Our guest: Christie Moon JD, CHC. Moon Compliance Consulting
Drug diversion in healthcare facilities remains one of the most complex challenges facing hospitals today. In our latest podcast episode, we sit down with Christie Moon, founder of Moon Compliance Consulting, LLC and an attorney specializing in healthcare compliance. With extensive experience helping facilities navigate diversion investigations, Christie shares critical insights on common missteps hospitals make when handling suspected diversion cases.
From the crucial first steps following a diversion alert to managing the intricate web of regulatory requirements from the DEA, Boards of Pharmacy, and licensing boards, Christie breaks down the essential elements of an effective response. She also addresses the delicate balance hospitals must strike between protecting employee rights and maintaining patient safety when investigating potential diversion.
Listen as we explore practical strategies for: Immediate actions following a diversion alert Coordinating investigations across multiple regulatory bodies Protecting both employee and patient interestsBuilding an effective diversion response program.
This episode provides valuable guidance for healthcare leaders looking to strengthen their facility’s approach to handling suspected diversion cases.
Thanks to our sponsor, MIDAS Healthcare Solutions Learn more about V.I.E.W. Waste and Return System: https://midashs.com/products/”
Transcript
Terri
Welcome back everybody to Diversion Insights. Our sponsor for this episode is MIDAS Healthcare Solutions, taking technology to the next level to help deter and prevent medication diversion. Their key features include their real time visual proof the medications were disposed of compliantly with machine learning and AI to identify drug wasting behaviors, technology integration and reconciliation with the ADC EMR and diversion software, and Anytime Witness technology which allows the convenience and flexibility when a witness is required in the disposal of unused controlled substances. Joining me today is Christie Moon. She’s an expert in healthcare law and we are about to explore some eye opening insights about diversion and its implications legally. Christie is certified in healthcare compliance and she runs her own consulting firm.
Terri
Prior to launching out on her own, she has worked for some big name entities, Sutter, Safeway, Kaiser, just to name a few. And she has held positions such as Chief Compliance and Privacy Officer and Senior Legal Counsel. Her work includes creating drug diversion prevention protocols and providing legal oversight during diversion events. Welcome Christie.
Christie Moon
Thank you Terri. I appreciate the opportunity.
Terri
Let’s jump in and let’s start talking about your resume first. Very impressive. And it also includes a travel sabbatical, I noticed. So let’s walk through the highlights of your professional career and perhaps your travel sabbatical and tell us what your focus is now as a consultant.
Christie Moon
So I started my professional legal career as a criminal prosecutor. Many and I did that for the cities of Redmond, Washington and Pasadena, California until I had twins. And at that point I went in house at Kaiser Permanente and their labor and Employment Law practice group. And from that I began helping them, having had the criminal prosecution background with their internal investigations in the areas of crime and fraud. And that led me to helping Kaiser Permanente do some very early versions of AI data mining for drug diversion within their pharmacy units across the nation. And from there I went into helping advise when we had active investigations for the regulatory process as far as the dea, the Board of Pharmacy, the Medical Board, the Nursing Board, and collaborating with all the various diverse practice and stakeholders in that area.
Christie Moon
And so that led me to build Kaiser Permanente’s first national Special Investigations Unit and staffed that with a number of very well qualified retired FBI agents and local law enforcement officers. So that team served all of the nation’s Kaiser Permanente’s drug diversion program in close partnership with their pharmacy operations to detect the diversion, then investigate it, then appropriately report it and address it as far as learnings and preventions going in the future. I did take a travel sabbatical, walking the Camino across
Spain and some other adventures. And then I returned and began helping Sutter Health in Northern California build their Special Investigations Unit, which also covers and partners with pharmacy for drug diversion.
Terri
Right? Yeah. So lots of stuff going on. And you currently, half the time, live in the US or part of the time, and part of the time between.
Christie Moon
Portugal and Seattle, Washington and the west coast, as well as with certain clients across the United States with compliance and legal support services.
