Norton Rose Fulbright - Telemedicine

Telemedicine: A disruptive technology
Lisa Atlas Genecov, Head of Healthcare Transactions, Dallas
Lane Wood, Senior Associate
Lidia Niecko-Najjum, Associate
Norton Rose Fulbright US LLP
October 13, 2015
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Agenda
• Introduction
• Jurisdictional Disparity
– States’ Various Telemedicine Laws
– Regulatory Issues
• Reimbursement
• Case study: Teladoc Inc.
4
Telemedicine – A Disruptive Technology
• With the Affordable Care Act’s emphasis on lower costs, access
to care and efficiencies in the delivery of health care services, as
well as its focus on technology, telemedicine has become a
disruptive market force that is rapidly changing the way patients
seek and obtain medical care.
• With this increasing interest in telemedicine and telehealth
technologies, funding for digital health care technology
companies exceeded $4.1 Billion in 2014 with over 293
transactions completed with an average transaction size of $14.1
Million.1
• Venture funding of digital health companies in the last half of
2015 surpassed $2 Billion. Four venture-backed digital health
companies went public in the first half of 2015, and Teladoc, a
telemedicine company, went public early in the second half of
2015.2
Rock Health, “Digital Health Funding: 2014 Year in Review”, available at
http://www.rockhealth.com.
2. Rock Health, “Digital Health Funding: 2015 Midyear Review”, available at
http://www.rockhealth.com.
1.
5
Hospital Participation in Telemedicine is Growing
• Many hospitals and healthcare providers already offer
telemedicine services. According to a 2014 report, hospitals
more likely to have such capabilities are teaching hospitals,
those equipped with advanced medical technology, those that
are members of a large health system, and non-profit
institutions.3
• Rates of hospital telehealth adoption by state vary substantially
and are associated with differences in state policy (e.g., policies
that promote payor reimbursement for telehealth are associated
with greater likelihood of adoption).4
3. Julia Adler-Milstein, Joseph Kvedar and David Bates, “Telehealth
Among US Hospitals: Several Factors, Including State Reimbursement
And Licensure Policies, Influence Adoption” Health Affairs, 33, No. 2
(2014): 207-215
4. Id.
Hospital Participation in Telemedicine is Growing
7
Julia Adler-Milstein, Joseph Kvedar and David Bates, “Telehealth Among US Hospitals:
Several Factors, Including State Reimbursement And Licensure Policies, Influence Adoption”
Health Affairs, 33, No. 2 (2014): 207-215
Telemedicine Applications and Initiatives
• The range of telemedicine applications are many, and include
remote monitoring programs used by hospitals for post-discharge
monitoring to reduce readmissions, to hospital emergency
departments that use remote video communications to enable
patients to receive telephsychiatric screening.
• Specific Examples of Telemedicine Initiatives Include:
•
•
•
8
North Carolina in 2013 established a statewide telepsychiatry system in
which all North Carolina hospitals are allowed to participate.
For several years, the Veterans Health Administration has used telehealth
for home health monitoring to track vital signs and conditions for patients
with chronic diseases or who have been released recently from the hospital,
leading to improved patient care and significant reductions in hospital
readmissions.
Mayo Clinic has launched a pilot program to provide workforce telehealth
kiosks at two if its facilities in Minnesota for use by employees of the Mayo
Clinical Health System. Patients can walk up to a kiosk without an
appointment and can be treated for minor health conditions by doctors,
nurse practitioners and physician assistants.
Telemedicine – Potential Savings and Current
Hurdles
• A 2014 consultant’s report suggests that telemedicine could
potentially deliver more than $6 Billion a year in health care
savings to U.S. companies. While this highlights a maximum
potential savings, a significantly lower level of use could
generate hundreds of millions of dollars in savings.5
• The push for health care services delivered through telemedicine
technologies will only increase.
