January 6, 2026 • 48 mins
Stewart Kameen, Partner, Bass Berry & Sims PLC, Brandon Helms, Shareholder, Hall Render Killian Heath & Lyman PC, and Matthew Westbrook, Senior Counsel, Proskauer Rose LLP, discuss some of the key health care fraud and abuse trends from 2025 and what to expect in 2026. They cover the current landscape; Administration priorities; general trends; and key settlements, cases, and advisory opinions. From AHLA's Fraud and Abuse Practice Group.
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Learn more about the AHLA Fraud and Abuse Practice Group’s February 18 webinar, “Fraud and Compliance Year In Review”: https://educate.americanhealthlaw.org/local/catalog/view/product.php?productid=1691
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
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_03 (00:16):
Hello, uh, and thank you for uh joining us today for
this Healthcare Fraud YearInterview podcast brought to you
by the American Health LawAssociation, the Fraud and Abuse
Practice Group.
My name is Stuart Camille.
I'm the chair of the fraud andabuse practice group, and I'm
joined by my colleagues Matt andBrandon, who will introduce
themselves in a moment.
I'm a partner at the law firmBassberry ⁇ Sims in the firm's
(00:36):
Washington, D.C.
office, where I work in theregulatory space, primarily in
the anti-kickback statute andbeneficiary inducement fraud
areas.
I advise clients on front-endcounseling issues, deal
diligence issues, and defensework in the False Claims Act
space.
Prior to joining BassBerry, Iworked at HHS OIG in the Office
of Counsel, specifically in theindustry guidance branch, which
(00:58):
is the branch that issuesadvisory opinions, safe harbor
regulations, and other guidance.
As I mentioned, I'm joined byother vice chairs here from the
fraud and abuse practice groupwho I'll introduce themselves
now.
SPEAKER_02 (01:09):
Hi, everyone.
My name is Brandon Helms.
I'm a shareholder at HallRender.
I focus mainly on complianceinvestigations and then also
defending governmentinvestigations under the False
Claims Act and also False ClaimsAct litigation.
Before I joined Hall Render, Ispent eight years as an
assistant U.S.
attorney in Detroit, where I uhI started on the civil side
(01:29):
doing False Claims Actinvestigations, and then I
switched to the criminal sideand I handled criminal health
care fraud prosecutions.
And now I'm still located inDetroit.
SPEAKER_01 (01:40):
Hi everyone, I'm Matt Westbrook.
I'm senior counsel in the DCoffice of Prosgow Rose.
Like Stuart, I spent the firsthalf of my career with OIG,
specifically in theadministrative and civil
remedies branch.
While at OIG, I assisted AUSAslike Brandon with investigating
and resolving false claims actallegations, and in connection
(02:01):
with those, determining whetherCIAs or exclusions were
appropriate.
I also advised on theanti-kickback statute, the STARK
law, CMPL and Mtala, and Ihandled self-disclosures
submitted through OIG'sprotocol.
And now that I'm in privatepractice at Proscauer, I advise
our clients about the same kindsof matters as they assess
(02:22):
certain transactions or businessdevelopment opportunities.
Looking forward to thediscussion, guys.
SPEAKER_03 (02:26):
Yeah, thank you both.
And as I mentioned, this is ahealthcare fraud year interview.
It's not a not a deep dive or ofa highlights uh reel for things
we're observing in the industry.
Um I should say a couple mattersof housekeeping.
The first being this recordingis taking place in the middle of
December.
So to the extent there are latebreaking updates in the final
two weeks of the year, whichoften there are, um, those will
(02:48):
have to be covered by by otheruh product from AHLA and other
sources.
Um, and to that end, we uh thatthe fraud and abuse practice
group does put on annually ahealthcare fraud and compliance
year interview webinar, muchmore substantive, um, covering
some of what we're going to talkabout today and other issues in
more detail.
And so we thought today we wouldjust touch on our observations,
(03:09):
um, starting with sort ofgeneral happenings.
Um, it's been a fairly busyyear, um, and we'd shift over to
uh administration prioritiesthat impact the healthcare fraud
space that we sit in, then moveover to some trends we're
observing throughout the yearand what those might mean for
next year and future years ofenforcement.
Um, and we'll touch on a few keyuh settlements and cases that
(03:30):
we're following, maybe some OIGadvisory opinions and the like,
um, and then make somepredictions to the extent we can
on where things may be headed.
Um, so with that, I'll kick usoff here with some of the sort
of I'm calling them happeningsthat we're seeing.
Um obviously, you know, 2025 Ithink can be uh characterized as
a busy year in many regards aswell as kind of an odd and quiet
year in other regards.
(03:51):
Um as you all know, probably,you know, the the new
administration took took over uhat the beginning of the year,
and pretty shortly thereafter wesaw uh the mass firing of a
number of inspectors generalacross multiple agencies.
Um, those included Christy Grimmat HHS, uh OIG.
Um obviously some lawsuits camefollowing that, but at the
moment, um, the Office ofInspector General for HHS is
(04:12):
under the leadership of anacting inspector general, um, a
seasoned veteran that Matt and Iknow from our work there.
And you know, my advice uh toclients early in the year was to
sort of expect business as usualfrom that agency, you know, the
leadership there and that sortof the system that operates
there is moving forward as itnormally does.
That said, we also saw uh prettyearly in the year sort of the
(04:36):
doge-related changes that camefrom the administration, which
for many who work in governmentagencies saw you know early
retirement packages beingoffered, um, others who just
voluntarily moved on to newroles in the private sector, law
firms, in-house, et cetera.
Um, and you know, this did meansome significant departures, I
think, um, in the agencies,including at OIG and some in
(04:56):
senior roles.
Um, for instance, Matt, and Iknow many attorneys over there
at the Office of Counsel uh wholeft for new roles.
Those included an assistantinspector general, but also
included the chief counselhimself.
Um, you know, again, OCIG isunder the leadership of seasoned
veterans.
I believe there are two seasonedveterans there who are rotating
in an acting chief role.
Um, I know the the industryguidance branch where I used to
(05:18):
work, the women issues advisoryopinions and other guidance,
they saw several departures.
Um, so you know what that mightmean uh over at OIG is sort of
yet to be seen.
As I mentioned, there's plentyof fantastic lawyers there still
doing the work, plenty of otherprofessionals and the other
components doing that work.
We're seeing reports come outand whatnot, um, and that that
machine is moving forward.
Um, at the same time, you know,I think uh sort of on the quiet
(05:40):
front, um, you know, we we doknow that OIG has has um
undertaken to overhaul thiscompliance program guidance, for
instance.
Um, under the prioradministration, we saw an
overhaul of the general, veryhelpful general compliance
program guidance document comeout, um, and then shifting to
industry-specific guidancedocuments, we saw at the end of
2024, um, the nursing facilityguidance document.
(06:01):
Um, I just checked this morningto make sure, but as we sit here
today, um, OED's website doessay that it, you know, there's a
half dozen or moreindustry-specific compliance
program guidance documents uhslated to be issued, including
three that are uh indicated tobe issued in 2025.
Um, those those included for umuh Medicare Advantage, for
hospitals, for clinical labs.
(06:22):
Um, there are a few weeks leftin the year, a couple weeks
left.
We'll we'll see if we see thosedocuments, but um, you know, to
date we have we have not seenthem.
So again, you know, uh unclearif all of these other priorities
um have impacted that work orwhether there's there's some
other objective uh takingpriority there.
Um Matt, Brandon, I don't knowif you all have other thoughts
of your observations around whatthis year and and some of the
(06:44):
agency departures has meant um,you know, for your work.
SPEAKER_02 (06:48):
In terms of the Department of Justice, there
have certainly been a number ofshake-ups.
Obviously, we have a newattorney general, Pam Bondi, a
new deputy attorney general,Todd Blanch.
They wasted no time puttingtheir own stamp on their
priorities.
So we we know they're interestedin civil rights investigations
involving DEI, uh gendertransition treatment, uh,
immigration issues, just to namea few that they're focusing on.
(07:11):
Uh relevant to False Claims Actwork, Michael Granson used to
oversee the DOJ's commerciallitigation branch, which
oversees False Claims Actinvestigations.
He departed earlier this year,and Brennan Jenny from Siddhilly
Austin has taken his place.
Um it'll remain to be seen howthat changes in general, but it
has led to a working groupbetween HHS and CMS that we'll
(07:34):
talk about.
And then anecdotally, uh there'sbeen some high-level departures
of DOJ trial attorneys andAUSAs, but under the radar,
there's been a lot of massdepartures.
Um much so that I think themarket is flooded right now with
former DOJ or with DOJ attorneystrying to leave for private
practice.
And in general, I think that'sgoing to lose uh lead to a huge
(07:56):
loss of institutional knowledge,um, which may or may not be a
good thing for the targets ofDOJ investigations.
On the one hand, they they arenot going to be um as efficient
or as streamlined.
But in my experience, on thedefense side, dealing with an
AUSA or DOJ trial attorney who'snot particularly experienced can
sometimes be more problematicthan dealing with an experienced
(08:18):
one.
SPEAKER_03 (08:21):
Yeah.
Um thanks, Brandon.
And and I guess I should wrapthat whole sort of happening
section up with uh a note on thegovernment shutdown, which
obviously impacted agencies farand wide.
Um, you know, DOJ is prettyinsulated from shutdowns given
the work they do.
Um HHS OIG similarly isinsulated from shutdowns given
how they're funded.
But um one thing I did I didnotice during the shutdowns,
(08:44):
sort of for a combination of thefactors, including departures
and the shutdown, but also Ithink some uh various agency
procedures around uh governmentattendance and speaking
commitments at uh conferencesand at webinars, uh somewhat
less less visibility.
Uh fewer, fewer of those folksattending uh those conferences,
speaking at those conferences,um, and on webinars.
Um if you you know if youattended those conferences, you
(09:06):
you probably did notice anabsence of government speakers
or and again or the or thewebinar space.
Um so uh why don't we shift overto Brandon?
You touched on this already,sort of new administration
priorities that we've observedover the last 11, 12 months.
Um I know that there's been youknow some some uh expansion of
priorities and and tools withthe False Claims Act into
(09:28):
different spaces we haven'tnecessarily seen before.
SPEAKER_02 (09:32):
Yeah, so um there's been a number of those.
I mean, priorities in generalstill involve opioid
trafficking, that's one of them.
Uh Medicare advantages we'lltouch on, uh COVID-19 fraud,
although that's that fraud's notstill happening, but it's still
being investigated andprosecuted.
Um but one of the biggest thingsuh shift in focus would have
(09:55):
been the focus on DEI now.
Um if you know, if you've beenpaying attention to the news,
you know that this currentadministration is in a war
against DEI.
Uh regardless of how you feelabout those programs, some
people feel they didn't go farenough, some people feel like
they went far too far too um inthe favor of promoting certain
things.
Um regardless of how you feel,there is a real risk now for for
(10:20):
companies who have not gone backand evaluated their DEI programs
in terms of the one, the theexternal comments that they're
making, so what's on theirwebsites, what they've done in
press releases, and then two,how their internal policies uh
and and procedures look.
And so every entity needs to belooking at that, especially
(10:42):
healthcare entities that receivea lot of federal funding.
