telemedicine risk exposures and mitigation strategies · telemedicine risk exposures and mitigation...

Fay A. Rozovsky, JD, MPH

President

The Rozovsky Group, Inc.

1Wolters Kluwer Law & Business

Telemedicine Risk Exposuresand Mitigation Strategies

Wolters Kluwer Law & BusinessWebinarJune 9, 2015

Objectives

To describe key clinical and enterprise risk exposuresin telemedicine.

2. To examine potential risk exposure outcomesstemming from telemedicine.

3. To discuss practical strategies to mitigatetelemedicine risk management exposures.

Wolters Kluwer Law & Business 2

What is Telemedicine, Anyway?

“…the use of medical information exchanged from onesite to another via electronic communications toimprove a patient’s clinical health status.

Telemedicine includes a growing variety ofapplications and services using two-way video, email,smart phones, wireless tools and other forms oftelecommunications technology.”


American Telemedicine Associationhttp://www.americantelemed.org/about-telemedicine/what-is-telemedicine#.VXH82-en5nc

What is Telehealth

“Telehealth is the use of electronic information andtelecommunications technologies to support long-distance clinical health care, patient and professionalhealth-related education, public health and healthadministration.”


HRSA, http://www.hrsa.gov/ruralhealth/about/telehealth/

Do You See A Distinction?

Two-way electroniccommunications toimprove a patient’sclinical health status.


Long-distance support forclinical health care,patient and professionalhealth-related education,public health and healthadministration.

Telemedicine Telehealth

CMS Weighs in on the Definition

Telehealth includes such technologies as telephones, facsimilemachines, electronic mail systems, and remote patient monitoringdevices, which are used to collect and transmit patient data formonitoring and interpretation.

While they do not meet the Medicaid definition of telemedicinethey are often considered under the broad umbrella of telehealthservices. Even though such technologies are not considered"telemedicine," they may nevertheless be covered and reimbursedas part of a Medicaid coverable service, such as laboratoryservice, x-ray service or physician services (under section 1905(a)of the Social Security Act).


Are We Just Splitting Hairs?

• ATA says that it uses the terms interchangeably.

• But look closely at laws and regulations. This may not bethe case.

• Splitting the definitional hairs may be important in termsof regulatory risk, reimbursement, and more.


Something to keep in mind beyond public policy. Quite relevantfor all healthcare entities along the continuum of care.


Key Telemedicine RiskExposures

Key Clinical TelemedicineRisk Exposures


Licensure Scope of Practice

Credentialing &Recredentialing

ConsentStandard of

Care/Negligence

Interstate Medical Licensure


“Alabama became the seventh state to enact the Interstate MedicalLicensure Compact after Governor Robert Bentley signed thelegislation into law today, triggering the formation of the InterstateMedical Licensure Compact Commission. The Commission willadminister a new streamlined process for qualified physiciansseeking to obtain licensure in multiple states and jurisdictionsparticipating in the Compact.”

http://licenseportability.org/assets/pdf/5192015_Seven_States_Enact_Compact.pdf

Interstate Medical Licensure Compact Established With SeventhState Enactment; Formation of Compact Commission Triggered

Federation of State Medical Boards 5/19/2015

The Licensure Compact &Telemedicine


“A state's existing Medical Practice Act and related regulatory laws applyonce a physician obtains state licensure through the Compact.Therefore, a physician licensed by a state via the Compact pathwayMUST abide by all of the laws, rules, and regulations of that state wherethe patient is located and the practice of medicine occurs.

FSMB. http://licenseportability.org/#panel7

Interstate Medical Licensure Compact

http://licenseportability.org/assets/pdf/Interstate-Medical-Licensure-Compact-%28FINAL%29.pdf

A Teleradiology Negligence Case


Radiologist was working from home.She interpreted one set of imagessent to her electronically.Radiologist was unaware that therewas a second set of images to read.

Radiologist took time off to attend awake. Did not advise the hospital.When she returned she found thesecond set of images Realized thepatient had a significant problem,but it was too late. Patient unstablefor transport. Died on the operatingroom table.

• Duty of Care.• Breach of the Duty of Care.• Causal link with the breach

resulting in foreseeableharm.

And how aboutprofessional discipline?

Example: Clinical Risk


67 year-old patient at a critical access hospital (CAH) needs an MRIwith contrast dye of a part of the abdomen. Remote radiologist is“doing” the study that was ordered by the local PCP. Rad tech isunavailable at the CAH. However, an RN is available who hascompleted some in-service programs on using the MRI machine.

Remote radiologist located in another state assumed that the PCP andRN had obtained appropriate patient history to identify risks that wouldrule out the MRI and contrast dye.

Intravenous gadolinium was administered as the contrast media for theMRI. The patient experienced an adverse reaction called nephrogenicsystemic fibrosis (NSF). Only after he was transferred to a tertiaryhospital for treatment did the remote radiologist learn that the patienthad a major contraindication for the contrast media: impaired renalfunction.

Clinical Example, Continued


Carrying out the MRIwas beyond the RNsjob description and it

exceeded her scope ofpractice.

