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Oct. 16, 2023

Navigating Pharmacy Law and Regulations | Lucas Morgan, Atty, Frier Levitt

Navigating Pharmacy Law and Regulations | Lucas Morgan, Atty, Frier Levitt
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The Business of Pharmacy™

Lucas Morgan, a partner at Frier Levitt, joins host Mike Koelzer for an in-depth discussion on pharmacy law, working with boards of pharmacy, common issues that pharmacists face, and tips for avoiding trouble.

https://www.frierlevitt.com/about/attorneys/lucas-w-morgan/

[00:00:15] Introducing Lucas Morgan

[00:01:05] Interacting with pharmacy board inspectors

[00:02:56] Mistakes made when dealing directly with boards

[00:04:00] Unique pharmacy regulations by state

[00:05:51] Emotions involved with board disciplinary actions

[00:06:52] The role of intent and negligence

[00:08:06] Discretion given to pharmacy boards

[00:09:47] Challenging board conclusions

[00:11:16] Using boards to determine correct interpretations

[00:12:57] Level of formality in board procedures

[00:15:10] Obtaining advisory opinions from boards

[00:16:29] Requirements for pharmacy operating hours

[00:17:59] Limitations of new pharmacy licenses

[00:20:13] Temporary pharmacy closures

[00:21:05] Saddest disciplinary cases

[00:24:11] Power dynamics with licensing boards

[00:27:42] Differences between mitigating and exculpatory factors

[00:29:34] Violations vs. intent and penalties

[00:32:24] Objectivity challenges with boards

[00:36:54] Transparency in board rulemaking processes

[00:40:10] One action listeners could take regarding boards

[00:42:03] Staying informed on pharmacy laws and regulations

[00:43:04] Challenges researching pharmacy laws

[00:44:17] Value of legal expertise

The Business of Pharmacy Podcast™ offers in-depth, candid conversations with pharmacy business leaders. Hosted by pharmacist Mike Koelzer, each episode covers new topics relevant to pharmacists and pharmacy owners. Listen to a new episode every Monday morning.

Thank you for tuning in to The Business of Pharmacy Podcast™. If you found this episode informative, don't forget to subscribe for more in-depth conversations with pharmacy business leaders every Monday. For additional resources and updates, visit www.bizofpharmpod.com. Together, let's navigate the ever-evolving world of pharmacy business.

Transcript

This transcript was generated automatically. Its accuracy may vary.

[00:00:15] Mike Koelzer, Host: Lucas, for those that haven't come across you online, introduce yourself and tell our listeners what we're talking about today. 

[00:00:23] Lucas Morgan: My name is Lucas Morgan. I'm an attorney and a partner at the law firm, frier Levitt, which is based in New Jersey. And we also have offices in the New York City area. And I work in healthcare and life sciences and we're going to be talking about the Board of Pharmacy today, which on one hand could be perceived as very narrow, but also in many ways can be very broad.

[00:00:44] Mike Koelzer, Host: Lucas, I got to tell you right off the bat here, after, oh golly, how long have I been 30 some years in pharmacy. I had my first bad experience with our pharmacy board and I'm not gonna get into it right now, but if I get really hot later, it's all gonna come out.

[00:01:05] Lucas Morgan: All right, I'll see if I can calm you down if that happens.

[00:01:08] Mike Koelzer, Host: Lucas, how does that work? Are you licensed to work with any state 

[00:01:14] Lucas Morgan: I'm licensed in many different states New York, New Jersey, Texas, just to name a few. There are others, but pretty much every state as it relates to the practice of law has a process that allows for an attorney to work in the state on a temporary

basis. Yes.

[00:01:30] Mike Koelzer, Host: Oh, that's interesting.

[00:01:31] Lucas Morgan: and so anytime that I'm working with a pharmacy in a state where I myself am not licensed to practice law, first I will make sure that the state has that, and the answer is they do, they almost always do.

And then I'll make sure that I get that temporary permission to handle that matter on a case by case basis. 

[00:01:49] Mike Koelzer, Host: Lucas, let's cut to the chase. What's the stupidest thing that pharmacists do?

[00:01:57] Lucas Morgan: The thing that I think is, it's not so much what they do, it's how these things get found out. And one of the big trends that I see is the Board of Pharmacy inspector or Board of Pharmacy personnel coming to the pharmacy for an inspection. And this is where you start to go, wait a minute.

