Telemedicine Liability Law and Liability HIF 3-4 Final

TELEMEDICINENEW TRENDS:VIEWING THE RISKS

Hospital Insurance ForumMarch 2016

TELEMEDICINE: NEW TRENDSVIEWING THE RISKS

Overview Telemedicine: An Overview Legal and Regulatory Issues Liability Issues Risk Management Issues Final Thoughts

Paul Greve JD RPLUExecutive Vice President Willis Health Care Practicepaul.greve@willlistowerswatson.com260 348-5873

TELEMEDICINE DEFINED

The remote diagnosis and treatment of patients by means of telecommunications technology• Competing definitions abound: ATA, CMS, etc.• There is no set definition of telemedicine at

present• Very few states have defined it to date• Some states exclude telephone consults from

definition• Not a distinct medical specialty

TELEMEDICINE:Telemedicine Defined

The term “telehealth” is sometimes used

The ATA considers it synonymous

TELEMEDICINE:CMS Definition

“A two-way, real-time interactive communication between a patient and a physician or practitioner at a distant site through telecommunications equipment that includes, at a minimum, audio and visual equipment.”

Telemedicinemedicaid.govhttp://www.medicaid.gov/medicaid-CHIP-Program--InformationFrom/By-The Topics/Delivery-Systems/Telemedicine html

TELEMEDICINE:American Telemedicine Association (ATA) Definition

“The use of medical information exchanged from one site to another via electronic communications fro the health and education of the patient or health care provider and for the purposes of improving patient care, treatment and services.”

TELEMEDICINE:INITIAL THOUGHTS

Telemedicine is becoming much more accepted and widespread – images are better / clearer

Many think it is an extension of what physicians have always done

Health insurers are increasingly accepting it/reimbursing for it - Medicare is slow to accept

Billions are being invested in new digital telehealth technology.

Health care executives are embracing it

TELEMEDICINE:5 KEY TRENDS IN 2016*

Expanding reimbursement

Growth in international arrangements

Growth in state laws related to telemedicine especially reimbursement

Rise of retail clinics and employer on-site health centers

More (Medicare) ACOs projected to use telemedicine to cut costs

Source: Foley & Lardner LLP http://www.foly.com/five-telemedicine-trends-transforming-health-care-in-2016/

TELEMEDICINE:Telemedicine is Exploding*

Reimbursement for its use is growing• UnitedHealth and Anthem in 2016• 20 million insureds each will get coverage

Walgreens: Using smartphone apps for virtual doctor visits

*USA Today 6/24/15

TELEMEDICINE:Medicare Health Priority Act of 2015

Representative Mike Thompson, D-California, July 2015 said:

“Both patients and providers want telehealth for two simple reasons – it saves money and it saves lives.”

http://mhealthnews.com/print31881

TELEMEDICINE:Reimbursement is Key

29 States and D.C. mandate health insurer reimbursement for some telemedicine services*

Medicare reimbursement is still restrictive

Medicaid reimbursement more closely follows private insurers in willingness to reimburse

Most major commercial health insurers are now offering various telehealth benefits

*www.businessinsurance.com/article/20160222/NEW503/160229990

TELEMEDICINE:2014 AMA Report on Coverage and Payment for Telemedicine

Described three different types of telemedicine technology

1. Remote Monitoring Technology

2. Store-and-Forward Technology

3. Real-Time Interactive Services

(Another modality is mHealth)

TELEMEDICINE:Modalities

Real Time Interactive Services

Live, two-way interaction between a patient and a health acre provider using audiovisual technology

Remote Monitoring Technology

Collection of a patient’s personal health and medical data via electronic communication technologies. Once collected, the data is transmitted to a provider at another location

