Rob and Greg are joined by healthcare attorney Mark Ogunsusi to discuss 340B patient definition, including the 1996 HRSA guidance, key regulatory developments over the years, and the impact that recent litigation might have on enforcement of this standard.

Ep 93 |  340B Patient Definition

340B Unscripted

# Full Transcript

**Podcast:** 340B Unscripted

## Transcript

I have an unscripted question for you. Oh, no. Yeah, there's lots, lots happening in the 340B space. This one, it feels like this one's going to take a village. 340B just keeps doing 340B things.

Hey, everyone. Thanks for listening to 340B Unscripted. I'm Greg Wilson here with my co-host, Rob DeHuby. Hoopi, what's happening, man? In 340B? Yeah. There's a few things. There's a few things going on at the moment. People were mad. I got a couple people saying, hey, you guys missed a week or two of podcasts. So I think we're like a week behind. I think we had audits and vacation and stuff like that. So it's been a while. It's been busy. Yeah. No, it's been good. Actually, timing-wise, and of course, we should share.

Sometimes we postpone because we're trying to get a guest on and just lining up schedules for everybody can be difficult. And once somebody says, okay, it's just taking too long, you and I record and we just cover the hot topics. And maybe something a little different if there's something on the agenda or on our topic list. But I think this time we had a pretty good guest that we were trying to line up and we finally recorded. So I think we're back on. Yeah. Stick around. Rob and I are going to go through some updates.

But on the other side of our break, Mark Oginshushi, he is a healthcare attorney and pharmacist from K&L Gates picking his brain around patient definition. With the AbbVie lawsuit recently filed against HRSA over patient definition, we thought it would be good to get some legal thoughts around the validity of AbbVie's complaint and kind of where we're at from a legislative and enforcement perspective around patient definition. So Mark will be on here shortly.

In terms of news and noteworthy updates, Rob, let's go through claim level data submission policy updates. I think since we last met, Sanofi and GSK are two manufacturers that have issued policies indicating that they want covered entities to provide entity-owned retail pharmacy claims data in addition to all the data that needs to be submitted for contract pharmacy. So we're still seeing kind of proliferation and piling on of this call for claims data. No surprise, I guess. Not at all. If you're counting, that's 10.

I say 10, but remember the first one is Exalexis, which because it's two drugs and just in-house retail and a little smaller scope. You know, we often think of Lilly as the first major drug company. That's definitely the one, first one asking for medical claim data, so administer drug claim data. Yeah. Much broader scope. But technically, that makes 10 with Sanofi and GSK. And yeah, it's becoming real, right? And the decision for covered entities to determine if they're going to comply and provide the data or not is now becoming a little more testy.

So I think that's probably the big topic for the week is Lilly, right? So as we recall, Lilly being the first one, even two months ahead of t...

Ep 93 | 340B Patient Definition

Transcript

Built for investment professionals

Every day you wait, your competitors are finding
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Ep 93 | 340B Patient Definition

Transcript

Built for investment professionals

Every day you wait, your competitors are findingedge in conversations you're not hearing.

Every day you wait, your competitors are finding
edge in conversations you're not hearing.