Notice2024-24189
Neeraj B. Shah, M.D.; Decision and Order
Primary source
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Published
October 21, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 89 Issue 203 (Monday, October 21, 2024)</title>
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[Federal Register Volume 89, Number 203 (Monday, October 21, 2024)]
[Notices]
[Pages 84195-84199]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24189]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23-65]
Neeraj B. Shah, M.D.; Decision and Order
On August 30, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Neeraj B. Shah,
M.D., (Respondent) of Austin, Texas. Administrative Law Judge Exhibit
(ALJX) 1 (OSC), at 1. The OSC proposed the revocation of Respondent's
DEA Certificate of Registration (registration), No. FS2968444, and
alleged that Respondent's continued registration is inconsistent with
the public interest. Id. (citing 21 U.S.C. 823(g)(1), 824(a)(4)).
A hearing was held before DEA Administrative Law Judge (ALJ) Teresa
A. Wallbaum who, on March 8, 2024, issued her Recommended Rulings,
Findings of Fact, Conclusions of Law, and Decision of the
Administrative Law Judge (RD). The RD recommended that Respondent's
registration be revoked. RD, at 33. Neither party filed exceptions to
the RD. Having reviewed the entire record, the Agency adopts and hereby
incorporates by reference the entirety of the ALJ's rulings,
credibility findings,\1\ findings of fact, conclusions of law,
sanctions analysis, and recommended sanction in the RD and summarizes
and expands upon portions thereof herein.\2\
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\1\ The Agency adopts the ALJ's summary of the witnesses'
testimonies as well as the ALJ's assessment of the witnesses'
credibility. RD, at 3-21.
\2\ On May 30, 2024, Respondent signed a DEA Form 104, Surrender
for Cause of DEA Certificate of Registration. See 21 CFR 1301.52(a).
Even when a registration is terminated, the Agency has discretion to
adjudicate the OSC to finality. See Jeffrey D. Olsen, M.D., 84 FR
68,474, 68,479 (2019) (declining to dismiss an immediate suspension
order when the registrant allowed the registration to expire before
final adjudication); Steven M. Kotsonis, M.D., 85 FR 85667, 85668-69
(2020) (concluding that termination of a registration under 21 CFR
1301.52 does not preclude DEA from issuing a final decision and that
the Agency would assess such matters on a case-by-case basis to
determine if a final adjudication is warranted); The Pharmacy Place,
86 FR 21008, 21008-09 (2021) (``Adjudicating this matter to finality
will create a public record to educate current and prospective
registrants about the Agency's expectations regarding the
responsibilities of registrant[s] . . . under the CSA and allow
stakeholders to provide feedback regarding the Agency's enforcement
priorities and practices.''); Creekbend Community Pharmacy, 86 FR
40627, 40628 n.4 (2021) (``Adjudicating this matter to finality will
create an official record the Agency can use in any future
interactions with Respondent . . . or other persons who were
associated with Respondent.''). As in these cases, the Agency has
evaluated the circumstances of this matter and determined that the
matter should be adjudicated to finality for the purpose of creating
an official record of the allegations and evidence, and educating
the registrant community, the public, and stakeholders about the
responsibilities associated with holding a DEA registration and the
Agency's enforcement priorities.
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I. Findings of Fact
The Agency finds from clear, unequivocal, and convincing evidence
that Respondent failed to maintain sole possession of his hard token
for issuing electronic controlled substance prescriptions, that he
allowed unauthorized individuals to issue electronic controlled
substance prescriptions using his DEA credentials, and that in doing
so, he allowed controlled substances to be prescribed outside the usual
course of professional practice and without a legitimate medical
purpose. RD, at 24-27.