Terri
Okay, great. And you’re recording now in Portugal, I believe you had said.
Christie Moon
Yep. I’m coming to you from Portugal.
Terri
I’m a little jealous, I have to.
Christie Moon
Admit, but, well, you’ll have to come over and visit. It’s beautiful.
Terri
Yeah, I’ve never been to Portugal. I would like to do that. That sounds great. So you’ve had a lot of legal oversight and diversion cases. More than one, I imagine. Some that you may be able to share, some that you probably can’t do. I recall something when we spoke last, and that is you said the coordination of the dea, the board of pharmacy and a licensing board is like conducting an orchestra. Tell me a little bit more what you meant by that.
Christie Moon
Well, that’s the way I like to describe it to the client. So they understand that in this area of work, you really cannot be in a silo because doing that is dangerous. For example, you have a number of very qualified nursing departments. They detect a diversion, they immediately document a termination for the nurse that’s diverting, if that’s what they decide to do. And in that termination notice, they say, diverting 17 vials of fentanyl between this date and this date. But nobody was connected to the pharmacy, and the pharmacy only has one day to report, one business day to report on the DEA, 106, that they’ve had a diversion. So later on, if the pharmacy were to actually report it in the documentation on the investigation by the dea, they would likely be cited for failing to meet the one business day reporting requirement.
Christie Moon
So helping to understand, with the right attorney and the right background, all the different areas that need to come together, not just for an investigation, but for effective management of drug diversion in general. You have one. One section could be nursing, or it could be physicians, and then you have pharmacy, and they all have corresponding
regulatory boards. So you’ve got the DEA for pharmacy, but you also have the board of pharmacy for each state, and they have certain reporting requirements that depend on what state you’re in, as well as the board of nursing in each state. Or if it’s a physician that’s involved, her medical board might be at issue. So making sure. That all of the pieces come together in a cohesive and coordinated way to meet all the different expectations.
Christie Moon
Because if not, you get into a situation like I was working one time in a case where we responded to the Board of Pharmacy, gave them everything they asked for, and then we had an investigator come from the Board of Registered Nursing, and we gave her everything she asked for. But then she came back to us and said, well, how come you gave the Board of Pharmacy A, B and C? Well, our answer to her was, well, because they asked for it and you didn’t. And in a regulatory setting, as you know, Terri, we only give them what they asked for. We don’t actually go overboard.
Christie Moon
So all these nuances of the different regulatory boards and the different departments within an organization have to be really organized and coordinated and cannot be siloed in order to have the organization have the best regulatory outcome possible.
Terri
Yeah, that makes sense. Have you found. And maybe not in the organizations you’ve worked in, because you made sure that they were all on the same page. But what I tend to see is you may have in an organization, okay, maybe Pharmacy is very passionate. They really get it. They know what they need to do, but perhaps nursing doesn’t, or HR is a little bit weak, or compliance is sort of there, but not. Or it could be compliance is really passionate and gets it, whereas maybe Pharmacy doesn’t really. So then you really are trying to bring these people together, and it’s kind of that one person that’s trying to tie them all together. Almost like, you know, mom, like, do this, do that. Like, you have to, like, come on, you guys. Do you find that.
Christie Moon
Yes. And I’ve been the mom before, and I would say that each organization is vastly different in that I’ve had organizations where Pharmacy has the passion, and I’ve had organizations where they haven’t been here. So we’re not going to worry about this. And so it really depends on the situation and the organizations, you know, how they’re made up and their risk philosophies or risk tolerances.
Terri
Yeah. Do you have any suggestions for. I mean, all I can think of is education. I mean, it’s education giving them real stories, letting them see how it’s happened in other organizations. But to get all of these people on the same page, because I think some people still don’t think diversion is a thing and certainly doesn’t happen at their organization. And so they’re just not very attuned to it or they. They excuse it. No, it’s just poor practice. That’s not what’s going on. I mean, how have you found what works to get all of these departments?
