Maura Tuso, D.M.D.' Decision and Order, 59196-59198 [2021-23262]
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59196
Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices
arrangement was both periodic and
ongoing for multiple years, giving
Respondent plenty of opportunity to
correct course, but there is nothing in
the record to indicate that he had any
intention of ending the arrangement.
After receiving 2 to 3 thousand dollars
per month, Id. at 70, there must have
been a point at which he was no longer
‘‘financially pressed,’’ and yet he
continued.
Furthermore, the exclusion letter
notes that HHS/OIG deemed
Respondent’s criminal misconduct
egregious enough to warrant an
exclusion period in excess of the
statutory minimum. GX 2, at 2. The
exclusion letter explains that HHS/OIG
excluded Respondent for ten years
instead of the statutory minimum of five
years because (1) Respondent’s
misconduct caused or was intended to
cause financial loss of more than
$50,000 to a government agency or
program; (2) Respondent committed the
misconduct over a period of at least a
year; and (3) Respondent’s sentence
included incarceration. Id. See Michael
Jones, M.D., 86 FR 20728, 20732 (2021)
(considering the length of the HHS
exclusion in assessing egregiousness).
D. Letters of Support
My final item of consideration is the
collection of eighteen letters that
Respondent submitted from patients,
colleagues, friends, and family to
demonstrate his high level of care as a
physician and his commitment to the
Hippocratic Oath. Respondent’s PostHearing Brief, at 3–4;RX 1. Although I
find the letters to be sincere, they can
only be of limited weight in this
proceeding because of the limited
ability to assess the credibility of the
letters given their written form. See
Michael S. Moore, M.D., 76 FR 45867,
45873 (2011) (evaluating the weight to
be attached to letters provided by the
respondent’s hospital administrators
and peers in light of the fact that the
authors were not subjected to the rigors
of cross examination). Furthermore,
these letters were not written for the
purposes of recommending that
Respondent be granted a controlled
substances registration and therefore
offer little value in assessing the
Respondent’s suitability to discharge the
duties of a DEA registrant. William
Ralph Kinkaid, M.D., 86 FR 40636,
40641 (2021). Instead, Respondent’s
letters were used by his criminal
defense counsel prior to his sentencing,
with most of the letters dated back to
2017. RX 1;Tr. 41. Additionally, almost
all of the letters are unsigned, four are
undated, and none of the letters are
addressed to anyone at DEA. RX 1.
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Finally, because Respondent has not
demonstrated an unequivocal
acceptance of responsibility, any value
that the letters may have offered in
evaluating my ability to trust
Respondent with a DEA registration is
nullified by the fact that he, himself, has
not shown that he can be so entrusted.
Kinkaid, M.D., 86 FR 40641.
As discussed above, to receive a
registration when grounds for denial
exist, a respondent must convince the
Administrator that his acceptance of
responsibility is sufficiently credible to
demonstrate that the misconduct will
not occur and that he can be entrusted
with a registration. Having reviewed the
record in its entirety, I find that
Respondent has not met this burden.
Although Respondent expressed
remorse and took some responsibility
for his actions through his guilty plea
and his efforts at remediation, his
acceptance of responsibility was not
unequivocal. Respondent’s consistent
focus on his own suffering and his
minimization of his wrongdoings both
raise concerns that he does not truly
understand the severity of his
misconduct. Further, Respondent’s
remediation efforts, though genuine,
suggest to me that Respondent views the
negative consequences he has faced as
obstacles to overcome in restoring his
career rather than the result of a serious
lapse in ethics that calls for selfreflection. As such, I am not convinced
that Respondent would not commit
similar misconduct again in the future
if he believed that it would not result in
negative consequences, if he found
himself in difficult financial times, or if
he was persuaded by a friend or family
member. Accordingly, I will order the
denial of Respondent’s application for a
certificate of registration.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C. 823,
I hereby order that the pending
application for a Certificate of
Registration, Control Number
W19115227C, submitted by Nicholas P.
Roussis, M.D., is denied. This Order is
effective November 26, 2021.
Anne Milgram,
Administrator.
