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INTEGRATED COMPLIANCE PLAN
UNIVERSITY OF ROCHESTER MEDICAL CENTER
AND UR MEDICINE AFFILIATES
ARTICLEI:ESTABLISHMENT,PURPOSEANDSCOPEOFTHEURMEDICINECOMPLIANCEPLAN.
A. INTRODUCTION:Thisdocumentisthe“URMedicineCompliancePlan(the“CompliancePlan”).ItwasadoptedbytheBoardoftheUniversityofRochesterMedicalCenter(“URMC”)onMay22,2018.ItsupersedestheUniversityofRochesterMedicalCenter–StrongHealthCompliancePlan(the“StrongHealthPlan”)datedDecember31,1998andtheUniversityofRochesterMedicalCenter–StrongHealthBillingCompliancePlandatedDecember31,1998.ThepurposeofthePlanistodescribetheintegratedURMedicineComplianceProgram(the“ComplianceProgram”)andtocreateaframeworkforitseffectiveoperation.
B. PURPOSESOFTHECOMPLIANCEPROGRAM:
1. Topromotehonest,ethicalbehaviorandfosteraculturewhereindividualsunderstandtheyareexpectedtoobeythelaw,reportimproperandillegalactivity,andconductthemselveswithIntegrityoftheHighestOrder;
2. Toachievecorrectdocumentation,codingandbillingforallhealthcareservices(includingthoseassociatedwithclinicalresearchstudyprotocolsatURMC)andcompliancewithapplicablelaws,regulations,policiesandmanualinstructionspertainingtoMedicare,Medicaidandfederalhealthcareprograms,whilereducing,totheextentpossible,practitionerburden.
3. Topreventanddetectfraud,wasteandabuse;
4. Toensurecompliancewiththelaws,regulationsandpoliciesthatapplytoStateandFederalHealthCarePrograms(collectively,“GovernmentProgramRequirements”),includingbutnotlimitedto,thefollowing:
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(i) TheStateandFederalCivilFalseClaimsActs,
(ii) TheFederalAnti‐kickbackLaw;
(iii) TheCivilMonetaryPenaltiesLaw;
(iv) ThePhysicianSelf‐Referral(Stark)Law;
(v) StateandFederalprohibitionsagainstemployingorcontractingwithdebarred,excludedorineligibleindividuals;
(vi) StateandFederalcriminalfraudstatutes.
5. TomitigatefinancialandreputationalrisktoURMCandURMedicineAffiliates;
6. TopromotetimelyandefficientComplianceProgramcoordinationamongURMCandURMedicineAffiliates;
7. ToimplementtheComplianceGuidancerecommendationsoftheOfficeoftheInspectorGeneraloftheUnitedStatesDepartmentofHealthandHumanServices(HHS/OIG);
8. TomeetmandatorycomplianceprogramrequirementsestablishedbyStateorFederallaw(the“MandatoryComplianceProgramRequirements”)includingthefollowing:
(i) Section363‐doftheNewYorkStateSocialServicesLawandPart521oftheRegulationsoftheNewYorkStateDepartmentofSocialServices(applicabletoMedicaidproviders);
(ii) Parts422and423oftheCMSMedicareRegulations(42CFRParts422and423)(applicabletoMedicareAdvantagecontractorsandMedicarePartDproviders);and
(iii) TheMedicareConditionsofParticipationforLongTermCareFacilities(42CFR483.85)(applicabletoSkilledNursingFacilities).
C. SCOPEOFTHEPROGRAM:TheComplianceProgramappliestothefollowing:
1. ToURMCandeachofitsDivisions;
2. SubjecttoSectionDbelow,toallcurrentandfuture“URMedicineAffiliates”,whichshallincludeall:
(i) Not‐for‐profitorganizationsengagedinthedeliveryofhealthcareitemsorservices,iftheUniversityofRochester(“UR”)isthesolememberoftheorganizationoradirectorindirectcorporateparentoftheorganization;
(ii) For‐profitcorporationsengagedinthedeliveryofhealthcareitemsorservices,iftheURoranyURMedicineAffiliateownsallorsubstantiallyalloftheshares.
3. TotheOfficersandBoardMembersofURMCandtotheOfficersandDirectorsofeachURMedicineAffiliate;
4. Toall“URMedicineClinicalandAdministrativeStaff”whichshallincludeallemployees,
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independentcontractorsandmembersofthemedicalstafforalliedhealthprofessionalstaffofURMC,anylicensedURMCfacility(e.g.,StrongMemorialHospital,EastmanInstituteofOralHealth)oranyURMedicineAffiliate,whoperformclinicaloradministrativeservicesonbehalfof,oronthepremisesof,anyURMCorURMedicineAffiliate.1
5. Exclusions:TheCompliancePlandoesnotapplytothefollowing:
(i) UniversityMedicalImaging,PC;
(ii) AccountableHealthPartners,IPA‐LLC;
(iii) AccountableHealthPartners,LLC;
D. AFFILIATESELF‐GOVERNANCEANDACCOUNTABILITY.
1. URMCacknowledgesthatURMedicineAffiliateshavegoverningboardsthatalsooverseecompliance.ItisthegoaloftheURMCComplianceProgramtoworkwithinthegovernancestructuresofeachURMedicineAffiliatetoprovideavailablepersonnelresourcesandexpertisetomeetsuchaffiliate’scomplianceobligations.
2. Consistentwiththatgoal,theCompliancePlandifferentiatesbetweenURMedicineAffiliatesthatrelyupontheURMCComplianceOfficetofulfillcoreresponsibilitiesunderthePlan(“CentrallyManaged”)andthosethatprimarilyutilizetheirownstafftofulfilltheseresponsibilities(“LocallyManaged”).
