[Federal Register Volume 89, Number 142 (Wednesday, July 24, 2024)]
[Notices]
[Pages 59934-59938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16185]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23-42]
John Qian, MD; Decision and Order
On May 3, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to John Qian, M.D.,
(Respondent) of San Diego, CA. OSC, at 1, 7. The OSC proposed the
denial of Respondent's application for a DEA Certificate of
Registration (Registration), Application Control No. W22061401C,
alleging that the issuance of the registration would be inconsistent
with the public interest. Id. at 1 (citing 21 U.S.C. 823(g)(1)).
A hearing was held before DEA Chief Administrative Law Judge John
J. Mulrooney (the Chief ALJ), who, on October 19, 2023, issued his
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
(Recommended Decision or RD), which recommended denial of Respondent's
application. RD, at 27. Respondent did not file Exceptions to the RD.
Having reviewed the entire record, the Agency adopts and hereby
incorporates by reference the entirety of the ALJ's rulings, findings
of fact, conclusions of law, and recommended sanction as found in the
RD and summarizes and expands upon portions thereof herein.
I. Findings of Fact
Respondent was previously registered with the DEA to prescribe
controlled substances in California. John X. Qian, M.D. (``Qian I''),
87 FR 8039, 8058 (2022). The Agency issued an OSC and Immediate
Suspension of Registration to Respondent on November 18, 2019 (2019
OSC/ISO), recommending that his previous Registrations be revoked on
the grounds that they were inconsistent with the public interest. RD,
at 3 (citing 21 U.S.C. 824(a)(4)). Respondent's Registrations were
immediately suspended because the Agency determined that there was an
imminent danger to the public health or safety from continuing his
Registrations during the pendency of the proceeding. RD, at 3 (citing
21 U.S.C. 824(d); 21 CFR 1301.36(e)). On February 11, 2022, following a
hearing on the merits (2020 Hearing), the Agency revoked Respondent's
previous Registrations. RD, at 3; Qian I, 87 FR at 8058.\1\
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\1\ Following publication of Qian I in the Federal Register,
Respondent filed a Petition for Review with the Court of Appeals.
Qian v. DEA, No. 22-70039 (9th Cir. filed Mar. 2, 2022). After the
Court of Appeals extended the initial briefing schedule on four
separate occasions, the petition was administratively closed on
December 15, 2022. On April 13, 2023, Respondent filed a Motion to
Voluntarily Dismiss the Appeal, which the Court of Appeals granted
on April 28, 2023.
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Approximately three months later, on May 26, 2022, Respondent filed
an application for a new registration. RD, at 3. The Agency issued an
OSC on May 3, 2023, proposing that the application be denied based on
the same conduct alleged in the 2019 OSC/ISO. Id. at 2. Following
Respondent's request for a hearing, the Government filed a Partial
Motion for Summary Disposition (the PMSD), arguing that the Agency's
final order in Qian I satisfied the Government's prima facie case that
it would be inconsistent with the public interest to grant Respondent's
application. Id. at 2-3; ALJX 8, at 5-17. The Chief ALJ granted the
Government's unopposed PMSD and found that the sole remaining issue to
determine at the August 2023 Hearing (2023 Hearing) was whether
Respondent could be entrusted with a registration. RD, at 2-3. The
Chief ALJ also found that the Agency's factual findings, legal
conclusions, and credibility determinations in Qian I should be
afforded preclusive effect in this proceeding.\2\ The Agency agrees.
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\2\ RD, at 3-4, 4 n.9 (citing Jose G. Zavaleta, M.D., 78 FR
27431, 27434 (2013) (``[T]he Agency's factual findings and legal
conclusions are entitled to preclusive effect in a subsequent
proceeding.''); Robert L. Dougherty, M.D., 76 FR 16823, 16830 (2011)
(``[W]here, as here, an applicant has previously been the subject of
an Agency Final Order, the doctrine of res judicata bars the
relitigation of the factual findings and conclusions of law of the
prior proceeding absent the applicant's establishing that he falls
within one of the doctrine's recognized exceptions.''); see also
Univ. of Tenn. v. Elliott, 478 U.S. 788, 797 (1986) (``[I]t is sound
policy to apply principles of issue preclusion to the factfinding of
administrative bodies acting in a judicial capacity.''); United
States v. Utah Constr. & Mining Co., 384 U.S. 394, 422 (1966)
(``When an administrative agency is acting in a judicial capacity
and resolved disputed issues of fact properly before it which the
parties have had an adequate opportunity to litigate, the courts
have not hesitated to apply res judicata to enforce repose.'')).
