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A Refresh: What's New in the New OIG General Compliance Program Guidance

 

Published:

June 12, 2024
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Related Industry:

Healthcare 

Related Service:

Hospice & Palliative Care 
 
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Compliance gets a dust off with the new General Compliance Program Guidance released by the federal Office of the Inspector General (OIG) in November 2023. While there is a lot to digest, Husch Blackwell’s Josi Wergin and Natasha Sumner join host Meg Pekarske to break it down highlighting important differences from past guidance and key implementation considerations. They also read the tea leaves on what to expect in forthcoming hospice specific compliance guidance. An important listen for everyone in hospice!

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This transcript has been auto generated

00;00;05;01 - 00;00;29;18

Meg Pekarske

Hello and welcome to Hospice Insights: The Law and Beyond where we connect you to what matters in the ever changing world of hospice and palliative care. A Refresh: What's New in the New OIG General Compliance Program Guidance. Josi, Natasha, thank you for joining me. This is a first time for us doing a podcast, so very exciting. Thanks for taking the time.

00;00;30;25 - 00;00;31;28

Natasha Sumner

Yeah, thanks for having us.

00;00;32;06 - 00;00;33;00

Josi Wergin

Yeah, thank you.

00;00;33;16 - 00;00;59;22

Meg Pekarske

So I put new in the title twice for a reason because that's like like I'm enthusiastic. It's new. New, right. Because at least for hospices, there hasn't been new compliance program guidance since 1999. So but but and I know this isn't specific to hospices, but that's foreshadowing that there's going to be an update to that. But you know, that's sort of start out.

00;01;00;05 - 00;01;09;01

Meg Pekarske

What are we looking at here? Because this is General OIG Compliance Guidance. So this is this for everyone in the health care industry that.

00;01;09;21 - 00;01;32;02

Josi Wergin

Yes, it's for all individuals and entities involved in the health care industry. And this is also part of the new aspect of it. We haven't had a general compliance program guidance before, but as you mentioned, Mag, we are going to get industry specific guidances coming starting this year. We expect one for hospice. It is not among the first four that have been announced thus far, though.

00;01;32;24 - 00;01;59;25

Meg Pekarske

Yeah. And I mean, it will be interesting, I'm sure we'll do a podcast when that comes out. I feel like there's so much that do, but then also sort of the same old traps that the government was concerned about, you know, 25 years ago. So Natasha, as we look at this compliance guidance, what are the big takeaways here?

00;01;59;25 - 00;02;07;29

Meg Pekarske

Because it's, as you said, a very lengthy document. So you know what the distillation. What's the upshot here?

00;02;08;13 - 00;02;41;24

Natasha Sumner

Yeah, I think there's, you know, a couple of different things here. I think the main thing is as always, the government is concerned with fraud, waste and abuse, and that that's been since the dawn of time. But I think what we're seeing in this guidance is a more sort of proactive and sort of holistic approach to compliance. You know, that that sort of concept of things start from the top and roll down.

00;02;41;24 - 00;02;53;28

Natasha Sumner

So everybody needs to be involved. Everybody in your company needs to understand what do we need to do to be in compliance for our particular company and what we do?

00;02;54;15 - 00;03;16;23

Meg Pekarske

And I've always said compliance is everyone's problem and that's a you set it in a much kinder way. But I mean, I do think for a while now it's it's about it's not just the compliance officers job because, you know, you don't have a great compliance program. If you ask, have you ever gotten any complaints? And they're like, No, we haven't.

00;03;16;24 - 00;03;50;01

Meg Pekarske

We're doing a great job. And that means like, well, no one's filing any complaints. You've never gotten a hotline call because no one knows about it or they don't feel comfortable raising things. And so I think that whole living, breathing compliance program, which I think a really important part comes in terms of what is your audit plan and topic, because that's a lot of the stuff you're doing every single year or even more frequently revamping what you're looking at in terms of risk areas.

00;03;50;01 - 00;04;08;13

Meg Pekarske

But I guess why do you think the OIG came out with this now as opposed to think, as you said, since the dawn of time, they've cared about fraud, waste and abuse. Like, why now is it just they're getting around to it or what do you think the rationale is?

