Speaker 1 (00:04):
Welcome to 340B Insight from 340B Health.
David Glendinning (00:12):
Hello from Washington D.C. and welcome back to 340B Insight, the podcast about the 340B drug pricing program. I'm your host, David Glendinning with 340B Health. Our guests today are Rodney Whitlock and Debbie Curtis, who are both vice presidents at McDermott Plus Consulting based here in Washington, D.C. The results of the recent national elections mean that there will be a new presidential administration and a new Congress both starting in January.
(00:44)
So we brought back two of our most trusted health policy experts to find out what this could mean for the 340B community. But first, let's take a minute to cover some of the latest news about 340B. Two major drug companies have sued the Department of Health and Human Services as part of their efforts to impose rebate models on 340B hospitals.
(01:13)
The drugmaker Johnson & Johnson recently tried to replace upfront discounts on two of its drugs with backend rebates, but suspended that plan after the Health Resources and Services administration warned J&J it would face steep penalties if it proceeded with the plan. Now J&J is asking a federal court in Washington, D.C. to block those enforcement actions and permit the rebate requirements to take effect.
(01:38)
And in a separate lawsuit with the same court, the drug company Eli Lilly is suing HHS so it can proceed with its own more expansive rebate plans. 340B Health members can read more on the latest developments on this issue by visiting the show notes. And now for our future interview with Rodney Whitlock and Debbie Curtis with McDermott Plus Consulting. Rodney spent more than two decades working on Capitol Hill, including as health policy director for Senator Chuck Grassley, a Republican from Iowa.
(02:16)
Debbie also served more than two decades on the Hill and she served most recently as Chief of Staff to the late Congressman Pete Stark, a Democrat from California. We sat down with Rodney and Debbie to chat about the 2024 election results and what they might mean for 340B starting in 2025. Here's that conversation.
(02:37)
I am joined today by two seasoned veterans of the healthcare policy world, Rodney Whitlock and Debbie Curtis. Both of these experts cut their teeth as legislative staffers on Capitol Hill, Rodney on the Republican side of the aisle and Debbie on the Democratic side. So they are the perfect team to speak with about the recent election results and what they might mean for those of us in the 340B community. Rodney and Debbie, welcome back to 340B Insight.
Debbie Curtis (03:07):
Always happy to join.
Rodney Whitlock (03:09):
Yes, I'd like to think I'm well seasoned as well. Salt, Pepper, a little paprika, brown sugar, and now I'm doing a Carolina barbecue rub, so I'm ready to go.
David Glendinning (03:18):
This is kind of a frenetic period here in the nation's capitol following the election. So let's try to distill down all the chatter going on. Rodney, what is the current state of play on the balance of power in Washington for 2025?
Rodney Whitlock (03:36):
Republican is the short version of the conversation. So we had an election, we now see an outcome and it is Republicans will control the White House. They will have 53 seats in the Senate and in the House. They're going to control the House.
(03:50)
220, 221, 222, it's going to land somewhere close to there, but it's going to be about where it was in the House the last Congress. Senate, actually Republicans have a bigger margin to work with than the Democrats did in either of the last two Congresses. So it's a red world and now we got to figure out what to do.
David Glendinning (04:12):
Okay. So Republicans needed 50 plus the Vice President for Senate majority. You're saying they're on track for about 53. And they needed 218 for the House majority on track for just over 220. So I guess we could say Republicans got the clean sweep in this election, but they don't have carte blanche necessarily to enact whatever they want, if I'm not mixing my metaphors too much. We know that every election involves some new folks coming into town, some established lawmakers heading out the door. Debbie, I'm thinking about members of Congress who've been more heavily involved in 340B issues. Were there any big changes for some of these familiar names?
Debbie Curtis (04:52):
Change comes when you have elections, there's no question about it. So first of all, let's start with the House. Representative Elise Stefanik from New York who has been part of the GOP leadership in the House is leaving to become the UN ambassador for the incoming Trump administration. So that is going to be a hole for someone who was really a strong advocate in the House of Representatives.
(05:16)
So far there have been three Republicans out of the House that the Trump administration seems to be pulling for positions. But as Rodney highlighted at the beginning with maybe a 220, 221, majority everyone down for a period of time makes it an even more narrow majority, which does spell some tough potential voting in the House of Representatives in the early in the new year.