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Because the Agency's factual findings in Qian I serve as the basis
for the Government's prima facie case, they are briefly summarized
here.\3\ In Qian I, the Agency found that Respondent had issued one-
hundred and fifteen prescriptions to three patients from 2017 through
2019 in violation of federal and state law and beneath the standard of
care for prescribing controlled substances in California. RD, at 4;
Qian I, 87 FR 8057. The Agency found that Respondent had issued these
prescriptions without performing or documenting adequate physical
examinations, developing or documenting adequate treatment plans,
developing or documenting a justification for prescribing controlled
substances, or resolving or documenting resolution of diversion red
flags. RD, at 4-5; Qian I, 87 FR 8039 n.1, 8040, 8045 n.27, 8050, 8055-
57. The Agency also found that Respondent had repeatedly copied
language verbatim throughout his medical records, which violated the
California standard of care and significantly undermined the medical
records' credibility. RD, at 5; Qian I, 87 FR 8055. Respondent's
recordkeeping errors were egregious; for example, in one medical
record, Respondent copied forward his description of a physical
examination verbatim over twenty-one visits for fifteen months without
adding any new information. Id. at 8048. Respondent then added an
additional
[[Page 59935]]
eight physical tests to the description and copied forward the new
description verbatim for an additional seventeen months. Id. Meanwhile,
Respondent was prescribing this patient ``astronomically high'' dosages
of opiates along with a long-acting benzodiazepine--a combination that
poses a serious risk of death--without documenting whether safer
methods had been tried or even what conditions he was treating with
these controlled substances. Id. at 8046-48, 8057. The Agency found
that Respondent's documentation was ``so egregiously bad that it [was]
difficult to determine what steps [he] was taking to ensure this
patient's safety, or even why a particular controlled substance was
being prescribed.'' Id. at 8058. Respondent failed to accept
responsibility for his recordkeeping violations, testifying that there
may have been ``some mistakes,'' but ``overall [his] charts [were]
good'' and ``above average.'' Id.
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\3\ The Government's only witness at the 2023 Hearing was
Diversion Group Supervisor (GS) Ann Malta-Chi, who testified briefly
to authenticate and lay foundation for Respondent's Certificate of
Non-Registration. RD, at 6; Tr. 21-23; GX. 1. The Agency agrees with
the Chief ALJ that the GS presented as an impartial regulator,
testifying to matters that were not in serious contention, and that
her testimony was sufficiently detailed, plausible, and internally
consistent to be fully credited. RD, at 6.
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Respondent also failed to resolve red flags presented by his
patients, including failing to adequately address an inconsistent urine
drug screen that showed that the patient was taking two controlled
substances that had not been prescribed and that posed serious risks
when taken with the opioids prescribed by Respondent. Id. at 8051-52.
Respondent's prescribing patterns were similar with all three patients
and they were so dangerous that the Agency determined that Respondent's
prescribing practices created a risk of death. RD, at 5-6; Qian I, 87
FR 8047-53, 8057.
As discussed in more detail below (see infra Sec. II), the Agency
found in Qian I that the Government had met its prima facie burden of
demonstrating that Respondent's registration was inconsistent with the
public interest under the Controlled Substances Act (CSA), and the
burden shifted to Respondent to prove that he could be entrusted with a
registration. Qian I, 87 FR 8057-58. The Agency found that Respondent
did not prove that he could be entrusted with a registration because he
did not accept responsibility for his egregious conduct, and determined
that the appropriate remedy was revocation. Id.
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 section 823 of this title
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 Government has the burden of proof in this proceeding. 21 CFR
1301.44. The Government satisfied its burden based on the Agency's
findings in Qian I, which are binding in this case. In Qian I, the
Agency considered all of the public interest factors in 21 U.S.C.
