October 7, 2025 • 36 mins
Leah Voigt, Chief Compliance Officer, Corewell Health, and Anthony J. Burba, Partner, Barnes & Thornburg, discuss takeaways from recent health care fraud enforcement activity, recent compliance guidance from DOJ and OIG, and practical steps that health care companies can take to address, mitigate, and remediate risks in key focus areas for the government. Anthony and Leah spoke about this topic at AHLA’s 2025 Annual Meeting in San Diego, CA.
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Episode Transcript
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SPEAKER_00 (00:04):
This episode of AHLA Speaking of Health Law is
brought to you by AHLA membersand donors like you.
For more information, visitAmericanHealthlaw.org.
SPEAKER_01 (00:17):
Hi everyone, my name is Leah Voigt, and my colleague
Tony Burba and I had thepleasure of presenting at the
AHLA annual meeting in June onthe topic of compliance from the
cheap seats.
And neither Tony nor I havereally been in the cheap seats.
We've actually both been in thetrenches when it comes to
healthcare compliance andenforcement activity.
(00:39):
I am a healthcare attorney bybackground and a compliance
professional.
Most recently, I was the chiefcompliance officer at Corwell
Health, an integrated healthsystem based in Grand Rapids,
Michigan.
Tony, let me hand it over toyou.
SPEAKER_02 (00:56):
Absolutely.
I'm excited to speak in thistopic again.
My name is Tony Berba.
I'm a partner at Barnes andThornburg.
I practice out of our Chicagoand Washington, D.C.
offices, and my practice reallycenters on fraud and abuse and
compliance issues, everythingfrom assisting uh clients with
(01:18):
their compliance program tointernal investigations, to
defense of governmentinvestigations, especially
around the False Claims Act.
So it's definitely an area thatI work in a lot, and we're
seeing a lot of things happeningin the market right now.
So I think it's a timelyconversation.
I will say that I'll start withthe same disclaimer that I gave
(01:40):
at our panel at the annualmeeting, which is these are all
potentially fraught politicaldiscussions, and that's not our
goal here.
Our goal is really to talkpractically about how some of
these things that are being uhput forward as priorities for
the current administration areaffecting companies in the
market and what companies can doto respond to those things both
(02:02):
proactively and in the eventthat they end up getting um uh
getting hit with some kind ofinvestigation or audit or
whatever.
Um I'll just start things offand say, you know, in my
practice, I am definitely seeingan uptick in several kinds of
investigations.
I think that, you know, withrespect to the um corporate
(02:27):
enforcement or the criminalenforcement priorities for uh
DOJ, which uh just as a as a uhreminder were sort of five key
areas.
One was national security,including trade, cartels, and
forest terrorist organizations,one was the opioid crisis, one
was government fraud and waste,and then another is um combating
(02:52):
actions which circumvent rulesand regulations to protect
American consumers andprioritize uh violations of the
Controlled Substance Act and theFDCA or the Food Drug Cosmetic
Act.
So um we had had a number of uhdiscuss this quite a bit.
I think within these priorities,which are pretty similar to the
(03:13):
civil priorities that werestated by the civil division,
um, you know, there's a numberof things that the government I
think is doing.
Some of those things are acontinuation from the Biden
administration.
Um, some of those things I thinkare a bit more um aggressive uh
or have been put forward.
So I think two areas that I'mseeing a lot of enforcement is
um number one, the UPICs areincredibly active right now.
(03:36):
Um really pursuing companiesthat are doing any kind of
advanced wound care, um woundcare related to skin grafts and
those kinds of things.
Um they're going after uhcompanies for you know
purportedly providing cosmeticprocedures.
Um and then sort of moretraditional areas as well, just
(04:00):
sort of medically unnecessaryservices and those kinds of
things.
Um and then another area,another key area is COVID
enforcement.
Um the UPICs are definitelytargeting as is the civil
division uh COVID testingcompanies, especially labs set
up by physicians during theearly days of the pandemic.
Um we got several clientsdealing with that issue right
(04:23):
now.
And then the civil divisionseems to have a task force
targeting uh those folks thattook the paycheck paycheck
protection program loans, and inparticular the second of those
loans.
Um and those are basically CIDscoming to American subsidiaries
(04:43):
of foreign uh inbound companies,and whether or not specifically
those companies counted theirforeign employees and their
employee count when they uhapplied for the second PPP loan.
So um just sort of starting itoff, those are two areas, those
are some areas where I see a lotof activity right now.
Um, you know, I'm not sure sortof um, you know, if you're sort
(05:06):
of seeing anything, experiencinganything, hearing about anything
sort of within those uhpriorities, um, or if you want
to sort of just sort of discusssome of the uh ways that a you
know, those at least two initialareas of enforcement might be um
addressed by a complianceofficer.
SPEAKER_01 (05:23):
Sure.
Yeah.
Well, well, Tony, you mentionedyou pick activity.
I would say I'm certainlyhearing um that that is an
increased area of focus.
Um and with respect to um CMS, Ithink I would just note, we know
it's in healthcare, we alwayshave to keep our eyes on you
know more than one agency orsub-agency within the federal
(05:44):
government, um, and certainlysomething that um starts within
CMS from uh, I'll say quoteunquote routine audit approach
can uh be handed over forenforcement, civil or criminal
in nature.
And certainly the False ClaimsAct is that that key.
One of the things that we saweven before the new
administration um came uh onboard earlier this year was an
(06:07):
increase in um target probe andeducate audits by CMS.
And some of those areas um thatthe agency was looking at are uh
what compliance officers mightcall low-hanging fruit, you
know, activities and TPEs inparticular, looking at you noted
wound care.
That was a key area that CMS isauditing on as well.
(06:29):
Also, medical necessity andABNs, advanced beneficiary
notices, the things that havebeen around for, you know, it
seems like forever.
Um, certainly if you've been acompliance officer in the last
10 to 15 years.
Um, and it seems that there isan increased focus on
reinforcing some of those rulesthat maybe hadn't been top of
mind for healthcareorganizations.
And so all of those thingstogether, I think, underscore
(06:51):
one of the key themes that youand I spoke about uh in June,
which is for compliance programsand for the healthcare
organizations in which theyreside to stay the course.
Um, this is not the time to takeyour foot off the gas to use
another analogy.
Um, there may be a general viewfrom executive leaders and from
(07:13):
boards of directors that underthe Trump administration that
compliance activities are lessimportant or not as prioritized.
Um, and I think that would be afoolish uh conclusion to make
because what we're actuallyseeing is that it's just as
important, um, if not in someways more intense, the
(07:36):
activities that we're seeing inthe enforcement priorities are
different.
I think as you're highlighting,Tony, and we'll get into this
here more, I know, in the next20, 20 plus minutes.
You know, where do healthcareorganizations need to shift
their compliance focus, not takethe foot off the gas or what
have you, but rather toreprioritize some of those
(07:58):
activities so that you're reallyfocusing on what we're seeing
are um, I'll say some new uhareas uh from the Trump
administration.
SPEAKER_02 (08:08):
Um yeah, no, I absolutely agree.
