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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”

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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

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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

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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?

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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.

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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

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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

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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

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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

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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

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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

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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

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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

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CMS approved CoPs & Joint Commission Standards

TheJointCommission’sfinalrevisiontoTelemedicineStandards• ApprovedbyCMS• Relatestocredentialingandprivilegingoftelemedicinepractitionersinhospitalsandcriticalaccesshospitals

CMS approved CoPs & Joint Commission Standards

• Originatingsitehasawrittenagreementwiththedistantsitecredentialingandprivileging

• BothhospitalsandCAHsarepermittedtorelyuponthecredentialingandprivilegingdecisionsmadebythedistantsitehospitalortelemedicineentity(effectiveJuly2011)

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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.

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Marcie R. Swenson, Regional Compliance Administrator,

Intermountain Healthcare

Suzie Draper, VP Business Ethics & Compliance,

Intermountain Healthcare

Tricia Hansen, Director of Compliance & Ethics,

Intermountain Healthcare