Respondent's Hard Token, Credentials, and Electronic Prescribing
In July 2019, Respondent \3\ received an unsolicited fax offering
employment as a prescribing practitioner with a telemedicine platform
called Church Ekklasia Sozo (CES).\4\ RD, at 11-12; Tr. 184-86, 327;
Respondent's Exhibit (RX) 1. The company was based out of North
Carolina and Respondent lived and worked in Texas. RD, at 4, 10, 12;
ALJX 8, at 2, Stips. 1-3. Respondent joined CES in September 2019 and
had his first patient intake and clinical encounter in May 2020. RD, at
12; Tr. 197-98. Respondent worked as a contractor physician for CES
from September 9, 2019, to December 13, 2021. RD, at 4, 11-12; Tr. 40,
192-94; ALJX 8, at 2, Stip. 2. As a condition of employment at CES,
Respondent was required to obtain a hard token \5\ for the purpose of
issuing electronic controlled substance prescriptions and to give the
hard token to CES staff in North Carolina. RD, at 4, 6-7, 13; Tr. 44-
45, 58-59, 227-29, 231, 280, 284. Respondent admitted to giving his
hard token to CES and allowing the company to keep his electronic
signature on file to issue controlled substance prescriptions under his
DEA registration. Id.
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\3\ The ALJ found that ``to the extent [Respondent's] testimony
contradicts with that offered by [the Diversion Investigator], [she]
gives full credit to the [Diversion Investigator]'s testimony.'' RD,
at 21. The Agency agrees with the amount of weight that the ALJ
afforded Respondent's testimony.
\4\ CES's staff did not hold DEA registrations. RD, at 5, 16;
Tr. 50, 225-26.
\5\ A hard token is a physical device similar to a key fob that
may be used to authenticate an electronic prescription. Tr. 45; 21
CFR 1311.115(a)(3), 1311.140(a)(5). The hard token which Respondent
used was not offered into evidence. Tr. 47. Instead, a picture of a
hard token similar to one used by Respondent was admitted into
evidence. Tr. 45-48; GX 22. The picture shows a small device,
roughly two inches in length, with a small screen on which a PIN
number would be displayed. Id. When a hard token is used to sign a
prescription, the token generates a unique identification PIN number
which serves as the signature on the prescription. RD, at 5; Tr. 46.
The PIN is unique to each prescription and can be traced to the
prescriber. Id.
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On December 1, 2021, a DEA Diversion Investigator (DI) \6\
conducted a regulatory inspection of Respondent's registered premises.
RD, at 3-4; Tr. 28, 31-38, 138, 141-42, 156; Government's Exhibit (GX)
2. At the inspection, the DI informed Respondent that over 1,900
prescriptions for buprenorphine products (a schedule III controlled
substance) had been issued under his registration in the past two
years. RD, at 4; Tr. 41-43. Respondent stated that this number was
``too high'' because he only saw ``about 20 to 25 patients.'' Id. The
DI asked Respondent to show her a prescription that he had issued, and
Respondent pulled up a recently issued controlled substance
prescription for patient J.O. RD, at 5-6; Tr. 50-53; GX 20, at 29. The
prescription bore a time stamp indicating that it had been signed by
Respondent while the DI was conducting the inspection. Id. Although the
prescription for J.O. purported to be signed by Respondent, Respondent
told the DI that he did not know this patient,
[[Page 84196]]
had never conducted a telemedicine appointment for this patient, and
had never established a doctor-patient relationship with this patient.
RD, at 8-9, 18; Tr. 107-09, 148-56, 161-63, 234, 236, 286-87, 296-97,
332; GX 24.
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\6\ The Agency agrees with the ALJ's assessment that the DI was
``a credible, reliable'' witness and that her testimony was clear,
objective, consistent, precise, and ``corroborated by the
documentary evidence.'' RD, at 9. The ALJ found that ``[t]o the
extent her testimony conflicts with Respondent's testimony, . . .
[she] credits [the DI].'' Id. The Agency agrees with the amount of
weight that the ALJ afforded Respondent's testimony.
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The DI asked how Respondent could have signed and issued this
prescription during the inspection when Respondent had not conducted
any telemedicine visits during that time. RD, at 5-6; Tr. 53.
Respondent explained that CES had his signature on file, which allowed
the company's unregistered staff to issue electronic prescriptions on
his behalf. RD, at 4; Tr. 44-45. Respondent also stated that he had
given his hard token to CES in North Carolina as a condition of his
employment with CES.\7\ RD, at 6-7, 13; Tr. 58-59, 227-29, 231, 280,
284-85. Further, CES's owner telephonically explained that it was CES's
standard procedure for nurses to sign the prescriptions, ``because the
[ nurses] were [ ] agent[s] of the doctor.'' RD, at 4-6; Tr. 53-54.
