Professional Documents
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D efendants.
CO M PLM NT
Plaintiff-RelatorsDerek Lewis and Joey N eim an,through theirattorneys,on behalfofthe
UnitedStatesofAmerica(theçEGovernmenf),fortheirComplaintagainstDefendants
CommunityHea1thSystems,Inc.(ç:CHSl''),CHSPSC,LLC,theCHShospitalsidentifiedin
ExhibitA andincorporatedbyreferenceherein(collectively,withCHSIandCHSPSC,:iCHS''),
andMedhost,lnc.(tûMedhosf')(collectively,tçDefendants''),allegebaseduponpersonal
knowledge,relevantdocum ents,and inform ation and belief,asfollow s:
1. IN TR ODU CTION
Thisis an action to recoverdam agesand civilpenaltieson behalfofthe United
StatesofA m erica arising from false and/orfraudulentrecords,statem ents and claim sm adeand
caused to be m ade by D efendantsand/ortheiragentsand em ployees,in violation ofthefederal
FalseClaimsAct,31U.S.C.jj3729etseq.rûtheFCA'').
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many ofitshospitals.
M edhost's software suffersfrom pervasive flaw sthatm ake itineligible for
certification undertheM eaningfulUseprogram ,including m ultiple design failures in its
softwareforcomputerizedphysician orderentry (i1CPOE'')andclinicaldecision support.These
flaw spreventhealthcare providersfrom providing clinicalcare in m ultiple CHS hospitalssafely
and reliably. M any ofthe flaw screatean acute risk to patienthealth and safety.
Based on inform ation and beliefaftera reasonable investigation,M eclhost
knowingly and falsely attested to itscertifying body thatitssoftware complied w ith the
requirem entsforStage 2 certification and fbrthepaym entofincentives underthe M eaningful
U se program .
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requiredMeaningfulUseobjectivesandmeasurestoobtainMeaningfulUsesubsidies.
l0. CH S knows,and knew ,thatthe M edhostsoftware deployed in itshospitalsis
defective and unreliable and doesnotm eetthe requirem entsforcertified EHR technology.
N onetheless,CHS and itshospitalspresented orcaused to bepresented attestationst()the
Governm entrepresenting eligibility forM eaningfulUse incentive paym ents.
CH S'Sim plem entation ofM edhost'ssoftware com pounded problem sw ith the
software m aking the M edhostsystem even m oreunreliable and often dangerous.
CHS implementedM edhost'ssoftwareatarapidpaceso astobeabletosubmit
attestationsforM eaningfulUse Stage2 incentive paym ents. ln itshaste,CH S took shortcutsand
additionaldefectswith perform ance ofthe software resulted.A m ong otherthings,CHS m apped
m any ordersetsincorrectly to hospitalform ularies,causing doctorsto inadvertently place orders
forincorrectm edicationsand m edication dosages.One CHS em ployee warned these tlaw shad
;ta vely high potentialforcausing a catastrophic event.''
Even though the flaw sand lack ofreliability with both the M edhostsoftware and
CH S'Simplem entation ofthe software should have m ade the CH S hospitalsineligible for
M eaningfulUse incentivepaym ents,CHS and CH S hospitalsknow ingly m isrepresented to the
Govem m entthatthe hospitalsw ere eligible for subsidy payments.
CH S also know ingly m isrepresented itseligibility forM eaningfulU se incentive
paym entsforsixty hospitalsthatCHS acquired through a m ergerw ith H ea1th M anagem ent
Associates($$HM A'').Thesesixtyhospitalsusedamodularelectronichealthrecordsoftware
know n asPULSE. The PU LSE EHR m odulesatthese sixty hospitalswere notintegrated
properly and these hospitals could not,and in m any cases,cannot,perform tasksthatrequired
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required functions.
18. Defendants'falseand fraudulentstatem entsand conductalleged in thiisComplaint
violatethefederalFalseClaimsAct(FCA),31U.S.C.jj3729etseq.TheFCA allowsany
personhavinginformationaboutanFCA violation(referredtoasaquitam plaintiffor:trelator'')
to bring an action on behalfofthe Governm ent,and to share in any recovery. The FCA requires
thatthecomplaintbefiledundersealforaminimum of60days(withoutserviceonthe
defendantduringthattime)to allow theGovel
mmenttimeto conductitsown investigation andto
determinewhethertojointhesuit.
19. Quitam Plaintiff-RelatorsDerekLewisand JoeyN eim anseekthroughthisaction
to recovera1lavailable dam ages,civilpenalties,and otherreliefforthe FCA violationsalleged
hereinineveryjurisdictiontowhichDefendants'misconducthasextended.
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1I. PARTIES
A . Plaintiffs
SecurityAct,42U.S.C.jj1395-1395k1/-1(Medicare),andadministersgrantstostatesfor
M edicalAssistanceProgram spursuantto Title XlX ofthe SocialSecurity Act,42 U .S.C.
jj1396,c/seq.(M edicaid).TheUnitedStates,actingthroughHHS,alsoadministefsthe
M eaningfulUseprogram and a certifcation program forEH R technology.
formanagingEHR implementationprojectsatCHShospitals.
22. Quitam Plaintiff-RelatorJoeyNeiman(çdlkelatorNeiman'')isaresidentof
Thom pson'sStation,Tennessee. RelatorN eim an w orked forDefendantCH S from M arch 2012
toDecember2016.HejoinedCHSasaTechnicalSpecialistforCHS'STier1ClinicalSystems
(CHS hospitalsthatutilized M edhost'sEHR software)andwasresponsibleforleadingtechnical
projectsinvolvingtheclinicalsystemsatCHS'Shospitals.lnFebruary2014,RelatorNeiman
w asprom oted to CH S'SM anagerofHealth Inform ation System D elivery,Deploym entServices.
ln thatrole,he w asresponsible forbuilding EHR system saspartofhospitalconversionsand
acquisitions,aswellasprogram managemelltforvariousprojectsinvolvingCHS'SEHR
softw are.
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B. Defendants
Com m unity H ealth System s,lnc.