Perhaps it was planned in advance. They knew they were coming, but they think they're really coming to look at one thing. Perhaps it's, Hey, we just made some renovations to put the finishing touches on this process. We need you to come in to approve them and inspect them to see that they were done in a very high quality, safe and effective manner.

And the pharmacy and pharmacist for very practical reasons, expects that the scope of the visit is going to be approving these renovations. And they walk in and say while I was there, it turns out you had five pharmacy technicians working and as far as I can tell, you only had one pharmacist

 It's that idea of walking into an issue completely unknowingly and not realizing that, that could be a basis for something to happen.

[00:03:01] Mike Koelzer, Host: So the pharmacist will open that door, but the inspectors are not blind.

They get interested in what they see and you might get more than you bargained for.

[00:03:16] Lucas Morgan: They might be there for one particular reason, but they're also not blind. 

There's nothing to stop them from en route to, I don't know, use the restroom or something saying, while I was on my way there, I saw that you got some expired medications on the shelf. What's up with that?

[00:03:30] Mike Koelzer, Host: Lucas are the inspectors or the investigators, are they remunerated at all for. The amount of success they've had in bringing things to the board in a negative sense. In other words, do they get incentive to catch more things?

[00:03:52] Lucas Morgan: No think the answer to that is

just a hard

[00:03:55] Mike Koelzer, Host: Somehow they say cops need to get their quota with speeding tickets and things like that.

[00:04:00] Lucas Morgan: The answer to that is a hard no except, except that there's always the but, but I would say any employee of any type of entity is always gonna have the incentive of doing a good job. And I think when someone who works for the Board of Pharmacy is working for a government agency whose mission is protecting the health, safety, and well being of the citizens of their state, when they come in and do an inspection, there is a motivation to do a good, thorough

[00:04:27] Mike Koelzer, Host: To protect, to do a good job.

[00:04:29] Lucas Morgan: yes.

[00:04:30] Mike Koelzer, Host: What's an unwise move the pharmacy can make with the board?

[00:04:38] Lucas Morgan: An unwise move that a pharmacy or a pharmacist can make with the board is handling things on their own without. Legal representation and that obviously I'm sitting here as an attorney and I'm not gonna be shy about that. So that sounds like Lucas, yeah. You're obviously motivated to say that, right?

No, because I've seen horrific consequences of people who have said, I can handle this on my own. And I absolutely see the temptation. One of the things I love about the clientele that I work with is they're really smart. They're very intelligent,

And I think they're used to dealing with very objective issues 

where there's a clear right answer and a clear, wrong answer, or I didn't do anything wrong here, what's the worst that could 

happen, 

and so it goes back to what you think, and I'm just making up a hypothetical. You go to a Board of Pharmacy meeting on your own, handling the matter on your own, without an attorney present, and you think, oh they. Said that I didn't have my hours posted in the window, and I'm just going to go and explain to them that it was just a mistake.

It was an honest mistake. We were cleaning, we had the windows professionally cleaned, we took everything off the windows, including our posted hours. And you happened to catch me in that one moment, and they were up a few days later. Again, it goes back to that notion when you put yourself in front of that board, knowingly and voluntarily on your own, and the board says, would you like to have an attorney here today?

No, I don't. I'm ready to handle this on my own. Okay. And now they ring the bell and everything starts, they can ask you about anything they want, even if it seems unrelated to the core issue that brought you there that day. And if they start asking questions that you weren't prepared to discuss before you know it, you could be talking about a matter that is just going in a whole different direction. Again, these are all hypotheticals, but based loosely on stuff I've seen. Something that's really a high level of priority right now is marketing practices. right? And that's not to suggest that just because an individual goes without an attorney and ends up having to talk about marketing practices that they're doing anything illegal, but they may not be prepared to speak about the legalities or lack thereof of their marketing

practices. 

[00:06:51] Mike Koelzer, Host: When my wife and I are driving around and if I roll through a stop sign, if I do just hypothetically, I might roll through a stop sign and she'll say you just rolled through that stop sign.

And I'll say, Margaret, it's in a condominium association. It's not a real stop sign. Plus it doesn't even look real. It's about half the size and it's on carved wood and stuff like that. I think some people, they don't think of an attorney always with the board because they think it's not a legal thing. It's, Different, It might feel that way, but you might have your license writing on the line this thing that you think is too small to be consequential. .

But I think people don't always think about attorneys because it's like in a Disney world, it's like its own little world, but attorneys sure are needed in that.