823(g)(1),\4\ and revoked Respondent's registration primarily based on
evidence under Factors B and D (formerly Factors 2 and 4). 87 FR 8055-
58; RD, at 21-22. Evidence is considered under 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 1095, 1097 (2023); Kareem Hubbard, M.D., 87 FR
21156, 21162 (2022). The Agency found that Factors B and D weighed
against Respondent's continued registration because Respondent had
issued numerous controlled substance prescriptions in violation of
state and federal law and beneath the standard of care in California.
Qian I, 87 FR 8055-57. Based on the Agency's findings in Qian I, the
Agency finds that Respondent's continued registration is inconsistent
with the public interest under 21 U.S.C. 823(g)(1). RD, at 21-22.\5\
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\4\ In Qian I, Respondent argued that Factor A weighed in his
favor because the Medical Board of California (MBC) had ordered
probation rather than revocation after receiving a complaint against
his license. 87 FR 8054. The Agency found that the MBC's order
should receive ``minimal to no weight'' under Factor A because the
conduct at issue in Qian I involved different patients, a different
timeframe, and altogether different misconduct than the subject of
the MBC's order, and there was no evidence of what the MBC would
have concluded if it had considered the same misconduct as the
Agency considered in Qian I. Id. Regarding Factor C, the Agency
found that the absence of a conviction related to controlled
substances was not dispositive based on longstanding Agency
precedent. Id. (citing Dewey C. MacKay, M.D., 75 FR 49956, 49973
(2010)). Finally, the Agency found that the absence of evidence of
``other conduct which may threaten the public health and safety''
under Factor E did not militate for or against a finding that
Respondent's registration was inconsistent with the public interest.
RD, at 21-22 n.57.
\5\ Respondent offered into evidence four letters drafted by
doctors to support his request for early termination of the MBC's
probation. RD, at 17-18; RX L, M, N, O. The Agency considered these
letters, but found them to have limited probative value because they
do not address whether granting Respondent's application is in the
public interest. RD, at 18 (citing, e.g., George Pursley, M.D., 85
FR 80162, 80180 (2020) (noting that the applicant submitted
``written statements of support . . . [that] provided limited
evidence relevant to Applicant's controlled substance prescribing''
and therefore were ``of limited value''); Mark P. Koch, D.O., 79 FR
18714, 18736-37 (2014) (finding that supportive testimony about a
practitioner's professional reputation ``carries little value under
the public interest analysis because it does not bear a connection
to Respondent's ability to handle controlled substances''); Michael
S. Moore, M.D., 76 FR 45867, 45873 (2011) (``In evaluating the
weight to be attached to the representations in the letters provided
by the Respondent's hospital administrators and peers, it can hardly
escape notice that, in addition to the fact that the authors were
not subjected to the rigors of cross examination, each source has a
significant influencing consideration that bears caution.'')).
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III. Sanction
Where, as here, the Government has established sufficient grounds
to deny Respondent's Application, the burden shifts to Respondent to
show why he can be entrusted with the responsibility carried by a
registration. Garret Howard Smith, M.D., 83 FR 18882, 18904 (2018).
When a registrant has committed acts inconsistent with the public
interest, he must both accept responsibility and demonstrate that he
has undertaken remedial measures. Holiday CVS, L.L.C., dba CVS Pharmacy
Nos 219 and 5195, 77 FR 62316, 62339 (2012). Trust is necessarily a
fact-dependent determination based on individual circumstances;
therefore, the Agency looks at factors such as the acceptance of
responsibility, 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. See, e.g., Robert Wayne Locklear, M.D., 86
FR 33738, 33746 (2021).
At the 2020 Hearing in Qian I, Respondent explicitly denied
[[Page 59936]]
responsibility for his misconduct, maintaining that his recordkeeping
was ``above average'' and offering other incredulous and false
testimony under oath. Qian I, 87 FR 8052. The Agency found that some of
his testimony was ``self-serving to the point it denied belief.'' Id.
at 8042. For example, Respondent defended an inconsistent urine drug
screen by suggesting that there might have been ``liquid
contamination'' that caused the substance to show up in the screen
without the patient having consumed the substance. Id. When asked what
``liquid contamination'' meant, Respondent suggested that the patient
may have been in close proximity to someone else who was taking the
drug, and that person may have dropped some of the substance into the
patient's food, causing her to accidentally ingest it. Id. at 8051.
