[Federal Register Volume 90, Number 26 (Monday, February 10, 2025)]
[Notices]
[Pages 9243-9253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02421]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23-5]
David Bockoff, M.D.; Decision and Order
I. Introduction
On October 25, 2022, the United States Department of Justice
(Agency) issued an Order to Show Cause and Immediate Suspension of
Registration (collectively, OSC) to David Bockoff, M.D., (Respondent)
of Beverly Hills, California. OSC, at 1, 8. The OSC immediately
suspended, and proposes the revocation of, Respondent's Drug
Enforcement Administration (DEA) registration, No. BB4591839, ``because
. . . [Respondent's] continued registration constitutes `an imminent
danger to the public health or safety,' '' and ``because . . .
[Respondent's] continued registration is inconsistent with the public
interest, as that term is defined in 21 U.S.C. 823[(g)(1)].'' \1\ Id.
at 1 (citing 21 U.S.C. 824(d) and (a)(4)).
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\1\ Effective December 2, 2022, the Medical Marijuana and
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat.
2257 (2022) (Marijuana Research Amendments or MRA), amended the
Controlled Substances Act (CSA) and other statutes. Relevant to this
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as
21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current
designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA
throughout.
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Respondent timely requested a hearing. Request for Hearing
(November 4, 2022), at 1; Prehearing Ruling (November 30, 2022), at 1.
DEA Administrative Law Judge (ALJ) Teresa A. Wallbaum conducted a four-
day hearing at the DEA Hearing Facility, attended by Respondent and his
Counsel by video teleconference, on January 19, 20, 23, and 24, 2023.
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge (RD), at 2. On May 2, 2023, the ALJ
issued her RD recommending revocation of Respondent's registration.\2\
Id. at 43.
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\2\ Neither party filed exceptions to the RD.
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Having thoroughly analyzed the record and applicable law, the
Agency summarizes its findings and conclusions: (1) DEA (the
Government) presented a prima facie case, (2) Respondent attempted, but
failed, to rebut the Government's prima facie case, and (3) substantial
and uncontroverted record evidence, including the testimony of the
Government's expert witness, shows Respondent's violations of
applicable law go to the core of the Controlled Substances Act (CSA).
Accordingly, the Agency will revoke Respondent's registration. Infra
Order.
II. California Physicians' and Surgeons' Standard of Care
According to the CSA, ``[e]xcept as authorized by this subchapter,
it shall be unlawful for any person knowingly or intentionally . . . to
. . . distribute, . . . dispense, or possess with intent to . . .
distribute[ ] or dispense, a controlled substance.'' 21 U.S.C.
841(a)(1). The CSA's implementing regulations state that a lawful
controlled substance order or prescription is one that is ``issued for
a legitimate medical purpose by an individual practitioner acting in
the usual course of his professional practice.'' 21 CFR 1306.04(a).
The OSC is addressed to Respondent at his registered address in
California. Therefore, the Agency also evaluates Respondent's actions
according to California law, including the applicable California
standard of care.\3\ Authorities in the ``Legal Requirements'' and
``Standard of Care'' sections of the OSC give Respondent notice of the
bases for the OSC's allegations and, accordingly, are the authorities
that the Agency is using to adjudicate those allegations. OSC, at 2-3;
infra.
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\3\ See Gonzales v. Oregon, 546 U.S. 243, 269-71 (2006); see
also OSC, at 2-3. The versions of the California authorities cited
in this Decision/Order were in effect from at least January 2020
through June 2022, the time period alleged in the OSC. OSC, at 3-8.
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The first California authority listed in the OSC's ``Legal
Requirements'' section is California Health and Safety Code Sec.
11153(a). During the time period alleged in the OSC, that California
provision, similar to the CSA, required that 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.
11153(a) (West 2023-24); OSC, at 2.
[[Page 9244]]
The provision explicitly includes two examples of prescriptions that
are not legal. First, in salient part, ``an order purporting to be a
prescription which is issued not in the usual course of professional
treatment'' and, second, ``an order for an addict or habitual user of
controlled substances, which is issued not in the course of
professional treatment or as part of an authorized narcotic treatment
program, for the purpose of providing the user with controlled
substances, sufficient to keep him or her comfortable by maintaining
customary use.'' Cal. Health & Safety Code Sec. 11153(a). A violation
of this provision is punishable by imprisonment, fine, or both. Id.
Sec. 11153(b).
Further, California authorities cited in the OSC define
unprofessional conduct relevant to the OSC's allegations. OSC, at 2.
According to the California Business and Professions Code, it is
unprofessional conduct to prescribe a dangerous drug ``without an
appropriate prior examination and a medical indication.'' \4\ Cal. Bus.
& Prof. Code Sec. 2242(a) (West 2023-24); OSC, at 2; Tr. 261-63
(Government's expert witness, Dr. Munzing, testifying). The California
Business and Professions Code also states that ``[r]epeated acts of
clearly excessive prescribing . . . of drugs or treatment . . . is
unprofessional conduct for a physician.'' \5\ Cal. Bus. & Prof. Code
Sec. 725(a) (West 2023-24); OSC, at 2. The same California Code states
that unprofessional conduct includes a physician's ``failure . . . to
maintain adequate and accurate records relating to the provision of
services.'' Cal. Bus. & Prof. Code Sec. 2266 (West 2023-24); OSC, at
2.
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\4\ The California Code's definition of ``dangerous drug''
includes any drug whose dispensing without a prescription is
prohibited by federal law. Cal. Bus. & Prof. Code Sec. 4022 (West
2023-24).
Further, regarding ``unprofessional conduct,'' the California
Business and Professions Code references the provisions of Division
2, Chapter 5, and Article 12 for what constitutes ``unprofessional
conduct,'' and states that the Medical Board of California ``shall
take action against any licensee who is charged with unprofessional
conduct.'' Id. Sec. 2234 (West 2023-24), see also id. Sec.
2241.5(a) and (b) (West 2023-24), that Respondent successfully
offered into the record as RX 13 (``A physician . . . may prescribe
for . . . a person under his or her treatment for a medical
condition dangerous drugs or prescription controlled substances for
the treatment of pain or a condition causing pain including, but not
limited to, intractable pain. . . . No physician . . . shall be
subject to disciplinary action for prescribing . . . dangerous drugs
or prescription controlled substances in accordance with this
section.''); but see id. Sec. 2241.5(c) (explicitly excepting from
its disciplinary action prohibition violations of section 2234
(regarding gross negligence, repeated negligent acts, or
incompetence), Sec. 2241 (regarding treatment of an addict), and
Sec. 2242 (regarding performing an appropriate prior examination
and the existence of a medical indication for prescribing dangerous
drugs), among others).
Respondent also successfully offered California Health and
Safety Code Sec. 124961 (West 2023-24) (RX 12) (Pain Patient's Bill
of Rights). The Agency notes that the primary foci of this provision
are the rights of a ``pain patient,'' and that, regarding
practitioners like Respondent, its subsection (f) states that
``[n]othing in this section shall do either of the following: (1)
Limit any reporting or disciplinary provisions applicable to
licensed physicians . . . who violate prescribing practices or other
provisions set forth in the Medical Practices Act, Chapter 5
(commencing with Section 2000) of Division 2 of the Business and
Professions Code, or the regulations adopted thereunder)'' and ``(2)
Limit the applicability of any federal statute or federal regulation
or any of the other statutes or regulations of this state that
regulate dangerous drugs or controlled substances.''
\5\ Such clearly excessive prescribing is a misdemeanor
punishable by fine, imprisonment, or both. Cal. Bus. & Prof. Code
Sec. 725(b) (West 2023-24). The section also states that a
``practitioner who has a medical basis for prescribing, furnishing,
dispensing, or administering dangerous drugs or prescription
controlled substances shall not be subject to disciplinary action or
prosecution under this section,'' and ``[n]o physician and surgeon
shall be subject to disciplinary action pursuant to this section for
treating intractable pain in compliance with section 2241.5.'' Id.
Sec. Sec. 725(c) and (d).
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After researching and analyzing the California standard of care,
and reviewing the testimony of Dr. Munzing, the Agency credits Dr.
Munzing's standard of care testimony in this matter as an accurate
reflection of California law. Accordingly, the Agency agrees with the
RD's assessment of Dr. Munzing's testimony, and affords Dr. Munzing's
testimony full and controlling weight. See also RD, at 9-14; infra
section III.A.
III. Findings of Fact 6
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\6\ The Agency incorporates the parties' Stipulations and
accepts them as fact. RD, at 4, n.4; see also Prehearing Ruling, at
2-3. Among other things, the parties' stipulations state that
oxycodone, methadone, fentanyl, meperidine, morphine sulfate, and
oxymorphone are Schedule II controlled substances, that ketamine is
a Schedule III controlled substance, and that carisoprodol and
alprazolam are Schedule IV controlled substances. Prehearing Ruling,
at 2-3. The first and second stipulations address Respondent's DEA
registration and its status. Id. at 2.
