Top 5 Telemedicine Regulatory Hurdles To Overcome

© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. ebglaw.com
Top 5 Telemedicine Regulatory
Hurdles To Overcome
Charles C. Dunham IV
Epstein Becker Green
Houston / New York
CDunham@ebglaw.com
www.ebglaw.com

© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
Brief Discussion Topics
 Multi-State Telemedicine Practices
 Compliance with Remote Prescribing and Diagnostic Test Orders
 Coverage and Reimbursement for Telemedicine Services under Medicare,
Medicaid and Commercial Insurers
 Patient Privacy and Cybersecurity Compliance
 Legislation Impacting Telemedicine Operations
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© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com 3
Licensure and Telehealth
States monitor practices of
health care professionals within
their boundaries
State licensure rules run counter
to the practice of telehealth,
which transcends geographical
boundaries
Licensure is the process by
which states validate the
credentials of health care
professionals
Health care professionals who provide services
via telehealth modalities generally are subject
to the licensure rules of: (1) the state(s) in
which their patients are physically located; and
(2) the state(s) in which they (the professionals)
are practicing.

Licensure and Telehealth
Traditional
License
Special
Telehealth
License
Endorsement
RegistrationReciprocity
“Bordering
States”
Exception
Consultation
Exception

Corporate Practice of Medicine

Malpractice Coverage

State Regulatory Issues
 Scope and Standard of Practice
 Patient Consent
 PCP Notice and Report
 Physician-Patient Relationships
 Remote Prescribing and Diagnostic Test Orders
7

Telehealth Professional Liability
Common Questions / Issues
Supervision
• When is it medically appropriate to
supervise other practitioners via
telehealth modalities?
• What about supervision of machines and
devices that provide medical services?
International Telehealth
• Will I be covered while providing services
internationally?
• Who has jurisdiction over international
telehealth services?
Practice Standards and Protocols
• Is telehealth sufficiently different from usual care as to
require its own protocols and standards?
• Do established guidelines exist?
Telehealth Informed Consent
• Does my state require informed consent?
• What are the standards of care?
Liability Insurance
• Are telehealth services covered
under my existing policy?
• What would adding coverage for
telehealth services entail?
Physician-Patient Relationship
• How is it defined for purposes of scope of
practice?
• How is defined in relation to liability
claims?
Telehealth Industry
• Is telehealth changing the nature
of the relationship between
patients and providers?
• Is telehealth fundamentally
different from traditional forms of
health care?
Procedural Issues: Jurisdiction
• Choice of law analysis
8

Scope of Practice –
Establishing the Physician-Patient Relationship
 Traditionally, establishing a
physician-patient relationship has
required at least an initial in-person
encounter between a physician and
a patient
 Increased use of telehealth
technologies raises questions
regarding this traditional view of
physician-patient relationships
• When is a physician “consulting”?
• When is a physician making a
“diagnosis”?
• When is a physician “treating” a
patient?
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Who can order a
laboratory
testing service?
Who can receive
the test results?
What is the
criteria for
establishing a
physician-
patient
relationship via
telehealth?
Does an
obligation exist
to continue
treatment?
Scope of Practice – Diagnostic Test Orders
Key Questions
10

Are there any
special licenses
required to
prescribe via
telehealth?
What is the
criteria for
establishing a
physician-
patient
relationship via
telehealth?
Who can
prescribe via
telehealth?
What can be
prescribed via
telehealth?
Scope of Practice – Remote Prescribing
Key Questions
11

2011
TMB tells Teladoc they
cannot prescribe remotely
without conducting a face-to-
face physical examination of
the patient
Dec. 2014
Texas Court of Appeals rules
that TMB’s “face-to-face” rule
is invalid
Jan. 2015
TMB issues emergency rule
limiting telephone use in
telemedicine
Apr. 2015
Teladoc files antitrust suit
alleging that TMB’s rule
illegally limits competition
May 2015
Court issues temporary
injunction, allowing providers
to continue offering
telemedicine services
Sept. 2016
FTC and DOJ inform the Court
they are siding with Teladoc
Oct. 2016
TMB withdraws appeal
Mar. 2017
State Sen. Charles
Schwertner introduces S.B.
1107
May 2017
Texas Governor Greg
Abbott signs S.B. 1107 into
law, allowing the new law
to take effect immediately
Scope of Practice – Remote Prescribing
Teladoc v. The Texas Medical Board
12

 Amended the Controlled Substances Act (21 U.S.C. § 802 et seq.) and
regulates online prescribing of controlled substances
 Specifically prohibits dispensing controlled substances via the internet
without a “valid prescription” and provides that a prescription is “valid” only
when issued for a legitimate medical purpose and if a physician conducted at
least one in-person medical evaluation of the patient before issuing the
remote prescription
 Includes certain exceptions considered potentially applicable to telehealth
practice; however, many physician-to-patient virtual models of care delivery
likely not covered
 Describes a process for creating a “special telemedicine registration” that
DEA has not yet made available to providers seeking to prescribe remotely
• An April 2016 notice indicated DEA had proposed to “amend the registration requirements
to permit such a special registration” and sought comments; however, no action yet by DEA
 Presently, federal prohibition remains a regulatory hurdle for telehealth
providers seeking to prescribe controlled substances
Federal Law – Remote Prescribing
Ryan Haight Online Pharmacy Consumer Protection Act of 2008
13

Coverage and Reimbursement
Medicare: Currently
offers its beneficiaries
the most limited access
to telehealth services;
coverage rules are
extremely rigid
Medicaid: 48 states
and D.C. provide at
least some coverage of
and reimbursement for
telehealth services (as
of Apr. 2017)
Private Payers: Many
leading private payers
offer coverage and
reimbursement for
telehealth services,
although these policies
vary widely
14

 Medicare Telehealth Parity Act of 2017 (H.R. 2550)
• Would provide for an incremental expansion of telehealth coverage under the
Medicare program
 Telehealth Innovation and Improvement Act of 2017 (S. 787)
• Would establish a telehealth service model and Medicare payment rules with
respect to certain services tested under the model
 CONNECT for Health Act of 2017 (H.R. 2556)
• Would expand access to telehealth services for Medicare beneficiaries
 CHRONIC Care Act of 2017 (S. 870)
• Would implement Medicare payment policies designed to improve management
of chronic disease, to streamline care coordination, and to improve quality
outcomes (through use of telehealth, among other things)
Federal Legislative Efforts
115th Congress (2017-2018)
15

Privacy and Security Generally
HIPAA
•Privacy Rule
•Security Rule
•Breach Notification
FTC Act
State Privacy
and Security
Laws
16

Telehealth Privacy and Security Issues
Distributing Notice of Privacy Practices to telehealth patients
Managing presence of non-clinical personnel (non-Covered Entities) supporting provision of telehealth services
Entering into BAAs with technical providers (non-Covered Entities) supporting provision of telehealth services
Providing HIPAA training and education for telehealth providers
Breach notification (verifying breaches)
Transmission security
Using web-based platforms (Skype, FaceTime, etc.) to deliver care in a compliant manner
Incorporating telehealth-specific risks into compliance program
Complying with privacy laws in multiple states
Determining what should be maintained as part of the medical record
Sharing data and management responsibility with other providers

Epstein Becker Green Resources
18
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