Notice2025-19599
Ali Elhorr, M.D.; Decision and Order
Primary source
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Published
October 20, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 90 Issue 200 (Monday, October 20, 2025)</title>
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[Federal Register Volume 90, Number 200 (Monday, October 20, 2025)]
[Notices]
[Pages 48375-48378]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19599]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Ali Elhorr, M.D.; Decision and Order
On May 22, 2025, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Ali Elhorr, M.D.
(Applicant), of Dearborn, Michigan. Request for Final Agency Action
(RFAA), Exhibit (RFAAX) 1, at 1, 4. The OSC proposed the denial of
Applicant's application for DEA registration, Control No. W22137646C,
alleging that Applicant is mandatorily excluded from participation in
Medicare, Medicaid, and all Federal health care programs pursuant to 42
U.S.C. 1320a-7(a) and that Applicant materially falsified his
application for registration. Id., at 2-3 (citing 21 U.S.C. 824(a)(5),
824(a)(1)).
On July 7, 2025, the Government submitted an RFAA requesting that
the Agency issue a default final order denying Applicant's application.
RFAA, at 1, 5. After carefully reviewing the entire record and
conducting the analysis as set forth in detail below, the Agency finds
that Applicant is in default, finds that Applicant is
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mandatorily excluded, and finds that Applicant materially falsified his
application for registration. Accordingly, the Agency grants the
Government's RFAA and denies Applicant's application.
I. Default Determination
Under 21 CFR 1301.43, an applicant entitled to a hearing who fails
to file a timely hearing request ``within 30 days after the date of
receipt of the [OSC] . . . shall be deemed to have waived their right
to a hearing and to be in default'' unless ``good cause'' is
established for the failure. 21 CFR 1301.43(a), (c)(1). In the absence
of a demonstration of good cause, an applicant who fails to timely file
an answer also is ``deemed to have waived their right to a hearing and
to be in default.'' 21 CFR 1301.43(c)(2). Unless excused, a default
constitutes ``an admission of the factual allegations of the [OSC].''
21 CFR 1301.43(e).
The OSC notified Applicant of his right to file a written request
for hearing and answer, and that if he failed to file such a request
and answer, he would be deemed to have waived his right to a hearing
and be in default.\1\ RFAAX 1, at 3 (citing 21 CFR 1301.43). Applicant
has not requested a hearing or filed an answer. RFAA, at 2. Thus, the
Agency finds that Applicant is in default and therefore has admitted to
the factual allegations in the OSC. 21 CFR 1301.43(e).
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\1\ Based on the Government's submission in its RFAA dated July
7, 2025, the Agency finds that service of the OSC on Applicant was
adequate. The included attachment shows that on June 3, 2025, a
Diversion Investigator personally served the OSC on Applicant and
Applicant signed a receipt of service. RFAAX 2.
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II. Mandatory Exclusion
A. Findings of Fact
The Agency finds that, in light of Applicant's default, the factual
allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
Accordingly, Applicant admits that in September 2016, he pled guilty to
health care fraud in violation of 18 U.S.C. 1347. RFAAX 1, at 2. As a
result of Applicant's conviction,\2\ the United States Department of
Health and Human Services, Office of Inspector General (HHS/OIG),
mandatorily excluded Applicant from participation in Medicare,
Medicaid, and all Federal health care programs pursuant to 42 U.S.C.
1320a-7(a) for a minimum period of 15 years, effective on February 20,
2017. Id.
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\2\ The underlying conviction forming the basis for mandatory
exclusion from participation in Federal health care programs need
not involve controlled substances to provide the grounds for
revocation or denial pursuant to section 824(a)(5). See Moustafa M.
Aboshady, M.D., 90 FR 15992, 15993 n.5 (2025) (collecting cases).
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B. Discussion
Pursuant to 21 U.S.C. 824(a)(5), the Agency \3\ is authorized to
suspend or revoke a registration upon finding that the registrant ``has
been excluded (or directed to be excluded) from participation in a
program pursuant to [42 U.S.C. 1320a-7(a)].'' The Agency has
consistently held that it may also deny an application upon finding
that an applicant has been excluded from a Federal health care program.
Mark Agresti, M.D., 90 FR 30098, 30099 (2025); Samirkumar Shah, M.D.,
89 FR 71931, 71933 (2024); Arvinder Singh, M.D., 81 FR 8247, 8248
(2016).