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\7\ The DI informed Respondent and CES's owner that CES must
cease using Respondent's registration for prescribing controlled
substances and that the hard token must be returned to Respondent.
RD, at 6; Tr. 58, 157, 163. After the inspection ended, Respondent
sent an email to CES's owner directing CES to stop using his
registration for issuing prescriptions and to overnight return his
hard token to his home. RD, at 7, 17; Tr. 62, 66-69, 159, 237; GX
14.
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II. Discussion
A. The Five Public Interest Factors
Under the CSA, ``[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 [21 U.S.C. 823]
inconsistent with the public interest as determined under such
section.'' 21 U.S.C. 824(a). In making the public interest
determination, the CSA requires consideration of the following factors:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1).
The Agency considers these public interest factors in the
disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each
factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin.,
412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination
of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508
(1993). The inquiry is ``focuse[d] on protecting the public interest.''
Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
The Government has the burden of proof in this proceeding. 21 CFR
1301.44. While the Agency has considered all the public interest
factors in 21 U.S.C. 823(g)(1), the Government's evidence in support of
its prima facie case for revoking Respondent's registration is confined
to Factors B and D. RD, at 24 n.24 (finding that Factors A, C, and E do
not weigh for or against the sanction sought by the Government). Having
reviewed the record and the RD, the Agency adopts the ALJ's analysis,
and agrees that the Government's evidence satisfies its prima facie
burden of showing that Respondent's continued registration would be
inconsistent with the public interest. RD, at 27, 33; 21 U.S.C.
824(a)(4).
B. Factors B and D
Evidence is considered under public interest factors B and D when
it reflects compliance or non-compliance with laws related to
controlled substances and experience dispensing controlled substances.
See Sualeh Ashraf, M.D., 88 FR 1,095, 1,097 (2023); Kareem Hubbard,
M.D., 87 FR 21,156, 21,162 (2022).
DEA regulations allow registrants to issue electronic prescriptions
for controlled substances in schedules II-V. 21 CFR 1311.100(b); RD, at
23. To issue an electronic prescription for a controlled substance, the
prescriber must authenticate the prescription using at least two of the
following factors: (1) ``Something only the practitioner knows, such as
a password or response to a challenge question''; (2) ``Something the
practitioner is, biometric data such as a fingerprint or iris scan'';
and/or (3) ``Something the practitioner has, a device (hard token)
separate from the computer to which the practitioner is gaining
access.'' 21 CFR 1311.115(a), 1311.120(b)(5), (11); RD, at 23; Tr. 45.
This two-factor authentication process ``constitute[s] the signing of
the prescription by the practitioner.'' 21 CFR 1311.140(a)(5). ``[O]nly
the registrant may sign the prescription,'' and when signing the
prescription, the registrant must comply with the two-factor
authentication requirement. 21 CFR 1311.135(a); RD, at 23. Although DEA
regulations permit a non-registered agent to enter data on the
prescription, the registrant must sign the prescription himself. Id.
DEA regulations make clear that ``[t]he practitioner must retain
sole possession of the hard token'' and ``must not allow any other
person to use the token.'' \8\ 21 CFR 1311.102(a); RD, at 23. The
regulation further states that the practitioner ``must not share the
password or other knowledge factor, or biometric information, with any
other person'' and ``[t]he practitioner must not allow any other person
to use the token or enter the knowledge factor or other identification
means to sign prescriptions for controlled substances.'' Id. ``Failure
by the practitioner to secure the hard token, knowledge factor, or
biometric information may provide a basis for revocation or suspension
of registration.'' Id.
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\8\ It is important to emphasize the clarity with which this
requirement is stated in the regulation. The requirement to ``retain
sole possession'' is stated simply, clearly, and unambiguously in
plain language. See Electronic Prescriptions for Controlled
Substances, 75 FR 16236, 16277 (Mar. 31, 2010). To further emphasize
this point, the RD put it well: the requirement to retain sole
possession of the hard token is set forth ``in plain, simple
English, and is consistent with basic common sense.'' RD, at 32.
