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0:45

My name's Alyssa Fleming, and I'm a health law

0:47

shareholder in Baker Donaldson's Charleston,

0:49

South Carolina office. With

0:51

me today is Sarah Bowman , with PYA.

0:54

Sarah and I are delighted to be presenting this

0:57

podcast to you today with

0:59

the A HLA . And our discussion will focus

1:01

on voluntary repayments, overpayments,

1:05

and the many factors that come into play when determining

1:07

whether a provider has an overpayment

1:10

or repayment and considerations

1:12

, um, once an overpayment has

1:14

been identified. Again,

1:16

my name is Alyssa Fleming and I'm a health law shareholder

1:19

with Baker Donaldson. My

1:21

practice focuses on healthcare regulatory compliance

1:23

with a focus on reimbursement and

1:25

fraud abuse.

1:28

Thanks, Alyssa. My name is Sarah

1:30

Bowman . I'm a principal with PYA and I serve

1:32

clients on , um, a variety of different

1:35

matters within our revenue and compliance

1:37

advisory program. Been with the firm for

1:39

about 10 years now, and I enjoy

1:41

assisting on a variety of compliance,

1:44

operational and managed care topics.

1:48

Um , in terms of background, I've worked , uh, within the

1:50

revenue cycle management area for a couple of

1:52

health systems and various roles prior

1:54

to my consulting life. So definitely have

1:57

an appreciation for the auditing

1:59

and monitoring process and, and identification

2:01

of potential issues from both a

2:04

provider perspective as well as from a consulting

2:06

perspective, and really appreciate the

2:08

opportunity to record this podcast and , um,

2:10

to speak with Alyssa today. So

2:13

with that, we will , um, kick

2:15

it off as Alyssa mentioned. Um,

2:18

we are gonna be talking today about , um,

2:21

voluntary repayments and, and kind of

2:23

how these items come about and things

2:26

to keep in mind as well as some, some

2:28

lessons learned and our insights and

2:30

various hot topic areas that

2:32

we are seeing in our work with various clients.

2:36

So first and foremost, just to

2:38

kinda level set, of course , um,

2:42

as part of maintaining an effective

2:44

compliance program and adhering to the seven elements

2:46

of an effective compliance program, internal

2:49

auditing and monitoring and the identification

2:52

and, and response to

2:54

detected offenses is, is really key

2:56

and really important. And oftentimes

2:59

that is the way that , um,

3:02

these initial issues

3:04

or potential issues oftentimes

3:06

come about. Um, and

3:09

so it's, it's first the,

3:11

okay, I think we might have a problem within

3:13

the organization. Perhaps we've

3:15

build something incorrectly or , um,

3:18

provider's documentation isn't supporting

3:21

, um, the level of service that

3:23

went out the door on the claim. Um,

3:25

and so then from that identification

3:27

point, it's really important

3:30

to kind of have a, have a pause moment

3:32

there within the organization to make

3:34

sure that the scope of the issue

3:37

is really identified clearly. Um,

3:40

and we'll talk about that some more throughout the

3:42

podcast, but when

3:44

we think about the scope of the issues, is

3:47

really just doing that internal

3:49

analysis to say, okay, here's what we think

3:51

that the problem is, or here's the , the problem

3:54

as we've identified it. Here's

3:56

the timeline that we think is

3:59

associated with the issue. And really testing

4:01

that to make sure , um, that

4:03

you've got some, some clear date parameters.

4:06

Um, looking at what potential payers

4:09

are associated with the issue, what

4:11

potential providers. Sometimes an

4:13

area , uh, excuse me, sometimes an issue

4:15

may be limited to, you know, one

4:18

or two providers. It may be an entire group.

4:21

Um, we've sometimes seen , um,

4:23

issues related to specific

4:25

service areas. So maybe it's

4:27

not all of a particular type of procedure.

4:30

Maybe it's, you know, an issue that

4:32

was identified at a particular location.

4:35

So, you know, at an, at an A SC as

4:37

part of a, of a larger health system, for

4:39

example. And then , um,

4:41

obviously at the end of the day, what everyone

4:44

is, is concerned with is making sure that

4:46

that gets remediated at appropriately,

4:49

that the financial impact gets quantified

4:51

, um, and that everyone

4:53

can be comfortable with those steps that

4:55

they were taken , um, carefully

4:58

and , um, in accordance with , um, all

5:00

of the requirements. And

5:03

so, just as a reminder, when

5:05

we talk about an overpayment that's

5:07

really defined as any funds that

5:09

a person receives or , um,

5:12

those that are retained to

5:14

which the, the person or the

5:16

provider after reconciliation

5:19

has determined that they , they were not entitled to.

5:21

So receiving funds that, that, that you should

5:23

not have received. And

5:25

so it's important to,

5:28

to make sure that , um,

5:31

that that piece of, of

5:34

funds that are being received, that are

5:36

not, not aligned with billing or

5:38

payment rules that could

5:40

be related to something that was

5:42

intentional or something that was inadvertent,

5:45

something that was accidental. Um,

5:47

so either way, gotta make sure that

5:49

, um, you know, if you submitted the claim and

5:51

then you later found out that you had submitted it

5:53

incorrectly or you'd submitted it, you know, without

5:56

the, the appropriate modifier or

5:58

something like that, either way, it's,

6:00

it's gotta be corrected. So overpayments

6:03

include payments received for claims

6:06

that were submitted , um, in violation

6:08

of Stark and anti-kickback, and

6:11

then anything that's retained after

6:13

the repayment deadline , um, obviously

6:15

becomes an obligation of the False Claims Act.

6:17

So really important that, that

6:20

, um, these things are taken care of and

6:22

taken care of properly.