DefendantCommunityHealtlkSystems,Inc.($$CHS1'')isoneofthelargest
publicly traded hospitalcom paniesin the United Statesand a leading operatorofgeneralacute
carehospitals.CH SIis incorporated underthe law softhe state ofD elaw are and headquartered at
4000 M eridian Boulevard,Franklin,Tennessee 37067.Through itsw holly owned director
indirectsubsidiaries,CH SIow ns,leases,or(lperates l27 hospitalsin 20 statesw ith an aggregate
ofapproxim ately 26,000 licensed beds.Togtrther,CH SIand its directly orindirectly ow ned
affiliate companiesarereferred to herein asS'CH S.''
2. CH SPSC,LLC
24. DefendantCHSPSC,LLC (formerlyCommunityHea1th SystemsProfessional
ServicesCorporation)isaDelawarecorporationheadquartered at4000 M eridianBoulevard,
Franklin,Tennessee 37067. CH SPSC isa subsidiary ofCH SIthatm anagesCH S'Shospitalsand
otheraffiliates.
CH S H ospitals
25. The DefendantCH S hospitalsare identified in ExhibitA and incorporated by
reference herein. CHSIand/oritswholly-owned directand indirectsubsidiariesow ned,leased,
oroperated each ofthehospitalsduring the relevanttim e period. Each hospitalattested to
M eaningfulUse ofcertified EHR technology based on theiruse ofM edhostorPULSE software.
4. M edhost,lnc.
DefendantMedhost,Inc.,Ckldedhosf')isahealthinformationtechnology
company thatprovidesenterprise,departm ental,and healthcare engagem entsolutionsto over
1,100 healthcarefacilitiesin theU nited States.Itisheadquartered at6550 CarothersParltw ay,
Suite 100,Franklin,TN 37067.M edhost'ssuite ofEH R softw are consistsofm ultiple
applications,including an Entep rise System forinpatientcare,an ED IS system forEm ergency
Departments,aPerioperativelnformationManagementSystem ((TIM S'')system forsurgical
operationsand scheduling,and a businessilltelligence system fortracking and reporting
M eaningfulUse.
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istheBrentwood,Tennessee-basedLifepointHealth,lnc.(dstzifepoinf'),anotherlargehospital
chain. Lifepointhospitalshave also certifieclto M eaningfulUse,and received incentive
paym ents,based on the use ofM edhost'ssuite ofEHR software.
111. JUR ISDICTIO N A ND VENUE
28. ThisCourthasjurisdictionoverthesubjectmatterofthisactionpursuantto28
U.S.C.j1331and31U.S.C.j3732,thelatterofwhichspecificallyconfersjurisdictëononthis
Courtforactionsbroughtpursuantto31U.S.C.jj3729and3730.Althoughtheissueisno
longerjurisdictionalafterthe2009amendmentstotheFCA,toRelators'knowledgetherehas
been no statutorily relevantpublic disclosure ofthe itallegationsortransactions''in this
Complaint,asthoseconceptsareusedin31U.S.C.j3730(e),asamendedbyPub.L.No.111-
148,j10104()(2),124Stat.119,901-02.Regardlessofwhethersuchadisclosurehasoccurred,
Relatorsqualify as(doriginalsources''ofthe inform ation on which the allegationsortransactions
in this Com plaintare based. Before filing thisaction,Relatorsvoluntarily disclosed to the
Governm entthe inform ation on which the allegationsortransactions in thisCom plaintare based.
A dditionally,Relatorshavedirectand independentknowledge aboutthe m isconductalleged
herein and thatknow ledge isindependentof'and m aterially addsto any publicly disclosed
allegationsortransactionsrelevantto theirclaim s.
ThisCourthaspersonaljurisdictionovertheDefendantspursuantto: !1U.S.C.
j3732(a)becausethatsection authorizesnationwideserviceofprocessandbecause the
Defendantshave m inim um contactswith the United States. M oreover,one orm ore D efendants
can be found in and/ortransactbusinessin the Southern DistrictofFlorida.
30. Venue isproper in the Southel'
n D istrictofFloridapursuantto 28 U.S.C.
jj1391(b)-(c)and31U.S.C.j3732(a)becauseoneormoreDefendantscanbefourt
dinand/or
transactbusinessinthisDistrict,andbecauseviolationsof31U.S.C.jj3729etseq.alleged
herein occurred w ithin thisDistrict. CH S,forexample,operated hospitalsw ithin thisD istrict,
including theLow erKeysM edicalCenterlocated in Key W est,Florida. A sdiscussed below ,the
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LowerKeysM edicalCentersubm itted false attestationsto the Govem m entto claim incentive
j3729(b)(2).
The FCA definesthe term sEEknow ing''and itknowingly''to mean Gtthata person,
withrespecttoinformation-(i)hasactualknowledgeoftheinformation;(ii)actsin deliberate
ignoranceofthetruth orfalsityoftheinformation;or(iii)actsin recklessdisregard ofthetruth
orfalsityoftheinformation.Id.atj3729(b)(l)(A).TheFCA doesnotrequireprocfofspecific
intenttodefraud.1d.atj3729(b)(1)(B).
34. TheFCA providesthatthe term EEm aterial''m eanstlhaving a naturaltendency to
intluence,orbe capable ofinfluencing,the paym entorreceiptofm oney orproperty.
'' fJ.at
j3729(b)(4).
35. Any person who violatesthe FCA isliable for am andatory civilpenalty foreach
suchclaim,plusthreetimesthedamagessustainedbytheGovemment.1d.atj3729(a)(1).
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orfraudulentclaim forthepurposesofrtheFalseClaimsActj.''
The PPACA also clariied the intentrequirem entofthe Anti-K ickback Statute,
and providesthat$ûa person need nothave actualknow ledge ofthis section orspecific intentto
com m ita violation''ofthe AK S in orderto be found guilty ofa ççw illfulviolation.''vrJ.
C. C ertified EHR Technoloa ' and the M eanineful Use Prozram
1. Certification ofEH R Sof- are
40. On Febnzal'y 17,2009,the H ITECH A ctw asenacted to prom ote the adoption and
meaningfuluse ofcertified EHR technology.Underthe HITECH Act,the HH S Office ofthe
NationalCoordinatorforHealthInformatiollTechnology($6ONC'')establishedacertification
program forEHR tecimology.A spartofthe certification program ,EH R vendors attestto ON C
authorizedcertificationbodies(tW CB'')anclaccreditedtestinglaboratories(çûATL'')thattheir
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requirem ents.