SPEAKER_03 (10:48):
Yeah, and I think there's also been a push towards
um uh you know priorities in theimmigration space as well, and
whether that might have some umimpact on uh False Claims Act,
False Claims Act work and howthe government may use the False
Claims Act tools in that space.
Um it's you know, I think it'spresenting just new and
different challenges for theindustry and for the attorneys
that represent the industry touh to to sort of the expansion
(11:11):
of the government's focus ondifferent areas using familiar
tools like the False Claims Act,um, where we're typically
dealing with stark and kickbackissues as the underlying uh
predicate, you know, uhcausation related to the
submission of a false claim.
Um so it certainly keeps us onour toes.
SPEAKER_02 (11:26):
So it's uh it's it's not something I would have
expected before this year.
If when when I first heard thatthe administration was trying to
use the false claims act to goafter civil rights issues
related to DEI, I thought they'dhave a hard problem.
Uh it would be difficult forthem to meet the three elements
of a false claims act claim.
And I still think that's truefor pre-2025 conduct.
(11:50):
But now with all of the pressreleases and memos that have
been going out and attempts tochange the attestations that
have to be made when submittinguh applications and payment
claims for payment to Medicareand other agencies, I think
going forward, there's a realrisk that if you aren't changing
certain policies, you you may befacing a false claims act
investigation.
SPEAKER_03 (12:11):
Yeah, something to watch out for, certainly.
Um, and I think in that samevein, you mentioned, I think you
referenced the joint workinggroup.
We we saw over the summer inJuly, um OIG and DOJ announced
the it's not really new, it's arenewal of the the False Claims
Act working group to strengthenthe collaboration between those
agencies and healthcare fraudenforcement.
I think um helpfully andtellingly, they did include in
(12:34):
that announcement certainpriorities for their enforcement
um objectives here, and thoseinclude uh Medicare Advantage,
which we'll touch on in amoment.
They also include uh the drug,device, and biologic pricing
space, including rebates andprice reporting.
Um, they highlighted theirenforcement will look into
barriers to patient access, suchas network adequacy violations,
(12:54):
um, of course, kickbacks, andspecifically the government
referenced kickbacks related todrugs, devices, and durable
medical equipment.
Um, they also referenced uhenforcement around defective
devices that impact patientsafety and the manipulation of
EHR systems to driveinappropriate utilization again
is a key objective.
So we'll touch on that in amoment as well.
Um, you know, I think whilecollaboration between these
(13:17):
agencies is nothing new, as weall know from our time there,
that they work closely togetheron these cases and the
underlying um you know policyissues of the day.
Um, but you know, I think it'sclear that the government's
anti-fraud work is still aliveand well, and we should at least
take notice of these enforcementareas as we develop um you know
our outlook to next year.
(13:37):
Um, I noticed that CMS umrecently hosted uh it was I
think it was called CrushingFraud Competition, and it was
styled as a chili cook-off.
Uh, I'm not sure if any chiliwas actually made in the
process, but the idea was tofoster competition in the
industry.
Um, and CMS was seekingexpertise in machine learning
models, you know, AI to detectanomalies in claims data, uh,
(13:59):
which of course could drivefuture enforcement.
And I think that's a key trendwe're seeing here.
It's not, again, nothing new,it's just getting better and
more effective, but but the umability uh of these agencies to
apply data analytics um todetect fraud and then also to
populate their their enforcementactions themselves, including
the damages.
Um But I think it all speaks toyou know, the government's is
(14:22):
clearly uh emphasizing its goalsto prevent and detect fraud
instead of you know pay andchase as it's been described.
Um, you know, the governmenteven last spring created
effectively a fraud war roompilot program.
Um so I think you know we're allstill sort of under the uh very
real notion that that theseenforcement actions are going to
(14:42):
continue um in the sort ofrecord setting cases they always
have.
Um course you can juxtaposethat, I think, a little bit with
um early in the year inFebruary, February, we saw the
government um policyannouncement, DOJ effectively
reinstating the administration'sprior prohibition on the use of
subregulatory guidancedocuments, uh, those that have
not undergone the sort of formalrulemaking process.
(15:03):
Um the effects of this ban willplay out on the courts, I think,
and it will impact our defensework, certainly.
And in some ways, it's beenplaying out since the Supreme
Court decision in Loper Bright,sort of adjacent to this.
Um, but I think you know it doesgive the defense bar some some
fuel to combat allegations thatstem from you know
interpretations that we see insub-regulatory guidance.
SPEAKER_02 (15:23):
Yeah, they will definitely have an effect on
defending uh OIG investigationsand DOJ investigations.
Uh, this policy was kind of putinto effect back during the
first Trump administration.
It was rescinded somewhat underthe Biden administration, and
now it's being brought backagain.
I think it can be helpful,especially in the early stages
of a DOJ investigation, if itseems like they are relying on
(15:46):
subregulatory guidance to drivethe alleged uh fraudulent
conduct, pushing back on thatand explaining why the why the
investigators can't use that canbe helpful.
Um it it stems from some SupremeCourt cases that say that if
guidance if agency guidancehasn't gone through the notice
and rule uh comment makingnotice and comment rulemaking
(16:07):
process, then it doesn't havethe force of law.
And so, based on that, as anexample, like a local coverage
determination or you know, anadvisory opinion, if that's what
DOJ is using to suggest thatthere's been a false claims act
violation, that alone is notgoing to carry the day under the
current administration.
And so pushing back on that canbe effective.
SPEAKER_03 (16:28):
Certainly, yeah, especially as you mentioned
early on.
Um, if you if you detect thatthat's really the basis for the
claim, uh that can give you somesome leverage in in
understanding the real risk tothe client there.
Um well, how about some sometrends we're we're seeing?
We keep referencing uh MedicareAdvantage.
I know, Matt, you're followingcertain things in that
enforcement space and otherother areas.
(16:49):
We've we've seen that trendcontinue to grow.
SPEAKER_01 (16:52):
Yeah, definitely.
Um and and like you mentionedearlier, uh, you know, OIG is
was expected or is expected.
There's still a couple of weeksleft in December to issue uh
industry-specific guidancerelated to Medicare Advantage.
And uh it would be great if wedo get that.
If not, I wouldn't be surprisedif perhaps, you know, based on
historical precedent, they theytie it to some some you know
(17:13):
AHLA happening, some conferenceuh where they can make a public
announcement and then you knowissue it on online.
Um but yeah, definitely uh, youknow, the the government, DOJ,
and OIG uh are definitelyincreasing their scrutiny of
Medicare Advantage with morethan half of Medicare
beneficiaries have having somesort of Medicare Advantage plan.
And there, while we've seen ahandful of enforcement actions
(17:36):
and resolutions with healthplans and downstream providers
in the past few years, a notable2025 uh enforcement action was
uh, as we're all probablyfamiliar with, is DOJ's
complaint against uh Aetna,Elevated and Humana, as well as
three broker organizations,eHealth, Go Health, and so let
quote.
Um, that complaint alleges akickback conspiracy to pay the
(17:58):
brokers in exchange forenrolling patients into the MA
Health plans.
And I I I think that thatkickback theory is not
surprising given uh its apparentconsistency with OIT's brush of
fraud alert that was issuedabout a year ago, um, which
potentially is about conductthat OIG is becoming
increasingly concerned about.
(18:19):
And as we've seen withhistorical precedents, if OIG
takes a certain position aboutcertain types of conduct, we see
DOJ enforcement in the act inthat area and um take you know
action against entities that areuh allegedly violating the laws
uh consistent with what OIG hassort of proclaimed in their
guidance.
(18:39):
So that case, I believe, wasfiled in the District of
Massachusetts.
That's definitely something tokeep an eye on next year as uh
the government ramps up itsenforcement in that area.
Um something you touched on wasuh uh notice and common
rulemaking.
So we saw movement also in theRAME space this year in the
Northern District of Texas.
(19:00):
So CMS is a final rule.
Um the the court there grantedsome rejudgments of the MA
health plan, ruling that CMS hadactually failed to appropriately
follow the APA procedures whenbetween the time that it had
issued its proposed rule and itsfinal rule, it had removed that
(19:20):
fee-for-service adjuster fromactual equivalence analysis.
And not surprisingly, about aweek or two ago, um the federal
government appealed thatdecision, uh, given that
actuarial equivalence isbasically at the heart of and
carries the day when you'retalking about uh its formula and
its analysis on reimbursementfor RAD fee.
So definitely something to keepan eye on and see how the
(19:42):
government uh you know changesthings in the interim or how the
court at the circuit level rulesum if they, you know, uh approve
essentially of the summaryjudgment that was granted.
Um, sort of a last area um tokeep an eye on um that we've
seen this year and and also Weshould keep an eye on next year
as CMS rolled out its, you know,what it's called, quote unquote,
(20:04):
an aggressive strategy toenhance and accelerate its RAD v
audits.
In that announcement, CMS hadexplained that it was going to
attack that backlog that's beenbuilding up over the years,
possibly by using AI.
It says it's going to beexpanding its workforce over
500-fold from 40 to 2,000employees or contractors.
(20:26):
It's also going to attack theremaining RAD V audits that need
to be completed for paymentyears 2018 through 2024 by early
next year.
I don't know about you guys.
I haven't really heard about anyadditional hirings or internal
movements within CMS to increasethat workforce to 2000, but
(20:47):
we'll talk about this a littlebit later.
But we have seen a lot ofmovement in the AI space.
So I wouldn't be surprised ifperhaps that six years worth of
backlog and Rad V audits isattacked first by using some
sort of AI algorithm and thenmaybe spot checked or
double-checked on the back endby those 2,000 employees or
(21:09):
contractors to ensureconsistency and accuracy and
provision uh precision in thatregard.
I'm not sure what else you guysthink about that.
SPEAKER_03 (21:18):
Well, I think that you know does sort of track with
the uh the crushing fraudcompetition, which has you know
the drive towards AI algorithmicuh solutions to go through
claims data to find out, youknow, find those anomalies and
whatnot, um, as well as youknow, the joint task force
announcement um regarding youknow their emphasis on EHR
(21:38):
systems that that might um havesort of inputs that manipulate
um factors that causeinappropriate, alleged
inappropriate uh utilization, etcetera.
Um yeah, Brandon, I don't know,do you have any other
observations there on trends?
SPEAKER_02 (21:52):
Yeah, just well, a couple points on Medicare
Advantage and then one othertrend.
In terms of Medicare Advantage,I think right now the focus from
OIG and DOJ has been on theMedicare Advantage organizations
themselves, like United Healthand Humana, especially that
lawsuit that's been that's beinglitigated right now against
United Health.
But I do think the trend isgoing to shift to the providers
(22:12):
who are supposedly assisting inuh making those risk adjustment
diagnoses that up the HCC score.
So right now the focus is on theorganizations, but I think it's
going to turn to the providerswho are are upcoding their
diagnoses so that the MAOs getmore money.
SPEAKER_01 (22:29):
Yeah, I've definitely observed a pivot in
that regard too.
We've you know historically seenover a couple of years against
MAOs health plans themselves inthat space, and then more
recently, more actively on theprovider space.
So I would I would definitelyagree that that is a trend to be
aware of, possibly at beginningnext year.