[FR Doc. 2021–23263 Filed 10–25–21; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Maura Tuso, D.M.D.’ Decision and
Order
I. Procedural Background
On August 20, 2018, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Maura Tuso,
D.M.D. (hereinafter, Applicant) of San
Diego, California. OSC, at 1. The OSC
proposed the denial of Applicant’s
application for DEA Certificate of
Registration, Application Control No.
W18011889C, because Applicant has
‘‘been convicted of a felony relating to
controlled substances and because [she
has] committed acts which render [her]
registration inconsistent with the public
interest.’’ Id. (citing 21 U.S.C. 824(a)(2)
& (a)(4)).
Specifically, the OSC alleged that on
August 25, 2015, Applicant entered a
guilty plea to ‘‘four felony counts
related to unlawfully issuing controlled
substance prescriptions in violation of
California Health and Safety Code
Section 11153(a), and related counts of
conspiracy, prescription fraud, and
insurance fraud. This guilty plea was
accepted in the Superior Court of
California, County of San Diego, as part
of the Court’s Finding and Order.’’ Id. at
2.
The OSC also alleged that,
‘‘[p]ursuant to a July 6, 2016 Stipulated
Settlement and Disciplinary Order
between [Applicant] and the Dental
Board of California (the ‘‘Board’’), which
was effective on September 16, 2016,
[Applicant was] ordered to surrender a
DEA Registration which [she]
previously held and ordered not to
reapply for a new DEA Registration
without approval from the Board.’’ Id.
Further, the OSC stated that, ‘‘[o]n
April 12, 2018 and April 13, 2018, the
[DEA San Diego Field Division
(hereinafter, SDFD)] attempted to
provide’’ Applicant with a proposed
Memorandum of Agreement with
conditions in order to grant her
application. Id. During Applicant’s
visits to the SDFD, the OSC alleged that
she used ‘‘vulgar language and
obscenities in an uncivilized display.’’
Id.
The OSC continued to allege that
since this encounter, Applicant has
‘‘engaged in a pattern of sending many
dozens of emails to various DEA
personnel, including emails of a
harassing nature.’’ Id. It alleged that
Applicant’s actions constitute ‘‘conduct
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which may threaten the public health
and safety within the meaning of 21
U.S.C. 823(f)(5) and [ ] acts that render
[her] registration inconsistent with the
public interest within the meaning of 21
U.S.C. 824(a)(4).’’ Id.
The OSC notified Applicant of the
right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 4 (citing 21
CFR 1301.43). The OSC also notified
Applicant of the opportunity to submit
a corrective action plan. OSC, at 4–5
(citing 21 U.S.C. 824(c)(2)(C)).
On October 2, 2018, Applicant,
represented by counsel, filed a timely
request for hearing, in which she
disputed the allegations. Request for
Final Agency Action (hereinafter,
RFAA) Exhibit (hereinafter, RFAAX) 3.
However, on October 25, 2018,
Applicant withdrew her request for
hearing. RFAAX 5. The Administrative
Law Judge thereby entered an Order
Terminating Proceedings on October 25,
2018. RFAAX 6.
The Government forwarded its RFAA,
along with the evidentiary record, to
this office on April 1, 2020. The
Government requests denial of
Applicant’s application for a DEA
Certificate of Registration, ‘‘because of
her previous state felony conviction
related to controlled substances.’’ 1 2 Id.
at 5.
I find that Applicant has waived the
right to a hearing and the right to submit
a written statement and corrective
action plan. 21 CFR 1301.43(d) and 21
U.S.C. 824(c)(2)(C). I, therefore, issue
this Decision and Order based on the
record submitted by the Government,
which constitutes the entire record
before me. 21 CFR 1301.43(e).
II. Findings of Fact
A. Applicant’s DEA Application
On February 8, 2018, Applicant
submitted an application (Application
1 It is noted that the Government no longer
requests denial of Applicant’s DEA application
based on the allegation in the OSC that her
registration would be inconsistent with the public
interest; therefore, I will not assess the allegations
in the OSC related to the public interest grounds.
2 In the RFAA, the Government also argued for
revocation based on a ground that does not appear
in the OSC—that the Applicant currently lacks a
dental license in California, the state in which she
is applying for a DEA registration, and that her
application is thus also subject to denial pursuant
to 21 U.S.C. 824(a)(3). Although state authority is
a prerequisite to holding (or having) a DEA
registration, see 21 U.S.C. 823, I see no evidence in
the record that Applicant was notified of this
additional charge and I am declining to consider it
at this time. See Shelton Barnes, M.D., 85 FR 5983
n.3 (2020).
