[Federal Register Volume 90, Number 72 (Wednesday, April 16, 2025)]
[Notices]
[Pages 15992-15993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06426]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Moustafa M. Aboshady, M.D.; Decision and Order
On January 18, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Moustafa M.
Aboshady, M.D. (Applicant). Request for Final Agency Action (RFAA),
Attachment (Attach.) A, at 1, 3. The OSC proposed the denial of
Applicant's application for a DEA registration, No. W23147064C, in Salt
Lake City, Utah. Id. at 1. The OSC alleged that Applicant's application
should be denied because he has ``been mandatorily excluded from
participation in Medicare, Medicaid, and all Federal health care
programs pursuant to 42 U.S.C. 1320a-7(a).'' Id. (citing 21 U.S.C.
824(a)(5)).
The OSC notified Applicant of his right to ``file with DEA a
written request for a hearing,'' and that if he failed to file such a
request, he would ``be deemed to have waived [his] right to a hearing
and to be in default.'' Id. at 2 (citing 21 CFR 1301.43). The OSC
further notified Applicant that if he requested a hearing but failed to
``timely file an answer, plead, or otherwise defend,'' he would ``be
deemed to have waived the right to a hearing and to be in default, and
DEA may enter an order terminating the proceeding.'' Id. (citing 21 CFR
1301.43(c)(2), (c)(3), (d)). The OSC also notified Applicant that
``[d]efault constitutes a waiver of [his] right to a hearing and an
admission of the factual allegations of the [OSC].'' Id. (citing 21 CFR
1301.43(e)).
On February 6, 2024, the OSC was served on Applicant by email.
RFAA, at 1. On February 13, 2024, Applicant filed a timely hearing
request with the DEA Office of Administrative Law Judges (OALJ) and the
matter was assigned to the Chief Administrative Law Judge (Chief ALJ).
Id. at 2. On the same day, the Chief ALJ issued an Order for Prehearing
Statements and Directing Compliance (Order), noting that Applicant had
failed to file an answer to the OSC as required by DEA regulations, and
establishing a deadline of February 21, 2024, for filing an answer.
RFAA, Attach. B, at 1-2 (citing 21 CFR 1301.37(d), 1316.47(b)).
On February 20, 2024, the day before the Chief ALJ's deadline for
filing an answer, Applicant informed OALJ by email that he desired
additional time to respond to the Order because he was in the process
of hiring a lawyer. RFAA, Attach. C, at 1. That same day, the Chief ALJ
denied the request for additional time, explaining that filing an
answer could be completed within the allotted time and that ``more time
could be allowed for preparation if/when he was successful in procuring
representation.'' Id. at 1-2. On February 21, 2024, Applicant submitted
a Corrective Action Plan, but he did not file an answer. Id. at 2.
On February 22, 2024, the day after the answer was due, the
Government filed a Motion to Terminate Proceedings (Motion to
Terminate), arguing that Applicant had waived his right to a hearing by
failing to file an answer and by failing to show good cause for such
failure. Id. at 2. On the same day, the Chief ALJ issued a Briefing
Order directing Applicant to file a response to the Motion to Terminate
by February 28, 2024. Id. On February 27, 2024, Applicant sent an email
to OALJ indicating that he ``request[ed] to withdraw[ ] [his]
application.'' \1\ Id. Applicant did not otherwise respond to the
Motion to Terminate. On February 28, 2024, the Chief ALJ issued an
Order Terminating Proceedings (Termination Order), finding that the
Motion to Terminate stood unopposed and that Applicant's withdrawal
request demonstrated that he was ``no longer seeking a hearing on the
matter.'' Id. Applicant has not filed a motion to set aside the
Termination Order. 21 CFR 1301.43(c)(3).
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\1\ To the extent that Applicant's email can be construed as a
desire to withdraw his application for registration, the Agency has
considered the relevant factors and denies Applicant's withdrawal
request because it is not in the public interest. See Edge Pharmacy,
81 FR 72092, 72102 (2016) (discussing 21 CFR 1301.16(a)).
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``In the event that [an applicant] . . . is deemed to be in default
. . . DEA may then file a request for final agency action with the
Administrator, along with a record to support its request. In such
circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] Sec. 1316.67.'' 21 CFR 1301.43(f)(1). Here, the
Government has requested final agency action based on Applicant's
default pursuant to 21 CFR 1301.43(c), (f), because Applicant did not
timely file an answer to the OSC, did not ``otherwise defend'' himself
against the Government's Motion to Terminate, has not filed a motion
with the Administrator to set aside the Termination Order, has
indicated a desire to withdraw his hearing request or application, and
has not filed a motion with the Administrator to set aside the default.
See also id. Sec. 1316.67.
The Agency finds that Applicant is in default based on his failure
to ``plead . . . or otherwise defend himself,'' as evidenced by his
failure to substantively respond to the Government's Motion to
Terminate, his failure to file a motion to set aside the Chief ALJ's
termination order, and his request to withdraw his application.\2\ Id.
Sec. 1301.37(c)(3).
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\2\ Here, the OSC was served on February 6, 2024. The matter was
terminated from the hearing stage on February 28, 2024, which was
well after the Chief ALJ's established deadline for filing an
answer, but before the regulatory deadline set forth in 21 CFR
1301.37(d). Because the Agency already finds Applicant to be in
default based on 1301.37(c)(3), it need not consider whether
Applicant is in default under 21 CFR 1301.37(c)(2).
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I. Applicable Law
Pursuant to 21 U.S.C. 824(a)(5), the Attorney General 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 section 1320a-7(a) of Title 42.'' Id. Sec.
