Keeping Your Compliance Program in Pace with Rapidly ... · Safe Harbors protect arrangements from...
Transcript of Keeping Your Compliance Program in Pace with Rapidly ... · Safe Harbors protect arrangements from...
4/8/2015
1
Keeping Your Compliance Program in Pace with
Rapidly Expanding TeleHealth Services
In April 1924, an imaginative cover for the magazine
Radio News foreshadowed
telemedicine in its depiction of a "radio doctor”
4/8/2015
2
Key TermsoTelemedicineistheuseofmedicalinformationexchangedfromonesitetoanotherviaelectroniccommunicationstoimproveapatient’sclinicalhealthstatus.
Key Termso Telemedicineistheuseofmedicalinformationexchangedfromonesitetoanotherviaelectroniccommunicationstoimproveapatient’sclinicalhealthstatus.
oTelemedicine ‐ includesagrowingvarietyofapplicationsandservicesusingtwo‐wayvideo,email,smartphones,wirelesstoolsandotherformsoftelecommunicationstechnology.
Key Termso Telemedicineistheuseofmedicalinformationexchangedfromonesitetoanotherviaelectroniccommunicationstoimproveapatient’sclinicalhealthstatus.
o Telemedicine includesagrowingvarietyofapplicationsandservicesusingtwo‐wayvideo,email,smartphones,wirelesstoolsandotherformsoftelecommunicationstechnology.
oATA usesthetermsTeleHealth andTelemedicineinterchangeably
4/8/2015
3
Brief History of Telemedicine
Over40yearsago‐ hospitalsextendedcaretopatientsinrural
areas
Telemedicinehasrapidlyexpanded
Integratedintoongoing
operationsofhospitals
SpecialtyDepartments
HomeHealthAgencies
PrivatePhysicianOffices
Consumer’shomesandworkplaces
Issue Spotting
Video Conferencing v. Still Images Video Conferencing v. Still Images
eHealtheHealth
Patient PortalsPatient Portals
Remote Monitoring Remote Monitoring
Nursing Call CentersNursing Call Centers
Issue Spotting
Fraud & Abuse LawsFraud & Abuse Laws
TechnologyTechnology
HardwireHardwire
CredentialingCredentialing
PrivilegingPrivileging
4/8/2015
4
Issue Spotting
Record MaintenanceRecord Maintenance
Physician LicensingPhysician Licensing
Identify PartiesIdentify Parties
Regulatory OverlapRegulatory Overlap
Issue Spotting
ePrescribingePrescribing
Conditions of ParticipationConditions of Participation
BillingBilling
Paper Transmission & Archival Paper Transmission & Archival
Fraud & Abuse
If all answers are “Yes” a Stark exception must apply!
Is the service provided to the patient covered by Medicare or Medicaid?
Is the service provided to the patient a DHS? Is the service provided by an
“entity?”
Pursuant to a “referral?”
From a “physician”
Does the physician, or
physician’s family member, have a
“financial relationship”
with the entity?
4/8/2015
5
Fraud & Abuse
Anti‐KickbackStatute(AKS) Itisacriminaloffensetoknowinglyandwillfullyoffer,pay,solicit,orreceiveanyremunerationtoinducereferralsofitemsorservicesreimbursablebyanyfederalhealthcareprogram.
SafeHarborsprotectarrangementsfrombeingprosecuted,whichwouldotherwiseimplicateAKS.
New Safe Harbors & Exceptions Related to Telemedicine
Applytosituationsinwhichaphysicianreceivesfreeelectronicprescribingtechnologyortraining,orfreeelectronichealthrecordssoftware,orinformationtechnologyortraining.
False Claims Act (FCA) & Civil Monetary Penalties (CMP)
AKS&StarkviolationsareoftencoupledwithFCA&CMPsanctions.
FCAprohibitsknowinglysubmittingorcausingtobesubmittedfalseorfraudulentclaimsforpaymentorfalsestatementsorcertificationstothegovernment.
4/8/2015
6
FCA & CMP Continued . . . CMPsapplyifapersonknowinglypresents,orcausestobepresented,toastateorfederalgovernmentemployeeoragentanyfalseorimproperclaims.
FCAandCMPcouldapplytotelemedicineactivitiesthatreachacrossstatelinesifappropriatelicensureprecautionsarenottaken.
FCA & CMP Continued . . . FCAandCMPcouldapplytotelemedicineactivitiesthatreachacrossstatelinesifappropriatelicensureprecautionsarenottaken.
Medicarerequiresthatthepractitionerprovidingservices&submittingaclaimbelicensedtoprovidetheservicebytheapplicablestateentity.