[00:07:46] Lucas Morgan: Yeah, you're absolutely right. And I think a good adjective to describe what you're getting at is they think it's informal. That's not the only one, but they think it's informal, which leads them to the notion of being able to handle it on their own effectively. And I totally agree with that and I would actually say it's because you are navigating this kind of very unique and complex area of the law that we would refer to as lawyers, as administrative law.

Because that's exactly what the Board of Pharmacy is. It's an administrative agency. One of the little things a lot of people don't realize, and I certainly didn't know this until I finished law school and started practicing in the area, administrative agencies have a high level of discretion and also are given a very high level of deference when the work that they do is being reviewed by another set of eyes, namely a judge that's reviewing an appeal that's been filed by someone who feels that the board got it wrong in their case.

High level of discretion and a high level of deference is a recipe for good luck getting that thing overturned or overruled by a second set of eyes at a later date. If you don't like what happened, 

[00:08:59] Mike Koelzer, Host: Okay, so let me see if I got this, a lot of times in the movies and maybe Judge Judy, people think they just think it through and they say, you're guilty. But from the courts that I've been in, they don't have a lot of. discretion , every time they say something, especially when given the verdict, they're like, such and such case, this and that. And they quote this and then they say, and on this charge looking back at Smith versus so and so 1962, I they're not like artists.

They don't get to go willy nilly, But your thing, you're saying that in the pharmacy area, that they do maybe have more of that leniency to make up. I don't want to say make up their own mind, but it's a little bit looser.

[00:09:45] Lucas Morgan: Yeah. That's a really good word. think looser and not as strictly adherent to formal rules of procedure, whether that means in how they go about conducting a hearing, whether that is the rules of evidence. Like we know, there's cases that have been in the spotlight, so to speak, because of one reason or another.

Typically, they will be criminal cases. Criminal cases have one of the strictest set of rules as it relates to introducing evidence, 

And the reason is because the stakes there are people's individual and personal liberties and freedoms.

 

The idea is not talking about that.

We're really talking about your license status. And that's just a piece of paper. And, pretty serious. But we're also experts in the field, so we shouldn't have to adhere to those strict rules. This is stuff that textbooks have been written on that alone, so we go on and on.

But that's just one example of some of the formalities that are disposed of when you're dealing with an administrative agency.

[00:10:46] Mike Koelzer, Host: Also the general court has to get it right because you might trample on civil liberties or constitutional law, your God given rights, this and that. in pharmacy they can say this is more of a privilege than a Right. And, we know as much as you do because we're in the business.

 That's why, here's x versus having to deal with all the other things in the more general court.

[00:11:13] Lucas Morgan: You nailed it, Mike. I think you said it much better than I did, and in much simpler terms

[00:11:18] Mike Koelzer, Host: I had a situation I alluded to earlier, where I disagreed with the board on something. It was just initials on a prescription and the inspector came in. I didn't really like what she had to say. I didn't agree with her. I don't think the law backed her up. she called me back a week later and said we can let that go, but just don't do this for now on.

And I'm like, yeah, but the problem is I don't agree with you. I told her, I said, I don't agree that you've got this right. instead of agreeing with her, and then later bringing something up with the board. I used the board to judge if my interpretation was correct and it backfired on me because a week later I got this thing that says, you owe 1, 000 because you were wrong. I should have just said yes to her and then fought it later.

So that's my bad mouthing to them 

 It was dumb of me because I'm just stubborn and I just should have said okay. And then went later for an advisement and then I could have changed my opinion on that, but, 

[00:12:23] Lucas Morgan: yeah, 

I think that's one of the things that you go back to one of the themes you started off with. What's some of the things that pharmacists or pharmacies do that if in hindsight you can tell them not to do this or do X, Y, and Z 'cause it, it's really going to pay dividends down the road.

It's that idea of issue spotting. And anticipating issues. So if you're starting to do something and you have any questions about whether that practice complies with the law don't take the wait and see approach, get an advisory

 opinion. 

[00:12:55] Mike Koelzer, Host: Is that typically like a letter to the board, something like that?

[00:12:58] Lucas Morgan: Yeah. And some of the states have very formal procedures for that. I say very formal, but they have a process clearly described, which is, an advisory opinion should be submitted but when in doubt it's typically a letter to the board and you just basically say, we have this issue.