I think that now is a very goodtime to do some uh sort of good
practices, house cleaning, uhespecially for those companies
that are providing things likewound care, companies that took
significant um you know moniesor loans during the pandemic, or
companies that were involved inCOVID testing.
(08:28):
Um similarly, you know,companies involved in the opioid
industry, both pharmacies uhprescribing physicians and
particular sober homes and othertypes of recovery um providers.
You know, what I'm seeing a lotof is especially my clients that
are smaller providers, smallersuppliers are running into
(08:49):
issues uh with documentation,finding data that they need when
they once the UPEG shows up inparticular, or if the DOJ sends
us on OCID.
I've also seen some of thestates, including Ohio, becoming
a bit more aggressive with theirinvestigation.
So, you know, now is the time toreally think through where your
risk areas are and start doingyour own internal audits, making
(09:10):
sure your documentation is whereit needs to be, uh, making
corrections, uh, doing providereducation on things like um
documentation and those kinds ofthings, which are I think very
traditional areas of uhcompliance work.
Um to your point, uh these arecertainly not areas that are
slowing down and if anythingthey're picking up.
(09:32):
Um, my my standard joke with thegovernment these days is it's
not entirely clear that anyoneworks there anymore.
Um, but you know, I think thatbecause of that, and because
there's been such a you knowrestructuring, especially at CMS
and HHS uh and DOJ, that theyreally are leaning into their
(09:52):
private contractors like theUPEX and the Macs and expecting
them to carry the load in a lotof these areas.
And because a lot of these uhaudits are pretty predictable
and what they're looking for ispretty well known, um it's
definitely a good time to be uhdoing some house cleaning.
unknown (10:11):
Yeah.
SPEAKER_01 (10:13):
Tony, could we shift gears um just a bit and talk
about um the executive ordersand the the number of things
that have occurred since thoseum early executive orders came
out?
It seemed like you know it was aslew of things um day after day
from the space of Januarythrough March.
Um what are we seeing now interms of how the administration
(10:38):
is continuing to reinforce whatare some pretty significant
policy changes, some departuresfrom policies that really have
largely been unchanged for thelast uh 10 to 20 years?
SPEAKER_02 (10:52):
Um Yeah, I think that uh you know we at our panel
in uh San Diego talked about thetwo specifically two executive
orders, executive order 14173and 14168, both of which were
signed on uh President Trump'sfirst day in office.
Um 14173 being the one thateffectively um declared uh that
(11:15):
the DOJ was going to disband allillegal government programs and
directing the DOJ to uh uhpursue private companies,
identify private companies thatwere in the words of the
executive order in uhinstituting illegal DEI.
(11:35):
Um and then the other uh 14168being the one that sort of
related to the definition ofbiological sex and tying it to
the uh the gender at birth asopposed to the gender that is
identified by individual.
Um and so at least with respectto my practice, I'm seeing a lot
(11:56):
more activity related to the DEIuh area.
Um many of my clients and manylaw firms and other institutions
are uh even the ones that areremaining committed to uh
diversity policies andprocedures, are uh rebranding,
uh, finding ways to uhrestructure their programs,
(12:18):
doing evaluations of thoseprograms, pursuing to some
recent guidance from DOJ thatwas put out, I believe, by Todd
Blanch related to whatconstitutes, you know, quote,
illegal diversity, equity andinclusion programs.
I think that's not a badpractice to be in generally.
Obviously, everyone wants to uhyou know, end of pursuing
diversity, equity, andinclusion, make sure that there
(12:40):
is a focus on equity andinclusion for everyone.
And uh I think that's a goodthing.
I think that um certainly theEEOC has stepped up enforcement,
has been sending out a lot ofletters, um, sending out letters
in particular uh to federalgrant and uh recipients of
federal money, asking them tovoluntarily produce documents um
(13:02):
and to voluntarily cooperatewith the administration uh to
provide information and data onit.
Uh diversity, equity, andinclusion.
Um at least so far, I think youknow, best practices seems to be
to politely decline thoseinvitations.
Um generally speaking, theydon't have the power under the
contracts.
And um I think you're justasking for uh a lot of trouble
(13:25):
if you start producing a lot ofinformation that could be
protected by various state andfederal laws and other things
without proper process.
I think my general advice toclients is to respectfully
request that they provide somekind of you know actual legal
process, so whether it's asubpoena or uh an administrative
warrant or any number of othertools they have at their
(13:46):
disposal so that there is a youknow lawful basis for providing
that information.
SPEAKER_01 (13:53):
One of the other tools, which is um really a key
component of an effectivecompliance program is ensuring
um free and fair, I will say,disclosure of any potential
violations of law and inparticular disclosure within an
(14:13):
organization.
Um, the idea of whistleblowerprotections, the ability for um
potential whistleblowers tocommunicate any um alleged
violation of law has been,again, at the core of what we've
considered an effectivecompliance program.
Um, and we've seen theadministration highlight the
(14:37):
whistleblower activity as a wayto further enforce the policies
of the administration, bothwithin the context of DEI as
well as gender-affirming care.
Um we uh saw the administrationfocus, for instance, on the
(14:58):
whistleblower hotline maintainedby the Office for Civil Rights.
Um, and in that context, theadministration focused on
provider conscious rights,conscious rights.
So the ability of a provider tosay, you know, I don't agree
with gender affirming care andtherefore I don't want to
participate in it in any waywhatsoever.
And so the administration um hashighlighted that that hotline as
(15:22):
a way for individuals to comeforward and therefore to find
another enforcement mechanism,um, particularly again around
the DEI executive order and thepolicies contained therein, as
well as the biological, sex, andgender affirming care um
policies that the theadministration has put forward.
(15:43):
Are you hearing from any of yourclients concerns about that
whistleblower activity andanything that they are doing to
shift, again, shift focus fortheir compliance programs?
SPEAKER_02 (15:58):
Yeah, I mean, I think in particular, as I'm sure
you painfully aware, um, at youknow, institutions, large
companies of any kind, but evenin healthcare, um, you know, 90%
of what comes through atraditional hotline is what
would be consideredtraditionally to be more HR type
issues.
Um, I've had clients and um youknow seen other trends in the in
(16:22):
the um some companies where theyeven you know have the HR
department primarily responsiblefor reviewing the hotline
reports and sending any of thesort of ring in compliance over
to the compliance department toinvestigate further.
Now, I think that is a not agreat practice to begin with
because I don't think that youshould be trusting your HR
professionals to be able toassess and identify what a
(16:45):
compliance issue may be.
I think you need a little moreassociated.
So but now especially many ofthese what would have been
considered HR workplacecomplaints related to being
passed over for a promotion orrequired to do certain types of
training or having a boss who'sgiving favor to a particular
group or class of people.
(17:07):
Those are now potentiallycompliance issues and certainly
uh based on you know some of theguidance that's come out of the
Department of Justiceencouraging whistleblowers to
come forward, um, I think it'snow going to be uh an area where
if there is legit legitimatefalse claims act and other types
of enforcement risk.
(17:27):
Um, so I think that uh for surelike you know certainly the
clients I'm working with, uhothers I'm talking to in the
industry are certainly cognizantof that and sensitive to that
and really rethinking how theylook at those things.