(05:40)
So going back now to other folks who are leading, representative Abigail Spanberger from Virginia has been a huge champion in the House for 340B. She has led major letters, she has led bills, she has left because she is going to run for governor of Virginia. So hopefully she can still be helpful to us in the future, but from a different seat. But that is someone we will definitely miss.
(06:05)
In the Senate, we've lost both Debbie Stabenow and Ben Cardin who are retiring and they have been champions and part of that bigger Gang of Six. Now, when you think about losing champions, there's also some other people that are leaving the Congress that maybe we won't miss as much as some others. But what I would say is what elections also bring is the opportunity to create new champions and that's where the focus of everyone needs to be now.
David Glendinning (06:34):
Wonderful. We are eagerly awaiting those new champions, of course. Now we know not every member of Congress works on 340B or even on healthcare, and we know that not every 340B bill comes up for consideration on the House and Senate floor. So I'm interested in who's going to lead things in both chambers and in some of the key committees on 340B issues starting in January. Rodney, who are we looking at?
Rodney Whitlock (07:02):
On the Republican side, we're going to see a lot of consistency. The Speaker of the House, Mike Johnson, will stay at the helm. In the Senate side, it'll be John Thune who we know from the Gang of Six, he will likely not continue that role in the Gang of Six because leaders do leader things. They don't do member things.
(07:21)
He'll probably leave the finance committee, which is traditionally the case leaders don't serve on the committees. Which turning to the finance committee, Senator Mike Crapo of Idaho will then move to the chair when the Senate takes shape in January with Republicans in charge. There'll be one, maybe two members over on the Senate help committee. Bill Cassidy will still be there. He will then move over to become the Senate help Committee chairman. Four, maybe five new members on the Republican side.
(07:52)
Now let's flip over to the House where Ways and Means, Jason Smith. Pretty much the same cast of characters there in the membership, maybe one or two on the Republican side, they'll add. Finally, we go to the House Energy and Commerce Committee now that's where we will see some change. Cathy McMorris Rodgers is retired.
(08:09)
She's going to be replaced with either a Bob Latta of Ohio or Brett Guthrie of Kentucky and then we'll have somebody new at the subcommittee if it's Guthrie becomes the full committee chair. We're looking at Morgan Griffith, maybe Gus Bilirakis, outside shot of Buddy Carter. Certainly a new group of members coming in six, seven, eight on the Republican side. So that's some of the turnover we'll see on the Red Jerseys in Congress.
David Glendinning (08:36):
Okay. Let's talk about the same for the Blue Jerseys. So Debbie, same question for you. How might leadership and committee makeup be changing on the Democratic side?
Debbie Curtis (08:46):
So on the Democratic side, at the leadership level, we're really not going to see change. We will have Chuck Schumer remain the top Democrat in the Senate. Though he will switch to being the minority leader instead of the majority leader. And in the House, Hakeem Jeffries, he will remain the head of the Democrats. On Senate Finance Committee, Ron Wyden will switch to being the ranking Democrat as opposed to being the lead, the chair of the committee.
(09:12)
There are going to be a number of new members to the finance committee and probably five new Democratic members. On the Senate help committee, we expect Bernie Sanders will stay on that committee as the ranking member, but he has not made that official yet. We don't expect that there's probably any new Democratic members there based on moving to the minority and the roster staying fairly consistent. We're now moving to the House, Energy and Commerce is going to see more change.
(09:40)
Frank [inaudible 00:09:41], he's the ranking member now. He will stay, but there will be a new Democrat at the health subcommittee leadership level and everyone is saying that's Diana DeGette from Colorado. So we fully expect that and she has been a friend to 340B. And then we look at the Ways and Means Committee. Richie Neal will remain the senior Democrat on the Ways and Means Committee.
(10:04)
And the change that we'll see there on the Democratic side is two new members being added because of retirements and those members are very, very likely to be members who were on the committee before when the Democrats had the majority. And so that would be Congressman Brendan Boyle from Pennsylvania and Stacey Plaskett from the Virgin Islands. Fully expect they will both come back on the committee.
David Glendinning (10:28):
All right. So some rearrangement of chairs and we certainly will be seeing some new faces once committee hearings and floor action gets started in 2025. Of course, we're always trying to read the tea leaves as best as possible on 340B issues. And I'd like to hear from both of you on that. Let's start with Rodney. What could all of these shifts in power and influence mean for 340B?
