You are on page 1of 57

Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 1 of 57

'
# 7rc == a= . .t .= rr .'.
,
!;-*qj .-..
,
' . o .
*l*$h.hk%
1 't
-*%'r
e..x...=x.w
,'
w
m.*
.' '
&! - -b
';'.Y$e

' z'y t J1
.Nr. %,
'
()
.n
jK.
1
tn
..
4l
Q ' ;t
.'zq
U NITED STATES DISTR ICT CO U RT t
< ..1t :.r:
.L.' : ,t'
... A
. ''
N..'' o!-e'
&.Q.
K'' '
FO R TH E SOU TH ER.
N DISTRICT O F FLO R IDA C. .,
...,, .. . !
M IM II DIVISIO N *
ii . , .
' . . I
..
...

UN ITED STATES OF A M ERICA ex rel. Case3..8 -20394


(UNDER SEAL),
COMPLMNTFORVIOLATIo x f lV-8cou
Plaintiffs, THE FALSE CLM M S ACT 131U.S.C.
jj3729etJN .1
FILED UNDER SEAL PURSUM TTO/19
(UNDER SEAL), 31U.S.C.j3730(b)(2)
Defendants. JUR Y TRIA L D EM A NDED

D O CUM ENT TO BE K EPT UN DER SEAL


D O N OT ENTER O N PA CER

JeffreyW .Dickstein(FL BarNo.434892)


PHILLIPS & COHEN LLP
SoutheastFinancialCenter
200 S.BiscayneBlvd.,Suite2790
M iam i,Florida33131
Tel:(305)372-5200
jdickstein@phillipsandcohen.com
ColetteG.M atzzie
LukeJ.Diamond
PHILLIPS & COHEN LLP
2000 M assachusettsAve.,NW
W mshington,DC 20036
Tel:(202)833-4567
Fax:(202)833-1815
EdwardH.Arens
PHILLIPS & COHEN LLP
100 TheEmbarcadero,Suite300
San Francisco,CA 94105
Tel:(415)836-9000
Fax:(415)836-9001
Attorneysfor(UNDER SEAL)

(00077663)1)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 2 of 57

UNITED STATES DISTRICT C OU RT


FO R TH E SO UTHER N DISTR IC T O F FLOR IDA
M IAM ID IV ISIO N

UN ITED STA TES OF A M ERICA ex rel. Case No.


1 8 -20 3 9 4
DEREK LEW IS and JOEY N EIM AN ,
COMPLMNTFORWOLATIONW #-$c0O
Plaintiffs, THE FALSE CLM M SACT I31U.S.C.jj
3729etseq.j
FILED U NDER SEAL PUR SUAN T TO
COMMU NITYHEALTH SYSTEMVINC.; 31U.S.C.j3730(b)(2)
CH SPSC,LLC;ALLIA N CE HEA LTH
PARTNER S,LLC D /B/A M ERIT HEALTH JURY TRIAL DEM A NDED
BA TESVILLE;A M ORY HM A LLC D/B/A
M ERIT HEA LTH GILM ORE M EM ORIA L;
AN NA H OSPITA L CORPORATION D/B/A
UN ION COUNTY H OSPITM ,;ARM C LP
D /B/A ABILEN E REGION AL M EDICAL
CENTER ;AU GU STA HO SPITAL LLC
D/B/A TRINITY H OSPITAL OF AU GUSTA ;
BAN NER HEALTH D/B/A BAN NER
PAYSON M EDICAL CEN TER;BA RTO W
HM A LLC D/B/A BA RTO W REGIONA L
M EDICAL CENTER;BERW ICK
HO SPITAL COM PAN Y LLC D /B/A
BERW ICK HO SPITA L CEN TER;BIG
BEND HO SPITAL CORPORATION D/B/A
B1G BEN D REGION AL M ED ICAL
CEN TER;B1G SPRIN G HO SPITAL
CORPOR ATION D/B/A SCEN IC
M OUN TA IN M EDICA L CENTER;BILOXI
HM A LLC D/B/A M ERIT HEALTH
BILOXI;BLACKW ELL HM A LLC DIBLX
A LLIAN CEHEALTH BLA CK W ELL;BLUE
RIDG E GEORGIA HO SPITAL COM PAN Y
LLC D/B/A FAN NIN REGION AL
HO SPITAL;BLUEFIELD HO SPITAL
COM PAN Y LLC D/B/A BLUEFIELD
REGIONA L M EDICA L CEN TER;
BRAN D ON HM A LLC D/B/A M ERIT
HEALTH RANK IN ;BRO W N W OOD
HO SPITA L LP D/B/A BROW NW OOD
REGIONA L M ED ICAL CENTER;
BU LLHEAD CITY HO SPITAL

(00077663;1) 2
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 3 of 57

CORPORATION D/B/A W ESTERN


A RIZON A REG ION AL M ED ICA L
CEN TER ;CARLISLE H M A ,LLC D/B/A
CARLISLE REGIONA L M EDICAL
CEN TER;CARLSBAD M EDICA L CENTER
LLC D /B/A CA RLSBA D M EDICAL
CENTER;CEDA R PA RK HEALTH
SYSTEM LP D/B/A CED AR PARK
REGIONA L M EDICAL CEN TER;CEN TILE
H OSPITAL CORPORATION D/B/A
CH EROK EE M EDICM CEN TER;
CH ESTER HM A LLC D/B/A CH ESTER
REGION AL M ED ICAL CEN TER;
CHESTERFIELD M A RLBORO LP D/B/A
CHESTERFIELD GEN ERAL HO SPITAL;
CITRUS HM A IN C D/B/A SEVEN RIVERS
REGION AL M EDICAL CEN TER;
CLARK SDALE H M A LLC D/B/A M ERIT
HEALTH N ORTHW EST M ISSISSIPPI;
CLIN TON HM A rLLC D/B/A
ALLIAN CEHEA LTH CLIN TON ;CLIN TON
H OSPITAL CORPORATION D /B/A LOCK
HAVEN HOSPITA L;CO LLEGE STATION
HO SPITA L LP D/B/A COLLEGE STA TION
M ED ICAL CEN TER;CRESTVIEW
HO SPITAL CORPORATION D/B/A N ORTH
OK ALOO SA M EDICAL CEN TER;
CRESTW OOD HEA LTH CA RE LP D/B/A
CRESTW OOD M ED ICAL CEN TER;
D EA CON ESS HEALTH SYSTEM LLC
D/B/A A LLIANCEHEALTH D EA CON ESS;
DEM ING H OSPITAL CORPO RATION
D/B/A M IM BRES M EM ORIA L HO SPITA L;
D URAN T HM A LLC D/B/A
ALLIAN CEH EALTH D URANT;
D YERSBURG HO SPITAL COM PAN Y LLC
D/B/A TEN N OVA H EA LTHCARE-
D YERSBURG REGION AL;EA ST
GEORGIA REGIONA L M EDICA L
CENTEV LLC;EMPORIA HOSPITM
CORPORATION D/B/A SOU TH ERN
VIRGINIA REGIONA L M EDICAL
CEN TER;EVAN STON H O SPITAL
CORPORATION D/B/A EVAN STON
REGIONA L H O SPITAL;FOLEY
H O SPITA L CORPORATION D/B/A SOtJTH

(00077663;1J 3
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 4 of 57

BALD W IN REG IONA L M ED ICAL


CEN TER;FORREST CITY A RK AN SA S
H OSPITAL COM PAN Y LLC D/B/A
FORREST CITY M ED ICAL CEN TER ;
FORT PA N'NE HO SPITAL CORPORA TION
D/B/A D EKALB REGION AL M ED ICAL
CEN TER;FRANKLIN H OSPITA L
CORPORATION D/B/A SOUTHA M PTON
M EM OIU AL HO SPITAL;GA FFN EY HM A
LLC;G ALESBURG HO SPITAL
CO RPOM TION D/B/A GALESBURG
COTTAG E H OSPITA L;GM NBURY
H OSPITAL CO RPORATION ;GR AN ITE
CITY ILLINOIS H OSPITA L COM PANY
LLC D/B/A GATEW AY REG IONA L
M EDICAL CEN TER;GREEN BRIER V M C
LLC D /B/A GREEN BRIER VALLEY
M ED ICAL CEN TER ;GREEN VILLE
HO SPITAL CORPORATION D/B/A LV
STA BLER M EM ORIA L HO SPITAL;
HA INES CITY HM A LLC D/B/A HEART
OF FLORIDA REGIONA L M ED ICA L
CEN TER ;HA M LET HM A LLC D/B/A
SAND HILLS REGION AL M EDICAL
CEN TER;HA RTSVILLE,LLC D/B/A
CAROLIN A PIN ES REGION AL M ED ICAL
CEN TER;HERN AN D O H M A LLC;HM A
FEN TRESS COUNTY GEN ERAL
H OSPITA L LLC;H 51A SAN TA ROSA
M ED ICAL CEN TER LLC;H O SPITAL O F
BARSTOW IN C D/B/A BAR STOW
COM M UN ITY H O SPITAL;H OSPITAL ()F
LOU ISA ,IN C.D/B/A THREE RIVERS
M ED ICAL CEN TER;HO SPITAL OF
M ORRISTO W N LLC D/B/A LA KEW AY
REG ION AL HO SPITAL;JA CK SON HM A
LLC ;JA CKSON HO SPITAL
CO RPORATION D/B/A K ENTU CK Y
RIV ER M ED ICAL CEN TER;JA CK SON
TEN N ESSEE H OSPITA L COM PAN Y LLC;
JOLJRDAN TON HO SPITAL
CORPOR ATION D/B/A SOUTH TEXA S
REGIONA L M EDICA L CEN TER;
K EN NETT HM A LLC;K EY W EST Hv /k
LLC;K IRK SVILLE M ISSOURIH OSPITAL
COM PAN Y,LLC;LAK E SH ORE HM A ,