3. WhetheranAffiliate’scomplianceactivitiesareCentrallyManagedorLocallyManaged,theAffiliateisaccountable,toitsSeniorLeadershipandBoardofDirectorsandtoURMC,foroperatinginaccordancewithapplicablelawsandformeetingthestandardsinthisCompliancePlan.
4. ComplianceactivitiesofaURMedicineAffiliatemaybetransferredfromLocalManagementtoCentralManagementorfromCentralManagementtoLocalManagementuponagreementofURMCandtheURMedicineAffiliate.
5. Currently,HighlandHospitalisCentrallyManaged.AllotherAffiliatesareLocallyManaged.IfanAffiliatebecomesCentrallyManagedpursuanttoSection4aboveaftertheadoptionoftheCompliancePlan,allprovisionsoftheCompliancePlanthatapplytoCentrallyManagedAffiliatesasofthedatetheAffiliatebecomesCentrallyManagedshallautomaticallyapplytothatAffiliatewithoutneedforfurtheramendmentofthisCompliancePlanorapprovalbytheURMCBoard.
E. COORDINATIONWITHOTHERREGULATORYOVERSIGHTACTIVITIES:
1. TheComplianceProgramwillbecarriedoutwithanawarenessofotherlaws,regulationsandstandardsapplicabletotheoperationsofURMCandURMedicineAffiliatesincludingthosethatpertaintohealthcareprivacyandsecurity,quality,credentialing,financialaccounting,human
1 Specificprogramrequirementsmaybedifferentforemployedindividualsthanfornon‐employedindividuals.RequirementsmayalsodifferforindividualswhoperformservicesbilledbyURMCoraURMedicineAffiliatethanforthosewhodonot.
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subjectprotection,researchintegrity,andtothedrugdiscountprogramauthorizedbySection340BofthePublicHealthServicesAct.
2. Whenpotentialrisksarisingunderotherstatutoryandregulatoryschemesareidentified,referralswillbemadetotheindividualsresponsibleformanagingtherisks.Effortswillalsobemadetocoordinateactivitiestoensureappropriatecoverageandtoavoidduplicationofeffort.
3. ForpurposesofmeetingtherequirementsoftheNewYorkStateMedicaidProgram(see18NYCRR521.3[a])theexistingprogramsofURMCandURMedicineAffiliatesforcredentialing,medicalnecessity,qualityofcareandmandatoryreportingwillbeconsideredtobepartoftheComplianceProgram.Toensureappropriatecoordination,theComplianceProgramSteeringCommitteedescribedbelowwillincludeindividualsresponsibleforthosefunctions.
ARTICLEII:COMPLIANCEPROGRAMPERSONNELANDSTAFFING.
A. ComplianceOfficer(s)
1. URMCChiefComplianceOfficer:
(i) TheChiefComplianceOfficerisanindividualwithexpertiseandtraininginhealthcarecompliance.Heorshehasanunderstandingoftherequirementsforcorrectdiagnosisandprocedurecodinganddocumentation,andthelaws,regulationsandpoliciesthatpertaintotheprovisionof,andbillingfor,healthcareservicesprovidedtoMedicareandMedicaidbeneficiaries.HeorshehasexpertiseintheGovernmentProgramRequirements.
(ii) TheChiefComplianceOfficerreportsdirectlytotheSeniorVicePresidentforHealthSciences.Heorsheisnot,andshallnot,reporttotheChiefFinancialOfficer,theGeneralCounseloranyoftheirsubordinates.
(iii) TheChiefComplianceOfficerperiodicallyreportstotheURMCBoardoritsAuditandRiskCommitteeontheactivitiesoftheComplianceProgramandshallperiodicallymeetwiththeURMCBoardorAuditandRiskCommitteeinexecutivesession.
(iv) OnehundredpercentoftheChiefComplianceOfficer’stimeandeffortwillbedevotedtotheoperationoftheComplianceProgram.
(v) TheChiefComplianceOfficer’sresponsibilitiesincludethefollowing:
(a) ImplementingtheURMedicineCompliancePlan;
(b) ManagingtheComplianceProgramofURMCandeachCentrallyManagedURMedicineAffiliate;
(c) ManagingtheURMCComplianceOfficeandsupervisingComplianceOfficeAnalysts,EducatorsandAuditors;
(d) EvaluatingComplianceProgramrelatedrisk;
(e) Identifyingareasofpotentialnon‐compliancewithGovernmentProgram
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Requirements;
(f) DevelopingandfulfillingannualcomplianceworkplansforURMCandforallCentrallyManagedURMedicineAffiliates;
(g) OverseeingandcoordinatingresponsebyURMCandCentrallyManagedURMedicineAffiliatestoexternalauditsfromhealthinsurancepayers,“HealthOversightAgencies”,suchastheOfficeoftheInspectorGeneraloftheDepartmentofHealthandHumanServices(“OIG/HHS”),theOfficeoftheNewYorkStateMedicaidInspectorGeneral(“OMIG”),theCenterforMedicareandMedicaidServices(“CMS”),andcontractorsactingonbehalfofhealthinsurancepayersandHealthOversightAgencies(“ExternalAudits”);
(h) Conductinginternalcomplianceinvestigations;
(i) AssistingCounsel,asdirected,inrespondingtoexternalcivilandcriminalinvestigationsinitiatedbytheUnitedStatesDepartmentofJustice,theUnitedStatesAttorney’sOffice,theAttorneyGeneraloftheStateofNewYorkortheMedicaidFraudControlUnit;
(j) Facilitatingidentification,quantificationandreturnofidentifiedoverpaymentsrelatedtoURMCandCentrallyManagedURMedicineAffiliates,andassistingwithquantificationandreturnofoverpaymentsidentifiedbyLocallyManagedURMedicineAffiliates;
(k) PeriodicallyassessingtheComplianceProgram’sfulfillmentoftheMandatoryComplianceProgramRequirements;
(l) EvaluatingthesufficiencyoftheComplianceProgram’sresources,includingtechnologyandstaffing;
(m) EngaginginstrategicplanningonbehalfoftheComplianceProgram;
(n) PromotingdaytodayComplianceProgramcollaborationandcommunicationamongallURMCandallURMedicineAffiliates;
(o) MonitoringComplianceProgramactivitiesofLocallyManagedComplianceProgramsofURMedicineAffiliates;
(p) IdentifyingandpursuingopportunitiesforgreaterURMedicineComplianceProgramintegration,coordinationandresourcesharing.