Store-and-Forward

Transmission of a patient’s recorded health history through a secure electronic communication system to a health care provider

mHealth

Wearable devices/smart phones to track health and wellness

TELEMEDICINE:Examples

Teleradiology

• Primary Care/Specialist Consultation— Skype Chat— Video Chat

TeleStroke

TelePsych / Behavioral Health

Connected Otoscopes: Ear Exams

Connected BP Monitors

Remote Cardiac Monitoring

Kiosks for Telemedicine in Retail Settings

TELEMEDICINE:The Benefits of Telemedicine*

Improved Access

Cost Efficiencies

Improved Quality

Meeting Patient Demand

*www.americantelemed.org/about-telemedicine/what-is-telemedicine

LEGAL AND REGULATORY ISSUESTelemedicine: Regulatory Risks Licensure of the physician providing services is essential Lack of state consistency here is a huge challenge but one must

know the laws before proceeding Not all states’ laws address telemedicine but many do Any act of diagnosing or recommending care is generally

considered the practice of medicine Some states have special telemedicine licensing even for in-state

functions; others require full medical licensure Most states’ medical boards offer a “common consultation

exception” (exempting from licensure) that may apply to telemedicine scenarios

LEGAL AND REGULATORY ISSUES Other types of licensing exemptions that may apply across all the

states • Emergency exceptions (e.g. patient coding)• Consultation exceptions (scope varies)• Special/temporary telemedicine license• License endorsement (reciprocity from other state medical boards)

Other State Regulation of Telemedicine May Apply• Informed consent• Privacy• Medical records• Credentialing• Many more: quality, standard of care, etc.• This is a rapidly evolving area of state regulation

LEGAL AND REGULATORY ISSUES Telemedicine Across State Lines: Which State Laws Apply?

• Usual answer for tort law: where the patient is when receiving care• But jurisdiction can be problematic; not really tested• But whether there is a state standard of care or a local standard of care may

vary• No case law yet in a court of last resort on requiring a “foreign” physician to

know what the practice is by state or locality

Source: Joseph P. McMenamin, M.D., J.D.McMenamin Law Offices, PLLCjoe.mcmenamin@venebio.com

804.921.4856

LEGAL AND REGULATORY ISSUESTelemedicine: Scope of Practice and Risk Is there a valid physician-patient relationship thru telemedicine? Is the provider required to conduct an in-person exam? What limitations are there in making a diagnosis or plan of

treatment during a telemedicine encounter? Is the provider using remote monitoring, mobile telemedicine, or

Internet-connected medical devices (e.g. BP monitor)? Will the provider issue a remote prescription? If prescribing is remote, any restrictions on types of meds (opioids,

etc.)?

TELEMEDICINE: LIABILITY ISSUESPotential Malpractice Liability Jurisdiction is problematic: across state lines or international Standard of care may vary by venue Reform laws may differ, e.g. damage caps Statute of limitations may vary, e.g. minors The hospital or other entity has a corporate legal duty to credential all

telemedicine providers if originating site May need to create a category for this under medical staff bylaws Bylaws may need to take into account state laws, CMS, JCAHO,

and other guidelines

TELEMEDICINE: LIABILITY ISSUESPotential Malpractice Liability

Negligent credentialing/privileging Hospital have a corporate legal duty to

credential all providers; also CMS and Joint Commission requirements here

Networks, ACOS, have a credentialing obligation

Is there a true doctor-patient relationship? Inadequate/negligent telemedicine consult Failure to obtain a telemedicine consult Ostensible agency liability Equipment malfunction/software failure

TELEMEDICINE: LIABILITY ISSUESPotential Malpractice Liability

Lack of an informed consent that discloses the limits of a telemedicine consult

Practicing outside clinical practice protocols or guidelines promulgated by various entities, such as ATA or medical specialties

LIABILITY ISSUESPrivacy, Security, and Patient Confidentiality All normal laws and regulations still apply HIPAA Hospital must verify the security of vendor’s systems No use of unencrypted platforms, e.g. Skype

Informed Consent Patients must be aware of and consent to risks of telemedicine Delays from telecommunications devices, failures of same, potential

security breaches Physicians should discuss the risks/benefits and especially limitations

of a telemedicine exam/consult Obtain a signed consent form

LIABILITY ISSUESContinuity of Care Documentation of telemedicine encounters must occur in the

medical record Choice of the best clinical context for a telemedicine encounter is

key: e.g. acute primary care, chronic disease, psychiatry, but probably not trauma or surgical advice where bedside assessment is what is really required