(00077663)1) 4
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 5 of 57

LLC;LAKE W ALES H O SPITAL


CORPORATION ;LAN CA STER H M A LLC
D/B/A HEART OF LAN CA STER
REGIONAL M ED ICA L CENTER;LA S
CRU CES M EDICAL CENTER LLC;LEA
REGIONA L H OSPITA L LLC;LEBAN ON
HM A LLC;LEH IGH HM A LLC D/B/A
LEH IGH REGION AL M EDICAL CEN TER ;
LEX IN GTON H OSPITA L CORPOM TION
D/B/A HEND ER SON COUN TY
COM M UN ITY H O SPITA L;LON GVIEW
M EDICA L CEN TER LP D/B/A LON GVIEW
REGION AL M ED ICAL CENTER ;
M AD ISON H M A LLC;M ARION
H OSPITAL CORPORA TION D/B/A
H EA RTLAN D REGIONA L M EDICAL
CEN TER ;M A RSH ALL COUN TY HM A
LLC;MARTIN HOSPITALCOMPANY)LC
D/B/A TEN NOVA HEALTH CARE-
V OLUNTEER M ARTIN;M ARY BLACK
HEALTH SYSTEM LLC D /B/A M ARY
BLA CK HEALTH SY STEM
SPARTAN BURG;M AT-SU V ALLEY
M EDICAL CENTER LLC D /B/A M AT-SU
REGIONA L M EDICAL CEN TER;G YES
C O UN TY H M A ,LLC D JB/A
A LLIAN CEH EA LTH PRY OR;M CKEN ZIE
TEN NESSEE H OSPITA L COM PAN Y LLC
D/B/A M CK ENZIE REGION AL H OSPITAL;
M CKEN ZIE W ILLAM ETTE REGIONA L
M EDICA L CEN TER ASSO CIA TES LLC
D/B/A M CKENZIE-W ILLA M ETTE
M EDICA L CEN TER;M CSA LLC D/B/A
M EDICA L CEN TER OF SOU TH
A RKAN SA S;M ELBOURN E H M A ,LLC
D/B/A W UESTHOFF M ED ICAL CEN TER -
M ELBOU RNE;M ID W EST REGIONM
M ED ICAL CEN TER ,LLC D/B/A
M ID W EST REG ION AL M ED ICAL
CEN TER;M M C OF NEVADA LLC D/B/A
M ESA VIEW REGIONA L H OSPITA L;
M OBERLY H OSPITA L COM PAN Y LLC
D/B/A M OBERLY REGIONA L M ED ICA L
CEN TER;M ON ROE HM A ,LLC D/B/A
CLEA RV IEW REGIONA L M EDICAL
CEN TER;M OORESV ILLE H OSPITA L

(.00077663)1J 5
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 6 of 57

M AN A GEM EN T A SSO CIATES LLC D/B/A


LAK E N ORM AN REGIONA L M EDICAL
CEN TER;N APLES HM A LLC D/B/A
PHY SICIAN S REGION AL M ED ICAL
CEN TER;N ATCHEZ COM M UNITY
HO SPITAL LLC D/B/A N ATCHEZ
COM M UN ITY H OSPITAL;NA TIONM
HEA LTHCARE OF LEESV ILLE,IN C .
D/B/A BYRD REGIONAL HOSPITAL;
N ATIONA L HEALTH CARE OF M T
V ERN ON IN C D/B/A CROSSROA DS
COM M UN ITY H OSPITA L;NA VARRO
HO SPITAL LP D/B/A N AVA RRO
REGION A L H OSPITAL;N H CIOF
H ILLSBOR O IN C D/B/A HILL REGION AL
H O SPITAL;OAK H ILL HO SPITA L
CORPORATION D/B/A PLATEAU
M ED ICAL CEN TER;OSCEOLA SC LLC;
PA INTSVILLE H OSPITAL COM PAN Y ,
LLC D/B/A PAUL B HA LL REGION AL
M EDICA L CENTER ;PA SCO REGION AL
M ED ICA L CENTER ,LLC;PHILLIPS
H OSPITAL CORPORATION D/B/A
HELENA REGION AL M EDICAL CEN TER;
PIN EY W OOD S HEA LTHCARE SY STEM ,
L.P.D /B/A W OODLAND HEIGHTS
M EDICA L CENTER;POPLAR BLUFF
REGION AL M ED ICAL CEN TER LLC;
PO RT CHARLOTTE HM A LLC D/B/A
BA YFRON T H EM TH PORT
CHA RLOTTE;PRIM E HEALTH CA RE
SERVICES M ESQUITE LLC;PUNTA
GORDA HM A LLC;QHG OF ENTERPRISE
IN C D/B/A M ED ICAL CEN TER
ENTERPRISE;QHG OF SOUTH
CAROLm A IN C D/B/A CA ROLINA S
H OSPITA L SY STEM M ARION ;RED BtJD
ILLIN OIS H OSPITAL COM PA NY LLC
D/B/A RED BUD REGIONA L H OSPITA L;
RIVER OA KS H OSPITA L LLC D/B/A
M ERIT H EALTH RIV ER OAK S;
ROCKLEDGE H M A ,LLC D/B/A
W UESTHOFF M EDICA L CEN TER -
ROCKLED GE;R OH LLC;RO SE CITY
HM A LLC D/B/A LAN CA STER
REGION AL M ED ICAL CEN TER;RUSTON

(00077663;lJ 6
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 7 of 57

LOUISIAN A HO SPITAL COM PAN Y LLC


D/B/A N ORTHERN LOUISIAN A
M EDICAL CEN TER;SALEM H O SPITA L
CORPORATION D/B/A THE M EM ORIA I.
HO SPITAL OF SALEM COUN TY ;SAN
AN GELO H OSPITAL LP D/B/A SAN
AN GELO COM M UN ITY M EDICAL
CENTER;SAN M IGUEL HO SPITAL
CORPOR ATION D/B/A ALTA V ISTA
REGIONA L HO SPITAL;SEBA STIAN
HO SPITAL LLC D/B/A SEBA STIAN
RIVER M EDICAL CEN TER;SEBIU N G
H OSPITAL M AN AGEM EN T A SSOCIATES
LLC D /B/A HIGHLAN D S REGION AL
M ED ICAL CENTER;SEM IN OLE HM A ,
LLC D/B/A ALLIAN CEHEM TH
SEM W OLE;SHELBYV ILLE H OSPITAL
COM PAN Y LLC D/B/A TEN NOVA
H EA LTHCA RE-SH ELBYVILLE;SILOA M
SPIU NGS ARK AN SA S H O SPITAL
COM PAN Y LLC D/B/A SILOAM SPRIN GS
REGION AL HO SPITAL;STARKE HM A
LLCD/B/A SHANDSSTARKEREGIONV
M ED ICAL CEN TER;STATESV ILLE H M A
LLC D/B/A DAV IS REGION AL M ED ICAL
CENTER;SUN BURY H OSPITA L
COM PAN Y LLC D/B/A SUN BURY
COM M UNITY H OSPITAL;THE HEALTH
CARE AU TH ORITY OF Tl' lE CITY OF
AN NISTON D/B/A STR IN GFELLOW
M EM ORIAL H OSPITAL;TOOELE
H OSPITA L CORPOM TION D/B/A
M OUN TAIN W EST M ED ICA L CENTER ;
TULLAH OM A HM A LLC D/B/A
TENN OVA H EALTHCARE-HA RTON ;
TUN KHAN NO CK H OSPITAL COM PAN Y
LLC D/B/A TYLER M EM ORIM
H OSPITA L;VAN BUREN I'IM A LLC D/B/A
SPA RX S M EDICA L CEN TER-VAN
BUREN ;V EN ICE HM A LLC D/B/A
VEN ICE REGION AL BAYFRON T
HEALTH ;VICTORIA OF TEXA S LP D/B/A
DETAR HO SPITAL NA VARRO ;
W ATSON VILLE HO SPITAL
CORPORATION D/B/A W A TSON VILLIT
COM M UN ITY H OSPITAL;W EST GRO VE

(00077663)1) 7
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 8 of 57

H O SPITAL COM PAN Y LLC D/B/A


JEN NERSVILLE REGION AL H OSPITM ;
W HITE COUN TY M EDICA L CEN TER
D/B/A UNITY HEA LTH HA RR IS
M EDICA L CENTER;W ILLIA M SON
M EM ORIAL HO SPITAL LLC D/B/A
W ILLIAM SON M EM ORIAL HO SPITAL;
W ILLIAM STON H OSPITAL
CORPOM TION D/B/A M ARTIN
GENERAL H OSPITAL;W IND ER HM A
LLC D/B/A BARROW REGION AL
M EDICA L CEN TER;W OM EN &
CHILDREN S H OSPITAL LLC D/B/A LA KE
AREA M EDICA L CEN TER;W OOD W A RD
HEALTH SY STEM LLC D/B/A
A LLIAN CEHEALTH W O ODW ARD ;
YA KIM A HM A LLC D/B/A TOPPEN ISH
COM M UN ITY HO SPTIAL;Y AKIM A H M A
LLC D/B/A YAKIM A REGION AL
M EDICAL A ND CARDIA C CEN TER;and
M EDH OST,lN C.,

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'').

(00077663;1) 8
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 9 of 57

Thisaction allegesthatD efendantssubm itted orcaused to be subm itted hundreds


ofmillionsofdollarsinfalseclaimstotheDepartmentofHea1thandHumanServices($(HHS'')
forfederalincentivepaymentsthroughtheElectronicHealthRecord(($EHR'')Incentive
Program s.
Pursuantto theH ealth lnform ation Technology forEconom ic and ClinicalHealth
Act(HITECH Act),HHSestablishedtheMedicareandMedicaidEHR IncentiveProlj
rams(also
knownastheiçM eaningfulUseprogram'),whichprovidedincentivepaymentstohealthcare
providerswho dem onstrated (çm eaningfuluse''ofcertified EHR technology.
D efendantCH S isone ofthelargesthospitaloperatorsin the nation,w ith 127
hospitalfacilitieslocated in twenty states.The incentivepaym ents in the HITECH A ctw ere an
importantrevenuestream forCHS,which received$544 million in incentivepayments.W ith
large am ountsofm oney atstake,CHS m ade ita businesspriority forasm any ofitshospitlsas
possible to subm itattestationsforM eaningfulUse incentive paym ents. Through the use of
specialimplem entation team s,CH S aim ed to m axim ize the num berofitshospitalsreceiving

M eaningfulUse incentivepaym ents.


D efendantM edhostdeveloped the EHR technology thatCHS im plem ented at

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 .