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Control No. W18011889C) for a DEA
Certificate of Registration, at the
proposed registered location of 4177
West Point Loma Blvd., San Diego, CA
92110, for the business activity of
practitioner in drug schedule V. RFAAX
1 (Certification of Nonregistration), at 1.
The application is in ‘‘a new pending
status.’’ Id.
B. Applicant’s Conviction
On August 25, 2015, Applicant 3
entered a guilty plea to one felony count
related to unlawfully issuing controlled
substance prescriptions in violation of
California Health and Safety Code
Section 11153(a), and one related count
for obtaining a prescription by fraud
under California Health and Safety Code
Section 11173(a), and two other felony
counts for conspiracy and insurance
fraud related to the prescriptions.
RFAAX 8, at 12–14.
On August 25, 2015, the Superior
Court of California, County of San Diego
(the ‘‘state court’’) accepted Applicant’s
guilty plea. Id. at 12–14. In her guilty
plea, Applicant admitted that she
‘‘knowingly and unlawfully obtained
prescriptions for controlled substances
. . . for reasons other than a medical
purpose.’’ Id. at 14.
In its Finding and Order, the state
court held, it ‘‘accepts the defendant’s
plea and admissions, and the defendant
is convicted thereby.’’ Id. On September
23, 2015, the state court ordered
Applicant to receive five years of
probation. Id. at 17–19. On October 2,
2017, the state court reduced the four
felony counts to misdemeanors and
ordered summary probation. Id. at 20–
21.
III. Discussion
A. Analysis of Applicant’s Application
for Registration
In this matter, the Government calls
for my adjudication of the application
for registration based on the charge that
Applicant was convicted of a felony
related to controlled substances, which
is a basis for revocation or suspension
under 21 U.S.C. 824(a)(2). OSC, at 1–2.
The Government dropped the allegation
that Applicant’s application should be
denied because her registration would
be inconsistent with the public interest
3 There is substantial record evidence to support
a finding that Maura Cathleen O’Neill is the same
person as Maura Tuso. The Government’s
Certification of Non Registration for Maura Tuso
lists previous registrations ‘‘assigned to Maura Tuso
under the name of Maura C O’Neill DMD.’’ RFAAX
1, at 2; see also, RFAAX 7a & b (Dental Board of
California records naming Maura Tuso as an alias
for Maura O’Neill). Therefore, I find that the
substantial record evidence demonstrates that the
conviction in RFAAX 8 for Maura O’Neill applies
to Applicant.
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59197
pursuant to section 823 in the OSC and
did not advance any arguments or
present any evidence under the public
interest factors in its RFAA. See supra
n.1. Accordingly, the remaining
actionable substantive basis for
proposing the denial of applicant’s
registration application is her felony
conviction under 21 U.S.C. 824(a)(2).
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
33744–45 (collecting cases). In the
recent decision Robert Wayne Locklear,
M.D., the former Acting Administrator
stated his agreement with the results of
these past decisions and reaffirmed that
a provision of section 824 may be the
basis for the denial of a practitioner
registration application. 86 FR 33745.
He also clarified that allegations related
to section 823 remain relevant to the
adjudication of a practitioner
registration application when a
provision of section 824 is involved. Id.
Accordingly, when considering an
application for a registration, I will
consider any actionable allegations
related to the grounds for denial of an
application under 823 and will also
consider any allegations that the
applicant meets one of the five grounds
for revocation or suspension of a
registration under section 824. Id.; see
also Dinorah Drug Store, Inc., 61 FR
15972, 15973–74 (1996).
1. 21 U.S.C. 823(f): The Five Public
Interest Factors
Under Section 304 of the Controlled
Substances Act, ‘‘[a] registration . . . to
. . . dispense a controlled substance
. . . may be suspended or revoked by
the Attorney General upon a finding
that the registrant . . . has committed
such acts as would render his
registration under section 823 of this
title inconsistent with the public
interest as determined by such section.’’
