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URL: | https://www.deadiversion.usdoj.gov/.../aug_2018/miller_2.pdf |
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Title: | Registration Issues |
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Body: | Practitioner Diversion
Awareness Conference
Registration
Loren Miller, Associate Section Chief
Liaison and Policy Section
The following presentation was accompanied by an
oral presentation on August 6 and 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
§
Explain why the DEA issues registrations, the type
of registrations that the DEA issues, and how such
registrations fit into the closed system of
distribution.
§
Explain how a practitioner obtains a DEA
registration, and what is required by the DEA as
part of this process.
§
Explain the limits of a DEA registration, and the
coincident activities that a practitioner can
perform.
Course Objectives
U.S. Drug Enforcement Administration
Diversion Control Division
§
Outline when a practitioner would need more than
one DEA registration.
§
Review some common problems practitioners have
encountered regarding their DEA registration and
how they were resolved.
§
Explain some of the basic steps a practitioner can
take to reduce the chance of their DEA registration
being used in the diversion of controlled substances.
Course Objective
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.
What is the current number of DEA
registrants?
2.
As an individual practitioner, how many
associates in my practice can I authorize to use
my registration number to prescribe controlled
substances?
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
3.
Is a DEA practitioner registration always for a
three year period?
4.
Is a DEA registration number publically
available?
5.
What should I do to prevent my DEA
registration from being used for diversion?
U.S. Drug Enforcement Administration
Diversion Control Division
U.S. Drug Enforcement Administration
Diversion Control Division
Registration Requirements
for Practitioners
First, let's begin by clarifying a few points.
The truth is that although a DEA registration is a
Federal registration it does NOT allow you to
prescribe controlled substances anywhere you wish
to in the United States.
Registration Requirements
U.S. Drug Enforcement Administration
Diversion Control Division
§
A DEA registration is NOT required for you to
issue prescriptions for non-controlled substances.
§
If you change your last name you are NOT
required to obtain a new DEA registration
number.
§
A DEA registration number is NOT privileged
information, but is available to the public.
Registration Requirements
U.S. Drug Enforcement Administration
Diversion Control Division
Closed System of Distribution
Cyclic
Investigations
Security
Requirements
Record Keeping
Requirements
ARCOS
Established
Quotas
Registration
Established
Schedules
U.S. Drug Enforcement Administration
Diversion Control Division
The Registrant Community
U.S. Drug Enforcement Administration
Diversion Control Division
§Total number of DEA registrants: 1,764,894
§Total number of Practitioners: 1,290,589
§Total number of Mid Level Practitioners: 366,572
§Total number of Pharmacies: 71,679
§Total number of Hospitals: 17,940
§
Website: www.DEAdiversion.usdoj.gov
§
Go to "Registration" (located at the top of the page)
§
Form used by the new applicant: DEA Form 224
How to Apply
U.S. Drug Enforcement Administration
Diversion Control Division
How to Apply
What if you encounter problems?
If you encounter problems, contact the DEA
Registration Service Center.
DEA.Registration.Help@usdoj.gov
Or
1-800-882-9539
Or . . .
U.S. Drug Enforcement Administration
Diversion Control Division
How to Apply
Contact the DEA Registration Specialist in your
area. To find their contact information go to the
above website and look under "About Us."
For example, using this method the Registration
Specialist's contact information for Louisville is
Phone - (313) 234 4229.
U.S. Drug Enforcement Administration
Diversion Control Division
The Registration Specialist for
your area can be located on the
Diversion Control Divisions
web-site.
You can search by zip code, city,
county, or state.
U.S. Drug Enforcement Administration
Diversion Control Division
Federal and State Resources
Drug Enforcement Administration
40202
How to Apply
U.S. Drug Enforcement Administration
Diversion Control Division
The DEA cannot consider an application unless
you first have state controlled substance authority,
and each state is different:
§
State Medical License
§
State controlled substance registration (if
required)
§
Other state licensure (if required)
§
Certificates of advanced training (if required)
Practice Address vs
Mailing Address
During the application process you are asked for
your Practice Address, and you are asked for
your Mail-to Address if these two addresses are
different.
Your Practice Address is your principal place of
business or professional practice pursuant to
Title 21, C.F.R. 1301.12(a). This is the address
on your DEA certificate.
Your mail-to address is for correspondence.
U.S. Drug Enforcement Administration
Diversion Control Division
Public Access
The DEA is required to turn over the practice
address to the U.S. Department of Commerce.
The Department of Commerce sells this
information through the National Technical
Information Service to registrants and others.
Other companies then legally resell this
information.
