Transcript Tele-psychiatry and the Ryan Haight Online

Tele-psychiatry and the Ryan Haight Online
Pharmacy Consumer Protection Act
June 8, 2015
Libby Baney, Senior Director, FaegreBD Consulting
Tele-psychiatry and the Ryan Haight Online Pharmacy
Consumer Protection Act
► Background
► The
Issue
► Recommendation
► Next
steps
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Background: What is Telehealth
(aka telemedicine, m-health, e-health)?
 The use of electronic information and telecommunications technologies to
support remote clinical health care, patient and professional health-related
education, public health activities, and health administration.
 Telehealth involves real-time, synchronous audio-video encounters
between patients and providers
Background
►
An independent research firm recently estimated the 2014 worldwide telemedicine,
m-health, and tele-health markets at $1.5 billion, and predicts explosive growth
to $45.4 billion within seven years.
►
Tele-psychiatry is a thriving area of telemedicine. Indeed, one million telepsychiatry consultations are estimated to occur in the U.S. in 2015 according to
an executive with InSight Telepsychiatry.
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Benefits of tele-psychiatry include:
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Increased access to medical specialists
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Cost savings (from reduced ER visits)
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Mitigating provider shortages
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Increased efficiency
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Convenience for patients and doctors
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The Issue
►
Issue: Psychiatrists have been prohibited from
issuing a prescription for a controlled substance
by means of the Internet (via telemedicine) by the
US Drug Enforcement Agency, finding such
violates the Ryan Haight Online Pharmacy
Consumer Protection Act (“Ryan Haight Act”).
►Among
other things, the Act requires that no controlled substance may be “delivered,
distributed or dispensed by means of the Internet without a valid prescription.”
Unless a telemedicine exception applies, a valid prescription may only be obtained (1)
by a practitioner who has conducted at least one in-person medical evaluation of the
patient, or (2) by a covering practitioner.
The Act provides for seven (7) exceptions, including the most common exception
for when the patient is located at a facility registered with the DEA and is being
treated by a DEA-registered provider. But none of these apply here …
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The Issue
Real Life Example
►
►
Facts:
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Patient A is at a mental health clinic that is not registered with the DEA.
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Patient A is in the physical presence of a mental health worker, but is not in the
physical presence of a DEA registered provider.
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Psychiatrist B is registered with DEA and treats the patient via telemedicine.
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Physiatrist B’s treatment includes a prescription for a controlled substance.
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DEA finds that this issuance of a prescription via telemedicine violates the Ryan
Haight Act.
Question: What should be done to allow psychiatrists to prescribe
controlled substances via telemedicine to patients in this circumstance,
without creating a loophole in the law that may be exploited by
unscrupulous actors?
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What Can We Do About This?
Overview of the Options
• Ask DEA to create a new a regulatory exception
• Lobby Congress to change the statute
Recommendation
► Ask
DEA to use their authority under the Act to create a new
exception, by regulation, to the in-person medical evaluation
requirement:
DEA could require facilities that are not otherwise registered with
DEA (like mental health clinics), but who nonetheless have the
need to engage in telemedicine involving prescriptions for
controlled substances to register as a DEA telemedicine site
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Recommendation
► Considerations:
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Does not require Congress to act; DEA may solve the problem by regulation.
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Gives DEA transparency into the business practices of clinics/facilities not registered
with the DEA under section 303(f) but who nonetheless desire to engage in the practice
of telemedicine involving controlled substances.
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Gives DEA jurisdiction over the clinics/entities for violation of the Ryan Haight Act
should the clinic/facility fail to comply with the requirements of the new, proposed
exception.
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Enables facilitates to attract DEA registered providers to work with them, as the
provider no longer faces the risk of being investigated under the Ryan Haight Act.
►
Preserves the purpose of the Act, avoids creating a legal loophole that could be
abused by pill mills, unscrupulous doctors and illegal online drug sellers.
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Question for the Group
Should NCBH engage on this issue?
If so, should NCBH pursue the proposed approach?