21 U.S.C. 824(a)(4). Because the
Government has not alleged that
Applicant’s registration is inconsistent
with the public interest under section
823, I will not deny Applicant’s
application based on section 823, and
although I have considered 823, I will
not analyze Applicant’s application
under the public interest factors.
Therefore, in accordance with prior
agency decisions, I will move to assess
whether the Government has proven by
substantial evidence that a ground for
revocation exists under 21 U.S.C. 824(a).
Supra II.C.
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2. Applicant’s Felony Conviction
Pursuant to section 304(a)(2) of the
CSA, the Attorney General is authorized
to suspend or revoke a registration
‘‘upon a finding that the registrant . . .
has been convicted of a felony under
this subchapter or subchapter II of this
chapter or any other law of the United
States, or of any State, relating to any
substance defined in this subchapter as
a controlled substance or a list I
chemical.’’ 21 U.S.C. 824(a)(2); see also
Edward A. Ridgill, M.D., 83 FR 58599,
58600 (2018) (denying application based
on conviction under 21 U.S.C. 841 for
unlawful prescribing of controlled
substances). Each subsection of Section
824(a) provides an independent ground
to impose a sanction. Arnold E.
Feldman, M.D., 82 FR 39614, 39617
(2017).
Here, there is no dispute in the record
that Applicant was convicted of felony
counts related to unlawfully issuing
controlled substance prescriptions in
violation of California Health and Safety
Code Section 11153(a), prescription
fraud under California Health and
Safety Code Section 11173(a), and
related felony counts of conspiracy and
insurance fraud. See RFAAX 8. Two of
these state statutes specifically address
controlled substance prescriptions and
the underlying facts of the fraud and
conspiracy counts were related to
Applicant’s unlawful prescribing and
obtaining of controlled substances. See
Cal. Health & Safety Code § 11153(a) (‘‘A
prescription for a controlled substance
shall only be issued for a legitimate
medical purpose by an individual
practitioner acting in the usual course of
his or her professional practice.’’); Cal.
Health & Safety Code § 11173(a) (‘‘No
person shall obtain or attempt to obtain
controlled substances, or procure or
attempt to procure the administration of
or prescription for controlled substances
. . . by fraud, deceit, misrepresentation,
or subterfuge’’). Therefore, I find that
these provisions constitute state laws
‘‘relating to’’ controlled substances, as
those terms are defined in 21 U.S.C.
824(a)(2). See Uvienome Linda Sakor,
N.P., 86 FR 50173, 50178 (2021).
Although the Government has noted
in its RFAA that two years after
Applicant’s conviction, the state court
reduced the four felony counts to
misdemeanors and ordered summary
probation, see RFAAX 8, at 20 and
RFAA, at 6, the Agency established over
thirty years ago, and has recently
reiterated, that a deferred adjudication
is ‘‘still a ‘conviction’ within the
meaning of the . . . [CSA] even if the
proceedings are later dismissed.’’
Kimberly Maloney, N.P., 76 FR 60922,
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60922 (2011). In reaching this
conclusion, the Agency explained that,
‘‘[a]ny other interpretation would mean
that the conviction could only be
considered between its date and the
date of its subsequent dismissal.’’ Id.
(citing Edson W. Redard, M.D., 65 FR
30616, 30618 (2000)); see also Erica N.
Grant, M.D., 40,641, 40,650 (2021).
Thus, in accordance with prior agency
decisions, I find that the subsequent
reduction of Applicant’s charges, much
like a subsequent deferral or dismissal,
does not affect my finding that she was
convicted of a felony related to
controlled substances for purposes of 21
U.S.C. 824(a)(2).
Although the language of 21 U.S.C.
824(a)(2) discusses suspension and
revocation of a registration, for the
reasons discussed above in supra III.A,
it may also serve as the basis for the
denial of a DEA registration application.
Applicant’s felony conviction, therefore,
serves as an independent basis for
denying her application for a DEA
registration. 21 U.S.C. 824(a)(2).
