In this episode, we dive into the critical topic of patient definition and the responsibility of care for 340B Covered Entities. Tune in as we discuss the complexities of responsibility of care and how covered entities like FQHCs can navigate their responsibility to provide accessible, high-quality care while staying compliant.
Michael Gonzalez is a healthcare consultant with eight years of experience in 340B Program and pharmacy management services, offering comprehensive support including program coordination, audits, and pharmacy development. Previously, he served as audit manager at Terry Horne C.P.A. & Associates, where he conducted over 120 audits and provided expertise in FQHC financial advisory services during his four-year tenure.
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Welcome to 340 Banter. With recent litigation and HRSA audit trends,
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a hot topic that's been on everyone's minds lately has been patient definition
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and responsibility of care.
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So today we're going to delve into the nuances of determining and applying patient
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definition through different covered entities.
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Music.
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I'm super excited that we're finally here you
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know we've been working on this podcast and kind
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of developing what we want this to be I feel like
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we're ready, I feel like we're going to be there, the hope and
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kind of my dream as we've been talking about this is that
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it feels like when the night
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of a conference right you go to conference all day you do your sessions
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and then everyone kind of relaxes after that last session everyone relaxes and
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you meet down in the lobby and we start having great conversations some personal,
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some 340B specific and really excited to see that play out here and see what we can do with it.
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I think something I've noticed is that when I entered 340B, there wasn't much
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content out on the internet you really had to dig for content.
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And we've seen a lot of different webinars and opportunities like that
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are more structured come out, but there's less of this casual conversation,
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just discussing the topics in more of a relaxed manner
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and we think that this is a great opportunity for stakeholders in the 340B program
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to really learn about these topics from a different perspective.
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I couldn't agree more. And I think that in a lot of the conferences we've been
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to recently in thinking about a lot of the topics that have been on webinars
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and newsletters and things,
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one of those hot topics that seems to come up in the lobby after a conference
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when people just can't seem to stop talking about work is patient definition.
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There's been a lot of talk about it, you know, based on different lawsuits and
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different applications within policy and procedure
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and I think that might be a good place for us to start kind of kicking things
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around. Yeah, what we've seen is that...
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Health centers, hospitals, other covered entities are just struggling to take
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all this massive amount of information and pare it down to what they actually need.
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It's a challenge because you're dealing with different stakeholder types that
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are coming to the program in different aspects. You look at hospitals that are
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more episodic in care compared to an FQHC that might be the patient-centered medical home.
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So it's a different perspective. So it does get challenging,
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but I think that there are opportunities to really improve your 340B program
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by taking a deep look at how you're defining your patient definition and making sure it's one,
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compliant because we ultimately want a compliant program,
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but two, that it provides the opportunities to expand your patient care as much as possible.
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I think my biggest recommendation on anything when consulting is don't do something
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that you don't understand. And I think that's where a lot of folks are.
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And I think that's where a lot of folks are going to find trouble is,
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you know, they're going to hear something at a conference or they see something
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that a consultant or some vendor has sent out and not understand the nuts and bolts of it.
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And that really kind of scares me. Now, you know, we have a great team of consultants.
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I believe we have the best consultants in the country.
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But with that, we get a deeper understanding, right? We can all kind of feed off each other.
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And, we've seen that internally on internal calls, right?
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Where we're like, someone will bring, oh, this is great cause we can do this.
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And then the other person, not in a mean way, but kind of tears it down of here's
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the reasons why I don't think that's appropriate.
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And so we get that luxury, but inside a health center, you're not going to have that in most cases.
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Right. And so I think it's really important that if when you,
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especially patient definition is like, understand why you're doing what you're doing.
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I totally agree with you with it being a patient-centered medical home.
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You know, you're responsible for the patient. And if the federal statute says
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that you cannot provide 340B products to someone who is not a patient of the
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organization, that can be fairly broad.
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But I think for, you know, maybe a hospital or someone that may have a different take.
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And what are your thoughts? You know, for me personally, I've grown up in my professional
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career in the FQHC market, right? I live and breathe FQHCs.
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That's what I know. And you've spent, though, you know tons about FQHCs,
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you've also spent a lot of time consulting hospitals.
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And so my question would be, what would be your take that makes it a little
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bit different in the hospital market than it does in the FQHC market when we're
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talking about this new patient definition that people are
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not new, but statutory patient definition?
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What do you see as the differences, and what should people be aware of from the hospital industry?
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Honestly, my response is going to be more expansive than just the hospital industry,
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because I think that the same concept applies, is that you're responsible for the patient's care.
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And we have, outside of 340B, so many other accrediting bodies that look at what a patient is.
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So for hospitals and for health centers, you might have the Joint Commission.
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For health centers, we also have AAAHC or NCQA.
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Probably a million other things that hospitals and health centers have,
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but they all have specific criteria. Even thinking about UDS measures for health
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centers, there are specific criteria for what is a patient of the covered entity
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of the health center in that instance.
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And it helps to be able to take a step back and say, as a health center in general,
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outside of 340B, what do we consider our patient?
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And how does that play into the 340B program? From a hospital standpoint,
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point. Your patients that are there for episodic care are very much like the
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patients that you get at a health center for walk-in care or urgent care that
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aren't your patients long-term.
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So you're there taking care of them for that episode, for that acute instance.
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But you also, in hospitals, have medical office buildings and other services
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where you are responsible for the care of the patient over the long-term.
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You are having ongoing responsibility of care. And in those instances,
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it does make sense, just like with the patient-centered medical home,
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to approach it from a more holistic point of view, I feel like.
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And then, again, if you go back to those accreditation standards for those other
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bodies, you're going to see it represented there as well. So you have additional
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documentation and rationale to back up your approach.
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I think that's a good point. I think your policy and procedures are always stronger
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when you have a rationale.
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If you can point to a specific reason as to why you chose a,
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say it's a two-year patient definition that the patients had to have been seen
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in the last 24 months, if you can point to another guideline that shows that
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that is what defines a patient,
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it makes your position even stronger.
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That's something we always try to do is include links to guidance documents and other
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statutes and different programs that would support that,
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for example, the 330 language for FQHCs has very specific language in what makes
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a health center patient a patient.
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So I think that that is a good practice when you're writing those policies and procedures.
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And so what you're saying is essentially, you don't want to just put on there
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that a patient that has been seen in the past 24 months is a patient and your
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support for that be, well, because my consultant told me I could do that, right?
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And I think that's a good practice in life in general, right?
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Let's find some authoritative guidance, something that we can utilize that's
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set in stone, whether it comes from the government, whether it comes from payers, right?
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Sometimes that can be a play as far as what's considered a patient.
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So I think it's really interesting. And again, though consultants are great,
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and I love consultants. Obviously, we are consultants.
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It's totally good and okay for us to say
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hey that's great, but can you can you
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show me where I can find that and some regulations or you know what I mean I
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feel like we need support for things not just well they're well known and we
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should listen to them I think you know always do your due diligence right and
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so I think that's a great point from both y'all and
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patient definition it's funny it's actually been kind of tested for some time
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now right. There's another vendor that years ago was telling
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me about this and was like, no, why don't you have everyone doing,
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you know, look at the statute.