6:25

Yeah , and along those lines, in

6:27

terms of, you know, potential false claims, liability

6:30

for retention, the improper retention of

6:32

overpayments, and that really

6:34

, you know, Sarah , as you mentioned, you

6:37

know, falls under the reverse false claims provision

6:39

of the act. And in more recent

6:42

years, including, you know, this year we've

6:45

seen more and more relators

6:47

coming forward with , uh,

6:50

complaints about

6:52

, uh, failure to return

6:55

overpayments, you know , providers identifying

6:57

overpayments and then , um, making

6:59

a determination either not to refund

7:02

it or , um, just disregarding

7:04

the fact that they've identified the overpayment. So

7:06

there is an awareness there. Um,

7:09

and we're seeing more and more of that,

7:11

you know, type of claim where we typically

7:14

didn't really see false claims cases

7:16

based on, you know, voluntary

7:19

repayments. I think along those lines

7:21

, um, you know, as Sarah

7:23

mentioned, you know, identifying, you

7:26

know, the potential identification

7:28

of an issue

7:31

and then really looking at,

7:33

you know, what is the scope of that issue

7:35

is, is really important because when

7:38

you're dealing with , um, you

7:40

know, potential repayment and,

7:43

and the obligations that flow from that,

7:45

you know , there is, you know, a a fairly, there's

7:49

a fairly tight timeframe to start working

7:51

and , um, and really sort

7:53

of identifying what the potential repayment

7:56

liability might be , uh,

7:58

under the, under the 60 day rule.

8:01

Uh, and just by way of, you know, background,

8:03

it's really the 60 day repayment

8:07

window is really in effect once the

8:10

issues identified and quantified , uh,

8:12

and the government takes the position that,

8:14

you know, the , the 60 day rule

8:17

takes into consideration when

8:20

the provider received credible information of

8:22

a potential repayment

8:24

and the reasonable diligence period

8:26

. It's, it's

8:28

really, you know , the , the leader of

8:30

the two, unless the, if the

8:32

provider decides not

8:35

to, not to conduct reasonable

8:37

diligence. And so , um, you

8:39

know, credible information can mean any information

8:42

that supports a reasonable belief

8:44

that an overpayment may have been received

8:46

, uh, sources of,

8:49

you know, credible information. You know , where do these, where

8:51

do these things kind of come up or

8:53

arise? And as Sarah mentioned , you know , through

8:55

the, you know, normal everyday

8:58

internal compliance reviews , uh, that's

9:00

certainly pretty fairly common.

9:03

Um, employee complaints, hotline complaints

9:05

, um, government audits,

9:08

unexplained changes in revenue increases,

9:11

so, you know, unusually high , um,

9:14

WVU or profits, things like that are

9:16

all sort of red flags

9:18

that as you are working

9:21

through some of these issues or issues are spotted,

9:24

can give rise to , uh,

9:27

credible information , uh, leading to

9:29

the reasonable diligence

9:32

period. And

9:35

so, you know, just to kind of, I

9:37

think some of the challenges that flow from this, are

9:39

you identification of, you

9:42

know, a single claim, you know, does that give

9:44

rise to an obligation to do

9:47

more? And I think the, I

9:49

think the answer to that generally and,

9:52

and is yes , um, that,

9:55

you know, there is, there is, you

9:57

know, identification of, you know, overpaid

9:59

claims requires further

10:02

investigation, and that's when the relevant

10:04

time period really starts. And

10:06

, um, Sarah , I

10:09

don't know if from your experience you've

10:11

run into providers that have

10:14

or have confused, you know, the

10:16

60 day timeframe , um,

10:18

the 60 day rule, and really what their parameters

10:21

are for working through a reasonable

10:24

diligence period. Um,

10:26

I know that can be challenging to

10:29

, um, to try to, to try to work

10:31

through.

10:34

Yeah, a absolutely, Alyssa, that

10:37

is something that , um, oftentimes

10:39

I think, I think outside of, you

10:42

know, counsel outside of perhaps

10:44

the, the compliance officer,

10:47

oftentimes that is something that,

10:49

that folks hear the 60 day rule

10:51

and, and sometimes think, okay, we,

10:54

we found out that we have an issue, you

10:56

know, potentially today with this matter. So

10:58

in 60 days, we've gotta , we've gotta pay

11:00

back . Um, and it's really not quite

11:03

that clear cut. Um, and,

11:05

and really we try to encourage clients

11:08

to , um, obviously

11:10

make it a priority within the organization

11:12

and , and kind of with all these other operational

11:15

factors that are at play, but, but

11:17

to take the time that's needed to

11:20

make sure that the issue is, is kind of fully

11:23

identified. So again, what's that , what's that

11:25

scope , um, as , um, as we mentioned

11:27

earlier, and then to, to quantify

11:30

the extent of that. And sometimes that

11:34

quantification step can take more

11:36

time than, than anyone would like

11:38

for it too . There are so many factors

11:41

that really play into that in

11:43

terms of availability of, of

11:45

data and the quality of information that's

11:47

able to be pulled from, you know, various

11:49

systems, whether it's the EMR , whether

11:52

it's, you know , backend billing systems

11:54

, um, because , um,

11:56

because of the, you know, increasing reliance

11:59

on technology and healthcare , um,

12:02

providers are really kind of at the mercy of

12:04

whenever the last upgrade was or the last system change,

12:07

sometimes we're, we're getting into legacy systems

12:09

and things to really , um, make

12:12

sure that quantification piece is able

12:14

to happen and happen in the the

12:17

correct way, so that it's , um, that

12:19

it's a , a full analysis and, and that

12:21

it's defensible, but also that , um,

12:23

that we're not overstating that

12:25

, um, that financial obligation

12:28

either.

12:32

No , that , that makes sense. And I think, you

12:34

know, part of understanding

12:36

the reasonable diligence period really

12:38

is understanding, like, to your point, you

12:41

know , the scope of really what, what

12:43

needs to be done to identify, right,

12:45

the relevant , uh, the relevant

12:48

lookback period, the , um,

12:50

the claims that are really , um,

12:53

at issue Mm-Hmm, <affirmative> , right ? And

12:55

then some of the challenges that can arise,

12:57

as you mentioned. And sometimes, you know, you're going

12:59

from, you know, a a you've

13:02

gone from during the relevant back of

13:04

paper EA paper record to an EMR or

13:06

the ve the, the EMR

13:09

, um, has changed.

13:11

And so there can be , uh, there

13:14

can be challenges just technologically with

13:16

what we're, or, or from a

13:18

practical perspective with what we're, you know , we're

13:20

working with Mm-Hmm . <affirmative> , um, you know, just

13:22

as a reminder, I mean the, the reasonable diligence

13:25

period begins , you know, when

13:28

a provider has credible information and

13:30

the government CMS typically allows, you

13:33

know, a six month period of

13:35

reasonable diligence at which point then,

13:37

you know, during

13:40

that timeframe , um, you're hoping

13:42

to really identify the full scope of

13:44

the issue and quantify.