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A. The Government's Case
The Government presented three witnesses--two Diversion
Investigators and its expert, Dr. Timothy Munzing. After Respondent
stated that he had no objection, the ALJ accepted Dr. Munzing ``as an
expert in the practice of medicine in California, including, but not
limited to, the applicable standards of care in California for the
prescribing of controlled substances within the usual course of the
professional practice of medicine, which is what he was proffered as an
expert in the government's prehearing statement and his witness
summary.'' \7\ Tr. 224. Having thoroughly analyzed the record and
applicable law, the Agency agrees with the RD that Dr. Munzing
``presented as a knowledgeable and reliable expert witness'' whose
testimony about the applicable standard of care and its application to
specific individuals and circumstances was ``detailed'' and
``consistent.'' RD, at 9; supra section II. The Agency agrees with the
RD's assessment that Dr. Munzing is a ``reliable and credible witness''
whose testimony deserves ``full and controlling weight'' and,
accordingly, also affords Dr. Munzing's testimony full and controlling
weight. RD, at 10; supra section II.
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\7\ The first DI (DI1) testified about the search of
Respondent's office for medical records and authenticated the
medical records that the Government gathered into Government
Exhibits (GX) for the hearing. Tr. 30-62. Respondent did not object
to the admission of any of those GX and the ALJ admitted all of
them. Id. at 38-62.
The Agency agrees with the RD that DI1's ``testimony was
sufficiently detailed, plausible, and internally consistent to be
afforded full credibility,'' and further agrees with the RD to give
DI1's testimony full weight. RD, at 5.
The second DI who testified, the lead of the two, (DI2)
addressed the investigative steps taken to follow up on the lead
that DEA's Los Angeles Field Division received about Respondent.
E.g. Tr. 72-78, 86-87, 95-97, 113-19, 130-32; see also RD, at 5. The
Agency agrees with the RD's assessment that Respondent's Counsel's
attempts to impeach DI2 were not successful. RD, at 6-7.
The Agency agrees with the RD that DI2 ``presented as an
objective, credible witness with no motive to fabricate,'' and that
she testified ``clear[ly], consistent[ly], and specific[ally].'' Id.
at 7. The Agency, therefore, gives DI2's testimony ``full weight.''
Id.
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B. Respondent's Case
Although his filed submissions and statements indicate an intention
to present an affirmative case, Respondent, in the end, chose not to
testify or to call any witness.\8\ Tr. 615 (Respondent's Counsel
stating that ``[t]here's an independent criminal investigation. And,
I'm assuming you figured that out, given this case. And so, we are
choosing not to'' put on a case). Respondent successfully accomplished
the admission of three documents, RX 8, RX 12, and RX 13. Supra section
II, infra section III.C.2.a. His counsel cross-examined all of the
Government's witnesses and presented an opening statement and a closing
argument.\9\ Tr.
[[Page 9245]]
17-26 (opening statement), Tr. 657-84 (closing argument). Although he
indicated that he would, Respondent did not submit a brief or other
written, final argument after the hearing.\10\ The Agency carefully
reviewed and analyzed Respondent's position in this adjudication,
evidenced through items such as his filings, his cross-examinations of
the Government's witnesses, the documents he successfully moved into
evidence, and his opening statement and closing argument at the
hearing. In sum, the Agency concludes that Respondent's arguments are
not based on admitted record evidence, are not persuasive, and/or do
not successfully rebut the record evidence sponsored by the Government
or the Government's prima facie case. Infra sections III.C.2. and IV.B.
Accordingly, and as discussed further throughout, the Agency does not
credit Respondent's arguments.
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\8\ Further, Respondent failed to comply with hearing deadlines
and processes, resulting in a ruling by the ALJ that disallowed his
ability to call an expert to testify on his behalf. Respondent did
not request interlocutory review of this ruling, and neither his
opening statement nor his closing argument mentions this ALJ ruling.
\9\ Respondent's closing argument, on January 24, 2023, involved
Counsel's use of ``slides.'' E.g., Tr. 658, 659. As he did not move
the slides into evidence, they are not available to the Agency for
this adjudication. It is noteworthy that, on January 20th, the
second day of the hearing, after a short break at about noon
(Eastern), the ALJ provided ``general notice to the parties'' that
``an administrative law judge is not required to comb through the
record in search for information. Given the size and complexity of
this record,'' the ALJ continued, she wants ``to just state that
upfront during the hearing so that you are aware that if you want .
. . [her] to consider things, please address them through your
witnesses otherwise there is no guarantee that it is going to be
considered because this is just, as you can see, it is a large
record. It is going to be a complex record.'' Id. at 306-07. The ALJ
did not ``want anybody to be surprised by that,'' she stated, as she
wanted ``to give both sides notice of that general principle that .
. . [she] will be adhering to in this case.'' Id. at 307.
\10\ Eleven individuals who claim Respondent is their doctor
sought to intervene in the administrative proceeding to dissolve the
order that immediately suspended Respondent's registration, among
other things. Emergency Motion--Request a Hearing to Move to
Intervene (November 22, 2022). The ALJ denied that stay request and
their request to participate in the hearing. Order Denying Patients'
Emergency Motion to Intervene (December 2, 2022); see also Order
Denying Patients' Request to Participate in Prehearing Conference
(November 28, 2022). At the beginning of the hearing, the ALJ stated
that the eleven ``sought a stay of these proceedings in the D.C.
Circuit Court'' and that ``[t]hat stay request was denied last
night.'' Tr. 10. As the ALJ does not have authority to alter the
immediate suspension of a registration, the ALJ correctly denied the
relief that the eleven requested.
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C. Allegation That Respondent Issued Prescriptions for Controlled
Substances Beneath the Applicable Standard of Care and Outside the
Usual Course of Professional Practice
Having read and analyzed the transmitted record, the Agency finds
substantial and uncontroverted record evidence that Respondent, between
January 2020 and June 2022, repeatedly issued controlled substance
prescriptions in California beneath the applicable standard of care and
outside the usual course of professional practice.\11\ See also RD, at
14-33. The record includes evidence of many such controlled substance
prescriptions documented in the thousands of pages of the voluminous,
transmitted record.\12\ Examples of Respondent's illegal prescribing
are set out below.
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\11\ During the prehearing phase, Respondent sought federal
court relief in the Central District of California from the
immediate suspension of his registration (ISO), including a
temporary restraining order (TRO). Bockoff v. Garland, et al., No.
2:22-cv-09046 (December 15, 2022). The Federal Court denied
Respondent's request for a TRO stating, among other things, that
Respondent ``concedes that there were issues with his recordkeeping
but argues that he did in fact conduct appropriate medical
evaluation [sic], testing, and monitoring to justify the high
dosages of controlled substances that he prescribed.'' Order Denying
Plaintiff's Application for a Temporary Restraining Order, at 3.
\12\ To maintain the focus on relevant evidence, the Agency is
not considering the references in Respondent's closing argument that
pertain to a period before or after the period alleged in the OSC.
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1. Examples of Respondent's Unlawful Controlled Substance Prescribing
From January 2020 Through June 2022
The Agency finds substantial, uncontroverted record evidence of
multiple controlled substance prescriptions that Respondent issued for
multiple individuals from January 2020 through June 2022 beneath the
applicable standard of care and outside the usual course of
professional practice.
a. Examples of Unlawful Prescribing to Individual 1
The Agency finds substantial, uncontroverted record evidence that
on January 24, 2020, Respondent issued two oxycodone (Schedule II)
prescriptions to Individual 1: (1) oxycodone HCl ER 80 mg, #240
(thirty-day supply), with the instructions to ``take one tablet by
mouth every three to four hours for severe pain''; and (2) oxycodone
HCl 30 mg, #240 (thirty-day supply), with instructions to ``take one
tablet by mouth every three to four hours as needed for severe
breakthrough pain.'' GX 2c, at 3-4. These prescriptions were issued
without a single substantive medical data point, note, or comment in
Individual 1's medical record associated with the date of this office
visit. GX 2a, at 137.\13\ The office visit records state only that
Individual 1 will ``. . . bring old records `again' that `office lost.'
'' Id.
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\13\ The record evidence indicates that each page of
Respondent's medical record form should have been used for two
patient interactions; however, regarding Individual 1, Respondent
used one page of the medical record form to inadequately record nine
interactions with Individual 1 from May 13, 2019 to January 24,
2020. Id.
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Dr. Munzing testified that Respondent's January 24, 2020 controlled
substance prescribing for Individual 1 was beneath the applicable
standard of care. Tr. 296-305, 306-12. Regarding the January 24, 2020
progress notes for Individual 1, Dr. Munzing testified that, ``there's
no information. . . . [I]t says it's an office visit but there's no
history, there's no vital signs, there's no exam. . . . [T]here's no
listing of diagnoses and no listing of medication. . . . There's
nothing else. . . . It is missing more details in regards to the
updated condition. It is lacking anything regarding are there any
adverse or side effects. It has a minimal examination, but very
minimal. There is no assessment listed. There is no management plan
listed. . . . It also does not list even what the medications the
patients were taking at any of these specific dates and visits.'' Tr.
299-310. Based on this substantial, uncontroverted record evidence,
including the expert testimony of Dr. Munzing, the Agency finds that
Respondent issued these two Schedule II controlled substance
prescriptions to Individual 1 beneath the applicable standard of care
and outside the usual course of professional practice.\14\
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\14\ Dr. Munzing testified about the standard of care for a
legacy patient, i.e., someone who was previously treated by someone
different, such as Individual 1, and concluded that Respondent
prescribed controlled substances to Individual 1 beneath that
standard of care. Tr. 272, 355-58 (Dr. Munzing testifying that
Respondent was still required to take a detailed history, confirm
the treatment was actually happening, independently evaluate the
treatment's appropriateness, determine that the medications were
truly prescribed, perform a urine drug test to confirm what
medications were actually being taken, and independently determine
how to treat the person); see also Tr. 339-45 (Dr. Munzing
testifying about the lack of an appropriate informed consent by
Individual 1 anywhere in Respondent's medical records for the
controlled substances that Respondent was issuing Individual 1); see
also id. at 325-33 (Dr. Munzing testifying about the insufficiency
of Respondent's examinations of Individual 1 prior to the period
covered in the OSC).