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\3\ The Controlled Substances Act (CSA) delegates power to the
Attorney General, who has delegated it to the Administrator of the
DEA (the Agency) by 28 CFR 0.100.
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Here, the Agency finds substantial record evidence \4\ that
Applicant is mandatorily excluded from participation in Medicare,
Medicaid, and all Federal health care programs pursuant to 42 U.S.C.
1320a-7(a) for a minimum of 15 years. RFAAX 1, at 2. Accordingly, the
Agency finds that the Government established a prima facie case for
sanction based on mandatory exclusion, that Applicant did not rebut
that prima facie case, and that there is substantial record evidence
supporting the imposition of sanctions. 21 U.S.C. 824(a)(5).
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\4\ According to the CSA, ``[f]indings of fact by the [DEA
Administrator], if supported by substantial evidence, shall be
conclusive.'' 21 U.S.C. 877. Here, where Applicant is found to be in
default, all the factual allegations in the OSC are deemed to be
admitted. These uncontested and deemed admitted facts constitute
evidence that exceeds the ``substantial evidence'' standard of 21
U.S.C. 877; it is unrebutted evidence.
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III. Material Falsification
A. Findings of Fact
The Agency finds that, in light of Applicant's default, the factual
allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
Accordingly, Applicant is deemed to have admitted to each of the
following facts. On October 19, 2022, Applicant submitted an
application for DEA registration as a practitioner in Schedules II
through V. RFAAX 1, at 2. The application form contained the following
liability question: ``[h]as the applicant ever been . . . excluded or
directed to be excluded from participation in a medicare or state
health care program, or [is] any such action pending?'' Id., at 3
(``Liability Question 1''). Applicant answered ``No'' to Liability
Question 1. Id. At the time he submitted his application, Applicant was
mandatorily excluded from ``participation in Medicare, Medicaid, and
all Federal health care programs'' by HHS/OIG. Id.; see supra Section
II.
B. Discussion
A DEA registration may be denied, suspended, or revoked upon a
finding that the applicant or registrant materially falsified any
application filed pursuant to or required by the CSA. 21 U.S.C.
824(a)(1).\5\ To present a prima facie case for material falsification,
the Government's record evidence must show (1) the submission of an
application, (2) containing a false statement and/or omitting
information that the application requires, (3) when the submitter knew
or should have known that the statement is false and/or that the
omitted information existed and the application required its
disclosure, and (4) the false statement and/or required but omitted
information is material, that is, it ``connects to at least one of the
section 823 factors that, according to the CSA, the Administrator shall
consider when analyzing whether issuing a registration would be
inconsistent with the public interest.'' Michael Bouknight, 90 FR
31247, 31249 (2025) (quoting Frank Joseph Stirlacci, M.D., 85 FR 45229,
45238 (2020)) (cleaned up) (citing 21 U.S.C. 823 and Kungys, 485 U.S.
at 771). The Government must establish material falsification with
record evidence that is clear, unequivocal, and convincing. Kungys, 485
U.S. at 772; Michael Bouknight, 90 FR at 31249-50; Sasha Melissa
Ikramelahai, 90 FR 32017, 32019-20 (2025); Frank Joseph Stirlacci,
M.D., 85 FR at 45230-39.
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\5\ A statutory basis to deny an application pursuant to section
823 is also a basis to revoke or suspend a registration pursuant to
section 824, and vice versa, because doing ``otherwise would mean
that all applications would have to be granted only to be revoked
the next day . . . .'' Robert Wayne Locklear, M.D., 86 FR 33738,
33744-45 (2021) (collecting cases).
The United States Supreme Court's decision in Kungys v. United
States, 485 U.S. 759 (1988), and its progeny, guide the Agency's
implementation of these CSA provisions.
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First, the Government must prove that the applicant or registrant
submitted an application for registration pursuant to the CSA.\6\ 21
U.S.C. 824(a)(1); see also 21 U.S.C. 822 (persons required to
register); 21 U.S.C. 823(g)(1) (registration requirements).
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\6\ ``The CSA and its implementing regulations set forth strict
requirements regarding registration'' as a part of Congress'
``closed regulatory system'' for the manufacture, distribution,
dispensing, and possession of controlled substances. Gonzales v.
Raich, 545 U.S. 1, 12-14 (2005).