• Barriers to growth include legal and regulatory barriers largely at
the state and local levels (e.g., standard of care, state licensure)
and on the federal level (Medicare reimbursement)
Telemedicine Technology Could Mean Big Savings,” August 11, 2014, available at
http://www.towerswatson.com
5“Current
9
Jurisdictional Disparities
1. FSMB Direct-to-Patient Telemedicine Model Policy
2. Physician-Patient Relationship
10
Federation of State Medical Board (FSMB) Model
Policy Framework
• Uniform definition of Telemedicine:
– “The practice of medicine using electronic communication,
information technology or other means between licensee in one
location, and a patient in another location with or without an
intervening healthcare provider”
• Physician-patient relationship
– Established when physician agrees to undertake diagnosis and
treatment of a patient and the patient agrees to be so treated
Federation of State Medical Board, “Model Policy for the Appropriate Use of Telemedicine
11 Technologies in the Practice of Medicine”, (April 2014).
Current Status – Variability per Jurisdiction
• Definition of telemedicine
• Licensing requirements
• Standard of care
12
•
Physician-patient relationship
•
E-prescribing
States’ Definitions of Telemedicine Vary
Ohio
North Carolina
Texas
• “Telemedicine certificate”
– “[T]he practice of
telemedicine” means the
practice of medicine in
this state through the
use of any
communications,
including oral, written, or
electronic
communication, by a
physician located
outside this state. Rev.
Code Ann. Sec.
4731.296
• "[T]elemedicine" is the
use of two-way real-time
interactive audio and
video between places
of lesser and greater
medical capability or
expertise to provide an
support health care
when distance separates
participants who are in
different geographical
locations. N.C. Gen.
Stat. Ann. Sec. 122C263.
• “Telemedicine medical service”
means a health care service
that is initiated by a physician or
provided by a health
professional acting under
physician delegation and
supervision, that is provided for
purposes of patient assessment
by a health professional,
diagnosis or consultation by a
physician, or treatment, or for
the transfer of medical data, and
that requires the use of
advanced telecommunications
technology, other than
telephone or facsimile
technology including: (A)
compressed digital interactive
video, audio, or data
transmission; (B) clinical data
transmission using computer
imaging by way of still-image
capture and store and forward;
and (C) other technology that
facilitates access to health care
services or medical specialty
expertise.”
13
States’ Definitions of Telemedicine Vary (cont’d)
14
New York
California
• “Telemedicine” means
the delivery of clinical
health care services by
means of real time twoway electronic audiovisual communications
which facilitate the
assessment, diagnosis,
consultation, treatment,
educations, care
management and self
management of a
patient’s health care
while such patient is at
the originating site and
the health care provider
is at a distant site.”
• “Telehealth” means the mode
of delivering health care
services and public health via
information and
communication technologies
to facilitate the diagnosis,
consultation, treatment,
education, care management,
and self-management of a
patient’s health care while the
patient is at the originating
site and the health care
provider is at a distant site.
Telehealth facilitates patient
self-management and
caregiver support for patients
and includes synchronous
interactions and
asynchronous store and
forward transfers. (Cal. Bus.
& Prof. Code § 2290.5(6))
Some States Require Telemedicine Licenses
Texas
The Out-of-State Telemedicine License is a limited license that allows a physician to practice medicine
across state lines. An Out-of-State Telemedicine License holder is not authorized to physically practice
medicine in the state of Texas.
The license holder’s practice of medicine under this license is limited exclusively: to the interpretation of
diagnostic testing and reporting of results to a Texas fully licensed physician practicing in Texas or; for the followup of patients where the majority of patient care was rendered in another state.
The holder of an Out-of-State Telemedicine License is subject to the Medical Practice Act and the same Rules of
the board as a person holding a full Texas medical license, which includes paying the same fees and meeting all
other requirements (such as CME) for issuance and renewal of the license as a person holding a full Texas
medical license.
Ohio
Nevada
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“The holder of a telemedicine certificate may engage in the practice of telemedicine in this state.