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Dr. Munzing went on to testify about the standard of care for a
follow-up visit and concluded that Respondent prescribed subsequent
controlled substances beneath that standard of care as well. Tr. 264-
65. Dr. Munzing testified that during follow-up visits, physicians
``use something called the five A's as a mnemonic. You know,
analgesics: so, how's your pain doing? Activity, functional level. How
are you functioning with, with the treatment, not just the medication
treatment but the treatment that we have you doing. Are you having any
adverse or side effects from the medications? How is the affect of the
patient, you know, standing, sitting before you? Do they look high, or
do they look like they're falling asleep, or are they actively engaged
appropriately in the conversation? And any potential aberrant
behaviors, whether it be either
[[Page 9246]]
the patient saying, well, I got this medicine from someone else, or
aberrant behaviors identified by whether it be the CURES reports or
urine drug tests, et cetera.'' Tr. 480-83.\15\
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\15\ The Agency further finds that the record also includes
substantial, uncontroverted evidence of Respondent's controlled
substance-related negative experience. For example, substantial,
uncontroverted record evidence shows that Respondent ordered urine
drug screens (UDS) for Individual 1 in March of 2020 and in March of
2021, yet failed to document how, if at all, he addressed the
screens' aberrant results. GX 2a, at 59-60; Tr. 345-46. Given the
seriousness, going to the core of the CSA, of the examples set out
in this section, any one of which, alone, is sufficient to support
the revocation of Respondent's registration, there is no need for
the Agency to detail any other examples of Respondent's negative
controlled substance-related experience.
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On February 24, 2020, Respondent re-issued to Individual 1 the same
two oxycodone prescriptions from January 24, 2020. GX 2b, at 59. Again,
Dr. Munzing testified that he did not ``see any assessment at all,''
that ``[t]here is no plan . . . as best that . . . [he] can see,'' that
the minimal-to-no documentation means that there is no medication list,
no impression documented, and no drug-testing/monitoring addressed
until after June 22, 2020. Tr. 316; see also Tr. 313-24. Accordingly,
the Agency finds substantial, uncontroverted record evidence that
Respondent's issuance of the two oxycodone prescriptions on February
24, 2020,\16\ was also beneath the applicable standard of care. Tr.
313-24. Notably, this illegal controlled substance prescribing by
Respondent gave Individual 1 access to 480 Schedule II tablets in a
thirty-day period. Supra.
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\16\ In addition, Respondent re-issued the same two Schedule II
controlled substance prescriptions (oxycodone) to Individual 1
monthly thereafter, at least through September 18, 2020. GX 2c, at
5-40.
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b. Examples of Unlawful Prescribing to Individual 2
The Agency finds substantial, uncontroverted record evidence of
illegal controlled substance prescribing regarding Individual 2. The
Agency finds that there is substantial, uncontroverted record evidence
that on March 18, 2020, Respondent added a new Schedule II controlled
substance prescription, methadone HCl 5 mg, #70 (thirty-day supply), to
two other controlled substance prescriptions that he had already
prescribed to Individual 2 six days before on March 12, 2020, namely,
morphine sulfate ER 100 mg, #90 (thirty-day supply) and oxycodone HCl
30 mg, #120 (thirty-day supply). GX 3c, at 7, 9, 10. Dr. Munzing
testified that the medical record form that Respondent created for the
associated encounter with Individual 2 contained information for
encounters on January 16, 2020, March 12, 2020, May 7, 2020, June 29,
2020, August 28, 2020, and October 22, 2020. Tr. 374-80; see also GX
3b, at 63. However, Respondent's medical records do not include any
entry for March 18, 2020, the date the methadone 5 mg prescription was
issued. Tr. 374-76.
Regarding Respondent's addition of methadone 5 mg to the controlled
substance prescriptions that he was issuing Individual 2, Dr. Munzing
testified that Respondent's medical records for Individual 2, ``just
under'' the March 12, 2020 date say ``not getting much help from
clonidine.'' \17\ Tr. 374; see also Tr. 375.\18\ Dr. Munzing testified,
``[c]lonidine is not a pain medication[, so] it [does not] explain why
methadone is started.'' Tr. 376. Dr. Munzing's testimony lists multiple
other items missing from Respondent's medical record for Individual 2
associated with the addition of methadone 5 mg, including: an
appropriate history, vital signs, a physical examination, an
assessment, a specific plan, and documentation of Respondent's
discussion with Individual 2 about the increased risk to Individual 2
of increasing the morphine milligram equivalent by adding methadone 5
mg.\19\ Tr. 376-77.
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\17\ Dr. Munzing testified that he cannot read Respondent's
handwriting in red ink next to ``OV: 3-12-20'' and directly after ``
`allergic' to'' something. Tr. 375. The word that Dr. Munzing could
not make out appears to possibly be ``buprenorphine.''
\18\ Dr. Munzing also testified that Respondent appears to have
indicated in Individual 2's medical record that Respondent
prescribed 20 mg of methadone per day when, in fact, according to
CURES he was prescribing 30 mg per day. Tr. 379. Further, Dr.
Munzing also testified that, on Respondent's medical record entry
for Individual 2's office visit on May 7, 2020, the month after
Respondent increased Individual 2's methadone dosage from 5 mg to 10
mg, ``there's no[t] even mention of methadone or any of the
controlled substances listed there.'' Id.; GX 3c, at 17
(Respondent's increased dosage of methadone for Individual 2 issued
on April 10, 2020, methadone HCl 10 mg, #90 (thirty-day supply)).
\19\ The Agency does not credit Respondent's closing argument
defense that he obtained a signed consent form from Individual 2 to
prescribe methadone. Even if Respondent had a signed consent form,
it does not excuse Respondent's failure to comply with the
applicable standard of care that requires Respondent to note in the
medical record why he decided to prescribe a controlled substance.
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The further substantial, undisputed record evidence is that on
April 10, 2020, Respondent increased the dosage of the methadone HCl he
had prescribed for Individual 2 from 5 mg to 10 mg, with instructions
that increased Individual 2's daily methadone dose to 30 mg. GX 3c, at
17; Tr. 379. The Agency notes that Respondent's medical records for
Individual 2 during this time period do not show an entry for any day
in April 2020, let alone an entry for April 10, 2020, specifically. GX
3b, at 63; GX 3c, at 23 (CURES Consolidated Report showing that the
methadone 10 mg prescription for Individual 2 was filled on April 14,
2020).
The Agency credits Dr. Munzing's testimony and finds substantial,
uncontroverted record evidence that Respondent issued the March 18,
2020 and April 14, 2020 methadone prescriptions to Individual 2 beneath
the applicable standard of care and outside the usual course of
professional practice. Tr. 376-80. Moreover, Respondent's illegal
morphine sulphate, oxycodone, and methadone controlled substance
prescribing to Individual 2 gave Individual 2 access to 280 Schedule II
controlled substance tablets in a thirty-day period. Supra.
c. Examples of Unlawful Prescribing to Individual 3
The Agency finds substantial, uncontroverted record evidence of
illegal controlled substance prescribing regarding Individual 3.
Substantial record evidence shows that on March 13, 2020, Respondent
prescribed methadone HCl 5 mg, #70 (thirty-day supply) to Individual 3.
GX 4d, at 30, 42. Dr. Munzing credibly testified that there is nothing
on the January 13, 2020 through April 9, 2020 page of Respondent's
medical record notes for Individual 3 documenting why Respondent issued
the methadone HCl 5 mg prescription to Individual 3 on March 13, 2020.
Tr. 420-23. The Agency, therefore, finds substantial, uncontroverted
record evidence that Respondent's medical records for Individual 3,
dated January 13, 2020, and March 13, 2020, do not include, as the
applicable standard of care requires, Respondent's medical analyses,
impressions, justifications, or rationales for prescribing methadone to
Individual 3 on March 13, 2020.\20\ Tr. 420-23; see also GX 4b, at 675;
RD, at 20-21.
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\20\ Dr. Munzing, when asked if he would agree that ``the huge
majority of patients that . . . [Respondent] was treating, in fact,
he was treating them for intractable pain,'' testified that he
thinks Respondent ``thought he was treating them for intractable
pain,'' but that the ``documentation doesn't really support that.''
Tr. 550-51. In explaining, Dr. Munzing used Individual 3 as an
example. His testimony counterposes Respondent's evaluation and
management of Individual 3 against those of Individual 3's
gastroenterologist who, in 2018, had not seen Individual 3 ``for
quite some time, ordered some tests, ordered some imaging studies
that we have no idea what those studies, the results of those
studies. We haven't seen those in the medical records. . . . The
gastroenterologist who had seen . . . [Individual 3] many years
before said . . . I really haven't seen you for quite some time and
you haven't had any recent workup. So, I don't believe the
gastroenterologist was assuming that . . . [Individual 3] had
intractable pain. He felt that we need to find out what's going
on.'' Tr. 550, 552.