SPEAKER_02 (22:48):
And then one trend that's been happening for a
while, but DOJ continues tocrack down on lab companies.
Since January of 2023, therehave been at least 31 false
claims act settlements involvinglab testing companies.
17 of those involve kickbackallegations, and 24 were
initiated by whistleblowers.
So it's it's definitely a spacewhere DOJ is focusing.
(23:11):
And I my firm has helped defenda few of these investigations,
and what seems to happen in someof them is DOJ will find a
corrupt salesperson or a corruptmarketing company or a corrupt
doctor, and then they'll look atevery person who that that
person has worked with, and thenthey may initiate investigations
into those people.
(23:32):
So it's led to some settlements,it's also led to some innocent
companies being caught in thecrosshairs.
So that is definitely happening.
Um, one other important thingthat happened from the first
circuit just recently, there wasa a decision from the OmniCare,
Omni Healthcare, uh, falseclaims that case uh from the
first circuit on December 1st ofthis year.
(23:54):
Um, and it it said that a a labcan rely on the medical
necessity of the doctor'sdecision to order the labs
rather than having tonecessarily question medical
necessity themselves, which isconsistent with OIG guidance,
but now lends um lends moresupport since it's coming from a
circuit court.
SPEAKER_03 (24:14):
Certainly, especially in the area of of the
sub-regulatory guidance, uh, youknow, uh questionable,
questionable reliance on thosedocuments.
Um you mentioned COVID-19.
Obviously, we're a couple ofyears past you know the official
pandemic uh ending and and youknow, in sort of what is a
post-COVID world, but I thinkyou know, we're still seeing
those cases that uh whereentities and individuals took
(24:36):
advantage of the COVID era andsome of the relaxed laws that
may have applied and increasingfunding.
Um those cases continue, Ithink, to come through.
We still see announcements.
If you follow the listservs forthe various agencies, you'll see
those settlements come through.
Um, think that'll continue forfor a good bit here.
SPEAKER_02 (24:54):
Definitely.
There actually was just asettlement that was released
yesterday in a DOJ press releaseinvolving some Chinese companies
that paid 3.7.3 million toresolve allegations involving
fraudulent PPP loans.
So I it's going to keephappening.
There were there was so muchmoney going out the door and not
much oversight.
It's going to take years for thedifferent agencies to
(25:15):
investigate those and prosecutethem.
SPEAKER_03 (25:17):
Yeah.
And one thing I've I've observedjust recently, and again, mostly
just because OIG was puttingthis content out recently, uh,
back in September, a report on acall to action in the in the
wound care space.
Um, OIG's report highlightedthat Medicare Part B
expenditures for skinsubstitutes have skyrocketed
(25:38):
over the last few years, uh,surpassing, I think, 10 billion
annually by the end of 2024.
Um, and and they cite OIG sitesbasically an increase in
utilization as well as higherprices.
Um, they also seem they focus onthe fact that you know, despite
that more than half of Medicareenrollees are in Medicare
Advantage, that utilization thatOIG was looking at primarily
(25:59):
occurred in original Medicare.
Um, and they highlighted thatthe cost disparity between
treatment in the home versustreatment in the office setting.
Um I think um just in the lastcouple of days, in fact, we saw
uh, I think you know, sort offirst of its kind prosecution, a
wound graft company, uh sorry,wound graph, several wound graft
company owners sentenced fortheir part in uh a$1.2 billion
(26:23):
uh fraud case, including some uhcivil liability they've got to
settle, they've got to repay.
Um, and and those essentiallyinvolved um alleged fraud around
medically unnecessary woundgrafts, as well as um claims
that were tainted by illegalkickbacks and ultimately applied
to you know elderly patients andterminally ill patients.
So I think the the wound carespace, you know, the government
(26:44):
is clearly indicating it's it'sgonna continue to focus on on
that.
I think the report recommendsaction by CMS and OIG and other
agencies around that.
So certainly a trend uh thatthat is worth paying attention
to.
Um we also had um, you know, I'mnot sure if it's annually, but
it's very frequent.
We we get these national healthcare takedowns.
I think notably this year, um,the the 2025 national takedown
(27:07):
was the largest of its kind.
Um they charged some 324defendants, including 96
doctors, uh nurse practitioners,pharmacists, other medical
professionals for theirparticipation in various
schemes.
I think that the the intendedloss number is something like$14
billion, which is more thandouble the previous record.
(27:27):
Um and the schemes you know werefar and wide.
They included transnationalorganizations, foreign
influence.
Um, but again, I think here thegovernment highlighted its work
with data analytics in theseefforts.
Um and I think one other trendworth just hitting on here is in
the DME space.
Um following a series of auditsand reports, OIG issued what
(27:48):
looked to be sort of aconsumer-focused, um, you know,
beneficiary-focused uh video onits website highlighting the
recurring fraud issues that itencounters in the DME space,
including issues like upcoding,uh kickbacks, medical necessity,
phantom billing, uh,telemarketing schemes, and
identity theft.
Um, and that video doesreference the 2025 takedown and
(28:09):
once again highlights OIG's useof and other agencies' use of
data analytics uh for thisenforcement work.
Um any other you know, majorcases settlements we should we
should highlight here.
I know we could we could spendhours on on that task.
There's been some some majorkickback settlements, you know,
tens and hundreds of millions ofdollars with large
pharmaceutical entities and thewhat and and the like, but any
(28:31):
specific issues y'all aretracking?
SPEAKER_02 (28:33):
Well, I I think one big issue that's it's been
happening and it's gonnacontinue to happen until the
Supreme Court weighs in is theconstitutionality of the False
Claims Act ketam provisions.
The the main argument being thatunder Article II, executive
power is is vested in thepresident, and that includes the
ability to investigate andlitigate on behalf of the United
(28:55):
States to enforce the laws.
And the argument is that whenCongress wrote the False Claims
Act Ketan provisions, givingrandom citizens the ability to
initiate investigations and thenlitigate these actions, that
usurped executive power andthere therefore violates Article
II.
Um, I think most district courtjudges, as we've been seeing,
(29:17):
have been upholding the FalseClaims Act.
There's only been one court thatdid not, that found it
unconstitutional.
That's the Zaprov case.
Uh the 11th Circuit just heldoral arguments this week.
Um, if I had to guess, I thinkthe 11th Circuit is going to uh
affirm, or I'm sorry, is goingto reverse the decision finding
the statute unconstitutional.
(29:39):
But I know they're very worriedabout what's going to happen at
the Supreme Court.
Um Justices Thomas Kavanaugh andBarrett seem to seem to feel
differently.
They've issued some dissentingand concurring opinions where
they're explicitly explicitlyasking people to challenge the
constitutionality of the falseclaims act so that they can
evaluate that.
And in some recent decisionsfrom the Supreme Court,
(30:01):
including the SEAL decision froma few years ago, this current
Supreme Court seems very intenton maximizing executive power.
And so if that trend continues,I could see the Supreme Court
deciding that certain provisionsof the False Claims Act are
unconstitutional.
Um so it we'll see what happensthere, but it it's going to take
(30:22):
some time to get to the SupremeCourt, but I I I think we may
lose some of those provisions.
SPEAKER_03 (30:29):
Yeah, certainly, certainly one to watch for all
those reasons you've just cited.
Um any other settlements or orother happenings you're you're
tracking, Matt?
Are you looking at any of the uhyour the work of your former
colleagues over at OSIG?
SPEAKER_01 (30:43):
Yes, uh and they've been just like DOJ quite busy.
Um took a look at the datathrough the end of November,
which is what has been public ispublicly available as of you
know the the time of thisrecording uh in terms of uh
affirmative CMP.
So those actions taken throughthe civil monetary penalties
law, which uh loops in byreference the exclusion statute,
(31:06):
um, OIG entered into 31resolutions for nearly six
million dollars.
And I will note that a goodchunk of those, about$2 million
or so, were for alleged Mtalaviolations.
So OIG has apparently ramped upits Mtala um enforcement
actions.
And I know that those uh takequite a bit of time to
investigate and to to to havesome sort of settlement.
(31:29):
So perhaps those were you knowin the works uh for maybe a year
or two, but um a good chunk ofthat six million dollars uh in
resolutions were for Mtalaviolations, so they've kind of
they finally saw an end tothose.
Um in terms of affirmativeexclusions, uh OIG affirmatively
excluded 23 individuals andentities for a whopping total of
(31:51):
200 years in the aggregate.
Um six of those actions, I willnote that they were the
exclusion action was takenbecause the individual or the
entity defaulted on theirpayment obligations pursuant to
an agreement that they hadentered into with OIG or DOJ.
And for those, um the exclusionlength is indefinite until the
(32:13):
payment obligations issue isresolved.
So essentially the default hasbeen lifted.
Um a noteworthy exclusion, uhanother one uh involved an
entity's failure to provideinformation requested in an OIG
subpoena.
Um I don't know about you guys,but I hadn't really thought
about that exclusion basis.
I believe it was uh subsectionB11.
(32:34):
I hadn't thought about that inquite some time, and it's sort
of a reminder to me.
And uh, you know, as I adviseclients that OIG's authority is
really broad, it has a reallybroad reach and it's quite
powerful.
So if OIG uh you know issues asubpoena for information that
requests, you know, so that theycan shore up certain questions
(32:55):
they have, the failure torespond, you know, even timely
or at all, could cause that umthe recipient to be excluded,
which could have you know uhsignificant uh uh financial
impact on them.
Um in terms of providerself-disclosures, there were 84
resolutions amounting to$63million.
Uh that's where OIG sees a lotof its work and it's sort of its
(33:19):
bread and butter in terms ofrecoveries.
Um, the majority, as we'vehistorically seen, uh involved
in entity's alleged employmentovercontracting with an excluded
individual, which is, you know,that you know, over the years
that has been uh one of thebiggest areas that OIG collects
uh in terms of self-disclosureresolutions.
And then OIG also has uh a grantand contractor fraud
(33:42):
self-disclosure protocol as wellthat they formally introduced
and issued a couple of yearsago.
This this year there was onlyone resolution for$130,000.
Now you might be thinking, okay,that's kind of low, but it's
actually par for the course.
Um so there were only tworesolutions in 2024, five in
2023, and from 2018 to 2022,there were only five as well.
(34:06):
So that one resolution this yearis actually it looks to be
standard.
And I will note that thatstandalone uh resolution in the
grant contract space is also forum that entity's alleged
employment or uh contracting ofan excluded individual, which uh
in the grand contract space, ifyou do employ or contract with
(34:27):
an excluded individual, it couldcause you know certain uh costs
that are reported to thegovernment to be allegedly false
because they were in connectionwith the provision of healthcare
items and services.
Um either of you want to addanything else to that, it's
pretty much data driven at thispoint.
SPEAKER_02 (34:43):
And on the CMPL front, I I do think it'll be
interesting to watch, similar tothe challenges to the FCA, uh,
based on the Supreme Court'sJarcosy decision, which I think
came out in 2024, they rule thatit's unconstitutional to for an
and for an agency to uh placefines, fines on a company or an
(35:05):
entity or a person, or excludethem from programs without a
jury trial.