2. URResearchComplianceOfficer
(i) TheURResearchComplianceOfficershallreporttotheAssociateVicePresidentforResearchAdministrationandtotheViceDeanforResearch.
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(ii) TheURResearchComplianceOfficerisanindividualwithexpertiseandtraininginclinicalresearchbillingcompliance.Heorshehasanunderstandingofthelaws,regulationsandpoliciesthatpertaintothebillingforhealthcareservicesassociatedtoclinicalresearchprotocolsprovidedtoMedicareandMedicaidbeneficiaries.
(iii) TheURResearchComplianceOfficerperiodicallyreportstotheURMCBoardortotheURMCAuditandRiskCommittee.
(iv) TheURResearchComplianceOfficer’sresponsibilitiesshallincludethefollowing:
(a) Evaluatingbillingriskandfinancialriskpertainingtoclinicalresearchstudyactivity;
(b) Developingandfulfillingannualworkplansforclinicalresearchstudybillingrisk;
(c) Facilitatingidentification,quantificationandreturnofidentifiedoverpaymentsrelatedtoclinicalresearchbillingtransactions;
(d) Overseeingresponsestoanyexternalauditsinvolvingclinicalresearchbillingtransactions;
(e) Conductinginternalcomplianceinvestigationsinvolvingclinicalresearchbillingtransactions;
(f) Providingtrainingopportunitiesforfaculty,otherclinicalresearchstudyteammembers,andadministrativepersonnelregardingclinicalresearchstudybillingcompliancerequirements;and
(g) CollaboratingwiththeURMCChiefComplianceOfficerandotherclinicalresearchoperationsleadership–asapplicable‐oneffortstocoordinate,integrateandshareresources.
(v) TheURResearchComplianceOfficershallpromptlynotifytheURMCChiefComplianceOfficerofthefollowing:
a) Anyactualorsuspectedidentifiedoverpaymentsthatarematerialinamountorthataffectalargenumberofclaims;
b) Anyactualorsuspectedinstanceoffraudormaterialwasteorabuse;and
c) TheinitiationofanyexternalauditsbyHealthOversightAgenciesortheirContactors.
(vi) ToensureconsistencyandcoordinationamongURMCandURMedicineAffiliates,theURResearchComplianceOfficerwillinvolvetheURMCChiefComplianceOfficerandCounselinanyevaluationordecisiontomakeaself‐disclosureandwillcoordinatewiththeURMCChiefComplianceOfficerandotherclinicalresearchoperationsleadership–asapplicable–regardingthepreparationandsubmissionofanyself‐disclosures.
3. AffiliateComplianceOfficers.
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(i) EachURMedicineAffiliatewithaLocallyManagedComplianceProgramshallappointaComplianceOfficer.TheAffiliateComplianceOfficershallreporttoaseniormemberoftheURMedicineAffiliate’sleadershipteamwhoshallnotbetheAffiliate’sChiefFinancialOfficerorGeneralCounseloranyoftheirsubordinates.TheAffiliateComplianceOfficermayhaveresponsibilityforoneormoreURMedicineAffiliatesthatareunderthecommoncontrolofasingleholdingcompany(e.g.ThompsonHealth).
(ii)TheAffiliateComplianceOfficerisanindividualwithexpertiseandtraininginhealthcarecompliance.Heorshehasanunderstandingoftherequirementsforcorrectdiagnosisandprocedurecodinganddocumentation,andthelaws,regulationsandpoliciesthatpertaintothebillingforhealthcareservicesprovidedtoMedicareandMedicaidbeneficiaries.HeorsheunderstandstheGovernmentProgramRequirementsapplicabletohisorherURMedicineAffiliate(s).
(iii)TheAffiliateComplianceOfficershallperiodicallyreportdirectlytotheAffiliate’sBoardofDirectorsandtotheAffiliateAuditCommittee,ComplianceCommitteeorotherBoardCommitteeresponsibleforcomplianceoversightontheactivitiesoftheAffiliateComplianceProgram,andshallbeaffordedtheopportunitytomeetwiththeBoardortheCommitteeinexecutivesession.
(iv)TheAffiliateComplianceOfficer’sresponsibilitiesshallincludethefollowing:
(a) DaytodaytooperationoftheAffiliateComplianceProgram;
(b) EvaluatingriskpertainingtotheAffiliate;
(c) IdentifyingareasofpotentialAffiliatenon‐compliancewithGovernmentProgramRequirements;
(d) DevelopingandfulfillingannualworkplansfortheAffiliate;
(e) Facilitatingidentification,quantificationandreturnofidentifiedoverpaymentsinvolvingtheAffiliate;
(f) OverseeingresponsestoExternalAuditsinvolvingtheAffiliate;
(g) AssistingCounsel,asdirected,inrespondingtoexternalcivilandcriminalinvestigationsinitiatedbytheUnitedStatesDepartmentofJustice,theUnitedStatesAttorney’sOffice,theAttorneyGeneraloftheStateofNewYorkortheMedicaidFraudControlUnit;
(h) ConductinginternalcomplianceinvestigationsinvolvingtheAffiliate;
(i) PeriodicallyassessingtheAffiliate’sfulfillmentoftheMandatoryComplianceProgramRequirements;
(j) EvaluatingthesufficiencyoftheAffiliate’sComplianceProgramresources,includingtechnologyandstaffing;
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(k) CollaboratingwithURMCandotherURMedicineAffiliatesoneffortstocoordinate,integrateandshareresources.
