Federal Health Policy in Focus: Key Legislative and Regulatory Takeaways from AMCP 2025
Adam Colborn, JD, Associate Vice President of Congressional Affairs at AMCP and Editorial Advisory Board Member for First Report Managed Care, shares key insights on federal legislative updates and regulatory changes from AMCP 2025.
Adam Colborn, JD: I'm Adam Colborn. I'm the associate vice president of Congressional Affairs at the Academy of Managed Care Pharmacy. I've been with AMCP for about 5 years. Before that, I did a little over 4 years with the Alzheimer's Association. Before that, I was in local government. I'm a lawyer by training. I'm not a pharmacist, so I can't answer any of the hard questions.
What were some of the key takeaways from your session on federal legislative and regulatory updates at AMCP this year?
Colborn: I think the key takeaway—regardless of the specific issue we're talking about—the key takeaway is that it's the wild west for health policy, whether that's legislative or especially regulatory. We're seeing things change very rapidly. To my audience, I want them to come away understanding that we're in a very fluid situation, and lots of things are on the table, and it's probably going to be hard to know what exactly is going to change until after the dust settles. I think some of the things we talked about in our session—PBM reform, right, that's still on the table [and it] might be in reconciliation, but more likely in a separate package. There's growing agreement that 340B needs reform, but there's not really any consensus on the Hill for an approach to reforming it. It looks like the Inflation Reduction Act provisions—health provisions at the very least—are going to continue to be in place. We haven't really seen any desire from Congress to repeal that or any indication from the Trump administration that they're looking to suspend implementation of the negotiations or Part D redesign. There's a lot of big things that are in the mix for this year. Especially if you're looking at the administration and what they're doing with the agencies, it can be very difficult to predict what changes might be in the works.
What were the results of your audience polling questions during the session?
Colborn: We asked 3 questions during the session. The first was, “Was the December package the best opportunity 8000 for Congress to pass PBM reform?” The second was, “What do you think of 340B reform?” And then the third was, “How do you feel about the Inflation Reduction Act?”
The PBM reform one was interesting. I think I probably should have asked that question twice. I asked it in the session at the beginning of my segment on PBMs. I should have asked it a second time after we finished because the audience by a small majority thought that the December continuing resolution that sort of fell apart 4000 at the last minute was Congress's best chance to pass a PBM reform package. I told them during the session that I disagreed with their assessment. It was a scale of 1 to 5 asking “How likely do you think that was the best chance?” And [their answer] was 3.5 in favor of that was their best opportunity. But in the conversations that I'm having with people on the Hill, the consensus really seems to be that there's an opportunity to move PBM reform this year. It had good bipartisan support last year. And I think if I were to ask that question a second time, their answer may have been different.
The 340B and IRA ones were interesting. Those mapped much more closely to what I expected people to say. Those were word clouds. And we asked, “What do you think of 340B reform?” And we got every answer under the sun. There was support for reform, there was opposition to reform. All of the words that were in the word cloud were very strong. There were words like “necessary” or “essential”. Other words like “hopeless” or “a waste of time” or “misguided”. And so that doesn't surprise me. I think that mirrors what we're hearing on the Hill. There's not widespread agreement on what kind of changes should be made, even among people who agree on sort of broader topics. If they agree, for example, that there should be a patient definition in the 340B program, then they don't agree on what that definition should be. And it was not super surprising to me that our audience had lots of different feelings. I think that's very in line with the general mood. And the same thing on the Inflation Reduction Act. We had support and opposition. We had some people say that it was a much needed program. We had other people say that it was a disaster. But just like we saw with 340B, there were lots of different opinions and they were all very strong.
What legislation and efforts for reform do you believe are most likely to advance in the current political climate?
Colborn: In the current Congress—the 119th Congress—I think PBM reform has a pretty strong chance at passing. It's really easy to see that moving in a year-end package right when we get to December and we're negotiating probably another continuing resolution. Really easy to see that making it in. It almost made it across the finish line last year. I wouldn't be surprised if it was like a stand-alone package either before that. I think that's certainly on the table. A couple of reasons for that. One, Brett Guthrie, a Congressman from Kentuckly [who] was formerly the chair of the Energy and Commerce Committee. When he was campaigning for committee chair last year he spoke about being interested in PBM reform in 2025, even if they had passed a 2024 package. Congressman Guthrie was formerly the chair of the health subcommittee under E&C, moved up to the full committee, and the new chair on the health subcommittee is Congressman Buddy Carter of Georgia. [He] is 1 of 2 pharmacists in Congress and he owns several pharmacies and is a big supporter of PBM reform. Given especially Congressman Carter's position with the E&C health subcommittee, I think he's got a lot of opportunity to push his priorities for the committee. And I really think PBM reform is probably the top of the list for me.