41. To obtain certification,EHR vendorsm ustattestto an A CB thattheirEHR
productsatisfiestheapplicable certitk ation criteria,subm itto certification testing by an A TL,
and pass such testing.
42. Afterobtaining certiûcation,an EHR vendormustm aintain thatcertifùcation by
com plying w ith al1applicable conditionsand requirementsofthe certification program . Am ong
otherthings,the EHR productmustbe ableto accurately,reliably,and safely perform its
certified capabilitieswhile in use in hospitalsand doctors'offices.EH R vendorsmustcooperate
w ith theprocessesestablished by ON C fortesting,certifying,and conducting ongoing
surveillance and review ofcertified EHR technology.
2. M eaningfulUseofCertilied EH m
43. Through the M eaningfulU se program ,CM S m akesincentive paym ents and
appliespenaltiesto healthcare providersbased on whethertheprovidersdem onstrate m eaningful
use ofcertified EHR technology. The healthcare providerseligibleto receive incentive
paymentsundertheprogram includehospitzls(ççEligibleHospitals''),criticalaccesshospitals
($$CAHs''),and individualpractitioners(sçEligibleProfessionals'').lncentivesareavailableunder
both the M edicare and M edicaid program s.
44. To qualify forincentive paym ents underthe M eaningfulUseprogram ,Eligible
Hospitals,CAHS,andEligibleProfessionalsarerequired,amongotherthings,to:(1)usean EHR
system thatqualifiesascertifiedEHR technology'
,and(2)satisfycertainobjectivesand
m easuresrelating to theirmeaningfuluse ofthe certifsed EHR technology.
45. H H S im plem ented the EHR certification criteria and incentive paym ent
requirem ents in m ultiple stages. On Januaq/ 13,2010,HH S published in the FederaLRegister
interim finalrulessetting forth the 6:2011Edition''certifcation criteria and a proposed rule
setting forth theçûstage 1''requirem entsforincentivepaym ents. HH S finalized these
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! .
payments.lnStage2,EligibleHospitalsandCAHSneededtosatisfysixteen(dcoreobjectives''
andthreeoutofsixEçmenusetobjectives.''AnEligibleProfessional'suseofcertifiedEHR
technologygenerallyneededtosatisfyseventeenûûcoreobjectives''andthreeoutofsixddmenuset
objectives.''
47. On October16,20l5,CM S published in the FederalRegistera finalrulew ith
com m entperiod setting forth the SsM odified Stage 2''requirem entsforincentivepayrnents. For
years2015through2017,ModifiedStage2eliminatedtheconceptofGémenusetobjectives''and
required allEligible Hospitals,CAHS,and Eligible Professionals,to attestto a single setof
objectivesandmeasures.
48. In October2015,CM S also released afinalrule thatestablished Stage 3 in 2017
and beyond,which focuses on using certified EHR technology to im prove quality,safety,and
efficacy ofhealth care,including prom oting patientaccessto self-m anagem enttoolsand
im proving population health.
49. Starting in 2015,allprovidersw ere required to useteclm ology certified to the
2014 Edition. For2016 and 2017,providerscan choose to use technology certified to the 2014
Edition orthe 20l5 Edition.
50. To qualify forincentive paym ents in each Stage oftheM eaningfulU seprogram ,
healthcare providersare required each yearto attestthatthey used certified EHR technology and
satisfiedtheapplicableMeaningfulUseobjectivesandmeasures.UseofcertifiedE14R
technologyandsatisfactionofapplicableMeaningfulUseobjectivesandmeasuresarematerial
to paym entunderthe M eaningfulUse program .
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program s.
52. The incentive paym entsfrom M edicare and/orM edicaid aretheproductofthree
factors:(1)andsinitialamount''between$2,000,000and$6,370,200,whichisdeterminedbased
onthenumberofdischarges;(2)theM edicareorMedicaidtdsharepercentage,''whichisbased
onthehospital'sratioofM edicareorMedicaidinpatientdaystototalinpatientdays(modified
bychargesforcharitycare);and(3)a(ûtransitionfactor''basedontheyearthehospitalbegan
receiving incentivepaym ents.
M edicare paym entsto EligibleH ospitalsunderthis form ula ended aftar2016.
M edicaid paym entsto Eligible H ospitals can continue until2021,although hospitalsm ay not
for2017andafter.TherearenopaymentadjustmentsundertheMedicaidprogram.
CriticalAccessHospitals(CçCAHs'')arealsoeligibleforM edicareand M edicaid
incentivesundertheprogram ;however,the M edicare incentivesare calculated differently.CAH S
couldqualifyforanincentivepaymentfrom M edicareequaltotheproductof:(l)theCAH'S
reasonablecostsincurredforthepurchasecfcertifiedEHR technology;and(2)theCAH'S
M edicare share percentage,w hich in thisinstance istheM edicare sharepercentage ascom puted
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forEligibleHospitalsplus20percentagepoi
Lnts,subjecttoamaximum sharepercentageof
100% . M edicare incentive paym entsunderthisformulaforCA HSended after2015.
Eligible Professionals,undertheM eaningfulUseprogram ,could qualify forup to
$43,720overfiveyearsfrom Medicare(endingafter2016)orupto$63,750oversixyearsfrom
Medicaid(endingafter2021).
Starting in 2017,the M edical'eEH R lncentive Program forEligibleProfessionals
59. SimilartothenegativepaymentadjustmentforfailuretomeetMeaningfulUse
requirem ents,failuretoreportthedatarequired undertheIQR Program resultsin anegative
paymentadjustmenttothehospital,calculatedasapercentagereductioninMedicare'sannual
increasetotheIPPS.ThepaymentadjustmentoccurstwoyearsaftertheIQR reportingperiod.
ln 2005-2006,thepenalty wasa .4% reduction,in 2007-2014 itw asa 2% reduction,and from
2015 onw ard,thepenalty isa 25% reductioll.
60. Originally,hospitalshad to nlanually com pile a11ofthe data forsubm ission to the
Program . However,beginning in 2014,CM S gave hospitalsthe option ofreporting som e ofthe
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subm itthe data using either2014 Edition or2015 Edition Certified EH R technology. These
rulesforthe Program w illcontinue atleastfl
zrough the 20l8 reporting period.
