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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 (00:12):
Hello from Washington DC and welcome back to 340B Insight, the podcast about the 340B drug pricing program. I'm David Glendinning Glendinning with 340B Health.
(00:23):
Our guest today is Abby Reale, director of Government and External Affairs with Mountain Health Network in West Virginia. A major element of Abby's job includes advocating for her health system with West Virginia State lawmakers, including on 340B related issues. Given a recent surge in 340B legislative activity in state houses throughout the US, we wanted to hear from her about how she advocates in this area as well as how other 340B supporters can do the same in their states. Before we go to that discussion, let's take a minute to cover some of the latest news about 340B.
(01:10):
The drug giant Johnson & Johnson has announced it will be imposing the most restrictive limits on 340B pricing for drugs dispensed at contract pharmacies of any drug maker to date. When the updated J&J policy takes effect March 7th, hospitals will be limited to a single outside 340B pharmacy location for the vast majority of the company's restricted drugs. And that location must be within 40 miles of the hospital parent site. Hospitals that have in-house retail pharmacies will be restricted to using only one outside pharmacy and must hand over claims data to J&J for hospital patients that use either the outside pharmacy or any of those in-house pharmacies.
(01:53):
In a statement 340B Health president and CEO Maureen Testoni noted that the development from the second-largest drug company in the world comes soon after a federal appeals court based in Philadelphia ruled largely in favor of three drug makers that have their own 340B pricing restrictions. But she noted that none of those companies limits are as severe as the ones that J&J is imposing. Maureen goes on to say, "Despite its assertion that it remains committed to 340B, the company is pulling as far back from offering 340B discounts through community and specialty pharmacies as it believes it can. This is a massive escalation of the harm that the company is causing to the healthcare safety net and the patients in need who rely on it." Visit the show notes to read the full statement and access 340B Health member resources detailing the new J&J policy.
(03:00):
Now for our feature interview with Abby Reale at Mountain Health Network. The US Congress is not the only legislative body that debates and legislates on health policy that can affect 340B hospitals. All 50 states have their own legislatures, and lately some of these state houses have been hotbeds of 340B activity. Abby is very familiar with how that activity has played out in West Virginia, which was the first state to take on discriminatory payment against 340B providers. Myles Goldman spoke with Abby to hear about how that experience can inform 340B professionals who are keeping track of 340B legislative activity in their own states. Here's that conversation.
Myles Goldman (03:42):
Thank you, David. I'm joined by Abby Reale from Mountain Health Network. Abby, welcome to 340B Insight.
Abby Reale (03:50):
Thank you, Myles. I'm happy to be here today.
Myles Goldman (03:53):
I'm happy to be discussing with you 340B state advocacy. We've talked before on this podcast about advocacy to the federal government, but there's a state piece to advocacy too that we really want to dive deeper on today. But before we get to that, tell us about Mountain Health Network and the communities you serve.
Abby Reale (04:14):
Yes, Mountain Health Network, it was formed back in 2018 here in West Virginia, Huntington, West Virginia. It's the southern part of the state. We are a border hospital health system. There is four different hospitals within the system right now. And Mount Health, we're committed to improving the health wellbeing of everybody within our 23 to 38 county radius. And we also have Ohio, Kentucky on our border. And so we dive into those areas as well.
(04:42):
So Mountain Health, of course, where we are in academic medical center. It's very exciting for us to be doing things for substance use disorder programs. We actually had the first neonatal therapeutic unit in the entire country, which is for babies born substance exposed. And then of course we have the only burn center within our region within the state. And then of course with 340B, we've been able to do a lot of programs, especially related to substance use disorder for our community. So excited to be here today and talk about that.
Myles Goldman (05:09):
Well, that's all great to hear and looking forward to learning more about some of those programs over the course of our conversation. But one of the things I wanted to discuss first with you is how 340B, of course, as our listeners know, it's a federal government program so it might come as a surprise that we're talking about state advocacy for 340B. Why do you feel professionals working in 340B need to pay attention to health policymaking at the state level?