A person holding a telemedicine certificate shall not practice medicine in person in this state without
obtaining a special activity certificate….” Ohio Rev. Code Ann. Sec 4732.01(4)
The Board may issue “A special purpose license to a physician who is licensed in another state to
permit the use of equipment that transfers information concerning the medical condition of a
patient in this State across state lines electronically, telephonically or by fiber optics. […]” Nev.
Rev. Stat. ann. Sec. 630.261(1)(e)
Elements of Physician-Patient Relationship
Evaluation that meets applicable “Standard of Care”
• Identify patient
• Gather information
Informed Consent
• Patients should receive information necessary to make a meaningful decision about their medical care and treatment
Diagnosis
• Physician’s discretion to collect necessary information
Treatment
• Prescription of medicine
Follow-up care
• Ensure availability of f/u care by a physician located in patient’s state
• Establish an emergency situation referral plan
Documentation
• Confidentiality/EHR Requirements
• Maintain patients’ medical records and make available to both patients and patient’s health care providers
Continuous care
• Mostly prohibited through telemedicine (generally, for out of state physicians)
16
Standard of Care: In-Person Evaluation?
• General Definition: “The reasonable and customary conduct
demonstrating minimal competence under the circumstances”
• Telemedicine laws:
• At physicians’ discretion
• An intermediary assistant at a distant site required
• In-person evaluation required:
 Texas Ins. Code Ann. Sec. 1455.004: “A health benefit plan
may not exclude a telemedicine medical service or a
telehealth service from coverage under the plan solely
because the service is not provided through a face-to-face
consultation.”
 T.A.C. section 1190.8(L)(i)(c): “A defined physician-patient
relationship must include, at a minimum: …physical
examination that must be performed by either face-to-face
visit or in-person evaluation…”
17
E-Prescribing Authority
• Prescribing authority depends on being able to
establish a patient-physician relationship
– Most states have adopted blanket restrictions to prescribing based on an
internet questionnaire alone
• Controlled substances
– Many states ban the prescription of DEA controlled substances based on a
telemedicine encounter only
– Federal Ryan Haight Act that does not permit remote prescribing of
controlled substances and does not include exceptions for the direct-topatient virtual care model, preempting state laws
18
General Healthcare Regulations Also Applicable
• Although many states have at least some telemedicine-specific
law, it is important to keep in mind that telemedicine providers
must still follow established regulations, including:
– Fraud and Abuse
– Privacy and Security Regulations, and
– Corporate Practice of Medicine
19
Fraud & Abuse Considerations
• Anti-kickback: equipment exchange between providers
– OIG evaluated telemedicine-specific models in 1998, 1999, 2004 and 2011,
which focused on the value of the most often free consultative telemedicine
services to both the referring and consulting practitioners, and evaluated any
equipment exchange arrangements to determine inducement of referrals
– June 2015 OIG Fraud Alert on Physician Compensation Arrangements7
• Referrals: direct-to-consumer telemedicine programs necessitate
referrals for follow-up care or emergent care
OIG Adv. Op. No. 11-12 (Issued Aug. 29, 2011), OIG Advisory Op. No. 04-07 (issued June 17, 2004),
OIG Advisory Opinion OIG Advisory Op. No. 99-14 (issued Dec. 28, 1999 and OIG Advisory Opinion
OIG Advisory Op. No. 98-18 (issued Nov. 25, 1998. OIG, “Fraud Alert: Physician Compensation
20 Arrangements May Result in Significant Liability” (June 9, 2015) .
7
Privacy & Security Regulations
• HIPAA privacy and security protection requirements
– Applies to health care providers, health plans and other entities that process
health information (i.e. Covered Entities and Business Associates)
• State-specific privacy and security laws requiring greater security
measures than under HIPAA
– Ex.: Texas Medical Records Privacy Act
– Applies not only to health care providers, health plans and other entities
that process health insurance claims but also to any individual, business,
or organization that obtains, stores, or possesses protected health
information (defined as “any information that reflects that an individual
received health care from the covered entity;” and is not public
information), as well as their agents, employees and contractors if they
create, receive, obtain, use or transmit protected health information.
