Surviving a Federal Program Integrity Agreement with Jim Anliot

Episode 26 July 06, 2022 00:51:46
Surviving a Federal Program Integrity Agreement with Jim Anliot
Integrity Through Compliance
Surviving a Federal Program Integrity Agreement with Jim Anliot

Jul 06 2022 | 00:51:46

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Show Notes

Affiliated Monitor's Jim Anliot, Director of Healthcare Compliance Services discusses how best to navigate a federal program integrity agreement. Not only can you prepare yourself for such an unfortunate occurrence, but you can also take steps to try to prevent it from happening in the first place. Tune in as we discuss what to expect, best practices to adhere to, and stumbling blocks to avoid if your organization falls subject to a corporate integrity agreement or program integrity agreement with the OIG.

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Episode Transcript

Speaker 0 00:00:00 Even though you have appropriately documented the amount of time you spent with each patient and maybe selected the correct code or the amount of time you spent, if you don't have enough information in that underlying treatment and service record for that patient to show that those services are medically necessary, you may still be stuck being held liable for over payments on those services. Speaker 1 00:00:23 Hello, and welcome to integrity through compliance AMI business success series. This podcast was created by seasons compliance experts at affiliated monitors who will provide their observations on industry trends geared to raise your awareness and to protect your brand. So grab a cup of coffee and join us as we guide you to integrity through compliance. Speaker 2 00:00:47 Welcome to the good, the bad and the ugly, the coding compliance podcast with the coding network, Neil green and mark Babs gentleman. How are you doing today? Speaker 0 00:00:57 Great. We're well, Speaker 2 00:00:59 Excellent. Excellent. Well, appreciate you joining me today. Uh, it looks like we have a, a special guest here. Um, Jim en from affiliated monitors, Inc. He is the director director of healthcare compliance services. Uh, welcome Jim. Speaker 0 00:01:13 Hello. Welcome to everybody. Um, thank you for the opportunity to be here today. Appreciate Speaker 2 00:01:19 It. We're excited that you're here. I appreciate it. Um, why don't you tell us a little bit about yourself before we get, uh, too far into our topic of the day? Speaker 0 00:01:27 Um, I am the director of healthcare compliance services for affiliated monitors. Um, our company was organized back in 2004 to provide independent practice monitoring and oversight services for healthcare providers who get into difficulty with enforcement actions by state or federal regulatory agencies. Um, one of the things we have done a lot of work on over the last few years has been to serve as the independent review organization, um, for, uh, healthcare provider, clients of ours who have signed on to federal program, integrity agreements. Um, and my hope today is to help share some of our, the insights we've gained over the last few years about how those program, integrity agreements work and how you can best survive one. Speaker 2 00:02:20 Well, that that's excellent. I really appreciate that background. Um, you know, today's topic is how do you survive a federal program, integrity agreement, um, and, and there's many different kinds of, of integrity agreements. You can have corporate integrity agreements. You can have, um, uh, you know, a corporate compliance agreement if you will. And there's lots of different things that go around it. Um, we have, my, my personally have spent a lot of time with corporate integrity agreements over the years. And, um, love to get your take on this, especially from a monitor perspective, um, as well as how does, you know, a corporate integrity agreement dovetail with some of the coding and compliance audits of what's need be not necessarily on a routine reporting basis under the, a CIA as they're commonly known as, but just, how do you monitor your own program as you're getting ready for your annual corporate integrity agreement reporting? So this is a great, uh, combination and, and really glad that you joined us today. So we would start off with a little bit of telling us what is a corporate integrity agreement or a program integrity agreement with, uh, under the office of the inspector general in your, in your eyes? Speaker 0 00:03:32 Um, well program corporate integrity agreements are usually offered by the office of the inspector general. And I'm gonna reference that shorthand as the OIG, um, typically as an alternative to being excluded from the Medicare and Medicaid programs. Um, the key thing about a corporate integrity agreement is it's a sign that the government has detected that there is something seriously wrong with what's going on in your organization, in terms of, um, your documentation of the services you provide the way in which you're coding and billing those services, um, or you have something going on in terms of your business generation arrangements that is, um, leading to concerns about, um, the stark law or co compliance with federal anti kickback statutes. Um, the integrity agreements, um, are usually, um, offered in situations where, uh, the government does not have enough evidence for a criminal prosecution for fraud. Speaker 0 00:04:36 Um, and their objective in essence is to, um, get that provider to get back into compliance with overall Medicare program requirements. Um, for those federally health funded healthcare programs. Um, the corporate integrity agreement usually includes some stipulated fines and penalties for failure to