Podcast: Monitoring Ongoing 340B Changes and the Potential Impact for Health Systems

As one of our McKesson Professional & Advisory Services (P&AS) team experts, author of the newly published 340B Program Handbook: Integrating 340B into the Health System-Pharmacy Supply Chain, 2nd Edition, from ASHP, nationally recognized speaker, and more, Heather Easterling is an industry-leading voice in health system pharmacy program management.

We recently sat down with Heather to discuss the importance of monitoring ongoing changes in the 340B space, the potential impact for health systems, and other topics:

MHS Editorial Team: What are you currently hearing from health systems when it comes to navigating 340B? What are some of those front of mind challenges or observations or even successes you're seeing emerge today?

Heather Easterling: I think you hit the nail on the head when you said 340B is constantly changing. It's very challenging for covered entities to keep up with all the rules and regulations around 340B. In addition to the fact that there's a lot of new policies that come out around 340B, I think for the last four years or so, we've been talking about manufacturer policies around restricting 340B pricing in the contract pharmacy space. And now we have a new spate of state legislative actions that are taking place all around the country. And so again, the increase in complexity and the shifting around of how the rules are applied is very challenging for covered entities to keep up with.

In addition to that, the 340B program has become very well known by finance departments, by CEOs, by chief medical officers. It's not just a pharmacy program, it's really a whole system program, but with that comes all the complexity. I think covered entities really struggle with making sure they're compliant with all the rules that we just talked about, but also enhancing their programs where they can.

MHS Editorial Team: In terms of the more granular or the more specific factors themselves that covered entities should be watching most closely right at this very moment and in the near future, what are some of those you could pull out for us?

Heather Easterling: I've already mentioned the state level actions, but certainly we anticipate and expect that over time there could be some federal legislation that comes out regarding the 340B program. We know that soon the Inflation Reduction Act (IRA) will go into effect. The first 10 medications will go into effect in January of 2026, and that will overlap quite a bit with 340B and make it a challenge. The other issue that covered entities really face is making sure they have good data and documentation. So while that's always been an important component of the 340B program, we are now starting to get into shifting models where covered entities may have to submit their data to other sources to make sure it's reviewed, so they have to make sure they have defensible data and making sure they have those documentations.

MHS Editorial Team: What role does data play, and how significant is that role, in helping those covered entities stay strategic and compliant in their 340B programs?

Heather Easterling: Reliable data certainly is the foundation for how decisions are made in a healthcare system. We need to make sure we have quality data that's audit ready at all times. We know that HRSA comes in and of course audits covered entities across the country. They have to make sure their policies and procedures are up to date to make sure that they're qualifying patients appropriately within the framework of their policies. And of course, the strategic use of analytics can really help covered entities highlight where they can continue to grow. There are multiple platforms out there that can help them with this. We have one internally called 340B Impact. One of the major modules in that software helps covered entities highlight when they have a difference in how they're buying medications versus how they're charging for medications. So it helps uncover any time that maybe they're missing out on a 340B opportunity. Having data and putting it together in such a way that can really help covered entities understand their progress is really important to make sure that they're constantly enhancing their programs while staying compliant to all the rules.

Listen to the full podcast above to hear all of Heather’s insights, or download the complete transcript here.

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