(00077663)l)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 10 of 57

8. M edhost's software w ould nethave been eligible forcertification ifthe certifying


body had known thatM edhostcould notperl
rol'm m any ofthecriticalfunctionsitfalsely

represented itcould perform .


9. A sa resultofthe use ofM edllostsoftware,CH S and itshospitalspresanted,or
caused to be presented,false attestationsto the Govenmwntabouthospitalcompliance w ith

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
(00077663;l) 10
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 11 of 57

m orethan oneEHR m odule withoutresorting to paper. Basic w orkflows,such asadm itting a


patientfrom the em ergency departm entortransferring a patientfrom one inpatientdepartm entto
another,have required hospitalstaffto printoutthe patient'sm edicalrecordsfordelivery to the

new departm ent.


Theform erHM A hospitalsusingPULSE technology couldnotmeetthe
requirem entsfordem onstrating M eaningfull7se ofcertified EHR technology and should have

been ineligible forM U incentive paym ents.


CH S knowingly m isrepresented to the G overnm entthatthe CH S hospltalsusing
M edhostandPULSE metallrequiredMeaningfulUseobjectivesandmeasuresandwereeligible
forM eaningfulU se incentivepaym ents.
TheG overnm entw ould nothave m adeM eaningfulUse subsidy paym entsto the
CH S hospitalsthatused theM edhostorthe PU LSE software ifithasknown ofthe flaw sw ith
the software and problems with im plem entation ofthe softwarethatresulted in failureto perform

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.

(00077663;1)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 12 of 57

1I. PARTIES
A . Plaintiffs

20. PlaintiffUnited StatesofAm l


zrica istherealparty in interestherein. The United
States,acting through HH S,adm inistersthe M edicare program ,Title XV 111ofthe Social

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.

21. Quitam Plaintiff-RelatorDerekLewis(GGlkelatorLewis'')isaresidentof


M urfreesboro,Tennessee. RelatorLew isworked forD efendantCH S from January 2009to
Decem ber2016. Between Decem ber2012 and February 2015,RelatorLewisw asC HS'S
M anagerofD esign and M idrange Engineering,Technology. ln thatrole,hehelped to provide
infrastructure strategy and m anagem entto supportCHS'Supgrade of l30 facilitiestc'M edhost's
HM S 12.0 software. ln Februal'
y 2015,RelatorLew isbecam e CH S'SM anagerofProduct
Engineering,Deploym ent,where hew asresponsible forthe configuration m anagement,
autom ation,and userexperience componentsofCH S'SEHR productstrategy. In August2015,
he wasprom oted to DirectorofTechnology Adoption,Deploym ent,w here he wasresponsible

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.

(00077663)1)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 13 of 57

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.

(00077663)1)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 14 of 57

CH S is one ofM edhost'slargestcustom ers. M edhost'sothersignificantcustom er

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

((0077663)l) 14
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 15 of 57

LowerKeysM edicalCentersubm itted false attestationsto the Govem m entto claim incentive

paym entsforitsuseofPULSE and otherEH R m odules.


lV. STATUTORY AND REGULATOIW BACKGROUND
A. TheFalse Claim sAct
31. TheFCA imposescivilliabilityonanypersonwho,interJf/tz:(l)knowingly
presents,orcausesto be presented,to an officerorem ployee ofthe United StatesG overnm enta
falseorfraudulentclaim forpaymentorapproval'
,(2)knowinglymakes,usesorcausestobe
m ade orused a false record orstatem entto geta false orfraudulentclaim paid orapproved by

the Governm ent;(3)knowingly concealsorknowingly and improperlyavoidsordecreasesan


obligationtopayortransmitmoneyorpropertytotheGovernment;or(4)conspirestoviolate
theFCA.31U.S.C.jj3729(a)(l)(A),(B).(C),and(G).
32. The FCA definesaççclaim ''to include kkany requestordem and,whetherundera
contractorothelw ise,form oney orproperty and whetherornotthe United Stateshastitleto the
moneyorpropertythat-(i)ispresentedtoanofficer,employee,oragentoftheUnitedStates;or
(ii)ismadetoacontractor,grantee,orotherrecipient,ifthemoneyorpropertyistobespentor
used ontheGovem ment'sbehalforto advanceaGovernmentprogram orinterest....''fJ.at

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).

t00077663;1)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 16 of 57

B. The A nti-lfickback Statute


36. ThefederalAnti-Kickback Statute(6$AKS''),42U.S.C.j1320a-7b(b),provides,
in pertinentpart:
(2) W hoever knowingly and willfully offers or pays any remuneration
(including anykickback,bribe,orrebate)directly orindirectly,overtly orcovertly,
in cash orin kind to any person to induce such person -
(A) Toreferanindividualtoapersonforthefunzishingorarrangingfor
the furnishing of any item or service for which paym entm ay be m ade in
whole orin partundera Federalhealth careprogram ,or
(B) To purchase,lease,orderorarrangefororrecommendpurchasing,
leasing,or ordering any good,facility,service,oritem forw hich payment
m ay be m ade in whole orin partundera Federalhealth careprogram ,
Shallbe guilty ofa felony and upon conviction thereof,shallbetsned notm orethan
$25,000orimprisonedfornotmorethan fiveyears,orboth.
A ccordingly,m anufacturersofproductspaid forin w hole orin partby federal
healthcare program sm ay notofferorpay any rem uneration,in cash orin kind,directly or
indirectly,to induce physicians,m edicalpractices,orothersto orderorrecom m end products
paid forin whole orin partby Federalhealthcare program ssuch asM edicare and M edicaid.

38. ThePatientProtection and AffordableCareActCTPACA''),Publ.L No.1l1-48,


l24Stat.119(2010),providesthatviolationsoftheAKSarepprseviolationsoftheFCA:çça
claim thatincludes item sor selwicesresulting from a violation ofthis section constitutesa false

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

(00077663)1) 16
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 17 of 57

software m eetsthe certification requirem entsestablished by ON C. The certification bodies and


testing laboratoriestestand certify thatvendors'EHRSare com pliantw ith the certification

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

(00077663)1)
I

Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 18 of 57

! .

rulem akingsby publication in the FederalRegisteron July 28,2010. ln Stage 1,Eligible


HospitalsandCAHSneededtosatisfyfourteenEtcoreobjectives''andfiveoutoftenç'
m enuset
objectives.''AnEligibleProfessional'suseofcertifiedEHR technologygenerallyneededto
satisfyfifteenitcoreobjectives''andfiveoutoftenEçmenusetobjectives.''
46. On Septem ber4,2012,HH S published in the FederalRegisterthe finalrules
setting forth the :*2014 Edition''certification criteria and tistage 2''requirem entsforincentive

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 .
(00077663)1) 18
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 19 of 57

3. lncentivesAvailable Under the M eaningfulUseProgram


In general,H ospitalsand CA1Isare eligible forM edicare'sM eaningfulU se

incentivesiftheyarepaidusingtheM edicareInpatientProspectivePaymentSystem (k(1PPS''),


and are eligibleforM edicaid'sM eaningfultlseincentivesifthey have aM edicaid patient
volum e ofatleast 10 percent.H ospitalscan 13e dual-eligible and receive incentivesunderboth

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

gain eligibility after2016.


54. M eanwhile,EligibleH ospitalsthatfailto m eaningfully use Certified EHR
technologyaresubjecttonegativepaymentadjustmentsundertheM edicareprogram.Each
year,MedicareadjuststheIPPSforintlation.Hospitalsthatfailthecriteriaarepenalizedbya
reductioninthisincrease.ThepaymentadjustmentoccurstwoyearsaftertheEHR reporting
period,and w asa 25% reduction in 2015,a 50% reduction in 2016,and w illbe a 75% reduction

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

(00077663;1) 19
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 20 of 57

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

wasincorporatedintotheMerit-basedIncentivePaymentSystem (ççM lPS'')underthaQuality


PaymentProgram createdbytheM edicareAccessandCHIP ReauthorizationAct(ç11WAC1tA''),
42 U.S.C.j 1395ee.
D. Certified EHR Technoloev and theIOR Prozram
58. TheHospitallnpatientQualityReportingProgram (çç1QR'')isavoluntary
reporting program thatprovides afinancialincentive forhospiu lsto subm itdata to CM S on
specified quality m easuresforselwicesfurnished to M edicare beneficiaries. The Program 'sgoal
isto drivequality im provem entthrough measurem entand transparency by publicly (lisplaying
data thathelpsconsum ersm ake m ore inform ed decisionsabouthealth care.Itis also intended to
encourage hospitalsand cliniciansto im prove the quality and costofinpatientcare.

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

1QR datatoCM Selectronicallyintheform ofelectronicclinicalqualitymeasures((teCQM s'').


TosubmiteCQMS,CM SrequiredhospitalstouseCertifiedEHR technology.ln20L6,CM S
madethe submission ofeCQM SfortheIQR.Program mandatory,and requiredthathospitals

(00077663;1)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 21 of 57

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.

(00077663;1)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 22 of 57

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

program calledEmergencyDepartmentlnformationSystem (&$EDIS'').ln2010,theparentofa


Nashville-basedtechnologycompany,HeallhcareManagementSystems(iiHM S''),acquired
M edhostand incorporated theEDIS productinto aw idersuite ofhealthcaretechnology products.
Follow ing theM edhostacquisition,the productswere integrated into a single EHR system and
certified asa(tcom plete''EHR,w hich m eansan EH R thatm eetsal1m andatory certification
criteria forinpatientsettings.
67. The EHR system thatresulted did notfunction w ellasan integrated system ,
however,butwas,instead,a series ofm odules ofvarying quality. A seach m odule ofM edhost
w asdeveloped,M edhostfound thatthe system did notfunction welland wasunreliable,

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.

(00077663k1J 22
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 23 of 57

2. CH S'S lm plem entation oftheM edhostEH R


69. CH S w asoneofM edhost'slagestcustom ersand used itsEHR atdozensof
hospitalsin itsnetwork.B eginning in 2012,'
OHS im plem ented M edhost's2011Edition
softwareand attested to M eaningfulUse at78 hospitalsduring the Stage 1reporting period. ln
late 2013,CH S began to implem entM edhost's2014 Edition softw are atthe hospitalsthathad
used the 201lEdition forStage 1,while concurrently im plem enting 2011 Edition sopl
w are at
hospitalsthathad notattested to M eaningfulUse in Su ge 1. CH S'S goalw asto im plem ent
certified EH R technology atasm any ofitshospitalsaspossible ahead ofthe 2014 M eaningful

U se attestation reporting period.