Um obviously the sort of counterto that is there's now a judge
in the middle district ofFlorida who's ruled that the key
(17:48):
TAN provisions to the falseclaims act are unconstitutional,
and that case is kind of workingits way up.
And we know that there's atleast two Supreme Court justices
that may um agree with that.
So it'll be interesting to seehow you know those the the
tension between uh what'shappening in the courts and what
the administration isencouraging people to do
ultimately resolves itself.
(18:09):
But um but yes, I think thatespecially when it relates to
diversity, equity, andinclusion, um there needs to be
a heightened sensitivity aroundthe compliance request.
You know, I think even thingsthat you know maybe you know,
two years ago, eight months agowould have been considered to be
kind of a crank, you know, anduh a 50-year-old white male at
(18:33):
an executive level complainingabout being passed over for a
promotion, you know, I don'tknow that even HR would have
necessarily dealt with that.
Um, but I think that the waythey're dealing with it now is
very different and has to bevery different based on what the
administration has said.
That becomes a legitimate riskto the organization.
SPEAKER_01 (18:51):
And as you and I talked about in June, this is an
area of the compliance programwhere some re-energization is is
likely called for.
And I think, as you're noting,um for the compliance team to um
stay more involved, if notpotentially taking the lead
along with legal and HRcolleagues, of course, in
(19:13):
collaboration when these typesof concerns are being raised
because of the um new legal umquiet wire that organizations
are finding themselves in inthese areas.
I'm also wondering, Tony, if wecould talk a little about the um
shifting gears again a bit, theDOJ's um approach to white
(19:34):
collar enforcement and the shifttoward a voluntary
self-disclosure approach.
Um, the kind of general, I'llsay, gist of um the current
DOJ's perspective on this isthat prior enforcement
priorities were really placingtoo much of a burden on
(19:55):
businesses in the United States,including healthcare businesses,
um, that was essentially youknow too high of a cost from an
enforcement standpoint.
And again, um, you know, withoutdigging deeper into it, one
might conclude that, well, thismeans that, you know, the the
foot is off the gas.
Um, but there's another way oflooking at this because the DOJ
(20:17):
has said, well, really whatwe're talking about is the
importance of voluntaryself-disclosure as a way to
essentially avoid prosecution.
Self-disclosure requires theorganization to understand
what's actually going on withinits proverbial or um virtual
four walls.
And so the role of thecompliance program, again, is
(20:39):
just as important, if not moreimportant, if organizations are
trying to stay in line with theDOJ's current approach.
Could you talk a little bit moreabout that and again what you're
how you're seeing your clientsreact to um the criminal
enforcement approach?
SPEAKER_02 (20:57):
Um absolutely.
Uh, and I think that you knowone of the key changes in DOJ's
policy has been that whereas uha declination previously was
something that was on the tableif you self-disclosed, now it's
mandatory if you meet therequirements under the uh DOJ
self-disclosure protocol.
So there is a great benefit tocoming forward and
(21:19):
self-disclosing.
Um and I think you know, there'ssort of two things I would
highlight there and that I'vetalked about in other forums.
Um, one is uh just the interplaybetween legal and compliance.
You know, I think that a goodhealthy compliance program,
especially in an environmentthat's uh rewarding
self-disclosure, will give afair amount of autonomy to the
(21:43):
compliance department to conductnon-privileged investigations
because what all of thesegovernment policies, the CEP,
the um you know, guidance toprosecutors, prosecuting
business organizations, all ofthe guidance, even the OAG's
recent um program guidance oncompliance, um all of those
(22:03):
things really highlight the needfor uh transparency and for
those who are self-disclosing ordealing with the government and
investigation to be able to, youknow, when I say show your work,
right?
Um they don't just want to seeyour conclusion, they want to
understand how your program'sfunctioning and that it is
functioning, and if everything'soccurring behind the veil of
privilege, that can be achallenge at times.
(22:25):
Um the other thing I would sayis, you know, at least with
respect to um corruption-basedcrimes, um, while I think that
the Foreign Uh Corrupt PracticesAct investigations have
certainly shifted their focus,you know, any American company
that's operatinginternationally, device
manufacturers, drug uhmanufacturers, and distributors
(22:49):
are still likely subject to anynumber of other anti-corruption
laws in within the individualcountries where they are
operating, as well as the UnitedKingdom's anti-corruption law,
which has a breadth similar tothe traditional enforcement of
the FCPA.
So if you're doing business inthe United Kingdom, that can
(23:11):
also um tie you to moretraditional things.
The anti-kickback statute, onthe other hand, is aligned well,
as is the START law, and bothare being used um even by the
UPIX as a basis for seeking uhreimbursement.
SPEAKER_01 (23:29):
So, Tony, what um what things do you think
compliance officers should bethinking about that maybe
they're not thinking about ormaybe they haven't thought about
at least up until this year?
Where do they really need toshift their focus as we've been
talking about?
SPEAKER_02 (23:46):
Uh yeah, one area that we have not talked about
today, I think we touched on itin our presentation, would be
immigration.
Um, I think that that uh thatwould be on multiple, multiple
levels, right?
I think you know, verifying uhuh and making sure that all
visas and other documentation isin order when you bring in and
for instance a foreignphysician, um, that you
(24:08):
understand the requirements andthat you do everything as
closely to the letter of the lawas you can.
Um, and maybe going back throughif you're, for instance, a
university or an academicmedical center, going back
through and sort of auditingyour uh the paperwork on various
visa holders that are eithermatriculating or that are
teaching or that are you knowpracticing within your
(24:31):
organization.
Um and the other sort ofcritical thing here, and
something that I've been doing alot of, um, is that you know
traditionally healthcareproviders in particular were
relatively safe from ICEactivity.
They were sort of off-limitsalong with churches and schools.
Um there have been sort of viralvideos circulating on the
(24:52):
internet, and I've heard ofother instances with um
individuals showing up athospitals or at physicians'
offices trying to get access toa patient or an employee trying
to gain access to the uh office.
So I think now more than ever,there needs to be a compliance
focus on ensuring that thepeople, especially your
(25:13):
frontline employees,receptionists, uh schedulers,
those kinds of people umunderstand what the rights of
the organization are and whatthe preference of the
organization is as to how toenforce those rights and what
their own personal rights are.
Um, because there's also been uma number of um criminal
(25:35):
prosecutions, including a judgein Milwaukee, for people who
have, you know, to thegovernment's perspective, done
more than they are allowed to doto inhibit ICE from obtaining
access to a person.
Right.
And so to me, that's typicallyyou know, you don't lie, you
don't um you know, encourage anindividual to flee or anything
(25:59):
like that.
I think you need to have aprocess of in place so that you
know what's gonna happen, right?
I think you know, at a base uhat a base, you know, everyone
needs to understand that ahospital, uh physician practice,
even a factory floor is aprivate space, not open to the
public, which means that thegovernment must have a warrant
to come in.
(26:20):
And um I encourage all of myclients to demand that because
especially when you're talkingabout something as sensitive as
healthcare treatment, um, thelast thing you want is um people
who don't really have a needthere in terms of the treatment
of the patients coming into thatarea and disrupting you know
what's happening, uh, which isfar more critical, I think, for
(26:40):
patients.