Abby Reale (05:39):
So back in 2017, our state legislature actually followed Arkansas's legislation that they did to regulate PBMs. So I think as soon as you start seeing other states act on these things, it's good to get engaged on those. But for us, we've been looking at issues related to PBMs over the years, also on 340B and those protections. Those are things that we look at on the federal level, but then on the state level, how can our Insurance Commission or how can our state entities regulate those entities that are doing business here that are getting licenses here in the state under the Insurance Commission? So I think we often forget that we can do things on the state level, especially because preemption does come into play a lot, but when you're being regulated by a state entity like the Insurance Commission, that then allows us to be able to look at those things and how can we regulate those things or how can we make more transparency be available for issues like PBMs.
(06:37):
So for us here, it was really educating ourselves on what those issues were with the PBMs within our pharmacies for our patients. I know we had a white bagging issue a couple years back with a two-year-old within our cancer center that was waiting for a drug that would not be there for another month even though we could have mixed and given those drugs, those chemotherapy drugs that day. So we ended up actually contacting the Insurance Commission. It was right after we had passed some of our legislation that allowed us to regulate that. And we ended up having the Insurance Commissioner come in strong on that. We actually got to give that two year old child their cancer med that day. So for us, it's what can we do on that state level. And we did find that we were able to do a lot of things, especially with 340B and those protections on the state level.
Myles Goldman (07:22):
West Virginia is often held up as a leader among states in the efforts to protect 340B. Why do you think that is?
Abby Reale (07:30):
Well, I think that we were one of the only states following Arkansas. I believe it was 2017 when we did our Pharmacy Audit Integrity Act. And that's really what started at all. And then of course in 2018, we had another bill that went through. And I'll say that since 2017, we've had a bill related to pharmacy benefit managers and their regulation since 2017. We actually do not have a PBM bill that we're really pushing hard this session. So it's the first year since 2017 that we actually haven't had a bill run through the session.
(08:02):
We also have a difference here in West Virginia where we have rulemaking that falls under the legislature. So whenever a rule goes through a bureaucracy, if it's the Insurance Commission and that's who had the rulemaking authority for the PBM regulation, that has to go through our legislative process. And so we're one of the only states that does that. But 2019, we actually did Senate Bill 489, which was the first bill that banned PBMs from 340B discriminatory reimbursement and adjustments. It also led to oversight and of course legislative rules. And so that was the first bill in the entire country that regulated PBMs in relation to discriminatory reimbursement practices for 340B covered entities.
Myles Goldman (08:46):
Once the original 340B anti-discrimination law was enacted in 2019, what were next steps in terms of making sure it was enforced?
Abby Reale (08:55):
So during this time period, we had us at the hospitals, we got our hospital association engaged. We had the FQHCs, family medical centers, engaged in their association. We had pharmacies that it could be Walgreens. We even had some other larger retail pharmacies, but we also had smaller pharmacies. We have a lot of independent pharmacies here in West Virginia, and that was really key as well. And so that was really huge for us to be able to put that in. I believe it was 2021 that we did a complaint against Express Scripts whenever they put out a mandate on 340B entities that we would have to give them information related to 340B modifiers or put modifiers under 340B claims. And so we filed a complaint saying that that was a violation of our law, which it was. The Insurance Commissioner ended up agreeing with us on that and putting out a mandate to Express Scripts on that. And I will say to date, we really haven't had any issues related to that with PBMs and 340B modifiers.
Myles Goldman (09:56):
Well, I want to get into some of the details of how this all came to be, what you were describing there. When you were advocating for the original PBM law, the anti-discrimination law against 340B providers, you mentioned the work you were doing with other organizations for the pharmacies, the other provider organizations. Can you provide some more details about how this collaboration worked, how it came together, who was doing what?