LIABILITY ISSUESTelemedicine Malpractice Cases to Date Very little known about the cases that

have occurred: settled/dismissed PIAA: 50-60 reported out of 300,000

total One large national physician carrier

anecdotally said they have had 6 telemedicine cases out of 12,000 cases filed over the last six years but telemedicine was not a true focal point in any

Many cases to date are teleradiology cases

LIABILITY ISSUESTelemedicine Malpractice Cases to Date: Allegations Incorrect interpretations of images from

home or remote (radiology) Miscommunication over the timeliness

of the reading; e.g. “stat” reading requested but not done

Failure to communicate presenting symptoms to a remote examining neuro-radiologist and resulting failure to diagnose

Incorrect interpretation of remote reading of EFM strips

LIABILITY ISSUES

Telemedicine Malpractice Cases to Date: Allegations Suspected stroke incorrectly diagnosed

by a tele-stroke consult Failure to adequately remotely monitor

and assess an ICU patient and failure to request an intensivist to perform a more thorough bedside examination

LIABILITY ISSUES

Telemedicine: Potential Malpractice Allegations Exam should have been performed in-

person rather than by video Image distortion causing misdiagnosis Incomplete telemedicine exam Power failure resulting in delay/error Negligent prescribing based on a video

exam Negligence in the failure to provide

telemedicine support

RISK MANAGEMENTRegulatory Risks - Risk Management Get legal advice No consults without legality ascertained Remember state laws vary widely on

telemedicine Expect an expansion of these regulations in the

future to affect physician extenders and nurses

RISK MANAGEMENTLiability Risks - Risk Management Develop appropriate telemedicine protocols

• Peer Review/Credentialing• Informed Consent• The Patient Encounter• Documentation

Staff training and roles defined Monitor the literature Research all state/federal laws and accrediting entities: CMS, JCAHO,

others Physician extenders must practice within their state’s defined scope Provide services only where appropriately licensed Some specialties have telemedicine guidelines American Telemedicine Association may provide guidance

RISK MANAGEMENTDevelop Informed Consent Protocols Discuss the risk of the care as well as the risks of telemedicine Research any specific state laws on telemedicine informed

consent

Develop Patient Encounter Protocols Avoid if a physical exam is key Set low threshold for requiring physical exam Document encounter and patient comprehension Create written patient instructions Address follow-up care Information to patient’s PCP: continuity of care

RISK MANAGEMENT Develop Documentation Protocols Mode of service delivery Sites that were linked Attendee names Any technical difficulties

Insurance Issues Discuss insurance coverage with current carrier Address exposures often not covered in a physician medical

professional policy: o errors & omissionso negligent credentialingo privacy breaches/cyber liabilityo failure of equipment/products liability

Options: endorsement or new separate policy for telemedicine exposures

RISK MANAGEMENT

Underwriting/Risk Management Issues Compliance with all applicable laws/regulations especially state

medical board is key or an allegation of negligence per se may result

How were the telemedicine practice protocols and guidelines created and how are they kept current?

What kind of medical oversight is there of the telemedicine program(s)?

RISK MANAGEMENT

Underwriting/Risk Management Issues Using telemedicine may make patients feel like they are more in

control = less inclined to sue? Will there be a different expectation of care if it is delivered

virtually? Managing patient expectations thru informed consent and

disclosures about telemedicine’ limits is key

RISK MANAGEMENT

FINAL THOUGHTS Telemedicine is evolving rapidly

o The regulatory and legal framework is evolving rapidly Telemedicine risk is new and evolving but only an

infinitesimally small number of claims have occurred Telemedicine risk can be managed with planning and careful

thought, Telemedicine improves patient care Telemedicine will help reduce cost Get good legal advice before proceeding

AcknowledgementsAcknowledgments and Thanks

Bob Snyder J.D. and Jackie Bezaire R.N. J.D.Joseph McMenamin M.D. J.D.

Telemedicine Liability Law and Liability HIF 3-4 Final

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