comply with the terms of the settlement agreement. So any provider that enters into one, um, needs to be aware of the fact that they're going to meet need to meet the requirements of that agreement, um, on time and, and, uh, and substantial compliance with what the feds require. Um, the, uh, alternative of course, is exclusion from the Medicare and Medicaid program. And that is kind of the ultimate sanction for failure to comply with that integrity agreement as well. Speaker 2 00:05:34 You know, it's interesting. And, and, and in my experience, there's, there's a couple of different levels of, or at least terms of a, of a corporate integrity agreement. And, you know, the three to five years, what I see most often, I don't know about yourself, but mm-hmm, <affirmative> most often I'm, I'm, I'm seeing the five year pieces of it. Um, and, and when we look at, um, companies, for example, and if they have a corporate integrity agreement. So, so twofold one time, you know, sometimes when, when you come across a company who let's say you have an investor or someone who wants to purchase one, um, sometimes they look at a corporate integrity agreement as being a bad thing. Um, as well as sometimes when you're in a, in a situation where you're under a corporate integrity agreement, um, they, they think that that's the end of the world, um, from a compliance program standpoint and, and from a compliance officer perspective, I always felt that, that it gives you an added strength with your program added strength with what you're doing from a, from a compliance perspective. And it really does help show the world that not only, yeah, there was something that was wrong, <laugh>, there's something that happened. Um, but in, in, in retrospect, you're really doing something to change the company and how it looks. Do you see that kind of, uh, commonality with the clients that you're serving with as, as monitor and, and, and, uh, serving with Speaker 0 00:07:00 I do. I think of, you know, I see a corporate integrity agreement as a potential win-win, um, situation for both sides. The government gets the kind of ongoing oversight. It needs to make sure that the Medicare and Medicaid programs are protected against fraud or abuse. Um, but the provider gets the opportunity to stay in those programs, uh, continue to receive Medicare and Medicaid reimbursement, um, and gets a chance to correct the problems that gave rise to the integrity agreement in the first place. Um, so in most sit in situations like this, as we see in most of the, the other kinds of monitoring, uh, services that we provide, um, we see that as a win-win situation for both sides Speaker 2 00:07:48 And most providers feel like sometimes in, in the fines are the worst part and a corporate integrity, agreement's the worst part, but in reality, exclusion is the worst part <laugh> mm-hmm <affirmative> because most of these, these companies that we deal with 40, 50, 60% of their business comes from the federal government. And once you're excluded, you're, you're in trouble, uh, Neil, from your perspective, and, and mark, you know, what do you guys see as it relates to, um, you know, helping these, these companies out with their corporate integrity agreements and, and staying compliant? Speaker 3 00:08:21 Well, I'll just say that from my standpoint, oftentimes we're, I, we're talking about coding compliance programs, at least for that portion of it. Sometimes I think that leadership, uh, in organizations don't always get that the doing the work ahead of time before you get to one of these, uh, situations where you're mandated to do it, um, that this is literally the cheapest insurance in the world. And, uh, you know, you look around the healthcare industry and people in the C-suite have a very difficult time putting together a budget that makes sense for corporate compliance, because they don't truly understand the ramifications of what happens if you do it wrong. So, while I agree with both of you that, uh, once an organization's thrown into this, they're, they're forced to do the right thing. Um, it also comes with three to five years of scrutiny of intense scrutiny and, uh, additional costs that they wouldn't have necessarily done is usually some legal costs go along with it. There's, uh, reporting, uh, efforts that are are costly. And so all I'll say is, yes, it is good to understand this because we understand it. You should clearly want to not fight. <laugh> what the department of justice is telling you to do from a coding compliance standpoint, but you should welcome it. Speaker 2 00:10:05 And I agree, you know, most of the work that, that we've done with you all and, and, uh, on a regular monitoring basis, if you have a compliance program, it, um, sorry about that. It, um, it, it really does prevent a lot of these things from happening. And even if you do get some scrutiny on it, you can, uh, use those coding audits to say, look, this is what we've done to mitigate things, but now as we move on, you know, Jim, we got one, right. We have a corporate integrity agreement. It's in our, it's in our laps, right? What's the first thing that we should do. And, and what do we do now that we have one? Speaker 0 00:10:39 Well, I think the first, I think the first step is to identify the problem areas that gave rise to that corporate integrity agreement in the first place. And you can get out a lot of clues about that, um, by, um, paying attention to what the government focused on when they were investigating you in the first place. Um, what are they looking at? What kinds of records are they requesting? What kind of information are they seeking that can give you some very important clues as to what the future holds