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Regarding the hard token, substantial record evidence, including
Respondent's admission, establishes that Respondent gave his hard token
to CES staff in North Carolina and allowed them to maintain physical
possession of it. RD, at 25-26; Tr. 53-59, 66-67, 227-31, 237, 285.
Accordingly, substantial record evidence establishes that Respondent
failed to ``retain sole possession of the hard token,'' in violation of
21 CFR 1311.102(a). RD, at 25-26; see also Allan Alexander Rashford,
M.D., 87 FR 77637, 77637-38 (2022) (revoking respondent's registration,
in part, for violating 21 CFR 1311.102(a) due to ``entrusting his
secure credentials to his wife and son and allowing them to access and
provide his PIN'' to prescribe controlled substances).
Regarding credentials, substantial record evidence, including
Respondent's admission, establishes that Respondent allowed CES to keep
his signature on file to use in conjunction with the hard token in
order to complete the two-factor authentication process for signing and
issuing electronic controlled substance prescriptions on his behalf.
RD, at 26; Tr. 44-45, 53-59, 157, 163, 222, 225-27, 229, 231, 280, 284;
GX 14; GX 20-21 (prescriptions issued by CES staff to J.O. and three
other patients). In so doing, Respondent violated federal and state
regulations that prohibit any person other than the registrant from
signing
[[Page 84197]]
and authenticating an electronic controlled substance prescription. RD,
at 26; Tr. 57-58; 21 CFR 1311.135(a); 22 Tex. Admin. Code Sec.
315.3(c)(1) (requiring Texas practitioners to comply with the
requirements set forth in 21 CFR 1311).
Respondent allowed illegal electronic controlled substance
prescriptions to be issued under his registration by giving away his
hard token and two-factor authentication credentials.\9\ RD, at 4-5,
16, 26, 32; Tr. 42-43, 226. The regulations governing the issuance of
electronic controlled substance prescriptions do not ``relieve[] a
practitioner of his responsibility to dispense controlled substances
only for a legitimate medical purpose while acting in the usual course
of his professional practice.'' 21 CFR 1311.102(k); RD, at 23; see also
21 CFR 1311.100(f). ``The practitioner has the same responsibilities
when issuing [an electronic prescription] as when issuing a paper or
oral prescription,'' including the requirement ``to ensure the validity
of [that] prescription.'' 21 CFR 1311.102(k); RD, at 23.
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\9\ The Agency finds that it is not necessary to determine the
precise number of prescriptions that were issued by CES with
Respondent's hard token and credentials. RD, at 26. The record
clearly establishes and Respondent admitted that prescriptions were
being issued under Respondent's registration for at least one
patient he never saw (J.O.) and at quantities that exceeded the
patients he did see. See RD, at 4, 20, 26; GX 20, at 17-29; Tr. 41-
43 (when the DI informed Respondent that the PMP showed 1,900
prescriptions had been issued under his registration, he responded
that this number was ``too high'' because he only saw ``about 20 to
25 patients''); Tr. 234, 236, 286-87, 297, 332.
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Under DEA regulations, a controlled substance prescription may only
``be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional practice.''
21 CFR 1306.04(a). Similarly, under Texas law, a controlled substance
prescription may only be issued ``for a valid medical purpose and in
the course of medical practice.'' Tex. Health & Safety Code Sec.
481.071(a). Texas law states that prescribing a controlled substance
``without first establishing a valid practitioner-patient
relationship'' falls outside the scope of professional medical
practice. 22 Tex. Admin. Code Sec. 190.8(1)(L).
Respondent admitted that he never established a doctor-patient
relationship with J.O., yet thirteen prescriptions were written for
J.O. using Respondent's hard token and electronic signature.\10\ RD, at
8-9, 18, 26; Tr. 107-09, 148-56, 161-63, 234, 286-87, 296-97, 332; GX
20, 24. Accordingly, these prescriptions were issued without a
legitimate medical purpose and outside the usual course of professional
practice, in violation of federal and state law.\11\ RD, at 26; 21 CFR
1306.04(a); Tex. Health & Safety Code Sec. 481.071(a); 22 Tex. Admin.