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Second, the Government must prove that the application contained a
false
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statement or omitted information that the application required, either
of which may constitute a material falsity. See, e.g., Emed Medical
Company LLC and Med Assist Pharmacy, 88 FR 21719, 21720 (2023)
(applicant falsely answered ``no'' to Liability Question 3 on seventeen
applications when the true answer was ``yes''); Richard J. Settles,
D.O., 81 FR 64940, 64945-46 (2016) (applicant failed to disclose an
interim consent agreement restricting his license based on findings
that he issued controlled substance prescriptions without federal or
state legal authority to do so). In making this assessment, the Agency
will examine the entire application, including registrant's ``yes/no''
answers to the liability questions and any follow-up response(s).
Daniel A. Glick, D.D.S., 80 FR 74800, 74802, 74808-09 (2015). To
establish an omission, the Government must show both that omitted
information existed and that the application required inclusion of that
information. See, e.g., Richard A. Herbert, M.D., 76 FR 53942, 53956
(2011) (omission of a probation which the application required to be
identified); Michel P. Toret, M.D., 82 FR 60041, 60042 (2017)
(Voluntary Surrender Form alone is insufficient evidence to find
material falsification based on registrant's ``no'' answer to the
question regarding ``surrender[s] (for cause)'').
Third, the Government must prove that the applicant or registrant
knew or should have known that the statement is false and/or that the
omitted information existed and the application required its
disclosure. See John J. Cienki, M.D., 63 FR 52293, 52295 (1998) (``[I]n
finding that there has been a material falsification of an application,
it must be determined that the applicant knew or should have known that
the response given to the liability question was false.''); Samuel
Arnold, D.D.S., 63 FR 8687, 8688 (1998) (``It is also undisputed that
Respondent knew that his Ohio dental license had previously been
suspended.''); Bobby Watts, M.D., 58 FR 46995, 46995 (1993)
(``Respondent knew that the Tennessee Board of Medical Examiners had
suspended his medical license on May 7, 1987, and had placed his state
medical license on probation on May 2, 1988.''); see also Frank Joseph
Stirlacci, M.D., 85 FR at 45236-37 & nn.22-23 (collecting cases).
Fourth, the Government must prove that the false statement and/or
required but omitted information is ``material.'' The Kungys Court held
that a statement is material if it is ``predictably capable of
affecting, i.e., had a natural tendency to affect, the [Agency's]
official decision,'' or stated differently, ``had a natural tendency to
influence the decision.'' Kungys, 485 U.S. at 771-72. As already
discussed, materiality, for the purposes of the CSA, is tied to the
factors that the Administrator ``shall'' consider when determining
whether issuance of a registration ``would be inconsistent with the
public interest.'' \7\ 21 U.S.C. 823; Kungys, 485 U.S. at 771-72; Frank
Joseph Stirlacci, M.D., 85 FR at 45234, 45238.
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\7\ Because the bases for revocation listed in 21 U.S.C. 824 may
also serve as bases to deny an application, see supra n.5, a finding
of materiality may also be tied to 21 U.S.C. 824(a)(1)-(5).
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The Government has the burden of proof in this proceeding. 21 CFR
1301.44. Here, the Agency finds that the Government's clear,
unequivocal, and convincing record evidence presents a prima facie case
that Applicant submitted a materially false application. 21 U.S.C.
823(g)(1), 824(a)(1).
In light of Applicant's default admissions, the Agency finds clear,
unequivocal, and convincing record evidence of the following facts. On
October 19, 2022, Applicant submitted an application for DEA
registration. RFAAX 1, at 2. The application required Applicant to
state whether or not he has ever been excluded from participation in
Federal or state health care programs, to which Applicant responded
``no'' despite having been excluded from all Federal health care
programs by HHS/OIG. Id., at 3. Thus, Applicant falsified his
application by representing that he was not excluded from Federal
health care programs when he, in fact, knew or should have known that
he was excluded and that the application required disclosure of this
information. See Lee S. Altman, M.D., 90 FR 23955, 23958 (2025) (``the
applicant bears the responsibility to carefully read the liability
questions and to answer them honestly''); Zelideh I. Cordova-Velazco,
M.D., 83 FR 62902, 62906 (2018) (``[a]llegedly misunderstanding or
misinterpreting liability questions does not relieve the applicant of
this responsibility'').