Now they don't necessarily respond to every request for an advisory opinion, and I don't want to suggest that they do. But I think if they feel that the issue that's been presented to them, Is worthy of a response, that is, is open to some gray interpretations or there's not a clear answer in that state's rules and regulations.

 You'll probably get something.

[00:13:35] Mike Koelzer, Host: In most things in my life, when I look back, I don't regret too many things. I have too much anxiety. I think about stuff too much ahead of time. But once I make a decision, it's usually pretty good. This one was like, why the hell did I do that? What was I thinking? Hey, it was a thousand dollars and it was uh, pre-tax kind of thing.

And so it cost me, 700 bucks or something just to have this experience and get to bitch about it a little bit. 

 with the different states, are there any of them that just have something weird and you say, really shouldn't be in there.

[00:14:14] Lucas Morgan: I would not say that it shouldn't be in there, but I have seen some states that have unique requirements that are often overlooked and a lot of people aren't aware of. So there's no one state where I'm going to be like, this one state has this crazy rule. You're never going to believe this. That if you open your pharmacy on a Tuesday and it's the second Tuesday of the month, nothing like that.

But some states have a little wrinkle in their law, which is this idea that when you first receive your license from the State Board of Pharmacy, that a clock starts ticking. And that within a certain period of time, your pharmacy has to be open and operational in the truest sense of the term and be able to show that through some legitimate claims activity.

And if they can't, they can be punished for failing to operate the business within that requisite time period. It might be 90 days, six months, a year, something like that. 

 I think it's interesting in and of itself, but what's even more interesting and potentially concerning is the idea that if you're not aware of this, let's face it, six months can fly

A year can fly by, and opening a pharmacy does not happen quickly and overnight, especially considering that in order to get into the major payer networks, you have to be licensed as a pharmacy. But getting into the networks is time consuming. process in and of 

itself. 

[00:15:42] Mike Koelzer, Host: And what would happen if you invest all your money into the new pharmacy but you don't want to get your license yet because you can't run into the 90-day limit And then for some reason you don't get it. Obviously you need that to open up.

[00:15:52] Lucas Morgan: Yeah, exactly. And I think the biggest one is that sometimes there's a little bit of a disconnect between the practical realities of owning and operating, especially in an independent pharmacy, is just how time consuming, getting into the largest PBM networks can be if you're just starting from scratch.

[00:16:11] Mike Koelzer, Host: Besides the topic you mentioned, pharmacies have a mandated amount of hours, right? Like most state laws say you have to be open for 40 hours, something like that. Is that right or not?

[00:16:24] Lucas Morgan: Yes, So typically states will have some sort of rules and requirements in terms of the total number of hours they need to be open, because there's a point at which they're going to say, look, you're not open for all practical purposes, so we're concerned that the public's going to rely on you as an operating pharmacy where they can go to get their prescriptions so on and so forth.

Yeah, it varies from state to state, but generally speaking, there is a minimum number of hours that they're going to need to be open because at some point the board of Pharmacy is just going to get concerned about, are you really 

an open and operational

pharmacy? 

[00:16:59] Mike Koelzer, Host: If people see your sign or whatever, you're part of a neighborhood's answer to health problems and so on. And if you're never there, it doesn't stifle other competition, but it could, someone might say, I'm not going to open a pharmacy because there's one right there.

 If it's only open one hour a week it might have made sense for another pharmacy to go in.

[00:17:18] Lucas Morgan: Yep. I actually think that is like another good example of something we see as a common mistake that's made is the idea of a smaller, independent pharmacy operating just like many other businesses where they have emergencies come up and they need to close the pharmacy. On a Tuesday they end up closing the pharmacy at 1 o'clock.

It says, I'll be back as soon as possible. We had an emergency. But if that keeps happening and the board gets wind of it, they're going to start saying, Hey. , you can't do that because you're deviating from your posted hours in the hours that are listed on the internet, including through the Board of Pharmacy

website. 

[00:17:55] Mike Koelzer, Host: Do clients or potential clients, do they ever cry when they're talking to you?

[00:18:02] Lucas Morgan: Oh. I don't think that's an uncommon thing 

[00:18:05] Mike Koelzer, Host: sometimes there's fear, sometimes there's 

frustration, 

[00:18:07] Lucas Morgan: absolutely. I think you see, depending on the circumstances, a whole range of emotions when people are dealing with certain types of legal issues, especially with the Board of Pharmacy, because if it's a, if it's a pharmacy or they're a pharmacist licensed and they've been in the business for 20, 30, 40 years and they put everything into it, but they end up in a situation where the license could be on the

line, Yeah, that can be a very emotional experience.