Code Sec. 190.8(1)(L).
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\10\ The allegation that Respondent failed to establish a
doctor-patient relationship in this case pertains only to J.O. Tr.
92. Although the Government admitted additional prescriptions into
evidence that CES staff issued using Respondent's hard token--all of
which were issued in violation of 21 CFR 1311.135(a)--the Government
has not alleged that Respondent failed to establish a doctor-patient
relationship with these patients. Tr. 81-82, 92.
\11\ It is a long-standing principle of diversion law that DEA
registrants are ``strictly liable for all activities which occur
under the authority of their registrations.'' Sigrid Sanchez, M.D.,
78 FR 39331, 39336 (2013). In line with this well-established
principle, it is reasonable to find that a registrant can be held
liable for controlled substances being prescribed outside the usual
course of professional practice even when issued by someone else
under his registration. For instance, where a registrant's actions
allow an unregistered person to prescribe controlled substances, as
Respondent did here, the registrant can be found in violation of 21
CFR 1306.04(a). Robert G. Hallermeier, M.D., 62 FR 26818, 26820
(1997). This is because the purpose of Sec. 1306.04(a)--to ensure
that ``patients use controlled substances under the supervision of a
doctor so as to prevent'' diversion--is thwarted when a registrant
allows an unregistered person to prescribe controlled substances
under the registrant's registration to patients the registrant has
never seen, which occurred in this case. Gonzales v. Oregon, 546
U.S. 243, 274 (2006). When a registrant allows an unauthorized
person to prescribe controlled substances, such as when Respondent
allowed CES's unregistered staff to prescribe controlled substances
to patients Respondent had never seen, the registrant creates a
``substantial risk that the drugs would be diverted and abused,''
which undermines the purpose of Sec. 1306.04(a)'s prescription
requirement. Arvinder Singh, M.D., 81 FR 8247, 8249 (2016).
Holding a registrant liable for violating Sec. 1306.04(a)
where prescriptions are issued by someone else under his
registration is an extension of the Agency's precedent and the
principle that registrants are ``strictly liable for all activities
which occur under the authority of their registrations.'' Sigrid
Sanchez, M.D., 78 FR at 39336. For example, in the context of
electronic prescriptions, the Agency has revoked a registration, in
part, due to the registrant ``improperly issu[ing] electronic
controlled substance prescriptions by entrusting his secure
credentials to his wife and son and allowing them to access and
provide his PIN in the issuance of those prescriptions.'' Allen
Alexander Rashford, M.D., 87 FR at 77638. Similarly, DEA has long
held that when a registrant allows other individuals to use their
registration, a serious violation is committed. See Brian Thomas
Nichol, M.D., 83 FR 47352, 47367 (2018) (concluding respondent
committed a ``serious violation of the CSA'' when he pre-signed
prescriptions and gave them to unregistered staff, creating a
``substantial risk'' of diversion and abuse); Rose Mary Jacinta
Lewis, M.D., 72 FR 4035, 4041-42 (2007) (affirming an immediate
suspension order where a registrant allowed another person to use
her DEA credentials to obtain controlled substances and where such
misconduct demonstrated ``indifference to her obligations'' and
created a danger to public safety); Anthony L. Cappelli, M.D., 59 FR
42288, 42288 (1994) (``By allowing an unregistered and unauthorized
person to use his DEA number, Respondent was responsible for any use
and misuse of that number. Moreover, such a violation is aggravated
by the fact that Respondent allowed a non-practitioner to use his
DEA number at an unregistered location.'').
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In sum, and in agreement with the RD, the Agency finds that the
record contains substantial evidence that Respondent acted in violation
of both federal and state law. RD, at 24-27; 21 U.S.C. 823(g)(1),
824(a)(4); 21 CFR 1306.04(a), 1311.100(f), 1311.102(a), (k),
1311.115(a), 1311.120(b)(5), (b)(11), 1311.125(c), 1311.135(a),
1311.140(a)(5); 22 Tex. Admin. Code Sec. 315.3(c)(1); Tex. Health &
Safety Code Sec. 481.071(a). In weighing factors B and D, the Agency
finds that the Government has established a prima facie case that
Respondent committed acts that render his registration inconsistent
with the public interest and support revocation of his registration. 21
U.S.C. 823(g)(1); RD, at 27.
