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| URL: | https://www.deadiversion.usdoj.gov/.../july_2019/arnold2.pdf |
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| Title: | Telemedicine |
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| Body: | Telemedicine and the
Controlled Substances Act
Practitioner Diversion Awareness Conference
Indianapolis, Indiana
July 23-24, 2019
James "Jim" Arnold
Chief, Liaison and Policy
Drug Enforcement Administration
The following presentation was accompanied by an oral
presentation on July 22-23, 2019, and does not purport to
establish legal standards that are not contained in statutes,
regulations, or other competent law. Statements contained in
this presentation that are not embodied in the law are not
binding on DEA. Summaries of statutory and regulatory
provisions that are summarized in this presentation do not
purport to state the full extent of the statutory and regulatory
requirements of the cited statutes and regulations. I have no
financial relationships to disclose.
LEGAL DISCLAIMER
U.S. Drug Enforcement Administration
Diversion Control Division
This presentation is for educational purposes only. This presentation may not be
further copied or used, with the embedded images and videos, without an
independent analysis of the application of the Fair Use doctrine.
Fair Use
Under section 107 of the Copyright Act of 1976, allowance is made for "Fair Use"
for purposes such as criticism, comment, news reporting, teaching, scholarship,
education and research.
Fair Use is a use permitted by the copyright statute that might otherwise be
infringing. Any potentially copyrighted material used in this presentation has been
reviewed and found to be used in a manner consistent with Fair Use. A completed
Fair Use checklist is attached.
Fair Use Act Disclaimer
U.S. Drug Enforcement Administration
Diversion Control Division
§
Discuss the Ryan Haight Online Pharmacy
Consumer Protections Act.
§
Discuss the requirements of prescribing
controlled substances using telemedicine
under Federal law.
Course Objectives
U.S. Drug Enforcement Administration
Diversion Control Division
§
Discuss the requirements of a
telecommunications system when using
telemedicine.
§
Discuss practitioners who are exempt from the
Ryan Haight Act in-person medical evaluation
requirement.
Course Objectives
U.S. Drug Enforcement Administration
Diversion Control Division
§
Discuss the telemedicine requirements to abide
by both state and federal laws.
Course Objectives
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
At the completion of this block of instruction you
will be able to answer the following questions:
1.
Does the Ryan Haight Act only apply to on-line
pharmacies?
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
2. For a prescription to be valid it must be issued
for a legitimate medical purpose in the usual
course of professional practice?
3. Are you required to have one in-person visit
with your patient in order to conduct
telemedicine?
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
4. Does e-mail or fax meet the communication
requirements for telemedicine?
5. For most practitioners conducting telemedicine
the patient must be in:
(a) DEA registered hospital/clinic or
(b) in the physical presence of a DEA
registered practitioner?
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
6.
When conducting telemedicine does the
remote practitioner need to have a DEA
registration in the state where the patient is
located?
U.S. Drug Enforcement Administration
Diversion Control Division
Ryan Haight Online Pharmacy
Consumer Protection Act
of 2008
PL-110-425
110
th
Congress
October 15, 2008
U.S. Drug Enforcement Administration Diversion Control
Division
"The Ryan Haight Act"
U.S. Drug Enforcement Administration Diversion Control
Division
Amended
The Controlled Substances Act
U.S. Drug Enforcement Administration Diversion Control
Division
Basically:
Added New Provisions
to the
(Controlled Substances Act)
U.S. Drug Enforcement Administration Diversion Control
Division
Purpose of the
Ryan Haight Act
Prevent
illegal distribution
and
dispensing
of controlled substances
by means of the Internet.
U.S. Drug Enforcement Administration Diversion Control
Division
Controlled Substances Dispensed
by Means of the Internet
21 U.S.C. § 829 (Prescriptions)
was amended as follows:
No controlled substance may be delivered,
distributed, or dispensed without a Valid
Prescription
U.S. Drug Enforcement Administration Diversion Control
Division
Valid Prescription
A prescription issued
for a
legitimate medical purpose
in the
usual course of professional practice
U.S. Drug Enforcement Administration Diversion Control
Division
A Prescription Issued By
A practitioner
who has conducted
at least 1 "in-person medical evaluation"
of the patient
U.S. Drug Enforcement Administration Diversion Control
Division
In-Person Medical Evaluation
A medical evaluation that is
conducted
with the patient
in the physical presence of the
practitioner.