I know there have been somecourt cases where that's already
been challenged, and I think oneat least one defendant's been
successful.
So it will be interesting to seeif there if there's like a
circuit split on that issue, andI think it would ultimately
it'll get to the Supreme Courttoo.
SPEAKER_01 (35:23):
Yeah, definitely something to watch, watch uh
because uh, you know, as theCongress created the statute for
CMPs, you know, it gave OIG, youknow, the secretary in
particular, great, you know,leeway and uh great latitude to
implement regulations relatingto it.
And so up until now they havebeen left unchallenged.
(35:43):
So definitely a case to keep aneye on.
SPEAKER_03 (35:47):
And do you think, Matt, you mentioned sort of the
fairly low number ofgrant-related fraud settlements
um being fairly consistentacross the years.
Would do you expect maybe ashift in that space, given the
government's broader, thisadministration's broader
objectives uh sort of ofpreventing and detecting fraud
and and the crushing fraud uhyou know concepts?
SPEAKER_01 (36:10):
Yeah, I I think it is definitely a possibility.
I think up until now, um, youknow, there have been uh you
know, the self-disclosure issort of prima fascia evidence of
an effective compliance program.
OIG has said that repeatedly.
Now, with the the growing uhsort of scrutiny on DEI, on
gender-affirming care,transition care, and those sorts
(36:31):
of areas that the government isinterested in, those entities
are contract and contractrecipients, our grant awardees.
And so, you know, we may see anuptick in self-disclosures as uh
those entities take intoconsideration the executive
orders and the forthcoming uhregulations that we are
expecting as they take a lookinside and within their
(36:55):
organization to see if there'sanything that is worthwhile
self-disclosing, perhaps as youknow, sometimes we advise
clients to get ahead of apotential enforcement action or
to you know self-disclosebecause it is something that
now, given the legal landscape,has changed.
And so therefore self-disclosuremight be appropriate.
So I think there is apossibility in 2026 and even
(37:18):
beyond, we see an uptick inthose kinds of self-disclosures.
SPEAKER_03 (37:21):
Yeah, something to watch, as you said.
Yeah.
Uh I'll just touch maybe on umadvisory opinions.
My the the industry guidancebranch um, you know, issues
advisory opinions sort of umwith you know, only as presented
by by requesters.
So we never quite know how manythey've got um on hand, you
know, as sort of live issues.
(37:43):
But um as we sit here midmid-December, um, we've we've
seen 10 opinions from OIG, 10advisory opinions.
Um, and and you know,historically there is kind of a
flurry at the end of the year,so we may see a few more um
between now and and uh 2026.
But but putting that aside, weare at 10 today.
Eight of those were favorable,two were unfavorable.
(38:04):
Um, you know, the year startedwith an opinion, a favorable
opinion in January regarding aprogram to provide free access
to pharmaceutical products forpatients who meet certain
financial and other eligibilitycriteria and who didn't have
coverage.
Then we didn't see anotheropinion until April.
Um, we saw a pretty busy summerwith three issued in June, three
in July, one in August, and onein September.
(38:25):
And then again, nothing sincethen, as we sit here
mid-December.
Um, I would say that the trendsin these, uh the various issues
on ORG was looking at includedcharitable care, charitable
support.
Um, there were requests from thepharmaceutical industry, uh,
requests that involvedtechnology, uh, and then medical
device uh requests as well.
Um, for instance, you know, wesaw favorable advisor opinion
(38:47):
2505.
Um, this was regarding aproposed arrangement uh pursuant
to which a medical devicemanufacturer would offer up to
$2,500 to reimburse purchasersfor the actual cost they
incurred associated with aneedle stick injury caused by
the failure of the device thatthey manufacture, which was not
supposed to permit needlesticks, essentially a warranty
type question.
(39:08):
Um we also saw unfavorableadvisory opinion 2504 regarding
a medical device company'sproposal to pay the costs that
its customers otherwise wouldincur for a third-party company
to screen them and monitor themfrom for exclusion from federal
healthcare programs, the areathat you were just touching on,
Matt.
We saw uh favorable advisoryopinion 2507 regarding a program
(39:30):
operated by a pharmaceuticalmanufacturer to sponsor a
companion lab test for eligiblepatients before a provider could
could prescribe a certain drugthat the manufacturer made.
So kind of running the gamutthis year.
And again, we may see a few moreuh in the last few weeks of
December as as we might as wellsee uh maybe some industry
specific uh compliance programguidance.
(39:50):
Um well, with we've got a coupleminutes left here to maybe touch
on predictions.
I know we've we've sort oflayered them in as we go here.
Um, you know, I mentionedMentioned early on that the
subregulatory guidance questionthat we're all following.
I should put a plug-in for anAHLA article, great article on
this topic in uh connectionsmagazine issued.
(40:11):
I think it was in September.
So for future further reading,go check that out.
Very in-depth dive onto whatthat guidance might look like.
And again, I think that that oneis a wait and see.
Um, and and we will it will beup to I think the defense bar to
um you know to make someprogress on what that ban on the
use of subregulatory guidancemeans for clients and for the
litigation defense approach.
(40:32):
Um, Brendan, you mentioned uhthe FCA constitutionality piece.
I think that that certainly isone to watch.
Um I think arguments wererecently held, you said, so
we're sort of waiting for adecision.
I'm not sure when we'll see thatfrom the 11th circuit, and we'll
see where they go from there.
Um we keep touching on sort ofdata analytics, um, AI, things
(40:52):
like that.
Uh, you know, I think it's umit's here to stay, obviously,
and it's getting it's gettingbetter by the day.
Where do you see that impactingyour clients through practices
these days?
And and what and what that mightmean next year?
SPEAKER_02 (41:08):
In terms of compliance programs, I mean,
every every company probablyhas, and if they don't, they
they need to have a governancepolicy for how they vet and
implement new AI um programs,whether it affects patient care
or coding or claim submissions,they they all need to be vetted.
And what my colleagues whohandle a lot of that have
(41:29):
advised is that you need totreat AI like a new employee,
um, and and sometimes like a badnew employee.
And then you can't just stopdoing that because you have to
continue to monitor it becauseeven if it's working fine right
now, its inputs and outputs, itstarts to shift how it does
things.
And so six months down the road,it might have a bias, you might
(41:51):
be getting some hallucinationsin whatever type of product
you're using.
So on that front, AI tools canbe great, but they need to be
monitored and be part of acompliance program.
And then on the flip side, interms of uh government use to
investigate, I mean thegovernment was already using
pretty sophisticated dataanalytics tools to look at
(42:12):
extreme outliers and then alsopotential you know fraudulent
issues with the use of AI, andand this administration is
definitely promoting the use ofAI.
I think those efforts are goingto get stronger.
And it's also going to lead tosome false positives.
So there are going to be someinvestigations that are based on
AI that probably shouldn't haveinitiated because the AA is not
(42:33):
going to get it right.
SPEAKER_03 (42:35):
Right.
And I think, you know, similarlyon the industry side where the
MA does run afoul andpotentially cause issues that um
you know that may result in thesubmission of alleged false
claims, I think that's gonna bean interesting thing for the for
the attorneys to unpack, um, youknow, specifically when we get
into questions around uh intentand the like.
Um you know, other technologyissues, I think what else is out
(42:57):
there, Matt?
I know you had your hands onsome info blocking uh updates
and things we should all belooking out for here.
SPEAKER_01 (43:04):
Yeah, so you know, the OIG CMP authority for
information blocking is prettysteep.
It's a million dollars peralleged violation.
Um, we we saw that final rulecome down from OIG a couple of
years ago, and then CMS createdits disincentives final rule.
Haven't really seen any uhenforcement in this area,
although OIG did recently issueuh uh an alert, which I read as
(43:28):
like a reminder to the publicthat, hey, you know, this is how
you can report alleged, youknow, information blocking if
it's occurring, and it's areminder to, you know,
re-emphasize how steep thepenalties are.
I wouldn't be surprised if youknow we started seeing overt
investigations uh relating toinformation blocking in 2026.
And and actually it's quitetimely that, you know, OIG and I
(43:51):
believe DOJ as well justrecently issued job postings for
senior attorney physicians uhspecifically relating to this
kind of conduct.
So it looks like you know thosefederal agencies are looking to
ramp up their investigations andthey're trying to find personnel
that will find a home at thoseagencies to specifically
investigate informationblocking.
(44:12):
And uh perhaps that's a a signto the public that they have
whistleblower actions thatthey're sitting on and they're
investigating, or they havehotline complaints that they've
received and they just need thepeople to investigate them
because I I would suspectpotentially a reason is that
it's overwhelming.
Um, so they need additionalpeople to be hired and they're
(44:34):
looking for more seniorattorneys, uh more experienced
uh attorneys to most likely beeffective and efficient in that.
Um so I would I wouldn't besurprised if we started seeing
that the the first informationblocking settlement or overt
investigation next year forsure.
SPEAKER_02 (44:51):
There's also some issue, two issues involving the
anti-kickback statute that aredeveloping and will continue to
develop.
I think one is the circuit spliton butt four causation.
More circuits continue todisagree with each other.
So I think eventually that willget to the Supreme Court and
that will a huge effect on thoseinvestigations and litigations
going forward.
(45:12):
The other one is um the SorsenSorensen case from the Seventh
Circuit.
And I know our practice groupdid a a webinar for that uh
earlier in 2025, which is a ifyou haven't checked it out, it's
a great webinar.
But the the case involved it wasa criminal case involving uh a
DME company that was payingrecruiters to to find uh doctors
(45:35):
to to prescribe their DMEproducts.
Um but the problem was therecruiters they could request
that these doctors prescribe theservices, but the doctors had
full discretion to say no.
And so the the court found thateven if there was a payment
being made, it has to be it hasto induce a person to make a
(45:59):
referral or purchase a product.
And here the doctors themselvescould do ever could do it
whatever they wanted to, andthere were examples of where
they refused to order the DMEproducts.
Um so it's DOJ has beenaggressive in trying to take
this approach, but this is goingto scale it back some.
Where it might work fornon-providers would be if you're
paying like an office managerwho has a lot of control over
(46:23):
which companies are chosen forvarious products, paying that
person might still be effective.
But if you're if you're payingsomeone to like a recruiting
service to find these patientsor these doctors and they don't
have any influence over theperson making the referral, it
it's not going to be a kickbackviolation.
SPEAKER_03 (46:40):
And that was in the Seventh Circuit, if I'm not
mistaken.
So we'll see if other circuitspick up on that theme as we as
we go forward here.
SPEAKER_02 (46:47):
And I have seen courts already apply from other
circuits apply that decision.
SPEAKER_03 (46:52):
So well again, this is really just a quick take
highlight reel um the things weare observing, following,
working on this this past uhyear, 2025.
Um and as I mentioned at theoutset, uh forgive us if late
breaking news strikes uh in theweeks that follow this recording
um uh uh you know at the end ofDecember here.
(47:14):
Um and again, Brendan, I want touh Brandon, I want to plug the
uh the fraud and abuse PG's yearin review webinar.
Uh I think that's taking placein February.
SPEAKER_02 (47:25):
Yes, that'll be on February 18th.
So anything that happens betweennow and then, we'll try to
update and give you uh thelatest scoops on those issues.