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[[Page 9247]]
Similarly, the Agency finds substantial, uncontroverted record
evidence that the following month, on April 9, 2020, Respondent
increased the dosage of the methadone HCl prescribed to Individual 3 to
10 mg and the frequency from once a day to three times a day. GX 4d, at
51, 54; GX 4b, at 674. Again, Dr. Munzing testified that Respondent
issued the April 9, 2020 prescription to Individual 3 without any
explanation for the increased dosage in Respondent's corresponding
medical record notes. Tr. 423-27. The Agency, therefore, finds that
based on the substantial, uncontroverted record evidence, Respondent's
April 9, 2020 medical record note does not include, as the applicable
standard of care requires, Respondent's medical analyses, impressions,
justifications, or rationales for increasing the methadone dosage for
Individual 3 on that date. Tr. 423-27; see also RD, at 21.
Accordingly, based on the documentary record evidence and crediting
the record testimony of Dr. Munzing, the Agency finds substantial,
uncontroverted record evidence that in March and April of 2020,
Respondent prescribed methadone for Individual 3 beneath the applicable
standard of care and outside the usual course of professional practice.
Tr. 422-27. Further, Respondent's illegal controlled substance
prescribing to Individual 3 gave Individual 3 access to 70 Schedule II
tablets for a thirty-day period.
d. Examples of Unlawful Prescribing to Individual 4
The Agency finds substantial, uncontroverted record evidence of
illegal controlled substance prescribing regarding Individual 4.
Substantial record evidence shows that on January 17, 2020, Respondent
issued three controlled substance prescriptions to Individual 4: (1)
alprazolam 2 mg, a benzodiazepine, #60 (thirty-day supply); (2)
oxycodone 30 mg, #60 (fifteen-day supply); and (3) methadone 10 mg, #90
(fifteen-day supply). GX 6e, at 3-5; Tr. 489-90. The Agency finds that
Respondent's medical record for Individual 4 associated with these
three controlled substance prescriptions is dated January 10, 2020. Tr.
490-91; GX 6c, at 63. The Agency further finds substantial,
uncontroverted record evidence that Respondent's medical record notes
associated with the issuance of these three controlled substance
prescriptions ``lack[s] . . . a lot of information that would be
expected and would be required.'' Tr. 490-91 (Dr. Munzing testifying);
see also RD, at 24-25. Accordingly, the Agency finds that, based on the
documentary record evidence and the record testimony of Dr. Munzing,
the substantial, uncontroverted record evidence shows that Respondent
issued these three controlled substance prescriptions to Individual 4
beneath the applicable standard of care and outside the usual course of
professional practice. Tr. 490-91. Further, Respondent's illegal
controlled substance prescribing to Individual 4 gave Individual 4
access to 390 controlled substance tablets for a thirty-day period, of
which 300 tablets were Schedule II and 90 tablets were Schedule IV.
e. Examples of Unlawful Prescribing to Individual 5
The Agency finds substantial, uncontroverted record evidence of
illegal controlled substance prescribing regarding Individual 5.
Substantial, uncontroverted record evidence shows that on January 7,
2020, Respondent issued four controlled substance prescriptions to
Individual 5: (1) oxymorphone HCl ER 20 mg, #240 (thirty-day supply);
(2) oxymorphone HCl 10 mg, #180 (thirty-day supply); (3) carisoprodol
350 mg, #90 (thirty-day supply); and 4) buprenorphine HCl 8 mg, #60
(thirty-day supply). GX 5c, at 1-8; Tr. 473-75. The Agency finds that
the office visit associated with Respondent's issuance of these four
controlled substance prescriptions was on January 7, 2020. GX 5b, at
82; Tr. 475-76. Although Respondent recorded that Individual 5 visited
his office on January 7, 2020, he wrote nothing after the date of the
office visit in Individual 5's medical records. GX 5b, at 82; RD, at
26. Dr. Munzing testified that Respondent's controlled substance
prescribing to Individual 5 on January 7, 2020, was beneath the
applicable standard of care because Respondent failed to document
Individual 5's medical history, vital signs, and medications; an
appropriate physical examination of Individual 5; an updated assessment
of Individual 5; and a treatment plan for Individual 5. Tr. 476.
The Agency, therefore, finds that based on the substantial,
uncontroverted record evidence and the testimony of Dr. Munzing,
Respondent issued the four controlled substance prescriptions on
January 7, 2020, beneath the applicable standard of care and outside
the usual course of professional practice. Tr. 476; see also RD, at 26.
Further, Respondent's illegal controlled substance prescribing for
Individual 5 gave Individual 5 access to 570 controlled substance
tablets for a thirty-day period, of which 420 tablets were Schedule II,
60 tablets were Schedule III, and 90 tablets were Schedule IV.
In sum, the Agency finds substantial, uncontroverted record
evidence of multiple controlled substance prescriptions that Respondent
issued for multiple individuals from January 2020 through June 2022
beneath the applicable standard of care and outside the usual course of
professional practice.
2. Respondent's Arguments Against the Government's Evidence
Respondent sought to impugn the Government's evidence, including
Dr. Munzing's credibility and testimony, in multiple ways.\21\
Regarding Dr. Munzing's testimony about Respondent's medical records of
his controlled substance prescribing, Respondent argues that Dr.
Munzing is not in a position to formulate an expert opinion on the
matter because he was not present during Respondent's interactions with
any of the five individuals discussed in the OSC. Tr. 310-11
(Respondent arguing that ``Dr. Munzing continues to conflate what is in
the records and what happened at the actual exam. He acts as though,
and testifies as such, that he knows what happened at this examination
and that just simply is not true unless he has interviewed someone or
is looking at other notes. He is perfectly capable, and it is proper
for him to talk about the sufficiency of the medical records. And there
is no indication in the records that these things occur. But that is
not what he is saying. He is saying that these things never happened.
And I do not believe there is a basis for that in the record nor do I
believe he has a basis to make such a statement.''), id. at 319-20
(Respondent arguing that Dr. Munzing ``continues to act as though the
fact that something doesn't appear in the record means it didn't happen
when in fact the evidence is to the contrary.''), id. at 344
(Respondent arguing that Dr. Munzing ``clearly specifically is
conflating the standard of care for informed consent with the standard
of care for documentation''). The Agency does not
[[Page 9248]]
credit this category of Respondent's objections.
---------------------------------------------------------------------------
\21\ The Agency carefully evaluated each of Respondent's
objections based on the parameters of the OSC's allegations--between
January 2020 through June 2022. E.g., Tr. 326, 332, 358. None of the
findings in this Decision are based on evidence dated outside of the
OSC's January 2020 through June 2022 parameter. Evidence dated
outside of the parameter is only considered for context, as
appropriate given the OSC's allegations. Supra section III.C.1.
---------------------------------------------------------------------------
Section 2266 of the California Business and Professions Code is
clear: it is unprofessional conduct for a physician to fail ``to
maintain adequate and accurate records relating to the provision of
services.'' Supra section II. The ALJ handled Respondent's arguments
correctly. Tr. 311 (ALJ stating that ``there is agency case law that
says if it is not in a document, then it did not happen''); RD, at 4,
n.5 (citing prior Agency decisions, stating that they ``make clear''
that a controlled substance prescription is issued beneath the
applicable standard of care and outside the usual course of
professional practice when a registrant fails to create adequate
documentation of his controlled substance prescribing, including of all
of the steps that led to his issuing each controlled substance
prescription), see also RD, at 38 (citing prior Agency decisions); Tr.
360-61 (ALJ ruling that Dr. Munzing ``is reviewing documentation. He
can make conclusions based on that documentation regarding the standard
of care and I just didn't want to leave anybody with a misunderstanding
of how I was approaching it. I'm not viewing it as just a recordkeeping
violation and I will allow respondent to address on cross examination
his point that Dr. Munzing is relying on documentation and was
obviously not present during the examinations.'').
Respondent further argues that he is allowed to write ``follow-up
prescriptions'' without ``these intense examinations'' that Dr. Munzing
``has previously described.'' Id. at 324-25. The Agency thoroughly
reviewed California's standard of care and finds no support in it for
Respondent's argument. Supra sections II and III.C.1.a.
Regarding the Government's allegation that Respondent's monitoring
through UDS was beneath the applicable standard of care and outside the
usual course of professional practice, Respondent argues that the
``Government's theory has now shifted from the OSC. Now they say that .
. . [Respondent] did not adequately address aberrant results.'' Tr.
679. Based on the multiple references to UDS and UDS-related
allegations in the OSC, the Agency does not credit Respondent's
argument that the Government's theory about UDS ``shifted from the
OSC.'' \22\
---------------------------------------------------------------------------
\22\ The Agency notes that the OSC includes multiple references
to, and allegations about, UDS and Respondent's use or lack of use
of UDS. Regarding Individual 2 and Individual 1, the OSC states that
Respondent ``failed to order regular urine drug screening, and
failed to properly address the results.'' OSC, at 4, 7. Regarding
Individual 3, Individual 4, and Individual 5, the OSC states that
Respondent ``failed to order regular urine drug screening.'' Id. at
5, 6, 7. The OSC also states that the CDC Guidelines for the
Prescription of Opioids for Chronic Pain ``direct clinicians to
address aberrant urine drug screen results with the patients.'' Id.
at 3.