Christie Moon
I definitely think in the education on investigations and outcomes and regulatory expectations about, you knowing that we have a mandatory reporting obligation within one business day if we detect lost or diverted drugs, controlled substances for the dea. I think early coordination, but really what’s most key is a cross functional drug diversion work group or committee where everybody develops together and has equal feedback and coordination and participation to look at the risks. Maybe have a privileged gap assessment or something like that, work on mitigating the risks ahead of time, work on making sure people know where and how and when to report, but also just pulling that together and having that committee get used to working with each other so that one entity or one piece doesn’t get out ahead of the other or that doesn’t disregard it to the detriment of the organization.
Terri
Okay, that makes sense. You mentioned a privileged gap assessment. Can you go into a little bit more detail on that? I mean, I think most of the listeners know what a gap assessment is for their risks. But what is a privileged gap assessment?
Christie Moon
So in a nutshell, if you’re in a high risk situation, so for example, you already have an active DEA investigation or you’ve had adverse patient outcomes related to a drug diversion situation in some organizations, they will want to coordinate and work very closely with their in house counsel or even their outside attorney to conduct a gap assessment under the attorney client privilege. And the attorney client privilege is a historic legal privilege that doesn’t protect the facts, it doesn’t protect the fact that you got a drug diversion situation in your organization or that X and Y fentanyl is missing.
Christie Moon
But it protects the analytical discussions with pharmacy trying to make sure they understand how they have to get this right, or when someone coordinates and discusses it in a meeting, we don’t want to have them all testify in their depositions in either the civil lawsuit or the criminal investigation by the government as to what was said in those meetings when they’re working with counsel. So it basically protects the analytical portions of the gap assessment or the internal audit so that the organization can adapt and learn from all of that without having to put that all into the either criminal or civil case that’s related to the drug diversion, if that makes sense. So that case would be put under attorney client privilege by legal counsel and then they would direct either the investigation or the analytics around the gap assessment.
Terri
Interesting. And so as opposed to just having somebody do like, okay, we’re in trouble. Let’s do, let’s see where our risks are. Let’s perform a gap assessment, a privileged one. Is it just legal declaring it or.
Christie Moon
Are there certain things they actually have to request it in anticipation of litigation? And then, for example, if were to retain you for your services, Terri, as an expert, which we know you are, then we would request that in a privileged letter. And then you would be working with your, with the legal counsel on all the gaps that you identified to help explain to them what they mean and how they can most effectively mitigate those without that report
having to become part of either a civil lawsuit or a criminal lawsuit. Criminal investigation.
Terri
Yeah. Would you recommend doing that even if you’re not in trouble, but you want a gap assessment?
Christie Moon
It depends. It really depends on council’s opinion as to whether there’s risk in the analytical discussions. And so I recommend that organizations that think they need a gap assessment, if they’re being proactive in doing it, maybe that’s not necessary. But if they’re doing it in reaction to, you know, a death in the, in the scenario, or an adverse patient outcome where we already know that we’ve got risk involved with lawyers and there’s a plaintiff’s attorney, etc. They’re doing it in that setting. Definitely. Because the unique thing about drug diversion is that the risk and liabilities can come from so many directions and so many different regulators.
Terri
True, very true. Okay, that all makes sense. What do you find? What do you think is the biggest mistake that a hospital can make when they first realize they have a diversion case on their hands? And your answer might be different depending on if there’s been harm or not harm. But what is the biggest mistake that they typically make?
Christie Moon
Ignoring it or brushing it under the rug because they’ve never been in trouble before and they don’t need to start, you know, stirring up the regulators by reporting it. So not reporting it, not taking prompt and effective action to investigate it. Because if you can, for example, if you’re in the high reliability organizational path, you’re going to want to be focusing on the errors and what do we call that? Sorry, one second. I’m just trying to think preoccupation with failure. You want to find those little mini anomalies early when the nurse has taken her first two fentanyl vials and mitigate it and stop it and prevent it from happening to where it’s actually impacting a patient. Because one of the riskiest things about drug diversion is that it can easily become A patient safety problem.