U.S. Drug Enforcement Administration
Diversion Control Division
DEA Registration Limits
A DEA registration cannot authorize you to do
something that is otherwise prohibited by state law.
For Example: If you are registered by the state in only
schedules III-V the DEA cannot authorize you to
handle schedule II.
For Example: If state law says you cannot procure
controlled substances, the DEA cannot allow you to do
so.
U.S. Drug Enforcement Administration
Diversion Control Division
DEA Registration Limits
Final Rule: Clarification of Registration Requirements for
Individual Practitioners (December 1, 2006)
A practitioner can only administer, dispense, prescribe,
procure, or store controlled substances in a state if they
first hold a DEA registration in that state. The authority
granted under this registration ends at that state's border.
A practitioner can only administer, dispense, procure, or
store a controlled substance at a location where he or she is
registered with the DEA.
U.S. Drug Enforcement Administration
Diversion Control Division
DEA Registration Limits
U.S. Drug Enforcement Administration
Diversion Control Division
When more than one DEA registration number is needed:
§
If a practitioner plans to administer, dispense,
procure or store controlled substances at more than
one location in a state.
§
If a practitioner plans to administer, dispense,
prescribe, procure, or store controlled substances in
more than one state.
§
If the practitioner is registered with the DEA in one
state and is treating a patient in another state by
telemedicine.
DEA Registration Limits
Unique exception: The Medical Bag.
Administering or dispensing a controlled
substance inside a state where a practitioner is
registered, but at other than the practitioner's
DEA registered location.
Note: Random and as needed is - fact specific
U.S. Drug Enforcement Administration
Diversion Control Division
DEA Registration Limits
Coincident Activities allowed.
21 C.F.R. 1301.13(e)(1)(iv)
Practitioner: May conduct research and
instructional activities with those substances for
which registration was granted, except that a
mid-level practitioner may conduct such
research only to the extent expressly authorized
under state statute.
U.S. Drug Enforcement Administration
Diversion Control Division
Common Problems
Encountered
The applicant does not have appropriate state
authority.
The registrant assumes their first registration will be
for 36 months.
The applicant, or renewing registrant, fails to mark
all appropriate schedules.
The registrant fails to renew their registration in a
timely manner.
U.S. Drug Enforcement Administration
Diversion Control Division
Common Problems
Encountered
Failure to maintain state licensure once achieved.
Failure to notify the DEA of an email address change.
Believing that the practitioner needs a separate DEA
registration for each location in the same state where
they only prescribe, (other than the one registration
they already hold in that state).
U.S. Drug Enforcement Administration
Diversion Control Division
Common Problems
Encountered
Renewals submitted simultaneously by both the
practitioner and the practitioner's office.
Applying or renewing using an expired credit card or
using a check from a closed account.
Relying upon an office manager to renew for the
practitioner (but they do not).
Applying for new DEA # due to a name change.
U.S. Drug Enforcement Administration
Diversion Control Division
Common Problems
Encountered
U.S. Drug Enforcement Administration
Diversion Control Division
Changing practice address:
§
In same state
§
To another state
§
In a national emergency
Common Problems
Encountered
Going inactive, and what to do with the
registration:
Semi-retired
Health Issues
Sabbatical
U.S. Drug Enforcement Administration
Diversion Control Division
Common Problems
Encountered
Discontinuing Practice:
Permanently
U.S. Drug Enforcement Administration
Diversion Control Division
Hospitals and DEA
Registrations
Title 21 C.F.R. § 1301.22(c)(1-6)
An individual practitioner who is an agent or
employee of a hospital or other institution may, when
acting in the normal course of business or
employment, administer, dispense, or prescribe
controlled substances under the registration of the
hospital or other institution which is registered in lieu
of being registered him/herself, provided that 6
conditions are met.
U.S. Drug Enforcement Administration
Diversion Control Division
Hospitals and DEA
Registrations
Using the number off-site:
When you can use it off-site
When you cannot use it off-site
U.S. Drug Enforcement Administration
Diversion Control Division
Group Practice Setting
Title 21 C.F.R. 1301.22(b)
(b) An individual practitioner who is an agent or employee of
another practitioner (other than a mid-level practitioner)
registered to dispense controlled substances may, when acting
in the normal course of business or employment, administer or
dispense (other than by issuance of prescription) controlled
substances if and to the extent that such individual practitioner
is authorized or permitted to do so by the jurisdiction in which
he or she practices, under the registration of the employer or
principal practitioner in lieu of being registered him/herself.