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And I'm like, I don't know. I just don't feel comfortable. I don't feel comfortable.
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I don't feel comfortable with that.
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And so. Well, because the statute itself doesn't say anything about drugs, right?
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You got, you got one mention ever. And then it really comes down to that 1996
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guidance, which laid out more criteria, but then you get into the gray area
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of guidance isn't necessarily enforceable. Well, yeah, so I think it's tougher.
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And I think you mentioning feeling comfortable, I think is an important point.
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It would not be something that I would recommend if you weren't doing referral
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capture at all, jumping to a statutory patient definition.
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That doesn't feel like a logical jump, a logical progression
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because you're skipping a few steps in between.
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So I whenever I'm having these discussions about if a program is OK or an interpretation is OK,
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my first thing I like to talk to that person about is ask them, does it feel OK?
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Because your gut's there for a reason.
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And sometimes if you step back and think, if I were in a HRSA audit,
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would I feel comfortable defending this?
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That gives you your answer because there's a lot of things I could possibly
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defend in a HRSA audit that I don't feel comfortable with.
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And it's not worth stretching the intent of the program to be able to capture a few more dollars.
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I actually had a conversation at the end of last week specifically about that
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level of comfort in grayer areas.
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So your policy, you know, we mentioned that a common one for health centers
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is that you've seen a patient within the last 24 months, which is pretty standard.
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It's used for a lot of UDS measures.
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Makes sense. But looking at your actual operations and procedures,
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you can have your policy be one thing and then your procedures be a little bit
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more specific and nuanced.
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And we were talking about how for really drilling down into how do you know
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if you've seen a patient the last two years, how do you know that they're still
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your patient if there's not like a formal discharge to another organization?
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And one of the things I talked about was that when I'm working,
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you know, with our referral clients, looking at the patient themselves,
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if it's a young, healthy individual, It's not uncommon for someone to not have
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an annual visit. You know, maybe they come in every 18 months.
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So if that's the last time they were seen was 18 months ago,
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they, you know, they got prescriptions, they're getting refills, whatever.
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Reasonably or reasonable to expect that they're still using the covered entities,
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the primary health care provider.
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By contrast, you've got a 75-year-old with 10 comorbidities and 15 drugs,
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and they haven't been in 18 months,
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it's likely they're seeing someone else for primary care.
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So being able to apply some gray area and nuance within your procedures and
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your operations so that you don't end up in a situation where you're like, does this feel good? No.
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Does it technically meet our policy. We've seen them in the last 24 months? Yes.
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But if I was asked in a HRSA audit to defend that I'm responsible for this patient's
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care, I probably wouldn't.
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I work with health centers in a similar situation that their procedure,
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policies and procedures, are pretty broad and go to that 24-month definition.
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But in practice, they actually, we hear about closing the loop.
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In practice, they do that because it's good clinical care. We want to see that
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referral going out to the provider and see a consult note coming back in.
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That's just taking care of the patient and doing what we should as clinicians.
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I'm a pharmacist by trade.
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That's what I want to see happen for the patient care. But in some cases,
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that's not possible, so they set their procedure as being a little broad.
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That way, if that falls through and doesn't happen, they're not in violation.
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But they're still, they have the intent to make that their practice.
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Yeah. And I think it's a really good, you know.
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What both of you said is a good time to say, you know, 340B is not a set it
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and forget it program, right?
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It's not some, and that's the thing is so much of this is ran on technology
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and data and automation.
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If you rely on that solely, you're going to find yourself in some trouble,
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right? And so you need people, you need people to be in there operating.
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You need people to be having opinions on this stuff and kind of,
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you know, things stand out to you, to people. And if you don't code
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this computer to catch every little oddball thing, it's going to slip through the cracks.
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And so I think that's super important, especially because
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I think a lot of vendors are pushing people to do this because you're going to process more claims.
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It's better for your organization and your patients.
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But at the end of the day, the vendor, this is the 340B program.
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The covered entity is the one who's responsible for noncompliance, right?
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Whether that be reimbursements or paybacks that we have to do for non-eligible
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claims that were deemed.
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Not the vendor, and I put ourselves in the hot seat.
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We advise a lot of clients on what to do and what should be appropriate,
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but we really want them to understand because at the end of the day,
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it's not me on the line. It is the covered entity.
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Now, I mean, some degree reputation wise is on the line, but I think it goes
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back to that concept of you should be at least comfortable.
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You don't have to know every single in and out if your organization is going
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this certain route, but you should be comfortable and have a common sense test
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to say, does this make sense in my brain? Is this something that we should be doing?
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And if you have pause, figure out why you have that pause and see if you can prove it wrong.
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What do you see as the biggest concern
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regarding not just health centers, but covered entities and patient definition
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and making sure we don't set it and forget it?
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Like, what are the areas that we could pick out to say these are the ones you
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really want to watch out for?
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Any concept, any ideas on that? I think the first thing that comes to my mind
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is thinking of your policy and procedure as a living document and that you're
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revisiting it regularly.
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Often, those are documents that no one reads other than once and then they get
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stuck in a file within your computer, and you don't look at them until the next
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time they need to be reviewed.
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So making sure that you're sitting
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down with your 340B program oversight committee and going through it.
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Maybe you do it every six months. Maybe you do it once a year to make sure what's
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in there is what you're actually doing.
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Because that's one of the worst mistakes you can make when you go into a HRSA
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audit is if your actual practices are not
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compliant with your policy and procedure.
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I think kind of going along with the policies and procedures,
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but also thinking about those nuances of operations, trying to think through
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the places in your program where there might be more gray area around patient definition.
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I know we commonly get questions about patients who are only dental patients
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of the covered entity or only mental health patients of the covered entity.
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And it's really hard from either of those standpoints to say that you're responsible
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for the patient's care as a whole because I don't know any dentists that do
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comprehensive assessments of a patient's diabetes,
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hypertension, and asthma before doing a cleaning.
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So it's really hard to say that you're responsible for their care there.
00:16:20.956 --> 00:16:26.496
Being able to kind of suss those out. I think another one we see is emergency meds.
00:16:26.636 --> 00:16:30.456
So emergency kits or code carts because you may be utilizing the medications
00:16:30.456 --> 00:16:35.616
in those on individuals that didn't come to your clinic for a visit or didn't
00:16:35.616 --> 00:16:36.696
come to your hospital for a visit.
00:16:36.796 --> 00:16:40.356
But something happened to them while they're on the premises and you're going to take care of them.
00:16:40.556 --> 00:16:43.756
So there are some folks that will say, well, they're not our patient.
00:16:44.016 --> 00:16:48.296
We're not taking care of them. So we can't use 340B medications on those because
00:16:48.296 --> 00:16:50.476
they don't meet the 340B patient definition.
00:16:50.756 --> 00:16:55.856
But when you look at it, your covered entity, your staff, your health care team
00:16:55.856 --> 00:16:59.476
is taking care of that patient and you do document what's being administered.