00;04;08;27 - 00;04;47;07

Natasha Sumner

Well, that certainly, certainly could be true, that they're just getting around to it be a government entity. But but, no, I think what we're seeing is more complicated business structures. We're seeing more regulations that need to be complied with. We're seeing a lot of new technology which changes the way that these health care entities function, things like value based care, which we're seeing a lot of in the Medicare space right now, that, you know, the private equity and other folks getting into the health care industry.

00;04;47;17 - 00;05;00;04

Natasha Sumner

So I think there's so many more new players, different types of business structures that there needs to be sort of almost like an overhaul of what does compliance look like.

00;05;00;28 - 00;05;25;23

Meg Pekarske

So Josi, when our hospice listeners are hearing this, they're thinking about the 1999 program guidance and gathering one's program guidance has the seven elements. Everyone knows what those seven elements are, but maybe you just rehash those briefly. What are the seven elements of an effective compliance program, and are those the same ones that are adhere or not?

00;05;25;23 - 00;05;52;25

Josi Wergin

Right. The seven elements, are they mapped pretty closely onto the elements from the 1999 hospice guidance? There are some nuances that we'll talk about, but the seven elements are number one is written policies and procedures. Number two is compliance, leadership and oversight. Number three is training and education. Number four is effective lines of communication with the compliance officer.

00;05;53;18 - 00;06;24;28

Josi Wergin

Number five is enforcing standards. So that's talking about consequences and incentives. Number six is risk assessment, auditing and monitoring. And number seven is responding to the defect detected offenses and developing corrective action. So that should sound pretty familiar to everybody in the hospice world. Like I said, maps pretty closely onto the prior guidance, but there are some important differences and I think they reflect that more holistic approach that Natasha mentioned earlier.

00;06;25;23 - 00;07;05;09

Josi Wergin

Some of the new areas of emphasis or greater areas of emphasis are keeping policies current board responsibility for oversight of compliance, general compliance, training for everybody, plus targeted training for groups who need specific instruction and education on particular areas related to their job functions, not just consequences like discipline, but also incentives. And that could come in the form of maybe even some additional compensation in recognition, if appropriate.

00;07;05;09 - 00;07;31;15

Josi Wergin

We know we can't always recognize people who report or just other creative strategies. And one area really like to mention is there's a new emphasis on conducting formal risk assessments. Risk assessments are barely mentioned in the old guidance, but I think they're critically important because they're foundational. You need to formally evaluate what your compliance risk are for a variety of reasons.

00;07;31;22 - 00;07;56;25

Josi Wergin

You want to make sure you're not missing anything. You want to make sure you're looking internally at what has actually been happening in your organization, but also looking external only at things that might be changing. Like Natasha mentioned, there's a fast, fast pace of change in regulatory regulations themselves and also regulatory focuses of of, you know, agencies and things like that.

00;07;57;16 - 00;08;23;02

Josi Wergin

You also need to do that to to prioritize your compliance efforts. We've a lot of times done these this risk assessment process in our heads, or we've done it on paper or in a committee and kind of talked it out. But doing it formally means really putting a structure in place to make sure we're looking externally and internally and learning from the past and the present.

00;08;23;29 - 00;08;48;29

Josi Wergin

They mentioned using an enterprise risk management approach to formal risk assessment, and that is just a very holistic and comprehensive way of looking at risk. And you can apply that to compliance risk as well. There are resources linked to in the guidance that point to some things that you can use to some tools to adopt an enterprise risk management approach specifically for compliance risks.

00;08;49;26 - 00;09;04;27

Josi Wergin

There's also some new areas of focus beyond the seven elements, so quality of care and patient safety as potential indicators of compliance concerns. Like Natasha mentioned, new entrants to the health care sector and changes in ownership and financial arrangements.

00;09;05;13 - 00;09;35;15

Meg Pekarske

I'm just hearing this as you're going through this, Josi, and it's just really frustrating and the climate right now for for hospice and there's so much enforcement and I feel like there is a as an industry we feel like there's a real disconnect because, you know, I'm just thinking of so many of our clients who, you know, they're pepper report shows they're not an outlier and they're doing well from a data perspective.