13:46

And then once you've quantify the 60 day

13:49

time period begins to really, the

13:52

clock begins to tick on that. Um, I

13:54

think, you know, one of the, one of the challenges

13:57

that, that we have,

13:59

you know, sometimes is really

14:01

looking at, and Sarah , I'd

14:03

be curious to know your thoughts on this too

14:06

, is really looking at, you know, initially

14:08

what's our universe of

14:10

claims and is the

14:12

issue that came forward, is that

14:15

the only issue or are there

14:17

other issues involved that

14:19

we need to really think about? And

14:21

sometimes that really requires kind

14:23

of, I think, you know, peeling

14:26

back the layers a little bit and asking, you

14:29

know, fairly detailed questions

14:31

and trying to get an understanding

14:33

of, of how this was discovered, how

14:35

it came forward, you know, the root cause of

14:37

the problem or the issue and

14:41

what other issues are, are involved.

14:43

I mean , do you see any value in

14:46

, in your experience of

14:48

really kind slowing things

14:50

down and, you know, just

14:54

stepping back and taking kind of a higher level

14:56

look from a big picture , um,

14:59

standpoint?

15:01

Yeah , yeah, yeah, absolutely.

15:03

And sometimes, sometimes really

15:05

that, that is one of the key pieces

15:07

of, of, I guess, value. I

15:10

would say that that can be provided by

15:12

, um, leveraging a , a

15:14

partnership with , um, outside counsel

15:16

and, and with outside consultants

15:19

to help look at an issue once it's

15:22

identified. Because, because that kind

15:24

of outside objective

15:26

third party, you

15:28

know, we don't really have a dog in the fight, so to

15:30

speak. And so we're gonna come in and ask a whole lot of

15:33

questions. And sometimes just through that series

15:35

of of questions, we're able to

15:38

narrow down somewhat the,

15:40

the universe of, of claims that

15:42

are within the scope of the

15:45

, of the repayment matter and

15:47

, um, to the benefit of the organization,

15:50

but also just to the benefit of the

15:52

analysis itself, because everybody has a

15:54

vested interest in making sure that it is complete

15:56

and correct. Um, and , and

15:58

sometimes it might be as simple as, okay, we figured

16:01

out that this issue, you know, only pertain

16:03

to, to this area , um,

16:05

or only pertain to this, this provider

16:08

or this group of providers. And so,

16:10

you know, all the other providers, while they may have

16:12

been rendering services during this time period,

16:15

if they did not also, you know, if

16:17

they're , um, if the organization's analysis

16:20

determined that they did not also have this same

16:22

issue, then they can be excluded. And

16:24

then that, that makes that universe amount

16:27

that much smaller , um, to,

16:29

to work with. The other

16:31

thing that sometimes we see is just , um,

16:34

making sure that, that you

16:37

don't intermingle or , or commingle various

16:39

, um, coding issues. Um,

16:42

so it might be that that one,

16:45

one item is identified, but as

16:47

that review is taking place, as

16:49

that identification process is taking place,

16:52

you kind of alluded to this, Alyssa, there might be more

16:55

than one issue or, or a couple of issues at

16:57

hand. And making sure that, that

17:00

when we look at , um, the

17:02

variability of the issues and the payments

17:04

associated with the issues and , and various

17:07

metrics that , um, it

17:09

might make sense that within that you

17:11

have separate universes or separate

17:13

buckets , um, upon which to,

17:16

to probe and sample and , um,

17:18

eventually extrapolate if that's

17:20

what needs to occur. Um, and

17:22

so just making sure that that is as

17:24

specific and and complete as possible

17:27

is really gonna be to the benefit of the organization.

17:31

Yeah, and to your, to your point, you know, sometimes

17:33

you have situations where, I mean, just by

17:35

way of example , um, you've

17:38

identified, you know, maybe a,

17:40

a issue that involves coding, but

17:42

then there's also maybe overlaid on top

17:44

of that a medical necessity issue, right? And

17:47

so then we've got maybe different

17:49

types of procedures

17:52

or different types of services that

17:54

are, that are involved.

17:56

And, you know, I think in terms of identifying

18:00

a universe, we could collectively say, well, here's

18:02

our universe, but then to establish whether

18:04

or not that that, you

18:07

know , to , to, to look at, you know, what

18:09

the error rate is, for instance,

18:11

really wouldn't be accurate to

18:14

pull from that entire universe to

18:16

, which is to your point, you know, does it make sense to

18:18

separate, you know, issues

18:20

or claims into different buckets

18:23

and really sort of drill

18:25

down on, you know, something at

18:27

a, at a, a , a different

18:29

level of, of detail to make sure that

18:33

whatever you are identifying as

18:35

your universe and then your

18:38

probe sample is reflective of, you

18:41

know, the, is going to give you

18:43

an accurate, an accurate error

18:46

rate at the end of the day. Um

18:48

, and so I think that's something

18:50

else that, you know, that's to

18:53

consider. And I mean, you know, Sarah , you

18:55

and I , you and I have both worked on things together where

18:58

we, we really can't glean a sample

19:01

from , uh, just

19:03

a, you know, probe example of

19:06

claims. You know, you really have to actually look at

19:08

claims on a claim by claim basis, or

19:10

you've got to the medical record

19:13

or the billing records don't reflect the

19:15

issue, maybe because of

19:17

the way the services were documented,

19:19

which raises an another sort of

19:22

complexity to really

19:24

determining, you know, what your real error

19:27

rate is, so to speak, and how to,

19:30

how to really evaluate that, both

19:32

from a reasonable standpoint, but

19:34

also a more accurate and

19:37

I think conservative approach.