SPEAKER_03 (47:34):
Excellent.
Excellent.
Well, I think that that's a wrapfor us.
Um thank you for listening intoday.
We appreciate it.
SPEAKER_02 (47:42):
Thank you very much.
Thank you.
SPEAKER_00 (47:49):
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(48:12):
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SPEAKER_03 (00:16):
Hello, uh, and thank you for uh joining us today for
this Healthcare Fraud YearInterview podcast brought to you
by the American Health LawAssociation, the Fraud and Abuse
Practice Group.
My name is Stuart Camille.
I'm the chair of the fraud andabuse practice group, and I'm
joined by my colleagues Matt andBrandon, who will introduce
themselves in a moment.
I'm a partner at the law firmBassberry ⁇ Sims in the firm's
(00:36):
Washington, D.C.
office, where I work in theregulatory space, primarily in
the anti-kickback statute andbeneficiary inducement fraud
areas.
I advise clients on front-endcounseling issues, deal
diligence issues, and defensework in the False Claims Act
space.
Prior to joining BassBerry, Iworked at HHS OIG in the Office
of Counsel, specifically in theindustry guidance branch, which
(00:58):
is the branch that issuesadvisory opinions, safe harbor
regulations, and other guidance.
As I mentioned, I'm joined byother vice chairs here from the
fraud and abuse practice groupwho I'll introduce themselves
now.
SPEAKER_02 (01:09):
Hi, everyone.
My name is Brandon Helms.
I'm a shareholder at HallRender.
I focus mainly on complianceinvestigations and then also
defending governmentinvestigations under the False
Claims Act and also False ClaimsAct litigation.
Before I joined Hall Render, Ispent eight years as an
assistant U.S.
attorney in Detroit, where I uhI started on the civil side
(01:29):
doing False Claims Actinvestigations, and then I
switched to the criminal sideand I handled criminal health
care fraud prosecutions.
And now I'm still located inDetroit.
SPEAKER_01 (01:40):
Hi everyone, I'm Matt Westbrook.
I'm senior counsel in the DCoffice of Prosgow Rose.
Like Stuart, I spent the firsthalf of my career with OIG,
specifically in theadministrative and civil
remedies branch.
While at OIG, I assisted AUSAslike Brandon with investigating
and resolving false claims actallegations, and in connection
(02:01):
with those, determining whetherCIAs or exclusions were
appropriate.
I also advised on theanti-kickback statute, the STARK
law, CMPL and Mtala, and Ihandled self-disclosures
submitted through OIG'sprotocol.
And now that I'm in privatepractice at Proscauer, I advise
our clients about the same kindsof matters as they assess
(02:22):
certain transactions or businessdevelopment opportunities.
Looking forward to thediscussion, guys.
SPEAKER_03 (02:26):
Yeah, thank you both.
And as I mentioned, this is ahealthcare fraud year interview.
It's not a not a deep dive or ofa highlights uh reel for things
we're observing in the industry.
Um I should say a couple mattersof housekeeping.
The first being this recordingis taking place in the middle of
December.
So to the extent there are latebreaking updates in the final
two weeks of the year, whichoften there are, um, those will
(02:48):
have to be covered by by otheruh product from AHLA and other
sources.
Um, and to that end, we uh thatthe fraud and abuse practice
group does put on annually ahealthcare fraud and compliance
year interview webinar, muchmore substantive, um, covering
some of what we're going to talkabout today and other issues in
more detail.
And so we thought today we wouldjust touch on our observations,
(03:09):
um, starting with sort ofgeneral happenings.
Um, it's been a fairly busyyear, um, and we'd shift over to
uh administration prioritiesthat impact the healthcare fraud
space that we sit in, then moveover to some trends we're
observing throughout the yearand what those might mean for
next year and future years ofenforcement.
Um, and we'll touch on a few keyuh settlements and cases that
(03:30):
we're following, maybe some OIGadvisory opinions and the like,
um, and then make somepredictions to the extent we can
on where things may be headed.
Um, so with that, I'll kick usoff here with some of the sort
of I'm calling them happeningsthat we're seeing.
Um obviously, you know, 2025 Ithink can be uh characterized as
a busy year in many regards aswell as kind of an odd and quiet
year in other regards.
(03:51):
Um as you all know, probably,you know, the the new
administration took took over uhat the beginning of the year,
and pretty shortly thereafter wesaw uh the mass firing of a
number of inspectors generalacross multiple agencies.
Um, those included Christy Grimmat HHS, uh OIG.
Um obviously some lawsuits camefollowing that, but at the
moment, um, the Office ofInspector General for HHS is
(04:12):
under the leadership of anacting inspector general, um, a
seasoned veteran that Matt and Iknow from our work there.
And you know, my advice uh toclients early in the year was to
sort of expect business as usualfrom that agency, you know, the
leadership there and that sortof the system that operates
there is moving forward as itnormally does.
That said, we also saw uh prettyearly in the year sort of the
(04:36):
doge-related changes that camefrom the administration, which
for many who work in governmentagencies saw you know early
retirement packages beingoffered, um, others who just
voluntarily moved on to newroles in the private sector, law
firms, in-house, et cetera.
Um, and you know, this did meansome significant departures, I
think, um, in the agencies,including at OIG and some in
(04:56):
senior roles.
Um, for instance, Matt, and Iknow many attorneys over there
at the Office of Counsel uh wholeft for new roles.
Those included an assistantinspector general, but also
included the chief counselhimself.
Um, you know, again, OCIG isunder the leadership of seasoned
veterans.
I believe there are two seasonedveterans there who are rotating
in an acting chief role.
Um, I know the the industryguidance branch where I used to
(05:18):
work, the women issues advisoryopinions and other guidance,
they saw several departures.
Um, so you know what that mightmean uh over at OIG is sort of
yet to be seen.
As I mentioned, there's plentyof fantastic lawyers there still
doing the work, plenty of otherprofessionals and the other
components doing that work.
We're seeing reports come outand whatnot, um, and that that
machine is moving forward.
Um, at the same time, you know,I think uh sort of on the quiet
(05:40):
front, um, you know, we we doknow that OIG has has um
undertaken to overhaul thiscompliance program guidance, for
instance.
Um, under the prioradministration, we saw an
overhaul of the general, veryhelpful general compliance
program guidance document comeout, um, and then shifting to
industry-specific guidancedocuments, we saw at the end of
2024, um, the nursing facilityguidance document.
(06:01):
Um, I just checked this morningto make sure, but as we sit here
today, um, OED's website doessay that it, you know, there's a
half dozen or moreindustry-specific compliance
program guidance documents uhslated to be issued, including
three that are uh indicated tobe issued in 2025.
Um, those those included for umuh Medicare Advantage, for
hospitals, for clinical labs.
(06:22):
Um, there are a few weeks leftin the year, a couple weeks
left.
We'll we'll see if we see thosedocuments, but um, you know, to
date we have we have not seenthem.
So again, you know, uh unclearif all of these other priorities
um have impacted that work orwhether there's there's some
other objective uh takingpriority there.
Um Matt, Brandon, I don't knowif you all have other thoughts
of your observations around whatthis year and and some of the
(06:44):
agency departures has meant um,you know, for your work.
SPEAKER_02 (06:48):
In terms of the Department of Justice, there
have certainly been a number ofshake-ups.
Obviously, we have a newattorney general, Pam Bondi, a
new deputy attorney general,Todd Blanch.
They wasted no time puttingtheir own stamp on their
priorities.
So we we know they're interestedin civil rights investigations
involving DEI, uh gendertransition treatment, uh,
immigration issues, just to namea few that they're focusing on.
(07:11):
Uh relevant to False Claims Actwork, Michael Granson used to
oversee the DOJ's commerciallitigation branch, which
oversees False Claims Actinvestigations.
He departed earlier this year,and Brennan Jenny from Siddhilly
Austin has taken his place.
Um it'll remain to be seen howthat changes in general, but it
has led to a working groupbetween HHS and CMS that we'll
(07:34):
talk about.
And then anecdotally, uh there'sbeen some high-level departures
of DOJ trial attorneys andAUSAs, but under the radar,
there's been a lot of massdepartures.
Um much so that I think themarket is flooded right now with
former DOJ or with DOJ attorneystrying to leave for private
practice.
And in general, I think that'sgoing to lose uh lead to a huge
(07:56):
loss of institutional knowledge,um, which may or may not be a
good thing for the targets ofDOJ investigations.
On the one hand, they they arenot going to be um as efficient
or as streamlined.
But in my experience, on thedefense side, dealing with an
AUSA or DOJ trial attorney who'snot particularly experienced can
sometimes be more problematicthan dealing with an experienced
(08:18):
one.
SPEAKER_03 (08:21):
Yeah.
Um thanks, Brandon.
And and I guess I should wrapthat whole sort of happening
section up with uh a note on thegovernment shutdown, which
obviously impacted agencies farand wide.
Um, you know, DOJ is prettyinsulated from shutdowns given
the work they do.
Um HHS OIG similarly isinsulated from shutdowns given
how they're funded.
But um one thing I did I didnotice during the shutdowns,
(08:44):
sort of for a combination of thefactors, including departures
and the shutdown, but also Ithink some uh various agency
procedures around uh governmentattendance and speaking
commitments at uh conferencesand at webinars, uh somewhat
less less visibility.
Uh fewer, fewer of those folksattending uh those conferences,
speaking at those conferences,um, and on webinars.
Um if you you know if youattended those conferences, you
(09:06):
you probably did notice anabsence of government speakers
or and again or the or thewebinar space.
Um so uh why don't we shift overto Brandon?
You touched on this already,sort of new administration
priorities that we've observedover the last 11, 12 months.
Um I know that there's been youknow some some uh expansion of
priorities and and tools withthe False Claims Act into
(09:28):
different spaces we haven'tnecessarily seen before.
SPEAKER_02 (09:32):
Yeah, so um there's been a number of those.
I mean, priorities in generalstill involve opioid
trafficking, that's one of them.
Uh Medicare advantages we'lltouch on, uh COVID-19 fraud,
although that's that fraud's notstill happening, but it's still
being investigated andprosecuted.
Um but one of the biggest thingsuh shift in focus would have
(09:55):
been the focus on DEI now.
Um if you know, if you've beenpaying attention to the news,
you know that this currentadministration is in a war
against DEI.
Uh regardless of how you feelabout those programs, some
people feel they didn't go farenough, some people feel like
they went far too far too um inthe favor of promoting certain
things.
Um regardless of how you feel,there is a real risk now for for
(10:20):
companies who have not gone backand evaluated their DEI programs
in terms of the one, the theexternal comments that they're
making, so what's on theirwebsites, what they've done in
press releases, and then two,how their internal policies uh
and and procedures look.
And so every entity needs to belooking at that, especially
(10:42):
healthcare entities that receivea lot of federal funding.
SPEAKER_03 (10:48):
Yeah, and I think there's also been a push towards
um uh you know priorities in theimmigration space as well, and
whether that might have some umimpact on uh False Claims Act,
False Claims Act work and howthe government may use the False
Claims Act tools in that space.
