Expert: PBM, 340B Reform Are Key Legislative Issues for Pharmacy

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Although state efforts can be impactful, Downs said enforcement is a major hurdle.

In an interview with Pharmacy Times, Christian Downs, JD, MHA, executive director of the Association of Community Cancer Centers, discussed reform efforts around pharmacy benefit managers (PBMs)and 340B. Downs also discussed the issues in a session at the 2023 Community Oncology Alliance meeting.

Q: What are the key legislative issues currently affecting pharmacy and oncology?

Christian Downs, JD, MHA: Yeah, I think we got the 2 things I'm really looking at right now, from the oncology standpoint. One is going to be, obviously, PBMs or pharmacy benefit management. What's our opportunity to be able to provide some type of regulation on that, either through the regulatory state or through legislation and Congress. I think there's a couple of potential bills in Congress that have some really good pieces and I think we're starting to see some of the regulatory agencies—CMS, the FTC, folks like that—start to really look at what PBMs are doing. And there's an opportunity, I think, there for some regulation. The only thing I think that we need to keep in mind, and this is a big only, is it's a very well-organized lobby. The PBM industry has a lot of money in it, has a lot of organization behind it. And so, getting through the provider and the patient message is going to be really, really important.

The other thing I think we're starting to see that's going to be interesting, a little more at the state level than at the federal level, is what are we going to do from a scope of practice standpoint as it relates to pharmacy? And this is a big issue in oncology, especially when we start looking at some of the sophisticated and well-educated pharmacists that we have in the cancer space. How are we going to be able to extend their ability to work with patients, given the challenges that we have with the workforce in general? Now, I know this is controversial in a lot of levels, I'm not necessarily saying it's worked independently or getting into specifics, but it's what can we do the right way to make sure that you can expand the workforce?

Q: PBM reform is a major area of concern for pharmacies. Where does this issue currently stand and where do you see it heading?

Christian Downs, JD, MHA: Well, you know, I think the biggest thing on the PBM reform standpoint is what are some things that we can do that improve 2 areas: 1 [is] patient access, and this is particularly critical in cancer care. Obviously, patients can't wait 2 and 3 weeks to begin to get their treatments. You know, that's 1. And the second thing is, I just kind of put in the bucket of provider headache, which is making them jump through hoops to do a whole bunch of different things that really, in the long run, don't benefit the provider, don't benefit the patient. And I wish they'd understand that it, frankly, probably doesn't benefit the PBMs. It's just, you know, it's just extra rigamarole. And even if you think about it, too, you know, from a historical standpoint, I don't necessarily think PBMs were ever designed to do special events, at least in their original form. I think, look, chronic medication, you know, for low-risk diseases or illnesses. Yeah, you know, hey, maybe there's some level of convenience for some of that type of stuff in specialty pharmacy. But when you start to get into some of these more complex therapeutics that have timing issues and dosing issues, it's just not a model that works well.

Q: The Senate had a hearing about PBM reform on February 17. Were there any key takeaways for you?

Christian Downs, JD, MHA: Yeah, well, I think the main thing that I want pharmacists to understand is that this is a continuing fight. And you see that, and maybe the perspective to have on this is that getting this type of hearing was a difficult thing to do. I mean, this is not something that would have happened 5 years ago, and it took a lot of work of a lot of organizations to be able to get a hearing like that to take place. So, I think that's the first thing.

I think the second thing that I think pharmacists need to know is if they can find some summaries either at the Community Oncology Association website, ACCC’s website, ASHP’s website, you know, the HOPA website, take a look at it, look at some summaries and look at some of the questions. I think it's very interesting to go back and forth. You know, what questions were the provider community asking? And then what were the answers from the industry? And then what were some of the questions from the PBM side of this? What were some of our answers? I think that really gives you a good indication of where everybody sits, by looking not so much at the answers, but at the questions.

Q: State efforts have been particularly impactful. How important are state-level efforts and do you think these steps could have real impacts on the federal level?

