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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
© 2016 Willis Towers Watson. All rights reserved. 2
Paul Greve JD RPLUExecutive Vice President Willis Health Care [email protected] 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
© 2016 Willis Towers Watson. All rights reserved. 4
The term “telehealth” is sometimes used
The ATA considers it synonymous
TELEMEDICINE:CMS Definition
© 2016 Willis Towers Watson. All rights reserved. 5
“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
© 2016 Willis Towers Watson. All rights reserved. 6
“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
© 2016 Willis Towers Watson. All rights reserved. 7
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*
© 2016 Willis Towers Watson. All rights reserved. 8
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*
© 2016 Willis Towers Watson. All rights reserved. 9
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
© 2016 Willis Towers Watson. All rights reserved. 10
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
© 2016 Willis Towers Watson. All rights reserved. 11
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
© 2016 Willis Towers Watson. All rights reserved. 12
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
© 2016 Willis Towers Watson. All rights reserved. 13
Real Time Interactive Services
Live, two-way interaction between a patient and a health acre provider using audiovisual technology
TELEMEDICINE:Modalities
© 2016 Willis Towers Watson. All rights reserved. 14
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
© 2016 Willis Towers Watson. All rights reserved. 15
Store-and-Forward
Transmission of a patient’s recorded health history through a secure electronic communication system to a health care provider
TELEMEDICINE:Modalities
© 2016 Willis Towers Watson. All rights reserved. 16
mHealth
Wearable devices/smart phones to track health and wellness
TELEMEDICINE:Examples
© 2016 Willis Towers Watson. All rights reserved. 17
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*
© 2016 Willis Towers Watson. All rights reserved. 18
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
© 2016 Willis Towers Watson. All rights reserved. 19
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
© 2016 Willis Towers Watson. All rights reserved. 20
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, [email protected]
804.921.4856
© 2016 Willis Towers Watson. All rights reserved. 21
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.)?
© 2016 Willis Towers Watson. All rights reserved. 22
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
© 2016 Willis Towers Watson. All rights reserved. 23
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
© 2016 Willis Towers Watson. All rights reserved. 24
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
© 2016 Willis Towers Watson. All rights reserved. 25
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
© 2016 Willis Towers Watson. All rights reserved. 26
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
© 2016 Willis Towers Watson. All rights reserved. 27
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
© 2016 Willis Towers Watson. All rights reserved. 28
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
© 2016 Willis Towers Watson. All rights reserved. 29
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
© 2016 Willis Towers Watson. All rights reserved. 30
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
© 2016 Willis Towers Watson. All rights reserved. 31
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
© 2016 Willis Towers Watson. All rights reserved. 32
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
© 2016 Willis Towers Watson. All rights reserved. 33
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
© 2016 Willis Towers Watson. All rights reserved. 34
RISK MANAGEMENT Develop Documentation Protocols Mode of service delivery Sites that were linked Attendee names Any technical difficulties
© 2016 Willis Towers Watson. All rights reserved. 35
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
© 2016 Willis Towers Watson. All rights reserved. 36
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)?
© 2016 Willis Towers Watson. All rights reserved. 37
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
© 2016 Willis Towers Watson. All rights reserved. 38
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
© 2016 Willis Towers Watson. All rights reserved. 39
AcknowledgementsAcknowledgments and Thanks
Bob Snyder J.D. and Jackie Bezaire R.N. J.D.Joseph McMenamin M.D. J.D.
© 2016 Willis Towers Watson. All rights reserved. 40
THANK YOU.© 2016 Willis Towers Watson. All rights reserved.