U.S. Drug Enforcement Administration Diversion Control
Division
In-Person Medical Evaluation
Unless:
The practitioner is engaged in the
practice of Telemedicine
*21 U.S.C. § 829 (e)(3)(A)*
U.S. Drug Enforcement Administration Diversion Control
Division
TELEMEDICINE
"The Basics"
U.S. Drug Enforcement Administration Diversion Control
Division
TELEMEDICINE
21 U.S.C. § 802 (54)
U.S. Drug Enforcement Administration Diversion Control
Division
Definition of Telemedicine
The practice of medicine
in accordance with applicable
Federal and State laws
by a practitioner
(other than a pharmacist)
at a location remote from the patient, and
U.S. Drug Enforcement Administration Diversion Control
Division
Definition of Telemedicine
is communicating with the patient,
or health care professional
who is treating the patient,
using a telecommunications system referred
to in
42 C.F.R. § 410.78(a)(3)
U.S. Drug Enforcement Administration Diversion Control
Division
Telecommunications System
Multimedia communications equipment
that includes, at a minimum, audio and
video equipment permitting two-way, real
time interactive communication
between the patient and remote
practitioner.
U.S. Drug Enforcement Administration Diversion Control
Division
Telecommunications System
Telephones,
facsimile machines,
and electronic mail systems
do not meet this definition.
U.S. Drug Enforcement Administration Diversion Control
Division
Definition of Telemedicine
(A) is being conducted -
(i) while the patient is being treated
by, and physically located in a
DEA- registered hospital or clinic
and
U.S. Drug Enforcement Administration Diversion Control
Division
Definition of Telemedicine
(ii) by a practitioner -
(1) acting in the usual course of
professional practice;
(2) acting in accordance with
applicable State law; and
(3) is registered ...in the State in
which the patient is located,
unless the practitioner (is)-
U.S. Drug Enforcement Administration Diversion Control
Division
Definition of Telemedicine
(B) is being conducted
while the patient is being treated by,
and in the physical presence of, a
DEA-registered practitioner.
U.S. Drug Enforcement Administration Diversion Control
Division
Definition of Telemedicine
a practitioner -
(1) acting in the usual course of
professional practice;
(2) acting in accordance with
applicable State law; and
(3) is registered ...in the State in
which the patient is located,
unless the practitioner (is)-
U.S. Drug Enforcement Administration Diversion Control
Division
Minor "Exceptions" for
DEA Registration
Employee or Contractor of
Veterans Affairs
Indian Health Service
U.S. Drug Enforcement Administration Diversion Control
Division
"Exceptions"
Medical Emergency Situation
(Veterans Affairs)
U.S. Drug Enforcement Administration Diversion Control
Division
"Exceptions"
Public Health Emergency
U.S. Drug Enforcement Administration Diversion Control
Division
"Exceptions"
Special Registration for
Telemedicine
U.S. Drug Enforcement Administration Diversion Control
Division
"Exceptions"
Other Circumstances determined
by the Attorney General and the
(HHS) Secretary...
U.S. Drug Enforcement Administration Diversion Control
Division
The Remote Practitioner
The remote practitioner must be registered
with the DEA:
1. In the state where they are physically
located; and
2. In the every state where the patient is
located
21 U.S.C. § 822 (e)(1), 21 C.F.R. § 1301.12(a),
71 FR 69478, December 1, 2006
U.S. Drug Enforcement Administration Diversion Control
Division
How Can You Do Telemedicine?
(1)
Patient is in a DEA Registered Hospital
(2)
Patient is in the Physical Presence of a
DEA Registered Practitioner
(3)
DEA Registered Practitioner Travels to
the Residence or Other Physical Location
of the Patient
37
U.S. Drug Enforcement Administration
Diversion Control Division
How Can You Do This?
(4) Rent an Office and Have Your Patients Go
to the Office Where the DEA
Registered Practitioner is Located.
(5) Mobile Van (DEA Registered Practitioner
on Board)
38
U.S. Drug Enforcement Administration
Diversion Control Division
39
Post Questions
1.
Are you required to have one in person visit
with your patient in order to conduct
telemedicine?
A.
Yes
B.
No
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
2.
Does e-mail or fax meet the
communication requirements for
telemedicine?
A.Yes
B.No
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
3.
The Ryan Haight Act only applies to on-
line pharmacies.
A.True
B.False
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
4.
When conducting telemedicine does the
remote practitioner need to have a DEA
registration in the state where the patient is
located?
A.
Yes
B.
No
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
5.
For a prescription to be valid it must be
issued for a legitimate medical purpose in
the usual course of professional practice?
A.True
B.False
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
6.
For most practitioners conducting
telemedicine the patient must be in (a) DEA
registered hospital/clinic or (b) in the physical
presence of a DEA registered practitioner?
A.
True
B.
False
U.S. Drug Enforcement Administration
Diversion Control Division
Thank You
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