A LLEGA TIO NS
61. This case concernsfraud in obtaining hundreds ofm illions ofdollars in incentive
paym entsunderthe M eaningfulU se prograrn by CHS and M edhost.
Beginning in 2012,CH S replesented to the Governm entthatdozenscfits
hospitalsmettheobjectivesandmeasuresforMeaningfulUseofcertifiedEHR technology.
Basedonthoserepresentations,CHSreceivdld over$450million in M eaningfulUse incentive
paym entsbetween 2012 and 2015.
63. CH S'Sattestationsw erefalse. The EHR teclmologiesthatCH S im plem ented
contained seriousflaw sthatendangered patientsand m ade itshospitals ineligible forincentive
paym entsunderthe M eaningfulU seprograln. M edhost'sEHR,which dozens ofCHS hospitls
used,failed to pedbrm criticalfunctionssafzly and reliably. Som e ofthe defects in the software,
including an inability to calculate weight-based dosing accurately,exposed patientsto m istakes
thatwere easily m issed in institutionalsettingsand potentially catastrophic. The providerswho
relied on M edhostsoftware often view ed itasan im pedimentto care,ratherthan an
improvem ent.
Sim ilarproblem sexisted forthe CHS hospitalsthatused PULSE,a m odular
EH R. Thehospitalsfailed to integratethe differentPULSE EHR m odules,forcing yrovidersto
printclinicalinform ation when patientstransitioned from one care setting to another,asw ellas
w hen doctorsentered m edication orders. M any worktlowshave required nursesto enterthe
sam epatientinform ation into the EHR m ultiple tim es,w ith therisk ofpatientharm increasing
w ith each unnecessary step.
The Governm entw ould notllave m ade M eaningfulU se incentive paym entsto
CH S,orany otherprovidersthatused M edhost'ssoftware,had itknown ofthe serioustlaws in
itsEHR system s.
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A. Backaround
1. Background on M edihost's Sof- are and Certifications
66. M edhostisa healthcaretechllology com pany. Founded in 1984,M edhost
originally lim ited itsbusinessto developing softw are foruse in em ergency departm entsw ith a
includingwithcomputerizedphysicianorderentry(((CPOE'')andclinicaldecisionsupport
(ûûCDS'')functions.A systemicproblem wasthatthemodulesdidnotcommunicateinformation
w ellw ithin the EHR,m aking itdifficultforusersto perform tasksthatrelied on m ultiple
m odules. Forpatientsin an inpatientsetting,risksarose ateach step through the inpatient
experience including forordering ofm edications and laboratory studies.
68. In addition to poorintegration,the M edhostsystem isshoddily designed and lacks
required functionalities. Forexam ple,fora physician using the CPOE function to place an order
fora drug,there isno standard orcomprehensive drug database triggered. lnstead,M edhost
triggersonly the hospitalformulary drugsand doesnotrecognize non-form ulary drugs. lfa
providerentersa drug into theEHR thatthe hospitaldoesnotliston itsform ulary,the softw are
w illnotrecognize it. W hen thathappens,theEHR w illtreatthe drug asunstnzctured çéfree text''
thatexistsw ithin the system butw illnotengage the EHR'Sfunctionality. D ue to this lim itation
and others,m any ofthe providerswho use M edhost'sEHR regard itassubstandard.
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74. lnconjunctionwiththecalls,CHSissuedregularadvisorymemorandatothe
hospitals. M any ofthe advisories cam e frorn CH S Vice Presidentand ChiefM edical
Inform ation OfficerA nw arH ussein asw ellasCH S Vice Presidentand ChiefN ursing Officer
Pam Rudisill.Theadvisoriesweredirectedtothemedicalshffandseniorexecutives(e.g.,
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ChiefExecutive OfficersandChiefNursingOfficers)atthehospitals.Theadvisorieswarned of
serious,unresolved problem sw ith the M edhostEH R softw are and instructed CH S hospitalsto
im plem entadditionalsafety checksbecause ofthem . Forexam ple,M s.Rudisillsentadvisories
to the hospitalstitled çûDouble Checking M ulti-D ose m edication adm inistration,''çr auble
Checking ofM edicationswith M ultipleTabletsDispensed,''andCVIM PORTANT ACTION
REQUIRED:M edhost/l-lM s OrderSets.''
75. In theircapacity asM anagersworking on CH S team sto rolloutand support
health IT softw are,Relatorsw erenotified by physicians and otherhospitalpersonnelofthe
functionaland safety issueswith the CPOE software,including,asdescribed furtherbelow ,
errorsin m edication selection and dose calculation,failureto triggerdelivery ofm edication at
the correcttim e,inability to reliably perform drug-drug,drug-allergy,and duplicate therapy
checks,and an inability to lock patientchartsw hile open. Relatorsbelieve thatthis '
listofissues
represents only a sam ple ofthe CpoE-related tlaw sthatexistand existed in CHS'SM edhost
EH R softw are.Taken together,these tlaw srevealan EH R thatisnotableto perform asrequired
by federallaw and isdangerously broken.
76. The Governm entcreated the EH R incentive program to facilitatethe use of
softwareto enhancepublic health and achieve superiorhealth outcom es,and itchosethe specific
criteria required undertheprogram to advancethatgoal.The ability ofEHR software to m eetthe
basic criteria forCPOE and CD s- and to do so safely- are m aterialto the govem m ent's
decision to pay aw ardsunderthe EHR incentiveprogram s.
B. M edhost's Com puterized Phvsician O rder Entrv ($$CPO E'3 Softw are Failed
to M eetthe R equirem entsfor Certified EH R Technoloa
To be certified asa Com plete EHR under2014 Edition certification criteria,an
EHR mustbeabletoperform computerizedproviderorderentry(EçCPOE'')inaccordancewith
CM S standardsand im plem entation specifications.A m ong otherthings,the EHR m ustenable
usersto electronically record,store,retrieve,and m odify m edication orders,laboratory orders,
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and radiology/im aging orders. The EHR m lxstbe able to perform these functionsaccurately,
reliably,and safely.