III. Sanction
Where, as here, the Government has established sufficient grounds
to issue a sanction against Respondent's registration, the burden
shifts to the registrant to show why he can be entrusted with the
responsibility carried by a registration. Garret Howard Smith, M.D., 83
FR 18882, 18910 (2018). ``[T]rust is necessarily a fact-dependent
determination based'' on individual circumstances; therefore, the
Agency looks at factors such as ``the acceptance of responsibility and
the credibility of that acceptance as it relates to the probability of
repeat violations or behavior,'' ``the nature of the misconduct that
forms the basis for sanction,'' and ``the Agency's interest in
deterring similar acts.'' Robert Wayne Locklear, M.D., 86 FR 33738,
33746 (2021). To be effective, acceptance of responsibility must be
unequivocal. Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018). When a
registrant has committed acts inconsistent with the public interest, he
must both accept responsibility and demonstrate that he has undertaken
corrective measures. Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219
and 5195, 77 FR 62316, 62339 (2012) (internal quotations omitted).
Here, Respondent has failed to fully and credibly accept
responsibility for the proven misconduct. RD, at 27-29. When asked
about his decision to surrender physical possession of the hard token
to CES, Respondent expressed regret and remorse. RD, at 28; Tr. 229,
316. Respondent testified that turning over the hard token was ``a
decision that [he] now regret[s] and [is] extremely remorseful about.''
RD, at 28; Tr. 229, 316. Regret and remorse, however, are not the same
as taking
[[Page 84198]]
ownership of the misconduct, its gravity, and its threat to public
safety.\12\
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\12\ See Nicholas P. Roussis, M.D., 86 FR 59190, 59194 (2021)
(explaining ``remorse and acceptance of responsibility are not the
same thing'' in that a respondent's remorse is primarily concerned
with his unpleasant feelings whereas a full acceptance of
responsibility acknowledges the harm his actions posed to the
public); Ibrahim Al-Qawaqneh, D.D.S., 86 FR 10354, 10357 (2021)
(finding that regret did not amount to acceptance of
responsibility).
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When specifically asked whether he accepted responsibility, he
testified that he ``accept[s] full responsibility for the mistakes that
occurred.'' RD, at 28; Tr. 335. However, that acceptance of
responsibility was far from unequivocal as Respondent repeatedly blamed
his decision to give up possession of the token on CES. RD, at 28.
Respondent testified that in trusting CES with his hard token, he had
``the wool pulled over [his] eyes.'' Id.; Tr. 238. He testified that
CES created an impression of being compliant with state and federal
law. RD, at 13-17. Specifically, he testified about receiving a
memorandum from the company's CEO detailing the effects of the Drug
Addiction Treatment Act (DATA) of 2000 on the company's prescribing
practices, RD, at 16; Tr. 199-204; RX 4, and how this memorandum gave
him assurance that CES was taking regulatory compliance seriously. RD,
at 16; Tr. 209-10. He also testified about a July 2021 audit report
written by the company's compliance officer, a former DEA DI, which
memorialized the policy that the company and its agents were authorized
to issue controlled substance prescriptions on behalf of the provider.
RD, at 13-16; Tr. 219-27, 314; RX 2, at 18. Respondent testified that
he was ``impressed that [CES] took the trouble and had retained a
retired DEA investigator as their chief compliance officer to ensure
that the company was following rules and regulations.'' RD, at 12; Tr.
189-93, 334. He testified that all these assurances led him to believe
that CES had more expertise than he did regarding regulatory
compliance. RD, at 13, 31-32; Tr. 230, 283-84, 321.
Respondent also testified that he read the requirement to retain
sole possession of the hard token prior to joining CES,\13\ but blamed
the company for misinterpreting the regulation.\14\ RD, at 28, 31-32;
Tr. 315-16. Shifting the blame onto the company further undermines his
attempt to accept responsibility.\15\ Id.
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\13\ Respondent testified that he read 21 CFR 1311.102(a) as
part of his due diligence before joining CES; however, when the
Government asked whether he was aware of a regulation prohibiting
the surrender of a hard token to someone else, Respondent stated:
``No. Not before I joined CES. I was not aware of this.'' Tr. 316.