00:16:59.476 --> 00:17:02.536
And it does make it back into a medical record.
00:17:03.336 --> 00:17:07.736
Oftentimes it's paper documentation that sometimes gets loaded in, you know, much later.
00:17:07.736 --> 00:17:13.476
But being aware of what those different processes are and being able to walk through them,
00:17:14.156 --> 00:17:17.836
addressing them in your policies, and then in your procedures afterwards,
00:17:18.136 --> 00:17:22.436
kind of making sure that you've accounted for those things that don't necessarily
00:17:22.436 --> 00:17:23.756
fall in the black and white.
00:17:24.556 --> 00:17:30.116
I think a good example of that is that may or may not fit that test would be
00:17:30.116 --> 00:17:36.416
psychiatrist. In my experience and my history at a health center,
00:17:37.544 --> 00:17:44.504
I could tell you that my psychiatrist notes were as in-depth or more so than
00:17:44.504 --> 00:17:45.724
primary care providers.
00:17:45.844 --> 00:17:50.824
So I would feel comfortable in my situation where I've seen other notes from
00:17:50.824 --> 00:17:55.584
psychiatrists that do not go in-depth into MedList and doing that comprehensive
00:17:55.584 --> 00:18:00.704
review of the patient where it might be a little less gray to classify that.
00:18:00.864 --> 00:18:05.804
So you really have to look at the specifics of your program and how it's set
00:18:05.804 --> 00:18:08.164
up. Pharmacists are another example of that.
00:18:08.444 --> 00:18:15.164
We're hearing that a lot of covered entities are choosing to qualify 340B status
00:18:15.164 --> 00:18:18.084
based on an interaction with a pharmacist.
00:18:18.484 --> 00:18:22.084
Well, what's that look like? Because I can make an argument for it,
00:18:22.204 --> 00:18:26.584
but then I see a lot of times that that may not meet the intent of the program.
00:18:26.924 --> 00:18:32.944
So you need to look, is that comprehensive medication and health review happening?
00:18:33.384 --> 00:18:35.924
Is it making it an eligible encounter?
00:18:36.384 --> 00:18:42.304
Is that proving responsibility of care? I think you can tie that right back to, is it episodic care?
00:18:42.424 --> 00:18:45.084
Is it a one-time visit to capture eligibility?
00:18:45.424 --> 00:18:50.864
Or is it ongoing care to, you know, comprehensively take care of the patient?
00:18:51.244 --> 00:18:54.044
Yeah, and I think that brings up like a bit of noise, right?
00:18:54.124 --> 00:18:57.384
Because the question is, you know let's
00:18:57.384 --> 00:18:59.924
just think about an independent pharmacy and
00:18:59.924 --> 00:19:03.364
the pharmacist is they're filling a prescription for
00:19:03.364 --> 00:19:06.144
a patient right and so I think that's why
00:19:06.144 --> 00:19:09.064
there's so much confusion about this is because we're just looking
00:19:09.064 --> 00:19:12.144
at the term patient and though that's what it says we
00:19:12.144 --> 00:19:15.784
still want to be good stewards of the program right and so just because you
00:19:15.784 --> 00:19:19.904
fill the prescription for someone as a pharmacist though in your pharmacy
00:19:19.904 --> 00:19:25.004
life, Logan, you may say yeah that's my patient I don't think that just filling
00:19:25.004 --> 00:19:30.424
the prescription for a patient or a human is necessarily deeming them a
00:19:30.424 --> 00:19:31.964
patient in 340B eyes, right?
00:19:32.104 --> 00:19:36.644
Now, can you do MTMs? Can you do other things that make that appropriate? Yes.
00:19:36.864 --> 00:19:42.784
But, you know, it's this really loose term of patient that makes it difficult
00:19:42.784 --> 00:19:46.104
to define and can cause a lot of confusion among our space.
00:19:46.104 --> 00:19:50.204
I actually I think that's a great point for us to kind of kind of tie this up
00:19:50.204 --> 00:19:53.764
on is that even though there is a lot of gray area,
00:19:53.944 --> 00:19:58.664
we do have language that specifically states that a patient is not a patient
00:19:58.664 --> 00:20:04.784
of the covered entity for 340B purposes if the only service provided is the provision of a drug.
00:20:04.784 --> 00:20:10.244
So if it's just the dispensing of a prescription and there's not more care.
00:20:10.464 --> 00:20:14.864
More supportive care involved, then the covered entity shouldn't be claiming
00:20:14.864 --> 00:20:19.164
responsibility of care for that patient, as far as 340B program is concerned.
00:20:19.364 --> 00:20:22.904
I think it's really important to remember that as covered entities are going
00:20:22.904 --> 00:20:28.204
through those more nuanced or gray areas to come back to that kind of exclusion
00:20:28.204 --> 00:20:31.904
of the patient definition that feels less gray.
00:20:32.809 --> 00:20:36.829
And they're kind of trying to sort that out because this certainly is an area
00:20:36.829 --> 00:20:42.149
where there will continue to be a lot of differing opinions and approaches until
00:20:42.149 --> 00:20:46.809
we see legislation that provides more concrete direction.
00:20:47.189 --> 00:20:50.489
Yeah, absolutely. And again, it's all at the end of the day,
00:20:50.609 --> 00:20:51.909
this is an amazing program.
00:20:52.069 --> 00:20:56.129
The 340B program is an amazing program for our patients and our safety net providers.
00:20:56.909 --> 00:21:01.049
And again, I'll keep harping on the fact that I don't really know a lot of the
00:21:01.049 --> 00:21:04.909
other entities like y'all. You have more experience with different grantees and stuff.
00:21:05.069 --> 00:21:09.129
I've really focused my career on the FQHC market, but you know,
00:21:09.449 --> 00:21:13.829
for FQHCs, in my eyes, this is what the program was intended for, right?
00:21:14.149 --> 00:21:16.729
We're taking care of patients who need us to take care of them.
00:21:16.829 --> 00:21:18.409
That's the whole reason an FQHC is there.
00:21:19.029 --> 00:21:24.289
We have single audits once a year where a CPA firm comes in and confirms that
00:21:24.289 --> 00:21:27.809
we're spending those dollars within the scope of our 330 grant.
00:21:27.989 --> 00:21:30.849
That's a requirement. And a lot of people don't think about that when they say,
00:21:30.949 --> 00:21:36.069
you know, there's arguments that 340B is abused and that they're not spending it how they should be.
00:21:36.969 --> 00:21:41.809
Go to any FQHC. I can show you the single audit report, where we can prove that information.
00:21:41.949 --> 00:21:46.069
Someone has tested this and submitted that information to the federal audit clearinghouse.
00:21:46.909 --> 00:21:51.889
And, but all that being said, this great program that gives back to our patients,
00:21:52.029 --> 00:21:54.449
helped us provide additional services to our patients.