IV. Sanction
Where, as here, the Government has
met its prima facie burden of showing
that a ground for revocation exists, the
burden shifts to the Applicant to show
why she can be entrusted with a
registration. See Jeffrey Stein, M.D., 84
FR 46968, 46972 (2019). Applicant, as
already discussed, waived her right to a
hearing and failed to submit a written
statement. See RFAA, at 6. Therefore,
among other things, Applicant has not
accepted responsibility for her
criminality, shown any remorse for it, or
provided any assurance that she would
not repeat it. See Jeffrey Stein, M.D., 84
FR 46972–74. Such silence weighs
against granting the Applicant’s
registration. Zvi H. Perper, M.D., 77 FR
64131, 64142 (2012) (citing Medicine
Shoppe-Jonesborough, 73 FR 264, 387
(2008); Samuel S. Jackson, 72 FR 23848,
23853 (2007)); see also Jones Total
Health Care Pharmacy, LLC v. Drug
Enf’t Admin., 881 F3d. 823, 831 (11th
Cir. 2018) (‘‘‘An agency rationally may
conclude that past performance is the
best predictor of future performance.’’’
(quoting Alra Laboratories, Inc. v. Drug
Enf’t Admin., 54 F.3d 450, 452 (7th Cir.
1995))).
Further, the CSA authorizes the
Attorney General to ‘‘promulgate and
enforce any rules, regulations, and
procedures which he may deem
necessary and appropriate for the
efficient execution of his functions
under this subchapter.’’ 21 U.S.C.
871(b). This authority specifically
relates ‘‘to ‘registration’ and ‘control,’
and ‘for the efficient execution of his
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functions’ under the statute.’’ Gonzales
v. Oregon, 546 U.S. 243, 259 (2006). A
clear purpose of this authority is to
‘‘bar[] doctors from using their
prescription-writing powers as a means
to engage in illicit drug dealing and
trafficking . . . .’’ Id. at 270. In this
case, Applicant pled guilty to counts
directly related to issuing controlled
substance prescriptions without a
legitimate medical purpose. Applicant’s
unlawful activity is exactly the type of
activity that the CSA was intended to
prevent and she has given me no
indication that she will not repeat her
illicit behavior.
Based on the record before me, I
conclude that Applicant’s founded
criminality makes her ineligible for a
DEA registration. Accordingly, I shall
order the sanction the Government
requested, as contained in the Order
below.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C. 823,
I hereby order that the pending
application for a Certificate of
Registration, Control Number
W18011889C, submitted by Maura
Tuso, D.M.D., is denied. This Order is
effective November 26, 2021.
Anne Milgram,
Administrator.
[FR Doc. 2021–23262 Filed 10–25–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–915]
Importer of Controlled Substances
Application: Indigenous Peyote
Conservation Initiative
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Indigenous Peyote
Conservation Initiative has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to SUPPLEMENTARY INFORMATION
listed below for further drug
information.
SUMMARY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before November 26, 2021. Such
persons may also file a written request
for a hearing on the application on or
before November 26, 2021.
DATES:
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[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59196-59198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23262]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Maura Tuso, D.M.D.' Decision and Order
I. Procedural Background
On August 20, 2018, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause (hereinafter, OSC) to Maura
Tuso, D.M.D. (hereinafter, Applicant) of San Diego, California. OSC, at
1. The OSC proposed the denial of Applicant's application for DEA
Certificate of Registration, Application Control No. W18011889C,
because Applicant has ``been convicted of a felony relating to
controlled substances and because [she has] committed acts which render
[her] registration inconsistent with the public interest.'' Id. (citing
21 U.S.C. 824(a)(2) & (a)(4)).
Specifically, the OSC alleged that on August 25, 2015, Applicant
entered a guilty plea to ``four felony counts related to unlawfully
issuing controlled substance prescriptions in violation of California
Health and Safety Code Section 11153(a), and related counts of
conspiracy, prescription fraud, and insurance fraud. This guilty plea
was accepted in the Superior Court of California, County of San Diego,
as part of the Court's Finding and Order.'' Id. at 2.
The OSC also alleged that, ``[p]ursuant to a July 6, 2016
Stipulated Settlement and Disciplinary Order between [Applicant] and
the Dental Board of California (the ``Board''), which was effective on
September 16, 2016, [Applicant was] ordered to surrender a DEA
Registration which [she] previously held and ordered not to reapply for
a new DEA Registration without approval from the Board.'' Id.