Don’tforgettoreviewStateFraud&AbuseLaws
Regulatory Overlap
Federal Communications Commission (FCC)
Federal Trade Commission (FTC)
Office of the Nat’l Coordinator for Health
Info. Tech. (ONC)
Centers for Medicare and Medicaid (CMS)
FDA
4/8/2015
7
FDA Safety & Innovation Act (2012)
• FDA,FCC,& ONCassignedtoprovideanoutlinethatwillavoidregulatoryduplication.
• April3,2014,draftreport:Administrativeandhealthmanagementfunctionsposedlittlerisktopatientsafetyandrequiredeithernoorlimitedadditionaloversight.
• MedicaldevicehealthITfunctionsremainunderFDAoversight – duetorecognizedrisks.
HIPAA, HITECH,Privacy & Security
TechnologySafeGuards
TechnologySafeGuards
EncryptedVideoConsultationsEncryptedVideoConsultations
HardwareBased,Hardwired
HardwareBased,Hardwired
SafeguardsSameasIn‐personCare
SafeguardsSameasIn‐personCare
SecureRecordsTransfer(fax?Mail?)SecureRecords
Transfer(fax?Mail?)
MoreDifficultWithmHealth
MoreDifficultWithmHealth
HIPAA, HITECH,Privacy & Security
HostedSolutions–NeedTechnical
Specs
HostedSolutions–NeedTechnical
Specs
WirelessHardtoSecure
WirelessHardtoSecure
ArchivingInformationon
Devices
ArchivingInformationon
DevicesLostDevicesLostDevices
ServicesDocumentation
ServicesDocumentation
TransfersBetweenCareSettings
TransfersBetweenCareSettings
4/8/2015
8
HIPAA, HITECH,Privacy & Security
Connectivity with EHR
Connectivity with EHR
Records Maintenance and Responsibility
Records Maintenance and Responsibility
Participating Entities Agreements
Participating Entities Agreements
Agreements for Privacy/Security Requirements
Agreements for Privacy/Security Requirements
Are BAAs Needed?Are BAAs Needed?
Monitor & Control Access to Patient
Info
Monitor & Control Access to Patient
Info
OIG Advisory Opinions
AdvisoryOpinion11‐12• Important to remember the AOs only address risk associated with AKS not any other risks.
• AO 11‐12 is characteristic of past telemedicine AOs – “Although the arrangement could violate the [AKS] if the requisite intent to induce referrals were present, the OIG would not impose sanctions because of the low risk posed by the arrangement and its benefits for patients.”
OIG Advisory OpinionsTelemedicineAOsagree:• Unlikelytoproducereferrals• Likelypreexistingclinicalaffiliation• Primarybeneficiariesofthearrangementarethepatients
• Unlikelytoincreasecoststofederalhealthprograms
• Reducestransfers• Reducesdisabilityduetodelayedtreatment• CompareAdvisoryOpinions:98‐18,99‐14,04‐07
4/8/2015
9
Physician Licensure & Portability
• TraditionallythePhysicianmustbelicensedinthestatewherethepatientresides
• Statelicensurelawsdiffer& aredifficulttochange
• Multi‐statelicensureispossiblebuttimeconsuming& costly
• MostStateshavesometypeofConsultationException
Physician Licensure & Portability
Consulting Exceptions
Endorsement
Limited Licensure
Reciprocity
Mutual Recognition/Compact
Proposed options/models to increase portability
Physician Licensure & Portability
Mutual Recognition/Compact
Partial Preemption by Federal Laws & Regulations
National Licensure
Federal Licensure
Proposed options/models to increase portability
4/8/2015
10
Common Provisions in State Laws & Rules
• Requiresin‐personphysicalexam(20)• Requirespreexistingrelationship(18)• Allowsphysicalexam&relationshiptobeestablishedviatelehealth (48)
• Requiresin‐personfollowup(3)• Informedconsent(15)• RequiresTelepresenter (6)• Specifiestypeofprovider(4)
California Comparison
ApplicableProvisions:• Requiresinitialin‐personexam• Requiresexistingrelationship• Allowsphysicalexamviatelehealth (afterinitialexam)
• Verbalconsentrequiredbydistantsite• Telepresenter mustfacilitatewrittenconsentonsitew/patient
• Teleconsultation ExemptionApplies
Florida Comparison
ApplicableProvisions:• Requirespre‐existingrelationship• AllowsonlyMD,DO,PA• Allowsphysicalexamviatelehealth(oncerelationshipisestablished)
• ConsultationsforFLphysiciansallowedbyanyphysicianlicensedinanotherstate/country
4/8/2015
11
New York Comparison