in terms of what you're going to have to do once that integrity agreement is in place? The other thing is the integrity agreement itself usually includes a couple of appends. Um, and the last of those app dependencies, it's usually appendix B sometimes it's appendix C um, outlines what they're going to expect the independent review organization to do. Speaker 0 00:11:34 And I'll talk a little bit more about the IROs role in a moment, um, but it gives you a pretty good idea as to what the independent review organization is going to be expected to monitor essentially for the federal government. And what kinds of analysis is gonna be involved in that now the potential problem areas that you look at, um, in these agreements typically kind of focus on three things. One is, um, the quality and sufficiency of your clinical documentation of the services that you're providing to your patients or clients. And that kind of has two sub components to it. One of which is, um, the issue of whether there is enough information in your treatment and service records to show that the services that you built were actually delivered and were delivered at the level at which, for which you build. Um, the other component is the medical necessity component. Speaker 0 00:12:35 And that is a question about whether the services that you provided were truly clinically necessary for the patients, given the condition that they were in at the time. Um, and both of those are important things to, to, to pay attention to. And I wanna take a moment here, just kind of sound out a warning note. Um, if I might to physician practices and medical groups, um, that may be listening to this, to this podcast today, um, as most of, you know, the center for Medicare and Medicaid services changed the guidelines about documentation of evaluation and management services for purposes of, for coding and billing purposes about a year ago, um, they offered physicians among other things and option to choose their billing codes on the basis of the amount of time they spent with their patients. And I think a lot of providers have kind of seized on that as an easy way to figure out how to, and a much easier way than the, than the old one of figuring out how to code and bill for the services they provide. Speaker 0 00:13:45 The problem with it is that there's a hidden risk in that the medical necessity requirement that the feds impose mean that even though you have appropriately documented the amount of time you spent with each patient and maybe selected the correct code for the amount of time you spent, if you don't have enough information in that underlying treatment and service record for that patient to show that those services are medically necessary, you may still be stuck, um, being held liable for overpays on those services. So a word to the whys here, um, take a moment and make sure that the, the medical record you compile is still sufficient because the time based form of, of coding and billing is not gonna get you out from underneath those requirements Speaker 2 00:14:35 And Neil or, or mark on that, on that point is a great point. Um, you know, and who knows how the enforcement actions are gonna come through from the OIG after these changes were made in, in 2021. But do you guys see a lot of focus on this area of improvement for those new coding guidelines and exactly what Jim was saying? You know, time is, time is an interesting, uh, piece of that when, you know, there's a lot of medical decision making that goes on as well, and, and trying to get the doctors to really document that medical decision making, how do you see that maybe, um, affecting corporate integrity agreements in the future and, and leading to them? Speaker 4 00:15:15 Yeah, well, go ahead, mark. Oh, I, I was just gonna say that, um, with the, um, popularity, I guess is, it might be the right word of electronic medical records. There is a lot of sloppiness when it comes to diagnoses, um, and, and, uh, cloning of other people's records that, uh, uh, I, that I think that, uh, Jim's comments about the accuracy of diagnoses is, um, one of the things we often see in our, um, uh, in our audits, uh, external audits for, uh, providers that the, um, uh, the pro the, the doctor doesn't spend enough time thoroughly documenting the diagnoses that are essentially the, the medical necessity of the services done. And that leads to not only claim rejections, but the, uh, OIG exposure that Jims described. So, Neil, you were going to say something Speaker 0 00:16:23 We we've had, we've had some experience with our, with our clients, um, uh, suggesting that they've had trouble with that whole cloning process in electronic medical records that mark referred to just a moment ago. Um, and we warn our clients about, um, doing that, uh, all the time. We <laugh>, we, I actually saw one record for example, uh, which we were evaluating for, um, not in the context of an integrity agreement, but in the context of a, uh, uh, some monitoring we were doing for one of our state licensing boards and the records, um, identified the patient as a male patient. Uh, and then we saw progress notes, which had been lifted apparently from another record in which the, the, the progress notes said she reports that her pain levels are increased today. Um, <laugh> and, you know, it's one of those things where you stack up your head, you call the client and say, uh, you have a problem here. <laugh>, I've Speaker 2 00:17:33 Seen it before where it says you're pregnant. He, Hey guys, I, I, and then, you know, anyways, Speaker 0 00:17:42 But it's interesting because, because at the same time, electric electronic medical records clearly have some advantages. And particularly