Abby Reale (10:26):
So in 2017, I actually started working for our hospital and for our health system. And so I actually got contacted by a fellow colleague of mine that I had lobbied with for years and years that represented FQHCs and had reached out about this issue on PBMs. That was in 2017 when we decided to do our Pharmacy Audit Integrity Act. And so that kind of started the friendship that started the entities coming together. We got our hospital association, other hospitals engaged on that issue as well as independent pharmacies. And then we of course kept expanding it. And then in 2018, late 2018 right before our legislative session, we had all of these PBMs come out asking for those modifiers and things like that and discriminating against 340B reimbursements. And so that was West Virginia acted very swiftly when it came to that legislation. We were very swift to act. We were very excited when that went through. It was a very tough bill at that time to get through as we were first state to do it.
Myles Goldman (11:27):
What were some of the messages to policymakers in West Virginia that you found were really effective in helping them understand the importance of this issue that there not be discrimination against 340B providers?
Abby Reale (11:43):
Well, in West Virginia, we've had four hospital closures, two bankruptcies in just the last five, 10 years. And for us, 340B is a vital lifeline for safety net providers here. It supports critical health services in our communities. And the 340B program is over $300 million in West Virginia that goes towards patient care and access. And so for us, it was really that access to care. It was also patient access is patient freedom, right? So making a patient drive all the way back to my hospital to try to get that 340B benefit when they could go to their local pharmacy or they should be able to pick whatever pharmacy they want to be able to fill that prescription, right? And so what's easiest for them? I mean, a lot of West Virginians, transportation's hard. So that was one key issue that we focused on, is that patient access, patient care, having a patient drive back to the hospital when they live an hour two hours away. Even 20 minutes away can be tough for transportation for some West Virginians.
(12:40):
So that along with the discriminatory aspect of it. And so that was really key for us. And then talking with legislators over the years. What is a PBM? What is 340B? So being able to explain those in terms related to patients and how it's affecting patient care. So one of the keys, a lot of our cancer patients, a lot of our patients in the neonatal therapeutic unit, a lot of our patients that have COPD, I know that I had calls multiple times from our neurologist and cardiologists about access for 340B for their patients and how detrimental some of these cuts were that were coming down from Caremark and these other PBMs during that 2018 time period. And so when that happens and being able to take those examples to the legislature, I really think that's key, is that not only explaining how 340B affects the community, affects your hospital, your healthcare entity, the patient care access, but also just how it's affecting care every day and how it really goes into how they're discriminating and gets rural West Virginians essentially.
Myles Goldman (13:44):
Were there specific resources you were using in your advocacy, certain materials, that type of thing?
Abby Reale (13:50):
Well, I'll tell you what was really helpful is we got a lot of support from 340B Health and working and seeing what resources they had especially. Of course, we were the first state to do the 340B, so it was really a shot in the dark. "Is this going to work? Is it not?" Our biggest thing is when it comes to solving a problem, you got to figure out what the problem is first. And so internally, I look to my pharmacy, I look to my providers and say, "What's going on? Why aren't these patients able to access these things?" And so figuring out what those issues are and then of course, taking that personal message. So I will tell you, when we first started doing the PBM reforms, we had legislators that realized that, "This is personal for me because I didn't have coverage for a medication or I got denied something because of a PBM." And so that was something that was personal.
(14:42):
It was kind of interesting to see those conversations. And then of course, when you're in stakeholder meetings, we would have constant stakeholder meetings throughout legislative session on this and you know would have the PBM entities in there that would have their local contract lobbyists here at the state. Sometimes they'd fly in other people, and then of course they had their association, but you're kind of going up against the power and numbers on our side that are local versus the massive corporations like ESI, Optum, Caremark. And so I think that really hits home of being able to show we're here in West Virginia, we're seeing these patients every day, meanwhile these massive corporations are discriminating against this very successful program that has helped our patients.