(v) TheAffiliateComplianceOfficershallpromptlynotifytheURMCChiefComplianceOfficerofthefollowing:
a) AnyactualorsuspectedidentifiedoverpaymentsreceivedbytheURMedicineAffiliatethatarematerialinamountorthataffectalargenumberofclaims;
b) Anyactualorsuspectedmaterialnon‐compliancebytheURMedicineAffiliatewiththeGovernmentProgramRequirements;
c) Anyactualorsuspectedinstanceoffraudormaterialwasteorabuse;
d) TheinitiationofanyExternalAuditsbyHealthOversightAgenciesortheirContactors.
(vi) ToensureconsistencyandcoordinationamongURMCandURMedicineAffiliates,theAffiliateComplianceOfficerwillinvolvetheURMCChiefComplianceOfficerandCounselinanyevaluationordecisiontomakeaself‐disclosureandwillcoordinatewiththeURMCChiefComplianceOfficerthepreparationandsubmissionofanyself‐disclosures.
B. ComplianceProgramMedicalDirector:
1. TheComplianceProgramMedicalDirectoristheChairorChiefofaURMCClinicalDepartmentorDivisionoranothermemberoftheURMCclinicalfacultywhohasexpertiseinhealthcaredocumentation,coding,billingand/orreimbursement;
2. TheComplianceProgramMedicalDirectorisasenioradvisortotheChiefComplianceOfficer,URResearchComplianceOfficer,AffiliateComplianceOfficersandtheComplianceProgram;
3. TheComplianceProgramMedicalDirectorworkswiththeChiefComplianceOfficertoidentifyrisk,planstrategicallyforthecontinuingdevelopmentoftheComplianceProgram,andprioritizeComplianceProgramactivities;
4. TheComplianceMedicalDirectorisanadvocateforcomplianceandactsasliaisontoURMCSeniorLeadership,toChairsandChiefs,tomembersofURMFGandtheURMCMedicalandDentalStaff,theAlliedHealthProfessionalStaffandotherclinicians,andtoAffiliateSeniorLeadershipandclinicalproviders;
5. TheComplianceMedicalDirectorservesasaresourcetotheComplianceProgramonadaytodaybasisonmattersrequiringclinicalexpertise,andassiststheChiefComplianceOfficer,URResearchComplianceOfficerandAffiliateComplianceOfficersininterpretingclinicalquestionsandresolvingcompliance‐relateddisputeswithclinicalproviders;
6. TheChiefComplianceOfficerandComplianceMedicalDirectorconferregularlyonmattersrelatedtotheoperationoftheComplianceProgram.
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C. TheComplianceProgramStaff.
1. TheComplianceProgramshallmaintainahighly‐qualifiedstaffwhoaresufficientinnumberandtrainingtocarryouttheeducation,auditing,andmonitoringactivitiesoftheComplianceProgramasdescribedintheCompliancePlan,takingintoaccountthevolumeandcomplexityoftheoperationsofURMCanditsURMedicineAffiliates,thedegreetowhichURMedicineAffiliatesareCentrallyManagedorLocallyManaged,andthedegreetowhichURMedicineAffiliatesandURMCclinicaldepartmentsandprogramsengageinself‐auditingandmonitoringactivities;
2. UnderthedirectionoftheChiefComplianceOfficer,theComplianceProgramstaffidentifiesrisk,providescomplianceeducationandtrainingtoproviders,administratorsandstaff,assistsindevelopingandfulfillingtheannualworkplan,engagesinauditingandmonitoringactivity,assistswiththeresponsetoexternalauditsandinvestigationsandotherwiseassiststheChiefComplianceOfficerincarryingouthisorherresponsibilities.
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ARTICLEIII:COMPLIANCECOMMITTEESTRUCTURE
A. TheURMedicineComplianceProgramSteeringCommittee.
1. TheURMedicineComplianceProgramSteeringCommitteeisresponsibleforthefollowing:
(i) PeriodicallyreviewingandupdatingtheCompliancePlantoreflectchangesinthestructureandoperationofURMCandtheURMedicineAffiliates,changesinapplicablelaw,andnewlyidentifiedandemergingrisks,andtoensurethattheCompliancePlancontinuestomeetMandatoryComplianceProgramRequirements;
(ii) ProvidingoversighttotheComplianceProgramtoensureitisbeingcarriedouteffectivelyandefficiently;
(iii) Adopting,reviewingandrevisingComplianceProgrampoliciesandproceduresapplicabletoURMCandtoURMedicineAffiliates;
(iv) ApprovingtheannualworkplanfortheURMCComplianceProgram,includingclinicalresearchstudyactivity;
(v) ReviewingtheannualworkplansforURMedicineAffiliates;
(vi) ReceivingreportsoncomplianceauditingandmonitoringactivityfromtheURMCComplianceProgram,includingclinicalresearchstudyactivity,andfromURMedicineAffiliates;
(vii) FacilitatingstrategicplanningfortheComplianceProgram;
(viii) AppointingAd‐Hocandstandingcommitteesandworkgroupstocarryoutdelegatedand/oradvisoryactivities;
(ix) Identifyingopportunitiestoshareresourcesandoptimizeprogramintegrationandresourceutilization;
(x) Championinghonestethicalbehaviorandacultureofcompliancethroughouttheenterprise.