– In most instances, the Act prohibits covered entities from using or
disclosing protected health information without first obtaining an
individual's authorization through the standard Authorization to Disclose
Protected Health Information form that Texas Attorney General had
adopted8
21
8
http://www.texasattorneygeneral.gov/
Corporate Practice of Medicine
• A non-physician person, partnership, association or corporation
is prohibited from directly or indirectly aiding or abetting the
practice of medicine.
o Ex. Texas: Provides for exceptions that allow employment of physicians by
nonprofit health corporations, FQHCs, migrant health centers, non-profit
medical schools, school districts and certain state institutions and hospital
districts9
• Typical contractual structure used to comply with the corporate
practice of medicine doctrine is through management or
administrative services arrangement or telemedicine/vendor
platform only.
22
9
Tex. Occupations Code Sec. 164.052.
State Regulatory Wrap-Up
• Current physician / mid-level provider regulations
• New regulations related to telemedicine
• State-specific law and guidance
• Political process and industry influence
23
Reimbursement
1. Medicare
2. Medicaid
3. Private payors
24
Reason for Failure to Bill for Services Delivered via
Telemedicine
25 Mary Ann Liebert, Inc. Vol. 20 No. 6 (June 2014) Telemedicine and e-Health
Medicare
• Defines telemedicine as a distinct service apart from inperson health care services and thus restricts
reimbursement coverage based upon the following factors:
•
•
•
•
26
Location of the patient
Type of technology
Type of provider
Eligibility of the service
Medicare – Location and Originating Site
• Facilities qualifying as originating sites are:
–
–
–
–
–
–
Physician offices
Hospitals
Critical access hospitals
Rural health clinics
Federally qualified health centers
Hospital-based or critical access hospital-based renal dialysis
centers
– Skilled nursing facilities
– Community mental health centers
– Sites participating in federal telemedicine demonstration
projects approved by the DHHS.
27
Medicare – Technology
• Provider must use an interactive audio and video
telecommunications system
• Differentiates between real-time video (synchronous)
versus store-and-forward (asynchronous) models
28
Medicare – Provider Types
•
•
•
•
•
•
•
•
29
Physicians
PAs
NPs
Nurse-midwives
Clinical nurse specialists
Clinical psychologists
Clinical social workers
Registered dietitians or nutrition professionals
Medicare – Service Type
•
Examples of eligible types of services covered under
Medicare:
– Office or other outpatient visits
– Professional consults
– Individual psychotherapy
– Individual pharmacology
– Transitional care management
– Alcohol and other substance abuse counseling and treatment
30
Medicare – Remote Chronic Care Coordination
Programs
• Medicare will pay providers a monthly fee to manage and
coordinate the care of patients with two or more chronic
conditions (heart disease, diabetes and depression).
• Non-face-to-face communication styles include telephone,
secure messaging and e-mail.