in the context of corporate integrity agreements, where reporting timelines are very tight, um, paper medical records can be very, very difficult to deal with because it takes a lot more time to scan those in and upload them to the folks at the independent review organization who are going to be looking at them. Um, so one of the things I recommend I do recommend is that providers move from paper records to electronic medical records if they possibly can, but they have to be very careful about that business, the, the temptation to get into cloning notes or getting into, um, the sort of thing where the program provides you with a can set of sentences. Right? And so your progress note reads sentence two plus sentence seven plus sentence 10, you know, and you know, it doesn't, in essence, it doesn't act accurately reflect what's going on with your patient. Speaker 3 00:18:50 Yeah. I think those are all excellent points. I would just point out as well, that I think CMS did themselves a major disservice by, uh, naming the changes for outpatient coding to the simplification act. Um, I, I, I, I, I have yet to do an audit so that the introduction where, uh, providers or coders have uniformly done this. Right. Um, and a lot of it has to do with Jim's mention of this issue of picking time, or even when they go off on medical decision making, doing it that way. Um, I, I think that, you know, they think it's one or the other it's very simple and all you need to do is the minimum amount. And, um, I, I think the whole issue about especially time based coding is when you're documenting that record, you know, as mark pointed out for those diagnoses is, is there any diagnosis that, you know, you've, uh, put in there that would even suggest from medical necessity basis that you spend 45 minutes with that patient and why that was, you know, and, and I think that, um, there's a lot of unfortunate, uh, situations where providers, um, well, I will not call it gaming, uh, will like to maximize their revenue in a way that's not consistent with the theory of the program. Speaker 2 00:20:23 Definitely a slippery slope. Yeah, absolutely. A slippery slope. So we talked about documentation, we talked a lot about coding and errors in a, in a corporate integrity, the things that have led up to, um, a corporate integrity agreement or a settlement agreement that has happened, what else is there? Is there a few more things that we would see in a corporate integrity agreement that you should dig into? There, there, Speaker 0 00:20:42 There are a couple of other, um, potential bases by for which an integrity agreement might be offered. Um, one is a situation in which you have failed to screen your employees or your business vendors appropriately. Um, and that's actually a fairly easy problem to, to remedy really because the federal government has two exclusion lists, one man maintained by the OIG and the other one maintained by the, um, uh, by the government, by the general services administration. And those two, um, databases are very easy to access. Um, so that screening your, um, a, your current and prospective employees against those exclusion lists and screening your business vendors against those lists as well, is actually a fairly simple process and can be done, can be done pretty easily. Um, and it's a worthwhile step. It's definitely a worthwhile step to take. Um, the other thing in which the other situation in which we see an increasing number of integrity agreements, um, are in situations where providers have engaged in, I, in improper, uh, patient referral or business generation arrangements. Speaker 0 00:22:02 Um, the two areas are the stark law, um, which briefly S very briefly over generalized, um, says if you're referring a patient to another entity for a particular healthcare service and you, or a member of your immediate family stands to derive a financial benefit from that referral, because you have an ownership, interest, or financial interest, or an employment relationship with that other entity, okay, you are on the wrong side of the law. Um, the anti kickback statute is typically implicated where a, uh, a provider is offering something of value or providing something of value to a potential source of, of new business in exchange for that new business referring patients, um, to them. Uh, let me give you an example, a quick example of that some years ago, we were developing a, a compliance program for a network of chiropractic practices, um, here in Massachusetts, and in the process of, of doing that, we conducted an initial evaluation of those practice settings. Speaker 0 00:23:21 And one of the questions I asked during the course of our evaluation was, um, do employees of the practice receive any bonuses or financial rewards for bringing in new patients for generating new business for the practice and the receptionist in the office popped up and said, oh, yes, Mr. An ant, um, we do that, um, we get a hundred dollars added to our paycheck. Um, if we find a new, if we bring in a new patient and it's $200, if we bring in a new patient who has a personal injury attorney representing us in an automobile injury case, um, at that time in the state of Massachusetts, a state law provided that that pro that doing so resulted in at least a year in prison and a $10,000 fine. So we called the client and we said, you're going to issue a memorandum to all of your employees this afternoon that says that program no longer operates. Speaker 0 00:24:27 Um, what was worse though, was the fact that the receptionist was able to provide me with a form on which they actually documented this and had any federal or state investigator gotten a hold of it, case would've been open and