Further, the OSC stated that, ``[o]n April 12, 2018 and April 13,
2018, the [DEA San Diego Field Division (hereinafter, SDFD)] attempted
to provide'' Applicant with a proposed Memorandum of Agreement with
conditions in order to grant her application. Id. During Applicant's
visits to the SDFD, the OSC alleged that she used ``vulgar language and
obscenities in an uncivilized display.'' Id.
The OSC continued to allege that since this encounter, Applicant
has ``engaged in a pattern of sending many dozens of emails to various
DEA personnel, including emails of a harassing nature.'' Id. It alleged
that Applicant's actions constitute ``conduct
[[Page 59197]]
which may threaten the public health and safety within the meaning of
21 U.S.C. 823(f)(5) and [ ] acts that render [her] registration
inconsistent with the public interest within the meaning of 21 U.S.C.
824(a)(4).'' Id.
The OSC notified Applicant of the right to request a hearing on the
allegations or to submit a written statement, while waiving the right
to a hearing, the procedures for electing each option, and the
consequences for failing to elect either option. Id. at 4 (citing 21
CFR 1301.43). The OSC also notified Applicant of the opportunity to
submit a corrective action plan. OSC, at 4-5 (citing 21 U.S.C.
824(c)(2)(C)).
On October 2, 2018, Applicant, represented by counsel, filed a
timely request for hearing, in which she disputed the allegations.
Request for Final Agency Action (hereinafter, RFAA) Exhibit
(hereinafter, RFAAX) 3. However, on October 25, 2018, Applicant
withdrew her request for hearing. RFAAX 5. The Administrative Law Judge
thereby entered an Order Terminating Proceedings on October 25, 2018.
RFAAX 6.
The Government forwarded its RFAA, along with the evidentiary
record, to this office on April 1, 2020. The Government requests denial
of Applicant's application for a DEA Certificate of Registration,
``because of her previous state felony conviction related to controlled
substances.'' \1\ \2\ Id. at 5.
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\1\ It is noted that the Government no longer requests denial of
Applicant's DEA application based on the allegation in the OSC that
her registration would be inconsistent with the public interest;
therefore, I will not assess the allegations in the OSC related to
the public interest grounds.
\2\ In the RFAA, the Government also argued for revocation based
on a ground that does not appear in the OSC--that the Applicant
currently lacks a dental license in California, the state in which
she is applying for a DEA registration, and that her application is
thus also subject to denial pursuant to 21 U.S.C. 824(a)(3).
Although state authority is a prerequisite to holding (or having) a
DEA registration, see 21 U.S.C. 823, I see no evidence in the record
that Applicant was notified of this additional charge and I am
declining to consider it at this time. See Shelton Barnes, M.D., 85
FR 5983 n.3 (2020).
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I find that Applicant has waived the right to a hearing and the
right to submit a written statement and corrective action plan. 21 CFR
1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this
Decision and Order based on the record submitted by the Government,
which constitutes the entire record before me. 21 CFR 1301.43(e).
II. Findings of Fact
A. Applicant's DEA Application
On February 8, 2018, Applicant submitted an application
(Application Control No. W18011889C) for a DEA Certificate of
Registration, at the proposed registered location of 4177 West Point
Loma Blvd., San Diego, CA 92110, for the business activity of
practitioner in drug schedule V. RFAAX 1 (Certification of
Nonregistration), at 1. The application is in ``a new pending status.''
Id.
B. Applicant's Conviction
On August 25, 2015, Applicant \3\ entered a guilty plea to one
felony count related to unlawfully issuing controlled substance
prescriptions in violation of California Health and Safety Code Section
11153(a), and one related count for obtaining a prescription by fraud
under California Health and Safety Code Section 11173(a), and two other
felony counts for conspiracy and insurance fraud related to the
prescriptions. RFAAX 8, at 12-14.
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\3\ There is substantial record evidence to support a finding
that Maura Cathleen O'Neill is the same person as Maura Tuso. The
Government's Certification of Non Registration for Maura Tuso lists
previous registrations ``assigned to Maura Tuso under the name of
Maura C O'Neill DMD.'' RFAAX 1, at 2; see also, RFAAX 7a & b (Dental
Board of California records naming Maura Tuso as an alias for Maura
O'Neill). Therefore, I find that the substantial record evidence
demonstrates that the conviction in RFAAX 8 for Maura O'Neill
applies to Applicant.