70. TheseniorCHSexecutiveresponsiblefortheimplementationprojectwasCHS'S
SeniorVicePresidentand ChiefInform ation Officer,J.Gary Seay. Seay m anaged a largeteam
from CH S'Scorporate-levelclinicaloperationsand IT departm ents,including a deploym entteam
thatim plem ented M edhost'sEHR softw are atCH S hospitalsaswellasa clinicalapplications
team thatw asresponsible fortesting new software releases and w orking supportticketsfrom the
field. The clinicalapplicationsteam reported to CHS Deputy CIO M anish Shah and was1ed by
VicePresidentofClinicalApplicationsJay Sbinski,DirectorofClinicalApplication System s
Gal'y Fritz,and SeniorM anagerofPhysician ToolsTim M oore. Thedeploym entteam reported
to M r.Seay and w as1ed by V ice PresidentM ichaelYzerm an,SeniorD irector Steve Hernandez,
and Program M anagem entDirectorTeriM itchell.Together,the team swere responsible for
deploying EH RSatCHS hospitalsand forensuring thatthehospitalsw ereprepared 1.
o subm it

M eaningfulU se attestationsto the Governm ent.


ln the m onthsleading up to the 2014 M eaningfulUse attestation reporting period,
CH S rolled outupdated versionsofM edhostsoftware atnum erousCHS hospitals,which
included new CPO E functionality intended to satisfy the Stage 2 M eaningfulU se crïteria.
D uring therollout,CH S wasfocused prim arily on im plem entation ofthe softw are w ith the speed
necessary to ensure receiptoftensofm illionsofdollarsin Governm entaw ardsthrough the EHR
incentiveprogram s. CH S'Sfocuson speed cam e atthe expense ofpatientsafety. A sitbecam e

(00077663;1) 23
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 24 of 57

apparentto CH S thatthe M edhostEHR software w asincapable ofsafely perform ing CPOE,


CH S did nothalttherollout,and instead choseto m ove forward so asnotrisk receiptofthe
M eaningfulU se incentive paym ents.
72. Soon afterthe M edhostrolloutbegan,doctors and hospitaladm inistratorsbegan
to reportthattheupdated M edhostsoftware wasnotable to perform ,and thatthe tlawsw ith the
system w ereputting the safety ofCHS patientsatrisk. Forexam ple,on July 8,2011,the
DirectorofPhysician ServicesatCH S'SDeaconessHospitalwrote to the hospitalCl!O

regarding physician frustration with thesystem:thedoctorsareCdfrustrategedlregardingthefact


thattheissueswithMedhostarestillawayfrom beingresolvedthroughupgrades,etc....gand)
they are expected to practice safety butthe system hascreated an unsafepractice.''Another
doctoratD eaconess,responding w ith am essage thatw asfom arded on July 9 to CH S Chief
M edicalInform ation OfficerA nw arHussain,w entfurther:
Please pass this along to any and every person who can leverage this.There are
Sknow n issues'from m any m onthsago from previousdeploym entsw hich havenot
been addressed.W e are finding new issuesevery,and lm ean every,day.Irealize
itwould be convenientifal1these could be addressed in a single m assive upgrade
later.M any ofthese cannotw aittwo orthree or six m onths.An easy exam ple of
ttsafety issue''isthere is no warning m echanism w hen m edshave been duplicated,
ortestsduplicated.W e cannotpush safety aswehavebeen doing forthe last2 years
asapriority ifwegivenoprioritytoasafe(EHR).Thingsweidentifiedamonth
ago are stillunresolved.Ourlistis growing,and frustration isnotlessening.
A sm ore and m ore hospitalssounded the alarm ,CH S instituted w eekly Sscritical
issues''callsto discusstheproblem sthe hospitalsw ere experiencing with M edhost'sEHR . The
callsw ere led by corporate-levelexecutives,including M r.Fritz and M r.M oore,and included IT
and clinicalinform aticspersonnelfrom eacllofthe M edhosthospitals. The callsbegan in
approximately A ugust2014 and continued into atleastN ovem ber20l4. On the calls,the
hospitalsrepeatedly voiced theirconcern abouttheEH R'S lack offunctionality and safety.

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.,
(00077663;1J 24
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 25 of 57

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,

(00077663;l) 25
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 26 of 57

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.

(00077663)1) 26
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 27 of 57

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

tim estoo high.


83. On learning ofthisflaw in the system ,CH S instructed itspharmacistsnotto rely
on the M edhostEHR'Sdrip-rate calculations,and to instead m anually calculate a new rate.
(2) Weight-BasedDosing Window CanDisplaylncorrect
M edication
84. Undercertain circumstances,the Clinv iew application suffersa m edication nam e
m ism atch in itsweight-based dosing w indow .The issue can occurwhen a doctorutilizesthe
m odule to calculate the dose fora weight-based m edication.A fterthe doctorentersthenam e of
the desired medication,the Clinview application calculatesthe dosage foran entirely different

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

(00077663)1) 27
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 28 of 57

87. M edhostprovided aSssend D oseN ow''checkbox in the Clinv iew orderentry


w indow thatdoctorscould selectwhilem aking am edication order. The purpose ofthe checkbox
w asso physicianscould indicate thatthey u'
anted them edication to be im m ediately delivered to
the patient. H ow ever,the (dsend D ose Now ''checkbox did not,in fact,create m edication orders
designated forim m ediate delively,butinstead created orders scheduled fornorm aldelivery at
thenextscheduled frequency.
88. Forexam ple,ifaphysician entered a m edication orderto be adm inistered every
threehours,and checked theçdsend D oseN ow ''checkbox,theM edhostsoftware created an order
forthe m edication specifying adm inistration ofthem edication every threehours,w ith the first
dose scheduled to be delivered three hours in the future. Thetooltherefore did nottriggerthe
im m ediate adm inistration ofa dose. Physicianswho relied on the toolforthatpurpcse were at
risk ofunw ittingly delaying treatm ent.
89. CHS and M edhostbecam e aw are ofthisissue no laterthan April2014.Rather
than disable the broken feature,how ever,CH S instructed doctorsto eithercallthe pharm acy to
clarify theirorders,orto entertwo separate ordersforthe m edication thereby circumventing the
requirem entofplacing m edication ordersthrough the EHR system .
90. D espite being tlagged asSdhigh priority''and (timpacting al1sites,''M edhostw as
unable to fix the flaw . M edhostdid notdisable the feature untiltheend ofJuly 2011 allowing
providersto attem ptto use a broken feature form edication ordering foroverfourmonths
w ithoutnotifying them ofthe problem sw ith the ordering m echanism . An August2014 issue log
reported the issue wasresolved by disabling thebroken feature,stating:ûûsend D oseN ow is
disabled w ith sitestrained to notuse button.''
b. OtherM edication OrderingFlawsintheM edhostEHR Software
Arfctf/itl-
çf'
sEHR CanCalculateIncorrectDosesfor
MedicationsBasedonStaticClinicalHistoryProhleData
M edhost'sEHR softw are isincapable ofreliably calculating correctrnedication

dosesbasedonthepatient'sweight,bodystlrfacearea(((BSA'')orcreatinine($$CrC1'')levels.

(00077663;l)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 29 of 57

TheEHR usesinformationfrom thepatient'sClinicalHistoryProfile(ç(CHP'')todeterminethe


w eight,BSA ,and CrC1used in the dosage calculation. Providerstypically complete the Cl-lp
w hen the patientisadm itted to the hospital.
92. O verthecourse ofan inpatientstay,a patient'sm easurem entscan change
significantly,often enough toyield relevantchangesinmedication dosage.W hen ahospital
takesnew m easurem entsfrom thepatient,Nledhost'ssoftw are willsavethenew m easurem ents
in the EHR butwillnotupdatethe inform ation in the patient'sCHP. Even though the
inform ation in the CHP isno longercurrentforthe patient,the softwarew illcontinueto usethe
Cl-lp to calculatethepatient'sm edication dosages. Consequently,a patientwho suffersw eight
lossordeclining renalfunction while in the hospitalisatrisk ofreceiving m edicationsatdoses
theEHR calculatedbasedon hisorhercondition upon admission.Patientswho receivesuch
dosesm ay be atrisk ofsignificantoverdosing orunderdosing.
M edhostLJck:the Capability to Accurately Cteate f'#.N'
M edication Orders
M edhost'sEH R isalso incapable ofreliably creating PRN m edication orders
orders--ordersto be adm inistered Ssasneeded.'' W hen aphysician entersa PRN m edication
orderthatincludesan expiration tim eforthe orderand a maxim um num berofdoses,M edhost's
EHR mayterminatetheorderearly(i.e.,priortotheexpirationdatethephysicianchose)orfail
to display the m axim um num berofdoses.
94. On July 30,2014,the DirectorofPhannacy SelwicesatCHS'SFallbrook Hospital
w roteto CH S Pharm acy InfonnaticsM anagerJeannie Bennetand othersregarding Eçtlaw ed PRN
frequencies in CPOE representa m edication safety risk.'' In the email,the Directorused the
exam ple ofan orderfor6m g ofthe m igrainem edication Sum itripon,to be adm inistered every
hourasneeded form igraineheadache,butw ith a m axim um of3 dosesto be adm iniqtered over
notmorethan 12 hours.TheDirectorwarnedthattheEHR wasincapableofrecordingtheorder
astheproviderhad intended--depending 0:
1
4how the providerentered theorderinto the M edhost
EHR,thesoftwarew ould eithercreate an orderforam axim um of3 dosesto be adrninistered

(00077663;1J 29
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 30 of 57

overnotmorethan2.hours,orforunlimited dosesto beadministered overnotmorethanJ-2


hours.étEitherw ay,''the D irectorwrote,çtthe orderasentered would notactually retlectwhat
w as ordered.''
95. M edhostacknowledged to CIIS thattheproblem w ith PRN m edication orders
wasa Sslim itation ofthe system .'' M edhostrefused to fix theproblem ,however,w ith one
em ployeew riting CHS that:dçatsom e pointllursestreating patientshaveto take som e Eclinical

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

(00077663;1) 30
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 31 of 57

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

m edication from the Physician Favoritetool.