shut. Um, it would've been over. Um, so we've seen other situations too. Um, we've seen situations in which, um, clinical laboratories are trying to generate business in terms of referrals, for drug testing, from physicians in the area. And if you're providing something to those physicians like printers, um, that they don't have to pay for, or pre completed patient test authorization forms, um, those are real trouble spots. And one of the things that that providers have difficulty doing is reconciling the fact that they can't do these things with the fact that their sales force and their business generation force may be paid on a commission basis in which the, the amount of compensation that their sales people get is determined by the, um, volume or value of the services they bring in. Um, and so you have a conflict between an internal compliance program that says we don't exchange things of value and exchange for referrals of, of patients and a compensation system for the business generation employees that works absolutely in an absolutely opposite direction. Um, and so you, this is part of the issue involved in, in developing an effective compliance program, because you have to make sure that you have aligned your compensation arrangements for your business generation personnel, with what you say you're going to do in terms of obeying law Speaker 2 00:26:29 In the compliance world. And there's two types of CIAs, right? One's a billing CIA. And then one is a focus arrangement, CIA mm-hmm <affirmative>. And I think perfectly described exactly what those are from that perspective. And we did look at, you know, did diving into the source problem, right? That is going to be what the corporate integrity agreement's about. What do you do next? I mean, do you start looking at whatever those controls are to, to manage your internal, your internal process from a corporate integrity agreement? What's next on that standpoint? Speaker 0 00:27:00 AB absolutely. I think, I think after you've identified what your, what your potential problem are ears are the next step, it seems to me is to really take a close look at your compliance program. Um, and it was interesting. We were talking earlier about, um, compliance programs and I have been literally astonished, um, at the number of clients we have seen over the years that do not in fact have a compliance program somehow 20 years ago, they missed the memo. Um, and that's a serious mistake. I have literally walked into physician practice groups in for example, or chiropractic practices or dental offices in which the compliance program consists of an employee handbook, which outlines when you're supposed to work, what hours the office is open, um, what some basic kind of general ground rules about how we conduct ourselves in the office, um, and a description of your employee benefits. Speaker 0 00:28:06 Uh, folks, that's not a compliance program that doesn't even come close. Um, your compliance program has to involve a number of different and number of different components. Um, one of which certainly is a set of written policies and procedures, but it's gotta go beyond basic. I mean, there are some rules and standards of conduct that you need to have for your employees. Um, and you need to have a set of disciplinary procedures for enforcement of that code of conduct. Those disciplinary procedures need to be fair and they need to be consistently applied. Um, but you need much more than that. You also need written policies and procedures that govern things like how are clinical records maintained? What kind of content do we expect to see in those clinical records? Um, how quickly do they need to be completed? Um, we need, you need some ground rules about patient referrals, marketing arrangements, advertising, um, practices, that sort of thing. Speaker 0 00:29:16 Um, and then you have to look at, um, you also need some, some procedures of some written policies and procedures that deal with, um, um, coding with, um, coding and building of services. How is that done? You know, does anybody review those, um, and internal auditing procedures are an essential part of any good compliance program. Um, you need to be looking at from on a periodic basis, you should be looking at a randomly selected sample of your treatment and billing records internally to see whether your clinical documentation measures up, um, to the standards that the, those billing codes require, and whether you can show that those services were medically necessary. Um, the not having that kind of an internal auditing process is a, is a major, major deficiency. Uh, if you don't have that in place. And I would add to that, um, that it's also a really good idea, um, to have some sort of external source come in and do the same kind of auditing on your treatment and billing records to see whether, um, that's being done correctly. Speaker 0 00:30:36 And part of the reason for that is because from the inside, when you're, when you're inside a particular organization, it's very, very hard to be objective about whether your compliance program is working or not. This applies generally to all elements of the compliance program, but particularly to the auditing process. Um, there are some very, oftentimes some very powerful incentives to let things slide, um, and you know, so it's very difficult to be completely objective about that. It's a good idea to bring in somebody from the outside to look at that for you and tell you, give you an honest and, and more, and perhaps more neutral assessment of whether you're you're billing and coding your services correctly or not. Um, and I think you've got to have, um, reporting mechanisms for inappropriate behavior that work. Um, and