2. TheURMedicineComplianceProgramSteeringCommitteemembershipshallincludeseniorleadershipfromURMCandURMedicineAffiliates,includingthefollowing:
(i) TheURMCChiefFinancialOfficer;
(ii) TheChiefExecutiveOfficer,ChiefOperatingOfficerandChiefFinancialOfficersofStrongMemorialHospital;
(iii) TheChiefFinancialOfficerandChiefComplianceOfficerofEastmanInstituteforOralHealth;
(iv) TheChiefExecutiveOfficer,ChiefOperatingOfficerandChiefFinancialOfficeroftheUniversityofRochesterMedicalFacultyGroup;
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(v) TheChiefExecutiveOfficer,ChiefOperatingOfficerandChiefFinancialOfficerofeachURMedicineAffiliatehospital;
(vi) TheComplianceProgramMedicalDirector,theURMCChiefComplianceOfficerandtheComplianceOfficerforeachLocallyManagedAffiliate;
(vii) TheURMCMedicalDirectorandindividualsresponsibleforcredentialing,medicalnecessity,qualityofcareandmandatoryreporting;
(viii) TheURMCDirectorofPharmacyandthe340BBusinessManager;
(ix) TheResearchComplianceOfficer;
(x) TheMedicalCenterGeneralCounselandtheSeniorCounselassignedtohealthcarecompliance;
(xi) EmployedPrimaryCareandSpecialtyPhysicianswhoareknowledgeableandcommittedtothepurposesandgoalsoftheComplianceProgram;
(xii) IndividualsresponsibleforareasintegraltothesuccessoftheComplianceProgramandformeetingtheGovernmentProgramRequirements,includingindividualsvestedwithprogrammaticoroperationalresponsibilityforclinicaloperations,healthinformationmanagement,electronicmedicalrecordoptimization,accreditation,revenueintegrity,revenuecyclemanagementandpatientfinancialservices.
3. TheComplianceProgramSteeringCommitteeshallbeco‐chairedbytheChiefComplianceOfficerandbyaseniorexecutiveofaURMCdivisionoraURMedicineAffiliateonarotatingbasis.
4. InJanuaryofeachyear,eachLocallyManagedaffiliateshallpresenttotheComplianceProgramSteeringCommitteeanannualreport.ThereportshallbeinsuchformandshallcontainsuchcontentastheCommitteeprescribes,whichshallinclude,butnotbelimitedto,theLocallyManagedaffiliate’sworkplanforthenextcalendaryearandtheauditingandmonitoringactivities,externalaudits,investigations,falseclaimsactlitigation,identifiedcomplianceissuesandprioritiesduringtheprecedingcalendaryear.2
5. InJulyofeachyear,theChiefComplianceOfficerandtheURResearchComplianceOfficershallpresenttotheComplianceProgramSteeringCommitteeajointannualreport.ThereportshallbeinsuchformandshallcontainsuchcontentastheCommitteeprescribes,whichshallinclude,butnotbelimitedto,thejointworkplanforthenextcalendaryearforURMCComplianceProgram–includingclinicalresearchstudyactivity‐andforCentrallyManagedAffiliates.Thejointannualreportwillalsosummarizetheself‐initiatedauditingandmonitoringactivities,anyexternalaudits,anyinvestigations,andanyfalseclaimsactlitigationduringtheprecedingcalendaryear,includingidentifiedcomplianceissues
2 Distributionofsomeportionsofthereportmaybelimitedtoprotecttheconfidentialityofongoinginvestigations,tomaintainattorneyclientprivilege,shieldtheidentifyofindividualswhosoughtanonymityorconfidentiality,orforotherappropriatereasons
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6. TheCommitteeshallmeetquarterlyorbi‐monthly,asdeterminedbythechairs.Ad‐hoccommitteesestablishedbytheCommitteemaymeetatdifferentintervalsbetweenmeetingsoftheCommitteetoaccomplishspecialprojectsandtoensurethatthemeetingsoftheCommitteeareefficientandeffective.
B. TheURMedicineComplianceExecutiveCommittee.
1. TheURMedicineComplianceExecutiveCommitteeshallberesponsibleforplanningthemeetingsoftheURMedicineComplianceProgramSteeringCommittee.TheCommitteeshallalsomeettodiscussissuesofcommoncomplianceconcern.
2. Membershiponthecommitteeshallconsistofthefollowing:
(i) TheComplianceProgramMedicalDirector;
(ii) TheChiefComplianceOfficer;
(iii) TheResearchComplianceOfficer;
(iv) TheCo‐ChairoftheURMedicineComplianceProgramSteeringCommittee;
(v) TheURMCChiefFinancialOfficer;
(vi) TheMedicalCenterGeneralCounsel;
(vii) TheSeniorCounselassignedtocompliance;
(viii) TheComplianceOfficersfortheLocallyManagedAffiliates.
3. Thecommitteewillmeetregularly(monthlyorbi‐monthly)inmonthswhentheComplianceProgramSteeringCommitteedoesnotmeet.
C. AffiliateComplianceCommittees.EachLocallyManagedAffiliateshallestablishandmaintainanAffiliateComplianceCommitteewhichshallberesponsibleforprovidinglocaloversightoftheLocallyManagedAffiliate’scomplianceprogram.
D. OtherCommittees.TheChiefComplianceOfficerandtheAffiliateComplianceOfficersmaydevelopsuchotherspecializedcommitteesandworkgroupsasarenecessarytopromoteandfulfilltheobjectivesoftheprogram.
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ARTICLEIV:POLICIES,PROCEDURESANDSTANDARDSOFCONDUCT
A. TheURMedicineComplianceProgramSteeringCommitteeshallberesponsiblefordeveloping,adoptingandrecommendingforapprovalpoliciesandproceduresthatpertaintotheoperationoftheComplianceProgram.