78. The M edhostsoftware installed atCHS'Shospit lsw asincapable ofperform ing
CPOE in a safe and reliable m annerand thusdid notm eetthe requirem entsforcertilsed EHR
technology. The defectsincluded flaw sthatexisted w ithin M edhost'ssoftw are,thusaffecting al1
healthcare providersthatused the softw are,aswellasflaw sthatCH S introduced in configuring
and deploying the software atitshospitals. M any ofthe defectsremain unaddressed,asM edhost
haslaid offstafffrom itsdevelopmentteam sand repeatedly delayed therelease ofcriticalfixes.
M edhostEH R Flaw sRelating to M edication O rder Entry
a. Flaws in the Java Cllnical W cw M edication Fa/ry Portal
79. M edhost'sEHR software suite,implem ented atCH S,ism ade up ofmany
separate applications,w hich are supposed to work togetherasa single integrated system .Several
ofthe M edhostapplicationscan be used by providersto place m edication orders,including the
Java-basedClinicalView portal(tûClinView''),theweb-basedddphysDoc''module,theClinical
Reconciliationmodule($dClinRec''),andthePharmacymoduleC:GUI'').Duringthetimeperiod
relevantto thisCom plaint,physiciansand nurses atthe CH S M edhosthospitalsprim arily used
PhysD oc and Clinv iew to enterm edication ordersinto the M edhostsystem .
80. Clinv iew 'sm edication ordering functionality containsnum erousdangerous
flaw s,which can cause and have caused m edication ordersto be incorrectly entered and recorded
in the system ,rendering itunsafe forCH S patientsand non-com pliantw ith the M eaningfulUse
CPOE criterion. These tlaws include,butare notlim ited to,the follow ing:
W eight-Based Dosing Feature CalculatesIncorrectDri
p-
Ju /c-/brM edications
Undercertain circum stances,the Clinv iew m odule failsto calculatethecorrect
dose forweight-based m edications.The issue occursw hen the softw are calculates a dosage for
w eight-based m edicationsrequiring a çtdrip-rate''- the m easurem entofrate atwhich m edications
aretobeadministeredthroughanintravenous(1V)drip.
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82. Forexam ple,CH S found errorsin how Clinv iew calculated thedrip rate on an
orderforSodium Chloride0.9% Bag 1000 nllSolution,foranindividualweighing 158lbs.The
correctdrip-rate fora l58 lb.individualis5.991m lperhour.How ever,the Clinview m odule
instead created an orderforthe m edication with a drip-rate of4l.666 m lperhour,nearly seven
medication.
85. On M ay 5,2014,follow ing a training associated w ith therolloutoftheM edhost
software updates,the D irectorofPharm acy atCH S'SDeTarHealthcare System alerted CH S'S
softwaredeploym entteam to theproblem :$tltried outthew eightbased dosing and gotsom e
scary results.Please see the screen shotsIhave attached.ltisnotalwayspulling the rightdrug
forthedosing,ifgsicjfactitiswrongmorethatgsicjitisright.lsthisaknownissue?''
86. TheD irectorofPharm acy illustrated two separate instancesofthe issue through
screenshotsattached to herem ail.One screenshotshow ed am edication orderentry fbrthe drug
Clindam ycin Phosphate.The otherscreenshotshow ed an entry forthe drug Cefazolin Sodium .
H owever,both screenshotsrevealed thatthe weight-based dosage feature had pulled the wrong
m edication,Gentam icin Sulfate,forthe calculation.
''Send DoseNow ''Checkbox CreatedM edication Orders
ScheduledforDelayedDelively
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dosesbasedonthepatient'sweight,bodystlrfacearea(((BSA'')orcreatinine($$CrC1'')levels.
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responsibility'becausegM edhostsoftware)cannotbemadefoolproof.''TotheRelators'
knowledge,M edhosthad notcorrected theproblem asoflate 20l6.
Physician Favorites Feature Can Cause Hospital
Pharm aciesto FillM edication OrdersIncorrectly
96. The M edhostEHR doesnotreliably create m edication orders entered using a
feature called dsphysician Favorites,''w hich allow s doctorsto create a listofthe m edication
configurationsthey com m only orderfrom thehospitalform ulary. Thepurpose ofthe lististo
allow the doctorto quickly selectand orderthe configurationsthey tend to use in practice. The
feature containsa tlaw ,however,thatin certain circum stancescan cause the hospitalpharm acy
tofi11theorderincorrectly.
97. W hen a doctorsetsa Physician Favorite,the EHR displaysa description ofthe
medication(type,dose,route,etc.)inthedoctor'sPhysicianFavoriteslistandassignsita
ism nem onic''textstring thatcorrespondsto thetextstring used forthem edication in the
hospital'sform ulary. The EHR usesthe textstring to record and place ordersforthe Physician
Favorite.W hen adoctorentersan order,the EHR comparesthe mnem onic string to the listof
stringsin theform ulary database,and placesan orderforthe resulting m atch.
98. M edhostdoesnotconnectthe inform ation displayed to theprovideri1zthe
Physician Favorite listw ith hospitalfonnularies. Hospitalscan,and do,changethe
configuration ofdrugs in the form ulary withoutchanging the m nem oniccode thatidantifiesthe
drugs on the form ulary. ln such instances,the EHR w illdisplay the originalconfiguration to the
doctorOn the Physician Favorite list. W hen the doctorordersthe m edication,however,the EHR
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w illm atch thetextstring to thetextstring in the formulary forthe new configuration. The EHR
w illtriggeran orderforthe new configuration,notthe configuration thatthe doctor intended to
order. TheEH R doesnotalertthe doctorto the change in the form ulaly orrem ove the
hospital'sformulal'
y(e.g.,50mgofdrugX,
,when 100mgisthesmallestdoseavailablefrom the
Pyxismachinel- thePyxismachinewillt5lltheorderforthefulldoseunlessapharmacist
noticesthe conflictand intervenes.
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and safely.
106. Safe CPOE also requiressim ilarelectronic capabilitiesregarding checksfor
duplicationofmedication therapy (i.e.thatthepatienthasnotalready been prescribedthe same
medication)and thatmedication ordersfallwithin safedoseranges.