[00:18:33] Mike Koelzer, Host: What's the saddest thing for you to see? In other words, you have a client and. you think boy, this was a sad story. What sad stories do you see?

[00:18:44] Lucas Morgan: I think it's that idea of someone who's done everything right and is really a cornerstone in their community in terms of the pharmacy operation. And because of a complete misunderstanding or lack of awareness of a certain rule or requirement has ended up getting itself into a really challenging legal situation.

No one's gotten hurt. No patient's lives were put in harm's way, but for whatever reason, they've gotten themselves into a uniquely challenging legal situation that if it's not handled correctly, could have. That domino effect of consequences, 

in the type of situation where I see that is a pharmacy that's licensed in multiple states.

Because I think that's where you get that kind of describe it as a triangular relationship where it's the relationship between the pharmacy, and the board of pharmacy in their home state and the major payers, which, when I say payers, we're talking about the major PBMs and if they're licensed in multiple states, you can have one thing go wrong in that home state, or it doesn't even have to be the home state.

And you've immediately triggered reporting obligations to every other state that you're licensed in, as well as every major PBM or payer. And the second you start having to disclose. That one thing to multiple different third parties, all bets are off because you don't know how they're going to respond.

They could respond by taking, if it's another board of pharmacy, they could say you know what thank you for letting us know. We're actually very concerned about this, so we're actually going to take our own actions separate from your home state. Or A PBM might say, thank you for complying with your contractual obligations to report this.

We're going to terminate you because we don't like that you got into trouble with the Board of pharmacy.

[00:20:35] Mike Koelzer, Host: Your mind can play tricks like, all right, now I've got my thousand dollar fine , I'm the most wanted pharmacist in Michigan. My face is up at all the U. S. post offices and things like that. Your mind plays tricks on that. Thankfully I'm an old fart and people could do anything they wanted to me and I'd be fine.

But cOVID. We had a lot of people with COVID trying out these alternative medicines and our governor was as much into covid as you can imagine with her rules and so on. I stopped doing these alternative medicines for people.

One of the reasons was I knew that our governor was so much into closing down the mass and all that kind of stuff. And she was so powerful. I'm just a licensed business. It can be just a yes or no for someone to take a license away from a business and everything's riding on that license.

and when you're dealing with the boards and things they have the power ultimately to take away your livelihood in a way.

[00:21:45] Lucas Morgan: That makes so much sense. In terms of what I see, because of one of the other things I like, as a practicing attorney, I feel like in some ways I can relate to that notion of being a licensed professional. And sometimes you get just so used to doing business as a licensed professional, you often forget that there's a regulatory board that

has It's, Oversight over you.

 It's that power of the ability to revoke the license

and the second that license is revoked, you're like, wait, now what do I do to 

make a living? 

One of the things I would say though, just as a general proposition: To help soften that your mind playing tricks on your revocation of a professional license is, in my experience, reserved for the most egregious sorts of conduct and action.

[00:22:33] Mike Koelzer, Host: You can't just depend on ignorance , but I'm sure your intent probably has a lot to do with that too.

[00:22:39] Lucas Morgan: Yeah, I think that's very true. The notion of ignorance of the law is no excuse. But you're definitely right about intent. If someone is engaged in some sort of a business practice that they just know there's no two ways about it. We're just panicking about not getting caught.

We know that this violates the law, but we're doing it because there's a lot of financial upside, so we're just gonna do it, cross our fingers that we don't get caught. That's gonna be a real problem. But I do think that in instances where there's a genuine lack of awareness and a misunderstanding and no one got hurt, so to speak, that you're gonna be in a much better position to navigate that.

And the great thing is that pretty much every state has a term for that, and it's all codified under their rules and regulations. And that's what we call mitigating factors. 

And so boards definitely look at mitigating factors when they're trying to assess what is an appropriate form of discipline under the circumstances or whether to invoke a right of disciplinary action at all.

But again, and I always come back to this because it's one of the questions I get the most, what are some of the most common trends you see in mistakes that people make? One of the big mistakes that I see, another big mistake is confusing mitigating factors and the idea of exculpatory factors, if you will.

The difference being mitigating factors means, hey, we did something wrong, but it's not egregious because we didn't realize we were doing anything wrong. Or, we're not in that much trouble because nobody got hurt or, it's really a technical issue. It's not like a material issue or a material breach of the law kind of thing.