99. Thisproblem occursm ostcolnm only when a hospitalchangesa m edication's unit
ofmeasurement(e.g.,from gramsto milligrams).AtCHS,thetextstring foramedication will
notchange when ahospitalchangestheunitofm easurem entforthe m edication in itsform ulary.
Ifadoctorentersan orderforsuch adrug usingtheEHR'SnormalCPOE interface,theinterface
willdisplay the new unitofm easurem ent,alerting the doctorto the change. lfthe dcctoruses
the Physician Favorite tool,however,the EHR w illdisplay the old unitofm easurem ent. The
dose the doctororders,therefore,w illbe based on an incorrectunitofm easurem ent1brthe drug.
M aking the problem especially dangerous,the pharmacistwho fillsthe orderm ay have no reason
to suspectthatthe dose isbased on an outdated unitofm easurem ent.
100. The dangerposed by thistlaw was am plified by a series offlawed formulary
changes,described below ,which CHS im plem ented atitshospitalsduring the sam etim efram e

and thatincluded m any unitofmeasurem entchanges.


M edication Orders to AutomatedM edication Ltispensing
Systems Have YieldedlncorrectDoses
101. TheM edhostEHR softw are failsto reliably ensure thatpatientsreceive proper
doseswhen a hospitaldispensesm edicationsusing an autom atic dispensing system .
102. CHS hospitalsusethe Pyxis autom ated m edication dispensing system to dispense
som e m edications,and providerscan routem edication ordersto Pyxisusing M edhost'sEHR.
Pyxisdispensesm edicationsbased on the dose inform ation in the hospital's form ulary. W hen a
doctororders aççpartialdose''ofa m edication- adose thatis lessthan the fulldose found in the

hospital'sformulal'
y(e.g.,50mgofdrugX,
,when 100mgisthesmallestdoseavailablefrom the
Pyxismachinel- thePyxismachinewillt5lltheorderforthefulldoseunlessapharmacist
noticesthe conflictand intervenes.

(00077663;1J
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 32 of 57

103. The M edhostEHR doesnothing to alertprovidersw hen an ordercallsfora partial


dose. The EHR doesnotalertthe doctorwh4acreatesthe ordersthepharm acistwh0 verifiesthe
order,orthenurse who adm inistersthe m edication. Furtherm ore,the hospital'seM A R system ,
w hich servesasa lastline ofelectronic defezlseagainstm edication errors,w illnotalertthe nurse
tothedosing issuewhen thenursescansthe patient'sbarcodepriorto adm inisteringthe
m edication. lfprovidersdo notaffirm atively check thatthe orderthe doctorentered matchesthe
orderthatPyxisdispensed,the patientm ay receive an overdose ofthe m edication.
104. This flaw ed system led atleastone CH S patientto receive an overdose of
Potassium .The erroroccurred in CH S'SLake W ales,Floridafacility and w asraised by the
hospital'spharmacy directorduring an October l6,2014 issuescall.
2. M edhost'sEH R Software CannotR eliably Perform D rug-D rug,
D rug-A llergy,D uplicateTherapy,or Dose R ange Checlks
105. T0 m eetthe requirem entsfora certified EHR ,the EHR m ustcheck al1m edication
ordersfordrug-drug and drug-allergy interactions,which require thatitautom atically and
electronically indicateto the userpriorto completing and acting upon the m edicatioc orderany
drug-drug and drug-allergy contraindicationsbased on the patient'sm edication listand
medication allergy list. The EHR m ustperform the drug interaction checksaccurateLy,reliably,

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

(00077663;1) 32
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 33 of 57

M edi-span identifiercode(ltxNorm).TheM edhostEHR usestheM edi-span identifiersto


perform a variety ofitsCPOE functions,including a1lofitsdrug interaction checks. Only
m edicationsorallergiesthatare m apped to l'
dedi-span identifiersin the form ulary can be
considered forinteractionsby the system .
l09. Though M edhostrelies on M edi-span identifiersto perform drug interaction
checks,CH S and M edhostallow usersto enterm edicationsand allergiesinto theEH R system
withoutmappingthem to M edi-span identifiers(ssfree-textentries'').W henmedicationsand
allergiesare entered into the system w ithoutM edi-span identifiers,the EHR system does not
include them in drug interaction checks,increasing the risk thatpatientsw illreceive
contraindicated m edications. By notchecking form edicationsand allergiesin thepatient's
m edicalrecord in areliablem anner,thehospitalsdid notm eetCM S requirem entsfor
M eaningfulUse.
M edhost'
s EHR CannotReliably M ap M edicine and
AllergvListskom theEmergencyRoom ModuletoMedi-
SpanNcn/Wcr. &
l10. The M edhostVCED IS''EHR m odulethatCH S usesforits em ergency departm ents
usesa differentdrug codifcation schem e than the M edhostitEnterprise''m odules used in CHS'S
inpatientdepartm ents.lnstead ofthe M edi-span vocabulary,ED IS refersto drugsusing a

codification schemecreated by FirstDatabank CTD'').


W hen apatientis adm itted to a CH S em ergency room ,the em ergency departm ent
w illrecord the patient'shom e m edicationsand allergies in ED IS,w hich assignsthera FD codes.
Ifthe patientisadm itted to the hospital,the hospitalm ustim portthe patient'shom e m edications
and allergiesfrom ED IS into M edhostEntel-prise. Because M edhostEntem rise usesa different
codification schem e,M edi-span,itm usttranslatethepatient'sFD codesinto M edi-span
identitsers.
l12. M edhost'stranslation m echanism appliesa basic text-m atching algorëthm to the
FD codes,looking foratextualm atch to thefonnulary database in M edhostEnterprise. W hen

(00077663)1) 33
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 34 of 57

M edhostEnterprise successfully m atchesan !


FD code to the form ulary database,itw illm ap that
code to a M edi-span identifier. IfM edhostilnterprise isunableto m atch the FD code,how ever,

itw illim portthe code asunstructured ttfreetext.''


l13. Like allfree-textentries,M edhostEntep rise excludesthe unm atched codesfrom
themedication and allergylistsitusesfordrug interactionchecks.M oreover,when M edhost
Enterprise im portsa code asfree text,itfailsto im portany inform ation on the route,frequency,
orunitofm easurem entfortherelevantmedication,which can lead to errorsifthe doi
ator
continuesthe m edication while the patientis in the hospital.
1l4. The text-m atching algorithm hasa high failure rate. Even afterm ultiple revisions,
forexam ple,the algorithm w orkslessthan seventy percentofthe tim e undertestconditionsin
the case ofhom em edications. Consequently,CH S excludesa significantpercentge ofhom e
m edicationsfrom its drug interaction checks.
M edhost'
s EHR CannotReliably M ap Custom t'ntffocal
MedictltionstoMedi-spanIdentfers
115. TheM edhostEHR 'Sdrug interaction checksdo notfunction reliably with custom
and localm edications.Custom m edications arem edicationsthatarem odified by adoctorto suit
aparticularpatient'sneeds.Localm edications are thosethatdoctorsorpatientsprovide
them selves,outsideofthenorm alhospitalpharm acy process.
116. The M edhostEHR containsan incom plete database ofM edi-span identifiers,
w ith m ostincluded only asneeded forthe hdlspitalform ularies.H owever,custom medications
and localm edicationsare frequently noton thehospitalform ulary,and thereforedo nothave
available M edi-span identifiersin the M edhostdatabase.W ithoutavailableM edi-syan
identifiers,providersare forced to enterthe medicationsasfree-textentries,which are not
considered by M edhostdrug interaction checks.

(00077663;1) 34
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 35 of 57

b. M edhost'sFJTA FailstoFlagM edicationAllerglesIfthe


M edication OrtlerIsAlready zzzthe System
M edhost'sEHR softwareonly nm sm edication allergy checksw hen a m edication
orderistsrstentered into the system .A patierl
t'sallergy lististypically com piled atadm ission,

and stored in the patient'sCHP.


l18. lfnew allergies are subsequently added to a patient'sCHP,theM edhostEH R
software failsto run anew drug interaction dneck forthe allergy againstthe patient'soutstanding
m edication orders,such as ordersthathave notyetbeen adm inistered ororders thatare
scheduled foradm inistration in the future.
c. M edhost's EH R Fails to Lock Open PatientCharts,R lsklng
D uplicateM edication Orders
1l9. M edhost'sEHR softw are failsto lock open patientcharts,allow ing mtlltiple
providersto open apatient'schartatthe sam e tim e.Undersuch circum stances,both providers
(forexampleadoctorandaphanmacist)canmakemedicationordersforthepatientatthesame
tim e,which overridestheEHR 'Sability to perfonu duplication therapy ordose range checking.
120. Sim ilarly,theEH R doesnotsynchronizethe infonnation displayed in PhysD oc
and Clinv iew. Ifa providerhas both applicationsopen in separatew indows,theprovider's
w orktlow in one application w illnotbe retlected in the other. Forexam ple,ifa provideris
w orking on chartsform ultiple patients,switching from one patientto the nextin PhysD ocw ill
notprom ptClinview to sw itch asw ell,resulting in theapplicationsdisplaying infonnation on
differentpatients. lfthe providerdoesnotcatch thatthe patientsare different,the providerm ay
m ake clinicaldecisionsforonepatientbased on inform ation listed in the otherpatient'schart.
M ultiple CH S hospitalshave reported these defectsto CH S m anagem entas
presenting a seriousrisk to patientsafety,howeverCH S and M edhosthave notresolved the

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

(00077663;1J 35
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 36 of 57

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.

(00077663)1) 36
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 37 of 57

126. During the deploym ent,CHS rolled outa seriesofelectronic ordersetsthat


doctorswere supposed to use with the EHR softw are. To m ake the ordersetsfuncticn w ith
M edhost'sCPOE,each m edication orderem bedded within an ordersetm ustbem apped to the
hospitalform ulary using mnem onics.To create the m apping forthe ordersets,CH S started from
tem platescreated by Zynx H ea1th,a source 4)fevidence-based clinicalinform ation. CH S
m odified theZynx templatesand then m apped them to each hospital'sform ulary using a
software toolcreated by M edhost.
127. The CHS processfailed to accountforthe num erousdifferencesin hospital

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.