PCP failed to meet theapplicable standard ofcare in screening the

patient forcontraindications to

contrast media. Patient was in a statethat required the

remote telemedicineprovider to be

physically located inthe same jurisdiction.

Consent and Telemedicine


Indications for telemedicine. Explanation of the process. Probable benefits, probable risks. Alternatives and related probable benefits,

probable risks. Consequences of declining recommended

and alternate diagnostic or therapeuticmeasures.

Answer questions in an understandablemanner.

Teach-back affirmation. Document.

Check out the FSMB consent recommendations, too!FSMB_Telemedicine_Policy.pdf April 2014

Telemedicine Consent Risks


Failure to meet state consentrequirements for telemedicine

Using telemedicine when in-personconsent process is required. (Abortion)

Not providing key information:Alternatives. Cost information.

Credentialing/Recredentialing forTelemedicine


http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/pdf/2011-10875.pdf

“Medicare and Medicaid Programs:Changes Affecting Hospital and

Critical Access Hospital Conditions ofParticipation: Telemedicine

Credentialing and Privileging, Final Rule”

Federal Register 76(87): 25550-25565,May 5, 2011.

Telemedicine Credentialing Risks


Who is conducting the workfor your patients?

There is a one-way route forQuality & Adverse Event

Data

Consent: Did the patientauthorize the contracted

telemedicine provider

When was the list last updated?

Are there providers on the list whohave been debarred by Medicare orMedicaid?

As a compliant organization, canyou utilize the services of adebarred provider?

Key Legal-Regulatory TelemedicineRisks


Who is collecting the data?

Who is using the data?

What evidentiary protectionsare in place?

Is telemedicine dataaddressed in the e-

Discovery Plan?

Who is in control: the statesor the federal government?

Current Federal Financial Constraint


“Payment may not be made for a medicalservice (or a portion of it) that wassubcontracted to another provider or supplierlocated outside the United States. For example,if a radiologist who practices in India analyzesimaging tests that were performed on abeneficiary in the United States, Medicarewould not pay the radiologist or the U.S. facilitythat performed the imaging test for any of theservices that were performed by the radiologistin India.”

Medicare Beneficiary Policy Manual, (Rev. 198, 11-06-14)60 - Services Not Provided Within United States(Rev. 102; Issued: 02-13-09; Effective/Implementation Date: 03-13-09)

But Medicare Pays for ManyTelehealth Services


Medicare Benefit Policy ManualChapter 15 –Covered Medicaland Other Health ServicesTable of Contents(Rev. 202, 12-31-14)

Medicare Access and CHIPReauthorization Act of 2015


Public Law 114–10, April 16, 2015

• How the definition of telehealth across various Federal programs andFederal efforts can inform the use of telehealth in the Medicareprogram.

• Issues that can facilitate or inhibit the use of telehealth under theMedicare program…including oversight and professional licensure,changing technology, privacy and security, infrastructure requirements,and varying needs across urban and rural areas.

• Implications of greater use of telehealth regarding payment and deliverysystem transformations under Medicare..

• How CMS monitors payments made under the Medicare to providers fortelehealth services.

Risks and Public Law 114–10


Requires the Comptroller General to Study & Report Recommendationswithin 24 months to Congress.

It is not the ONLY “Act” in town – more Congressional changes thatseem like overlap are under consideration now.

What does this mean for the healthcare industry?

• Greater interest/encouragement in use of telehealth.• The “John Wayne” Syndrome: get the process now in control out of

the way. But will that increase risk.• Be ready for rigorous financial accountability scrutiny for fraud &

abuse.

Potential Changes in Federal Control


21st Century CuresAct

H.R. 6

TITLE III—DELIVERYSubtitle B—Telehealth

Sec. 3021. Telehealthservices under theMedicare program.

Looking at population health datainvolving telehealth

Activities by CMMI examining uses oftelehealth services in models, projects,or initiatives funded through the SocialSecurity Act

The types of high volume procedurescodes or diagnoses suitable to thefurnishing of services via telehealth.

Identify barriers that might prevent theexpansion of telehealth services

05/19/2015 approved byHouse Energy & Commerce

Committee

And Then There is Texas


“physical examination that must be performed by either a face-to-face visit or in-person evaluation as defined in §174.2(3) and (4)of this title (relating to Definitions). The requirement for a face-to-face or in-person evaluation does not apply to mental healthservices, except in cases of behavioral emergencies.”

“An online questionnaire or questions and answers exchanged throughemail, electronic text, or chat or telephonic evaluation of or consultationwith a patient are inadequate to establish a defined physician-patientrelationship.”

Changes to Texas Administrative Code 22 §190.8 Disciplinary Guidelines

State Grip on Control Eroding?


Is it possible that Texas style board requirements violate antitrust laws?

Follow the Teledoc case argument:

North Carolina Board of Dental Examiners v. FTC (February 2015)US Supreme ruled that when a controlling number of the [Dental]Board’s “decision makers are active market participants in theoccupation the Board regulates, the Board can invoke state-actionantitrust immunity only if it was subject to active supervision by theState.”