Myles Goldman (15:27):
Well, that's really interesting to hear that contrast in the providers in the local pharmacies versus the PBMs. I want to go a bit broader here in terms of you are of course familiar with advocating at both the federal and state levels. What are the differences between the two?
Abby Reale (15:49):
On the federal level, it's not always a quick process to me. And so it can take years to get traction on different legislation. 340B can be a difficult one kind of on the federal level with what's going on in different states, right? And so on the state level, it's really more close to home and can be a quicker process compared to the federal level. And then also you have different regulations that you can do on the state level that can be stricter than the federal, right? And so that was what we were trying to do when it came to regulating PBMs. Federal government doesn't really regulate PBMs as of right now. I know they're looking at that in detail and we're excited to be part of that conversation.
Myles Goldman (16:29):
And of course, some of our listeners might not have participated in 340B state level advocacy before. How would you suggest they become involved?
Abby Reale (16:39):
Well, I'm a big believer that you can't fix a problem that you don't know about. So first, finding out what issues may exist as it relates to protecting your 340B program and access to care for patients. So what issues do your pharmacies or providers have with PBMs or drug companies right now when it comes to 340B? Then have to review what your current state legislation may be. What protections do you have where majority of states now are at least regulating PBMs? What does that look like? Are they being transparent? Are they having to report actually to the state what their business practices are? And then also, do you have recourse when they do violate the law? Because that's what we have found here is even though you might have a law in the books, it doesn't mean they're not violating it.
(17:22):
And so really it's looking at on the state level, what can you do and really having more join us on that effort. So we're looking at our surrounding states and what do they have on the books because over 30% of my patients come from Ohio and Kentucky. It's really looking at what issues are there and what recourse can we have when it comes to those.
Myles Goldman (17:41):
Some of our listeners are working in the pharmacy department. How do you sort of see that collaboration working between someone like yourself who's in government relations and the pharmacy team, and who's responsible for what when you're thinking about legislation advocacy and also keeping track of whether laws are actually being followed?
Abby Reale (18:04):
It's really a joint effort. So our director of pharmacy at Cabell Huntington Hospital at the time was really engaged with me on this for the get-go. And then of course, it expanded over at St. Mary's and our other hospitals to see, "Hey, is this an issue for you?" And so it actually got brought up from the pharmacy as well as, "Hey, this could be an issue that we could look at." So really, if you have a government affairs person, of course go to them first. I mean, that's one of the first things that I try to do. And I try to have a process internally that if you come across an issue, it doesn't matter if it's a legislative fix or an administrative fix, that's what I'm here for and I'll sort of go look for what issues do we need to fix. But if you don't have a government affairs person, there's always an association usually. There's usually a state association.
Myles Goldman (18:49):
It's great to hear about that collaboration, Abby. It's been great to learn more about the work you've been doing at the state level to protect 340B, especially around this issue of discrimination against 340B providers by PBMs. Abby, thank you for taking the time to join us today.
Abby Reale(19:10):
Yes. Thank you, Myles.
David Glendinning (19:12):
Thanks again to Abby Reale for sharing her perspective on how Mountain Health Network and other providers advocated for 340B in the mountain state. While we often are focused here in Washington DC on what is happening with 340B on Capitol Hill, we also work closely with 340B professionals and government relations experts such as Abby to stay involved in the debates playing out in all the state laboratories of democracy.
(19:38):
Federal and state advocacy will be high on the agenda at the 340B Coalition Winter Conference, which is happening in less than a month. If you have not yet signed up for the conference, which takes place March 27th through March 29th in San Diego, please sign up by the March 17th pre-registration deadline. Do you have 340B advocacy experiences of your own that you would like to share with the podcast? Please keep sending those stories and episode topic ideas to podcast@340bhealth.org. We will be back later this month with our next episode. In the meantime, as always, thanks for listening and be well.
Speaker 1 (20:23):
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.
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