So um, you know, and I think youhave to be careful.
The enforcement in this area hasbeen, let's call it
non-traditional.
Um you know, I think thoseoperating as ICE agents and
those um deputized to go alongand work with ICE agents,
including FBI agents and ATFagents and others, even IRS
(27:01):
agents um feel emboldened.
Um, you know, I've heard thatthey have you know, they'll come
in wearing masks, they will youknow, represent to the
individuals on the floor thatthey have more authority than
they do.
They threaten they threatenpeople with prosecution for
demanding a warrant.
Um while all of these thingswould be concerning to me on a
(27:23):
number of different levels, um,I think it just reinforces the
fact that comp a good complianceprogram right now really needs
to be educating all of the theentire organization on what the
institution's priorities are,um, what you know their rights
are, and what they expect ofthose frontline employees should
(27:44):
they have an interaction withimmigration authorities.
SPEAKER_01 (27:48):
So, Tony, you're highlighting what has been the
case for some time now, which isthat interactions between
healthcare organizations,particularly those that are
providing direct patient careand law enforcement, is uh can
be a legal and regulatorylandmine for everyone involved,
um, and can also have a realimpact, of course, on community
(28:10):
relations between theorganizations.
Um, one of the things that Ithink is important is not only
the education on the prioritiesand what the policy and process
is within a healthcareorganization to address a
request from or the presence oflaw enforcement, but also
creating very simple processesfor your frontline caregivers
(28:34):
and your other team members, whodo they reach out to when law
enforcement is contacting themor standing in front of them
because this is such a fraughtarea, and in particular now with
ICE enforcement and it beingwhat it is, um making sure that
your team members know who tocall, where do they go to?
(28:55):
If you're a large healthcareorganization, you probably have
um a physical security team thatcan really step in and help.
If you're a smallerorganization, um, you know, that
can be really tough.
And this is where I think yourcompliance officer, your risk
manager, um, your legal counsel,someone who can take that call
because having your team membersnavigate that on their own, even
(29:18):
with all of the education, theunderstanding in the world, um
is still just incrediblydifficult and in a very um what
can be a very tense situation.
So who to call and identifyingwho that is, I think is is first
and foremost from myperspective.
SPEAKER_02 (29:33):
Yeah, and I think that uh you know one of the
things that we've worked a lotwith our clients on is
development policies.
I think now more than ever,that's an important thing to
have that lays out what you knowwho might come, what kinds of
service they might provide, youknow, what what the difference
between a you know judicialwarrant and an administrative
(29:53):
warrant and a grand jurysubpoena and a you know
administrative subpoena are, andwhat your rights are and what
you can't.
Can and can't uh or that doesand does not allow the
government to do.
And as part of those policies,we're recommending that you have
sort of a first response team oran inspection team that's
identified with contactinformation within that policy,
(30:15):
and that's posted at allfrontline locations where the
public is interfacing with theemployee.
So again, if it's a physicianpractice, likely to throw desk,
uh on the sign, you know, signson the doors indicating that
areas are private, and then alist of people right next to the
telephone that you know theperson should be empowered to
(30:35):
call immediately when the uhgovernment uh agent does show
up.
SPEAKER_01 (30:40):
Yeah.
Well, Tony, this has been afar-ranging conversation.
Again, I know you and I couldspend hours um and then some um
talking about everything that ishealthcare compliance.
Um, we are rounding out ourtime.
So one more uh question for you,Tony.
What is the the one or twothings that um you want to be
(31:03):
sure to share that you haven'thad a chance to share yet?
And then I'll uh provide mythoughts and wrap us up.
SPEAKER_02 (31:09):
Absolutely.
Um, you know, I think one thingthat we talked about at length
during our presentation in Junethat I think is just as relevant
now.
Um, as I said at the beginning,these are politically fraught in
some instances, moral umquestions as to how these
organizations are going torespond.
And the time to have thoseconversations is not while the
(31:30):
government's on our doorstep.
Um I'm really encouraging myclients to have those sort of
what I would consider to benormative or ethical discussions
now, well before the governmentshows up because that's going to
inform what your policy is andwhat you're gonna do in
different situations.
Um, if your uh board ofdirectors is very uh
(31:55):
pro-immigrant, for instance, butyou have a CEO who's very you
know pro government enforcement,you know, that conflict could
really cause a lot of harm tothe organization if it's playing
out while the government istrying to access that facility.
And so I think organizations attheir board meetings, at their
(32:16):
executive meetings, at theircompliance team meetings need to
be having these conversationsabout you know, what are our
values as an organization?
How do we do these differentthings that the government's
doing and how are we going toreact?
Um, because again, um you'rereally not those conversations
take time.
Sometimes they take mediation,they take outside uh consultants
(32:39):
to come in and help theorganization through conflict.
And you just don't have time forthat if the government, if
there's a federal agent at yourdoor demanding access to your
facility in order to go after aspecific employee, or to just go
through and do an audit of allyour employees who may be
undergressed to see if they canbe taken.
So those are all uh veryimportant conversations, and I
(33:02):
think that organizations shouldbe having those conversations
and renewing those conversationson a monthly or quarterly basis
to make sure that you knowthey're they continue to be
aligned with what's actuallyhappening, you know, in the in
the industry.
SPEAKER_01 (33:16):
Yeah, I couldn't agree with you more, Tony.
Um having the time with yourexecutive leadership and your
board to talk about what reallyare kind of first or
foundational principles for yourorganization is always important
uh from a compliance officer'slens.
It's even more important nowwhen we are uh continue to
experience, again, significantdepartures from policies that
(33:39):
have been in place for the lastdecades and where we've seen
historically incremental changeadministration over
administration.
We're seeing some pretty uhsignificant departures, if not
um, might I say radicaldepartures from policy.
And so it is imperative, asyou're noting, to have those
conversations, have themproactively, know where your
(34:02):
values are as an organization.
And I would add also know whereyour risk appetite is with
respect to not only the variouspolicy initiatives, but then
also with respect to yourpotential for enforcement.
Um, you know, that's notsomething that historically
compliance officers like to talkmuch about.
(34:24):
Um, that we follow the lawregardless, or at least we want
our organizations to do so.
But I think given all of thethings that we're experiencing
as a healthcare industry, thatit is really important to have
those foundational discussions.
And then, as you said, to keepcoming back to them.
Um, it's great to have theconversation once and say, well,
we've done that, let's check thebox.
(34:45):
Um, but given the pace and thevolatility um that we're
experiencing, uh you have tocontinue to come back to it.
So carving out that time isabsolutely crucial.
SPEAKER_02 (34:56):
Absolutely.
If your organization is going tobe on the front page of the Wall
Street Journal, what do you wantthe headline to read?
SPEAKER_01 (35:02):
That's right.
That's right.
Well, let's hope neither one ofus or our organizations, uh,
current or former findthemselves in that situation.
Um, Tony, thank you as alwaysfor the conversation.
Thank you, everyone, forlistening.
Um, we want to give a shout outfor AHLA's annual meeting next
summer, uh, June of 2026 in NewYork City.
(35:23):
Um, can't wait to see you allthere.
And hopefully we'll have morecompliance uh uh to talk about
with you then.