Teledoc asserts the Texas “in person” rule violates antitrust laws – getspreliminary injunction.

Teladoc Inc. v. Texas Medical Board, No. 1-15-CV-343-RP (W.D. Tex. May 29, 2015).

Insurance Coverages Risk


ProfessionalLiability Coverage

Cyber-RiskCoverage

Tech Error &Omissions Coverage

Business Continuity

Property Coverage(TelehealthProviders)

Telemedicine Infrastructure Risks


Note: Some stateshave requirements for

technology &telemedicine

Interoperability HIPAA Privacy HIPAA Security HIPAA HITECH Encryption standards mHealth devices Store and Forward requirements Beware software Upgrades” Response time with rollover to back-up Time and Date conventions Report format conventions

Potential Vulnerabilities:

Telemedicine Contracting Risks


• One-sided agreements.• Overly broad terms and conditions.• No block on subcontracting to third parties.• No “right of first refusal” on contract being picked

up as part of a merger or acquisition.• No opportunity to cure deficiencies.• No opportunity to terminate if provider is debarred

by Medicare or Medicaid.

Beware: the “missing” schedule, exhibits or addendum.

Billing and Code Risk Issues


Private PayerParity Issues

Medicare

Medicaid

Coding issues

Appropriate level ofreimbursement

Upcoding

Fraud and Abuse

Delay in Payments


Practical Strategies toMitigate TelemedicineRisk Exposures

Strategy One: Identify RiskTolerance

• Articulate your organization’s “appetite for risk” intelemedicine and telehealth.

• Quantify what is your organization’s “total cost ofrisk” (TCOR) in telemedicine and telehealth.


Strategy Two: Use an EnterpriseRisk Approach


Strengths

ThreatsOpportunities

WeaknessesComplete a RiskInventory for your

organization intelemedicine

Accept Risk Eliminate Risk Adjust Risk Transfer Risk

Action Plan

Strategy Three: Applied ERM


Contracting

Credentialing

Consent

Financial & RegulatoryMonitoring

Require Two-Way Qualityand Adverse Event

Reporting

Monitor and Act on Legaland Market Trends

Example: Telemedicine Contracts


Content experts participate Team effort looking at organizational impact Use your own standard terms Close the loopholes Build in requirements for contingencies Proof of insurance in specified amounts No subcontracting Set reporting conventions Breach notification Curing deficiencies Termination

Monitor for contractual compliance!

Example: TelemedicineCredentialing


Governing Body should set the policy: Local credentialing Taking advantage of the CMS rule for “proxy

credentialing” Consider costs Consider control of data and evidentiary

protection Consider data access Be consistent in credentialing

Example: Telemedicine Consents


Not just a piece of paper Medical history The consent “process” Compliant with state law Consistent with FSMB Policy Document authorization

Example: Financial & RegulatoryMonitoring


• Internal audit for billing and coding private and publicpayers

• Monitor for HIPAA – HITECH compliance

• Monitor for Medicare – Medicaid Debarment

• Follow-up promptly on variances

Example: Two-way QualityMonitoring


Leverage contract terms – make certain to getcomplete information on quality, patientsatisfaction, adverse events, adversecredentialing actions and potentialcompensatory events.

Work with legal counsel to design procedures forleveraging evidentiary protection requirements.

Start with a legal-HIM agreed upon approach fordata e-Discovery and legal hold.

Strategy Four: Internal & ExternalScans


Laws

Regulations

Judicial Decisions

Interpretive Guidelines

Market trends

Market share

Technology changes

Payment models


Conclusion

Telemedicine Take-Aways

• Dynamic not static.

• New models emerging.

• New payment approaches.

• Relaxing of some federal requirements; expecttightening of others linked to funding controls.

• Avoid a silo-approach. Use an enterprise riskapproach.

• Involve the content experts on the telemedicine –telehealth team.


Resources - IFederal

CMMI

CMS

Private Sector


http://innovation.cms.gov/

http://.cms.gov/

American Health LawyersAssociation, (AHLA)

American Society forHealthcare Risk Management(ASHRM)

American TelemedicineAssociation (ATA)

Federation of State MedicalBoards (FSMB)

National Association forMedical Staff Services(NAMSS)

http://www.americantelemed.org/

http://www.fsmb.org/

http://www.ashrm.org/

http://www.healthlawyers.org/

http://www.namss.org/

Resources

Consent to Treatment: A Practical Guide, 5th Edition. Wolters Kluwer Law& Business.

Health Care Organizations Risk Management: Forms, Checklists andGuidelines, 3rd Edition. Wolters Kluwer Law & Business.

Health Care Credentialing: A Guide to Innovative Practices. WoltersKluwer Law & Business.


Contact Information


Fay A. Rozovsky, JD, MPHThe Rozovsky Group, Inc.

[email protected]

(860) 242-1302

Thank you!

telemedicine risk exposures and mitigation strategies · telemedicine risk exposures and mitigation...

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