19:41

Yeah . Yep . Absolutely. There

19:43

have been instances in which we

19:45

, um, you know, either based

19:47

on data limitations from,

19:50

you know, the , the client's legacy system

19:52

or because of the, the

19:54

complex nature of the issue

19:56

that was identified, where we

19:59

end up walking away from kind of

20:01

that, that probe approach. And we have to take a

20:03

completely different approach because we know that because

20:06

of, you know, there are one or more kind

20:08

of limiting factors that we know would make

20:10

that approach , um, not,

20:13

not provide a , an accurate result

20:15

at the end of the day, not provide something

20:17

that from a statistical standpoint could,

20:20

could , um, result in a statistically

20:22

valid random sample to, to be able to rely

20:25

upon. And so then , um, that's

20:27

when we've gotta be , um, give, give

20:29

quite a bit of, of thought and, and

20:32

analysis work to, okay, what,

20:34

what does our review now look like? Is

20:37

it a , a larger sample of claims , um,

20:39

to be comprehensive in that way? Is it

20:41

a data-driven approach that we can get comfortable

20:44

with? Um, again, depending on the

20:46

nature of the issue, it becomes, it

20:48

becomes pretty , um, pretty subjective

20:50

and pretty specific to the, to

20:52

the issue at hand by that, by that point.

20:56

Um, but that's definitely , um, that's

20:58

definitely always our goal. Um,

21:00

and that really gets into , um, what

21:03

does the, what does the universe look like at,

21:05

at the end of the day? Um, you

21:07

know, is it something that we're, we're gonna be pulling data

21:10

from , um, a a number of disparate

21:12

systems to, to get to the, to

21:14

get to the starting point. And then , um,

21:18

as I mentioned, you know, statistical insight

21:20

is really needed , um, if,

21:23

if you're gonna go that route from an extrapolation

21:25

perspective,

21:28

Right.

21:29

I , I , both of those situations

21:32

<laugh>. Yeah,

21:33

No, exactly. And, and just from a statistical

21:35

, um, you know

21:37

, uh, perspective, I mean, I think ensuring

21:40

that your sample is statistically

21:43

valid is really important if that's

21:45

what you are going to rely on as

21:47

the basis, you know, for the

21:50

repayment. And so , um,

21:53

you know, that's where really I think, Sarah , to

21:55

your point, the value of , um,

21:58

you know , working with a statistician can

22:00

be particularly helpful because, I mean,

22:02

what you're , from a provider perspective, anytime

22:05

, you know , you're making a

22:07

, um, voluntary repayment or

22:09

you're, you know, you've got a situation that may be during

22:12

the reasonable diligence period you

22:14

started and you think, oh, it's, it's really

22:17

along the lines of a repayment, but we learn through

22:19

the course of reasonable diligence that maybe

22:22

we've got other issues that make, you

22:24

know, self-disclosure under OIG g self-disclosure

22:27

protocol or CMSs, self-disclosure,

22:29

self-disclosure protocol more

22:32

appropriate. You really start

22:34

thinking about, you know, what

22:36

is the government, what,

22:38

what's the most credible approach to take?

22:41

And , um, and wanting to ensure

22:44

that whatever methodology is

22:46

used is going

22:49

to yield and valid and

22:51

statistically, and , and even if we're

22:53

doing this on a claim by claim basis from a

22:55

, you know, the methodology can be

22:57

explained and backed up.

23:02

Yep , yep . Absolutely.

23:05

Absolutely. And that is definitely where

23:07

, um, you know, sometimes we've had

23:10

clients that, that have tried to, to

23:12

do these analysis steps internally, and,

23:14

and certainly there are some that, that have

23:16

success with that, and that's fantastic. But

23:18

, um, it , it, it is nice

23:21

to be able to have that external , um,

23:24

third party to , um, give

23:26

those steps and that those pieces kind

23:29

of the , the green light at the end of the day because

23:31

, um, again,

23:33

as consultants, we, we , um,

23:37

because we're not the operators and we don't

23:39

have all of the institutional knowledge

23:41

about the providers and the care

23:43

locations and all of those pieces, you know,

23:45

we're just gonna come in and ask a whole lot of questions

23:48

and really try to try to validate

23:50

all of those steps and all of those pieces. And

23:53

oftentimes , um, the result is, is

23:55

, um, impactful in a positive way

23:57

to the organization , um, and that

23:59

we're able to narrow that focus, or we're able

24:02

to sometimes revise the approach

24:04

if it's something that is complex

24:06

and , um, having to be pieced

24:09

together over, you know, a longer period of

24:11

time. If we're looking at a full six year look back

24:13

, for example, a lot can happen these

24:15

days in healthcare in six years. And so

24:17

, um, that's where it can become challenging

24:20

if some data is available for

24:22

, um, a particular period of

24:24

time, but then perhaps a different data

24:27

set , different parameters, et cetera, are

24:29

available , um, from, from a

24:31

a , a further distance

24:34

look back period , um, perhaps

24:36

the legacy system, you know, data

24:38

pools are , are not able to be as robust

24:40

and as detailed as what we need for

24:43

the issue. Um, that's where

24:45

we've gotta get, get comfortable

24:47

with , um, the ability to put

24:49

those two data pieces together

24:52

and get a full picture. So

24:54

that's definitely something that, that we

24:57

see with clients often and are able

24:59

to help with.

25:01

Yeah . And oftentimes during that, you know, six,

25:03

if you're, I mean, you can really

25:05

be any look back period, but let's

25:07

hypothetically say, you know, we've got a six year look

25:10

back , and sometimes you're working, you

25:12

know, particularly with federal healthcare program payers,

25:14

sometimes we've got multiple player payers,

25:17

multiple fee schedules, the fee schedules change

25:19

, um, uh, you know, over

25:22

a period of time or annually. And

25:24

so there's, you know, it can

25:26

be, a lot of it can

25:28

be cumbersome for a

25:30

provider to try to work through that on their own. But then just having

25:33

the validation , um, too

25:35

from, you know, an objective third party

25:38

to, to demonstrate to the government that,

25:40

you know, as part of the reasonable diligence, there

25:42

has been an effort to, you know, verify

25:45

and confirm that what

25:47

maybe, you know, the compliance team

25:50

has, has worked through is

25:53

can be backed up and supported and

25:55

is , um, is, is

25:58

accurate. So it's a , it's a way to, you know, really

26:01

bolster, you know, maybe what you,

26:03

the the analysis or the evaluation that

26:05

perhaps a , a client has already

26:09

undertaken. And then, you know, there are

26:11

circumstances where, you know, from,

26:13

like I said, you know, during reasonable diligence

26:16

or even prior to, you know,

26:18

maybe something's discovered that creates

26:20

concern of a potential, you

26:23

know, that there's, that there really is a situation where

26:25

in addition to identifying overpayments,

26:27

you're really looking at a situation

26:30

that's more appropriate for self-disclosure.