This illogical testimony was discredited by the Government's expert.
Id. at 8042. Another area where the Agency found that Respondent's
testimony was untruthful was his suggestion that rather than
mechanically copying forward the same description month-after-month in
his medical records, he performed the same exact examination each month
and made the same selections in the software, which generated an
identical description. Id. The Agency called a representative from the
software company to testify, who discredited Respondent's testimony and
conclusively established that the medical records had been copied
forward repeatedly. Id. at 8041. Respondent's lack of candor during the
2020 Hearing bolstered the Agency's conclusion that he could not be
entrusted with a registration.
Although Respondent was more contrite at the 2023 Hearing, his
acceptance of responsibility lacked the requisite remorse and sincerity
to be considered unequivocal.\6\ During the course of his testimony,
Respondent indicated that he accepted responsibility for several
defects in his treatment of patients in Qian I, as well as defects in
his treatment of patients identified in a January 31, 2020 probationary
order by the Medical Board of California (MBC Order). For example,
Respondent indicated that he accepted responsibility for failing to
adequately monitor and assess the patients under his care taking
opioids, Tr. 116, 125-27, 135-38, 150-53; failing to recognize signs of
drug abuse in cases where some of his patients should have been
referred to addictionologists, id. at 123-24; failing to adequately
document his medication decisions, id. at 123-24, 131-132, 139-40, 142-
46, 156-57; failing to consider the input of his patients' family
members, id. at 136; failing to conduct adequate physical examinations,
id. at 147-49, 156, 161; and failing to acquire sufficient patient
histories, id. at 149. RD, at 13. Respondent also acknowledged that he
failed to recognize the risks of concurrently prescribing opioids,
benzodiazepines, and carisoprodol. RD, at 13; Tr. 116-22, 126, 134-35.
Additionally, Respondent testified that he broadly accepted
responsibility for the findings in Qian I. RD, at 14; Tr. 158.
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\6\ The Agency incorporates herein the entire summary of
Respondent's testimony and the Chief ALJ's credibility findings with
respect to Respondent. RD, at 12-21. The Agency agrees with the
Chief ALJ that Respondent was the witness at the 2023 Hearing with
the most to gain by his testimony and that there are additional
features of his testimony that supply reason for caution, including
that he declined to unequivocally accept responsibility for his
perjurious statements in Qian I. RD, at 20-21. The Agency also
agrees with the Chief ALJ that while there are certain portions of
this testimony that appear truthful, such as biographical details,
his claims of remorse and acceptance of responsibility were not
sufficiently credible for him to prevail on this issue. Id.
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However, many of Respondent's statements accepting responsibility
were undermined by other portions of his testimony, particularly his
explanations for why he committed the errors and omissions in Qian I.
For example, he blamed his failure to comply with the standard of care
on unspecified ``guideline changes,'' and referred to the pain
management guidelines as ``rapidly changing.'' RD, at 14; Tr. 128; RX
R, at 8. He testified that the guidelines had changed three times since
he had been practicing, and that the changes were ``always indicated
for primary care physician,'' but as a specialist he became ``a little
bit [ ] complacent.'' Tr. 128. Respondent, however, did not explain
what rules had changed, how those rules had changed, or why the rules
were different for him as a specialist.\7\ This testimony is concerning
because the deficiencies outlined in Qian I--such as failure to have a
medical justification for the controlled substances prescribed, failure
to warn about the dangers of concurrent prescriptions for opioids and
benzodiazepines, failure to resolve red flags of abuse and diversion,
and failure to maintain accurate medical records--are core failures
that violated bedrock principles of the CSA.
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\7\ Respondent contends that the guidelines for pain management
specialists are less defined than for general physicians, but
California law requires all doctors to maintain adequate and
accurate records, perform appropriate physical examinations, and
establish a medical indication before prescribing controlled
substances. RD, at 15, 17; RX R, at 9; Cal. Bus. & Prof. Code
sections 2266, 2242(a).