Um it's you know, I think it'spresenting just new and
different challenges for theindustry and for the attorneys
that represent the industry touh to to sort of the expansion
(11:11):
of the government's focus ondifferent areas using familiar
tools like the False Claims Act,um, where we're typically
dealing with stark and kickbackissues as the underlying uh
predicate, you know, uhcausation related to the
submission of a false claim.
Um so it certainly keeps us onour toes.
SPEAKER_02 (11:26):
So it's uh it's it's not something I would have
expected before this year.
If when when I first heard thatthe administration was trying to
use the false claims act to goafter civil rights issues
related to DEI, I thought they'dhave a hard problem.
Uh it would be difficult forthem to meet the three elements
of a false claims act claim.
And I still think that's truefor pre-2025 conduct.
(11:50):
But now with all of the pressreleases and memos that have
been going out and attempts tochange the attestations that
have to be made when submittinguh applications and payment
claims for payment to Medicareand other agencies, I think
going forward, there's a realrisk that if you aren't changing
certain policies, you you may befacing a false claims act
investigation.
SPEAKER_03 (12:11):
Yeah, something to watch out for, certainly.
Um, and I think in that samevein, you mentioned, I think you
referenced the joint workinggroup.
We we saw over the summer inJuly, um OIG and DOJ announced
the it's not really new, it's arenewal of the the False Claims
Act working group to strengthenthe collaboration between those
agencies and healthcare fraudenforcement.
I think um helpfully andtellingly, they did include in
(12:34):
that announcement certainpriorities for their enforcement
um objectives here, and thoseinclude uh Medicare Advantage,
which we'll touch on in amoment.
They also include uh the drug,device, and biologic pricing
space, including rebates andprice reporting.
Um, they highlighted theirenforcement will look into
barriers to patient access, suchas network adequacy violations,
(12:54):
um, of course, kickbacks, andspecifically the government
referenced kickbacks related todrugs, devices, and durable
medical equipment.
Um, they also referenced uhenforcement around defective
devices that impact patientsafety and the manipulation of
EHR systems to driveinappropriate utilization again
is a key objective.
So we'll touch on that in amoment as well.
Um, you know, I think whilecollaboration between these
(13:17):
agencies is nothing new, as weall know from our time there,
that they work closely togetheron these cases and the
underlying um you know policyissues of the day.
Um, but you know, I think it'sclear that the government's
anti-fraud work is still aliveand well, and we should at least
take notice of these enforcementareas as we develop um you know
our outlook to next year.
(13:37):
Um, I noticed that CMS umrecently hosted uh it was I
think it was called CrushingFraud Competition, and it was
styled as a chili cook-off.
Uh, I'm not sure if any chiliwas actually made in the
process, but the idea was tofoster competition in the
industry.
Um, and CMS was seekingexpertise in machine learning
models, you know, AI to detectanomalies in claims data, uh,
(13:59):
which of course could drivefuture enforcement.
And I think that's a key trendwe're seeing here.
It's not, again, nothing new,it's just getting better and
more effective, but but the umability uh of these agencies to
apply data analytics um todetect fraud and then also to
populate their their enforcementactions themselves, including
the damages.
Um But I think it all speaks toyou know, the government's is
(14:22):
clearly uh emphasizing its goalsto prevent and detect fraud
instead of you know pay andchase as it's been described.
Um, you know, the governmenteven last spring created
effectively a fraud war roompilot program.
Um so I think you know we're allstill sort of under the uh very
real notion that that theseenforcement actions are going to
(14:42):
continue um in the sort ofrecord setting cases they always
have.
Um course you can juxtaposethat, I think, a little bit with
um early in the year inFebruary, February, we saw the
government um policyannouncement, DOJ effectively
reinstating the administration'sprior prohibition on the use of
subregulatory guidancedocuments, uh, those that have
not undergone the sort of formalrulemaking process.
(15:03):
Um the effects of this ban willplay out on the courts, I think,
and it will impact our defensework, certainly.
And in some ways, it's beenplaying out since the Supreme
Court decision in Loper Bright,sort of adjacent to this.
Um, but I think you know it doesgive the defense bar some some
fuel to combat allegations thatstem from you know
interpretations that we see insub-regulatory guidance.
SPEAKER_02 (15:23):
Yeah, they will definitely have an effect on
defending uh OIG investigationsand DOJ investigations.
Uh, this policy was kind of putinto effect back during the
first Trump administration.
It was rescinded somewhat underthe Biden administration, and
now it's being brought backagain.
I think it can be helpful,especially in the early stages
of a DOJ investigation, if itseems like they are relying on
(15:46):
subregulatory guidance to drivethe alleged uh fraudulent
conduct, pushing back on thatand explaining why the why the
investigators can't use that canbe helpful.
Um it it stems from some SupremeCourt cases that say that if
guidance if agency guidancehasn't gone through the notice
and rule uh comment makingnotice and comment rulemaking
(16:07):
process, then it doesn't havethe force of law.
And so, based on that, as anexample, like a local coverage
determination or you know, anadvisory opinion, if that's what
DOJ is using to suggest thatthere's been a false claims act
violation, that alone is notgoing to carry the day under the
current administration.
And so pushing back on that canbe effective.
SPEAKER_03 (16:28):
Certainly, yeah, especially as you mentioned
early on.
Um, if you if you detect thatthat's really the basis for the
claim, uh that can give you somesome leverage in in
understanding the real risk tothe client there.
Um well, how about some sometrends we're we're seeing?
We keep referencing uh MedicareAdvantage.
I know, Matt, you're followingcertain things in that
enforcement space and otherother areas.
(16:49):
We've we've seen that trendcontinue to grow.
SPEAKER_01 (16:52):
Yeah, definitely.
Um and and like you mentionedearlier, uh, you know, OIG is
was expected or is expected.
There's still a couple of weeksleft in December to issue uh
industry-specific guidancerelated to Medicare Advantage.
And uh it would be great if wedo get that.
If not, I wouldn't be surprisedif perhaps, you know, based on
historical precedent, they theytie it to some some you know
(17:13):
AHLA happening, some conferenceuh where they can make a public
announcement and then you knowissue it on online.
Um but yeah, definitely uh, youknow, the the government, DOJ,
and OIG uh are definitelyincreasing their scrutiny of
Medicare Advantage with morethan half of Medicare
beneficiaries have having somesort of Medicare Advantage plan.
And there, while we've seen ahandful of enforcement actions
(17:36):
and resolutions with healthplans and downstream providers
in the past few years, a notable2025 uh enforcement action was
uh, as we're all probablyfamiliar with, is DOJ's
complaint against uh Aetna,Elevated and Humana, as well as
three broker organizations,eHealth, Go Health, and so let
quote.
Um, that complaint alleges akickback conspiracy to pay the
(17:58):
brokers in exchange forenrolling patients into the MA
Health plans.
And I I I think that thatkickback theory is not
surprising given uh its apparentconsistency with OIT's brush of
fraud alert that was issuedabout a year ago, um, which
potentially is about conductthat OIG is becoming
increasingly concerned about.
(18:19):
And as we've seen withhistorical precedents, if OIG
takes a certain position aboutcertain types of conduct, we see
DOJ enforcement in the act inthat area and um take you know
action against entities that areuh allegedly violating the laws
uh consistent with what OIG hassort of proclaimed in their
guidance.
(18:39):
So that case, I believe, wasfiled in the District of
Massachusetts.
That's definitely something tokeep an eye on next year as uh
the government ramps up itsenforcement in that area.
Um something you touched on wasuh uh notice and common
rulemaking.
So we saw movement also in theRAME space this year in the
Northern District of Texas.
(19:00):
So CMS is a final rule.
Um the the court there grantedsome rejudgments of the MA
health plan, ruling that CMS hadactually failed to appropriately
follow the APA procedures whenbetween the time that it had
issued its proposed rule and itsfinal rule, it had removed that
(19:20):
fee-for-service adjuster fromactual equivalence analysis.
And not surprisingly, about aweek or two ago, um the federal
government appealed thatdecision, uh, given that
actuarial equivalence isbasically at the heart of and
carries the day when you'retalking about uh its formula and
its analysis on reimbursementfor RAD fee.
So definitely something to keepan eye on and see how the
(19:42):
government uh you know changesthings in the interim or how the
court at the circuit level rulesum if they, you know, uh approve
essentially of the summaryjudgment that was granted.
Um, sort of a last area um tokeep an eye on um that we've
seen this year and and also Weshould keep an eye on next year
as CMS rolled out its, you know,what it's called, quote unquote,
(20:04):
an aggressive strategy toenhance and accelerate its RAD v
audits.
In that announcement, CMS hadexplained that it was going to
attack that backlog that's beenbuilding up over the years,
possibly by using AI.
It says it's going to beexpanding its workforce over
500-fold from 40 to 2,000employees or contractors.
(20:26):
It's also going to attack theremaining RAD V audits that need
to be completed for paymentyears 2018 through 2024 by early
next year.
I don't know about you guys.
I haven't really heard about anyadditional hirings or internal
movements within CMS to increasethat workforce to 2000, but
(20:47):
we'll talk about this a littlebit later.
But we have seen a lot ofmovement in the AI space.
So I wouldn't be surprised ifperhaps that six years worth of
backlog and Rad V audits isattacked first by using some
sort of AI algorithm and thenmaybe spot checked or
double-checked on the back endby those 2,000 employees or
(21:09):
contractors to ensureconsistency and accuracy and
provision uh precision in thatregard.
I'm not sure what else you guysthink about that.
SPEAKER_03 (21:18):
Well, I think that you know does sort of track with
the uh the crushing fraudcompetition, which has you know
the drive towards AI algorithmicuh solutions to go through
claims data to find out, youknow, find those anomalies and
whatnot, um, as well as youknow, the joint task force
announcement um regarding youknow their emphasis on EHR
(21:38):
systems that that might um havesort of inputs that manipulate
um factors that causeinappropriate, alleged
inappropriate uh utilization, etcetera.
Um yeah, Brandon, I don't know,do you have any other
observations there on trends?
SPEAKER_02 (21:52):
Yeah, just well, a couple points on Medicare
Advantage and then one othertrend.
In terms of Medicare Advantage,I think right now the focus from
OIG and DOJ has been on theMedicare Advantage organizations
themselves, like United Healthand Humana, especially that
lawsuit that's been that's beinglitigated right now against
United Health.
But I do think the trend isgoing to shift to the providers
(22:12):
who are supposedly assisting inuh making those risk adjustment
diagnoses that up the HCC score.
So right now the focus is on theorganizations, but I think it's
going to turn to the providerswho are are upcoding their
diagnoses so that the MAOs getmore money.
SPEAKER_01 (22:29):
Yeah, I've definitely observed a pivot in
that regard too.
We've you know historically seenover a couple of years against
MAOs health plans themselves inthat space, and then more
recently, more actively on theprovider space.
So I would I would definitelyagree that that is a trend to be
aware of, possibly at beginningnext year.
SPEAKER_02 (22:48):
And then one trend that's been happening for a
while, but DOJ continues tocrack down on lab companies.
Since January of 2023, therehave been at least 31 false
claims act settlements involvinglab testing companies.
17 of those involve kickbackallegations, and 24 were
initiated by whistleblowers.
So it's it's definitely a spacewhere DOJ is focusing.