26:33

And so , um, a lot

26:35

of this work, you know, can be, you

26:37

know, done at the direction of council and, and,

26:39

you know, you

26:41

know, there's some work product considerations

26:44

that, that come into play . Um,

26:47

you know, I think overall,

26:52

I mean, some of the things, Sarah , that, you know, we've

26:54

seen just that giving rise

26:57

to some of these issues you mentioned, you know, legacy

27:00

builds and changes and , and

27:02

software, but also, you know, like

27:05

EMR builds and , um, you

27:09

know , um, changes in billing rules

27:11

or providers not understanding the

27:13

rules , um, things like that, or

27:16

just the software glitches where, you

27:18

know, something's not really

27:20

, uh, something's not updated or

27:22

added, and therefore the, the billing is really

27:24

, um, inadvertently,

27:27

you know , uh, uh, there's

27:30

a mistake in how something's coded , um,

27:32

or billed , um, you

27:35

know, changes to fee schedules , um,

27:37

billing rules, all of that. And

27:40

now I think, you know, we've,

27:43

certainly, both of us I know have been working with our

27:45

clients to come sort of back into

27:47

compliance post PHE with

27:49

the waivers, and then with some of

27:51

the , uh, flexibilities

27:54

being extended through , uh,

27:56

2024 through the, through

27:58

the fee schedule and , and things

28:00

like that. And so there's a , this

28:02

can be fairly nuanced, you

28:04

know, working through just, you

28:07

know, once you've identified your universe,

28:09

I mean, really what all the different issues are

28:11

that come in, come into play. Um,

28:17

Yeah. Yeah. And

28:19

I think, Alyssa, one thing that,

28:22

that we have seen in

28:24

addition to, you know, obviously

28:27

during, during covid and certainly in the height of

28:29

the pandemic, everyone was trying to

28:31

stay, you know, stay current, stay abreast

28:33

of, of all the various waivers

28:35

and, and flexibilities during the public

28:38

health emergency. And so what

28:40

we are really seeing now is, is not

28:42

only the, you know, how do we kind of shift

28:45

back to a pre covid state of,

28:47

of operations and maintaining

28:49

compliance there, but also during

28:53

that PHE period , um,

28:55

we know that, you know, providers

28:58

were really focused on patient care as

29:00

they should be. And, and , um,

29:03

some of the more routine,

29:05

perhaps compliance auditing and monitoring

29:08

activities that were standard

29:10

operation pre covid may

29:12

have shifted some during that time, either

29:14

because of staffing, you know, patient

29:17

volumes , um, other,

29:20

other things that were at the time, you

29:22

know, obviously far greater priority.

29:25

And so now some of those,

29:27

some of those issues and some of those things

29:29

that, that were, that were missed , um,

29:32

during the PHE are starting to come

29:34

to light too. And , um, a

29:36

lot of them, you know, we kinda look at from a consulting

29:38

perspective and think, okay, probably if

29:41

it hadn't been for Covid, this might not have been an

29:43

issue. This might have been something that was able

29:45

to be identified and captured earlier.

29:48

Um, but, but because of, because of

29:51

the pandemic and, and folks kind of shifting

29:53

their focus , um, some

29:55

of these things are, are just now sort of coming to

29:57

light. So the good news is , um,

30:00

with those, you know, there are some issues

30:02

that are gonna have a shorter look

30:05

back period because they may have been, you

30:07

know, doing everything right pre

30:10

covid and something shifted during

30:13

the PHE . So , um, hopefully

30:15

in some instances, a shorter look lookback

30:17

period. But, but some of those pieces

30:20

are really just now coming to light for , um,

30:22

for our clients, for providers that we're

30:25

starting to see. So

30:27

it's, it's really , um, kind of a

30:29

convergence of a lot of things right now.

30:31

And, and that's really just to, to reemphasize

30:34

the importance of, of , um, taking

30:36

that, that time , um, taking

30:39

that reasonable diligence period and , um,

30:42

not rushing that quantification step

30:44

, um, which can be tempting to,

30:47

to do. Um, Alyssa,

30:50

do you wanna talk a little bit about the , the six month kind

30:52

of period and, and when that might,

30:55

an organization may even need beyond the

30:57

six months for

30:59

that? Yeah , no vacation step.

31:02

Yeah, that , that's a great, that's a great point.

31:04

So, I mean, generally CMS guidance, you

31:07

know, they reasonable diligence. They say reasonable

31:09

diligence should and can be conducted within,

31:11

you know, the six a six month timeframe

31:14

, um, absent extraordinary

31:16

circumstances. And so, you know, we

31:18

start thinking about, well, what does , what does that really

31:20

mean? And it's, you know, typically in situations

31:23

where the investigation is fairly

31:26

complex , um, or

31:28

very complex and usually complex , um,

31:30

sometimes we've seen that happen with, you

31:32

know, certain star law violations , um,

31:34

and then you've got exceptions for

31:37

natural disasters and states of emergency.