this is particularly difficult in small healthcare practices because, you know, John and Susan sit right next to one another, if John's not doing his job, right. Speaker 0 00:31:49 And Susan is the one who goes to the Boston and tells him about it, John's gonna know who, who ratted him out, right. Um, in larger organizations, it may be somewhat easier. So for smaller organizations, one of the things we recommend is the idea of using some sort of external resource as this, as a hotline so that, um, people can report complaints and concerns that they may have about compliance to somebody anonymously and with some protection. And you need to, and your, your, your reporting program needs to go beyond that because it needs to protect not only the whistle blower, but it also needs to protect anybody else who provides information in the course of the investigation into those alleged problems. Um, because one of the things that happens is if you don't, if you're in a, if you're in a company, like one of our clients where the chief executive officer of the company's position was, I don't wanna hear about any problems. Speaker 0 00:32:54 I want people to come my senior managers to come to their senior management meetings and tell me five good things that happened in the company today. Okay. And I don't wanna hear about any problems because the problems are years to deal with you take care of that on your own. Um, this guy, by the way, <laugh> the settlement agreement between him and the federal government excluded him from any participation in the company from that day forward <laugh>. But, um, but the, the, the point is the point is, is an important one here. Your employees need to understand that if they are concerned about something, if they, they think that something has gone wrong, okay, they need to have a process that they can trust in order to be able to bring those issues forward and get them resolved. If there, if that program doesn't exist, you can't track the compliance problems that occur. Speaker 0 00:33:54 Um, you just don't, you don't know when they've happened and you don't know what you, what you've got in your hands. So you need those reporting mechanisms as well. We've already talked of course, about the importance of screening employees and, and, and business vendors. That's also an, an essential element of good compliance program. Um, now let's say you have a, but let's say you have a, a, a compliance program with all of these elements in it. Okay. Then the question becomes, how do you evaluate whether that program actually works? And that's something that the federal government's paying increasing attention to. Um, the department of justice has made it very, very clear that when they're looking at healthcare providers or anybody else in the, in the, the world of business that has a compliance program in place, they want to see evidence that that compliance program is effective, that it works. Speaker 0 00:34:50 Um, and that is something that is best evaluated, frankly, um, by somebody from the outside, as I said earlier, you know, it's very, very hard to be objective about whether your compliance program is working effectively or not. You really, you really oftentimes can't judge that effectively. I'll give you an example. We had a client, um, that ran a, um, uh, it was a behavioral health organization and they had a compliance program. Um, but they were in the midst of undergoing an ownership change. And the new owners asked us to come in and evaluate the compliance program to see whether it was effective. And, um, when we talked to staff, when we interviewed employees at various levels in the company, we asked them about the compliance program. How does it work? Does it, is, do you think it's effective, et cetera. And most of the employees basically laughed at us and said, compliance program is a joke. Speaker 0 00:35:54 And we said, why? And somebody let it slip. The inside story was the chief compliance officer in the program had been having an inappropriate, personal relationship with the outgoing chief executive officer of the company. Um, <laugh> so that, you know, there are all sorts of reasons why people may not be willing to step up to the plate and say the compliance program works, but I I'll tell you that there is a tendency, I think, in among most businesses and most, most organizations to think that if there has been a failure in terms of compliance with the law, the failure is the result of some individual misconduct by some particular employee or group of employees within the company. And there's a tendency to think that the answer to the problem is simply to get rid of the apples. And let me suggest to you that that's not, that's not going to solve the problem in most cases. Speaker 0 00:37:00 Um, in most instances you may have instances of, of individual misconduct that certainly does occur. Um, and I don't wanna wanna minimize the importance of, of addressing that, but in more cases than not, the problem really arises out of a problem with the process, a problem with the system, there is something missing some component of, of the process that's, that's missing that isn't working effectively. Um, either because employees don't understand it, or because employees are getting, um, implicit, explicit or implicit messages from the top, that it doesn't really matter that it's something that we don't need really need to pay all that close attention to, um, or they don't understand how it affects the way in which they perform their jobs. And one of the things that really helps to unearth those kinds of problems is to have somebody from the outside, come in and evaluate that program, conduct interviews with staff, talk