Thank you.
SPEAKER_02 (35:31):
Thank you.
SPEAKER_00 (35:37):
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SPEAKER_01 (00:17):
Hi everyone, my name is Leah Voigt, and my colleague
Tony Burba and I had thepleasure of presenting at the
AHLA annual meeting in June onthe topic of compliance from the
cheap seats.
And neither Tony nor I havereally been in the cheap seats.
We've actually both been in thetrenches when it comes to
healthcare compliance andenforcement activity.
(00:39):
I am a healthcare attorney bybackground and a compliance
professional.
Most recently, I was the chiefcompliance officer at Corwell
Health, an integrated healthsystem based in Grand Rapids,
Michigan.
Tony, let me hand it over toyou.
SPEAKER_02 (00:56):
Absolutely.
I'm excited to speak in thistopic again.
My name is Tony Berba.
I'm a partner at Barnes andThornburg.
I practice out of our Chicagoand Washington, D.C.
offices, and my practice reallycenters on fraud and abuse and
compliance issues, everythingfrom assisting uh clients with
(01:18):
their compliance program tointernal investigations, to
defense of governmentinvestigations, especially
around the False Claims Act.
So it's definitely an area thatI work in a lot, and we're
seeing a lot of things happeningin the market right now.
So I think it's a timelyconversation.
I will say that I'll start withthe same disclaimer that I gave
(01:40):
at our panel at the annualmeeting, which is these are all
potentially fraught politicaldiscussions, and that's not our
goal here.
Our goal is really to talkpractically about how some of
these things that are being uhput forward as priorities for
the current administration areaffecting companies in the
market and what companies can doto respond to those things both
(02:02):
proactively and in the eventthat they end up getting um uh
getting hit with some kind ofinvestigation or audit or
whatever.
Um I'll just start things offand say, you know, in my
practice, I am definitely seeingan uptick in several kinds of
investigations.
I think that, you know, withrespect to the um corporate
(02:27):
enforcement or the criminalenforcement priorities for uh
DOJ, which uh just as a as a uhreminder were sort of five key
areas.
One was national security,including trade, cartels, and
forest terrorist organizations,one was the opioid crisis, one
was government fraud and waste,and then another is um combating
(02:52):
actions which circumvent rulesand regulations to protect
American consumers andprioritize uh violations of the
Controlled Substance Act and theFDCA or the Food Drug Cosmetic
Act.
So um we had had a number of uhdiscuss this quite a bit.
I think within these priorities,which are pretty similar to the
(03:13):
civil priorities that werestated by the civil division,
um, you know, there's a numberof things that the government I
think is doing.
Some of those things are acontinuation from the Biden
administration.
Um, some of those things I thinkare a bit more um aggressive uh
or have been put forward.
So I think two areas that I'mseeing a lot of enforcement is
um number one, the UPICs areincredibly active right now.
(03:36):
Um really pursuing companiesthat are doing any kind of
advanced wound care, um woundcare related to skin grafts and
those kinds of things.
Um they're going after uhcompanies for you know
purportedly providing cosmeticprocedures.
Um and then sort of moretraditional areas as well, just
(04:00):
sort of medically unnecessaryservices and those kinds of
things.
Um and then another area,another key area is COVID
enforcement.
Um the UPICs are definitelytargeting as is the civil
division uh COVID testingcompanies, especially labs set
up by physicians during theearly days of the pandemic.
Um we got several clientsdealing with that issue right
(04:23):
now.
And then the civil divisionseems to have a task force
targeting uh those folks thattook the paycheck paycheck
protection program loans, and inparticular the second of those
loans.
Um and those are basically CIDscoming to American subsidiaries
(04:43):
of foreign uh inbound companies,and whether or not specifically
those companies counted theirforeign employees and their
employee count when they uhapplied for the second PPP loan.
So um just sort of starting itoff, those are two areas, those
are some areas where I see a lotof activity right now.
Um, you know, I'm not sure sortof um, you know, if you're sort
(05:06):
of seeing anything, experiencinganything, hearing about anything
sort of within those uhpriorities, um, or if you want
to sort of just sort of discusssome of the uh ways that a you
know, those at least two initialareas of enforcement might be um
addressed by a complianceofficer.
SPEAKER_01 (05:23):
Sure.
Yeah.
Well, well, Tony, you mentionedyou pick activity.
I would say I'm certainlyhearing um that that is an
increased area of focus.
Um and with respect to um CMS, Ithink I would just note, we know
it's in healthcare, we alwayshave to keep our eyes on you
know more than one agency orsub-agency within the federal
(05:44):
government, um, and certainlysomething that um starts within
CMS from uh, I'll say quoteunquote routine audit approach
can uh be handed over forenforcement, civil or criminal
in nature.
And certainly the False ClaimsAct is that that key.
One of the things that we saweven before the new
administration um came uh onboard earlier this year was an
(06:07):
increase in um target probe andeducate audits by CMS.
And some of those areas um thatthe agency was looking at are uh
what compliance officers mightcall low-hanging fruit, you
know, activities and TPEs inparticular, looking at you noted
wound care.
That was a key area that CMS isauditing on as well.
(06:29):
Also, medical necessity andABNs, advanced beneficiary
notices, the things that havebeen around for, you know, it
seems like forever.
Um, certainly if you've been acompliance officer in the last
10 to 15 years.
Um, and it seems that there isan increased focus on
reinforcing some of those rulesthat maybe hadn't been top of
mind for healthcareorganizations.
And so all of those thingstogether, I think, underscore
(06:51):
one of the key themes that youand I spoke about uh in June,
which is for compliance programsand for the healthcare
organizations in which theyreside to stay the course.
Um, this is not the time to takeyour foot off the gas to use
another analogy.
Um, there may be a general viewfrom executive leaders and from
(07:13):
boards of directors that underthe Trump administration that
compliance activities are lessimportant or not as prioritized.
Um, and I think that would be afoolish uh conclusion to make
because what we're actuallyseeing is that it's just as
important, um, if not in someways more intense, the
(07:36):
activities that we're seeing inthe enforcement priorities are
different.
I think as you're highlighting,Tony, and we'll get into this
here more, I know, in the next20, 20 plus minutes.
You know, where do healthcareorganizations need to shift
their compliance focus, not takethe foot off the gas or what
have you, but rather toreprioritize some of those
(07:58):
activities so that you're reallyfocusing on what we're seeing
are um, I'll say some new uhareas uh from the Trump
administration.
SPEAKER_02 (08:08):
Um yeah, no, I absolutely agree.
I think that now is a very goodtime to do some uh sort of good
practices, house cleaning, uhespecially for those companies
that are providing things likewound care, companies that took
significant um you know moniesor loans during the pandemic, or
companies that were involved inCOVID testing.
(08:28):
Um similarly, you know,companies involved in the opioid
industry, both pharmacies uhprescribing physicians and
particular sober homes and othertypes of recovery um providers.
You know, what I'm seeing a lotof is especially my clients that
are smaller providers, smallersuppliers are running into
(08:49):
issues uh with documentation,finding data that they need when
they once the UPEG shows up inparticular, or if the DOJ sends
us on OCID.