Christie Moon
When you have a healthcare worker, physician, or nurse that is diverting from the patients. We’ve gotten so good at tracking the supply chain of controlled drugs that one of the few areas where they can now steal the drugs is by falsifying that they gave them to the patient and taking themselves. Which is sort of unbelievable to many people that happens, but it can happen. And so in that realm, I think it’s important that we make sure we’re pulling that together, addressing it early and often so that the organization doesn’t get to the point where they have one of these larger, dangerous, media sensitive cases.
Terri
Right, Yeah, I agree. So an entity gets wind of the fact that they may have something going on, what would you suggest as, say, the first three things that they do, like the minute, I mean, somebody finds out.
Christie Moon
Right.
Terri
It could be the director of pharmacy, it could be compliance, it could be the nurse manager, that, you know, here’s of something. What are the first three things they should do?
Christie Moon
Great question. Let’s say you got a call through the compliance line that somebody’s anonymously reporting that their coworker is diverting fentanyl from patients. Okay, red flag. You need to get risk involved, because you hear the word patient, if the patient’s involved, there’s a risk for professional liability, medical malpractice, all that. Get pharmacy involved. Looking at the analytics, whether it’s in Pyxis or Omnicell, Most of the drug diversion analytics products now have an AI component to it. So they’re giving their clients the biggest user of this drug, the dispensing outside of the normal deviations in analytics, looking at your data, making sure that person’s no longer in a position to put patients at risk while you conduct an investigation, but doing as much as you can without tipping them off, because sometimes the tip off can spoil evidence as well.
Christie Moon
So basically, it’s a multifaceted, like, coordinate with pharmacy, coordinate with legal, understand the data analytics, and begin pulling things together for your investigative interview. So, for example, if it happened to be a travel nurse, looking at where that nurse had been in the background in coordination with whatever agency brought you the nurse, what other states have they been licensed in that maybe they’re no longer licensed in? Looking for red flags in the background and pulling all of those different siloed, typically siloed areas together for one coordinated and cohesive investigative response.
Terri
Yeah, that makes sense. And at what point in there is the DEA made aware? I mean.
Christie Moon
Well, the DEA has to be made aware within one business Day of you concluding that it’s a theft. So that’s got to happen pretty fast, you know, and then some people take a strategy. Different attorneys have different positions on when have. When can you conclude that, you know, is it when you’re missing that drug or do you get a couple days to look and see whether it got kicked under the Pyxis machine?
Terri
Right, right. Yeah, yeah. If the hotline somebody, I mean, just because someone reports the hotline doesn’t mean there’s anything yet. Pharmacy’s got to do their review.
Christie Moon
Yeah. It could just be an erroneous thing where, you know, they’re dating the ex of this person and they want to get in trouble. Get them in trouble. You don’t know. But you have to do your due diligence to assess the allegation credibly and look at all of the sources you can for evidence to coordinate.
Terri
Yeah. And as you said many times, it’s often taking what was intended for the patient, but it’s charted. So then there’s like nothing is missing yet at this point. So I mean, still then the question is, when do you alert the dea? I suspect, but I can’t prove anything.
Christie Moon
And some of that you look at analytics like we’ve got some really sophisticated pharmacists that look at like clarity analytics or analytics that look at how, let’s say a nurse charts pain scales and this nurse a on the evening shift says the patient’s pain is a 5, but the next nurse that comes on, who’s our suspected diverter, is always charting about five points ahead of the person on the shift before her. That’s another red flag. So you start pulling those together to determine, you know, what you have and where you have it. Potentially you may want to interview them and if they admit it, obviously you’ve got one day from that admission to terminating. But if you conclude it in writing and fire them, that’s a red flag that you need to also notify the dea. And sometimes that’s where.
Christie Moon
If nursing is not well coordinated with pharmacy, that’s where they get hung up in coordination issues at documenting things for the nursing board and not necessarily always realizing that may need to go to the pharmacy board and the DEA as well.