31:40

Um, you know , I think that a

31:43

lot can be done in a six month

31:46

period of time, but sometimes, you know,

31:48

it's, it's just the,

31:51

the issues, like I said, you know, sometimes

31:54

the issues sort of start as one

31:56

issue, and as reasonable diligence

31:59

progresses, more information

32:03

comes to light that either changes the

32:05

course of the investigation

32:08

and valuation or, you know , adds

32:10

to it. And so, or

32:12

the issues are just , um, you

32:14

know, the , like I said, I mean, some circumstances

32:17

where, you know , you can't

32:19

pull a sample set of claims and derive

32:22

anything from that because of the way information

32:26

may or may not have been documented in , in

32:28

a medical record or , uh,

32:30

some other, you know, reason. And

32:32

so it warrants a different level and

32:35

, and type of , uh, scrutiny

32:37

and evaluation. So , um,

32:42

you know, if I would say, you know, if, if

32:44

there are situations where there's

32:47

more time needed to complete this and

32:49

just be mindful and be, you

32:51

know, prepared to identify exactly

32:54

why, the reason why

32:56

the investigation is

32:59

unusually complex and,

33:01

and to I be prepared to identify

33:03

that when any, any voluntary

33:07

repayment is made or disclosure

33:09

is , uh, is conducted. So

33:13

Sarah , have you , um, you've worked, you

33:15

know, in situations where, you

33:17

know , issues have come up through normal

33:20

compliance measures, but then I

33:22

think, you know, we've both been

33:25

involved on the transactional side

33:28

and, and through diligence issues

33:30

can come up in that

33:32

way, which raises sort of a

33:35

different , um, sometimes

33:38

different implications and action plans

33:40

because you're trying to really assess, you know,

33:42

potential liability and,

33:44

and things like that. You know, have

33:46

you, what , what's been sort

33:48

of your experience or your, you know,

33:52

your, you know, insight, you

33:55

know, in the difference between the two when something

33:57

comes to you all?

34:00

Yep , yep . Absolutely. So

34:02

, um, that's a, that's

34:04

a really good question. So , um,

34:07

you know, when an issue is identified

34:10

and it's not associated, you know, we're not, we're

34:13

not looking at a , a target for a potential transaction.

34:15

It's just sort of the, the provider and whether

34:18

it comes through the, you know, a hotline

34:20

complaint or an employee tip or, or

34:22

, um, you know, through that,

34:24

that regular routine auditing and monitoring

34:27

process, you know, it's,

34:30

it's kind of up to the organization.

34:32

The organization is bearing that risk, and

34:34

the organization is bearing that responsibility for

34:37

remediating that identified issue

34:39

after the, the extent of it has

34:42

been quantified. When

34:44

we think about a compliance issue

34:47

and a , and a repayment sated with

34:49

a potential transaction, then

34:51

you have kind of two risk

34:54

profiles to sort of take into consideration.

34:57

There's the buyer's risk profile,

34:59

and then there's the, the targets

35:01

kind of historical compliance risk profile

35:04

and the way that they have historically

35:06

handled issues within their organization.

35:09

And , um, then you also, you

35:11

know, kind of have to layer on top of that, what

35:14

is the future state gonna look like post-transaction?

35:18

So what's the ownership gonna look like? What's,

35:20

what are the plans for the, for the tax id? How's

35:22

the billing going to occur , um, from

35:25

an ownership perspective? Um, and

35:28

so that is, you know, those

35:30

are additional layers and additional

35:32

factors. Um, depending

35:35

on the, the timing of the, the

35:37

date, you know, when the issue is identified

35:40

and the anticipated close date,

35:42

you know, the, the, the transaction itself

35:44

could obviously be at risk, but also

35:46

the, the, the timeline

35:49

for the transaction can also shift

35:51

, um, as well, assuming

35:53

that it's an issue that everyone

35:55

is comfortable with, you know, continuing

35:58

to, to move forward knowing that that issue

36:00

exists. And so , um, it

36:02

, it becomes sort of multifactorial

36:04

, um, when we're talking about it

36:06

from a transaction standpoint versus when

36:08

we're talking about an issue that's,

36:10

you know, sort of I'll say just within the, the

36:14

providers , um, organizational

36:16

realm, and it's not associated with a transaction.

36:20

Um, there , you

36:22

know, oftentimes things are able to be remediated

36:24

without , um, without, you

36:26

know, the , the transaction being , um,

36:29

put, put in jeopardy. But sometimes there are

36:32

risks and things that are identified that

36:34

can absolutely impact what

36:36

that transaction looks like. It can impact

36:38

the overall , um, dollars

36:40

associated with the purchase price, even, you

36:42

know, worst case scenario. So , um,

36:45

it's really important, again, that I go back to,

36:48

you know, once that issue's identified,

36:50

kind of quantifying it. Um,

36:53

and that can take, that can take on,

36:55

you know, a couple of different looks

36:57

and, and roles , um, within

37:00

that target organization. Um,

37:03

depending upon the, the

37:06

state of affairs and the state of the targets

37:08

business, you know, if they've had a lot of turnover in

37:10

leadership and , um, maybe they've

37:12

been on a number of different billing platforms

37:15

, um, if they are, you

37:17

know, really struggling from

37:19

a financial perspective, it may

37:21

be a bit harder to quantify, okay, what,

37:24

what was the normal state of business and, and what

37:27

, what point did this occur? And how far

37:29

back, you know, how far back does this

37:31

really go? Um, we've had sometimes

37:33

a , a more challenging time getting to all

37:35

of those answers , um, depending

37:38

on the state of, of the targets

37:40

business. And so really , um,

37:43

that's where it's again, important to, to

37:45

take the time that's needed , um,

37:48

to, to be able to fully get

37:50

in and, and figure out the extent of

37:53

the issue, and then determine what type

37:55

of disclosure is needed. You know,

37:57

is there anything that can be , um, submitted,

38:00

you know, buil as a corrected claim, is everything,

38:02

you know, part of that , um, disclosure

38:05

process or repayment process, or is

38:07

there any remediation that can be done if it's

38:09

something that occurred more recently? Um,

38:11

so those are really things to, to

38:13

think through from a transaction perspective.

38:16

And then also from a provider perspective

38:18

, um, you know, when

38:20

we, when we are working with counsel as

38:22

consultants , um, on

38:25

anything that's related to an overpayment matter,

38:28

that data is key because we are

38:30

coming in as, as outsiders to the

38:32

organization, and we don't have that, you

38:34

know, institutional knowledge of, you

38:36

know, when Dr. Smith started with the organization

38:39

and when a new wing of the hospital was

38:41

opened or when a new service, you

38:43

know, began to be , um,

38:45

offered and, and submitted and build . You

38:47

know, we are really relying upon , um, our

38:50

ability to ask lots of questions, and also

38:52

the client's ability to be able to provide

38:54

us with a lot of information and dates and

38:57

facts. And sometimes, you know, depending

39:00

upon the, the tenure of those involved

39:02

at the hospital , um, or the, you

39:04

know, whatever the provider organization is,

39:07

you know, who's the best historian on some

39:09

of this. And so sometimes it may take , um,

39:11

meeting with a number of folks to kind of get

39:14

all of the, the facts and the dates and the circumstances

39:17

down pat in a way that everybody is comfortable

39:19

with. And then obviously

39:21

from a legal perspective and understanding

39:24

the regulatory changes that may have occurred over

39:26

time as well. Um, in

39:28

addition to, you know, Alyssa , as we talked about

39:30

some of the EMR changes and things. So

39:34

we definitely , um, continue

39:36

to see some, some risks both

39:39

from a transactions perspective and then just

39:41

as I mentioned earlier, as

39:44

providers kind of go back to, I'll

39:46

say normal, whatever normal means

39:48

these days, normal compliance , um,

39:50

activities in a, in a post covid

39:54

PHE kind of environment. Um,

39:56

Alyssa , you know, would it be helpful we can kind of run

39:59

through maybe some of the , um,

40:01

examples of some of the issues that we're

40:03

seeing lately , um, in

40:06

, in terms of actual matters that

40:08

have required repayment? Would that be helpful?