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Respondent also occasionally blamed others for his violations. For
example, when asked why he failed to refer one of his patients to an
addictionologist, he testified that he had made the referral, but it
``never got carried out.'' RD, at 13 n.37; Tr. 123. And while
Respondent admitted to errors in his recordkeeping, he also explained
that he was new to electronic medical records (EMRs), the copy forward
feature was important for patient flow, and the physician's assistants
who worked with him were complaining that the paperwork was arduous.
RD, at 14; Tr. 130-33, 161, 163. Respondent also declined an
opportunity to accept responsibility for falsifying his medical
records. RD, at 14-15; Tr. 143-45. Although he conceded that he
probably needed to conduct more detailed examinations, he testified
that his examinations had been consistent with his training and that he
thought they had been complete. Id.
Respondent was also evasive when asked to address the areas in Qian
I where the Agency found that he had presented false testimony.
Respondent initially explained that he was not lying to the prior ALJ
and offered various explains for his testimony, including that he had
been defensive, hypothetical, nervous, and speculative, and that he had
misspoken. RD, at 14; Tr. 158-61, 163, 166-67. After returning from a
recess requested by his counsel, Respondent reluctantly conceded that
some of his statements were not accurate or truthful. RD, at 14; Tr.
158-61, 166-67). Respondent's testimony falls short of the unequivocal
acceptance that is required from someone who previously lied under
oath.
Respondent entered a proposed Corrective Action Plan (CAP) into the
record, which contains additional statements that detract from his
acceptance of responsibility and minimize the Agency's findings in Qian
I.\8\ The CAP asserts that ``the underlying reasons for the revocation
of [Respondent's registration] did not involve patient harm.'' RD, at
16; RX R, at 6. Although it is not necessary for the Agency to find
patient harm to revoke
[[Page 59937]]
a registration,\9\ and the Agency did not find specific evidence of
patient harm in Qian I, the Agency found that Respondent's prescribing
created a risk of death and that his ``documentation [was] too
deficient to conclusively determine that no harm occurred.'' 87 FR
8057. Respondent's statement that Qian I did not involve patient harm
indicates that he does not appreciate the dangers posed by his
prescribing.\10\
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\8\ Although the CAP was submitted to the Agency after the
deadline set by the OSC, the Agency agrees with the Chief ALJ's
decision to accept it into the record and treat it as a sworn
statement, because Respondent testified that he would adhere to its
terms and the Government had an opportunity to cross examine him.
RD, at 15-16; ALJX 1, at 6; see 21 U.S.C. 824(c)(2)(C). The Agency
also agrees with the Chief ALJ that the CAP is of limited utility in
supporting Respondent's application. RD, at 17.
\9\ Melanie Baker, N.P., 86 FR 23998, 24009 (2021); Larry C.
Daniels, M.D., 86 FR 61630, 61660-61 (2021); Jeanne E. Germeil,
M.D., 85 FR 73786, 73799 n.32 (2020); Qian I, 87 FR 8056 (noting
that Respondent had not cited any legal authority for the
proposition that the Agency must find patient harm in order to
suspend or revoke a registration, and revoking Respondent's
registration notwithstanding the absence of a specific demonstration
of harm).
\10\ The Agency has previously found that a respondent's
minimization of his misconduct weighs against a finding of
unequivocal acceptance of responsibility. See, e.g., Morris &
Dickson Co., 88 FR 34523, 34538 (2023) (citing Ronald Lynch, M.D.,75
FR 78745, 78754 (2010) (finding that Respondent did not accept
responsibility after noting that he ``repeatedly attempted to
minimize his [egregious] misconduct''); Michael White, M.D., 79 FR
62957, 62967 (2014) (similar)).
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Further, in Qian I, the Agency noted that Respondent's ``repeated
and systematic violations of [his] obligations to document required
elements of the standard of care when prescribing high dosages of
opioids manifests a disturbing pattern of indifference.'' 87 FR 8057.
This indifference carried over into Respondent's testimony at the 2023
hearing. He testified that he had become complacent with some of his
patients, particularly those who were medical practitioners or personal
acquaintances. Tr. 127. For example, he testified, ``often you have
nurse practitioner, could be a little bit loose, a more combo.'' Id. He
also testified that he let his guard down with long-term patients and
they became more like friends. Id. at 200. This testimony exhibits a
lack of appreciation for medical ethics and the dangers of prescribing
controlled substances, and Respondent's testimony did little to
convince the Agency that he has been sufficiently rehabilitated to be
trusted with a registration. Thus, the ALJ found, and the Agency
agrees, that Respondent did not unequivocally accept responsibility for
his misconduct. RD, at 24.