Versus exculpatory is more of a, just you're just wrong . You have incorrect information that's not accurate. And let me explain to you why that's not accurate . Going . back to that. Idea of, hey, under our state rules, you need to have the pharmacy open and operational within a one year period, and you didn't do that.

And you can actually say no, actually we did here I have the claims data to show you. I just think there was mistake and you didn't get complete claims 

data for that period of time. Here it is, we're good. they'll probably say, oh yeah, you're right, because you presented new information they weren't previously aware of.

Whereas a mitigating factor could be, it was out of our hands, was out of our control. It absolutely happened, but it was out of our control. And the mistake I see is that pharmacies, pharmacists, and so on will often think that a compelling set of mitigating factors is enough to get the action dismissed in its entirety without the board taking action.

And the unfortunate reality is that is not usually the case. And I would actually go so far as to say very rarely the

case. 

[00:25:13] Mike Koelzer, Host: there's two things. The law is black and white, even though there might be a lot of reasons. The law is black and white. Either this happened or it didn't happen, and then that maybe goes down to the penalty phase. But even if there was ignorance, you still broke the rule, but maybe the penalty is different. though you were ignorant, don't just go away.

[00:25:36] Lucas Morgan: Exactly. That's exactly right. Another good example is closing down. A lot of people don't realize that if you close the pharmacy, and this goes back to that hypothetical of it's Tuesday afternoon and I had an emergency, I had to leave the pharmacy that I own and operate and I'm the pharmacist in charge or the managing pharmacist and my child was sick at school and I had to leave and go pick them up and take them home, and I left the pharmacy closed for a day.

Okay, maybe that goes unnoticed or something like that, but let's change the facts. You had a fire and you need to get major renovations done. You can't operate because there was a fire. You need to give the board notice that you're closing down because that happened. And let the board know, Hey, we are temporarily closing the pharmacy because there was a fire and we need to have the pharmacy properly repaired and renovated because of this horrific, unfortunate incident.

We expect that this will be completed within a 60 day period, at which time we will touch base with you to update you. That kind of thing. You gotta let them know. A lot of people would assume, oh no, I'm not getting in trouble because I closed the pharmacy. There was a fire. You're gonna have sympathy for that,

 They would probably be sympathetic, but it's not going away.

[00:26:49] Mike Koelzer, Host: Because in that case, the rule was still broken. You may or may not get Penalized for it, but they can't have this big heart all over the place because then they're not really a licensing board.

[00:27:03] Lucas Morgan: I think that's right. I think they do try to view things through an objective lens as much as they can. And I think again, at that point there was a violation. Then the mitigating factors come in to help frame, should this be on the harsher end of the spectrum or on, on the less harsh, more sympathetic end of the spectrum, but it's rarely just going to go away.

in 

its 

entirety. 

[00:27:25] Mike Koelzer, Host: How clean are the boards? We always think justice is blind and things like that.

In your opinion, and let's just take ones you deal with out of this and your opinion across the country. Is there some greasing of the palms? I'm just going to say like A PBM or a big chain or something that's on these boards and are they funding anything?

 In your opinion, is it happening anywhere?

[00:27:52] Lucas Morgan: no, in my opinion it's not happening .

 Because what I've seen is that most times these boards, first of all, there's a lot of individuals on them, so one particular type of entity's interests are not outweighing the others. I've seen board panels that are composed of pharmacists from the retail chain setting, the independent setting prior experience working in big corporations, hospitals.

So I see a wide variety of experiences. The other thing I'll say is, and I think this is really a protection, but pharmacists need to be aware of it. And pharmacies, they're all public proceedings. These are highly public proceedings. You can find out just about anything you want about Board of pharmacy proceedings.

And I think that, That goes a long way in terms of preventing that type of concern.

Because there's a very public record of how a large chain pharmacy is treated when it's in front of a board of pharmacy versus a small, independent, one location pharmacy. And as far as I can tell, having looked at that, there's no favoritism going in either direction.

I've looked at a lot of different states.

It's really easy to monitor a record of public disciplinary action, and I look at these for a variety of different reasons all the time. And I can tell you from having reviewed public board meetings and hearings, That are all, again, publicly available in various different states.

I'm not seeing any type of favoritism or treatment of certain types of pharmacies, meaning like the large chains versus smaller independents getting treated. You could see it going either direction, depending on the makeup of a particular board, where they might have it out for the large chains and want to protect their own independence.