00:21:55.049 --> 00:22:00.049
We want it to exist. So I think this can't be the wild wild west we have to
00:22:00.049 --> 00:22:02.409
be good stewards of the program and we have to,
00:22:03.209 --> 00:22:07.069
participate in a manner that makes sense for everybody and
00:22:07.069 --> 00:22:10.689
I just really want to harp on that like yes, you
00:22:10.689 --> 00:22:14.949
know you should maximize it 330 grant requires that we maximize third-party
00:22:14.949 --> 00:22:19.029
payers and all these things, but please be a good steward of the program you
00:22:19.029 --> 00:22:22.789
know I want to see it here for a while I want to see our patients be able
00:22:22.789 --> 00:22:27.789
to to seek these savings that that is contributed from the 340B program.
00:22:28.029 --> 00:22:31.709
And I think it starts at the top, right?
00:22:31.769 --> 00:22:36.629
I think it starts with people like us who are in positions to advise different
00:22:36.629 --> 00:22:39.469
people in the community, around the country.
00:22:40.569 --> 00:22:45.509
We really need to take some good stewardship notes as well, right?
00:22:45.629 --> 00:22:51.649
Because my biggest fear is that consultants can cause this to
00:22:51.649 --> 00:22:53.929
be crazy, and it really doesn't need to be.
00:22:54.009 --> 00:22:57.529
And I think that, I think we wear that hat very well inside our firm.
00:22:58.169 --> 00:23:01.249
But I think that's where it starts. Like, who's advising us?
00:23:01.389 --> 00:23:05.329
Those people need to have good head on their shoulders and, you know,
00:23:06.029 --> 00:23:07.989
care about the program, not just money.
00:23:08.189 --> 00:23:11.789
It's, you know, sometimes that gets caught up. I think that's something,
00:23:12.229 --> 00:23:15.749
like you said, at our firm, a lot of us came from FQHCs.
00:23:16.009 --> 00:23:22.969
So we understand the mission, we understand the purpose, and we're very protective over the program.
00:23:23.169 --> 00:23:28.609
So really keeping in mind that being a good steward of the program and defending
00:23:28.609 --> 00:23:31.889
the intent of it. That way it's there for decades to come.
"340B is not a set-it-and-forget-it program. So much of this is run on technology, data & automation. If you rely on that, solely, you're going to find yourself in some trouble."
Meet Logan Yoho, PharmD, BCACP, 340B ACE, and co-host of the 340Banter Podcast. With nearly a decade of experience in the 340B industry, Logan is dedicated to helping health centers optimize and maintain successful, compliant 340B Programs. As Director of Advocacy and Education at FQHC 340B Compliance, he focuses on implementing entity-owned pharmacies and guiding advocacy efforts for 340B. Logan’s extensive background includes leading the pharmacy and 340B programs at Hopewell Health Centers, serving as Apexus 340B University Faculty, and chairing the Ohio 340B FQHC Consortium. Logan’s leadership and expertise have earned him multiple awards, and he brings a wealth of knowledge to every episode of 340Banter.
Meet Chelsea Violette, PharmD, BCACP, 340B ACE, and your co-host for the 340Banter Podcast. With over a decade of experience in pharmacy and 340B Program management, Chelsea brings a wealth of knowledge to the table. As Chief Operating Officer at FQHC 340B Compliance, she works tirelessly to support health centers across the country, ensuring they have the tools and strategies they need to succeed. Chelsea’s hands-on experience as a 340B Consultant and Pharmacy Manager, combined with her expertise as a subject matter expert for the Apexus 340B Prime Vendor Program, makes her a trusted voice in the world of 340B compliance. Tune in for her practical insights, guidance, and lively discussions on all things 340B.
00:00:00.017 --> 00:00:04.837
Welcome to 340 Banter. With recent litigation and HRSA audit trends,
00:00:05.077 --> 00:00:08.857
a hot topic that's been on everyone's minds lately has been patient definition
00:00:08.857 --> 00:00:10.457
and responsibility of care.
00:00:10.797 --> 00:00:14.937
So today we're going to delve into the nuances of determining and applying patient
00:00:14.937 --> 00:00:17.337
definition through different covered entities.
00:00:17.520 --> 00:00:37.520
Music.
00:00:37.297 --> 00:00:40.217
I'm super excited that we're finally here you
00:00:40.217 --> 00:00:43.237
know we've been working on this podcast and kind
00:00:43.237 --> 00:00:46.077
of developing what we want this to be I feel like
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we're ready, I feel like we're going to be there, the hope and
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kind of my dream as we've been talking about this is that
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it feels like when the night
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of a conference right you go to conference all day you do your sessions
00:00:59.297 --> 00:01:04.897
and then everyone kind of relaxes after that last session everyone relaxes and
00:01:04.897 --> 00:01:09.477
you meet down in the lobby and we start having great conversations some personal,
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some 340B specific and really excited to see that play out here and see what we can do with it.
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I think something I've noticed is that when I entered 340B, there wasn't much
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content out on the internet you really had to dig for content.
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And we've seen a lot of different webinars and opportunities like that
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are more structured come out, but there's less of this casual conversation,
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just discussing the topics in more of a relaxed manner
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and we think that this is a great opportunity for stakeholders in the 340B program
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to really learn about these topics from a different perspective.
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I couldn't agree more. And I think that in a lot of the conferences we've been
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to recently in thinking about a lot of the topics that have been on webinars
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and newsletters and things,
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one of those hot topics that seems to come up in the lobby after a conference
00:02:02.157 --> 00:02:06.517
when people just can't seem to stop talking about work is patient definition.
00:02:06.917 --> 00:02:12.237
There's been a lot of talk about it, you know, based on different lawsuits and
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different applications within policy and procedure
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and I think that might be a good place for us to start kind of kicking things
00:02:18.777 --> 00:02:22.017
around. Yeah, what we've seen is that...
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Health centers, hospitals, other covered entities are just struggling to take
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all this massive amount of information and pare it down to what they actually need.
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It's a challenge because you're dealing with different stakeholder types that
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are coming to the program in different aspects. You look at hospitals that are
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more episodic in care compared to an FQHC that might be the patient-centered medical home.
00:02:46.525 --> 00:02:49.025
So it's a different perspective. So it does get challenging,
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but I think that there are opportunities to really improve your 340B program
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by taking a deep look at how you're defining your patient definition and making sure it's one,
00:03:01.105 --> 00:03:04.565
compliant because we ultimately want a compliant program,
00:03:05.025 --> 00:03:09.585
but two, that it provides the opportunities to expand your patient care as much as possible.
00:03:09.785 --> 00:03:14.845
I think my biggest recommendation on anything when consulting is don't do something
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that you don't understand. And I think that's where a lot of folks are.
00:03:19.765 --> 00:03:23.285
And I think that's where a lot of folks are going to find trouble is,
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you know, they're going to hear something at a conference or they see something
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that a consultant or some vendor has sent out and not understand the nuts and bolts of it.
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And that really kind of scares me. Now, you know, we have a great team of consultants.
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I believe we have the best consultants in the country.
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But with that, we get a deeper understanding, right? We can all kind of feed off each other.
00:03:45.445 --> 00:03:49.445
And, we've seen that internally on internal calls, right?