M edhost'sEHR doesnotreliably perform the drug interaction checksrequired for
certified EH R technology.
a. M edhostEHR 'sDruqInteraction ChecksFailtofrtz/z,
Wlez'
GFree-Text''aWedicatlon andAllergy E ntries
108. CHS M edhosthospitalsuse a codification schem e fortheirform ulariesthatis
basedontheM edi-spanElectronicDrugFile($$Medi-Span'').Eachmedicationavailableina
hospital'spharm acy willbe listed in the hospital'sform ulary database and identified by a unique
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issue.
d. M edhost'sF.ê;r# FailstoR un Drug Interaction Checks on
M edications t'
/rJereflatD ischarge
122. ProvidersatCH S hospitalsperform a clinicalreconciliation atdischarge
(tddischargereconciliation''),inwhichtheprovidercancontinueordiscontinuemedicationsthat
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the patientreceived during the inpatientstay and can reso rtany hom e m edicationsthathad been
discontinued upon adm ission.
123. M edhost'sEHR software is ilzcapable ofperform ing drug interaction checkswhen
a providercontinues ordiscontinuesa m edication during discharge reconciliation. M edhostonly
screensfordrug-drug ordrug-allergy contrar
indicationsatthe tim e aprovidercreates a
m edication order,notwhen theprovidercontinuesordiscontinuesa m edication during discharge
reconciliation. Consequently,ifa providercontinuesam edication atdischarge,the EHR w ill
notindicate drug-drug ordrug-allergy contraindicationsto theprovider,contrary to CM S
requirem ents. Instead,the EH R sim ply instl-uctstheproviderto selectSscontinue''or
ttdiscontinue''foreach m edication orderin the dischargereconciliation form ,w ithoutidentifying
any contraindications. CHS and M edhostconfigured the discharge reconciliation folm notto
display contraindicationsbecauseproviders com m only orderpatientsto continue horne
m edicationsatdischarge and M edhost'sEH R frequently storesthose m edicationsasfreetext.
Because the EHR cannotscreen such drugsforcontraindications,the RelatorsbelievethatCH S
and M edhostdisabled screening altogetherfordischargereconciliationsso thatproviderswould
notm istakenly rely on the EHR forthatfunction.
C. CH S Contributed to the CPO E lssues bv R olline O utO rder Sets 'rhat
Connicted w ith H ospitalForm ularies.Causinz AdditionalM edication O rder
Errors
124. CH S com pounded theproblem sw ith M edhost's software by taking dangerous
shortcutswhen deploying the system . One ofthe m ostseriousshortcutsinvolved C1.1S'S
deploym entofelectronic ordersets.
125. A n ordersetisa curated selection ofrelated m edication and otherorders-
designed forapplication in a specific scenario- thata doctorcan selectquickly and easily using
CPOE.W hen used correctly,ordersetscan reduce m edicalerrors,standardizehospital
procedures,and increase efficiency.CH S and M edhostintended to use ordersetsastheprim ary
m ethod formedication ordering in the M edhostEHR.
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fonuularies,andCHSdidnotdesignatephaj-macistsorotherswithsubject-matterexpertiseto
overseethem apping process.A sa result,ordersetswere rolled outto the hospitalsw ith a large
volum e ofdangerouserrors in the m apping ofindividualorders.
128. CH S and M edhostlearned ofthe issuesalm ostim m ediately,asm em bersofthe
CHS im plem entation team and practitionersatindividualhospitalsbegan to tlag concerns. For
exam ple,on M arch 10,2014,CH S M anagerofPharm acy Inform aticsCliffK olb wrote to others
ontheCHSimplementationteam inanemailwithsubjectline:(dseriousconcernsonOrdersets
and m odelbuild.'' The em aildeo iled concernsfrom a review thatM r.Kolb had conducted of
the build atthe firstsix sitesscheduled to go livew ith the new ordersets:
W ithin a few m inutes,w e found som e glaring issues.Zofran 4 m g w as mapped to
the 40m gvialnotthe4m g vialw hich could causea 10fold overdose.W hen looking
atthe Hydrom orphone and M orphine,they were m apped to regularform when the
m apping should have been presetwative free.W ith this briefreview ,itbroughtup
red tlagsasto whatelse is outtherethatwe did nothavetim eto f5nd....
W e are seeing thisattheother5 facilitiesaswell...
W e have been asking who is com pleting the quality review .W e w ere told today
thatthe setsare being review ed by analystnotpharmacists.W ehave concernsthat
thisshouldonlybedonebyclinicalstff...However,gtheydo)notcurrentlyhave
accessto the ordersets so they can review ....
In the above exam ple, the Zofran w ould never be in the Pyxis m achines as
(describedl....(T)henursewouldnotbeabletogetitandthepharmacistwillhave
to editit.Thisw ould notm eetM U standards.
W eneedsomeonetogoinandcleanupthegmodelordersetlbeforemoresetsare
pushed to any sites....Based on com mentsfrom M edhostfolks,thisisa oneto two
week processto clean up.1am notsurew ehavetim ebutitisapatientsafety issue.
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thosehospitals.CHSdidnotassignpharmacistsorsubject-matterexpertstocorrectthe
problem s ithad identified atthe hospitalsthathad already received the ordersets. Instead,CH S
instructed non-clinicalstaff,including RelatorN eim an,to resolve the safety issuesw hile
prioritizing strategiesto m eetthe targetdatesforim plem entation to ensure thatCH S w ould
receive M eaningfulU se incentive paym ents.
The inaccuratem apping betw een ordersetsand hospitalform ulariesprevented
physiciansfrom creating orderssafely,accurately,and reliably using the EH R. Because there
wasno assurancethatthe medication infornlation in the ordersetswould m atch thelnedication
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inform ation thatpharm acistsused to fillm edication orders,CH S'Shospitals did notm eetthe
objectiveofusingCPOE formedicationorders.
D. M edhost'sEHR CannotRel,iabl
v Perform ClinicalDecision Suppft
133. ClinicalDecision Support((dC!DS'')isaprocessdesignedtoaiddirectlyinclinical
decision m aking,in which characteristics of individualpatientsare used to generate patient-
specific interventions,assessm ents,recom m endations,orotherform s ofguidance thatare then
presented to a decision-m aking recipientortecipientsthatcan include clinicians,patients,and
45CFR j170.314(a)(8)(i),(iii).Suchinterventionsiçmustautomaticallyandelectronically
occurwhenauserisinteractingwithEHR technology.''j170.3l4(a)(8)(iv).ONC hasissued
guidance providing thatçEthebestm ethod oftracking CD S interventionsisto capturew hen they
areenabled''andthat(ditshouldbeapparent(from thesoftwarelwhentheseusersgspecifiedin
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nothinghappened....CheckedgtheCDSinterventionsjforstroke,diabetes,ischemicstrokeand
AM l.''