The first words of 21 CFR 1311.102(a) are ``[t]he practitioner must
retain sole possession of the hard token.'' Respondent's testimony
that he read this regulation, given his claim that he was not aware
that he had to keep the hard token, causes the Agency to question
Respondent's credibility. RD, at 31; see also Daniel A. Glick,
D.D.S., 80 FR 74,800, 74809 (2015) (holding ignorance of the CSA or
DEA's regulations are no defense to proven violations).
\14\ He acknowledged that nowhere in the company's protocols or
manuals was there an assurance from the company that surrendering
his hard token complied with DEA regulations. RD, at 18; Tr. 318-19.
\15\ He testified that he ``understand[s] the gravity of my--the
mistakes that have occurred.'' RD, at 28; Tr. 244. Rather than take
ownership by calling them ``my mistakes,'' he referred to mistakes
in a passive and general sense. See also Tr. 335 (referring broadly
to ``mistakes that occurred''). Indeed, the majority of his
testimony reveals that Respondent understands the ``mistakes'' to
mean the mistakes that CES made and the mistake that he made in
trusting CES. RD, at 28; see Sualeh Ashraf, M.D., 88 FR at 1098
(discrediting respondent's acceptance of responsibility due to him
blaming someone else for being the ``criminal mind'' behind the
misconduct); Michael A. White, M.D., 79 FR 62957, 62967-68 (2014)
(finding that the standard for accepting responsibility was not met
where respondent blamed others for his misconduct); Robert Raymond
Reppy, D.O., 76 FR 61,154, 61,180 (2011) (finding that respondent
failed to fully and credibly accept responsibility where most of his
testimony shifted blame to others and focused on how he was
``duped'' into violating the CSA). Furthermore, although Respondent
acknowledged at the hearing that protecting his registration is
``solely'' his responsibility, this after-the-fact realization
conflicts with other parts of his testimony where he blamed CES for
his failure to protect his DEA registration. Tr. 335.
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Furthermore, Respondent testified that when he gave up physical
possession of his hard token, he believed CES would only use the token
and his credentials to issue controlled substance prescriptions for
patients with whom Respondent had established a doctor-patient
relationship. RD, at 16, 32; Tr. 222-23, 230, 284. Even if this was his
intention, relinquishing control of the token in-and-of-itself was a
clear violation of 21 CFR 1311.102(a) that allowed diversion to occur.
Respondent's attempt to downplay his misconduct further undermines his
acceptance of responsibility and calls into question whether he truly
understands the gravity of his misconduct. RD, at 30-32. In sum, the
Agency agrees with the RD that Respondent failed to unequivocally
accept responsibility for the proven violations. RD, at 27-29.
The Agency is only required to consider remedial measures where a
respondent has tendered a full and credible acceptance of
responsibility. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019);
Daniel A. Glick, D.D.S., 80 FR at 74810. Here, the Agency need not
consider remedial measures given the lack of acceptance of
responsibility. RD, at 29. Nevertheless, even if Respondent had
accepted responsibility, his proposed remedial measures would not
change the outcome of this case.\16\ Id.
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\16\ Respondent's proposed remedial measures included
deactivating all tokens that he was no longer using; hiring a third-
party to conduct a regulatory compliance audit of his practice;
searching the PMP for prescriptions issued under his COR; and
writing a controlled substances protocol for other practitioners.
Tr. 238-43. Although these measures are not without merit, the
proposed remediation fails to convince the Agency that he can be
trusted with a registration. John Qian, M.D., 89 FR 59934, 59937-38
(2024). In this regard, even if these measures were enacted,
Respondent's insufficient acceptance of responsibility demonstrated
that he believes it was CES, not himself, who bore ultimate
responsibility for the proven misconduct. RD, at 27-28. In this
sense, Respondent's proposed measures are not backed up by his
willingness to take personal responsibility for his actions, and
therefore, their remedial efficacy rings hollow. Jeffrey Pollock,
P.A., 89 FR 54052, 54058 n.38 (2024). Additionally, the proposed
measures are misplaced. Deactivating unused tokens and auditing his
practice have no relevance to the proven violation of failing to
maintain sole possession of his hard token and not sharing his
authentication credentials. Likewise, checking the PMP and
instructing other practitioners on their responsibilities have no
bearing on the misconduct, especially given the fact that he
believes the misconduct was primarily CES's fault for misleading
him. RD, at 27-28. Furthermore, in light of the egregiousness of the
misconduct and the need for deterrence, his proposed remedial
measures are insufficient. Id. at 29.