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Where we're like, someone will bring, oh, this is great cause we can do this.
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And then the other person, not in a mean way, but kind of tears it down of here's
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the reasons why I don't think that's appropriate.
00:03:59.045 --> 00:04:04.545
And so we get that luxury, but inside a health center, you're not going to have that in most cases.
00:04:04.685 --> 00:04:08.665
Right. And so I think it's really important that if when you,
00:04:08.705 --> 00:04:13.565
especially patient definition is like, understand why you're doing what you're doing.
00:04:14.434 --> 00:04:17.474
I totally agree with you with it being a patient-centered medical home.
00:04:17.634 --> 00:04:22.634
You know, you're responsible for the patient. And if the federal statute says
00:04:22.634 --> 00:04:27.794
that you cannot provide 340B products to someone who is not a patient of the
00:04:27.794 --> 00:04:30.534
organization, that can be fairly broad.
00:04:30.834 --> 00:04:34.754
But I think for, you know, maybe a hospital or someone that may have a different take.
00:04:34.894 --> 00:04:38.574
And what are your thoughts? You know, for me personally, I've grown up in my professional
00:04:38.574 --> 00:04:42.214
career in the FQHC market, right? I live and breathe FQHCs.
00:04:42.874 --> 00:04:46.794
That's what I know. And you've spent, though, you know tons about FQHCs,
00:04:47.014 --> 00:04:49.394
you've also spent a lot of time consulting hospitals.
00:04:49.674 --> 00:04:54.974
And so my question would be, what would be your take that makes it a little
00:04:54.974 --> 00:04:58.374
bit different in the hospital market than it does in the FQHC market when we're
00:04:58.374 --> 00:05:02.434
talking about this new patient definition that people are
00:05:02.754 --> 00:05:06.254
not new, but statutory patient definition?
00:05:06.634 --> 00:05:13.074
What do you see as the differences, and what should people be aware of from the hospital industry?
00:05:13.594 --> 00:05:16.974
Honestly, my response is going to be more expansive than just the hospital industry,
00:05:17.014 --> 00:05:22.014
because I think that the same concept applies, is that you're responsible for the patient's care.
00:05:22.654 --> 00:05:29.494
And we have, outside of 340B, so many other accrediting bodies that look at what a patient is.
00:05:29.614 --> 00:05:32.814
So for hospitals and for health centers, you might have the Joint Commission.
00:05:33.074 --> 00:05:36.534
For health centers, we also have AAAHC or NCQA.
00:05:37.218 --> 00:05:39.818
Probably a million other things that hospitals and health centers have,
00:05:39.958 --> 00:05:44.878
but they all have specific criteria. Even thinking about UDS measures for health
00:05:44.878 --> 00:05:50.218
centers, there are specific criteria for what is a patient of the covered entity
00:05:50.218 --> 00:05:51.778
of the health center in that instance.
00:05:52.158 --> 00:05:56.778
And it helps to be able to take a step back and say, as a health center in general,
00:05:56.978 --> 00:05:59.138
outside of 340B, what do we consider our patient?
00:05:59.438 --> 00:06:03.498
And how does that play into the 340B program? From a hospital standpoint,
00:06:03.498 --> 00:06:08.038
point. Your patients that are there for episodic care are very much like the
00:06:08.038 --> 00:06:11.478
patients that you get at a health center for walk-in care or urgent care that
00:06:11.478 --> 00:06:13.258
aren't your patients long-term.
00:06:13.458 --> 00:06:17.978
So you're there taking care of them for that episode, for that acute instance.
00:06:18.158 --> 00:06:23.098
But you also, in hospitals, have medical office buildings and other services
00:06:23.098 --> 00:06:26.338
where you are responsible for the care of the patient over the long-term.
00:06:26.478 --> 00:06:30.358
You are having ongoing responsibility of care. And in those instances,
00:06:30.358 --> 00:06:34.418
it does make sense, just like with the patient-centered medical home,
00:06:34.558 --> 00:06:37.098
to approach it from a more holistic point of view, I feel like.
00:06:37.538 --> 00:06:41.358
And then, again, if you go back to those accreditation standards for those other
00:06:41.358 --> 00:06:44.718
bodies, you're going to see it represented there as well. So you have additional
00:06:44.718 --> 00:06:47.738
documentation and rationale to back up your approach.
00:06:48.098 --> 00:06:52.658
I think that's a good point. I think your policy and procedures are always stronger
00:06:52.658 --> 00:06:53.718
when you have a rationale.
00:06:54.058 --> 00:06:58.238
If you can point to a specific reason as to why you chose a,
00:06:58.238 --> 00:07:03.638
say it's a two-year patient definition that the patients had to have been seen
00:07:03.638 --> 00:07:08.158
in the last 24 months, if you can point to another guideline that shows that
00:07:08.158 --> 00:07:09.658
that is what defines a patient,
00:07:09.918 --> 00:07:12.178
it makes your position even stronger.
00:07:13.038 --> 00:07:18.398
That's something we always try to do is include links to guidance documents and other
00:07:19.385 --> 00:07:23.705
statutes and different programs that would support that,
00:07:23.865 --> 00:07:31.265
for example, the 330 language for FQHCs has very specific language in what makes
00:07:31.265 --> 00:07:32.725
a health center patient a patient.
00:07:32.765 --> 00:07:38.105
So I think that that is a good practice when you're writing those policies and procedures.
00:07:38.105 --> 00:07:43.225
And so what you're saying is essentially, you don't want to just put on there
00:07:43.225 --> 00:07:48.785
that a patient that has been seen in the past 24 months is a patient and your
00:07:48.785 --> 00:07:52.385
support for that be, well, because my consultant told me I could do that, right?
00:07:52.385 --> 00:07:55.905
And I think that's a good practice in life in general, right?
00:07:55.985 --> 00:08:00.105
Let's find some authoritative guidance, something that we can utilize that's
00:08:00.105 --> 00:08:05.445
set in stone, whether it comes from the government, whether it comes from payers, right?
00:08:05.605 --> 00:08:08.745
Sometimes that can be a play as far as what's considered a patient.
00:08:09.265 --> 00:08:13.045
So I think it's really interesting. And again, though consultants are great,
00:08:13.205 --> 00:08:15.405
and I love consultants. Obviously, we are consultants.
00:08:16.205 --> 00:08:18.865
It's totally good and okay for us to say
00:08:18.865 --> 00:08:21.745
hey that's great, but can you can you
00:08:21.745 --> 00:08:25.605
show me where I can find that and some regulations or you know what I mean I
00:08:25.605 --> 00:08:30.185
feel like we need support for things not just well they're well known and we
00:08:30.185 --> 00:08:34.845
should listen to them I think you know always do your due diligence right and
00:08:34.845 --> 00:08:39.085
so I think that's a great point from both y'all and
00:08:39.725 --> 00:08:44.185
patient definition it's funny it's actually been kind of tested for some time
00:08:44.185 --> 00:08:49.405
now right. There's another vendor that years ago was telling
00:08:49.405 --> 00:08:51.725
me about this and was like, no, why don't you have everyone doing,
00:08:51.925 --> 00:08:52.905
you know, look at the statute.