I've also seen some of thestates, including Ohio, becoming
a bit more aggressive with theirinvestigation.
So, you know, now is the time toreally think through where your
risk areas are and start doingyour own internal audits, making
(09:10):
sure your documentation is whereit needs to be, uh, making
corrections, uh, doing providereducation on things like um
documentation and those kinds ofthings, which are I think very
traditional areas of uhcompliance work.
Um to your point, uh these arecertainly not areas that are
slowing down and if anythingthey're picking up.
(09:32):
Um, my my standard joke with thegovernment these days is it's
not entirely clear that anyoneworks there anymore.
Um, but you know, I think thatbecause of that, and because
there's been such a you knowrestructuring, especially at CMS
and HHS uh and DOJ, that theyreally are leaning into their
(09:52):
private contractors like theUPEX and the Macs and expecting
them to carry the load in a lotof these areas.
And because a lot of these uhaudits are pretty predictable
and what they're looking for ispretty well known, um it's
definitely a good time to be uhdoing some house cleaning.
unknown (10:11):
Yeah.
SPEAKER_01 (10:13):
Tony, could we shift gears um just a bit and talk
about um the executive ordersand the the number of things
that have occurred since thoseum early executive orders came
out?
It seemed like you know it was aslew of things um day after day
from the space of Januarythrough March.
Um what are we seeing now interms of how the administration
(10:38):
is continuing to reinforce whatare some pretty significant
policy changes, some departuresfrom policies that really have
largely been unchanged for thelast uh 10 to 20 years?
SPEAKER_02 (10:52):
Um Yeah, I think that uh you know we at our panel
in uh San Diego talked about thetwo specifically two executive
orders, executive order 14173and 14168, both of which were
signed on uh President Trump'sfirst day in office.
Um 14173 being the one thateffectively um declared uh that
(11:15):
the DOJ was going to disband allillegal government programs and
directing the DOJ to uh uhpursue private companies,
identify private companies thatwere in the words of the
executive order in uhinstituting illegal DEI.
(11:35):
Um and then the other uh 14168being the one that sort of
related to the definition ofbiological sex and tying it to
the uh the gender at birth asopposed to the gender that is
identified by individual.
Um and so at least with respectto my practice, I'm seeing a lot
(11:56):
more activity related to the DEIuh area.
Um many of my clients and manylaw firms and other institutions
are uh even the ones that areremaining committed to uh
diversity policies andprocedures, are uh rebranding,
uh, finding ways to uhrestructure their programs,
(12:18):
doing evaluations of thoseprograms, pursuing to some
recent guidance from DOJ thatwas put out, I believe, by Todd
Blanch related to whatconstitutes, you know, quote,
illegal diversity, equity andinclusion programs.
I think that's not a badpractice to be in generally.
Obviously, everyone wants to uhyou know, end of pursuing
diversity, equity, andinclusion, make sure that there
(12:40):
is a focus on equity andinclusion for everyone.
And uh I think that's a goodthing.
I think that um certainly theEEOC has stepped up enforcement,
has been sending out a lot ofletters, um, sending out letters
in particular uh to federalgrant and uh recipients of
federal money, asking them tovoluntarily produce documents um
(13:02):
and to voluntarily cooperatewith the administration uh to
provide information and data onit.
Uh diversity, equity, andinclusion.
Um at least so far, I think youknow, best practices seems to be
to politely decline thoseinvitations.
Um generally speaking, theydon't have the power under the
contracts.
And um I think you're justasking for uh a lot of trouble
(13:25):
if you start producing a lot ofinformation that could be
protected by various state andfederal laws and other things
without proper process.
I think my general advice toclients is to respectfully
request that they provide somekind of you know actual legal
process, so whether it's asubpoena or uh an administrative
warrant or any number of othertools they have at their
(13:46):
disposal so that there is a youknow lawful basis for providing
that information.
SPEAKER_01 (13:53):
One of the other tools, which is um really a key
component of an effectivecompliance program is ensuring
um free and fair, I will say,disclosure of any potential
violations of law and inparticular disclosure within an
(14:13):
organization.
Um, the idea of whistleblowerprotections, the ability for um
potential whistleblowers tocommunicate any um alleged
violation of law has been,again, at the core of what we've
considered an effectivecompliance program.
Um, and we've seen theadministration highlight the
(14:37):
whistleblower activity as a wayto further enforce the policies
of the administration, bothwithin the context of DEI as
well as gender-affirming care.
Um we uh saw the administrationfocus, for instance, on the
(14:58):
whistleblower hotline maintainedby the Office for Civil Rights.
Um, and in that context, theadministration focused on
provider conscious rights,conscious rights.
So the ability of a provider tosay, you know, I don't agree
with gender affirming care andtherefore I don't want to
participate in it in any waywhatsoever.
And so the administration um hashighlighted that that hotline as
(15:22):
a way for individuals to comeforward and therefore to find
another enforcement mechanism,um, particularly again around
the DEI executive order and thepolicies contained therein, as
well as the biological, sex, andgender affirming care um
policies that the theadministration has put forward.
(15:43):
Are you hearing from any of yourclients concerns about that
whistleblower activity andanything that they are doing to
shift, again, shift focus fortheir compliance programs?
SPEAKER_02 (15:58):
Yeah, I mean, I think in particular, as I'm sure
you painfully aware, um, at youknow, institutions, large
companies of any kind, but evenin healthcare, um, you know, 90%
of what comes through atraditional hotline is what
would be consideredtraditionally to be more HR type
issues.
Um, I've had clients and um youknow seen other trends in the in
(16:22):
the um some companies where theyeven you know have the HR
department primarily responsiblefor reviewing the hotline
reports and sending any of thesort of ring in compliance over
to the compliance department toinvestigate further.
Now, I think that is a not agreat practice to begin with
because I don't think that youshould be trusting your HR
professionals to be able toassess and identify what a
(16:45):
compliance issue may be.
I think you need a little moreassociated.
So but now especially many ofthese what would have been
considered HR workplacecomplaints related to being
passed over for a promotion orrequired to do certain types of
training or having a boss who'sgiving favor to a particular
group or class of people.
(17:07):
Those are now potentiallycompliance issues and certainly
uh based on you know some of theguidance that's come out of the
Department of Justiceencouraging whistleblowers to
come forward, um, I think it'snow going to be uh an area where
if there is legit legitimatefalse claims act and other types
of enforcement risk.
(17:27):
Um, so I think that uh for surelike you know certainly the
clients I'm working with, uhothers I'm talking to in the
industry are certainly cognizantof that and sensitive to that
and really rethinking how theylook at those things.
Um obviously the sort of counterto that is there's now a judge
in the middle district ofFlorida who's ruled that the key
(17:48):
TAN provisions to the falseclaims act are unconstitutional,
and that case is kind of workingits way up.
And we know that there's atleast two Supreme Court justices
that may um agree with that.
So it'll be interesting to seehow you know those the the
tension between uh what'shappening in the courts and what
the administration isencouraging people to do
ultimately resolves itself.
(18:09):
But um but yes, I think thatespecially when it relates to
diversity, equity, andinclusion, um there needs to be
a heightened sensitivity aroundthe compliance request.