824(a)(5).\3\ 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. Arvinder Singh, M.D., 81 FR 8247, 8248 n.3
(2016) (quoting Kwan Bo Jin, M.D., 77 FR 35021, 35021 n.2 (2012))
(``[W]here a registration can be revoked under [21 U.S.C.] 824, it can,
a fortiori, be denied under [21 U.S.C.] 823 since the law would not
require an agency to indulge in the useless act of granting a license
on one day only to withdraw it on the next.''); Robert Wayne Locklear,
M.D., 86 FR 33745 (citing South Corp. v. United States, 690 F.2d 1369,
1374 (Fed. Cir. 1982)) (``A statutory construction which would impute a
useless act to Congress will be viewed as unsound and rejected.'').
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\3\ In its OSC, the Government relies upon grounds Congress
provided to support revocation/suspension, not denial of an
application. Prior Agency decisions have addressed whether it is
appropriate to consider a provision of 21 U.S.C. 824(a) when
determining whether or not to grant a practitioner registration
application. For over forty-five years, Agency decisions have
concluded that it is. Robert Wayne Locklear, M.D., 86 FR 33738,
33744-45 (2021) (collecting cases).
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[[Page 15993]]
II. Findings of Fact
The Agency finds that, in light of Applicant's default, the factual
allegations in the OSC are admitted. 21 CFR 1301.43(e). Accordingly,
Applicant is deemed to have admitted that in 2018 he was convicted of
one count of conspiracy to make false statements in connection with
health care benefits programs in violation of 18 U.S.C. 371 and two
counts of making false statements in connection with health care
benefits programs or aiding and abetting in violation of 18 U.S.C.
1035.\4\ RFAA, Attach. A, at 2. Applicant further admits that, as a
result of his conviction,\5\ the U.S. 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 of
15 years. Id. The exclusion became effective on August 30, 2019. Id.
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\4\ Applicant further admits that his conviction was upheld on
appeal in 2020. RFAA, Attach. A, at 2.
\5\ 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). Jeffrey Stein,
M.D., 84 FR 46,968, 46,971-46,972 (2019); see also Narciso Reyes,
M.D., 83 FR 61678, 61681 (2018); KK Pharmacy, 64 FR 49507, 49510
(1999) (collecting cases).
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Accordingly, the Agency finds substantial record evidence that
Applicant has been excluded from participation in Medicare, Medicaid,
and all Federal health care programs.
III. Discussion
The OSC's sole allegation is that Applicant's application should be
denied as a result of his mandatory exclusion ``from participation in
Medicare, Medicaid, and all Federal health care programs pursuant to 42
U.S.C. 1320a-7(a).'' RFAA, Attach. A, at 1 (citing 21 U.S.C.
824(a)(5)). Here, the Agency found above that 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 of 15 years. Id. at 2. Accordingly, the Agency finds that the
Government established a prima facie case for denying Applicant's
registration, that Applicant did not rebut that prima facie case, and
that there is substantial record evidence supporting the denial of
Applicant's application. 21 U.S.C. 824(a)(5).
III. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Applicant's application for a registration should be
denied, the burden shifts to the Applicant to show why he can be
entrusted with the responsibility carried by a registration. Morall,
412 F.3d. at 174; Jones Total Health Care Pharmacy, 881 F.3d 823, 830
(11th Cir. 2018); Garrett Howard Smith, M.D., 83 FR 18882 (2018). The
issue of trust is necessarily a fact-dependent determination based on
the circumstances presented by the individual registrant. Jeffrey
Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total Health
Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is the
best predictor of future performance, DEA Administrators have required
that a registrant who has committed acts inconsistent with the public
interest must accept responsibility for those acts and demonstrate that
it will not engage in future misconduct. Jones Total Health Care
Pharmacy, 881 F.3d at 833. A registrant's acceptance of responsibility
must be unequivocal. Id. at 830-31. In addition, a registrant's candor
during the investigation and hearing has been an important factor in
determining acceptance of responsibility and the appropriate sanction.
Id. Further, DEA Administrators have found that the egregiousness and
extent of the misconduct are significant factors in determining the
appropriate sanction. Id. at 834 and n.4. DEA Administrators have also
considered the need to deter similar acts by the specific registrant
and by the community of registrants. Jeffrey Stein, M.D., 84 FR 46972-
73.
Here, although Applicant initially requested a hearing, he failed
to ``plead . . . or otherwise defend'' and was deemed to be in default.
21 CFR 1301.43(c)(3). To date, Applicant has not filed any motion to
set aside the default with the Office of the Administrator. 21 CFR
1301.43(c). Applicant has thus failed to answer the allegations
contained in the OSC and has not otherwise availed himself of the
opportunity to refute the Government's case. As such, Applicant has
made no representations as to his future compliance with the CSA nor
made any demonstration that he can be entrusted with registration.
Moreover, the evidence presented by the Government shows that Applicant
was convicted of charges related to making false statements in
connection with health care benefits programs, further indicating that
Applicant cannot be entrusted.
Accordingly, the Agency will order the denial of Applicant's
application.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(g)(1), I hereby deny the pending application for a DEA
Certificate of Registration, Control No. W23147064C, submitted by
Moustafa M. Aboshady, M.D., as well as any other pending application of
Moustafa M. Aboshady, M.D., for additional registration in Utah. This
Order is effective May 16, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 10, 2025, by Acting Administrator Derek Maltz. 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. 2025-06426 Filed 4-15-25; 8:45 am]
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