00:08:53.085 --> 00:08:56.005
And I'm like, I don't know. I just don't feel comfortable. I don't feel comfortable.
00:08:56.145 --> 00:08:57.205
I don't feel comfortable with that.
00:08:57.665 --> 00:09:01.945
And so. Well, because the statute itself doesn't say anything about drugs, right?
00:09:02.105 --> 00:09:06.825
You got, you got one mention ever. And then it really comes down to that 1996
00:09:06.825 --> 00:09:11.565
guidance, which laid out more criteria, but then you get into the gray area
00:09:11.565 --> 00:09:16.585
of guidance isn't necessarily enforceable. Well, yeah, so I think it's tougher.
00:09:16.945 --> 00:09:21.645
And I think you mentioning feeling comfortable, I think is an important point.
00:09:22.635 --> 00:09:26.395
It would not be something that I would recommend if you weren't doing referral
00:09:26.395 --> 00:09:30.555
capture at all, jumping to a statutory patient definition.
00:09:30.675 --> 00:09:34.455
That doesn't feel like a logical jump, a logical progression
00:09:34.475 --> 00:09:37.075
because you're skipping a few steps in between.
00:09:37.075 --> 00:09:45.335
So I whenever I'm having these discussions about if a program is OK or an interpretation is OK,
00:09:45.715 --> 00:09:52.655
my first thing I like to talk to that person about is ask them, does it feel OK?
00:09:52.655 --> 00:09:55.035
Because your gut's there for a reason.
00:09:55.455 --> 00:10:01.055
And sometimes if you step back and think, if I were in a HRSA audit,
00:10:01.355 --> 00:10:03.675
would I feel comfortable defending this?
00:10:04.255 --> 00:10:08.815
That gives you your answer because there's a lot of things I could possibly
00:10:08.815 --> 00:10:12.015
defend in a HRSA audit that I don't feel comfortable with.
00:10:12.075 --> 00:10:18.455
And it's not worth stretching the intent of the program to be able to capture a few more dollars.
00:10:18.675 --> 00:10:23.195
I actually had a conversation at the end of last week specifically about that
00:10:23.195 --> 00:10:25.855
level of comfort in grayer areas.
00:10:25.855 --> 00:10:30.355
So your policy, you know, we mentioned that a common one for health centers
00:10:30.355 --> 00:10:34.895
is that you've seen a patient within the last 24 months, which is pretty standard.
00:10:35.015 --> 00:10:37.055
It's used for a lot of UDS measures.
00:10:37.255 --> 00:10:41.635
Makes sense. But looking at your actual operations and procedures,
00:10:41.915 --> 00:10:45.555
you can have your policy be one thing and then your procedures be a little bit
00:10:45.555 --> 00:10:48.475
more specific and nuanced.
00:10:48.515 --> 00:10:53.495
And we were talking about how for really drilling down into how do you know
00:10:53.495 --> 00:10:55.775
if you've seen a patient the last two years, how do you know that they're still
00:10:55.775 --> 00:11:00.015
your patient if there's not like a formal discharge to another organization?
00:11:00.295 --> 00:11:03.295
And one of the things I talked about was that when I'm working,
00:11:03.295 --> 00:11:07.255
you know, with our referral clients, looking at the patient themselves,
00:11:07.555 --> 00:11:12.535
if it's a young, healthy individual, It's not uncommon for someone to not have
00:11:12.535 --> 00:11:15.235
an annual visit. You know, maybe they come in every 18 months.
00:11:15.595 --> 00:11:18.655
So if that's the last time they were seen was 18 months ago,
00:11:18.815 --> 00:11:21.395
they, you know, they got prescriptions, they're getting refills, whatever.
00:11:22.302 --> 00:11:27.382
Reasonably or reasonable to expect that they're still using the covered entities,
00:11:27.602 --> 00:11:28.982
the primary health care provider.
00:11:29.382 --> 00:11:34.182
By contrast, you've got a 75-year-old with 10 comorbidities and 15 drugs,
00:11:34.342 --> 00:11:35.782
and they haven't been in 18 months,
00:11:35.882 --> 00:11:38.682
it's likely they're seeing someone else for primary care.
00:11:38.882 --> 00:11:44.462
So being able to apply some gray area and nuance within your procedures and
00:11:44.462 --> 00:11:49.862
your operations so that you don't end up in a situation where you're like, does this feel good? No.
00:11:50.062 --> 00:11:53.802
Does it technically meet our policy. We've seen them in the last 24 months? Yes.
00:11:53.942 --> 00:11:58.302
But if I was asked in a HRSA audit to defend that I'm responsible for this patient's
00:11:58.302 --> 00:12:00.082
care, I probably wouldn't.
00:12:00.402 --> 00:12:05.542
I work with health centers in a similar situation that their procedure,
00:12:06.042 --> 00:12:10.902
policies and procedures, are pretty broad and go to that 24-month definition.
00:12:11.242 --> 00:12:15.602
But in practice, they actually, we hear about closing the loop.
00:12:15.902 --> 00:12:20.142
In practice, they do that because it's good clinical care. We want to see that
00:12:20.142 --> 00:12:25.322
referral going out to the provider and see a consult note coming back in.
00:12:25.462 --> 00:12:28.762
That's just taking care of the patient and doing what we should as clinicians.
00:12:28.762 --> 00:12:30.142
I'm a pharmacist by trade.
00:12:30.282 --> 00:12:35.482
That's what I want to see happen for the patient care. But in some cases,
00:12:35.482 --> 00:12:39.822
that's not possible, so they set their procedure as being a little broad.
00:12:40.002 --> 00:12:43.502
That way, if that falls through and doesn't happen, they're not in violation.
00:12:43.842 --> 00:12:48.222
But they're still, they have the intent to make that their practice.
00:12:48.862 --> 00:12:51.422
Yeah. And I think it's a really good, you know.
00:12:52.262 --> 00:12:56.642
What both of you said is a good time to say, you know, 340B is not a set it
00:12:56.642 --> 00:12:58.002
and forget it program, right?
00:12:58.122 --> 00:13:02.482
It's not some, and that's the thing is so much of this is ran on technology
00:13:02.482 --> 00:13:04.502
and data and automation.
00:13:05.322 --> 00:13:08.602
If you rely on that solely, you're going to find yourself in some trouble,
00:13:08.722 --> 00:13:12.182
right? And so you need people, you need people to be in there operating.
00:13:12.402 --> 00:13:15.962
You need people to be having opinions on this stuff and kind of,
00:13:16.462 --> 00:13:20.522
you know, things stand out to you, to people. And if you don't code
00:13:20.522 --> 00:13:24.642
this computer to catch every little oddball thing, it's going to slip through the cracks.
00:13:24.702 --> 00:13:28.882
And so I think that's super important, especially because
00:13:28.882 --> 00:13:32.802
I think a lot of vendors are pushing people to do this because you're going to process more claims.