---------------------------------------------------------------------------
Respondent's argument about the OSC's UDS allegations then states
that ``the logical inference from looking at the patient files is that
. . . [Respondent] addressed the issue with his patients to his
satisfaction, sufficient to make him comfortable to continue
prescribing. The notion that he ignored aberrant results is absurd. Why
would . . . [Respondent] be doing regular urine drug screening to just
ignore the results. It does not make any sense.'' \23\ Id. at 679. The
Agency has not credited this argument in the past, and it does not
credit Respondent's iteration of it now. E.g., Benton D. Wynn, M.D., 87
FR 24,228, 24,234-35 (2022); Craig S. Rosenblum, M.D., 87 FR 21,181,
21,203 (2022); John X. Qian, M.D., 87 FR 8039, 8051-52 (2022).
---------------------------------------------------------------------------
\23\ This Decision and Order do not reach the OSC's allegations
about Respondent's use or non-use of UDS. Infra n.35.
Respondent employs a similar argument concerning whether
Respondent had ongoing management plans as required by the
California standard of care. Concerning Dr. Munzing's testimony that
he does not see Respondent's management plan for Individual 1,
Respondent argues that Dr. Munzing ``is complaining [sic] what the
plan should be and whether or not the plan is documented. He is
acting and testifying as though the fact that information does not
appear in the medical records means that this didn't happen. . . . I
would say exactly the opposite. The fact that . . . [Respondent] put
the word plan in here indicates he has a plan, and he has talked
about it with his patient on this day. Whether or not this is a
documentation issue is a separate argument that we can make at a
later date and time. But he continues to act as though the fact that
something doesn't appear in the record means it didn't happen when
in fact the evidence is to the contrary.'' Tr. 319-20. The Agency
rejects this and similar arguments by Respondent as non sequiturs.
---------------------------------------------------------------------------
Regarding Respondent's continued controlled substance prescribing
as his medical records improved, Dr. Munzing acknowledges that the
``medical records improved a lot.'' Tr. 537. When Respondent's Counsel
retorted that Respondent ``did nothing wrong'' after his medical
records improved and ``had come into compliance,'' Dr. Munzing answered
that ``[i]f the prescribing continued as it was, . . . I still don't
agree that the prescribing was . . . okay.'' Id. at 537-38.
Respondent's argument that improved medical records also mean that the
underlying controlled substance prescribings then become legitimate is
a non sequitur. The Agency does not credit Respondent's argument that
his improved medical records mean that his controlled substance
prescribing then fell within the applicable standard of care and the
usual course of professional practice.
The Agency addresses Respondent's other arguments below, starting
with the arguments based on Respondent's three exhibits, and then
categorizing Respondent's remaining arguments into those concerning Dr.
Munzing and those concerning DEA's investigation. In sum, the Agency
does not credit any of Respondent's arguments. See also, e.g., RD, at
4, 7-10, 26, 38-40.
a. Respondent's Arguments Based on His Three Exhibits
As already discussed, Respondent successfully offered three
documents into evidence. First, RX 8 is titled ``How to Prescribe
Controlled Substances to Patients During the COVID-19 Public Health
Emergency'' (Pandemic Prescribing).\24\ This one-page document states
that DEA ``adopted policies to allow DEA-registered practitioners to
prescribe controlled substances without having to interact in-person
with their patients.'' RX 8, at 1. It is a ``guidance document'' that
is ``not binding and lack[s] the force and effect of law, unless
expressly authorized by statute or expressly incorporated into a
contract, grant, or cooperative agreement.'' Id. Pandemic Prescribing
states that its ``policies are effective beginning March 31, 2020, and
will remain in effect for the duration of the public health emergency,
unless DEA specifies an earlier date.'' Id. Pandemic Prescribing states
that, ``[u]nder federal law, all controlled substance prescriptions
must be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his/her professional
practice. 21 CFR 1306.04(a).'' Id. It continues that, ``[i]n all
circumstances when prescribing a controlled substance, including those
summarized below, the practitioner must use his/her sound judgment to
determine that s/he has sufficient information to conclude that the
issuance of the prescription is for a bona fide medical purpose.'' Id.
Its prefatory content concludes by stating that ``[p]ractitioners must
also comply with applicable state law.'' Id. Finally, Pandemic
Prescribing cites to the DEA Diversion internet address and ``relevant
law and regulations'' for ``[f]ull details.'' Id.
---------------------------------------------------------------------------
\24\ Respondent's Counsel references an expert, Dr. H., but Dr.
H. did not testify, nor did Respondent seek the admission of any
written opinion by Dr. H. See, e.g. Tr. 594.
---------------------------------------------------------------------------
According to RX 8, how a practitioner evaluates a patient, from
March 31, 2020 through the duration of the public health emergency,
depends on whether
[[Page 9249]]
the practitioner previously examined the patient in person. Id. If so,
then the ``[p]ractitioner may conduct any needed follow-up evaluation
by any method in person, telemedicine, telephone, email, etc.'' Id. If
not, then a Practitioner who is prescribing ``buprenorphine for
maintenance or detoxification treatment of an opioid use disorder . . .
[e]valuate[s the] patient . . . in person, or via telemedicine using a
real-time, two-way, audio-visual communications device.'' Id. If the
practitioner has not previously examined the patient in person and is
not prescribing buprenorphine for maintenance or detoxification
treatment of an opioid use disorder, then the practitioner
``[e]valuates [the] patient . . . in person or via telemedicine using a
real-time, two-way, audio-visual communications device.'' Id. In short,
the DEA document about prescribing controlled substances during the
COVID-19 public health emergency does not dispense with the legal
standards of the required evaluation; it expands the options available
to practitioners for conducting the required evaluation. Id.
The Agency finds substantial record evidence that Dr. Munzing's
testimony accurately describes the content of Pandemic Prescribing.
See, e.g., Tr. 610-11. The Agency further finds substantial record
evidence that Dr. Munzing's testimony accurately identifies which of
Respondent's medical records concern in-person visits and which of
Respondent's medical records describe telehealth interactions. See,
e.g., id. at 609 (Dr. Munzing's testimony explaining that Respondent's
medical records identify whether the note concerns an in-person visit
or a telehealth interaction, and how they do so). Respondent,
nevertheless, during his closing argument criticizing Dr. Munzing,
argues that he ``talked a lot about in[-]person examinations and the
need for the practitioner to lay hands on a patient if you're seeing
them in person. But he ignored the DEA's own guidelines for the COVID
pandemic that said in person visits were not required during the
pandemic.'' Tr. 680. The Agency carefully considered this argument of
Respondent and concludes that it is not a valid criticism of Dr.
Munzing. On the one hand, Respondent's argument, cited in full above,
accurately states that Dr. Munzing testified about the patient
examination required by the applicable standard of care. This is to Dr.
Munzing's credit.
On the other hand, Respondent's argument asserts, without support
or citation to the record, that Dr. Munzing ``ignored'' Pandemic
Prescribing. As already discussed, the record evidence shows the
opposite and, therefore, the Agency does not credit this Respondent
criticism of Dr. Munzing. Further, the Decision's findings that the
Government established a prima facie case and that Respondent did not
successfully rebut it are based solely on Respondent's in-person
interactions. The Agency concludes that those in-person interactions
and associated controlled substance prescribings do not comply with the
applicable standard of care. Supra sections II and III, infra sections
IV and V.
The second item that Respondent successfully moved into evidence is
RX 12, a copy of section 124961 of the California Health and Safety
Code. According to this provision, titled the ``Pain Patient's Bill of
Rights,'' a ``patient who suffers from severe chronic intractable pain
has the option to request or reject the use of any or all modalities in
order to relieve his or her pain,'' and ``has the option to choose
opiate medications to relieve that pain without first having to submit
to an invasive medical procedure,'' among other things. Cal. Health &
Safety Code Sec. 124961(a) and (b). The provision also includes
clauses addressing practitioners, such as ones explicitly stating that
a ``patient's physician may refuse to prescribe opiate medication,''
and that a ``physician who uses opiate therapy to relieve severe
chronic intractable pain may prescribe a dosage deemed medically
necessary to relieve the patient's pain, as long as that prescribing is
in conformance with Section 2241.5 of the Business and Professions
Code.'' Id. Sec. 124961 (c) and (d).
Indeed, Respondent successfully moved into evidence, as RX 13,
section 2241.5 of the California Business and Professions Code, a
provision mentioned in section 124961 multiple times. Infra. Section
124961 references section 2241.5 when it states that, ``[n]othing in
this section shall be construed to alter any of the provisions set
forth in Section 2241.5 of the Business and Professions Code.'' Id.
Sec. 124961 (preface). Section 124961 further states, explicitly, that
it shall not ``[l]imit any reporting or disciplinary provisions
applicable to licensed physicians and surgeons who violate prescribing
practices or other provisions set forth in the Medical Practice Act,''
and that it shall not ``[l]imit the applicability of any federal
statute or federal regulation or any of the other statutes or
regulations of this state that regulate dangerous drugs or controlled
substances.'' Id. Sec. 124961 (preface) and (f)(2).
The Agency finds that the provisions of section 124961, while
called the ``Pain Patient's Bill of Rights,'' do not alter the standard
of care applicable to physicians treating those ``Pain Patients.'' For
example, the provisions afford a patient ``who suffers from severe
chronic intractable pain . . . the option to request or reject the use
of any or all modalities in order to relieve his or her pain.'' Id.
Sec. 124961(a). At the same time, though, the section explicitly
states that practitioners may refuse to prescribe opioids, and that
practitioners who do prescribe opioids must continue to comply with all
associated state and federal legal requirements when doing so. Id.
Sec. 124961(c) and (f)(2). In other words, the Agency finds that the
provision does not alter a practitioner's responsibility to comply with
the applicable standard of care.