(23:11):
And I my firm has helped defenda few of these investigations,
and what seems to happen in someof them is DOJ will find a
corrupt salesperson or a corruptmarketing company or a corrupt
doctor, and then they'll look atevery person who that that
person has worked with, and thenthey may initiate investigations
into those people.
(23:32):
So it's led to some settlements,it's also led to some innocent
companies being caught in thecrosshairs.
So that is definitely happening.
Um, one other important thingthat happened from the first
circuit just recently, there wasa a decision from the OmniCare,
Omni Healthcare, uh, falseclaims that case uh from the
first circuit on December 1st ofthis year.
(23:54):
Um, and it it said that a a labcan rely on the medical
necessity of the doctor'sdecision to order the labs
rather than having tonecessarily question medical
necessity themselves, which isconsistent with OIG guidance,
but now lends um lends moresupport since it's coming from a
circuit court.
SPEAKER_03 (24:14):
Certainly, especially in the area of of the
sub-regulatory guidance, uh, youknow, uh questionable,
questionable reliance on thosedocuments.
Um you mentioned COVID-19.
Obviously, we're a couple ofyears past you know the official
pandemic uh ending and and youknow, in sort of what is a
post-COVID world, but I thinkyou know, we're still seeing
those cases that uh whereentities and individuals took
(24:36):
advantage of the COVID era andsome of the relaxed laws that
may have applied and increasingfunding.
Um those cases continue, Ithink, to come through.
We still see announcements.
If you follow the listservs forthe various agencies, you'll see
those settlements come through.
Um, think that'll continue forfor a good bit here.
SPEAKER_02 (24:54):
Definitely.
There actually was just asettlement that was released
yesterday in a DOJ press releaseinvolving some Chinese companies
that paid 3.7.3 million toresolve allegations involving
fraudulent PPP loans.
So I it's going to keephappening.
There were there was so muchmoney going out the door and not
much oversight.
It's going to take years for thedifferent agencies to
(25:15):
investigate those and prosecutethem.
SPEAKER_03 (25:17):
Yeah.
And one thing I've I've observedjust recently, and again, mostly
just because OIG was puttingthis content out recently, uh,
back in September, a report on acall to action in the in the
wound care space.
Um, OIG's report highlightedthat Medicare Part B
expenditures for skinsubstitutes have skyrocketed
(25:38):
over the last few years, uh,surpassing, I think, 10 billion
annually by the end of 2024.
Um, and and they cite OIG sitesbasically an increase in
utilization as well as higherprices.
Um, they also seem they focus onthe fact that you know, despite
that more than half of Medicareenrollees are in Medicare
Advantage, that utilization thatOIG was looking at primarily
(25:59):
occurred in original Medicare.
Um, and they highlighted thatthe cost disparity between
treatment in the home versustreatment in the office setting.
Um I think um just in the lastcouple of days, in fact, we saw
uh, I think you know, sort offirst of its kind prosecution, a
wound graft company, uh sorry,wound graph, several wound graft
company owners sentenced fortheir part in uh a$1.2 billion
(26:23):
uh fraud case, including some uhcivil liability they've got to
settle, they've got to repay.
Um, and and those essentiallyinvolved um alleged fraud around
medically unnecessary woundgrafts, as well as um claims
that were tainted by illegalkickbacks and ultimately applied
to you know elderly patients andterminally ill patients.
So I think the the wound carespace, you know, the government
(26:44):
is clearly indicating it's it'sgonna continue to focus on on
that.
I think the report recommendsaction by CMS and OIG and other
agencies around that.
So certainly a trend uh thatthat is worth paying attention
to.
Um we also had um, you know, I'mnot sure if it's annually, but
it's very frequent.
We we get these national healthcare takedowns.
I think notably this year, um,the the 2025 national takedown
(27:07):
was the largest of its kind.
Um they charged some 324defendants, including 96
doctors, uh nurse practitioners,pharmacists, other medical
professionals for theirparticipation in various
schemes.
I think that the the intendedloss number is something like$14
billion, which is more thandouble the previous record.
(27:27):
Um and the schemes you know werefar and wide.
They included transnationalorganizations, foreign
influence.
Um, but again, I think here thegovernment highlighted its work
with data analytics in theseefforts.
Um and I think one other trendworth just hitting on here is in
the DME space.
Um following a series of auditsand reports, OIG issued what
(27:48):
looked to be sort of aconsumer-focused, um, you know,
beneficiary-focused uh video onits website highlighting the
recurring fraud issues that itencounters in the DME space,
including issues like upcoding,uh kickbacks, medical necessity,
phantom billing, uh,telemarketing schemes, and
identity theft.
Um, and that video doesreference the 2025 takedown and
(28:09):
once again highlights OIG's useof and other agencies' use of
data analytics uh for thisenforcement work.
Um any other you know, majorcases settlements we should we
should highlight here.
I know we could we could spendhours on on that task.
There's been some some majorkickback settlements, you know,
tens and hundreds of millions ofdollars with large
pharmaceutical entities and thewhat and and the like, but any
(28:31):
specific issues y'all aretracking?
SPEAKER_02 (28:33):
Well, I I think one big issue that's it's been
happening and it's gonnacontinue to happen until the
Supreme Court weighs in is theconstitutionality of the False
Claims Act ketam provisions.
The the main argument being thatunder Article II, executive
power is is vested in thepresident, and that includes the
ability to investigate andlitigate on behalf of the United
(28:55):
States to enforce the laws.
And the argument is that whenCongress wrote the False Claims
Act Ketan provisions, givingrandom citizens the ability to
initiate investigations and thenlitigate these actions, that
usurped executive power andthere therefore violates Article
II.
Um, I think most district courtjudges, as we've been seeing,
(29:17):
have been upholding the FalseClaims Act.
There's only been one court thatdid not, that found it
unconstitutional.
That's the Zaprov case.
Uh the 11th Circuit just heldoral arguments this week.
Um, if I had to guess, I thinkthe 11th Circuit is going to uh
affirm, or I'm sorry, is goingto reverse the decision finding
the statute unconstitutional.
(29:39):
But I know they're very worriedabout what's going to happen at
the Supreme Court.
Um Justices Thomas Kavanaugh andBarrett seem to seem to feel
differently.
They've issued some dissentingand concurring opinions where
they're explicitly explicitlyasking people to challenge the
constitutionality of the falseclaims act so that they can
evaluate that.
And in some recent decisionsfrom the Supreme Court,
(30:01):
including the SEAL decision froma few years ago, this current
Supreme Court seems very intenton maximizing executive power.
And so if that trend continues,I could see the Supreme Court
deciding that certain provisionsof the False Claims Act are
unconstitutional.
Um so it we'll see what happensthere, but it it's going to take
(30:22):
some time to get to the SupremeCourt, but I I I think we may
lose some of those provisions.
SPEAKER_03 (30:29):
Yeah, certainly, certainly one to watch for all
those reasons you've just cited.
Um any other settlements or orother happenings you're you're
tracking, Matt?
Are you looking at any of the uhyour the work of your former
colleagues over at OSIG?
SPEAKER_01 (30:43):
Yes, uh and they've been just like DOJ quite busy.
Um took a look at the datathrough the end of November,
which is what has been public ispublicly available as of you
know the the time of thisrecording uh in terms of uh
affirmative CMP.
So those actions taken throughthe civil monetary penalties
law, which uh loops in byreference the exclusion statute,
(31:06):
um, OIG entered into 31resolutions for nearly six
million dollars.
And I will note that a goodchunk of those, about$2 million
or so, were for alleged Mtalaviolations.
So OIG has apparently ramped upits Mtala um enforcement
actions.
And I know that those uh takequite a bit of time to
investigate and to to to havesome sort of settlement.
(31:29):
So perhaps those were you knowin the works uh for maybe a year
or two, but um a good chunk ofthat six million dollars uh in
resolutions were for Mtalaviolations, so they've kind of
they finally saw an end tothose.
Um in terms of affirmativeexclusions, uh OIG affirmatively
excluded 23 individuals andentities for a whopping total of
(31:51):
200 years in the aggregate.
Um six of those actions, I willnote that they were the
exclusion action was takenbecause the individual or the
entity defaulted on theirpayment obligations pursuant to
an agreement that they hadentered into with OIG or DOJ.
And for those, um the exclusionlength is indefinite until the
(32:13):
payment obligations issue isresolved.
So essentially the default hasbeen lifted.
Um a noteworthy exclusion, uhanother one uh involved an
entity's failure to provideinformation requested in an OIG
subpoena.
Um I don't know about you guys,but I hadn't really thought
about that exclusion basis.
I believe it was uh subsectionB11.
(32:34):
I hadn't thought about that inquite some time, and it's sort
of a reminder to me.
And uh, you know, as I adviseclients that OIG's authority is
really broad, it has a reallybroad reach and it's quite
powerful.
So if OIG uh you know issues asubpoena for information that
requests, you know, so that theycan shore up certain questions
(32:55):
they have, the failure torespond, you know, even timely
or at all, could cause that umthe recipient to be excluded,
which could have you know uhsignificant uh uh financial
impact on them.
Um in terms of providerself-disclosures, there were 84
resolutions amounting to$63million.
Uh that's where OIG sees a lotof its work and it's sort of its
(33:19):
bread and butter in terms ofrecoveries.
Um, the majority, as we'vehistorically seen, uh involved
in entity's alleged employmentovercontracting with an excluded
individual, which is, you know,that you know, over the years
that has been uh one of thebiggest areas that OIG collects
uh in terms of self-disclosureresolutions.
And then OIG also has uh a grantand contractor fraud
(33:42):
self-disclosure protocol as wellthat they formally introduced
and issued a couple of yearsago.
This this year there was onlyone resolution for$130,000.
Now you might be thinking, okay,that's kind of low, but it's
actually par for the course.
Um so there were only tworesolutions in 2024, five in
2023, and from 2018 to 2022,there were only five as well.
(34:06):
So that one resolution this yearis actually it looks to be
standard.
And I will note that thatstandalone uh resolution in the
grant contract space is also forum that entity's alleged
employment or uh contracting ofan excluded individual, which uh
in the grand contract space, ifyou do employ or contract with
(34:27):
an excluded individual, it couldcause you know certain uh costs
that are reported to thegovernment to be allegedly false
because they were in connectionwith the provision of healthcare
items and services.
Um either of you want to addanything else to that, it's
pretty much data driven at thispoint.
SPEAKER_02 (34:43):
And on the CMPL front, I I do think it'll be
interesting to watch, similar tothe challenges to the FCA, uh,
based on the Supreme Court'sJarcosy decision, which I think
came out in 2024, they rule thatit's unconstitutional to for an
and for an agency to uh placefines, fines on a company or an
(35:05):
entity or a person, or excludethem from programs without a
jury trial.
I know there have been somecourt cases where that's already
been challenged, and I think oneat least one defendant's been
successful.
So it will be interesting to seeif there if there's like a
circuit split on that issue, andI think it would ultimately
it'll get to the Supreme Courttoo.
SPEAKER_01 (35:23):
Yeah, definitely something to watch, watch uh
because uh, you know, as theCongress created the statute for
CMPs, you know, it gave OIG, youknow, the secretary in
particular, great, you know,leeway and uh great latitude to
implement regulations relatingto it.