Terri
True. Yeah. It’s like, well, you know, she refused to. The nurse refused to drug test or refuse to talk to us. And so, you know, she’s gone and it’s like. Yeah.
Christie Moon
And sometimes in that situation we’d also want to look at how they’re managing non controlled drugs because In a lot of the cases that I’ve investigated, all these anomalies and extra waste and they’re wasting at five times the rate of their peers. But they’re only doing that on controlled drugs, not necessarily other drugs. So there’s lots of different investigative tells that the more you do these, the more you see them. But most important thing is to be collaborative and coordinated within the organization.
Terri
Yeah, it’s the rabbit hole of audits that can take you hours and hours because you keep like, oh, let me check this. Yeah, no, there’s definitely a lot to look at. Let’s talk about patient safety. Then. You, you mentioned, you know, get your risk involved because it’s a patient saf. Do you find that most facilities recognize this, that this is a patient safety issue? Almost first and foremost. I mean, this is why it’s so important. Yeah.
Christie Moon
When the drug diversion is happening on the patient side as opposed to. I’ve had a number of other very large investigations on the distribution side. For example, a nursing director diverting while she’s ordering and falsifying documents. Those aren’t necessarily a patient safety risk, though. There’s a risk of where those drugs going and who are they harming. They’re not patient safety like when we have healthcare providers jumping in and substituting water. You know, for example, there is a case pending right now in the state of Oregon with a hospital where there are nine deaths that are being attributed to one nurse who allegedly was swapping out fentanyl for tap water in an icu. And in that scenario,
numerous patients were infected and they noticed a spike in the infection on the pic blinds for the drugs being dripped to the patients.
Christie Moon
And come to find out she was taking the fentanyl, giving the patients water, which also means they’re not getting their pain management, but she was contaminating the water. There are two prior cases that are about 10 years old in Colorado that did the same. And these cases are definitely patient safety because their diversion for their self use due to their addiction typically is putting patients at risk and contaminating them because they’re adulterating the syringes or the needles. And so that’s definitely a patient safety risk. And I think many organizations see it, but the ones that see it best are the ones that have gone through that and experienced it.
Terri
You know, I’m sure, yeah, I’m sure that is true. Well, I mean, do you. I consider it a patient safety risk, even if there isn’t that kind of tampering. It’s just, you know, I’m working impaired, or I want to end my shift because I’m not using at work necessarily, but I got to take what I got from work and go home and. Because I’m starting to go through withdrawals. And I mean, I think there’s a lot of.
Christie Moon
Definitely there’s. There’s layers to patient safety. You know, obvious infection that’s going to harm them or kill them is obviously out there in front. But an impaired worker, a healthcare awareness anesthesiologist, or a nurse at the bedside inpatient, they can all put a patient at risk by being impaired or by not being in their workspace because they’re in the bathroom somewhere injecting themselves and somebody else is stuck with the patient. And then you also see this somewhat phenomenon of the star nurse, the star provider, who’s always there for everyone, to help everyone. And nobody in nursing leadership can fathom that they’re the diverter because they just got the Daisy Award. And so there’s a lot of nuances to it, but definitely there’s layers to the patient safety, right down to just the worker themselves being impaired.
Terri
Yeah. And interesting. Yeah. You talk about the Daisy Award. I almost feel bad for nurses that are just truly nice and helpful because it’s like, no, don’t be too helpful, because, yeah, so many times you do hear that. That is. She’s the most helpful. She’s the best. She takes all the hard cases. Yeah. Kind of a rough spot. Tell me a little bit of a different topic, but very much related. What is your perspective from a safety and legal approach to. Somebody is returning to work. Let’s say the hospital has a program. They’ve gone through the recovery program. They’re working with whatever recovery program that they work with in their state, they bring the person back. They have defined some parameters and stuff. But let’s say they do have access to controlled substances.