CH S discussed the problem w ith M edhostduring a weekly/biw eekly issue callon
Septem ber30,2014. M edhostacknow ledged the issue on the calland inform ed CH S that
M edhostw ould have to re-build the CD S code to resolve the problem . M edhostfurther
explained thatthe CD S interventionswould notfire untilthe re-build w ascom plete.
M edhostttre-built''theCD S functionality in itsEHR softw are in early October,
and CH S again planned to rely on thefunctionality forits second w ave ofattestation,w hich
began itsreporting period October 1.
149. By late October,CH S m anagem entlearned thatM edhost'sCD S functionality w as
stillfailing. On October28,2014,a CH S RegionalClinicallnform aticist,who had previously
reported CD S issuesathospitalsduring the firstw ave,em ailed the implementation team
regarding furtherfailures:
lhaveanotherone.lwasatgthehospitalin)Selmertodayandwetookalookat
the CDS rulesto m ake surethey were running. 1am seeing a sim ilarscenario as1
saw at(the hospitalin)Lexington a few weeksago. ltappears,accordingto the
A cknowledgem ent reportthat the triggers stopped firing on the 15th. H ow ever,
according to the statusreportthe ruleshavenotbeen active for0 of28 days....
W e could really use som e help in identifying ifthe ruleshave indeed stopped and
ifso why thiskeepsoccurring.
On N ovem ber20,2014,in a1)em ailrespondingto an issueticketsublnitted by a
CH S hospital,M edhostconfirmed thatthe ('
-D S reporting problem wasaknown issuew ith the
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software,andthatitaffectedfacilitiesbeyorldjustCHS.Medhostalsoindicatedthatithadno
estim ate forwhen itcould provide a fix:
g'l-jheissueyou arehavingwith established ClinicalDecision Supportrulesnot
show ing on the ODS A cknow ledgem ent Report is a known issue. This has
happened on severalotherfacilitiesin oursystem ....
Thereisaproyram fixthatisbeingdevelopedandtestedtoresolvethisissue,P1F
l711.Atthistlm e,w e do nothave a:
n ETA on the com pletion and implem entation
of this PIF, but we do believe tllat it w ill be soon. W e apologize for any
inconveniencethishascaused foryoa asyou arew orking through yourAttestation.
A soflate Decem ber2014,Nledhosthad two softwareenhancem entrequests
(PlRs)opentoaddresstheissue,howeveritdidnotimplementafsxforthesoftwareuntilit
released V ersion 2014 1k2 Sll.
3 ofthe EHR in M arch 20l5.Even aftertherelease,aslate asM ay
2015,CH S facilitieswere stillreporting thatthe CD S auditreportswere notw orking reliably.
CH S did notbegin to im plem entV ersion 2(I14 112 Sr untilJune2015.
2. CHS Did NotM eetM eaningfulUseObjectivesforCDS
CHSdidnotmeetMeaningfulUseobjectivesin Stage1orStage2.lnStage1,
CH S did notimplem entM edhost'srulesengine and falsely attested to M eaningfulUse
com pliance on the basisofa softw arefeature thatresem bled,butw asnot,aCD S intzrvention.
ln Stage2,CH S attested to M eaningfulU se com pliance despite the factthatM edhost'srules
engine had nottriggered CD S interventionsduring the reporting period. To concealitsfailureto
meetacoreobjectiveoftheprogram,CHStookthepositioninitsattestationsthattheordersets
ithad builtinto theEH R m etthe requirementsforCD S,when itknew they did not.
a. CHS'S UseoftheFallRiskAssessmentFailedtoM eda/theCDS
Objective in Stage1
153. ln M edhost'sEH R,the CDS rulesengine isdesigned foruse w ith the CPOE
application.BecauseCHSdidnotimplementCPOE inStagel(itwasnotyetacoreobjective),
itdid notprogram a single CD S intervention using M edhost'srulesengine. D espitenotusing
theCDSfunctionalityinMedhost'sEHR,C'
,HSattestedtomeetingtheobjectivesandmeasures
forCD S on the basisofa Eçworkaround.'' C HS'Sw orkaround wasto cite an unrelated function of
theEH R- aprotocolthatnursesused to perfonn fallrisk assessm ents- asthough itwere CDS.
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157. Thisfallriskççintel-vention''wasinsufficienttomeetthecoreobjectiNeforCDSin
Stage 1and did nothing to im provethe quality,safety,orefficiency ofpatientcare. CH S did not
use dem ographic inform ation,problem lists,m edication lists,viu lsigns,orlaboratory resultsto
determ ine which patientsneeded a fallrisk assessm entupon adm ission,nordid itusethat
infonnation to triggerthe tEintervention''in the assessmentworkflow . Instead,nursesrem ained
responsible foridentifying the need fora fallrisk assessmentwhen a patientwasadm itted to the
hospital,aswellasforidentifying any issuesin thepatient'smedicalrecord. Because CH S'S
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w orkaround did notconstitute a CD S rule underthe M eaningfulU se program ,CHS did m eetthe
coreobjectiveandmeasureforCDS in Stage1anditsattestationsofMeaningfulUsewerefalse.
158. CHSknew thatthefallriskassessmentworkarounddidnotmeettheobjective
and m easure for CD S. A sone CH S em ployee explained:
Forstage1wedidnothaveanyactualCDSrulesbuiltgintheMedhostrulesengine)
because CPOE w asnotactive. So,w hatwe did was,w e used the N ursing Fallrisk
assessm entw ithin Ptcare. W hen a lzurse com pleted the fallrisk assessm entthen
the assessm entw ould prom ptthe nurse to create arisk specific care plan based on
the fallrisk score.
l59. ln addition to the assessm entsnotconstituting ççactualCD S rules''within the
EHR,CH S knew thatitlacked the abilit'
y to track providers'com pliance w ith theûûintelwention''
in the assessm ents. On April8,2014,Lisa Fitts,CHS'SClinicalIS Team Lead- physicalTools,
em ailed severalCH S em ployees abouttheireffortsto m ap the workaround to a CD S auditreport,
which w ould enable CH S to determ ine ifthe (dintervention''wasoperative. In herem ail,M s.