00;09;35;15 - 00;10;10;29

Meg Pekarske

And, you know, they have a grade compliance program and then you're still getting targeted for a lot of scrutiny by government over length of stay or something. And it just if it's and obviously compliance programs are much broader than just, you know, payment issues. But it just is, I think, a really frustrated when there's a disconnect between, you know, enforcement now that enforcement is not, quote, fraud.

00;10;10;29 - 00;10;36;05

Meg Pekarske

Right. I mean, they're not we're not talking about false complaint risk. It's just payment risk. But when, you know, people are taking back millions of dollars is by Monday morning quarterbacking and second guessing eligibility. It's, I think, really frustrating. So so anyway, because you do get points for having a compliance program under the sentencing guidelines and other things.

00;10;36;06 - 00;11;04;24

Meg Pekarske

And so you hope never to have to, you know, issue that that at card and obviously it doesn't really come up in the audits that that we're working on because I feel like you could show a very effective compliance program, but it doesn't really make a lick of difference. But so I think something that's really important that that you both of you have talked about is the role of the board.

00;11;04;24 - 00;11;34;17

Meg Pekarske

And I think that that's been a drumbeat for a while now, because there were two reports that I think the OIG put out in collaboration with the American Health Lawyers Association about the importance of health care boards being engaged and have a good knowledge base and understanding that. And I think how that translates in that, that, you know, for profit but also not for profit sector is.

00;11;35;00 - 00;12;04;12

Meg Pekarske

Yes, you want a community board, but they need to be conversant in health care even if they don't work in health care. And that that's not like the nuts and bolts of everything. But I think a appreciate the highly regulated area in which hospices work in. And so I think a lot of board education and and I think a lot of our clients are doing that, but interesting that they continue to put a great emphasis on that.

00;12;05;16 - 00;12;13;11

Meg Pekarske

And so any anything else interesting about board board engagement with compliance? Yeah, that.

00;12;13;11 - 00;12;39;27

Natasha Sumner

I, I just wanted to, to add to that as you were talking about that, one of the issues that's come up a lot I've seen it a lot is the question of whether legal and compliance can be the same person, especially with smaller companies that don't have a lot of money. They don't have a lot of sort of working capital and there's been thoughts both ways on this.

00;12;40;29 - 00;13;07;27

Natasha Sumner

The federal government in this particular guidance says, no, they really need to be separate. And not only that, but the compliance officer really should be reporting directly to the board, which means the board, as you say, needs to really understand what risk looks like for your company and and sort of how to create a risk assessment and a compliance program.

00;13;08;08 - 00;13;33;21

Meg Pekarske

Yeah, I think that's really important. And I think that that like everyone that's involved for for our hospice clients over time and I think our clients are doing that the best they have for a long time had a direct line where the compliance officer, if they're doing quarterly reports to the board or whatever. Now, this doesn't mean the board is micromanaging, right?

00;13;33;21 - 00;14;08;17

Meg Pekarske

That the board's function is never to micromanage, but they need to know like enough about what's going on and why it's important. And because it's not. No news is good news, right? Like and I think also not self serving maybe isn't the right language, but I think when you do good board education, regular board education, when these things happen, like if you do have a complaint, people aren't freaking out because it's like, well, this is compliance and action.

00;14;08;17 - 00;14;31;28

Meg Pekarske

This is what we want to have happen. This is what we expect to have happen. And then we work our process like we do the internal investigation, we do this, we do that, and also that you need to spend money on the asset. So having a third party come and do an assessment, you know, every year of your, you know, compliance program or whatever that is.

00;14;31;28 - 00;14;56;04

Meg Pekarske

I mean, I think that boards appreciation for the environment, which is highly regulated, lots of enforcement, lots of government audits, those things are to be expected. It's also to be expected that we do have sometimes complaints we might need to make repayment to the government affirmatively. I mean, all of those things aren't, you know, by hairs on fire things.