(00077663;1)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 38 of 57

Tw o w eekslater,CH S had notbegun to addressthe issue. On M arch 25,CH S


DirectorofPharm acy Operations,Jerly Reed,sentan em ailexpressing hisalarm to CH S Vice
PresidentofOperations SupportTim Park:
I am not sure where my authority stops,butw illpush forward until1geta cease
and desist.
N one ofm y pharm acists are involved in the build.
'
-

M ostoftheissuesgo back to the gmodelordersetj.Ithink urgentcleanup is


-

necessary.The ordersetsarebeing mapped outofthe gmodelordersetlto the


facilitiesanduntilthisiscleaned uq '
wearegoing to continueto experiencetl1is....
Examples:Aceà m inophen supposltories is m apped to orally.N orm al saline is
asking forweightbased dosing.
-
pharmacistsmustoverseethedrugcomponentofthe(modelordersetlandraodel
build.
- cliffand Jeannie have been bringing up these issues forthe lastm onth.
-'rhe readiness docum entation does not even include pharm acy directors because
the deploym entteam still seem s to think thatpharmacy had nothing to do with
CPOE.
130. ln responseto the em ail,M r.Park acknow ledged thatthe issue created fertile
ground forpatientharm ,w riting thattt-
l-hese m edication sentenceshave a ver'v hieh potential
forcausing a catastrophic event.''
Despite acknow ledging the dangerofrolling outtlaw ed ordersets,hcwever,CH S
continued to push forward w ith deploying the ordersetsatadditionalhospitalsin advance ofthe
2014 attestation period with itsintended purpose being to collectM eaningfulU se subsidiesfor

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

(00077663)1)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 39 of 57

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

othersinvolved in care delivery.


134. ON C hasidentified CDS as akey functionality ofhealth inform ation technology
that- when effectively applied--contributesto içim proved care quality,enhanced health
outcom es,errorand adverse eventavoidance,im proved efficiency,reduced costs,and enhanced
providerand patientsatisfaction.'' ON C,ClfnicalD ecision Support..M ore than Just Alerts'
Ti
psheet,July2014 (notingthat(tcongressincluded CDS asacenterpieceoftheM edicareand
M edicaidEHR IncentivePrograms'').
135. To becertified under201l or2014 Edition certification criteria,CM S requires
EHRSto becapable ofim plementing autom ated,electronic CD S rulesbased on data in problem
lists,m edication lists,dem ographics,vitalsigns,and laboratory testresults. EHRSm ustfurther
be capable ofautom atically and electronically generating and indicating in realtim e notiscations
and care suggestionsbased on CDS rules.
136. To meettheserequirements,EHRSmustenableisusersto select(ï.c.,activate)one
orm ore electronic clinicaldecision supportinterventions''based on patientdata and to ççenable
interventionsto be electronically triggered''based on patientdata and during transitiansin care.

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

(00077663;1) 39
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 40 of 57

j l70.314(a)(8)(i)!haveenabled certain intel


rventions.''77Fed.Reg.54163,54213 (Sept.4,
2012).
Forhealthcareprovidersto receive incentivepaym ents,they m ustattestto having
im plem ented CD S rules. ln Stage 1,providerswere required to im plem entone CDS rule
relevantto theirspecialty,high clinicalpriority,orhigh priority hospitalcondition,along w ith
the ability to track compliance w ith thatrule. ln Stage 2,providersw ere required to im plem ent
five CDS interventionsrelated to fourorm ore clinicalquality m easuresatarelevantpointin
patientcare forthe entire EHR reporting period.
As discussed below,M edhost'sEHR software isunable to reliably perform CD S
ortrack when and whetherCD S ruleshave been enabled.
1. M edhost'sEH R D id NotEnable Users to Im plem entCD S Rules
D uring the2014 A ttestation Period
139. M edhost'sEH R software containsaprogram m able(drulesengine''thatdeterm ines
when to dsfire''CD S interventionsusing sim ple logicaloperationsbased on data in theEH R

system @.g.,ifX istrueandY isfalsethendisplaypopupZ onthescreen).Inadditiontothe


rulesengine,theEHR softwarecontainsa CD S audittoolto track and record information about
the CDS interventions,including when rulesw ere firstcreated and enabled,and every tim e arule
tsred in the system .
140. ln early 2014,CHS program m ed CD S interventions into the M edhostEHR rules
engine in preparation forthe Stage 2 attestation period. Problem sw ith theM edhostCD S
functionality arose soon thereafter. ln April2014,CH S DirectorofIT InternalAuditK risti
M eyernoticed gaps- unexplained periodsoftime during which the CDS rulesdid notfire- in
hospitals'CD S auditlog reports. In June 2014,M s.M eyerraised the issue directly w ith
M edhostCorporateA ccountM anagerN ate M iller:
After looking atthe (auditlog and CDSIdata,we would liketo geta better
understanding ofthe stability ofthese logs.ltappears as ifthe logs did notcheck
the statusforseveraldays.1wantto understand why thatis.Also,lw antto getan
(siclperspectiveoniftheselogsaresomethingmyteam canrelyonfrom anAudit
perspective.

(00077663;1)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 41 of 57

M edhostsubsequently identified a credentialing issue w ith the CD S audittooland issued an

update thatpurportedly resolved the problec .


141. On July 1,2014,CH S began itsfirstoftwo planned waves ofM eaningfulU se
attestation.Foreach w ave,a setofhospitals would undergo athree-m onth M eaningfulU se
reporting period,during w hich tim ethe CD S functionality had to be continuously enabled.
142. ln m id-A ugust2014,afterM edhostissued an update to itsEHR softw are,the
software stopped triggering CD S interventionsatCHS'Shospitals.
143. CHS m anagem entdid notlearflofthe CD S failuresuntilSeptem ber,two thirdsof
the way through the firstreporting period. On Septem ber l2,20l4,CH S DirectorofProgram
lnfonnaticsConnie Senseney sentan em ailto RelatorN eim an:ççon 8/l8 apparently allofthe
CD S rule acknow ledge reportswere turned ()ff.ltshow sthatthe rulesare stillactive.Did

som ething happen?''


144. Onew eek later,theM s.Senseney follow ed up w ith RelatorN eim an aboutthe
issue,writingthattigalpparentlytheCDSrulesactuallyquitegsic)firingonoraroundthe15thof
August....So,itm ay notbethe reportthatstopped,butthe rules are no longerfiring....This
needs im m ediate attention since itaffectsa1lsites in Stage 2.''
On Septem ber24,2014,CH S D irectoroflnform ation System sforthe M edhost
D eploym entTeam TeriM itchellcirculated a problem sum m ary by em ail:
-ToM eetCoreMeasure,weneedtoprove1)It'sbuiltand2)therulesareactive
and continuouslyfiring duringthereportingperiod(7/1thru9/30)
Last w eek, Internal audit was conducting a dttrial'' run of the report pri. or to
subm ission for 10/1 attestation.D uring thattrialrun,itw as discovered the report
w asn'tw orking.Connie S.reached outto M edhostfor assistance.M edhostfixed
thereport.Afterreview ing thereport,itwasdiscovered thatatseveralsitestherules
w ere not acknow ledged, which m eans the rules did not tsre,or show a gap in
firing....

-Based on thereportresults,CD S rulesarenotfiring/firing consistently atm ultiple


facilities.SG tus:O PEN .
W hatisIm pacted
- Core m easure m eeting attestation l'
equirem ents
W ho islmpacted

(00077663;1) 41
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 42 of 57

-During a quick spotcheck of 17 facilitiesby Joey'steam ,all17 show a gap...


N extSteps
-M edhostisconfirm ing ifthe rulesare firing and reportisw rong
-Iffiring and the reportisw rong,a differentm ethod ofproofw illbe requirad to
attest
- Ifnotfiring,according to Connie,we can'tattest.
146. ln anotherem ail,sentto RelatorN eim an the sam e day astheproblem sum m ary,
the ClinicalSystem sCoordinatoratCH S'S(zedarPark RegionalM edicalCenterconfirm ed that

the CDSnzleswerenotfiring in hishospitl'ssystem duringtests:Cslljtdoesnotappearthatany


ofourruleshavebeen firing sinceA ugust 14th. 1tried severalrules on severalpatientsand

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
(00077663;1) 42
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 43 of 57

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.

(00077663;1) 43
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 44 of 57

154. In late 2011 orearly 2012,CHS distributed aguide to instructnurses on the


workflow forthe fallrisk dsintervention.'' U nderthew orkflow ,nursesw ereresponsiblefor
identifying theneed to perfbrm a fallrisk assessm enton thepatient. Oncethenursesdecided to
perform the assessm enton apatient,they wereto selectthe assessm entin theEH R,which w ould
display a seriesofquantitative questionsbased on a com m on m ethod to calculate fallrisk.The
nurseswere to assign a score foreach questl
ion. Atthe end ofthe assessm ent,the sohware
would autom atically totalthe scores,producing a single C$FallRisk''scorethatitdisplayed in an
outputfield entitled ttscoreTotal.''
Atthispoint,in a step the guide described asççm andatory forthe M eaningfulUse
requirem ents,''the software would display aw indow in which the nursew ould selecta checkbox
indicating whetherthe Score Totalwasm ore orlessthan 25. Ifthenurse selected the checkbox
fora score lessthan 25,the assessm entended. lfthe nurse selected the checkbox fora score
over25,the EHR prompted the nurse to selecta careplan forthepatientfrom a list(bneofthe
plansthenursescould choosewasEçfallrisk'').Thenursethenhadtom anually add1hecareplan
to the patient'sprofile.
156. Thus,CH S fabricated a CD S (tintervention''by creating an extra,unnecessary step
in the nurses'worktlow concerning fallrisk assessm ents,indicating to thenursethata score
under25 did notrequire furtheraction while a score over25 w arranted the selection ofa care
plan.