And have not seen that. And look I'm not naive, like I realize that there's certain things that can always be happening. But I would say that they're presumably the exception, not the

rule. 

[00:29:53] Mike Koelzer, Host: For years I was on this police civilians appeal board where if someone made a complaint about the police, it would come back to our board of nine people and we would either agree or disagree with this whether the police were in their right manner to act that way I'm sorry to say, but it always went down certain lines of, whatever association somebody had with this person, if they could see themselves in this person, it went down that line.

So as much as it was supposed to be pure it wasn't. 

[00:30:29] Lucas Morgan: I'm not seeing any. I'll give you a really good example, although it's not directly on point with the Board of Pharmacy. It's a related bureau. It's the New York Pharmacy Benefits Bureau. This is a bureau that is basically one year old, it was established in June of last year, so June, 2022. And they just last week issued a whole host of proposed rules and regulations and different guidance that they are now eliciting comments from the public on. 

Now you better believe that the companies like the major PBMs are gonna have something to say about this. And guess what? There's a process for that. It's called notice and comment rulemaking. And they are gonna advocate for changes that are going to help them and make their life easier As 

they should, 

And, yeah. And they're gonna oppose changes that are gonna result in like onerous obligations on them as they should. Who in their right mind wouldn't do that? But guess who else has an opportunity to participate in this exact same process? Independent pharmacy owners, independent pharmacists, all of the different associations that advocate for those interests.

And so what I say is if you decide to sit on the bench during that process and you believe that when it's all said and done, those rules and regulations seem one sided. 

You have no one to blame but

yourself. 

 I'm telling you right now, I've looked very closely at these proposed rules and regulations. There are proposed rules and regulations that offer a lot of protections to pharmacies, but there's also a lot of rules and regulations that I look at them and go, this looks like something that was advocated for by the interests of the major PBMs.

And I'm certain I'm right, but guess what? The New York Pharmacy Benefits Bureau has been eliciting information from the general public for the last year. And so guess who was probably very responsive to that? 

The legal teams for all of the major pBMs. I don't view anything improper about that process at all.

The only thing I view as improper is complaining about it when you could have been completely involved in 

and did nothing. 

[00:32:38] Mike Koelzer, Host: Lucas, that brings up a point because whenever I think about the pharmacy board, I think of a group of people sitting around thinking about all the pharmacy licenses. But as you were maybe alluding to there, there's also the other side of that, there's the consumers and there's PBMs and there's manufacturers and all that stuff has to go through. The board, because the board is the one that makes the rules and things. And so there's a lot of people probably putting their input into the board. They're just not overseers. or A pharmacist.

[00:33:18] Lucas Morgan: Yeah, I think that's right. 'cause there's a lot of different entities that oversee the various entities that are all working together. And I do think that's actually a really interesting point because boards of pharmacy typically oversee pharmacies and pharmacists, but they typically do not have direct oversight or jurisdiction over pharmacy benefit managers.

They typically will fall under the jurisdiction of the insurance commissioners 

or the Department of Insurance, 

But you can see why they may have a high level of interest in certain rules and regulations that may be implemented in the Board of Pharmacy realm. Even though that board may not have direct oversight over them, it's going to have direct oversight of all of the different pharmacies that are in their networks.

They're participating in the legislative rulemaking process, just like any other individual has the right to.

[00:34:06] Mike Koelzer, Host: One thing I like now is the internet's been great about getting people to see what these elected people are doing. In pharmacy now, somebody can probably get on a newsletter of all the pharmacy stuff that's happening where years ago, what are you going to do?

Go down to the public library and read something that's six years old. So it's easy for people to get more involved.

[00:34:36] Lucas Morgan: It really is. And that's the thing is I don't want it to sound like I'm being critical of something that's super easy to do. because people are very busy and they might say, Lucas, it's really easy for you to talk about these large corporations just being involved in the legislative process because they can hire these high powered legal teams and pay them tons of money to submit these sophisticated responses, but, You can do that too.

We're very involved in this stuff. And we try to work with clients of all types of financial capabilities. So this stuff can be done on your behalf in a very cost efficient manner. and it's worth it. 

 the other thing I was going to say is I think it's really important that you also keep an eye on not just what's happening in your home state, 

but also what's happening in the other states, because they learn from one another and look at what's working in one 

state versus the other. 