00;14;56;04 - 00;15;16;08

Meg Pekarske

Right. Those are things that I think if you educate your board well, they will not obviously be concerned and want to know, you know, at a high level what's going on. But they're not going to be like, oh, we're doing something wrong because these events happen because we're still humans caring for humans and said humans make mistakes and and whatnot.

00;15;16;08 - 00;15;48;15

Meg Pekarske

So interesting that they they continue that that line that is very important for board involvement and and separation between legal and compliance. I think the old adage we've had is always been a compliance program. Shouldn't it be on the shelf, right. That like, oh, I paid a consultant to do that. Yes. I look at it there and you know, that's 25 years ago we were saying that that still seems to be, you know, very much an emphasis.

00;15;48;15 - 00;16;17;23

Meg Pekarske

And this new guidance. Right, is like it seems to be living and breathing. And so the fact that 25 years later, they're still saying stuff too, like this shows that still must be a problem for many people. So I think obviously having that accountability within the organization like the CEO appreciates that. The board appreciates that. The board expects certain things that we're we're doing auditing, we're doing the staff, but other practical pointers.

00;16;17;23 - 00;16;41;04

Meg Pekarske

Because I know, Josi, you've been looking at a lot of compliance program plans recently. So what are you seeing? That's that's sort of a problem for people in terms of, you know, they're trying to do it right. But it's just it's not the holistic enterprise. That's another word. Words say proactive model, like, what are you seeing in practice?

00;16;41;23 - 00;17;00;23

Josi Wergin

A big challenge is exactly what you were just talking about, is that you have to really make it workable. It has to be real. It can't just be on the shelf. It can't just be on paper. So first step, I would say is check out the new guidance. Make sure you're doing at least the key things for each of the seven elements.

00;17;00;23 - 00;17;29;19

Josi Wergin

And the new guidance does have a section that talks about how smaller organizations can adapt each of these seven elements. So check out that section in particular. I would also say routinely review your compliance related policies and procedures to make sure you're actually doing what you say that you're doing. And if there's a disconnect between what's written on the paper and when you're actually doing, don't necessarily assume that more education is going to fix the problem.

00;17;30;04 - 00;17;53;27

Josi Wergin

It could be that the policies and procedures themselves are unusable, unworkable or confusing just just too much. Maybe so. Your goal is to design the policies and procedures in a way that makes them, number one, easy to use. Number two, they fit the day to day workflows of the people who use them and number three, of course, achieves your compliance goals.

00;17;54;10 - 00;18;11;19

Josi Wergin

I'd rather see a small but usable set of compliance related policies and procedures then gigantic handbook of really long, overly complicated policies and procedures that are ignored really because they're to use they're too hard to use.

00;18;12;08 - 00;18;50;26

Meg Pekarske

So and I couldn't agree more. I think that's a really, really important point, Josi, because I think that people think like I'll get the gold star because it's big and it's like has a pretty binder with a nice binding on the side and it's really not about that. I mean, I think everyone sort of knows that, but more complex isn't better because and I think another thing that you said, which is great, which is education overload is education is important, but people are getting thrown a lot of stuff.

00;18;50;26 - 00;19;30;11

Meg Pekarske

And like we're also struggling with staff turnover and, you know, staff engagement and we're moving to value based care. So people are getting, you know, a lot of pressure, lots of different ways. So you got to sort of, you know. Right, this is reality, not the perfect world. And so what's most important and like choosing, picking and choosing and you know, even like I remember this is probably too old school now, but like people would send out compliance tips via email, like smart, you know, short little chunks instead of I'm going to do a two hour compliance session.

00;19;30;23 - 00;19;54;14

Meg Pekarske

But and then you don't ever test people's knowledge either. It's like, okay, I dating through 2 hours of compliance training there is no post test, there's no retention. And I think, you know, to what you said is tailoring to people's jobs that not everyone needs. We talk about that with HIPA, too. It's like not everyone needs to know everything.

00;19;54;14 - 00;20;20;20

Meg Pekarske

And so, you know, compliance code is everyone's problem, but it's like to what degree, right? And so I think, you know, the person who answers your phone, you know, maybe needs to know, like, right, if there are certain government officials that come to the office that they're you know, I mean, there are certain things that even that person from a compliance standpoint needs to know.