to people and find out what the program does, what their understanding of it is. Speaker 0 00:38:07 Do they understand how it affects their jobs? Um, are they receiving training and guidance, um, on compliance issues from people in management positions? Um, and what's the role of the chief compliance officer in the, in the company. Um, you know, from, from our perspective, uh, a good compliance officer has to strike a, an appropriate balance between being a detective and being a, a counselor. Um, both roles are important. You know, the compliance officer needs to be, um, firm and diligent about investigating potential compliance problems and, uh, making sure they get addressed. But at the same time, um, for a compliance program to really work, the compliance officer needs to be a trusted resource for people at all levels of the company. Um, people who come in and say, you know, I'm not sure whether this is a problem or not. I'm not sure whether we're doing this the right way. Speaker 0 00:39:12 Um, and having a compliance officer who can step in and say, look, this is the way we wanna do this, because this is, these are the potential consequences. If we don't, um, and have somebody and have somebody that everybody in the organization from the chief executive officer write down to the front desk, receptionist can trust, um, to be an advisor, to be there, to provide guidance about how to do it, right. Um, that's a really important role for that compliance officer to play. And when you're searching for a compliance officer for your company, you wanna look for somebody who has the kind of interpersonal skills to make sure that that happens Speaker 2 00:39:55 Well, those are great points. And, and I couldn't agree with you more on, on all aspects of, of what's needed under a corporate integrity agreement and, and who needs to be fulfilling those internally. And, and the compliance officer I think, is, is a pivotal key piece to that. And that person does have to be a collaborator and not a, uh, always a no person, always they need to be more of a collaborator so that people can bring that information to them as, as necessary. Now we're done with this, we have all the requirements, there's this appendix B like you referred to, and sometimes it's C um, related to an independent review organization or something that is required on a, on a, you know, periodic basis. Tell me a little bit about those required reviews and how should you prepare for those? Speaker 0 00:40:47 Okay. Um, as, as we said earlier, most program integrity agreements require, uh, involve essentially payment claims reviews there in which the government asks the independent review organization to look at, um, your claims for Medicare and Medicare or Medicaid payment, and whether the clinical documentation that you have supports what you have coded and billed. Um, and that basically the IRO is expected in those cases to address both of the elements we talked about earlier. One does the clinical documentation show that the services were actually delivered at the level for which you build. Um, and that second question about whether, um, the services that you provided were medically necessary, um, in that situation, in, in that kind of, of program integrity agreement, when you're looking for an independent review organization, you wanna look for an IRO, which has access to, uh, clinicians who know how to evaluate a, uh, a clinical record, and you need access to certified professional coders, um, who have the background and experience to be able to judge whether services have been coded correctly and build and build correctly. Speaker 0 00:42:14 Um, in those circumstances, you're usually working with a particular sample size, which has been, um, specified by the, the federal government. And I wanna point out that there may be some room for negotiation, um, with the, uh, with the, the OIG about those terms. Um, and that's can be really important because in these integrity agreements, the timeframes for these payment claims reviews are usually very tight. Um, typically you have no more than 60 days between the end of a specified reporting period, and the time that the final report of the results has to be submitted to the OIG by your independent review organization. So it's very important to be on top of this and to be, um, be organized and ready to roll when that first review, um, takes place. Um, but there may be some room to, to negotiate with the OIG about both that timeline and the number of records that need to be reviewed. Speaker 0 00:43:28 Um, we're seeing a lot of variation, uh, in that, uh, we've seen some, uh, situations in which providers have been asked to have 30, um, paid claims reviewed per quarter. Uh, but we've also seen situations in which, and this is more common in for skilled nursing facilities in which we're looking at the records for 50 different resident stays, um, for each of three different facilities in the network. Um, that's done on an annual basis, but those 50 resident days may involve claims for two or three, possibly four or five months worth of, of payment. That's a lot of documentation to be required to look at in a 60 day period. It's very tough. Um, so think about that and, and talk about that with the OIG. There may be some, some flexibility there. Um, but in terms of preparing for the reviews, I mean, nothing substitutes for being organized in terms of your records, um, know where your clinical documentation is, um, know how to retrieve it quickly and, and accurately, um, so that the reviews can proceed smoothly. Speaker 0 00:44:50 And one of the things we've discovered is, is very helpful, um, is to sit down with your independent review organization early