In addition, the provisions of RX 13, section 2241.5, include
permission for a ``physician and surgeon . . . [to] prescribe for . . .
a person under his or her treatment for a medical condition dangerous
drugs or prescription controlled substances for the treatment of pain
or a condition causing pain . . . including, but not limited to,
intractable pain.'' Cal. Bus. & Prof. Code Sec. 2241.5(a). It also
includes protections from disciplinary action for a physician who
prescribes dangerous drugs or controlled substances ``in accordance
with this section,'' and caveats that the section does not impact
medical board action against a physician who, among other things,
engages in unprofessional conduct including gross negligence, repeated
negligent acts, or incompetence, violates the requirement to perform an
appropriate prior examination before prescribing a dangerous drug,
prescribes in violation of California law, or fails to comply with all
state controlled substance recordkeeping requirements. Id. Sec.
2241.5(b) and (c).
Regarding RX 12 and RX 13, Respondent, during his cross-examination
of Dr. Munzing and his closing oral argument, primarily focuses on the
prohibition of disciplinary action ``for prescribing or administering a
controlled substance in the course of treatment of a person for
intractable pain'' and how the ``clear'' California ``public policy in
favor of making sure patients have access to adequate treatment for
their pain . . . would be severely undermin[ed]'' if Respondent's
registration were revoked. E.g., Tr. 554, 683. Respondent places much
less, if any, emphasis on the fact that neither of these California
statutes, or Pandemic Prescribing, authorizes a registrant to violate
the applicable standard of care
[[Page 9250]]
when prescribing a controlled substance. Supra. This fact is of the
utmost importance for the appropriate adjudication of the OSC and leads
to the inescapable conclusion that neither RX 8, RX 12, nor RX 13
justifies or excuses Respondent's violations of the applicable standard
of care while prescribing controlled substances.
b. Respondent's Additional Arguments Concerning Dr. Munzing
Respondent levels multiple, additional criticisms against Dr.
Munzing.\25\ After carefully considering each of them, the Agency
credits none of them. See also RD, at 7-8.
---------------------------------------------------------------------------
\25\ The record shows that the ALJ clearly, explicitly, and
repeatedly afforded Respondent the opportunity to ask the
Government's witnesses questions during cross-examination. E.g. Tr.
342, 482.
---------------------------------------------------------------------------
Respondent argues that Dr. Munzing does not have the expertise, as
a career employee of Kaiser who is not board certified in pain, to
testify about Respondent's controlled substance prescribing for
individuals with intractable pain. E.g., Tr. 546-47. When given the
opportunity during the hearing to address the Government's proffering
of Dr. Munzing as an expert, however, Respondent twice stated that he
had no objection to the acceptance of Dr. Munzing as an expert. Id. at
205, 224. Upon Respondent's final ``no objection'' response to the ALJ
regarding qualifying Dr. Munzing as an expert, the ALJ accepted Dr.
Munzing as an expert ``in the practice of medicine in California,
including, but not limited to, the applicable standards of care in
California for the prescribing of controlled substances within the
usual course of the professional practice of medicine, which is what he
was proffered as an expert in the [G]overnment's prehearing statement
and his witness summary [emphasis added].'' Id. at 224.
Respondent had more than two months' notice of the Government's
proposed parameters for Dr. Munzing's testimony. Id.; see also
Government Prehearing Statement (November 16, 2022), at 5-6.
Accordingly, this notice and Respondent's ``no objection'' responses to
the ALJ about the Government's proffering Dr. Munzing as its expert
foreclose Respondent's subsequent, closing argument challenges to Dr.
Munzing's expert qualifications. They further foreclose Respondent's
closing argument assertions that, ``Dr. Munzing's opinion about the
California standard of care is unreliable,'' including that Dr. Munzing
``rambled'' and testified to best practices, not necessarily to the
applicable standard of care.\26\ Id. at 667. The Agency, as already
discussed, finds that the testimony of Dr. Munzing, on which this
Decision is based, is fully consistent with the applicable standard of
care; it is not ``rambling'' and it does not confuse the Agency as to
the difference between the applicable standard of care and matters that
are not incumbent on registrants, like Respondent, to follow. Supra
sections II and III.C.1, infra section IV.B; see also RD, at n.10.
Accordingly, the Agency does not credit the ``rambling'' and ``best
practices'' criticisms that Respondent levels against Dr. Munzing's
expert testimony.
---------------------------------------------------------------------------
\26\ In this portion of Respondent's closing argument,
Respondent's Counsel states: ``Fourth, Dr. Munzing's opinion about
the California standard of care is unreliable. During his testimony,
it was not clear when something he was opining on was what he viewed
as a best practice or something that actually fell below the
standard of care. As Your Honor knows, there is a wide range of
conduct that falls within the standard of care. Revocation is only
appropriate if his practices fell outside the balance of legitimate
medical practice and outside the ordinary course of professional
practice. Dr. Munzing's opinions were not focused on that narrow
issue, were often rambling, and did not reliably establish a
violation of the standard of care. In fact, at times, when the Court
posed direct questions to Dr. Munzing about the standard of care, he
was evasive and did not directly answer the questions.'' Tr. 667.
---------------------------------------------------------------------------
The Agency does not credit Respondent's closing argument and
statements during Dr. Munzing's testimony criticizing Dr. Munzing
because he never examined, interviewed, or otherwise interacted with
any of the individuals who saw Respondent and whose medical records are
referenced in the OSC. E.g., Tr. 312-13 (Dr. Munzing testifying that he
did not speak to anybody whose medical records by Respondent he
reviewed), id. at 592-93 (Dr. Munzing testifying that he reviewed the
materials about the five individuals referenced in the OSC), id. at 311
(Respondent's Counsel stating that Dr. Munzing ``acts as though, and
testifies as such, that he knows what happened at this examination and
that just simply is not true unless he has interviewed someone or is
looking at other notes'' and that Dr. Munzing ``is saying that these
things never happened. And I do not believe there is a basis for that
in the record nor do I believe he has a basis to make such a
statement.''), id. at 666-67 (Respondent's Counsel arguing that Dr.
Munzing's testimony ``lacks foundation'' because he does not know how
Respondent ``actually examined his patients,'' ``[h]e has never
examined these patients nor has he or anyone else from the DEA ever
attempted to speak to them''), id. at 678 (Respondent's Counsel arguing
that ``notably, Dr. Munzing never testified that the course of
treatment for these patients was inappropriate in any way. He merely
testified that it was not adequately documented.''); id. at 311-12 (ALJ
overruling Respondent's objection, stating that, ``[t]he point is well
taken . . . I would like precision here. I will note that there is
agency case law that says if it is not in a document, then it did not
happen. . . . [W]hat he [Dr. Munzing] is saying is his reading of the .
. . records, that is not documented anywhere in these notes and that
should be documented in these notes,'' but interrupted by Respondent's
Counsel stating that, ``I fully accept that, Your Honor'').
As already discussed in the standard of care section, the Agency
finds that Dr. Munzing's testimony accurately conveys and applies the
applicable standard of care to the record evidence he was asked to
address. Supra section II. Accordingly, Dr. Munzing's credible
testimony informs this Decision's finding that the Government
established a prima facie case and that Respondent did not successfully
rebut it.\27\ Supra
[[Page 9251]]
sections II., III.A., and III.C.1; see also RD, at 7-14.
---------------------------------------------------------------------------
\27\ The Agency notes that Respondent's oral closing argument
cites only three specific exhibit references: GX 3b, at 161 and 163
and GX 3b, at 129. Tr. 658-84. Respondent claims that these
documents date back to 2012 and 2013 to 2015, respectively. Id. at
670. While the Agency confirms that GX 3b, at 161 and 163 concern
matters dating from 2012, there is no visible date on the page at GX
3b, at 129. Further, according to Respondent's closing argument, GX
3b, at 161 and 163 show that Individual 2 ``first came to see . . .
[Respondent] in 2012 and at that time, Individual 2 was already on
opioid medications from another doctor.'' Id. The Agency confirms
Respondent's statement only to the extent that GX 3b, at 161 is a
page showing 2012 CURES data, indicating that Individual 2 filled
oxycodone HCl 30 mg and apap/oxycodone 325 mg-10 mg prescriptions on
April 15, 2012 and August 18, 2012, respectively, issued by a
physician other than Respondent. The Agency also confirms that GX
3b, at 163, consisting of CURES data, indicates that Individual 2
filled oxycodone hydrochloride 30 mg prescriptions on August 1, 2012
and August 29, 2012 issued by the same other physician. Regarding GX
3b, at 129, Respondent's closing argument states that the page
``shows that there is a significant gap in medical records for
[Individual 2], and that's because . . . [Individual 2] was not
receiving opioids during that time.'' Id. The Agency does not agree
with Respondent's representation of GX 3b, at 129. GX 3b, at 129 is
an undated LabCorp form with Individual 2's name and check marks
next to comprehensive metabolic panel and CBC blood tests. There is
no legible reference to an opioid on the page. GX 3b, at 129.
The third specific exhibit that Respondent references during
his closing argument is GX 2a, at 136, concerning Individual 1. Tr.
663. According to Respondent's closing argument, it is ``not true''
that Respondent did not attempt to reduce controlled substance use
by utilizing safer alternatives.'' Id. Instead, Respondent
``attempted to taper the patients down and in some cases, he was
successful in doing so.'' Id. It is immediately after these words
that the closing argument references GX 2a, at 136, stating that
this page ``shows [Individual 1's] previous doctor prescribed the
trinity combination to him. . . . [Respondent] did not do so. He
prescribed oxycodone HCl and oxycodone.'' Id.