Although it is not necessary to consider Respondent's remedial
measures if he has failed to unequivocally accept responsibility,\11\
Respondent presented very little evidence that can be fairly
characterized as remedial measures, and most of these measures were
either mandated by the MBC or lacked sufficient specificity to signal
meaningful change. Id. at 24-25. First, Respondent submitted evidence
of approximately 342 hours of continuing medical education (CME)
courses from 2020 through 2022,\12\ approximately seventy-five of which
arguably relate to remedial measures.\13\ Id. at 19. However, most of
these classes were either required by the MBC Order, or had also been
previously completed by Respondent in 2013 and 2018 prior to issuing
many of the prescriptions in this case. Id.; RX E-F; ALJX 15, app. at
118. The Agency has no reason to believe that Respondent would change
his practices after taking these same courses again, and the fact that
these courses were required by the MBC's Order detracts some from their
weight as remedial measures.
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\11\ Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019); Jones
Total Health Care Pharmacy, L.L.C., & SND Health Care, 81 FR 79188,
79202-03 (2016).
\12\ Respondent's records include duplicate certificates and
repeated courses, which the Agency does not credit. RD, at 19.
Several of Respondent's certificates are also unsigned, and they do
not claim any credits for the courses, which calls into question the
level of Respondent's participation in these classes. RD, at 19; RX
E-F. The courses direct the student to ``claim the credit
commensurate with the extent of their participation in the
activity.'' Id.
\13\ These courses related to physician prescribing and medical
recordkeeping. RD, at 19.
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Second, Respondent asserts that he has implemented a new EMR
software that does not allow for patient examination records to be
copied forward, but he did not supply any corroborating documentation
confirming that the EMR lacks that feature. RD, at 17; Tr. 130. Even if
it does, the implementation of a new EMR requires minimal effort and
does not address the Agency's underlying concerns that Respondent does
not fully appreciate his obligations under the CSA.
Third, as discussed in more detail supra, Respondent offered
extensive testimony pledging to follow California's most recent
Guidelines for Prescribing Controlled Substances for Pain. RD, at 20.
To the extent that this testimony may be considered remedial in nature,
the Agency agrees with the Chief ALJ that this testimony was not
compelling, and it is unclear why the Agency should trust Respondent to
comply with guidelines in the future that he declined to comply with
previously. Id.
Finally, Respondent has been under mandatory monitoring by an MBC-
appointed physician, Dr. Bitonte, since January 2021, and Respondent
testified that he is willing to retain Dr. Bitonte as a monitor even if
his probation with the MBC ends.\14\ However, neither Dr. Bitonte nor
Respondent demonstrated in their testimony that Dr. Bitonte's
monitoring has aided in remediating Respondent. Dr. Bitonte did not
oversee Respondent's prescribing of controlled substances because
Respondent did not possess a DEA registration while Dr. Bitonte
monitored him (RD, at 12; Tr. 46, 56, 62, 73; ALJ Ex. 28, at 6). Dr.
Bitonte also did not observe any of Respondent's encounters with his
patients, which precluded him from addressing one of the Agency's
primary concerns in Qian I, that Respondent's medical records did not
accurately reflect what occurred during the patient encounters. RD, at
8-9. Additionally, Dr. Bitonte testified that he has not prescribed
controlled substances since 2014 and is no longer comfortable doing so
because opiate prescribing has become a specialty. RD, at 7; Tr. 83-84.
This testimony suggests that Dr. Bitonte would not be the ideal
candidate for monitoring Respondent's reinstated prescribing of
controlled substances. Finally, Dr. Bitonte's opinions at the hearing
and in his regular practice monitoring reports (PMRs) were conclusory
and repetitive,\15\ which suggests that Dr. Bitonte's monitoring lacked
the level of involvement necessary to help Respondent reform his
recordkeeping practices, which are a vital component of the CSA's
efforts to prevent diversion of controlled substances.\16\ Thus, the
Agency agrees with the Chief ALJ that the potential remedial measures
identified by Respondent are not sufficient to establish that
Respondent can be trusted with a registration, especially in light of
[[Page 59938]]
his failure to unequivocally accept responsibility for his actions. RD,
at 19-21.