[00:35:29] Mike Koelzer, Host: Lucas a pharmacist is listening to this and maybe they're pulling up to their store or pulling in home and let's say that they're willing to give some of their time to this conversation, whether it's to make a pledge to do something, or to look something up online or connect with somebody.

What suggestion would you have for a pharmacist?

[00:35:52] Lucas Morgan: I think it is worth spending some time, investing some time into your business or your license, if you will. To get a better understanding of, I'm going to say three categories of things, those rules and regulations in your state that you just might not be aware of that might be a little unique or different that could fly under the radar to make sure you're not caught off guard. The second thing would be investing some time in the kind of thing that you always want to do and wish you could do, but you just never find the time to change the future of your profession. I have found that boards of pharmacy throughout the country are constantly looking at ways to improve and enhance the rules and regulations that govern the profession.

If they are looking at making a change to the rules and regulations that govern your pharmacy or your pharmacist's license, get involved in that.

 Neither do it on your own, but I'm going to suggest investing a little money in the profession, your license and hiring an attorney to do it for you. I think you may be pleasantly surprised that it's not as expensive as you may think.

That was very specific to the boards of pharmacy, the third thing I was going to say is take some time and get involved. Don't sit on the sidelines to what is happening at both the federal and state level as it relates to legislation. Is going to impact the industry as it relates to the major payers.

Because we all know that if you don't have relationships with the major players and the major PBMs in the country, you're really going to struggle to make a go of it. And there is a lot happening right now at both the federal and state level. And I think that it is a shame for there to be that type of unique opportunity to have a say in these things and not involve yourself in some way, shape, or form.

[00:37:45] Mike Koelzer, Host: what would you say the best resource is for that? If you were to go to your computer right now, type something in, Google or something, would be the best resource to stay up on those? 

Is it just going to the Board of Pharmacy and maybe there's a newsletter or something like that?

[00:37:58] Lucas Morgan: I have to say it just because we write so much on it, but Friar Leavitt's website.

We are constantly publishing articles about legislative developments and everything. We've already posted some things about what's happening in the New York Pharmacy Benefits Bureau and we'll have more up this week.

So that can be a source . But I would also say generally speaking, one that's very available is LinkedIn. I said it like no one's ever heard of it before, but, I'm surprised at the 

number of different groups you can follow on LinkedIn and that can be a very cost effective way to stay up to date and apprised of things.

And then I would also say state boards of pharmacy, their websites are a really good information source in terms of legislative development, whether it's going through a rule making process. Those types of things.

[00:38:43] Mike Koelzer, Host: What really sucks in our state is that I go on to look up rules and stuff, and it's always like the health care Act of 1978 and you don't know where the hell things are. Any government website normally sucks. They don't hire outside firms to do it.

You look up something and it's in a PDF somewhere, and you don't know, I can't tell you how many hours I've wasted minutes, times, weeks, and years of trying to look for something on our state rules. And I'm not sure if the feds are a whole lot better. It's like the DEA website.

It looks like Sally, in Human Resources, is making the website and doesn't have experience in it.

[00:39:28] Lucas Morgan: I can relate to That 

That is a great example. That's why you hire an attorney. 

We monitor that stuff. That's part of the duty of working in this area of the law. So we're constantly monitoring this stuff so we can navigate through that very quickly. But I just want to say, I can relate to you entirely because I often will say, oh my gosh, forget whether you're a lawyer, like even if you are a lawyer, a lot of times when you first go to.

find something, you're like, why is the rule and regulation that governs, telemarketing buried within the and I'm just making up a 

name, the Department of Education Act of 1934 and it is an amendment that passed in 1967 and it was just updated yesterday.

[00:40:11] Mike Koelzer, Host: Golly, Lukas, nice meeting you. And that was a fun conversation. Even though we think maybe the law is black and white and pharmacy is black and white you're dealing with a lot more than that. There's a lot of nuances.

Both legal nuances, but also just dealing with people, dealing with personalities. And so thanks for talking that through. We'll put a link to your website in the show notes. Thank you for what you're doing for the profession and for standing up for the people on the front line.

[00:40:43] Lucas Morgan: Absolutely. Mike, thank you so much. This has been a pleasure and it has been a really fun but interesting conversation, so I really appreciate the opportunity to speak with you.

[00:40:51] Mike Koelzer, Host: All right, thanks Lucas. We'll keep in touch.

[00:40:53] Lucas Morgan: Sounds good.