And so up until now they havebeen left unchallenged.
(35:43):
So definitely a case to keep aneye on.
SPEAKER_03 (35:47):
And do you think, Matt, you mentioned sort of the
fairly low number ofgrant-related fraud settlements
um being fairly consistentacross the years.
Would do you expect maybe ashift in that space, given the
government's broader, thisadministration's broader
objectives uh sort of ofpreventing and detecting fraud
and and the crushing fraud uhyou know concepts?
SPEAKER_01 (36:10):
Yeah, I I think it is definitely a possibility.
I think up until now, um, youknow, there have been uh you
know, the self-disclosure issort of prima fascia evidence of
an effective compliance program.
OIG has said that repeatedly.
Now, with the the growing uhsort of scrutiny on DEI, on
gender-affirming care,transition care, and those sorts
(36:31):
of areas that the government isinterested in, those entities
are contract and contractrecipients, our grant awardees.
And so, you know, we may see anuptick in self-disclosures as uh
those entities take intoconsideration the executive
orders and the forthcoming uhregulations that we are
expecting as they take a lookinside and within their
(36:55):
organization to see if there'sanything that is worthwhile
self-disclosing, perhaps as youknow, sometimes we advise
clients to get ahead of apotential enforcement action or
to you know self-disclosebecause it is something that
now, given the legal landscape,has changed.
And so therefore self-disclosuremight be appropriate.
So I think there is apossibility in 2026 and even
(37:18):
beyond, we see an uptick inthose kinds of self-disclosures.
SPEAKER_03 (37:21):
Yeah, something to watch, as you said.
Yeah.
Uh I'll just touch maybe on umadvisory opinions.
My the the industry guidancebranch um, you know, issues
advisory opinions sort of umwith you know, only as presented
by by requesters.
So we never quite know how manythey've got um on hand, you
know, as sort of live issues.
(37:43):
But um as we sit here midmid-December, um, we've we've
seen 10 opinions from OIG, 10advisory opinions.
Um, and and you know,historically there is kind of a
flurry at the end of the year,so we may see a few more um
between now and and uh 2026.
But but putting that aside, weare at 10 today.
Eight of those were favorable,two were unfavorable.
(38:04):
Um, you know, the year startedwith an opinion, a favorable
opinion in January regarding aprogram to provide free access
to pharmaceutical products forpatients who meet certain
financial and other eligibilitycriteria and who didn't have
coverage.
Then we didn't see anotheropinion until April.
Um, we saw a pretty busy summerwith three issued in June, three
in July, one in August, and onein September.
(38:25):
And then again, nothing sincethen, as we sit here
mid-December.
Um, I would say that the trendsin these, uh the various issues
on ORG was looking at includedcharitable care, charitable
support.
Um, there were requests from thepharmaceutical industry, uh,
requests that involvedtechnology, uh, and then medical
device uh requests as well.
Um, for instance, you know, wesaw favorable advisor opinion
(38:47):
2505.
Um, this was regarding aproposed arrangement uh pursuant
to which a medical devicemanufacturer would offer up to
$2,500 to reimburse purchasersfor the actual cost they
incurred associated with aneedle stick injury caused by
the failure of the device thatthey manufacture, which was not
supposed to permit needlesticks, essentially a warranty
type question.
(39:08):
Um we also saw unfavorableadvisory opinion 2504 regarding
a medical device company'sproposal to pay the costs that
its customers otherwise wouldincur for a third-party company
to screen them and monitor themfrom for exclusion from federal
healthcare programs, the areathat you were just touching on,
Matt.
We saw uh favorable advisoryopinion 2507 regarding a program
(39:30):
operated by a pharmaceuticalmanufacturer to sponsor a
companion lab test for eligiblepatients before a provider could
could prescribe a certain drugthat the manufacturer made.
So kind of running the gamutthis year.
And again, we may see a few moreuh in the last few weeks of
December as as we might as wellsee uh maybe some industry
specific uh compliance programguidance.
(39:50):
Um well, with we've got a coupleminutes left here to maybe touch
on predictions.
I know we've we've sort oflayered them in as we go here.
Um, you know, I mentionedMentioned early on that the
subregulatory guidance questionthat we're all following.
I should put a plug-in for anAHLA article, great article on
this topic in uh connectionsmagazine issued.
(40:11):
I think it was in September.
So for future further reading,go check that out.
Very in-depth dive onto whatthat guidance might look like.
And again, I think that that oneis a wait and see.
Um, and and we will it will beup to I think the defense bar to
um you know to make someprogress on what that ban on the
use of subregulatory guidancemeans for clients and for the
litigation defense approach.
(40:32):
Um, Brendan, you mentioned uhthe FCA constitutionality piece.
I think that that certainly isone to watch.
Um I think arguments wererecently held, you said, so
we're sort of waiting for adecision.
I'm not sure when we'll see thatfrom the 11th circuit, and we'll
see where they go from there.
Um we keep touching on sort ofdata analytics, um, AI, things
(40:52):
like that.
Uh, you know, I think it's umit's here to stay, obviously,
and it's getting it's gettingbetter by the day.
Where do you see that impactingyour clients through practices
these days?
And and what and what that mightmean next year?
SPEAKER_02 (41:08):
In terms of compliance programs, I mean,
every every company probablyhas, and if they don't, they
they need to have a governancepolicy for how they vet and
implement new AI um programs,whether it affects patient care
or coding or claim submissions,they they all need to be vetted.
And what my colleagues whohandle a lot of that have
(41:29):
advised is that you need totreat AI like a new employee,
um, and and sometimes like a badnew employee.
And then you can't just stopdoing that because you have to
continue to monitor it becauseeven if it's working fine right
now, its inputs and outputs, itstarts to shift how it does
things.
And so six months down the road,it might have a bias, you might
(41:51):
be getting some hallucinationsin whatever type of product
you're using.
So on that front, AI tools canbe great, but they need to be
monitored and be part of acompliance program.
And then on the flip side, interms of uh government use to
investigate, I mean thegovernment was already using
pretty sophisticated dataanalytics tools to look at
(42:12):
extreme outliers and then alsopotential you know fraudulent
issues with the use of AI, andand this administration is
definitely promoting the use ofAI.
I think those efforts are goingto get stronger.
And it's also going to lead tosome false positives.
So there are going to be someinvestigations that are based on
AI that probably shouldn't haveinitiated because the AA is not
(42:33):
going to get it right.
SPEAKER_03 (42:35):
Right.
And I think, you know, similarlyon the industry side where the
MA does run afoul andpotentially cause issues that um
you know that may result in thesubmission of alleged false
claims, I think that's gonna bean interesting thing for the for
the attorneys to unpack, um, youknow, specifically when we get
into questions around uh intentand the like.
Um you know, other technologyissues, I think what else is out
(42:57):
there, Matt?
I know you had your hands onsome info blocking uh updates
and things we should all belooking out for here.
SPEAKER_01 (43:04):
Yeah, so you know, the OIG CMP authority for
information blocking is prettysteep.
It's a million dollars peralleged violation.
Um, we we saw that final rulecome down from OIG a couple of
years ago, and then CMS createdits disincentives final rule.
Haven't really seen any uhenforcement in this area,
although OIG did recently issueuh uh an alert, which I read as
(43:28):
like a reminder to the publicthat, hey, you know, this is how
you can report alleged, youknow, information blocking if
it's occurring, and it's areminder to, you know,
re-emphasize how steep thepenalties are.
I wouldn't be surprised if youknow we started seeing overt
investigations uh relating toinformation blocking in 2026.
And and actually it's quitetimely that, you know, OIG and I
(43:51):
believe DOJ as well justrecently issued job postings for
senior attorney physicians uhspecifically relating to this
kind of conduct.
So it looks like you know thosefederal agencies are looking to
ramp up their investigations andthey're trying to find personnel
that will find a home at thoseagencies to specifically
investigate informationblocking.
(44:12):
And uh perhaps that's a a signto the public that they have
whistleblower actions thatthey're sitting on and they're
investigating, or they havehotline complaints that they've
received and they just need thepeople to investigate them
because I I would suspectpotentially a reason is that
it's overwhelming.
Um, so they need additionalpeople to be hired and they're
(44:34):
looking for more seniorattorneys, uh more experienced
uh attorneys to most likely beeffective and efficient in that.
Um so I would I wouldn't besurprised if we started seeing
that the the first informationblocking settlement or overt
investigation next year forsure.
SPEAKER_02 (44:51):
There's also some issue, two issues involving the
anti-kickback statute that aredeveloping and will continue to
develop.
I think one is the circuit spliton butt four causation.
More circuits continue todisagree with each other.
So I think eventually that willget to the Supreme Court and
that will a huge effect on thoseinvestigations and litigations
going forward.
(45:12):
The other one is um the SorsenSorensen case from the Seventh
Circuit.
And I know our practice groupdid a a webinar for that uh
earlier in 2025, which is a ifyou haven't checked it out, it's
a great webinar.
But the the case involved it wasa criminal case involving uh a
DME company that was payingrecruiters to to find uh doctors
(45:35):
to to prescribe their DMEproducts.
Um but the problem was therecruiters they could request
that these doctors prescribe theservices, but the doctors had
full discretion to say no.
And so the the court found thateven if there was a payment
being made, it has to be it hasto induce a person to make a
(45:59):
referral or purchase a product.
And here the doctors themselvescould do ever could do it
whatever they wanted to, andthere were examples of where
they refused to order the DMEproducts.
Um so it's DOJ has beenaggressive in trying to take
this approach, but this is goingto scale it back some.
Where it might work fornon-providers would be if you're
paying like an office managerwho has a lot of control over
(46:23):
which companies are chosen forvarious products, paying that
person might still be effective.
But if you're if you're payingsomeone to like a recruiting
service to find these patientsor these doctors and they don't
have any influence over theperson making the referral, it
it's not going to be a kickbackviolation.
SPEAKER_03 (46:40):
And that was in the Seventh Circuit, if I'm not
mistaken.
So we'll see if other circuitspick up on that theme as we as
we go forward here.
SPEAKER_02 (46:47):
And I have seen courts already apply from other
circuits apply that decision.
SPEAKER_03 (46:52):
So well again, this is really just a quick take
highlight reel um the things weare observing, following,
working on this this past uhyear, 2025.
Um and as I mentioned at theoutset, uh forgive us if late
breaking news strikes uh in theweeks that follow this recording
um uh uh you know at the end ofDecember here.
(47:14):
Um and again, Brendan, I want touh Brandon, I want to plug the
uh the fraud and abuse PG's yearin review webinar.
Uh I think that's taking placein February.
SPEAKER_02 (47:25):
Yes, that'll be on February 18th.
So anything that happens betweennow and then, we'll try to
update and give you uh thelatest scoops on those issues.
SPEAKER_03 (47:34):
Excellent.
Excellent.
Well, I think that that's a wrapfor us.
Um thank you for listening intoday.
We appreciate it.
SPEAKER_02 (47:42):
Thank you very much.
Thank you.
SPEAKER_00 (47:49):
If you enjoyed this episode, be sure to subscribe to
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For more information about AHLAand the educational resources
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