The Agency examined GX 2a, at 136. The page is a ``consolidated
report'' from CURES. It shows that Individual 1 filled controlled
substance prescriptions issued by three doctors, the most recent
being Respondent, from October 16, 2018 to April 20, 2019. There are
two prescriptions that Individual 1 filled immediately before
Respondent started prescribing for Individual 1 on March 14, 2019:
oxycodone HCl 30 mg, 120 tablets for a fifteen day supply, and
oxycodone HCl 80 mg, 45 tablets, also for a fifteen day supply. GX
2a, at 136. There is no indication on GX 2a, at 136 that this
physician ``prescribed the trinity combination'' to Individual 1.
Id.
Further, the exhibit does not show that Respondent ``attempted
to taper'' Individual 1 ``down and . . . was successful in doing
so.'' Id. Instead, it shows the opposite. The page shows that
Individual 1 filled four controlled substance prescriptions issued
by Respondent: on March 20, 2019, Individual 1 filled a controlled
substance prescription issued by Respondent for oxycodone HCl 80 mg,
240 tablets for a thirty-day supply; on March 28, 2019, Individual 1
filled a controlled substance prescription issued by Respondent for
oxycodone HCl 30 mg, 240 tablets for a thirty-day supply; and again,
on April 18, 2019, Individual 1 filled a controlled substance
prescription issued by Respondent for oxycodone HCl 80 mg, 240
tablets for a thirty-day supply; and on April 20, 2018, Individual 1
filled a controlled substance prescription issued by Respondent for
oxycodone HCl 30 mg, 240 tablets for a thirty-day supply. Id.
Accordingly, based on the face of GX 2a, at 136, the Agency
disagrees with Respondent's characterization of it. Id. The Agency
finds that GX 2a, at 136 shows that Respondent continued the prior
physician's prescribing of oxycodone HCl 30 mg, although Respondent
extended the prescribing from a fifteen-day supply to a thirty-day
supply, thus making twice the number of tablets available to
Individual 1 upon the filling of one prescription. Id. As for the
oxycodone HCl 80 mg prescribing, while the Agency also finds that
Respondent extended this prescribing for Individual 1 from a
fifteen-day to a thirty-day supply, the Agency further finds that
Respondent tripled the dosage, from three tablets a day (forty-five
tablets for a fifteen-day supply) to eight tablets a day (two
hundred forty tablets for a thirty-day supply). Id. Since the data
appearing on GX 2a, at 136 are from a period that is outside the
period alleged in the OSC, however, this Decision's finding that the
Government established a prima facie case and that Respondent did
not successfully rebut it are not based on those data.
Further, despite Respondent's argument that the ``voluminous''
number of his medical records shows that ``there is no doubt that .
. . [Respondent] was carefully treating people,'' the Agency finds
that there is no necessary correlation between the number of pages
in a medical record and the medical record's compliance with legal
standards. Supra sections II. and III.C.1., infra section IV.B.
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Respondent criticizes Dr. Munzing's consulting work, including his
work for United States law enforcement, stating that it compromises the
independence Dr. Munzing needs to be a credible witness in this
adjudication. See, e.g., Tr. 514-17, 563-74. Further, Respondent, based
on Dr. Munzing's curriculum vitae, GX 7, criticizes Dr. Munzing for
lecturing about ``collaborating'' with law enforcement, suggesting that
it shows ``inappropriate collaboration'' with law enforcement. GX 7, at
13; e.g., Tr. 514-17. The Agency considered these criticisms of Dr.
Munzing's independence and does not credit them for multiple reasons,
namely because the Agency finds that Dr. Munzing's standard-of-care
testimony conforms to the applicable standard of care and Dr. Munzing
credibly and consistently applied the standard of care to the facts in
this case. Supra section II; see also RD, at 7-9.
Similarly, Respondent asked Dr. Munzing about whether he had
foreknowledge of the search warrant, including whether he had a role in
drafting the search warrant for Respondent's medical records, about
whether he was involved in the Government's deployment of undercover
officers during its investigation of Respondent, and about financial
aspects of his service as a medical consultant to law enforcement,
including insinuating financial irregularities by Dr. Munzing.\28\
E.g., Tr. 575-92, 611-14. Although Respondent was given the opportunity
and tried, the Agency finds that he did not successfully articulate the
relevance of these questions. Even if he had been successful, Dr.
Munzing's credible and consistent testimony is that he played no role
in the search warrant drafting, that he did not see the search warrant
affidavit before the September 2021 search took place, that he would
not typically discuss whether to send undercover officers into a
registrant's office, and that he ``does not believe'' that he discussed
sending undercover officers into Respondent's office before the
investigators took that action.\29\ Id. at 521-22, 517.
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\28\ As for Respondent's questions about the financial
arrangements associated with Dr. Munzing's consulting work, the
Agency finds that Respondent merely insinuated financial
irregularities; he did not offer any evidence, let alone proof, of
them.
\29\ The Agency agrees with the ALJ that the pending criminal
investigation matters that Respondent raised are not relevant to
this administrative adjudication. E.g., Tr. 518-20 (Respondent
arguing that Respondent's physical examinations of undercover
officers are relevant and the ALJ responding that ``they have at
best nominal relevance''); see also id. at 615 (Respondent's Counsel
stating that the existence of an ``independent criminal
investigation'' is the reason for Respondent's decision not to ``put
on a case'' to defend himself against the OSC).
---------------------------------------------------------------------------
Further, as already discussed, the Agency finds that Dr. Munzing's
testimony accurately states the applicable standard of care, and
accurately applies that standard of care to the record evidence that he
was asked to address and that forms the bases of this Decision's
findings of fact and conclusions of law. See also RD, at 8-10.
c. Respondent's Arguments Concerning DEA's Investigation
Respondent also challenges the process used during the Government's
investigation of him and the ensuing issuance of the OSC. E.g., Tr.
525-30. For example, Respondent argues that DEA issued the OSC before
it possessed all of Respondent's medical records and, therefore,
Respondent posits, before it had a basis to allege that Respondent's
controlled substance prescribing violates the applicable standard of
care. E.g., id. at 620-25 (Respondent arguing that DEA's search warrant
affidavit falsely states that the search warrant is necessary because
Respondent's medical practice is ``illegitimate'' when DEA did not
possess all of the records needed to reach such a conclusion). The
Agency finds that the questions Respondent raises about DEA's
investigation of his practice are not creditable. The Agency certainly
understands that Respondent would have preferred for DEA to have
possessed all of Respondent's medical records at once, for DEA to have
assessed that Respondent's medical recordkeeping improved after he
became aware of DEA's investigation of his practice, and for the Agency
not to have suspended Respondent's registration due to Respondent's
improved recordkeeping.\30\ The Agency disagrees, though, as it
recently reasserted. Morris & Dickson Co., LLC, 88 FR 34,523, 34,539-40
(2023) (``[T]he Agency has also made it abundantly clear that
remediation alone is not adequate to avoid a sanction and that limited-
to-no-weight is given to remedial measures when the effort is not made
until after enforcement begins. See Mireille Lalanne, M.D., 78 FR
47,750, 47,777 (2013) (quoting Liddy's Pharmacy, L.L.C., 76 FR 48,887,
48,897 (2011) (``The Agency has recognized that a cessation of illegal
behavior only when `DEA comes knocking at one's door,' can be afforded
a diminished weight borne of its own opportunistic timing.'')); see
also Southwood Pharm. Inc., 72 FR at 36,503 (giving no weight to
respondent's `stroke-of-midnight decision' to cease supplying suspect
pharmacies with controlled substances
[[Page 9252]]
and to employ a compliance officer''); infra section V.\31\
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\30\ The Agency is not saying that an OSC is inappropriate if a
registrant shows improvement in medical record keeping.
In this matter, as Dr. Munzing testified, Respondent's medical
record keeping improved, but the Agency does not find substantial
record evidence that Respondent's controlled substance prescribing
conforms to the applicable standard of care. Tr. 537-38 (Dr. Munzing
testifying).
\31\ Improved medical recordkeeping is insufficient to resolve
all of the OSC's allegations.
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After carefully reviewing the record, the Agency concludes that
Respondent's arguments and defenses are not creditable, and do not
successfully rebut the Government's case.
IV. Discussion
A. The Controlled Substances Act
Pursuant to the CSA, ``[a] registration . . . to . . . distribute[
] or 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 by such
section.'' 21 U.S.C. 824(a)(4). In the case of a ``practitioner,''
Congress directed the Attorney General to consider five factors in
making the public interest determination. 21 U.S.C. 823(g)(1)(A-E).\32\
The five factors are considered in the disjunctive. Gonzales v. Oregon,
546 U.S. 243, 292-93 (2006) (Scalia, J., dissenting) (``It is well
established that these factors are to be considered in the
disjunctive,'' citing In re Arora, 60 FR 4447, 4448 (1995)); Robert A.
Leslie, M.D., 68 FR 15,227, 15,230 (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. Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C.
Cir. 2007); Morall, 412 F.3d. at 185 n.2; David H. Gillis, M.D., 58 FR
37,507, 37,508 (1993).
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\32\ The five factors of 21 U.S.C. 823(g)(1)(A-E) are:
(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.