00:13:32.982 --> 00:13:35.182
It's better for your organization and your patients.
00:13:35.482 --> 00:13:38.782
But at the end of the day, the vendor, this is the 340B program.
00:13:39.342 --> 00:13:43.002
The covered entity is the one who's responsible for noncompliance, right?
00:13:43.122 --> 00:13:47.102
Whether that be reimbursements or paybacks that we have to do for non-eligible
00:13:47.102 --> 00:13:48.082
claims that were deemed.
00:13:48.682 --> 00:13:52.282
Not the vendor, and I put ourselves in the hot seat.
00:13:52.842 --> 00:13:55.662
We advise a lot of clients on what to do and what should be appropriate,
00:13:55.662 --> 00:13:58.582
but we really want them to understand because at the end of the day,
00:13:58.742 --> 00:14:02.522
it's not me on the line. It is the covered entity.
00:14:02.922 --> 00:14:08.102
Now, I mean, some degree reputation wise is on the line, but I think it goes
00:14:08.102 --> 00:14:11.682
back to that concept of you should be at least comfortable.
00:14:11.922 --> 00:14:14.942
You don't have to know every single in and out if your organization is going
00:14:14.942 --> 00:14:19.622
this certain route, but you should be comfortable and have a common sense test
00:14:19.622 --> 00:14:23.722
to say, does this make sense in my brain? Is this something that we should be doing?
00:14:23.922 --> 00:14:28.362
And if you have pause, figure out why you have that pause and see if you can prove it wrong.
00:14:28.962 --> 00:14:34.182
What do you see as the biggest concern
00:14:35.982 --> 00:14:39.902
regarding not just health centers, but covered entities and patient definition
00:14:39.902 --> 00:14:44.842
and making sure we don't set it and forget it?
00:14:44.962 --> 00:14:47.782
Like, what are the areas that we could pick out to say these are the ones you
00:14:47.782 --> 00:14:49.402
really want to watch out for?
00:14:49.982 --> 00:14:54.742
Any concept, any ideas on that? I think the first thing that comes to my mind
00:14:54.742 --> 00:14:59.482
is thinking of your policy and procedure as a living document and that you're
00:14:59.482 --> 00:15:00.902
revisiting it regularly.
00:15:01.302 --> 00:15:06.362
Often, those are documents that no one reads other than once and then they get
00:15:06.362 --> 00:15:10.642
stuck in a file within your computer, and you don't look at them until the next
00:15:10.642 --> 00:15:11.742
time they need to be reviewed.
00:15:12.342 --> 00:15:13.962
So making sure that you're sitting
00:15:13.962 --> 00:15:19.642
down with your 340B program oversight committee and going through it.
00:15:20.042 --> 00:15:24.402
Maybe you do it every six months. Maybe you do it once a year to make sure what's
00:15:24.402 --> 00:15:26.142
in there is what you're actually doing.
00:15:26.462 --> 00:15:30.882
Because that's one of the worst mistakes you can make when you go into a HRSA
00:15:30.882 --> 00:15:35.102
audit is if your actual practices are not
00:15:36.076 --> 00:15:39.356
compliant with your policy and procedure.
00:15:39.636 --> 00:15:42.876
I think kind of going along with the policies and procedures,
00:15:43.056 --> 00:15:47.936
but also thinking about those nuances of operations, trying to think through
00:15:47.936 --> 00:15:53.796
the places in your program where there might be more gray area around patient definition.
00:15:53.796 --> 00:15:57.956
I know we commonly get questions about patients who are only dental patients
00:15:57.956 --> 00:16:01.916
of the covered entity or only mental health patients of the covered entity.
00:16:01.916 --> 00:16:05.496
And it's really hard from either of those standpoints to say that you're responsible
00:16:05.496 --> 00:16:10.336
for the patient's care as a whole because I don't know any dentists that do
00:16:10.336 --> 00:16:12.956
comprehensive assessments of a patient's diabetes,
00:16:13.636 --> 00:16:16.956
hypertension, and asthma before doing a cleaning.
00:16:16.956 --> 00:16:20.536
So it's really hard to say that you're responsible for their care there.
00:16:20.956 --> 00:16:26.496
Being able to kind of suss those out. I think another one we see is emergency meds.
00:16:26.636 --> 00:16:30.456
So emergency kits or code carts because you may be utilizing the medications
00:16:30.456 --> 00:16:35.616
in those on individuals that didn't come to your clinic for a visit or didn't
00:16:35.616 --> 00:16:36.696
come to your hospital for a visit.
00:16:36.796 --> 00:16:40.356
But something happened to them while they're on the premises and you're going to take care of them.
00:16:40.556 --> 00:16:43.756
So there are some folks that will say, well, they're not our patient.
00:16:44.016 --> 00:16:48.296
We're not taking care of them. So we can't use 340B medications on those because
00:16:48.296 --> 00:16:50.476
they don't meet the 340B patient definition.
00:16:50.756 --> 00:16:55.856
But when you look at it, your covered entity, your staff, your health care team
00:16:55.856 --> 00:16:59.476
is taking care of that patient and you do document what's being administered.
00:16:59.476 --> 00:17:02.536
And it does make it back into a medical record.
00:17:03.336 --> 00:17:07.736
Oftentimes it's paper documentation that sometimes gets loaded in, you know, much later.
00:17:07.736 --> 00:17:13.476
But being aware of what those different processes are and being able to walk through them,
00:17:14.156 --> 00:17:17.836
addressing them in your policies, and then in your procedures afterwards,
00:17:18.136 --> 00:17:22.436
kind of making sure that you've accounted for those things that don't necessarily
00:17:22.436 --> 00:17:23.756
fall in the black and white.
00:17:24.556 --> 00:17:30.116
I think a good example of that is that may or may not fit that test would be
00:17:30.116 --> 00:17:36.416
psychiatrist. In my experience and my history at a health center,
00:17:37.544 --> 00:17:44.504
I could tell you that my psychiatrist notes were as in-depth or more so than
00:17:44.504 --> 00:17:45.724
primary care providers.
00:17:45.844 --> 00:17:50.824
So I would feel comfortable in my situation where I've seen other notes from
00:17:50.824 --> 00:17:55.584
psychiatrists that do not go in-depth into MedList and doing that comprehensive
00:17:55.584 --> 00:18:00.704
review of the patient where it might be a little less gray to classify that.
00:18:00.864 --> 00:18:05.804
So you really have to look at the specifics of your program and how it's set
00:18:05.804 --> 00:18:08.164
up. Pharmacists are another example of that.
00:18:08.444 --> 00:18:15.164
We're hearing that a lot of covered entities are choosing to qualify 340B status
00:18:15.164 --> 00:18:18.084
based on an interaction with a pharmacist.
00:18:18.484 --> 00:18:22.084
Well, what's that look like? Because I can make an argument for it,
00:18:22.204 --> 00:18:26.584
but then I see a lot of times that that may not meet the intent of the program.
00:18:26.924 --> 00:18:32.944
So you need to look, is that comprehensive medication and health review happening?