Terri
At this point, what is your thought on notifying the diversion team that this person is back? I’ve seen HR departments be very much. We’re not telling you. This is, you know, it’s. It’s just not right for you to know. But at the same time, the diversion team is like, but we have to know because the data analytics is part of what we keep an eye on, and we might see a
relapse sooner than if we didn’t know. So I’m curious what your thoughts are on that.
Christie Moon
Yeah, that’s a really good question and a tough question because you definitely have to understand and respect your HR Partners in all of these investigations. And the way I like to explain it to the pharmacy side and the analytics side is, you know, we’re all wearing different risk hats and the HR people are wearing the risk hat of are we going to get sued by the employee for discrimination under the substance use disorder loss, which definitely prescribed them to do something. At the same time, you’ve got pharmacy operations and nursing looking at what does the DEA and the board of Pharmacy and the boarding of Nursing expect in those cases. My hope is that the board of nursing is closely regulating that person.
Christie Moon
And typically in the organizations where I have served, we are not putting them back into patient care where they have access to controlled substances. We’re going to put them in a call center. John. Or in a different type of nursing role where they’re not accessing those drugs. But if an organization does put them back where they have access to drugs, I think in a confidential setting, there ought to be enhanced analytics for them just like there are enhanced analytics for the top 10 administrators of fentanyl in certain hospitals. Because the data that’s being received on not receiving, but dispensing, administering the medications is leading you to some red flags for different folks.
Terri
Right? Yeah, that makes sense. Yeah, I can see. Good point about the different risk hats that different people feel. Yeah, you’re coming at it from a different perspective. I mean it seems like a no brainer for those in the diversion monitoring space, but I can see the HR space. And so it’s not necessarily that they don’t view it as an issue, a real issue. They’re just coming at it from a different perspective.
Christie Moon
And you know, just like when you’re bringing in an attorney, sometimes you’re working with an employment law attorney, sometimes you’re working with a health and regulatory attorney and sometimes you have to work with both of them because not all organizations have someone who’s done. I’ve done all of those jobs so I kind of can help each side understand the other hat. I’ve been an employment law attorney, I’ve been a health and regulatory attorney. And when that comes together, we have to understand that everybody’s got their risk and their focus that they want to mitigate and that’s that sometimes can be contemptuous.
Christie Moon
And once you’ve gone through a few of those and coordinated, then you’re in a better shape, which is what makes the cross functional investigative program for drug diversion using all the tools and including all the departments, the more effective and appropriate way to manage this really challenging issue.
Terri
Yeah, that makes good sense? Yeah, very much so. Okay, is there anything, summing this up,
is there anything that you would like to share with the listeners out there as to just things that they should. I mean, you’ve shared a lot of what they should consider, what their approach should be if there’s an active case, maybe something before you have an active case. I mean, what are the top things they should be doing to mitigate an active case?
Christie Moon
I think the most successful programs educate and communicate really well, coordinate and meet and discuss the challenges in the different risk bubbles on a regular basis and then work really hard to get to the point in especially in the high reliability organization environment where they’re focusing early and often on the small failure that they can prevent from becoming a big failure.
Terri
So yeah, that makes perfect sense. Great.
Christie Moon
Okay.
Terri
Well, this is great. I know I learned a lot and it’s a perspective that is not my forte. I’m not in the legal world. So it’s interesting to hear it from that perspective. Definitely.
Christie Moon
Well, thank you very much Terri for having Moon Compliance Consulting be on your podcast and I look forward to watching future episodes of your podcast.
Terri
Absolutely. Thank you very much, Christie. And I want to thank our sponsor, Minus Healthcare Solutions. Learn more about their technology integration, real time visual proof of medication disposal, any time witness feature and customizing sample collection with secure chain of custody. You can visit them at ASHP Mid Year Meeting in New Orleans where you can see a live demonstration of their entire portfolio at booth 409. You can also visit their website www.midas.com and thank you again, Christie.
Christie Moon
Thanks so much Terri.