Discussion/Questions
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Thanks!
Libby Baney, JD
Senior Director, FaegreBD Consulting
Counsel, Faegre Baker Daniels
P: 202-312-7438
[email protected]
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Appendix A
Other Approaches Considered
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Appendix A – Other Approaches Considered
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Exception for Community Mental Health Clinic/Facilities. Craft an exception that only
applies to prescriptions issued by (a) DEA registered provider who is (b) affiliated with a
licensed mental health clinic or facility that (c) is not registered with the DEA and does not
dispense controlled substances. As proposed, elements (a) through (c) all must exist in order
for the exception to apply.
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Requiring providers to be affiliated with a licensed clinic of facility helps guard against individual practitioners
advertising “telemedicine services” (i.e. online prescription mills) for controlled substances directly to consumers,
but it may be difficult to define and apply the “affiliated with” standard
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Requiring the facility or clinic to be licensed gives law enforcement another compliance hook, whereby state or
federal officials could shut-down an unlicensed clinic and/or sanction any provider engaging in online prescribing
of controlled substances without affiliation with a licensed clinic/facility;
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Limiting the exception to clinics/facilities that are not registered with DEA and does not dispense controlled
substances further prevents against possible abuses, as the clinics/facilities would not have a financial interest in
the volume of controlled substance prescriptions issued.
Should this approach be pursued, it would be important to understand the possible nature of the
relationship between providers and clinics/facilities so that the term “affiliated with a state licensed mental
health clinic or facility” may be defined for purposes of the exception without cutting off access to
legitimate medical services. More research would be needed on this point.
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Appendix A – Other Approaches Considered
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Exception for activity consistent with state law/regulation. Under this approach, prescribing for
controlled substances could be done via telemedicine so long as the activity is consistent with state laws
and regulations. This raises a few issues:
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State laws vary widely on the issue of telemedicine standards. Currently there is no uniform national
standard for telemedicine activities and online prescribing. E.g. Minnesota vs. Alabama/Texas.
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Deferring to state laws/regulations is risky as state laws are in flux, and inefficient, as such would
not yield a consistent standard for tele-psychiatry nationwide.
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Members of Congress, may oppose an exception that defers to state laws, as state laws could lead
to lower standards for the prescribing and dispensing of controlled substances than intended by the
Ryan Haight Act.
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This would also give rise to forum- shopping by unscrupulous actors to avoid restrictive prescribing
and dispensing laws.
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Further, without the threat of federal enforcement under the Ryan Haight Act, bad actors may be
more willing to take the risk of violating state medical board laws and regulations related to online
prescribing and dispensing.
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This potential for abuse could raise concern by stakeholders including e.g. federal authorities and
policymakers, state regulatory organizations, drug abuse and diversion organizations, pharmacy
groups, and safe medicines advocates.
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Appendix A – Other Approaches Considered
►
Statutory Change. Advocate for Congress to add a new clause at USC 829(e)(2)(A)(i) that
defines “in-person medical evaluation” as being inclusive of a videoconference evaluation
conducted via telemedicine by a properly registered practitioner with their patient. There are a
few issues to consider here:
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Statutory change is a heavier lift than seeking a regulatory exception.
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The plain language, legislative history and implementing regulations of the Act indicate
that Congress intended for “in-person medical evaluation” to require physical presence
so that the practitioner could fully assess the physical and mental health of the patient.
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Opponents may argue that an in-person patient medical evaluation creates a checkpoint for
patients seeking controlled substances. Plus, consumers seeking controlled substances for
recreation, not medical, purposes are less likely to go see a doctor in-person verses their
willingness to go online and video chat with a doctor.
We do not know what FSMB and AMA would think about revising the Act to allow
providers to issue a prescription for a controlled substance without a prior physical
medical evaluation.
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Recent FSMB and AMA model telemedicine policies were issued after the enactment of the
Ryan Haight Act, and both require compliance with other applicable state and federal laws
(including the Ryan Haight Act).
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