You know, I think even thingsthat you know maybe you know,
two years ago, eight months agowould have been considered to be
kind of a crank, you know, anduh a 50-year-old white male at
(18:33):
an executive level complainingabout being passed over for a
promotion, you know, I don'tknow that even HR would have
necessarily dealt with that.
Um, but I think that the waythey're dealing with it now is
very different and has to bevery different based on what the
administration has said.
That becomes a legitimate riskto the organization.
SPEAKER_01 (18:51):
And as you and I talked about in June, this is an
area of the compliance programwhere some re-energization is is
likely called for.
And I think, as you're noting,um for the compliance team to um
stay more involved, if notpotentially taking the lead
along with legal and HRcolleagues, of course, in
(19:13):
collaboration when these typesof concerns are being raised
because of the um new legal umquiet wire that organizations
are finding themselves in inthese areas.
I'm also wondering, Tony, if wecould talk a little about the um
shifting gears again a bit, theDOJ's um approach to white
(19:34):
collar enforcement and the shifttoward a voluntary
self-disclosure approach.
Um, the kind of general, I'llsay, gist of um the current
DOJ's perspective on this isthat prior enforcement
priorities were really placingtoo much of a burden on
(19:55):
businesses in the United States,including healthcare businesses,
um, that was essentially youknow too high of a cost from an
enforcement standpoint.
And again, um, you know, withoutdigging deeper into it, one
might conclude that, well, thismeans that, you know, the the
foot is off the gas.
Um, but there's another way oflooking at this because the DOJ
(20:17):
has said, well, really whatwe're talking about is the
importance of voluntaryself-disclosure as a way to
essentially avoid prosecution.
Self-disclosure requires theorganization to understand
what's actually going on withinits proverbial or um virtual
four walls.
And so the role of thecompliance program, again, is
(20:39):
just as important, if not moreimportant, if organizations are
trying to stay in line with theDOJ's current approach.
Could you talk a little bit moreabout that and again what you're
how you're seeing your clientsreact to um the criminal
enforcement approach?
SPEAKER_02 (20:57):
Um absolutely.
Uh, and I think that you knowone of the key changes in DOJ's
policy has been that whereas uha declination previously was
something that was on the tableif you self-disclosed, now it's
mandatory if you meet therequirements under the uh DOJ
self-disclosure protocol.
So there is a great benefit tocoming forward and
(21:19):
self-disclosing.
Um and I think you know, there'ssort of two things I would
highlight there and that I'vetalked about in other forums.
Um, one is uh just the interplaybetween legal and compliance.
You know, I think that a goodhealthy compliance program,
especially in an environmentthat's uh rewarding
self-disclosure, will give afair amount of autonomy to the
(21:43):
compliance department to conductnon-privileged investigations
because what all of thesegovernment policies, the CEP,
the um you know, guidance toprosecutors, prosecuting
business organizations, all ofthe guidance, even the OAG's
recent um program guidance oncompliance, um all of those
(22:03):
things really highlight the needfor uh transparency and for
those who are self-disclosing ordealing with the government and
investigation to be able to, youknow, when I say show your work,
right?
Um they don't just want to seeyour conclusion, they want to
understand how your program'sfunctioning and that it is
functioning, and if everything'soccurring behind the veil of
privilege, that can be achallenge at times.
(22:25):
Um the other thing I would sayis, you know, at least with
respect to um corruption-basedcrimes, um, while I think that
the Foreign Uh Corrupt PracticesAct investigations have
certainly shifted their focus,you know, any American company
that's operatinginternationally, device
manufacturers, drug uhmanufacturers, and distributors
(22:49):
are still likely subject to anynumber of other anti-corruption
laws in within the individualcountries where they are
operating, as well as the UnitedKingdom's anti-corruption law,
which has a breadth similar tothe traditional enforcement of
the FCPA.
So if you're doing business inthe United Kingdom, that can
(23:11):
also um tie you to moretraditional things.
The anti-kickback statute, onthe other hand, is aligned well,
as is the START law, and bothare being used um even by the
UPIX as a basis for seeking uhreimbursement.
SPEAKER_01 (23:29):
So, Tony, what um what things do you think
compliance officers should bethinking about that maybe
they're not thinking about ormaybe they haven't thought about
at least up until this year?
Where do they really need toshift their focus as we've been
talking about?
SPEAKER_02 (23:46):
Uh yeah, one area that we have not talked about
today, I think we touched on itin our presentation, would be
immigration.
Um, I think that that uh thatwould be on multiple, multiple
levels, right?
I think you know, verifying uhuh and making sure that all
visas and other documentation isin order when you bring in and
for instance a foreignphysician, um, that you
(24:08):
understand the requirements andthat you do everything as
closely to the letter of the lawas you can.
Um, and maybe going back throughif you're, for instance, a
university or an academicmedical center, going back
through and sort of auditingyour uh the paperwork on various
visa holders that are eithermatriculating or that are
teaching or that are you knowpracticing within your
(24:31):
organization.
Um and the other sort ofcritical thing here, and
something that I've been doing alot of, um, is that you know
traditionally healthcareproviders in particular were
relatively safe from ICEactivity.
They were sort of off-limitsalong with churches and schools.
Um there have been sort of viralvideos circulating on the
(24:52):
internet, and I've heard ofother instances with um
individuals showing up athospitals or at physicians'
offices trying to get access toa patient or an employee trying
to gain access to the uh office.
So I think now more than ever,there needs to be a compliance
focus on ensuring that thepeople, especially your
(25:13):
frontline employees,receptionists, uh schedulers,
those kinds of people umunderstand what the rights of
the organization are and whatthe preference of the
organization is as to how toenforce those rights and what
their own personal rights are.
Um, because there's also been uma number of um criminal
(25:35):
prosecutions, including a judgein Milwaukee, for people who
have, you know, to thegovernment's perspective, done
more than they are allowed to doto inhibit ICE from obtaining
access to a person.
Right.
And so to me, that's typicallyyou know, you don't lie, you
don't um you know, encourage anindividual to flee or anything
(25:59):
like that.
I think you need to have aprocess of in place so that you
know what's gonna happen, right?
I think you know, at a base uhat a base, you know, everyone
needs to understand that ahospital, uh physician practice,
even a factory floor is aprivate space, not open to the
public, which means that thegovernment must have a warrant
to come in.
(26:20):
And um I encourage all of myclients to demand that because
especially when you're talkingabout something as sensitive as
healthcare treatment, um, thelast thing you want is um people
who don't really have a needthere in terms of the treatment
of the patients coming into thatarea and disrupting you know
what's happening, uh, which isfar more critical, I think, for
(26:40):
patients.
So um, you know, and I think youhave to be careful.
The enforcement in this area hasbeen, let's call it
non-traditional.
Um you know, I think thoseoperating as ICE agents and
those um deputized to go alongand work with ICE agents,
including FBI agents and ATFagents and others, even IRS
(27:01):
agents um feel emboldened.
Um, you know, I've heard thatthey have you know, they'll come
in wearing masks, they will youknow, represent to the
individuals on the floor thatthey have more authority than
they do.
They threaten they threatenpeople with prosecution for
demanding a warrant.