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\14\ Although Dr. Bitonte and Respondent testified that they are
willing to continue Dr. Bitonte's monitoring if the Agency orders
them to do so, the record indicates that Respondent is requesting
early termination of his probation with the MBC, which would
eliminate the monitoring requirement. RD, at 16; RX R, at 3; ALJX
15, app. at 173.
\15\ Dr. Bitonte's PMRs primarily consist of statements that
Respondent's records were ``complete and in order'' and
``excellent,'' and that Respondent's practice is ``markedly
different from the [practice] described in the [MBC Order]'' because
he is ``now almost exclusively providing pain management by
interventional procedures, consulta[tions] for outside physicians,
and electrodiagnostics for outside providers.'' RD, at 8-10; Tr. 73,
77-78; RX H at 7, 14, 18, 23, 27, 40, 47.
\16\ The Agency incorporates herein the entire summary of Dr.
Bitonte's testimony and the Chief ALJ's credibility findings with
respect to Dr. Bitonte. RD, at 7-12. The Agency agrees with the
Chief ALJ that there were inconsistencies and weaknesses that
detracted from Dr. Bitonte's credibility, including that Dr. Bitonte
initially testified that he had reviewed Qian I, and then later
conceded that he had not. Id. at 11-12; Tr. 46, 89-94, 99-101. The
Agency also agrees that there were portions of Dr. Bitonte's
testimony that can be afforded full credibility, such as details of
his monitoring assessment and his monitoring methodology. RD, at 12.
Ultimately, however, the Agency does not find that Dr. Bitonte's
testimony is entitled to significant weight in analyzing whether
Respondent can be entrusted with a registration because he did not
observe his patient encounters.
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In addition to acceptance of responsibility, the Agency considers
both specific and general deterrence when determining an appropriate
sanction. Daniel A. Glick, D.D.S., 80 FR 74800, 74810 (2015). In this
case, the Agency agrees with the Chief ALJ that Respondent's failure to
fully acknowledge his wrongdoing suggests that these revocation
proceedings have not sufficiently deterred him from future violations.
RD, at 25-26. Although Respondent demonstrated some level of interest
in complying with the applicable rules and regulations going forward,
which suggests that the likelihood of recidivism may be reduced, on
balance the considerations of specific deterrence do not support
Respondent's application in this case. Id. Further, the Agency agrees
with the Chief ALJ that the interests of general deterrence also
support revocation. Id. at 26. A decision to grant Respondent's
application now, despite Respondent's failure to fully accept
responsibility for his misconduct, would send a message to the
registrant community that lying to the Agency and prescribing
controlled substances without conducting and documenting even the most
basic examinations and mitigation measures can be overlooked or
excused. Id.
Moreover, the Agency agrees with the Chief ALJ that Respondent's
actions were egregious. Id. at 25. Respondent prescribed dangerous
combinations of benzodiazepines and high-dose opioids while failing to
conduct appropriate examinations, monitor for compliance, or maintain
accurate medical records, leading the Agency to conclude that he had
put his patients at risk of death. Id. Respondent also misled the
tribunal in his first hearing and failed to adequately acknowledge the
untruthful testimony in his second hearing. In this case, the Agency
believes that denial of Respondent's application would encourage the
general registrant community to exhibit candor when dealing with the
Agency, conduct and document appropriate medical examinations, and
monitor their patients carefully to ensure that the controlled
substances that they prescribe do not harm their patients or fall into
illegitimate channels where they can be abused or diverted.
In sum, Respondent has not offered any credible evidence on the
record to rebut the Government's case for denial of his application and
Respondent has not demonstrated that he can be entrusted with the
responsibility of registration. Id. at 26-27. Accordingly, the Agency
will order that Respondent's application be denied.
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
Certificate of Registration, Control Number W22061401C, submitted by
John Qian, M.D., as well as any other pending application of John Qian,
M.D., for additional registration in California. This Order is
effective August 23, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
July 16, 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. 2024-16185 Filed 7-23-24; 8:45 am]
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