B. Policiesshallbeinoneoftwoforms:
1. ComplianceProgramStandards;
2. ComplianceProgramPolicies.
C. ComplianceProgramStandards:
1. ComplianceProgramStandardssetforthstandardsforprogramoperationthatapplytoURMCandtoallURMedicineAffiliates;
2. Theyprescribeexpectationspertainingtospecificcompliancegovernanceoroperationalissues,suchastheneedforURMCandeachURMedicineAffiliatetohaveapolicyandprocesstoensurethattheorganizationdoesnothireindividualswhoareexcludedfromparticipationinfederalhealthcareprograms;
3. ComplianceProgramStandardsensurethatallCentrallyManagedandLocallyManagedprogramsmeetthesamehighlevelofqualityandeffectivenessandthateachURMedicineAffiliatefulfillsitsobligationtobeaccountabletoURMConmattersofcompliance;
4. ComplianceProgramStandardsadoptedbytheCommitteearesubjecttothefinalapprovaloftheURMCBoard.
D. ComplianceProgramPolicies:
1. ComplianceProgramPoliciesdirectlyregulateactivityatURMCandattheURMedicineAffiliatestowhichtheyapply;
2. ComplianceProgramPoliciesaresubjecttotheapprovaloftheBoardorGoverningBodyortheorganization(s)towhichtheypertain;
3. ItisanticipatedthatComplianceProgramPolicieswillbeadoptedtoapply,inthefirstinstance,toURMC,andwillserveasmodelsthatmaybeadaptedforusebyLocallyManagedURMedicineAffiliates.
E. PolicyStatshallbetheofficialrepositoryfor:
1. ComplianceProgramStandardsadoptedbytheComplianceProgramSteeringCommittee;
2. ComplianceProgramPoliciesapprovedbytheURMCBoard;and,
3. ComplianceProgramPoliciesapprovedbytheHighlandBoard.
F. ComplianceProgramStandardsandComplianceProgramPoliciesshallbesubjecttoreview
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biennially.Theindividual(s)identifiedasthepolicyownershallberesponsibleforensuringthatthereviewiscompleted;
G. EachLocallyManagedAffiliateshallberesponsibleforadoptingappropriatepolicies,includingaCodeofConductconsistentwiththisCompliancePlanandanysubsequentlyadoptedComplianceProgramStandards,andformaintainingapolicymanualthatincludesthecurrentpoliciesandproceduresapplicabletotheLocallyManagedComplianceProgram.
H. PolicieswilleitherbedistributedperiodicallytoAffectedIndividuals,ormadegenerallyavailabletoAffectedIndividualsviapostingontheorganization’spublicorinternalwebsite.
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ARTICLEV:REGULARTRAININGANDEDUCATION
A. URMCandeachURMedicineAffiliateshallprovideregulareffectivetrainingtoalldirectors,officersandemployeeswhoareinvolvedinanywayintheprovisionofhealthcareservicesoradministrativeormanagerialactivitiesrelatedtotheprovisionofhealthcareservices(“AffectedIndividuals”).
B. Trainingmayvarybaseduponjobclassification,levelofauthorityandindividualresponsibilities,but,ataminimum,shallgenerallyincludethefollowingtopics:
1. Adescriptionofthecomplianceprogram;
2. AreviewoftheCodeofConduct;
3. KeylawsapplicabletotheMedicareandMedicaidprograms,includingtheGovernmentProgramRequirements;
4. Examplesofreportablenon‐compliance;
5. Adiscussionoffraud,wasteandabuse;
6. Adiscussionoftheorganization’scommitmenttobusinessethicsandoftheorganizationandemployee’sobligationstocomplywiththerequirementsoftheMedicareandMedicaidprograms;
7. Anoverviewofhowandwheretoaskcompliancequestionsandtoreportsuspectednoncompliance,fraud,wasteandabuse,includingtheavailabilityoftheIntegrityHotlineandtheopportunityitaffordstoreportsuspectedproblemsconfidentiallyoranonymously;
8. Adiscussionoftheobligationtorefrainfromharassment,intimidationorretaliationagainstanypersonforraisingcompliancerelatedissues,orforreportingactualorsuspectednoncomplianceorfraud,wasteorabuse;
9. Areviewofthedisciplinaryguidelinesfornon‐compliantorfraudulentbehavior;
10. AnyothermattersdeemedhelpfultofurtheringthegoalsoftheComplianceProgram;
11. AnyothermattersrequiredtofulfilltheMandatoryComplianceProgramRequirements.
C. Trainingmaybeprovidedinperson,electronicallyorbyanyothereffectivemeans.
D. TrainingcoveringthesubjectsdescribedabovewillbeprovidedtoallAffectedIndividualswithinninety(90)daysoftheAffectedIndividual’semploymentorappointment,andannuallythereafter.
E. URMCandeachURMedicineAffiliateshallmaintainrecordsdemonstratingcompliancewiththetrainingrequirementsoutlinedinthisArticleforaperiodoftenyearsfollowingtheyearinwhichthetrainingwasprovided.
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ARTICLEVI:EFFECTIVELINESOFCOMMUNICATION
A. URMCandeachURMedicineAffiliateshallmaintainopenlinesofcommunicationtoensuretimelyandeffectivecommunicationtotheapplicableComplianceOfficerofreportsofactualorsuspectednon‐complianceorfraud,wasteandabuse.
B. TheChiefComplianceOfficer,theAffiliateComplianceOfficersandtheResearchComplianceOfficershallbeidentifiedbytitleintheapplicableon‐linephonedirectoryforURMCortheURMedicineAffiliate.ThephonenumbersandemailaddressesfortheseindividualsandfortheComplianceOfficeshallbeavailableontheapplicableorganization’swebsite.
C. Thelinesofcommunicationshallincludeoneormorehotlinesthatallowforanonymousreportingofcomplianceconcerns.Hotlinesmaybeoperatedindividuallyorsharedbyaffiliates.
D. Thehotline(s)willbeavailabletoreceivemessages24hoursperday,365daysperyearandwillbewell‐publicizedtotheapplicableURMedicineClinicalandAdministrativeStaffthroughmeanssuchaspostersandpostingontheorganization’sinternalorexternalhomepage.