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On August 25, 2015, the Superior Court of California, County of San
Diego (the ``state court'') accepted Applicant's guilty plea. Id. at
12-14. In her guilty plea, Applicant admitted that she ``knowingly and
unlawfully obtained prescriptions for controlled substances . . . for
reasons other than a medical purpose.'' Id. at 14.
In its Finding and Order, the state court held, it ``accepts the
defendant's plea and admissions, and the defendant is convicted
thereby.'' Id. On September 23, 2015, the state court ordered Applicant
to receive five years of probation. Id. at 17-19. On October 2, 2017,
the state court reduced the four felony counts to misdemeanors and
ordered summary probation. Id. at 20-21.
III. Discussion
A. Analysis of Applicant's Application for Registration
In this matter, the Government calls for my adjudication of the
application for registration based on the charge that Applicant was
convicted of a felony related to controlled substances, which is a
basis for revocation or suspension under 21 U.S.C. 824(a)(2). OSC, at
1-2. The Government dropped the allegation that Applicant's application
should be denied because her registration would be inconsistent with
the public interest pursuant to section 823 in the OSC and did not
advance any arguments or present any evidence under the public interest
factors in its RFAA. See supra n.1. Accordingly, the remaining
actionable substantive basis for proposing the denial of applicant's
registration application is her felony conviction under 21 U.S.C.
824(a)(2).
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 33744-45 (collecting cases). In the recent
decision Robert Wayne Locklear, M.D., the former Acting Administrator
stated his agreement with the results of these past decisions and
reaffirmed that a provision of section 824 may be the basis for the
denial of a practitioner registration application. 86 FR 33745. He also
clarified that allegations related to section 823 remain relevant to
the adjudication of a practitioner registration application when a
provision of section 824 is involved. Id.
Accordingly, when considering an application for a registration, I
will consider any actionable allegations related to the grounds for
denial of an application under 823 and will also consider any
allegations that the applicant meets one of the five grounds for
revocation or suspension of a registration under section 824. Id.; see
also Dinorah Drug Store, Inc., 61 FR 15972, 15973-74 (1996).
1. 21 U.S.C. 823(f): The Five Public Interest Factors
Under Section 304 of the Controlled Substances Act, ``[a]
registration . . . to . . . dispense a controlled substance . . . may
be suspended or revoked by the Attorney General upon a finding that the
registrant . . . has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined by such section.'' 21 U.S.C. 824(a)(4).
Because the Government has not alleged that Applicant's registration is
inconsistent with the public interest under section 823, I will not
deny Applicant's application based on section 823, and although I have
considered 823, I will not analyze Applicant's application under the
public interest factors. Therefore, in accordance with prior agency
decisions, I will move to assess whether the Government has proven by
substantial evidence that a ground for revocation exists under 21
U.S.C. 824(a). Supra II.C.
[[Page 59198]]
2. Applicant's Felony Conviction
Pursuant to section 304(a)(2) of the CSA, the Attorney General is
authorized to suspend or revoke a registration ``upon a finding that
the registrant . . . has been convicted of a felony under this
subchapter or subchapter II of this chapter or any other law of the
United States, or of any State, relating to any substance defined in
this subchapter as a controlled substance or a list I chemical.'' 21
U.S.C. 824(a)(2); see also Edward A. Ridgill, M.D., 83 FR 58599, 58600
(2018) (denying application based on conviction under 21 U.S.C. 841 for
unlawful prescribing of controlled substances). Each subsection of
Section 824(a) provides an independent ground to impose a sanction.
Arnold E. Feldman, M.D., 82 FR 39614, 39617 (2017).
Here, there is no dispute in the record that Applicant was
convicted of felony counts related to unlawfully issuing controlled
substance prescriptions in violation of California Health and Safety
Code Section 11153(a), prescription fraud under California Health and
Safety Code Section 11173(a), and related felony counts of conspiracy
and insurance fraud. See RFAAX 8. Two of these state statutes
specifically address controlled substance prescriptions and the
underlying facts of the fraud and conspiracy counts were related to
Applicant's unlawful prescribing and obtaining of controlled
substances. See Cal. Health & Safety Code Sec. 11153(a) (``A
prescription for a controlled substance shall only be issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his or her professional practice.''); Cal. Health &
Safety Code Sec. 11173(a) (``No person shall obtain or attempt to
obtain controlled substances, or procure or attempt to procure the
administration of or prescription for controlled substances . . . by
fraud, deceit, misrepresentation, or subterfuge''). Therefore, I find
that these provisions constitute state laws ``relating to'' controlled
substances, as those terms are defined in 21 U.S.C. 824(a)(2). See
Uvienome Linda Sakor, N.P., 86 FR 50173, 50178 (2021).