00;20;20;25 - 00;20;44;02

Meg Pekarske

But that's very different than the staff, like your marketers who are going out and meeting with vendors. And they might get paid incentive for something like a, you know, the kind of compliance program they need to have training is, you know, going to look very different. So I think those are really, really excellent points, Josi. Hard stuff. That's the thing.

00;20;44;02 - 00;21;13;06

Meg Pekarske

It's like maybe I'm just now getting to the age where like, oh yeah, that. So like it's new but really old and nothing has really changed because I feel like it's sort of deja vu talking about some of the staff that it's not this isn't rocket science. Like I've never heard this before, but it sounds like maybe bringing it to the next level is dusting it off and making, you know, it.

00;21;13;24 - 00;21;35;19

Meg Pekarske

As you said, integrated within the organization is maybe the key that it's not just the compliance department and stuff like that. And so it is it is challenging times from a compliance officer perspective. But I guess any other practical points as we as we close out here, Josi, that you've seen in practice?

00;21;36;02 - 00;22;01;01

Josi Wergin

Yeah. One thing and I think this again goes with making your program really effective, really making it holistic and integrated is not just looking at outcomes like when you're doing auditing and things like that, but also process improvement. So not just do we have all the required documentation, do we have the elections statements, the certifications of terminal illness, etc., etc.?

00;22;01;18 - 00;22;32;07

Josi Wergin

But how can we improve our admission processes to more consistently and seamlessly to achieve those goals? What can we do to make it slow, to make it work well, and to just be effective every time a little bit more easily? How key and how can you make people's jobs on a day to day basis easier in a way that's going to facilitate the day to day work of compliance and staying in compliance with all of the many obligations that we have.

00;22;32;19 - 00;22;49;14

Josi Wergin

So taking a step backward, it's not just looking at the end result that's important too, and that will inform what you're going to do for process improvement, what you're going to prioritize. But for it really just kind of take a step back. What are you concerned about? How can you make it better? How can you make it easier?

00;22;49;14 - 00;22;56;08

Josi Wergin

How can you make it actually work? I think that's the big theme for this new compliance program guidance is how do you make it work?

00;22;56;15 - 00;23;26;24

Meg Pekarske

Yeah, I think that's that that's a great point, Josi. And I think that people are really trying to latch on to technology to solve every single problem for them. And obviously, as I'm thinking about, you know, boxes people don't check and election forms and you know, all this the parade of horribles we deal with, you know, I think technology can be an aid in in certain areas.

00;23;26;24 - 00;23;50;03

Meg Pekarske

But I don't think you should always just reach for the technology component. And also, I think taking that fresh eyes approach and I think great example with the election form because as we all know, folks had to retool that couple of years ago. And when you use take a step back, you look like, oh my gosh, my election form got so massive.

00;23;50;03 - 00;24;12;25

Meg Pekarske

It's solving, you know, different problems than it was intended to solve. What right. Like you threw a bunch of stuff that's not required in this document. And then you had people, you know, have initial like every line of the document. And it's like, why are you doing that? Why are you having people sign multiple places on a document that they can just sign once?

00;24;12;25 - 00;24;50;01

Meg Pekarske

Because so I mean, I think it's also that small stuff, but that can be really meaningful improvement that's going to enhance compliance. But when you also talk about workflow, maybe you're going to actually make people's lives easier. And when we're looking and staff are feeling like I'm spending more time with documentation and less time with patients, like when you can streamline things, get a higher compliance, higher quality like and have more, you know, staff engagement and less burnout because I'm having to deal with the paperwork all the time.

00;24;50;01 - 00;25;10;21

Meg Pekarske

I mean, it's it's going to be a win win. But even if you can't retool everything, all at once, it's just like take really important things based on your risk assessment and, you know, bite off what you can chew. Because it's it's the same thing with survey certifications that people write plans, a correction, and they overdo it. They overpromise.