40:11

Yeah, I think that would be great. I did wanna just add

40:13

one thing with , you know , in the transactional

40:16

, um, space, sometimes, you

40:18

know, it can be a little challenging

40:21

because, you know, whether you're buyer side or seller

40:23

side, sometimes they're competing viewpoints

40:26

on an issue are competing evaluations.

40:29

And so sometimes you're really trying to work

40:31

toward , uh, what that middle ground

40:33

is with regard to regulatory

40:36

risk and exposure. And

40:39

then, you know, ultimately, you know, it

40:41

can affect, you know , post-closing obligations,

40:44

including indemnities. So

40:46

those are just things that, you

40:48

know, are relevant in, in

40:51

walking through and an identification

40:53

of, of, of issues. But

40:55

yeah, in terms of, you know, things that we've

40:58

seen lately , um,

41:02

you know, i i

41:05

I one, you know, issue

41:07

in particular that seems to be kind of hot

41:09

on my desk recently are

41:11

a lot of provider based issues and

41:13

provider based billing. Um, you

41:16

know, and, and inadvertently,

41:18

you know, billing claims , um,

41:21

you know , you

41:25

know, as a freestanding versus provider based

41:27

and trying to reconcile those issues

41:29

or just even compliance within, you

41:32

know, the, the regulatory requirements

41:34

, um, to Bill is

41:36

provider based is, is one thing. I mean , sometimes

41:39

too, you know, with , um, scope

41:41

of practice is always a big deal,

41:44

particularly when you've got large providers that

41:46

operate in many states.

41:48

And so , uh, you're all , you're looking

41:51

not just at, you know, what are the, maybe

41:53

the Medicare or , uh, Medicare

41:55

rules, but you've got to drill down on the state

41:57

level , um, you know, to

42:00

really identify is this within this individual

42:02

scope of practice under state law? Are

42:04

they, are they appropriately supervised? Is

42:07

the level of supervision different based

42:09

at , you know, on the state level versus the federal

42:12

level? Um, are the Medicaid

42:14

billing rules, you know, similar

42:16

or different? I think Sarah , you and I have both

42:18

seen this , um, in

42:21

the behavioral health space

42:23

with the sort of expansion of providers

42:26

, um, for furnishing

42:28

services in that

42:30

space. Um, and

42:33

, um, you know, also just things

42:35

that really kind of get missed, like

42:38

, um, you know,

42:40

issues with enrollment or remote

42:42

practitioners, not just telehealth, but a

42:44

lot of remote , um, radiology,

42:48

you know, reads and things like that. Um,

42:52

um, you

42:54

know, the EMR , we've run into this with

42:56

EMR builds several times now where

42:58

, um, you know, we, the

43:01

build was built one way requiring certain

43:03

attestations on , um,

43:06

and, you know, that was not always

43:09

in line with how a provider functioned

43:11

operationally, but , um,

43:14

maybe wasn't set up, you know, in

43:17

the, in the, in the way that really made

43:20

a lot of sense. Um, so,

43:24

you know , do you, Sarah,

43:27

do you wanna add, you know , to that from the,

43:29

from some of your more recent

43:31

, um, experiences?

