Industry Insights
Jones Day partners Todd Kelly and Elizabeth
Myers and associate Eric Jackson recently coauthored an article
titled "While Rules Evolve Telemedicine is Alive and Well
in Texas," published in Texas Lawyer. The article
explores various telemedicine models that are being used in
America's second most populous state, despite the uncertainty
and litigation disputes regarding recent amendments to the Texas
Medical Board's rules on telemedicine and prescribing that
threaten some direct-to-consumer delivery models. The article
concludes that "little has changed consultations among
licensed providers or referrals by physicians who have already
evaluated the patient."
Reprinted with permission from the September 2015 edition
of Texas Lawyer. © 2015 ALM Media Properties, LLC.
All rights reserved. Further duplication without permission is
prohibited.
Federal Features
ONC—The Office of National Coordinator
for Health Information Technology ("ONC") recently
released a white paper, titled Designing the Consumer-Centered Telehealth
& eVisit Experience: Considerations for the Future of Consumer
Healthcare, which ONC had commissioned as a summary of its
April 2015 design workshop on the topic.
According to the paper, the workshop identified the following nine
guidelines for consumer-centered telehealth:
- There cannot be friction for the user.
- Team-based care must include smart triggers.
- Real world and online world must converge.
- We must be sensitive to data overload.
- Consumers are the hubs of their own health care data.
- Converge data for interactions to be safe and meaningful.
- Expand role for care team based on new data triggers.
- Integrate technology and human interaction in the physical world.
- Increase focus on patient data security.
Although the paper explains that it should not be interpreted as a
policy statement of ONC, it does provide an overview of the state
regulatory landscape, other challenges faced by telehealth
providers, and general principles for what it describes as four
levels of the integration-to-fracturing of care: (i) integrated
care (primary care provider ("PCP"), patient, and family
members); (ii)telehealth-enabled care (use of telehealth by same
PCP); (iii) extended integration (telehealth-enabled encounter with
networked providers); and (iv) outside care (telehealth-enabled
encounters with "one-off" clinicians, i.e., no
preexisting relationship). The white paper indicates that ONC
expects to continue discussing these issues and has a stated goal
of expanding the adoption and use of telehealth and mobile
health.
FTC—On September 17, 2015, the Consumer
Protection Bureau of the Federal Trade Commission ("FTC")
released details of a recent enforcement action against the
marketers of a mobile application that provides visual exercises
focused on reading and other activities. Under the terms of a proposed settlement, the company has agreed to
disgorge $150,000 and to stop making certain claims about the app.
The FTC had alleged that the company did not have scientific
evidence to support its claims that the app could improve
users' vision. This action serves as a reminder of the
importance for careful consumer disclosures and registration terms,
especially for mHealth apps.
Telehealth Legislation—Members of Congress
and outside organizations continue to discuss the Telemedicine for
Medicare (TELE-MED) Act of 2015, which has been introduced in both
the House of Representatives and Senate. The bill would enable
physicians licensed in one state to provide care remotely to
Medicare patients located in other states without obtaining a
license in the patient's state. Although limited to Medicare
services, the bill has a similar purpose as other initiatives aimed
at streamlining professional medical standards, such as the Interstate Medical Licensure Compact, which has
been adopted by 11 states.
State Summaries
Alabama—On August 19, 2015, the Alabama
Board of Medical Examiners announced it had repealed and
immediately suspended enforcement of its telehealth rules,
explaining the decision was based on its concerns regarding
potential antitrust issues following the recent U.S. Supreme Court
decision in North Carolina State Board of Dental Examiners v.
FTC. The repealed rules included an "appropriate physical
examination" requirement that limited the use of certain
telehealth delivery models in the state. The Board is not expected
to issue replacement rules until the state legislature approves new
telehealth legislation, possibly as early as spring 2016.
Colorado—On August 20, 2015, the Colorado
Medical Board issued new guidelines on the appropriate use of
telehealth in the context of "direct to consumer"
business models. The guidelines closely track the Model Policy of
the Federation of State Medical Boards by providing that a
provider–patient relationship can be established via
telehealth and that the same standard of care applies to both
telehealth and in-person delivery models. Other notable features
include: (i) the definition of "telehealth" covers both
synchronous interactions and store-and-forward transfers; (ii) the
use of telehealth requires informed consent with appropriate
disclosures on the modality; (iii) a formal written protocol must
be developed for handling emergency services; and (iv)
recommendations of medical marijuana may not be made via telehealth
technologies.
Idaho—The Idaho Board of Medicine recently
adopted " Guidlinesfor Appropriate Regulation of
Telemedicine." The guidelines mark a significant reform
for a state that has been the source of relatively high-profile
enforcement actions against telehealth providers. Specifically, the
new policy recognizes that a physician–patient relationship
may be established remotely but advises physicians not to render
medical advice or care using telemedicine without verifying the
location of the patient, disclosing the provider's identity and
credentials, and obtaining any special informed consents regarding
the use of telemedicine technologies, among other requirements. The
Board is in the process of codifying these policies into
regulations and held a public hearing on the matter on September
15, 2015.
North Carolina—Pursuant to a new rule effective August 1, 2015, North
Carolina pharmacists are permitted to use professional judgment in
refusing to fill a prescription in cases where the prescription
order's accuracy, validity, or authenticity or the
patient's safety is at issue. Additionally, the rule provides
that a prescription order is valid "only if it is a lawful
order for a drug, device, or medical equipment issued by a health
care provider for a legitimate medical purpose, in the context of a
patient–prescriber relationship, and in the course of
legitimate professional practice." Previously, state law had
imposed an obligation on pharmacists to decline prescriptions when
it was believed the prescriber had not conducted "a physical
[in-person] exam" of the patient. This change helps bring the
pharmacy regulations in line with current policies of the state
Medical Board as it relates to telemedicine.