00;25;10;21 - 00;25;45;23

Meg Pekarske

And it's like, that's not about the Gold Star. It's like, you could do this other stuff and that might be nice once you do like the baseline stuff, right? So I think it's like you don't need to have, you know, super whatever is after Gold Star platinum start something right like just began and and take fresh eyes to different things that you're doing so I think really well said Josi I guess any any other closing thoughts this is really helpful and I should put a plug in that we have links to the new guidance.

00;25;45;23 - 00;25;57;22

Meg Pekarske

We also have a link to the blog post you all wrote and then links to some of the historical guides too. But I guess any other closing thoughts?

00;25;58;13 - 00;26;28;26

Natasha Sumner

I have just one. One sort of thought is as you were talking, Meg, so first and foremost, I think that the regulators are not, although I'm sure some people may feel differently. I don't think they're, you know, out there to sort of get everybody. I think that one of the important pieces is is really when these regulators, from what I've seen of working with some of these folks, you know, to clean up some kind of an issue that's going on is what what have you been doing?

00;26;28;26 - 00;26;56;02

Natasha Sumner

Are you just sort of sitting back and doing nothing or are you actually trying to make your compliance program better? And one of the ways to do that is to look at a lot of the resources that these regulators have. So in this guidance, towards the end, there are a ton of links to these resources. And I really urge folks to, you know, to take a look at those.

00;26;56;02 - 00;27;23;10

Natasha Sumner

Again, not you don't have to memorize as as you say. I mean, no one's memorizing a 90 page document like this one. It's it's long, it's tedious. But I think understanding what the thought process is from the regulators perspective is, is one of the key elements to being able to work with them when there is, you know, some kind of issue that comes up, because inevitably there will be an issue that will come up.

00;27;23;19 - 00;27;51;01

Meg Pekarske

Yeah. The bigger you get, the more problems you have, which again isn't a sign that you're doing something bad. It's just like humans make problems, you know, like humans make errors or bad judgments or, you know, whatever it may be. So. So I do think whatever most organizations are larger than they were 25 years ago. And so you wouldn't have the same compliance program.

00;27;51;01 - 00;28;17;04

Meg Pekarske

And so I think, you know, this needs to be as you grow a bigger and bigger sort of part of what you do. And you don't always need to reinvent the wheel, though, because there are a lot of resources. And again, not that consultants can't be helpful, but just don't go buy something. You have to understand what it is that you're doing and why you're doing it and that it's tailored to you because it's not really a check the box thing.

00;28;17;04 - 00;28;44;24

Meg Pekarske

It's a, you know, trying to have, you know, results and hopefully, you know, achieve these other things, which is make your staff, you know, as you said, Josie, make their life easier. In some respects. This isn't for always red tape. It actually could by, you know, looking and questioning, why are we doing something? Because because we did this for it this way for 25 years should not be the answer.

00;28;45;11 - 00;29;14;24

Meg Pekarske

So. Right. But but anyway. Well, well, helpful stuff here. Thanks so much for your your time and and we have a link to to those helpful things you're all gathered and prepared. So thanks for sharing those and I look forward to next time. Who knows? Sometimes they say hospice, even though it's hired or spent priorities, I doubt is going to, like you said, be in the first tranche of, you know, program guidance.

00;29;14;24 - 00;29;35;12

Meg Pekarske

My guest says that will be, you know, other provider types. So maybe it will be talking in, you know, a year or it could be five years. Who knows? I guess in five years, maybe I'll be, like out on a beach with a pina colada and you guys will be doing this podcast by yourself or something. But yeah.

00;29;35;15 - 00;29;39;27

Meg Pekarske

Anyway, so well thanks again for your time. I really appreciate it.

00;29;40;15 - 00;29;44;17

Natasha Sumner

Thanks for having us, Meg. Thank you.

00;29;45;08 - 00;30;02;25

Meg Pekarske

Well, that's it for today's episode of Hospice Insights: The Law and Beyond. Thank you for joining the conversation. To subscribe to our podcast, visit our website at huschblackwell.com or sign up wherever you get your podcasts. Until next time, may the wind behind your back.

Professionals:

Natasha V. Sumner

Senior Counsel

Josi Wergin

Associate