Rodney Whitlock (10:54):
So we have depended upon certain folks to be our backstops. It's clear there are a number of folks in Congress who look at the 340B program with a jaundiced eye. They take what they hear from the pharmaceutical world and they run with it and they put us on the defensive. In a lot of cases, they're still going to be there and they may be in more positions of authority. And some of the folks we depended on as backstops, we don't have anymore.
(11:24)
We're going to be watching very carefully in the administration who goes into key positions that have authority over our program. We're going to watch and see from the members to the staffers who are taking roles and what is their general take all on the 340B program.
(11:40)
We're going to have to roll up our sleeves and go back to advocacy that we have to do because there are all sorts of areas where people can talk about the 340B program from definitions to reporting to legislation to potential action out of the administration. There are lots of places that this new world could come at us with potential changes, potential changes we might not like. So it's going to be on us to double down and go back to our core advocacy as we look at what these changes might meet.
David Glendinning (12:13):
And Debbie, what's your 340B take on this new Washington scene?
Debbie Curtis (12:18):
My take is not going to be different than Rodney. I agree with everything he said, but I would add a couple of other points. The number one point I think is oversight, oversight, oversight. I think we have to be prepared that there will be more hearings and more scrutiny of 340B. This is the jurisdiction of energy and commerce. There are going to be a lot of new members there.
(12:40)
We're going to have to be focused on educating those members because we all know that when people understand this program and see the value it brings to their community, they become advocates for the program. I would also remind us that 340B has existed through a lot of turmoil in Congress, a lot of changes, a lot of threats, and we keep going. So let's just remember we're good at what we do. We've got to keep focused on that.
David Glendinning (13:10):
Very important perspectives. Thank you both for sharing. Let's move away from the legislative branch for a bit and speak about what we might expect or need to be on the lookout from the executive branch as we look ahead to President Trump's second term in office. So Rodney, what about 340B changes the White House could make without Congress?
Rodney Whitlock (13:35):
The trick with that question, David, I will say is that because those of us on this particular conversation typically work to try to preserve the 340B program, we don't spend a lot of time trying to dream up incipit ways that somebody who opposes the program could mess us up. We saw somebody come in very early in the Trump administration and with part B cuts related to 340B program and in a regulatory activity that went all the way to the Supreme Court to be struck down.
(14:06)
Could that be revived to follow on to what the Supreme Court said? Again, it's who sits where and what ideas are germinating in their own heads of which we're probably not the ones they're talking to about it, but we're just going to have to be prepared for that and react when it happens. Getting ahead of it, it's a little bit of a challenge I will admit.
David Glendinning (14:27):
And Debbie, what are you on the lookout from this incoming White House?
Debbie Curtis (14:32):
I'd like to pick up on something Rodney said that I think deserves a little more focus, which is what happens to 340B in a Trump administration or what happens on anything in healthcare in a Trump administration is really dependent upon who is tapped for key healthcare roles. Personnel really is policy. If you said to incoming President Trump, "What do you think about 340B?" He would have no idea what you were talking about.
(15:00)
This has not risen to the presidential politics level. So who's sitting there, where they come from, what their knowledge over the years, the bias that they bring is going to be really, really important for us to understand and to keep a very close eye on. And then there are things we're going to be able to watch. I mean, we know the Inflation Reduction Act is law and even with the change of administration, it's going to continue.
(15:29)
So watching how a new administration goes about implementing the drug pricing caps could have an impact on 340B. The last time that President Trump was in office, he pursued most favored nation status. We're hearing less interest in that this time, but I don't think any of us feel confident about where the Trump administration could choose to go on policy in almost any area. So we're going to have to be very alert to see what ideas come up because ideas in drug pricing can have impacts on 340B that are not intended impacts on the program, but just because of the complexities of healthcare pricing, they end up impacting it.
Rodney Whitlock (16:12):
And one thing I do want to point out that you just mentioned there I think is worthwhile, the pharmaceutical companies are going to want to look at the Inflation Reduction Act and some of the consequences they face from that. But I'm not feeling like they have the ability to be able to do a, take on a full-frontal assault on the Inflation Reduction Act.