South Carolina—At its August 3, 2015
meeting, the S.C. Board of Medical Examiners approved a
telemedicine provider guidance document and updated its advice on establishing a
physician–patient relationship as a prerequisite to
prescribing drugs. The guidance document clarifies that
telemedicine is held to the same standard of care as in-person
services. With respect to establishing a physician–patient
relationship, while the Board's updated guidance indicates that
such a relationship can be established solely through telemedicine,
the guidance appears to require the use of patient-site ancillary
providers where there is no preexisting physician–patient
relationship (with limited exceptions such as writing admission
orders for a newly hospitalized patient, prescribing for a patient
of another licensee for whom the prescriber is taking call, and
others).
Virginia—Virginia recently amended its rules regarding telemedicine prescribing. As
of July 1, 2015, a prescriber may establish a
practitioner–patient relationship through "two-way,
real-time" communication or store-and-forward technology if
the licensed prescriber has a medical history available for review,
makes the diagnosis at the time of prescribing, and conforms to
standards of care for in-person treatment, among other
requirements.
Wisconsin—In a notice dated September 21, 2015, the Wisconsin
Medical Examining Board announced it has begun the process for
proposing new telemedicine regulations. The current administrative
code is silent with regard to telemedicine, but the proposed rule
would define the practice of telemedicine, explain how a valid
physician–patient relationship can be established in a
telemedicine setting, and specify licensure and technology
requirements for the use of telemedicine. The notice cites federal
bill H.R. 691 (Telehealth Modernization Act of 2015) as a model for
the issues that will be addressed by the Wisconsin proposed
rule.
Reimbursement Review
Delaware—In September 2015, the Delaware
Division of Medicaid and Medical Assistance ("DMMA")
adopted an amendment recognizing the Medicaid
beneficiary's home as an originating site for reimbursement of
interactive, real-time audio-video telemedicine. In response to
public comments, the DMMA also revised the final rule to include
nonresidential day programs and alternate locations as originating
sites.
Michigan—On September 16, 2015, Michigan
legislators introduced Senate Bill No. 495, which would require coverage for
asynchronous store-and-forward and real-time telemedicine provision
of care as long as the provider is licensed in the state where the
patient is located. Additionally, the legislation would clarify
that insurance policies may "not require
face-to-face-contact" for telemedicine services to qualify for
reimbursement.
Texas—Effective September 1, 2015, an
amendment to Texas Medicaid Rule § 355.7001 clarifies that physicians
will be reimbursed for telemedicine services provided in a
school-based setting even if the physician is not the patient's
primary care provider. To qualify, the child must be located at
school and enrolled in Medicaid. A health professional, such as a
school nurse, must be present with the child during treatment, and
the parent or guardian must give consent before the telemedicine
services are provided.
Washington—The Washington Apple Health
(Medicaid) program recently held a public hearing regarding a proposed rule that would cover
"HIPAA-compliant, interactive, real-time audio and video
telecommunications (including web-based applications) or store and
forward technology [used] to deliver covered services that are
within his or her scope of practice to a client at a site other
than the site where the provider is located." Eligible
originating sites would include clinics, hospitals, and
patients' homes, among other listed locations. As the proposed
rule goes though the rulemaking process, the program has
temporarily implemented a less expansive rule that covers only real-time audio and video
telemedicine.
Global Happenings
EU Digital Single Market—On September 23,
2015, the European Commission launched a public consultation on Standards for the
Digital Single Market ("DSM"). Andrus Ansip, Commission
Vice President for the Digital Single Market, explained that common
standards and interoperability will "make the best of
fast-growing sectors such as cloud computing and the Internet of
Things." The Commission is gathering views on priorities for
standards in key technology areas that are, in the Commission's
opinion, critical to achieving the DSM and, once delivered, can
constitute a technological foundation upon which other standards
can be built. eHealth is one of the key topics on which the
Commission is looking for input. Public comments are due December
16, 2015. Please contact Cristiana
Spontoni if you are interested in discussing how we can assist
you with submitting comments.
EU–US Data Protection—Telehealth
providers hoping to bridge the North Atlantic face challenging
issues for cross-jurisdictional compliance in the area of data
protection. As a general principle, EU Directive 95/46/EC and
national implementing legislation prohibit the processing of
personal data related to health, except in certain conditions, such
as obtaining the explicit consent of the data subject or where
processing is required for the purposes of preventative medicine or
medical care and is performed by health care professionals subject
to confidentiality obligations. In the United States, the real
issue concerning data protection is often which authorities apply:
U.S. Department of Health and Human Services or Federal Trade
Commission regulations, state-specific data privacy rules, or all
of the above. This topic is explored in an August 2015 article in eHealth Law & Policy,
coauthored by Jones Day partners Alexis
Gilroy, Cristiana Spontoni, and Undine
von Diemar and associate Katherine
Llewellyn.
Upcoming Events
October 21, 2015: Maureen
Bennett will give a presentation on International Clinical
Research Issues to the Boston Bar Association's Health Law
Education Committee.
October 26–27, 2015: Alexis
Gilroy will speak about Lessons on
Telemedicine—Opportunities and Unique Diligence and Payment
Considerations at the AHLA Health Plan Counsel Institute in
Chicago, IL.
November 19–20, 2015: Cathy
Livingston will present on Compensation Issues and Joint
Ventures, Subsidiaries, and Contractual Issues at the Western
Conference on Tax Exempt Organizations in Los Angeles, CA.
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