Um while all of these thingswould be concerning to me on a
(27:23):
number of different levels, um,I think it just reinforces the
fact that comp a good complianceprogram right now really needs
to be educating all of the theentire organization on what the
institution's priorities are,um, what you know their rights
are, and what they expect ofthose frontline employees should
(27:44):
they have an interaction withimmigration authorities.
SPEAKER_01 (27:48):
So, Tony, you're highlighting what has been the
case for some time now, which isthat interactions between
healthcare organizations,particularly those that are
providing direct patient careand law enforcement, is uh can
be a legal and regulatorylandmine for everyone involved,
um, and can also have a realimpact, of course, on community
(28:10):
relations between theorganizations.
Um, one of the things that Ithink is important is not only
the education on the prioritiesand what the policy and process
is within a healthcareorganization to address a
request from or the presence oflaw enforcement, but also
creating very simple processesfor your frontline caregivers
(28:34):
and your other team members, whodo they reach out to when law
enforcement is contacting themor standing in front of them
because this is such a fraughtarea, and in particular now with
ICE enforcement and it beingwhat it is, um making sure that
your team members know who tocall, where do they go to?
(28:55):
If you're a large healthcareorganization, you probably have
um a physical security team thatcan really step in and help.
If you're a smallerorganization, um, you know, that
can be really tough.
And this is where I think yourcompliance officer, your risk
manager, um, your legal counsel,someone who can take that call
because having your team membersnavigate that on their own, even
(29:18):
with all of the education, theunderstanding in the world, um
is still just incrediblydifficult and in a very um what
can be a very tense situation.
So who to call and identifyingwho that is, I think is is first
and foremost from myperspective.
SPEAKER_02 (29:33):
Yeah, and I think that uh you know one of the
things that we've worked a lotwith our clients on is
development policies.
I think now more than ever,that's an important thing to
have that lays out what you knowwho might come, what kinds of
service they might provide, youknow, what what the difference
between a you know judicialwarrant and an administrative
(29:53):
warrant and a grand jurysubpoena and a you know
administrative subpoena are, andwhat your rights are and what
you can't.
Can and can't uh or that doesand does not allow the
government to do.
And as part of those policies,we're recommending that you have
sort of a first response team oran inspection team that's
identified with contactinformation within that policy,
(30:15):
and that's posted at allfrontline locations where the
public is interfacing with theemployee.
So again, if it's a physicianpractice, likely to throw desk,
uh on the sign, you know, signson the doors indicating that
areas are private, and then alist of people right next to the
telephone that you know theperson should be empowered to
(30:35):
call immediately when the uhgovernment uh agent does show
up.
SPEAKER_01 (30:40):
Yeah.
Well, Tony, this has been afar-ranging conversation.
Again, I know you and I couldspend hours um and then some um
talking about everything that ishealthcare compliance.
Um, we are rounding out ourtime.
So one more uh question for you,Tony.
What is the the one or twothings that um you want to be
(31:03):
sure to share that you haven'thad a chance to share yet?
And then I'll uh provide mythoughts and wrap us up.
SPEAKER_02 (31:09):
Absolutely.
Um, you know, I think one thingthat we talked about at length
during our presentation in Junethat I think is just as relevant
now.
Um, as I said at the beginning,these are politically fraught in
some instances, moral umquestions as to how these
organizations are going torespond.
And the time to have thoseconversations is not while the
(31:30):
government's on our doorstep.
Um I'm really encouraging myclients to have those sort of
what I would consider to benormative or ethical discussions
now, well before the governmentshows up because that's going to
inform what your policy is andwhat you're gonna do in
different situations.
Um, if your uh board ofdirectors is very uh
(31:55):
pro-immigrant, for instance, butyou have a CEO who's very you
know pro government enforcement,you know, that conflict could
really cause a lot of harm tothe organization if it's playing
out while the government istrying to access that facility.
And so I think organizations attheir board meetings, at their
(32:16):
executive meetings, at theircompliance team meetings need to
be having these conversationsabout you know, what are our
values as an organization?
How do we do these differentthings that the government's
doing and how are we going toreact?
Um, because again, um you'rereally not those conversations
take time.
Sometimes they take mediation,they take outside uh consultants
(32:39):
to come in and help theorganization through conflict.
And you just don't have time forthat if the government, if
there's a federal agent at yourdoor demanding access to your
facility in order to go after aspecific employee, or to just go
through and do an audit of allyour employees who may be
undergressed to see if they canbe taken.
So those are all uh veryimportant conversations, and I
(33:02):
think that organizations shouldbe having those conversations
and renewing those conversationson a monthly or quarterly basis
to make sure that you knowthey're they continue to be
aligned with what's actuallyhappening, you know, in the in
the industry.
SPEAKER_01 (33:16):
Yeah, I couldn't agree with you more, Tony.
Um having the time with yourexecutive leadership and your
board to talk about what reallyare kind of first or
foundational principles for yourorganization is always important
uh from a compliance officer'slens.
It's even more important nowwhen we are uh continue to
experience, again, significantdepartures from policies that
(33:39):
have been in place for the lastdecades and where we've seen
historically incremental changeadministration over
administration.
We're seeing some pretty uhsignificant departures, if not
um, might I say radicaldepartures from policy.
And so it is imperative, asyou're noting, to have those
conversations, have themproactively, know where your
(34:02):
values are as an organization.
And I would add also know whereyour risk appetite is with
respect to not only the variouspolicy initiatives, but then
also with respect to yourpotential for enforcement.
Um, you know, that's notsomething that historically
compliance officers like to talkmuch about.
(34:24):
Um, that we follow the lawregardless, or at least we want
our organizations to do so.
But I think given all of thethings that we're experiencing
as a healthcare industry, thatit is really important to have
those foundational discussions.
And then, as you said, to keepcoming back to them.
Um, it's great to have theconversation once and say, well,
we've done that, let's check thebox.
(34:45):
Um, but given the pace and thevolatility um that we're
experiencing, uh you have tocontinue to come back to it.
So carving out that time isabsolutely crucial.
SPEAKER_02 (34:56):
Absolutely.
If your organization is going tobe on the front page of the Wall
Street Journal, what do you wantthe headline to read?
SPEAKER_01 (35:02):
That's right.
That's right.
Well, let's hope neither one ofus or our organizations, uh,
current or former findthemselves in that situation.
Um, Tony, thank you as alwaysfor the conversation.
Thank you, everyone, forlistening.
Um, we want to give a shout outfor AHLA's annual meeting next
summer, uh, June of 2026 in NewYork City.
(35:23):
Um, can't wait to see you allthere.
And hopefully we'll have morecompliance uh uh to talk about
with you then.
Thank you.
SPEAKER_02 (35:31):
Thank you.
SPEAKER_00 (35:37):
If you enjoyed this episode, be sure to subscribe to
AHLA Speaking of Health Lawwherever you get your podcasts.
For more information about AHLAand the educational resources
available to the health lawcommunity, visit
Americanhealthlaw.org and stayupdated on breaking healthcare
industry news from the majormedia outlets with AHLA's Health
Law Daily Podcast, exclusivelyfor AHLA comprehensive members.
(36:00):
To subscribe and add thisprivate podcast feed to your
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