• Eligible chronic care management services must be
furnished using an e-health record or other health IT or
health information exchange platform
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Medicaid Reimbursement for Telemedicine
• Federal Medicaid statute does not recognize telemedicine
as a distinct service
• States may determine:
•
•
•
•
whether or not telehealth services are covered,
what services are covered in what geographic areas,
which practitioners are reimbursed, and
how much services are reimbursed
• Differs from state to state, though the states must still
satisfy the federal requirements of efficiency, economy and
quality of care
32
Medicaid Reimbursement – State Survey (July 2015)
• 47 state Medicaid programs and DC are now reimbursing
for live video telehealth
• 9 state Medicaid programs offer some reimbursement for
store-and-forward, not counting states that only reimbursed
for teleradiology
• 16 state Medicaid programs reimburse for remote patient
monitoring
• 29 state Medicaid programs provide for a transmission or
facility fee for telemedicine services
• 27 states require a telemedicine-specific informed consent
be obtained from the patient
33
Center for Connected Health Policy (CCHP’s) July 2015 “State Telehealth Laws and Medicaid Program
Policies, A Comprehensive Scan of the 50 States and District of Columbia:”
Private Payors
• Some health insurance companies partner with
telemedicine service companies
• State Parity Legislation – payors may not distinguish
between coverage for in-person services and telemedicine
services
– Denial of payment is higher for telemedicine services than inperson services12
• According to the American Telemedicine Association,
twenty-nine states and D.C. require parity and eight states
have proposed parity legislation13
12 Chris Anderson, Private Payers Are Advancing the Use of Telemedicine Technology, Healthcare IT
News
(May 5, 2013).
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13 American Telemedicine Association 2015 State Telemedicine Legislation Tracking
Administrative Barriers to Billing Private Payors
• Preauthorization
• Using code modifiers
• Required case review prior to service delivery
• Required preferred provider status
• Other barriers not associated with the same care delivered
in person
Nina M. Antoniotti, RN, MBA, PhD,1 Kenneth P. Drude, PhD,2 and Nancy Rowe, BS. “Private Payer
35 Telehealth Reimbursement in the United States” Vol. 20 No. 6 (June 2014) Telemedicine and e-Health.
Credentialing and Privileging
• States typically require licensed health care facilities to
credential all individuals providing professional medical
services at the facility
• Government and commercial payors also typically require
health care facilities or provider organizations to credential
all practitioners as a condition of participation
• A provider needs to be credentialed at both the originating
site and the distant site
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Credentialing by Proxy
• CMS adopted a process to allow for credentialing by proxy
– Originating site may rely on distant site’s prior credentialing of
the provider
• Requires an agreement between both the distant site and
originating site facilities that contains ongoing reporting
requirements by the originating site facility on outcomes
data
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Credentialing by Proxy – Practical Implications
• Benefits:
– Streamlines administrative process
– Saves time
– Saves money
• Originating site hospitals should review their medical staff
bylaws, policies and procedures related to credentialing
and privileging to comply with conditions of participation
38
Promising Legislation for Expansion of Telemedicine
Medicare Access and
CHIP Reauthorization
Act (passed into law
April 16, 2015)
• Recognizes telehealth and remote patient monitoring as part
of the definition of “Clinical Practice Improvement Activities”
• “Alternative Payment Models” may include payment for
telehealth services, even if the service is not otherwise
covered by the traditional Medicare Program.
21St Century Cures
Act
• EHR interoperability & intensive study of Medicare
population and services that “may be improved most” by the
expansion of telehealth services
Medicare Telehealth
Parity Act of 2015
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• Expansion of originating sites, provider types and services
Promising Programs
Chronic Care Management
(covered by Medicare,
effective January 1, 2015)
40
Federation of State Medical
Boards’ Interstate Medical
Licensure Compact
•Participating state medical boards
would retain their licensing and
disciplinary authority but would
share information and processes
essential to the licensing and
regulations of physicians who
practice across state borders
Next Generation ACOs
•Administration announcement that
Medicare reimbursement will be
expanded with regard to
telemedicine (not yet lifted for the
Pioneer and MSSP ACOs)
Case Study: Teladoc, Inc.
• Teledoc Inc.
