us to be part of contract pharmacy arrangements. It appears very much that this is happening at a time in which we're in the middle of the pandemic. There's just been an interminable period of nonstop responding to crises over the course of the past seven or eight months. Julie Clements (14:52): And so to suddenly be put in a position where you're being told, "Hey, you may only be able to get the 340B price at one particular contract pharmacy and or you have to adopt this specific platform and file all this paperwork to be able to still get the price. Or, we're going to limit the price to only this select group of drugs." It's something that kind of took us by surprise as far as the timing of it. It just seemed like really bad timing. But I think we all are resolute in our position that this is a valuable program. The discount, we see it as is permissible as the program is currently configured in these contract pharmacy arrangements. And so we're just very glad to have 340B Health advocating for us. And we want to be helpful to the cause of showcasing to members, how we're using the program as it's intended. Julie Clements (15:43): And so I didn't mention this at the outset, but the University of California medical centers, we see upwards of 65 to 70% of our patients are either on Medicaid, Medicare or uninsured. There is no question that these are safety net providers. Our DSH percentages at each one of these hospitals are very high. We have done a great job I think, getting all of our chief pharmacy officers, the 340B program administrators, our communications folks to help us showcase to legislators and policymakers and administration that we are complying with the full intent of this program. Kathryn DiBitetto (16:22): Along those lines, what are some of the greatest challenges you have faced when you've been advocating on 340B? And how did you overcome them? Julie Clements (16:30): I think it's really hard for people to understand that this program is a discount program. Everybody, when they hear the word savings, they think, oh my gosh, you're getting a check at the end of the year that's written out that says, "This much in savings." And I think our best way of trying to get around that has been to try to describe it as kind of a coupon. To try to show people, hey, the money is moving through, the savings is moving through. We are here's at this particular medical center, we may be having a clinic for HIV patients. At this other medical center, we may be able to afford to send specialists out to see patients in an impoverished part of California to provide highly specialized services. Whatever it may be. I think that's the way we have to try and communicate it. Julie Clements (17:21): A few years ago, there was a lot of concern about this program that was expressed across the aisle in Congress. There was a lack of understanding of it. And so it was a real opportunity to educate members of Congress, specifically the House oversight and investigation subcommittee of energy and commerce undertook an inquiry into the 340B drug pricing program. And several hospitals were given an opportunity to appear before the subcommittee and explain kind of how they rely on the 340B program and how they're utilizing the savings. And it was a really beneficial experience for the University of California, because it's the first time I know my recollection that we've had a chief pharmacy officer testify to the program and it's importance. He testified, we have the chief pharmacist from University of California San Diego Health, Dr. Chuck Daniels, who spoke to the importance of the program, not just throughout the whole UC Health system, but he was kind of the expert witness who was invited to speak on behalf of all the safety net institutions that benefit from this program. Julie Clements (18:31): That was an invaluable experience and I think that it really enlightened a lot of members of Congress as to how important the program is for safety net providers. But additionally, I think what he was able to showcase that couldn't have been done so well on paper was just speaking to the flexibility of the program and the administration of the program. I heard, we got a lot of gratitude from members across the aisle that they felt they knew more after hearing directly from a chief pharmacist. Kathryn DiBitetto (19:00): Thanks for sharing and reliving that experience, Julie. I know how much work goes into prepping for congressional hearings and you and your team did an excellent job representing the 340B program. Let's close out the episode with a brief discussion on how the year may end. We have an election just days away. Congress has a lot of unfinished business to tend to. As for 340B, we should remain vigilant. We need to continue to emphasize the importance of this program to lawmakers. Again, no matter what the climate is, no matter which party is in power. Would you agree, Julie? And is your crystal ball ready to predict what might happen in a lame duck session this year? Julie Clements (19:44): I think the one thing I can say is that regardless of who wins the presidency, regardless of the composition of the Senate, the 340B program is something that is super important. We support the program as it's currently configured and we're going to continue to work across the aisle with members on both sides, members from each political party in each chamber, to advocate for how important this program is to the sustaining our ability to basically fulfill our tripartite mission as I've referenced earlier. We need to do all we can with both the White House and with the legislature to preserve the program as it's currently configured. Kathryn DiBitetto (20:25): Thank you, Julie, for helping our audience understand the importance of advocating for 340B. And thank you for all the good work you do to support the healthcare safety net. We're so pleased to have you as a guest today. Thank you so much for your time. Julie Clements (20:39): Thank you so, Kathryn. This organization means a lot to our members and so we thank you for your steadfast work championing this important program. Kathryn DiBitetto (20:47): If our listeners have questions about ways to become more involved in 340B advocacy, please reach out to us by emailing podcast@340bhealth.org and we will be sure to connect. David Glendinning (20:59): Our thanks again to Julie Clements for sharing her advocacy expertise and for inspiring more experts in the 340B field to engage with their elected officials. We look forward to seeing Julie and her colleagues at our next 340B Health Hill day, whether it's virtual or in person. David Glendinning (21:19): What questions about advocacy do you still have following today's episode? As always, if you have any questions or comments about any of the items we cover here at 340B Insight, please email us at podcast@340bhealth.org. Please mark your calendars for Thursday, November 19th when Kathryn, the rest of the government relations team and a congressional expert will walk our members through the election results during a 340B Health webinar. You'll hear what the outcomes at the polls might mean for 340B hospitals, both for the rest of 2020 and into the new legislative year. The registration link for this webinar is included in the show notes. We will be covering many of these points on our post-election podcast episodes as well. We will be back in a couple of weeks with our next episode. Until then, thanks for listening and be well. Speaker 1 (22:15): 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.