U.S. Drug Enforcement Administration
Diversion Control Division
Group Practice Setting
What this lets you do
What this does not let you do
U.S. Drug Enforcement Administration
Diversion Control Division
Fee Exempt Registrations
Conditions under which it is granted
Limits of this registration
Conversion to a fee paid registration
U.S. Drug Enforcement Administration
Diversion Control Division
U.S. Military - DEA
Registration
Conditions under which it can be used.
Conditions under which it cannot be used.
When you leave the military.
U.S. Drug Enforcement Administration
Diversion Control Division
Steps to Reduce Diversion
U.S. Drug Enforcement Administration
Diversion Control Division
Steps you can take to reduce the chance of your
registration being used in the diversion of controlled
substances.
Check your PMP for use:
§
False prescriptions
§
Sloppy use by pharmacies
§
Misuse by office staff
Steps to Reduce Diversion
U.S. Drug Enforcement Administration
Diversion Control Division
§
Monitor the use of your practice's credit card and
checking account.
§
Have all controlled substances you purchase be
checked in upon delivery by two employees.
Steps to Reduce Diversion
If you dispense controlled substances, including
samples, conduct random audits to ensure they
are not getting diverted.
Do not create an atmosphere of self-use in your
practice by your staff.
U.S. Drug Enforcement Administration
Diversion Control Division
Steps to Reduce Diversion
Do not print your full DEA registration number on
your prescription. Instead add the last few digits
yourself.
Limit the amount you prescribe and the refills you
authorize, if this is not already required by your state.
U.S. Drug Enforcement Administration
Diversion Control Division
Steps to Reduce Diversion
Stick with certain controlled substances, and
strengths thus calling to attention any deviation from
this pattern.
When issuing paper prescrptions, list both the #
being prescribed and write out the amount.
Cooperate with your local pharmacists.
Do not leave your prescription pad unattended, and
lock it up if not in use.
U.S. Drug Enforcement Administration
Diversion Control Division
Steps to Reduce Diversion
SCAM!!!
Criminals posing as DEA employees are targeting
practitioners using an extortion scam. They use a
disguised telephone number that appears on a
practitioners' caller ID as the "DEA's 800
registration support number". The criminals then
demand money and threaten to suspend a
practitioner's DEA registration if they do not comply.
You were sent an email about this on April 2, 2018
U.S. Drug Enforcement Administration
Diversion Control Division
Qualified Practitioners and
Other Qualified Practitioners
The Unique Identification Number, often called the X
number, is not a DEA registration. It is certification
that the prescriber has met all the necessary
requirements to use FDA approved Schedules III-V
narcotics for the treatment of opioid use disorder.
Unlike the DEA registration number, only one
Unique Identification Number is issued.
U.S. Drug Enforcement Administration
Diversion Control Division
Qualified Practitioners and
Other Qualified Practitioners
When prescribing FDA approved Schedules
III-V narcotics for the treatment of opioid use
disorder the prescriber must place both their
DEA registration number and their Unique
Identification Number on the prescription.
U.S. Drug Enforcement Administration
Diversion Control Division
Course Review
We reviewed why the DEA issues registrations, how to
apply, and how registrations fit into the closed system
of distribution.
We identified and discussed what a DEA registration
does, and does not let you do.
We reviewed some common problems practitioners
have encountered regarding their DEA registration,
and how these are resolved.
We listed some of the steps a practitioner can take to
reduce the chance that their DEA registration will be
used to divert controlled substances.
U.S. Drug Enforcement Administration
Diversion Control Division
Post Question
1.
What is the current number of DEA
registrants?
A.
Under 250,000
B.
780, 000
C.
1, 100,000
D. Over 1,700,000
U.S. Drug Enforcement Administration
Diversion Control Division
Post Question
2.
As an individual practitioner, how many
associates in my practice can I authorize
to use my registration number to
prescribe controlled substances.
A.
None
B.
One
C.
Up to three
D.
Up to five
U.S. Drug Enforcement Administration
Diversion Control Division
Post Question
3.
Is a DEA practitioner registration always for a
three year period?
A.
Yes
B.
No
U.S. Drug Enforcement Administration
Diversion Control Division
Post Question
4. Is a DEA registration number publically
available?
A.
Yes
B.
No
U.S. Drug Enforcement Administration
Diversion Control Division
Post Question
5.
What should I do to prevent my DEA
registration from being used for diversion?
A.
Lock up my prescription pads.
B.
Limit my prescribing to the amount I
believe is currently medically necessary.
C.
Check my state's prescription
monitoring program.
D.
All of the above.
U.S. Drug Enforcement Administration
Diversion Control Division
Thank you for your time
and attention !
U.S. Drug Enforcement Administration
Diversion Control Division
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