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In addition to acceptance of responsibility, the Agency looks to
the egregiousness and extent of the misconduct. Garrett Howard Smith,
M.D., 83 FR at 18910 (collecting cases), and considers both specific
and general deterrence when determining an appropriate sanction. Daniel
A. Glick, D.D.S., 80 FR at 74810.
Here, the Agency agrees with the ALJ that Respondent's misconduct
was egregious. RD, at 29-30. The CSA establishes a ``closed system for
regulating the distribution'' of controlled substances ``to prevent the
diversion of these substances to those who would either abuse them or
sell them to those who do.'' Holiday CVS, L.L.C., d/b/a CVS/Pharmacy
Nos. 219 and 5195, 77 FR at 62317 (citing Gonzales, 546 U.S. at 250).
DEA regulations contain a clear mandate to ``retain sole possession of
the hard token'' for a reason: to keep the closed system of
distribution closed.\17\ Gonzales, 546 U.S. at 250-51.
[[Page 84199]]
In this case, Respondent enabled unregistered individuals at an
unregistered location to issue multiple controlled substance
prescriptions, including at least a year's worth of controlled
substance prescriptions for patient J.O. whom Respondent had never
evaluated. RD, at 4-5, 16, 18, 26, 29-30; Tr. 42-43, 50, 225-26.
Therefore, by giving away his hard token and two-factor authentication
data to unauthorized persons, Respondent committed egregious violations
of DEA's regulations that created a risk of diversion and threatened
public safety. RD, at 29-31.
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\17\ In a Notice of Proposed Rulemaking, the Agency explained
that by requiring registrants to retain sole possession of the hard
token, ``the practitioner can eliminate the risk of fraudulent
prescriptions and, if the token is lost, stolen, or compromised, he
will be immediately alerted to the threat and have the
authentication protocol revoked.'' See Electronic Prescriptions for
Controlled Substances, 73 FR 36722, 36737 (June 27, 2008). The
Agency further explained that the requirement for the practitioner
to retain sole possession of the hard token serves to protect the
practitioner as well as the pharmacy from forged or fraudulent
prescriptions, and to provide ``assurance that only a legitimate
practitioner issued the prescription.'' Id.
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The Agency also concludes that revocation of Respondent's
registration is necessary to deter the registrant community from
engaging in similar misconduct. RD, at 30-31. There is simply no
conceivable world in which it is acceptable for a practitioner to give
away his or her prescribing credentials to anyone else, including a
telemedicine platform. When a practitioner is awarded the privilege of
prescribing controlled substances in the form of a registration, that
privilege belongs to the registrant and the registrant alone--it cannot
be given away. The Agency agrees with the ALJ that the interests of
general deterrence support revocation, as a lack of sanction in the
current matter would send a message to the registrant community that
giving away a hard token and two-factor authentication credentials can
be overlooked and excused. RD, at 30; see also Jeffrey Pollock, P.A.,
89 FR at 54058. Revocation is also necessary to impress upon Respondent
the seriousness of his misconduct and to deter him from committing the
same misconduct in the future. Id.
In sum, Respondent has not offered sufficient mitigating evidence
to establish that he can be trusted with the responsibility of
maintaining a DEA registration. RD, at 27-33. Accordingly, the Agency
will order that Respondent's registration be revoked. RD, at 33.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
FS2968444 issued to Neeraj B. Shah, M.D. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Neeraj B. Shah, M.D., to renew
or modify this registration, as well as any other pending application
of Neeraj B. Shah, M.D., for additional registration in Texas. This
Order is effective November 20, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 10, 2024, by Administrator Anne Milgram. 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. 2024-24189 Filed 10-18-24; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on October 21, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.