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

(00077663;1) 44
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 45 of 57

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
(00077663)1) 45
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 46 of 57

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

the firstattestation wave:


M eayan and connieagreethatthe gorderset)extractisexactly whatweneed asa
startmg point.W ewillusethatextractfortheM edhosthospitalsto validatew ehave
5 thatapply forCD S Rules.
Canyouhelpruntheseforusforevery7/1gfirstwaveqStage2site?
166. O n O ctober6,2014,a week aftertheend ofthe reporting period fortbe hospitals,
M s.M eyerrealized thatseveralofthe hospitalsdid n0thave the five ordersetsthatthey intended
to use forattestation.She asked RelatorN eim an to investigate.
gAjfter reviewing the evidence,we identified 8 hospitnls thatonly had 3 ofthe
ûûapproved''ordersetsactivethe entiretim e.Therefore,could yourteam provideus
with alisting ofal1active order setsfrom 7/1-9/30 forthose 8 hospitals?Based on
your output,w e w illwork w ith OPS to determ ine the other order setto use for
attestation.
Threew eekslater,on October 30,2014,M s.M eyersentanotherupdateregarding
the issue,stating thatthe eightfacilitiesm entioned w ere stillin Eûlim bo,''lacking sufficientorder
setsforattestation.She subsequently determ ined to add the fallrisk assessm ent,which CH S had
relied upon forStage 1,as afinalintervention.Soon after,CH S subm itted attestationsto CM S
foral1thehospitals.

(00077663;1) 46
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 47 of 57

l68. W hile CH S waspreparing to attestto CD S functionality using static ordersetsfor


the first-w avehospitals,m em bersofthe implem entation and auditteam sstillbelieved thatthe
hospitals in the second wave,forwhich the rl
zporting period began on October 1,2014,w ould be
able to attestusing the actualCD S interventionsin M edhost'sEHR.
169. However,asdescribed above,CH S learned in October2014 thatthe M edl-lost
CD S functionality had again failed. On N ovem ber20,2014,CHS D irectorofClinical
Inform aticslm plem entation Connie Senseney wrote to hercolleagues:$ûW e are going to have to

usethe ordersetsagain 1believe.''


170. Indeed,CH S subsequently attested forthe wave two hospitalsusing the ordersets

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

asM edhostEnterpriseFinancialsClM edhostFinancials''),isasuiteoffinancialapplications,


capable ofperform ing hospitalaccounting,billing,and otherm anagem entfunctions.The
productsinclude A ccountsPayable,GeneralLedger,M aterialsM anagem ent,Payrollm um an
Resources,PatientAccounting,and Health Inform ation M anagem entapplications. :% license for

(00077663;1) 47
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 48 of 57

I .

M edhostFinancialsisworth approximately $250,000.M edhostprovidedfreelicensestoatleast


19 CHS hospitals,totalingkickbackswitha valueofover$4,750,000.
173. Fornearly three decadespriorto the kickback schem e,CH S had used--and paid
for- the M edhostfinancialsoftware atmostofitshospitals.
174. M edhostinitiated the illegalkickback schem e atthe same tim e itexpanded the
M edhostEnterprise software suiteto include M edhost'sclinicalpackage,which CHS laterused
to attestto M eaningfulUse. Itoffered to provide M edhostFinancials forfreeto allCH S
hospitals,both those thatutilized the fullM edhostEnterprise EHR suite and thosethatused
third-party EHRS. Foreach hospital,M edhostonly required thatCHS pay approxim ately
$137,000foraccompanying softwareproductsandinterfaces,includingAdvanced Security,
eArchive,lnsurance Eligibility,and SSIElectronicBilling.
175. D uring the relevanttime period,Relatorsboth worked asdirectreportsto Steve
Hernandez,CHS'S SeniorD irectoroflnformation System s,who w asresponsibleforfinalizing
softwarepricing with M edhost. D uring thattim e,itwascom m only known and discussed am ong
CH S employeesthatM edhost'sofferw asintended to induce CH S to continue doing business
w ith M edhostand,specifically,to purchase M edhostEnterprise. Even forCH S hospitalsthat
continuedtousethird-pao EHRS,M edhost'sgoalwastomaintain asoftwarepresenceatthe
hospitalsto increase the likelihood thatCH S w ould convertthose hospitalsto the M edhostEHR
in the future.
176. CHS notonly accepted M edhost'skickbacks,butalso purchased additional
licensesofM edhost'sEHR as aresult. CH S knew thatM edhost'sofferoffree productwas
intended to induce itto purchaseEHR softw are. On m ultiple occasions,CH S corporate
leadershipchosetheMedhostEHR forhospiolsovertheobjectionofCHSimplementationand
hospitalstaff,who w ere concerned aboutthe M edhostEHR'Spoortrack record and 11strong
preference by doctorsforotherEH RSthatw ere ofsim ilarcost. The explanation thatCH S gave
to Relators and otherem ployeesw asthatCI'
lS needed to Sdtake care ofitsfriends,''referring to
M edhost,and iim ake sure they getsom ebusiness.''
'
(00077663)l) 48
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 49 of 57

TheEHR thatCH S acquired from M edhostis funded in partby M edicare and


M edicaid through the EHR incentiveprogram s.
F. CH S Falselv Attested to M çaninefulUse ofCertified EH R in Leeacv H M A
H ospitals
lnJanuary 2014,CHS acquired Hea1thM anagementAssociatesCçHM A''),a
competing for-protithospitalchain. The transaction expanded CH S'S hospitalnetwork from 135
to 206 facilities.
ThehospitalsthatCHSacquiredfrom HMA (theCûHMA hospitxals'')usedmodular
EH R teclm ologiesratherthan com plete EH1l.
S. UndertheM eaningfulU seprogram ,eligible
hospitalsm ay combine EHR m odulesto m eetthe definition ofcertified EH R technology,
provided they ensure thatthe m odules are interoperable and can properly perform in their
expected operationalenvironm entto supportthehospitals'achievem entofm eaningfuluse.
l80. The EH R m odulesthatthe HM A hospitalsdeployed during the Stage 2 reporting
period were notinteroperable. D espite relying on m ultiple EH R technologiesforpatientcare,
theH M A hospitalsfailed to integrate thetechnologiesso thatthe clinicalinform ation stored in
one system wasreliably accessibleto the othersystem s. In particular,theHM A hospitalsdid not
develop key software interfaces- protocolsby w hich the applications could exchange
inform ation- thatw ould allow the hospitalsto transferinform ation on m edication orders
electronically from one departm entto another. W ithoutthe interfaces,providerscotlld notm ove
a patientfrom oneEH R m oduleto anotherw ithoutprinting the patient'sm edicalrecord and
entering the contentsby hand into the new lnodule.
l81. First,the hospitals'em ergency departm entinfonuation system ,M edhostEDIS,
did notinterface w ith the hospitals'inpatientEHR system ,PU LSE,to transm itinfofm ation on
m edication orders. W hen the hospiu lsadm itted apatientfrom the em ergency depaltm ent,the
em ergency departm entw ould haveto printthepatient'schartso thatan inpatientnurse could
enterthe chartinform ation into PULSE.

(00077663k1) 49
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 50 of 57

182. Second,PULSE did notprovide a m edication orderinterface w ith the hospitals'


CPO E application,Patientlteeper. Atthe H1.
/fA hospitals,physiciansentered m edication orders

usingaproprietaryapplicationcalledtheM edicalAccessPortal(tçM AP'').Whenaphysician


created an orderusing M AP,the application would com m unicate the orderto Patientlkeepervia
a software interface.N ursesatthe H M A hospitalsused PULSE fortheirw orkflows and did not
have accessto M AP orPatientKeeper. Therew asno interfaceto com m unicate infonnation from
PatientKeeperto PULSE,which prevented nursesfrom view ing the m edication ordersin the
patient'sEM R. W hen physicians signed m edication orders,the hospitalshad to printthe orders
in the appropriate hospitaldepartm entforreview by the nursing staff. Becausetheproblem
affected every m edication orderentered in the hospital,the I-1M A hospitalsprogram rned
PatientKeeperto printm edication orders autom atically. Therefore,the H M A hospitalsdid not
have a CPOE processthatw astruly electronic.
183. Third,theHM A hospitals lacked an interface from PatientKeeperto their
pharmacy managementsystem,HorizonM edsM anager(tfHM M '').W hen aphysicianentered a
medication order,the orderw ould notappearin HM M . lnstead,PatientKeeperwould generate
an em ailto the pharm acist,who would haveto transcribethe contents ofthe em ailirto HM M .
M anually copying m edication order inform ation from PatientKeeperto HM M increased the risk
ofm edication errors. M oreover,itmade the hospitals'M eaningfulUsereporting less accurate,
aspharm acistswho received ordersvia em ailhad to guessw hetherthose ordersoriginally had

been entered using CPOE.


184. Because PULSE did notcornmunicate w ith M edhostED IS orPatientKeeper,and
because HM M did notcom m unicate w ith PatientKeeper,the HM A hospitalsw ere unable to
safely and reliably m aintain patients'problem lists,active m edication lists,and m edication
historiesforthe duration ofthe patient's entirehospitalization.
185. The lack ofinteroperability also prevented usersfrom using EH R teci
bnology to
reconcile clinicalinform ation. The hospitalsstore active m edication lists,problem lists,and
m edication allergy lists in PULSE. Physiciansdo nothave accessrightsto PU LSE.Physicians

(00077663k1J
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 51 of 57

also cannotaccessthe inform ation in PULSE indirectly becausetheirapplications- r4A p and


PatientKeeper--do notinterface with PU LSE. Forphysiciansto reconcile the clinical
inform ation in PULSE w ith clinicalinformation from othersources,a nursem ustprintthe
patient'sm edication reconciliation form forthe physician to com plete by hand. Once the form is
com plete,the nurse mustm anually re-enterthe contentsofthe fonn into PULSE.
186. Because physicianscannotelectronically reconcilethe clinicalinformation in
PULSE,the HM A hospitalsdid not,and,in m any cases,do notm eettherequirem entthat
providerssafely and reliably electronically reconcile a patient's active m edication listat
adm ission and otherrelevantencounters.
l87. BecausetheEH R m odulesatthe HM A hospitalsdid notm eetCM S requirem ents
forcertified EHR technology,the hospitalsw ere ineligible forincentive paym entsunderthe
M eaningfulUse program . Despitetheir ineligibility,60 ofthe HM A hospitalssubm itted
M eaningfulUseattestationsduring Stages land/or2 andwerepaid atotx
'tlof$206million in
incentivepaym ents.
188. CH S knew thattheEH R technology atthe HM A hospitalsw asseriously tlaw ed.
Priorto itsacquisition,HM A hired a consulting finn,Accenture,to evaluateH M A 'sreadinessto
meetStage 2 requirements. In a Decem ber3,2013 report,Accenture warned thatCVHM A 'S
com plex application portfolio resultsin excessivepotentialpointsoffailureand lim itskey
functionality.'' One ofthe failure pointsA ccenture identified wastheprocessing oflnedication
orders,which itfound w eretçhighly fragm ellted involving duplicatedata entry and m anual
workaroundsthatincreasethepotentialforerrors.''Accenturenotedthatdsgtlhenum beroforder
entry system sand com plex setofclinicalw orkflowsthathave been created increasethe
opportunity form ore gaps in careand patientsafety risks.''
189. D ue in partto these flaw s,Accenture concluded thatH M A wasnotcloseto
m eeting Stage 2 requirem ents. Itfound thatH M A had deployed PatientK eeperatorly 32 ofits
71hospitalsand w asnotscheduled to com plete deploym entatthe rem aining hospitalsuntilM ay
27,2014.A ccenture also found thatdsclinicalDecision Support,akey functionality ofM U
400077663)l) 51
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 52 of 57

