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[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).
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    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.'').
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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
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