Christian Downs, JD, MHA: I think we're seeing a lot more activity across the board at the state level. And that's not just in PBM reform, but that's in many other things. I think there are 2 big challenges we run into [with] any type of state reform. The first is it only applies to those entities regulated by the state, so a vast majority of the [Employee Retirement Income Security Act] exempt or, for purposes of our discussion, self-funded plans aren't governed by state law. So, depending on the state that you're in, that can narrow the number of people who the law actually applies to. So, the first issue is narrowing of the law. The second issue that happens, and this happens quite a bit in the states, is what we kind of call implementation of activation, which is okay, the law gets passed, everyone goes home. Now, how are you going to make sure that that law is enforced? If you look at a lot of these laws, the enforcement mechanism is the key piece. Who's going to do it? And what's the penalty for not following this law? Unfortunately, this happens quite a bit in state-level legislation, but the enforcement mechanism is not as robust, because frankly, a lot of states don't have the infrastructure of the federal government, Department of Justice, you know, each one of the agencies. I mean, there's lots of options for enforcement, that's not always the case at the state level. And the threat, and frankly, what winds up happening a lot of times, is in order for you to actually engage your rights under the law, a lot of times you have to go to the courthouse. In other words, so the legislature passes something to say, hey, you know, the legislature says, you’ve got to do this. They say, all right, make us. And then what do you do? You have to go to the courthouse, and the judge has to tell them. And that's not the easiest thing to do. I mean, even providers and organized medicine struggle with that, that's not an easy thing to do, you know, forget to have an individual patient be able to do something like that. So, I'm super excited about the opportunities that we create at the state level, and I think it's great to kind of give an indication of what can happen at the federal level. But there's some tricks, and there's some challenges too, in the state.

Q: Where do 340B reform efforts currently stand?

Christian Downs, JD, MHA: Yeah, so, you know, 340B has been an interesting political policy, frankly, policy football for 4 years. ACCC has always wanted to have some meaningful reform so that providers, whether they're in hospitals or in practices, are encouraged to seek patients who would be eligible for 340B. And we've been really pushing that. I think if we looked at these different issues, I think from a legislative standpoint, getting any type of reform is going to be pretty tough. Because it's just a complicated issue. There are no easy answers, and everyone understands this. That's why it's been we've been going through this for 20 years. So, I think legislatively, it's a bit of a challenge. You know, from a regulatory standpoint, we've gone to all of the agencies that we think impact this and say, “Hey, here's some ideas about how we can make this long term and work better for providers and patients.” And there's really an inertia that exists. I think some of it is people don't think they have the authority to make change. Some people feel like they don't want to do that change. Some people want more direction from Congress. And so that presents an interesting challenge. And then, of course, the courts are stepping into this now, and, you know, there's some level of confusion there. And for example, some of the recent court rulings have indicated that that turns out good for the hospitals, let's say the 340B hospitals. That doesn't necessarily say that the program is working well, okay. The court says, you know, procedurally, this shouldn't happen. It's kind of, frankly, agnostic to whether the program is a good program or not. And so I tell some of my 340B friends, listen, it's not an endorsement of the 340B program, it's just saying the way that you went about changing the program was wrong. And I think there's some things we can learn about that. And I also think that gives pauses to some of the regulatory agencies to want to take this on and say, and say, “Hey, let's try to change it this way.” At the end of the day, it’s just going to be a legislative thing, and Congress is going to have to step in and make it what they want to make it.

Q: Are there any specific steps or vehicles that you foresee being used to address 340B?

Christian Downs, JD, MHA: You know, if you're talking legislation, you know, you’ve got to put something on this on any of these issues we've talked about. Usually, though, in some of the larger bills, given the politics behind a lot of them, they're probably not standalone bills. It could be, but generally speaking, they get lumped into some other stuff. I think the problem that we're having right now is we have a divided Congress and thin majorities in both the House and the Senate. So, there's not really a compelling appetite to either politically take things on, or frankly, practically take some of these more controversial issues on. So, I do worry that, you know, even if we add some vehicles, getting them through the meat grinder that is both the House and Senate is going to be tough.

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