[With] 340B, we talked about there being not a lot of consensus there. And I think the prevailing attitude is that it's important, but it's also very politically challenging. We've seen sort of the different stakeholders wrestle each other into a stalemate for this issue. I don't want to rule out something happening, but it seems unlikely at this point.
A couple of other things I think have a good shot at moving. I think drug patent litigation reform could be an easy next target for Congress after PBMs. I think Congress likes to take turns focusing on industries. After they satisfy themselves with whatever they're going to do on PBMs, I think they'll turn their attention to pharmaceutical manufacturers and look to limit the number of challenges that can be asserted in patent litigation for a single molecule. I think that's a little bit of a slept on issue, but it shouldn't be. There was a bill to do just that that passed the Senate unanimously last year in 2024. But then it didn't really move in the house. I think that could very easily come back up this year or next year.
And then the last one—we haven't spent a ton of time talking about it, we didn't really touch on it too much at the AMCP session—is site-neutral payment. I think [this] is probably something that people should keep an eye on. It's a very tempting pay-for for the reconciliation package that's being negotiated right now. The Congressional Budget Office estimates that it will save quite a bit of money. I think if you're the Republican Party looking to craft this really large reconciliation bill, you need offsets and site neutral payments which would essentially standardize the the amount that Medicare pays providers between settings—a physician in a private office gets paid the same as a physician in a hospital. And that I think [it] has a pretty good chance of being passed in the reconciliation package this summer.
Given the pace and volume of executive orders and the shifting regulatory landscape, how do you see the role of Congressional Affairs evolving in balancing long-term legislative goals with short-term regulatory disruptions?
Colborn: I think balancing is a good word for it in the sense that you have to balance multiple spinning plates. It's fairly complicated. I think when it comes to legislation, the longer timeline that we have for passing legislation—which can take months or years—makes it essential to stay informed on what's going on at the regulatory level. And not just what's happening or what's already happened with the agencies, but what do we think might happen in the coming weeks and months that would influence what we're looking at on the Hill? Actions taken by agencies can have a really big impact on not just the language—they offer technical assistance to legislation that can be sort of consistent with an administration's goals—but they can also do something like implement guidance or a rule that changes how a piece of legislation might impact patients and the managed care industry. Further, a little bit less direct to changes, it can also change the psychology of how members and staffers on the Hill think about an issue. It's not unreasonable to think that a bill might be moving along, it's being considered, and then HHS does something and all of a sudden people on the Hill feel like, “There's no longer any urgency on this, we can put it on the back burner” or “It's been made redundant” or something like that. Even if that's not necessarily the case, perception can be reality in a lot of ways. It is definitely important to keep all of those things in mind as you're working through the legislative process.
We have the regulatory news break, which is probably the fastest paced update that's very responsive to the agency actions that are coming out on a fairly quick basis. We also have a state policy map that users can click on and see what legislation we're tracking at the state level. We're hundreds of bills, I think 500 the last time I looked at it and probably more now. And that covers the waterfront, right? That's utilization management, it's AI, 340B. There's a lot going on there, but then we also do policy memos as well on some of the larger legislative issues that we see in Congress.
Are there any other key messages you wanted your audience to walk away with?
Colborn: I think the one thing that I would want to to leave people with that I haven't already covered is [that] it's crazy right now and there is a lot going on right now and things are moving quickly [but] it will eventually slow down and we will eventually reach a point where the Trump administration feels like they have crossed enough items off of their to do list and they've sort of created the agency framework that they want to have. And while it can be a little bit of a challenge now to keep up with it, I think we will eventually reach a point where it's easier to get our heads around it. We'll be seeing fewer unanticipated or unexpected changes, especially as we get some more of the appointees confirmed. They'll sort of settle into their roles and move into a longer-term agenda. I would just say have a little bit of patience. We will eventually see the picture clearly and be able to go from there.