E. TheComplianceOfficeandtheComplianceOfficerforeachLocallyManagedURMedicineAffiliateshallmaintainalogofhotlinecalls,whichshallincludeatleastthefollowinginformation:
1. Thedateandtimeofthecall;
2. Thenatureofthereportedcomplaint;
3. Theactiontakentofacilitateresolutionofthecomplaint,whichmayincludereferraltoanotheroperationalarea(e.g.,theOfficeofCounsel,thePrivacyOffice,HumanResourcesorPatientFinancialServices);
4. Theresolution.
F. ThelogsforeachURMedicineAffiliatewillbesubmittedonaquarterlybasistotheChiefComplianceOfficer.TheURMCChiefComplianceOfficerwillsubmitthelogsquarterlytotheURMCChiefFinancialOfficerandtheURSeniorVicePresidentforAdministrationandFinanceandwillcompilethelogsannuallyintoareporttobesubmittedtotheURMCAuditandRiskCommitteeandtotheURBoardofTrustees.Whenappropriate,dueconsiderationshallbegiventoredactionoflogcontenttopreservecalleranonymity.
G. URMCandeachLocallyManagedAffiliateshallpromptlyforwardanyhotlinecallinvolvinganotherAffiliatetotheComplianceOfficerresponsibleforthatAffiliate.
H. CurrenthotlinesmaintainedbyURMCandAffiliatesincludethefollowing:
1. URMCIntegrityHotline756‐8888Covers:URMC,HighlandHospital,HighlandsatBrighton,HighlandsLivingCenterandNicholasNoyesHospital,St.James
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2. FFThompsonHotline:396‐6234CoversFFThompsonHospitalandMMEwingContinuingCareCenter
3. JonesMemorialHospitalIntegrityHotline596‐4095
4. URMedicineHomeCareIntegrityHotline(585)274‐4256Covers:VisitingNurseServiceofRochesterandMonroeCounty,FingerLakesVisitingNurseService,VisitingNurseHospiceandOntarioYatesHospice.
I. Everyeffortwillbemadetoprotecttheanonymityofanyindividualwhoreportsaconcernanonymously.Everyeffortwillbemadetolimitdisclosureoftheidentityofanyindividualwhobringsforwardanyconcernconfidentially,tothosewhohaveabusinessneedtoknowtheindividual’sidentity.Sometimes,however,theinstitution’sresponsibilitytoinvestigateoraddressaviolationwilloverrideanindividual’sdesireforanonymityorconfidentiality;
J. Noindividualmayberetaliatedagainst,harassedorintimidatedforsubmittingareportofpotentialnon‐complianceingoodfaith,whetherornotthereportturnsouttobewell‐founded.AnyindividualcoveredbytheComplianceProgramwhoengagesinretaliation,harassmentorintimidationwillbesubjecttofulldisciplinaryactionuptoandincludingterminationofemploymentandlossofmedicalstaffprivileges.
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ARTICLEVII:DISCIPLINARYSTANDARDS
A. URMCandeachURMedicineAffiliateshallevaluatetheimposition,and,whenappropriate,shallimpose,disciplineuponanyOfficerorDirectorofURMCoranyURMedicineAffiliate,anduponanymemberoftheClinicalandAdministrativeStaffofURMCoranyURMedicineAffiliatewhoengagesinthefollowingconduct:
1. KnowinglyorrecklesslycausingorcontributingtothereceiptofanyoverpaymentbyURMCoranyURMedicineAffiliatethroughfailuretocomplywithanylaw,regulation,rule,manualinstructionorpolicy,pertainingtothesubmissionofclaimsforpaymenttoanyhealthcareprogram;
2. Committingorparticipatinginthecommissionofanyactoffraud,wasteorabuse;
3. Violatinganyapplicablelaw,includinganyGovernmentProgramRequirementoranyMandatoryComplianceProgramRequirement;
4. ViolatinganyCompliancePolicyadoptedbyURMCoranyURMedicineAffiliate;
5. FailingtopromptlyreporttotheappropriateComplianceOfficertheidentificationofanynon‐routine/systematicoverpaymentsreceivedforanyhealthcareitemsorservices;
6. Harassing,intimidating,discharging,demoting,threatening,suspending,discriminatingagainst,orinanyothermanner,retaliatingagainstanyindividualfor:
i. Submittingingoodfaithareportofpotentialnon‐compliance,whetherornotthereportturnsouttobewell‐founded;
ii. Cooperatingorparticipatingingoodfaithinanyinternalorinanyexternalinvestigationorinquiryconductedbyanystateorfederalgovernmentagencyorcontractor;
iii. EngaginginconductinfurtheranceofaclaimundereithertheStateorFederalCivilFalseClaimsActs;
iv. PreventingorattemptingtopreventaviolationorviolationsoftheStateorFederalCivilFalseClaimsActs.
7. Failingtoreport,oractivelyconcealing,anyviolationofthestandardslistedabove.
B. Thelistaboveisnotexhaustive.NordoesitlimitorreducethetypesorrangeofbehaviorthatmaysubjectanOfficer,DirectorormemberoftheClinicalandAdministrativeStaffofURMCoranyURMedicineAffiliatetodisciplinaryactionunderapplicablelaw,oranyotherpolicy,procedureorstandardadoptedbyURMCoranyURMedicineAffiliate.
C. Impositionofanydisciplinaryactionshallbeconsistentwithapplicablelaw,humanresourcepolicies,medicalstaffby‐lawsandotherstandards(including,inthecaseofURMC,theFacultyHandbookandtheRegulationsoftheFacultyoftheSchoolofMedicineandDentistry),includinganydueprocessrequirements.