43:35

Y yeah, sure. I'd be happy to, Alyssa . Thank

43:37

you. Um, and one of the things that I should

43:39

have mentioned when we were just, if I could step back

43:41

for a minute and we were talking about , um,

43:44

you know, from a transaction perspective,

43:47

if we're identifying an , an issue

43:49

with a, with a target that's associated with

43:51

a potential transaction, a

43:53

across provider types, regardless

43:57

of of what care setting we

44:00

are talking about, we are absolutely

44:02

seeing, you know, a heightened

44:04

focus from a regulatory standpoint

44:06

on private equity transactions. And

44:09

so if it is a , a , a , a

44:11

PE related transaction, just

44:13

know that that is gonna , um, have

44:15

a little bit more regulatory scrutiny associated

44:17

with it. Um, in particular,

44:20

we're seeing a lot of , um, a

44:22

lot of risks, a lot of repayment issues

44:25

, um, for behavioral health, but that's

44:27

not, that's certainly not the only , um,

44:30

the only PE target these

44:32

days are the only area where there could

44:34

be , um, um, a

44:37

repayment need. Um, but behavioral

44:39

health providers, you know, there were a

44:41

lot of new entrants to the market , um,

44:44

during covid , um, with the telemedicine

44:47

expansion. Um, even existing

44:49

behavioral health providers that had been

44:52

offering services for a long time, you

44:54

know, we saw some shifts operationally

44:57

to meet the needs of , um,

44:59

you know, patients being, being at home and not

45:02

really wanting to come in for therapy or not feeling comfortable

45:04

coming in to, to do that. Um,

45:07

supervision, I know you mentioned this,

45:09

Alyssa, it continues to be , um,

45:11

kind of a hot button item , um,

45:13

making sure that you've got, you know, records

45:15

and documentation where needed

45:17

to support what was happening , um,

45:20

from a business standpoint. And then , um,

45:24

because of the, the influx of

45:26

new providers, or perhaps in addition

45:28

, um, you know, making sure state

45:30

scope of practice , um, requirements

45:33

are met , um, oftentimes

45:35

state Medicaid requirements for

45:38

, um, providers and,

45:40

and who is able to provide what type

45:42

of services , um, can

45:45

vary from Medicare, which can be confusing,

45:48

particularly , um, depending

45:50

upon the sophistication level of the organization

45:53

and the tenure of their, their billing staff

45:55

and the experience and education level, making

45:57

sure that, that all of those pieces are aligned

45:59

so that when you're billing, you know, state

46:02

Medicaid, that , that you're doing so correctly,

46:04

but also when you're billing Medicare that

46:06

you're meeting those requirements, understanding that

46:08

they may be , um, in some instances

46:10

they may be different. And then another

46:13

area where we've seen , um, a

46:15

fair amount of activity this year would be related to

46:17

infusion services. Um, you

46:20

know, making sure the documentation

46:23

there , um, supports the

46:25

service and, and making sure the supervision

46:27

there supports the service. And

46:29

sometimes it gets really , um,

46:32

it , it can get really , um, granular

46:35

in terms of looking at, looking at

46:37

the requirements and, and , um,

46:39

you know, looking at the ways that the patients

46:41

are scheduled, you know, are patients scheduled just through

46:44

the Monday through Friday, like a traditional

46:46

work week schedule , um, is,

46:48

is this, is the center offering weekend

46:51

coverage, you know, if they're offering coverage

46:53

on the weekends, do they have the,

46:55

the correct , um, staff compliment

46:58

to be able to do that? Are they, are

47:00

they , um, ensuring that they're maintaining

47:02

the appropriate level of supervision for

47:04

billing of those services? And that's where sometimes,

47:08

you know, when you think about identification

47:10

of an issue and, and quantification of

47:12

an issue, it may be multi-step,

47:15

it may be multifaceted, it might be looking at the, you

47:18

know , billing data as well as the

47:20

medical record as well as, you know, obviously

47:23

communication with the client to kind of walk through

47:25

, um, all of those, all

47:27

of those pieces. So , um, there

47:30

, there's a lot from a provider standpoint.

47:32

There, there are a lot of moving parts there.

47:36

I think too, one of the areas that's really

47:38

kind of getting a lot of at least focus

47:40

because there's been an increase

47:43

in the ability to provide these types of

47:45

services is really the remote

47:47

patient monitoring and rebo remote therapeutic

47:50

monitoring and , um, monitoring.

47:52

And really with those types

47:55

of services, again comes,

47:57

you know, to your point, the relevant , um,

48:00

scope of practice , um, issues,

48:03

the , um, supervision issues, and

48:06

then also the setting in which those

48:08

services mm-hmm , <affirmative> are being furnished is relevant

48:10

to, you know, some of the issues and

48:12

, um, the, the payment issues. And

48:15

so that's something that, you

48:17

know, that, you know, we've seen also,

48:19

you know, in the , um, um,

48:22

outpatient dialysis space, which kind

48:24

of goes to your point about infusion

48:27

Mm-Hmm , <affirmative> , um, because you are really looking at, you know,

48:30

you know, was there, you know, a , a

48:32

physician , um, encounter

48:35

at the appropriate time. And so it's

48:37

not just the billing record that becomes relevant,

48:41

right? It's the actual medical

48:43

record that you're having to then

48:45

look at and, and then, you know, depending

48:48

on that documentation, maybe there's even more

48:50

that needs to come into play. So I

48:53

think really, you know, as we sort

48:55

of wrap up , um,

48:58

our, our discussion today, I mean, I think really

49:00

the, the focus on, you

49:02

know, a lot of this really needs to be, you

49:05

know, being thorough and

49:08

, um, and, and as you work, you

49:10

know, as you work together, you know, council

49:13

, outside council working with, you

49:15

know, consultants is really to , you know, identifying

49:18

whether there's additional risk.

49:20

And I think that's where, you know,

49:22

during that reasonable diligence period,

49:26

we're , we're , while the focus can

49:29

be on, you know, all

49:32

the other things we talked about, you know, identifying universal

49:34

claim , the universe of claims, identifying the root cause,

49:37

I mean , we're really also too constantly

49:40

evaluating what the potential risk

49:43

is and what the potential exposure

49:46

is. And, and also with that comes,

49:48

you know, materiality. Um, you

49:51

know, and, and if as council

49:53

, if we're gonna have to defend an issue

49:55

on materiality, then we

49:57

certainly really want the,

50:00

the methodology to

50:02

be, you know, to be

50:04

solid and explainable and credible.

50:07

And I think that's where, you

50:10

know, you're, you're really working together as

50:12

a, as a team and , um,

50:14

through this is , is really , um,

50:17

is really important.

50:20

Yep . And we, so we so appreciate , um,

50:23

you know, having the opportunity to, to

50:25

do this type of work and to help clients

50:27

in this way. And , um, you know,

50:29

working, working alongside , um,

50:32

council from from that perspective

50:34

, um, really helps strengthen

50:37

, um, you know, to

50:39

the extent that that a disclosure is determined

50:42

to be, to be necessary really

50:44

helps strengthen that , um, and,

50:47

and close that loop. Um,

50:49

we found we've had really great

50:51

success with , um, submitting

50:54

those , um, types of, of self

50:56

disclosures both to Medicare

50:58

administrative contractors and, and also to , um,

51:01

the OIG with,

51:03

you know, very few if any questions , um,

51:06

at the end of the day when we're able to have a

51:08

really tight process and a really defensible

51:10

set of, of action steps to

51:13

get to that, that quantification

51:15

to get to that dollar amount at the end of the

51:17

day. Um, so we,

51:19

we so appreciate being able to do

51:22

that.

51:24

Absolutely. And , um, well, it's been so

51:26

wonderful, Sarah , to talk with you today

51:28

and thank you to the A HLA for

51:31

the opportunity to , um,

51:34

to, to have this conversation and, and

51:36

to present. And , um, if

51:38

anyone has any questions, certainly welcome

51:40

to reach out , reach out to Sarah

51:43

or me directly. And again,

51:45

it's been a really nice opportunity and

51:48

thank you very much.

51:50

Thank you.

51:58

Thank you for listening. If you enjoyed

52:00

this episode, be sure to subscribe to

52:02

a HLA speaking of health law wherever

52:04

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52:07

learn more about a HLA and the educational

52:09

resources available to the health law community,

52:12

visit American health law.org.