Match Context and Document information |
These search terms are highlighted: dea verification
URL: | https://www.deadiversion.usdoj.gov/.../aug_2018/arnold_2.pdf |
Depth: | 4 clicks away from Home |
Size: | 1,716,566 bytes |
Modified: | 2024-05-28 12:28:33 |
Categories: | -None- |
Title: | Telemedicine |
Description: | -None- |
Keywords: | -None- |
Meta data: | -None- |
Body: | Telemedicine and the
Controlled Substances Act
Practitioner Diversion Awareness Conference
Louisville, Kentucky
August 6-7, 2018
James "Jim" Arnold
Chief, Liaison and Policy
Drug Enforcement Administration
The following presentation was accompanied by an
oral presentation on August 6 & 7, 2018, 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
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
36
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)
37
U.S. Drug Enforcement Administration
Diversion Control Division
38
39
40
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
47
|
|