00:18:33.384 --> 00:18:35.924
Is it making it an eligible encounter?
00:18:36.384 --> 00:18:42.304
Is that proving responsibility of care? I think you can tie that right back to, is it episodic care?
00:18:42.424 --> 00:18:45.084
Is it a one-time visit to capture eligibility?
00:18:45.424 --> 00:18:50.864
Or is it ongoing care to, you know, comprehensively take care of the patient?
00:18:51.244 --> 00:18:54.044
Yeah, and I think that brings up like a bit of noise, right?
00:18:54.124 --> 00:18:57.384
Because the question is, you know let's
00:18:57.384 --> 00:18:59.924
just think about an independent pharmacy and
00:18:59.924 --> 00:19:03.364
the pharmacist is they're filling a prescription for
00:19:03.364 --> 00:19:06.144
a patient right and so I think that's why
00:19:06.144 --> 00:19:09.064
there's so much confusion about this is because we're just looking
00:19:09.064 --> 00:19:12.144
at the term patient and though that's what it says we
00:19:12.144 --> 00:19:15.784
still want to be good stewards of the program right and so just because you
00:19:15.784 --> 00:19:19.904
fill the prescription for someone as a pharmacist though in your pharmacy
00:19:19.904 --> 00:19:25.004
life, Logan, you may say yeah that's my patient I don't think that just filling
00:19:25.004 --> 00:19:30.424
the prescription for a patient or a human is necessarily deeming them a
00:19:30.424 --> 00:19:31.964
patient in 340B eyes, right?
00:19:32.104 --> 00:19:36.644
Now, can you do MTMs? Can you do other things that make that appropriate? Yes.
00:19:36.864 --> 00:19:42.784
But, you know, it's this really loose term of patient that makes it difficult
00:19:42.784 --> 00:19:46.104
to define and can cause a lot of confusion among our space.
00:19:46.104 --> 00:19:50.204
I actually I think that's a great point for us to kind of kind of tie this up
00:19:50.204 --> 00:19:53.764
on is that even though there is a lot of gray area,
00:19:53.944 --> 00:19:58.664
we do have language that specifically states that a patient is not a patient
00:19:58.664 --> 00:20:04.784
of the covered entity for 340B purposes if the only service provided is the provision of a drug.
00:20:04.784 --> 00:20:10.244
So if it's just the dispensing of a prescription and there's not more care.
00:20:10.464 --> 00:20:14.864
More supportive care involved, then the covered entity shouldn't be claiming
00:20:14.864 --> 00:20:19.164
responsibility of care for that patient, as far as 340B program is concerned.
00:20:19.364 --> 00:20:22.904
I think it's really important to remember that as covered entities are going
00:20:22.904 --> 00:20:28.204
through those more nuanced or gray areas to come back to that kind of exclusion
00:20:28.204 --> 00:20:31.904
of the patient definition that feels less gray.
00:20:32.809 --> 00:20:36.829
And they're kind of trying to sort that out because this certainly is an area
00:20:36.829 --> 00:20:42.149
where there will continue to be a lot of differing opinions and approaches until
00:20:42.149 --> 00:20:46.809
we see legislation that provides more concrete direction.
00:20:47.189 --> 00:20:50.489
Yeah, absolutely. And again, it's all at the end of the day,
00:20:50.609 --> 00:20:51.909
this is an amazing program.
00:20:52.069 --> 00:20:56.129
The 340B program is an amazing program for our patients and our safety net providers.
00:20:56.909 --> 00:21:01.049
And again, I'll keep harping on the fact that I don't really know a lot of the
00:21:01.049 --> 00:21:04.909
other entities like y'all. You have more experience with different grantees and stuff.
00:21:05.069 --> 00:21:09.129
I've really focused my career on the FQHC market, but you know,
00:21:09.449 --> 00:21:13.829
for FQHCs, in my eyes, this is what the program was intended for, right?
00:21:14.149 --> 00:21:16.729
We're taking care of patients who need us to take care of them.
00:21:16.829 --> 00:21:18.409
That's the whole reason an FQHC is there.
00:21:19.029 --> 00:21:24.289
We have single audits once a year where a CPA firm comes in and confirms that
00:21:24.289 --> 00:21:27.809
we're spending those dollars within the scope of our 330 grant.
00:21:27.989 --> 00:21:30.849
That's a requirement. And a lot of people don't think about that when they say,
00:21:30.949 --> 00:21:36.069
you know, there's arguments that 340B is abused and that they're not spending it how they should be.
00:21:36.969 --> 00:21:41.809
Go to any FQHC. I can show you the single audit report, where we can prove that information.
00:21:41.949 --> 00:21:46.069
Someone has tested this and submitted that information to the federal audit clearinghouse.
00:21:46.909 --> 00:21:51.889
And, but all that being said, this great program that gives back to our patients,
00:21:52.029 --> 00:21:54.449
helped us provide additional services to our patients.
00:21:55.049 --> 00:22:00.049
We want it to exist. So I think this can't be the wild wild west we have to
00:22:00.049 --> 00:22:02.409
be good stewards of the program and we have to,
00:22:03.209 --> 00:22:07.069
participate in a manner that makes sense for everybody and
00:22:07.069 --> 00:22:10.689
I just really want to harp on that like yes, you
00:22:10.689 --> 00:22:14.949
know you should maximize it 330 grant requires that we maximize third-party
00:22:14.949 --> 00:22:19.029
payers and all these things, but please be a good steward of the program you
00:22:19.029 --> 00:22:22.789
know I want to see it here for a while I want to see our patients be able
00:22:22.789 --> 00:22:27.789
to to seek these savings that that is contributed from the 340B program.
00:22:28.029 --> 00:22:31.709
And I think it starts at the top, right?
00:22:31.769 --> 00:22:36.629
I think it starts with people like us who are in positions to advise different
00:22:36.629 --> 00:22:39.469
people in the community, around the country.
00:22:40.569 --> 00:22:45.509
We really need to take some good stewardship notes as well, right?
00:22:45.629 --> 00:22:51.649
Because my biggest fear is that consultants can cause this to
00:22:51.649 --> 00:22:53.929
be crazy, and it really doesn't need to be.
00:22:54.009 --> 00:22:57.529
And I think that, I think we wear that hat very well inside our firm.
00:22:58.169 --> 00:23:01.249
But I think that's where it starts. Like, who's advising us?
00:23:01.389 --> 00:23:05.329
Those people need to have good head on their shoulders and, you know,
00:23:06.029 --> 00:23:07.989
care about the program, not just money.
00:23:08.189 --> 00:23:11.789
It's, you know, sometimes that gets caught up. I think that's something,
00:23:12.229 --> 00:23:15.749
like you said, at our firm, a lot of us came from FQHCs.
00:23:16.009 --> 00:23:22.969
So we understand the mission, we understand the purpose, and we're very protective over the program.
00:23:23.169 --> 00:23:28.609
So really keeping in mind that being a good steward of the program and defending
00:23:28.609 --> 00:23:31.889
the intent of it. That way it's there for decades to come.
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