Stage 2,iscurrently notim plem ented in M A P norevidentin productroadmap.'' Accenture


warnedthatççltlhefragmentationofapplications,workflowsandclinicalprocessesimpacts
patientsafetyandpotentiallycreatessignifkantfinancialrisks(MU Stage2andHIP,A.
A
compliancel.''
190. In a subsequentreportto CHS dated January 6,2014,A ccenture found that
significantapplicationsrem ained in developm ent. PULSE,forexam ple,lacked functionality for
transitionsofcare,dataportability,C-CDA ,and interfacesw ith otherapplications. A ccenture
wrote thatPULSE wasçûstillin theplanning phase''forC-CDA and Sçstillin developrnentand
testing''forintegrating CD S with otherEH R m odules.Fortransitionsin care,Accenture found
thatPULSE'SElbusiness requirem entsforthisfunctionality are stillin review ,''while
itgilnterfacesforvendorsoftwaresuchasMEDHOST,PatientSafeSystemsandMedicityneedto
bedeveloped.'' FortheHM A hospitalsto attestto M eaningfulU se in Stage2,Accenture
advised thatCH S deploy theapplicationsno laterthan April1,2014,leaving only threem onths
to develop corefunctionality from scratch.
Despiteknow ing thatthe HNIA hospitals lacked the functionality necessary for
m eaningfuluse,CHS decided itwould be too costly to convertthe hospitalsto a diffèrentEHR
system . Even beforecom pleting the acquisition,however,CH S and HM A reduced the num ber
ofthe developersresponsible forPULSE and M AP and did notallocate otherresourcesto
developing the applications. A sa result,CI'
IS did notdevelop the functionality needed to m eet
Stage 2 requirem ents and the problem sthatA ccenture had identified priorto the HM A
acquisition persisted through the Stage 2 reporting period and beyond.
192. The HM A hospitalsknew thattheirEH R system sw ere defective and alerted CHS

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

(00077663)lJ
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 53 of 57

Regionalifthe problem scontinued. The purpose ofthe visitwasto evaluatew hetherto

transition M idw estRegionalto adifferentEIIR system .


193. During thevisit,physicianstold the CH S executivesthatthe hospiu lw asrelying
on paperto bridge itsdisparate EH R system sand thatthistthybrid system ''posed a signifk ant
safety concern. Thephysicianssaid thatthe lack ofan integrated EHR system forced the
hospitalto printand re-enterchartinformation w heneverpatientsw ere adm itted from the ER or
transferred from one departm entto another. Thephysiciansalso said thatthehospitalwasforced
to chartm edicationson paperatthesam e tim e itwasusing PULSE to adm inisterm edications.
The physiciansw arned thatifthere w asan errorordelay in entering a m edication orderfrom a
paperchartinto PULSE,a nurse using the hospital'seS4A R system could m issthem edication

orderoradm inistera duplicate dose.


194. Physicians in the cardiology departm ent,m eanwhile,identified m edication
reconciliation as aûfhugepatientsafety concern''thatthey feared w ould étkilla patient.'' One
cardiologisttold the CH S executivesthatphysiciansw ereusing paperto reconcile m edication
listsbecause they did nothave accessto PU LSE and thatnursesw ereentering the completed
reconciliation form sinto PU LSE by hand. According to the cardiologist,physicianshad caught
errorsin the re-entered form sthatw ould have sentpatientshom ew ith thew rong drugs,doses,or
instructions.The cardiologistsaid thatphysiciansatM idwestR egionalrequired nursesto print
the re-entered form s so thatthey could check forsuch errors.
195. Atthetim e ofthe visit,M idwestRegionalhad attested to itsm eaningtkluse of
certifiedEHR technologyon fouroccasionsand received$5.95million in M eaningfalUse
incentive paym entsfrom the Governm ent.BecauseM idwestRegionalhad neverim plem ented
EH R technology thatm etCM S'Scertification requirem ents,each ofthe hospital'sattestations

had been know ingly false.


V 1. DEFEND M TS V IO LA TED TH A:FA LSE CLM M S A CT
196. M edhostknowingly m isrepresented to custom ersthatitsEHR products satisfied
federalM eaningfulUserequirem ents. These m isrepresentationsforeseeably caused custom ers,

(00077663;l) 53
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 54 of 57

/ p

including CH S,to purchase itsEHR technology. The m isrepresentations also foreseeably


caused the purchasersto attestto com pliance w ith M eaningfulUse requirem entswhen they w ere
notin com pliancew ith thoserequirem ents,and foreseeably caused thepurchasersto subm it
claim sto the FederalGovernm entforEHR incentive paym entsto w hich they were natentitled.
ln thism anner,M edhostknow ingly caused false claim s,and false statem entsm aterialto false

claim s,to be subm itted to the Govem m ent.


197. M edhosthascaused federalM eaningfulU se incentive paym entsto bepaid for its
EHR system even though itssoftw are isflawed and unreliable and doesnotm eetfundam ental
requirem entsforperform ance asdefined by theM eaningfulUse criteria. These standardsfor
perfonnance are core requirem entsforany IIH R system . Evel
'y claim forpaym entslzbm itted to
the Governm entforincentive paym entsforuse ofEH R softw arethatisdefective and/ordoesnot
m eetM eaningfulU serequirem entsisafalse orfraudulentclaim in violation oftheFCA .
198. CHS knew thatM edhost'sEH R technology was defective and did notsatisfy
federalM eaningfulU se requirem ents. CH S and CH S hospitals knowingly presented and caused
to bepresented subm ission offalse claim st()the Governm entforEHR incentive paym entsto
which they w erenotentitled. CH S and CHS hospitalsalso presented and caused the presentm ent
offalse attestationsofcom pliance w ith M eaningfulUse requirements,which were m aterialto
theirfalse claim sforEHR incentivepaym erlts.
199. CH S knew thatthe m odularPULSE EHR software used by theform er-l'lM A
hospitals also did notsatisfy M eaningfulU se requirem ents. CHS and the form er-l-
lhlA hospitals
know ingly presented and caused thepresentm entoffalseclaim s,and m ade and caused to be
m ade false recordsand statem entsm aterialto false claim s,forEHR incentivepaym entsto which
they were notentitled.
200. By arranging forM edhostto provideCH S w ith valuable financialsoftware for
free in return forCHS'Spurchase offulllicenses ofM edhost'sEHR software suite,M edhostand
CH S know ingly and w illfully offered and accepted unlawfulrem uneration in violation ofthe
AK S. Com pliance w ith the AK S ism aterialto the Governm ent'sdecision to pay the claim sthat
(00077663;1) 54
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 55 of 57

CHS subm itted forpaym entorapprovalundertheM eaningfulUseprogram . A 11claim sm ade to


the Governm entunderthe M eaningfulU seprogram asaresultofservicestainted by these
unlaw fulpaym ents are false and/orfraudulelltwithin the m eaning oftheFCA .
201. Through the conductdiscussed above,the Defendantsknow ingly caused the
subm ission offalse claim s and false statem entsm aterialto false claim sto be subm itted to the
G overnm entin violation oftheFalse Claim sA ct.
False C laim sA ct
31U.S.C.QQ3729(a)(1)(A).(B).(C).& (G)
Relatorsreallege and incorporate by reference the allegationscontained in
paragraphs 1 through 201above asthough fully setforth herein.
Thisisa claim fortreble dam agesand penaltiesundertheFalse Claim sA ct,31

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

fraudulentclaim s forpaym entby the Governm ent.


By virtueofthe actsdescribed above,Defendantsknow ingly caused the
concealm entorim properavoidance ordecrease ofan obligation to pay ortransmitm oney or
property to the Governm ent;
By virtue ofthe actsdescribed above,D efendantsknowingly conspired w ith
othersto violate the FCA . M oreover,Defendantstook substantialstepstoward the completion of
the goals ofthatconspiracy by the conductalleged herein.
Relatorscannotatthistim e identify allofthe false claim sforpaym entthatwere
caused by D efendants'conduct. The false claim swerepresented by severalseparate entities.

(00077663k1j 55
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 56 of 57

Relators do nothave accessto the records ofallsuch false orfraudulentstatem ents,records,or

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.

(00077663)1)
Case 1:18-cv-20394-RNS Document 1 Entered on FLSD Docket 02/01/2018 Page 57 of 57

D ate:January 31,2018 By:Jf,J.


V &y W .D t
'ok,<paa.
'

ColetteG.M atzzie Jeffrey W .Dickstein(FL BarNo.


LukeJ.Diamond 434892)
PHILLIPS & COHEN LLP PHILLIPS & COHEN LLP
2000 M assachusettsAve.,NW Southe% tFinancialCenter
W ashington,DC 20036 200 S.BiscayneBlvd.,Suite2790
Te1:(202)833-4567 M inmi,Florida33131
Fax:(202)833-1815 Tel:(305)372-5200
jdickstein@ phillipsr dcohen.com
Edward Arens
PHILLIPS & COHEN LLP
100TheEmbarcadero,Suite 300
San Francisco,CA 94105 AttorneysforQuitam P/tzïnf#./,
l
Tel:(415)836-9000 D erekLewisandloey Neiman
Fax:(415)836-9001

(00077663)1J

You might also like