in the game and figure out a timetable for the completion of the claims reviews, set deadlines for when samples have to be selected when the records have to be submitted when the reports are due, um, and hold to those timetables as firmly as you possibly can. Um, the other thing to remember is that in choosing your, your I R O um, there is one other thing that that's important here, make sure that your I R O is not the same organization that is helping you develop your compliance plan or provide your compliance training for your employees. The OIG will not let any organization play both of those roles. Um, so you have to make sure that the I O uh, is independent of that process and keep in mind and there's, and, and I know that this is difficult for providers because, um, these integrity agreements always impose a lot of stress on, on their staff. Speaker 0 00:46:03 Um, the, I O is not your enemy. Um, the IRO, isn't your friend. They're not here to cover, help you cover for your mistakes, but they're not your enemy either. The, I O is not out to get you, um, or to try and find stuff that that's wrong, um, if they possibly can, um, they don't work that way. Um, the, I O uh, a good I R O um, takes a neutral, independent stance and says, here is based on the information you've provided us here is an objective assessment of what you're doing well and what you're not doing so well. Um, the IROs are, are required by the integrity agreements to comment on your con on the controls you have in place and how effective they are. Um, and IROs, uh, good IRO will make you some will provide you with some concrete recommendations on improvements where they're necessary, um, take those recommendations seriously, um, pay attention to the changes they recommend and implement them if you possibly can. Um, because that's the surest way to get stuff back on the rails, um, get yourself through the pro the, the provider integrity agreement successfully, and get yourself on the other side, um, on the, on the right trajectory, Speaker 4 00:47:30 Jim, you mentioned, uh, a little bit ago that, um, it's important to get, uh, to have access to, uh, certified coders to review your work. And I just want to mention that, um, not all coders are created equal in, and by that, I mean, uh, particularly if you're, um, in a multi-specialty practice, um, getting, um, a coder who knows more than one or two specialties is really, really difficult. So it's not just one coder. If you earn a multi-specialty practice, it's getting coders for each individual specialty or subspecialty that are being examined, Speaker 0 00:48:20 Right. Um, that's, that's an excellent point mark, because you, you wanna make sure, um, in selecting your, I O that you've got, um, people with the right skill set, um, for the task at hand, and when you're in a multi-specialty healthcare practice, you really do need coders who know the, you know, in, in each of those separate specialty areas who really know their stuff. Um, that's, that's vitally important. Speaker 2 00:48:53 Well, you know, really appreciate everybody's time today. A lot of information coming through, you know, wish we had two hours to talk through <laugh> this, and, and maybe we need a version two of the corporate integrity agreements, cuz we'd really like to dig in a little bit more about the IROs and their skill sets because, um, a good IRO is, is very, um, important to fulfilling your terms of your corporate integrity agreement from a compliance officers standpoint and, uh, having that right partner to be able to, to make sure your controls are in place are, are very important. So, um, you know, just to recap what we talked about today, you know, we talked about what is a corporate integrity agreement and, and what kinds might a, an organization see, um, and, and how you need to deal with one as soon as you, you come through, um, with, with executing it and, you know, sources of problems, um, how you identify those problems and looking at your internal compliance program, uh, making sure that it's up to speed and making sure that it's doing what needs to be doing under the corporate integrity agreement, as well as, um, uh, you know, according to the federal sentencing guidelines and the OIG, um, guidance for, for compliance programs, and then finally what your IRO should and shouldn't be doing and, and how you work with them and their periodic reviews. Speaker 2 00:50:07 So, um, great information mark or anything we wanna kinda wrap up here with from that standpoint. Speaker 4 00:50:15 I'm good. Thank you, Jim. Thank you very much. You were, uh, uh, very informing, Speaker 0 00:50:22 Thank you very much for being, for giving me the opportunity to be part of this today. I really it Speaker 1 00:50:27 Thank you for joining affiliated monitors, podcasts, integrity through compliance a I's business success series. Today's segment is just a sample of the subject matter expertise captured by AMI compliance professionals. Go to our [email protected] to view the comprehensive list of industry and in-house talent. AMI has available to enhance professional and business integrity programs and controls. Also connect with us on LinkedIn to receive updates and trends in the areas of enforcement and compliance. If you have any questions about today's podcast or would like to learn more, please contact us at podcasts, affiliated monitors.com. Our affiliated monitors podcast production team of Dolores Syed, our compliance associate, and Dan Barton, our editor and podcast music composer. Look forward to you joining us again for our next installment of integrity through compliance AMI business success series.

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