Telemedicine Liability Law and Liability HIF 3-4 Final

TELEMEDICINE
NEW TRENDS:
VIEWING THE RISKS
Hospital Insurance Forum
March 2016

TELEMEDICINE: NEW TRENDS
VIEWING THE RISKS
Overview
 Telemedicine: An Overview
 Legal and Regulatory Issues
 Liability Issues
 Risk Management Issues
 Final Thoughts
© 2016 Willis Towers Watson. All rights reserved. 2
Paul Greve JD RPLU
Executive Vice President
Willis Health Care Practice
paul.greve@willlistowerswatson.com
260 348-5873

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
© 2015 MLO
3© 2016 Willis Towers Watson. All rights reserved. 3

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.gov
http://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

TELEMEDICINE:
Modalities
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

TELEMEDICINE:
Modalities
Store-and-Forward
Transmission of a patient’s recorded health
history through a secure electronic
communication system to a health care provider

TELEMEDICINE:
Modalities
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 ISSUES
Telemedicine: 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

 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

 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, PLLC
joe.mcmenamin@venebio.com
804.921.4856

Telemedicine: 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 ISSUES
Potential 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

 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

 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 ISSUES
Privacy, 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 ISSUES
Continuity 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 ISSUES
Telemedicine 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 ISSUES
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
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 MANAGEMENT
Regulatory 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 MANAGEMENT
Liability 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 MANAGEMENT
Develop 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 & omissions
o negligent credentialing
o privacy breaches/cyber liability
o 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

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

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