ApplicableProvisions:• Requiresexistingrelationship• Allowsphysicalexamviatelehealth (oncerelationshipisestablished)
• Verbalconsentrequiredbydistantsite• Allowsborderingstatephysiciantoprovidetelehealth toNYresidents
• ConsultationExemption
Texas ComparisonApplicableProvisions:
• Requiresinitialin‐personexam(exceptwhenpatientislocatedatamedicalsite)
• Requiresexistingrelationship• Allowsphysicalexamviatelehealth afterinitialin‐personexamandrequiresanin‐personF/Uvisiteveryyear
• Requireswrittenconsent• Telepresenter requiredexceptmentalhealth• LicensedMD,DO,PA,&NP
Billing, Coding and Payment
• Subjecttorestrictions– Geographic– Service
• Expansioneffortscontinue• Recentchangesincoverage
– CMSaddedtothelistofcoveredtelehealthservices(Oct2014)
Medicare
4/8/2015
12
Billing, Coding and Payment
• GenerallymorerestrictivethanMedicare• VariesbyState
– Specialprograms– Specificareasofneedaretargeted
• AmericanTelemedicineAssociationprovidesStatebyStatepolicyinformation
Medicaid
Billing, Coding and Payment
• Coveragevariesgreatly• ChangesaresmallbutfrequentOpportunities• MonitorchangestoMedicareandMedicaidcoverage– Establishcommunicationchannelswithmajorpayorsinyourareatostayuptodatewithcoveragepolicies
• Lookforopportunitiesoutsideofnormalpaymentrelationships
Private Payors
Billing, Coding and Payment
• Whereisthepatient(originatingsite)?• Whereistheprovider(distantsite)?• Medicalrecorddocumentation
– Wherewillitbelocated(system/physicalstorage)?
– DoestheCPTcoderequireatimecomponent?– Providershoulddocumentthattheserviceswereprovidedthroughtheuseoftelemedicine.
Checklistfornewservices
4/8/2015
13
Billing, Coding and Payment
• Whoarethelicensed/unlicensedprovidersateachsite?– Arestatelicensinglawsandpracticestandardsmet?
– Istheprovidereligibleandappropriatelycredentialedandprivileged?
• Isthereaprocessforauthorizationorpre‐certification?
Checklistfornewservices
Auditing and Monitoring
• Trackeachprojectonatimeline• Identifythestartdate
– Reviewchartstoensuredocumentationiscomplete
• At60to90daysfromstartdate– Reviewsmallsamplesize,expandingasneeded
Monitoringdocumentationtoensureaccuratepayment
Auditing and Monitoring
• Additionalreviewsarescheduleddependentuponresults
• Review– Clinicaldocumentation– Billingdata
Monitoringdocumentationtoensureaccuratepayment
4/8/2015
14
CMS approved CoPs & Joint Commission Standards
TheJointCommission’sfinalrevisiontoTelemedicineStandards• ApprovedbyCMS• Relatestocredentialingandprivilegingoftelemedicinepractitionersinhospitalsandcriticalaccesshospitals
CMS approved CoPs & Joint Commission Standards
• Originatingsitehasawrittenagreementwiththedistantsitecredentialingandprivileging
• BothhospitalsandCAHsarepermittedtorelyuponthecredentialingandprivilegingdecisionsmadebythedistantsitehospitalortelemedicineentity(effectiveJuly2011)
4/8/2015
15
Case Study No. 1
MedicalCenterusesmobiletechnologiesforin‐homepatientcareforchronicconditionsthatrequireongoingIVcatheters.iPadsareusedforvideoconferencing,dataexchange,andreal‐timeintervention.Thetabletsgivepatientsaccesstoevidence‐basedinterventions,step‐by‐stephome‐caregivingalgorithms,videosillustratinghomeIVprocedures,andinfectioncontrolprocedures.
Case Study No. 2
Hospitalprovidesspecialtycareusingsecureonlineandvideo‐basedconsultationsincludingaccesstospecialistsforwomen’shealth,cancercare,andENT.Inaddition,thehospitaloffersvideo‐basedconsultationsusingPC‐basedwebcamsandoff‐the‐shelfvideoservices.
Case Study No. 3Hospitalhasstrokeprotocolusingneurologistsfromanon‐callspecialistsgroup.ImmediatelyafterpatientCTscan,theSpecialist,viainteractivevideo,conductsacompleteneuroassessment– attendingnursehelps.Theneurologistexplainsfindings,suggeststreatments,overseesadministrationoftPA &otherprocedures,andperiodicallychecksinonthepatient.
4/8/2015
16
Marcie R. Swenson, Regional Compliance Administrator,
Intermountain Healthcare
Suzie Draper, VP Business Ethics & Compliance,
Intermountain Healthcare
Tricia Hansen, Director of Compliance & Ethics,
Intermountain Healthcare