Fittswrote:içltdoesnotsoundlikethecareplan wouldbecaptured on aCDS auditreport.lsay
thisbecause1don'tknow thatacareplancanbedesignatedasaCDSrulerintherulesenginej.''
b..CHS'SUseofstaticOrderSetsFailedtoM eettheC'.
DS Objective
fa Stage 2
CHS developed tsve CD S interventionsusing M edhost'srules engine in advance
ofthe Stage2 reporting period. O n July 1,2014,atthe startofthe reporting period fbrCHS'S
firstw aveofhospitals,the required five interventionshad been program m ed into the system .
Asdiscussed above,the CD S rulesenginefailed atCH S'SM edhosthospitals
beginning in A ugust2014. M any ofthe hospitalsthatno longergenerated CDS inteE
rventions
w erein the m iddle ofthe Stage 2 attestation period.
162. W ithin itscop orateoffices,CH S acknow ledged thatitcould notattestto m eeting
thecoreobjectiveduringtheattesotionperiodbecauseitsrulesenginehadbeenbrokenfor
m uch ofit. ln a Septem ber24,2014 em ailto CH S m anagem ent,CH S Directoroflnform ation
System sTeriM itchellw rotethatSswe can'tattest''ifthe CDS ruleswere notfiring.
163. CH S,however,wasunw illing to forego incentivepaym entsforthehospitals,and
decidedtoattesttomeetingtheCDSobjecttveeventhoughthehospitalshadnotusedCDSfor
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m uch ofthe attestation period. A sin Stxage J,CH S turned to atiw orkaround''to supportits
attestations. In thisinstance,CH S subm itted attestationson thebasis ofordersets. CH S
selected five ordersetsthatrelated to fourol'm ore clinicalquality m easuresand treated them as
CD S interventionsforpurposesofitsattestations.
164. CH S'Sordersetsdid notm eetthe requirem entsfora CD S intervention. Unlike a
CDS intervention,thecontentoftheordersetswasstaticanddid notchange(ortriggeralerts)
based on the patient'sproblem list,medication list,dem ographics,vitalsigns,or1ab results. The
EHR also did notsuggestparticularordersetsto providersbased on patientinform ation.
lnstead,providershad to choose the ordersetsm anually from a widerlistofavailable ordersets
inthesystem.Consequently,theordersetsdidnotmeettheobjectivesormeasuresforCDS.
l65. On October3,2014,Relatorw asdirected by CH S SeniorM anagerofIT lnternal
Auditand Com pliance KristiM eyerto ensure thatthe ordersetsw ere installed atthe hospitalsin
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topurportedlysatisfytheStage2CDSobjective.
l7l. W hile CH S subm itted attestationsbased on the ordersets,itfailed to inform the
providers atitshospiulsthatthe EHR could notgenerate CD S interventionsand thatCH S had
substituted the broken CD S functionality w ith ordersets. Even though the issue w asknown
w ithin CH S'Sheadquarters,CH S neverreleased an advisol'y to alertphysiciansthatthey could
notrely on the CD S nllesto providepotentially criticalintervention information. Thus,CH S did
notalertprovidersto a known defectin theEH R,even asitwasdeveloping aw orkaround in
orderforthe hospitalsto subm itM eaningfulU se attestations.
M edhostIlleeallv Provided Free Softwareto Induce CH S to Purchase
M edhost's EH R Software
172. CHS'SuseofM edhost'ssoftw arew aspartly the resultofillegalkickbacks.N o
laterthan 2013,M edhostbegan to provide CH S with free financialsoftw are forthepurpose of
inducing CH S to purchase fulllicensesofitsEHR software suite. The financialsoftware,know n
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I .
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tothedefects.InJune2015,forexample,RelatorLewisjoinedtwooftheleadersofCHS'S
deploymentteam ,M r.Yzennan and M r.Htlrnandez,on avisitto M idw estRegionalM edical
Center,an HM A hospitallocated in M idw estCity,Oklahom a. CH S had received num erous
com plaintsfrom thehospitalaboutPULSE'Scum bersom ew orkflow s,unsafe functionality,and
unstable infrastructure,w ith physiciansthreatening to no longerreferpatientsto M idw est
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/ p
U.S.C.j3729,etseq.,asamended.
By virtue ofthe actsdescribed above,Defendantsknow ingly presented orcaused
to bepresented,false orfraudulentclaim sto the U nited States Governm entforpaymentor
approval.
205. By virtue ofthe actsdescribed above,Defendantsknowingly m ade orused,or
caused to be m ade orused,falseorfraudulentrecordsorstatem entsm aterialto false or
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claim s.
The Government,unaware of.thefalsity ofthe records,statem entsand claim s
m ade orcaused to bem ade by D efendants,paid and continuesto pay the claim sthatw ould not
bepaid butforDefendants'illegalconduct.
By reason ofD efendants'acts,theU nited Stateshasbeen damaged,and continues
to be dam aged,in a substantialamountto be determ ined attrial.
Additionally,the United Statesisentitled to the m axim um penalty foreach and
every violation arising from D efendants'unlawfulconductalleged herein.
PR AY ER
W HEREFORE,quitam Plaintiff-RelatorsDerek Lew is and Joey N eim an pray for
judgmentagainsttheDefendantsasfollows:
ThatDefendantsceaseanddesistfrom violating31U.S.C.j3729 c/,
%eq.;
ThatthisCourtenterjudgmentagainstDefendantsinanamountequaltothree
tim esthe am ountofdam agesthe United Stateshas sustained because ofD efendants'actions,
plusacivilpenaltyforeachviolationof31U.S.C.j3729;
ThatRelatorsbeawardedthemaximum amountallowedpursuantto j3730(d)of
the False Claim sA ct;
ThatRelatorsbe aw arded a11costsofthisaction,including attorneys'feesand
expenses;and
ThatRelatorsrecoversuchotherreliefastheCourtdeemsjustandproper.
DEM AND FOR JURY TR IAL
Pursuantto Rule 38 oftheFederalRules ofCivilProcedure,Relatorhereby dem ands a
trialbyjury.
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Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 57 of 57
(00077663)1J