Although the Government has noted in its RFAA that two years after
Applicant's conviction, the state court reduced the four felony counts
to misdemeanors and ordered summary probation, see RFAAX 8, at 20 and
RFAA, at 6, the Agency established over thirty years ago, and has
recently reiterated, that a deferred adjudication is ``still a
`conviction' within the meaning of the . . . [CSA] even if the
proceedings are later dismissed.'' Kimberly Maloney, N.P., 76 FR 60922,
60922 (2011). In reaching this conclusion, the Agency explained that,
``[a]ny other interpretation would mean that the conviction could only
be considered between its date and the date of its subsequent
dismissal.'' Id. (citing Edson W. Redard, M.D., 65 FR 30616, 30618
(2000)); see also Erica N. Grant, M.D., 40,641, 40,650 (2021). Thus, in
accordance with prior agency decisions, I find that the subsequent
reduction of Applicant's charges, much like a subsequent deferral or
dismissal, does not affect my finding that she was convicted of a
felony related to controlled substances for purposes of 21 U.S.C.
824(a)(2).
Although the language of 21 U.S.C. 824(a)(2) discusses suspension
and revocation of a registration, for the reasons discussed above in
supra III.A, it may also serve as the basis for the denial of a DEA
registration application. Applicant's felony conviction, therefore,
serves as an independent basis for denying her application for a DEA
registration. 21 U.S.C. 824(a)(2).
IV. Sanction
Where, as here, the Government has met its prima facie burden of
showing that a ground for revocation exists, the burden shifts to the
Applicant to show why she can be entrusted with a registration. See
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019). Applicant, as already
discussed, waived her right to a hearing and failed to submit a written
statement. See RFAA, at 6. Therefore, among other things, Applicant has
not accepted responsibility for her criminality, shown any remorse for
it, or provided any assurance that she would not repeat it. See Jeffrey
Stein, M.D., 84 FR 46972-74. Such silence weighs against granting the
Applicant's registration. Zvi H. Perper, M.D., 77 FR 64131, 64142
(2012) (citing Medicine Shoppe-Jonesborough, 73 FR 264, 387 (2008);
Samuel S. Jackson, 72 FR 23848, 23853 (2007)); see also Jones Total
Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F3d. 823, 831 (11th
Cir. 2018) (```An agency rationally may conclude that past performance
is the best predictor of future performance.''' (quoting Alra
Laboratories, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir.
1995))).
Further, the CSA authorizes the Attorney General to ``promulgate
and enforce any rules, regulations, and procedures which he may deem
necessary and appropriate for the efficient execution of his functions
under this subchapter.'' 21 U.S.C. 871(b). This authority specifically
relates ``to `registration' and `control,' and `for the efficient
execution of his functions' under the statute.'' Gonzales v. Oregon,
546 U.S. 243, 259 (2006). A clear purpose of this authority is to
``bar[] doctors from using their prescription-writing powers as a means
to engage in illicit drug dealing and trafficking . . . .'' Id. at 270.
In this case, Applicant pled guilty to counts directly related to
issuing controlled substance prescriptions without a legitimate medical
purpose. Applicant's unlawful activity is exactly the type of activity
that the CSA was intended to prevent and she has given me no indication
that she will not repeat her illicit behavior.
Based on the record before me, I conclude that Applicant's founded
criminality makes her ineligible for a DEA registration. Accordingly, I
shall order the sanction the Government requested, as contained in the
Order below.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823, I hereby order that the pending application for a
Certificate of Registration, Control Number W18011889C, submitted by
Maura Tuso, D.M.D., is denied. This Order is effective November 26,
2021.
Anne Milgram,
Administrator.
[FR Doc. 2021-23262 Filed 10-25-21; 8:45 am]
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