In addition, this falsification was material. Applicant's provision
of false information in response to Liability Question 1 on his
application deprived the Agency of the legally relevant information
needed to make an informed decision regarding his application. See 21
U.S.C. 824(a)(5); Lee S. Altman, M.D., 90 FR at 23958; Frank Joseph
Stirlacci, M.D., 85 FR at 45234. Therefore, Applicant's provision of
false information was ``predictably capable of affecting . . . the
[Agency's] official decision.'' Kungys, 485 U.S. at 771; see also
Daniel R. Nevarre, M.D., 87 FR 3340, 3342-43 (2022) (finding that
providing a false response regarding exclusion from health care
programs constitutes material falsification); Michael Jones, M.D., 86
FR 20728, 20730-32 (2021) (same).
As a result of this established violation, the Agency finds that
the Government has established a prima facie case for sanction based on
material falsification, that Applicant did not rebut that prima facie
case, and that there is substantial record evidence supporting the
imposition of sanctions. 21 U.S.C. 824(a)(1).
IV. Sanction
Where, as here, the Government has presented a prima facie case
showing that an applicant is mandatorily excluded from Federal health
care programs and submitted a materially false application for
registration, the burden shifts to Applicant to show why he can be
trusted with a registration. Morall v. Drug Enf't Admin., 412 F.3d 165,
181 (D.C. Cir. 2005); Jones Total Health Care Pharmacy, LLC v. Drug
Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith,
M.D., 83 FR 18882, 18904 (2018). The issue of trust is a fact-dependent
determination based on the circumstances presented by the individual
practitioner. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also
Jones Total Health Care Pharmacy, 881 F.3d at 833. Historically, the
Agency has considered acceptance of responsibility, egregiousness, and
deterrence when making this assessment. See Michael Bouknight, 90 FR at
31250; Sasha Melissa Ikramelahai, 90 FR at 32020-21; Frank Joseph
Stirlacci, M.D., 85 FR at 45239-40.
Specifically, the Agency requires the practitioner to accept
responsibility for his or her violation. Jones Total Health Care
Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't Admin., 54
F.3d 450, 452 (7th Cir. 1995). Acceptance of responsibility must be
unequivocal. Janet S. Pettyjohn, D.O., 89 FR 82639, 82641 (2024);
Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); see also Jones Total
Health Care Pharmacy, 881 F.3d at 830-31. In addition, the Agency
considers the egregiousness and extent of the misconduct in determining
the appropriate sanction. Jones Total Health Care Pharmacy, 881 F.3d at
834 & n.4. The Agency also considers the need to deter similar acts by
Applicant and by future applicants for registration. Jeffrey Stein,
M.D., 84 FR at 46972-73.
Here, Applicant failed to answer the allegations contained in the
OSC and did not otherwise avail himself of the opportunity to refute
the Government's
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case. See supra Section I. Thus, there is no record evidence that
Applicant takes responsibility, let alone unequivocal responsibility,
for the misconduct. Accordingly, he has not convinced the Agency that
his future controlled-substance-related actions will comply with the
CSA such that he can be entrusted with the responsibilities of a
registration.
Further, the interests of specific and general deterrence weigh in
favor of denial. Applicant's conduct in this matter concerns the CSA's
``strict requirements regarding registration'' and, therefore, goes to
the heart of the CSA's ``closed regulatory system'' specifically
designed ``to conquer drug abuse and to control the legitimate and
illegitimate traffic in controlled substances.'' Gonzales, 545 U.S. at
12-14. If the Agency were to issue a registration to Applicant under
these circumstances, it would send a dangerous message that compliance
with the law is not essential to obtaining a registration.
Accordingly, the Agency will order the denial of Applicant's
application.\8\
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\8\ In this matter there are two separate and distinct grounds
by which the Government proposed denial, Applicant's mandatory
exclusion and his material falsification; each ground, standing
alone, supports the Agency's decision to deny.
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824, I hereby deny the pending application for a DEA Certificate
of Registration, Control No. W22137646C, submitted by Ali Elhorr, M.D.,
as well as any other pending applications of Ali Elhorr, M.D., for
additional registration in Michigan. This Order is effective November
19, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 9, 2025, by Administrator Terrance Cole. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-19599 Filed 10-17-25; 8:45 am]
BILLING CODE 4410-09-P
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