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D. Disciplineshallbeimposedfairlyandequitablybaseduponfullconsiderationofthetotalityoftheapplicablecircumstances.Factorsthatmaybetakenintoaccountinclude,withoutlimitation:thepresenceorabsenceofbadfaithorintentionalmisconduct;theprevalenceanddurationoftheconduct;theknowledge,training,responsibilityandexperienceoftheindividual;whetherornottheindividualpromptlyreportedtheissuewhenitwasidentified;thedegreeofcooperationandassistanceprovidedbytheindividualinresolvingtheissue;thecomplexityoftheissueandtheclarityoftheavailableguidancerelatedtotheissue;operationalimpedimentstoachievingeffectivecompliance;adherenceornon‐adherencetopriorcomplianceorotherexpertadvicefurnishedtotheindividualabouttheissue;whetherthebehaviorwasisolated,pervasiveorpersistent;andwhetherimpositionofdisciplinaryactionwouldfurtherordetractfromtheComplianceProgram’soverridinggoalofencouragingindividualstoreportandhelpresolveidentifiedissues.
E. Disciplinaryactionwillbeappropriatetothecircumstances.Anon‐exhaustivelistofdisciplinaryactionsmayincludeaverbalorwrittenwarning,suspension,privilegerevocation,adjustmenttocompensation,demotion,reassignment,supervisedpractice,ortermination.
F. TheCodeofConductforURMCandeachURMedicineAffiliatewilladdressthegroundsfordisciplinesetforthinthispolicy.
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ARTICLEIX:AUDITINGANDMONITORING
A. URMCandeachLocallyManagedURMedicineAffiliate,shalldevelopawrittenworkplanwhichshalldescribetheauditingandmonitoringactivitiesintendedtobeundertakenbyURMCortheURMedicineAffiliateduringtheapplicableyear.TheURMCplanshallcoverURMCandeachCentrallyManagedAffiliateandshallbedevelopedonafiscalyearbasis.LocallyManagedplansforURMedicineAffiliatesshallbedevelopedonacalendaryearbasis.
B. EachWorkPlanshallbedevelopedbaseduponajudgmentalassessmentofthecompliancerisksfacedbytheorganizationandExternalAuditplansannouncedbyHealthOversightAgenciessuchastheOIGorOMIGintheirworkplans.TheyshallalsotakeintoaccountrisksidentifiedelsewherewithintheURMedicinesystem.
C. EachWorkPlanshallidentifytheindividualorindividualsresponsibleforundertakingtheauditingandmonitoringactivity,whichmayincludecentralComplianceOfficepersonnel,externalauditorsorcontractors,orClinicalandAdministrativeStaffwhohavedaytodayresponsibilityforthesubjectmatterunderreview.
D. Onanannualbasis,URMCandeachLocallyManagedURMedicineAffiliateshallsubmittotheComplianceProgramSteeringCommitteeanannualreportinsuchformandcontainingsuchcontentastheCommitteeprescribes,whichshallinclude,butnotbelimitedto,theLocallyManagedaffiliate’sworkplanforthenextcalendaryearandshalldescribetheauditingandmonitoringactivitiescarriedoutduringtheprecedingcalendaryear.3
E. TheChiefComplianceOfficerandtheComplianceOfficersfortheLocallyManagedURMedicineAffiliateswillworktoidentifyopportunitiestosharepersonnel,audittoolsandotherworkproducttopromoteefficiencyandtoreduceduplicationofeffortandinconsistencyinresults.
3 Distributionofsomeportionsofthereportmaybelimitedtoprotecttheconfidentialityofongoinginvestigations,tomaintainattorneyclientprivilege,shieldtheidentityofindividualswhosoughtanonymityorconfidentiality,orforotherappropriatereasons.
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ARTICLEIX:RESPONDINGTOPOTENTIALISSUES
A. TheComplianceOfficerforanyLocallyManagedComplianceProgramshallpromptlyreporttotheURMCChiefComplianceOfficeranyofthefollowing:
1. AnyactualorsuspectedidentifiedoverpaymentsreceivedbytheURMedicineAffiliatethatarematerialinamountorthataffectalargenumberofclaims;
2. Anyactualorsuspectedmaterialnon‐compliancebytheURMedicineAffiliatewiththeGovernmentProgramRequirements;
3. Anyactualorsuspectedinstanceoffraudormaterialwasteorabuse.
B. ItshallbetheresponsibilityoftheURMCChiefComplianceOfficer(forURMCandCentrallyManagedAffiliates)ortheURMedicineAffiliateComplianceOfficer(forLocallyManagedAffiliates)totracktheinvestigationofanypotentialcomplianceissuesidentifiedbytheURMedicineAffiliateoverwhichtheComplianceOfficerhasprimaryoversightresponsibility.
C. Theinvestigationofeverycomplianceissuewillbescaledinsuchamannerastobeappropriatetothepotentialfinancialmagnitude,liability(administrative,criminalorcivil)andreputationalrisksposedbytheissue.
D. Investigationswillbecommencedpromptly,andwillbeprioritizedbasedupontheperceivedseverityandvelocityoftheissuepresented,ascomparedtootherknownorsuspectedissuesunderinvestigationorreviewbytheorganizationoritsComplianceProgram.
E. Issuesinvolvingpotentialoverpaymentsorfraud,wasteandabusepertainingtofederalhealthcareprogramswillgenerallyreceivepriorityoverotherpotentialissuestoachieve,tothedegreepossible,compliancewithstateandfederalrequirementstoreportandreturnoverpaymentswithinsixty(60)daysfollowingcompleteidentificationandquantification,andtomitigateriskunderStateandFederalCivilFalseClaimsActs.
F. PotentiallyseriousissuesshallbereferredforevaluationandinstructionstotheOfficeofCounselpriortothecommencementofinvestigation.PotentiallyseriousissuesincludesuspectedviolationsoftheStarkorAnti‐kickbacklaws,intentionalprovisionofmedicallyunnecessaryservices,fraudulentbilling,orothermisconductthatmaypotentiallyinvolvecriminalactivity.TheyalsoincludemattersthatareanticipatedtohavethepotentialtohaveamaterialfinancialeffectuponURMCortheapplicableURMedicineAffiliate(s).