(16:32)
And if they feel like they're getting stiff arm there, I think the other thing we have to be concerned about is they've set up and now have very clearly, if you're in this town you know, there other two whipping boys are the PBM's and 340B. And so we definitely need to be concerned that attacks on the Inflation Reduction Act meet a wall, they're going to go for other people.
Debbie Curtis (16:53):
I think that's spot-on, Rodney. When Trump was president before, drug pricing was a key issue for him. To think that they're going to go, that his administration will go straight at the Inflation Reduction Act and say, "We're going to stop negotiating drug prices," just feels absolutely impossible. It's going to move forward. And so folks will have to turn to other places, and Rodney is exactly right, that we could be one of those places.
David Glendinning (17:20):
I'm glad you both mentioned those other drug pricing and broader healthcare policy issues because we certainly know from experience that moves in those areas can have effects on 340B and the folks who work with it whether those effects are intended or expected or not.
(17:37)
Before we wrap things up, I want to make sure we acknowledge that the 118th Congress is still the current Congress until January 3rd. And not only that, but it is still in session and doing the people's work. Rodney, that makes it what they call a lame duck session of Congress for these final weeks of 2024. What might happen during this time?
Rodney Whitlock (18:00):
We are expecting, and I will cite, I think I first saw my colleague Debbie here use this phrase, a lame, lame duck. The idea that we're going to have a very productive lame duck requires you to imagine an outbreak of cooperation. This is not feeling like that environment right now, particularly with the election outcome, the change over the Republican sweep, the extenders, those things like the Medicaid dish and community health center funding type things that we've seen regularly.
(18:30)
They should be safe. Telehealth should be safe. We might see something with physicians. But beyond that, bringing in other policies, particularly other policies that spend money, then you have to get agreement on things that save money and that's where the wheels come off the tracks if you're expecting people to cooperate. So we are going to continue to keep expectations low on much at all coming out of lame duck, which then sets up for 2025 to be where the world is.
David Glendinning (18:59):
And Debbie, we started things off with Rodney, so I'll give you the last word here. What else should listeners in the 340B community be thinking about and doing in the coming weeks and months?
Debbie Curtis (19:11):
I want to bring us back to something I said at the beginning, bring us full circle so to speak, because what people need to be doing now is educating their newly elected members of Congress on the 340B program. And you don't have to wait for that. If you have a way to get at someone who's recently been elected, you should be trying to see them and educate them on this program. When they convene in January, that's something we've got to be doing early.
(19:40)
And my emphasis is that you do this in Washington. And the fly-ins are very important, they show that there's a huge volume of people who support the 340B program, but you have to do it at home too. Because when you do it at home, members of Congress see you as of their community. You're a constituent. You are speaking on behalf of people who likely voted for them.
(20:07)
And remember, the other thing is that oversight and scrutiny is going to be on this program, and that means to the extent you have your impact profiles, do those. We need to be presenting information that shows that 340B is doing what it's intended to do, which is extending scarce federal resources so that we can take care of the safety net populations in districts across America. If you happen to be a hospital that thinks, "Oh, I haven't had time to do that impact notice yet, my impact profile," you want to do it for this year. You really want to be prepared.
David Glendinning (20:48):
Well, excellent advice, no matter which political party is in control on Capitol Hill and no matter who sits in the Oval Office. Debbie, Rodney, I know the demand for your insights is fierce around this time of year, so I very much appreciate you taking the time to share them with our listeners. Thank you again for being here.
Debbie Curtis (21:09):
Happy to do so and we look forward to working together in the new Congress.
Rodney Whitlock (21:13):
Deeply enjoy spending time with you all. You're some of our favorite folks. Looking forward to working together in 2025.
David Glendinning (21:20):
Our thanks again to Rodney Whitlock and Debbie Curtis for their perspective on the election results and their sage advice for members of the 340B community who are preparing to navigate the new political landscape. Debbie mentioned filling out 340B impact profiles as part of her advice to hospitals.
(21:37)
If your hospital or health system has not yet created an impact profile or needs to update one, please visit the show notes. You'll find a link to all the information you need to complete your profile, with the help of the 340B Health government relations team. We will be back in a few weeks with our next episode. In the meantime, as always, thanks for listening and be well.
Speaker 1 (22:02):
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.
Speaker 5 (22:24):
Voxtopica.