• Company that allows users to create an online profile, to
upload medical records, and request a telemedicine
consultation with a physician, including treatment by
prescribing medicine
• Texas Medical Board (TMB)
• April 10, 2015 adopted revised T.A.C. § 190.8(1)(L) that now
requires a face-to-face examination for a physician to
prescribe medicine to a patient
41
Teladoc, Inc., et al v. Texas Medical Board et. al
Teladoc sued TMB to enjoin it from
implementing the newly revised
section 190.8(1)(L), arguing:
TMB is not immune from antitrust suits because “state licensing
boards made up of active members of the licensed profession are
not immune from the antitrust laws when they take anticompetitive
actions without the active supervision of the State.” N. Carolina
Board of Dental Examiners v. FTC, 574 U.S. ___ (2015)
TMB has not objected to on-call physicians treating patients they
have never physically examined by phone and that there is no
evidence that the telehealth services Teladoc has provided are
not up to standard.
TMB did not object to Teladoc’s telehealth services until its
business started to grow exponentially in 2009 and significantly
competing with the traditional physician offices; the new rule
would put Teladoc out of business in Texas, and have a
detrimental effect on Teladoc nationwide.
42
TMB is concerned
for public safety
The revision to
section 190.8(1)(L) is
based on TMB’s
concerns for public
safety, to maintain the
quality standard of
health care services
in Texas.
TMB is entitled to take
(and has taken)
disciplinary action
against physicians
who fail to “practice
medicine in an
acceptable
professional manner
consistent with public
health and welfare.”
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Speaker
Lisa Atlas Genecov
Head of Healthcare Transactions, Dallas
Norton Rose Fulbright US LLP
With 30 years of experience, Lisa Genecov has built a practice focused on providing
legal services to the health care industry. She devotes her practice to the regulatory,
business, corporate, governance, compliance, M&A and transactional aspects of
health care law.
She advises clients on transaction structures, implementation matters, compliance
obligations and strategic opportunities under the Affordable Care Act and related
healthcare laws and regulations. She also regularly advises the boards of health care
entities on governance issues.
Lisa counsels various hospitals and health systems, medical groups and other health
care providers in both regulatory matters as well as business transactions, including:
acquisitions and divestitures of hospitals, ancillary service lines and medical
practices; co-management and service line management arrangements; the
development and formation of accountable care organizations, clinically integrated
networks and physician/hospital/payor alignment strategies; physician and hospital
contracting, physician employment and recruitment issues; physician practice
management and management services agreements; corporate practice of medicine
and fee splitting issues; as well as advising on fraud and abuse and Stark Law
compliance, tax-exempt and antitrust issues, and licensure and CHOW matters.
Lisa has been recognized and included for many years in the prestigious Chambers
USA: America's Leading Lawyers for Business rankings for health lawyers, as well as
the Best Lawyers in America for Health Care, Texas Super Lawyers, Best Lawyers in
Dallas, and was the only private law firm lawyer selected by the Dallas Business
Journal for inclusion in its 2013 "Who's Who in Health Care" edition.
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Speaker
Lane Wood
Senior Associate, Norton Rose Fulbright US LLP
Lane Wood concentrates her practice on corporate health care transactions
including the sale and purchase of health care entities and professional practices,
joint ventures, acquisition and disposition transactions, professional services
agreements, and employment and management services agreements. She also
represents health care providers and health care industry companies in connection
with regulatory issues and fraud and abuse issues related to the Anti-Kickback Act,
the Stark Act, HIPAA and data protection, and other federal and state law issues.
45
Speaker
Lidia Niecko-Najjum
Associate, Norton Rose Fulbright US LLP
Lidia Niecko-Najjum is a health care transactional associate in the Washington, D.C.
office. She focuses her practice on health care regulatory, coverage and payment,
transaction, compliance, and policy matters, including FDA issues. Representative
clients include academic medical centers, health systems, physician groups,
physician/hospital joint ventures, long-term care facilities and multinational
companies.
Prior to joining Norton Rose Fulbright, she worked for the Association of American
Medical Colleges (AAMC) in Government Relations where she conducted policy and
health care regulatory research in support of AAMC's advocacy agenda. As part of
her responsibilities, she co-authored peer reviewed articles on health care policies
related to academic medicine and physician workforce planning. Lidia began her
professional career as a clinical nurse at Georgetown University Hospital.
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