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According to DEA regulations, ``[a]t any hearing for the revocation
. . . of a registration, the . . . [Government] shall have the burden
of proving that the requirements for such revocation . . . pursuant to
. . . 21 U.S.C. [Sec. ] 824(a) . . . are satisfied.'' 21 CFR
1301.44(e); see also Morall, 412 F.3d. at 174.
In this matter, while all of the 21 U.S.C. 823(g)(1) factors have
been considered, the Agency finds that the Government's evidence in
support of its prima facie public interest revocation case is confined
to factors B and D.\33\ Government's Proposed Findings of Fact and
Conclusions of Law, at 19-28; see also RD, at 35-40.
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\33\ Neither Respondent nor the Government argues that he/it
offered evidence relevant to Factors A, C, or E. Although the Agency
considered Factors A, C, and E, it finds that they are not relevant
to this adjudication. Accord RD, at 16.
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B. Unlawful Prescribing and Public Interest Analysis
Factors B and/or D--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
According to the CSA's implementing regulations, a lawful
prescription for controlled substances is one that is ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a); see
Gonzales v. Oregon, supra, 546 U.S. at 274, United States v. Hayes, 595
F.2d 258 (5th Cir. 1979), rehearing den., 598 F.2d 620 (5th Cir. 1979),
cert. denied, 444 U.S. 866 (1979). Applicable California law, similar
to applicable federal law, provides that ``prescriptions 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. 11153(a);
OSC, at 2; supra section II. Applicable California law also provides
that it is unprofessional conduct to prescribe a controlled substance,
or other ``dangerous drug,'' ``without an appropriate prior examination
and a medical indication.'' Cal. Bus. & Prof. Code Sec. 2242(a); OSC,
at 2; supra section II. Further, California law states that
``unprofessional conduct'' by a physician includes the physician's
``failure . . . to maintain adequate and accurate records relating to
the provision of services.'' Cal. Bus. & Prof. Code Sec. 2266; OSC, at
2; supra section II.
As already noted, there is substantial, uncontroverted record
evidence of violations of applicable law. Supra sections II and
III.C.1. Those violations go to the heart of this Agency's law
enforcement mission.
Having thoroughly analyzed the record evidence and applicable law,
the Agency finds substantial, uncontroverted record evidence that
Respondent issued multiple controlled substance prescriptions without,
for example, having conducted an appropriate prior examination and
establishing a medical indication, and that Respondent did not maintain
adequate and accurate records, or maintained no records at all,
relating to his controlled substance prescribing. Supra sections II and
III.C.1; e.g. Tr. 296-324, 355-58, 374-80, 420-27, 490-91, 473-75.\34\
In addition, as already discussed, the Agency finds that Respondent's
case, including his arguments, three admitted exhibits, and challenges
to the Government's evidence, does not rebut this substantial record
evidence. Supra sections III.B. and III.C.2. Accordingly, the Agency
concludes that Respondent issued multiple controlled substance
prescriptions other than for a legitimate medical purpose while acting
in the usual course of professional practice, prescribed controlled
substances without an appropriate prior examination and a medical
indication, and failed to maintain adequate and accurate records
relating to the provision of services, thus committing multiple
violations of California law and, therefore, of federal law. Cal.
Health & Safety Code Sec. 11153(a), Cal. Bus. & Prof. Code Sec.
2242(a), Cal. Bus. & Prof. Code Sec. 2266, 21 CFR 1306.04(a); supra
sections II and III.C.1; see also RD, at 7-10, 14-15, 20-21, 24-26, 28-
29. Substantial record evidence of any one of the founded violations is
sufficient for the Agency to revoke Respondent's registration.
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\34\ Indeed, Respondent admitted maintaining inadequate medical
records. Supra n.11 (Respondent ``concedes that there were issues
with his recordkeeping but argues that he did in fact conduct
appropriate medical evaluation [sic], testing, and monitoring to
justify the high dosages of controlled substances that he
prescribed.'') This admission does not constitute an unequivocal
acceptance of responsibility. Infra section V.
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In sum, the Agency finds substantial record evidence that the
Government established a prima facie case that Respondent violated
federal and state law. Accordingly, the Agency finds that the
Government established a prima facie case, that Respondent did not
successfully rebut that prima facie case, and that there is substantial
record evidence supporting the revocation of Respondent's registration.
21 U.S.C. 824(a)(4) and 823(g)(1)(B) and (D).\35\
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\35\ Given the egregiousness and number of these violations,
violations that go to the core of the Controlled Substances Act's
purpose to ``conquer drug abuse and to control the legitimate and
illegitimate traffic in controlled substances,'' the Agency is
adjudicating only the OSC allegations of issuing controlled
substance prescriptions beneath the applicable standard of care and
outside the usual course of professional practice, and is not
reaching the other OSC allegations. Gonzales v. Oregon, 546 U.S.
243, 269 (2006). While the Agency is adjudicating a subset of the
OSC's allegations, each of them, alone, is sufficient to support
revocation of Respondent's registration.
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[[Page 9253]]
V. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Respondent's continued registration is inconsistent with
the public interest due to its numerous violations pertaining to
controlled substances, the burden shifts to Respondent to show why it
can be entrusted with a registration. Morall, 412 F.3d. at 174; Jones
Total Health Care Pharmacy, 881 F.3d at 830; Garrett Howard Smith,
M.D., 83 FR 18882 (2018). The issue of trust is necessarily a fact-
dependent determination based on the circumstances presented by the
individual respondent. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019);
see also Jones Total Health Care Pharmacy, 881 F.3d at 833. Moreover,
as past performance is the best predictor of future performance, DEA
Administrators have required that a registrant who has committed acts
inconsistent with the public interest must accept responsibility for
those acts and demonstrate that it will not engage in future
misconduct. Jones Total Health Care Pharmacy, 881 F.3d at 833 (citing
authority including Alra Labs., Inc. v. Drug Enf't Admin., 54 F.3d 450,
452 (7th Cir. 1995) (``An agency rationally may conclude that past
performance is the best predictor of future performance.''). ``[T]hat
consideration is vital to whether continued registration is in the
public interest.'' MacKay v. Drug Enf't Admin., 664 F.3d 808, 820 (10th
Cir. 2011). A registrant's acceptance of responsibility must be
unequivocal. Jones Total Health Care Pharmacy, 881 F.3d at 830-31. In
addition, a registrant's candor during the investigation and hearing
has been an important factor in determining acceptance of
responsibility and the appropriate sanction. Id. Further, DEA
Administrators have found that the egregiousness and extent of the
misconduct are significant factors in determining the appropriate
sanction. Id. at 834 and n.4. DEA Administrators have also considered
the need to deter similar acts by the respondent and by the community
of registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Regarding these matters, Respondent did not testify, and there is
no indication in the record that Respondent takes responsibility, let
alone unequivocal responsibility, for the founded, egregious violations
involving his controlled substance prescribing.\36\ Supra sections II,
III.C, and IV; cf. Osmin A. Morales, 88 FR 75,309, 75,311-12. Instead,
Respondent's case consists of one baseless or irrelevant argument after
another, often seemingly to deflect attention away from his unlawful
controlled substance prescribing. E.g. Tr. 672-73 (Respondent's closing
argument statements that he used CURES to ``check[ ]'' whether a
patient is ``taking medications . . . prescribed to him'' and that the
``dozens, if not hundreds of these CURES printouts'' show that
Respondent ``was carefully monitoring the medication that the patients
were taking and carefully issuing prescriptions and making sure
patients were taking the drugs at the right time and in the correct
quantities''); \37\ RD, at 37 (``Despite Respondent's efforts at
misdirection, the evidence is overwhelming that Respondent prescribed
high-dosage opioids . . . and other powerful controlled substances,
without a medical diagnosis to justify the prescription--there was,
inter alia, no meaningful medical or mental health history taken, no
adequate physical examination conducted, and no pain management plan
recorded.'').
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\36\ Respondent's admitting ``issues with his recordkeeping'' is
not accepting responsibility, let alone unequivocally accepting
responsibility. Supra n.34.
\37\ CURES only shows that a controlled substance prescription
was filled. It does not show what then happened to the pills in that
filled controlled substance prescription.
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The interests of specific and general deterrence weigh in favor of
revocation. Respondent has not convinced the Agency that he understands
that his controlled substance prescribing fell short of the applicable
standard of care, and that substandard controlled substance prescribing
has serious negative ramifications for the health, safety, and medical
care of individuals who come to him for medical treatment. See, e.g.,
Garrett Howard Smith, M.D., 83 FR at 18910 (collecting cases) (``The
egregiousness and extent of the misconduct are significant factors in
determining the appropriate sanction.''). As such, it is not reasonable
to believe that Respondent's future controlled substance prescribing
will comply with legal requirements. Indeed, Respondent's own actions
suggest that he has no intention of complying fully with the CSA and
the California standard of care in the future. Tr. 537-38 (Respondent
inexplicably suggesting that he ``did nothing wrong'' after his medical
records improved).
Further, given the foundational nature and vast number of
Respondent's violations, a sanction less than revocation would send a
message to the existing and prospective registrant community that
compliance with the law is not a condition precedent to maintaining a
registration.
Accordingly, the Agency 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. 824(a)(4), I hereby revoke DEA registration No. BB4591839 issued
to David Bockoff, 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 application of David Bockoff, M.D., for a DEA Registration in
California. This Order is effective March 12, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
February 3, 2025, by Acting Administrator Derek Maltz. That document
with the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-02421 Filed 2-7-25; 8:45 am]
BILLING CODE 4410-09-P